TY - JOUR AU - Le Dű, Katell AU - Chauchet, Adrien AU - Sadot-Lebouvier, Sophie AU - Fitoussi, Olivier AU - Fontanet, Bijou AU - Saint-Lezer, Arnaud AU - Maloisel, Frédéric AU - Rossi, Cédric AU - Carras, Sylvain AU - Parcelier, Anne AU - Balavoine, Magali AU - Septans, Anne-Lise PY - 2025/5/6 TI - Comparison of Electronic Surveillance With Routine Monitoring for Patients With Lymphoma at High Risk of Relapse: Prospective Randomized Controlled Phase 3 Trial (Sentinel Lymphoma) JO - JMIR Cancer SP - e65960 VL - 11 KW - patient-reported outcome measures KW - lymphoma KW - risk of relapse KW - relapse KW - randomized trial KW - web-based KW - quality of life KW - survival KW - detection KW - progression KW - T-cell lymphoma KW - Hodgkin lymphoma N2 - Background: Relapse is a major event in patients with lymphoma. Therefore, early detection may have an impact on quality of life and overall survival. Patient-reported outcome measures have demonstrated clinical benefits for patients with lung cancer; however, evidence is lacking in patients with lymphoma. We evaluated the effect of a web-mediated follow-up application for patients with lymphoma at high risk of relapse. Objective: This study aims to demonstrate that monitoring patients via a web application enables the detection of at least 30% more significant events occurring between 2 systematic follow-up consultations with the specialist using an electronic questionnaire. Methods: We conducted a prospective, randomized phase 3 trial comparing the impact of web-based follow-up (experimental arm) with a standard follow-up (control arm). The trial was based on a 2-step triangular test and was designed to have a power of 90% to detect a 30% improvement in the detection of significant events. A significant event was defined as a relapse, progression, or a serious adverse event. The study covered the follow-up period after completion of first-line treatment or relapse (24 months). Eligible patients were aged 18 years and older and had lymphoma at a high risk of relapse. In the experimental arm, patients received a 16-symptom questionnaire by email every 2 weeks. An email alert was sent to the medical team based on a predefined algorithm. The primary objective was assessed after the inclusion of the 40th patient. The study was continued for the duration of the analysis. Results: A total of 52 patients were included between July 12, 2017, and April 7, 2020, at 11 centers in France, with 27 in the experimental arm and 25 in the control arm. The median follow-up was 21.3 (range 1.3?25.6) months, and 121 events were reported during the study period. Most events occurred in the experimental arm (83/119, 69.7%) compared with 30.2% (36/119) in the control arm. A median number of 3.5 (range 1-8) events per patient occurred in the experimental arm, and 1.8 (range 1-6) occurred in the control arm (P=.01). Progression and infection were the most frequently reported events. Further, 19 patients relapsed during follow-up: 6 in the experimental arm and 13 in the control arm (P<.001), with a median follow-up of 7.7 (range 2.8?20.6) months and 6.7 (range 1.9?16.4) months (P=.94), respectively. Statistical analysis was conducted after including the 40th patient, which showed no superiority of the experimental arm over the control arm. The study was therefore stopped after the 52nd patient was enrolled. Conclusions: The primary objective was not reached; however, patient-reported outcome measures remain essential for detecting adverse events in patients with cancer, and the electronic monitoring method needs to demonstrate its effectiveness and comply with international safety guidelines. Trial Registration: ClinicalTrials.gov NCT03154710; https://clinicaltrials.gov/ct2/show/NCT03154710 UR - https://cancer.jmir.org/2025/1/e65960 UR - http://dx.doi.org/10.2196/65960 ID - info:doi/10.2196/65960 ER - TY - JOUR AU - Bennetot, Adrien AU - Zia Ur Rehman, Rana AU - Romijnders, Robbin AU - Li, Zhi AU - Macrae, Victoria AU - Davies, Kristen AU - Ng, Wan-Fai AU - Maetzler, Walter AU - Kudelka, Jennifer AU - Hildesheim, Hanna AU - Emmert, Kirsten AU - Paulides, Emma AU - van der Woude, Janneke C. AU - Reilmann, Ralf AU - Aufenberg, Svenja AU - Chatterjee, Meenakshi AU - Manyakov, V. Nikolay AU - Pinaud, Clémence AU - Avey, Stefan PY - 2025/5/5 TI - Characterizing Patient-Reported Fatigue Using Electronic Diaries in Neurodegenerative and Immune-Mediated Inflammatory Diseases: Observational Study JO - JMIR Form Res SP - e65879 VL - 9 KW - chronic disease KW - fatigue KW - neurodegenerative diseases KW - immune-mediated inflammatory diseases KW - diary, patient-reported outcomes KW - electronic diaries KW - digital technologies KW - digital health KW - eHealth KW - mobile phone N2 - Background: Fatigue is a prevalent and debilitating symptom in many chronic conditions, including immune-mediated inflammatory diseases (IMIDs) and neurodegenerative diseases (NDDs). Fatigue often fluctuates significantly within and between days, yet traditional patient-reported outcomes (PROs) typically rely on recall periods of a week or more, potentially missing these short-term variations. The development of digital tools, such as electronic diaries (eDiaries), offers a unique opportunity to collect granular, real-time data. However, the feasibility, adherence, and comparability of eDiary-based assessments to established PROs require further investigation. Objective: This study aimed to evaluate the feasibility and acceptability of using a high-frequency eDiary to capture intraday variability in fatigue and to compare eDiary data with scores obtained from the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), a validated weekly recall PRO. Methods: Data were collected from 159 participants enrolled in the IDEA-FAST (Identifying Digital Endpoints to Assess Fatigue, Sleep and Activities in Daily Living in Neurodegenerative Disorders and Immune-Mediated Inflammatory Diseases) feasibility study; a 4-week prospective observational study conducted at 4 European centers. Participants included individuals with NDDs (n=39), IMIDs (n=78), and healthy volunteers (n=42). Participants used an eDiary to report their physical and mental fatigue levels up to 4 times daily on a 7-point Likert scale (0=low and 6=high). Adherence was calculated as the proportion of completed eDiary entries relative to the total expected entries. Correlations between averaged eDiary scores and weekly FACIT-F scores were analyzed. Results: Adherence to the eDiary protocol was 5505/8880 (61.99%) overall, varying by cohort, with the highest adherence (1117/1200, 93.07%) observed in the primary Sjögren syndrome cohort and the lowest adherence in the Parkinson disease (410/960, 42.7%) and Huntington disease (320/720, 44.4%) cohorts. The average adherence was 430/1680 (43.45%) in the NDD cohorts and 3367/4560 (73.84%) in the IMID cohorts. Fatigue levels showed clear diurnal variation, with significantly higher fatigue reported in the evening compared to the morning (P<.001). A moderate correlation (Spearman=0.46, P<.001) was observed between eDiary fatigue scores and FACIT-F scores, with stronger cohort-specific associations for certain FACIT-F items. These results indicate that eDiaries provide complementary insights to weekly PROs by capturing intraday fluctuations in fatigue. Conclusions: This study demonstrates the feasibility, acceptability, and validity of using high-frequency eDiaries to assess fatigue in chronic conditions. By effectively detecting intra- and interday fatigue variations, eDiaries complement traditional PROs such as FACIT-F, offering a more nuanced understanding of fatigue patterns. Future research should explore optimized eDiary protocols to balance participant burden with data granularity. UR - https://formative.jmir.org/2025/1/e65879 UR - http://dx.doi.org/10.2196/65879 ID - info:doi/10.2196/65879 ER - TY - JOUR AU - Sasseville, Maxime AU - Supper, Wilfried AU - Gartner, Jean-Baptiste AU - Layani, Géraldine AU - Amil, Samira AU - Sheffield, Peter AU - Gagnon, Marie-Pierre AU - Hudon, Catherine AU - Lambert, Sylvie AU - Attisso, Eugčne AU - Ouellet, Steven AU - Breton, Mylaine AU - Poitras, Marie-Eve AU - Roux-Lévy, Pierre-Henri AU - Plaisimond, James AU - Bergeron, Frédéric AU - Ashcroft, Rachelle AU - Wong, T. Sabrina AU - Groulx, Antoine AU - Paquette, Jean-Sébastien AU - D'Anjou, Natasha AU - Langlois, Sylviane AU - LeBlanc, Annie PY - 2025/5/5 TI - Electronic Implementation of Patient-Reported Outcome Measures in Primary Health Care: Mixed Methods Systematic Review JO - J Med Internet Res SP - e63639 VL - 27 KW - patient-reported outcomes measures KW - digital health KW - implementation science KW - systematic review KW - PRISMA N2 - Background: Managing chronic diseases remains a critical challenge in primary health care (PHC) across the Organization for Economic Co-operation and Development countries. Electronic patient-reported outcome measures (ePROMs) are emerging as valuable tools for enhancing patient engagement, facilitating clinical decision-making, and improving health outcomes. However, their implementation in PHC remains limited, with significant variability in effectiveness and adoption. Objective: This systematic review aimed to assess the implementation and effectiveness of ePROMs in chronic disease management within PHC settings and to identify key barriers and facilitators influencing their integration. Methods: A mixed methods systematic review was conducted following the Cochrane Methods and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. We included studies that implemented ePROMs among adults for chronic disease management in PHC. The extracted data included patient health outcomes, provider workflow implications, implementation factors, and cost considerations. The reach, effectiveness, adoption, implementation, and maintenance framework was used. Results: Our search yielded 12,525 references, from which 22 (0.18%) studies were included after screening and exclusions. These studies, primarily conducted in the United States (n=9, 41%) and Canada (n=8, 36%), covered various chronic diseases and used diverse ePROM tools, predominantly mobile apps (n=9, 41%). While some studies (n=10, 45%) reported improvements in patient health outcomes and self-management, others (n=12, 55%) indicated no significant change. Key barriers included digital literacy gaps, integration challenges within clinical workflows, and increased provider workload. Facilitators included strong patient-provider relationships, personalized interventions, and technical support for users. While some studies (n=10, 45%) demonstrated improved patient engagement and self-management, long-term cost-effectiveness and sustainability remain uncertain. Conclusions: Success in implementing ePROMs in PHC appears to hinge on addressing digital literacy, ensuring personalization and meaningful patient-provider interactions, carefully integrating technology into clinical workflows, and conducting thorough research on their long-term impacts and cost-effectiveness. Future efforts should focus on these areas to fully realize the benefits of digital health technologies for patients, providers, and health care systems. Trial Registration: PROSPERO CRD42022333513; https://www.crd.york.ac.uk/PROSPERO/view/CRD42022333513 International Registered Report Identifier (IRRID): RR2-10.2196/48155 UR - https://www.jmir.org/2025/1/e63639 UR - http://dx.doi.org/10.2196/63639 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/63639 ER - TY - JOUR AU - Haun, N. Jolie AU - Fowler, A. Christopher AU - French, D. Dustin AU - McHugh, C. Megan AU - Heuer, N. Jacquelyn AU - Ballistrea, M. Lisa AU - Benzinger, C. Rachel AU - Klanchar, Angel S. AU - Sandbrink, Friedhelm AU - Murphy, L. Jennifer PY - 2025/5/5 TI - Characterization and Evaluation of Department of Veterans Affairs Commission on Accreditation of Rehabilitation Facilities?Accredited Interdisciplinary Pain Rehabilitation Programs: Protocol for a Mixed Methods Program Evaluation JO - JMIR Res Protoc SP - e72091 VL - 14 KW - chronic pain KW - veterans KW - interdisciplinary KW - pain program KW - pain rehabilitation KW - pain management KW - multidisciplinary N2 - Background: Veterans are more likely to experience chronic pain than civilians, with significant negative impacts on long-term health outcomes. Evidence for the effectiveness of prescription opioids for chronic pain management is limited, and chronic use of opioids is associated with an increased risk of sleep-disordered breathing, cardiovascular complications, and bowel dysfunction, as well as opioid misuse and overdose. Veterans Affairs (VA) and Department of Defense guidelines are prioritizing low-risk, evidence-based interdisciplinary pain management strategies while optimizing pain-related outcomes (PRO) for veterans. Commission on Accreditation of Rehabilitation Facilities (CARF)?Accredited VA Interdisciplinary Pain Rehabilitation Programs (IPRPs) have shared characteristics, while maintaining their unique characteristics as individual pain management programs. Though little is known about the characteristics of VA?s IPRPs (eg, staffing, services, and patients served), implementation, and sustainability of these mandated programs. Objective: The goals of our operational partner-driven evaluation are to (1) characterize IPRPs across multiple program factors, including but not limited to, service delivery methods, team composition, program characteristics, services and modalities offered, and patients served; (2) triangulate data to inform data visualization that characterizes and illustrates the IPRPs individually and collectively as a system of care; and (3) identify patient-reported outcomes (PROs) and metrics to measure program effectiveness and determine overlap across IPRPs. Methods: This partnered-driven program evaluation will use a sequential mixed methods prospective design, including interviews and surveys. The Consolidated Framework for Implementation Research (CFIR), Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, and Expert Recommendations for Implementing Change (ERIC) strategies will be used to contextualize qualitative data. Rapid content analysis will be used to iteratively analyze qualitative data, while descriptive statistics will be used to analyze quantitative data. Datasets will be triangulated to support data visualization for partners to inform clinical and operational decision support. Results: As of April 2025, All IPRP sites are engaged, and survey and interview data have been collected and prepared for analysis. The results and deliverables will inform VA CARF-accredited IPRP characterization, evaluation, and implementation as a learning health system. Conclusions: The results of this evaluation will characterize CARF-accredited IPRPs and identify determinants affecting the implementation of this complex intervention, made up of multiple evidence-based practices. Partner-driven data will inform the state of implementation at each site, and quantitative measures will provide options for collecting standardized outcome measures for continued program evaluation. This operational partner-driven evaluation will inform future efforts for quality improvement to improve veterans? pain management outcomes. This protocol informs the use of a mixed methods approach to evaluate a multimodal intervention (ie, IPRP), made up of multiple evidence-based practices to treat a complex comorbid condition. Future work may include data management infrastructure development and cost evaluations to inform clinical and operational decision-making. International Registered Report Identifier (IRRID): DERR1-10.2196/72091 UR - https://www.researchprotocols.org/2025/1/e72091 UR - http://dx.doi.org/10.2196/72091 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/72091 ER - TY - JOUR AU - Zerrouk, Amine AU - Migchels, Charlotte AU - De Ruysscher, Clara AU - Fernandez, Kim AU - Antoine, Jerome AU - De Meyer, Florian AU - Matthys, Frieda AU - van den Brink, Wim AU - Crunelle, Lina Cleo AU - Vanderplasschen, Wouter PY - 2025/4/30 TI - Incorporating Patient-Reported Outcome Measures and Patient-Reported Experience Measures in Addiction Treatment Services in Belgium: Naturalistic, Longitudinal, Multicenter Cohort Study JO - JMIR Form Res SP - e65686 VL - 9 KW - patient-reported outcome measures KW - patient-reported experience measures KW - substance use disorder KW - recovery KW - ICHOM KW - International Consortium for Health Outcomes Measurement KW - addiction KW - PROMs KW - PREMs KW - SUD KW - treatment KW - protocol KW - substance use KW - inpatient KW - services KW - perspectives KW - treatment outcome N2 - Background: Traditionally, treatment outcomes of service users with a substance use disorder (SUD) are measured using objective and provider-reported indicators. In recent years, there has been a shift toward incorporating patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) to capture service users? perspectives on treatment outcomes and experiences. Objective: The OMER-BE (Outcome Measurement and Evaluation as a Routine Practice in Alcohol and Other Drug Services in Belgium) study evaluates the acceptability and feasibility of PROMs and PREMs in different SUD treatment services, using the recently developed International Consortium for Health Outcomes Measurement Standard Set for Addictions. This paper presents the design and baseline characteristics of the study, indicators of attrition at 45-day follow-up, and the feasibility of the implementation of PROMs and PREMs in residential and outpatient services. Methods: A convenience sample of 189 treatment-seeking individuals with SUD from different inpatient (therapeutic communities and psychiatric centers) and outpatient treatment services was followed for six months. Sociodemographic characteristics; clinical factors; and PROMs including recovery strengths, quality of life, and global health were assessed at baseline and within 3 weeks after starting treatment. Additionally, PROMs and PREMs were measured 45, 90, and 180 days later. Comparisons were made between treatment modalities, and indicators of attrition at the 45-day follow-up were assessed using ANOVA and chi-square tests. Results: Baseline differences were observed between the three treatment modalities regarding education, SUD treatment history, primary substance, and Attention-Deficit/Hyperactivity Disorder Self-Report scores. Overall, patients in psychiatric treatment centers had a higher education level and less polysubstance use, while outpatients had fewer previous SUD treatments but received relatively more often opioid agonist treatment. Inpatients reported more attention-deficit/hyperactivity disorder symptoms and higher SUD severity than outpatients. Additionally, recovery strength scores were significantly lower in the outpatient group compared to the other groups, particularly in the subdomains of ?Substance Use,? ?Self-care,? and ?Outlook on Life.? At the 45-day follow-up assessment, the attrition rate was 36.6%. Comparisons between participants who completed the 45-day follow-up and those who dropped out revealed that completers were significantly older, had a higher level of education, were more likely to live alone, and were more likely to have a mother born in Belgium. They also had higher average scores on the ?Material Resources? domain of the Substance Use Recovery Evaluator, which includes questions about stable housing, a steady income, and effective financial management. Conclusions: Evaluating PROMs and PREMs appears to be feasible in a diverse group of treatment-seeking patients with SUD in Belgium. However, challenges remain for structural implementation in practice, especially in outpatient services. Routine monitoring of PROMs and PREMs has the potential to empower patients, service providers, and policy makers by providing a comprehensive understanding of service users? needs and treatment effectiveness. UR - https://formative.jmir.org/2025/1/e65686 UR - http://dx.doi.org/10.2196/65686 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/65686 ER - TY - JOUR AU - Hubel, J. Niclas AU - Vorbach, M. Samuel AU - de Ligt, M. Kelly AU - Rathgeber, S. Ines AU - Beyer, Katharina AU - Wintner, M. Lisa AU - Faller, Barbara AU - Nemec, Jasmin AU - Holzner, Bernhard AU - Sztankay, Monika AU - Lehmann, Jens PY - 2025/4/25 TI - Sustainability and Time Trends in Electronic Patient-Reported Outcome Assessment in Routine Cancer Care: Systematic Scoping Review and Follow-Up Survey JO - J Med Internet Res SP - e69398 VL - 27 KW - patient-reported outcome measures KW - cancer, clinical routine KW - health-related quality of life KW - quality of care KW - mobile applications KW - digital technology N2 - Background: Routine electronic assessment of patient-reported outcomes (ePROs) can improve cancer care; yet, its implementation in routine practice and long-term sustainability remain unclear. Understanding these aspects is critical to advancing the field. Objective: To review and describe the past and current status, time trends, and long-term sustainability of clinical ePRO applications in routine oncology care. Methods: We conducted a systematic review of publications on ePRO use in oncology care up to December 31, 2023, searching PubMed and Web of Science and extracting data on clinical ePRO applications. We included peer-reviewed studies including patients with cancer using ePRO assessments in clinical practice, excluding research letters and conference abstracts. Data from the review were analyzed using descriptive statistics and univariate regression models to evaluate time trends, with year of publication as the predictor. A follow-up survey was sent to authors of published ePRO applications to assess their current use of the application or reasons for discontinuation. Responses from the follow-up survey were analyzed descriptively. Results: For the review, we screened 2933 references, and 303 met inclusion criteria. Results showed that Europe was the most common region (n=141, 46.5%), and study populations consisted mostly of adult patients (n=276, 91.1%) under chemotherapy treatment (n=124, 40.9%) assessed in an outpatient setting (n=261, 86.1%). The EORTC (European Organisation for Research and Treatment of Cancer; n=77, 25.4%) and PRO-CTCAE (Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events) questionnaires (n=65, 21.5%) were most frequently integrated into ePRO applications. In the univariate analysis, we found that publications increased significantly over time (2003-2023, P<.001). Trends showed a rise in mobile app use (odds ratio [OR] 1.211, P<.001), remote assessments (OR 1.094, P=.002), and feedback provided to patients (OR 1.060, P=.04). Of the 303 studies, 221 unique clinical ePRO applications were identified, merging publications at the application level. The follow-up survey had a 35.3% response rate (78/221), with 61.1% of ePRO applications still in use, lasting a median of 5 years. The most common reason for discontinuation was a lack of funding and resources (42.9%, 12/28). Conclusions: The field of ePRO assessment in oncology is rapidly evolving, with a shift toward remote, app-based tools and a growing emphasis on providing feedback to patients. We present, for the first time, data on the sustainability of ePRO use in routine care. While our findings offer valuable insights, they should be interpreted in light of potential response bias in the follow-up survey. Several ePRO applications remain in active use, highlighting potential for long-term integration into clinical practice. However, financial constraints, limited reimbursement models, and challenges with workflow integration continue to hinder broader and more sustainable adoption. Addressing these barriers will be essential to support the continued use of ePROs in clinical care. UR - https://www.jmir.org/2025/1/e69398 UR - http://dx.doi.org/10.2196/69398 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/69398 ER - TY - JOUR AU - Rudin, S. Robert AU - Santacroce, M. Leah AU - Ganguli, Ishani AU - Solomon, H. Daniel PY - 2025/4/21 TI - Tailoring Rheumatoid Arthritis Visit Timing Based on mHealth App Data: Mixed Methods Assessment of Implementation and Usability JO - JMIR Form Res SP - e60854 VL - 9 KW - mobile health KW - patient-reported outcomes KW - visit timing KW - visit frequency KW - rheumatoid arthritis KW - rheumatology N2 - Background: Visits to medical subspecialists are common, with follow-up timing often based on heuristics rather than evidence. Unnecessary visits contribute to long wait times for new patients. Specialists could enhance visit timing and reduce frequency by systematically monitoring patients? symptoms between visits, especially for symptom-driven conditions like rheumatoid arthritis (RA). We previously designed an intervention using a mobile health (mHealth) app to collect patient-reported outcomes (PRO). One of several aims of the app was to assist rheumatologists in determining visit timing for patients with RA. The intervention did not reduce visit frequency. Objective: To explore possible reasons for the lack of association between the intervention and visit frequency, we describe app usage, assess usability, and identify barriers and facilitators for using between-visit PRO data to reduce visits when patients? symptoms are stable. Methods: We analyzed patients? use of the app by reporting adherence (percent of PRO questionnaires completed during the 12-month study) and retention (use in the last month of the study). To examine rheumatologists? experiences, we summarized views of the electronic health record (EHR)?embedded PRO dashboard and EHR inbox messages suggesting early or deferred visits. We assessed app usability using the interactive mHealth App Usability Questionnaire for Ease of Use and Usefulness for patients and the System Usability Scale for rheumatologists. We assessed rheumatologist-level effects of intervention usage using Kruskal-Wallis rank sum and equality of proportion tests. We identified barriers and facilitators through interviews and surveys. Results: The analysis included 150 patients with RA and their 11 rheumatologists. Patients answered a median of 53.3% (IQR 34.1%-69.2%) of PRO questionnaires; this proportion varied by rheumatologist (range 40.7%?67%). Over half of the patients used the app during the final month of the study (56%, range 51%?65%, by rheumatologists); the median number of months of use was 12 (IQR 9-12). Rheumatologists viewed the dashboard 78 times (17.6% of 443 visits) with significant differences in viewing rates by rheumatologist (range 10%?66%; P<.01). There were 108 generated messages sent to rheumatologists suggesting a deferred visit (24.4% of 443 visits) with significant differences in message counts received per visit by rheumatologist (range 10.8%?22.6%; P=.03). Rheumatologists? reported barriers to offering visit deferrals included already scheduling as far out as they were comfortable and rescheduling complexities for staff. Based on 39 patient interviews and 44 surveys, patients reported 2 main barriers to app usage: questionnaire frequency not being tailored to them and reduced motivation after not discussing PRO data with their rheumatologist. A total of 5 interviewed patients received the option to defer their visits, of which 3 elected to defer the appointment and 2 chose to keep it. Conclusions: While an mHealth app for reporting RA PROs was used frequently by patients, using these data to reduce the frequency of unneeded visits was not straightforward. Better engagement of clinicians may improve the use of PRO data. UR - https://formative.jmir.org/2025/1/e60854 UR - http://dx.doi.org/10.2196/60854 ID - info:doi/10.2196/60854 ER - TY - JOUR AU - Wiesmüller, Fabian AU - Prenner, Andreas AU - Ziegl, Andreas AU - El-Moazen, Gihan AU - Modre-Osprian, Robert AU - Baumgartner, Martin AU - Brodmann, Marianne AU - Seinost, Gerald AU - Silbernagel, Günther AU - Schreier, Günter AU - Hayn, Dieter PY - 2025/4/10 TI - Support of Home-Based Structured Walking Training and Prediction of the 6-Minute Walk Test Distance in Patients With Peripheral Arterial Disease Based on Telehealth Data: Prospective Cohort Study JO - JMIR Form Res SP - e65721 VL - 9 KW - mHealth KW - telehealth KW - peripheral arterial disease KW - home-based structured walking training KW - trend estimation KW - predictive modeling KW - continuous data KW - walking KW - walking training KW - prediction KW - prediction model KW - cardiovascular disease KW - stroke KW - heart failure KW - physical fitness KW - telehealth system N2 - Background: Telehealth has been effective in managing cardiovascular diseases like stroke and heart failure and has shown promising results in managing patients with peripheral arterial disease. However, more work is needed to fully understand the effect of telehealth-based predictive modeling on the physical fitness of patients with peripheral arterial disease. Objective: For this work, data from the Keep Pace study were analyzed in depth to gain insights on temporal developments of patients? conditions and to develop models to predict the patients? total walking distance at the study end. This could help to determine patients who are likely to benefit from the telehealth program and to continuously provide estimations to the patients as a motivating factor. Methods: This work analyzes continuous patient-reported telehealth data, in combination with in-clinic data from 19 Fontaine stage II patients with peripheral arterial disease who underwent a 12-week telehealth-based walking program. This analysis granted insights into the increase of the total walking distance of the 6-minute walk tests (6MWT) as a measure for physical fitness, the steady decrease in the patients? pain, and the positive correlation between well-being and the total walking distance measured by the 6MWT. Results: This work analyzed trends of and correlations between continuous patient-generated data. Findings of this study include a significant decrease of the patients? pain sensation over time (P=.006), a low but highly significant correlation between pain sensation and steps taken on the same day (r=?0.11; P<.001) and the walking distance of the independently performed 6MWTs (r=?0.39; P<.001). Despite the reported pain, adherence to the 6MWT measurement protocol was high (85.53%). Additionally, patients significantly improved their timed-up-and-go test times during the study (P=.002). Predicting the total walking distance at the study end measured by the 6MWT worked well at study baseline (root mean squared error of 30 meters; 7.04% of the mean total walking distance at the study end of 425 meters) and continuously improved by adding further telehealth data. Future work should validate these findings in a larger cohort and in a prospective setting based on a clinical outcome. Conclusions: We conclude that the prototypical trend estimation has great potential for an integration in the telehealth system to be used in future work to provide tailored patient-specific advice based on these predictions. Continuous data from the telehealth system grant a deeper insight and a better understanding of the patients? status concerning well-being and level of pain as well as their current physical fitness level and the progress toward reaching set goals. Trial Registration: ClinicalTrials.gov Identifier: NCT05619835; https://tinyurl.com/mrxt7y9u UR - https://formative.jmir.org/2025/1/e65721 UR - http://dx.doi.org/10.2196/65721 ID - info:doi/10.2196/65721 ER - TY - JOUR AU - Cagnacci, Angelo AU - Grandi, Giovanni AU - Capobianco, Giampiero AU - Fulghesu, Maria Anna AU - Morgante, Giuseppe AU - Biondelli, Vincenzo AU - Piccolo, Elena AU - Casolati, Elena AU - Mangrella, Mario PY - 2025/3/31 TI - Effects of a Monophasic Hormonal Contraceptive With Norgestimate+Ethinyl Estradiol on Menstrual Bleeding: Protocol and Design of a Multicenter, Prospective, Open-Label, Noncomparative Study in Italy JO - JMIR Res Protoc SP - e63683 VL - 14 KW - combined oral contraceptive KW - ethinyl estradiol KW - menstrual cycle KW - monophasic KW - norgestimate KW - hormonal contraceptive KW - menstrual health KW - Italy KW - women?s health KW - patient-reported outcomes KW - methodology KW - observational study KW - reproductive health KW - data analysis KW - assessment N2 - Background: Norgestimate (NGM) is a progestin with negligible androgenic activity that is available in combination with ethinyl estradiol (EE) as a monophasic combined oral contraceptive (COC). It has been more than 30 years since a clinical study evaluated the effects of monophasic NGM/EE on menstrual cycle characteristics in healthy women, and in the interim, there has been growing recognition that clinical trials of contraceptives should evaluate a wide range of potential positive and negative impacts for users. Objective: The aim of this study is to investigate menstrual cycle control during the use of a monophasic COC formulation containing NGM 0.25 mg and EE 0.035 mg (Effimia; Italfarmaco SpA), using established methodologies as well as patient-reported outcomes. Methods: This is a prospective observational study being undertaken in a target population of 228 healthy Italian women aged 18-35 years who are starting oral contraception for the first time or switching from another COC. The participants are asked to complete a diary for 6 cycles recording information about their menstrual cycles (frequency, duration, regularity, estimated flow volume, and breakthrough bleeding), any unscheduled bleeding, and an evaluation of dysmenorrhea, using a 100-mm visual analog scale from 0=no pain to 100=very severe pain, and any adverse events. Compliance is assessed after 3 and 6 months via returned medication. The primary end point is the change from baseline in the rate of intermenstrual bleeding during the sixth cycle. At baseline, 3 months, and 6 months, acne will also be assessed using the Global Acne Grading Scale, and participants will complete a Profile of Mood State to assess premenstrual syndrome and the Female Sexual Function Index to evaluate the quality of their sex life. A subgroup of 28 participants at 1 site (Genoa) is also providing a blood sample for the assessment of metabolic, endocrine, and coagulation parameters. Results: Study enrollment began in July 2023 and is expected to be complete by December 2024. Data analysis is expected to be complete by October 2025. Conclusions: This study into the effects of monophasic NGM/EE 0.25/0.035 mg on menstrual characteristics in healthy Italian women will provide up-to-date data on these effects and includes assessments of a range of other parameters, such as acne severity and patient-reported outcomes, in line with recent international consensus recommendations. Trial Registration: ClinicalTrials.gov NCT06067256; https://clinicaltrials.gov/study/NCT06067256 and EudraCT 2021-003027-15; https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-003027-15/IT International Registered Report Identifier (IRRID): DERR1-10.2196/63683 UR - https://www.researchprotocols.org/2025/1/e63683 UR - http://dx.doi.org/10.2196/63683 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/63683 ER - TY - JOUR AU - Hestevik, Hillestad Christine AU - Varsi, Cecilie AU - Řsterĺs, Nina AU - Tveter, Therese Anne AU - Skandsen, Jon AU - Eik, Hedda PY - 2025/3/28 TI - Perspectives on and Experiences With Remote Monitoring and Patient-Initiated Care Among Norwegian Patients With Axial Spondyloarthritis: Qualitative Study JO - J Med Internet Res SP - e63569 VL - 27 KW - remote monitoring KW - patient-initiated care KW - patient-reported outcome measures KW - chronic disease KW - rheumatology KW - axial spondyloarthritis KW - joint disease KW - spine KW - medication KW - therapy KW - rheumatic KW - patient care KW - randomized controlled trial KW - interventions KW - decision-making N2 - Background: Axial spondyloarthritis (axSpA) is a chronic inflammatory joint disease affecting the spine and sacroiliac joints, requiring frequent, lifelong monitoring and treatment. This involves regular symptom monitoring, assessing medication tolerance and side effects, and prompt therapy adjustments. Typically, patients with axSpA attend prescheduled hospital visits, but once stable disease has been attained, these seldom align with periods of high disease activity. Remote monitoring and patient-initiated care offer flexible, need-based, follow-up options. However, knowledge about how patients with axSpA perceive and experience these approaches is limited. To effectively implement these strategies in clinical practice, understanding patient perspectives is crucial. Objective: This study aims to explore how patients with axSpA perceive and experience remote monitoring and patient-initiated care. Methods: Our qualitative study was embedded in a randomized controlled trial. Participants were allocated to either usual care, remote monitoring, or patient-initiated care. The 2 intervention groups had no prescheduled visits and used a remote monitoring app, but only the remote monitoring group received monitoring by health care professionals. Semistructured interviews were conducted with 18 participants from the intervention groups to explore their experiences. The interviews were audio recorded, transcribed, anonymized, and analyzed using thematic analysis. Participants provided informed consent. Results: Eighteen patients (11 men and 7 women, aged 26-65 years) participated, 10 from the remote monitoring group and 8 from the patient-initiated care group. Transcripts were analyzed into four key themes: (1) ?I don?t need to go to the hospital just to report I?m doing well.? When patients felt well, they perceived in-person consultations as less important. They acknowledged health care resource challenges and were willing to adapt but expressed concerns about rapid technological advancement, fearing it could exclude vulnerable groups. They emphasized the need for shared decision-making in determining follow-up strategies; (2) ?It feels safer to meet healthcare personnel in person? highlighted participants? preference for in-person interactions as a safety net for detecting changes or signs of disease. They felt more secure when communicating face-to-face with health care professionals; (3) Remote monitoring can promote a sense of freedom and self-efficacy. The app provided autonomy, enabling patients to monitor their health without disrupting daily routines and promoting their health competency; and (4) Practical challenges and limitations of technology affect sense of security. Concerns about app deactivation, digital privacy, and lack of personalized settings negatively affected confidence in technology and sense of security. Conclusions: Remote monitoring and patient-initiated care can adequately meet the needs of patients with axSpA with low disease activity, reducing unnecessary visits and enhancing self-efficacy. However, these approaches should not be one-size-fits-all. Care must adapt to evolving disease activity, circumstances, and preferences. Human interaction and support remain crucial, and future technological developments must address practical challenges to ensure user-friendly and reliable interfaces. UR - https://www.jmir.org/2025/1/e63569 UR - http://dx.doi.org/10.2196/63569 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/63569 ER - TY - JOUR AU - Young, P. Nathan AU - Stern, I. Jennifer AU - Steel, J. Stephanie AU - Ebbert, O. Jon PY - 2025/3/26 TI - Mobile App-Based Interactive Care Plan for Migraine: Survey Study of Usability and Improvement Opportunities JO - JMIR Form Res SP - e66763 VL - 9 KW - migraine KW - remote monitoring KW - mobile app KW - mHealth KW - patient-reported outcomes KW - care plan KW - digital health KW - app KW - smartphone KW - eHealth KW - technology KW - survey study KW - headache KW - electronic health record KW - remote assessment KW - older adult KW - adult KW - electronic survey KW - pain KW - mobile phone KW - telehealth KW - telemedicine N2 - Background: We implemented a novel mobile app-based Migraine Interactive Care Plan (MICP) integrated with our electronic health records (EHRs). The MICP facilitates remote assessment of adult patients with migraine, educational content delivery, and care team communication. Feasibility of the MICP was demonstrated in a pilot implementation study. Objective: We aimed to assess the preferences and satisfaction of patients with migraine users of a mobile app-based care plan integrated with the EHR. Methods: An electronic survey was administered to a single cohort of MICP users between December 6, 2021, and December 30, 2021. The survey assessed patient preferences for which data to track, frequency of tracking, and satisfaction with the MICP. Survey responses were compared between subsets determined by patient-reported headache frequency and treatment with and without botulinum toxin and calcitonin gene-related peptide (CGRP) antagonist therapy. The Wilcoxon rank-sum test was used for continuous variables and the ?2 test or Fisher exact test for categorical variables. Results: The total sample size was 184 and the survey response rate was 30.4% (56/184). No significant differences in age (P=.26) or sex (P=.19) between respondents and nonrespondents were observed. Respondent median age was 42 (range 20?72) years and 94.6% (53/56) were female. Headache frequency was (1) 0 to 8 days (26/56, 46.4%), (2) 9 to 14 days (12/56, 21.4%), and (3) 15 or more days (18/56, 32.1%). No difference was observed in any survey responses based on headache frequency or treatment. The majority of respondents preferred to track headache days weekly (30/56, 53.6%) or daily (15/56, 26.8%) and preferred to change the frequency of headache tracking reminders (42/56, 75%). Respondents were somewhat or very interested in daily tracking personal observations in free text (41/52, 78.8%), medication treatment (43/52, 82.7%) and treatment response (39/56, 69.6%), class of medication treatment (36/52, 69.2%), severity of functional impairment (39/56, 69.6%), type of functional impairment (35/53, 66%), headache day (40/54, 74.1%), and headache pain level on a scale of 1 to 10 (38/53, 71.7%). Respondents agreed or strongly agreed that the education content was useful (31/51, 60.8%) but lacked personalization (25/51, 49%). Most respondents agreed or strongly agreed that they were satisfied with the MICP (38/50, 76%) and that it helped them communicate with their care team (38/53, 71.7%). Conclusions: Most MICP users were motivated to track headache frequency, medication treatment with response, functional impairment, and pain intensity. Opportunities to improve the MICP include (1) allowing patients to change the frequency of assessments and notifications; (2) recording personal observations or comments through free text, which may include headache triggers; (3) assessment of headache severity using a 1 to 10 pain scale; and (4) tailoring headache education based on frequency and severity (episodic vs chronic migraine). These observations may be useful to improve the usability of the MICP and similar EHR-integrated migraine care platforms that others may develop. UR - https://formative.jmir.org/2025/1/e66763 UR - http://dx.doi.org/10.2196/66763 ID - info:doi/10.2196/66763 ER - TY - JOUR AU - Crafoord, Marie-Therése AU - Ekstrand, Joakim AU - Sundberg, Kay AU - Nilsson, I. Marie AU - Fjell, Maria AU - Langius-Eklöf, Ann PY - 2025/3/11 TI - Mobile Electronic Patient-Reported Outcomes and Interactive Support During Breast and Prostate Cancer Treatment: Health Economic Evaluation From Two Randomized Controlled Trials JO - JMIR Cancer SP - e53539 VL - 11 KW - cost-effectiveness KW - ePRO KW - mHealth KW - disease monitoring KW - cancer KW - RCT KW - randomized controlled trial KW - controlled trials KW - digital intervention KW - patient-reported outcomes KW - management KW - payers' perspective KW - health care costs KW - apps KW - prostate cancer KW - breast cancer N2 - Background: Digital interventions for supportive care during cancer treatment incorporating electronic patient-reported outcomes (ePROs) can enhance early detection of symptoms and facilitate timely symptom management. However, economic evaluations are needed. Objective: This study aims to conduct a cost-utility analysis of an app for ePRO and interactive support from the perspective of the payer (Region Stockholm Health Care Organization) and to explore its impact on patient health care utilization and costs. Methods: Two open-label randomized controlled trials (RCTs) were conducted, including patients undergoing neoadjuvant chemotherapy for breast cancer (B-RCT; N=149) and radiotherapy for prostate cancer (P-RCT; N=150), recruited from oncology clinics at 2 university hospitals in Stockholm, Sweden. EORTC QLQ-C30 scores were mapped to EQ-5D-3L to calculate quality-adjusted life years (QALYs). Intervention and implementation costs and health care costs, obtained from an administrative database, were used to calculate incremental cost-effectiveness ratios (ICERs) in 3 ways: including all health care costs (ICERa), excluding nonacute health care costs (ICERb), and excluding health care costs altogether (ICERc). Nonparametric bootstrapping was used to explore ICER uncertainty. Health care costs were analyzed by classifying them as disease-related or acute. Results: In both RCT intervention groups, fewer QALYs were lost compared with the control group (P<.001). In the B-RCT, the mean intervention cost was ?92 (SD ?2; ?1=US $1.03). The mean cost for the intervention and all health care was ?36,882 (SD ?1032) in the intervention group and ?35,427 (SD ?959) in the control group (P<.001), with an ICERa of ?202,368 (95% CI ?152,008-?252,728). The mean cost for the intervention and acute health care was ?3585 (SD ?480) in the intervention group and ?3235 (SD ?494) in the control group (P<.001). ICERb was ?49,903 (95% CI ?37,049-?62,758) and ICERc was ?13,213 (95% CI ?11,145-?15,281); 22 out of 74 (30%) intervention group patients and 24 out of 75 (32%) of the control group patients required acute inpatient care for fever. In the P-RCT, the mean intervention cost was ?43 (SD ?0.2). The mean cost for the intervention and all health care was ?3419 (SD ?739) in the intervention group and ?3537 (SD ?689) in the control group (P<.001), with an ICERa of ??1,092,136 (95% CI ??3,274,774 to ?1,090,502). The mean cost for the intervention and acute health care was ?1219 (SD ?593) in the intervention group and ?802 (SD ?281) in the control group (P<.001). ICERb was ?745,987 (95% CI ??247,317 to ?1,739,292) and ICERc was ?13,118 (95% CI ?68,468 to ?94,704). As many as 10 out of the 75 (13%) intervention group patients had acute inpatient care, with the most common symptom being dyspnea, while 9 out of the 75 (12%) control group patients had acute inpatient care, with the most common symptom being urinary tract infection. Conclusions: ePRO and interactive support via an app generated a small improvement in QALYs at a low intervention cost and may be cost-effective, depending on the costs considered. Considerable variability in patient health care costs introduced uncertainty around the estimates, preventing a robust determination of cost-effectiveness. Larger studies examining cost-effectiveness from a societal perspective are needed. The study provides valuable insights into acute health care utilization during cancer treatment. Trial Registration: ClinicalTrials.gov NCT02479607; https://clinicaltrials.gov/ct2/show/NCT02479607, ClinicalTrials.gov NCT02477137; https://clinicaltrials.gov/ct2/show/NCT02477137 International Registered Report Identifier (IRRID): RR2-10.1186/s12885-017-3450-y UR - https://cancer.jmir.org/2025/1/e53539 UR - http://dx.doi.org/10.2196/53539 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/53539 ER - TY - JOUR AU - Barclay, Jayne AU - Sullivan, Clair AU - Beckmann, Michael AU - Mattison, Graeme AU - Runciman, Rebecca AU - Martin, Elizabeth PY - 2025/3/4 TI - Use of Remote Assessment Tools to Substitute Routine Outpatient Care: Scoping Review JO - J Med Internet Res SP - e65938 VL - 27 KW - remote assessment KW - remote patient monitoring KW - telemedicine KW - mHealth KW - applications KW - patient-reported outcome measures KW - self-reported KW - health care cost reduction KW - hybrid care models N2 - Background: The increasing global demand for health care, driven by demographic shifts, the rise of personalized medicine, and technological innovations necessitate novel approaches to health care delivery. Digital remote assessment tools have emerged as a promising solution, enabling hybrid care models that combine traditional and remote patient management. These tools support the quadruple aim of health care by enhancing the monitoring and evaluation of patient-reported data, thereby improving patient care, boosting operational efficiency, reducing costs, and improving the experience of patients and clinicians. This review seeks to understand how remote assessment tools are used for routine consultation substitution in adult tertiary care centers. Objective: This scoping review aims to evaluate the implementation and health outcomes of digital remote assessment tools used for routine consultation substitutions in adult tertiary care centers. The objectives include assessing the extent of use, types, and effectiveness of these tools in substituting conventional outpatient care. Methods: A comprehensive scoping review was conducted, adhering to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. The review focused on studies that used internet-dependent remote assessment technologies for patient data transfer in tertiary care settings. A detailed search strategy was used across multiple databases, with studies selected based on predefined inclusion and exclusion criteria. Data extraction and analysis were performed by independent reviewers, with a focus on the functionalities of the tools and their alignment with the Quadruple Aim of Healthcare. Results: The review included 12 studies, highlighting a growing interest in remote assessment technologies across diverse clinical settings. The interventions varied in length, from 4 weeks to 12 months, and demonstrated a range of functionalities, including symptom monitoring and postsurgical follow-ups. The use of these tools was associated with improved clinical outcomes, such as timely intervention for clinical deterioration and enhanced clinical protocol adherence. Additionally, a small number of studies identified potential cost savings in terms of reduced unplanned health care contacts and optimized clinical resource use. Patient and clinician experiences were generally positive, with high adherence to remote assessments and an appreciation for the personalized and timely care facilitated by these technologies. Barriers included high initial setup costs for digital technologies, leading to an inflated cost per patient in small sample studies. Conclusions: Digital remote assessment tools offer significant potential to enhance health care delivery by improving health outcomes, reducing costs, and enriching patient and clinician experiences. Their flexibility and adaptability make them suitable for various clinical contexts, supporting the personalization of care and operational efficiency. While digital remote assessment tools offer significant potential, careful consideration of implementation strategies, equity, cost, and clinician and patient experiences is crucial for successful clinical integration. UR - https://www.jmir.org/2025/1/e65938 UR - http://dx.doi.org/10.2196/65938 UR - http://www.ncbi.nlm.nih.gov/pubmed/40053751 ID - info:doi/10.2196/65938 ER - TY - JOUR AU - Stein, Maike AU - Stegherr, Regina AU - Narayanaswami, Pushpa AU - Legg, David AU - Herdick, Meret AU - Meisel, Andreas AU - Gerischer, Lea AU - Lehnerer, Sophie PY - 2025/3/3 TI - App- and Wearable-Based Remote Monitoring for Patients With Myasthenia Gravis and Its Specialists: Feasibility and Usability Study JO - JMIR Form Res SP - e58266 VL - 9 KW - myasthenia gravis KW - myasthenia KW - remote monitoring KW - PROMs KW - digital platform KW - wearables KW - telemedicine KW - spirometry KW - app KW - usability KW - feasibility KW - autoimmune disorder KW - web-based portal KW - activity tracker KW - communication KW - wearable data KW - digital tool KW - mobile phone N2 - Background: Myasthenia gravis (MG) is rare, chronic autoimmune disorder of the neuromuscular junction that requires specialized care and often lifelong treatment, facing challenges due to its rarity and the limited availability of specialists. Telemedical solutions in specialized centers hold considerable promise in bridging this gap by increasing access to this care to a broader patient population in a timely manner. However, there is no research regarding interventional remote care solutions in the field of MG to date. Objective: This study aimed to assess the feasibility and usability among patients with MG and specialists of a telemedicine platform, tailored to patients with MG and designed to facilitate remote monitoring, treated in a specialized center. Methods: The telemedicine platform consisted of an app for patients and a web-based portal for physicians. Over a period of 3 months, 30 patients continuously monitored their vital parameters through external devices, including a digital spirometer and a wearable (activity tracker). Furthermore, patients completed 7 different patient-reported outcome measures (PROMs) through the app at predefined intervals. Specialists could review this monitoring data and adjust therapy as necessary. In addition, communication between patients and physicians was facilitated through a chat module. Feasibility was evaluated by total adherence rates for completing PROMs within the app, alongside the collection of spirometry and wearable data. Furthermore, user satisfaction was assessed among both patients with MG and physicians at the end of study. Results: Total adherence rates ranged from 74.3% (1830/2464) to 97.9% (327/334) across all data types, with the highest adherence observed for PROMs (1139/1179, 96.6%), followed by spirometry (293/334, 87.7%) and wearables (1830/2261, 80.9%). Notably, patients wore the wearable longer than required by protocol and conducted a higher number of spirometry measurements during the study than required per protocol (median 20 h/d [IQR 15-24] vs 14 h/d and median 49 [IQR 15-59] measurements vs 11 measurements, respectively). Technical issues and discomfort with wearables were factors affecting lower adherence in some patients. The System Usability Scale yielded a median score of 85 indicating ?excellent usability.? In addition, results from a more detailed user evaluation questionnaire showed high levels of user satisfaction among both patients and health care professionals across diverse categories, including their experience of the care program, communication, and evaluation of the program. Conclusions: Remote monitoring of patients with MG through the telemedical platform demonstrated good feasibility and acceptability, as evidenced by above-average adherence rates and user satisfaction for both patients and physicians. The majority of patients wanted to continue using the app. These findings highlight the potential for user-friendly digital tools to enhance care for patients with MG, although addressing technical challenges and ensuring patient comfort with wearables are essential for optimal implementation. Further research involving larger cohorts and longer study duration is warranted to validate these findings. Trial Registration: Deutsches Register Klinischer Studien DRKS00029907; https://drks.de/search/en/trial/DRKS00029907 UR - https://formative.jmir.org/2025/1/e58266 UR - http://dx.doi.org/10.2196/58266 ID - info:doi/10.2196/58266 ER - TY - JOUR AU - Byrom, Bill AU - Everhart, Anthony AU - Cordero, Paul AU - Garratt, Chris AU - Meyer, Tim PY - 2025/2/28 TI - Leveraging Patient-Reported Outcome Measures for Optimal Dose Selection in Early Phase Cancer Trials JO - JMIR Cancer SP - e64611 VL - 11 KW - clinical trials KW - early phase KW - dose finding KW - patient-reported outcome KW - PRO KW - electronic patient-reported outcome KW - ePRO KW - PRO-CTCAE KW - adverse events KW - tolerability KW - optimal dose KW - cancer trials KW - dose toxicity KW - oncology KW - drug development KW - electronic collection KW - dose level KW - pharmacodynamic KW - cytotoxic chemotherapy drugs KW - cytotoxic KW - chemotherapy drug KW - life-threatening disease KW - Common Terminology Criteria for Adverse Events UR - https://cancer.jmir.org/2025/1/e64611 UR - http://dx.doi.org/10.2196/64611 ID - info:doi/10.2196/64611 ER - TY - JOUR AU - Steele, Brian AU - Fairie, Paul AU - Kemp, Kyle AU - D'Souza, G. Adam AU - Wilms, Matthias AU - Santana, Jose Maria PY - 2025/2/24 TI - Identifying Patient-Reported Care Experiences in Free-Text Survey Comments: Topic Modeling Study JO - JMIR Med Inform SP - e63466 VL - 13 KW - natural language processing KW - patient-reported experience KW - topic models KW - inpatient KW - artificial intelligence KW - AI KW - patient reported KW - feedback KW - survey KW - patient experiences KW - bidirectional encoder representations from transformers KW - BERT KW - sentiment analysis KW - pediatric caregivers KW - patient safety KW - safety N2 - Background: Patient-reported experience surveys allow administrators, clinicians, and researchers to quantify and improve health care by receiving feedback directly from patients. Existing research has focused primarily on quantitative analysis of survey items, but these measures may collect optional free-text comments. These comments can provide insights for health systems but may not be analyzed due to limited resources and the complexity of traditional textual analysis. However, advances in machine learning?based natural language processing provide opportunities to learn from this traditionally underused data source. Objective: This study aimed to apply natural language processing to model topics found in free-text comments of patient-reported experience surveys. Methods: Consumer Assessment of Healthcare Providers and Systems?derived patient experience surveys were collected and linked to administrative inpatient records by the provincial health services organization responsible for inpatient care. Unsupervised topic modeling with automated labeling was performed with BERTopic. Sentiment analysis was performed to further assist in topic description. Results: Between April 2016 and February 2020, 43.4% (43,522/100,272) adult patients and 46.9% (3501/7464) pediatric caregivers included free-text responses on completed patient experience surveys. Topic models identified 86 topics among adult survey responses and 35 topics among pediatric responses that included elements of care not currently surveyed by existing questionnaires. Frequent topics were generally positive. Conclusions: We found that with limited tuning, BERTopic identified care experience topics with interpretable automated labeling. Results are discussed in the context of person-centered care, patient safety, and health care quality improvement. Furthermore, we note the opportunity for the identification of temporal and site-specific trends as a method to identify patient care and safety concerns. As the use of patient experience measurement increases in health care, we discuss how machine learning can be leveraged to provide additional insight on patient experiences. UR - https://medinform.jmir.org/2025/1/e63466 UR - http://dx.doi.org/10.2196/63466 ID - info:doi/10.2196/63466 ER - TY - JOUR AU - de Ligt, M. Kelly AU - Hommes, Saar AU - Vromans, D. Ruben AU - Boomstra, Eva AU - van de Poll, V. Lonneke AU - Krahmer, J. Emiel PY - 2025/2/5 TI - Improving the Implementation of Patient-Reported Outcome Measure in Clinical Practice: Tackling Current Challenges With Innovative Digital Communication Technologies JO - J Med Internet Res SP - e60777 VL - 27 KW - patient reported outcome measures KW - quality of life KW - health communication KW - delivery of health care KW - digital sciences KW - clinical practice: patient reported outcomes KW - patient reported outcome KW - digital communication KW - communication KW - health management KW - digital technologies UR - https://www.jmir.org/2025/1/e60777 UR - http://dx.doi.org/10.2196/60777 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/60777 ER - TY - JOUR AU - Kelly, Charlotte Sofia AU - Wegener, Kauffeldt Emilie AU - Kayser, Lars PY - 2025/2/5 TI - Creation of Text Vignettes Based on Patient-Reported Data to Facilitate a Better Understanding of the Patient Perspective: Design Study JO - JMIR Hum Factors SP - e58077 VL - 12 KW - patient-reported outcome KW - text vignette KW - data representation KW - Readiness and Enablement Index for Health Technology KW - understanding KW - health care system KW - data analysis KW - clinical training KW - clinician KW - health professional N2 - Background: Patient-reported outcome (PRO) data refer to information systematically reported by patients, or on behalf of patients, without the influence of health care professionals. It is a focal point of the health care system?s ambition toward becoming more involving and personalized. It is recognized that PROs provide valuable data. However, despite this recognition, there are challenges related to both patients? and clinicians? accurate interpretations of the quantitative data. To overcome these challenges, this study explores text vignettes as a representation of PROs. Objective: This study aimed to develop data-informed text vignettes based on data from the Readiness and Enablement Index for Health Technology (READHY) instrument as another way of representing PRO data and to examine how these are perceived as understandable and relevant for both patients and clinicians. Methods: The text vignettes were created from participant responses to the READHY instrument, which encompasses health literacy, health education, and eHealth literacy. The text vignettes were created from 13 individual text strings, each corresponding to a scale in the READHY instrument. This study consisted of 3 sequential parts. In part 1, individuals with chronic obstructive pulmonary disease completed the READHY instrument, providing data to be used to create vignettes based on cluster profiles from the READHY instrument. Part 2 focused on the development of scale-based strings representing all READHY dimensions, which were evaluated through iterative cognitive interviews. In part 3, clinicians and patients assessed the understanding and relevance of the text vignettes. Results: Clinicians and patients both understood and related to the text vignettes. Patients viewed the text vignettes as an accurate reflection of their PRO responses, and clinicians perceived the text vignettes as aligned with their understanding of patients? experiences. Conclusions: Text vignettes can be developed using PRO instruments, with individual scales as input strings. This provides an opportunity to present numeric values in a text format that is understandable and recognizable to most patients and clinicians. Challenges with the vignette?s language and layout require customization and clinician training to ensure meaningful interpretation. Findings also support the need to expand the study and enhance clinical relevance with alternative or contextually relevant text vignettes. UR - https://humanfactors.jmir.org/2025/1/e58077 UR - http://dx.doi.org/10.2196/58077 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/58077 ER - TY - JOUR AU - Kim, Yesol AU - Kim, Geonah AU - Cho, Hyeonmi AU - Kim, Yeonju AU - Choi, Mona PY - 2025/2/4 TI - Application of Patient-Generated Health Data Among Older Adults With Cancer: Scoping Review JO - J Med Internet Res SP - e57379 VL - 27 KW - patient-generated health data KW - wearable devices KW - patient-reported outcomes KW - patient-centered care KW - older adults KW - cancer KW - scoping review N2 - Background: The advancement of information and communication technologies has spurred a growing interest in and increased applications of patient-generated health data (PGHD). In particular, PGHD may be promising for older adults with cancer who have increased survival rates and experience a variety of symptoms. Objective: This scoping review aimed to identify the characteristics of research on PGHD as applied to older adults with cancer and to assess the current use of PGHD. Methods: Guided by Arksey and O?Malley as well as the JBI (Joanna Briggs Institute) methodology for scoping reviews, 6 electronic databases were searched: PubMed, Embase, CINAHL, Cochrane Library, Scopus, and Web of Science. In addition, the reference lists of the selected studies were screened to identify gray literature. The researchers independently screened the literature according to the predefined eligibility criteria. Data from the selected studies were extracted, capturing study, participant, and PGHD characteristics. Results: Of the 1090 identified studies, 88 were selected. The publication trend gradually increased, with a majority of studies published since 2017 (69/88, 78%). Almost half of the studies were conducted in North America (38/88, 43%), followed by Europe (30/88, 34%). The most common setting in which the studies were conducted was the participant?s home (69/88, 78%). The treatment status varied; the median sample size was 50 (IQR 33.8-84.0). The devices that were used to measure the PGHD were classified as research-grade wearable devices (57/113, 50.4%), consumer-grade wearable devices (28/113, 24.8%), or smartphones or tablet PCs for mobile apps (23/113, 20.4%). More than half of the studies measured physical activity (69/123, 56.1%), followed by patient-reported outcomes (23/123, 18.7%), vital signs (13/123, 10.6%), and sleep (12/123, 9.8%). The PGHD were mainly collected passively (63/88, 72%), and active collection methods were used from 2015 onward (20/88, 23%). In this review, the stages of PGHD use were classified as follows: (1) identification, monitoring, review, and analysis (88/88, 100%); (2) feedback and reporting (32/88, 39%); (3) motivation (30/88, 34%); and (4) education and coaching (19/88, 22%). Conclusions: This scoping review provides a comprehensive summary of the overall characteristics and use stages of PGHD in older adults with various types and stages of cancer. Future research should emphasize the use of PGHD, which interacts with patients to provide patient-centered care through patient engagement. By enhancing symptom monitoring, enabling timely interventions, and promoting patient involvement, PGHD have the potential to improve the well-being of older adults with cancer, contributing to better health management and quality of life. Therefore, our findings may provide valuable insights into PGHD that health care providers and researchers can use for geriatric cancer care. Trial Registration: Open Science Framework Registry OSF.IO/FZRD5; https://doi.org/10.17605/OSF.IO/FZRD5 UR - https://www.jmir.org/2025/1/e57379 UR - http://dx.doi.org/10.2196/57379 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/57379 ER - TY - JOUR AU - Alami, Sarah AU - Schaller, Manuella AU - Blais, Sylvie AU - Taupin, Henry AU - Hernández González, Marta AU - Gagnadoux, Frédéric AU - Pinto, Paula AU - Cano-Pumarega, Irene AU - Bedert, Lieven AU - Braithwaite, Ben AU - Servy, Hervé AU - Ouary, Stéphane AU - Fabre, Céline AU - Bazin, Fabienne AU - Texereau, Joëlle PY - 2025/1/31 TI - Evaluating the Benefit of Home Support Provider Services for Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea: Protocol for an Ambispective International Real-World Study JO - JMIR Res Protoc SP - e65840 VL - 14 KW - obstructive sleep apnea KW - positive airway pressure KW - real-world evidence KW - home support provider KW - adherence KW - electronic patient-reported outcome KW - comparative real-world study N2 - Background: Adherence and persistence to positive airway pressure (PAP) therapy are key factors for positive health outcomes. Home support providers participate in the home implementation and follow-up of PAP therapy for patients with obstructive sleep apnea (OSA). In Europe, home support provider service levels are country (or area) specific, resulting in differences in content and frequency of patient interactions. However, no robust evaluation of the impact of these differences on clinical and patient outcomes has been performed. Objective: The AWAIR study aims to evaluate and compare the impact of different home support provider service levels on PAP adherence and persistence in 4 European countries. Methods: This real-world, ambispective, cohort study?conducted in France, Belgium, Spain, and Portugal?will recruit adults with OSA who started PAP therapy between 2019 and 2023 and were followed by an Air Liquide Healthcare home support provider. Given the large number of eligible participants (around 150,000), the study will use a decentralized and digital approach. A patient video will present the study objectives and the participation process. A secure electronic solution will be used to manage patient information and consent, as well as to administer a web-based questionnaire. Retrospective data, collected during routine patient follow-up by home support providers, include the level of service and device data, notably PAP use. Prospective data collected using an electronic patient-reported outcome tool include health status, OSA-related factors, patient-reported outcomes including quality of life and symptoms, OSA and PAP literacy, patient-reported experience, and satisfaction with PAP therapy and service. Hierarchical models, adjusted for preidentified confounding factors, will be used to assess the net effect of home support provider services on PAP adherence and persistence while minimizing real-world study biases and considering the influence of country-level contextual factors. We hypothesize that higher levels of home support provider services will be positively associated with adherence and persistence to PAP therapy. Results: As of December 2024, the study has received approval in France, Portugal, and 2 regions of Spain. The study began enrollment in France in October 2024. Results are expected in the second quarter of 2025. Conclusions: The AWAIR study has a unique design, leveraging an unprecedented number of eligible participants, decentralized technologies, and a real-world comparative methodology across multiple countries. This approach will highlight intercountry differences in terms of patient characteristics, PAP adherence, and persistence, as well as patient-reported outcomes, patient-reported experiences, and satisfaction with the home service provider. By assessing the added value of home support provider services, the results will support best practices for patient management and for decision-making by payers and authorities. International Registered Report Identifier (IRRID): PRR1-10.2196/65840 UR - https://www.researchprotocols.org/2025/1/e65840 UR - http://dx.doi.org/10.2196/65840 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/65840 ER - TY - JOUR AU - Sugawara, Yuka AU - Hirakawa, Yosuke AU - Iwagami, Masao AU - Inokuchi, Ryota AU - Wakimizu, Rie AU - Nangaku, Masaomi PY - 2025/1/31 TI - Metrics for Evaluating Telemedicine in Randomized Controlled Trials: Scoping Review JO - J Med Internet Res SP - e67929 VL - 27 KW - patient experience KW - patient-reported outcome KW - quality of life KW - quality-adjusted life year KW - telehealth KW - eHealth KW - mobile phone KW - metrics KW - telemedicine KW - systematic review KW - scoping review KW - review KW - telecommunications KW - database KW - health care KW - patient-centeredness KW - patient satisfaction KW - patient outcome KW - clinical parameter KW - cost-effectiveness KW - evaluation metrics KW - mHealth KW - mobile health N2 - Background: Telemedicine involves medical, diagnostic, and treatment-related services using telecommunication technology. Not only does telemedicine contribute to improved patient quality of life and satisfaction by reducing travel time and allowing patients to be seen in their usual environment, but it also has the potential to improve disease management by making it easier for patients to see a doctor. Recently, owing to IT developments, research on telemedicine has been increasing; however, its usefulness and limitations in randomized controlled trials remain unclear because of the multifaceted effects of telemedicine. Furthermore, the specific metrics that can be used as cross-disciplinary indicators when comparing telemedicine and face-to-face care also remain undefined. Objective: This review aimed to provide an overview of the general and cross-disciplinarity metrics used to compare telemedicine with in-person care in randomized controlled trials. In addition, we identified previously unevaluated indicators and suggested those that should be prioritized in future clinical trials. Methods: MEDLINE and Embase databases were searched for publications that met the inclusion criteria according to PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analysis Extension for Scoping Reviews). Original, English-language articles on randomized controlled trials comparing some forms of telemedicine with face-to-face care from January 2019 to March 2024 were included, and the basic information and general metrics used in these studies were summarized. Results: Of the 2275 articles initially identified, 79 were included in the final analysis. The commonly used metrics that can be used across medical specialties were divided into the following 3 categories: (1) patient-centeredness (67/79, 85%), including patient satisfaction, workload, and quality of life; (2) patient outcomes (57/79, 72%), including general clinical parameters such as death, admission, and adverse events; and (3) cost-effectiveness (40/79, 51%), including cost assessment and quality-adjusted life year. Notably, only 25 (32%) of 79 studies evaluated all the 3 categories. Other metrics, such as staff convenience, system usability, and environmental impact, were extracted as indicators in different directions from the three categories above, although few previous reports have evaluated them (staff convenience: 8/79, 10%; system usability: 3/79, 4%; and environmental impact: 2/79, 3%). Conclusions: A significant variation was observed in the metrics used across previous studies. Notably, general indicators should be used to enhance the understandability of the results for people in other areas, even if disease-specific indicators are used. In addition, indicators should be established to include all three commonly used categories of measures to ensure a comprehensive evaluation: patient-centeredness, patient outcomes, and cost-effectiveness. Staff convenience, system usability, and environmental impact are important indicators that should be used in future trials. Moreover, standardization of the evaluation metrics is desired for future clinical trials and studies. Trial Registration: Open Science Forum Registries YH5S7; https://doi.org/10.17605/OSF.IO/YH5S7 UR - https://www.jmir.org/2025/1/e67929 UR - http://dx.doi.org/10.2196/67929 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/67929 ER - TY - JOUR AU - Sahandi Far, Mehran AU - Fischer, M. Jona AU - Senge, Svea AU - Rathmakers, Robin AU - Meissner, Thomas AU - Schneble, Dominik AU - Narava, Mamaka AU - Eickhoff, B. Simon AU - Dukart, Juergen PY - 2025/1/28 TI - Cross-Platform Ecological Momentary Assessment App (JTrack-EMA+): Development and Usability Study JO - J Med Internet Res SP - e51689 VL - 27 KW - digital biomarkers KW - mobile health KW - remote monitoring KW - smartphone KW - mobile phone KW - monitoring KW - biomarker KW - ecological momentary assessment KW - application KW - costly KW - user experience KW - data management KW - mobility N2 - Background: Traditional in-clinic methods of collecting self-reported information are costly, time-consuming, subjective, and often limited in the quality and quantity of observation. However, smartphone-based ecological momentary assessments (EMAs) provide complementary information to in-clinic visits by collecting real-time, frequent, and longitudinal data that are ecologically valid. While these methods are promising, they are often prone to various technical obstacles. However, despite the potential of smartphone-based EMAs, they face technical obstacles that impact adaptability, availability, and interoperability across devices and operating systems. Deficiencies in these areas can contribute to selection bias by excluding participants with unsupported devices or limited digital literacy, increase development and maintenance costs, and extend deployment timelines. Moreover, these limitations not only impede the configurability of existing solutions but also hinder their adoption for addressing diverse clinical challenges. Objective: The primary aim of this research was to develop a cross-platform EMA app that ensures a uniform user experience and core features across various operating systems. Emphasis was placed on maximizing the integration and adaptability to various study designs, all while maintaining strict adherence to security and privacy protocols. JTrack-EMA+ was designed and implemented per the FAIR (findable, accessible, interpretable, and reusable) principles in both its architecture and data management layers, thereby reducing the burden of integration for clinicians and researchers. Methods: JTrack-EMA+ was built using the Flutter framework, enabling it to run seamlessly across different platforms. This platform comprises two main components. JDash (Research Centre Jülich, Institute of Neuroscience and Medicine, Brain and Behaviour [INM-7]) is an online management tool created using Python (Python Software Foundation) with the Django (Django Software Foundation) framework. This online dashboard offers comprehensive study management tools, including assessment design, user administration, data quality control, and a reminder casting center. The JTrack-EMA+ app supports a wide range of question types, allowing flexibility in assessment design. It also has configurable assessment logic and the ability to include supplementary materials for a richer user experience. It strongly commits to security and privacy and complies with the General Data Protection Regulations to safeguard user data and ensure confidentiality. Results: We investigated our platform in a pilot study with 480 days of follow-up to assess participants? compliance. The 6-month average compliance was 49.3%, significantly declining (P=.004) from 66.7% in the first month to 42% in the sixth month. Conclusions: The JTrack-EMA+ platform prioritizes platform-independent architecture, providing an easy entry point for clinical researchers to deploy EMA in their respective clinical studies. Remote and home-based assessments of EMA using this platform can provide valuable insights into patients? daily lives, particularly in a population with limited mobility or inconsistent access to health care services. UR - https://www.jmir.org/2025/1/e51689 UR - http://dx.doi.org/10.2196/51689 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/51689 ER - TY - JOUR AU - McMullan, Christel AU - Turner, Grace AU - Retzer, Ameeta AU - Belli, Antonio AU - Davies, Haf Elin AU - Nice, Laura AU - Flavell, Luke AU - Flavell, Jackie AU - Calvert, Melanie PY - 2025/1/23 TI - Testing an Electronic Patient-Reported Outcome Platform in the Context of Traumatic Brain Injury: PRiORiTy Usability Study JO - JMIR Form Res SP - e58128 VL - 9 KW - usability study KW - usability KW - patient reported outcome KW - PRO KW - electronic patient reported outcome KW - ePRO KW - traumatic brain injury KW - TBI KW - think aloud KW - cognitive interviews KW - early warning KW - early detection KW - mobile phone N2 - Background: Traumatic brain injury (TBI) is a significant public health issue and a leading cause of death and disability globally. Advances in clinical care have improved survival rates, leading to a growing population living with long-term effects of TBI, which can impact physical, cognitive, and emotional health. These effects often require continuous management and individualized care. Traditional paper-based assessments can be cumbersome, potentially impeding regular monitoring of patient-reported outcomes (PROs). Electronic PROs (ePROs) offer a promising alternative by enabling real-time symptom tracking, which can facilitate early identification of issues, support shared decision-making, and improve outcomes for patients with TBI. Objective: This study evaluates the usability of an ePRO platform?Atom5?for individuals with TBI. By analyzing how patients use the system to report their symptoms, the study aims to identify usability issues, assess user satisfaction, and determine the potential of Atom5 to support ongoing patient-centered care. Methods: Atom5 was customized to enable individuals with TBI to report their symptoms. Usability testing was conducted through one-on-one sessions with participants recruited from Headway UK?an organization supporting brain injury survivors. Each participant took part in cognitive interviews using with the ?Think Aloud? method, encouraging them to verbalize their thoughts and experiences while using the platform. This approach provided qualitative insights into areas of difficulty, usability strengths, and accessibility barriers. User satisfaction was quantitatively assessed with a brief 4-item questionnaire based on the System Usability Scale. Usability outcomes were analyzed for critical and noncritical errors, focusing on user experience and overall satisfaction. Results: In total, 9 participants completed a single usability testing session using Atom5, including 4 men, 4 women, and 1 nonbinary individual; 4 participants were under 55 years old, and 6 had their TBI <10 years ago. Finally, 8 participants used an Android device. The platform included measures for anxiety (Generalized Anxiety Disorder-2 item), depression (Patient Health Questionnaire-2), posttraumatic stress disorder (Posttraumatic Stress Disorder checklist 2), and TBI-specific quality of life (Traumatic Brain Injury ? Quality of Life Short form) and a total of 26 questions. Overall, all participants were satisfied with the system, noting that it was easy to navigate and accessible despite difficulties in understanding some questions. Further, 6 participants encountered no errors, while 1 participant reported one critical error and 2 others reported one noncritical error each. The participants rated their overall satisfaction with the platform at an average score of 3.9 (SD 0.49) out of 5. Conclusions: This usability study suggests that individuals living with TBI can effectively report symptoms using the Atom5 ePRO platform, with generally high satisfaction and few usability issues, thereby enabling continuous monitoring and proactive symptom management. Future ePRO development should focus on inclusivity and adaptability to address the diverse needs of patients with TBI, ensuring these tools can effectively support a wide range of users. UR - https://formative.jmir.org/2025/1/e58128 UR - http://dx.doi.org/10.2196/58128 ID - info:doi/10.2196/58128 ER - TY - JOUR AU - Brunelli, Cinzia AU - Alfieri, Sara AU - Zito, Emanuela AU - Spelta, Marco AU - Arba, Laura AU - Lombi, Linda AU - Caselli, Luana AU - Caraceni, Augusto AU - Borreani, Claudia AU - Roli, Anna AU - Miceli, Rosalba AU - Tine', Gabriele AU - Zecca, Ernesto AU - Platania, Marco AU - Procopio, Giuseppe AU - Nicolai, Nicola AU - Battaglia, Luigi AU - Lozza, Laura AU - Shkodra, Morena AU - Massa, Giacomo AU - Loiacono, Daniele AU - Apolone, Giovanni PY - 2025/1/22 TI - Patient Voices: Multimethod Study on the Feasibility of Implementing Electronic Patient-Reported Outcome Measures in a Comprehensive Cancer Center JO - JMIR Cancer SP - e56625 VL - 11 KW - feasibility KW - oncology KW - patient-reported outcomes KW - PROMs KW - quality of life KW - mixed methods study KW - cancer KW - electronic patient-reported outcomes KW - patient compliance KW - barrier KW - implementation KW - usability scale KW - semistructured interview KW - questionnaire KW - clinical management KW - eHealth N2 - Background: ?Patient Voices? is a software developed to promote the systematic collection of electronic patient-reported outcome measures (ePROMs) in routine oncology clinical practice. Objective: This study aimed to assess compliance with and feasibility of the Patient Voices ePROM system and analyze patient-related barriers in an Italian comprehensive cancer center. Methods: Consecutive patients with cancer attending 3 outpatient clinics and 3 inpatient wards were screened for eligibility (adults, native speakers, and being able to fill in the ePROMs) and enrolled in a quantitative and qualitative multimethod study. Compliance, reasons for not administering the ePROMs, patients? interaction needs, and patient-perceived System Usability Scale (range 0-100) were collected; semistructured interviews were carried out in a subsample of patients. Results: From June 2020 to September 2021, a total of 435 patients were screened, 421 (96.7%) were eligible, and 309 completed the ePROMs (309/421, 73.4%; 95% CI 69.8%-77.5%; mean age 63.3, SD 13.7 years). Organization problems and patient refusal were the main reasons for not administering the ePROMs (outpatients: 40/234, 17.1% and inpatients: 44/201, 21.9%). Help for tablet use was needed by 27.8% (47/169) of outpatients and 10.7% (15/140) of inpatients, while the support received for item interpretation was similar in the 2 groups (outpatients: 36/169, 21.3% and inpatients: 26/140, 18.6%). Average System Usability Scale scores indicated high usability in both groups (outpatients: mean 86.8, SD 15.8 and inpatients: mean 83.9, SD 18.8). Overall, repeated measurement compliance was 76.9% (173/225; outpatients only). Interviewed patients showed positive attitudes toward ePROMs. However, there are barriers to implementation related to the time and cognitive effort required to complete the questionnaires. There is also skepticism about the usefulness of ePROMs in interactions with health care professionals. Conclusions: This study provides useful information for future ePROM implementation strategies, aimed at effectively supporting the routine clinical management and care of patients with cancer. In addition, these findings may be relevant to other organizations willing to systematically collect PROMs or ePROMs in their clinical routines. Trial Registration: ClinicalTrials.gov NCT03968718; https://clinicaltrials.gov/study/NCT03968718 UR - https://cancer.jmir.org/2025/1/e56625 UR - http://dx.doi.org/10.2196/56625 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/56625 ER - TY - JOUR AU - Tremblay, Dominique AU - Joly-Mischlich, Thomas AU - Dufour, Annick AU - Battista, Marie-Claude AU - Berbiche, Djamal AU - Côté, José AU - Décelles, Marco AU - Forget, Catherine AU - Guérin, Brigitte AU - Larivičre, Manon AU - Lemay, Frédéric AU - Lemonde, Manon AU - Maillet, Éric AU - Moreau, Nathalie AU - Pavic, Michel AU - Soldera, Sara AU - Wilhelmy, Catherine PY - 2025/1/20 TI - Telehomecare Monitoring for Patients Receiving Anticancer Oral Therapy: Protocol for a Mixed Methods Evaluability Study JO - JMIR Res Protoc SP - e63099 VL - 14 KW - telehealth KW - virtual care KW - telehomecare monitoring KW - anticancer oral therapy KW - oncology KW - electronic patient-reported outcomes KW - electronic patient-reported experience KW - evaluability study KW - mixed methods KW - implementation. N2 - Background: Telehomecare monitoring (TM) in patients with cancer is a complex intervention. Research shows variations in the benefits and challenges TM brings to equitable access to care, the therapeutic relationship, self-management, and practice transformation. Further investigation into these variations factors will improve implementation processes and produce effective outcomes. Objective: This study aims to concurrently analyze implementation and evaluate the effectiveness of TM for patients receiving anticancer oral therapy. The objectives are to (1) contextualize how and why TM is implemented according to (a) site characteristics, (b) team characteristics, and (c) characteristics of patients receiving anticancer oral therapy; (2) assess TM effectiveness for recording electronic patient-reported outcome measures (ePROMs) and patient-reported experience measures (ePREMs) according to the site, implementation process, and patient characteristics; (3) describe the acceptability and feasibility of TM from the perspectives of the people directly or indirectly involved and provide evidence-based actionable guidance in anticipation of provincewide implementation. Methods: This type II hybrid effectiveness-implementation study uses a concurrent mixed methods design. Evaluability assessment is integrated into an emerging practice in 3 participating sites to enable the evaluation of implementation strategies on TM clinical outcomes. Quantitative data for ePROMs and ePREMs will be collected using validated oncology questionnaire. Descriptive statistics and repeated measures using multiple linear mixed models and generalized estimating equations analyses will be undertaken alongside interpretive descriptive coding of qualitative data. Qualitative data will be gathered from key informants guided by the RE-AIM (reach, efficacy, adoption, implementation, maintenance) framework and its extension, PRISM (practical robust implementation and sustainability model). The concurrent approach allows results at multiple stages of this study to be integrated iteratively. The methodological choice aims to provide real-world data that are rigorous, rapidly usable in practice, and transferable to other settings. Results: Questionnaires were pretested and the technological platform was codeveloped with members of the cancer care team and patients. Preparatory work was carried out to configure the TM platform and activate coordinating mechanisms between members of the cancer care team, patients, information technology experts, and the research team. A steering committee with 3 working groups was established to oversee the technological, clinical, and evaluation aspects of this study. Recruitment of patients for ePROMs started in February 2024, and data collection is expected to continue until March 2025. Interviews with members of the cancer care team began in November 2024. Full analysis should be completed by September 2025. Conclusions: This study will clarify how, why, for whom, and under what conditions TM can complement current care models. Our evaluability assessment will help to address implementation complexities and better understand intervention-to-practice operationalization so that implementation might be adapted to contextual factors without potentially harmful or inequitable impacts on patients. International Registered Report Identifier (IRRID): DERR1-10.2196/63099 UR - https://www.researchprotocols.org/2025/1/e63099 UR - http://dx.doi.org/10.2196/63099 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/63099 ER - TY - JOUR AU - Tang, Dongmei AU - Peng, Yuzhu AU - Gu, Dantong AU - Wu, Yongzhen AU - Li, Huawei PY - 2025/1/17 TI - Digital Frequency Customized Relieving Sound for Chronic Subjective Tinnitus Management: Prospective Controlled Study JO - J Med Internet Res SP - e60150 VL - 27 KW - tinnitus KW - digital frequency customized relieving sound KW - unmodified music KW - sound therapy KW - prospective study KW - mobile phone N2 - Background: Tinnitus is a major health issue, but currently no tinnitus elimination treatments exist for chronic subjective tinnitus. Acoustic therapy, especially personalized acoustic therapy, plays an increasingly important role in tinnitus treatment. With the application of smartphones, personalized acoustic stimulation combined with smartphone apps will be more conducive to the individualized treatment and management of patients with tinnitus. Objective: The aim of this study was to evaluate the efficacy of a new personalized approach known as the digital frequency customized relieving sound (DFCRS) for tinnitus treatment and to explore the factors that may influence its therapeutic effect. Methods: Patients with subjective tinnitus were enrolled in this study from July 14, 2020, to May 24, 2021, in the tinnitus specialist clinic of Eye and ENT Hospital, Fudan University, Shanghai, China. In this nonrandomized concurrent controlled trial, a total of 107 participants were assigned to listen to personalized DFCRS through our developed app, while the other 77 participants who did not want to download and use the app were assigned to listen to unmodified music (UM). All the recruits were instructed to listen to DFCRS or UM for at least 2 hours a day and complete follow-up assessments at baseline, 1, 2, and 3 months. Multidimensional assessment scales, that is, Tinnitus Handicapped Inventory (THI), Hospital Anxiety and Depression Scale (HADS), Athens Insomnia Scale (AIS), Fear of Tinnitus Questionnaire (FTQ), and Tinnitus Catastrophizing Scale (TCS) were used to evaluate the severity of tinnitus and the quality of life. Linear mixed models were used to test for changes in the THI scores across 3 months of acoustic treatment between group (DFCRS or UM treatment) and time. A multiclass logistic model was built with a stepwise function to determine the influence of the different covariates on the effects of acoustic treatment. Results: The results of the multidimensional assessment scales after 3 months of treatment showed that DFCRS-treated patients had significant tinnitus relief compared to those in the UM group. Linear mixed models revealed a significant reduction in the THI scores over time (P<.001), with the DFCRS group showing significantly greater improvement than the UM group (P<.001). At 3 months, 92.5% (99/107) of the patients undergoing DFCRS reported tinnitus relief or disappearance, and longer daily treatment time was associated with better outcomes (P=.007). Multiclass logistic regression confirmed that longer treatment time (odds ratio [OR] 13.07-64.78; P<.001) and more severe tinnitus at baseline (OR 10.46-83.71; P<.001) predicted better treatment response. All secondary outcomes (HADS, AIS, FTQ, TCS) showed significant improvements over time (P<.001). Conclusions: Our study suggests that DFCRS is a new promising and noninvasive therapy for chronic tinnitus, and it can be delivered through a mobile app to bring more convenience to patients with tinnitus. UR - https://www.jmir.org/2025/1/e60150 UR - http://dx.doi.org/10.2196/60150 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/60150 ER - TY - JOUR AU - Vestergaard, Bech Sofie AU - Roost, Mette AU - Christiansen, Hřyrup David AU - Schougaard, Valen Liv Marit PY - 2025/1/14 TI - Determinants of Dropping Out of Remote Patient-Reported Outcome?Based Follow-Up Among Patients With Epilepsy: Prospective Cohort Study JO - JMIR Form Res SP - e58258 VL - 9 KW - patient-reported outcome measures KW - dropouts KW - digital solutions KW - outpatient care KW - epilepsy KW - seizure disorder KW - neurological condition KW - cohort study KW - health care KW - Denmark KW - self-reported KW - self-management KW - mental health KW - patient satisfaction KW - logistic regression KW - social support N2 - Background: The use of patient-reported outcome (PRO) measures is an emerging field in health care. In the Central Denmark Region, epilepsy outpatients can participate in remote PRO-based follow-up by completing a questionnaire at home instead of attending a traditional outpatient appointment. This approach aims to encourage patient engagement and is used in approximately half of all epilepsy outpatient consultations. However, dropout in this type of follow-up is a challenging issue. Objective: This study aimed to examine the association between potential self-reported determinants and dropout in remote PRO-based follow-up for patients with epilepsy. Methods: This prospective cohort study (n=2282) explored the association between dropout in remote PRO-based follow-up for patients with epilepsy and 9 potential determinants covering 3 domains: health-related self-management, general and mental health status, and patient satisfaction. The associations were examined using multiple logistic regression analyses with adjustment for sex, age, education, and cohabitation. Results: A total of 770 patients (33.7%) dropped out of remote PRO-based follow-up over 5 years. Statistically significant associations were identified between all potential determinants and dropouts in PRO-based follow-up. Patients with low social support had an odds ratio of 2.20 (95% CI 1.38-3.50) for dropout. Patients with poor health ratings had an odds ratio of 2.17 (95% CI 1.65-2.85) for dropout. Similar estimates were identified for the remaining determinants in question. Conclusions: Patients with reduced self-management, poor health status, and low patient satisfaction had higher odds of dropout in remote PRO-based follow-up. However, further research is needed to determine the reasons for dropout. UR - https://formative.jmir.org/2025/1/e58258 UR - http://dx.doi.org/10.2196/58258 ID - info:doi/10.2196/58258 ER - TY - JOUR AU - Bartel, Christianna AU - Chen, Leeann AU - Huang, Weiyu AU - Li, Qichang AU - Li, Qingyang AU - Fedor, Jennifer AU - Durica, C. Krina AU - Low, A. Carissa PY - 2025/1/10 TI - Design and Use of Patient-Facing Electronic Patient-Reported Outcomes and Sensor Data Visualizations During Outpatient Chemotherapy JO - JMIR Cancer SP - e62711 VL - 11 KW - oncology KW - cancer KW - data visualization KW - remote monitoring KW - mobile technology KW - patients KW - outpatient KW - chemotherapy KW - symptoms KW - side effects KW - cancer treatment KW - electronic patient-reported outcome KW - online KW - monitoring KW - self-management UR - https://cancer.jmir.org/2025/1/e62711 UR - http://dx.doi.org/10.2196/62711 ID - info:doi/10.2196/62711 ER - TY - JOUR AU - Cinotti, Raphael AU - Derouin, Yvan AU - Chenet, Amandine AU - Oujamaa, Lydia AU - Glize, Bertrand AU - Launey, Yoann AU - Dahyot-Fizelier, Claire AU - Cartron, Emmanuelle AU - Renvoise, Melodie AU - Sautenet, Benedicte AU - Sebille, Veronique PY - 2025/1/9 TI - Standardized Outcomes for Randomized Controlled Trials Targeting Early Interventions in Patients With Moderate-to-Severe Traumatic Brain Injury: Protocol for the Development of a Core Outcome Set JO - JMIR Res Protoc SP - e54525 VL - 14 KW - core outcome set KW - outcomes research KW - patient-centered outcomes KW - traumatic brain injury KW - patient outcome KW - head trauma KW - patient-centered N2 - Background: : With more than 60 million new cases around the world each year, traumatic brain injury (TBI) causes substantial mortality and morbidity. Managing TBI is a major human, social, and economic concern. In the last 20 years, there has been an increase in clinical trials in neurocritical care, leading mostly to negative results. The evaluation of neurological outcomes, predominantly as primary outcomes, using clinical scales (Glasgow Outcome Scale) has limitations that could explain these results. Moreover, patient-centered outcomes are seldom reported despite their recognized clinical relevance. Objective: : The aim of this project is to establish a core outcome set (COS) for patients with moderate-to-severe TBI in randomized control trials in neurocritical care research. Methods: This study will follow five distinct steps: (1) systematic review to identify outcomes that have been reported in trials; (2) semistructured interviews with patients and their families to identify their priorities after TBI and explore potential patient-centered outcomes; (3) health care stakeholder focus groups with clinicians, researchers, and policy makers to describe potential outcomes; (4) an eDelphi survey with stakeholder groups to make a list of previously identified core outcomes; and (5) a consensus workshop to establish a COS for moderate-to-severe TBI clinical trials. Results: : The systematic review was published in August 2024. Regarding Step 2, 30 semistructured interviews of patients and relatives were performed from July 2021 to December 2023, and analyses were completed in October 2024. Step 3 is currently under development, and Step 4 is planned for the end of 2025. Step 5 is expected to occur during fall/winter 2026.Conclusions: Establishing a COS, to be consistently measured and reported in TBI trials in neurocritical care will ensure rigorous reporting, avoid bias, and improve the integrity, transparency, and usability of clinical research. The French context of the study is the main limitation, but we are seeking international collaboration on the project. The results of each step of the project will be disseminated through abstracts, publications, and patient associations. Conclusions: Establishing a COS, to be consistently measured and reported in TBI trials in neurocritical care will ensure rigorous reporting, avoid bias, and improve the integrity, transparency, and usability of clinical research. The French context of the study is the main limitation, but we are seeking international collaboration on the project. The results of each step of the project will be disseminated through abstracts, publications, and patient associations. International Registered Report Identifier (IRRID): DERR1-10.2196/54525 UR - https://www.researchprotocols.org/2025/1/e54525 UR - http://dx.doi.org/10.2196/54525 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/54525 ER - TY - JOUR AU - Su, Jianwei AU - Ye, Cuiling AU - Zhang, Qian AU - Liang, Yi AU - Wu, Jianwei AU - Liang, Guixi AU - Cheng, Yalan AU - Yang, Xiaojuan PY - 2025/1/1 TI - Impact of Remote Symptom Management on Exercise Adherence After Video-Assisted Thoracic Surgery for Lung Cancer in a Tertiary Hospital in China: Protocol for a Prospective Randomized Controlled Trial JO - JMIR Res Protoc SP - e60420 VL - 14 KW - thoracic surgery KW - rehabilitation medicine KW - patient-reported outcome measures KW - patient participation KW - telemedicine KW - eHealth KW - mobile phone N2 - Background: Regular pulmonary rehabilitation exercises are crucial for patients with lung cancer after surgery. However, poor adherence to outpatient exercises is difficult to address due to inadequate supervision. The integration of remote symptom management through electronic patient-reported outcomes (ePROs) offers a potential solution to improve adherence by enabling more effective monitoring and intervention. Objective: This study aims to evaluate the impact of ePRO-based remote symptom management on enhancing adherence to outpatient pulmonary rehabilitation exercises following video-assisted thoracic surgery for lung cancer. Methods: In this single-center, prospective, randomized controlled trial, 736 patients undergoing minimally invasive lung resection will be recruited. All patients will use a smartphone app for perioperative management, allowing periodic PRO measurement and recording of exercise participation. Upon discharge, patients will be randomly assigned 1:1 into either an intervention or control group. The intervention group will complete the Perioperative Symptom Assessment for Patients Undergoing Lung Surgery (PSA-Lung) scale on the day of discharge and postdischarge days 3, 7, 14, 21, and 28. Alerts will be triggered at the provider side if any of the 5 core symptoms (pain, cough, shortness of breath, sleep disturbance, and fatigue) scored ?4, prompting remote symptom management. The control group will complete the PRO measures without triggering alerts. The primary outcome is the rehabilitation exercise adherence rate. Secondary outcomes include postdischarge pulmonary complication rate, 30-day readmission rate, trajectory of symptom severity changes, exercise participation rate, and patient satisfaction. Results: The enrollment of study participants started in December 2023 and is expected to end in March 2025. The final comprehensive analysis of the results is planned for May 2025, after all data have been collected and thoroughly reviewed. Conclusions: This study is among the first to investigate the feasibility and effectiveness of ePRO-based remote symptom management in enhancing rehabilitation adherence after video-assisted thoracic surgery for lung cancer. If successful, this approach could significantly influence postoperative care practices and potentially be adopted in similar settings. Trial Registration: ClinicalTrials.gov NCT05990946; https://clinicaltrials.gov/study/NCT05990946 International Registered Report Identifier (IRRID): DERR1-10.2196/60420 UR - https://www.researchprotocols.org/2025/1/e60420 UR - http://dx.doi.org/10.2196/60420 UR - http://www.ncbi.nlm.nih.gov/pubmed/39610048 ID - info:doi/10.2196/60420 ER - TY - JOUR AU - Rong, Jian AU - Pathiravasan, H. Chathurangi AU - Zhang, Yuankai AU - Faro, M. Jamie AU - Wang, Xuzhi AU - Schramm, Eric AU - Borrelli, Belinda AU - Benjamin, J. Emelia AU - Liu, Chunyu AU - Murabito, M. Joanne PY - 2024/12/31 TI - Baseline Smartphone App Survey Return in the Electronic Framingham Heart Study Offspring and Omni 1 Study: eCohort Study JO - JMIR Aging SP - e64636 VL - 7 KW - mHealth KW - mobile health KW - mobile application KW - smartphone KW - digital health KW - digital technology KW - digital intervention KW - gerontology KW - geriatric KW - older adult KW - aging KW - eFHS KW - eCohort KW - smartphone app KW - baseline app surveys KW - Framingham Heart Study KW - health information KW - information collection KW - mobile phone N2 - Background: Smartphone apps can be used to monitor chronic conditions and offer opportunities for self-assessment conveniently at home. However, few digital studies include older adults. Objective: We aim to describe a new electronic cohort of older adults embedded in the Framingham Heart Study including baseline smartphone survey return rates and survey completion rates by smartphone type (iPhone [Apple Inc] and Android [Google LLC] users). We also aim to report survey results for selected baseline surveys and participant experience with this study?s app. Methods: Framingham Heart Study Offspring and Omni (multiethnic cohort) participants who owned a smartphone were invited to download this study?s app that contained a range of survey types to report on different aspects of health including self-reported measures from the Patient-Reported Outcomes Measurement Information System (PROMIS). iPhone users also completed 4 tasks including 2 cognitive and 2 physical function testing tasks. Baseline survey return and completion rates were calculated for 12 surveys and compared between iPhone and Android users. We calculated standardized scores for the PROMIS surveys. The Mobile App Rating Scale (MARS) was deployed 30 days after enrollment to obtain participant feedback on app functionality and aesthetics. Results: We enrolled 611 smartphone users (average age 73.6, SD 6.3 y; n=346, 56.6% women; n=88, 14.4% Omni participants; 478, 78.2% iPhone users) and 596 (97.5%) returned at least 1 baseline survey. iPhone users had higher app survey return rates than Android users for each survey (range 85.5% to 98.3% vs 73.8% to 95.2%, respectively), but survey completion rates did not differ in the 2 smartphone groups. The return rate for the 4 iPhone tasks ranged from 80.9% (380/470) for the gait task to 88.9% (418/470) for the Trail Making Test task. The Electronic Framingham Heart Study participants had better standardized t scores in 6 of 7 PROMIS surveys compared to the general population mean (t score=50) including higher cognitive function (n=55.6) and lower fatigue (n=45.5). Among 469 participants who returned the MARS survey, app functionality and aesthetics was rated high (total MARS score=8.6 on a 1?10 scale). Conclusions: We effectively engaged community-dwelling older adults to use a smartphone app designed to collect health information relevant to older adults. High app survey return rates and very high app survey completion rates were observed along with high participant rating of this study?s app. UR - https://aging.jmir.org/2024/1/e64636 UR - http://dx.doi.org/10.2196/64636 ID - info:doi/10.2196/64636 ER - TY - JOUR AU - Abogazalah, Naif AU - Yiannoutsos, Constantin AU - Soto-Rojas, E. Armando AU - Bindayeld, Naif AU - Yepes, F. Juan AU - Martinez Mier, Angeles Esperanza PY - 2024/12/20 TI - Distal and Proximal Influences on Self-Reported Oral Pain and Self-Rated Oral Health Status in Saudi Arabia: Retrospective Study Using a 2017 Nationwide Database JO - JMIR Public Health Surveill SP - e53585 VL - 10 KW - dental health surveys KW - nationwide database KW - public health dentistry KW - path analysis KW - oral health influences KW - oral pain KW - self-rated oral health KW - cross-sectional study KW - dental health KW - dentistry KW - oral health KW - self-reported KW - retrospective study KW - Saudi Arabia KW - proximal KW - distal KW - adult KW - children KW - youth KW - adolescent KW - teen KW - sociodemographic N2 - Background: Oral health significantly influences overall well-being, health care costs, and quality of life. In Saudi Arabia, the burden of oral diseases, such as dental caries and periodontal disease, has increased over recent decades, driven by various lifestyle changes. Objective: To explore the associations between proximal (direct) and distal (indirect) influences that affect oral pain (OP) and self-rated oral health (SROH) status in the Kingdom of Saudi Arabia (KSA) using an adapted conceptual framework. Methods: This retrospective cross-sectional study used data from a national health survey conducted in KSA in 2017. The sample included adults (N=29,274), adolescents (N=9910), and children (N=11,653). Sociodemographic data, health characteristics, and access to oral health services were considered distal influences, while frequency and type of dental visits, tooth brushing frequency, smoking, and consumption of sweets and soft drinks were considered proximal influences. Path analysis modeling was used to estimate the direct, indirect, and total effects of proximal and distal influences on OP and SROH status. Results: The mean age of adult respondents was 42.2 years; adolescents, 20.4 years; and children, 10.58 years. Despite OP reports from 39% of children, 48.5% of adolescents, and 47.1% of adults, over 87% across all groups rated their oral health as good, very good, or excellent. A higher frequency of tooth brushing showed a strong inverse relationship with OP and a positive correlation with SROH (P<.001). Frequent dental visits were positively associated with OP and negatively with SROH (P<.001). Sweet consumption increased OP in adolescents (?=0.033, P=.007) and negatively affected SROH in children (?=?0.086, P<.001), adolescents (?=?0.079, P<.001), and adults (?=?0.068, P<.001). Soft drink consumption, however, was associated with lower OP in adolescents (?=?0.034, P=.005) and improved SROH in adolescents (?=0.063, P<.001) and adults (?=0.068, P<.001). Smoking increased OP in adults (?=0.030, P<.001). Distal influences like higher education were directly linked to better SROH (?=0.046, P=.003) and less OP (indirectly through tooth brushing, ?=?0.004, P<.001). For children, high household income correlated with less OP (?=?0.030, P=.02), but indirectly increased OP through other pathways (?=0.024, P=.003). Lack of access was associated with negative oral health measures (P<.001). Conclusions: Among the KSA population, OP and SROH were directly influenced by many proximal and distal influences that had direct, indirect, or combined influences on OP and SROH status. UR - https://publichealth.jmir.org/2024/1/e53585 UR - http://dx.doi.org/10.2196/53585 UR - http://www.ncbi.nlm.nih.gov/pubmed/39706582 ID - info:doi/10.2196/53585 ER - TY - JOUR AU - Feng, Y. Kent AU - Short, A. Sarah AU - Saeb, Sohrab AU - Carroll, K. Megan AU - Olivier, B. Christoph AU - Simard, P. Edgar AU - Swope, Susan AU - Williams, Donna AU - Eckstrand, Julie AU - Pagidipati, Neha AU - Shah, H. Svati AU - Hernandez, F. Adrian AU - Mahaffey, W. Kenneth PY - 2024/12/20 TI - Resting Heart Rate and Associations With Clinical Measures From the Project Baseline Health Study: Observational Study JO - J Med Internet Res SP - e60493 VL - 26 KW - resting heart rate KW - wearable devices KW - remote monitoring KW - physiology KW - PBHS KW - Project Baseline Health Study KW - Verily Study Watch KW - heart rate KW - observational study KW - cohort study KW - wearables KW - electrocardiogram KW - regression analyses KW - socioeconomic status KW - medical condition KW - vital signs KW - laboratory assessments KW - physical function KW - electronic health KW - eHealth N2 - Background: Though widely used, resting heart rate (RHR), as measured by a wearable device, has not been previously evaluated in a large cohort against a variety of important baseline characteristics. Objective: This study aimed to assess the validity of the RHR measured by a wearable device compared against the gold standard of ECG (electrocardiography), and assess the relationships between device-measured RHR and a broad range of clinical characteristics. Methods: The Project Baseline Health Study (PHBS) captured detailed demographic, occupational, social, lifestyle, and clinical data to generate a deeply phenotyped cohort. We selected an analysis cohort within it, which included participants who had RHR determined by both ECG and the Verily Study Watch (VSW). We examined the correlation between these simultaneous RHR measures and assessed the relationship between VSW RHR and a range of baseline characteristics, including demographic, clinical, laboratory, and functional assessments. Results: From the overall PBHS cohort (N=2502), 875 (35%) participants entered the analysis cohort (mean age 50.9, SD 16.5 years; n=519, 59% female and n=356, 41% male). The mean and SD of VSW RHR was 66.6 (SD 11.2) beats per minute (bpm) for female participants and 64.4 (SD 12.3) bpm for male participants. There was excellent reliability between the two measures of RHR (ECG and VSW) with an intraclass correlation coefficient of 0.946. On univariate analyses, female and male participants had similar baseline characteristics that trended with higher VSW RHR: lack of health care insurance (both P<.05), higher BMI (both P<.001), higher C-reactive protein (both P<.001), presence of type 2 diabetes mellitus (both P<.001) and higher World Health Organization Disability Assessment Schedule (WHODAS) 2.0 score (both P<.001) were associated with higher RHR. On regression analyses, within each domain of baseline characteristics (demographics and socioeconomic status, medical conditions, vitals, physical function, laboratory assessments, and patient-reported outcomes), different characteristics were associated with VSW RHR in female and male participants. Conclusions: RHR determined by the VSW had an excellent correlation with that determined by ECG. Participants with higher VSW RHR had similar trends in socioeconomic status, medical conditions, vitals, laboratory assessments, physical function, and patient-reported outcomes irrespective of sex. However, within each domain of baseline characteristics, different characteristics were most associated with VSW RHR in female and male participants. Trial Registration: ClinicalTrials.gov NCT03154346; https://clinicaltrials.gov/study/NCT03154346 UR - https://www.jmir.org/2024/1/e60493 UR - http://dx.doi.org/10.2196/60493 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/60493 ER - TY - JOUR AU - McCann, Lisa AU - Lewis, Liane AU - Oduntan, Olubukola AU - Harris, Jenny AU - Darley, Andrew AU - Berg, V. Geir AU - Lubowitzki, Simone AU - Cheevers, Katy AU - Miller, Morven AU - Armes, Jo AU - Ream, Emma AU - Fox, Patricia AU - Furlong, Patricia Eileen AU - Gaiger, Alexander AU - Kotronoulas, Grigorios AU - Patiraki, Elisabeth AU - Katsaragakis, Stylianos AU - McCrone, Paul AU - Miaskowski, Christine AU - Cardone, Antonella AU - Orr, Dawn AU - Flowerday, Adrian AU - Skene, Simon AU - Moore, Margaret AU - De Souza, Nicosha AU - Donnan, Peter AU - Maguire, Roma PY - 2024/12/3 TI - Patients? and Clinicians? Experiences Using a Real-Time Remote Monitoring System for Chemotherapy Symptom Management (ASyMS): Qualitative Study JO - J Med Internet Res SP - e53834 VL - 26 KW - cancer KW - clinician experiences KW - digital interventions KW - patient experiences KW - remote monitoring KW - qualitative methods N2 - Background: Patients receiving chemotherapy require ongoing symptom monitoring and management to optimize their outcomes. In recent years, digital remote monitoring interventions have emerged to provide enhanced cancer care delivery experiences to patients and clinicians. However, patient and clinician experiential evaluations of these technologies are rare. Therefore, we explored user experiences and perceptions of one such intervention?Advanced Symptom Management System (ASyMS)?after its scaled deployment in the context of the Electronic Symptom Management System Remote Technology (eSMART) trial. The eSMART trial was a large, multicenter randomized controlled trial to evaluate the efficacy of ASyMS in 12 clinical sites in 5 European countries. Objective: In this qualitative study, both patients? and clinicians? experiences of using ASyMS for up to 6 cycles of chemotherapy were explored to understand the impact of ASyMS on patients? experiences, clinical practice, and supportive care delivery. Methods: For this analysis, individual, semistructured, one-to-one interviews with 29 patients with breast, colorectal, and hematological cancers and 18 clinicians from Austria, Greece, Ireland, Norway, and the United Kingdom were conducted. Interviews focused on patients? and clinicians? experiences of using ASyMS, care organization and changes in practice following the introduction of ASyMS, perceived changes in care associated with the use of ASyMS, and its potential for future integration into routine chemotherapy care pathways. Results: Thematic analysis identified several themes that describe patients? and clinicians? experiences using ASyMS. One central orienting theme?ASyMS as a facilitator of change?was supported by 5 key themes associated with human and technology monitoring: reassurance, enhanced communications and relationships, knowing what is ?normal? and what is to be expected, enhancing cancer care experiences, and informing future cancer care. Conclusions: This study is the first to evaluate both patients? and clinicians? experiences of using a digital health intervention to remotely monitor chemotherapy symptoms across 5 countries. Experiences with ASyMS were positive from both patients? and clinicians? perspectives, although some improvements to support the wider-scale rollout and sustained implementation were identified. Overall, this study demonstrates that real-time remote monitoring systems can help patients feel more reassured during their chemotherapy treatments and can help clinicians provide the right care, at the right time, and in the right place. Trial Registration: ClinicalTrials.gov NCT02356081; https://clinicaltrials.gov/study/NCT02356081 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2016-015016 UR - https://www.jmir.org/2024/1/e53834 UR - http://dx.doi.org/10.2196/53834 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/53834 ER - TY - JOUR AU - Wagenaar, Josephine AU - Mah, Crystal AU - Bodell, Fredrik AU - Reiss, Irwin AU - Kleinsmann, Maaike AU - Obermann-Borst, Sylvia AU - Taal, Rob H. PY - 2024/12/2 TI - Opportunities for Telemedicine to Improve Parents? Well-Being During the Neonatal Care Journey: Scoping Review JO - JMIR Pediatr Parent SP - e60610 VL - 7 KW - telemedicine KW - telehealth KW - neonatal care KW - parental well-being KW - family-centered care KW - pediatrics KW - neonates KW - newborns KW - parents KW - neonatal intensive care unit KW - NICU N2 - Background: Neonatal intensive care unit admissions of newborns are emotional and stressful for parents, influencing their mental and physical well-being and resulting in high rates of psychological morbidities. Significant research has been undertaken to understand and quantify the burden of a newborn?s medical journey on parents? well-being. Simultaneously, an increase has been observed in the development and implementation of telemedicine interventions, defined as the remote delivery of health care. Telemedicine is used as an overarching term for different technological interventions grouped as real-time audio-visual communication, remote patient monitoring, and asynchronous communication. Various telemedicine interventions have been proposed and developed but scarcely with the primary goal of improving parental well-being during their newborn?s medical journey. Objective: This study aims to identify telemedicine interventions with the potential to improve parents? well-being and to present the methods used to measure their experience. Methods: A scoping review was conducted, including empirical studies evaluating telemedicine in neonatal care that either measured parental well-being or included parents in the evaluation. Abstract and title screening, full-text screening, and data extraction were performed by three researchers. Two researchers were needed to reach decisions on both the inclusion and extraction of articles. Results: The review included 50 out of 737 screened articles. Telemedicine interventions focused mainly on daily visits at the neonatal intensive care unit and discharge preparedness for parents. Surveys were the primary tool used for outcome measurement (36/50, 72%). Aspects of parents? well-being were evaluated in 62% (31/50) of studies. Telemedicine interventions developed to provide education and support showed a potential to improve self-efficacy and discharge preparedness and decrease anxiety and stress when they included a real-time telemedicine component. Conclusions: This scoping review identified specific telemedicine interventions, such as real-time audio-visual communication and eHealth apps, that have the potential to improve parental well-being by enhancing self-efficacy and discharge preparedness, and reducing anxiety and stress. However, more insights are needed to understand how these interventions affect well-being. Parents should be included in future research in both the development and evaluation stages. It is important to not only measure parents? perceptions but also focus on the impact of a telemedicine intervention on their well-being. UR - https://pediatrics.jmir.org/2024/1/e60610 UR - http://dx.doi.org/10.2196/60610 ID - info:doi/10.2196/60610 ER - TY - JOUR AU - Chen, You AU - Lehmann, U. Christoph AU - Malin, Bradley PY - 2024/12/2 TI - Digital Information Ecosystems in Modern Care Coordination and Patient Care Pathways and the Challenges and Opportunities for AI Solutions JO - J Med Internet Res SP - e60258 VL - 26 KW - patient care pathway KW - care journey KW - care coordination KW - digital information ecosystem KW - digital technologies KW - artificial intelligence KW - information interoperability KW - information silos KW - workload KW - information retrieval KW - care transitions KW - patient-reported outcome measures KW - clinical workflow KW - usability KW - user experience workflow KW - health care information systems KW - networks of health care professionals KW - patient information flow UR - https://www.jmir.org/2024/1/e60258 UR - http://dx.doi.org/10.2196/60258 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/60258 ER - TY - JOUR AU - Mitchell, E. Suzanne AU - Kallen, A. Michael AU - Troost, P. Jonathan AU - De La Cruz, A. Barbara AU - Bragg, Alexa AU - Martin-Howard, Jessica AU - Moldovan, Ioana AU - Miner, A. Jennifer AU - Jack, W. Brian AU - Carlozzi, E. Noelle PY - 2024/11/22 TI - Four New Patient-Reported Outcome Measures Examining Health-Seeking Behavior in Persons With Type 2 Diabetes Mellitus (REDD-CAT): Instrument Development Study JO - JMIR Diabetes SP - e63434 VL - 9 KW - diabetes mellitus KW - social determinants of health KW - patient-reported outcome measures KW - outcomes assessment KW - health care KW - patient reported KW - health-seeking behavior KW - type 2 diabetes KW - hospitalization KW - diabetes computer adaptive test KW - primary care KW - socioeconomic KW - assessments N2 - Background: The management of type 2 diabetes mellitus (T2DM) includes mastery of complex care activities, self-management skills, and routine health care encounters to optimize glucose control and achieve good health. Given the lifelong course of T2DM, patients are faced with navigating complex medical and disease-specific information. This health-seeking behavior is a driver of health disparities and is associated with hospitalization and readmission. Given that health-seeking behavior is a potentially intervenable social determinant of health, a better understanding of how people navigate these complex systems is warranted. Objective: To address this need, we aimed to develop new patient-reported outcome (PRO) measures that evaluate health-seeking behavior in persons with T2DM. These new PROs were designed to be included in the Re-Engineered Discharge for Diabetes-Computer Adaptive Test (REDD-CAT) measurement system, which includes several other PROs that capture the importance of social determinants of health. Methods: Overall, 225 participants with T2DM completed 56 self-report items that examined health-seeking behaviors. Classical Test Theory and Item Response Theory were used for measurement development. Exploratory factor analysis (EFA; criterion ratio of eigenvalue 1 to eigenvalue 2 being >4; variance for eigenvalue 1 ?40%) and confirmatory factor analysis (CFA; criterion 1-factor CFA loading <.50; 1-factor CFA residual correlation >.20; comparative fit index ?0.90; Tucker-Lewis index ?0.90; root mean square error of approximation <0.15) were used to determine unidimensional sets of items. Items with sparse responses, low-adjusted total score correlations, nonmonotonicity, low factor loading, and high residual correlations of high error modification indices were candidates for exclusion. A constrained graded response model was used to examine item misfit, and differential item functioning was examined to identify item bias. Cronbach ? was used to examine internal consistency reliability for the new PROs (criterion ?0.70), and floor and ceiling effects were examined (criterion ?20%). Results: Four unidimensional sets of items were supported by EFA (all EFA eigenvalue ratios >4; variance for eigenvalue 1=41.4%-67.3%) and CFA (fit statistics all exceeded criterion values). This included (1) ?Health-Seeking Behavior: PCP-Specific? (6 items); (2) ?Health-Seeking Behavior: General Beliefs? (13 items); (3) ?Health-Seeking Behavior: Family or Friends-Specific? (5 items); and (4) ?Health-Seeking Behavior: Internet-Specific? (4 items). All items were devoid of differential item functioning for age, sex, education, or socioeconomic status factors. ?Health-Seeking Behavior: General Beliefs? was developed to include both a computer adaptive test and a 6-item short form version; all other PROs were developed as static short forms. The psychometric reliability of these new PROs was supported; internal consistency ranged from acceptable to excellent (Cronbach ?=.78-.91), and measures were free of significant floor or ceiling effects (floor effects range: 0%-8.9%; ceiling effects range: 0%-8.4%). Conclusions: The new REDD-CAT Health-Seeking Behavior PROs provide reliable assessments of health-seeking behaviors among those with T2DM. UR - https://diabetes.jmir.org/2024/1/e63434 UR - http://dx.doi.org/10.2196/63434 UR - http://www.ncbi.nlm.nih.gov/pubmed/39576685 ID - info:doi/10.2196/63434 ER - TY - JOUR AU - Kissler, Katherine AU - Phillippi, C. Julia AU - Erickson, Elise AU - Holmes, Leah AU - Tilden, Ellen PY - 2024/11/8 TI - Collecting Real-Time Patient-Reported Outcome Data During Latent Labor: Feasibility Study of the MyCap Mobile App in Prospective Person-Centered Research JO - JMIR Form Res SP - e59155 VL - 8 KW - patient-reported outcomes KW - survey methods KW - smartphone KW - labor onset KW - prodromal symptoms KW - prospective studies N2 - Background: The growing emphasis on patient experience in medical research has increased the focus on patient-reported outcomes and symptom measures. However, patient-reported outcomes data are subject to recall bias, limiting reliability. Patient-reported data are most valid when reported by patients in real time; however, this type of data is difficult to collect from patients experiencing acute health events such as labor. Mobile technologies such as the MyCap app, integrated with the REDCap (Research Electronic Data Capture) platform, have emerged as tools for collecting patient-generated health data in real time offering potential improvements in data quality and relevance. Objective: This study aimed to evaluate the feasibility of using MyCap for real-time, patient-reported data collection during latent labor. The objective was to assess the usability of MyCap in characterizing patient experiences during this acute health event and to identify any challenges in data collection that could inform future research. Methods: In this descriptive cohort study, we quantified and characterized data collected prospectively through MyCap and the extent to which participants engaged with the app as a research tool for collecting patient-reported data in real time. Longitudinal quantitative and qualitative surveys were sent to (N=18) enrolled patients with term pregnancies planning vaginal birth at Oregon Health Sciences University. Participants were trained in app use prenatally. Then participants were invited to initiate the research survey on their personal smartphone via MyCap when they experienced labor symptoms and were asked to return to MyCap every 3 hours to provide additional longitudinal symptom data. Results: Out of 18 enrolled participants, 17 completed the study. During latent labor, 13 (76.5%) participants (all those who labored at home and two-thirds of those who were induced) recorded at least 1 symptom report during latent labor. A total of 191 quantitative symptom reports (mean of 10 per participant) were recorded. The most commonly reported symptoms were fatigue, contractions, and pain, with nausea and diarrhea being less frequent but more intense. Four participants recorded qualitative data during labor and 14 responded to qualitative prompts in the postpartum period. The study demonstrated that MyCap could effectively capture real-time patient-reported data during latent labor, although qualitative data collection during active symptoms was less robust. Conclusions: MyCap is a feasible tool for collecting prospective data on patient-reported symptoms during latent labor. Participants engaged actively with quantitative symptom reporting, though qualitative data collection was more challenging. The use of MyCap appears to reduce recall bias and facilitate more accurate data collection for patient-reported symptoms during acute health events outside of health care settings. Future research should explore strategies to enhance qualitative data collection and assess the tool?s usability across more diverse populations and disease states. UR - https://formative.jmir.org/2024/1/e59155 UR - http://dx.doi.org/10.2196/59155 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/59155 ER - TY - JOUR AU - Kumar, Komal AU - Childs, W. Amber AU - Kohlmeier, Jonathan AU - Kroll, Elizabeth AU - Zant, Izabella AU - Stolzenbach, Stephanie AU - Fenkel, Caroline PY - 2024/10/23 TI - Measurement-Based Care in a Remote Intensive Outpatient Program: Pilot Implementation Initiative JO - JMIR Form Res SP - e58994 VL - 8 KW - measurement-based care KW - MBC KW - remote KW - intensive outpatient program KW - IOP KW - mental health KW - implementation N2 - Background: The ongoing mental health crisis, especially among youth, has led to a greater demand for intensive treatment at the intermediate level, such as intensive outpatient programs (IOPs). Defining best practices in remote IOPs more broadly is critical to understanding the impact of these offerings for individuals with high-acuity mental health service needs in the outpatient setting. Measurement-based care (MBC), or the routine and systematic collection of patient-reported data throughout the course of care to make meaningful changes to treatment, is one such practice that has been shown to improve patient outcomes in mental health treatment. Despite the literature linking MBC to beneficial clinical outcomes, the adoption of MBC in clinical practice has been slow and inconsistent, and more research is needed around MBC in youth-serving settings. Objective: The aim of this paper is to help bridge these gaps, illustrating the implementation of MBC within an organization that provides remote-first, youth-oriented IOP for individuals with high-acuity psychiatric needs. Methods: A series of 2 quality improvement pilot studies were conducted with select clinicians and their clients at Charlie Health, a remote IOP program that treats high-acuity teenagers and young adults who present with a range of mental health disorders. Both studies were carefully designed, including thorough preparation and planning, clinician training, feedback collection, and data analysis. Using process evaluation data, MBC deployment was repeatedly refined to enhance the clinical workflow and clinician experience. Results: The survey completion rate was 80.08% (3216/4016) and 86.01% (4218/4904) for study 1 and study 2, respectively. Quantitative clinician feedback showed marked improvement from study 1 to study 2. Rates of successful treatment completion were 22% and 29% higher for MBC pilot clients in study 1 and study 2, respectively. Depression, anxiety, and psychological well-being symptom reduction were statistically significantly greater for MBC pilot clients (P<.05). Conclusions: Our findings support the feasibility and clinician acceptability of a rigorous MBC process in a real-world, youth-serving, remote-first, intermediate care setting. High survey completion data across both studies and improved clinician feedback over time suggest strong clinician buy-in. Client outcomes data suggest MBC is positively correlated with increased treatment completion and symptom reduction. This paper provides practical guidance for MBC implementation in IOPs and can extend to other mental health care settings. UR - https://formative.jmir.org/2024/1/e58994 UR - http://dx.doi.org/10.2196/58994 UR - http://www.ncbi.nlm.nih.gov/pubmed/39441653 ID - info:doi/10.2196/58994 ER - TY - JOUR AU - van Engen, Veerle AU - Bonfrer, Igna AU - Ahaus, Kees AU - Den Hollander-Ardon, Monique AU - Peters, Ingrid AU - Buljac-Samardzic, Martina PY - 2024/10/18 TI - Enhancing Clinicians? Use of Electronic Patient-Reported Outcome Measures in Outpatient Care: Mixed Methods Study JO - J Med Internet Res SP - e60306 VL - 26 KW - patient-reported outcome measure KW - value-based health care KW - implementation KW - clinician KW - behavior KW - barrier KW - facilitator KW - strategies KW - professionalization KW - mixed methods N2 - Background: Despite the increasing use of patient-reported outcome measures (PROMs) for collecting self-reported data among hospital outpatients, clinicians? use of these data remains suboptimal. Insight into this issue and strategies to enhance the use of PROMs are critical but limited. Objective: This study aimed to examine clinicians? use of PROM data for value-based outpatient consultations and identify efforts to enhance their use of PROMs in a Dutch university hospital. First, we aimed to investigate clinicians? use of outpatients? PROM data in 2023, focusing on adoption, implementation, and maintenance. Second, we aimed to develop insights into the organizational-level strategies implemented to enhance clinicians? use of PROM data from 2020 to 2023. This included understanding the underlying rationales for these strategies and identifying strategies that appeared to be missing to address barriers or leverage facilitators. Third, we aimed to explore the key factors driving and constraining clinicians? use of PROMs in 2023. Methods: We integrated data from 4 sources: 1-year performance data on clinicians? use of PROMs (n=70 subdepartments), internal hospital documents from a central support team (n=56), a survey among clinicians (n=47), and interviews with individuals contributing to the organizational-level implementation of PROMs (n=20). The Reach, Effectiveness, Adoption, Implementation, and Maintenance framework was used to analyze clinicians? adoption, implementation, and maintenance of PROMs. Strategies were analyzed using the Expert Recommendations for Implementing Change taxonomy, and results were structured around the constructs of capability, opportunity, and motivation. Results: On average, around 2023, clinicians accessed PROM data for approximately 3 of 20 (14%) patients during their outpatient consultation, despite numerous strategies to improve this practice. We identified issues in adoption, implementation, and maintenance. The hospital?s strategies, shaped organically and pragmatically, were related to 27 (37%) out of 73 Expert Recommendations for Implementing Change strategies. These strategies focused on enhancing clinicians? capability, opportunity, and motivation. We found shortcomings in the quality of execution and completeness of strategies in relation to addressing all barriers and leveraging facilitators. We identified variations in the factors influencing the use of PROMs among frequent PROM users, occasional users, and nonusers. Challenges to effective facilitation were apparent, with certain desired strategies being unfeasible or impeded. Conclusions: Enhancing clinicians? use of PROMs has remained challenging despite various strategies aimed at improving their capability, opportunity, and motivation. The use of PROMs may require more substantial changes than initially expected, necessitating a shift in clinicians? professional attitudes and practices. Hospitals can facilitate rather than manage clinicians? genuine use of PROMs. They must prioritize efforts to engage clinicians with PROMs for value-based outpatient care. Specific attention to their professionalization may be warranted. Tailored strategies, designed to address within-group differences in clinicians? needs and motivation, hold promise for future efforts. UR - https://www.jmir.org/2024/1/e60306 UR - http://dx.doi.org/10.2196/60306 UR - http://www.ncbi.nlm.nih.gov/pubmed/39422999 ID - info:doi/10.2196/60306 ER - TY - JOUR AU - Bischof, Yvonne Anja AU - Kuklinski, David AU - Salvi, Irene AU - Walker, Carla AU - Vogel, Justus AU - Geissler, Alexander PY - 2024/10/2 TI - A Collection of Components to Design Clinical Dashboards Incorporating Patient-Reported Outcome Measures: Qualitative Study JO - J Med Internet Res SP - e55267 VL - 26 KW - clinical dashboards KW - design components KW - patient-reported outcome measures (PROMs) KW - patient-reported outcomes (PROs) N2 - Background: A clinical dashboard is a data-driven clinical decision support tool visualizing multiple key performance indicators in a single report while minimizing time and effort for data gathering. Studies have shown that including patient-reported outcome measures (PROMs) in clinical dashboards supports the clinician?s understanding of how treatments impact patients? health status, helps identify changes in health-related quality of life at an early stage, and strengthens patient-physician communication. Objective: This study aims to determine design components for clinical dashboards incorporating PROMs to inform software producers and users (ie, physicians). Methods: We conducted interviews with software producers and users to test preselected design components. Furthermore, the interviews allowed us to derive additional components that are not outlined in existing literature. Finally, we used inductive and deductive coding to derive a guide on which design components need to be considered when building a clinical dashboard incorporating PROMs. Results: A total of 25 design components were identified, of which 16 were already surfaced during the literature search. Furthermore, 9 additional components were derived inductively during our interviews. The design components are clustered in a generic dashboard, PROM-related, adjacent information, and requirements for adoption components. Both software producers and users agreed on the primary purpose of a clinical dashboard incorporating PROMs to enhance patient communication in outpatient settings. Dashboard benefits include enhanced data visualization and improved workflow efficiency, while interoperability and data collection were named as adoption challenges. Consistency in dashboard design components is preferred across different episodes of care, with adaptations only for disease-specific PROMs. Conclusions: Clinical dashboards have the potential to facilitate informed treatment decisions if certain design components are followed. This study establishes a comprehensive framework of design components to guide the development of effective clinical dashboards incorporating PROMs in health care practice. UR - https://www.jmir.org/2024/1/e55267 UR - http://dx.doi.org/10.2196/55267 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/55267 ER - TY - JOUR AU - Griffin, C. Ashley AU - Mentch, Lucas AU - Lin, Feng-Chang AU - Chung, E. Arlene PY - 2024/9/24 TI - mHealth Physical Activity and Patient-Reported Outcomes in Patients With Inflammatory Bowel Diseases: Cluster Analysis JO - J Med Internet Res SP - e48020 VL - 26 KW - inflammatory bowel diseases KW - patient-reported outcome measures KW - cluster analysis KW - wearable electronic devices KW - medical informatics KW - mHealth KW - mobile health KW - physical activity KW - bowel disease KW - psychosocial KW - smartphone KW - wearables KW - mobile phone N2 - Background: Regular physical activity is associated with improved quality of life in patients with inflammatory bowel diseases (IBDs), although much of the existing research is based on self-reported data. Wearable devices provide objective data on many rich physical activity dimensions including steps, duration, distance, and intensity. Little is known about how patients with IBDs engage in these varying dimensions of exercise and how it may influence their symptom and disease-specific patient-reported outcomes (PROs). Objective: This study aims to (1) cluster physical activity patterns from consumer-grade wearable devices and (2) assess the relationship between the clusters and PROs in patients with IBDs. Methods: We conducted a cross-sectional and longitudinal cohort study among adults with IBDs in the Crohn?s and Colitis Foundation IBD Partners cohort. Participants contribute physical activity data through smartphone apps or wearable devices in a bring-your-own-device model. Participants also complete biannual PRO questionnaires from the Patient-Reported Outcomes Measurement Information System short forms and IBD-specific questionnaires. K-means cluster analysis was used to generate physical activity clusters based on 3 key features: number of steps, duration of moderate to vigorous activity (minutes), and distance of activity (miles). Based on the clusters, we conducted a cross-sectional analysis to examine differences in mean questionnaire scores and participant characteristics using one-way ANOVA and chi-square tests. We also conducted a longitudinal analysis to examine individual cluster transitions among participants who completed multiple questionnaires, and mean differences in questionnaire scores were compared using 2-tailed paired sample t tests across 6-month periods. Results: Among 430 participants comprising 1255 six-week physical activity periods, we identified clusters of low (33.7%, n=423), moderate (46%, n=577), and high (20.3%, n=255) physical activity. Scores varied across clusters for depression (P=.004), pain interference (P<.001), fatigue (P<.001), sleep disturbance (P<.001), social satisfaction (P<.001), and short Crohn Disease Activity Index (P<.001), with those in the low activity cluster having the worst scores. Sociodemographic characteristics also differed, and those with low physical activity were older (P=.002), had higher BMIs (P<.001), and had longer disease durations (P=.02) compared to other clusters. Among 246 participants who completed at least 2 consecutive questionnaires consisting of 726 questionnaire periods, 67.8% (n=492) remained in the same cluster, and only 1.2% (n=9) moved to or from the furthest clusters of low and high activity across 6-month periods. Conclusions: For patients with IBDs, there were positive associations between physical activity and PROs related to disease activity and psychosocial domains. Physical activity patterns mostly did not fluctuate over time, suggesting little variation in exercise levels in the absence of an intervention. The use of real-world data to identify subgroups with similar lifestyle behaviors could be leveraged to develop targeted interventions that provide support for psychosocial symptoms and physical activity for personalized IBD care. UR - https://www.jmir.org/2024/1/e48020 UR - http://dx.doi.org/10.2196/48020 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/48020 ER - TY - JOUR AU - Anthony, J. Samantha AU - Pol, J. Sarah AU - Selkirk, K. Enid AU - Matthiesen, Amarens AU - Klaassen, J. Robert AU - Manase, Dorin AU - Silva, Amanda AU - Barwick, Melanie AU - Stinson, N. Jennifer AU - Damer, Alameen AU - Ayibiowu, Mowa AU - Dong, X. Selina AU - Oreskovich, Stephan AU - Brudno, Michael PY - 2024/9/19 TI - User-Centered Design and Usability of Voxe as a Pediatric Electronic Patient-Reported Outcome Measure Platform: Mixed Methods Evaluation Study JO - JMIR Hum Factors SP - e57984 VL - 11 KW - eHealth KW - end user engagement KW - mobile phone KW - patient-reported outcome KW - patient-reported outcome measures KW - pediatric KW - user-centered design N2 - Background: Electronic patient-reported outcome measures (ePROMs) are standardized digital instruments integrated into clinical care to collect subjective data regarding patients? health-related quality of life, functional status, and symptoms. In documenting patient-reported progress, ePROMs can guide treatment decisions and encourage measurement-based care practices. Voxe is a pediatric and user-centered ePROM platform for patients with chronic health conditions. Objective: We aimed to describe the user-centered design approach involving feedback from end users and usability testing of Voxe?s platform features to support implementation in a pediatric health care setting. Methods: Purposive sampling was used to recruit patients aged 8-17 years from 2 chronic illness populations in 2 pediatric hospitals in Canada. Patients? health care team members were also purposively recruited. One-on-one iterative testing sessions were conducted digitally by research team members with participants to obtain feedback on the appearance and functionalities of the Voxe platform prototype. Patients and health care providers (HCPs) completed Voxe-related task-based activities. International Organization for Standardization key performance indicators were tracked during HCP task-based activities. HCPs also completed the System Usability Scale. To test platform usability, the think-aloud technique was used by participants during the completion of structured tasks. After completing all task-based activities, patient participants selected 5 words from the Microsoft Desirability Toolkit to describe their overall impression and experience with the Voxe platform. Qualitative data about likes, dislikes, and ease of use were collected through semistructured interviews. Feedback testing sessions were conducted with patients and HCPs until Voxe was acceptable to participating end users, with no further refinements identified. Quantitative and qualitative data analysis were completed using descriptive statistics and content analysis. Results: A total of 49 patients and 38 HCPs were recruited. Patients were positive about Voxe?s child-centered design characteristics and notification settings. HCPs rated Voxe as user-friendly and efficient, with the time to complete tasks decreasing over time. HCPs were satisfied with the Voxe platform functionalities and identified the value of Voxe?s system notifications, summarized display of ePROM results, and its capacity to integrate with electronic medical records. Patients? and HCPs? high satisfaction rates with the Voxe prototype highlight the importance of being responsive to user suggestions from the inception of eHealth platform developments to ensure their efficient and effective design. Conclusions: This paper describes the user-centered creation and usability testing of Voxe as an ePROM platform for implementation into clinical care for pediatric patients with chronic health conditions. As a patient-facing platform that can be integrated into electronic medical records, Voxe aligns with measurement-based care practices to foster quality patient-centered approaches to care. End users? positive feedback and evaluation of the platform?s user-friendliness and efficiency suggest that Voxe represents a valuable and promising solution to systematically integrate patient-related outcome (PRO) data into complex and dynamic clinical health care settings. International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2021-053119 UR - https://humanfactors.jmir.org/2024/1/e57984 UR - http://dx.doi.org/10.2196/57984 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/57984 ER - TY - JOUR AU - Attamimi, Sultan AU - Marshman, Zoe AU - Deery, Christopher AU - Radley, Stephen AU - Gilchrist, Fiona PY - 2024/9/17 TI - A Behavior-Based Model to Validate Electronic Systems Designed to Collect Patient-Reported Outcomes: Model Development and Application JO - JMIR Form Res SP - e56370 VL - 8 KW - patient-reported outcome KW - PRO KW - electronic PRO KW - user acceptance testing KW - system validation KW - patient-reported outcomes KW - electronic PROs KW - user acceptance KW - validation model KW - paediatric dentistry N2 - Background: The merits of technology have been adopted in capturing patient-reported outcomes (PROs) by incorporating PROs into electronic systems. Following the development of an electronic system, evaluation of system performance is crucial to ensuring the collection of meaningful data. In contemporary PRO literature, electronic system validation is overlooked, and evidence on validation methods is lacking. Objective: This study aims to introduce a generalized concept to guide electronic patient-reported outcome (ePRO) providers in planning for system-specific validation methods. Methods: Since electronic systems are essentially products of software engineering endeavors, electronic systems used to collect PRO should be viewed from a computer science perspective with consideration to the health care environment. On this basis, a testing model was blueprinted and applied to a newly developed ePRO system designed for clinical use in pediatric dentistry (electronic Personal Assessment Questionnaire-Paediatric Dentistry) to investigate its thoroughness. Results: A behavior-based model of ePRO system validation was developed based on the principles of user acceptance testing and patient-centered care. The model allows systematic inspection of system specifications and identification of technical errors through simulated positive and negative usage pathways in open and closed environments. The model was able to detect 15 positive errors with 1 unfavorable response when applied to electronic Personal Assessment Questionnaire-Paediatric Dentistry system testing. Conclusions: The application of the behavior-based model to a newly developed ePRO system showed a high ability for technical error detection in a systematic fashion. The proposed model will increase confidence in the validity of ePRO systems as data collection tools in future research and clinical practice. UR - https://formative.jmir.org/2024/1/e56370 UR - http://dx.doi.org/10.2196/56370 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/56370 ER - TY - JOUR AU - Yanez Touzet, Alvaro AU - Houhou, Tatiana AU - Rahic, Zerina AU - Laufer, Ilya AU - Margetis, Konstantinos AU - Martin, R. Allan AU - Dea, Nicolas AU - Ghogawala, Zoher AU - Kapushesky, Misha AU - Kotter, N. Mark R. AU - Davies, M. Benjamin AU - PY - 2024/9/9 TI - Validity of a Smartphone App to Objectively Monitor Performance Outcomes in Degenerative Cervical Myelopathy: Preliminary Findings From a Longitudinal Observational Study JO - JMIR Neurotech SP - e52832 VL - 3 KW - validation study KW - patient outcome assessment KW - smartphone KW - neurology KW - psychometrics KW - validity KW - validation KW - outcomes KW - degenerative KW - myelopathy KW - neuroscience KW - spine KW - monitor KW - monitoring KW - neuromuscular KW - muscular KW - mHealth KW - apps KW - measure KW - measures KW - measurements N2 - Background: Developing new clinical measures for degenerative cervical myelopathy (DCM) is an AO Spine RECODE-DCM research priority. Difficulties detecting DCM, and changes in DCM, cause diagnostic and treatment delays in clinical settings and heightened costs in clinical trials due to elevated recruitment targets. Digital outcome measures can tackle these challenges due to their ability to measure disease remotely, repeatedly, and more economically. Objective: The study aims to assess the validity of MoveMed, a battery of performance outcome measures performed using a smartphone app, in the measurement of DCM. Methods: A prospective observational study in decentralized secondary care was performed in England, United Kingdom. Validity and risk of bias were assessed using criteria from the COSMIN (Consensus-Based Standards for the Selection of Health Measurement Instruments) manual. Each MoveMed outcome was compared with 2 patient-reported comparators, with a priori hypotheses of convergence or divergence tested against consensus thresholds. The primary outcome was the correlation coefficient between the MoveMed outcome and the patient-reported comparators. The secondary outcome was the percentage of correlations that aligned with the a priori hypotheses. The comparators used were the patient-derived modified Japanese Orthopaedic Association score and the World Health Organization Quality of Life Brief Version questionnaire. Thresholds for convergence or divergence were set at ?0.3 for convergence, <0.3 for divergence, and >0/<0 for directionality. Results: A total of 27 adults aged 60 (SD 11) years who live with DCM and possess an approved smartphone were included in a preliminary analysis. As expected, MoveMed tests of neuromuscular function correlated most with questionnaires of neuromuscular function (?0.3) and least with questionnaires of quality of life (<0.3). Furthermore, directly related constructs correlated positively to each other (>0), while inversely related constructs correlated negatively (<0). Overall, 74% (67/90) and 47% (8/17) of correlations (unidimensional and multidimensional, respectively) were in accordance with hypotheses. No risk-of-bias factors from the COSMIN Risk of Bias checklist were recorded. Overall, this was equivalent to ?very good? quality evidence of sufficient construct validity in DCM. Conclusions: MoveMed outcomes and patient-reported questionnaires converge and diverge in accordance with expectations. These findings support the validity of the MoveMed tests in an adult population living with DCM. Criteria from COSMIN provide ?very good? quality evidence to support this. UR - https://neuro.jmir.org/2024/1/e52832 UR - http://dx.doi.org/10.2196/52832 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/52832 ER - TY - JOUR AU - Roberts, Anne Natasha AU - Pelecanos, Anita AU - Alexander, Kimberly AU - Wyld, David AU - Janda, Monika PY - 2024/8/27 TI - Implementation of Patient-Reported Outcomes in a Medical Oncology Setting (the iPROMOS Study): Type II Hybrid Implementation Study JO - J Med Internet Res SP - e55841 VL - 26 KW - implementation science KW - iPARIHS KW - clinical practice KW - intervention KW - implementation KW - facilitator KW - facilitation KW - patient-reported outcomes, patient-reported outcome measures KW - oncology KW - symptom KW - symptoms KW - detection KW - investigate KW - service KW - services KW - clinic KW - clinics KW - Australia KW - binary logistic models KW - regression model KW - regression models KW - patient KW - patients KW - supportive care N2 - Background: Clinical trials have demonstrated that patient-reported outcome measures (PROMs) can improve mortality and morbidity outcomes when used in clinical practice. Objective: This study aimed to prospectively investigate the implementation of PROMs in routine oncology. Outcomes measured included improved symptom detection, clinical response to symptom information, and health service outcomes. Methods: Two of 12 eligible clinics were randomized to implement symptom PROMs in a medical oncology outpatient department in Australia. Randomization was carried out at the clinic level. Patients in control clinics continued with usual care; those in intervention clinics completed a symptom PROM at presentation. This was a pilot study investigating symptom detection, using binary logistic models, and clinical response to PROMs investigated using multiple regression models. Results: A total of 461 patient encounters were included, consisting of 242 encounters in the control and 222 in the intervention condition. Patients in these clinics most commonly had head and neck, lung, prostate, breast, or colorectal cancer and were seen in the clinic for surveillance and oral or systemic treatments for curative, metastatic, or palliative cancer care pathways. Compared with control encounters, the proportion of symptoms detected increased in intervention encounters (odds ratio 1.05, 95% CI 0.99-1.11; P=.08). The odds of receiving supportive care, demonstrated by nonroutine allied health review, increased in the intervention compared with control encounters (odds ratio 3.54, 95% CI 1.26-9.90; P=.02). Conclusions: Implementation of PROMs in routine care did not significantly improve symptom detection but increased the likelihood of nonroutine allied health reviews for supportive care. Larger studies are needed to investigate health service outcomes. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618000398202; https://tinyurl.com/3cxbemy4 UR - https://www.jmir.org/2024/1/e55841 UR - http://dx.doi.org/10.2196/55841 UR - http://www.ncbi.nlm.nih.gov/pubmed/39190468 ID - info:doi/10.2196/55841 ER - TY - JOUR AU - Tanaka, L. Hideaki AU - Rees, R. Judy AU - Zhang, Ziyin AU - Ptak, A. Judy AU - Hannigan, M. Pamela AU - Silverman, M. Elaine AU - Peacock, L. Janet AU - Buckey, C. Jay AU - PY - 2024/8/20 TI - Emerging Indications for Hyperbaric Oxygen Treatment: Registry Cohort Study JO - Interact J Med Res SP - e53821 VL - 13 KW - hyperbaric oxygen KW - inflammatory bowel disease KW - calciphylaxis KW - post?COVID-19 condition KW - PCC KW - postacute sequelae of COVID-19 KW - PASC KW - infected implanted hardware KW - hypospadias KW - frostbite KW - facial filler KW - pyoderma gangrenosum N2 - Background: Hyperbaric oxygen (HBO2) treatment is used across a range of medical specialties for a variety of applications, particularly where hypoxia and inflammation are important contributors. Because of its hypoxia-relieving and anti-inflammatory effects HBO2 may be useful for new indications not currently approved by the Undersea and Hyperbaric Medical Society. Identifying these new applications for HBO2 is difficult because individual centers may only treat a few cases and not track the outcomes consistently. The web-based International Multicenter Registry for Hyperbaric Oxygen Therapy captures prospective outcome data for patients treated with HBO2 therapy. These data can then be used to identify new potential applications for HBO2, which has relevance for a range of medical specialties. Objective: Although hyperbaric medicine has established indications, new ones continue to emerge. One objective of this registry study was to identify cases where HBO2 has been used for conditions falling outside of current Undersea and Hyperbaric Medical Society?approved indications and present outcome data for them. Methods: This descriptive study used data from a web-based, multicenter, international registry of patients treated with HBO2. Participating centers agree to collect data on all patients treated using standard outcome measures, and individual centers send deidentified data to the central registry. HBO2 treatment programs in the United States, the United Kingdom, and Australia participate. Demographic, outcome, complication, and treatment data, including pre- and posttreatment quality of life questionnaires (EQ-5D-5L) were collected for individuals referred for HBO2 treatment. Results: Out of 9726 patient entries, 378 (3.89%) individuals were treated for 45 emerging indications. Post?COVID-19 condition (PCC; also known as postacute sequelae of COVID-19; 149/378, 39.4%), ulcerative colitis (47/378, 12.4%), and Crohn disease (40/378, 10.6%) accounted for 62.4% (n=236) of the total cases. Calciphylaxis (20/378, 5.3%), frostbite (18/378, 4.8%), and peripheral vascular disease?related wounds (12/378, 3.2%) accounted for a further 13.2% (n=50). Patients with PCC reported significant improvement on the Neurobehavioral Symptom Inventory (NSI score: pretreatment=30.6; posttreatment=14.4; P<.001). Patients with Crohn disease reported significantly improved quality of life (EQ-5D score: pretreatment=53.8; posttreatment=68.8), and 5 (13%) reported closing a fistula. Patients with ulcerative colitis and complete pre- and post-HBO2 data reported improved quality of life and lower scores on a bowel questionnaire examining frequency, blood, pain, and urgency. A subset of patients with calciphylaxis and arterial ulcers also reported improvement. Conclusions: HBO2 is being used for a wide range of possible applications across various medical specialties for its hypoxia-relieving and anti-inflammatory effects. Results show statistically significant improvements in patient-reported outcomes for inflammatory bowel disease and PCC. HBO2 is also being used for frostbite, pyoderma gangrenosum, pterygium, hypospadias repair, and facial filler procedures. Other indications show evidence for improvement, and the case series for all indications is growing in the registry. International Registered Report Identifier (IRRID): RR2-10.2196/18857 UR - https://www.i-jmr.org/2024/1/e53821 UR - http://dx.doi.org/10.2196/53821 UR - http://www.ncbi.nlm.nih.gov/pubmed/39078624 ID - info:doi/10.2196/53821 ER - TY - JOUR AU - Choucair, Kareem AU - Corrigan, Mark AU - O'Sullivan, Adrian AU - Barber, Sean AU - Stankiewicz, Lucja AU - Henn, Patrick AU - Dennehy, Oscar AU - Kayyal, Yasser Mohd AU - Tan, Yu Yong AU - Fadahunsi, Philip Kayode AU - O'Donoghue, John PY - 2024/8/19 TI - Acceptability, Perceptions, and Experiences Regarding Electronic Patient-Reported Outcomes After Laparoscopic Cholecystectomy: Protocol for a Mixed Methods Feasibility Study JO - JMIR Res Protoc SP - e57344 VL - 13 KW - patient-reported outcomes KW - digital technology KW - hepatobiliary surgery KW - surgery KW - laparoscopic cholecystectomy KW - electronic patient KW - general surgeon KW - mixed methods KW - prospective study KW - quantitative KW - qualitative KW - Qualtrics KW - interview KW - Microsoft Teams KW - data collection KW - patient care KW - patient-centric KW - patient-doctor communication KW - eHealth N2 - Background: Patient-reported outcomes (PROs) can be defined as any report of a patient?s health taken directly from the patient. Routine collection of PRO data has been shown to offer potential benefits to patient-doctor communication. Electronic forms of PRO measures (PROMs) could be more beneficial in comparison to traditional PROMs in obtaining PROs from patients. However, it is currently unclear whether the routine collection of electronic PRO data could result in better outcomes for patients undergoing laparoscopic cholecystectomy (LC). Objective: This study aims to explore the perspectives of patients and surgeons on the use of electronic PROMs. Based on prior research, technical skill and experience level of the surgeon, long-term quality of life, patient involvement in decision-making, communication skills of the surgeon, cleanliness of the ward environment, and standards of nursing care are identified to be the most important factors for the patients. Methods: This is a mixed methods prospective study that will collect both quantitative (survey) and qualitative (interview) data. The study has two components. The first involves the distribution of an electronic presurvey to patients who received elective LC within 48 hours of their surgery (n=80). This survey will explore the perspective of patients regarding the procedure, hospital experience, long-term outcomes, and the perceived value of using PROMs. These patients will then be followed up after 1 year and given another survey. The second component involves the distribution of the same survey and the completion of structured interviews with general surgeons (n=10). The survey will ascertain what PROs from the participants are most useful for the surgeons and the interviews will focus on how the surgeons view routine PRO collection. A convenience sampling approach will be used. Surveys will be distributed through Qualtrics and interviews will be completed on Microsoft Teams. Results: Data collection began on February 14, 2023. As of February 12, 2024, 71 of 80 recruited patients have been given the presurvey. The follow-up with the patients and the general surgeon components of the study have not begun. The expected completion date of this study is in April 2025. Conclusions: Overall, this study will investigate the potential of electronic PRO collection to offer value for patients and general surgeons. This approach will ensure that patient care is investigated in a multifaceted way, offering patient-centric guidance to surgeons in their approach to care. International Registered Report Identifier (IRRID): DERR1-10.2196/57344 UR - https://www.researchprotocols.org/2024/1/e57344 UR - http://dx.doi.org/10.2196/57344 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/57344 ER - TY - JOUR AU - Nikkhah, Janis AU - Steinbeck, Viktoria AU - Grobe, G. Thomas AU - Breitkreuz, Thorben AU - Pross, Christoph AU - Busse, Reinhard PY - 2024/8/5 TI - Evaluating the Population-Based Usage and Benefit of Digitally Collected Patient-Reported Outcomes and Experiences in Patients With Chronic Diseases: The PROMchronic Study Protocol JO - JMIR Res Protoc SP - e56487 VL - 13 KW - health care policy KW - PROM KW - PREM KW - PRO feedback KW - health behavior KW - chronic disease KW - asthma KW - COPD KW - diabetes KW - coronary artery disease KW - value-based health care KW - quality of care KW - artery disease KW - chronic KW - self-management KW - effectiveness KW - Germany KW - cohort study KW - pulmonary disease KW - utilization N2 - Background: Chronic diseases are associated with a high disease burden. Under- and overprovision of care as well as quality variation between health care providers persists, while current quality indicators rarely capture the patients? perspective. Capturing patient-reported outcome measures (PROMs) as well as patient-reported experience measures (PREMs) is becoming more and more important to identify gaps in care provision, prioritize services most valuable to patients, and aid patients' self-management. Objective: This study aims to measure the potential benefits and effectiveness of using electronic patient-reported outcome measures (ePROMs) and electronic patient-reported experience measures in a structured and population-based manner to enhance health care for chronic disease patients in Germany. Methods: This prospective cohort study aims to evaluate the potential benefits of PROM usage in patients with chronic diseases. We evaluate whether (1) digitally collected PROMs and PREMs can be used for health system performance assessment by generating a representative response of chronically diseased individuals with asthma, chronic obstructive pulmonary disease, diabetes, and coronary artery disease across Germany, and (2) based on the PROMs and PREMs, low-value care can be identified. As patient-reported outcomes (PROs) are rarely presented back to patients, (3) this study also examines patients? reactions to their PROM scores in the form of digital PRO feedback. For these purposes, randomly selected patients from a nationwide German insurer are digitally surveyed with generic and disease-specific PROMs and PREMs, as well as additional questions on their health-related behavior, 4 times over 1 year. Individual PRO feedback is presented back to patients longitudinally and compared to a peer group after each survey period. Patient-reported data is linked with health insurance data. Response rates, changes in health and experience outcomes over time, self-reported changes in health behavior, and health care system usage will be analyzed. Results: The PROMchronic study explores the usage of PROMs in patients with chronic diseases. Data collection began in October 2023, after the initial invitation letter. All the 200,000 potential patients have been invited to participate in the study. Data have not yet been analyzed. Publication of the interim results is planned for the autumn of 2024, and the results are planned to be published in 2025. Conclusions: We aim to fill the research gap on the population-based usage of PROMs and PREMs in patients with chronic diseases and add to the current understanding of PROM data-sharing with patients. The study?s results can thereby inform whether a health care system-wide approach to collecting PROMs and PREMs can be used to identify low-value care, assess quality variation within and across chronic conditions, and determine whether PRO feedback is helpful and associated with any changes in patients? health behaviors. Trial Registration: German Clinical Trials Register DRKS00031656; https://drks.de/search/en/trial/DRKS00031656 International Registered Report Identifier (IRRID): DERR1-10.2196/56487 UR - https://www.researchprotocols.org/2024/1/e56487 UR - http://dx.doi.org/10.2196/56487 UR - http://www.ncbi.nlm.nih.gov/pubmed/39102279 ID - info:doi/10.2196/56487 ER - TY - JOUR AU - Perry, Betty Melissa AU - Taylor, Sally AU - Khatoon, Binish AU - Vercell, Amy AU - Faivre-Finn, Corinne AU - Velikova, Galina AU - Marsden, Antonia AU - Heal, Calvin AU - Yorke, Janelle PY - 2024/7/31 TI - Examining the Effectiveness of Electronic Patient-Reported Outcomes in People With Cancer: Systematic Review and Meta-Analysis JO - J Med Internet Res SP - e49089 VL - 26 KW - telemedicine KW - patient-reported outcome measure KW - neoplasms KW - quality of life KW - systematic review KW - meta-analysis KW - randomized controlled trial N2 - Background: Electronic patient-reported outcomes (ePROs) are commonly used in oncology clinical practice and have shown benefits for patients and health resource use. Objective: The aim of this study was to compare the isolated effect of administering ePROs to patients with cancer versus a control condition. Methods: The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed. Randomized controlled trials evaluating ePRO interventions that aimed to improve health-related outcomes among patients with cancer were included. The primary outcome was health-related quality of life (HRQOL), and the secondary outcomes were symptoms, hospital admissions, unplanned visits, chemotherapy completion, survival, and satisfaction with care. The effect sizes of ePROs on health-related outcomes were analyzed as standardized mean differences (SMDs) with 95% CIs using a random effects model. Results: The search identified 10,965 papers, of which 19 (0.17%) from 15 studies were included. The meta-analysis showed an improvement in HRQOL at 3 months, measured by the Functional Assessment of Cancer Therapy?General (SMD 0.29, 95% CI 0.19 to 0.39), and at 6 months, assessed using various HRQOL measures (SMD 0.21, 95% CI 0.11 to 0.30). Of the 15 studies, 9 (60%) reported a positive signal on HRQOL, with two-thirds of the studies (n=6, 67%) including tailored patient advice and two-thirds (n=6, 67%) using clinician alert systems. Conclusions: The meta-analysis showed an improvement in HRQOL at 6 months and in Functional Assessment of Cancer Therapy?General scores at 3 months for studies that included tailored advice and clinician alerts, suggesting that these elements may improve ePRO effectiveness. The findings will provide guidance for future use and help health care professionals choose the most suitable ePRO features for their patients. Trial Registration: PROSPERO CRD42020175007; https://tinyurl.com/5cwmy3j6 UR - https://www.jmir.org/2024/1/e49089 UR - http://dx.doi.org/10.2196/49089 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/49089 ER - TY - JOUR AU - Görges, Matthias AU - Sujan, Jonath AU - West, C. Nicholas AU - Sreepada, Syamala Rama AU - Wood, D. Michael AU - Payne, A. Beth AU - Shetty, Swati AU - Gelinas, P. Jean AU - Sutherland, M. Ainsley PY - 2024/7/2 TI - Postsurgical Pain Risk Stratification to Enhance Pain Management Workflow in Adult Patients: Design, Implementation, and Pilot Evaluation JO - JMIR Perioper Med SP - e54926 VL - 7 KW - patient-oriented research KW - patient-reported outcome measures KW - risk prediction KW - pain KW - individualized risk KW - surgery KW - anesthesia KW - opioid analgesia KW - short-term opioid use KW - care planning KW - digital health platforms N2 - Background: Exposure to opioids after surgery is the initial contact for some people who develop chronic opioid use disorder. Hence, effective postoperative pain management, with less reliance on opioids, is critical. The Perioperative Opioid Quality Improvement (POQI) program developed (1) a digital health platform leveraging patient-survey-reported risk factors and (2) a postsurgical pain risk stratification algorithm to personalize perioperative care by integrating several commercially available digital health solutions into a combined platform. Development was reduced in scope by the COVID-19 pandemic. Objective: This pilot study aims to assess the screening performance of the risk algorithm, quantify the use of the POQI platform, and evaluate clinicians? and patients? perceptions of its utility and benefit. Methods: A POQI platform prototype was implemented in a quality improvement initiative at a Canadian tertiary care center and evaluated from January to September 2022. After surgical booking, a preliminary risk stratification algorithm was applied to health history questionnaire responses. The estimated risk guided the patient assignment to a care pathway based on low or high risk for persistent pain and opioid use. Demographic, procedural, and medication administration data were extracted retrospectively from the electronic medical record. Postoperative inpatient opioid use of >90 morphine milligram equivalents per day was the outcome used to assess algorithm performance. Data were summarized and compared between the low- and high-risk groups. POQI use was assessed by completed surveys on postoperative days 7, 14, 30, 60, 90, and 120. Semistructured patient and clinician interviews provided qualitative feedback on the platform. Results: Overall, 276 eligible patients were admitted for colorectal procedures. The risk algorithm stratified 203 (73.6%) as the low-risk group and 73 (26.4%) as the high-risk group. Among the 214 (77.5%) patients with available data, high-risk patients were younger than low-risk patients (age: median 53, IQR 40-65 years, vs median 59, IQR 49-69 years, median difference five years, 95% CI 1-9; P=.02) and were more often female patients (45/73, 62% vs 80/203, 39.4%; odds ratio 2.5, 95% CI 1.4-4.5; P=.002). The risk stratification was reasonably specific (true negative rate=144/200, 72%) but not sensitive (true positive rate=10/31, 32%). Only 39.7% (85/214) patients completed any postoperative quality of recovery questionnaires (only 14, 6.5% patients beyond 60 days after surgery), and 22.9% (49/214) completed a postdischarge medication survey. Interviewed participants welcomed the initiative but noted usability issues and poor platform education. Conclusions: An initial POQI platform prototype was deployed operationally; the risk algorithm had reasonable specificity but poor sensitivity. There was a significant loss to follow-up in postdischarge survey completion. Clinicians and patients appreciated the potential impact of preemptively addressing opioid exposure but expressed shortcomings in the platform?s design and implementation. Iterative platform redesign with additional features and reevaluation are required before broader implementation. UR - https://periop.jmir.org/2024/1/e54926 UR - http://dx.doi.org/10.2196/54926 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/54926 ER - TY - JOUR AU - Mercadal-Orfila, Gabriel AU - Herrera-Pérez, Salvador AU - Piqué, Núria AU - Mateu-Amengual, Francesc AU - Ventayol-Bosch, Pedro AU - Maestre-Fullana, Antonia María AU - Serrano-López de las Hazas, Ignacio Joaquín AU - Fernández-Cortés, Francisco AU - Barceló-Sansó, Francesc AU - Rios, Santiago PY - 2024/6/28 TI - Implementing Systematic Patient-Reported Measures for Chronic Conditions Through the Naveta Value-Based Telemedicine Initiative: Observational Retrospective Multicenter Study JO - JMIR Mhealth Uhealth SP - e56196 VL - 12 KW - chronic conditions KW - eHealth KW - value-based care KW - patient-reported outcome measures KW - patient-reported experience measures KW - questionnaires KW - response rate KW - telemedicine platform N2 - Background: Patient-reported outcome and experience measures can play a critical role in providing patient-centered and value-based health care to a growing population of patients who are chronically ill. Value-based telemedicine platforms such as the Naveta initiative may facilitate the effective integration of these tools into health care systems. Objective: This study aims to evaluate the response rate to electronic patient-reported outcome measures (ePROMs) and electronic patient-reported experience measures (ePREMs) among patients participating in the Naveta telemedicine initiative and its correlations with sociodemographic and clinical characteristics, as well as the evolution of the response rates over time. Methods: Between January 1, 2021, and June 30, 2023, a total of 53,364 ePREMs and ePROMs for 20 chronic conditions were administered through the Naveta-Phemium platform. Descriptive statistics were used to summarize continuous and categorical variables. Differences in response rates within each sociodemographic variable were analyzed using logistic regression models, with significance assessed via chi-square and post hoc Tukey tests. Two-way ANOVA was used to examine the interaction between time interval and disease type on response rate evolution. Results: A total of 3372 patients with severe chronic diseases from 64 public hospitals in Spain participated in the Naveta health questionnaire project. The overall response rate to ePROMs and ePREMs during the first 2.5 years of the Naveta initiative was 46.12% (24,704/53,364), with a baseline rate of 53.33% (7198/13,496). Several sociodemographic factors correlated with lower response rates, including male gender, older age, lower education level, frequent alcohol use, being a student, and not being physically active. There were also significant variations in response rates among different types of chronic conditions (P<.001), with the highest rates being for respiratory (433/606, 71.5%), oncologic (200/319, 62.7%), digestive (2247/3601, 62.4%), and rheumatic diseases (7506/12,982, 57.82%) and the lowest being for HIV infection (7473/22,695, 32.93%). During the first 6 months of follow-up, the response rates decreased in all disease types, except in the case of the group of patients with oncologic disease, among whom the response rate increased up to 100% (6/6). Subsequently, the overall response rate approached baseline levels. Conclusions: Recognizing the influence of sociodemographic factors on response rates is critical to identifying barriers to participation in telemonitoring programs and ensuring inclusiveness in patient-centered health care practices. The observed decline in response rates at follow-up may be due to survey fatigue, highlighting the need for strategies to mitigate this effect. In addition, the variation in response rates across chronic conditions emphasizes the importance of tailoring telemonitoring approaches to specific patient populations. UR - https://mhealth.jmir.org/2024/1/e56196 UR - http://dx.doi.org/10.2196/56196 UR - http://www.ncbi.nlm.nih.gov/pubmed/38545697 ID - info:doi/10.2196/56196 ER - TY - JOUR AU - Kramer, Joanna AU - Wilens, E. Timothy AU - Rao, Vinod AU - Villa, Richard AU - Yule, M. Amy PY - 2024/6/25 TI - Feasibility of a 2-Part Substance Use Screener Self-Administered by Patients on Paper: Observational Study JO - JMIR Form Res SP - e52801 VL - 8 KW - patient reported outcome measures KW - patient reported outcomes KW - substance use screening KW - paper and pencil screening KW - screening KW - tobacco KW - prescription medication KW - medication KW - substance use KW - care KW - mental health KW - symptoms N2 - Background: Measurement-based care in behavioral health uses patient-reported outcome measures (PROMs) to screen for mental health symptoms and substance use and to assess symptom change over time. While PROMs are increasingly being integrated into electronic health record systems and administered electronically, paper-based PROMs continue to be used. It is unclear if it is feasible to administer a PROM on paper when the PROM was initially developed for electronic administration. Objective: This study aimed to examine the feasibility of patient self-administration of a 2-part substance use screener?the Tobacco, Alcohol, Prescription medications, and other Substances (TAPS)?on paper. This screener was originally developed for electronic administration. It begins with a limited number of questions and branches to either skip or reflex to additional questions based on an individual?s responses. In this study, the TAPS was adapted for paper use due to barriers to electronic administration within an urgent care behavioral health clinic at an urban health safety net hospital. Methods: From August 2021 to March 2022, research staff collected deidentified paper TAPS responses and tracked TAPS completion rates and adherence to questionnaire instructions. A retrospective chart review was subsequently conducted to obtain demographic information for the patients who presented to the clinic between August 2021 and March 2022. Since the initial information collected from TAPS responses was deidentified, demographic information was not linked to the individual TAPS screeners that were tracked by research staff. Results: A total of 507 new patients were seen in the clinic with a mean age of 38.7 (SD 16.6) years. In all, 258 (50.9%) patients were male. They were predominantly Black (n=212, 41.8%), White (n=152, 30%), and non-Hispanic or non-Latino (n=403, 79.5%). Most of the patients were publicly insured (n=411, 81.1%). Among these 507 patients, 313 (61.7%) completed the TAPS screener. Of these 313 patients, 76 (24.3%) adhered to the instructions and 237 (75.7%) did not follow the instructions correctly. Of the 237 respondents who did not follow the instructions correctly, 166 (70%) answered more questions and 71 (30%) answered fewer questions than required in TAPS part 2. Among the 237 patients who did not adhere to questionnaire instructions, 44 (18.6%) responded in a way that contradicted their response in part 1 of the screener and ultimately affected their overall TAPS score. Conclusions: It was challenging for patients to adhere to questionnaire instructions when completing a substance use screener on paper that was originally developed for electronic use. When selecting PROMs for measurement-based care, it is important to consider the structure of the questionnaire and how the PROM will be administered to determine if additional support for PROM self-administration needs to be implemented. UR - https://formative.jmir.org/2024/1/e52801 UR - http://dx.doi.org/10.2196/52801 UR - http://www.ncbi.nlm.nih.gov/pubmed/38916950 ID - info:doi/10.2196/52801 ER - TY - JOUR AU - Guardado, Sharon AU - Karampela, Maria AU - Isomursu, Minna AU - Grundstrom, Casandra PY - 2024/5/31 TI - Use of Patient-Generated Health Data From Consumer-Grade Devices by Health Care Professionals in the Clinic: Systematic Review JO - J Med Internet Res SP - e49320 VL - 26 KW - patient-generated health data KW - mHealth KW - health care professionals KW - mobile technologies KW - self-management N2 - Background: Mobile health (mHealth) uses mobile technologies to promote wellness and help disease management. Although mHealth solutions used in the clinical setting have typically been medical-grade devices, passive and active sensing capabilities of consumer-grade devices like smartphones and activity trackers have the potential to bridge information gaps regarding patients? behaviors, environment, lifestyle, and other ubiquitous data. Individuals are increasingly adopting mHealth solutions, which facilitate the collection of patient-generated health data (PGHD). Health care professionals (HCPs) could potentially use these data to support care of chronic conditions. However, there is limited research on real-life experiences of HPCs using PGHD from consumer-grade mHealth solutions in the clinical context. Objective: This systematic review aims to analyze existing literature to identify how HCPs have used PGHD from consumer-grade mobile devices in the clinical setting. The objectives are to determine the types of PGHD used by HCPs, in which health conditions they use them, and to understand the motivations behind their willingness to use them. Methods: A systematic literature review was the main research method to synthesize prior research. Eligible studies were identified through comprehensive searches in health, biomedicine, and computer science databases, and a complementary hand search was performed. The search strategy was constructed iteratively based on key topics related to PGHD, HCPs, and mobile technologies. The screening process involved 2 stages. Data extraction was performed using a predefined form. The extracted data were summarized using a combination of descriptive and narrative syntheses. Results: The review included 16 studies. The studies spanned from 2015 to 2021, with a majority published in 2019 or later. Studies showed that HCPs have been reviewing PGHD through various channels, including solutions portals and patients? devices. PGHD about patients? behavior seem particularly useful for HCPs. Our findings suggest that PGHD are more commonly used by HCPs to treat conditions related to lifestyle, such as diabetes and obesity. Physicians were the most frequently reported users of PGHD, participating in more than 80% of the studies. Conclusions: PGHD collection through mHealth solutions has proven beneficial for patients and can also support HCPs. PGHD have been particularly useful to treat conditions related to lifestyle, such as diabetes, cardiovascular diseases, and obesity, or in domains with high levels of uncertainty, such as infertility. Integrating PGHD into clinical care poses challenges related to privacy and accessibility. Some HCPs have identified that though PGHD from consumer devices might not be perfect or completely accurate, their perceived clinical value outweighs the alternative of having no data. Despite their perceived value, our findings reveal their use in clinical practice is still scarce. International Registered Report Identifier (IRRID): RR2-10.2196/39389 UR - https://www.jmir.org/2024/1/e49320 UR - http://dx.doi.org/10.2196/49320 UR - http://www.ncbi.nlm.nih.gov/pubmed/38820580 ID - info:doi/10.2196/49320 ER - TY - JOUR AU - Manz, R. Christopher AU - Schriver, Emily AU - Ferrell, J. William AU - Williamson, Joelle AU - Wakim, Jonathan AU - Khan, Neda AU - Kopinsky, Michael AU - Balachandran, Mohan AU - Chen, Jinbo AU - Patel, S. Mitesh AU - Takvorian, U. Samuel AU - Shulman, N. Lawrence AU - Bekelman, E. Justin AU - Barnett, J. Ian AU - Parikh, B. Ravi PY - 2024/5/17 TI - Association of Remote Patient-Reported Outcomes and Step Counts With Hospitalization or Death Among Patients With Advanced Cancer Undergoing Chemotherapy: Secondary Analysis of the PROStep Randomized Trial JO - J Med Internet Res SP - e51059 VL - 26 KW - wearables KW - accelerometers KW - patient-reported outcomes KW - step counts KW - oncology KW - accelerometer KW - patient-generated health data KW - cancer KW - death KW - chemotherapy KW - symptoms KW - gastrointestinal cancer KW - lung cancer KW - monitoring KW - symptom burden KW - risk KW - hospitalization KW - mobile phone N2 - Background: Patients with advanced cancer undergoing chemotherapy experience significant symptoms and declines in functional status, which are associated with poor outcomes. Remote monitoring of patient-reported outcomes (PROs; symptoms) and step counts (functional status) may proactively identify patients at risk of hospitalization or death. Objective: The aim of this study is to evaluate the association of (1) longitudinal PROs with step counts and (2) PROs and step counts with hospitalization or death. Methods: The PROStep randomized trial enrolled 108 patients with advanced gastrointestinal or lung cancers undergoing cytotoxic chemotherapy at a large academic cancer center. Patients were randomized to weekly text-based monitoring of 8 PROs plus continuous step count monitoring via Fitbit (Google) versus usual care.?This preplanned secondary analysis included 57 of 75 patients randomized to the intervention who had PRO and step count data. We analyzed the associations between PROs and mean daily step counts and the associations of PROs and step counts with the composite outcome of hospitalization or death using bootstrapped generalized linear models to account for longitudinal data. Results: Among 57 patients, the mean age was 57 (SD 10.9) years, 24 (42%) were female, 43 (75%) had advanced gastrointestinal cancer, 14 (25%) had advanced lung cancer, and 25 (44%) were hospitalized or died during follow-up. A 1-point weekly increase (on a 32-point scale) in aggregate PRO score was associated with 247 fewer mean daily steps (95% CI ?277 to ?213; P<.001). PROs most strongly associated with step count decline were patient-reported activity (daily step change ?892), nausea score (?677), and constipation score (524). A 1-point weekly increase in aggregate PRO score was associated with 20% greater odds of hospitalization or death (adjusted odds ratio [aOR] 1.2, 95% CI 1.1-1.4; P=.01). PROs most strongly associated with hospitalization or death were pain (aOR 3.2, 95% CI 1.6-6.5; P<.001), decreased activity (aOR 3.2, 95% CI 1.4-7.1; P=.01), dyspnea (aOR 2.6, 95% CI 1.2-5.5; P=.02), and sadness (aOR 2.1, 95% CI 1.1-4.3; P=.03). A decrease in 1000 steps was associated with 16% greater odds of hospitalization or death (aOR 1.2, 95% CI 1.0-1.3; P=.03). Compared with baseline, mean daily step count decreased 7% (n=274 steps), 9% (n=351 steps), and 16% (n=667 steps) in the 3, 2, and 1 weeks before hospitalization or death, respectively. Conclusions: In this secondary analysis of a randomized trial among patients with advanced cancer, higher symptom burden and decreased step count were independently associated with and predictably worsened close to hospitalization or death. Future interventions should leverage longitudinal PRO and step count data to target interventions toward patients at risk for poor outcomes. Trial Registration: ClinicalTrials.gov NCT04616768; https://clinicaltrials.gov/study/NCT04616768 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2021-054675 UR - https://www.jmir.org/2024/1/e51059 UR - http://dx.doi.org/10.2196/51059 UR - http://www.ncbi.nlm.nih.gov/pubmed/38758583 ID - info:doi/10.2196/51059 ER - TY - JOUR AU - Menger, S. Nick AU - Tognetti, Arnaud AU - Farruggia, C. Michael AU - Mucignat, Carla AU - Bhutani, Surabhi AU - Cooper, W. Keiland AU - Rohlfs Domínguez, Paloma AU - Heinbockel, Thomas AU - Shields, C. Vonnie D. AU - D'Errico, Anna AU - Pereda-Loth, Veronica AU - Pierron, Denis AU - Koyama, Sachiko AU - Croijmans, Ilja PY - 2024/5/10 TI - Giving a Voice to Patients With Smell Disorders Associated With COVID-19: Cross-Sectional Longitudinal Analysis Using Natural Language Processing of Self-Reports JO - JMIR Public Health Surveill SP - e47064 VL - 10 KW - parosmia KW - anosmia KW - phantosmia KW - hyposmia KW - hyperosmia KW - long-hauler KW - sentiment classification KW - web-based study KW - COVID-19 KW - smell disorders N2 - Background: Smell disorders are commonly reported with COVID-19 infection. The smell-related issues associated with COVID-19 may be prolonged, even after the respiratory symptoms are resolved. These smell dysfunctions can range from anosmia (complete loss of smell) or hyposmia (reduced sense of smell) to parosmia (smells perceived differently) or phantosmia (smells perceived without an odor source being present). Similar to the difficulty that people experience when talking about their smell experiences, patients find it difficult to express or label the symptoms they experience, thereby complicating diagnosis. The complexity of these symptoms can be an additional burden for patients and health care providers and thus needs further investigation. Objective: This study aims to explore the smell disorder concerns of patients and to provide an overview for each specific smell disorder by using the longitudinal survey conducted in 2020 by the Global Consortium for Chemosensory Research, an international research group that has been created ad hoc for studying chemosensory dysfunctions. We aimed to extend the existing knowledge on smell disorders related to COVID-19 by analyzing a large data set of self-reported descriptive comments by using methods from natural language processing. Methods: We included self-reported data on the description of changes in smell provided by 1560 participants at 2 timepoints (second survey completed between 23 and 291 days). Text data from participants who still had smell disorders at the second timepoint (long-haulers) were compared with the text data of those who did not (non?long-haulers). Specifically, 3 aims were pursued in this study. The first aim was to classify smell disorders based on the participants? self-reports. The second aim was to classify the sentiment of each self-report by using a machine learning approach, and the third aim was to find particular food and nonfood keywords that were more salient among long-haulers than those among non?long-haulers. Results: We found that parosmia (odds ratio [OR] 1.78, 95% CI 1.35-2.37; P<.001) as well as hyposmia (OR 1.74, 95% CI 1.34-2.26; P<.001) were more frequently reported in long-haulers than in non?long-haulers. Furthermore, a significant relationship was found between long-hauler status and sentiment of self-report (P<.001). Finally, we found specific keywords that were more typical for long-haulers than those for non?long-haulers, for example, fire, gas, wine, and vinegar. Conclusions: Our work shows consistent findings with those of previous studies, which indicate that self-reports, which can easily be extracted online, may offer valuable information to health care and understanding of smell disorders. At the same time, our study on self-reports provides new insights for future studies investigating smell disorders. UR - https://publichealth.jmir.org/2024/1/e47064 UR - http://dx.doi.org/10.2196/47064 UR - http://www.ncbi.nlm.nih.gov/pubmed/38728069 ID - info:doi/10.2196/47064 ER - TY - JOUR AU - Jia, Yan AU - Li, Qi AU - Zhang, Xiaowen AU - Yan, Yi AU - Yan, Shiyan AU - Li, Shunping AU - Li, Wei AU - Wu, Xiaowen AU - Rong, Hongguo AU - Liu, Jianping PY - 2024/5/8 TI - Application of Patient-Reported Outcome Measurements in Adult Tumor Clinical Trials in China: Cross-Sectional Study JO - J Med Internet Res SP - e45719 VL - 26 KW - patient-reported outcomes KW - tumor KW - cross-sectional study KW - quality of life KW - outcome study N2 - Background: International health policies and researchers have emphasized the value of evaluating patient-reported outcomes (PROs) in clinical studies. However, the characteristics of PROs in adult tumor clinical trials in China remain insufficiently elucidated. Objective: This study aims to assess the application and characteristics of PRO instruments as primary or secondary outcomes in adult randomized clinical trials related to tumors in China. Methods: This cross-sectional study identified tumor-focused randomized clinical trials conducted in China between January 1, 2010, and June 30, 2022. The ClinicalTrials.gov database and the Chinese Clinical Trial Registry were selected as the databases. Trials were classified into four groups based on the use of PRO instruments: (1) trials listing PRO instruments as primary outcomes, (2) trials listing PRO instruments as secondary outcomes, (3) trials listing PRO instruments as coprimary outcomes, and (4) trials without any mention of PRO instruments. Pertinent data, including study phase, settings, geographic regions, centers, participant demographics (age and sex), funding sources, intervention types, target diseases, and the names of PRO instruments, were extracted from these trials. The target diseases involved in the trials were grouped according to the American Joint Committee on Cancer Staging Manual, 8th Edition. Results: Among the 6445 trials examined, 2390 (37.08%) incorporated PRO instruments as part of their outcomes. Within this subset, 26.82% (641/2390) listed PRO instruments as primary outcomes, 52.72% (1260/2390) as secondary outcomes, and 20.46% (489/2390) as coprimary outcomes. Among the 2,155,306 participants included in these trials, PRO instruments were used to collect data from 613,648 (28.47%) patients as primary or secondary outcomes and from 74,287 (3.45%) patients as coprimary outcomes. The most common conditions explicitly using specified PRO instruments included thorax tumors (217/1280, 16.95%), breast tumors (176/1280, 13.75%), and lower gastrointestinal tract tumors (173/1280, 13.52%). Frequently used PRO instruments included the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire?30, the visual analog scale, the numeric rating scale, the Traditional Chinese Medicine Symptom Scale, and the Pittsburgh Sleep Quality Index. Conclusions: Over recent years, the incorporation of PROs has demonstrated an upward trajectory in adult randomized clinical trials on tumors in China. Nonetheless, the infrequent measurement of the patient?s voice remains noteworthy. Disease-specific PRO instruments should be more effectively incorporated into various tumor disease categories in clinical trials, and there is room for improvement in the inclusion of PRO instruments as clinical trial end points. UR - https://www.jmir.org/2024/1/e45719 UR - http://dx.doi.org/10.2196/45719 UR - http://www.ncbi.nlm.nih.gov/pubmed/38718388 ID - info:doi/10.2196/45719 ER - TY - JOUR AU - MacEwan, R. Sarah AU - Olvera, G. Ramona AU - Jonnalagadda, Pallavi AU - Fareed, Naleef AU - McAlearney, Scheck Ann PY - 2024/5/8 TI - Patient and Provider Perspectives About the Use of Patient-Generated Health Data During Pregnancy: Qualitative Exploratory Study JO - JMIR Form Res SP - e52397 VL - 8 KW - patient-generated health data KW - patient-centered care KW - obstetrics KW - postpartum period KW - qualitative methods N2 - Background: There is increasing interest in using patient-generated health data (PGHD) to improve patient-centered care during pregnancy. However, little research has examined the perspectives of patients and providers as they report, collect, and use PGHD to inform obstetric care. Objective: This study aims to explore the perspectives of patients and providers about the use of PGHD during pregnancy, including the benefits and challenges of reporting, collecting, and using these data, as well as considerations for expanding the use of PGHD to improve obstetric care. Methods: We conducted one-on-one interviews with 30 pregnant or postpartum patients and 14 health care providers from 2 obstetrics clinics associated with an academic medical center. Semistructured interview guides included questions for patients about their experience and preferences for sharing PGHD and questions for providers about current processes for collecting PGHD, opportunities to improve or expand the collection of PGHD, and challenges faced when collecting and using this information. Interviews were conducted by phone or videoconference and were audio recorded, transcribed verbatim, and deidentified. Interview transcripts were analyzed deductively and inductively to characterize and explore themes in the data. Results: Patients and providers described how PGHD, including physiologic measurements and experience of symptoms, were currently collected during and between in-person clinic visits for obstetric care. Both patients and providers reported positive perceptions about the collection and use of PGHD during pregnancy. Reported benefits of collecting PGHD included the potential to use data to directly inform patient care (eg, identify issues and adjust medication) and to encourage ongoing patient involvement in their care (eg, increase patient attention to their health). Patients and providers had suggestions for expanding the collection and use of PGHD during pregnancy, and providers also shared considerations about strategies that could be used to expand PGHD collection and use. These strategies included considering the roles of both patients and providers in reporting and interpreting PGHD. Providers also noted the need to consider the unintended consequences of using PGHD that should be anticipated and addressed. Conclusions: Acknowledging the challenges, suggestions, and considerations voiced by patients and providers can inform the development and implementation of strategies to effectively collect and use PGHD to support patient-centered care during pregnancy. UR - https://formative.jmir.org/2024/1/e52397 UR - http://dx.doi.org/10.2196/52397 UR - http://www.ncbi.nlm.nih.gov/pubmed/38718395 ID - info:doi/10.2196/52397 ER - TY - JOUR AU - Piontek, Katharina AU - Nestler, Sophie AU - Holm, Anne AU - Brodersen, Brandt John AU - Apfelbacher, Christian PY - 2024/5/7 TI - Content Validity and Psychometric Properties of the German Version of the Holm and Cordoba Urinary Tract Infection Score for Uncomplicated Urinary Tract Infections in Women: Protocol for a Validation Study JO - JMIR Res Protoc SP - e49903 VL - 13 KW - uncomplicated urinary tract infections KW - patient-reported outcome measures KW - PROM KW - PROMs KW - content validity KW - psychometric properties KW - patient reported KW - validity KW - validation KW - urology KW - urinary KW - urinary tract infection KW - UTI KW - psychometric KW - scale KW - score KW - scoring KW - assessment KW - women?s health KW - internal medicine KW - women KW - urinary tract infections KW - bacterial infection KW - primary care KW - infection N2 - Background: Uncomplicated urinary tract infections (UTIs) in women are among the most common bacterial infections in primary care. Given the health threats related to the overuse of antibiotics, alternative options are of increasing importance. Patient-reported outcome measures are valuable tools for including the patients? perspective when evaluating the efficacy of these strategies. Aiming to identify a suitable instrument to measure the severity and bothersomeness of UTI symptoms in women, we performed a systematic review of the literature and identified the Holm and Cordoba Urinary Tract Infection Score (HCUTI), which measures the severity, bothersomeness, and impact of uncomplicated UTIs on daily activities. This instrument showed sufficient content validity but needs translation and further validation before it can be used in German research. Objective: For use in the German setting, we aim (1) to perform translation and linguistic validation of the HCUTI and (2) to evaluate content validity and psychometric properties of the German version of the HCUTI in a population of women with uncomplicated UTIs. Methods: The HCUTI will be translated and linguistically validated using the dual-panel method. This process involves a bilingual translation panel and a lay panel to check the comprehensibility of the translation. Content validity of the translated questionnaire will be assessed using cognitive interviews according to the criteria for good content validity as recommended by the COSMIN (Consensus-based Standards for the selection of health Measurement Instruments) group involving women with uncomplicated UTIs and health care professionals. Subsequent psychometric validation of the German version of the HCUTI in a population of women with uncomplicated UTIs will include the assessment of structural validity, internal consistency, test-retest reliability, construct validity, responsiveness, and interpretability. Results: Results of the translation and linguistic validation process and the results of the content validity study were obtained in September 2023 and will be published separately. Data on the psychometric properties of the German version of the HCUTI are anticipated in mid-2024. Conclusions: We expect that data from the content validity study will provide important suggestions for potential modifications of the HCUTI for use in the German setting. The final version of the questionnaire will be used for the assessment of its psychometric properties in a large population of women with uncomplicated UTIs. International Registered Report Identifier (IRRID): PRR1-10.2196/49903 UR - https://www.researchprotocols.org/2024/1/e49903 UR - http://dx.doi.org/10.2196/49903 UR - http://www.ncbi.nlm.nih.gov/pubmed/38713509 ID - info:doi/10.2196/49903 ER - TY - JOUR AU - Trojan, Andreas AU - Kühne, Christian AU - Kiessling, Michael AU - Schumacher, Johannes AU - Dröse, Stefan AU - Singer, Christian AU - Jackisch, Christian AU - Thomssen, Christoph AU - Kullak-Ublick, A. Gerd PY - 2024/5/6 TI - Impact of Electronic Patient-Reported Outcomes on Unplanned Consultations and Hospitalizations in Patients With Cancer Undergoing Systemic Therapy: Results of a Patient-Reported Outcome Study Compared With Matched Retrospective Data JO - JMIR Form Res SP - e55917 VL - 8 KW - systemic cancer therapy KW - electronic patient-reported outcome KW - ePRO KW - ePROs KW - Consilium Care KW - medidux KW - unplanned consultation KW - hospitalization KW - hospitalizations KW - hospitalized KW - cancer KW - oncology KW - side effect KW - side effects KW - adverse KW - chemotherapy KW - patient reported outcome KW - PRO KW - PROs KW - mobile health KW - mHealth KW - app KW - apps KW - application KW - applications KW - mobile phone N2 - Background: The evaluation of electronic patient-reported outcomes (ePROs) is increasingly being used in clinical studies of patients with cancer and enables structured and standardized data collection in patients? everyday lives. So far, few studies or analyses have focused on the medical benefit of ePROs for patients. Objective: The current exploratory analysis aimed to obtain an initial indication of whether the use of the Consilium Care app (recently renamed medidux; mobile Health AG) for structured and regular self-assessment of side effects by ePROs had a recognizable effect on incidences of unplanned consultations and hospitalizations of patients with cancer compared to a control group in a real-world care setting without app use. To analyze this, the incidences of unplanned consultations and hospitalizations of patients with cancer using the Consilium Care app that were recorded by the treating physicians as part of the patient reported outcome (PRO) study were compared retrospectively to corresponding data from a comparable population of patients with cancer collected at 2 Swiss oncology centers during standard-of-care treatment. Methods: Patients with cancer in the PRO study (178 included in this analysis) receiving systemic therapy in a neoadjuvant or noncurative setting performed a self-assessment of side effects via the Consilium Care app over an observational period of 90 days. In this period, unplanned (emergency) consultations and hospitalizations were documented by the participating physicians. The incidence of these events was compared with retrospective data obtained from 2 Swiss tumor centers for a matched cohort of patients with cancer. Results: Both patient groups were comparable in terms of age and gender ratio, as well as the distribution of cancer entities and Joint Committee on Cancer stages. In total, 139 patients from each group were treated with chemotherapy and 39 with other therapies. Looking at all patients, no significant difference in events per patient was found between the Consilium group and the control group (odds ratio 0.742, 90% CI 0.455-1.206). However, a multivariate regression model revealed that the interaction term between the Consilium group and the factor ?chemotherapy? was significant at the 5% level (P=.048). This motivated a corresponding subgroup analysis that indicated a relevant reduction of the risk for the intervention group in the subgroup of patients who underwent chemotherapy. The corresponding odds ratio of 0.53, 90% CI 0.288-0.957 is equivalent to a halving of the risk for patients in the Consilium group and suggests a clinically relevant effect that is significant at a 2-sided 10% level (P=.08, Fisher exact test). Conclusions: A comparison of unplanned consultations and hospitalizations from the PRO study with retrospective data from a comparable cohort of patients with cancer suggests a positive effect of regular app-based ePROs for patients receiving chemotherapy. These data are to be verified in the ongoing randomized PRO2 study (registered on ClinicalTrials.gov; NCT05425550). Trial Registration: ClinicalTrials.gov NCT03578731; https://www.clinicaltrials.gov/ct2/show/NCT03578731 International Registered Report Identifier (IRRID): RR2-10.2196/29271 UR - https://formative.jmir.org/2024/1/e55917 UR - http://dx.doi.org/10.2196/55917 UR - http://www.ncbi.nlm.nih.gov/pubmed/38710048 ID - info:doi/10.2196/55917 ER - TY - JOUR AU - Trojan, Andreas AU - Roth, Sven AU - Atassi, Ziad AU - Kiessling, Michael AU - Zenhaeusern, Reinhard AU - Kadvany, Yannick AU - Schumacher, Johannes AU - Kullak-Ublick, A. Gerd AU - Aapro, Matti AU - Eniu, Alexandru PY - 2024/4/4 TI - Comparison of the Real-World Reporting of Symptoms and Well-Being for the HER2-Directed Trastuzumab Biosimilar Ogivri With Registry Data for Herceptin in the Treatment of Breast Cancer: Prospective Observational Study (OGIPRO) of Electronic Patient-Reported Outcomes JO - JMIR Cancer SP - e54178 VL - 10 KW - breast cancer KW - biosimilar KW - trastuzumab KW - electronic patient-reported outcome KW - ePRO KW - medidux KW - app N2 - Background: Trastuzumab has had a major impact on the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC). Anti-HER2 biosimilars such as Ogivri have demonstrated safety and clinical equivalence to trastuzumab (using Herceptin as the reference product) in clinical trials. To our knowledge, there has been no real-world report of the side effects and quality of life (QoL) in patients treated with biosimilars using electronic patient-reported outcomes (ePROs). Objective: The primary objective of this prospective observational study (OGIPRO study) was to compare the ePRO data related to treatment side effects collected with the medidux app in patients with HER2-positive BC treated with the trastuzumab biosimilar Ogivri (prospective cohort) to those obtained from historical cohorts treated with Herceptin alone or combined with pertuzumab and/or chemotherapy (ClinicalTrials.gov NCT02004496 and NCT03578731). Methods: Patients were treated with Ogivri alone or combined with pertuzumab and/or chemotherapy and hormone therapy in (neo)adjuvant and palliative settings. Patients used the medidux app to dynamically record symptoms (according to the Common Terminology Criteria for Adverse Events [CTCAE]), well-being (according to the Eastern Cooperative Oncology Group Performance Status scale), QoL (using the EQ-5D-5L questionnaire), cognitive capabilities, and vital parameters over 6 weeks. The primary endpoint was the mean CTCAE score. Key secondary endpoints included the mean well-being score. Data of this prospective cohort were compared with those of the historical cohorts (n=38 patients; median age 51, range 31-78 years). Results: Overall, 53 female patients with a median age of 54 years (range 31-87 years) were enrolled in the OGIPRO study. The mean CTCAE score was analyzed in 50 patients with available data on symptoms, while the mean well-being score was evaluated in 52 patients with available data. The most common symptoms reported in both cohorts included fatigue, taste disorder, nausea, diarrhea, dry mucosa, joint discomfort, tingling, sleep disorder, headache, and appetite loss. Most patients experienced minimal (grade 0) or mild (grade 1) toxicities in both cohorts. The mean CTCAE score was comparable between the prospective and historical cohorts (29.0 and 30.3, respectively; mean difference ?1.27, 95% CI ?7.24 to 4.70; P=.68). Similarly, no significant difference was found for the mean well-being score between the groups treated with the trastuzumab biosimilar Ogivri and Herceptin (74.3 and 69.8, respectively; mean difference 4.45, 95% CI ?3.53 to 12.44; P=.28). Conclusions: Treatment of patients with HER2-positive BC with the trastuzumab biosimilar Ogivri resulted in equivalent symptoms, adverse events, and well-being as found for patients treated with Herceptin as determined by ePRO data. Hence, integration of an ePRO system into research and clinical practice can provide reliable information when investigating the real-world tolerability and outcomes of similar therapeutic compounds. Trial Registration: ClinicalTrials.gov NCT05234021; https://clinicaltrials.gov/study/NCT05234021 UR - https://cancer.jmir.org/2024/1/e54178 UR - http://dx.doi.org/10.2196/54178 UR - http://www.ncbi.nlm.nih.gov/pubmed/38573759 ID - info:doi/10.2196/54178 ER - TY - JOUR AU - Henderson, Kyra AU - Reihm, Jennifer AU - Koshal, Kanishka AU - Wijangco, Jaeleene AU - Sara, Narender AU - Miller, Nicolette AU - Doyle, Marianne AU - Mallory, Alicia AU - Sheridan, Judith AU - Guo, Chu-Yueh AU - Oommen, Lauren AU - Rankin, P. Katherine AU - Sanders, Stephan AU - Feinstein, Anthony AU - Mangurian, Christina AU - Bove, Riley PY - 2024/3/15 TI - A Closed-Loop Digital Health Tool to Improve Depression Care in Multiple Sclerosis: Iterative Design and Cross-Sectional Pilot Randomized Controlled Trial and its Impact on Depression Care JO - JMIR Form Res SP - e52809 VL - 8 KW - depression KW - quality of life KW - bring your own device KW - mHealth KW - closed-loop KW - clinical trial KW - multiple sclerosis N2 - Background: People living with multiple sclerosis (MS) face a higher likelihood of being diagnosed with a depressive disorder than the general population. Although many low-cost screening tools and evidence-based interventions exist, depression in people living with MS is underreported, underascertained by clinicians, and undertreated. Objective: This study aims to design a closed-loop tool to improve depression care for these patients. It would support regular depression screening, tie into the point of care, and support shared decision-making and comprehensive follow-up. After an initial development phase, this study involved a proof-of-concept pilot randomized controlled trial (RCT) validation phase and a detailed human-centered design (HCD) phase. Methods: During the initial development phase, the technological infrastructure of a clinician-facing point-of-care clinical dashboard for MS management (BRIDGE) was leveraged to incorporate features that would support depression screening and comprehensive care (Care Technology to Ascertain, Treat, and Engage the Community to Heal Depression in people living with MS [MS CATCH]). This linked a patient survey, in-basket messages, and a clinician dashboard. During the pilot RCT phase, a convenience sample of 50 adults with MS was recruited from a single MS center with 9-item Patient Health Questionnaire scores of 5-19 (mild to moderately severe depression). During the routine MS visit, their clinicians were either asked or not to use MS CATCH to review their scores and care outcomes were collected. During the HCD phase, the MS CATCH components were iteratively modified based on feedback from stakeholders: people living with MS, MS clinicians, and interprofessional experts. Results: MS CATCH links 3 features designed to support mood reporting and ascertainment, comprehensive evidence-based management, and clinician and patient self-management behaviors likely to lead to sustained depression relief. In the pilot RCT (n=50 visits), visits in which the clinician was randomized to use MS CATCH had more notes documenting a discussion of depressive symptoms than those in which MS CATCH was not used (75% vs 34.6%; ?21=8.2; P=.004). During the HCD phase, 45 people living with MS, clinicians, and other experts participated in the design and refinement. The final testing round included 20 people living with MS and 10 clinicians including 5 not affiliated with our health system. Most scoring targets for likeability and usability, including perceived ease of use and perceived effectiveness, were met. Net Promoter Scale was 50 for patients and 40 for clinicians. Conclusions: Created with extensive stakeholder feedback, MS CATCH is a closed-loop system aimed to increase communication about depression between people living with MS and their clinicians, and ultimately improve depression care. The pilot findings showed evidence of enhanced communication. Stakeholders also advised on trial design features of a full year long Department of Defense?funded feasibility and efficacy trial, which is now underway. Trial Registration: ClinicalTrials.gov NCT05865405; http://tinyurl.com/4zkvru9x UR - https://formative.jmir.org/2024/1/e52809 UR - http://dx.doi.org/10.2196/52809 UR - http://www.ncbi.nlm.nih.gov/pubmed/38488827 ID - info:doi/10.2196/52809 ER - TY - JOUR AU - Torbjřrnsen, Astrid AU - Spildo, Ingeborg AU - Mollestad, Aadland Maria AU - Jensen, Lunde Annesofie AU - Singstad, Tone AU - Weldingh, Mickelson Nina AU - Joranger, Pĺl AU - Ribu, Lis AU - Holmen, Heidi PY - 2024/3/5 TI - Investigating Digital Patient-Reported Outcome Measures in Patient-Centered Diabetes Specialist Outpatient Care (DigiDiaS): Protocol for a Multimethod Prospective Observational Study JO - JMIR Res Protoc SP - e52766 VL - 13 KW - patient-reported outcome measures KW - PROMs KW - diabetes mellitus KW - DM KW - type 1 KW - patient acceptance of health care KW - telemedicine KW - mobile apps KW - mobile phone N2 - Background: Living with type 1 diabetes is challenging, and to support self-management, repeated consultations in specialist outpatient care are often required. The emergence of new digital solutions has revolutionized how health care services can be patient centered, providing unprecedented opportunities for flexible, high-quality care. However, there is a lack of studies exploring how the use of digital patient-reported outcome measures (PROMs) for flexible specialist care affects diabetes self-management. To provide new knowledge on the relevance of using PROMs in standard care, we have designed a multimethod prospective study. Objective: The overall aim of this protocol is to describe our prospective multimethod observational study designed to investigate digital PROMs in a routine specialist outpatient setting for flexible patient-centered diabetes care (DigiDiaS). Methods: This protocol outlines the design of a multimethod prospective observational cohort study that includes data from electronic health records, self-reported questionnaires, clinical consultation field observations, and individual in-depth interviews with patients and diabetes health care personnel. All patients with type 1 diabetes at a designated outpatient clinic were invited to participate and use the digital PROM implemented in clinical care. Both users and nonusers of the digital PROM were eligible for the prospective study, allowing for a comparison of the two groups. Data were collected at baseline and after 12 months, including self-management as the primary outcome assessed using the Patient Activation Measure, along with the secondary outcomes of digital health literacy, quality of life, health economy, and clinical variables such as glycated hemoglobin. Results: The digital solution was implemented for routine clinical care in the department in November 2021, and data collection for the prospective study started in October 2022. As of September 6, 2023, 84.6% (186/220) of patients among those in the digital PROM and 15.5% (34/220) of patients among the nonusers have consented to participate. We expect the study to have enough participants by the autumn of 2023. With 1 year of follow-up, the results are expected by spring 2025. Conclusions: In conclusion, a multimethod prospective observational cohort study can offer valuable insights into the relevance, effectiveness, and acceptability of digital tools using PROMs in diabetes specialist care. Such knowledge is crucial for achieving broad and successful implementation and use of these tools in a large diabetes outpatient clinic. International Registered Report Identifier (IRRID): DERR1-10.2196/52766 UR - https://www.researchprotocols.org/2024/1/e52766 UR - http://dx.doi.org/10.2196/52766 UR - http://www.ncbi.nlm.nih.gov/pubmed/38441955 ID - info:doi/10.2196/52766 ER - TY - JOUR AU - Williams, Hants AU - Steinberg, Sarah AU - Leon, Kendall AU - Vingum, Ryan AU - Hu, Mengyao AU - Berzin, Robin AU - Hagg, Heather AU - Hanaway, Patrick PY - 2024/2/16 TI - Predictive Criterion Validity of the Parsley Symptom Index Against the Patient-Reported Outcomes Measurement Information System-10 in a Chronic Disease Cohort: Retrospective Cohort Study JO - JMIR Form Res SP - e53316 VL - 8 KW - chronic disease KW - eHealth KW - ePROM KW - mHealth KW - Parsley Symptom Index KW - patient-reported outcome measure KW - PROM KW - PSI KW - telehealth KW - telemedicine KW - validation KW - web-based N2 - Background: Approximately 60% of US adults live with chronic disease, imposing a significant burden on patients and the health care system. With the rise of telehealth, patient-reported outcomes measures (PROMs) have emerged as pivotal tools for managing chronic disease. While numerous PROMs exist, few have been designed explicitly for telehealth settings. The Parsley Symptom Index (PSI) is an electronic patient-reported outcome measure (ePROM) developed specifically for telehealth environments. Objective: Our aim is to determine whether the PSI predicts changes in the established Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) Global Health, a 10-question short form. Methods: We conducted a retrospective cohort study using data from 367 unique patients, amassing 1170 observations between August 30, 2017, and January 30, 2023. Patients completed the PSI and the PROMIS-10 multiple times throughout the study period. Using univariate regression models, we assess the predictive criterion validity of the PSI against PROMIS-10 scores. Results: This study revealed significant relationships between the PSI and PROMIS-10 physical and mental health scores through comprehensive univariate analyses, thus establishing support for the criterion validity of the PSI. These analyses highlighted the PSI?s potential as an insightful tool for understanding and predicting both mental and physical health dimensions. Conclusions: Our findings emphasize the importance of the PSI in capturing the nuanced interactions between symptomatology and health outcomes. These insights reinforce the value of the PSI in clinical contexts and support its potential as a versatile tool in both research and practice. UR - https://formative.jmir.org/2024/1/e53316 UR - http://dx.doi.org/10.2196/53316 UR - http://www.ncbi.nlm.nih.gov/pubmed/38363587 ID - info:doi/10.2196/53316 ER - TY - JOUR AU - Gunsilius, Zimmerman Chloe AU - Heffner, Joseph AU - Bruinsma, Sienna AU - Corinha, Madison AU - Cortinez, Maria AU - Dalton, Hadley AU - Duong, Ellen AU - Lu, Joshua AU - Omar, Aisulu AU - Owen, Whittington Lucy Long AU - Roarr, Nazario Bradford AU - Tang, Kevin AU - Petzschner, H. Frederike PY - 2024/1/12 TI - SOMAScience: A Novel Platform for Multidimensional, Longitudinal Pain Assessment JO - JMIR Mhealth Uhealth SP - e47177 VL - 12 KW - acute pain KW - acute-chronic pain transition KW - chronic pain KW - clinical outcome measurement KW - digital health KW - ecological momentary assessment KW - EMA KW - ESM KW - experience sampling methodology KW - mHealth KW - mobile health KW - pain management KW - pain self-management KW - patient reported outcomes KW - smartphone app UR - https://mhealth.jmir.org/2024/1/e47177 UR - http://dx.doi.org/10.2196/47177 UR - http://www.ncbi.nlm.nih.gov/pubmed/38214952 ID - info:doi/10.2196/47177 ER - TY - JOUR AU - Dunlop, Emma AU - Ferguson, Aimee AU - Mueller, Tanja AU - Baillie, Kelly AU - Laskey, Jennifer AU - Clarke, Julie AU - Kurdi, Amanj AU - Wales, Ann AU - Connolly, Thomas AU - Bennie, Marion PY - 2023/12/21 TI - Involving Patients and Clinicians in the Design of Wireframes for Cancer Medicines Electronic Patient Reported Outcome Measures in Clinical Care: Mixed Methods Study JO - JMIR Form Res SP - e48296 VL - 7 KW - cancer KW - clinicians KW - mHealth KW - mixed methods study KW - patient reported outcome measures KW - patients KW - technology acceptance model N2 - Background: Cancer treatment is a key component of health care systems, and the increasing number of cancer medicines is expanding the treatment landscape. However, evidence of the impact on patients has been focused more on chemotherapy toxicity and symptom control and less on the effect of cancer medicines more broadly on patients? lives. Evolving electronic patient-reported outcome measures (ePROMs) presents the opportunity to secure early engagement of patients and clinicians in shaping the collection of quality-of-life metrics and presenting these data to better support the patient-clinician decision-making process. Objective: The aim of this study was to obtain initial feedback from patients and clinicians on the wireframes of a digital solution (patient app and clinician dashboard) for the collection and use of cancer medicines ePROMs. Methods: We adopted a 2-stage, mixed methods approach. Stage 1 (March to June 2019) consisted of interviews and focus groups with cancer clinicians and patients with cancer to explore the face validity of the wireframes, informed by the technology acceptance model constructs (perceived ease of use, perceived usefulness, and behavioral intention to use). In stage 2 (October 2019 to February 2020), the revised wireframes were assessed through web-based, adapted technology acceptance model questionnaires. Qualitative data (stage 1) underwent a framework analysis, and descriptive statistics were performed on quantitative data (stage 2). Clinicians and patients with cancer were recruited from NHS Greater Glasgow & Clyde, the largest health board in Scotland. Results: A total of 14 clinicians and 19 patients participated in a combination of stage 1 interviews and focus groups. Clinicians and patients indicated that the wireframes of a patient app and clinician dashboard for the collection of cancer medicines ePROMs would be easy to use and could focus discussions, and they would be receptive to using such tools in the future. In stage 1, clinicians raised the potential impact on workload, and both groups identified the need for adequate IT skills to use each technology. Changes to the wireframes were made, and in stage 2, clinicians (n=8) and patients (n=16) indicated it was ?quite likely? that the technologies would be easy to use and they would be ?quite likely? to use them in the future. Notably, clinicians indicated that they would use the dashboard to enable treatment decisions ?with around half? of their patients. Conclusions: This study emphasizes the importance of consulting both patients and clinicians in the design of digital solutions. The wireframes were perceived positively by patients and clinicians who were willing to use such technologies if available in the future as part of routine care. However, challenges were raised, and some differences were identified between participant groups, which warrant further research. UR - https://formative.jmir.org/2023/1/e48296 UR - http://dx.doi.org/10.2196/48296 UR - http://www.ncbi.nlm.nih.gov/pubmed/38127422 ID - info:doi/10.2196/48296 ER - TY - JOUR AU - Schipp, Jasmine AU - Hendrieckx, Christel AU - Braune, Katarina AU - Knoll, Christine AU - O?Donnell, Shane AU - Ballhausen, Hanne AU - Cleal, Bryan AU - Wäldchen, Mandy AU - Lewis, M. Dana AU - Gajewska, A. Katarzyna AU - Skinner, C. Timothy AU - Speight, Jane PY - 2023/12/14 TI - Psychosocial Outcomes Among Users and Nonusers of Open-Source Automated Insulin Delivery Systems: Multinational Survey of Adults With Type 1 Diabetes JO - J Med Internet Res SP - e44002 VL - 25 KW - artificial KW - diabetes mellitus KW - hypoglycaemia KW - pancreas KW - patient-reported outcome measures, surveys, and questionnaires KW - quality of life KW - sleep quality KW - type 1 N2 - Background: Emerging research suggests that open-source automated insulin delivery (AID) may reduce diabetes burden and improve sleep quality and quality of life (QoL). However, the evidence is mostly qualitative or uses unvalidated, study-specific, single items. Validated person-reported outcome measures (PROMs) have demonstrated the benefits of other diabetes technologies. The relative lack of research investigating open-source AID using PROMs has been considered a missed opportunity. Objective: This study aimed to examine the psychosocial outcomes of adults with type 1 diabetes using and not using open-source AID systems using a comprehensive set of validated PROMs in a real-world, multinational, cross-sectional study. Methods: Adults with type 1 diabetes completed 8 validated measures of general emotional well-being (5-item World Health Organization Well-Being Index), sleep quality (Pittsburgh Sleep Quality Index), diabetes-specific QoL (modified DAWN Impact of Diabetes Profile), diabetes-specific positive well-being (4-item subscale of the 28-item Well-Being Questionnaire), diabetes treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire), diabetes distress (20-item Problem Areas in Diabetes scale), fear of hypoglycemia (short form of the Hypoglycemia Fear Survey II), and a measure of the impact of COVID-19 on QoL. Independent groups 2-tailed t tests and Mann-Whitney U tests compared PROM scores between adults with type 1 diabetes using and not using open-source AID. An analysis of covariance was used to adjust for potentially confounding variables, including all sociodemographic and clinical characteristics that differed by use of open-source AID. Results: In total, 592 participants were eligible (attempting at least 1 questionnaire), including 451 using open-source AID (mean age 43, SD 13 years; n=189, 41.9% women) and 141 nonusers (mean age 40, SD 13 years; n=90, 63.8% women). Adults using open-source AID reported significantly better general emotional well-being and subjective sleep quality, as well as better diabetes-specific QoL, positive well-being, and treatment satisfaction. They also reported significantly less diabetes distress, fear of hypoglycemia, and perceived less impact of the COVID-19 pandemic on their QoL. All were medium-to-large effects (Cohen d=0.5-1.5). The differences between groups remained significant after adjusting for sociodemographic and clinical characteristics. Conclusions: Adults with type 1 diabetes using open-source AID report significantly better psychosocial outcomes than those not using these systems, after adjusting for sociodemographic and clinical characteristics. Using validated, quantitative measures, this real-world study corroborates the beneficial psychosocial outcomes described previously in qualitative studies or using unvalidated study-specific items. UR - https://www.jmir.org/2023/1/e44002 UR - http://dx.doi.org/10.2196/44002 UR - http://www.ncbi.nlm.nih.gov/pubmed/38096018 ID - info:doi/10.2196/44002 ER - TY - JOUR AU - Govindaraj, Ramkumar AU - Agar, Meera AU - Currow, David AU - Luckett, Tim PY - 2023/11/28 TI - Assessing Patient-Reported Outcomes in Routine Cancer Clinical Care Using Electronic Administration and Telehealth Technologies: Realist Synthesis of Potential Mechanisms for Improving Health Outcomes JO - J Med Internet Res SP - e48483 VL - 25 KW - patient-reported outcome measure KW - PROM KW - PROMs KW - realist synthesis KW - oncology KW - eHealth KW - patient reported KW - outcome measure KW - outcome measures KW - realist KW - literature review KW - narrative review KW - search strategy KW - review methods KW - review methodology KW - electronic patient-reported outcome measure KW - ePROM KW - cancer KW - self-reporting KW - mobile phone N2 - Background: The routine measurement of patient-reported outcomes in cancer clinical care using electronic patient-reported outcome measures (ePROMs) is gaining momentum worldwide. However, a deep understanding of the mechanisms underpinning ePROM interventions that could inform their optimal design to improve health outcomes is needed. Objective: This study aims to identify the implicit mechanisms that underpin the effectiveness of ePROM interventions and develop program theories about how and when ePROM interventions improve health outcomes. Methods: A realist synthesis of the literature about ePROM interventions in cancer clinical care was performed. A conceptual framework of ePROM interventions was constructed to define the scope of the review and frame the initial program theories. Literature searches of Ovid MEDLINE, Ovid Embase, Scopus, and CINAHL, supplemented by citation tracking, were performed to identify relevant literature to develop, refine, and test program theories. Quality appraisal of relevant studies was performed using the Mixed Methods Appraisal Tool. Results: Overall, 61 studies were included in the realist synthesis: 15 (25%) mixed methods studies, 9 (15%) qualitative studies, 13 (21%) descriptive studies, 21 (34%) randomized controlled trials, and 3 (5%) quasi-experimental studies. In total, 3 initial program theories were developed regarding the salient components of ePROM interventions?remote self-reporting, real-time feedback to clinicians, and clinician-patient telecommunication. The refined theories posit that remote self-reporting enables patients to recognize and report symptoms accurately and empowers them to communicate these to clinicians, real-time feedback prompts clinicians to manage symptoms proactively, and clinician-patient telephone interactions and e-interactions between clinic encounters improve symptom management by reshaping how clinicians and patients communicate. However, the intervention may not achieve the intended benefit if ePROMs become a reminder to patients of their illness and are not meaningful to them and when real-time feedback to clinicians lacks relevance and increases the workload. Conclusions: The key to improving health outcomes through ePROM interventions is enabling better symptom reporting and communication through remote symptom self-reporting, promoting proactive management of symptoms through real-time clinician feedback, and facilitating clinician-patient interactions. Patient engagement with self-reporting and clinician engagement in responding to feedback are vital and may reinforce each other in improving outcomes. Effective ePROM interventions might fundamentally alter how clinicians and patients interact between clinic encounters. UR - https://www.jmir.org/2023/1/e48483 UR - http://dx.doi.org/10.2196/48483 UR - http://www.ncbi.nlm.nih.gov/pubmed/38015606 ID - info:doi/10.2196/48483 ER - TY - JOUR AU - Taramasco, Carla AU - Rimassa, Carla AU - Noël, René AU - Bravo Storm, Loreto María AU - Sánchez, César PY - 2023/11/27 TI - Co-design of a Mobile App for Engaging Breast Cancer Patients in Reporting Health Experiences: Qualitative Case Study JO - J Med Internet Res SP - e45968 VL - 25 KW - cancer KW - registration systems KW - patient-reported outcome measures KW - patient-reported experience measures KW - software analysis and design KW - cancer patient report KW - adverse event reporting KW - quality of life KW - eHealth KW - mHealth KW - mobile health N2 - Background: The World Health Organization recommends incorporating patient-reported experience measures and patient-reported outcome measures to ensure care processes. New technologies, such as mobile apps, could help report and monitor patients? adverse effects and doubts during treatment. However, engaging patients in the daily use of mobile apps is a challenge that must be addressed in accordance with the needs of people. Objective: We present a qualitative case study documenting the process of identifying the information needs of breast cancer patients and health care professionals during the treatment process in a Chilean cancer institution. The study aims to identify patients? information requirements for integration into a mobile app that accompanies patients throughout their treatment while also providing features for reporting adverse symptoms. Methods: We conducted focus groups with breast cancer patients who were undergoing chemotherapy (n=3) or who completed chemotherapy between 3 months and 1 year (n=1). We also surveyed health care professionals (n=9) who were involved in patient care and who belonged to the oncology committee of the cancer center where the study took place. Content analysis was applied to the responses to categorize the information needs and the means to satisfy them. A user interface was designed according to the findings of the focus groups and was assessed by 3 trained information system and user interaction design experts from 2 countries, using heuristic evaluation guidelines for mobile apps. Results: Patients? information needs were classified into 4 areas: an overview of the disease, information on treatment and day-to-day affairs, assistance on the normality and abnormality of symptoms during treatment, and symptoms relevant to report. Health care professionals required patients to be provided with information on the administrative and financial process. We noted that the active involvement of the following 4 main actors is required to satisfy the information needs: patients, caregivers, social network moderators, and health professionals. Seven usability guidelines were extracted from the heuristic evaluation recommendations. Conclusions: A mobile app that seeks to accompany breast cancer patients to report symptoms requires the involvement of multiple participants to handle the reports and day-to-day information needs. User interfaces must be designed with consideration of the patient?s social conventions and the emotional load of the disease information. UR - https://www.jmir.org/2023/1/e45968 UR - http://dx.doi.org/10.2196/45968 UR - http://www.ncbi.nlm.nih.gov/pubmed/38010791 ID - info:doi/10.2196/45968 ER - TY - JOUR AU - Oakley-Girvan, Ingrid AU - Yunis, Reem AU - Fonda, J. Stephanie AU - Longmire, Michelle AU - Veuthey, L. Tess AU - Shieh, Jennifer AU - Aghaee, Sara AU - Kubo, Ai AU - Davis, W. Sharon AU - Liu, Raymond AU - Neeman, Elad PY - 2023/11/21 TI - Correlation Between Remote Symptom Reporting by Caregivers and Adverse Clinical Outcomes: Mixed Methods Study JO - J Med Internet Res SP - e49100 VL - 25 KW - adverse events KW - cancer KW - decentralized clinical trials KW - electronic patient-reported outcomes KW - ePROs KW - mobile health app KW - observer-reported outcomes KW - Patient-Reported Outcomes Measurement Information System Patient-Reported Outcome Common Terminology Criteria for Adverse Events KW - patient-reported outcomes KW - PRO-CTCAE KW - PROMIS KW - remote clinical trials KW - remote monitoring KW - smartphone N2 - Background: Timely collection of patient-reported outcomes (PROs) decreases emergency department visits and hospitalizations and increases survival. However, little is known about the outcome predictivity of unpaid informal caregivers? reporting using similar clinical outcome assessments. Objective: The aim of this study is to assess whether caregivers and adults with cancer adhered to a planned schedule for electronically collecting patient-reported outcomes (PROs) and if PROs were associated with future clinical events. Methods: We developed 2 iPhone apps to collect PROs, one for patients with cancer and another for caregivers. We enrolled 52 patient-caregiver dyads from Kaiser Permanente Northern California in a nonrandomized study. Participants used the apps independently for 4 weeks. Specific clinical events were obtained from the patients? electronic health records up to 6 months following the study. We used logistic and quasi-Poisson regression analyses to test associations between PROs and clinical events. Results: Participants completed 97% (251/260) of the planned Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) surveys and 98% (254/260) of the Patient-Reported Outcomes Measurement Information System (PROMIS) surveys. PRO-CTCAE surveys completed by caregivers were associated with patients? hospitalizations or emergency department visits, grade 3-4 treatment-related adverse events, dose reductions (P<.05), and hospice referrals (P=.03). PROMIS surveys completed by caregivers were associated with hospice referrals (P=.02). PRO-CTCAE surveys completed by patients were not associated with any clinical events, but their baseline PROMIS surveys were associated with mortality (P=.03), while their antecedent or final PROMIS surveys were associated with all clinical events examined except for total days of treatment breaks. Conclusions: In this study, caregivers and patients completed PROs using smartphone apps as requested. The association of caregiver PRO-CTCAE surveys with patient clinical events suggests that this is a feasible approach to reducing patient burden in clinical trial data collection and may help provide early information about increasing symptom severity. UR - https://www.jmir.org/2023/1/e49100 UR - http://dx.doi.org/10.2196/49100 UR - http://www.ncbi.nlm.nih.gov/pubmed/37988151 ID - info:doi/10.2196/49100 ER - TY - JOUR AU - Nowell, B. William AU - Curtis, R. Jeffrey AU - Zhao, Hong AU - Xie, Fenglong AU - Stradford, Laura AU - Curtis, David AU - Gavigan, Kelly AU - Boles, Jessica AU - Clinton, Cassie AU - Lipkovich, Ilya AU - Venkatachalam, Shilpa AU - Calvin, Amy AU - Hayes, S. Virginia PY - 2023/11/7 TI - Participant Engagement and Adherence to Providing Smartwatch and Patient-Reported Outcome Data: Digital Tracking of Rheumatoid Arthritis Longitudinally (DIGITAL) Real-World Study JO - JMIR Hum Factors SP - e44034 VL - 10 KW - real-world evidence KW - real-world data KW - patients KW - rheumatoid arthritis KW - patient-reported outcomes KW - patient-generated health data KW - mobile technology KW - wearable digital technology KW - mobile phone N2 - Background: Digital health studies using electronic patient-reported outcomes (ePROs) and wearables bring new challenges, including the need for participants to consistently provide trial data. Objective: This study aims to characterize the engagement, protocol adherence, and data completeness among participants with rheumatoid arthritis enrolled in the Digital Tracking of Arthritis Longitudinally (DIGITAL) study. Methods: Participants were invited to participate in this app-based study, which included a 14-day run-in and an 84-day main study. In the run-in period, data were collected via the ArthritisPower mobile app to increase app familiarity and identify the individuals who were motivated to participate. Successful completers of the run-in period were mailed a wearable smartwatch, and automated and manual prompts were sent to participants, reminding them to complete app input or regularly wear and synchronize devices, respectively, during the main study. Study coordinators monitored participant data and contacted participants via email, SMS text messaging, and phone to resolve adherence issues per a priori rules, in which consecutive spans of missing data triggered participant contact. Adherence to data collection during the main study period was defined as providing requested data for >70% of 84 days (daily ePRO, ?80% daily smartwatch data) or at least 9 of 12 weeks (weekly ePRO). Results: Of the 470 participants expressing initial interest, 278 (59.1%) completed the run-in period and qualified for the main study. Over the 12-week main study period, 87.4% (243/278) of participants met the definition of adherence to protocol-specified data collection for weekly ePRO, and 57.2% (159/278) did so for daily ePRO. For smartwatch data, 81.7% (227/278) of the participants adhered to the protocol-specified data collection. In total, 52.9% (147/278) of the participants met composite adherence. Conclusions: Compared with other digital health rheumatoid arthritis studies, a short run-in period appears useful for identifying participants likely to engage in a study that collects data via a mobile app and wearables and gives participants time to acclimate to study requirements. Automated or manual prompts (ie, ?It?s time to sync your smartwatch?) may be necessary to optimize adherence. Adherence varies by data collection type (eg, ePRO vs smartwatch data). International Registered Report Identifier (IRRID): RR2-10.2196/14665 UR - https://humanfactors.jmir.org/2023/1/e44034 UR - http://dx.doi.org/10.2196/44034 UR - http://www.ncbi.nlm.nih.gov/pubmed/37934559 ID - info:doi/10.2196/44034 ER - TY - JOUR AU - Sivan, Manoj AU - Rocha Lawrence, Román AU - O'Brien, Paul PY - 2023/10/20 TI - Digital Patient Reported Outcome Measures Platform for Post?COVID-19 Condition and Other Long-Term Conditions: User-Centered Development and Technical Description JO - JMIR Hum Factors SP - e48632 VL - 10 KW - post?COVID-19 condition KW - post?COVID-19 syndrome KW - post-acute COVID-19 syndrome KW - C19-YRS KW - Yorkshire Rehabilitation Scale KW - ELAROS KW - chronic conditions KW - mobile app KW - digital technology KW - smartphone KW - chronic KW - respiratory KW - COVID-19 KW - Sars-CoV-2 KW - coronavirus KW - platform KW - patient-reported KW - outcome measure KW - outcome measures KW - health record KW - health records KW - report KW - reports KW - data sharing KW - information sharing KW - mobile phone N2 - Background: Post?COVID-19 condition (PCC), colloquially known as long COVID, is a multisystem condition characterized by persistent symptoms beyond 4 weeks after the SARS-CoV-2 infection. More than 60 million people with PCC worldwide need prompt assessment, diagnosis, and monitoring, with many requiring specialist help from a multidisciplinary team of health care professionals (HCPs). Consequently, a scalable digital system is required for both people with PCC and HCPs to capture the breadth of symptoms and their impact on health, using patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs). Objective: We aim to develop and implement a novel PCC digital PROM (DPROM) platform for (1) securely collecting PROM and PREM data from people with PCC, (2) enabling users to monitor symptoms longitudinally and assess response to treatment, (3) generating reports for the electronic health records (EHRs), (4) providing summary reports on PCC services based on national requirements, and (5) facilitating the sharing of relevant data with authorized research teams to accelerate our understanding of this new condition and evaluate new strategies to manage PCC. Methods: We (1) undertook requirement analysis with people with PCC, HCPs, and researchers to identify the needs of the DPROM platform and determine its required functionalities; (2) designed and developed a clinically useful web portal for staff and a mobile app for patients, with a web-based alternative app to improve patient and staff choice, limit the risk of digital exclusion, and account for variability across services; (3) determined the PROMs and PREMs that PCC services would prefer to use on the platform; and (4) designed the summary report function that can be generated for each user for the EHR and for reporting to national health authorities. Results: A DPROM platform to record PCC symptom profile, condition severity, functional disability, and quality of life, based on the C19-YRS (Yorkshire Rehabilitation Scale) and other PROMs and PREMs, was developed. Individual-level medical information and details on the COVID-19 illness can be captured systematically. The platform generates easy-to-understand scores, radar plots and line graphs for people with PCC to self-monitor their condition and for HCPs to assess the natural course of the condition and the response to interventions. Clinics can configure a suite of PROMs and PREMs based on their local and national service and commissioning requirements and support research studies which require large-scale data collection on PROMs. The DPROM platform enables automatic aggregate data analysis for services to undertake service evaluation and cost-effectiveness analysis. The DPROM platform generated summary report can be uploaded to the EHRs of people with PCC. Conclusions: A multifunctional DPROM platform to assess, grade, and monitor PCC has been developed. Future research will analyze the system?s usability in specialist PCC clinical services and other long-term conditions. UR - https://humanfactors.jmir.org/2023/1/e48632 UR - http://dx.doi.org/10.2196/48632 UR - http://www.ncbi.nlm.nih.gov/pubmed/37665334 ID - info:doi/10.2196/48632 ER - TY - JOUR AU - Sprave, Tanja AU - Pfaffenlehner, Michelle AU - Stoian, Raluca AU - Christofi, Eleni AU - Rühle, Alexander AU - Zöller, Daniela AU - Fabian, Alexander AU - Fahrner, Harald AU - Binder, Harald AU - Schäfer, Henning AU - Gkika, Eleni AU - Grosu, Anca-Ligia AU - Heinemann, Felix AU - Nicolay, Henrik Nils PY - 2023/10/19 TI - App-Controlled Treatment Monitoring and Support for Patients With Head and Neck Cancer Undergoing Radiotherapy: Results From a Prospective Randomized Controlled Trial JO - J Med Internet Res SP - e46189 VL - 25 KW - mHealth KW - head and neck cancer KW - head and neck squamous cell carcinoma KW - HNSCC KW - radiotherapy KW - mobile app KW - quality of life KW - patient-reported outcome measure KW - PROM KW - mobile health KW - head KW - neck KW - cancer KW - oncology KW - radiation KW - randomized controlled trial KW - RCT KW - satisfaction KW - treatment surveillance KW - patient surveillance KW - feasibility KW - patient reported KW - outcome measure KW - app-based N2 - Background: Head and neck cancers (HNCs) are very common malignancies, and treatment often requires multimodal approaches, including radiotherapy and chemotherapy. Patients with HNC often display a high symptom burden, both due to the disease itself and the adverse effects of the multimodal therapy. Close telemonitoring of symptoms and quality of life during the course of treatment may help to identify those patients requiring early medical support. Objective: The App-Controlled Treatment Monitoring and Support for Patients With Head and Neck Cancer (APCOT) trial aimed to investigate the feasibility of integrating electronic patient-reported outcomes (ePROs) in the treatment surveillance pathway of patients with HNC during the course of their radiotherapy. Additionally, the influence of app-based ePRO monitoring on global and disease-specific quality of life and patient satisfaction with treatment was assessed. Methods: Patients undergoing radiotherapy for histologically proven HNCs at the Department of Radiation Oncology, University Medical Center Freiburg, Germany, were enrolled in this trial and monitored by weekly physician appointments. Patients were randomized between additional ePRO monitoring on each treatment day or standard-of-care monitoring. Feasibility of ePRO monitoring was defined as ?80% of enrolled patients answering ?80% of their daily app-based questions. Quality of life and patient satisfaction were assessed by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30), the head and neck cancer module (H&N35), and the validated Patient Satisfaction Questionnaire Short Form (PSQ-18) at the completion of treatment and compared between trial arms. Results: A total of 100 patients were enrolled in this trial, and 93 patients were evaluable. All patients (100%) in the experimental arm answered ?80% of the ePRO questions during treatment, reaching the predefined threshold for the feasibility of ePRO monitoring (P<.001 in the binomial test). No clinical or patient-specific factor was found to influence feasibility. Global health and most domains of the general quality of life were comparable between trial arms, but an increased HNC-specific symptom burden was reported by patients undergoing ePRO surveillance. ePRO monitoring resulted in improved patient satisfaction regarding interpersonal manners (P=.01), financial aspects (P=.01), and time spent with a doctor (P=.01). Conclusions: This trial demonstrated the feasibility of incorporating daily app-based ePRO surveillance for patients with HNC undergoing radiotherapy. Our data, for the first time, demonstrate that telemonitoring in this setting led to increased reporting of HNC-specific symptom burden and significantly improved several domains of patient satisfaction. Further analyses are needed to assess whether our findings hold true outside the context of a clinical trial. Trial Registration: German Clinical Trials Register DRKS00020491; https://drks.de/search/en/trial/DRKS00020491 UR - https://www.jmir.org/2023/1/e46189 UR - http://dx.doi.org/10.2196/46189 UR - http://www.ncbi.nlm.nih.gov/pubmed/37856185 ID - info:doi/10.2196/46189 ER - TY - JOUR AU - da Silva Lopes, Manuel André AU - Colomer-Lahiguera, Sara AU - Darnac, Célia AU - Giacomini, Stellio AU - Bugeia, Sébastien AU - Gutknecht, Garance AU - Spurrier-Bernard, Gilliosa AU - Cuendet, Michel AU - Muet, Fanny AU - Aedo-Lopez, Veronica AU - Mederos, Nuria AU - Michielin, Olivier AU - Addeo, Alfredo AU - Latifyan, Sofiya AU - Eicher, Manuela PY - 2023/10/18 TI - Testing a Model of Care for Patients on Immune Checkpoint Inhibitors Based on Electronic Patient-Reported Outcomes: Protocol for a Randomized Phase II Controlled Trial JO - JMIR Res Protoc SP - e48386 VL - 12 KW - patient-reported outcomes KW - model of care KW - immune-related adverse events KW - remote symptom management KW - self-management support KW - self-efficacy KW - health-related quality of life KW - eHealth KW - telehealth KW - support KW - self-management KW - symptom KW - monitoring KW - cancer KW - electronic health record KW - immune KW - detection KW - questionnaire KW - treatment N2 - Background: Management of severe symptomatic immune-related adverse events (IrAEs) related to immune checkpoint inhibitors (ICIs) can be facilitated by timely detection. As patients face a heterogeneous set of symptoms outside the clinical setting, remotely monitoring and assessing symptoms by using patient-reported outcomes (PROs) may result in shorter delays between symptom onset and clinician detection. Objective: We assess the effect of a model of care for remote patient monitoring and symptom management based on PRO data on the time to detection of symptomatic IrAEs from symptom onset. The secondary objectives are to assess its effects on the time between symptomatic IrAE detection and intervention, IrAE grade (severity), health-related quality of life, self-efficacy, and overall survival at 6 months. Methods: For this study, 198 patients with cancer receiving systemic treatment comprising ICIs exclusively will be recruited from 2 Swiss university hospitals. Patients are randomized (1:1) to a digital model of care (intervention) or usual care (control group). Patients are enrolled for 6 months, and they use an electronic app to complete weekly Functional Assessment of Cancer Therapy-General questionnaire and PROMIS (PROs Measurement Information System) Self-Efficacy to Manage Symptoms questionnaires. The intervention patient group completes a standard set of 37 items in a weekly PROs version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire, and active symptoms are reassessed daily for the first 3 months by using a modified 24-hour recall period. Patients can add items from the full PRO-CTCAE item library to their questionnaire. Nurses call patients in the event of new or worsening symptoms and manage them by using a standardized triage algorithm based on the United Kingdom Oncology Nursing Society 24-hour triage tool. This algorithm provides guidance on deciding if patients should receive in-person care, if monitoring should be increased, or if self-management education should be reinforced. Results: The Institut Suisse de Recherche Expérimentale sur le Cancer Foundation and Kaiku Health Ltd funded this study. Active recruitment began since November 2021 and is projected to conclude in November 2023. Trial results are expected to be published in the first quarter of 2024 and will be disseminated through publications submitted at international scientific conferences. Conclusions: This trial is among the first trials to use PRO data to directly influence routine care of patients treated with ICIs and addresses some limitations in previous studies. This trial collects a wider spectrum of self-reported symptom data daily. There are some methodological limitations brought by changes in evolving treatment standards for patients with cancer. This trial's results could entail further academic discussions on the challenges of diagnosing and managing symptoms associated with treatment remotely by providing further insights into the burden symptoms represent to patients and highlight the complexity of care procedures involved in managing symptomatic IrAEs. Trial Registration: ClinicalTrials.gov NCT05530187; https://www.clinicaltrials.gov/study/NCT05530187 International Registered Report Identifier (IRRID): DERR1-10.2196/48386 UR - https://www.researchprotocols.org/2023/1/e48386 UR - http://dx.doi.org/10.2196/48386 UR - http://www.ncbi.nlm.nih.gov/pubmed/37851498 ID - info:doi/10.2196/48386 ER - TY - JOUR AU - Korb-Savoldelli, Virginie AU - Tran, Yohann AU - Perrin, Germain AU - Touchard, Justine AU - Pastre, Jean AU - Borowik, Adrien AU - Schwartz, Corine AU - Chastel, Aymeric AU - Thervet, Eric AU - Azizi, Michel AU - Amar, Laurence AU - Kably, Benjamin AU - Arnoux, Armelle AU - Sabatier, Brigitte PY - 2023/10/16 TI - Psychometric Properties of a Machine Learning?Based Patient-Reported Outcome Measure on Medication Adherence: Single-Center, Cross-Sectional, Observational Study JO - J Med Internet Res SP - e42384 VL - 25 KW - medication adherence KW - long-term therapies KW - machine learning KW - patient-reported outcome measure KW - decision tree KW - predict KW - Delphi KW - cross sectional KW - psychometric KW - mobile phone N2 - Background: Medication adherence plays a critical role in controlling the evolution of chronic disease, as low medication adherence may lead to worse health outcomes, higher mortality, and morbidity. Assessment of their patients' medication adherence by clinicians is essential for avoiding inappropriate therapeutic intensification, associated health care expenditures, and the inappropriate inclusion of patients in time- and resource-consuming educational interventions. In both research and clinical practices the most extensively used measures of medication adherence are patient-reported outcome measures (PROMs), because of their ability to capture subjective dimensions of nonadherence. Machine learning (ML), a subfield of artificial intelligence, uses computer algorithms that automatically improve through experience. In this context, ML tools could efficiently model the complexity of and interactions between multiple patient behaviors that lead to medication adherence. Objective: This study aimed to create and validate a PROM on medication adherence interpreted using an ML approach. Methods: This cross-sectional, single-center, observational study was carried out a French teaching hospital between 2021 and 2022. Eligible patients must have had at least 1 long-term treatment, medication adherence evaluation other than a questionnaire, the ability to read or understand French, an age older than 18 years, and provided their nonopposition. Included adults responded to an initial version of the PROM composed of 11 items, each item being presented using a 4-point Likert scale. The initial set of items was obtained using a Delphi consensus process. Patients were classified as poorly, moderately, or highly adherent based on the results of a medication adherence assessment standard used in the daily practice of each outpatient unit. An ML-derived decision tree was built by combining the medication adherence status and PROM responses. Sensitivity, specificity, positive and negative predictive values (NPVs), and global accuracy of the final 5-item PROM were evaluated. Results: We created an initial 11-item PROM with a 4-point Likert scale using the Delphi process. After item reduction, a decision tree derived from 218 patients including data obtained from the final 5-item PROM allowed patient classification into poorly, moderately, or highly adherent based on item responses. The psychometric properties were 78% (95% CI 40%-96%) sensitivity, 71% (95% CI 53%-85%) specificity, 41% (95% CI 19%-67%) positive predictive values, 93% (95% CI 74%-99%) NPV, and 70% (95% CI 55%-83%) accuracy. Conclusions: We developed a medication adherence tool based on ML with an excellent NPV. This could allow prioritization processes to avoid referring highly adherent patients to time- and resource-consuming interventions. The decision tree can be easily implemented in computerized prescriber order-entry systems and digital tools in smartphones. External validation of this tool in a study including a larger number of patients with diseases associated with low medication adherence is required to confirm its use in analyzing and assessing the complexity of medication adherence. UR - https://www.jmir.org/2023/1/e42384 UR - http://dx.doi.org/10.2196/42384 UR - http://www.ncbi.nlm.nih.gov/pubmed/37843891 ID - info:doi/10.2196/42384 ER - TY - JOUR AU - Riedl, David AU - Lehmann, Jens AU - Rothmund, Maria AU - Dejaco, Daniel AU - Grote, Vincent AU - Fischer, J. Michael AU - Rumpold, Gerhard AU - Holzner, Bernhard AU - Licht, Thomas PY - 2023/9/21 TI - Usability of Electronic Patient-Reported Outcome Measures for Older Patients With Cancer: Secondary Analysis of Data from an Observational Single Center Study JO - J Med Internet Res SP - e49476 VL - 25 KW - patient-reported outcomes KW - completion rate KW - geriatric KW - age KW - patient reported KW - elderly KW - older adults KW - older adult KW - cancer KW - oncology KW - survivor KW - survivors KW - questionnaire KW - questionnaires KW - self-reported KW - geriatrics KW - gerontology KW - survey KW - surveys KW - mobile phone N2 - Background: Patient-reported outcomes are considered the gold standard for assessing subjective health status in oncology patients. Electronic assessment of patient-reported outcomes (ePRO) has become increasingly popular in recent years in both clinical trials and practice. However, there is limited evidence on how well older patients with cancer can complete ePRO assessments. Objective: We aimed to investigate how well adult patients with cancer of different age ranges could complete ePRO assessments at home and in a treatment facility and to identify factors associated with the ability to complete questionnaires electronically. Methods: This retrospective longitudinal single-center study involved survivors of cancer who participated in inpatient rehabilitation. Patients completed ePRO assessments before rehabilitation at home (T1) and after rehabilitation at the facility (T2). We analyzed the rate of patients who could complete the ePRO assessment at T1 and T2, the proportion of patients who required assistance, and the time it took patients to complete standardized questionnaires. Multivariate logistic regression analyses were conducted to identify predictors of ePRO completion rate and the need for assistance. Results: Between 2017 and 2022, a total of 5571 patients were included in this study. Patients had a mean age of 60.3 (SD 12.2) years (range 18 to 93 years), and 1135 (20.3%) of them were classified as geriatric patients (>70 years). While more than 90% (5060/5571) of all patients completed the ePRO assessment, fewer patients in the age group of >70 years (924/1135, 81.4% at T1 vs 963/1135, 84.8% at T2) completed the assessment. Approximately 19% (1056/5571) of patients reported a need for assistance with the ePRO assessment at home, compared to 6.8% (304/4483) at the institution. Patients older than 70 years had a significantly higher need for assistance than those in younger age groups. Moreover, a gender difference was observed, with older women reporting a higher need for assistance than men (71-80 years: women requiring assistance 215/482, 44.6% vs men 96/350, 27.4%; P<.001 and >80 years: women 102/141, 72.3% vs men 57/112, 50.9%; P<.001). On average, patients needed 4.9 (SD 3.20) minutes to remotely complete a 30-item questionnaire (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) and patients in the older age groups took significantly longer compared to younger age groups. Lower age and higher physical functioning were the clearest predictors for both the ePRO completion rate and the need for assistance in the multivariate regression analysis. Conclusions: This study?s results indicate that ePRO assessment is feasible in older individuals with cancer, but older patients may require assistance (eg, from relatives) to complete home-based assessments. It may be more feasible to conduct assessments in-house in this population. Additionally, it is crucial to carefully consider which resources are necessary and available to support patients in using ePRO devices. UR - https://www.jmir.org/2023/1/e49476 UR - http://dx.doi.org/10.2196/49476 UR - http://www.ncbi.nlm.nih.gov/pubmed/37733409 ID - info:doi/10.2196/49476 ER - TY - JOUR AU - Harrison, Conrad AU - Trickett, Ryan AU - Wormald, Justin AU - Dobbs, Thomas AU - Lis, Przemys?aw AU - Popov, Vesselin AU - Beard, J. David AU - Rodrigues, Jeremy PY - 2023/9/14 TI - Remote Symptom Monitoring With Ecological Momentary Computerized Adaptive Testing: Pilot Cohort Study of a Platform for Frequent, Low-Burden, and Personalized Patient-Reported Outcome Measures JO - J Med Internet Res SP - e47179 VL - 25 KW - patient-reported outcome measures KW - ecological momentary assessment KW - computerized adaptive testing KW - EMCAT KW - symptom monitoring KW - monitoring KW - assessment KW - smartphone app KW - trauma KW - arthritis KW - usability KW - mobile phone N2 - Background: Remote patient-reported outcome measure (PROM) data capture can provide useful insights into research and clinical practice and deeper insights can be gained by administering assessments more frequently, for example, in ecological momentary assessment. However, frequent data collection can be limited by the burden of multiple, lengthy questionnaires. This burden can be reduced with computerized adaptive testing (CAT) algorithms that select only the most relevant items from a PROM for an individual respondent. In this paper, we propose ?ecological momentary computerized adaptive testing? (EMCAT): the use of CAT algorithms to reduce PROM response burden and facilitate high-frequency data capture via a smartphone app. We develop and pilot a smartphone app for performing EMCAT using a popular hand surgery PROM. Objective: The aim of this study is to determine the feasibility of EMCAT as a system for remote PROM administration. Methods: We built the EMCAT web app using Concerto, an open-source CAT platform maintained by the Psychometrics Centre, University of Cambridge, and hosted it on an Amazon Web Service cloud server. The platform is compatible with any questionnaire that has been parameterized with item response theory or Rasch measurement theory. For this study, the PROM we chose was the patient evaluation measure, which is commonly used in hand surgery. CAT algorithms were built using item response theory models derived from UK Hand Registry data. In the pilot study, we enrolled 40 patients with hand trauma or thumb-base arthritis, across 2 sites, between July 13, 2022, and September 14, 2022. We monitored their symptoms with the patient evaluation measure, via EMCAT, over a 12-week period. Patients were assessed thrice weekly, once daily, or thrice daily. We additionally administered full-length PROM assessments at 0, 6, and 12 weeks, and the User Engagement Scale at 12 weeks. Results: The use of EMCAT significantly reduced the length of the PROM (median 2 vs 11 items) and the time taken to complete it (median 8.8 seconds vs 1 minute 14 seconds). Very similar scores were obtained when EMCAT was administered concurrently with the full-length PROM, with a mean error of <0.01 on a logit (z score) scale. The median response rate in the daily assessment group was 93%. The median perceived usability score of the User Engagement Scale was 4.0 (maximum possible score 5.0). Conclusions: EMCAT reduces the burden of PROM assessments, enabling acceptable high-frequency, remote PROM data capture. This has potential applications in both research and clinical practice. In research, EMCAT could be used to study temporal variations in symptom severity, for example, recovery trajectories after surgery. In clinical practice, EMCAT could be used to monitor patients remotely, prompting early intervention if a patient?s symptom trajectory causes clinical concern. Trial Registration: ISRCTN 19841416; https://www.isrctn.com/ISRCTN19841416 UR - https://www.jmir.org/2023/1/e47179 UR - http://dx.doi.org/10.2196/47179 UR - http://www.ncbi.nlm.nih.gov/pubmed/37707947 ID - info:doi/10.2196/47179 ER - TY - JOUR AU - Spooner, Caitlin AU - Vivat, Bella AU - White, Nicola AU - Stone, Patrick PY - 2023/9/1 TI - Developing a Core Outcome Set for Prognostic Research in Palliative Cancer Care: Protocol for a Mixed Methods Study JO - JMIR Res Protoc SP - e49774 VL - 12 KW - core outcome set KW - palliative care KW - end-of-life KW - prognosis KW - advanced cancer KW - systematic review KW - interviews KW - Delphi study N2 - Background: Studies exploring the impact of receiving end-of-life prognoses in patients with advanced cancer use a variety of different measures to evaluate the outcomes, and thus report often conflicting findings. The standardization of outcomes reported in studies of prognostication in palliative cancer care could enable uniform assessment and reporting, as well as intertrial comparisons. A core outcome set promotes consistency in outcome selection and reporting among studies within a particular population. We aim to develop a set of core outcomes to be used to measure the impact of end-of-life prognostication in palliative cancer care. Objective: This protocol outlines the proposed methodology to develop a core outcome set for measuring the impact of end-of-life prognostication in palliative cancer care. Methods: We will adopt a mixed methods approach consisting of 3 phases using methodology recommended by the Core Outcome Measure in Effectiveness Trials (COMET) initiative. In phase I, we will conduct a systematic review to identify existing outcomes that prognostic studies have previously used, so as to inform the development of items and domains for the proposed core outcome set. Phase II will consist of semistructured interviews with patients with advanced cancer who are receiving palliative care, informal caregivers, and clinicians, to explore their perceptions and experiences of end-of-life prognostication. Outcomes identified in the interviews will be combined with those found in existing literature and taken forward to phase III, a Delphi survey, in which we will ask patients, informal caregivers, clinicians, and relevant researchers to rate these outcomes until consensus is achieved as to which are considered to be the most important for inclusion in the core outcome set. The resulting, prioritized outcomes will be discussed in a consensus meeting to agree and endorse the final core outcome set. Results: Ethical approval was received for this study in September 2022. As of July 2023, we have completed and published the systematic review (phase I) and have started recruitment for phase II. Data analysis for phase II has not yet started. We expect to complete the study by October 2024. Conclusions: This protocol presents the stepwise approach that will be taken to develop a core outcome set for measuring the impact of end-of-life prognostication in palliative cancer care. The final core outcome set has the potential for translation into clinical practice, allowing for consistent evaluation of emerging prognostic algorithms and improving communication of end-of-life prognostication. This study will also potentially facilitate the design of future clinical trials of the impact of end-of-life prognostication in palliative care that are acceptable to key stakeholders. Trial Registration: Core Outcome Measures in Effectiveness Trials 2136; https://www.comet-initiative.org/Studies/Details/2136 International Registered Report Identifier (IRRID): DERR1-10.2196/49774 UR - https://www.researchprotocols.org/2023/1/e49774 UR - http://dx.doi.org/10.2196/49774 UR - http://www.ncbi.nlm.nih.gov/pubmed/37656505 ID - info:doi/10.2196/49774 ER - TY - JOUR AU - Sasseville, Maxime AU - Supper, Wilfried AU - Gartner, Jean-Baptiste AU - Layani, Géraldine AU - Amil, Samira AU - Sheffield, Peter AU - Gagnon, Marie-Pierre AU - Hudon, Catherine AU - Lambert, Sylvie AU - Attisso, Eugčne AU - Bureau Lagarde, Victoria AU - Breton, Mylaine AU - Poitras, Marie-Eve AU - Pluye, Pierre AU - Roux-Levy, Pierre-Henri AU - Plaisimond, James AU - Bergeron, Frédéric AU - Ashcroft, Rachelle AU - Wong, Sabrina AU - Groulx, Antoine AU - Beaudet, Nicolas AU - Paquette, Jean-Sébastien AU - D'Anjou, Natasha AU - Langlois, Sylviane AU - LeBlanc, Annie PY - 2023/8/18 TI - Clinical Integration of Digital Patient-Reported Outcome Measures in Primary Health Care for Chronic Disease Management: Protocol for a Systematic Review JO - JMIR Res Protoc SP - e48155 VL - 12 KW - systematic review KW - patient-reported outcome measure KW - primary healthcare KW - health care KW - implementation science N2 - Background: Health measurement guides policies and health care decisions are necessary to describe and attain the quintuple aim of improving patient experience, population health, care team well-being, health care costs, and equity. In the primary care setting, patient-reported outcome measurement allows outcome comparisons within and across settings and helps improve the clinical management of patients. However, these digital patient-reported outcome measures (PROMs) are still not adapted to the clinical context of primary health care, which is an indication of the complexity of integrating these tools in this context. We must then gather evidence of their impact on chronic disease management in primary health care and understand the characteristics of effective implementation. Objective: We will conduct a systematic review to identify and assess the impact of electronic PROMs (ePROMs) implementation in primary health care for chronic disease management. Our specific objectives are to (1) determine the impact of ePROMs in primary health care for chronic disease management and (2) compare and contrast characteristics of effective ePROMs? implementation strategies. Methods: We will conduct a systematic review of the literature in accordance with the guidelines of the Cochrane Methods Group and in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for its reporting. A specific search strategy was developed for relevant databases to identify studies. Two reviewers will independently apply the inclusion criteria using full texts and will extract the data. We will use a 2-phase sequential mixed methods synthesis design by conducting a qualitative synthesis first, and use its results to perform a quantitative synthesis. Results: This study was initiated in June 2022 by assembling the research team and the knowledge transfer committee. The preliminary search strategy will be developed and completed in September 2022. The main search strategy, data collection, study selection, and application of inclusion criteria were completed between October and December 2022. Conclusions: Results from this review will help support implementation efforts to accelerate innovations and digital adoption for primary health care and will be relevant for improving clinical management of chronic diseases and health care services and policies. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42022333513; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=333513 International Registered Report Identifier (IRRID): DERR1-10.2196/48155 UR - https://www.researchprotocols.org/2023/1/e48155 UR - http://dx.doi.org/10.2196/48155 UR - http://www.ncbi.nlm.nih.gov/pubmed/37594780 ID - info:doi/10.2196/48155 ER - TY - JOUR AU - Haniuda, Yu AU - Tsubaki, Michihiro AU - Ito, Yoshiyasu PY - 2023/8/7 TI - Evaluating the Usability of Electronic Patient-Reported Outcome Apps: Comment on a Symptom Management Platform for Outpatients With Advanced Cancer JO - JMIR Form Res SP - e42153 VL - 7 KW - electronic patient-reported outcome KW - symptom management KW - advanced cancer KW - outpatient KW - follow-up KW - cancer UR - https://formative.jmir.org/2023/1/e42153 UR - http://dx.doi.org/10.2196/42153 UR - http://www.ncbi.nlm.nih.gov/pubmed/37548992 ID - info:doi/10.2196/42153 ER - TY - JOUR AU - Nagino, Ken AU - Okumura, Yuichi AU - Akasaki, Yasutsugu AU - Fujio, Kenta AU - Huang, Tianxiang AU - Sung, Jaemyoung AU - Midorikawa-Inomata, Akie AU - Fujimoto, Keiichi AU - Eguchi, Atsuko AU - Hurramhon, Shokirova AU - Yee, Alan AU - Miura, Maria AU - Ohno, Mizu AU - Hirosawa, Kunihiko AU - Morooka, Yuki AU - Murakami, Akira AU - Kobayashi, Hiroyuki AU - Inomata, Takenori PY - 2023/8/3 TI - Smartphone App?Based and Paper-Based Patient-Reported Outcomes Using a Disease-Specific Questionnaire for Dry Eye Disease: Randomized Crossover Equivalence Study JO - J Med Internet Res SP - e42638 VL - 25 KW - dry eye syndrome KW - mobile app KW - equivalence trial KW - Ocular Surface Disease Index KW - patient-reported outcome measures KW - mobile health KW - reliability KW - validity KW - telemedicine KW - precision medicine N2 - Background: Using traditional patient-reported outcomes (PROs), such as paper-based questionnaires, is cumbersome in the era of web-based medical consultation and telemedicine. Electronic PROs may reduce the burden on patients if implemented widely. Considering promising reports of DryEyeRhythm, our in-house mHealth smartphone app for investigating dry eye disease (DED) and the electronic and paper-based Ocular Surface Disease Index (OSDI) should be evaluated and compared to determine their equivalency. Objective: The purpose of this study is to assess the equivalence between smartphone app?based and paper-based questionnaires for DED. Methods: This prospective, nonblinded, randomized crossover study enrolled 34 participants between April 2022 and June 2022 at a university hospital in Japan. The participants were allocated randomly into 2 groups in a 1:1 ratio. The paper-app group initially responded to the paper-based Japanese version of the OSDI (J-OSDI), followed by the app-based J-OSDI. The app-paper group responded to similar questionnaires but in reverse order. We performed an equivalence test based on minimal clinically important differences to assess the equivalence of the J-OSDI total scores between the 2 platforms (paper-based vs app-based). A 95% CI of the mean difference between the J-OSDI total scores within the ą7.0 range between the 2 platforms indicated equivalence. The internal consistency and agreement of the app-based J-OSDI were assessed with Cronbach ? coefficients and intraclass correlation coefficient values. Results: A total of 33 participants were included in this study. The total scores for the app- and paper-based J-OSDI indicated satisfactory equivalence per our study definition (mean difference 1.8, 95% CI ?1.4 to 5.0). Moreover, the app-based J-OSDI total score demonstrated good internal consistency and agreement (Cronbach ?=.958; intraclass correlation=0.919; 95% CI 0.842 to 0.959) and was significantly correlated with its paper-based counterpart (Pearson correlation=0.932, P<.001). Conclusions: This study demonstrated the equivalence of PROs between the app- and paper-based J-OSDI. Implementing the app-based J-OSDI in various scenarios, including telehealth, may have implications for the early diagnosis of DED and longitudinal monitoring of PROs. UR - https://www.jmir.org/2023/1/e42638 UR - http://dx.doi.org/10.2196/42638 UR - http://www.ncbi.nlm.nih.gov/pubmed/37535409 ID - info:doi/10.2196/42638 ER - TY - JOUR AU - Rao, Kaushal AU - Speier, William AU - Meng, Yiwen AU - Wang, Jinhan AU - Ramesh, Nidhi AU - Xie, Fenglong AU - Su, Yujie AU - Nowell, Benjamin W. AU - Curtis, R. Jeffrey AU - Arnold, Corey PY - 2023/6/26 TI - Machine Learning Approaches to Classify Self-Reported Rheumatoid Arthritis Health Scores Using Activity Tracker Data: Longitudinal Observational Study JO - JMIR Form Res SP - e43107 VL - 7 KW - rheumatoid arthritis KW - rheumatic KW - rheumatism KW - Fitbit KW - classification KW - physical data KW - digital health KW - activity tracker KW - mobile health KW - machine learning KW - model KW - patient reported KW - outcome measure KW - PROMIS KW - nonclinical monitoring KW - mHealth KW - tracker KW - wearable KW - arthritis KW - mobile phone N2 - Background: The increasing use of activity trackers in mobile health studies to passively collect physical data has shown promise in lessening participation burden to provide actively contributed patient-reported outcome (PRO) information. Objective: The aim of this study was to develop machine learning models to classify and predict PRO scores using Fitbit data from a cohort of patients with rheumatoid arthritis. Methods: Two different models were built to classify PRO scores: a random forest classifier model that treated each week of observations independently when making weekly predictions of PRO scores, and a hidden Markov model that additionally took correlations between successive weeks into account. Analyses compared model evaluation metrics for (1) a binary task of distinguishing a normal PRO score from a severe PRO score and (2) a multiclass task of classifying a PRO score state for a given week. Results: For both the binary and multiclass tasks, the hidden Markov model significantly (P<.05) outperformed the random forest model for all PRO scores, and the highest area under the curve, Pearson correlation coefficient, and Cohen ? coefficient were 0.750, 0.479, and 0.471, respectively. Conclusions: While further validation of our results and evaluation in a real-world setting remains, this study demonstrates the ability of physical activity tracker data to classify health status over time in patients with rheumatoid arthritis and enables the possibility of scheduling preventive clinical interventions as needed. If patient outcomes can be monitored in real time, there is potential to improve clinical care for patients with other chronic conditions. UR - https://formative.jmir.org/2023/1/e43107 UR - http://dx.doi.org/10.2196/43107 UR - http://www.ncbi.nlm.nih.gov/pubmed/37017471 ID - info:doi/10.2196/43107 ER - TY - JOUR AU - Kraska, Jake AU - Bell, Karen AU - Costello, Shane PY - 2023/6/22 TI - Graded Response Model Analysis and Computer Adaptive Test Simulation of the Depression Anxiety Stress Scale 21: Evaluation and Validation Study JO - J Med Internet Res SP - e45334 VL - 25 KW - graded response model KW - DASS-21 KW - CAT KW - computer adaptive testing KW - simulation KW - psychological distress KW - depression KW - anxiety KW - stress KW - mental health KW - screening tool KW - tool KW - reliability KW - development KW - model N2 - Background: The Depression Anxiety Stress Scale 21 (DASS-21) is a mental health screening tool with conflicting studies regarding its factor structure. No studies have yet attempted to develop a computer adaptive test (CAT) version of it. Objective: This study calibrated items for, and simulated, a DASS-21 CAT using a nonclinical sample. Methods: An evaluation sample (n=580) was used to evaluate the DASS-21 scales via confirmatory factor analysis, Mokken analysis, and graded response modeling. A CAT was simulated with a validation sample (n=248) and a simulated sample (n=10,000) to confirm the generalizability of the model developed. Results: A bifactor model, also known as the ?quadripartite? model (1 general factor with 3 specific factors) in the context of the DASS-21, displayed good fit. All scales displayed acceptable fit with the graded response model. Simulation of 3 unidimensional (depression, anxiety, and stress) CATs resulted in an average 17% to 48% reduction in items administered when a reliability of 0.80 was acceptable. Conclusions: This study clarifies previous conflicting findings regarding the DASS-21 factor structure and suggests that the quadripartite model for the DASS-21 items fits best. Item response theory modeling suggests that the items measure their respective constructs best between 0? and 3? (mild to moderate severity). UR - https://www.jmir.org/2023/1/e45334 UR - http://dx.doi.org/10.2196/45334 UR - http://www.ncbi.nlm.nih.gov/pubmed/37347530 ID - info:doi/10.2196/45334 ER - TY - JOUR AU - Jahnke, R. Hannah AU - Rubin-Miller, Lily AU - Henrich, Natalie AU - Moss, Christa AU - Shah, Neel AU - Peahl, Alex PY - 2023/5/15 TI - Association Between the Use of a Digital Health Platform During Pregnancy and Helping Users Avoid Emergency and In-Person Care: Retrospective Observational Study JO - J Med Internet Res SP - e43180 VL - 25 KW - pregnancy KW - telehealth KW - web-based care KW - emergency room KW - value-based care KW - digital care KW - prenatal care N2 - Background: Almost one-third of pregnant people visit the emergency room during pregnancy. Although some emergency care is necessary, gaps in patient education and inaccessibility of preventive services have been identified as key reasons for high-cost, low-value care in pregnancy. Digital platforms present a promising solution for providing resources to supplement routine prenatal care, thereby reducing the use of low-value in-person services. Objective: This study aimed to describe the relationship between the use of Maven and in-person care avoidance (emergency room or office visits) during pregnancy. Maven is a digital prenatal health platform that supplements routine prenatal care. Maven offers educational content (articles, videos, and classes), care coordination (through a care advocate), and provider services (web-based appointments and communication with providers) designed to complement prenatal care. Specifically, the aims of this study were to examine whether the use of Maven is associated with in-person care avoidance overall and whether improvements in pregnancy-related knowledge facilitate in-person care avoidance. To assess aim 2, we tested if the use of Maven is associated with improvements in self-reported understanding of warning signs and medically accurate information and if self-reported understanding of medically accurate information and warning signs is associated with in-person care avoidance in a population of Maven users. Methods: In this retrospective study, we used adjusted logistic regression to examine the relationship between digital platform use, avoidance of in-person care, and the platform?s influence on pregnancy-related knowledge (learning medically accurate information and recognizing warning signs). Demographics, medical history, and in-person care avoidance were self-reported. Results: Of the 5263 users, 280 (5.32%) reported that Maven helped them avoid in-person care during pregnancy. More users who reported avoiding in-person care also reported that the digital platform helped them understand warning signs (231/280, 82.5%) and learned medically accurate information (185/280, 66.1%). In the adjusted models, all modes of digital service use (assessed as quartiles) were associated with avoiding in-person care in a dose-response manner (eg, web-based provider appointments: Q2 adjusted odds ratio [aOR] 1.57, 95% CI 1.00-2.41; Q3 aOR 2.53, 95% CI 1.72-3.72; Q4 aOR 5.26, 95% CI 3.76-7.42). Users were more likely to avoid in-person care if they reported that Maven helped them recognize warning signs (aOR 3.55, 95% CI 2.60-4.94) or learn medically accurate information (aOR 2.05, 95% CI 1.59-2.67). Conclusions: These results suggest that digital platforms can be effective in helping patients to avoid in-person care. The educational pathway suggests that digital platforms can be particularly effective in helping patients recognize warning signs and learn medically accurate information, which may help them avoid in-person care by recognizing when in-person care is medically appropriate. Future work is needed to assess other pathways through which digital resources can support pregnant people and improve perinatal care use. UR - https://www.jmir.org/2023/1/e43180 UR - http://dx.doi.org/10.2196/43180 UR - http://www.ncbi.nlm.nih.gov/pubmed/37184930 ID - info:doi/10.2196/43180 ER - TY - JOUR AU - García Abejas, Abel AU - Serra Trullás, Adriŕ AU - Sobral, Ana Maria AU - Canelas, Daniel AU - Leite Costa, Fábio AU - Salvador Verges, Ŕngels PY - 2023/5/3 TI - Improving the Understanding and Managing of the Quality of Life of Patients With Lung Cancer With Electronic Patient-Reported Outcome Measures: Scoping Review JO - J Med Internet Res SP - e46259 VL - 25 KW - lung cancer KW - electronic patient-reported outcome measures KW - ePROMs KW - health-related quality of life KW - sickness impact profile KW - quality improvement KW - review N2 - Background: Electronic patient-reported outcome measures (ePROMs) are essential to clinical practice and research. The growth of eHealth technologies has provided unprecedented opportunities to collect information systematically through ePROMs. Although they are widely used in scientific research, more evidence is needed to determine their use and implementation in daily clinical practice. For example, when diagnosed, patients with lung cancer are at an advanced stage of the disease. This entails tremendous burden because of high mortality and losses in the different dimensions of the human being. In this case, monitoring symptoms and other outcomes help improve the patient?s quality of life. Objective: ePROMs offered unprecedented opportunities to collect information systematically. Our goal was to demonstrate that ePROMs are more useful in controlling patient symptoms, lung cancer, and overall survival than their alternatives, such as nonelectronic PROMs. Methods: This exploratory review considered articles published between 2017 and 2022 identified through searches of PubMed, Scopus, Cochrane, CINAHL, and PsycINFO. We found 5097 articles; after removing the duplicates, we reduced them to 3315. After reading the summary, we were left with 56. Finally, after applying the exclusion criteria, we reviewed 12. The 5-step framework by Arksey and O?Malley was used to refine the initial search results with the following research questions: Do ePROMs help physician-patient communication? To what extent do they improve decision-making? Are institutions and their digitization policies barriers to or facilitators of this process? and What else is needed for routine implementation? Results: This review included 12 articles. We found that ePROMs are an integrative and facilitative communication tool, highlighting their importance in the relationship between palliative care and medical oncology. ePROMs help assess patient symptoms and functionality more accurately and facilitate clinical decision-making. In addition, it allows for more precise predictions of overall patient survival and the adverse effects of their treatments. The main institutional obstacles are the initial investment, which can be costly, and the data protection policy. However, enablers included better funding through the development of telemedicine, support from institutional leaders to overcome resistance to change, and transparent policies to ensure the safe and secure use of ePROMs. Conclusions: Routine collection of remote ePROMs is an effective and valuable strategy for providing real-time clinical feedback. In addition, it provides satisfaction to patients and professionals. Optimizing ePROMs in patients with lung cancer leads to a more accurate view of health outcomes and ensures quality patient follow-up. It also allows us to stratify patients based on their morbidity, creating specific follow-ups for their needs. However, data privacy and security are concerns when using ePROMs to ensure compliance with local entities. At least four barriers were identified: cost, complex programming within health systems, safety, and social and health literacy. UR - https://www.jmir.org/2023/1/e46259 UR - http://dx.doi.org/10.2196/46259 UR - http://www.ncbi.nlm.nih.gov/pubmed/37021695 ID - info:doi/10.2196/46259 ER - TY - JOUR AU - Harrison, Conrad AU - Apon, Inge AU - Ardouin, Kenny AU - Sidey-Gibbons, Chris AU - Klassen, Anne AU - Cano, Stefan AU - Wong Riff, Karen AU - Pusic, Andrea AU - Versnel, Sarah AU - Koudstaal, Maarten AU - Allori, C. Alexander AU - Rogers-Vizena, Carolyn AU - Swan, C. Marc AU - Furniss, Dominic AU - Rodrigues, Jeremy PY - 2023/4/27 TI - The Development, Deployment, and Evaluation of the CLEFT-Q Computerized Adaptive Test: A Multimethods Approach Contributing to Personalized, Person-Centered Health Assessments in Plastic Surgery JO - J Med Internet Res SP - e41870 VL - 25 KW - cleft lip KW - cleft palate KW - patient-reported outcome measures KW - outcome assessment KW - CLEFT-Q KW - computerized adaptive test KW - CAT N2 - Background: Routine use of patient-reported outcome measures (PROMs) and computerized adaptive tests (CATs) may improve care in a range of surgical conditions. However, most available CATs are neither condition-specific nor coproduced with patients and lack clinically relevant score interpretation. Recently, a PROM called the CLEFT-Q has been developed for use in the treatment of cleft lip or palate (CL/P), but the assessment burden may be limiting its uptake into clinical practice. Objective: We aimed to develop a CAT for the CLEFT-Q, which could facilitate the uptake of the CLEFT-Q PROM internationally. We aimed to conduct this work with a novel patient-centered approach and make source code available as an open-source framework for CAT development in other surgical conditions. Methods: CATs were developed with the Rasch measurement theory, using full-length CLEFT-Q responses collected during the CLEFT-Q field test (this included 2434 patients across 12 countries). These algorithms were validated in Monte Carlo simulations involving full-length CLEFT-Q responses collected from 536 patients. In these simulations, the CAT algorithms approximated full-length CLEFT-Q scores iteratively, using progressively fewer items from the full-length PROM. Agreement between full-length CLEFT-Q score and CAT score at different assessment lengths was measured using the Pearson correlation coefficient, root-mean-square error (RMSE), and 95% limits of agreement. CAT settings, including the number of items to be included in the final assessments, were determined in a multistakeholder workshop that included patients and health care professionals. A user interface was developed for the platform, and it was prospectively piloted in the United Kingdom and the Netherlands. Interviews were conducted with 6 patients and 4 clinicians to explore end-user experience. Results: The length of all 8 CLEFT-Q scales in the International Consortium for Health Outcomes Measurement (ICHOM) Standard Set combined was reduced from 76 to 59 items, and at this length, CAT assessments reproduced full-length CLEFT-Q scores accurately (with correlations between full-length CLEFT-Q score and CAT score exceeding 0.97, and the RMSE ranging from 2 to 5 out of 100). Workshop stakeholders considered this the optimal balance between accuracy and assessment burden. The platform was perceived to improve clinical communication and facilitate shared decision-making. Conclusions: Our platform is likely to facilitate routine CLEFT-Q uptake, and this may have a positive impact on clinical care. Our free source code enables other researchers to rapidly and economically reproduce this work for other PROMs. UR - https://www.jmir.org/2023/1/e41870 UR - http://dx.doi.org/10.2196/41870 UR - http://www.ncbi.nlm.nih.gov/pubmed/37104031 ID - info:doi/10.2196/41870 ER - TY - JOUR AU - Ke Wang, Will AU - Cesnakova, Lucia AU - Goldsack, C. Jennifer AU - Dunn, Jessilyn PY - 2023/4/18 TI - Defining the Digital Measurement of Scratching During Sleep or Nocturnal Scratching: Review of the Literature JO - J Med Internet Res SP - e43617 VL - 25 KW - atopic dermatitis KW - ontologies KW - nocturnal scratching KW - quality of life KW - outcomes measurement KW - dermatitis KW - scratch KW - review method KW - systematic review KW - literature review KW - pruritis N2 - Background: Digital sensing solutions represent a convenient, objective, relatively inexpensive method that could be leveraged for assessing symptoms of various health conditions. Recent progress in the capabilities of digital sensing products has targeted the measurement of scratching during sleep, traditionally referred to as nocturnal scratching, in patients with atopic dermatitis or other skin conditions. Many solutions measuring nocturnal scratch have been developed; however, a lack of efforts toward standardization of the measure?s definition and contextualization of scratching during sleep hampers the ability to compare different technologies for this purpose. Objective: We aimed to address this gap and bring forth unified measurement definitions for nocturnal scratch. Methods: We performed a narrative literature review of definitions of scratching in patients with skin inflammation and a targeted literature review of sleep in the context of the period during which such scratching occurred. Both searches were limited to English language studies in humans. The extracted data were synthesized into themes based on study characteristics: scratch as a behavior, other characterization of the scratching movement, and measurement parameters for both scratch and sleep. We then developed ontologies for the digital measurement of sleep scratching. Results: In all, 29 studies defined inflammation-related scratching between 1996 and 2021. When cross-referenced with the results of search terms describing the sleep period, only 2 of these scratch-related papers also described sleep-related variables. From these search results, we developed an evidence-based and patient-centric definition of nocturnal scratch: an action of rhythmic and repetitive skin contact movement performed during a delimited time period of intended and actual sleep that is not restricted to any specific time of the day or night. Based on the measurement properties identified in the searches, we developed ontologies of relevant concepts that can be used as a starting point to develop standardized outcome measures of scratching during sleep in patients with inflammatory skin conditions. Conclusions: This work is intended to serve as a foundation for the future development of unified and well-described digital health technologies measuring nocturnal scratching and should enable better communication and sharing of results between various stakeholders taking part in research in atopic dermatitis and other inflammatory skin conditions. UR - https://www.jmir.org/2023/1/e43617 UR - http://dx.doi.org/10.2196/43617 UR - http://www.ncbi.nlm.nih.gov/pubmed/37071460 ID - info:doi/10.2196/43617 ER - TY - JOUR AU - Rathgeb, Chiara AU - Pawellek, Maja AU - Behrends, Uta AU - Alberer, Martin AU - Kabesch, Michael AU - Gerling, Stephan AU - Brandstetter, Susanne AU - Apfelbacher, Christian PY - 2023/4/11 TI - The Evaluation of Health Care Services for Children and Adolescents With Post?COVID-19 Condition: Protocol for a Prospective Longitudinal Study JO - JMIR Res Protoc SP - e41010 VL - 12 KW - post-COVID KW - long COVID KW - post?COVID-19 condition KW - PCC KW - post?COVID-19 syndrome KW - PCS KW - CFS/ME KW - children and adolescents KW - health care services KW - EQ-5D KW - SDQ KW - PROMIS KW - DSQ-PEM KW - COVID-19 KW - pediatrics KW - child KW - adolescent KW - service delivery KW - healthcare delivery KW - healthcare service KW - care network KW - healthcare KW - therapeutic service KW - healthcare utilization KW - patient reported outcome N2 - Background: Some children and adolescents suffer from late effects of a SARS-CoV-2 infection despite a frequently mild course of the disease. Nevertheless, extensive care for post?COVID-19 condition, also known as post?COVID-19 syndrome, in children and young people is not yet available. A comprehensive care network, Post-COVID Kids Bavaria (PoCo), for children and adolescents with post?COVID-19 condition has been set up as a model project in Bavaria, Germany. Objective: The aim of this study is to evaluate the health care services provided within this network structure of care for children and adolescents with post?COVID-19 condition in a pre-post study design. Methods: We have already recruited 117 children and adolescents aged up to 17 years with post?COVID-19 condition who were diagnosed and treated in 16 participating outpatient clinics. Health care use, treatment satisfaction, patient-reported outcomes related to health-related quality of life (the primary endpoint), fatigue, postexertional malaise, and mental health are being assessed at different time points (at baseline and after 4 weeks, 3 months, and 6 months) using routine data, interviews, and self-report questionnaires. Results: The study recruitment process ran from April 2022 until December 2022. Interim analyses will be carried out. A full analysis of the data will be conducted after follow-up assessment is completed, and the results will be published. Conclusions: The results will contribute to the evaluation of therapeutic services provided for post?COVID-19 condition in children and adolescents, and avenues for optimizing care may be identified. International Registered Report Identifier (IRRID): DERR1-10.2196/41010 UR - https://www.researchprotocols.org/2023/1/e41010 UR - http://dx.doi.org/10.2196/41010 UR - http://www.ncbi.nlm.nih.gov/pubmed/36867709 ID - info:doi/10.2196/41010 ER - TY - JOUR AU - Looijen, M. Agnes E. AU - van Linschoten, A. Reinier C. AU - Brugma, Jan-Dietert AU - Hijnen, Jan Dirk AU - de Jong, P. Pascal H. AU - van der Kuy, M. P. Hugo AU - van Laar, M. Jan A. AU - van der Woude, Janneke C. AU - Pasma, Annelieke PY - 2023/3/30 TI - Digital Outcome Measurement to Improve Care for Patients With Immune-Mediated Inflammatory Diseases: Protocol for the IMID Registry JO - JMIR Res Protoc SP - e43230 VL - 12 KW - immune-mediated inflammatory diseases KW - IMID KW - value-based health care KW - patient-reported outcomes KW - web-based KW - tool KW - disease KW - patient KW - inflammatory KW - medicine KW - dermatology KW - rheumatology KW - gastroenterology KW - immunology KW - quality of life KW - mHealth KW - web-based tool KW - digital system N2 - Background: Despite enormous clinical improvements, due to better management strategies and the availability of biologicals, immune-mediated inflammatory diseases (IMIDs) still have a significant impact on patients? lives. To further reduce disease burden, provider- as well as patient-reported outcomes (PROs) should be taken into account during treatment and follow-up. Web-based collection of these outcomes generates valuable repeated measurements, which could be used (1) in daily clinical practice for patient-centered care, including shared decision-making; (2) for research purposes; and (3) as an essential step toward the implementation of value-based health care (VBHC). Our ultimate goal is that our health care delivery system is completely aligned with the principles of VBHC. For aforementioned reasons, we implemented the IMID registry. Objective: The IMID registry is a digital system for routine outcome measurement that mainly includes PROs to improve care for patients with IMIDs. Methods: The IMID registry is a longitudinal observational prospective cohort study within the departments of rheumatology, gastroenterology, dermatology, immunology, clinical pharmacy, and outpatient pharmacy of the Erasmus MC, the Netherlands. Patients with the following diseases are eligible for inclusion: inflammatory arthritis, inflammatory bowel disease, atopic dermatitis, psoriasis, uveitis, Behçet disease, sarcoidosis, and systemic vasculitis. Generic and disease-specific (patient-reported) outcomes, including adherence to medication, side effects, quality of life, work productivity, disease damage, and activity, are collected from patients and providers at fixed intervals before and during outpatient clinic visits. Data are collected and visualized through a data capture system, which is linked directly to the patients? electronic health record, which not only facilitates a more holistic care approach, but also helps with shared decision-making. Results: The IMID registry is an ongoing cohort with no end date. Inclusion started in April 2018. From start until September 2022, a total of 1417 patients have been included from the participating departments. The mean age at inclusion was 46 (SD 16) years, and 56% of the patient population is female. The average percentage of filled out questionnaires at baseline is 84%, which drops to 72% after 1 year of follow-up. This decline may be due to the fact that the outcomes are not always discussed during the outpatient clinic visit or because the questionnaires were sometimes forgotten to set out. The registry is also used for research purposes and 92% of the patients with IMIDs gave informed consent to use their data for that. Conclusions: The IMID registry is a web-based digital system that collects provider- and PROs. The collected outcomes are used to improve care for the individual patient with an IMID and facilitate shared decision-making, and they are also used for research purposes. The measurement of these outcomes is an essential step toward the implementation of VBHC. International Registered Report Identifier (IRRID): DERR1-10.2196/43230 UR - https://www.researchprotocols.org/2023/1/e43230 UR - http://dx.doi.org/10.2196/43230 UR - http://www.ncbi.nlm.nih.gov/pubmed/36995758 ID - info:doi/10.2196/43230 ER - TY - JOUR AU - Parisot III, E. Paul AU - Wheeler, Facerlyn AU - Bonnet, Kemberlee AU - Rebeiro, F. Peter AU - Schember, O. Cassandra AU - McCainster, Korlu AU - Cooper, L. Robert AU - Berthaud, Vladimir AU - Schlundt, G. David AU - Pettit, C. April PY - 2023/3/22 TI - Patient-Reported Outcomes Collection at an Urban HIV Clinic Associated With a Historically Black Medical College in the Southern United States: Qualitative Interview Study Among Patients With HIV JO - JMIR Form Res SP - e42888 VL - 7 KW - patient-reported outcomes KW - HIV infection KW - HIV continuum of care KW - HIV epidemic KW - questionnaire experience KW - cognitive behavioral model KW - implementation KW - vulnerable population KW - racial disparity N2 - Background: Black Americans, particularly in the southern United States, are disproportionately affected by the US HIV epidemic. Patient-reported outcome (PRO) data collection can improve patient outcomes and provide oft-overlooked data on mental health, substance use, and patient adherence to antiretroviral therapy. Objective: We piloted the use of an electronic tablet to collect PRO data on social and behavioral determinants of health among people with HIV at the Meharry Community Wellness Center, an HIV clinic affiliated with a Historically Black Medical College in Nashville, Tennessee. Our primary objective was to better understand patients? experiences and comfort with using an electronic PRO tool through patient interviews. Methods: We enrolled 100 people with HIV in care at the Meharry Community Wellness Center consecutively to completely validate PRO tools using the Research Electronic Data Capture platform on a hand-held tablet. Using a purposive sampling strategy, we enrolled 20 of the 100 participants in an in-depth interview (IDI). Interview guide development was grounded in the cognitive-behavioral model, in which thoughts, feelings, and behaviors are interrelated. IDIs were audio recorded, transcribed, deidentified, and formatted for coding. A hierarchical coding system was developed and refined using an inductive-deductive approach. Results: Among the 100 people with HIV enrolled, the median age was 50 (IQR 42-54) years; 89% (n=89) were Black, 60% (n=60) were male, and 82% (n=82) were living below 100% of the federal poverty level in 2016. Five major interview themes emerged: overall experience, question content, sensitive topics, clinic visit impact, and future recommendations. IDI participants felt that the tablet was easy to use and that the question content was meaningful. Question content related to trauma, sexual and drug use behaviors, mental health, stigma, and discrimination elicited uncomfortable or distressing feelings in some participants. Patients expressed a strong desire to be truthful, and most would complete these surveys without compensation at future visits if offered. Conclusions: The use of an electronic tablet to complete PRO data collection was well received by this cohort of vulnerable persons in HIV care in the southern United States. Despite some discomfort related to question content, our cohort overwhelmingly believed this was a meaningful part of their medical experience and expressed a high desire for truthfulness. Future research will focus on scaling up the implementation and evaluation of PRO data collection in a contextually appropriate manner while obtaining input from providers and staff to ensure that the collected data are both applicable and actionable. UR - https://formative.jmir.org/2023/1/e42888 UR - http://dx.doi.org/10.2196/42888 UR - http://www.ncbi.nlm.nih.gov/pubmed/36947109 ID - info:doi/10.2196/42888 ER - TY - JOUR AU - Kang, Danbee AU - Kim, Sooyeon AU - Kim, Hyunsoo AU - Lee, Mangyeong AU - Kong, Sun-Young AU - Chang, Jung Yoon AU - Sim, Hoon Sung AU - Kim, Yeon-Joo AU - Cho, Juhee PY - 2023/3/8 TI - Surveillance of Symptom Burden Using the Patient-Reported Outcome Version of the Common Terminology Criteria for Adverse Events in Patients With Various Types of Cancers During Chemoradiation Therapy: Real-World Study JO - JMIR Public Health Surveill SP - e44105 VL - 9 KW - surveillance KW - patient-reported outcome KW - symptoms KW - cancer N2 - Background: Over 90% of patients with cancer experience 1 or more symptoms caused directly by cancer or its treatment. These symptoms negatively impact on the completion of planned treatment as well as patients? health-related quality of life (HRQoL). It often results in serious complications and even life-threatening outcomes. Thus, it has been recommended that surveillance of symptom burden should be performed and managed during cancer treatment. However, differences in symptom profiles in various patients with cancer have not been fully elucidated for use in performing surveillance in the real world. Objective: This study aims to evaluate the burden of symptoms in patients with various types of cancers during chemotherapy or radiation therapy using the PRO-CTCAE (Patient-Reported Outcome Version of the Common Terminology Criteria for Adverse Events) and its impact on quality of life. Methods: We performed a cross-sectional study of patients undergoing outpatient-based chemotherapy, radiation therapy, or both at the National Cancer Center at Goyang or at the Samsung Medical Center in Seoul, Korea between December 2017 and January 2018. To evaluate cancer-specific symptom burden, we developed 10 subsets for using the PRO-CTCAE-Korean. To measure HRQoL, we used the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Participants answered questions prior to their clinic appointments on tablets. Multivariable linear regression was used to analyze symptoms based on cancer type and to evaluate the association between the PRO-CTCAE items and the EORTC QLQ-C30 summary score. Results: The mean age (SD) of the patients was 55.0 (11.9) years, and 39.94% (540/1352) were male. Overall, symptoms in the gastrointestinal category were the most dominant in all cancers. Fatigue (1034/1352, 76.48%), decreased appetite (884/1352, 65.38%), and numbness and tingling (778/1352, 57.54%) were the most frequently reported. Patients reported more local symptoms caused by a specific cancer. In terms of nonsite-specific symptoms, patients commonly reported concentration (587/1352, 43.42%), anxiety (647/1352, 47.86%), and general pain (605/1352, 44.75%). More than 50% of patients with colorectal (69/127, 54.3%), gynecologic (63/112, 56.3%), breast (252/411, 61.3%), and lung cancers (121/234, 51.7%) experienced decreased libido, whereas 67/112 (59.8%) patients with gynecologic cancer and lymphoma/myeloma reported pain during sexual intercourse. Patients with breast, gastric, and liver cancers were more likely to have the hand-foot syndrome. Worsening PRO-CTCAE scores were associated with poor HRQoL (eg, fatigue: coefficient ?8.15; 95% CI ?9.32 to ?6.97), difficulty in achieving and maintaining erection (coefficient ?8.07; 95% CI ?14.52 to ?1.61), poor concentration (coefficient ?7.54; 95% CI ?9.06 to ?6.01), and dizziness (coefficient ?7.24; 95% CI ?8.92 to ?5.55). Conclusions: The frequency and severity of symptoms differed by cancer types. Higher symptom burden was associated with poor HRQoL, which suggests the importance of appropriate surveillance of PRO symptoms during cancer treatment. Considering patients had comprehensive symptoms, it is necessary to include a holistic approach in the symptom monitoring and management strategies based on comprehensive patient-reported outcome measurements. UR - https://publichealth.jmir.org/2023/1/e44105 UR - http://dx.doi.org/10.2196/44105 UR - http://www.ncbi.nlm.nih.gov/pubmed/36884274 ID - info:doi/10.2196/44105 ER - TY - JOUR AU - Leiner, Johannes AU - König, Sebastian AU - Mouratis, Konstantinos AU - Kim, Igor AU - Schmitz, Pia AU - Joshi, Tanvi AU - Schanner, Carolin AU - Wohlrab, Lisa AU - Hohenstein, Sven AU - Pellissier, Vincent AU - Nitsche, Anne AU - Kuhlen, Ralf AU - Hindricks, Gerhard AU - Bollmann, Andreas PY - 2023/3/3 TI - A Digital Infrastructure for Cardiovascular Patient Care Based on Mobile Health Data and Patient-Reported Outcomes: Concept Details of the Helios TeleWear Project Including Preliminary Experiences JO - JMIR Form Res SP - e41115 VL - 7 KW - mHealth KW - wearable KW - patient-reported outcomes KW - electrocardiogram KW - cardiovascular disease KW - atrial fibrillation KW - telemedicine KW - mobile health KW - telehealth N2 - Background: Mobile health (mHealth) approaches are already having a fundamental impact on clinical practice in cardiovascular medicine. A variety of different health apps and wearable devices for capturing health data such as electrocardiograms (ECGs) exist. However, most mHealth technologies focus on distinct variables without integrating patients? quality of life, and the impact on clinical outcome measures of implementing those digital solutions into cardiovascular health care is still to be determined. Objective: Within this document, we describe the TeleWear project, which was recently initiated as an approach for contemporary patient management integrating mobile-collected health data and the standardized mHealth-guided measurement of patient-reported outcomes (PROs) in patients with cardiovascular disease. Methods: The specifically designed mobile app and clinical frontend form the central elements of our TeleWear infrastructure. Because of its flexible framework, the platform allows far-reaching customization with the possibility to add different mHealth data sources and respective questionnaires (patient-reported outcome measures). Results: With initial focus on patients with cardiac arrhythmias, a feasibility study is currently carried out to assess wearable-recorded ECG and PRO transmission and its evaluation by physicians using the TeleWear app and clinical frontend. First experiences made during the feasibility study yielded positive results and confirmed the platform?s functionality and usability. Conclusions: TeleWear represents a unique mHealth approach comprising PRO and mHealth data capturing. With the currently running TeleWear feasibility study, we aim to test and further develop the platform in a real-world setting. A randomized controlled trial including patients with atrial fibrillation that investigates PRO- and ECG-based clinical management based on the established TeleWear infrastructure will evaluate its clinical benefits. Widening the spectrum of health data collection and interpretation beyond the ECG and use of the TeleWear infrastructure in different patient subcohorts with focus on cardiovascular diseases are further milestones of the project with the ultimate goal to establish a comprehensive telemedical center entrenched by mHealth. UR - https://formative.jmir.org/2023/1/e41115 UR - http://dx.doi.org/10.2196/41115 UR - http://www.ncbi.nlm.nih.gov/pubmed/36867450 ID - info:doi/10.2196/41115 ER - TY - JOUR AU - van Barneveld, Esther AU - Lim, Arianne AU - van Hanegem, Nehalennia AU - van Osch, Frits AU - Vork, Lisa AU - Kruimel, Joanna AU - Bongers, Marlies AU - Leue, Carsten PY - 2023/3/3 TI - Real-time Symptom Assessment in Patients With Endometriosis: Psychometric Evaluation of an Electronic Patient-Reported Outcome Measure, Based on the Experience Sampling Method JO - JMIR Form Res SP - e29480 VL - 7 KW - endometriosis KW - pelvic pain KW - positive affect KW - negative affect KW - patient-reported outcome measure KW - momentary symptom assessment KW - experience sampling method KW - pain KW - PROM KW - outcome KW - patient-reported KW - assessment KW - symptom KW - sampling KW - method KW - evaluation KW - psychometric KW - real-time KW - prospective N2 - Background: The experience sampling method (ESM) holds advantages over traditional retrospective questionnaires including a high ecological validity, no recall bias, the ability to assess fluctuation of symptoms, and the ability to analyze the temporal relationship between variables. Objective: This study aimed to evaluate the psychometric properties of an endometriosis-specific ESM tool. Methods: This is a short-term follow-up prospective study, including patients with premenopausal endometriosis aged ?18 years who reported dysmenorrhea, chronic pelvic pain, or dyspareunia between December 2019 and November 2020. An ESM-based questionnaire was sent out by a smartphone application 10 times a day during 1 week on randomly chosen moments. Additionally, patients completed questionnaires concerning demographics, end-of-day pain scores, and end-of-week symptom scores. The psychometric evaluation included compliance, concurrent validity, and internal consistency. Results: Twenty-eight patients with endometriosis completed the study. Compliance for answering the ESM questions was as high as 52%. End-of-week pain scores were higher than ESM mean scores and showed peak reporting. ESM scores showed strong concurrent validity when compared with symptoms scored by the Gastrointestinal Symptom Rating Scale?Irritable Bowel Syndrome, 7-item Generalized Anxiety Disorders Scale, 9-question Patient Health Questionnaire, and the majority of questions of the 30-item Endometriosis Health Profile. Cronbach ? coefficients demonstrated a good internal consistency for abdominal symptoms, general somatic symptoms, and positive affect, and an excellent internal consistency for negative affect. Conclusions: This study supports the validity and reliability of a newly developed electronic instrument for the measurement of symptoms in women with endometriosis, based on momentary assessments. This ESM patient-reported outcome measure has the advantage of providing a more detailed view on individual symptom patterns and offers the possibility for patients to have insight in their symptomatology, leading to more individualized treatment strategies that can improve the quality of life of women with endometriosis. UR - https://formative.jmir.org/2023/1/e29480 UR - http://dx.doi.org/10.2196/29480 UR - http://www.ncbi.nlm.nih.gov/pubmed/36867439 ID - info:doi/10.2196/29480 ER - TY - JOUR AU - Teepe, Wilhelm Gisbert AU - Kowatsch, Tobias AU - Hans, Patricius Felix AU - Benning, Leo PY - 2023/2/27 TI - Postmarketing Follow-Up of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time-Series and Matched-Pair Analysis JO - J Med Internet Res SP - e43775 VL - 25 KW - digital therapeutics KW - digital health KW - musculoskeletal diseases KW - exercise training N2 - Background: Musculoskeletal conditions are the main drivers of global disease burden and cause significant direct and indirect health care costs. Digital health applications improve the availability of and access to adequate care. The German health care system established a pathway for the approval of ?Digitale Gesundheitsanwendungen? (DiGAs; Digital Health Applications) as collectively funded medical services through the ?Digitale-Versorgung-Gesetz? (Digital Health Care Act) in 2019. Objective: This article presents real-world prescription data collected through the smartphone-based home exercise program ?Vivira,? a fully approved DiGA, regarding its effect on self-reported pain intensity and physical inability in patients with unspecific and degenerative pain in the back, hip, and knee. Methods: This study included 3629 patients (71.8% [2607/3629] female; mean age 47 years, SD 14.2 years). The primary outcome was the self-reported pain score, which was assessed with a verbal numerical rating scale. The secondary outcomes were self-reported function scores. To analyze the primary outcome, we used a 2-sided Skillings-Mack test. For function scores, a time analysis was not feasible; therefore, we calculated matched pairs using the Wilcoxon signed-rank test. Results: Our results showed significant reductions in self-reported pain intensity after 2, 4, 8, and 12 weeks in the Skillings-Mack test (T3628=5308; P<.001). The changes were within the range of a clinically relevant improvement. Function scores showed a generally positive yet more variable response across the pain areas (back, hip, and knee). Conclusions: This study presents postmarketing observational data from one of the first DiGAs for unspecific and degenerative musculoskeletal pain. We noted significant improvements in self-reported pain intensity throughout the observation period of 12 weeks, which reached clinical relevance. Additionally, we identified a complex response pattern of the function scores assessed. Lastly, we highlighted the challenges of relevant attrition at follow-up and the potential opportunities for evaluating digital health applications. Although our findings do not have confirmatory power, they illustrate the potential benefits of digital health applications to improve the availability of and access to medical care. Trial Registration: German Clinical Trials Register DRKS00024051; https://drks.de/search/en/trial/DRKS00024051 UR - https://www.jmir.org/2023/1/e43775 UR - http://dx.doi.org/10.2196/43775 UR - http://www.ncbi.nlm.nih.gov/pubmed/36848211 ID - info:doi/10.2196/43775 ER - TY - JOUR AU - Varriale, Pasquale AU - Müller, Borna AU - Katz, Grégory AU - Dallas, Lorraine AU - Aguaron, Alfonso AU - Azoulai, Marion AU - Girard, Nicolas PY - 2023/1/26 TI - Patient Perspectives on Value Dimensions of Lung Cancer Care: Cross-sectional Web-Based Survey JO - JMIR Form Res SP - e37190 VL - 7 KW - lung KW - cancer KW - health quality of life KW - patient reported outcome KW - PROM KW - economic burden KW - cost KW - economic KW - burden KW - perspective KW - survey KW - QoL KW - quality of life KW - questionnaire KW - caregiver KW - caregiving KW - physical well-being KW - end of life KW - palliative KW - physical function KW - independence KW - distress N2 - Background: While the lung cancer (LC) treatment landscape has rapidly evolved in recent years, easing symptom burden and treatment side effects remain central considerations in disease control. Objective: The aim of this study was to assess the relative importance of dimensions of LC care to patients, and to explore the disease burden, including socioeconomic aspects not commonly covered in patient-reported outcomes instruments. Methods: A questionnaire was sent to patients with LC and their caregivers to rate the value of a diverse set of quality of life dimensions in care, to evaluate communication between health care professionals (HCPs) and patients, and to explore the economic impact on respondents. The survey included questions on the dimensions of care covered by patient-reported outcomes instruments for quality-of-life evaluation (Functional Assessment of Cancer Therapy?Lung scale, EQ-5D, the European Organization for Research and Treatment of Cancer?s Core Quality of Life questionnaire, and the European Organization for Research and Treatment of Cancer?s Core Quality of Life in lung cancer 13-item questionnaire), as well as the International Consortium for Health Outcomes Measurement (ICHOM) standard set of patient-centered outcomes for LC. The survey respondents were participants on Carenity?s patient community platform, living either in France, the United Kingdom, Germany, Italy, or Spain. Results: The survey included 150 respondents (115 patients and 35 caregivers). ?Physical well-being? and ?end-of-life care? (median scores of 9.6, IQR 7.7-10, and 9.7, IQR 8.0-10, on a 10-point scale) were rated highest among the different value dimensions assessed. ?Physical well-being and functioning? was the dimension most frequently discussed with health care professionals (82/150, 55%), while only (17/100, 17%) reported discussing ?end-of-life care.? After diagnosis, 43% (49/112) of patients younger than 65 years stopped working. Among respondents who indicated their monthly household income before and after diagnosis, 55% (38/69) reported a loss of income. Conclusions: Our results showed the relevance of a broad range of aspects of care for the quality of life of patients with LC. End-of-life care was the dimension of care rated highest by patients with LC, irrespective of stage at diagnosis; however, this aspect is least frequently discussed with HCPs. The results also highlight the considerable socioeconomic impact of the disease, despite insurance coverage of direct costs. UR - https://formative.jmir.org/2023/1/e37190 UR - http://dx.doi.org/10.2196/37190 UR - http://www.ncbi.nlm.nih.gov/pubmed/36416499 ID - info:doi/10.2196/37190 ER - TY - JOUR AU - Sohl, J. Stephanie AU - Duncan, W. Pamela AU - Thakur, Elyse AU - Puccinelli-Ortega, Nicole AU - Salsman, M. John AU - Russell, Greg AU - Pasche, C. Boris AU - Wentworth, Stacy AU - Miller Jr, P. David AU - Wagner, I. Lynne AU - Topaloglu, Umit PY - 2023/1/10 TI - Adaptation of a Personalized Electronic Care Planning Tool for Cancer Follow-up Care: Formative Study JO - JMIR Form Res SP - e41354 VL - 7 KW - cancer survivorship KW - cancer survivor KW - colorectal cancer KW - patient engagement KW - shared decision-making KW - follow-up care KW - patient care planning KW - electronic tool KW - patient-reported outcomes KW - behavior change N2 - Background: Most patients diagnosed with colorectal cancer will survive for at least 5 years; thus, engaging patients to optimize their health will likely improve outcomes. Clinical guidelines recommend patients receive a comprehensive care plan (CP) when transitioning from active treatment to survivorship, which includes support for ongoing symptoms and recommended healthy behaviors. Yet, cancer care providers find this guideline difficult to implement. Future directions for survivorship care planning include enhancing information technology support for developing personalized CPs, using CPs to facilitate self-management, and assessing CPs in clinical settings. Objective: We aimed to develop an electronic tool for colorectal cancer follow-up care (CFC) planning. Methods: Incorporating inputs from health care professionals and patient stakeholders is fundamental to the successful integration of any tool into the clinical workflow. Thus, we followed the Integrate, Design, Assess, and Share (IDEAS) framework to adapt an existing application for stroke care planning (COMPASS-CP) to meet the needs of colorectal cancer survivors (COMPASS-CP CFC). Constructs from the Consolidated Framework for Implementation Research (CFIR) guided our approach. We completed this work in 3 phases: (1) gathering qualitative feedback from stakeholders about the follow-up CP generation design and workflow; (2) adapting algorithms and resource data sources needed to generate a follow-up CP; and (3) optimizing the usability of the adapted prototype of COMPASS-CP CFC. We also quantitatively measured usability (target average score ?70; range 0-100), acceptability, appropriateness, and feasibility. Results: In the first phase, health care professionals (n=7), and patients and caregivers (n=7) provided qualitative feedback on COMPASS-CP CFC that informed design elements such as selection, interpretation, and clinical usefulness of patient-reported measures. In phase 2, we built a minimal viable product of COMPASS-CP CFC. This tool generated CPs based on the needs identified by patient-completed measures (including validated patient-reported outcomes) and electronic health record data, which were then matched with resources by zip code and preference to support patients? self-management. Elements of the CFIR assessed revealed that most health care professionals believed the tool would serve patients? needs and had advantages. In phase 3, the average System Usability Scale score was above our target score for health care professionals (n=5; mean 71.0, SD 15.2) and patients (n=5; mean 95.5, SD 2.1). Participants also reported high levels of acceptability, appropriateness, and feasibility. Additional CFIR-informed feedback, such as desired format for training, will inform future studies. Conclusions: The data collected in this study support the initial usability of COMPASS-CP CFC and will inform the next steps for implementation in clinical care. COMPASS-CP CFC has the potential to streamline the implementation of personalized CFC planning to enable systematic access to resources that will support self-management. Future research is needed to test the impact of COMPASS-CP CFC on patient health outcomes. UR - https://formative.jmir.org/2023/1/e41354 UR - http://dx.doi.org/10.2196/41354 UR - http://www.ncbi.nlm.nih.gov/pubmed/36626203 ID - info:doi/10.2196/41354 ER - TY - JOUR AU - Patel, Smit AU - Goldsack, C. Jennifer AU - Cordovano, Grace AU - Downing, Andrea AU - Fields, K. Karen AU - Geoghegan, Cindy AU - Grewal, Upinder AU - Nieva, Jorge AU - Patel, Nikunj AU - Rollison, E. Dana AU - Sah, Archana AU - Said, Maya AU - Van De Keere, Isabel AU - Way, Amanda AU - Wolff-Hughes, L. Dana AU - Wood, A. William AU - Robinson, J. Edmondo PY - 2023/1/4 TI - Advancing Digital Health Innovation in Oncology: Priorities for High-Value Digital Transformation in Cancer Care JO - J Med Internet Res SP - e43404 VL - 25 KW - digital health KW - innovation KW - oncology KW - cancer care KW - cancer KW - patient journey KW - digital transformation KW - digital divide KW - health care delivery KW - service delivery KW - equity KW - patient-reported outcome KW - PROM KW - biomarker KW - digital innovation UR - https://www.jmir.org/2023/1/e43404 UR - http://dx.doi.org/10.2196/43404 UR - http://www.ncbi.nlm.nih.gov/pubmed/36598811 ID - info:doi/10.2196/43404 ER - TY - JOUR AU - Brands, R. Martijn AU - Gouw, C. Samantha AU - Beestrum, Molly AU - Cronin, M. Robert AU - Fijnvandraat, Karin AU - Badawy, M. Sherif PY - 2022/12/22 TI - Patient-Centered Digital Health Records and Their Effects on Health Outcomes: Systematic Review JO - J Med Internet Res SP - e43086 VL - 24 IS - 12 KW - telemedicine KW - health records KW - personal KW - electronic health records KW - outcome assessment KW - health care N2 - Background: eHealth tools such as patient portals and personal health records, also known as patient-centered digital health records, can engage and empower individuals with chronic health conditions. Patients who are highly engaged in their care have improved disease knowledge, self-management skills, and clinical outcomes. Objective: We aimed to systematically review the effects of patient-centered digital health records on clinical and patient-reported outcomes, health care utilization, and satisfaction among patients with chronic conditions and to assess the feasibility and acceptability of their use. Methods: We searched MEDLINE, Cochrane, CINAHL, Embase, and PsycINFO databases between January 2000 and December 2021. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed. Eligible studies were those evaluating digital health records intended for nonhospitalized adult or pediatric patients with a chronic condition. Patients with a high disease burden were a subgroup of interest. Primary outcomes included clinical and patient-reported health outcomes and health care utilization. Secondary outcomes included satisfaction, feasibility, and acceptability. Joanna Briggs Institute critical appraisal tools were used for quality assessment. Two reviewers screened titles, abstracts, and full texts. Associations between health record use and outcomes were categorized as beneficial, neutral or clinically nonrelevant, or undesired. Results: Of the 7716 unique publications examined, 81 (1%) met the eligibility criteria, with a total of 1,639,556 participants across all studies. The most commonly studied diseases included diabetes mellitus (37/81, 46%), cardiopulmonary conditions (21/81, 26%), and hematology-oncology conditions (14/81, 17%). One-third (24/81, 30%) of the studies were randomized controlled trials. Of the 81 studies that met the eligibility criteria, 16 (20%) were of high methodological quality. Reported outcomes varied across studies. The benefits of patient-centered digital health records were most frequently reported in the category health care utilization on the ?use of recommended care services? (10/13, 77%), on the patient-reported outcomes ?disease knowledge? (7/10, 70%), ?patient engagement? (13/28, 56%), ?treatment adherence? (10/18, 56%), and ?self-management and self-efficacy? (10/19, 53%), and on the clinical outcome ?laboratory parameters,? including HbA1c and low-density lipoprotein (LDL; 16/33, 48%). Beneficial effects on ?health-related quality of life? were seen in only 27% (4/15) of studies. Patient satisfaction (28/30, 93%), feasibility (15/19, 97%), and acceptability (23/26, 88%) were positively evaluated. More beneficial effects were reported for digital health records that predominantly focus on active features. Beneficial effects were less frequently observed among patients with a high disease burden and among high-quality studies. No unfavorable effects were observed. Conclusions: The use of patient-centered digital health records in nonhospitalized individuals with chronic health conditions is potentially associated with considerable beneficial effects on health care utilization, treatment adherence, and self-management or self-efficacy. However, for firm conclusions, more studies of high methodological quality are required. Trial Registration: PROSPERO (International Prospective Register of Systematic Reviews) CRD42020213285; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=213285 UR - https://www.jmir.org/2022/12/e43086 UR - http://dx.doi.org/10.2196/43086 UR - http://www.ncbi.nlm.nih.gov/pubmed/36548034 ID - info:doi/10.2196/43086 ER - TY - JOUR AU - Wang, Ziqi AU - Zhu, Yaxin AU - Duan, Xiyu AU - Kang, Hao AU - Qu, Bo PY - 2022/12/8 TI - HIV-Specific Reported Outcome Measures: Systematic Review of Psychometric Properties JO - JMIR Public Health Surveill SP - e39015 VL - 8 IS - 12 KW - HIV KW - AIDS KW - people living with HIV and AIDS KW - patient-reported outcome measures KW - psychometric properties N2 - Background: The management of people living with HIV and AIDS is multidimensional and complex. Using patient-reported outcome measures (PROMs) has been increasingly recognized to be the key factor for providing patient-centered health care to meet the lifelong needs of people living with HIV and AIDS from diagnosis to death. However, there is currently no consensus on a PROM recommended for health care providers and researchers to assess health outcomes in people living with HIV and AIDS. Objective: The purpose of this systematic review was to summarize and categorize the available validated HIV-specific PROMs in adults living with HIV and AIDS and to assess these PROMs using the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) methodology. Methods: This systematic review followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. A literature search of 3 recommended databases (PubMed, Embase, and PsychINFO) was conducted on January 15, 2021. Studies were included if they assessed any psychometric property of HIV-specific PROMs in adults living with HIV and AIDS and met the eligibility criteria. The PROMs were assessed for 9 psychometric properties, evaluated in each included study following the COSMIN methodology by assessing the following: the methodological quality assessed using the COSMIN risk of bias checklist; overall rating of results; level of evidence assessed using the modified Grading of Recommendations, Assessment, Development, and Evaluation approach; and level of recommendation. Results: A total of 88 PROMs classified into 8 categories, assessing the psychometric properties of PROMs for adults living with HIV and AIDS, were identified in 152 studies including 79,213 people living with HIV and AIDS. The psychometric properties of most included PROMs were rated with insufficient evidence. The PROMs that received class A recommendation were the Poz Quality of Life, HIV Symptom Index or Symptoms Distress Module of the Adult AIDS Clinical Trial Group, and People Living with HIV Resilience Scale. In addition, because of a lack of evidence, recommendations regarding use could not be made for most of the remaining assessed PROMs (received class B recommendation). Conclusions: This systematic review recommends 3 PROMs to assess health outcomes in adults living with HIV and AIDS. However, all these PROMs have some shortcomings. In addition, most of the included PROMs do not have sufficient evidence for assessing their psychometric properties and require a more comprehensive validation of the psychometric properties in the future to provide more scientific evidence. Thus, our findings may provide a reference for the selection of high-quality HIV-specific PROMs by health care providers and researchers for clinical practice and research. UR - https://publichealth.jmir.org/2022/12/e39015 UR - http://dx.doi.org/10.2196/39015 UR - http://www.ncbi.nlm.nih.gov/pubmed/36222289 ID - info:doi/10.2196/39015 ER - TY - JOUR AU - Teepe, Wilhelm Gisbert AU - Kowatsch, Tobias AU - Hans, Patricius Felix AU - Benning, Leo PY - 2022/12/2 TI - Preliminary Use and Outcome Data of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time Series and Matched Analysis JO - JMIR Mhealth Uhealth SP - e38649 VL - 10 IS - 12 KW - digital health KW - home exercise KW - musculoskeletal conditions KW - digital intervention KW - exercise KW - physical activity KW - smartphone KW - pain KW - management KW - back pain KW - hip pain KW - knee pain KW - mobility KW - intervention N2 - Background: Musculoskeletal conditions are among the main contributors to the global burden of disease. International guidelines consider patient education and movement exercises as the preferred therapeutic option for unspecific and degenerative musculoskeletal conditions. Innovative and decentralized therapeutic means are required to provide access to and availability of such care to meet the increasing therapeutic demand for this spectrum of conditions. Objective: This retrospective observational study of preliminary use and outcome data explores the clinical outcomes of Vivira (hereafter referred to as ?program?), a smartphone-based program for unspecific and degenerative pain in the back, hip, and knee before it received regulatory approval for use in the German statutory health insurance system. Methods: An incomplete matched block design was employed to assess pain score changes over the intended 12-week duration of the program. Post hoc analyses were performed. In addition, a matched comparison of self-reported functional scores and adherence rates is presented. Results: A total of 2517 participants met the inclusion criteria and provided sufficient data to be included in the analyses. Overall, initial self-reported pain scores decreased significantly from an average of 5.19 out of 10 (SD 1.96) to an average of 3.35 out of 10 (SD 2.38) after 12 weeks. Post hoc analyses indicate a particularly emphasized pain score reduction over the early use phases. Additionally, participants with back pain showed significant improvements in strength and mobility scores, whereas participants with hip or knee pain demonstrated significant improvements in their coordination scores. Across all pain areas and pain durations, a high yet expected attrition rate could be observed. Conclusions: This observational study provides the first insights into the clinical outcomes of an exercise program for unspecific and degenerative back, hip, and knee pain. Furthermore, it demonstrates a potential secondary benefit of improved functionality (ie, strength, mobility, coordination). However, as this study lacks confirmatory power, further research is required to substantiate the clinical outcomes of the program assessed. Trial Registration: German Clinical Trials Register DRKS00021785; https://drks.de/search/en/trial/DRKS00021785 UR - https://mhealth.jmir.org/2022/12/e38649 UR - http://dx.doi.org/10.2196/38649 UR - http://www.ncbi.nlm.nih.gov/pubmed/36459399 ID - info:doi/10.2196/38649 ER - TY - JOUR AU - Shah, Payal AU - Raymond, K. Jennifer AU - Espinoza, Juan PY - 2022/11/30 TI - Modified e-Delphi Process for the Selection of Patient-Reported Outcome Measures for Children and Families With Type 1 Diabetes Using Continuous Glucose Monitors: Delphi Study JO - JMIR Diabetes SP - e38660 VL - 7 IS - 4 KW - type 1 diabetes KW - diabetes KW - diabetic KW - juvenile KW - pediatrics KW - paediatrics KW - child KW - youth KW - continuous glucose monitor KW - glucose KW - monitoring KW - patient reported KW - outcome measure KW - PROM KW - Delphi KW - disease management KW - self-management KW - measurement KW - instrument N2 - Background: Type 1 diabetes (T1D) management is complex and associated with significant psychosocial burden. Continuous glucose monitors (CGM) can improve disease management and outcomes and introduce new or exacerbate existing psychosocial concerns. Patient-reported outcome measures (PROMs) can be used to capture this information, but there is no consensus on which PROMs should be used in pediatric CGM research. Objective: Here we describe the process to (1) identify PROMs that could be used to assess the impact of CGMs on pediatric patients with T1D, (2) implement a modified electronic Delphi (e-Delphi) methodology to arrive at an expert consensus on which PROMs are most suitable for clinical and research applications, and (3) establish a periodicity table for the administration of PROMs over time in a real-world evidence study. Methods: To identify appropriate PROMs for pediatric patients and families with T1D and CGMs, we conducted an asynchronous, e-Delphi process with a multidisciplinary group of experts from around the country. We identified candidate instruments through a literature review. The 3-round e-Delphi process was conducted via a study website, email, and web-based forms. Participants provided opinions on the usefulness of instruments, age validation, feasibility, time, and frequency of administration. Results: In total, 16 experts participated in the e-Delphi process; 4 of whom consistently participated in all 3 rounds. We identified 62 candidate instruments, which were narrowed down to 12 final PROMs across 5 domains: diabetes distress and burden (n=4), autonomy (n=2), quality of life (n=1), psychosocial (n=3), and technology acceptance (n=2). A quarterly administration schedule was developed to reduce burden on participants. Conclusions: PROMs can provide critical insights into the psychosocial well-being of patients. The specific measures identified in the paper are particularly well suited for pediatric patients with T1D using CGMs. Clinical implementation could help health care providers, patients, and families to engage in more comprehensive disease management. UR - https://diabetes.jmir.org/2022/4/e38660 UR - http://dx.doi.org/10.2196/38660 UR - http://www.ncbi.nlm.nih.gov/pubmed/36265838 ID - info:doi/10.2196/38660 ER - TY - JOUR AU - Van Tiem, Jen AU - Wirtz, Elizabeth AU - Suiter, Natalie AU - Heeren, Amanda AU - Fuhrmeister, Lindsey AU - Fortney, John AU - Reisinger, Heather AU - Turvey, Carolyn PY - 2022/11/24 TI - The Implementation of Measurement-Based Care in the Context of Telemedicine: Qualitative Study JO - JMIR Ment Health SP - e41601 VL - 9 IS - 11 KW - telehealth KW - patient-reported outcome measures KW - measurement-based care KW - health information technology KW - data visualization N2 - Background: The Measurement Based Care in Mental Health Initiative launched by the Department of Veterans Affairs in 2016 is an example of an evidence-based practice that uses patient-reported outcome measures (PROMs) to improve patient outcomes. The acceptance of measurement-based care (MBC) among Veterans Affairs providers is relatively high. However, there are barriers to MBC for telehealth providers. Health information technologies might afford opportunities to address some of the barriers related to the uptake of MBC. Objective: This paper reports on an implementation effort to integrate MBC into mental health care telehealth practice using eHealth solutions. Methods: Qualitative data were generated from 22 semistructured interviews with psychiatrists (n=4), psychologists (n=3), social workers (n=3), nurses (n=6), a pharmacist (n=1), and administrative staff (n=5) who provide telemental health care through a community-based outpatient clinic in the rural Midwestern United States. The interviews were conducted during the pilot phase of an implementation initiative to increase the adoption of MBC by revising clinic workflows to integrate the use of eHealth technologies. Data were analyzed using thematic analysis. Results: Time burden and workflow issues were the most common barrier to provider adoption of MBC; sharing and reviewing pencil-and-paper measures and results in the same room was no longer possible in novel telehealth workflows necessitated by the COVID-19 pandemic. Providers voiced concerns about how long it would take to collect, adequately score, interpret, share, and document the PROMs during the telehealth visit. Concerns about time might also correspond to a gap in providers? familiarity with these assessments, greater comfort in assessing symptoms through clinical interviews, and being accustomed to using the assessments as screening tools more so than longitudinal outcome measures. Capacities associated with eHealth technologies may address workflow concerns and promote providers? understanding and use of the measures as tracking tools. Conclusions: The need to use limited appointment time well was a top priority for telemental health providers. eHealth technologies provided operative supports that protect time in appointments by shifting when and how PROMs are collected. Bolstering providers? familiarity with how to use PROMs in the course of treatment may impact providers? buy-in by encouraging them to reconsider how sharing and acting on PROMs could be time well spent. UR - https://mental.jmir.org/2022/11/e41601 UR - http://dx.doi.org/10.2196/41601 UR - http://www.ncbi.nlm.nih.gov/pubmed/36422884 ID - info:doi/10.2196/41601 ER - TY - JOUR AU - Scher, Nathaniel AU - Guetta, Liath AU - Draghi, Clément AU - Yahiaoui, Safia AU - Terzioglu, Mathilde AU - Butaye, Emilie AU - Henriques, Kathy AU - Alavoine, Marie AU - Elharar, Ayala AU - Guetta, Andre AU - Toledano, Alain PY - 2022/11/24 TI - Sleep Disorders and Quality of Life in Patients With Cancer: Prospective Observational Study of the Rafael Institute JO - JMIR Form Res SP - e37371 VL - 6 IS - 11 KW - cancer KW - sleep disorder KW - sleep KW - fatigue KW - nocturnal KW - oncology KW - cancer care KW - patient-centred approach KW - patient-centered KW - personalized KW - personalization KW - customized KW - customization KW - care plan KW - quality of life KW - mood KW - pain KW - cancer treatment KW - overweight KW - obese KW - hormone therapy KW - breast KW - prostate N2 - Background: Sleep disorders are a common occurrence in the general population. Yet today, it is clearly agreed that sleep disorders represent both a cancer risk factor and a biological consequence of the of the activation of the immuno-inflammatory system induced by cancer itself. Objective: The aim of this study was to assess the impact of sleep disorders on quality of life and identify the type of disorder and its causes in order to offer an adapted and personalized care plan. Methods: In a survey completed during the COVID-19 lockdown, 2000 hours of interviews were collected by remote consultations. During these calls, we administered a sleep questionnaire. This questionnaire was inspired by the STOP-BANG questionnaire and enquired about 6 items. The demographic details of each patient (eg, age and sex), the nature of the pathology, their past treatments, the ongoing cancer treatment, the mood, whether or not the patient is anxious or depressed, and the use of sleeping drug pills were analyzed. A univariate analysis was performed according to the presence or absence of fatigue. Chi-square test was applied to assess possible differences of variables? link to sleep disturbance between patients complaining of fatigue and those without fatigue. The same test was then used to analyze patients on hormone therapy and those with no hormone therapy for 2 types of cancer?breast cancer and prostate cancer. Results: A total of 905 patients were prospectively included in this study. The average age was 66.7 (5 SD) years, and 606 (67%) patients were women; 142 patients declared being overweight. Breast cancer was the most frequently reported cancer. Nocturnal awakening was reported by 70% (n=633), fatigue by 50% (n=452), difficulty falling asleep by 38% (n=343), snoring reported by an independent observer in 38% (n=343), and apnea reported by an independent observer in 9% (n=81) of the patients. The univariate analysis showed that the feeling of tiredness was significantly greater in patients reporting difficulty falling asleep (P?.99), pain (P<.001), and frequent awakening (P<.001), as well as in patients who were not receiving cancer treatment (P<.001). The univariate analysis showed that patients who were receiving breast cancer treatment and were under hormone therapy reported difficulty falling asleep (P=.04) and pain (P=.05). In a univariate analysis of patients treated for prostate cancer, being overweight was the only factor reported that had a statistically significant value. Conclusions: Our preliminary data support and are consistent with data in the literature regarding the importance of sleep disorders in oncology. This justifies the usefulness of a diagnosis and early treatment of sleep disorders in patients with cancer. The Rafael Institute sleep observatory will enable patients to be identified and treated. UR - https://formative.jmir.org/2022/11/e37371 UR - http://dx.doi.org/10.2196/37371 UR - http://www.ncbi.nlm.nih.gov/pubmed/36422866 ID - info:doi/10.2196/37371 ER - TY - JOUR AU - Wood, D. Michael AU - West, C. Nicholas AU - Sreepada, S. Rama AU - Loftsgard, C. Kent AU - Petersen, Luba AU - Robillard, M. Julie AU - Page, Patricia AU - Ridgway, Randa AU - Chadha, K. Neil AU - Portales-Casamar, Elodie AU - Görges, Matthias AU - PY - 2022/11/15 TI - Identifying Risk Factors, Patient-Reported Experience and Outcome Measures, and Data Capture Tools for an Individualized Pain Prediction Tool in Pediatrics: Focus Group Study JO - JMIR Perioper Med SP - e42341 VL - 5 IS - 1 KW - patient-oriented research KW - patient-reported outcome measures KW - patient-reported experience measures KW - risk prediction KW - pain KW - individualized risk KW - surgery KW - anesthesia KW - focus groups KW - thematic analysis KW - perioperative KW - participatory medicine KW - digital health tool KW - postsurgical pain KW - children KW - opioid use KW - virtual focus group KW - postoperative KW - pediatrics KW - health outcome N2 - Background: The perioperative period is a data-rich environment with potential for innovation through digital health tools and predictive analytics to optimize patients? health with targeted prehabilitation. Although some risk factors for postoperative pain following pediatric surgery are already known, the systematic use of preoperative information to guide personalized interventions is not yet widespread in clinical practice. Objective: Our long-term goal is to reduce the incidence of persistent postsurgical pain (PPSP) and long-term opioid use in children by developing personalized pain risk prediction models that can guide clinicians and families to identify targeted prehabilitation strategies. To develop such a system, our first objective was to identify risk factors, outcomes, and relevant experience measures, as well as data collection tools, for a future data collection and risk modeling study. Methods: This study used a patient-oriented research methodology, leveraging parental/caregiver and clinician expertise. We conducted virtual focus groups with participants recruited at a tertiary pediatric hospital; each session lasted approximately 1 hour and was composed of clinicians or family members (people with lived surgical experience and parents of children who had recently undergone a procedure requiring general anesthesia) or both. Data were analyzed thematically to identify potential risk factors for pain, as well as relevant patient-reported experience and outcome measures (PREMs and PROMs, respectively) that can be used to evaluate the progress of postoperative recovery at home. This guidance was combined with a targeted literature review to select tools to collect risk factor and outcome information for implementation in a future study. Results: In total, 22 participants (n=12, 55%, clinicians and n=10, 45%, family members) attended 10 focus group sessions; participants included 12 (55%) of 22 persons identifying as female, and 12 (55%) were under 50 years of age. Thematic analysis identified 5 key domains: (1) demographic risk factors, including both child and family characteristics; (2) psychosocial risk factors, including anxiety, depression, and medical phobias; (3) clinical risk factors, including length of hospital stay, procedure type, medications, and pre-existing conditions; (4) PREMs, including patient and family satisfaction with care; and (5) PROMs, including nausea and vomiting, functional recovery, and return to normal activities of daily living. Participants further suggested desirable functional requirements, including use of standardized and validated tools, and longitudinal data collection, as well as delivery modes, including electronic, parent proxy, and self-reporting, that can be used to capture these metrics, both in the hospital and following discharge. Established PREM/PROM questionnaires, pain-catastrophizing scales (PCSs), and substance use questionnaires for adolescents were subsequently selected for our proposed data collection platform. Conclusions: This study established 5 key data domains for identifying pain risk factors and evaluating postoperative recovery at home, as well as the functional requirements and delivery modes of selected tools with which to capture these metrics both in the hospital and after discharge. These tools have been implemented to generate data for the development of personalized pain risk prediction models. UR - https://periop.jmir.org/2022/1/e42341 UR - http://dx.doi.org/10.2196/42341 UR - http://www.ncbi.nlm.nih.gov/pubmed/36378509 ID - info:doi/10.2196/42341 ER - TY - JOUR AU - Holmen, Heidi AU - Singstad, Tone AU - Ribu, Lis AU - Jensen, Lunde Annesofie AU - Weldingh, Mickelson Nina AU - Torbjřrnsen, Astrid PY - 2022/11/15 TI - Adapting a Patient-Reported Outcome Measure to Digital Outpatient Specialist Health Care Services for Type 1 Diabetes: User Involvement Study JO - JMIR Hum Factors SP - e38678 VL - 9 IS - 4 KW - patient-reported outcome measures KW - user involvement KW - type 1 diabetes KW - digital interventions N2 - Background: Diabetes self-management is crucial for patients with type 1 diabetes, and digital services can support their self-management and facilitate flexible follow-up. The potential of using digital patient-reported outcome (PRO) measures in routine outpatient care is not fully used owing to a lack of adapted PRO measures. Objective: This study presents the process of identifying and adapting a digital PRO measure for use in clinical diabetes practice and describes the preferred item topics of the adapted PRO measure, as reported by patients and diabetes specialist nurses. Methods: With the involvement of patients, diabetes specialist nurses, management, and researchers, we hosted a series of workshops and 2 dialogue conferences. Scoping searches to identify relevant PRO measures formed the foundation for the process. An in-person dialogue conference was conducted with diabetes specialist nurses as participants, and a digital dialogue conference was conducted with patients with type 1 diabetes as participants. A diabetes-specific PRO measure was translated and adapted to our digital platform. Notes and summaries from the dialogue conferences were imported into NVivo (QSR International) and thematically analyzed as a single combined data set. Results: The thematic analysis of the 2 dialogue conferences aimed to explore the views of patients with type 1 diabetes and diabetes specialist nurses on the outcomes necessary to measure. An overarching theme, Ensuring that the PRO measure captures the patients? needs precisely and accurately, in a way that facilitates care and communication with health care personnel, was identified and supported with data from both the patients and diabetes specialist nurses. This theme contained four categories: The need for explanatory text after questions to ensure understanding and accurate response, Capturing individual needs in standardized questions, getting to the heart of the patient?s problem, and The questions increase patient reflection. Conclusions: We successfully conducted an iterative process that identified a PRO measure aligned with the topics raised by the diabetes specialist nurses. Similarly, the patients found the PRO measure to be relevant and one that was addressing their needs. Only minor adjustments were necessary when programming the PRO measure in the digital platform. Our management, patients, and diabetes specialist nurses had a valuable impact on the results. User involvement facilitated a specific focus on the clinical requests to be met by PRO measures and how they must be adapted to local and digital platforms. Overall, this has facilitated the current implementation of the adapted digital PRO measure. UR - https://humanfactors.jmir.org/2022/4/e38678 UR - http://dx.doi.org/10.2196/38678 UR - http://www.ncbi.nlm.nih.gov/pubmed/36378513 ID - info:doi/10.2196/38678 ER - TY - JOUR AU - Mandal, Soumik AU - Belli, M. Hayley AU - Cruz, Jocelyn AU - Mann, Devin AU - Schoenthaler, Antoinette PY - 2022/11/14 TI - Analyzing User Engagement Within a Patient-Reported Outcomes Texting Tool for Diabetes Management: Engagement Phenotype Study JO - JMIR Diabetes SP - e41140 VL - 7 IS - 4 KW - user engagement KW - patient-reported outcomes KW - mobile health KW - mHealth KW - digital health KW - SMS KW - type 2 diabetes KW - health behavior KW - digital phenotyping N2 - Background: Patient-reported outcomes (PROs) capture patients? views on their health conditions and its management, and are increasingly used in clinical trials, including those targeting type 2 diabetes (T2D). Mobile health (mHealth) tools offer novel solutions for collecting PRO data in real time. Although patients are at the center of any PRO-based intervention, few studies have examined user engagement with PRO mHealth tools. Objective: This study aimed to evaluate user engagement with a PRO mHealth tool for T2D management, identify patterns of user engagement and similarities and differences between the patients, and identify the characteristics of patients who are likely to drop out or be less engaged with a PRO mHealth tool. Methods: We extracted user engagement data from an ongoing clinical trial that tested the efficacy of a PRO mHealth tool designed to improve hemoglobin A1c levels in patients with uncontrolled T2D. To date, 61 patients have been randomized to the intervention, where they are sent 6 PRO text messages a day that are relevant to T2D self-management (healthy eating and medication adherence) over the 12-month study. To analyze user engagement, we first compared the response rate (RR) and response time between patients who completed the 12-month intervention and those who dropped out early (noncompleters). Next, we leveraged latent class trajectory modeling to classify patients from the completer group into 3 subgroups based on similarity in the longitudinal engagement data. Finally, we investigated the differences between the subgroups of completers from various cross-sections (time of the day and day of the week) and PRO types. We also explored the patient demographics and their distribution among the subgroups. Results: Overall, 19 noncompleters had a lower RR to PRO questions and took longer to respond to PRO questions than 42 completers. Among completers, the longitudinal RRs demonstrated differences in engagement patterns over time. The completers with the lowest engagement showed peak engagement during month 5, almost at the midstage of the program. The remaining subgroups showed peak engagement at the beginning of the intervention, followed by either a steady decline or sustained high engagement. Comparisons of the demographic characteristics showed significant differences between the high engaged and low engaged subgroups. The high engaged completers were predominantly older, of Hispanic descent, bilingual, and had a graduate degree. In comparison, the low engaged subgroup was composed mostly of African American patients who reported the lowest annual income, with one of every 3 patients earning less than US $20,000 annually. Conclusions: There are discernible engagement phenotypes based on individual PRO responses, and their patterns vary in the timing of peak engagement and demographics. Future studies could use these findings to predict engagement categories and tailor interventions to promote longitudinal engagement. Trial Registration: Clinicaltrials.gov NCT03652389; https://clinicaltrials.gov/ct2/show/NCT03652389 International Registered Report Identifier (IRRID): RR2-10.2196/18554 UR - https://diabetes.jmir.org/2022/4/e41140 UR - http://dx.doi.org/10.2196/41140 UR - http://www.ncbi.nlm.nih.gov/pubmed/36374531 ID - info:doi/10.2196/41140 ER - TY - JOUR AU - Strachna, Olga AU - Asan, Onur AU - Stetson, D. Peter PY - 2022/11/3 TI - Managing Critical Patient-Reported Outcome Measures in Oncology Settings: System Development and Retrospective Study JO - JMIR Med Inform SP - e38483 VL - 10 IS - 11 KW - patient-reported outcome measures KW - delivery of health care KW - self-report KW - quality of care KW - neoplasms KW - surveys and questionnaires KW - clinical decision support systems N2 - Background: Remote monitoring programs based on the collection of patient-reported outcome (PRO) data are being increasingly adopted in oncology practices. Although PROs are a great source of patient data, the management of critical PRO data is not discussed in detail in the literature. Objective: This first-of-its-kind study aimed to design, describe, and evaluate a closed-loop alerting and communication system focused on managing PRO-related alerts in cancer care. Methods: We designed and developed a novel solution using an agile software development methodology by incrementally building new capabilities. We evaluated these new features using participatory design and the Fit between Individuals, Task, and Technology framework. Results: A total of 8 questionnaires were implemented using alerting features, resulting in an alert rate of 7.82% (36,838/470,841) with 13.28% (10,965/82,544) of the patients triggering at least one alert. Alerts were reviewed by 501 staff members spanning across 191 care teams. All the alerts were reviewed with a median response time of 1 hour (SD 185 hours) during standard business hours. The most severe (red) alerts were documented 56.83% (2592/4561) of the time, whereas unlabeled alerts were documented 27.68% (1298/4689) of the time, signaling clinician concordance with the alert thresholds. Conclusions: A PRO-based alert and communication system has some initial benefits in reviewing clinically meaningful PRO data in a reasonable amount of time. We have discussed key system design considerations, workflow integration, and the mitigation of potential impact on the burden of care teams. The introduction of a PRO-based alert and communication system provides a reliable mechanism for care teams to review and respond to patient symptoms quickly. The system was standardized across many different oncology settings, demonstrating system flexibility. Future studies should focus on formally evaluating system usability through qualitative methods. UR - https://medinform.jmir.org/2022/11/e38483 UR - http://dx.doi.org/10.2196/38483 UR - http://www.ncbi.nlm.nih.gov/pubmed/36326801 ID - info:doi/10.2196/38483 ER - TY - JOUR AU - Lewis, Dana AU - Salmi, Liz AU - Staley, Alicia AU - Harlow, John PY - 2022/11/3 TI - From Individuals to Systems and Contributions to Creations: Novel Framework for Mapping the Efforts of Individuals by Convening The Center of Health and Health Care JO - J Particip Med SP - e39339 VL - 14 IS - 1 KW - patient-centered care KW - patient role KW - patient involvement KW - access to care KW - patient-centered outcomes KW - co-design KW - participatory design KW - patient and public involvement N2 - Background: People with lived health care experiences (often referred to as ?patients?) are increasingly contributing to health care and are most effective when they are involved as partners who can contribute complementary knowledge alongside other stakeholders in health care. Objective: Convening The Center aimed to bring together ?people known as patients??the center of health care?to address priorities as they defined them. Methods: According to the original project design, an in-person gathering was to be conducted; however, as a result of the COVID-19 pandemic, the in-person gathering was transformed into a series of digital gatherings, including an in-depth interview phase, small-group gatherings, and a collective convening of 25 participants (22 women and 3 men from the United States, India, Costa Rica, Sweden, and Pakistan). Each participant was interviewed on Zoom (Zoom Video Communications Inc), and the interview data were thematically analyzed to design a subsequent small group and then full cohort Zoom sessions. Visual note-taking was used to reinforce a shared understanding of each individual- and group-level conversation. Results: The interviews and gatherings for Convening The Center offered unique perspectives on patient activities in research, health innovation, and problem-solving. This project further developed a novel, two-spectrum framework for assessing different experiences that patients may have or seek to gain, based on what patients actually do, and different levels of patients? involvement, ranging from individual to community to systemic involvement. Conclusions: The descriptors of patients in academic literature typically focus on what health care providers think patients ?are? rather than on what patients ?do.? The primary result of this project is a framework for mapping what patients ?do? and ?where? they do their work along two spectra: from creating their own projects to contributing to work initiated by others and from working at levels ranging from individual to community to systems. A better understanding of these spectra may enable researchers to more effectively engage and leverage patient expertise in health care research and innovation. UR - https://jopm.jmir.org/2022/1/e39339 UR - http://dx.doi.org/10.2196/39339 UR - http://www.ncbi.nlm.nih.gov/pubmed/36326807 ID - info:doi/10.2196/39339 ER - TY - JOUR AU - Williams, Hants AU - Steinberg, Sarah AU - Leon, Kendall AU - O?Shea, Catherine AU - Berzin, Robin AU - Hagg, Heather PY - 2022/11/3 TI - Validity of the Parsley Symptom Index?an Electronic Patient-Reported Outcomes Measure Designed for Telehealth: Prospective Cohort Study JO - JMIR Form Res SP - e40063 VL - 6 IS - 11 KW - telemedicine KW - eHealth KW - mHealth KW - web-based N2 - Background: Electronic patient-reported outcomes measures (e-PROMs) are a valuable tool for the monitoring and management of chronic conditions over time. However, there are few validated tools available that capture symptoms across body systems in telehealth settings. The Parsley Symptom Index (PSI) is a recently developed symptom assessment for adults with chronic disease in telehealth settings. A previous study demonstrated the feasibility and acceptability of the PSI in a clinical telehealth setting. Objective: The purpose of this study was to assess convergent validity between the PSI and the self-rated health (SRH) item. Methods: This prospective cohort study took place from January 15, 2021, to December 15, 2021, among a sample of 10,519 adult patients at Parsley Health, a subscription-based holistic medical practice. The PSI and the SRH were completed by patients via an online portal. The association between the PSI and SRH was assessed via polyserial and polychoric correlations, while weighted ? scores provided information related to agreement between the PSI and SRH. Results: From 22,748 responses, there were moderate levels of association (polyserial r=0.51; polychoric r=0.52) and agreement (weighted ?=0.46) between the PSI and SRH. In total, 74.13% (n=16,865) of responses between the PSI and SRH were relatively congruent while 36.17% (n=8229) were literally congruent. Conclusions: The PSI demonstrates convergent validity with the SRH for adults with chronic disease in a telehealth setting. This finding further supports the validation of the PSI in a real-world clinical setting. Although it is conceptually similar to the 1-question SRH, the PSI is a 45-item PROM designed to capture quality of life and specific symptoms by body system. Future studies will compare the PSI to multi-item PROMs. UR - https://formative.jmir.org/2022/11/e40063 UR - http://dx.doi.org/10.2196/40063 UR - http://www.ncbi.nlm.nih.gov/pubmed/36326802 ID - info:doi/10.2196/40063 ER - TY - JOUR AU - Lim, Renly AU - Thornton, Christopher AU - Stanek, Jan AU - Ellett, Kalisch Lisa AU - Thiessen, Myra PY - 2022/10/7 TI - Development of a Web-Based System to Report Medication-Related Adverse Effects: Design and Usability Study JO - JMIR Form Res SP - e37605 VL - 6 IS - 10 KW - adverse drug reaction KW - adverse drug event KW - digital health KW - eHealth KW - medication safety KW - mHealth KW - participatory design KW - patient reported outcomes KW - telehealth N2 - Background: Medicine use is the most common intervention in health care. The frequency with which medicines are used means medication-related problems are very common. One common type of medication-related problems is adverse drug events, which are unintended and harmful effects associated with use of medicines. Reporting of adverse drug events to regulatory authorities is important for evaluation of safety of medicines; however, these adverse effects are frequently unreported due to various factors, including lack of consumer-friendly reporting tools. Objective: The aim of this study was to develop a user-friendly digital tool for consumers to report medication-related adverse effects. Methods: The project consisted of 3 parts: (1) content development, including a systematic literature search; (2) iterative system development; and (3) usability testing. The project was guided by participatory design principles, which suggest involving key stakeholders throughout the design process. The first 2 versions were developed as a mobile app and were tested with end users in 2 workshops. The third version was developed as a web application and was tested with consumers who were taking regular medicines. Consumers were asked to complete a modified version of the mHealth app usability questionnaire (MAUQ), an 18-item questionnaire with each item scored using a 7-point Likert scale ranging from 0 (strongly disagree) to 7 (strongly agree). The MAUQ assessed 3 subscales including ease of use (5 items), interface and satisfaction (7 items), and usefulness (6 items). Continuous variables were reported as mean (SD) values, whereas categorical variables were presented as frequencies (percentages). Data analysis was conducted in Microsoft Excel. Results: The content for the system was based on a systematic literature search and short-listing of questions, followed by feedback from project team members and consumers. Feedback from consumers in the 2 workshops were incorporated to improve the functionality, visual design, and stability of the third (current) version. The third version of the system was tested with 26 consumers. A total of 79% (N=307/390) of all responses on the MAUQ were scored 6 or 7, indicating that users generally strongly agree with the usability of the system. When looking at the individual domains, the system had an average score of 6.3 (SD 0.9) for ?ease of use,? 6.3 (SD 0.8) for ?interface and satisfaction,? and 5.2 (SD 1.4) for ?usefulness.? Conclusions: The web-based system for medicine adverse effects reporting is a user-friendly tool developed using an iterative participatory design approach. Future research includes further improving the system, particularly the usefulness of the system, as well as testing the scalability and performance of the system in practice. UR - https://formative.jmir.org/2022/10/e37605 UR - http://dx.doi.org/10.2196/37605 UR - http://www.ncbi.nlm.nih.gov/pubmed/36206034 ID - info:doi/10.2196/37605 ER - TY - JOUR AU - Perry, M. Laura AU - Morken, Victoria AU - Peipert, D. John AU - Yanez, Betina AU - Garcia, F. Sofia AU - Barnard, Cynthia AU - Hirschhorn, R. Lisa AU - Linder, A. Jeffrey AU - Jordan, Neil AU - Ackermann, T. Ronald AU - Harris, Alexandra AU - Kircher, Sheetal AU - Mohindra, Nisha AU - Aggarwal, Vikram AU - Frazier, Rebecca AU - Coughlin, Ava AU - Bedjeti, Katy AU - Weitzel, Melissa AU - Nelson, C. Eugene AU - Elwyn, Glyn AU - Van Citters, D. Aricca AU - O'Connor, Mary AU - Cella, David PY - 2022/9/21 TI - Patient-Reported Outcome Dashboards Within the Electronic Health Record to Support Shared Decision-making: Protocol for Co-design and Clinical Evaluation With Patients With Advanced Cancer and Chronic Kidney Disease JO - JMIR Res Protoc SP - e38461 VL - 11 IS - 9 KW - patient-reported outcome measures KW - shared decision-making KW - medical informatics KW - coproduction KW - learning health system KW - cancer KW - chronic kidney disease N2 - Background: Patient-reported outcomes?symptoms, treatment side effects, and health-related quality of life?are important to consider in chronic illness care. The increasing availability of health IT to collect patient-reported outcomes and integrate results within the electronic health record provides an unprecedented opportunity to support patients? symptom monitoring, shared decision-making, and effective use of the health care system. Objective: The objectives of this study are to co-design a dashboard that displays patient-reported outcomes along with other clinical data (eg, laboratory tests, medications, and appointments) within an electronic health record and conduct a longitudinal demonstration trial to evaluate whether the dashboard is associated with improved shared decision-making and disease management outcomes. Methods: Co-design teams comprising study investigators, patients with advanced cancer or chronic kidney disease, their care partners, and their clinicians will collaborate to develop the dashboard. Investigators will work with clinic staff to implement the co-designed dashboard for clinical testing during a demonstration trial. The primary outcome of the demonstration trial is whether the quality of shared decision-making increases from baseline to the 3-month follow-up. Secondary outcomes include longitudinal changes in satisfaction with care, self-efficacy in managing treatments and symptoms, health-related quality of life, and use of costly and potentially avoidable health care services. Implementation outcomes (ie, fidelity, appropriateness, acceptability, feasibility, reach, adoption, and sustainability) during the co-design process and demonstration trial will also be collected and summarized. Results: The dashboard co-design process was completed in May 2020, and data collection for the demonstration trial is anticipated to be completed by the end of July 2022. The results will be disseminated in at least one manuscript per study objective. Conclusions: This protocol combines stakeholder engagement, health care coproduction frameworks, and health IT to develop a clinically feasible model of person-centered care delivery. The results will inform our current understanding of how best to integrate patient-reported outcome measures into clinical workflows to improve outcomes and reduce the burden of chronic disease on patients and health care systems. International Registered Report Identifier (IRRID): DERR1-10.2196/38461 UR - https://www.researchprotocols.org/2022/9/e38461 UR - http://dx.doi.org/10.2196/38461 UR - http://www.ncbi.nlm.nih.gov/pubmed/36129747 ID - info:doi/10.2196/38461 ER - TY - JOUR AU - Rasmussen, Lind Ida Marie AU - Soerensen, Vest Anne AU - Mřller, Kirstine Anne AU - Persson, Fredberg Gitte AU - Palshof, Andreas Jesper AU - Taarnhřj, Assam Gry AU - Pappot, Helle PY - 2022/9/15 TI - Individualizing the Oncological Treatment of Patients With Metastatic Non?Clear Cell Renal Cell Carcinoma by Using Gene Sequencing and Patient-Reported Outcomes: Protocol for the INDIGO Study JO - JMIR Res Protoc SP - e36632 VL - 11 IS - 9 KW - patient-reported outcome KW - electronic patient-reported outcome KW - renal cell carcinoma KW - non?clear cell renal cell carcinoma KW - health-related quality of life KW - oncology KW - targeted therapy KW - precision medicine KW - eHealth KW - outcome KW - patient-reported N2 - Background: No phase 3 studies have yet been conducted for patients with non?clear cell (CC) renal cell carcinoma (RCC) exclusively due to the rare occurrence of the disease and the heterogenicity in tumor morphology. Consequently, there is no evidence of the optimal treatment, and new approaches are needed. One approach is individualizing treatment based on the gene sequencing of tumor tissue. Additionally, recent studies involving the patient-reported outcomes (PROs) of patients treated for metastatic cancer have shown significant benefits for quality of life, median overall survival, and overall survival. The use of gene sequencing and PROs can be of great importance to patients with rare cancer types, including patients with non-CC RCC, and should be investigated in clinical trials, especially for cases where evidence based on phase 3 studies is difficult to obtain. Objective: We describe the INDIGO study, in which patients, based on gene analyses, will be allocated into 4 treatment arms containing 14 treatments and use electronic PROs. We aim to improve the treatment of patients with non-CC RCC. The end points in the study will be the overall response rate (complete and partial) in the total patient population, which will be based on the RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 criteria, and the time to treatment failure. Methods: INDIGO is a prospective phase 2 trial, and 30 patients will be enrolled. The patients will receive systemic treatment based on genetic analyses of their tumor tissue. All patients will receive electronic questionnaires in a dedicated app?a questionnaire regarding symptoms and side effects and another regarding health-related quality of life. Depending on the treatment regimen, the patients will be seen by a medical doctor every third, fourth, or sixth week, and the effect of the systemic treatment will be evaluated every 6 weeks via a computed tomography scan. The study has been approved by the Danish Medicines Agency and the National Committee on Health Research Ethics (approval number: H-19041833), complies with good clinical practice guidelines, follows the General Data Protection Regulation, and is registered at the Capital Region of Denmark. Results: Recruitment started in March 2020, and at the time of submitting this paper (June 2022), a total of 9 patients have been enrolled. Conclusions: We aim to explore methods for improving the treatment outcomes of patients with non-CC RCC, and the INDIGO study will contribute further data on personalized medicine for rare types of RCC and provide new knowledge on the active use of electronic PROs. Trial Registration: ClinicalTrials.gov NCT04644432, https://clinicaltrials.gov/ct2/show/NCT04644432 ; European Union Drug Regulating Authorities Clinical Trials Database 2019-001316-38, https://tinyurl.com/2p8mb4aw International Registered Report Identifier (IRRID): DERR1-10.2196/36632 UR - https://www.researchprotocols.org/2022/9/e36632 UR - http://dx.doi.org/10.2196/36632 UR - http://www.ncbi.nlm.nih.gov/pubmed/36107483 ID - info:doi/10.2196/36632 ER - TY - JOUR AU - Akasaki, Yasutsugu AU - Inomata, Takenori AU - Sung, Jaemyoung AU - Okumura, Yuichi AU - Fujio, Kenta AU - Miura, Maria AU - Hirosawa, Kunihiko AU - Iwagami, Masao AU - Nakamura, Masahiro AU - Ebihara, Nobuyuki AU - Ide, Takuma AU - Nagino, Ken AU - Murakami, Akira PY - 2022/8/23 TI - Reliability and Validity of Electronic Patient-Reported Outcomes Using the Smartphone App AllerSearch for Hay Fever: Prospective Observational Study JO - JMIR Form Res SP - e38475 VL - 6 IS - 8 KW - hay fever KW - AllerSearch KW - smartphone app KW - mobile health KW - mHealth KW - patient-reported outcome KW - reliability KW - validity KW - Japanese Allergic Conjunctival Disease Standard Quality of Life Questionnaire KW - JACQLQ KW - questionnaire KW - allergic conjunctivitis N2 - Background: Hay fever is a highly prevalent, heterogenous, and multifactorial disease. Patients may benefit from longitudinal assessments using mobile health (mHealth) principles. We have previously attempted to establish an effective mHealth platform for patients with hay fever through AllerSearch, our in-house smartphone app that assesses electronic patient-reported outcomes through a questionnaire on hay fever and provides evidence-based advice. To be used by the public, an investigation on its reliability and validity is necessary. Objective: The aim of this paper is to assess the reliability and validity of subjective symptom data on hay fever collected through our app, AllerSearch. Methods: This study used a prospective observational design. The participants were patients aged ?20 years recruited from a single university hospital between June 2, 2021, and January 26, 2022. We excluded patients who could not use smartphones as well as those with incomplete data records and outlier data. All participants answered the Japanese Allergic Conjunctival Disease Standard Quality of Life Questionnaire (JACQLQ), first in the paper-and-pencil format and subsequently on AllerSearch on the same day. The JACQLQ comprises the following three domains: Domain I, with 9 items on ocular or nasal symptoms; Domain II, with 17 items on daily activity and psychological well-being; and Domain III, with 3 items on overall condition by face score. The concordance rate of each domain between the 2 platforms was calculated. The internal consistency of Domains I and II of the 2 platforms was assessed using Cronbach alpha coefficients, the concurrent validity of Domains I and II was assessed by calculating Pearson correlation coefficients, and the mean differences between the 2 platforms were assessed using Bland-Altman analysis. Results: In total, 22 participants were recruited; the data of 20 (91%) participants were analyzed. The average age was 65.4 (SD 12.8) years, and 80% (16/20) of the participants were women. The concordance rate of Domains I, II, and III between the paper-based and app-based JACQLQ was 0.78, 0.85, and 0.90, respectively. The internal consistency of Domains I and II between the 2 platforms was satisfactory (Cronbach alpha of .964 and .919, respectively). Pearson correlation analysis yielded a significant positive correlation between Domains I and II across the 2 platforms (r=0.920 and r=0.968, respectively). The mean difference in Domains I and II between the 2 platforms was 3.35 units (95% limits of agreement: ?6.51 to 13.2). Conclusions: Our findings indicate that AllerSearch is a valid and reliable tool for the collection of electronic patient-reported outcomes to assess hay fever, contributing to the advantages of the mHealth platform. UR - https://formative.jmir.org/2022/8/e38475 UR - http://dx.doi.org/10.2196/38475 UR - http://www.ncbi.nlm.nih.gov/pubmed/35998022 ID - info:doi/10.2196/38475 ER - TY - JOUR AU - Raclin, Tyler AU - Price, Amy AU - Stave, Christopher AU - Lee, Eugenia AU - Reddy, Biren AU - Kim, Junsung AU - Chu, Larry PY - 2022/7/18 TI - Combining Machine Learning, Patient-Reported Outcomes, and Value-Based Health Care: Protocol for Scoping Reviews JO - JMIR Res Protoc SP - e36395 VL - 11 IS - 7 KW - machine learning KW - artificial intelligence KW - algorithm KW - eHealth KW - patient-reported outcome measures KW - patient-reported experience measures KW - patient experience KW - value-based care KW - scoping review N2 - Background: Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are self-reporting tools that can measure important information about patients, such as health priorities, experience, and perception of outcome. The use of traditional objective measures such as vital signs and lab values can be supplemented with these self-reported patient measures to provide a more complete picture of a patient?s health status. Machine learning, the use of computer algorithms that improve automatically through experience, is a powerful tool in health care that often does not use subjective information shared by patients. However, machine learning has largely been based on objective measures and has been developed without patient or public input. Algorithms often do not have access to critical information from patients and may be missing priorities and measures that matter to patients. Combining objective measures with patient-reported measures can improve the ability of machine learning algorithms to assess patients? health status and improve the delivery of health care. Objective: The objective of this scoping review is to identify gaps and benefits in the way machine learning is integrated with patient-reported outcomes for the development of improved public and patient partnerships in research and health care. Methods: We reviewed the following 3 questions to learn from existing literature about the reported gaps and best methods for combining machine learning and patient-reported outcomes: (1) How are the public engaged as involved partners in the development of artificial intelligence in medicine? (2) What examples of good practice can we identify for the integration of PROMs into machine learning algorithms? (3) How has value-based health care influenced the development of artificial intelligence in health care? We searched Ovid MEDLINE(R), Embase, PsycINFO, Science Citation Index, Cochrane Library, and Database of Abstracts of Reviews of Effects in addition to PROSPERO and the ClinicalTrials website. The authors will use Covidence to screen titles and abstracts and to conduct the review. We will include systematic reviews and overviews published in any language and may explore additional study types. Quantitative, qualitative, and mixed methods studies are included in the reviews. Results: The search is completed, and Covidence software will be used to work collaboratively. We will report the review using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and Critical Appraisal Skills Programme for systematic reviews. Conclusions: Findings from our review will help us identify examples of good practice for how to involve the public in the development of machine learning systems as well as interventions and outcomes that have used PROMs and PREMs. International Registered Report Identifier (IRRID): DERR1-10.2196/36395 UR - https://www.researchprotocols.org/2022/7/e36395 UR - http://dx.doi.org/10.2196/36395 UR - http://www.ncbi.nlm.nih.gov/pubmed/35849426 ID - info:doi/10.2196/36395 ER - TY - JOUR AU - Depla, Louise Anne AU - Lamain-de Ruiter, Marije AU - Laureij, T. Lyzette AU - Ernst-Smelt, E. Hiske AU - Hazelzet, A. Jan AU - Franx, Arie AU - Bekker, N. Mireille AU - PY - 2022/7/5 TI - Patient-Reported Outcome and Experience Measures in Perinatal Care to Guide Clinical Practice: Prospective Observational Study JO - J Med Internet Res SP - e37725 VL - 24 IS - 7 KW - perinatal care KW - patient-reported outcomes KW - patient-reported experiences KW - patient-centered outcome measures KW - value-based health care KW - shared decision-making KW - personalized care KW - integrated care N2 - Background: The International Consortium for Health Outcomes Measurement has published a set of patient-centered outcome measures for pregnancy and childbirth (PCB set), including patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs). To establish value-based pregnancy and childbirth care, the PCB set was implemented in the Netherlands, using the outcomes on the patient level for shared decision-making and on an aggregated level for quality improvement. Objective: This study aims to report first outcomes, experiences, and practice insights of implementing the PCB set in clinical practice. Methods: In total, 7 obstetric care networks across the Netherlands, each consisting of 1 or 2 hospitals and multiple community midwifery practices (ranging in number from 2 to 18), implemented the PROM and PREM domains of the PCB set as part of clinical routine. This observational study included all women participating in the clinical project. PROMs and PREMs were assessed with questionnaires at 5 time points: 2 during pregnancy and 3 post partum. Clinical threshold values (alerts) supported care professionals interpreting the answers, indicating possibly alarming outcomes per domain. Data collection took place from February 2020 to September 2021. Data analysis included missing (pattern) analysis, sum scores, alert rates, and sensitivity analysis. Results: In total, 1923 questionnaires were collected across the 5 time points: 816 (42.43%) at T1 (first trimester), 793 (41.23%) at T2 (early third trimester), 125 (6.5%) at T3 (maternity week), 170 (8.84%) at T4 (6 weeks post partum), and 19 (1%) at T5 (6 months post partum). Of these, 84% (1615/1923) were filled out completely. Missing items per domain ranged from 0% to 13%, with the highest missing rates for depression, pain with intercourse, and experience with pain relief at birth. No notable missing patterns were found. For the PROM domains, relatively high alert rates were found both in pregnancy and post partum for incontinence (469/1798, 26.08%), pain with intercourse (229/1005, 22.79%), breastfeeding self-efficacy (175/765, 22.88%), and mother-child bonding (122/288, 42.36%). Regarding the PREM domains, the highest alert rates were found for birth experience (37/170, 21.76%), shared decision-making (101/982, 10.29%), and discussing pain relief ante partum (310/793, 39.09%). Some domains showed very little clinical variation; for example, role of the mother and satisfaction with care. Conclusions: The PCB set is a useful tool to assess patient-reported outcomes and experiences that need to be addressed over the whole course of pregnancy and childbirth. Our results provide opportunities to improve and personalize perinatal care. Furthermore, we could propose several recommendations regarding methods and timeline of measurements based on our findings. This study supports the implementation of the PCB set in clinical practice, thereby advancing the transformation toward patient-centered, value-based health care for pregnancy and childbirth. UR - https://www.jmir.org/2022/7/e37725 UR - http://dx.doi.org/10.2196/37725 UR - http://www.ncbi.nlm.nih.gov/pubmed/35787519 ID - info:doi/10.2196/37725 ER - TY - JOUR AU - Harris, A. Ian AU - Peng, Yi AU - Ackerman, Ilana AU - Graves, E. Stephen PY - 2022/6/30 TI - The Association Between Preoperative Patient-Reported Health Status and Postoperative Survey Completion Following Arthroplasty: Registry-Based Cohort Study JO - JMIR Perioper Med SP - e33414 VL - 5 IS - 1 KW - total knee arthroplasty KW - total hip arthroplasty KW - patient-reported outcomes KW - perioperative medicine KW - postoperative medicine KW - knee surgery KW - arthroplasty KW - quality of life KW - surgical outcomes KW - cohort study KW - survey KW - health survey KW - hip KW - knee KW - N2 - Background: Patient-reported outcome measures (PROMs) are commonly used to report outcomes after hip and knee arthroplasty, but response rates are rarely complete. Given that preoperative health status (as measured by PROMs) is a strong predictor of outcomes (using the same measures) and that these outcomes may influence the response rate, it is possible that postoperative response rates (the proportion of patients providing preoperative PROMs who also provide postoperative PROMs) may be influenced by preoperative health status. Objective: This study aims to test the association between preoperative PROMs and postoperative response status following hip and knee arthroplasty. Methods: Data from the PROMs program of the Australian national joint registry were used. The preoperative PROMs were the Oxford Hip Score or Oxford Knee Score, The EQ-5D Utility Index, and the EQ visual analog scale (VAS) for overall health. Logistic regression, adjusting for age, sex, BMI, and the American Society of Anesthesiologists (ASA) Physical Status Classification System, was used to test the association between each preoperative PROM and response status for the 6-month postsurgery survey. Results: Data from 9499 and 16,539 patients undergoing elective total hip arthroplasty (THA) and total knee arthroplasty (TKA) for osteoarthritis, respectively, were included in the analysis. Adjusting for age, sex, BMI, and ASA, there was no significant difference in response status at the postoperative follow-up based on the preoperative Oxford Hip or Knee Scores (odds ratio [OR] 1.00, 95% CI 0.99-1.01 for both; P=.70 for THA and P=.85 for TKA). Healthier patients (based on the EQ VAS scores) preoperatively were more likely to respond postoperatively, but this difference was negligible (OR 1.00, 95% CI 1.00-1.01 for THA and TKA; P=.004 for THA and P<.001 for TKA). The preoperative EQ Utility Index was not associated with the postoperative response rate for THA (OR 1.14, 95% CI 0.96-1.36; P=.13) or TKA patients (OR 1.05, 95% CI 0.91-1.22; P=.49). Conclusions: The likelihood of responding to a postoperative PROMs survey for patients undergoing hip or knee arthroplasty was not associated with clinically important differences in preoperative patient-reported joint pain, function, or health-related quality of life. This suggests that the assessment of postoperative outcomes in hip and knee arthroplasty is not biased by differences in preoperative health measures between responders and nonresponders. UR - https://periop.jmir.org/2022/1/e33414 UR - http://dx.doi.org/10.2196/33414 UR - http://www.ncbi.nlm.nih.gov/pubmed/35771616 ID - info:doi/10.2196/33414 ER - TY - JOUR AU - Al-Mondhiry, Jafar AU - D'Ambruoso, Sarah AU - Pietras, Christopher AU - Strouse, Thomas AU - Benzeevi, Dikla AU - Arevian, C. Armen AU - Wells, B. Kenneth PY - 2022/6/23 TI - Co-created Mobile Apps for Palliative Care Using Community-Partnered Participatory Research: Development and Usability Study JO - JMIR Form Res SP - e33849 VL - 6 IS - 6 KW - mobile phone KW - mobile apps KW - mobile health KW - mHealth KW - eHealth KW - digital health KW - palliative care KW - quality of life KW - survivorship KW - patient advocacy KW - oncology KW - patient-reported outcomes KW - PRO KW - community-partnered participatory research KW - CPPR N2 - Background: Open design formats for mobile apps help clinicians and stakeholders bring their needs to direct, co-creative solutions. Palliative care for patients with advanced cancers requires intensive monitoring and support and remains an area in high need for innovation. Objective: This study aims to use community-partnered participatory research to co-design and pretest a mobile app that focuses on palliative care priorities of clinicians and patients with advanced cancer. Methods: In-person and teleconference workshops were held with patient and family stakeholders, researchers, and clinicians in palliative care and oncology. Question prompts, written feedback, semistructured interviews, and facilitated group discussions identified the core palliative care needs. Using Chorus, a no-code app-building platform, a mobile app was co-designed with the stakeholders. A pretest with 11 patients was conducted, with semistructured interviews of clinician and patient users for feedback. Results: Key themes identified from the focus groups included needs for patient advocacy and encouragement, access to vetted information, patient-clinician communication support, and symptom management. The initial prototype, My Wellness App, contained a weekly wellness journal to track patient-reported symptoms, goals, and medication use; information on self-management of symptoms; community resources; and patient and caregiver testimonial videos. Initial pretesting identified value in app-based communication for clinicians, patients, and caregivers, with suggestions for improving user interface, feedback and presentation of symptom reports, and gamification and staff coordinators to support patient app engagement. Conclusions: The development of a mobile app using community-partnered participatory research is a low-technology and feasible intervention for palliative care. Iterative redesign and user interface expertise may improve implementation. UR - https://formative.jmir.org/2022/6/e33849 UR - http://dx.doi.org/10.2196/33849 UR - http://www.ncbi.nlm.nih.gov/pubmed/35737441 ID - info:doi/10.2196/33849 ER - TY - JOUR AU - Chytas, Vasileios AU - Costanza, Alessandra AU - Mazzola, Viridiana AU - Luthy, Christophe AU - Galani, Vasiliki AU - Bondolfi, Guido AU - Cedraschi, Christine PY - 2022/6/13 TI - Possible Contribution of Meaning in Life in Patients With Chronic Pain and Suicidal Ideation: Observational Study JO - JMIR Form Res SP - e35194 VL - 6 IS - 6 KW - meaning in life KW - suicidal ideation KW - chronic pain KW - pain KW - suicide N2 - Background: Chronic pain is associated with an elevated risk of suicidal ideation (SI). Objective: We aimed to examine if the presence or the search for Meaning in Life (MiL) are associated with less SI and explore whether MiL profiles emerge in our cohort. These profiles can be described as high presence?high search, high presence?low search, low presence?low search, and low presence?high search. Methods: In this observational study, we recruited 70 patients who were referred to the Multidisciplinary Pain Center of the Geneva University Hospitals and who answered positively to question 9 on the Beck Depression Inventory, 2nd Edition, investigating SI. Patients who agreed to participate in the study were further investigated; they participated in a structured diagnostic interview to screen for psychiatric diagnoses. During this interview, they completed the Meaning in Life Questionnaire and the semistructured Scale for Suicide Ideation (SSI) to assess the characteristics and severity of SI. Results: There was a statistically significant correlation between the presence of MiL subscale and the SSI. These 2 scales had a negative and statistically highly significant correlation (R=?.667; P<.001). The results also showed a negative and statistically highly significant correlation between the score of the search for MiL and the SSI (R=?.456; P<.001). The results thus pointed to the presence of MiL as a potential protective factor against the severity of SI, while the search for MiL is also a possible resiliency factor, although to a lesser extent. The profile low presence?low search grouped the vast majority (47%) of the patients; in these patients, the mean SSI score was 14.36 (SD 5.86), much higher compared with that of the other subgroups. Conclusions: This study?s results point to MiL as a concept of interest regarding devising psychotherapeutic interventions for chronic pain patients in order to reduce the suicidal risk and more accurately determine patients? suffering. UR - https://formative.jmir.org/2022/6/e35194 UR - http://dx.doi.org/10.2196/35194 UR - http://www.ncbi.nlm.nih.gov/pubmed/35699974 ID - info:doi/10.2196/35194 ER - TY - JOUR AU - Moens, Katrien AU - Peeters, Marc AU - Van den Bulcke, Marc AU - Leys, Mark AU - Horlait, Melissa PY - 2022/6/6 TI - Development, Testing, and Implementation of the Belgian Patient Reported Experience Measure for Pancreatic Cancer Care (PREPARE) Project: Protocol for a Multi-Method Research Project JO - JMIR Res Protoc SP - e29004 VL - 11 IS - 6 KW - patient-centered care KW - quality of health care KW - interdisciplinary research KW - decision-making KW - pancreatic cancer KW - quality KW - outcome KW - assessment KW - cancer KW - pancreas KW - development KW - testing KW - implementation KW - patient-reported KW - experience KW - protocol KW - participatory medicine N2 - Background: Patients with pancreatic cancer do not feel involved in the development of their treatment and care plans. In Belgium, these plans are decided on during multidisciplinary team meetings. However, limited time is spent on the discussion of the preferences of the patient during these meetings. This research project aims to develop a patient-reported experience measure (PREM) for pancreatic cancer and assess if its use can support collaborative treatment decision-making. Objective: This paper aims to outline the protocol for a multi-method research project to improve person-centered pancreatic cancer care in Belgium. Three subobjectives are pursued: (1) to develop a PREM to assess the experiences of care-related aspects in pancreatic cancer care, (2) to validate the PREM, and (3) to develop and evaluate an educational intervention to support the use of the PREM?s results. Methods: For the development of the PREM, an exploratory mixed methods study design will be used. The study will start with a survey followed by a telephone interview involving patients with pancreatic cancer and digestive oncology health care professionals. Study two is the testing of the content and construct validity of the PREM. Study three involves the implementation study according to the Medical Research Council framework of a complex intervention introducing the PREM in practice. The effectiveness of the intervention will be investigated using a pragmatic randomized controlled trial study design. Results: The protocol presents the entire structure of the research project. Ethics approval to conduct the exploratory mixed methods study (objective 1) has been obtained, and recruitment has started since January 2022. Conclusions: The poor prognosis of patients with pancreatic cancer should not be considered a hurdle to not study this patient population group. Involving patients in the research and decision-making processes early on is key. This project aims to realize a scientifically sound research process providing research outputs that can easily and timely be implemented in the care trajectory of patients with pancreatic cancer. This research project will also lead to recommendations on how to involve patients with pancreatic cancer and how the methodology of this research project can be translated to other patient groups. International Registered Report Identifier (IRRID): PRR1-10.2196/29004 UR - https://www.researchprotocols.org/2022/6/e29004 UR - http://dx.doi.org/10.2196/29004 UR - http://www.ncbi.nlm.nih.gov/pubmed/35666559 ID - info:doi/10.2196/29004 ER - TY - JOUR AU - Doubelt, Irena AU - Springer, M. Jason AU - Kermani, A. Tanaz AU - Sreih, G. Antoine AU - Burroughs, Cristina AU - Cuthbertson, David AU - Carette, Simon AU - Khalidi, A. Nader AU - Koening, L. Curry AU - Langford, Carol AU - McAlear, A. Carol AU - Moreland, W. Larry AU - Monach, A. Paul AU - Shaw, G. Dianne AU - Seo, Philip AU - Specks, Ulrich AU - Warrington, J. Kenneth AU - Young, Kalen AU - Merkel, A. Peter AU - Pagnoux, Christian PY - 2022/5/25 TI - Self-Reported Data and Physician-Reported Data in Patients With Eosinophilic Granulomatosis With Polyangiitis: Comparative Analysis JO - Interact J Med Res SP - e27273 VL - 11 IS - 1 KW - eosinophilic granulomatosis with polyangiitis KW - patient-reported outcomes measures KW - clinical outcomes KW - granulomatosis KW - patient outcomes KW - digital health KW - health network KW - health databases KW - research network N2 - Background: Patient-based registries can help advance research on rare diseases such as eosinophilic granulomatosis with polyangiitis (EGPA), a complex multiorgan form of antineutrophil cytoplasmic antibody (ANCA)?associated vasculitis. Objective: The aim of this study is to compare patient-reported and physician-reported data on manifestations, treatments, and outcomes for patients with EGPA. Methods: We completed a comparative analysis of patients ?18 years with EGPA in Canada and the United States from the following 2 cohorts: (1) The Vasculitis Patient-Powered Research Network (VPPRN), a self-enrolled secure portal with patient-entered data updated quarterly (2014-2019) and (2) the Vasculitis Clinical Research Consortium (VCRC) observational studies, a physician-entered database (2003-2019) of patients who fulfilled the 1990 American College of Rheumatology classification criteria for EGPA. The studied parameters included demographic characteristics, clinical manifestations, ANCA status, treatments, and relapses. Results: Data from 195 patients with a validated diagnosis of EGPA in the VPPRN and 354 patients enrolled in the VCRC were analyzed. Compared to the VCRC cohort, the patients in the VPPRN cohort were more likely to be female (135/195, 69.2% compared to 209/354, 59%; P=.02) and younger at diagnosis (47.3 compared to 50.0 years; P=.03); both cohorts reported similar frequencies of asthma (177/184, 96.2% in the VPPRN cohort compared to 329/354, 92.9% in the VCRC cohort; P=.13) and cardiac manifestations (44/153, 28.8% compared to 75/354, 21.2%; P=.06), but the VPPRN cohort reported less frequent lung manifestations other than asthma and more frequent disease manifestations in all other organ systems. The ANCA positivity was 48.9% (64/131) in the VPPRN patients compared to 38.9% (123/316; P=.05) in the VCRC cohort. Relapsing disease after study enrollment was reported in 32.3% (63/195) of patients in the VPPRN compared to 35.7% (99/277) of patients in the VCRC. Most therapies (GC, cyclophosphamide, mepolizumab) were used at similar frequencies in both groups, except for rituximab with VPPRN patients reporting more use than the VCRC cohort (47/195, 24.1% compared to 29/277, 10.5%; P<.001). Conclusions: Overall, patients and physicians report manifestations of EGPA at similar frequencies. However, observed differences between patient and physician reports imply the potential occurrence of selection biases. These results support the use of patient-reported data in EGPA but also the need for careful consideration of disease-specific definitions for the study of EGPA and how patient- and physician-reported data are collected. Trial Registration: ClinicalTrials.gov NCT00315380, https://clinicaltrials.gov/ct2/show/NCT00315380; ClinicalTrials.gov NCT01241305, https://clinicaltrials.gov/ct2/show/NCT01241305 UR - https://www.i-jmr.org/2022/1/e27273 UR - http://dx.doi.org/10.2196/27273 UR - http://www.ncbi.nlm.nih.gov/pubmed/35612893 ID - info:doi/10.2196/27273 ER - TY - JOUR AU - Mangsbacka, Maria AU - Gustavell, Tina PY - 2022/5/16 TI - Nurses? Experiences Using an Interactive System to Assess and Manage Treatment-Related Symptoms of Patients With Pancreatic Cancer: Interview Study JO - JMIR Nursing SP - e36654 VL - 5 IS - 1 KW - app KW - health care professionals KW - mobile health KW - mHealth KW - nurses KW - pancreatic cancer KW - person-centered care KW - symptom-management KW - qualitative interview KW - nursing KW - interview N2 - Background: Treatment for pancreatic cancer entails symptom distress and a high burden of self-care. Patient-reported outcomes, collected with the support of mobile health (mHealth), have shown positive effects on symptom management, patient satisfaction, and quality of life for patients with cancer. For mHealth tools to become an integral part of clinical routine, experiences from health care professionals are needed. Objective: The aim of this paper is to describe nurses? experiences of integrating an interactive system (Interaktor) for symptom assessment and management into daily practice, when caring for patients following pancreaticoduodenectomy and during chemotherapy treatment due to pancreatic cancer. Methods: Patients reported symptoms via the Interaktor app daily for 6 months. In the event of alarming symptoms, an alert was triggered to the patient?s nurse who then called the patient to offer advice and support. All nurses (n=8) who assessed patients were interviewed either individually or in a group. Transcribed interviews were analyzed using qualitative thematic analysis. Results: mHealth can facilitate person-centered care by offering nurses a way to gain knowledge about patients and to build relationships. Further, obstacles to implementation could be seen due to a lack of structural prerequisites and uncertainty about multiple ways to interact with patients. Conclusions: The Interaktor system can provide person-centered care. However, to implement mHealth tools as a clinical routine, focus needs to be placed on creating the necessary organizational conditions. UR - https://nursing.jmir.org/2022/1/e36654 UR - http://dx.doi.org/10.2196/36654 UR - http://www.ncbi.nlm.nih.gov/pubmed/35576577 ID - info:doi/10.2196/36654 ER - TY - JOUR AU - Tang, Lili AU - He, Yi AU - Pang, Ying AU - Su, Zhongge AU - Li, Jinjiang AU - Zhang, Yening AU - Wang, Xu AU - Han, Xinkun AU - Wang, Yan AU - Li, Zimeng AU - He, Shuangzhi AU - Song, Lili AU - Zhou, Yuhe AU - Wang, Bingmei AU - Li, Xiumin PY - 2022/5/10 TI - Implementing Symptom Management Follow-up Using an Electronic Patient-Reported Outcome Platform in Outpatients With Advanced Cancer: Longitudinal Single-Center Prospective Study JO - JMIR Form Res SP - e21458 VL - 6 IS - 5 KW - electronic patient-reported outcome KW - symptom management KW - advanced cancer KW - outpatient KW - follow-up N2 - Background: Patients with cancer experience multiple symptoms related to cancer, cancer treatment, and the procedures involved in cancer care; however, many patients with pain, depression, and fatigue, especially those outside the hospital, receive inadequate treatment for their symptoms. Using an electronic patient-reported outcome (ePRO) platform to conduct symptom management follow-up in outpatients with advanced cancer could be a novel and potentially effective approach. However, empirical evidence describing in detail the preparation and implementation courses in a real setting is needed. Objective: The purpose of this paper was to describe the implementation process and evaluation of an ePRO platform that facilitates symptom management for patients with cancer, share our experiences and the problems we encountered during the process of implementation, and share the solutions we identified for those problems. Moreover, we tested the feasibility, safety, and efficacy of the ePRO platform. Methods: This was a real-world, ongoing, longitudinal, single-center, prospective study with a total of 7 follow-ups conducted within 4 weeks after the first visit to the symptom management clinic (on days 1, 3, 7, 10, 14, 21, and 28). Participants were encouraged to complete scales for physical symptoms (pain, fatigue, and shortness of breath), cognitive symptoms (memory problems and impaired concentration), and affective symptoms (especially depression and anxiety) during follow-up. The design and function of the ePRO-doctor client and ePRO-patient client, the patient-reported outcome (PRO) scales used in the study, and the strategies to promote symptom tracking have been described. Moreover, the training and evaluation for research assistants have been presented. The efficacy of the ePRO platform was assessed with a comparison of the baseline and 4-week outcomes on the MD Anderson Symptom Inventory. Results: Using the ePRO platform for symptom management follow-ups in advanced cancer patients was associated with a high completion rate (72.7%-86.4%) and a low drop-off rate (23.6%). The ePRO platform sent 293 alert notifications to both patients and doctors, which promoted patient security. The short and sharp PRO tool selection, user-friendly interface, automatic reminder notifications and alerts, and multiple dimensional training were essential components for the preparation and implementation of the ePRO system. The results showed significant improvements in the mean scores of pain, fatigue, and numbness from baseline to day 28 (P=.02, P=.02, and P<.001, respectively). Conclusions: The use of an ePRO platform for symptom management follow-ups in advanced cancer patients is time-saving, energy-saving, and effective. PRO tool selection, platform design, and training of research assistants are important aspects for implementation. Future research should validate the ePRO platform in a larger randomized controlled study. UR - https://formative.jmir.org/2022/5/e21458 UR - http://dx.doi.org/10.2196/21458 UR - http://www.ncbi.nlm.nih.gov/pubmed/35536608 ID - info:doi/10.2196/21458 ER - TY - JOUR AU - Friedman, Diane AU - Grimaldi, Lamiae AU - Cariou, Alain AU - Aegerter, Philippe AU - Gaudry, Stéphane AU - Ben Salah, Abdel AU - Oueslati, Haikel AU - Megarbane, Bruno AU - Meunier-Beillard, Nicolas AU - Quenot, Jean-Pierre AU - Schwebel, Carole AU - Jacob, Laurent AU - Robin Lagandré, Ségločne AU - Kalfon, Pierre AU - Sonneville, Romain AU - Siami, Shidasp AU - Mazeraud, Aurelien AU - Sharshar, Tarek PY - 2022/5/9 TI - Impact of a Postintensive Care Unit Multidisciplinary Follow-up on the Quality of Life (SUIVI-REA): Protocol for a Multicenter Randomized Controlled Trial JO - JMIR Res Protoc SP - e30496 VL - 11 IS - 5 KW - critical illness KW - Post-ICU syndrome KW - Mortality KW - cognitive impairments KW - cognition KW - quality of life KW - patients KW - intensive care KW - post-traumatic KW - post intensive care N2 - Background: Critically ill patients are at risk of developing a postintensive care syndrome (PICS), which is characterized by physical, psychological, and cognitive impairments and which dramatically impacts the patient?s quality of life (QoL). No intervention has been shown to improve QoL. We hypothesized that a medical, psychological, and social follow-up would improve QoL by mitigating the PICS. Objective: This multicenter, randomized controlled trial (SUIVI-REA) aims to compare a multidisciplinary follow-up with a standard postintensive care unit (ICU) follow-up. Methods: Patients were randomized to the control or intervention arm. In the intervention arm, multidisciplinary follow-up involved medical, psychological, and social evaluation at ICU discharge and at 3, 6, and 12 months thereafter. In the placebo group, patients were seen only at 12 months by the multidisciplinary team. Baseline characteristics at ICU discharge were collected for all patients. The primary outcome was QoL at 1 year, assessed using the Euro Quality of Life-5 dimensions (EQ5D). Secondary outcomes were mortality, cognitive, psychological, and functional status; social and professional reintegration; and the rate of rehospitalization and outpatient consultations at 1 year. Results: The study was funded by the Ministry of Health in June 2010. It was approved by the Ethics Committee on July 8, 2011. The first and last patient were randomized on December 20, 2012, and September 1, 2017, respectively. A total of 546 patients were enrolled across 11 ICUs. At present, data management is ongoing, and all parties involved in the trial remain blinded. Conclusions: The SUVI-REA multicenter randomized controlled trial aims to assess whether a post-ICU multidisciplinary follow-up improves QoL at 1 year. Trial Registration: Clinicaltrials.gov NCT01796509; https://clinicaltrials.gov/ct2/show/NCT01796509 International Registered Report Identifier (IRRID): DERR1-10.2196/30496 UR - https://www.researchprotocols.org/2022/5/e30496 UR - http://dx.doi.org/10.2196/30496 UR - http://www.ncbi.nlm.nih.gov/pubmed/35532996 ID - info:doi/10.2196/30496 ER - TY - JOUR AU - Brown, G. Ethan AU - Schleimer, Erica AU - Bledsoe, O. Ian AU - Rowles, William AU - Miller, A. Nicolette AU - Sanders, J. Stephan AU - Rankin, P. Katherine AU - Ostrem, L. Jill AU - Tanner, M. Caroline AU - Bove, Riley PY - 2022/5/6 TI - Enhancing Clinical Information Display to Improve Patient Encounters: Human-Centered Design and Evaluation of the Parkinson Disease-BRIDGE Platform JO - JMIR Hum Factors SP - e33967 VL - 9 IS - 2 KW - human-centered design KW - personal health record KW - visualization in eHealth KW - Parkinson disease KW - digital health N2 - Background: People with Parkinson disease (PD) have a variety of complex medical problems that require detailed review at each clinical encounter for appropriate management. Care of other complex conditions has benefited from digital health solutions that efficiently integrate disparate clinical information. Although various digital approaches have been developed for research and care in PD, no digital solution to personalize and improve communication in a clinical encounter is readily available. Objective: We intend to improve the efficacy and efficiency of clinical encounters with people with PD through the development of a platform (PD-BRIDGE) with personalized clinical information from the electronic health record (EHR) and patient-reported outcome (PRO) data. Methods: Using human-centered design (HCD) processes, we engaged clinician and patient stakeholders in developing PD-BRIDGE through three phases: an inspiration phase involving focus groups and discussions with people having PD, an ideation phase generating preliminary mock-ups for feedback, and an implementation phase testing the platform. To qualitatively evaluate the platform, movement disorders neurologists and people with PD were sent questionnaires asking about the technical validity, usability, and clinical relevance of PD-BRIDGE after their encounter. Results: The HCD process led to a platform with 4 modules. Among these, 3 modules that pulled data from the EHR include a longitudinal module showing motor ratings over time, a display module showing the most recently collected clinical rating scales, and another display module showing relevant laboratory values and diagnoses; the fourth module displays motor symptom fluctuation based on an at-home diary. In the implementation phase, PD-BRIDGE was used in 17 clinical encounters for patients cared for by 1 of 11 movement disorders neurologists. Most patients felt that PD-BRIDGE facilitated communication with their clinician (n=14, 83%) and helped them understand their disease trajectory (n=11, 65%) and their clinician?s recommendations (n=11, 65%). Neurologists felt that PD-BRIDGE improved their ability to understand the patients? disease course (n=13, 75% of encounters), supported clinical care recommendations (n=15, 87%), and helped them communicate with their patients (n=14, 81%). In terms of improvements, neurologists noted that data in PD-BRIDGE were not exhaustive in 62% (n=11) of the encounters. Conclusions: Integrating clinically relevant information from EHR and PRO data into a visually efficient platform (PD-BRIDGE) can facilitate clinical encounters with people with PD. Developing new modules with more disparate information could improve these complex encounters even further. UR - https://humanfactors.jmir.org/2022/2/e33967 UR - http://dx.doi.org/10.2196/33967 UR - http://www.ncbi.nlm.nih.gov/pubmed/35522472 ID - info:doi/10.2196/33967 ER - TY - JOUR AU - Bailey, Michel Adrian Joseph AU - Li, Oi-Yee Heidi AU - Kirchhof, G. Mark PY - 2022/5/2 TI - Novel Kappa-Opioid Receptor Agonist for the Treatment of Cholestatic Pruritus: Systematic Review JO - JMIR Dermatol SP - e30737 VL - 5 IS - 2 KW - opioid KW - pruritus KW - cholestasis KW - dermatology KW - chronic pruritis KW - kappa-opioid receptor KW - opioid receptor UR - https://derma.jmir.org/2022/2/e30737 UR - http://dx.doi.org/10.2196/30737 UR - http://www.ncbi.nlm.nih.gov/pubmed/37632854 ID - info:doi/10.2196/30737 ER - TY - JOUR AU - Kudel, Ian AU - Perry, Toni PY - 2022/4/29 TI - Communicating Treatment-Related Symptoms Using Passively Collected Data and Satisfaction/Loyalty Ratings: Exploratory Study JO - JMIR Cancer SP - e29292 VL - 8 IS - 2 KW - electronic patient-reported outcomes KW - ePRO KW - cancer KW - symptoms KW - health-related quality of life N2 - Background: Electronic patient-reported outcomes? real time communication of treatment-related symptoms is increasingly associated with better outcomes including longer survival and less health care resource use, but the primary method of collecting this information, static questionnaires, has not evolved. Objective: The aim of this paper is to describe the use of Noona?s three methods of communicating treatment-related symptoms, which are as follows: (1) Noona symptom questionnaires (NSQ), which incorporate branching logic; (2) a diary; and (3) secure messaging, the last two of which have NSQ reporting functionality. It also aims to explore, using multivariable analyses, whether patients find value using these features. Methods: Noona users (N=1081) who have an active account for more than 30 days, who responded to the satisfaction/loyalty item, and who were undergoing active cancer treatment (systemic or radiotherapy) in the United States were included in this study. All study data were collected via software embedded within Noona code. This includes metadata, patient activities (measured in clicks), and responses to a satisfaction/loyalty question (?How likely are you to recommend Noona to another patient?) displayed on the Noona home page. Results: Noona users expressed a high degree of satisfaction/loyalty when asked to rate how likely they would recommend Noona to another patient. Multivariable analyses indicate small but significant effects for some of the analyses. Use of NSQs were significantly related to satisfaction/loyalty, users of NSQs had significantly higher satisfaction/loyalty than those who did not use any, and secure communication use was significantly higher for those who rated the app highly compared to those who did not. These relationships will likely be further explicated with the use of satisfaction/loyalty questions that focus specifically on feature use. Conclusions: Noona is well liked by respondents, and exploratory multivariable analyses demonstrate the potential for using passively and minimally invasive data to demonstrate value. UR - https://cancer.jmir.org/2022/2/e29292 UR - http://dx.doi.org/10.2196/29292 UR - http://www.ncbi.nlm.nih.gov/pubmed/35175206 ID - info:doi/10.2196/29292 ER - TY - JOUR AU - Kim, Hyeoneui AU - Jung, Jinsun AU - Choi, Jisung PY - 2022/4/21 TI - Developing a Dietary Lifestyle Ontology to Improve the Interoperability of Dietary Data: Proof-of-Concept Study JO - JMIR Form Res SP - e34962 VL - 6 IS - 4 KW - dietary lifestyle data KW - person-generated health data KW - ontology KW - common data element KW - data interoperability KW - data standardization KW - dietary KW - health informatics N2 - Background: Dietary habits offer crucial information on one's health and form a considerable part of the patient-generated health data. Dietary data are collected through various channels and formats; thus, interoperability is a significant challenge to reusing this type of data. The vast scope of dietary concepts and the colloquial expression style add difficulty to standardizing the data. The interoperability issues of dietary data can be addressed through Common Data Elements with metadata annotation to some extent. However, making culture-specific dietary habits and questionnaire-based dietary assessment data interoperable still requires substantial efforts. Objective: The main goal of this study was to address the interoperability challenge of questionnaire-based dietary data from different cultural backgrounds by combining ontological curation and metadata annotation of dietary concepts. Specifically, this study aimed to develop a Dietary Lifestyle Ontology (DILON) and demonstrate the improved interoperability of questionnaire-based dietary data by annotating its main semantics with DILON. Methods: By analyzing 1158 dietary assessment data elements (367 in Korean and 791 in English), 515 dietary concepts were extracted and used to construct DILON. To demonstrate the utility of DILON in addressing the interoperability challenges of questionnaire-based multicultural dietary data, we developed 10 competency questions that asked to identify data elements sharing the same dietary topics and assessment properties. We instantiated 68 data elements on dietary habits selected from Korean and English questionnaires and annotated them with DILON to answer the competency questions. We translated the competency questions into Semantic Query-Enhanced Web Rule Language and reviewed the query results for accuracy. Results: DILON was built with 262 concept classes and validated with ontology validation tools. A small overlap (72 concepts) in the concepts extracted from the questionnaires in 2 languages indicates that we need to pay closer attention to representing culture-specific dietary concepts. The Semantic Query-Enhanced Web Rule Language queries reflecting the 10 competency questions yielded correct results. Conclusions: Ensuring the interoperability of dietary lifestyle data is a demanding task due to its vast scope and variations in expression. This study demonstrated that we could improve the interoperability of dietary data generated in different cultural contexts and expressed in various styles by annotating their core semantics with DILON. UR - https://formative.jmir.org/2022/4/e34962 UR - http://dx.doi.org/10.2196/34962 UR - http://www.ncbi.nlm.nih.gov/pubmed/35451991 ID - info:doi/10.2196/34962 ER - TY - JOUR AU - Miranda, N. Rafael AU - Bhuiya, R. Aunima AU - Thraya, Zak AU - Hancock-Howard, Rebecca AU - Chan, CF Brian AU - Steele Gray, Carolyn AU - Wodchis, P. Walter AU - Thavorn, Kednapa PY - 2022/4/20 TI - An Electronic Patient-Reported Outcomes Tool for Older Adults With Complex Chronic Conditions: Cost-Utility Analysis JO - JMIR Aging SP - e35075 VL - 5 IS - 2 KW - eHealth KW - multimorbidity KW - primary care KW - cost-effectiveness KW - older adult KW - elder KW - cost KW - patient reported outcome KW - community KW - complex care KW - aging KW - Canada KW - North America KW - chronic disease KW - chronic condition KW - decision tree KW - model KW - sensitivity analysis N2 - Background: eHealth technologies for self-management can improve quality of life, but little is known about whether the benefits gained outweigh their costs. The electronic patient-reported outcome (ePRO) mobile app and portal system supports patients with multiple chronic conditions to collaborate with primary health care providers to set and monitor health-related goals. Objective: This study aims to estimate the cost of ePRO and the cost utility of the ePRO intervention compared with usual care provided to patients with multiple chronic conditions and complex needs living in the community, from the perspective of the publicly funded health care payer in Ontario, Canada. Methods: We developed a decision tree model to estimate the incremental cost per quality-adjusted life year (QALY) gained for the ePRO tool versus usual care over a time horizon of 15 months. Resource utilization and effectiveness of the ePRO tool were drawn from a randomized clinical trial with 6 family health teams involving 45 participants. Unit costs associated with health care utilization (adjusted to 2020 Canadian dollars) were drawn from literature and publicly available sources. A series of sensitivity analyses were conducted to assess the robustness of the findings. Results: The total cost of the ePRO tool was CAD $79,467 (~US $ 63,581; CAD $1733 [~US $1386] per person). Compared with standard care, the ePRO intervention was associated with higher costs (CAD $1710 [~US $1368]) and fewer QALYs (?0.03). The findings were consistent with the clinical evidence, suggesting no statistical difference in health-related quality of life between ePRO and usual care groups. However, the tool would be considered a cost-effective option if it could improve by at least 0.03 QALYs. The probability that the ePRO is cost-effective was 17.3% at a willingness-to-pay (WTP) threshold of CAD $50,000 (~US $40,000)/QALY. Conclusions: The ePRO tool is not a cost-effective technology at the commonly used WTP value of CAD $50,000 (~US $40,000)/QALY, but long-term and the societal impacts of ePRO were not included in this analysis. Further research is needed to better understand its impact on long-term outcomes and in real-world settings. The present findings add to the growing evidence about eHealth interventions? capacity to respond to complex aging populations within finite-resourced health systems. Trial Registration: ClinicalTrials.gov NCT02917954; https://clinicaltrials.gov/ct2/show/NCT02917954 UR - https://aging.jmir.org/2022/2/e35075 UR - http://dx.doi.org/10.2196/35075 UR - http://www.ncbi.nlm.nih.gov/pubmed/35442194 ID - info:doi/10.2196/35075 ER - TY - JOUR AU - Garcia-Rueda, Fernanda Maria AU - Bohorquez-Penaranda, Patricia Adriana AU - Gil-Laverde, Armando Jacky Fabian AU - Aguilar-Sierra, Javier Francisco AU - Mendoza-Pulido, Camilo PY - 2022/4/14 TI - Casting Without Reduction Versus Closed Reduction With or Without Fixation in the Treatment of Distal Radius Fractures in Children: Protocol for a Randomized Noninferiority Trial JO - JMIR Res Protoc SP - e34576 VL - 11 IS - 4 KW - radius fractures KW - distal radius KW - pediatric KW - remodeling KW - surgical reduction KW - cast immobilization KW - outcome measure N2 - Background: Acute treatment for distal radius fractures, the most frequent fractures in the pediatric population, represents a challenge to the orthopedic surgeon. Deciding on surgical restoration of the alignment or cast immobilization without reducing the fracture is a complex concern given the remodeling potential of bones in children. In addition, the lack of evidence-based safe boundaries of shortening and angulation, that will not jeopardize upper-extremity functionality in the future, further complicates this decision. Objective: The authors aim to measure functional outcomes, assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Physical Function v2.0 instrument. The authors hypothesize that outcomes will not be worse in children treated with cast immobilization in situ compared with those treated with closed reduction with or without percutaneous fixation. The authors also aim to compare the following as secondary outcomes: ulnar variance and fracture alignment in the sagittal and coronal planes, range of motion, pressure ulcers, pain control, radius osteotomy due to deformity, pseudoarthrosis cure, and remanipulation. Methods: This is the protocol of a randomized noninferiority trial comparing upper-extremity functionality in children aged 5 to 10 years, after sustaining a distal radius fracture, treated with either cast immobilization in situ or closed reduction with or without fixation in a single orthopedic hospital. Functional follow-up is projected at 6 months, while clinical and radiographic follow-up will occur at 2 weeks, 3 months, and 9 months. Results: Recruitment commenced in July 2021. As of January 2022, 23 children have been randomized. Authors expect an average of 5 patients to be recruited monthly; therefore, recruitment and analysis should be complete by October 2024. Conclusions: This experimental design that addresses upper-extremity functionality after cast immobilization in situ in children who have sustained a distal fracture of the radius may yield compelling information that could aid the clinician in deciding on the most suitable orthopedic treatment. Trial Registration: ClinicalTrials.gov NCT05008029; https://clinicaltrials.gov/ct2/show/NCT05008029 International Registered Report Identifier (IRRID): DERR1-10.2196/34576 UR - https://www.researchprotocols.org/2022/4/e34576 UR - http://dx.doi.org/10.2196/34576 UR - http://www.ncbi.nlm.nih.gov/pubmed/35436224 ID - info:doi/10.2196/34576 ER - TY - JOUR AU - Underwood, Jody AU - McCloskey, Susan AU - Raldow, Ann AU - Kishan, Amar AU - Zalkin, Chad AU - Navarro, Daniel AU - Holt, Scott Lisa AU - Webb, Andrew AU - Lynch, A. Kathleen AU - Atkinson, M. Thomas PY - 2022/4/12 TI - Developing a Mobile Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Administration System to Capture Postradiation Toxicity in Oncology: Usability and Feasibility Study JO - JMIR Form Res SP - e27775 VL - 6 IS - 4 KW - neoplasms KW - patient outcome assessment KW - radiation oncology KW - toxicity KW - public health informatics KW - mobile apps KW - mobile health KW - mobile administration system KW - radiation therapy KW - eHealth N2 - Background: Accurate self-reported symptomatic toxicity documentation via the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is essential throughout cancer treatment to ensure safety and understand therapeutic efficacy. However, the capture of accurate toxicities from patients undergoing radiation therapy is challenging because this is generally provided only at the time of scheduled visits. Objective: This study seeks to establish the usability and feasibility of a mobile PRO-CTCAE Administration System (mPROS) to capture toxicities related to radiation therapy. Methods: English-speaking adult patients who were undergoing radiation therapy for cancer were enrolled and given a brief demonstration of the Say All Your Symptoms (SAYS) and Symptom Tracking Entry Program (STEP) interfaces of the mPROS app, followed by a patient-use phase where patient actions were observed as they navigated mPROS to enter toxicities. Patient feedback was captured via a semistructured interview and brief questionnaire. Results: We enrolled 25 patients (age: mean 60.7 years; females: n=13, 52%; White patients: n=13; 52%; non-Hispanic patients: n=19, 76%; college graduates: n=17, 68%). Patients almost equally preferred the SAYS (n=14, 56%) or STEP (n=11, 44%) interfaces, with 21 patients (84%) agreeing that they would use mPROS to report their symptoms to their health care team and 19 patients (76%) agreeing that they would recommend mPROS to others. Conclusions: The mPROS app is usable and feasible for facilitating the patient reporting of radiation therapy?related symptomatic toxicities. A revised version of mPROS that incorporates patient input and includes electronic health record integration is being developed and validated as part of a multicenter trial. UR - https://formative.jmir.org/2022/4/e27775 UR - http://dx.doi.org/10.2196/27775 UR - http://www.ncbi.nlm.nih.gov/pubmed/35412466 ID - info:doi/10.2196/27775 ER - TY - JOUR AU - Coles, Theresa AU - Lucas, Nicole AU - Daniell, Erin AU - Sullivan, Caitlin AU - Wang, Ke AU - Olsen, M. Jennifer AU - Shepherd-Banigan, Megan PY - 2022/4/8 TI - Prioritizing Support Offered to Caregivers by Examining the Status Quo and Opportunities for Enhancement When Using Web-Based Self-reported Health Questionnaires: Descriptive Qualitative Study JO - JMIR Form Res SP - e30877 VL - 6 IS - 4 KW - caregiver KW - web-based questionnaires KW - self-report questionnaires KW - caregiver outcomes KW - intervention technology KW - patient-reported outcome measures N2 - Background: The Rosalynn Carter Institute for Caregivers (RCI) offers evidence-based interventions to promote caregivers? health and well-being. Trained coaches regularly meet with caregivers to offer education and instructions to improve caregiver health, build skill sets, and increase resilience. Two of these interventions, RCI Resources for Enhancing Alzheimer's Caregiver Health (REACH) and Operation Family Caregiver (OFC), use a set of caregiver-reported questionnaires to monitor caregivers? health status and needs. Objective: This study aims to describe how web-based assessment questionnaires are used to identify and monitor caregiver status in the RCI REACH and OFC programs and outlines perceived enhancements to the web-based system that could support caregiver-coach encounters by directing priorities. Methods: This was a descriptive, qualitative study. Data were collected via semistructured interviews with caregivers and coaches in the RCI REACH and OFC programs from July 2020 to October 2020. During the interviews, participants were asked to describe how the assessment questionnaires were used to inform caregiver-coach encounters, perceived usefulness of enhancements to web-based display, and preference for the structure of score results. The interviews were recorded, transcribed, and coded using structural and interpretive codes from a structured codebook. Qualitative content analysis was used to identify themes and summarize the results. Results: A total of 25 caregivers (RCI REACH: 13/25, 52%; OFC: 12/25, 48%) and 11 coaches (RCI REACH: 5/11, 45%; OFC: 6/11, 55%) were interviewed. Most caregivers indicated that the assessment questions were relevant to their caregiving experience. Some caregivers and coaches indicated that they thought the assessment should be administered multiple times throughout the program to evaluate the caregiver progress. Overall, caregivers did not want their scores to be compared with those of other caregivers, and there was heterogeneity in how caregivers preferred to view their results at the question or topic level. Coaches were uncertain as to which and how much of the results from the self-reported questionnaires should be shared with caregivers. Overall, the results were very similar, regardless of program affiliation (RCI REACH vs OFC). Conclusions: Web-based and procedural enhancements were identified to enrich caregiver-coach encounters. New and enhanced strategies for using web-based assessment questionnaires to direct priorities in the caregiver-coach encounters included integrating figures showing caregiver progress at the individual caregiver level, ability to toggle results through different figures focused on individual versus aggregate results, and support for interpreting scores. The results of this qualitative study will drive the next steps for RCI?s web-based platform and expand on current standards for administering self-reported questionnaires in clinical practice settings. UR - https://formative.jmir.org/2022/4/e30877 UR - http://dx.doi.org/10.2196/30877 UR - http://www.ncbi.nlm.nih.gov/pubmed/35394436 ID - info:doi/10.2196/30877 ER - TY - JOUR AU - Heath, L. Emma AU - Ackerman, Ilana AU - Lorimer, Michelle AU - Rainbird, Sophia AU - O'Donohue, Grace AU - Brock, Andrew AU - Graves, Stephen AU - Harris, Ian PY - 2022/4/8 TI - National Implementation of an Electronic Patient-Reported Outcome Measures Program for Joint Replacement Surgery: Pilot Study JO - JMIR Form Res SP - e30245 VL - 6 IS - 4 KW - cost KW - cost-benefit KW - online platform KW - patient-reported outcome measure KW - registry science KW - electronic data collection KW - electronic data KW - capture KW - joint replacement KW - PROMs KW - PROM KW - outcome measure KW - patient report KW - data capture KW - registry KW - surgery KW - operation KW - postoperative KW - surgical KW - data reporting KW - data collection N2 - Background: There is a global emphasis on expanding data collection for joint replacement procedures beyond implant attributes and progression to revision surgery. Patient-reported outcome measures (PROMs) are increasingly considered as an important measure of surgical outcomes from a patient?s perspective. However, a major limitation preventing wider use of PROMs data in national data collection has been the inability to systematically collect and share electronic information with relevant stakeholders in a comprehensive and financially sustainable manner. Objective: This study reports on the development of an electronic data capture and reporting system by a national registry for the collection of PROMs and the processes used to identify and overcome barriers to implementation and uptake. The study also aims to provide a cost breakdown of establishing and maintaining a nationwide electronic PROMs program. Methods: Between 2018 and 2020, 3 governance and advisory committees were established to develop and implement a PROMs pilot program nested within a nationwide joint replacement registry. The program involved electronic collection of preoperative and 6-month postoperative data for hip, knee, or shoulder replacement surgery from 44 Australian hospitals. Resource requirements for the program included a project manager, software developers, data manager, and statistician. An online platform was tested, refined, and implemented for electronic PROMs collection with scalability considered for future expansion to all Australian hospitals and additional data fields. Technical capabilities included different access for multiple user types, patient registration, automatic reminders via SMS text messages and email, online consent, and patient outcome real-time dashboards accessible for different user groups (surgeons, patients, hospitals, and project stakeholders). Results: During the PROMs pilot period there were 19,699 primary procedures undertaken with 10,204 registered procedures in the electronic system. This equated to 51.80% of people who had a joint replacement at participating hospitals during this period. Patient registration and data collection were efficient (20-30 seconds and 10-12 minutes, respectively). Engagement with the reporting dashboards (as a proportion of those who viewed their dashboard) varied by user group: 197/277 (71.1%) hospital administrators, 68/129 (52.7%) project stakeholders, 177/391 (45.3%) surgeons, and 1138/8840 patients (12.9%). Cost analysis determined an overall cost per patient of Aus $7-15 (approximately US $5-12) for 2 PROMs collections per joint replacement procedure once the program was established. Conclusions: Successful implementation of an orthopedic PROMs program with planned scalability for a broader national rollout requires significant funding and staffing resources. However, this expenditure can be considered worthwhile, given that collection and reporting of PROMs can drive health care improvement processes. Further consideration of strategies to improve stakeholder engagement with electronic reporting dashboards (particularly for patients and surgeons) will be critical to the ongoing success of a national PROMs program. UR - https://formative.jmir.org/2022/4/e30245 UR - http://dx.doi.org/10.2196/30245 UR - http://www.ncbi.nlm.nih.gov/pubmed/35394439 ID - info:doi/10.2196/30245 ER - TY - JOUR AU - Kwan, Heng Yu AU - Phang, Kie Jie AU - Yoon, Sungwon AU - Low, Leng Lian PY - 2022/3/31 TI - Authors? Reply to: Challenges in Measuring What Matters to Patients With Diabetes. Comment on ?Measurement Properties of Patient-Reported Outcome Measures for Diabetes: Systematic Review? JO - J Med Internet Res SP - e37957 VL - 24 IS - 3 KW - systematic review KW - measurement properties KW - patient-reported outcome measures KW - methodological quality KW - level of evidence KW - PROMs KW - patient reported outcome KW - diabetes UR - https://www.jmir.org/2022/3/e37957 UR - http://dx.doi.org/10.2196/37957 UR - http://www.ncbi.nlm.nih.gov/pubmed/35357327 ID - info:doi/10.2196/37957 ER - TY - JOUR AU - Rutters, Femke AU - Elsman, Ellen AU - Groeneveld, Lenka AU - Langendoen-Gort, Marlous AU - Mokkink, Lidwine AU - Terwee, Caroline PY - 2022/3/31 TI - Challenges in Measuring What Matters to Patients With Diabetes. Comment on ?Measurement Properties of Patient-Reported Outcome Measures for Diabetes: Systematic Review? JO - J Med Internet Res SP - e36876 VL - 24 IS - 3 KW - systematic review KW - measurement properties KW - patient-reported outcome measures KW - methodological quality KW - level of evidence KW - PROMs KW - patient reported outcome KW - diabetes UR - https://www.jmir.org/2022/3/e36876 UR - http://dx.doi.org/10.2196/36876 UR - http://www.ncbi.nlm.nih.gov/pubmed/35357322 ID - info:doi/10.2196/36876 ER - TY - JOUR AU - Nugent, Lisa AU - Anthony Kouyate, Robin AU - Jackson, Shawna AU - Smith, Y. Meredith PY - 2022/3/22 TI - Development of a Digital Health Intervention for Rheumatoid Arthritis Symptom Management in a Biotechnology Industry Context: Protocol for the Application of a Human-Centered Design Framework JO - JMIR Res Protoc SP - e16430 VL - 11 IS - 3 KW - human-centered design KW - patient-reported outcomes KW - rheumatoid arthritis KW - digital journal KW - patient diaries KW - data visualization KW - mobile phone N2 - Background: Involving chronically ill patients in the management of their health is widely recognized as a vital component of high-quality health care. However, to assume the role of informed participants, patients need both access to their health information and assistance in interpreting such data. Smartphone technology with SMS text messaging functionality offers a convenient and minimally demanding mechanism for providing such dual capabilities to patients. To date, a number of similar digital tools have been developed for use in various chronic and progressive disease conditions, including rheumatoid arthritis. Objective: This paper aims to describe the development of a research protocol that applies a human-centered design (HCD) approach to develop a mobile health (mHealth) intervention to support symptom management and treatment adherence for rheumatoid arthritis. Methods: To guide the development of the mHealth intervention for use within a commercial biotechnology context, we selected and applied an HCD framework consisting of three phases: understanding, ideation, and implementation. Results: Leveraging the framework, we mapped the key objectives and research questions to each phase and identified the HCD techniques and methods most suitable for addressing them. In addition, we identified the need to include a fourth phase, one that referred to postimplementation assessment, which would enable evaluation of patient engagement and intervention impact on symptom self-management. Conclusions: This paper presents a research protocol that applied an HCD framework to guide the development of an mHealth intervention within a commercial biotechnology context. This type of guidance is salient because commercial entities are becoming one of the leading producers of this type of intervention. However, the methodologies used and challenges faced from a research and development perspective are not well-represented in the published research literature to date. Our application of the HCD framework yielded important findings. Each phase of the HCD framework provided important guidance for increasing the likelihood that the final product would be understandable, acceptable, feasible, and engaging to use. Consistent with other researchers in the field of mHealth interventions, we identified the need to add a fourth phase to the HCD framework, one that focused on a postimplementation assessment to guide further improvements to support adoption in real-world settings. International Registered Report Identifier (IRRID): RR1-10.2196/16430 UR - https://www.researchprotocols.org/2022/3/e16430 UR - http://dx.doi.org/10.2196/16430 UR - http://www.ncbi.nlm.nih.gov/pubmed/35315784 ID - info:doi/10.2196/16430 ER - TY - JOUR AU - Chmiel, P. Francis AU - Burns, K. Dan AU - Pickering, Brian John AU - Blythin, Alison AU - Wilkinson, MA Thomas AU - Boniface, J. Michael PY - 2022/3/21 TI - Prediction of Chronic Obstructive Pulmonary Disease Exacerbation Events by Using Patient Self-reported Data in a Digital Health App: Statistical Evaluation and Machine Learning Approach JO - JMIR Med Inform SP - e26499 VL - 10 IS - 3 KW - COPD KW - machine learning KW - mHealth KW - exacerbation events KW - myCOPD KW - mobile health KW - digital applications KW - remote monitoring KW - chronic disease KW - digital health KW - health care applications N2 - Background: Self-reporting digital apps provide a way of remotely monitoring and managing patients with chronic conditions in the community. Leveraging the data collected by these apps in prognostic models could provide increased personalization of care and reduce the burden of care for people who live with chronic conditions. This study evaluated the predictive ability of prognostic models for the prediction of acute exacerbation events in people with chronic obstructive pulmonary disease by using data self-reported to a digital health app. Objective: The aim of this study was to evaluate if data self-reported to a digital health app can be used to predict acute exacerbation events in the near future. Methods: This is a retrospective study evaluating the use of symptom and chronic obstructive pulmonary disease assessment test data self-reported to a digital health app (myCOPD) in predicting acute exacerbation events. We include data from 2374 patients who made 68,139 self-reports. We evaluated the degree to which the different variables self-reported to the app are predictive of exacerbation events and developed both heuristic and machine learning models to predict whether the patient will report an exacerbation event within 3 days of self-reporting to the app. The model?s predictive ability was evaluated based on self-reports from an independent set of patients. Results: Users self-reported symptoms, and standard chronic obstructive pulmonary disease assessment tests displayed correlation with future exacerbation events. Both a baseline model (area under the receiver operating characteristic curve [AUROC] 0.655, 95% CI 0.689-0.676) and a machine learning model (AUROC 0.727, 95% CI 0.720-0.735) showed moderate ability in predicting exacerbation events, occurring within 3 days of a given self-report. Although the baseline model obtained a fixed sensitivity and specificity of 0.551 (95% CI 0.508-0.596) and 0.759 (95% CI 0.752-0.767) respectively, the sensitivity and specificity of the machine learning model can be tuned by dichotomizing the continuous predictions it provides with different thresholds. Conclusions: Data self-reported to health care apps designed to remotely monitor patients with chronic obstructive pulmonary disease can be used to predict acute exacerbation events with moderate performance. This could increase personalization of care by allowing preemptive action to be taken to mitigate the risk of future exacerbation events. UR - https://medinform.jmir.org/2022/3/e26499 UR - http://dx.doi.org/10.2196/26499 UR - http://www.ncbi.nlm.nih.gov/pubmed/35311685 ID - info:doi/10.2196/26499 ER - TY - JOUR AU - Davis, Selena AU - Antonio, Marcy AU - Smith, Mindy AU - Burgener, Paul AU - Lavallee, C. Danielle AU - Price, Morgan AU - Fletcher, C. Sarah AU - Lau, Francis PY - 2022/3/18 TI - Paving the Way for Electronic Patient-Centered Measurement in Team-Based Primary Care: Integrated Knowledge Translation Approach JO - JMIR Form Res SP - e33584 VL - 6 IS - 3 KW - patient-centered measurement KW - patient-centered care KW - primary health care KW - team-based care KW - knowledge translation KW - patient-oriented research KW - patient portals KW - patient-generated health data KW - patient-reported experience measures KW - patient-reported outcome measures KW - rural health services KW - patient data KW - digital health KW - electronic data KW - patient portal KW - mental health N2 - Background: Patient-centered measurement (PCM) aims to improve the overall quality of care through the collection and sharing of patient values, outcomes, and perspectives. However, the use of PCM in care team decisions remains limited. Integrated knowledge translation (IKT) offers a collaborative, adaptive approach to explore best practices for incorporating PCM into primary care practices by involving knowledge users, including patients and providers, in the exploratory process. Objective: This study aims to test the feasibility of using patient-generated data in team-based care; describe the use of these data for team-based mental health care; and summarize patient and provider care experiences with PCM. Methods: We conducted a multi-method exploratory study in a rural team-based primary care clinic using IKT to co-design, implement, and evaluate the use of PCM in team-based mental health care. Care pathways, workflows, and quality improvement activities were adjusted iteratively to improve integration efforts. Patient and provider experiences were evaluated using individual interviews relating to the use of PCM and patient portals in practice. All meeting notes, interview summaries, and emails were analyzed to create a narrative evaluation. Results: During co-design, a care workflow was developed to incorporate electronically collected patient-generated data from the patient portal into the electronic medical record, and customized educational tools and resources were added. During implementation, care pathways and patient workflows for PCM were developed. Patients found portal use easy, educational, and validating, but data entries were not used during care visits. Providers saw the portal as extra work, and the lack of portal and electronic medical record integration was a major barrier. The IKT approach was invaluable for addressing workflow changes and understanding the ongoing barriers to PCM use and quality improvement. Conclusions: Although the culture toward using PCM is changing, the use of PCM during care has not been successful. Patients felt validated and supported through portal use and could be empowered to bring these data to their visits. Training, modeling, and adaptable PCM methods are required before PCM can be integrated into routine care. UR - https://formative.jmir.org/2022/3/e33584 UR - http://dx.doi.org/10.2196/33584 UR - http://www.ncbi.nlm.nih.gov/pubmed/35302508 ID - info:doi/10.2196/33584 ER - TY - JOUR AU - Agarwal, K. Anish AU - Ali, S. Zarina AU - Shofer, Frances AU - Xiong, Ruiying AU - Hemmons, Jessica AU - Spencer, Evan AU - Abdel-Rahman, Dina AU - Sennett, Brian AU - Delgado, K. Mucio PY - 2022/3/17 TI - Testing Digital Methods of Patient-Reported Outcomes Data Collection: Prospective Cluster Randomized Trial to Test SMS Text Messaging and Mobile Surveys JO - JMIR Form Res SP - e31894 VL - 6 IS - 3 KW - patient-reported outcomes KW - mobile surveys KW - research methods KW - text messaging KW - mobile survey KW - data collection KW - patient engagement KW - response rate N2 - Background: Health care delivery continues to evolve, with an effort being made to create patient-centered care models using patient-reported outcomes (PROs) data. Collecting PROs has remained challenging and an expanding landscape of digital health offers a variety of methods to engage patients. Objective: The aim of this study is to prospectively investigate two common methods of remote PRO data collection. The study sought to compare response and engagement rates for bidirectional SMS text messaging and mobile surveys following orthopedic surgery. Methods: The study was a prospective, block randomized trial of adults undergoing elective orthopedic procedures over 6 weeks. The primary objective was to determine if the method of digital patient engagement would impact response and completion rates. The primary outcome was response rate and total completion of PRO questionnaires. Results: A total of 127 participants were block randomized into receiving a mobile survey (n=63) delivered as a hyperlink or responding to the same questions through an automated bidirectional SMS text messaging system (n=64). Gender, age, number of comorbidities, and opioid prescriptions were similar across messaging arms. Patients receiving the mobile survey were more likely to have had a knee-related surgery (n=50, 83.3% vs n=40, 62.5%; P=.02) but less likely to have had an invasive procedure (n=26, 41.3% vs n=39, 60.9%; P=.03). Overall engagement over the immediate postoperative period was similar. Prolonged engagement for patients taking opioids past postoperative day 4 was higher in the mobile survey arm at day 7 (18/19, 94.7% vs 9/16, 56.3%). Patients with more invasive procedures showed a trend toward being responsive at day 4 as compared to not responding (n=41, 59.4% vs n=24, 41.4%; P=.05). Conclusions: As mobile patient engagement becomes more common in health care, testing the various options to engage patients to gather data is crucial to inform future care and research. We found that bidirectional SMS text messaging and mobile surveys were comparable in response and engagement rates; however, mobile surveys may trend toward higher response rates over longer periods of time. Trial Registration: ClinicalTrials.gov NCT03532256; https://clinicaltrials.gov/ct2/show/NCT03532256 UR - https://formative.jmir.org/2022/3/e31894 UR - http://dx.doi.org/10.2196/31894 UR - http://www.ncbi.nlm.nih.gov/pubmed/35298394 ID - info:doi/10.2196/31894 ER - TY - JOUR AU - Sutton, Lynsey AU - Bell, Elliot AU - Every-Palmer, Susanna AU - Weatherall, Mark AU - Skirrow, Paul PY - 2022/3/17 TI - Survivorship of Patients After Long Intensive Care Stay With Exploration and Experience in a New Zealand Cohort (SPLIT ENZ): Protocol for a Mixed Methods Study JO - JMIR Res Protoc SP - e35936 VL - 11 IS - 3 KW - COVID-19 KW - critical illness KW - disability KW - intensive care unit KW - survivorship KW - Post Intensive Care Syndrome N2 - Background: Post Intensive Care Syndrome (PICS) was defined by the Society of Critical Care Medicine in 2012 with subsequent international research highlighting poor long-term outcomes; reduced quality of life; and impairments, for survivors of critical illness. To date, there has been no published research on the long-term outcomes of survivors of critical illness in New Zealand. Objective: The aim of this study is to explore long-term outcomes after critical illness in New Zealand. The primary objectives are to describe and quantify symptoms and disability, explore possible risk factors, and to identify unmet needs in survivors of critical illness. Methods: This will be a mixed methods study with 2 components. First, a prospective cohort study of approximately 100 participants with critical illness will be followed up at 1, 6, and 12 months after hospital discharge. The primary outcome will be disability assessed using the World Health Organization Disability Assessment Scale 2.0. Secondary outcomes will focus on mental health using the Hospital Anxiety and Depression Scale and the Impact of Events Scale-revised, cognitive function using the Montreal Cognitive Assessment (Montreal Cognitive Assessment?BLIND), and health-related quality of life using the European Quality of Life-Five Dimension-Five Level. The second element of the study will use qualitative grounded theory methods to explore participants experiences of recovery and highlight unmet needs. Results: This study was approved by the New Zealand Northern A Health and Disability Ethics Committee on August 16, 2021 (21/NTA/107), and has been registered with the Australian New Zealand Clinical Trials Registry on October 5, 2021. SPLIT ENZ is due to start recruitment in early 2022, aiming to enroll 125 patients over 2 years. Data collection is estimated to be completed by 2024-2025 and will be published once all data are available for reporting. Conclusions: Although international research has identified the prevalence of PICS and the extent of disability in survivors of critical illness, there is no published research in New Zealand. Research in this field is particularly pressing in the context of COVID-19, an illness that may include PICS in its sequelae. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN1262100133588; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382566&showOriginal=true&isReview=true International Registered Report Identifier (IRRID): PRR1-10.2196/35936 UR - https://www.researchprotocols.org/2022/3/e35936 UR - http://dx.doi.org/10.2196/35936 UR - http://www.ncbi.nlm.nih.gov/pubmed/35297773 ID - info:doi/10.2196/35936 ER - TY - JOUR AU - Limmroth, Volker AU - Bayer-Gersmann, Kirsten AU - Mueller, Christian AU - Schürks, Markus PY - 2022/3/14 TI - Ascertaining Medication Use and Patient-Reported Outcomes via an App and Exploring Gamification in Patients With Multiple Sclerosis Treated With Interferon ?-1b: Observational Study JO - JMIR Form Res SP - e31972 VL - 6 IS - 3 KW - digital observational study KW - BETACONNECT KW - app KW - interferon ?-1b KW - multiple sclerosis KW - medication adherence KW - medication compliance KW - medication persistence KW - health-related quality of life KW - gamification KW - mobile phone N2 - Background: The BETACONNECT autoinjector and myBETAapp app were designed to support patients with multiple sclerosis receiving interferon ?-1b and are an ideal platform for digital observational studies. A recent pilot study in Germany demonstrated the feasibility of using the app to recruit patients, obtain informed consent, and evaluate medication-taking behavior over 6 months. Objective: This study aims to describe medication-taking behavior for 1 year in patients with multiple sclerosis receiving interferon ?-1b based on data collected from the app and to provide information on patient-reported outcomes (PROs). The optional use of the cognitive training tool PEAK (Peak, formerly Brainbow Ltd) is included to test the feasibility of gamification in this setting. Methods: A prospective and retrospective, exploratory, digital, observational cohort study was conducted among users of the app in Germany. Invitations to participate were sent to patients? apps between February and May 2019. Participants provided electronic informed consent. Injection-related data from consenting patients? devices were collected prospectively for 1 year following the consent date and retrospectively for ?1 year from the first day of use (if historical data were available). Participants also completed three electronic PRO instruments every 3 months: the EuroQol 5-Dimension, 5-Level questionnaire (EQ-5D-5L); the Treatment Satisfaction Questionnaire for Medication (TSQM; version II); and a questionnaire on satisfaction with treatment support (on a server accessed via an emailed hyperlink). All patients were offered optional access to the professional version of PEAK. Results: Of 1778 registered app accounts (May 2019), 79 patients (4.44%) provided informed consent; 62 (3.49%) were eligible for inclusion in the prospective analysis, of whom, 60 (97%) also had retrospective data. The mean age of the 62 participants was 43.2 (SD 11.5) years and 41 (66%) were women. Compliance over the 1-year prospective observational period (primary end point) was high (median 98.9%, IQR 94.3%-100%) and similar among men and women. Persistence and adherence (coprimary end points) decreased from 85% (53/62) and 74% (46/62), respectively, at 6 months to 76% (47/62) and 65% (40/62), respectively, at 12 months; both were higher in men than in women. A retrospective analysis showed similar patterns. The PRO questionnaires were answered by 79% (49/62) of the participants at baseline and 50% (31/62) of them at month 12. Women had more severe problems in some EQ-5D-5L dimensions (mobility, usual activities, and pain/discomfort) and lower median convenience scores on the TSQM (version II) than men. At month 12, 84% (26/31) of the patients were satisfied or very satisfied with the app. PEAK was used by 67% (14/21) of men and 49% (20/41) of women. Conclusions: This study showed high compliance and decreasing persistence and adherence over 1 year and demonstrated the feasibility of including remotely completed electronic PRO instruments in digital observational studies. UR - https://formative.jmir.org/2022/3/e31972 UR - http://dx.doi.org/10.2196/31972 UR - http://www.ncbi.nlm.nih.gov/pubmed/35285806 ID - info:doi/10.2196/31972 ER - TY - JOUR AU - Açma, Ay?e AU - Carrat, Fabrice AU - Hejblum, Gilles PY - 2022/3/10 TI - Comparing SF-36 Scores Collected Through Web-Based Questionnaire Self-completions and Telephone Interviews: An Ancillary Study of the SENTIPAT Multicenter Randomized Controlled Trial JO - J Med Internet Res SP - e29009 VL - 24 IS - 3 KW - Bias, Epidemiologic KW - Effect Modifier, Epidemiologic KW - Forms as Topic KW - Interviews, Telephone KW - Internet KW - Patient Reported Outcome Measures KW - Patient Satisfaction KW - Quality of Life KW - Surveys and Questionnaires N2 - Background: The 36-Item Short Form Health Survey (SF-36) is a popular questionnaire for measuring the self-perception of quality of life in a given population of interest. Processing the answers of a participant comprises the calculation of 10 scores corresponding to 8 scales measuring several aspects of perceived health and 2 summary components (physical and mental). Surprisingly, no study has compared score values issued from a telephone interview versus those from an internet-based questionnaire self-completion. Objective: This study aims to compare the SF-36 score values issued from a telephone interview versus those from an internet-based questionnaire self-completion. Methods: Patients with an internet connection and returning home after hospital discharge were enrolled in the SENTIPAT multicenter randomized trial on the day of discharge. They were randomized to either self-completing a set of questionnaires using a dedicated website (internet group) or providing answers to the same questionnaires administered during a telephone interview (telephone group). This ancillary study of the trial compared SF-36 data related to the posthospitalization period in these 2 groups. To anticipate the potential unbalanced characteristics of the responders in the 2 groups, the impact of the mode of administration of the questionnaire on score differences was investigated using a matched sample of individuals originating from the internet and telephone groups (1:1 ratio), in which the matching procedure was based on a propensity score approach. SF-36 scores observed in the internet and telephone groups were compared using the Wilcoxon-Mann-Whitney test, and the score differences between the 2 groups were also examined according to Cohen effect size. Results: Overall, 29.2% (245/840) and 75% (630/840) of SF-36 questionnaires were completed in the internet and telephone groups, respectively (P<.001). Globally, the score differences between groups before matching were similar to those observed in the matched sample. Mean scores observed in the telephone group were all above the corresponding values observed in the internet group. After matching, score differences in 6 out of the 8 SF-36 scales were statistically significant, with a mean difference greater than 5 for 4 scales and an associated mild effect size ranging from 0.22 to 0.29, and with a mean difference near this threshold for 2 other scales (4.57 and 4.56) and a low corresponding effect size (0.18 and 0.16, respectively). Conclusions: The telephone mode of administration of SF-36 involved an interviewer effect, increasing SF-36 scores. Questionnaire self-completion via the internet should be preferred, and surveys combining various administration methods should be avoided. Trial Registration: ClinicalTrials.gov NCT01769261; https://www.clinicaltrials.gov/ct2/show/record/NCT01769261 UR - https://www.jmir.org/2022/3/e29009 UR - http://dx.doi.org/10.2196/29009 UR - http://www.ncbi.nlm.nih.gov/pubmed/35266869 ID - info:doi/10.2196/29009 ER - TY - JOUR AU - Jamieson Gilmore, Kendall AU - Bonciani, Manila AU - Vainieri, Milena PY - 2022/3/4 TI - A Comparison of Census and Cohort Sampling Models for the Longitudinal Collection of User-Reported Data in the Maternity Care Pathway: Mixed Methods Study JO - JMIR Med Inform SP - e25477 VL - 10 IS - 3 KW - longitudinal studies KW - mothers KW - pregnancy KW - survival analysis KW - patient-reported outcome measures KW - patient-reported experience measures KW - surveys KW - maternity KW - postpartum KW - online KW - digital health KW - digital collection N2 - Background: Typical measures of maternity performance remain focused on the technical elements of birth, especially pathological elements, with insufficient measurement of nontechnical measures and those collected pre- and postpartum. New technologies allow for patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) to be collected from large samples at multiple time points, which can be considered alongside existing administrative sources; however, such models are not widely implemented or evaluated. Since 2018, a longitudinal, personalized, and integrated user-reported data collection process for the maternal care pathway has been used in Tuscany, Italy. This model has been through two methodological iterations. Objective: The aim of this study was to compare and contrast two sampling models of longitudinal user-reported data for the maternity care pathway, exploring factors influencing participation, cost, and suitability of the models for different stakeholders. Methods: Data were collected by two modes: (1) ?cohort? recruitment at the birth hospital of a predetermined sample size and (2) continuous, ongoing ?census? recruitment of women at the first midwife appointment. Surveys were used to collect experiential and outcome data related to existing services. Women were included who passed 12 months after initial enrollment, meaning that they either received the surveys issued after that interval or dropped out in the intervening period. Data were collected from women in Tuscany, Italy, between September 2018 and July 2020. The total sample included 7784 individuals with 38,656 observations. The two models of longitudinal collection of user-reported data were analyzed using descriptive statistics, survival analysis, cost comparison, and a qualitative review. Results: Cohort sampling provided lower initial participation than census sampling, although very high subsequent response rates (87%) were obtained 1 year after enrollment. Census sampling had higher initial participation, but greater dropout (up to 45% at 1 year). Both models showed high response rates for online surveys. There were nonproportional dropout hazards over time. There were higher rates of dropout for women with foreign nationality (hazard ratio [HR] 1.88, P<.001), and lower rates of dropout for those who had a higher level of education (HR 0.77 and 0.61 for women completing high school and college, respectively; P<.001), were employed (HR 0.87, P=.01), in a relationship (HR 0.84, P=.04), and with previous pregnancies (HR 0.86, P=.002). The census model was initially more expensive, albeit with lower repeat costs and could become cheaper if repeated more than six times. Conclusions: The digital collection of user-reported data enables high response rates to targeted surveys in the maternity care pathway. The point at which pregnant women or mothers are recruited is relevant for response rates and sample bias. The census model of continuous enrollment and real-time data availability offers a wider set of potential benefits, but at an initially higher cost and with the requirement for more substantial data translation and managerial capacity to make use of such data. UR - https://medinform.jmir.org/2022/3/e25477 UR - http://dx.doi.org/10.2196/25477 UR - http://www.ncbi.nlm.nih.gov/pubmed/35254268 ID - info:doi/10.2196/25477 ER - TY - JOUR AU - Banerjee, Rahul AU - Huang, Chiung-Yu AU - Dunn, Lisa AU - Knoche, Jennifer AU - Ryan, Chloe AU - Brassil, Kelly AU - Jackson, Lindsey AU - Patel, Dhiren AU - Lo, Mimi AU - Arora, Shagun AU - Wong, W. Sandy AU - Wolf, Jeffrey AU - Martin III, Thomas AU - Dhruva, Anand AU - Shah, Nina PY - 2022/3/4 TI - Digital Life Coaching During Stem Cell Transplantation: Development and Usability Study JO - JMIR Form Res SP - e33701 VL - 6 IS - 3 KW - digital health KW - life coaching KW - multiple myeloma KW - stem cell transplantation KW - stem cell therapy KW - cancer KW - high-dose chemotherapy KW - patient engagement KW - feasibility KW - digital life coaching KW - mobile phone N2 - Background: For patients with multiple myeloma receiving high-dose chemotherapy followed by autologous stem cell transplantation (SCT), acute life disruptions and symptom burden may lead to worsened quality of life (QOL) and increased emotional distress. Digital life coaching (DLC), whereby trained coaches deliver personalized well-being?related support via phone calls and SMS text messaging, has been shown to improve QOL among SCT survivors. However, DLC has not been investigated during the acute peri-SCT period, which is generally characterized by symptomatic exacerbations and 2-week hospitalizations. Objective: We launched a single-arm pilot study to investigate the feasibility of patient engagement with DLC during this intensive period. Methods: We approached English-speaking adult patients with multiple myeloma undergoing autologous SCT at our center. Enrolled patients received 16 weeks of virtual access to a life coach beginning on day ?5 before SCT. Coaches used structured frameworks to help patients identify and overcome personal barriers to well-being. Patients chose the coaching topics and preferred communication styles. Our primary endpoint was ongoing DLC engagement, defined as bidirectional conversations occurring at least once every 4 weeks during the study period. Secondary endpoints were electronic patient-reported outcome assessments of QOL, distress, and sleep disturbances. Results: Of the 20 patients who were screened, 17 (85%) chose to enroll and 15 (75%) underwent SCT as planned. Of these 15 patients (median age 65 years, range 50-81 years), 11 (73%) demonstrated ongoing DLC engagement. The median frequency of bidirectional conversations during the 3-month study period was once every 6.2 days (range 3.9-28 days). During index hospitalizations with median lengths of stay of 16 days (range 14-31 days), the median frequency of conversations was once every 5.3 days (range 2.7-15 days). Electronic patient-reported outcome assessments (94% adherence) demonstrated an expected QOL nadir during the second week after SCT. The prevalence of elevated distress was highest immediately before and after SCT, with 69% of patients exhibiting elevated distress on day ?5 and on day +2. Conclusions: DLC may be feasible for older patients during intensive hospital-based cancer treatments such as autologous SCT for multiple myeloma. The limitations of our study include small sample size, selection bias among enrolled patients, and heterogeneity in DLC use. Based on the positive results of this pilot study, a larger phase 2 randomized study of DLC during SCT is underway to investigate the efficacy of DLC with regard to patient well-being. Trial Registration: ClinicalTrials.gov NCT04432818; https://clinicaltrials.gov/ct2/show/NCT04432818. UR - https://formative.jmir.org/2022/3/e33701 UR - http://dx.doi.org/10.2196/33701 UR - http://www.ncbi.nlm.nih.gov/pubmed/35039279 ID - info:doi/10.2196/33701 ER - TY - JOUR AU - Germini, Federico AU - Borg Debono, Victoria AU - Page, David AU - Zuk, Victoria AU - Kucher, Alexandra AU - Cotoi, Chris AU - Hobson, Nicholas AU - Sevestre, Michael AU - Skinner, W. Mark AU - Iorio, Alfonso AU - PY - 2022/3/2 TI - User-Centered Development and Testing of the Online Patient-Reported Outcomes, Burdens, and Experiences (PROBE) Survey and the myPROBE App and Integration With the Canadian Bleeding Disorder Registry: Mixed Methods Study JO - JMIR Hum Factors SP - e30797 VL - 9 IS - 1 KW - health-related quality of life KW - EQ-5D KW - mobile app KW - Patient-Reported Outcomes, Burdens, and Experiences (PROBE) KW - hemophilia KW - mobile health KW - mHealth KW - eHealth KW - telehealth KW - user-centered design N2 - Background: The Patient-Reported Outcomes, Burdens, and Experiences (PROBE) questionnaire is a tool for assessing the quality of life and disease burden in people living with hemophilia. Objective: The objectives of our study were (1) to assess the needs of relevant stakeholders involved in the use of PROBE, (2) to develop the software infrastructure needed to meet these needs, and (3) to test the usability of the final product. Methods: We conducted a series of semistructured interviews of relevant stakeholders, including PROBE investigators, people with hemophilia, and representatives of the sponsor. Based on these, we developed an online survey and a mobile app for iOS and Android. A user group evaluated the final product using the System Usability Scale (SUS) and an open feedback framework. Results: The online survey was updated, and the myPROBE app for mobile devices and a new application programming interface were developed. The app was tested and modified according to user feedback over multiple cycles. The final version of the app was released in July 2019. Seventeen users aged 23 to 67 years evaluated the final version of the app using the SUS. The median (first, third quartile) SUS score for the app was 85 (68, 88) out of 100. The newly introduced functionalities were as follows: (1) capability to longitudinally track repeated fillings of the questionnaire at different time points by the same participant (as opposed to anonymous completion); (2) linking of the questionnaire with hemophilia registries, starting with the Canadian Bleeding Disorders Registry as a proof of concept; (3) removing or adding questions as needed; and (4) sending notifications to the users (eg, reminders). A new secure database was built for securely storing personal information separately from the questionnaire data. The PROBE online survey is currently available in 96 countries and 34 languages. Conclusions: The online survey was updated successfully, and the myPROBE app was developed, with a SUS score of 85 (out of 100). The app has been released in 81 countries and 34 languages. This will facilitate data collection for research and advocacy purposes, and the use of this tool in everyday clinical practice. UR - https://humanfactors.jmir.org/2022/1/e30797 UR - http://dx.doi.org/10.2196/30797 UR - http://www.ncbi.nlm.nih.gov/pubmed/35234648 ID - info:doi/10.2196/30797 ER - TY - JOUR AU - Graf, Joachim AU - Sickenberger, Nina AU - Brusniak, Katharina AU - Matthies, Maria Lina AU - Deutsch, M. Thomas AU - Simoes, Elisabeth AU - Plappert, Claudia AU - Keilmann, Lucia AU - Hartkopf, Andreas AU - Walter, Barbara Christina AU - Hahn, Markus AU - Engler, Tobias AU - Wallwiener, Stephanie AU - Schuetz, Florian AU - Fasching, A. Peter AU - Schneeweiss, Andreas AU - Brucker, Yvonne Sara AU - Wallwiener, Markus PY - 2022/2/8 TI - Implementation of an Electronic Patient-Reported Outcome App for Health-Related Quality of Life in Breast Cancer Patients: Evaluation and Acceptability Analysis in a Two-Center Prospective Trial JO - J Med Internet Res SP - e16128 VL - 24 IS - 2 KW - eHealth KW - electronic patient-reported outcomes KW - evaluation KW - acceptability KW - breast cancer N2 - Background: One in eight women is diagnosed with breast cancer in the course of their life. As systematic palliative treatment has only a limited effect on survival rates, the concept of health-related quality of life (HRQoL) was developed for measurement of patient-centered outcomes. Various studies have already demonstrated the reliability of paper-based patient-reported outcome (pPRO) and electronic patient-reported outcome (ePRO) surveys and that the 2 means of assessment are equally valid. Objective: The aim of this study was to analyze the acceptance and evaluation of a tablet-based ePRO app for breast cancer patients and to examine its suitability, effort, and difficulty in the context of HRQoL and sociodemographic factors. Methods: Overall, 106 women with adjuvant or advanced breast cancer were included in a 2-center study at 2 major university hospitals in Germany. Patients were asked to answer HRQoL and PRO questionnaires both on a tablet on-site using a specific eHealth assessment website and on paper. The suitability, effort, and difficulty of the app and self-reported technical skills were also assessed. Only the results of the electronically acquired data are presented here. The results of the reliability of the pPRO data have already been published elsewhere. Results: Patients regarded the ePRO assessment as more suitable (80/106, 75.5%), less stressful (73/106, 68.9%), and less difficult (69/106, 65.1%) than pPRO. The majority of patients stated that ePRO assessment improves health care in hospitals (87/106, 82.1%). However, evaluation of ePROs depended on the level of education (P=.003) in the dimensions of effort and difficulty (regression analysis). The app was rated highly in all categories. HRQoL data and therapy setting did not show significant correlations with the app?s evaluation parameters. Conclusions: The results indicate that ePRO surveys are feasible for measuring HRQoL in breast cancer patients and that those patients prefer ePRO assessment to pPRO assessment. It can also be seen that patients consider ePRO assessment to improve hospital health care. However, studies with larger numbers of patients are needed to develop apps that address the needs of patients with lower levels of education and technical skills. UR - https://www.jmir.org/2022/2/e16128 UR - http://dx.doi.org/10.2196/16128 UR - http://www.ncbi.nlm.nih.gov/pubmed/35133288 ID - info:doi/10.2196/16128 ER - TY - JOUR AU - Renner, Simon AU - Marty, Tom AU - Khadhar, Mickaďl AU - Foulquié, Pierre AU - Voillot, Paméla AU - Mebarki, Adel AU - Montagni, Ilaria AU - Texier, Nathalie AU - Schück, Stéphane PY - 2022/1/28 TI - A New Method to Extract Health-Related Quality of Life Data From Social Media Testimonies: Algorithm Development and Validation JO - J Med Internet Res SP - e31528 VL - 24 IS - 1 KW - health-related quality of life KW - social media use KW - measures KW - real world KW - natural language processing KW - social media KW - NLP KW - infoveillance KW - quality of life KW - digital health KW - social listening N2 - Background: Monitoring social media has been shown to be a useful means to capture patients? opinions and feelings about medical issues, ranging from diseases to treatments. Health-related quality of life (HRQoL) is a useful indicator of overall patients? health, which can be captured online. Objective: This study aimed to describe a social media listening algorithm able to detect the impact of diseases or treatments on specific dimensions of HRQoL based on posts written by patients in social media and forums. Methods: Using a web crawler, 19 forums in France were harvested, and messages related to patients? experience with disease or treatment were specifically collected. The SF-36 (Short Form Health Survey) and EQ-5D (Euro Quality of Life 5 Dimensions) HRQoL surveys were mixed and adapted for a tailored social media listening system. This was carried out to better capture the variety of expression on social media, resulting in 5 dimensions of the HRQoL, which are physical, psychological, activity-based, social, and financial. Models were trained using cross-validation and hyperparameter optimization. Oversampling was used to increase the infrequent dimension: after annotation, SMOTE (synthetic minority oversampling technique) was used to balance the proportions of the dimensions among messages. Results: The training set was composed of 1399 messages, randomly taken from a batch of 20,000 health-related messages coming from forums. The algorithm was able to detect a general impact on HRQoL (sensitivity of 0.83 and specificity of 0.74), a physical impact (0.67 and 0.76), a psychic impact (0.82 and 0.60), an activity-related impact (0.73 and 0.78), a relational impact (0.73 and 0.70), and a financial impact (0.79 and 0.74). Conclusions: The development of an innovative method to extract health data from social media as real time assessment of patients? HRQoL is useful to a patient-centered medical care. As a source of real-world data, social media provide a complementary point of view to understand patients? concerns and unmet needs, as well as shedding light on how diseases and treatments can be a burden in their daily lives. UR - https://www.jmir.org/2022/1/e31528 UR - http://dx.doi.org/10.2196/31528 UR - http://www.ncbi.nlm.nih.gov/pubmed/35089152 ID - info:doi/10.2196/31528 ER - TY - JOUR AU - Wilczynski, Ophélie AU - Boisbouvier, Anthony AU - Radoszycki, Lise AU - Cotté, François-Emery AU - Gaudin, Anne-Françoise AU - Lemasson, Hervé PY - 2022/1/11 TI - Integrating Quality of Life in the Care Pathway of Cancer Patients Undergoing Immunotherapy Treatment: Descriptive, Cross-sectional Survey of an Online Patient Community's Experiences and Expectations JO - J Med Internet Res SP - e25792 VL - 24 IS - 1 KW - cancer KW - quality of life KW - immunotherapy KW - patient community KW - patient satisfaction N2 - Background: New cancer treatments, such as immune checkpoint inhibitors (ICIs), can improve survival and health-related quality of life (HRQoL) in patients with cancer. Although long-term monitoring of HRQoL has been shown to improve survival, integration of HRQoL into everyday practice remains poorly documented. Objective: This study describes experiences and expectations of patients treated with ICIs regarding a discussion of HRQoL with health care professionals (HCPs) in cancer management. Methods: This cross-sectional study was conducted in an online patient community (Carenity) in France. Patients treated with ICIs for cancer, included between September 2018 and January 2019, completed a questionnaire to assess the involvement of HCP in a discussion of HRQoL and when and what was discussed. Results: Of 82 patients included (mean age: 56.9 years, 95% CI 54.2-59.6; 46 [56%] male; 34 [41%] with lung cancer), 62 (76%) reported discussing HRQoL at least once with HCPs, mainly general practitioners (54/82, 66%), oncologists (53/82, 65%), and hospital nurses (50/82, 61%). Around half (45/82, 55%) of the patients were satisfied with these discussions. Discussions with the oncologist were at the patient?s initiative (34/53, 64%). Discussions occurred primarily during follow-up visits (40/62, 65%), when adverse events occurred (30/62, 48%), and at treatment initiation (27/62, 32%). The most discussed dimensions were symptoms (48/62, 77%) and physical well-being (43/62, 69%). With respect to expectations, 54/82 (66%) patients considered oncologists as the most important HCPs for discussing HRQoL. These discussions were desirable throughout the care pathway, particularly at diagnosis (63/82, 77%) and when treatment was initiated (75/82, 92%) or changed (68/82, 83%). All HRQoL dimensions were considered important to discuss. Conclusions: With only around half of the patients satisfied with HRQoL discussions, impactful HRQoL integration in clinical practice is critical. According to patients, this integration should involve mainly oncologists and general practitioners, should happen at every step of the care pathway, and should be extended to dimensions that are currently rarely addressed. UR - https://www.jmir.org/2022/1/e25792 UR - http://dx.doi.org/10.2196/25792 UR - http://www.ncbi.nlm.nih.gov/pubmed/35014969 ID - info:doi/10.2196/25792 ER - TY - JOUR AU - Paalimäki-Paakki, Karoliina AU - Virtanen, Mari AU - Henner, Anja AU - Nieminen, T. Miika AU - Kääriäinen, Maria PY - 2022/1/6 TI - Effectiveness of Digital Counseling Environments on Anxiety, Depression, and Adherence to Treatment Among Patients Who Are Chronically Ill: Systematic Review JO - J Med Internet Res SP - e30077 VL - 24 IS - 1 KW - mHealth KW - mobile health KW - eHealth KW - digital health KW - mobile apps KW - smartphone apps KW - web-based KW - telemedicine KW - chronic diseases KW - noncommunicable diseases KW - web-based interventions KW - mobile phone N2 - Background: Patients who are chronically ill need novel patient counseling methods to support their self-care at different stages of the disease. At present, knowledge of how effective digital counseling is at managing patients? anxiety, depression, and adherence to treatment seems to be fragmented, and the development of digital counseling will require a more comprehensive view of this subset of interventions. Objective: This study aims to identify and synthesize the best available evidence on the effectiveness of digital counseling environments at improving anxiety, depression, and adherence to treatment among patients who are chronically ill. Methods: Systematic searches of the EBSCO (CINAHL), PubMed, Scopus, and Web of Science databases were conducted in May 2019 and complemented in October 2020. The review considered studies that included adult patients aged ?18 years with chronic diseases; interventions evaluating digital (mobile, web-based, and ubiquitous) counseling interventions; and anxiety, depression, and adherence to treatment, including clinical indicators related to adherence to treatment, as outcomes. Methodological quality was assessed using the standardized Joanna Briggs Institute critical appraisal tool for randomized controlled trials or quasi-experimental studies. As a meta-analysis could not be conducted because of considerable heterogeneity in the reported outcomes, narrative synthesis was used to synthesize the results. Results: Of the 2056 records screened, 20 (0.97%) randomized controlled trials, 4 (0.19%) pilot randomized controlled trials, and 2 (0.09%) quasi-experimental studies were included. Among the 26 included studies, 10 (38%) digital, web-based interventions yielded significantly positive effects on anxiety, depression, adherence to treatment, and the clinical indicators related to adherence to treatment, and another 18 (69%) studies reported positive, albeit statistically nonsignificant, changes among patients who were chronically ill. The results indicate that an effective digital counseling environment comprises high-quality educational materials that are enriched with multimedia elements and activities that engage the participant in self-care. Because of the methodological heterogeneity of the included studies, it is impossible to determine which type of digital intervention is the most effective for managing anxiety, depression, and adherence to treatment. Conclusions: This study provides compelling evidence that digital, web-based counseling environments for patients who are chronically ill are more effective than, or at least comparable to, standard counseling methods; this suggests that digital environments could complement standard counseling. UR - https://www.jmir.org/2022/1/e30077 UR - http://dx.doi.org/10.2196/30077 UR - http://www.ncbi.nlm.nih.gov/pubmed/34989681 ID - info:doi/10.2196/30077 ER - TY - JOUR AU - Pronk, Yvette AU - Pilot, Peter AU - van der Weegen, Walter AU - Brinkman, Justus-Martijn AU - Schreurs, Willem Berend PY - 2021/12/20 TI - A Patient-Reported Outcome Tool to Triage Total Hip Arthroplasty Patients to Hospital or Video Consultation: Pilot Study With Expert Panels and a Cohort of 1228 Patients JO - JMIR Form Res SP - e31232 VL - 5 IS - 12 KW - PROMs KW - total hip arthroplasty KW - triage tool KW - video consultation KW - telemedicine KW - digital transformation N2 - Background: The digital transformation in health care has been accelerated by the COVID-19 pandemic. Video consultation has become the alternative for hospital consultation. It remains unknown how to select patients suitable for video consultation. Objective: This study aimed to develop a tool based on patient-reported outcomes (PROs) to triage total hip arthroplasty (THA) patients to hospital or video consultation. Methods: A pilot study with expert panels and a retrospective cohort with prospectively collected data from 1228 THA patients was executed. The primary outcome was a PRO triage tool to allocate THA patients to hospital or video consultation 6 weeks postoperatively. Expert panels defined the criteria and selected the patient-reported outcome measure (PROM) questions including thresholds. Data were divided into training and test cohorts. Distribution, floor effect, correlation, responsiveness, PRO patient journey, and homogeneity of the selected questions were investigated in the training cohort. The test cohort was used to provide an unbiased evaluation of the final triage tool. Results: The expert panels selected moderate or severe pain and using 2 crutches as the triage tool criteria. PROM questions included in the final triage tool were numeric rating scale (NRS) pain during activity, 3-level version of the EuroQol 5 dimensions (EQ-5D-3L) questions 1 and 4, and Oxford Hip Score (OHS) questions 6, 8, and 12. Of the training cohort, 201 (201/703, 28.6%) patients needed a hospital consultation, which was statistically equal to the 150 (150/463, 32.4%) patients in the test cohort who needed a hospital consultation (P=.19). Conclusions: A PRO triage tool based on moderate or severe pain and using 2 crutches was developed. Around 70% of THA patients could safely have a video consultation, and 30% needed a hospital consultation 6 weeks postoperatively. This tool is promising for selecting patients for video consultation while using an existing PROM infrastructure. UR - https://formative.jmir.org/2021/12/e31232 UR - http://dx.doi.org/10.2196/31232 UR - http://www.ncbi.nlm.nih.gov/pubmed/34931989 ID - info:doi/10.2196/31232 ER - TY - JOUR AU - Hill, K. Mary AU - Laughter, R. Melissa AU - Harmange, I. Cecile AU - Dellavalle, P. Robert AU - Rundle, W. Chandler AU - Dunnick, A. Cory PY - 2021/12/16 TI - The Contact Dermatitis Quality of Life Index (CDQL): Survey Development and Content Validity Assessment JO - JMIR Dermatol SP - e30620 VL - 4 IS - 2 KW - contact dermatitis KW - allergic contact dermatitis KW - irritant contact dermatitis KW - quality of life KW - outcomes instruments KW - health outcomes N2 - Background: There is limited measurement and reporting of quality of life (QoL) outcomes for patients with contact dermatitis (CD). Objective: The purpose of this study is to develop a standardized Contact Dermatitis Quality of Life index (CDQL) for adult patients. Methods: A list of 81 topics was compiled from a review of QoL measures used previously in CD research. A total of 2 rounds of web-based Delphi surveys were sent to physicians who registered to attend the 2018 American Contact Dermatitis Society meeting, asking that they rank the relevance of topics for measuring QoL in CD using a 4-point scale. Items met consensus for inclusion if at least 78% of respondents ranked them as relevant or very relevant, and their median score was ?3.25. Results: Of the 210 physicians contacted, 34 physicians completed the initial survey and 17 completed the follow-up survey. A total of 22 topics met consensus for inclusion in the CDQL, addressing symptoms, emotions, functions of daily living, social and physical functions, work/school functions, and treatment. Conclusions: This study was limited by the following factors: few open-ended questions in the initial survey, a lack of direct patient feedback, and long survey length, which likely contributed to lower survey participation. The CDQL is a comprehensive, CD-specific QoL measure developed on the basis of expert consensus via a modified Delphi process to be used by physicians and other health care professionals who care for adult patients with contact dermatitis. UR - https://derma.jmir.org/2021/2/e30620 UR - http://dx.doi.org/10.2196/30620 UR - http://www.ncbi.nlm.nih.gov/pubmed/37632827 ID - info:doi/10.2196/30620 ER - TY - JOUR AU - Oerlemans, Simone AU - Arts, Johanna Lindy Paulina AU - Kieffer, M. Jacobien AU - Prins, Judith AU - Hoogendoorn, Mels AU - van der Poel, Marjolein AU - Koster, Ad AU - Lensen, Chantal AU - Stevens, Catharina Wendy Bernadina AU - Issa, Djamila AU - Pruijt, M. Johannes F. AU - Oosterveld, Margriet AU - van der Griend, René AU - Nijziel, Marten AU - Tick, Lidwine AU - Posthuma, M. Eduardus F. AU - van de Poll-Franse, V. Lonneke PY - 2021/12/14 TI - Web-Based Return of Individual Patient-Reported Outcome Results Among Patients With Lymphoma: Randomized Controlled Trial JO - J Med Internet Res SP - e27886 VL - 23 IS - 12 KW - lymphoma KW - patient-reported outcomes KW - return of individual results KW - randomized controlled trial KW - self-management N2 - Background: There has been a cultural shift toward patient engagement in health, with a growing demand from patients to access their results. Objective: The Lymphoma Intervention (LIVE) trial is conducted to examine the impact of return of individual patient-reported outcome (PRO) results and a web-based self-management intervention on psychological distress, self-management, satisfaction with information, and health care use in a population-based setting. Methods: Return of PRO results included comparison with age- and sex-matched peers and was built into the Patient-Reported Outcomes Following Initial Treatment and Long-Term Evaluation of Survivorship registry. The self-management intervention is an adaptation of a fully automated evidence-based intervention for breast cancer survivors. Patients with lymphoma who completed the web-based questionnaire were equally randomized to care as usual, return of PRO results, and return of PRO results plus self-management intervention. Patients completed questionnaires 9 to 18 months after diagnosis (T0; n=227), 4 months (T1; n=190), 12 months (T2; n=170), and 24 months (T3; n=98). Results: Of all invited patients, 51.1% (456/892) responded and web-based participants (n=227) were randomly assigned to care as usual (n=76), return of PRO results (n=74), or return of PRO results and access to Living with lymphoma (n=77). Return of PRO results was viewed by 76.7% (115/150) of those with access. No statistically significant differences were observed for psychological distress, self-management, satisfaction with information provision, and health care use between patients who received PRO results and those who did not (P>.05). Use of the self-management intervention was low (2/76, 3%), and an effect could therefore not be determined. Conclusions: Return of individual PRO results seems to meet patients? wishes but had no beneficial effects on patient outcome. No negative effects were found when individual PRO results were disclosed, and the return of individual PRO results can therefore be safely implemented in daily clinical practice. Trial Registration: Netherlands Trial Register NTR5953; https://www.trialregister.nl/trial/5790 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-017-1943-2 UR - https://www.jmir.org/2021/12/e27886 UR - http://dx.doi.org/10.2196/27886 UR - http://www.ncbi.nlm.nih.gov/pubmed/34904948 ID - info:doi/10.2196/27886 ER - TY - JOUR AU - Ankersen, Vedel Dorit AU - Weimers, Petra AU - Bennedsen, Mette AU - Haaber, Birgitte Anne AU - Fjordside, Lund Eva AU - Beber, Emanuel Moritz AU - Lieven, Christian AU - Saboori, Sanaz AU - Vad, Nicolai AU - Rannem, Terje AU - Marker, Dorte AU - Paridaens, Kristine AU - Frahm, Suzanne AU - Jensen, Lisbeth AU - Rosager Hansen, Malte AU - Burisch, Johan AU - Munkholm, Pia PY - 2021/12/14 TI - Long-Term Effects of a Web-Based Low-FODMAP Diet Versus Probiotic Treatment for Irritable Bowel Syndrome, Including Shotgun Analyses of Microbiota: Randomized, Double-Crossover Clinical Trial JO - J Med Internet Res SP - e30291 VL - 23 IS - 12 KW - irritable bowel syndrome KW - web-based low-FODMAP diet KW - probiotics KW - randomized trial KW - web-based KW - IBS KW - symptom management KW - treatment outcomes KW - outcomes KW - treatment KW - microbiota KW - microbiome KW - gastroenterology KW - mobile app KW - mHealth KW - eHealth N2 - Background: The long-term management of irritable bowel syndrome (IBS) poses many challenges. In short-term studies, eHealth interventions have been demonstrated to be safe and practical for at-home monitoring of the effects of probiotic treatments and a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs). IBS has been linked to alterations in the microbiota. Objective: The aim of this study was to determine whether a web-based low-FODMAP diet (LFD) intervention and probiotic treatment were equally good at reducing IBS symptoms, and whether the response to treatments could be explained by patients? microbiota. Methods: Adult IBS patients were enrolled in an open-label, randomized crossover trial (for nonresponders) with 1 year of follow-up using the web application IBS Constant Care (IBS CC). Patients were recruited from the outpatient clinic at the Department of Gastroenterology, North Zealand University Hospital, Denmark. Patients received either VSL#3 for 4 weeks (2 × 450 billion colony-forming units per day) or were placed on an LFD for 4 weeks. Patients responding to the LFD were reintroduced to foods high in FODMAPs, and probiotic responders received treatments whenever they experienced a flare-up of symptoms. Treatment response and symptom flare-ups were defined as a reduction or increase, respectively, of at least 50 points on the IBS Severity Scoring System (IBS-SSS). Web-based ward rounds were performed daily by the study investigator. Fecal microbiota were analyzed by shotgun metagenomic sequencing (at least 10 million 2 × 100 bp paired-end sequencing reads per sample). Results: A total of 34 IBS patients without comorbidities and 6 healthy controls were enrolled in the study. Taken from participating subjects, 180 fecal samples were analyzed for their microbiota composition. Out of 21 IBS patients, 12 (57%) responded to the LFD and 8 (38%) completed the reintroduction of FODMAPs. Out of 21 patients, 13 (62%) responded to their first treatment of VSL#3 and 7 (33%) responded to multiple VSL#3 treatments. A median of 3 (IQR 2.25-3.75) probiotic treatments were needed for sustained symptom control. LFD responders were reintroduced to a median of 14.50 (IQR 7.25-21.75) high-FODMAP items. No significant difference in the median reduction of IBS-SSS for LFD versus probiotic responders was observed, where for LFD it was ?126.50 (IQR ?196.75 to ?76.75) and for VSL#3 it was ?130.00 (IQR ?211.00 to ?70.50; P>.99). Responses to either of the two treatments were not able to be predicted using patients? microbiota. Conclusions: The web-based LFD intervention and probiotic treatment were equally efficacious in managing IBS symptoms. The response to treatments could not be explained by the composition of the microbiota. The IBS CC web application was shown to be practical, safe, and useful for clinical decision making in the long-term management of IBS. Although this study was underpowered, findings from this study warrant further research in a larger sample of patients with IBS to confirm these long-term outcomes. Trial Registration: ClinicalTrials.gov NCT03586622; https://clinicaltrials.gov/ct2/show/NCT03586622 UR - https://www.jmir.org/2021/12/e30291 UR - http://dx.doi.org/10.2196/30291 UR - http://www.ncbi.nlm.nih.gov/pubmed/34904950 ID - info:doi/10.2196/30291 ER - TY - JOUR AU - Bailey, E. James AU - Gurgol, Cathy AU - Pan, Eric AU - Njie, Shirilyn AU - Emmett, Susan AU - Gatwood, Justin AU - Gauthier, Lynne AU - Rosas, G. Lisa AU - Kearney, M. Shannon AU - Robler, Kleindienst Samantha AU - Lawrence, H. Raymona AU - Margolis, L. Karen AU - Osunkwo, Ifeyinwa AU - Wilfley, Denise AU - Shah, O. Vallabh PY - 2021/12/7 TI - Early Patient-Centered Outcomes Research Experience With the Use of Telehealth to Address Disparities: Scoping Review JO - J Med Internet Res SP - e28503 VL - 23 IS - 12 KW - telehealth KW - scoping review KW - disparities KW - implementation science N2 - Background: Health systems and providers across America are increasingly employing telehealth technologies to better serve medically underserved low-income, minority, and rural populations at the highest risk for health disparities. The Patient-Centered Outcomes Research Institute (PCORI) has invested US $386 million in comparative effectiveness research in telehealth, yet little is known about the key early lessons garnered from this research regarding the best practices in using telehealth to address disparities. Objective: This paper describes preliminary lessons from the body of research using study findings and case studies drawn from PCORI seminal patient-centered outcomes research (PCOR) initiatives. The primary purpose was to identify common barriers and facilitators to implementing telehealth technologies in populations at risk for disparities. Methods: A systematic scoping review of telehealth studies addressing disparities was performed. It was guided by the Arksey and O?Malley Scoping Review Framework and focused on PCORI?s active portfolio of telehealth studies and key PCOR identified by study investigators. We drew on this broad literature using illustrative examples from early PCOR experience and published literature to assess barriers and facilitators to implementing telehealth in populations at risk for disparities, using the active implementation framework to extract data. Major themes regarding how telehealth interventions can overcome barriers to telehealth adoption and implementation were identified through this review using an iterative Delphi process to achieve consensus among the PCORI investigators participating in the study. Results: PCORI has funded 89 comparative effectiveness studies in telehealth, of which 41 assessed the use of telehealth to improve outcomes for populations at risk for health disparities. These 41 studies employed various overlapping modalities including mobile devices (29/41, 71%), web-based interventions (30/41, 73%), real-time videoconferencing (15/41, 37%), remote patient monitoring (8/41, 20%), and store-and-forward (ie, asynchronous electronic transmission) interventions (4/41, 10%). The studies targeted one or more of PCORI?s priority populations, including racial and ethnic minorities (31/41, 41%), people living in rural areas, and those with low income/low socioeconomic status, low health literacy, or disabilities. Major themes identified across these studies included the importance of patient-centered design, cultural tailoring of telehealth solutions, delivering telehealth through trusted intermediaries, partnering with payers to expand telehealth reimbursement, and ensuring confidential sharing of private information. Conclusions: Early PCOR evidence suggests that the most effective health system- and provider-level telehealth implementation solutions to address disparities employ patient-centered and culturally tailored telehealth solutions whose development is actively guided by the patients themselves to meet the needs of specific communities and populations. Further, this evidence shows that the best practices in telehealth implementation include delivery of telehealth through trusted intermediaries, close partnership with payers to facilitate reimbursement and sustainability, and safeguards to ensure patient-guided confidential sharing of personal health information. UR - https://www.jmir.org/2021/12/e28503 UR - http://dx.doi.org/10.2196/28503 UR - http://www.ncbi.nlm.nih.gov/pubmed/34878986 ID - info:doi/10.2196/28503 ER - TY - JOUR AU - Kalf, J. Rachel R. AU - Delnoij, J. Diana M. AU - Ryll, Bettina AU - Bouvy, L. Marcel AU - Goettsch, G. Wim PY - 2021/12/7 TI - Information Patients With Melanoma Spontaneously Report About Health-Related Quality of Life on Web-Based Forums: Case Study JO - J Med Internet Res SP - e27497 VL - 23 IS - 12 KW - reimbursement decision-making KW - QoL KW - health care KW - quality of life N2 - Background: There is a general agreement on the importance of health-related quality of life (HRQoL). This type of information is becoming increasingly important for the value assessment of health technology assessment agencies in evaluating the benefits of new health technologies, including medicines. However, HRQoL data are often limited, and additional sources that provide this type of information may be helpful. Objective: We aim to identify the HRQoL topics important to patients with melanoma based on web-based discussions on public social media forums. Methods: We identified 3 public web-based forums from the United States and the United Kingdom, namely the Melanoma Patient Information Page, the Melanoma International Forum, and MacMillan. Their posts were randomly selected and coded using qualitative methods until saturation was reached. Results: Of the posts assessed, 36.7% (150/409) of posts on Melanoma International Forum, 45.1% (198/439) on MacMillan, and 35.4% (128/362) on Melanoma Patient Information Page focused on HRQoL. The 2 themes most frequently mentioned were mental health and (un)certainty. The themes were constructed based on underlying and more detailed codes. Codes related to fear, worry and anxiety, uncertainty, and unfavorable effects were the most-often discussed ones. Conclusions: Web-based forums are a valuable source for identifying relevant HRQoL aspects in patients with a given disease. These aspects could be cross-referenced with existing tools and they might improve the content validity of patient-reported outcome measures, including HRQoL questionnaires. In addition, web-based forums may provide health technology assessment agencies with a more holistic understanding of the external aspects affecting patient HRQoL. These aspects might support the value assessment of new health technologies and could therefore help inform topic prioritization as well as the scoping phase before any value assessment. UR - https://www.jmir.org/2021/12/e27497 UR - http://dx.doi.org/10.2196/27497 UR - http://www.ncbi.nlm.nih.gov/pubmed/34878994 ID - info:doi/10.2196/27497 ER - TY - JOUR AU - Janvrin, Lynn Miranda AU - Korona-Bailey, Jessica AU - Koehlmoos, Pérez Tracey PY - 2021/12/6 TI - Re-examining COVID-19 Self-Reported Symptom Tracking Programs in the United States: Updated Framework Synthesis JO - JMIR Form Res SP - e31271 VL - 5 IS - 12 KW - COVID-19 KW - coronavirus KW - framework analysis KW - information resources KW - monitoring KW - patient-reported outcome measures KW - self-reported KW - surveillance KW - symptom tracking KW - synthesis KW - digital health N2 - Background: Early in the pandemic, in 2020, Koehlmoos et al completed a framework synthesis of currently available self-reported symptom tracking programs for COVID-19. This framework described relevant programs, partners and affiliates, funding, responses, platform, and intended audience, among other considerations. Objective: This study seeks to update the existing framework with the aim of identifying developments in the landscape and highlighting how programs have adapted to changes in pandemic response. Methods: Our team developed a framework to collate information on current COVID-19 self-reported symptom tracking programs using the ?best-fit? framework synthesis approach. All programs from the previous study were included to document changes. New programs were discovered using a Google search for target keywords. The time frame for the search for programs ranged from March 1, 2021, to May 6, 2021. Results: We screened 33 programs, of which 8 were included in our final framework synthesis. We identified multiple common data elements, including demographic information such as race, age, gender, and affiliation (all were associated with universities, medical schools, or schools of public health). Dissimilarities included questions regarding vaccination status, vaccine hesitancy, adherence to social distancing, COVID-19 testing, and mental health. Conclusions: At this time, the future of self-reported symptom tracking for COVID-19 is unclear. Some sources have speculated that COVID-19 may become a yearly occurrence much like the flu, and if so, the data that these programs generate is still valuable. However, it is unclear whether the public will maintain the same level of interest in reporting their symptoms on a regular basis if the prevalence of COVID-19 becomes more common. UR - https://formative.jmir.org/2021/12/e31271 UR - http://dx.doi.org/10.2196/31271 UR - http://www.ncbi.nlm.nih.gov/pubmed/34792469 ID - info:doi/10.2196/31271 ER - TY - JOUR AU - van Barneveld, Esther AU - Lim, Arianne AU - van Hanegem, Nehalennia AU - Vork, Lisa AU - Herrewegh, Alexandra AU - van Poll, Mikal AU - Manders, Jessica AU - van Osch, Frits AU - Spaans, Wilbert AU - van Koeveringe, Gommert AU - Vrijens, Desiree AU - Kruimel, Joanna AU - Bongers, Marlies AU - Leue, Carsten PY - 2021/12/3 TI - Patient-Reported Outcome Measure for Real-time Symptom Assessment in Women With Endometriosis: Focus Group Study JO - JMIR Form Res SP - e28782 VL - 5 IS - 12 KW - endometriosis KW - pelvic pain KW - positive affect KW - negative affect KW - patient-reported outcome measure KW - focus groups KW - experience sampling method KW - momentary symptom assessment KW - mobile phone N2 - Background: Symptoms related to endometriosis have a significant impact on the quality of life, and symptoms often recur. The experience sampling method (ESM), a digital questioning method characterized by randomly repeated momentary assessments, has several advantages over traditionally used measurements, including the ability to assess the temporal relationship between variables such as physical, mental, and social factors. Objective: The aim of this study is to develop an ESM tool for patients with endometriosis to accurately measure symptoms and their course over time, allowing for personalized treatment and adequate monitoring of treatment efficacy in individual patients. Methods: On the basis of international guidelines, items from validated questionnaires were selected through a literature review and during focus groups and multidisciplinary expert meetings. Data analysis was conducted using ATLAS.ti (ATLAS.ti Scientific Software Development GmbH). The feasibility and usability of the newly developed momentary assessment tool were tested for 28 consecutive days in 5 patients with endometriosis-related pain symptoms. Results: Momentary assessment items contained questions concerning endometriosis symptoms, general somatic symptoms, psychological symptoms, contextual information, and the use of food and medication. A morning questionnaire on sleep and sexuality was included. In a pilot study, the patients considered the tool easy to use but time consuming. The average compliance rate of momentary assessments was 37.8% (106/280), with the highest completion rate during the first week (39/70, 56%). Therefore, it is advisable to use the ESM for a maximum of 7 days. Conclusions: A new digital tool for endometriosis symptom assessment was developed using the ESM, which may help overcome the limitations of current retrospective questionnaires. After validation and testing, future studies will be planned to evaluate the use of this tool in a clinical setting in order to propose a personalized treatment plan for women with endometriosis. UR - https://formative.jmir.org/2021/12/e28782 UR - http://dx.doi.org/10.2196/28782 UR - http://www.ncbi.nlm.nih.gov/pubmed/34870608 ID - info:doi/10.2196/28782 ER - TY - JOUR AU - Steele Gray, Carolyn AU - Chau, Edward AU - Tahsin, Farah AU - Harvey, Sarah AU - Loganathan, Mayura AU - McKinstry, Brian AU - Mercer, W. Stewart AU - Nie, Xin Jason AU - Palen, E. Ted AU - Ramsay, Tim AU - Thavorn, Kednapa AU - Upshur, Ross AU - Wodchis, P. Walter PY - 2021/12/2 TI - Assessing the Implementation and Effectiveness of the Electronic Patient-Reported Outcome Tool for Older Adults With Complex Care Needs: Mixed Methods Study JO - J Med Internet Res SP - e29071 VL - 23 IS - 12 KW - older adults KW - goal-oriented care KW - quality of life KW - self-management KW - primary care KW - eHealth KW - pragmatic trial KW - mobile phone N2 - Background: Goal-oriented care is being adopted to deliver person-centered primary care to older adults with multimorbidity and complex care needs. Although this model holds promise, its implementation remains a challenge. Digital health solutions may enable processes to improve adoption; however, they require evaluation to determine feasibility and impact. Objective: This study aims to evaluate the implementation and effectiveness of the electronic Patient-Reported Outcome (ePRO) mobile app and portal system, designed to enable goal-oriented care delivery in interprofessional primary care practices. The research questions driving this study are as follows: Does ePRO improve quality of life and self-management in older adults with complex needs? What mechanisms are likely driving observed outcomes? Methods: A multimethod, pragmatic randomized controlled trial using a stepped-wedge design and ethnographic case studies was conducted over a 15-month period in 6 comprehensive primary care practices across Ontario with a target enrollment of 176 patients. The 6 practices were randomized into either early (3-month control period; 12-month intervention) or late (6-month control period; 9-month intervention) groups. The primary outcome measure of interest was the Assessment of Quality of Life-4D (AQoL-4D). Data were collected at baseline and at 3 monthly intervals for the duration of the trial. Ethnographic data included observations and interviews with patients and providers at the midpoint and end of the intervention. Outcome data were analyzed using linear models conducted at the individual level, accounting for cluster effects at the practice level, and ethnographic data were analyzed using qualitative description and framework analysis methods. Results: Recruitment challenges resulted in fewer sites and participants than expected; of the 176 target, only 142 (80.6%) patients were identified as eligible to participate because of lower-than-expected provider participation and fewer-than-expected patients willing to participate or perceived as ready to engage in goal-setting. Of the 142 patients approached, 45 (32%) participated. Patients set a variety of goals related to self-management, mental health, social health, and overall well-being. Owing to underpowering, the impact of ePRO on quality of life could not be definitively assessed; however, the intervention group, ePRO plus usual care (mean 15.28, SD 18.60) demonstrated a nonsignificant decrease in quality of life (t24=?1.20; P=.24) when compared with usual care only (mean 21.76, SD 2.17). The ethnographic data reveal a complex implementation process in which the meaningfulness (or coherence) of the technology to individuals? lives and work acted as a key driver of adoption and tool appraisal. Conclusions: This trial experienced many unexpected and significant implementation challenges related to recruitment and engagement. Future studies could be improved through better alignment of the research methods and intervention to the complex and diverse clinical settings, dynamic goal-oriented care process, and readiness of provider and patient participants. Trial Registration: ClinicalTrials.gov NCT02917954; https://clinicaltrials.gov/ct2/show/NCT02917954 UR - https://www.jmir.org/2021/12/e29071 UR - http://dx.doi.org/10.2196/29071 UR - http://www.ncbi.nlm.nih.gov/pubmed/34860675 ID - info:doi/10.2196/29071 ER - TY - JOUR AU - Wiebe, E. Deanna AU - Remers, Shannon AU - Nippak, Pria AU - Meyer, Julien PY - 2021/12/1 TI - Evaluation of an Online System for Routine Outcome Monitoring: Cross-sectional Survey Study JO - JMIR Ment Health SP - e29243 VL - 8 IS - 12 KW - routine outcome monitoring KW - progress monitoring and feedback KW - outcome measures KW - web-based outcome monitoring KW - routine outcome monitoring software KW - outcome measurement questionnaire KW - measurement-based care N2 - Background: The use of routine outcome monitoring (ROM) in the treatment of mental health has emerged as a method of improving psychotherapy treatment outcomes. Despite this, very few clinicians regularly use ROM in clinical practice. Online ROM has been suggested as a solution to increase adoption. Objective: The aim of this study is to identify the influence of moving ROM online on client completion rates of self-reported outcome measures and to identify implementation and utilization barriers to online ROM by assessing clinicians? views on their experience using the online system over previous paper-based methods. Methods: Client completion rates of self-reported outcome measures were compared pre- and postimplementation of an online system of ROM. In addition, a survey questionnaire was administered to 324 mental health service providers regarding their perception of the benefits with an online system of ROM. Results: Client completion rates of self-reported measures increased from 15.62% (427/2734) to 53.98% (1267/2347) after they were moved online. Furthermore, 57% (56/98) of service providers found the new system less time-consuming than the previous paper-based ROM, and 64% (63/98) found that it helped monitor clients. However, the perceived value of the system remains in doubt as only 23% (23/98) found it helped them identify clients at risk for treatment failure, and only 18% (18/98) found it strengthened the therapeutic alliance. Conclusions: Although the current study suggests mixed results regarding service providers? views on their experience using an online system for ROM, it has identified barriers and challenges that are actionable for improvement. UR - https://mental.jmir.org/2021/12/e29243 UR - http://dx.doi.org/10.2196/29243 UR - http://www.ncbi.nlm.nih.gov/pubmed/34855615 ID - info:doi/10.2196/29243 ER - TY - JOUR AU - Petracca, Francesco AU - Tempre, Rosaria AU - Cucciniello, Maria AU - Ciani, Oriana AU - Pompeo, Elena AU - Sannino, Luigi AU - Lovato, Valeria AU - Castaman, Giancarlo AU - Ghirardini, Alessandra AU - Tarricone, Rosanna PY - 2021/12/1 TI - An Electronic Patient-Reported Outcome Mobile App for Data Collection in Type A Hemophilia: Design and Usability Study JO - JMIR Form Res SP - e25071 VL - 5 IS - 12 KW - mobile apps KW - mHealth KW - hemophilia A KW - rare diseases KW - usability KW - user-centered design KW - design science KW - mobile phone N2 - Background: There is currently limited evidence on the level and intensity of physical activity in individuals with hemophilia A. Mobile technologies can offer a rigorous and reliable alternative to support data collection processes but they are often associated with poor user retention. The lack of longitudinal continuity in their use can be partly attributed to the insufficient consideration of stakeholder inputs in the development process of mobile apps. Several user-centered models have been proposed to guarantee that a thorough knowledge of the end user needs is considered in the development process of mobile apps. Objective: The aim of this study is to design and validate an electronic patient-reported outcome mobile app that requires sustained active input by individuals during POWER, an observational study that aims at evaluating the relationship between physical activity levels and bleeding in patients with hemophilia A. Methods: We adopted a user-centered design and engaged several stakeholders in the development and usability testing of this mobile app. During the concept generation and ideation phase, we organized a need-assessment focus group (FG) with patient representatives to elicit specific design requirements for the end users. We then conducted 2 exploratory FGs to seek additional inputs for the app?s improvement and 2 confirmatory FGs to validate the app and test its usability in the field through the mobile health app usability questionnaire. Results: The findings from the thematic analysis of the need-assessment FG revealed that there was a demand for sense making, for simplification of app functionalities, for maximizing integration, and for minimizing the feeling of external control. Participants involved in the later stages of the design refinement contributed to improving the design further by upgrading the app?s layout and making the experience with the app more efficient through functions such as chatbots and visual feedback on the number of hours a wearable device had been worn, to ensure that the observed data were actually registered. The end users rated the app highly during the quantitative assessment, with an average mobile health app usability questionnaire score of 5.32 (SD 0.66; range 4.44-6.23) and 6.20 (SD 0.43; range 5.72-6.88) out of 7 in the 2 iterative usability testing cycles. Conclusions: The results of the usability test indicated a high, growing satisfaction with the electronic patient-reported outcome app. The adoption of a thorough user-centered design process using several types of FGs helped maximize the likelihood of sustained retention of the app?s users and made it fit for data collection of relevant outcomes in the observational POWER study. The continuous use of the app and the actual level of engagement will be evaluated during the ongoing trial. Trial Registration: ClinicalTrials.gov NCT04165135; https://clinicaltrials.gov/ct2/show/NCT04165135 UR - https://formative.jmir.org/2021/12/e25071 UR - http://dx.doi.org/10.2196/25071 UR - http://www.ncbi.nlm.nih.gov/pubmed/34855619 ID - info:doi/10.2196/25071 ER - TY - JOUR AU - Seckin, Gul AU - Hughes, Susan PY - 2021/11/24 TI - Patient-Reported Outcomes in a Nationally Representative Sample of Older Internet Users: Cross-sectional Survey JO - JMIR Aging SP - e16006 VL - 4 IS - 4 KW - internet KW - information KW - health KW - communication KW - strain KW - education KW - eHealth literacy N2 - Background: The rapid diffusion of the internet has decreased consumer reliance on health care providers for health information and facilitated the patients? ability to be an agent in control of their own health. However, empirical evidence is limited regarding the effects of health-related internet use among older adults, which is complicated by the proliferation of online health and medical sources of questionable scientific accuracy. Objective: We explore the effects of health-related internet use, education, and eHealth literacy on medical encounters and patient-reported outcomes. Patient-reported outcomes are categorized into two dimensions: (1) self-reported health problem and (2) affective distress (feeling worried and anxious) due to information obtained. We were particularly interested in whether education and eHealth literacy moderate the association between perceived strain in medical encounters and patient-reported outcomes. Methods: Our study sample consisted of online panel members who have used the internet as a resource for health information, randomly drawn from one of the largest probability-based online research panels. This paper specifically reports results obtained from older panel members (age?60 years: n=194). First, we examined descriptive statistics and bivariate associations (Pearson correlations and independent samples t tests). We used hierarchical ordinary least squares regression analyses by running separate regressions for each patient-reported outcome. In model 1, we entered the main effects. In model 2, technology and medical encounter variables were included. Model 3 added the statistical interaction terms. Results: Age (?=?.17; P=.02), gender (?=?.22; P=.01), and medical satisfaction (?=?.28; P=.01) were significant predictors of self-reported health problems. Affective distress was positively predicted by gender (?=.13; P=.05) and satisfaction with medical encounters (?=.34; P<.001) but negatively predicted by education (?=?.18; P=.03) and eHealth literacy (?=?.32; P=.01). The association between experiencing a health problem in relation to health-related internet use and perception of strained medical encounters was greater among respondents with lower levels of education (?=?.55; P=.04). There was also a significant interaction between education and eHealth literacy in predicting the level of affective distress (?=?.60; P=.05), which indicated that higher levels of education predicted lower averages of feeling anxiety and worry despite lower eHealth literacy. Older women reported higher averages of affective distress (?=.13; P=.05), while older men reported higher averages of experiencing a self-reported health problem (?=?.22; P=.01). Conclusions: This study provides evidence for the effect of health-related internet use on patient-reported outcomes with implications for medical encounters. The results could be used to guide educational and eHealth literacy interventions for older individuals. UR - https://aging.jmir.org/2021/4/e16006 UR - http://dx.doi.org/10.2196/16006 UR - http://www.ncbi.nlm.nih.gov/pubmed/34822340 ID - info:doi/10.2196/16006 ER - TY - JOUR AU - Beckers, B. Abraham AU - Snijkers, W. Johanna T. AU - Weerts, M. Zsa Zsa R. AU - Vork, Lisa AU - Klaassen, Tim AU - Smeets, M. Fabienne G. AU - Masclee, M. Ad A. AU - Keszthelyi, Daniel PY - 2021/11/24 TI - Digital Instruments for Reporting of Gastrointestinal Symptoms in Clinical Trials: Comparison of End-of-Day Diaries Versus the Experience Sampling Method JO - JMIR Form Res SP - e31678 VL - 5 IS - 11 KW - irritable bowel syndrome KW - functional dyspepsia KW - digital diary KW - experience sampling method KW - smartphone app KW - mobile phone application KW - mHealth KW - eHealth KW - compliance KW - patient-reported outcome measures N2 - Background: Questionnaires are necessary tools for assessing symptoms of disorders of the brain-gut interaction in clinical trials. We previously reported on the excellent adherence to a smartphone app used as symptom diary in a randomized clinical trial on irritable bowel syndrome (IBS). Other sampling methods, such as the experience sampling method (ESM), are better equipped to measure symptom variability over time and provide useful information regarding possible symptom triggers, and they are free of ecological and recall bias. The high frequency of measurements, however, could limit the feasibility of ESM in clinical trials. Objective: This study aimed to compare the adherence rates of a smartphone-based end-of-day diary and ESM for symptom assessment in IBS and functional dyspepsia (FD). Methods: Data from 4 separate studies were included. Patients with IBS participated in a randomized controlled trial, which involved a smartphone end-of-day diary for a 2+8-week (pretreatment + treatment) period, and an observational study in which patients completed ESM assessments using a smartphone app for 1 week. Patients with FD participated in a randomized controlled trial, which involved a smartphone end-of-day diary for a 2+12-week (pretreatment + treatment) period, and an observational study in which patients completed ESM assessments using a smartphone app for 1 week. Adherence rates were compared between these 2 symptom sampling methods. Results: In total, 25 patients with IBS and 15 patients with FD were included. Overall adherence rates for the end-of-day diaries were significantly higher than those for ESM (IBS: 92.7% vs 69.8%, FD: 90.1% vs 61.4%, respectively). Conclusions: This study demonstrates excellent adherence rates for smartphone app?based end-of-day diaries as used in 2 separate clinical trials. Overall adherence rates for ESM were significantly lower, rendering it more suitable for intermittent sampling periods rather than continuous sampling during longer clinical trials. UR - https://formative.jmir.org/2021/11/e31678 UR - http://dx.doi.org/10.2196/31678 UR - http://www.ncbi.nlm.nih.gov/pubmed/34821561 ID - info:doi/10.2196/31678 ER - TY - JOUR AU - Tait, Margaret-Ann AU - Costa, J. Daniel S. AU - Campbell, Rachel AU - Norman, Richard AU - Schug, Stephan AU - Rutherford, Claudia PY - 2021/11/24 TI - A Quality-of-Life Evaluation Study Assessing Health-Related Quality of Life in Patients Receiving Medicinal Cannabis (the QUEST Initiative): Protocol for a Longitudinal Observational Study JO - JMIR Res Protoc SP - e32327 VL - 10 IS - 11 KW - medicinal cannabis KW - patient-reported outcomes KW - quality of life KW - chronic pain KW - pain management KW - mental health KW - depression KW - anxiety KW - cannabis oil N2 - Background: Evidence supports several countries introducing legislation to allow cannabis-based medicine as an adjunctive treatment for the symptomatic relief of chronic pain, chemotherapy-induced nausea, spasticity in multiple sclerosis (MS), epileptic seizures, depression, and anxiety. However, clinical trial participants do not represent the entire spectrum of disease and health status seen in patients currently accessing medicinal cannabis in practice. Objective: This study aims to collect real-world data to evaluate health-related quality of life in patients prescribed medicinal cannabis oil and describe any differences over time, from before starting therapy to after 3 and 12 months of therapy. Methods: Adult patients newly prescribed medicinal cannabis oil by authorized prescribers and under the Special Access Schemes across Australia will be screened for eligibility and invited to participate. A sample size of 2142 is required, with a 3-month follow-up. All participants will complete the EuroQol 5-Dimension; European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30; Depression, Anxiety, and Stress Scale-21; Patients? Global Impression of Change; Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) version 1.0: Sleep Disturbance 8b; and PROMIS SF Fatigue 13a questionnaires. Patients with chronic pain conditions will also complete the PROMIS SF version 1.0: Pain Intensity 3a and PROMIS SF version 1.0: Pain Interference 8a. Patients with movement disorders will also complete Quality of Life in Neurological Disorders (Neuro-QoL) SF version 1.0: Upper Extremity Function (Fine Motor and Activities of Daily Living) and if chorea is indicated, the Neuro-QoL SF version 2.0: Huntington?s Disease health-related Quality of LIFE-Chorea 6a. All questionnaires will be administered at baseline, 2 weeks (titration), monthly up to 3 months, and then every 2 months up to 1 year. Results: Recruitment commenced in November 2020. By June 2021, 1095 patients were screened for the study by 69 physicians in centers across 6 Australian states: Australian Capital Territory, New South Wales, Queensland, South Australia, Victoria, and Western Australia. Of the patients screened, 833 (39% of the target sample size) provided consent and completed baseline questionnaires. Results are expected to be published in 2022. Results of this study will show whether patient-reported outcomes improve in patients accessing prescribed medicinal cannabis from baseline to 3 months and whether any changes are maintained over a 12-month period. This study will also identify differences in improvements in patient-reported outcomes among patients with different chronic conditions (eg, chronic pain, MS, epilepsy, Parkinson disease, or cancer). Conclusions: This protocol contains detailed methods that will be used across multiple sites in Australia. The findings from this study have the potential to be integral to treatment assessment and recommendations for patients with chronic pain and other health indicators for accessing medicinal cannabis. Trial Registration: Australian New Zealand Clinical Trials Registry: ANZCTRN12621000063819; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380807&isReview=true International Registered Report Identifier (IRRID): DERR1-10.2196/32327 UR - https://www.researchprotocols.org/2021/11/e32327 UR - http://dx.doi.org/10.2196/32327 UR - http://www.ncbi.nlm.nih.gov/pubmed/34821570 ID - info:doi/10.2196/32327 ER - TY - JOUR AU - Knapp, Andreas AU - Harst, Lorenz AU - Hager, Stefan AU - Schmitt, Jochen AU - Scheibe, Madlen PY - 2021/11/17 TI - Use of Patient-Reported Outcome Measures and Patient-Reported Experience Measures Within Evaluation Studies of Telemedicine Applications: Systematic Review JO - J Med Internet Res SP - e30042 VL - 23 IS - 11 KW - telemedicine KW - telehealth KW - evaluation KW - outcome KW - patient-reported outcome measures KW - patient-reported outcome KW - patient-reported experience measures KW - patient-reported experience KW - measurement instrument KW - questionnaire N2 - Background: With the rise of digital health technologies and telemedicine, the need for evidence-based evaluation is growing. Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are recommended as an essential part of the evaluation of telemedicine. For the first time, a systematic review has been conducted to investigate the use of PROMs and PREMs in the evaluation studies of telemedicine covering all application types and medical purposes. Objective: This study investigates the following research questions: in which scenarios are PROMs and PREMs collected for evaluation purposes, which PROM and PREM outcome domains have been covered and how often, which outcome measurement instruments have been used and how often, does the selection and quantity of PROMs and PREMs differ between study types and application types, and has the use of PROMs and PREMs changed over time. Methods: We conducted a systematic literature search of the MEDLINE and Embase databases and included studies published from inception until April 2, 2020. We included studies evaluating telemedicine with patients as the main users; these studies reported PROMs and PREMs within randomized controlled trials, controlled trials, noncontrolled trials, and feasibility trials in English and German. Results: Of the identified 2671 studies, 303 (11.34%) were included; of the 303 studies, 67 (22.1%) were feasibility studies, 70 (23.1%) were noncontrolled trials, 20 (6.6%) were controlled trials, and 146 (48.2%) were randomized controlled trials. Health-related quality of life (n=310; mean 1.02, SD 1.05), emotional function (n=244; mean 0.81, SD 1.18), and adherence (n=103; mean 0.34, SD 0.53) were the most frequently assessed outcome domains. Self-developed PROMs were used in 21.4% (65/303) of the studies, and self-developed PREMs were used in 22.3% (68/303). PROMs (n=884) were assessed more frequently than PREMs (n=234). As the evidence level of the studies increased, the number of PROMs also increased (?=?0.45), and the number of PREMs decreased (?=0.35). Since 2000, not only has the number of studies using PROMs and PREMs increased, but the level of evidence and the number of outcome measurement instruments used have also increased, with the number of PREMs permanently remaining at a lower level. Conclusions: There have been increasingly more studies, particularly high-evidence studies, which use PROMs and PREMs to evaluate telemedicine. PROMs have been used more frequently than PREMs. With the increasing maturity stage of telemedicine applications and higher evidence level, the use of PROMs increased in line with the recommendations of evaluation guidelines. Health-related quality of life and emotional function were measured in almost all the studies. Simultaneously, health literacy as a precondition for using the application adequately, alongside proper training and guidance, has rarely been reported. Further efforts should be pursued to standardize PROM and PREM collection in evaluation studies of telemedicine. UR - https://www.jmir.org/2021/11/e30042 UR - http://dx.doi.org/10.2196/30042 UR - http://www.ncbi.nlm.nih.gov/pubmed/34523604 ID - info:doi/10.2196/30042 ER - TY - JOUR AU - Hammam, Nevin AU - Izadi, Zara AU - Li, Jing AU - Evans, Michael AU - Kay, Julia AU - Shiboski, Stephen AU - Schmajuk, Gabriela AU - Yazdany, Jinoos PY - 2021/11/12 TI - The Relationship Between Electronic Health Record System and Performance on Quality Measures in the American College of Rheumatology?s Rheumatology Informatics System for Effectiveness (RISE) Registry: Observational Study JO - JMIR Med Inform SP - e31186 VL - 9 IS - 11 KW - rheumatoid arthritis KW - electronic health record KW - patient-reported outcomes KW - quality measures KW - disease activity KW - quality of care KW - performance reporting KW - medical informatics KW - clinical informatics N2 - Background: Routine collection of disease activity (DA) and patient-reported outcomes (PROs) in rheumatoid arthritis (RA) are nationally endorsed quality measures and critical components of a treat-to-target approach. However, little is known about the role electronic health record (EHR) systems play in facilitating performance on these measures. Objective: Using the American College Rheumatology?s (ACR?s) RISE registry, we analyzed the relationship between EHR system and performance on DA and functional status (FS) quality measures. Methods: We analyzed data collected in 2018 from practices enrolled in RISE. We assessed practice-level performance on quality measures that require DA and FS documentation. Multivariable linear regression and zero-inflated negative binomial models were used to examine the independent effect of EHR system on practice-level quality measure performance, adjusting for practice characteristics and patient case-mix. Results: In total, 220 included practices cared for 314,793 patients with RA. NextGen was the most commonly used EHR system (34.1%). We found wide variation in performance on DA and FS quality measures by EHR system (median 30.1, IQR 0-74.8, and median 9.0, IQR 0-74.2), respectively). Even after adjustment, NextGen practices performed significantly better than Allscripts on the DA measure (51.4% vs 5.0%; P<.05) and significantly better than eClinicalWorks and eMDs on the FS measure (49.3% vs 29.0% and 10.9%; P<.05). Conclusions: Performance on national RA quality measures was associated with the EHR system, even after adjusting for practice and patient characteristics. These findings suggest that future efforts to improve quality of care in RA should focus not only on provider performance reporting but also on developing and implementing rheumatology-specific standards across EHRs. UR - https://medinform.jmir.org/2021/11/e31186 UR - http://dx.doi.org/10.2196/31186 UR - http://www.ncbi.nlm.nih.gov/pubmed/34766910 ID - info:doi/10.2196/31186 ER - TY - JOUR AU - Yu, Hongfan AU - Yu, Qingsong AU - Nie, Yuxian AU - Xu, Wei AU - Pu, Yang AU - Dai, Wei AU - Wei, Xing AU - Shi, Qiuling PY - 2021/11/9 TI - Data Quality of Longitudinally Collected Patient-Reported Outcomes After Thoracic Surgery: Comparison of Paper- and Web-Based Assessments JO - J Med Internet Res SP - e28915 VL - 23 IS - 11 KW - patient-reported outcome (PRO) KW - data quality KW - MDASI-LC KW - postoperative care KW - symptoms N2 - Background: High-frequency patient-reported outcome (PRO) assessments are used to measure patients' symptoms after surgery for surgical research; however, the quality of those longitudinal PRO data has seldom been discussed. Objective: The aim of this study was to determine data quality-influencing factors and to profile error trajectories of data longitudinally collected via paper-and-pencil (P&P) or web-based assessment (electronic PRO [ePRO]) after thoracic surgery. Methods: We extracted longitudinal PRO data with 678 patients scheduled for lung surgery from an observational study (n=512) and a randomized clinical trial (n=166) on the evaluation of different perioperative care strategies. PROs were assessed by the MD Anderson Symptom Inventory Lung Cancer Module and single-item Quality of Life Scale before surgery and then daily after surgery until discharge or up to 14 days of hospitalization. Patient compliance and data error were identified and compared between P&P and ePRO. Generalized estimating equations model and 2-piecewise model were used to describe trajectories of error incidence over time and to identify the risk factors. Results: Among 678 patients, 629 with at least 2 PRO assessments, 440 completed 3347 P&P assessments and 189 completed 1291 ePRO assessments. In total, 49.4% of patients had at least one error, including (1) missing items (64.69%, 1070/1654), (2) modifications without signatures (27.99%, 463/1654), (3) selection of multiple options (3.02%, 50/1654), (4) missing patient signatures (2.54%, 42/1654), (5) missing researcher signatures (1.45%, 24/1654), and (6) missing completion dates (0.30%, 5/1654). Patients who completed ePRO had fewer errors than those who completed P&P assessments (ePRO: 30.2% [57/189] vs. P&P: 57.7% [254/440]; P<.001). Compared with ePRO patients, those using P&P were older, less educated, and sicker. Common risk factors of having errors were a lower education level (P&P: odds ratio [OR] 1.39, 95% CI 1.20-1.62; P<.001; ePRO: OR 1.82, 95% CI 1.22-2.72; P=.003), treated in a provincial hospital (P&P: OR 3.34, 95% CI 2.10-5.33; P<.001; ePRO: OR 4.73, 95% CI 2.18-10.25; P<.001), and with severe disease (P&P: OR 1.63, 95% CI 1.33-1.99; P<.001; ePRO: OR 2.70, 95% CI 1.53-4.75; P<.001). Errors peaked on postoperative day (POD) 1 for P&P, and on POD 2 for ePRO. Conclusions: It is possible to improve data quality of longitudinally collected PRO through ePRO, compared with P&P. However, ePRO-related sampling bias needs to be considered when designing clinical research using longitudinal PROs as major outcomes. UR - https://www.jmir.org/2021/11/e28915 UR - http://dx.doi.org/10.2196/28915 UR - http://www.ncbi.nlm.nih.gov/pubmed/34751657 ID - info:doi/10.2196/28915 ER - TY - JOUR AU - Lu, Zhaohua AU - Sim, Jin-ah AU - Wang, X. Jade AU - Forrest, B. Christopher AU - Krull, R. Kevin AU - Srivastava, Deokumar AU - Hudson, M. Melissa AU - Robison, L. Leslie AU - Baker, N. Justin AU - Huang, I-Chan PY - 2021/11/3 TI - Natural Language Processing and Machine Learning Methods to Characterize Unstructured Patient-Reported Outcomes: Validation Study JO - J Med Internet Res SP - e26777 VL - 23 IS - 11 KW - natural language processing KW - machine learning KW - PROs KW - pediatric oncology N2 - Background: Assessing patient-reported outcomes (PROs) through interviews or conversations during clinical encounters provides insightful information about survivorship. Objective: This study aims to test the validity of natural language processing (NLP) and machine learning (ML) algorithms in identifying different attributes of pain interference and fatigue symptoms experienced by child and adolescent survivors of cancer versus the judgment by PRO content experts as the gold standard to validate NLP/ML algorithms. Methods: This cross-sectional study focused on child and adolescent survivors of cancer, aged 8 to 17 years, and caregivers, from whom 391 meaning units in the pain interference domain and 423 in the fatigue domain were generated for analyses. Data were collected from the After Completion of Therapy Clinic at St. Jude Children?s Research Hospital. Experienced pain interference and fatigue symptoms were reported through in-depth interviews. After verbatim transcription, analyzable sentences (ie, meaning units) were semantically labeled by 2 content experts for each attribute (physical, cognitive, social, or unclassified). Two NLP/ML methods were used to extract and validate the semantic features: bidirectional encoder representations from transformers (BERT) and Word2vec plus one of the ML methods, the support vector machine or extreme gradient boosting. Receiver operating characteristic and precision-recall curves were used to evaluate the accuracy and validity of the NLP/ML methods. Results: Compared with Word2vec/support vector machine and Word2vec/extreme gradient boosting, BERT demonstrated higher accuracy in both symptom domains, with 0.931 (95% CI 0.905-0.957) and 0.916 (95% CI 0.887-0.941) for problems with cognitive and social attributes on pain interference, respectively, and 0.929 (95% CI 0.903-0.953) and 0.917 (95% CI 0.891-0.943) for problems with cognitive and social attributes on fatigue, respectively. In addition, BERT yielded superior areas under the receiver operating characteristic curve for cognitive attributes on pain interference and fatigue domains (0.923, 95% CI 0.879-0.997; 0.948, 95% CI 0.922-0.979) and superior areas under the precision-recall curve for cognitive attributes on pain interference and fatigue domains (0.818, 95% CI 0.735-0.917; 0.855, 95% CI 0.791-0.930). Conclusions: The BERT method performed better than the other methods. As an alternative to using standard PRO surveys, collecting unstructured PROs via interviews or conversations during clinical encounters and applying NLP/ML methods can facilitate PRO assessment in child and adolescent cancer survivors. UR - https://www.jmir.org/2021/11/e26777 UR - http://dx.doi.org/10.2196/26777 UR - http://www.ncbi.nlm.nih.gov/pubmed/34730546 ID - info:doi/10.2196/26777 ER - TY - JOUR AU - Skovlund, E. Soren AU - Troelsen, Havbćk Lise AU - Noergaard, Mellergaard Lise AU - Pietraszek, Anna AU - Jakobsen, Erik Poul AU - Ejskjaer, Niels PY - 2021/11/3 TI - Feasibility and Acceptability of a Digital Patient-Reported Outcome Tool in Routine Outpatient Diabetes Care: Mixed Methods Formative Pilot Study JO - JMIR Form Res SP - e28329 VL - 5 IS - 11 KW - patient-reported outcomes KW - diabetes KW - person-centered care KW - person-centered communication KW - dialog KW - mental health KW - self-management KW - collaborative care KW - value-based health care KW - mixed-methods KW - mobile phone KW - mHealth N2 - Background: Improvements in the digital capabilities of health systems provide new opportunities for the integration of patient-reported outcome (PRO) solutions in routine care, which can facilitate the delivery of person-centered diabetes care. We undertook this study as part of our development of a new digital PRO diabetes questionnaire and clinical dialog support tool for use by people with diabetes and their health care professionals (HCPs) to improve person-centered diabetes care quality and outcomes. Objective: This study evaluates the feasibility, acceptability, and perceived benefits and impacts of using a digital PRO diabetes tool, DiaProfil, in routine outpatient diabetes care. Methods: Overall, 12 people with diabetes scheduled for routine medical diabetes visits at the outpatient clinic were recruited. Purposive sampling was used to optimize heterogeneity regarding age, gender, duration, type of diabetes, treatment modality, and disease severity. Participants filled out a PRO diabetes questionnaire 2 to 5 days before their visit. During the visit, HCPs used a digital PRO tool to review PRO data with the person with diabetes for collaborative care planning. Participants completed evaluation forms before and after the visit and were interviewed for 30 to 45 minutes after the visit. HCPs completed the evaluation questionnaires after each visit. All visits were audio-recorded and transcribed for analysis. Data were analyzed using quantitative, qualitative, and mixed methods analyses. Results: People with diabetes found the PRO diabetes questionnaire to be relevant, acceptable, and feasible to complete from home. People with diabetes and HCPs found the digital PRO tool to be feasible and acceptable for use during the diabetes visit and would like to continue using it. HCPs were able to use the tool in a person-centered manner, as intended. For several people with diabetes, completion of the questionnaire facilitated positive reflection and better preparation for the visit. The use of the PRO tool primarily improved the quality of the dialog by improving the identification and focus on the issues most important to the person with diabetes. People with diabetes did not report any negative aspects of the PRO tool, whereas HCPs highlighted that it was demanding when the person with diabetes had many PRO issues that required attention within the predefined time allocated for a visit. Conclusions: The Danish PRO diabetes questionnaire and the digital tool, DiaProfil, are feasible and acceptable solutions for routine diabetes visits, and this tool may generate important benefits related to advancement of person-centered care. Further research is now required to corroborate and expand these formative insights on a larger scale and in diverse health care settings. The results of this study are therefore being used to define research hypotheses and finalize real-world PRO evaluation tools for a forthcoming large-scale multisector implementation study in Denmark. UR - https://formative.jmir.org/2021/11/e28329 UR - http://dx.doi.org/10.2196/28329 UR - http://www.ncbi.nlm.nih.gov/pubmed/34730545 ID - info:doi/10.2196/28329 ER - TY - JOUR AU - Pyatak, Ann Elizabeth AU - Hernandez, Raymond AU - Pham, T. Loree AU - Mehdiyeva, Khatira AU - Schneider, Stefan AU - Peters, Anne AU - Ruelas, Valerie AU - Crandall, Jill AU - Lee, Pey-Jiuan AU - Jin, Haomiao AU - Hoogendoorn, J. Claire AU - Crespo-Ramos, Gladys AU - Mendez-Rodriguez, Heidy AU - Harmel, Mark AU - Walker, Martha AU - Serafin-Dokhan, Sara AU - Gonzalez, S. Jeffrey AU - Spruijt-Metz, Donna PY - 2021/10/22 TI - Function and Emotion in Everyday Life With Type 1 Diabetes (FEEL-T1D): Protocol for a Fully Remote Intensive Longitudinal Study JO - JMIR Res Protoc SP - e30901 VL - 10 IS - 10 KW - ecological momentary assessments KW - type 1 diabetes KW - patient-centered outcomes research KW - actigraphy KW - ambulatory monitoring KW - continuous glucose monitoring KW - EMA KW - diabetes KW - patient-centered outcome KW - outcome KW - monitoring KW - function KW - emotion KW - longitudinal KW - well-being N2 - Background: Although short-term blood glucose levels and variability are thought to underlie diminished function and emotional well-being in people with type 1 diabetes (T1D), these relationships are poorly understood. The Function and Emotion in Everyday Life with T1D (FEEL-T1D) study focuses on investigating these short-term dynamic relationships among blood glucose levels, functional ability, and emotional well-being in adults with T1D. Objective: The aim of this study is to present the FEEL-T1D study design, methods, and study progress to date, including adaptations necessitated by the COVID-19 pandemic to implement the study fully remotely. Methods: The FEEL-T1D study will recruit 200 adults with T1D in the age range of 18-75 years. Data collection includes a comprehensive survey battery, along with 14 days of intensive longitudinal data using blinded continuous glucose monitoring, ecological momentary assessments, ambulatory cognitive tasks, and accelerometers. All study procedures are conducted remotely by mailing the study equipment and by using videoconferencing for study visits. Results: The study received institutional review board approval in January 2019 and was funded in April 2019. Data collection began in June 2020 and is projected to end in December 2021. As of June 2021, after 12 months of recruitment, 124 participants have enrolled in the FEEL-T1D study. Approximately 87.6% (7082/8087) of ecological momentary assessment surveys have been completed with minimal missing data, and 82.0% (82/100) of the participants provided concurrent continuous glucose monitoring data, ecological momentary assessment data, and accelerometer data for at least 10 of the 14 days of data collection. Conclusions: Thus far, our reconfiguration of the FEEL-T1D protocol to be implemented remotely during the COVID-19 pandemic has been a success. The FEEL-T1D study will elucidate the dynamic relationships among blood glucose levels, emotional well-being, cognitive function, and participation in daily activities. In doing so, it will pave the way for innovative just-in-time interventions and produce actionable insights to facilitate tailoring of diabetes treatments to optimize the function and well-being of individuals with T1D. International Registered Report Identifier (IRRID): DERR1-10.2196/30901 UR - https://www.researchprotocols.org/2021/10/e30901 UR - http://dx.doi.org/10.2196/30901 UR - http://www.ncbi.nlm.nih.gov/pubmed/34463626 ID - info:doi/10.2196/30901 ER - TY - JOUR AU - Phanareth, Klaus AU - Dam, Laura Astrid AU - Hansen, C. Martin A. B. AU - Lindskrog, Signe AU - Vingtoft, Sřren AU - Kayser, Lars PY - 2021/10/19 TI - Revealing the Nature of Chronic Obstructive Pulmonary Disease Using Self-tracking and Analysis of Contact Patterns: Longitudinal Study JO - J Med Internet Res SP - e22567 VL - 23 IS - 10 KW - COPD KW - exacerbations KW - patient-reported outcomes KW - Epital Care Model KW - early interventions N2 - Background: Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death and is characterized by a progressive loss of pulmonary function over time with intermittent episodes of exacerbations. Rapid and proactive interventions may reduce the burden of the condition for the patients. Telehealth solutions involving self-tracking of vital parameters such as pulmonary function, oxygen saturation, heart rate, and temperature with synchronous communication of health data may become a powerful solution as they enable health care professionals to react with a proactive and adequate response. We have taken this idea to the next level in the Epital Care Model and organized a person-centered technology-assisted ecosystem to provide health services to COPD patients. Objective: The objective is to reveal the nature of COPD by combining technology with a person-centered design aimed to benefit from interactions based on patient-reported outcome data and to assess the needed kind of contacts to best treat exacerbations. We wanted to know the following: (1) What are the incidences of mild, moderate, and severe exacerbations in a mixed population of COPD patients? (2) What are the courses of mild, moderate, and severe exacerbations? And (3) How is the activity and pattern of contacts with health professionals related to the participant conditions? Methods: Participants were recruited by convenience sampling from November 2013 to December 2015. The participants? sex, age, forced expiratory volume during the first second, pulse rate, and oxygen saturation were registered at entry. During the study, we registered number of days, number of exacerbations, and number of contact notes coded into care and treatment notes. Each participant was classified according to GOLD I-IV and risk factor group A-D. Participants reported their clinical status using a tablet by answering 4 questions and sending 3 semiautomated measurements. Results: Of the 87 participants, 11 were in risk factor group A, 24 in B, 13 in C, and 39 in D. The number of observed days was 31,801 days with 12,470 measurements, 1397 care notes, and 1704 treatment notes. A total of 254 exacerbations were treated and only 18 caused hospitalization. Those in risk factor group D had the highest number of hospitalizations (16), exacerbations (151), and contacts (1910). The initial contacts during the first month declined within 3 months to one-third for care contacts and one-half for treatment contacts and reached a plateau after 4 months. Conclusions: The majority of COPD patients in risk factor group D can be managed virtually, and only 13% of those with severe exacerbations required hospitalization. Contact to the health care professionals decreases markedly within the first months after enrollment. These results provide a new and detailed insight into the course of COPD. We propose a resilience index for virtual clinical management making it easier to compare results across settings. UR - https://www.jmir.org/2021/10/e22567 UR - http://dx.doi.org/10.2196/22567 UR - http://www.ncbi.nlm.nih.gov/pubmed/34665151 ID - info:doi/10.2196/22567 ER - TY - JOUR AU - Brusniak, Katharina AU - Feisst, Manuel AU - Sebesteny, Linda AU - Hartkopf, Andreas AU - Graf, Joachim AU - Engler, Tobias AU - Schneeweiss, Andreas AU - Wallwiener, Markus AU - Deutsch, Maximilian Thomas PY - 2021/10/12 TI - Measuring the Time to Deterioration for Health-Related Quality of Life in Patients With Metastatic Breast Cancer Using a Web-Based Monitoring Application: Longitudinal Cohort Study JO - JMIR Cancer SP - e25776 VL - 7 IS - 4 KW - eHealth KW - breast cancer KW - health-related quality of life KW - quality of life KW - time to deterioration KW - EQ-VAS KW - EQ-5D-5L KW - EORTC QLQ-C30 N2 - Background: Health-related quality of life (HRQoL) is used to evaluate the treatment of metastatic breast cancer. In a long-term therapy setting, HRQoL can be used as an important benchmark for treatment success. With the help of digital apps, HRQoL monitoring can be extended to more remote areas and be administered on a more frequent basis. Objective: This study aims to evaluate 3 common HRQoL questionnaires in metastasized breast cancer in terms of TTD in a digital, web-based setting. We further aim to examine the development of the HRQoL in different systemic treatment groups in each of these evaluation instruments. Methods: A total of 192 patients with metastatic breast cancer were analyzed in this bicentric prospective online cohort study at two German university hospitals. Patients completed questionnaires on HRQoL (EuroQol Visual Analog Scale [EQ-VAS], EuroQol 5 Dimension 5 Level [EQ-5D-5L], European Organization for Research and Treatment of Cancer Quality of Life Questionnaire?Core 30 item [EORTC QLQ-C30]) via an online platform over a 6-month period. Treatment schedules and medical history were retrieved from medical records. Unadjusted Cox regression analysis on treatment-related factors was performed. We conducted subgroup analyses in regard to TTD events between different treatments. Results: The EQ-VAS showed a higher rate of deterioration after 8 weeks (84/179, 46.9%) than the EQ-5D-5L (47/163, 28.8%) and EORTC QLQ-C30 (65/176, 36.9%). Unadjusted Cox regression revealed significant connections between known metastases in the liver (P=.03, HR 1.64, 95% CI 1.06-2.52) and pleura (P=.04, HR 0.42, 95% CI 0.18-0.96) in the EQ-VAS. Significant relations between EQ-VAS events and single EQ-5D-5L items and the EQ-5D-5L summary score were demonstrated. All treatment groups significantly differed from the CDK4/6 inhibition subgroup in the EQ-VAS. Conclusions: Compared to the EQ-5D-5L and QLQ-C30, the EQ-VAS showed a higher rate of deterioration after 8 weeks. Significant connections to certain metastatic locations were only detected in the EQ-VAS. The EQ-VAS is capable of reflecting the distinctive HRQoL profiles of different systemic treatments as well as the different aspects of HRQoL presented in the EQ-5D-5L. TTD with the EQ-VAS is an adequate mean of examining longitudinal development of HRQoL among breast cancer patients. UR - https://cancer.jmir.org/2021/4/e25776 UR - http://dx.doi.org/10.2196/25776 UR - http://www.ncbi.nlm.nih.gov/pubmed/34636732 ID - info:doi/10.2196/25776 ER - TY - JOUR AU - Maghfour, Jalal AU - Sivesind, Elise Torunn AU - Dellavalle, Paul Robert AU - Dunnick, Cory PY - 2021/10/1 TI - Trends in Hidradenitis Suppurativa Disease Severity and Quality of Life Outcome Measures: Scoping Review JO - JMIR Dermatol SP - e27869 VL - 4 IS - 2 KW - hidradenitis suppurativa KW - severity of illness index KW - patient-reported outcome measures KW - quality of life KW - treatment outcome KW - illness index KW - patient outcomes KW - disease severity KW - Sartorius KW - dermatology KW - treatment interventions N2 - Background: Although there has been an increase in the number of randomized controlled trials evaluating treatment efficacy for hidradenitis suppurativa (HS), instrument measurements of disease severity and quality of life (QoL) are varied, making the compilation of data and comparisons between studies a challenge for clinicians. Objective: We aimed to perform a systematic literature search to examine the recent trends in the use of disease severity and QoL outcome instruments in randomized controlled trials that have been conducted on patients with HS. Methods: A scoping review was conducted in February 2021. The PubMed, Embase, Web of Science, and Cochrane databases were used to identify all articles published from January 1964 to February 2021. In total, 41 articles were included in this systematic review. Results: The HS Clinical Response (HiSCR) score (18/41, 44%) was the most commonly used instrument for disease severity, followed by the Sartorius and Modified Sartorius scales (combined: 16/41, 39%). The Dermatology Life Quality Index (18/41, 44%) and visual analogue pain scales (12/41, 29%) were the most commonly used QoL outcome instruments in HS research. Conclusions: Randomized controlled trials conducted from 2013 onward commonly used the validated HiSCR score, while older studies were more heterogeneous and less likely to use a validated scale. A few (6/18, 33%) QoL measures were validated instruments but were not specific to HS; therefore, they may not be representative of all factors that impact patients with HS. Trial Registration: National Institute of Health Research PROSPERO CRD42020209582; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020209582 UR - https://derma.jmir.org/2021/2/e27869 UR - http://dx.doi.org/10.2196/27869 UR - http://www.ncbi.nlm.nih.gov/pubmed/37632807 ID - info:doi/10.2196/27869 ER - TY - JOUR AU - Veldhuijzen, Evalien AU - Walraven, Iris AU - Belderbos, José PY - 2021/9/14 TI - Selecting a Subset Based on the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events for Patient-Reported Symptom Monitoring in Lung Cancer Treatment: Mixed Methods Study JO - JMIR Cancer SP - e26574 VL - 7 IS - 3 KW - PRO-CTCAE KW - lung cancer KW - side effects KW - patient-reported outcomes KW - PROM KW - symptomatic adverse events N2 - Background: The Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) item library covers a wide range of symptoms relevant to oncology care. There is a need to select a subset of items relevant to specific patient populations to enable the implementation of PRO-CTCAE?based symptom monitoring in clinical practice. Objective: The aim of this study is to develop a PRO-CTCAE?based subset relevant to patients with lung cancer that can be used for monitoring during multidisciplinary clinical practice. Methods: The PRO-CTCAE?based subset for patients with lung cancer was generated using a mixed methods approach based on the European Organization for Research and Treatment of Cancer guidelines for developing questionnaires, comprising a literature review and semistructured interviews with both patients with lung cancer and health care practitioners (HCPs). Both patients and HCPs were queried on the relevance and impact of all PRO-CTCAE items. The results were summarized, and after a final round of expert review, a selection of clinically relevant items for patients with lung cancer was made. Results: A heterogeneous group of patients with lung cancer (n=25) from different treatment modalities and HCPs (n=22) participated in the study. A final list of eight relevant PRO-CTCAE items was created: decreased appetite, cough, shortness of breath, fatigue, constipation, nausea, sadness, and pain (general). Conclusions: On the basis of the literature and both professional and patient input, a subset of PRO-CTCAE items has been identified for use in patients with lung cancer in clinical practice. Future work is needed to confirm the validity and effectiveness of this PRO-CTCAE?based lung cancer subset internationally and in real-world clinical practice settings. UR - https://cancer.jmir.org/2021/3/e26574 UR - http://dx.doi.org/10.2196/26574 UR - http://www.ncbi.nlm.nih.gov/pubmed/34519658 ID - info:doi/10.2196/26574 ER - TY - JOUR AU - Denis, Fabrice AU - Krakowski, Ivan PY - 2021/9/9 TI - How Should Oncologists Choose an Electronic Patient-Reported Outcome System for Remote Monitoring of Patients With Cancer? JO - J Med Internet Res SP - e30549 VL - 23 IS - 9 KW - ePRO KW - cancer KW - remote monitoring KW - quality KW - effectiveness KW - security KW - digital monitoring KW - digital health KW - cancer patients KW - patients with cancer KW - oncology UR - https://www.jmir.org/2021/9/e30549 UR - http://dx.doi.org/10.2196/30549 UR - http://www.ncbi.nlm.nih.gov/pubmed/34499046 ID - info:doi/10.2196/30549 ER - TY - JOUR AU - Vellinga, Akke AU - Farrell, Karen AU - Fallon, Roisin AU - Hare, Daniel AU - Sutton-Fitzpatrick, Una AU - Cormican, Martin PY - 2021/9/3 TI - Presentation, Treatment, and Natural Course of Severe Symptoms of Urinary Tract Infections Measured by a Smartphone App: Observational and Feasibility Study JO - J Med Internet Res SP - e25364 VL - 23 IS - 9 KW - urinary tract infections KW - general practice KW - smartphone application KW - mobile phone N2 - Background: Urinary tract infections (UTIs) are one of the most common conditions in women. Current information on the presentation, management, and natural course of the infection is based on paper diaries filled out and subsequently posted by patients. Objective: The aim of this study is to explore the feasibility of a smartphone app to assess the natural course and management of UTIs. Methods: A smartphone app was developed to collect data from study participants presenting with symptoms of UTI in general practice. After initial demographic and treatment information, symptom severity was recorded by the patient after a reminder on their smartphone, which occurred twice daily for a period of 7 days or until symptom resolution. Results: A total of 181 women aged 18-76 years downloaded the smartphone app. The duration of symptoms was determined from the results of 178 participants. All patients submitted a urine sample, most patients were prescribed an antibiotic (163/181, 90.1%), and 38.7% (70/181) of the patients had a positive culture. Moderately bad or worse symptoms lasted a mean of 3.8 (SD 3.2; median 4) days, and 70.2% (125/178) of the patients indicated that they were cured on day 4 after consultation. This compares with other research assessing symptom duration and management of UTIs using paper diaries. Patients were very positive about the usability of the smartphone app and often found the reminders supportive. On the basis of the feedback and the analysis of the data, some suggestions for improvement were made. Conclusions: Smartphone diaries for symptom scores over the course of infections are an efficient and acceptable means of collecting data in research. UR - https://www.jmir.org/2021/9/e25364 UR - http://dx.doi.org/10.2196/25364 UR - http://www.ncbi.nlm.nih.gov/pubmed/34477567 ID - info:doi/10.2196/25364 ER - TY - JOUR AU - Skovlund, Eik Sřren AU - Nicolucci, Antonio AU - Balk-Mřller, Nina AU - Berthelsen, B. Dorthe AU - Glümer, Charlotte AU - Perrild, Hans AU - Kjćr, Pernille AU - Nřrgaard, Mellergaard Lise AU - Troelsen, Havbćk Lise AU - Pietraszek, Anna AU - Hessler, Danielle AU - Kaplan, Sherrie AU - Ejskjćr, Niels PY - 2021/9/3 TI - Perceived Benefits, Barriers, and Facilitators of a Digital Patient-Reported Outcomes Tool for Routine Diabetes Care: Protocol for a National, Multicenter, Mixed Methods Implementation Study JO - JMIR Res Protoc SP - e28391 VL - 10 IS - 9 KW - diabetes KW - type 1 diabetes KW - type 2 diabetes KW - multisector care KW - digital health KW - patient-reported outcomes KW - patient-centered care KW - internet-administered KW - feasibility KW - mixed-method research KW - mobile phone N2 - Background: There is growing evidence that digital patient-reported outcome (PRO) questionnaires and PRO-based decision support tools may help improve the active engagement of people with diabetes in self-care, thereby improving the quality of care. However, many barriers still exist for the real-world effectiveness and implementation of such PRO tools in routine care. Furthermore, limited research has evaluated the acceptability, feasibility, and benefits of such tools across different health care settings. Objective: This study aims to evaluate the acceptability, feasibility, and perceived benefits of the Danish digital PRO diabetes tool in different health care settings in Denmark and to determine the factors affecting its implementation. Furthermore, the study evaluates the psychometric characteristics of the Danish PRO Diabetes Questionnaire and the validity of the scoring algorithms for dialogue support. The objective of this study is to guide the ongoing optimization of the PRO diabetes tool, its implementation, and the design of future randomized controlled effectiveness studies. Methods: We designed a multicenter, mixed methods, single-arm acceptability-feasibility implementation study protocol to contribute to the real-world pilot test of a new digital PRO diabetes tool in routine diabetes care. The use of the tool involves two main steps. First, the people with diabetes will complete a digital PRO Diabetes Questionnaire in the days before a routine diabetes visit. Second, the health care professional (HCP) will use a digital PRO tool to review the PRO results together with the people with diabetes during the visit. The PRO diabetes tool is designed to encourage and support people to take an active role for the people with diabetes in their own care and to expedite the delivery of person-centered, collaborative, and coordinated care. Results: A multicenter pilot study protocol and psychometrically designed digital data collection tools for evaluation were developed and deployed as part of a national evaluation of a new digital PRO diabetes intervention. A total of 598 people with diabetes and 34 HCPs completed the study protocol by April 1, 2021. Conclusions: A large-scale, mixed methods, multicenter study for evaluating the use of the nationally developed PRO Diabetes Questionnaire in routine care across all health care sectors in Denmark by using the RE-AIM (Reach, Efficacy, Adoption, Implementation and Maintenance) model as a framework has been designed and is ongoing. This study is expected to provide new important and detailed information about the real-world acceptability, perceived relevance, and benefits of the PRO diabetes tool among a large heterogeneous population of people with diabetes in Denmark and HCPs in different care settings. The results will be used to further improve the PRO tool, design implementation facilitation support strategies, and design future controlled effectiveness studies. International Registered Report Identifier (IRRID): DERR1-10.2196/28391 UR - https://www.researchprotocols.org/2021/9/e28391 UR - http://dx.doi.org/10.2196/28391 UR - http://www.ncbi.nlm.nih.gov/pubmed/34477563 ID - info:doi/10.2196/28391 ER - TY - JOUR AU - Arutyunov, P. Gregory AU - Arutyunov, G. Alexander AU - Ageev, T. Fail AU - Fofanova, V. Tatiana PY - 2021/8/30 TI - Digital Technology Tools to Examine Patient Adherence to a Prescription-Only Omega-3 Polyunsaturated Fatty Acid Therapy To Mitigate Cardiovascular Risk: Protocol for a Prospective Observational Study and Preliminary Demographic Analysis JO - JMIR Res Protoc SP - e29061 VL - 10 IS - 8 KW - omega-3-acid ethyl esters KW - myocardial infarction KW - hypertriglyceridemia KW - adherence KW - compliance KW - persistence KW - mHealth KW - eHealth KW - patient-reported outcomes N2 - Background: Sustained adherence and persistence with prescription medications is considered essential to achieve maximal treatment benefit for patients with major chronic, noncommunicable diseases such as hyperlipidemia and lipid-associated cardiovascular disease. It is widely documented, however, that many patients with these conditions have poor long-term adherence to their treatments. The population of Russia is affected by poor adherence in the same ways as populations elsewhere and continues to have high rates of cardiovascular disease. Objective: The purpose of this study was to examine patient adherence to a prescription-only preparation of highly purified omega-3 polyunsaturated fatty acids (1.2 to 1 eicosapentaenoic acid to docosahexaenoic ratio, 90% purity) in a large sample of patients at risk for cardiovascular diseases using digital technology to monitor patient behavior and as an outreach facility for patient education and engagement. Methods: We conducted a 6-month prospective observational study (DIAPAsOn) at >100 centers in the Russian Federation. A bespoke electronic data capture and patient engagement system were developed with a well-established Russian technology supplier that enables information obtained during clinic visits to be supplemented by remote patient self-reporting. Other aspects of the program included raising patients' awareness about their condition via educational materials available in personal patient accounts in the electronic system. Results: From an initial cohort of 3000 patients, a safety population of 2572 patients (age: mean 60 years) with an equal proportion of men and women has been characterized. There was widespread concomitant cardiovascular pathology and commensurate use of multiple classes of cardiovascular medication, notably lipid-modifying and antihypertensive drugs. The program was completed by 1975 patients, of whom 780 were prescribed highly purified omega-3 polyunsaturated fatty acid supplements for secondary prevention after myocardial infarction and 1195 were prescribed highly purified omega-3 polyunsaturated fatty acid supplements for hypertriglyceridemia. Data collection and analysis have been completed. Conclusions: DIAPAsOn will provide insights into patient adherence with prescription-grade omega-3 polyunsaturated fatty acid therapy and perspectives on the role of mobile technology in monitoring and encouraging adherence to therapy. UR - https://www.researchprotocols.org/2021/8/e29061 UR - http://dx.doi.org/10.2196/29061 UR - http://www.ncbi.nlm.nih.gov/pubmed/34459746 ID - info:doi/10.2196/29061 ER - TY - JOUR AU - Beatty, L. Alexis AU - Peyser, D. Noah AU - Butcher, E. Xochitl AU - Carton, W. Thomas AU - Olgin, E. Jeffrey AU - Pletcher, J. Mark AU - Marcus, M. Gregory PY - 2021/8/30 TI - The COVID-19 Citizen Science Study: Protocol for a Longitudinal Digital Health Cohort Study JO - JMIR Res Protoc SP - e28169 VL - 10 IS - 8 KW - COVID-19 KW - digital technology KW - participant engagement KW - electronic health records KW - mobile app KW - mHealth KW - digital health N2 - Background: The COVID-19 pandemic has catalyzed a global public response and innovation in clinical study methods. Objective: The COVID-19 Citizen Science study was designed to generate knowledge about participant-reported COVID-19 symptoms, behaviors, and disease occurrence. Methods: COVID-19 Citizen Science is a longitudinal cohort study launched on March 26, 2020, on the Eureka Research Platform. This study illustrates important advances in digital clinical studies, including entirely digital study participation, targeted recruitment strategies, electronic consent, recurrent and time-updated assessments, integration with smartphone-based measurements, analytics for recruitment and engagement, connection with partner studies, novel engagement strategies such as participant-proposed questions, and feedback in the form of real-time results to participants. Results: As of February 2021, the study has enrolled over 50,000 participants. Study enrollment and participation are ongoing. Over the lifetime of the study, an average of 59% of participants have completed at least one survey in the past 4 weeks. Conclusions: Insights about COVID-19 symptoms, behaviors, and disease occurrence can be drawn through digital clinical studies. Continued innovation in digital clinical study methods represents the future of clinical research. International Registered Report Identifier (IRRID): DERR1-10.2196/28169 UR - https://www.researchprotocols.org/2021/8/e28169 UR - http://dx.doi.org/10.2196/28169 UR - http://www.ncbi.nlm.nih.gov/pubmed/34310336 ID - info:doi/10.2196/28169 ER - TY - JOUR AU - Teni, Sebsibe Fitsum AU - Rolfson, Ola AU - Devlin, Nancy AU - Parkin, David AU - Nauclér, Emma AU - Burström, Kristina AU - PY - 2021/8/27 TI - Variations in Patients? Overall Assessment of Their Health Across and Within Disease Groups Using the EQ-5D Questionnaire: Protocol for a Longitudinal Study in the Swedish National Quality Registers JO - JMIR Res Protoc SP - e27669 VL - 10 IS - 8 KW - EQ-5D KW - EQ VAS KW - experience-based values KW - health-related quality of life (HRQoL) KW - hypothetical values KW - patient values KW - Swedish National Quality Registers KW - health state valuation N2 - Background: EQ-5D is one of the most commonly used questionnaires to measure health-related quality of life. It is included in many of the Swedish National Quality Registers (NQRs). EQ-5D health states are usually summarized using ?values? obtained from members of the general public, a majority of whom are healthy. However, an alternative, which remains to be studied in detail, is the potential to use patients? self-reported overall health on the visual analog scale (VAS) as a means of capturing experience-based perspective. Objective: The aim of this study is to assess EQ VAS as a valuation method with an experience-based perspective through comparison of its performance across and within patient groups, and with that of the general population in Sweden. Methods: Data on nearly 700,000 patients from 12 NQRs covering a variety of diseases/conditions and nearly 50,000 individuals from the general population will be analyzed. The EQ-5D-3L data from the 12 registers and EQ-5D-5L data from 2 registers will be used in the analyses. Longitudinal studies of patient-reported outcomes among different patient groups will be conducted in the period from baseline to 1-year follow-up. Descriptive statistics and analyses comparing EQ-5D dimensions and observed self-assessed EQ VAS values across and within patient groups will be performed. Comparisons of the change in health state and observed EQ VAS values at 1-year follow-up will also be undertaken. Regression models will be used to assess whether EQ-5D dimensions predict observed EQ VAS values to investigate patient value sets in each patient group. These will be compared across the patient groups and with the existing Swedish experience-based VAS and time trade-off value sets obtained from the general population. Results: Data retrieval started in May 2019 and data of patients in the 12 NQRs and from the survey conducted among the general population have been retrieved. Data analysis is ongoing on the retrieved data. Conclusions: This research project will provide information on the differences across and within patient groups in terms of self-reported health status through EQ VAS and comparison with the general population. The findings of the study will contribute to the literature by exploring the potential of self-assessed EQ VAS values to develop value sets using an experience-based perspective. Trial Registration: ClinicalTrials.gov NCT04359628; https://clinicaltrials.gov/ct2/show/NCT04359628. International Registered Report Identifier (IRRID): DERR1-10.2196/27669 UR - https://www.researchprotocols.org/2021/8/e27669 UR - http://dx.doi.org/10.2196/27669 UR - http://www.ncbi.nlm.nih.gov/pubmed/34448726 ID - info:doi/10.2196/27669 ER - TY - JOUR AU - Wee, Ling Priscilla Jia AU - Kwan, Heng Yu AU - Loh, Fang Dionne Hui AU - Phang, Kie Jie AU - Puar, H. Troy AU - Řstbye, Truls AU - Thumboo, Julian AU - Yoon, Sungwon AU - Low, Leng Lian PY - 2021/8/13 TI - Measurement Properties of Patient-Reported Outcome Measures for Diabetes: Systematic Review JO - J Med Internet Res SP - e25002 VL - 23 IS - 8 KW - systematic review KW - measurement properties KW - patient-reported outcome measures KW - methodological quality KW - level of evidence KW - PROMs KW - patient reported outcome KW - diabetes N2 - Background: The management of diabetes is complex. There is growing recognition of the use of patient-reported outcome measures (PROMs) as a standardized method of obtaining an outlook on patients? functional status and well-being. However, no systematic reviews have summarized the studies that investigate the measurement properties of diabetes PROMs. Objective: Our aims were to conduct a systematic review of studies investigating the measurement properties of diabetes PROMs by evaluating the methodological quality and overall level of evidence of these PROMs and to categorize them based on the outcome measures assessed. Methods: This study was guided by the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) guidelines. Relevant articles were retrieved from the Embase, PubMed, and PsychINFO databases. The PROMs were evaluated with the COSMIN (COnsensus-based Standards for the selection of health Measurement Instruments) guidelines. Results: A total of 363 articles evaluating the measurement properties of PROMs for diabetes in the adult population were identified, of which 238 unique PROMs from 248 studies reported in 209 articles were validated in the type 2 diabetes population. PROMs with at least a moderate level of evidence for ?5 of 9 measurement properties include the Chinese version of the Personal Diabetes Questionnaire (C-PDQ), Diabetes Self-Management Instrument Short Form (DSMI-20), and Insulin Treatment Appraisal Scale in Hong Kong primary care patients (C-ITAS-HK), of which the C-PDQ has a ?sufficient (+)? rating for >4 measurement properties. A total of 43 PROMs meet the COSMIN guidelines for recommendation for use. Conclusions: This study identified and synthesized evidence for the measurement properties of 238 unique PROMs for patients with type 2 diabetes and categorized the PROMs according to their outcome measures. These findings may assist clinicians and researchers in selecting appropriate high-quality PROMs for clinical practice and research. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42020180978; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020180978. UR - https://www.jmir.org/2021/8/e25002 UR - http://dx.doi.org/10.2196/25002 UR - http://www.ncbi.nlm.nih.gov/pubmed/34397387 ID - info:doi/10.2196/25002 ER - TY - JOUR AU - Sivanandan, Ananth Mayuran AU - Sharma, Catherine AU - Bullard, Pippa AU - Christian, Judith PY - 2021/8/13 TI - Digital Patient-Reported Outcome Measures for Monitoring of Patients on Cancer Treatment: Cross-sectional Questionnaire Study JO - JMIR Form Res SP - e18502 VL - 5 IS - 8 KW - patient-reported outcome measures KW - patient-reported outcomes KW - remote monitoring KW - toxicity KW - outpatients KW - digital technology KW - digital health KW - mobile health KW - oncology KW - chemotherapy KW - immunotherapy KW - radiotherapy N2 - Background: Oncology has been facing increasing outpatient activity associated with higher cancer incidence, better survival rates, and more treatment options. Innovative technological solutions could help deal with this increasing demand. Using digital patient-reported outcome measures (PROMs) to identify patients who need a face-to-face (FTF) appointment is a potential approach. Objective: This study aims to assess the feasibility of digital PROM questionnaires to enable remote symptom monitoring for patients undergoing cancer treatment and their ability to highlight the requirement for an FTF appointment. Methods: This study was performed at a tertiary oncology center between December 2018 and February 2019. The Common Terminology Criteria for Adverse Events were adapted into patient-friendly language to form the basis of treatment-specific digital questionnaires covering specific cancer drugs and radiotherapy treatments. These treatment-specific digital PROM questionnaires were scored by both patients and their clinicians during FTF appointments. Patients and clinicians did not see each other?s scored PROMs. Agreement between patients and clinicians was assessed using descriptive statistics. Patient and staff feedback was also obtained. Results: In total, 90 patients participated in the study across 10 different treatment pathways. By comparing paired patient and clinician responses, the sensitivity of the patient-completed questionnaires in correctly highlighting the need for FTF review was 94% (44/47), and all patients with severe or grade 3+ symptoms were identified (6/6, 100%). Patient-completed PROMs appropriately revealed that 29% (26/90) of the participating patients did not need FTF review based on their symptoms alone. Certain oncological treatment pathways, such as immunotherapy, were found to have a larger proportion of patients with minimal symptoms than others, such as conventional chemotherapy. Patient and staff feedback showed high approval of digital PROMs and their potential for use in remote monitoring. Conclusions: Digital PROM questionnaires can feasibly highlight the need for FTF review in oncology clinics for treatment. Their use with specific treatments could safely reduce the requirement for FTF care, and future work should evaluate their application in the remote monitoring of patients. UR - https://formative.jmir.org/2021/8/e18502 UR - http://dx.doi.org/10.2196/18502 UR - http://www.ncbi.nlm.nih.gov/pubmed/34398785 ID - info:doi/10.2196/18502 ER - TY - JOUR AU - Trojan, Andreas AU - Leuthold, Nicolas AU - Thomssen, Christoph AU - Rody, Achim AU - Winder, Thomas AU - Jakob, Andreas AU - Egger, Claudine AU - Held, Ulrike AU - Jackisch, Christian PY - 2021/8/5 TI - The Effect of Collaborative Reviews of Electronic Patient-Reported Outcomes on the Congruence of Patient- and Clinician-Reported Toxicity in Cancer Patients Receiving Systemic Therapy: Prospective, Multicenter, Observational Clinical Trial JO - J Med Internet Res SP - e29271 VL - 23 IS - 8 KW - cancer KW - consilium KW - app KW - eHealth KW - ePRO KW - CTCAE KW - congruency KW - patient-reported KW - symptoms N2 - Background: Electronic patient-reported outcomes (ePRO) are a relatively novel form of data and have the potential to improve clinical practice for cancer patients. In this prospective, multicenter, observational clinical trial, efforts were made to demonstrate the reliability of patient-reported symptoms. Objective: The primary objective of this study was to assess the level of agreement ? between symptom ratings by physicians and patients via a shared review process in order to determine the future reliability and utility of self-reported electronic symptom monitoring. Methods: Patients receiving systemic therapy in a (neo-)adjuvant or noncurative intention setting captured ePRO for 52 symptoms over an observational period of 90 days. At 3-week intervals, randomly selected symptoms were reviewed between the patient and physician for congruency on severity of the grading of adverse events according to the Common Terminology Criteria of Adverse Events (CTCAE). The patient-physician agreement for the symptom review was assessed via Cohen kappa (?), through which the interrater reliability was calculated. Chi-square tests were used to determine whether the patient-reported outcome was different among symptoms, types of cancer, demographics, and physicians? experience. Results: Among the 181 patients (158 women and 23 men; median age 54.4 years), there was a fair scoring agreement (?=0.24; 95% CI 0.16-0.33) for symptoms that were entered 2 to 4 weeks before the intended review (first rating) and a moderate agreement (?=0.41; 95% CI 0.34-0.48) for symptoms that were entered within 1 week of the intended review (second rating). However, the level of agreement increased from moderate (first rating, ?=0.43) to substantial (second rating, ?=0.68) for common symptoms of pain, fever, diarrhea, obstipation, nausea, vomiting, and stomatitis. Similar congruency levels of ratings were found for the most frequently entered symptoms (first rating: ?=0.42; second rating: ?=0.65). The symptom with the lowest agreement was hair loss (?=?0.05). With regard to the latency of symptom entry into the review, hardly any difference was demonstrated between symptoms that were entered from days 1 to 3 and from days 4 to 7 before the intended review (?=0.40 vs ?=0.39, respectively). In contrast, for symptoms that were entered 15 to 21 days before the intended review, no congruency was demonstrated (?=?0.15). Congruency levels seemed to be unrelated to the type of cancer, demographics, and physicians? review experience. Conclusions: The shared monitoring and review of symptoms between patients and clinicians has the potential to improve the understanding of patient self-reporting. Our data indicate that the integration of ePRO into oncological clinical research and continuous clinical practice provides reliable information for self-empowerment and the timely intervention of symptoms. Trial Registration: ClinicalTrials.gov NCT03578731; https://clinicaltrials.gov/ct2/show/NCT03578731 UR - https://www.jmir.org/2021/8/e29271 UR - http://dx.doi.org/10.2196/29271 UR - http://www.ncbi.nlm.nih.gov/pubmed/34383675 ID - info:doi/10.2196/29271 ER - TY - JOUR AU - Herrmann, Susan AU - Power, Brad AU - Rashidi, Amineh AU - Cypher, Mark AU - Mastaglia, Frank AU - Grace, Amy AU - McKinnon, Elizabeth AU - Sarrot, Pierre AU - Michau, Christophe AU - Skinner, Matthew AU - Desai, Renae AU - Duracinsky, Martin PY - 2021/7/30 TI - Supporting Patient-Clinician Interaction in Chronic HIV Care: Design and Development of a Patient-Reported Outcomes Software Application JO - J Med Internet Res SP - e27861 VL - 23 IS - 7 KW - physician-patient communication KW - eHealth KW - primary care KW - ambulatory care KW - information systems KW - user-centered design KW - user context KW - patient reported outcomes KW - qualitative research KW - health care KW - HIV care KW - mobile phone N2 - Background: The consideration of health-related quality of life (HRQL) is a hallmark of best practice in HIV care. Information technology offers an opportunity to more closely engage patients with chronic HIV infection in their long-term management and support a focus on HRQL. However, the implementation of patient-reported outcome (PRO) measures, such as HRQL in routine care, is challenged by the need to synthesize data generated by questionnaires, the complexity of collecting data between patient visits, and the integration of results into clinical decision-making processes. Objective: Our aim is to design and pilot-test a multimedia software platform to overcome these challenges and provide a vehicle to increase focus on HRQL issues in HIV management. Methods: A multidisciplinary team in France and Australia conducted the study with 120 patients and 16 doctors contributing to the design and development of the software. We used agile development principles, user-centered design, and qualitative research methods to develop and pilot the software platform. We developed a prototype application to determine the acceptability of the software and piloted the final version with 41 Australian and 19 French residents using 2 validated electronic questionnaires, the Depression, Anxiety and Stress Scale-21 Items, and the Patient Reported Outcomes Quality of Life-HIV. Results: Testing of the prototype demonstrated that patients wanted an application that was intuitive and without excessive instruction, so it felt effortless to use, as well as secure and discreet. Clinicians wanted the PRO data synthesized, presented clearly and succinctly, and clinically actionable. Safety concerns for patients and clinicians included confidentiality, and the potential for breakdown in communication if insufficient user training was not provided. The final product, piloted with patients from both countries, showed that most respondents found the application easy to use and comprehend. The usability testing survey administered found that older Australians had reduced scores for understanding the visual interface (P=.004) and finding the buttons organized (P=.02). Three-fourths of the respondents were concerned with confidentiality (P=.007), and this result was more prevalent in participants with higher anxiety and stress scores (P=.01), as measured by the Depression, Anxiety and Stress Scale-21 Items. These statistical associations were not observed in 15 French patients who completed the same questionnaire. Conclusions: Digital applications in health care should be safe and fit for purpose. Our software was acceptable to patients and shows potential to overcome some barriers to the implementation of PROs in routine care. The design of the clinicians? interface presents a solution to the problem of voluminous data, both synthesizing and providing a snapshot of longitudinal data. The next stage is to conduct a randomized controlled trial to determine whether patients experience increased satisfaction with care and whether doctors perceive that they deliver better clinical care without compromising efficiency. UR - https://www.jmir.org/2021/7/e27861 UR - http://dx.doi.org/10.2196/27861 UR - http://www.ncbi.nlm.nih.gov/pubmed/34328442 ID - info:doi/10.2196/27861 ER - TY - JOUR AU - Harrison, J. Conrad AU - Sidey-Gibbons, J. Chris AU - Klassen, F. Anne AU - Wong Riff, Y. Karen W. AU - Furniss, Dominic AU - Swan, C. Marc AU - Rodrigues, N. Jeremy PY - 2021/7/30 TI - Recursive Partitioning vs Computerized Adaptive Testing to Reduce the Burden of Health Assessments in Cleft Lip and/or Palate: Comparative Simulation Study JO - J Med Internet Res SP - e26412 VL - 23 IS - 7 KW - cleft Lip KW - cleft palate KW - patient-reported outcome measures KW - outcome assessment KW - CLEFT-Q KW - computerized adaptive test KW - machine learning KW - decision tree KW - regression tree N2 - Background: Computerized adaptive testing (CAT) has been shown to deliver short, accurate, and personalized versions of the CLEFT-Q patient-reported outcome measure for children and young adults born with a cleft lip and/or palate. Decision trees may integrate clinician-reported data (eg, age, gender, cleft type, and planned treatments) to make these assessments even shorter and more accurate. Objective: We aimed to create decision tree models incorporating clinician-reported data into adaptive CLEFT-Q assessments and compare their accuracy to traditional CAT models. Methods: We used relevant clinician-reported data and patient-reported item responses from the CLEFT-Q field test to train and test decision tree models using recursive partitioning. We compared the prediction accuracy of decision trees to CAT assessments of similar length. Participant scores from the full-length questionnaire were used as ground truth. Accuracy was assessed through Pearson?s correlation coefficient of predicted and ground truth scores, mean absolute error, root mean squared error, and a two-tailed Wilcoxon signed-rank test comparing squared error. Results: Decision trees demonstrated poorer accuracy than CAT comparators and generally made data splits based on item responses rather than clinician-reported data. Conclusions: When predicting CLEFT-Q scores, individual item responses are generally more informative than clinician-reported data. Decision trees that make binary splits are at risk of underfitting polytomous patient-reported outcome measure data and demonstrated poorer performance than CATs in this study. UR - https://www.jmir.org/2021/7/e26412 UR - http://dx.doi.org/10.2196/26412 UR - http://www.ncbi.nlm.nih.gov/pubmed/34328443 ID - info:doi/10.2196/26412 ER - TY - JOUR AU - Skov Schacksen, Cathrine AU - Dyrvig, Anne-Kirstine AU - Henneberg, Celina Nanna AU - Dam Gade, Josefine AU - Spindler, Helle AU - Refsgaard, Jens AU - Hollingdal, Malene AU - Dittman, Lars AU - Dremstrup, Kim AU - Dinesen, Birthe PY - 2021/7/2 TI - Patient-Reported Outcomes From Patients With Heart Failure Participating in the Future Patient Telerehabilitation Program: Data From the Intervention Arm of a Randomized Controlled Trial JO - JMIR Cardio SP - e26544 VL - 5 IS - 2 KW - adherence KW - cardiology KW - cardiomyopathy KW - compliance KW - heart failure KW - heart KW - Kansas City Cardiomyopathy Questionnaire KW - monitoring KW - patient-reported outcome KW - patients KW - quality of life KW - rehabilitation KW - self-reporting KW - telehealth KW - telemonitoring N2 - Background: More than 37 million people worldwide have been diagnosed with heart failure, which is a growing burden on the health sector. Cardiac rehabilitation aims to improve patients? recovery, functional capacity, psychosocial well-being, and health-related quality of life. However, cardiac rehabilitation programs have poor compliance and adherence. Telerehabilitation may be a solution to overcome some of these challenges to cardiac rehabilitation by making it more individualized. As part of the Future Patient Telerehabilitation program, a digital toolbox aimed at enabling patients with heart failure to monitor and evaluate their own current status has been developed and tested using data from a patient-reported outcome questionnaire that the patient filled in every alternate week for 1 year. Objective: The aim of this study is to evaluate the changes in quality of life and well-being among patients with heart failure, who are participants in the Future Patient Telerehabilitation program over the course of 1 year. Methods: In total, 140 patients were enrolled in the Future Patient Telerehabilitation program and randomized into either the telerehabilitation group (n=70) or the control group (n=70). Of the 70 patients in the telerehabilitation group, 56 (80.0%) answered the patient-reported outcome questionnaire and completed the program, and these 56 patients comprised the study population. The patient-reported outcomes consisted of three components: (1) questions regarding the patients? sleep patterns assessed using the Spiegel Sleep Questionnaire; (2) measurements of physical limitations, symptoms, self-efficacy, social interaction, and quality of life assessed using the Kansas City Cardiomyopathy Questionnaire in 10 dimensions; and (3) 5 additional questions regarding psychological well-being that were developed by the research group. Results: The changes in scores during 1 year of the study were examined using 1-sample Wilcoxon signed-rank tests. There were significant differences in the scores for most of the slopes of the scores from the dimensions of the Kansas City Cardiomyopathy Questionnaire (P<.05). Conclusions: There was a significant increase in clinical and social well-being and quality of life during the 1-year period of participating in a telerehabilitation program. These results suggest that patient-reported outcome questionnaires may be used as a tool for patients in a telerehabilitation program that can both monitor and guide patients in mastering their own symptoms. Trial Registration: ClinicalTrials.gov NCT03388918; https://clinicaltrials.gov/ct2/show/NCT03388918 UR - https://cardio.jmir.org/2021/2/e26544 UR - http://dx.doi.org/10.2196/26544 UR - http://www.ncbi.nlm.nih.gov/pubmed/34255642 ID - info:doi/10.2196/26544 ER - TY - JOUR AU - Afrashtehfar, Ian Kelvin AU - Bryant, Ross Stephen PY - 2021/6/18 TI - Understanding the Lived Experience of North American Dental Patients With a Single-Tooth Implant in the Upper Front Region of the Mouth: Protocol for a Qualitative Study JO - JMIR Res Protoc SP - e25767 VL - 10 IS - 6 KW - esthetic dentistry KW - esthetics KW - implant dentistry KW - patient perception KW - patient-reported outcome measures KW - personal satisfaction KW - phenomenology KW - single-tooth dental implants KW - single-unit implant-supported restoration N2 - Background: Assessment of the subjective experiences of individuals with maxillary anterior (ie, the upper front region of the mouth) single-tooth implants is limited mainly to quantitative measurements of satisfaction with appearance. Interestingly, there is unexplained variability in the relationship between satisfaction and appearance. Objective: This qualitative study protocol aims to explore and better understand the satisfaction with appearance and function in a Canadian population with maxillary anterior single-tooth implants treated at a postgraduate university clinic. Thus, we aim to obtain diversity among participants relating to the identification of esthetically pleasing and displeasing cases from a clinician perspective. Methods: A qualitative research design using interpretative phenomenology analysis (IPA) will provide an adaptable inductive research approach. The participants will be recruited, and consent documents, photographs, digital intraoral scans, and self-administered questionnaire responses will be obtained from them. The transcribed verbatim data from audio-recorded, in-depth, semistructured, one-to-one interviews of the participants will be managed, coded, and analyzed thematically with computer-assisted qualitative data analysis software. The IPA will consider the COnsolidated criteria for REporting Qualitative (COREQ) guidelines when applicable. Results: For the qualitative interview, we plan to include at least eight patients to conduct up to 1.5 hours of open-ended interviews with each participant aided by an interview guide. Ethical approval was granted by the University of British Columbia Behavioral Research Ethics Board (H19-00107) in May 2019. Two American dental foundations funded this study. Conclusions: The analysis in this study will elucidate the aspects (including their value) that influence participant satisfaction at different dental implant treatment stages. This will be the first qualitative study on this group of the population to explore and obtain a better understanding of their satisfaction with appearance and function, as well as any other patient-reported outcome measures that could be identified. International Registered Report Identifier (IRRID): DERR1-10.2196/25767 UR - https://www.researchprotocols.org/2021/6/e25767 UR - http://dx.doi.org/10.2196/25767 UR - http://www.ncbi.nlm.nih.gov/pubmed/33886491 ID - info:doi/10.2196/25767 ER - TY - JOUR AU - Williams, Hants AU - Steinberg, Sarah AU - Berzin, Robin PY - 2021/6/11 TI - The Development of a Digital Patient-Reported Outcome Measurement for Adults With Chronic Disease (The Parsley Symptom Index): Prospective Cohort Study JO - JMIR Form Res SP - e29122 VL - 5 IS - 6 KW - patient-reported outcomes KW - PROMs KW - chronic diseases KW - symptom management KW - Parsley Symptom Index KW - Review of Symptoms N2 - Background: The monitoring and management of chronic illness has always been a challenge. Patient-reported outcome measures (PROMs) can be powerful tools for monitoring symptoms and guiding treatment of chronic diseases, but the available PROM tools are either too broad or too disease specific for the needs of a primary care practice focused on longitudinal care. Objective: In this study we describe the development and preliminary validation of the Parsley Symptom Index (PSI). Methods: This prospective cohort study took place from January 5, 2018, to June 05, 2020, among a sample of 4621 adult patients at Parsley Health. After a review of literature, followed by binning and winnowing of potential items, a 45-item PROM that also served as a review of systems (ROS) was developed. The PSI was deployed and completed by patients via an online portal. Construct and face validity was performed by clinicians, tested on patients, and feasibility was measured by response rate, completion rate, and percentage of missing data. Results: The response rate for 12,175 collected PSIs was 93.72% (4331/4621) with a 100% item completion rate. A confirmatory factor analysis confirmed the model structure was satisfactory by a Comparative Fit Index of 0.943, Tucker?Lewis index of 0.938, and root mean square error of approximation of 0.028. Conclusions: A 45-item ROS-style PROM designed to capture chronic disease symptoms was developed, and preliminary validation suggests that the PSI can be deployed, completed, and helpful to both patients and clinicians. UR - https://formative.jmir.org/2021/6/e29122 UR - http://dx.doi.org/10.2196/29122 UR - http://www.ncbi.nlm.nih.gov/pubmed/33999007 ID - info:doi/10.2196/29122 ER - TY - JOUR AU - Lehmann, Jens AU - Buhl, Petra AU - Giesinger, M. Johannes AU - Wintner, M. Lisa AU - Sztankay, Monika AU - Neppl, Lucia AU - Willenbacher, Wolfgang AU - Weger, Roman AU - Weyrer, Walpurga AU - Rumpold, Gerhard AU - Holzner, Bernhard PY - 2021/6/8 TI - Using the Computer-based Health Evaluation System (CHES) to Support Self-management of Symptoms and Functional Health: Evaluation of Hematological Patient Use of a Web-Based Patient Portal JO - J Med Internet Res SP - e26022 VL - 23 IS - 6 KW - quality of life KW - monitoring KW - patient portals KW - multiple myeloma KW - chronic lymphocytic leukemia KW - patient-reported outcome measures KW - eHealth KW - mHealth N2 - Background: Patient portals offer the possibility to assess patient-reported outcome measures (PROMs) remotely, and first evidence has demonstrated their potential benefits. Objective: In this study, we evaluated patient use of a web-based patient portal that provides patient information and allows online completion of PROMs. A particular focus was on patient motivation for (not) using the portal. The portal was developed to supplement routine monitoring at the Department of Internal Medicine V in Innsbruck. Methods: We included patients with multiple myeloma and chronic lymphocytic leukemia who were already participating in routine monitoring at the hospital for use of the patient portal. Patients were introduced to the portal and asked to complete questionnaires prior to their next hospital visits. We used system access logs and 3 consecutive semistructured interviews to analyze patient use and evaluation of the portal. Results: Between July 2017 and August 2020, we approached 122 patients for participation in the study, of whom 83.6% (102/122) consented to use the patient portal. Patients were on average 60 (SD 10.4) years old. Of patients providing data at all study time points, 37% (26/71) consistently used the portal prior to their hospital visits. The main reason for not completing PROMs was forgetting to do so in between visits (25/84, 29%). During an average session, patients viewed 5.3 different pages and spent 9.4 minutes logged on to the portal. Feedback from interviews was largely positive with no patients reporting difficulties navigating the survey and 50% of patients valuing the self-management tools provided in the portal. Regarding the portal content, patients were interested in reviewing their own results and reported high satisfaction with the dynamic self-management advice, also reflected in the high number of clicks on those pages. Conclusions: Patient portals can contribute to patient empowerment by offering sought-after information and self-management advice. In our study, the majority of our patients were open to using the portal. The low number of technical complaints and average time spent in the portal demonstrate the feasibility of our patient portal. While initial interest was high, long-term use was considerably lower and identified as the main area for improvement. In a next step, we will improve several aspects of the patient portal (eg, including a reminder to visit the portal before the next appointment and closer PROM symptom monitoring via an onconurse). UR - https://www.jmir.org/2021/6/e26022 UR - http://dx.doi.org/10.2196/26022 UR - http://www.ncbi.nlm.nih.gov/pubmed/34100765 ID - info:doi/10.2196/26022 ER - TY - JOUR AU - Siddiqui, Ayat AU - Ladak, Akbar Laila AU - Kazi, Momin Abdul AU - Kaleem, Sidra AU - Akbar, Fizza AU - Kirmani, Salman PY - 2021/6/3 TI - Assessing Health-Related Quality of Life, Morbidity, and Survival Status for Individuals With Down Syndrome in Pakistan (DS-Pak): Protocol for a Web-Based Collaborative Registry JO - JMIR Res Protoc SP - e24901 VL - 10 IS - 6 KW - Down syndrome KW - registry KW - web-based registry KW - health-related quality of life KW - lower-middle income country KW - mobile health KW - patient-reported outcome N2 - Background: Down syndrome is the most common chromosomal disorder, with a global incidence of 1 in 700 live births. However, the true prevalence, associated morbidities, and health-related quality of life (HRQOL) of these individuals and their families are not well documented, especially in low- and middle-income countries such as Pakistan. Disease-specific documentation in the form of a collaborative registry is required to better understand this condition and the associated health outcomes. This protocol paper describes the aims and processes for developing the first comprehensive, web-based collaborative registry for Down syndrome in a Pakistani cohort. Objective: This study aims to assess the HRQOL, long-term survival, and morbidity of individuals with Down syndrome by using a web-based collaborative registry. Methods: The registry data collection will be conducted at the Aga Khan University Hospital and at the Karachi Down Syndrome Program. Data will be collected by in-person interviews or virtually via telephone or video interviews. Participants of any age and sex with Down syndrome (trisomy 21) will be recruited. After receiving informed consent and assent, a series of tablet-based questionnaires will be administered. The questionnaires aim to assess the sociodemographic background, clinical status, and HRQOL of the participants and their families. Data will be uploaded to a secure cloud server to allow for real-time access to participant responses by the clinicians to plan prompt interventions. Patient safety and confidentiality will be maintained by using multilayer encryption and unique coded patient identifiers. The collected data will be analyzed using IBM SPSS Statistics for Windows, Version 22.0 (IBM Corporation), with the mean and SD of continuous variables being reported. Categorical variables will be analyzed with their percentages being reported and with a P value cutoff of .05. Multivariate regression analysis will be conducted to identify predictors related to the HRQOL in patients with Down syndrome. Survival analysis will be reported using the Kaplan-Meier survival curves. Results: The web-based questionnaire is currently being finalized before the commencement of pilot testing. This project has not received funding at the moment (ethical review committee approval reference ID: 2020-3582-11145). Conclusions: This registry will allow for a comprehensive understanding of Down syndrome in low- and middle-income countries. This can provide the opportunity for data-informed interventions, which are tailored to the specific needs of this patient population and their families. Although this web-based registry is a proof of concept, it has the potential to be expanded to national, regional, and international levels. International Registered Report Identifier (IRRID): PRR1-10.2196/24901 UR - https://www.researchprotocols.org/2021/6/e24901 UR - http://dx.doi.org/10.2196/24901 UR - http://www.ncbi.nlm.nih.gov/pubmed/34081014 ID - info:doi/10.2196/24901 ER - TY - JOUR AU - Efficace, Fabio AU - Breccia, Massimo AU - Fazi, Paola AU - Cottone, Francesco AU - Holzner, Bernhard AU - Vignetti, Marco PY - 2021/6/1 TI - The GIMEMA-ALLIANCE Digital Health Platform for Patients With Hematologic Malignancies in the COVID-19 Pandemic and Postpandemic Era: Protocol for a Multicenter, Prospective, Observational Study JO - JMIR Res Protoc SP - e25271 VL - 10 IS - 6 KW - digital health KW - hematology KW - leukemia KW - lymphoma KW - multiple myeloma KW - patient-reported outcomes KW - quality of life KW - symptoms KW - COVID-19 N2 - Background: The COVID-19 pandemic has raised unprecedented challenges in the management of patients with cancer and has increased the demands for digital health tools that, for example, could facilitate remote monitoring of patients. Based on this, the Gruppo Italiano Malattie Ematologiche dell?Adulto (GIMEMA) has recently developed a digital health tool dedicated to patients with hematologic malignancies: the GIMEMA-ALLIANCE platform. Objective: The main objectives of this web-based platform are to generate relevant data to better understand quality of life, symptoms, and medication adherence during the COVID-19 pandemic and postpandemic era; to develop a prospective real-life registry on outcomes of patients with hematologic cancer, with or without a diagnosis of COVID-19; and to facilitate patient-centered care in routine practice. Methods: The platform consists of physician- and patient-secure portals and enables electronic patient-reported outcome (ePRO) assessments with real-time graphical presentation to physicians of individual patient symptoms and quality-of-life outcomes. Automated alerts are sent to treating hematologists based on the following predetermined criteria: presence of clinically important problems and symptoms, problems with adherence to therapy, and risk of COVID-19 diagnosis. The platform also allows physicians to set up video consultations. Clinical information regarding disease and treatment as well as clinical and survival outcomes are also prospectively collected. Results: Recruitment of participants started in December 2020. As of April 2021, a total of 116 patients have been enrolled in this study. Use of this platform may help to improve patient-physician communication and help hematologists in the early recognition of clinically important problems and symptoms of their patients. More than 20 community and university-based hospitals have currently agreed to participate. In addition to patient-reported outcome data, the prospective collection of disease- and treatment-related information, as well as data on possible COVID-19 diagnosis and COVID-19 vaccination, will allow the development of a large database to also identify subgroups of patients at risk of poor outcomes. Conclusions: Data generated via this platform will help to answer clinically relevant questions for patients with hematologic malignancies during the COVID-19 pandemic and postpandemic era. The use of the GIMEMA-ALLIANCE platform in routine practice may also contribute to enhancing patient-centered care. Trial Registration: ClinicalTrials.gov NCT04581187; https://clinicaltrials.gov/ct2/show/NCT04581187 International Registered Report Identifier (IRRID): PRR1-10.2196/25271 UR - https://www.researchprotocols.org/2021/6/e25271 UR - http://dx.doi.org/10.2196/25271 UR - http://www.ncbi.nlm.nih.gov/pubmed/33890580 ID - info:doi/10.2196/25271 ER - TY - JOUR AU - Kleinert, Stefan AU - Bartz-Bazzanella, Peter AU - von der Decken, Cay AU - Knitza, Johannes AU - Witte, Torsten AU - Fekete, P. Sándor AU - Konitzny, Matthias AU - Zink, Alexander AU - Gauler, Georg AU - Wurth, Patrick AU - Aries, Peer AU - Karberg, Kirsten AU - Kuhn, Christoph AU - Schuch, Florian AU - Späthling-Mestekemper, Susanna AU - Vorbrüggen, Wolfgang AU - Englbrecht, Matthias AU - Welcker, Martin AU - PY - 2021/5/20 TI - A Real-World Rheumatology Registry and Research Consortium: The German RheumaDatenRhePort (RHADAR) Registry JO - J Med Internet Res SP - e28164 VL - 23 IS - 5 KW - registry KW - rheumatology KW - real-world data KW - symptom checker KW - patient-reported outcomes UR - https://www.jmir.org/2021/5/e28164 UR - http://dx.doi.org/10.2196/28164 UR - http://www.ncbi.nlm.nih.gov/pubmed/34014170 ID - info:doi/10.2196/28164 ER - TY - JOUR AU - Hawley, Steve AU - Yu, Joanna AU - Bogetic, Nikola AU - Potapova, Natalia AU - Wakefield, Chris AU - Thompson, Mike AU - Kloiber, Stefan AU - Hill, Sean AU - Jankowicz, Damian AU - Rotenberg, David PY - 2021/5/20 TI - Digitization of Measurement-Based Care Pathways in Mental Health Through REDCap and Electronic Health Record Integration: Development and Usability Study JO - J Med Internet Res SP - e25656 VL - 23 IS - 5 KW - REDCap KW - electronic health record KW - systems integration KW - measurement-based care KW - hospital information systems N2 - Background: The delivery of standardized self-report assessments is essential for measurement-based care in mental health. Paper-based methods of measurement-based care data collection may result in transcription errors, missing data, and other data quality issues when entered into patient electronic health records (EHRs). Objective: This study aims to help address these issues by using a dedicated instance of REDCap (Research Electronic Data Capture; Vanderbilt University)?a free, widely used electronic data capture platform?that was established to enable the deployment of digitized self-assessments in clinical care pathways to inform clinical decision making. Methods: REDCap was integrated with the primary clinical information system to facilitate the real-time transfer of discrete data and PDF reports from REDCap into the EHR. Both technical and administrative components were required for complete implementation. A technology acceptance survey was also administered to capture physicians? and clinicians? attitudes toward the new system. Results: The integration of REDCap with the EHR transitioned clinical workflows from paper-based methods of data collection to electronic data collection. This resulted in significant time savings, improved data quality, and valuable real-time information delivery. The digitization of self-report assessments at each appointment contributed to the clinic-wide implementation of the major depressive disorder integrated care pathway. This digital transformation facilitated a 4-fold increase in the physician adoption of this integrated care pathway workflow and a 3-fold increase in patient enrollment, resulting in an overall significant increase in major depressive disorder integrated care pathway capacity. Physicians? and clinicians? attitudes were overall positive, with almost all respondents agreeing that the system was useful to their work. Conclusions: REDCap provided an intuitive patient interface for collecting self-report measures and accessing results in real time to inform clinical decisions and an extensible backend for system integration. The approach scaled effectively and expanded to high-impact clinics throughout the hospital, allowing for the broad deployment of complex workflows and standardized assessments, which led to the accumulation of harmonized data across clinics and care pathways. REDCap is a flexible tool that can be effectively leveraged to facilitate the automatic transfer of self-report data to the EHR; however, thoughtful governance is required to complement the technical implementation to ensure that data standardization, data quality, patient safety, and privacy are maintained. UR - https://www.jmir.org/2021/5/e25656 UR - http://dx.doi.org/10.2196/25656 UR - http://www.ncbi.nlm.nih.gov/pubmed/34014169 ID - info:doi/10.2196/25656 ER - TY - JOUR AU - Mogle, Jacqueline AU - Hill, L. Nikki AU - Turner, R. Jennifer PY - 2021/5/14 TI - Individual Differences and Features of Self-reported Memory Lapses as Risk Factors for Alzheimer Disease Among Adults Aged 50 Years and Older: Protocol for a Coordinated Analysis Across Two Longitudinal Data Sets JO - JMIR Res Protoc SP - e25233 VL - 10 IS - 5 KW - subjective memory KW - individual differences KW - Alzheimer disease KW - daily assessment KW - multilevel modeling KW - coordinated analysis KW - mobile phone N2 - Background: Increasing evidence has promoted the clinical utility of self-reported memory problems for detecting early impairment associated with Alzheimer disease (AD). However, previous studies investigating memory problems often conflated the types of problems (ie, retrospective and prospective) with their features (ie, frequency and consequences). This bias limits the specificity of traditional measures of memory problems and minimizes their ability to detect differential trajectories associated with cognitive decline. In this study, we use a novel measure of self-reported memory problems that uses daily reports of memory lapses to disentangle types from features for analyzing the impact of each dimension in two longitudinal data sets. Furthermore, this study explores the individual difference factors of age and gender as potential moderators of the relationships between self-reported memory lapses and objective cognitive decline. Objective: The aim of this study is to describe the protocol for a secondary data analysis project that explores the relationship between experiences of daily memory lapses and their associations with cognitive decline in middle-aged and older adults. Methods: This study uses multilevel, coordinated analyses across two measurement burst data sets to examine the links between features and consequences of memory lapses (retrospective and prospective) and their association with objective cognitive decline. This study?s sample (N=392; aged 50-85 years; n=254, 64.8% women) is drawn from two ongoing, nationally funded research studies: The Effects of Stress on Cognitive Aging, Physiology, and Emotion study and the Einstein Aging Study. Both studies assess the daily experience of memory lapses, including the type as well as the emotional and functional outcomes, and objective measures of cognition, such as processing speed and episodic memory. We will use multilevel modeling to test our conceptual model demonstrating that differences in frequency and types of memory lapses show differential trends in their relationships with cognitive decline and that these relationships vary by the age and gender of participants. Results: This project was funded in August 2019. The approval for secondary data analysis was given by the institutional review board in February 2020. Data analysis for this project has not yet started. Conclusions: The early and accurate identification of individuals most at risk for cognitive decline is of paramount importance. Previous research exploring self-reported memory problems and AD is promising; however, limitations in measurement may explain previous reports of inconsistences. This study addresses these concerns by examining daily reports of memory lapses, how these vary by age and gender, and their relationship with objective cognitive performance. Overall, this study aims to identify the key features of daily memory lapses and the differential trajectories that best predict cognitive decline to help inform future AD risk screening tools. International Registered Report Identifier (IRRID): DERR1-10.2196/25233 UR - https://www.researchprotocols.org/2021/5/e25233 UR - http://dx.doi.org/10.2196/25233 UR - http://www.ncbi.nlm.nih.gov/pubmed/33988514 ID - info:doi/10.2196/25233 ER - TY - JOUR AU - Prioleau, Temiloluwa PY - 2021/5/11 TI - Learning From the Experiences of COVID-19 Survivors: Web-Based Survey Study JO - JMIR Form Res SP - e23009 VL - 5 IS - 5 KW - patient-reported outcomes KW - coronavirus KW - COVID-19 KW - outcome KW - crowdsourcing KW - social media KW - internet KW - survivor KW - experience N2 - Background: There are still many unanswered questions about the novel coronavirus; however, a largely underutilized source of knowledge is the millions of people who have recovered after contracting the virus. This includes a majority of undocumented cases of COVID-19, which were classified as mild or moderate and received little to no clinical care during the course of illness. Objective: This study aims to document and glean insights from the experiences of individuals with a first-hand experience in dealing with COVID-19, especially the so-called mild-to-moderate cases that self-resolved while in isolation. Methods: This web-based survey study called C19 Insider Scoop recruited adult participants aged 18 years or older who reside in the United States and had tested positive for COVID-19 or antibodies. Participants were recruited through various methods, including online support groups for COVID-19 survivors, advertisement in local news outlets, as well as through professional and other networks. The main outcomes measured in this study included knowledge of contraction or transmission of the virus, symptoms, and personal experiences on the road to recovery. Results: A total of 72 participants (female, n=53; male, n=19; age range: 18-73 years; mean age: 41 [SD 14] years) from 22 US states were enrolled in this study. The top known source of how people contracted SARS-CoV-2, the virus known to cause COVID-19, was through a family or household member (26/72, 35%). This was followed by essential workers contracting the virus through the workplace (13/72, 18%). Participants reported up to 27 less-documented symptoms that they experienced during their illness, such as brain or memory fog, palpitations, ear pain or discomfort, and neurological problems. In addition, 47 of 72 (65%) participants reported that their symptoms lasted longer than the commonly cited 2-week period even for mild cases of COVID-19. The mean recovery time of the study participants was 4.5 weeks, and exactly one-half of participants (50%) still experienced lingering symptoms of COVID-19 after an average of 65 days following illness onset. Additionally, 37 (51%) participants reported that they experienced stigma associated with contracting COVID-19. Conclusions: This study presents preliminary findings suggesting that emphasis on family or household spread of COVID-19 may be lacking and that there is a general underestimation of the recovery time even for mild cases of illness with the virus. Although a larger study is needed to validate these results, it is important to note that as more people experience COVID-19, insights from COVID-19 survivors can enable a more informed public, pave the way for others who may be affected by the virus, and guide further research. UR - https://formative.jmir.org/2021/5/e23009 UR - http://dx.doi.org/10.2196/23009 UR - http://www.ncbi.nlm.nih.gov/pubmed/33878012 ID - info:doi/10.2196/23009 ER - TY - JOUR AU - Altmann, Patrick AU - Hinterberger, Werner AU - Leutmezer, Fritz AU - Ponleitner, Markus AU - Monschein, Tobias AU - Zrzavy, Tobias AU - Zulehner, Gudrun AU - Kornek, Barbara AU - Lanzenberger, Rupert AU - Berek, Klaus AU - Rommer, Stefan Paulus AU - Berger, Thomas AU - Bsteh, Gabriel PY - 2021/5/7 TI - The Smartphone App haMSter for Tracking Patient-Reported Outcomes in People With Multiple Sclerosis: Protocol for a Pilot Study JO - JMIR Res Protoc SP - e25011 VL - 10 IS - 5 KW - mHealth KW - mobile health KW - remote monitoring KW - patient-reported outcomes KW - multiple sclerosis KW - telemedicine N2 - Background: Treatment and monitoring decisions in people with multiple sclerosis (MS) are based commonly on clinician-reported outcomes. These reflect physical and radiological disease activity and are the most relevant endpoints in clinical trials. Over the past few years, the number of studies evaluating so-called patient-reported outcomes (PROs) has been increasing. PROs are reports from patients concerning their own health perception. They are typically obtained by means of questionnaires and aim to quantify symptoms such as fatigue, depression, and sexual dysfunction. The emergence of PROs has made a tremendous contribution to understanding the individual impact of disease in people with MS and their health-related quality of life. However, the assessment of PROs consumes resources, including time and personnel. Thus, useful ways to conveniently introduce PROs into clinical practice are needed. Objective: We aim to provide a rationale and pilot study protocol for a mobile health (mHealth) solution named ?haMSter? that allows for remote monitoring of PROs in people with MS. Methods: The core function of haMSter is to provide three scientifically validated PRO questionnaires relevant to MS for patients to fill out at home once a month. Thereby, longitudinal and remote documentation of PROs is enabled. A scoring algorithm graphically plots PRO scores over time and makes them available at the next visit. Results: The pilot study is currently ongoing and will evaluate adherence to this mHealth solution in 50 patients over a period of 6 months. Results from the haMSter pilot study are expected in 2021. Conclusions: haMSter is a novel mHealth-based solution for modern PRO research, which may constitute the first step in achieving the ability to integrate PROs in clinical practice. This allows for a more problem-oriented approach in monitoring visits, which addresses patient needs and ultimately saves time. Trial Registration: ClinicalTrials.gov NCT04555863; https://clinicaltrials.gov/ct2/show/NCT04555863 International Registered Report Identifier (IRRID): DERR1-10.2196/25011 UR - https://www.researchprotocols.org/2021/5/e25011 UR - http://dx.doi.org/10.2196/25011 UR - http://www.ncbi.nlm.nih.gov/pubmed/33960949 ID - info:doi/10.2196/25011 ER - TY - JOUR AU - Peltola, Kristiina Maria AU - Poikonen-Saksela, Paula AU - Mattson, Johanna AU - Parkkari, Timo PY - 2021/5/6 TI - A Novel Digital Patient-Reported Outcome Platform (Noona) for Clinical Use in Patients With Cancer: Pilot Study Assessing Suitability JO - JMIR Form Res SP - e16156 VL - 5 IS - 5 KW - electronic patient-reported outcome KW - adverse events KW - patients with cancer N2 - Background: As the incidence of cancer is on the rise, there is a need to develop modern communication tools between patients and the medical personnel. Electronic patient-reported outcome (ePRO) measures increase the safety of cancer treatments and may have an impact on treatment outcome as well. ePRO may also provide a cost-efficient way to organize follow-up for patients with cancer. Noona is an internet-based system for patients to self-report symptoms and adverse events of cancer treatments from home via a computer or a smart device (eg, smartphone, tablet). Objective: In this pilot study, we assessed the suitability of a novel ePRO application (Noona) for patients with cancer, nurses, and doctors at the Helsinki University Hospital, Finland. Methods: The study included 44 patients with cancer (different solid tumor types) and 17 health care professionals (nurses or medical doctors). Patients were either operated or received systemic treatment or radiotherapy. Patients reported their symptoms to the medical staff via Noona. In addition, patients and clinicians answered a questionnaire, based on which Noona?s suitability for clinical use was evaluated in terms of usability (ease of use, operability, and learnability), reliability (subjective opinion of the participant), and incidence of harmful events reported by the participants. Results: A total of 41/44 (93%) patients and 15/17 (88%) professionals reported that the program was easy or quite easy to use; 38/44 (86%) patients and 11/17 (65%) professionals found Noona reliable, and 38/44 (86%) patients and 10/17 (59%) professionals would recommend Noona to other patients or their colleagues. No harmful incidences caused by the use of Noona were reported by the patients; however, 1 harmful incidence was reported by one of the professionals. Conclusions: The majority of the participants felt that Noona appeared reliable and it was easy to use. Noona seems to be a useful tool for monitoring patient?s symptoms during cancer therapy. Future studies will determine the impact of this ePRO platform in routine clinical practice. UR - https://formative.jmir.org/2021/5/e16156 UR - http://dx.doi.org/10.2196/16156 UR - http://www.ncbi.nlm.nih.gov/pubmed/33955841 ID - info:doi/10.2196/16156 ER - TY - JOUR AU - Hall, J. Natalie AU - Berry, K. Sameer AU - Aguilar, Jack AU - Brier, Elizabeth AU - Shah, Parth AU - Cheng, Derek AU - Herman, Jeremy AU - Stein, Theodore AU - Spiegel, R. Brennan M. AU - Almario, V. Christopher PY - 2021/5/4 TI - Impact of an Online Gastrointestinal Symptom History Taker on Physician Documentation and Charting Time: Pragmatic Controlled Trial JO - JMIR Form Res SP - e23599 VL - 5 IS - 5 KW - patient-provider portal KW - computer-generated patient history KW - patient-reported outcome KW - gastrointestinal KW - EHR N2 - Background: A potential benefit of electronic health records (EHRs) is that they could potentially save clinician time and improve documentation by auto-generating the history of present illness (HPI) in partnership with patients prior to the clinic visit. We developed an online patient portal called AEGIS (Automated Evaluation of Gastrointestinal [GI] Symptoms) that systematically collects patient GI symptom information and then transforms the data into a narrative HPI that is available for physicians to review in the EHR prior to seeing the patient. Objective: This study aimed to compare whether use of an online GI symptom history taker called AEGIS improves physician-centric outcomes vs usual care. Methods: We conducted a pragmatic controlled trial among adults aged ?18 years scheduled for a new patient visit at 4 GI clinics at an academic medical center. Patients who completed AEGIS were matched with controls in the intervention period who did not complete AEGIS as well as controls who underwent usual care in the pre-intervention period. Of note, the pre-intervention control group was formed as it was not subject to contamination bias, unlike for post-intervention controls. We then compared the following outcomes among groups: (1) documentation of alarm symptoms, (2) documentation of family history of GI malignancy, (3) number of follow-up visits in a 6-month period, (4) number of tests ordered in a 6-month period, and (5) charting time (difference between appointment time and time the encounter was closed). Multivariable regression models were used to adjust for potential confounding. Results: Of the 774 patients who were invited to complete AEGIS, 116 (15.0%) finished it prior to their visit. The 116 AEGIS patients were then matched with 343 and 102 controls in the pre- and post-intervention periods, respectively. There were no statistically significant differences among the groups for documentation of alarm symptoms and GI cancer family history, number of follow-up visits and ordered tests, or charting time (all P>.05). Conclusions: Use of a validated online HPI-generation portal did not improve physician documentation or reduce workload. Given universal adoption of EHRs, further research examining how to optimally leverage patient portals for improving outcomes are needed. UR - https://formative.jmir.org/2021/5/e23599 UR - http://dx.doi.org/10.2196/23599 UR - http://www.ncbi.nlm.nih.gov/pubmed/33944789 ID - info:doi/10.2196/23599 ER - TY - JOUR AU - Koyama, Sachiko AU - Ueha, Rumi AU - Kondo, Kenji PY - 2021/4/22 TI - Loss of Smell and Taste in Patients With Suspected COVID-19: Analyses of Patients? Reports on Social Media JO - J Med Internet Res SP - e26459 VL - 23 IS - 4 KW - COVID-19 KW - anosmia KW - ageusia KW - free reports on social media KW - symptomatic KW - asymptomatic KW - recovery of senses KW - symptom KW - social media KW - smell KW - taste KW - senses KW - patient-reported KW - benefit KW - limit KW - diagnosis N2 - Background: The year 2020 was the year of the global COVID-19 pandemic. The severity of the situation has become so substantial that many or even most of the patients with mild to moderate symptoms had to self-isolate without specific medical treatments or even without being tested for COVID-19. Many patients joined internet membership groups to exchange information and support each other. Objective: Our goal is to determine the benefits and limits of using social media to understand the symptoms of patients with suspected COVID-19 with mild to moderate symptoms and, in particular, their symptoms of anosmia (loss of the sense of smell) and ageusia (loss of the sense of taste). The voluntary reports on an internet website of a membership group will be the platform of the analyses. Methods: Posts and comments of members of an internet group known as COVID-19 Smell and Taste Loss, founded on March 24, 2020, to support patients with suspected COVID-19 were collected and analyzed daily. Demographic data were collected using the software mechanism called Group Insights on the membership group website. Results: Membership groups on social media have become rare sources of support for patients with suspected COVID-19 with mild to moderate symptoms. These groups provided mental support to their members and became resources for information on COVID-19 tests and medicines or supplements. However, the membership was voluntary, and often the members leave without notification. It is hard to be precise from the free voluntary reports. The number of women in the group (6995/9227, 75.38% as of October 12, 2020) was about three times more than men (2272/9227, 24.62% as of October 12, 2020), and the peak age of members was between 20-40 years in both men and women. Patients who were asymptomatic other than the senses comprised 14.93% (53/355) of the total patients. Recovery of the senses was higher in the patients who were asymptomatic besides having anosmia and ageusia. Most (112/123, 91.06%) patients experienced other symptoms first and then lost their senses, on average, 4.2 days later. Patients without other symptoms tended to recover earlier (P=.02). Patients with anosmia and ageusia occasionally reported distorted smell and taste (parosmia and dysgeusia) as well as experiencing or perceiving the smell and taste without the sources of the smell or taste (phantosmia and phantogeusia). Conclusions: Our analysis of the social media database of suspected COVID-19 patients? voices demonstrated that, although accurate diagnosis of patients is not always obtained with social media?based analyses, it may be a useful tool to collect a large amount of data on symptoms and the clinical course of worldwide rapidly growing infectious diseases. UR - https://www.jmir.org/2021/4/e26459 UR - http://dx.doi.org/10.2196/26459 UR - http://www.ncbi.nlm.nih.gov/pubmed/33788699 ID - info:doi/10.2196/26459 ER - TY - JOUR AU - van Noort, J. Esther M. AU - Claessens, Danny AU - Moor, C. Catharina AU - Berg, Den Carlijn A. L. Van AU - Kasteleyn, J. Marise AU - in 't Veen, M. Johannes C. C. AU - Van Schayck, P. Onno C. AU - Chavannes, H. Niels PY - 2021/3/31 TI - Online Tool for the Assessment of the Burden of COVID-19 in Patients: Development Study JO - JMIR Form Res SP - e22603 VL - 5 IS - 3 KW - COVID-19 KW - patient-reported outcomes KW - ABCoV tool KW - monitoring KW - patient outcome KW - long-term impact KW - tool KW - assessment KW - online patient platform N2 - Background: The impact of COVID-19 has been felt worldwide, yet we are still unsure about its full impact. One of the gaps in our current knowledge relates to the long-term mental and physical impact of the infection on affected individuals. The COVID-19 pandemic hit the Netherlands at the end of February 2020, resulting in over 900,000 people testing positive for the virus, over 24,000 hospitalizations, and over 13,000 deaths by the end of January 2021. Although many patients recover from the acute phase of the disease, experience with other virus outbreaks has raised concerns regarding possible late sequelae of the infection. Objective: This study aims to develop an online tool to assess the long-term burden of COVID-19 in patients. Methods: In this paper, we describe the process of development, assessment, programming, implementation, and use of this new tool: the assessment of burden of COVID-19 (ABCoV) tool. This new tool is based on the well-validated assessment of burden of chronic obstructive pulmonary disease tool. Results: As of January 2021, the new ABCoV tool has been used in an online patient platform by more than 2100 self-registered patients and another 400 patients in a hospital setting, resulting in over 2500 patients. These patients have submitted the ABCoV questionnaire 3926 times. Among the self-registered patients who agreed to have their data analyzed (n=1898), the number of females was high (n=1153, 60.7%), many were medically diagnosed with COVID-19 (n=892, 47.0%), and many were relatively young with only 7.4% (n=141) being older than 60 years. Of all patients that actually used the tool (n=1517), almost one-quarter (n=356, 23.5%) used the tool twice, and only a small group (n=76, 5.0%) used the tool 6 times. Conclusions: This new ABCoV tool has been broadly and repeatedly used, and may provide insight into the perceived burden of disease, provide direction for personalized aftercare for people post COVID-19, and help us to be prepared for possible future recurrences. UR - https://formative.jmir.org/2021/3/e22603 UR - http://dx.doi.org/10.2196/22603 UR - http://www.ncbi.nlm.nih.gov/pubmed/33729982 ID - info:doi/10.2196/22603 ER - TY - JOUR AU - Teckie, Sewit AU - Solomon, Jeffrey AU - Kadapa, Karthik AU - Sanchez, Keisy AU - Orner, David AU - Kraus, Dennis AU - Kamdar, P. Dev AU - Pereira, Lucio AU - Frank, Douglas AU - Diefenbach, Michael PY - 2021/3/19 TI - A Mobile Patient-Facing App for Tracking Patient-Reported Outcomes in Head and Neck Cancer Survivors: Single-Arm Feasibility Study JO - JMIR Form Res SP - e24667 VL - 5 IS - 3 KW - mHealth KW - ePROs KW - head and neck cancer KW - mobile phone N2 - Background: Patients with head and neck cancer (HNC) frequently experience disease-related symptoms and treatment adverse effects that impact their overall quality of life. Cancer-specific mobile health apps for patient-related outcomes allow patients to communicate with their clinicians and proactively track their symptoms, which have been shown to improve clinical management and disease outcomes. Objective: The purpose of this study was to evaluate the feasibility of LogPAL, a novel iPhone-based mobile health app designed to help HNC survivors track and manage their posttreatment symptoms. Methods: Patients who completed curative treatment for HNC in the preceding 24 months were recruited from 2 clinical sites within a single institution. Upon enrollment, participants completed a brief sociodemographic survey, downloaded the app onto their iPhone devices, and were asked to complete a series of biweekly questionnaires (based on the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) via the app for an 8-week study period. The primary feasibility endpoints included retention (retaining >80% of the enrolled participants for the duration of the study period), adherence (>50% of the participants completing 100% of the questionnaires over the study period), and usability (a mean system usability scale [SUS] score >68). Additional postintervention questions were collected to assess perceived usefulness, acceptance, and overall satisfaction. Results: Between January and October 2019, 38 participants were enrolled in the study. Three participants dropped out, and 3 were classified as nonusers. The remaining 32 (87%) were eligible for analysis. Their mean age was 57.8 (SD 12.3) years (range 24-77 years, 81% [26/32] male). Overall, 375 of 512 (73.2%) questionnaires were completed, with 17 (53%) of the 32 participants adherent. Participant-reported usability was acceptable; the mean SUS score was 71.9 (95% CI 64.3-79.5) with high satisfaction of LogPAL usefulness and likelihood to recommend to other cancer survivors. Conclusions: This single-arm prospective pilot study showed that LogPAL is a feasible, regularly used, accepted app for HNC survivors, justifying a full-scale pilot. Based on the findings from this study, future iterations will aim to improve usability and test intervention efficacy. UR - https://formative.jmir.org/2021/3/e24667 UR - http://dx.doi.org/10.2196/24667 UR - http://www.ncbi.nlm.nih.gov/pubmed/33739291 ID - info:doi/10.2196/24667 ER - TY - JOUR AU - Trojan, Andreas AU - Bättig, Basil AU - Mannhart, Meinrad AU - Seifert, Burkhardt AU - Brauchbar, N. Mathis AU - Egbring, Marco PY - 2021/3/17 TI - Effect of Collaborative Review of Electronic Patient-Reported Outcomes for Shared Reporting in Breast Cancer Patients: Descriptive Comparative Study JO - JMIR Cancer SP - e26950 VL - 7 IS - 1 KW - cancer KW - Consilium Care KW - smartphone app KW - eHealth KW - electronic patient-reported outcomes KW - Common Terminology Criteria for Adverse Events N2 - Background: Digital monitoring of treatment-related symptoms and self-reported patient outcomes is important for the quality of care among cancer patients. As mobile devices are ubiquitous nowadays, the collection of electronic patient-reported outcomes (ePROs) is gaining momentum. So far, data are lacking on the modalities that contribute to the quantity and quality of ePROs. Objective: The objective of our study was to compare the utilization of two versions of a subsequently employed mobile app for electronic monitoring of PROs and to test our hypothesis that a shared review of symptoms in patient-physician collaboration has an impact on the number of data entries. Methods: The Consilium Care app engages cancer patients to standardize reporting of well-being and treatment-related symptoms in outpatient settings. For descriptive comparison of the utilization of two slightly different app versions, data were obtained from an early breast cancer trial (version 1 of the app, n=86) and an ongoing study including patients with advanced disease (version 2 of the app, n=106). In both app versions, patients and doctors were allowed to share the information from data entries during consultations. Version 2 of the app, however, randomly selected symptoms that required a detailed and shared regular patient-doctor review in order to focus on the collection and appropriate interpretation regarding awareness and guidance for severity grading. The numbers and types of symptom entries, satisfaction with both app versions, and patients? perceived effects during consultations were included for analysis. Results: Symptom severity grading was performed according to the Common Terminology Criteria for Adverse Events (CTCAE) using a horizontal slider and was indicated in descriptive terminology in both apps, while a graphical display facilitated the illustration of symptom history charts. In total, 192 patients electronically reported 11,437 data entries on well-being and 33,380 data entries on individual symptoms. Overall, 628 (of 872 intended) requested patient-doctor symptom reviews were performed in version 2 of the app. Both the amount of data entries per patient and day for well-being (version 1 vs version 2: 0.3 vs 1.0; P<.001) and symptoms (version 1 vs version 2: 1.3 vs 1.9; P=.04) appeared significantly increased in version 2 of the app. Overall satisfaction with both app versions was high, although version 2 of the app was perceived to be more helpful in general. Conclusions: Version 2 of the app showed much better results than version 1 of the app. A request for collaborative patient-doctor symptom review is likely to affect the number of digital symptom data entries. This app shows high potential to improve the patient-doctor experience. Trial Registration: ClinicalTrials.gov NCT02004496; https://clinicaltrials.gov/ct2/show/NCT02004496 and ClinicalTrials.gov NCT03578731; https://clinicaltrials.gov/ct2/show/NCT03578731 UR - https://cancer.jmir.org/2021/1/e26950 UR - http://dx.doi.org/10.2196/26950 UR - http://www.ncbi.nlm.nih.gov/pubmed/33729162 ID - info:doi/10.2196/26950 ER - TY - JOUR AU - Cho, Youmin AU - Zhang, Huiting AU - Harris, Ruth Marcelline AU - Gong, Yang AU - Smith, Lavoie Ellen AU - Jiang, Yun PY - 2021/3/12 TI - Acceptance and Use of Home-Based Electronic Symptom Self-Reporting Systems in Patients With Cancer: Systematic Review JO - J Med Internet Res SP - e24638 VL - 23 IS - 3 KW - symptom KW - self report KW - telemedicine KW - technology KW - internet KW - mobile phone KW - patient preference KW - cancer KW - patient-reported outcomes N2 - Background: Electronic symptom self-reporting systems (e-SRS) have been shown to improve symptoms and survival in patients with cancer. However, patient engagement in using e-SRS for voluntary symptom self-reporting is less optimal. Multiple factors can potentially affect patients? acceptance and engagement in using home-based e-SRS. However, such factors have not been fully explored in cancer populations. Objective: The aim of this study is to understand the acceptance and use of home-based e-SRS by patients with cancer and identify associated facilitators and barriers. Methods: PubMed, CINAHL, Scopus, and PsycINFO (January 2010 to March 2020) were searched using a combination of Medical Subject Headings (MeSH) terms and keywords such as symptom self-reporting, electronic/technology, cancer, and their synonyms. Included studies focused on the use of home-based e-SRS by patients with cancer and their families. Studies on patients? use of e-SRS in clinical settings only were excluded. Of the 3740 papers retrieved, 33 were included in the final review. Factors associated with patient acceptance and use of e-SRS were extracted and synthesized. Results: Most e-SRS were web based (22/33, 66%) or mobile app based (9/33, 27%). The e-SRS initial acceptance, represented by patient enrollment rates, ranged from 40% (22/55) to 100% (100/100). High e-SRS acceptance was rated by 69% (59/85) to 77.6% (337/434) of the patients after they used the system. The e-SRS use, measured by patients? response rates to questionnaires (ranging from 1596/3521, 45.33% to 92%) or system log-on rates (ranging from 4/12, 33% to 99/100, 99%), declined over time in general patterns. Few studies (n=7) reported e-SRS use beyond 6 months, with the response rates ranging from 62% (40/64) to 85.1% (541/636) and the log-on rates ranging from 63.6% (103/162) to 77% (49/64). The availability of compatible devices and technical support, interactive system features, information accessibility, privacy, questionnaire quality, patient physical/psychosocial status, and age were associated with patient acceptance and use of home-based e-SRS. Conclusions: Acceptance and use of home-based e-SRS by patients with cancer varied significantly across studies, as assessed by a variety of approaches. The lack of access to technology has remained a barrier to e-SRS adoption. Interactive system features and personalized questionnaires may increase patient engagement. More studies are needed to further understand patients? long-term use of home-based e-SRS behavior patterns to develop personalized interventions to support symptom self-management and self-reporting of patients with cancer for optimal health outcomes. UR - https://www.jmir.org/2021/3/e24638 UR - http://dx.doi.org/10.2196/24638 UR - http://www.ncbi.nlm.nih.gov/pubmed/33709929 ID - info:doi/10.2196/24638 ER - TY - JOUR AU - White, M. Katie AU - Ivan, Alina AU - Williams, Ruth AU - Galloway, B. James AU - Norton, Sam AU - Matcham, Faith PY - 2021/3/9 TI - Remote Measurement in Rheumatoid Arthritis: Qualitative Analysis of Patient Perspectives JO - JMIR Form Res SP - e22473 VL - 5 IS - 3 KW - rheumatoid arthritis KW - remote measurement technologies KW - symptom assessment KW - disease management KW - smartphone KW - qualitative research KW - mobile phone N2 - Background: Rheumatoid arthritis (RA) is characterized by recurrent fluctuations in symptoms such as joint pain, swelling, and stiffness. Remote measurement technologies (RMTs) offer the opportunity to track symptoms continuously and in real time; therefore, they may provide a more accurate picture of RA disease activity as a complement to prescheduled general practitioner appointments. Previous research has shown patient interest in remote symptom tracking in RA and has provided evidence for its clinical validity. However, there is a lack of co-design in the current development of systems, and the features of RMTs that best promote optimal engagement remain unclear. Objective: This study represents the first in a series of work that aims to develop a multiparametric RMT system for symptom tracking in RA. The objective of this study is to determine the important outcomes for disease management in patients with RA and how these can be best captured via remote measurement. Methods: A total of 9 patients (aged 23-77 years; mean 55.78, SD 17.54) with RA were recruited from King?s College Hospital to participate in two semistructured focus groups. Both focus group discussions were conducted by a facilitator and a lived-experience researcher. The sessions were recorded, transcribed, independently coded, and analyzed for themes. Results: Thematic analysis identified a total of four overarching themes: important symptoms and outcomes in RA, management of RA symptoms, views on the current health care system, and views on the use of RMTs in RA. Mobility and pain were key symptoms to consider for symptom tracking as well as symptom triggers. There is a general consensus that the ability to track fluctuations and transmit such data to clinicians would aid in individual symptom management and the effectiveness of clinical care. Suggestions for visually capturing symptom fluctuations in an app were proposed. Conclusions: The findings support previous work on the acceptability of RMT with RA disease management and address key outcomes for integration into a remote monitoring system for RA self-management and clinical care. Clear recommendations for RMT design are proposed. Future work will aim to take these recommendations into a user testing phase. UR - https://formative.jmir.org/2021/3/e22473 UR - http://dx.doi.org/10.2196/22473 UR - http://www.ncbi.nlm.nih.gov/pubmed/33687333 ID - info:doi/10.2196/22473 ER - TY - JOUR AU - Ma, Jinfei AU - Zou, Zihao AU - Pazo, Eric Emmanuel AU - Moutari, Salissou AU - Liu, Ye AU - Jin, Feng PY - 2021/3/2 TI - Comparative Analysis of Paper-Based and Web-Based Versions of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (NFBSI-16) Questionnaire in Breast Cancer Patients: Randomized Crossover Study JO - JMIR Med Inform SP - e18269 VL - 9 IS - 3 KW - breast cancer KW - NFBSI-16 KW - patient-reported outcome KW - reproducibility KW - test-retest reliability KW - web-based questionnaire N2 - Background: Breast cancer remains the most common neoplasm diagnosed among women in China and globally. Health-related questionnaire assessments in research and clinical oncology settings have gained prominence. The National Comprehensive Cancer Network?Functional Assessment of Cancer Therapy?Breast Cancer Symptom Index (NFBSI-16) is a rapid and powerful tool to help evaluate disease- or treatment-related symptoms, both physical and emotional, in patients with breast cancer for clinical and research purposes. Prevalence of individual smartphones provides a potential web-based approach to administrating the questionnaire; however, the reliability of the NFBSI-16 in electronic format has not been assessed. Objective: This study aimed to assess the reliability of a web-based NFBSI-16 questionnaire in breast cancer patients undergoing systematic treatment with a prospective open-label randomized crossover study design. Methods: We recruited random patients with breast cancer under systematic treatment from the central hospital registry to complete both paper- and web-based versions of the questionnaires. Both versions of the questionnaires were self-assessed. Patients were randomly assigned to group A (paper-based first and web-based second) or group B (web-based first and paper-based second). A total of 354 patients were included in the analysis (group A: n=177, group B: n=177). Descriptive sociodemographic characteristics, reliability and agreement rates for single items, subscales, and total score were analyzed using the Wilcoxon test. The Lin concordance correlation coefficient (CCC) and Spearman and Kendall ? rank correlations were used to assess test-retest reliability. Results: Test-retest reliability measured with CCCs was 0.94 for the total NFBSI-16 score. Significant correlations (Spearman ?) were documented for all 4 subscales?Disease-Related Symptoms Subscale?Physical (?=0.93), Disease-Related Symptoms Subscale?Emotional (?=0.85), Treatment Side Effects Subscale (?=0.95), and Function and Well-Being Subscale (?=0.91)?and total NFBSI-16 score (?=0.94). Mean differences of the test and retest were all close to zero (?0.06). The parallel test-retest reliability of subscales with the Wilcoxon test comparing individual items found GP3 (item 5) to be significantly different (P=.02). A majority of the participants in this study (255/354, 72.0%) preferred the web-based over the paper-based version. Conclusions: The web-based version of the NFBSI-16 questionnaire is an excellent tool for monitoring individual breast cancer patients under treatment, with the majority of participants preferring it over the paper-based version. UR - https://medinform.jmir.org/2021/3/e18269 UR - http://dx.doi.org/10.2196/18269 UR - http://www.ncbi.nlm.nih.gov/pubmed/33650978 ID - info:doi/10.2196/18269 ER - TY - JOUR AU - Hong, Ho Taek AU - Kim, Ku Myung AU - Ryu, Jin Dong AU - Park, Sung Jun AU - Bae, Cheol Gi AU - Jeon, Sang Yoon PY - 2021/3/1 TI - The Reliability of Remote Patient-Reported Outcome Measures via Mobile Apps to Replace Outpatient Visits After Rotator Cuff Repair Surgery: Repetitive Test-Retest Comparison Study for 1-Year Follow-up JO - J Med Internet Res SP - e20989 VL - 23 IS - 3 KW - patient-reported outcome measures (PROMs) KW - location KW - remote PROMs using mobile application KW - smartphone KW - mobile phone KW - follow-up loss N2 - Background: With the development of health care?related mobile apps, attempts have been made to implement remote patient-reported outcome measures (PROMs). In order for remote PROMs to be widely used by mobile apps, the results should not be different depending on the location; that is, remote PROM results performed in locations other than hospitals should be able to obtain reliable results equivalent to those performed in hospitals, and this is very important. However, to our knowledge, there are no studies that have assessed the reliability of PROMs using mobile apps according to the location by comparing the results performed remotely from the hospital and performed at the outpatient visits. Objective: The purpose of this study was to evaluate the reliability of remote PROMs using mobile apps compared to PROMs performed during outpatient follow-up visits after arthroscopic shoulder surgery. Methods: A total of 174 patients who underwent arthroscopic rotator cuff repair completed questionnaires 2 days before visiting the clinic for the 1-, 2-, 3-, 6-, and 12-month follow-ups (test A). The patients completed the questionnaires at the clinic (test B) using the same mobile app and device for the 1-, 2-, 3-, 6-, and 12-month follow-ups. Test-retest comparisons were performed to analyze the differences and reliability of the PROMs according to the period. Results: Comparisons of tests A and B showed statistically significant differences at 1, 2, and 3 months (all Ps<.05 except for the ASES function scale at 3-months) but not 6 or 12 months after surgery (all Ps>.05). The intraclass correlation values between the two groups were relatively low at the 1-, 2-, and 3-month follow-ups but were within the reliable range at 6 and 12 months after surgery. The rate of completion of tests A and B using the mobile app was significantly lower in the group older than 70 years than in the other groups for all postoperative periods (P<.001). Conclusions: PROMs using mobile apps with different locations differed soon after surgery but were reliably similar after 6 months. The remote PROMs using mobile apps could be used reliably for the patient more than 6 months after surgery. However, it is to be expected that the use of mobile app?based questionnaires is not as useful in the group older than 70 years as in other age groups. UR - https://www.jmir.org/2021/3/e20989 UR - http://dx.doi.org/10.2196/20989 UR - http://www.ncbi.nlm.nih.gov/pubmed/33646133 ID - info:doi/10.2196/20989 ER - TY - JOUR AU - Reisner, L. Sari AU - Deutsch, B. Madeline AU - Mayer, H. Kenneth AU - Potter, Jennifer AU - Gonzalez, Alex AU - Keuroghlian, S. Alex AU - Hughto, MW Jaclyn AU - Campbell, Juwan AU - Asquith, Andrew AU - Pardee, J. Dana AU - Pletta, R. David AU - Radix, Asa PY - 2021/3/1 TI - Longitudinal Cohort Study of Gender Affirmation and HIV-Related Health in Transgender and Gender Diverse Adults: The LEGACY Project Protocol JO - JMIR Res Protoc SP - e24198 VL - 10 IS - 3 KW - cohort studies KW - transgender persons N2 - Background: Transgender and gender diverse (TGD) adults in the United States experience health disparities, especially in HIV infection. Medical gender affirmation (eg, hormone therapy and gender-affirming surgeries) is known to be medically necessary and to improve some health conditions. To our knowledge, however, no studies have assessed the effects of gender-affirming medical care on HIV-related outcomes. Objective: This study aims to evaluate the effects of medical gender affirmation on HIV-related outcomes among TGD primary care patients. Secondary objectives include characterizing mental health, quality of life, and unmet medical gender affirmation needs. Methods: LEGACY is a longitudinal, multisite, clinic-based cohort of adult TGD primary care patients from two federally qualified community health centers in the United States: Fenway Health in Boston, and Callen-Lorde Community Health Center in New York. Eligible adult TGD patients contribute electronic health record data to the LEGACY research data warehouse (RDW). Patients are also offered the option to participate in patient-reported surveys for 1 year of follow-up (baseline, 6-month, and 12-month assessments) with optional HIV and sexually transmitted infection (STI) testing. Biobehavioral data from the RDW, surveys, and biospecimen collection are linked. HIV-related clinical outcomes include pre-exposure prophylaxis uptake (patients without HIV), viral suppression (patients with HIV), and anogenital STI diagnoses (all patients). Medical gender affirmation includes hormones, surgeries, and nonhormonal and nonsurgical interventions (eg, voice therapy). Results: The contract began in April 2018. The cohort design was informed by focus groups with TGD patients (n=28) conducted between August-October 2018 and in collaboration with a community advisory board, scientific advisory board, and site-specific research support coalitions. Prospective cohort enrollment began in February 2019, with enrollment expected to continue through August 2020. As of April 2020, 7821 patients are enrolled in the LEGACY RDW and 1756 have completed a baseline survey. Participants have a median age of 29 years (IQR 11; range 18-82). More than one-third (39.7%) are racial or ethnic minorities (1070/7821, 13.68% Black; 475/7821, 6.07% multiracial; 439/7821, 5.61% Asian or Pacific Islander; 1120/7821, 14.32% other or missing) and 14.73% (1152/7821) are Hispanic or Latinx. By gender identity, participants identify as 33.79% (2643/7821) male, 37.07% (2900/7821) female, 21.74% (1700/7821) nonbinary, and 7.39% (578/7821) are unsure or have missing data. Approximately half (52.0%) of the cohort was assigned female sex at birth, and 5.4% (421/7821) are living with HIV infection. Conclusions: LEGACY is an unprecedented opportunity to evaluate the impact of medical gender affirmation on HIV-related health. The study uses a comprehensive research methodology linking TGD patient biobehavioral longitudinal data from multiple sources. Patient-centeredness and scientific rigor are assured through the ongoing engagement of TGD communities, clinicians, scientists, and site clinical staff undergirded by epidemiological methodology. Findings will inform evidence-based clinical care for TGD patients, including optimal interventions to improve HIV-related outcomes. International Registered Report Identifier (IRRID): DERR1-10.2196/24198 UR - https://www.researchprotocols.org/2021/3/e24198 UR - http://dx.doi.org/10.2196/24198 UR - http://www.ncbi.nlm.nih.gov/pubmed/33646126 ID - info:doi/10.2196/24198 ER - TY - JOUR AU - Lamprell, Klay AU - Fajardo Pulido, Diana AU - Tran, Yvonne AU - Nic Giolla Easpaig, Bróna AU - Liauw, Winston AU - Arnolda, Gaston AU - Braithwaite, Jeffrey PY - 2021/2/26 TI - Personal Accounts of Young-Onset Colorectal Cancer Organized as Patient-Reported Data: Protocol for a Mixed Methods Study JO - JMIR Res Protoc SP - e25056 VL - 10 IS - 2 KW - colorectal cancer KW - PROMs KW - young-onset cancer KW - cancer KW - patient reported outcome N2 - Background: Young-onset colorectal cancer is a contemporary issue in need of substantial research input. The incidence of colorectal cancer in adults younger than 50 years is rising in contrast to the decreasing incidence of this cancer in older adults. People with young-onset colorectal cancer may be at that stage of life in which they are establishing their careers, building relationships with long-term partners, raising children, and assembling a financial base for the future. A qualitative study designed to facilitate triangulation with extant quantitative patient-reported data would contribute the first comprehensive resource for understanding how this distinct patient population experiences health services and the outcomes of care throughout the patient pathway. Objective: The aim of this study was to undertake a mixed-methods study of qualitative patient-reported data on young-onset colorectal cancer experiences and outcomes. Methods: This is a study of web-based unsolicited patient stories recounting experiences of health services and clinical outcomes related to young-onset colorectal cancer. Personal Recollections Organized as Data (PROD) is a novel methodology for understanding patients? health experiences in order to improve care. PROD pivots qualitative data collection and analysis around the validated domains and dimensions measured in patient-reported outcome and patient-reported experience questionnaires. PROD involves 4 processes: (1) classifying attributes of the contributing patients, their disease states, their routes to diagnosis, and the clinical features of their treatment and posttreatment; (2) coding texts into the patient-reported experience and patient-reported outcome domains and dimensions, defined a priori, according to phases of the patient pathway; (3) thematic analysis of content within and across each domain; and (4) quantitative text analysis of the narrative content. Results: Relevant patient stories have been identified, and permission has been obtained for use of the texts in primary research. The approval for this study was granted by the Macquarie University Human Research Ethics Committee in June 2020. The analytical framework was established in September 2020, and data collection commenced in October 2020. We will complete the analysis in March 2021 and we aim to publish the results in mid-2021. Conclusions: The findings of this study will identify areas for improvement in the PROD methodology and inform the development of a large-scale study of young-onset colorectal cancer patient narratives. We believe that this will be the first qualitative study to identify and describe the patient pathway from symptom self-identification to help-seeking through to diagnosis, treatment, and to survivorship or palliation for people with young-onset colorectal cancer. International Registered Report Identifier (IRRID): DERR1-10.2196/25056 UR - https://www.researchprotocols.org/2021/2/e25056 UR - http://dx.doi.org/10.2196/25056 UR - http://www.ncbi.nlm.nih.gov/pubmed/33635274 ID - info:doi/10.2196/25056 ER - TY - JOUR AU - Berthelot, Simon AU - Breton, Mylaine AU - Guertin, Robert Jason AU - Archambault, Michel Patrick AU - Berger Pelletier, Elyse AU - Blouin, Danielle AU - Borgundvaag, Bjug AU - Duhoux, Arnaud AU - Harvey Labbé, Laurie AU - Laberge, Maude AU - Lachapelle, Philippe AU - Lapointe-Shaw, Lauren AU - Layani, Géraldine AU - Lefebvre, Gabrielle AU - Mallet, Myriam AU - Matthews, Deborah AU - McBrien, Kerry AU - McLeod, Shelley AU - Mercier, Eric AU - Messier, Alexandre AU - Moore, Lynne AU - Morris, Judy AU - Morris, Kathleen AU - Ovens, Howard AU - Pageau, Paul AU - Paquette, Jean-Sébastien AU - Perry, Jeffrey AU - Schull, Michael AU - Simon, Mathieu AU - Simonyan, David AU - Stelfox, Thomas Henry AU - Talbot, Denis AU - Vaillancourt, Samuel PY - 2021/2/22 TI - A Value-Based Comparison of the Management of Ambulatory Respiratory Diseases in Walk-in Clinics, Primary Care Practices, and Emergency Departments: Protocol for a Multicenter Prospective Cohort Study JO - JMIR Res Protoc SP - e25619 VL - 10 IS - 2 KW - emergency department KW - primary care KW - walk-in clinic KW - health economics KW - quality of care KW - patient preferences KW - patient-reported outcomes KW - outcome assessment, health care N2 - Background: In Canada, 30%-60% of patients presenting to emergency departments are ambulatory. This category has been labeled as a source of emergency department overuse. Acting on the presumption that primary care practices and walk-in clinics offer equivalent care at a lower cost, governments have invested massively in improving access to these alternative settings in the hope that patients would present there instead when possible, thereby reducing the load on emergency departments. Data in support of this approach remain scarce and equivocal. Objective: The aim of this study is to compare the value of care received in emergency departments, walk-in clinics, and primary care practices by ambulatory patients with upper respiratory tract infection, sinusitis, otitis media, tonsillitis, pharyngitis, bronchitis, influenza-like illness, pneumonia, acute asthma, or acute exacerbation of chronic obstructive pulmonary disease. Methods: A multicenter prospective cohort study will be performed in Ontario and Québec. In phase 1, a time-driven activity-based costing method will be applied at each of the 15 study sites. This method uses time as a cost driver to allocate direct costs (eg, medication), consumable expenditures (eg, needles), overhead costs (eg, building maintenance), and physician charges to patient care. Thus, the cost of a care episode will be proportional to the time spent receiving the care. At the end of this phase, a list of care process costs will be generated and used to calculate the cost of each consultation during phase 2, in which a prospective cohort of patients will be monitored to compare the care received in each setting. Patients aged 18 years and older, ambulatory throughout the care episode, and discharged to home with one of the aforementioned targeted diagnoses will be considered. The estimated sample size is 1485 patients. The 3 types of care settings will be compared on the basis of primary outcomes in terms of the proportion of return visits to any site 3 and 7 days after the initial visit and the mean cost of care. The secondary outcomes measured will include scores on patient-reported outcome and experience measures and mean costs borne wholly by patients. We will use multilevel generalized linear models to compare the care settings and an overlap weights approach to adjust for confounding factors related to age, sex, gender, ethnicity, comorbidities, registration with a family physician, socioeconomic status, and severity of illness. Results: Phase 1 will begin in 2021 and phase 2, in 2023. The results will be available in 2025. Conclusions: The end point of our program will be for deciders, patients, and care providers to be able to determine the most appropriate care setting for the management of ambulatory emergency respiratory conditions, based on the quality and cost of care associated with each alternative. International Registered Report Identifier (IRRID): PRR1-10.2196/25619 UR - https://www.researchprotocols.org/2021/2/e25619 UR - http://dx.doi.org/10.2196/25619 UR - http://www.ncbi.nlm.nih.gov/pubmed/33616548 ID - info:doi/10.2196/25619 ER - TY - JOUR AU - Khan, Zaman Danyal AU - Fitzpatrick, Mairead Siobhan AU - Hilton, Bryn AU - McNair, GK Angus AU - Sarewitz, Ellen AU - Davies, Marshall Benjamin AU - Kotter, RN Mark AU - PY - 2021/2/3 TI - Prevailing Outcome Themes Reported by People With Degenerative Cervical Myelopathy: Focus Group Study JO - JMIR Form Res SP - e18732 VL - 5 IS - 2 KW - cervical KW - myelopathy KW - spondylosis KW - spondylotic KW - stenosis KW - disc herniation KW - ossification posterior longitudinal ligament KW - qualitative KW - thematic analysis KW - core outcomes set KW - consensus KW - Delphi KW - patient perspectives N2 - Background: Degenerative cervical myelopathy (DCM) arises when arthritic changes of the cervical spine cause compression and a progressive injury to the spinal cord. It is common and potentially disabling. People with DCM have among the lowest quality of life scores (Short Form Health Survey?36 item [SF-36]) of chronic disease, although the drivers of the imapact of DCM are not entirely understood. DCM research faces a number of challenges, including the heterogeneous reporting of study data. The AO Spine Research Objectives and Common Data Elements for Degenerative Cervical Myelopathy (RECODE-DCM) project is an international consensus process that aims to improve research efficiency through formation of a core outcome set (COS). A key part of COS development process is organizing outcomes into domains that represent key aspects of the disease. To facilitate this, we sought to qualitatively explore the context and impact of patient-reported outcomes in DCM on study participants. Objective: The goal of the research was to qualitatively explore the patient-reported outcomes in DCM to improve understanding of patient perspective and assist the organization of outcomes into domains for the consensus process. Methods: Focus group sessions were hosted in collaboration with Myelopathy.org, a charity and support group for people with DCM. A 40-minute session was audiorecorded and transcribed verbatim. Two authors familiarized themselves with the data and then performed data coding independently. Codes were grouped into themes and a thematic analysis was performed guided by Braun and Clarke?s 6-phase approach. The themes were subsequently reviewed with an independent stakeholder with DCM, assisting in the process of capturing the true context and importance of themes. Results: Five people with DCM (3 men and 2 women) participated in the focus group session. The median age was 53 years, and the median score on the modified Japanese Orthopaedic Association scale was 11 (interquartile range 9.5-11.5), indicating the participants had moderate to severe DCM. A total of 54 codes were reviewed and grouped into 10 potential themes that captured the impact of the disability on people with DCM: acceptance of symptoms, anticipatory anxiety, coping mechanisms/resilience, feelings of helplessness, financial consequences, lack of recognition, mental health impact, loss of life control, social reclusiveness and isolation, and social stigma. Conclusions: This qualitative analysis of the perspectives of people with DCM has highlighted a number of prevailing themes currently unmeasured in clinical research or care. The determinants of low quality of life in DCM are currently unknown, and these findings provide a novel and so far, unique perspective. Continued inclusion of online communities and use of targeted digital software will be important in establishing a consensus-based COS for patients with DCM that is inclusive of all relevant stakeholders including people with DCM. UR - https://formative.jmir.org/2021/2/e18732 UR - http://dx.doi.org/10.2196/18732 UR - http://www.ncbi.nlm.nih.gov/pubmed/33533719 ID - info:doi/10.2196/18732 ER - TY - JOUR AU - Tiase, L. Victoria AU - Sward, A. Katherine AU - Del Fiol, Guilherme AU - Staes, Catherine AU - Weir, Charlene AU - Cummins, R. Mollie PY - 2021/1/26 TI - Patient-Generated Health Data in Pediatric Asthma: Exploratory Study of Providers' Information Needs JO - JMIR Pediatr Parent SP - e25413 VL - 4 IS - 1 KW - information needs KW - asthma KW - symptom management KW - mobile health KW - patient-generated health data KW - pediatrics KW - adolescents N2 - Background: Adolescents are using mobile health apps as a form of self-management to collect data on symptoms, medication adherence, and activity. Adding functionality to an electronic health record (EHR) to accommodate disease-specific patient-generated health data (PGHD) may support clinical care. However, little is known on how to incorporate PGHD in a way that informs care for patients. Pediatric asthma, a prevalent health issue in the United States with 6 million children diagnosed, serves as an exemplar condition to examine information needs related to PGHD. Objective: In this study we aimed to identify and prioritize asthma care tasks and decisions based on pediatric asthma guidelines and identify types of PGHD that might support the activities associated with the decisions. The purpose of this work is to provide guidance to mobile health app developers and EHR integration. Methods: We searched the literature for exemplar asthma mobile apps and examined the types of PGHD collected. We identified the information needs associated with each decision in accordance with consensus-based guidelines, assessed the suitability of PGHD to meet those needs, and validated our findings with expert asthma providers. Results: We mapped guideline-derived information needs to potential PGHD types and found PGHD that may be useful in meeting information needs. Information needs included types of symptoms, symptom triggers, medication adherence, and inhaler technique. Examples of suitable types of PGHD were Asthma Control Test calculations, exposures, and inhaler use. Providers suggested uncontrolled asthma as a place to focus PGHD efforts, indicating that they preferred to review PGHD at the time of the visit. Conclusions: We identified a manageable list of information requirements derived from clinical guidelines that can be used to guide the design and integration of PGHD into EHRs to support pediatric asthma management and advance mobile health app development. Mobile health app developers should examine PGHD information needs to inform EHR integration efforts. UR - http://pediatrics.jmir.org/2021/1/e25413/ UR - http://dx.doi.org/10.2196/25413 UR - http://www.ncbi.nlm.nih.gov/pubmed/33496674 ID - info:doi/10.2196/25413 ER - TY - JOUR AU - White, Judith AU - Knight, Laura AU - da Cruz, Lyndon AU - Stanga, E. Paulo AU - Patrick, Hannah AU - Powell, Helen AU - Berry, Lee AU - Withers, Kathleen AU - Carolan-Rees, Grace AU - Jackson, L. Timothy PY - 2021/1/20 TI - Effects of the Argus II Retinal Prosthesis System on the Quality of Life of Patients With Ultra-Low Vision Due to Retinitis Pigmentosa: Protocol for a Single-Arm, Mixed Methods Study JO - JMIR Res Protoc SP - e17436 VL - 10 IS - 1 KW - patient-reported outcomes KW - quality of life KW - qualitative methods KW - artificial vision KW - visual function KW - functional vision KW - ultra-low vision KW - low vision KW - visual function questionnaire N2 - Background: Retinitis pigmentosa is an incurable, degenerative retinal condition causing progressive sight loss, significantly affecting patients? quality of life. The Argus II Retinal Prosthesis is a surgically implanted medical device that delivers electrical stimulation to the retina. It is intended to produce a form of artificial vision for blind people with severe-to-profound retinitis pigmentosa by stimulating the remaining viable retinal cells to induce visual perception. This study has been initiated by National Health Service England?s Commissioning through Evaluation program and funded through the National Institute of Health Research of the United Kingdom. Objective: The aim of this study was to assess the effect of the Argus II device on patient?s daily activities and quality of life. Methods: This protocol is a prospective, single-arm, open-label, mixed methods study on 10 consecutive participants receiving the Argus II device. The patient representatives played an integral role in the design of this study. Eligibility criteria include ultra-low vision in both eyes as a result of end-stage retinitis pigmentosa and a willingness and capacity to complete the postimplantation rehabilitation program. Participants will be interviewed by independent researchers at baseline and 12 months later by using a semistructured, in-depth approach, alongside validated questionnaires (Impact of Vision Impairment-Very Low Vision, 5-level EuroQoL-5 dimensions scale, EuroQoL-visual analog scale, and Hospital Anxiety and Depression Scale) and a bespoke device-related questionnaire, which includes questions about users? experiences with the procedure, the device, and rehabilitation. The effect of the device on patients? functional vision and activities of daily living will be assessed by vision rehabilitation specialists using a set of tests measured on an ordinal scale (eg, ability to locate objects and avoid obstacles). Clinical outcomes include full-field stimulus light threshold, square localization, direction of motion, grating visual acuity, Landolt-C, procedural success, and adverse events. Qualitative and quantitative outcomes will be linked in a single database to enable individual participant measures to be considered in toto, comparing baseline to the final review. Results: This study was approved by the local ethics committee on April 24, 2019 (London-Camberwell St. Giles Research Ethics Committee, reference 19/LO/0429). It has also been approved by the Health Research Authority and Health and Care Research Wales. At the time of protocol writing, Argus II was available for use in the United Kingdom; however, the manufacturer recently withdrew the Argus II device from sale in the United Kingdom. Therefore, the study is not going ahead at this time. Conclusions: The mixed methods approach provides a rich and in-depth assessment of the effect of the device on participants? quality of life. Despite the work not going ahead, the publication of this publicly funded protocol is important for researchers planning similar work. International Registered Report Identifier (IRRID): PRR1-10.2196/17436 UR - http://www.researchprotocols.org/2021/1/e17436/ UR - http://dx.doi.org/10.2196/17436 UR - http://www.ncbi.nlm.nih.gov/pubmed/33470946 ID - info:doi/10.2196/17436 ER - TY - JOUR AU - Johnston, Sharon AU - Hogg, William AU - Wong, T. Sabrina AU - Burge, Fred AU - Peterson, Sandra PY - 2021/1/11 TI - Differences in Mode Preferences, Response Rates, and Mode Effect Between Automated Email and Phone Survey Systems for Patients of Primary Care Practices: Cross-Sectional Study JO - J Med Internet Res SP - e21240 VL - 23 IS - 1 KW - response rates KW - primary care KW - mixed-mode survey N2 - Background: A growing number of health care practices are adopting software systems that link with their existing electronic medical records to generate outgoing phone calls, emails, or text notifications to patients for appointment reminders or practice updates. While practices are adopting this software technology for service notifications to patients, its use for collection of patient-reported measures is still nascent. Objective: This study assessed the mode preferences, response rates, and mode effect for a practice-based automated patient survey using phone and email modalities to patients of primary care practices. Methods: This cross-sectional study analyzed responses and respondent demographics for a short, fully automated, telephone or email patient survey sent to individuals within 72 hours of a visit to their regular primary care practice. Each survey consisted of 5 questions drawn from a larger study?s patient survey that all respondents completed in the waiting room at the time of their visit. Automated patient survey responses were linked to self-reported sociodemographic information provided on the waiting room survey including age, sex, reported income, and health status. Results: A total of 871 patients from 87 primary care practices in British Columbia, Ontario, and Nova Scotia, Canada, agreed to the automated patient survey and 470 patients (45.2%) completed all 5 questions on the automated survey. Email administration of the follow-up survey was preferred over phone-based administration, except among patients aged 75 years and older (P<.001). Overall, response rates for those who selected an emailed survey (369/606, 60.9%) were higher (P<.001) than those who selected the phone survey (101/265, 38.1%). This held true irrespective of age, sex, or chronic disease status of individuals. Response rates were also higher for email (range 57.4% [58/101] to 66.3% [108/163]) compared with phone surveys (range 36% [23/64] to 43% [10/23]) for all income groups except the lowest income quintile, which had similar response rates (email: 29/63, 46%; phone: 23/50, 46%) for phone and email modes. We observed moderate (range 64.6% [62/96] to 78.8% [282/358]) agreement between waiting room survey responses and those obtained in the follow-up automated survey. However, overall agreement in responses was poor (range 45.3% [43/95] to 46.2% [43/93]) for 2 questions relating to care coordination. Conclusions: An automated practice-based patient experience survey achieved significantly different response rates between phone and email and increased response rates for email as income group rose. Potential mode effects for the different survey modalities may limit multimodal survey approaches. An automated minimal burden patient survey could facilitate the integration of patient-reported outcomes into care planning and service organization, supporting the move of our primary care practices toward a more responsive, patient-centered, continual learning system. However, practices must be attentive to furthering inequities in health care by underrepresenting the experience of certain groups in decision making based on the reach of different survey modes. UR - https://www.jmir.org/2021/1/e21240 UR - http://dx.doi.org/10.2196/21240 UR - http://www.ncbi.nlm.nih.gov/pubmed/33427675 ID - info:doi/10.2196/21240 ER - TY - JOUR AU - Vogel, E. Marco M. AU - Eitz, A. Kerstin AU - Combs, E. Stephanie PY - 2021/1/11 TI - Web-Based Patient Self-Reported Outcome After Radiotherapy in Adolescents and Young Adults With Cancer: Survey on Acceptance of Digital Tools JO - JMIR Mhealth Uhealth SP - e19727 VL - 9 IS - 1 KW - mHealth KW - eHealth KW - young adults N2 - Background: eHealth and mobile health (mHealth) are an evolving trend in the medical field. The acceptance of digital tools is high, and the need is growing. Objective: Young adults (18-40 years) confronted with a cancer diagnosis present unique needs and require special care. They often have a strong affinity and are familiar with modern technology. On that account, we implemented a web-based symptom and quality of life (QoL) assessment to address patients? attitudes and willingness to use mHealth tools. The study also aims to evaluate sociodemographic parameters that could influence patients? opinions. Methods: A total of 380 young patients aged 18-40 treated with radiotherapy between 2002 and 2017 were included in the trial. We assessed QoL via the European Organization for Research and Treatment of Cancer-Core 30 (EORTC C30) questionnaire and added general questions about mHealth technology. The added questions inquired patients? opinions regarding general aspects, including technical advances in medicine, mobile and app assistance during cancer treatment, data transfer, and app-specific features. The survey was conducted for 12 months. Participation was voluntary and pseudonymized; prior written consent was obtained. Results: We achieved a participation rate of 57.6% (219/380) and a completion rate of 50.2% (110/219). The median age was 33 years (range 18-40). Of all participants, 89.1% (98/110) considered new technologies in medicine as positive; 10.9% (12/110) answered with neutral. Nearly all patients (96.4%, 106/110) stated that they would send further data via a web-based platform. Of all, 96.4% (106/110) considered the provided pseudonymization of their data as safe. We further asked the patients if they would use a mobile app for symptom and QoL assessment similar to the present web-based system: 74.5% (82/110) answered with yes and 25.5% (28/110) said they would not use a mobile app in the future. We tested the willingness to use an app on several sociodemographic parameters, such as age, gender, education, health insurance status, and cancer-related parameters: tumor stage, time since radiation treatment, and treatment intention. None of these parameters correlated with app use in this group of young adults. Patients who were generally positive regarding using an app rated several possible functions of a future app. The 3 most requested features were appointment reminders (89.0%, 73/82), contact overview of all involved clinics and physicians (87%, 71/82), and making an appointment via app (78%, 64/82). Conclusions: eHealth and mHealth tools should be available as an integrated part of a comprehensive cancer care approach. It provides automated, thorough documentation of health parameters during therapy and follow-up for doctors, medical staff, and tumor patients to optimize treatment. With this study, we could show that young adults are the ideal patient population to use eHealth/mHealth tools. Such tools offer further digital support and improve the patients? need for constant QoL during cancer care. UR - http://mhealth.jmir.org/2021/1/e19727/ UR - http://dx.doi.org/10.2196/19727 UR - http://www.ncbi.nlm.nih.gov/pubmed/33427669 ID - info:doi/10.2196/19727 ER - TY - JOUR AU - Schmalz, Oliver AU - Jacob, Christine AU - Ammann, Johannes AU - Liss, Blasius AU - Iivanainen, Sanna AU - Kammermann, Manuel AU - Koivunen, Jussi AU - Klein, Alexander AU - Popescu, Andrei Razvan PY - 2020/12/21 TI - Digital Monitoring and Management of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Treated With Cancer Immunotherapy and Its Impact on Quality of Clinical Care: Interview and Survey Study Among Health Care Professionals and Patients JO - J Med Internet Res SP - e18655 VL - 22 IS - 12 KW - advanced or metastatic non-small cell lung cancer KW - cancer immunotherapy KW - digital patient monitoring KW - drug- and indication-specific cancer immunotherapy module KW - eHealth KW - mHealth KW - quality of patient care KW - patient-reported outcomes KW - real-time symptom reporting KW - user experience N2 - Background: Cancer immunotherapy (CIT), as a monotherapy or in combination with chemotherapy, has been shown to extend overall survival in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). However, patients experience treatment-related symptoms that they are required to recall between hospital visits. Digital patient monitoring and management (DPMM) tools may improve clinical practice by allowing real-time symptom reporting. Objective: This proof-of-concept pilot study assessed patient and health care professional (HCP) adoption of our DPMM tool, which was designed specifically for patients with advanced or metastatic NSCLC treated with CIT, and the tool?s impact on clinical care. Methods: Four advisory boards were assembled in order to co-develop a drug- and indication-specific CIT (CIT+) module, based on a generic CIT DPMM tool from Kaiku Health, Helsinki, Finland. A total of 45 patients treated with second-line single-agent CIT (ie, atezolizumab or otherwise) for advanced or metastatic NSCLC, as well as HCPs, whose exact number was decided by the clinics, were recruited from 10 clinics in Germany, Finland, and Switzerland between February and May 2019. All clinics were provided with the Kaiku Health generic CIT DPMM tool, including our CIT+ module. Data on user experience, overall satisfaction, and impact of the tool on clinical practice were collected using anonymized surveys?answers ranged from 1 (low agreement) to 5 (high agreement)?and HCP interviews; surveys and interviews consisted of closed-ended Likert scales and open-ended questions, respectively. The first survey was conducted after 2 months of DPMM use, and a second survey and HCP interviews were conducted at study end (ie, after ?3 months of DPMM use); only a subgroup of HCPs from each clinic responded to the surveys and interviews. Survey data were analyzed quantitatively; interviews were recorded, transcribed verbatim, and translated into English, where applicable, for coding and qualitative thematic analysis. Results: Among interim survey respondents (N=51: 13 [25%] nurses, 11 [22%] physicians, and 27 [53%] patients), mean rankings of the tool?s seven usability attributes ranged from 3.2 to 4.4 (nurses), 3.7 to 4.5 (physicians), and 3.7 to 4.2 (patients). At the end-of-study survey (N=48: 19 [40%] nurses, 8 [17%] physicians, and 21 [44%] patients), most respondents agreed that the tool facilitated more efficient and focused discussions between patients and HCPs (nurses and patients: mean rating 4.2, SD 0.8; physicians: mean rating 4.4, SD 0.8) and allowed HCPs to tailor discussions with patients (mean rating 4.35, SD 0.65). The standalone tool was well integrated into HCP daily clinical workflow (mean rating 3.80, SD 0.75), enabled workflow optimization between physicians and nurses (mean rating 3.75, SD 0.80), and saved time by decreasing phone consultations (mean rating 3.75, SD 1.00) and patient visits (mean rating 3.45, SD 1.20). Workload was the most common challenge of tool use among respondents (12/19, 63%). Conclusions: Our results demonstrate high user satisfaction and acceptance of DPMM tools by HCPs and patients, and highlight the improvements to clinical care in patients with advanced or metastatic NSCLC treated with CIT monotherapy. However, further integration of the tool into the clinical information technology data flow is required. Future studies or registries using our DPMM tool may provide insights into significant effects on patient quality of life or health-economic benefits. UR - http://www.jmir.org/2020/12/e18655/ UR - http://dx.doi.org/10.2196/18655 UR - http://www.ncbi.nlm.nih.gov/pubmed/33346738 ID - info:doi/10.2196/18655 ER - TY - JOUR AU - Kitsaras, George AU - Goodwin, Michaela AU - Allan, Julia AU - Kelly, Michael AU - Pretty, Iain PY - 2020/12/21 TI - An Interactive Text Message Survey as a Novel Assessment for Bedtime Routines in Public Health Research: Observational Study JO - JMIR Public Health Surveill SP - e15524 VL - 6 IS - 4 KW - digital technologies KW - mobile health KW - child KW - well-being KW - development KW - assessment KW - bedtime routines KW - P4 health care KW - text survey N2 - Background: Traditional research approaches, especially questionnaires and paper-based assessments, limit in-depth understanding of the fluid dynamic processes associated with child well-being and development. This includes bedtime routine activities such as toothbrushing and reading a book before bed. The increase in innovative digital technologies alongside greater use and familiarity among the public creates unique opportunities to use these technical developments in research. Objective: This study aimed to (1) examine the best way of assessing bedtime routines in families and develop an automated, interactive, text message survey assessment delivered directly to participants? mobile phones and (2) test the assessment within a predominately deprived sociodemographic sample to explore retention, uptake, feedback, and effectiveness. Methods: A public and patient involvement project showed clear preference for interactive text surveys regarding bedtime routines. The developed interactive text survey included questions on bedtime routine activities and was delivered for seven consecutive nights to participating parents? mobile phones. A total of 200 parents participated. Apart from the completion of the text survey, feedback was provided by participants, and data on response, completion, and retention rates were captured. Results: There was a high retention rate (185/200, 92.5%), and the response rate was high (160/185, 86.5%). In total, 114 participants provided anonymized feedback. Only a small percentage (5/114, 4.4%) of participants reported problems associated with completing the assessment. The majority (99/114, 86.8%) of participants enjoyed their participation in the study, with an average satisfaction score of 4.6 out of 5. Conclusions: This study demonstrated the potential of deploying SMS text message?based surveys to capture and quantify real-time information on recurrent dynamic processes in public health research. Changes and adaptations based on recommendations are crucial next steps in further exploring the diagnostic and potential intervention properties of text survey and text messaging approaches. UR - http://publichealth.jmir.org/2020/4/e15524/ UR - http://dx.doi.org/10.2196/15524 UR - http://www.ncbi.nlm.nih.gov/pubmed/33346734 ID - info:doi/10.2196/15524 ER - TY - JOUR AU - Sprave, Tanja AU - Zöller, Daniela AU - Stoian, Raluca AU - Rühle, Alexander AU - Kalckreuth, Tobias AU - Haehl, Erik AU - Fahrner, Harald AU - Binder, Harald AU - Grosu, Anca-Ligia AU - Heinemann, Felix AU - Nicolay, Henrik Nils PY - 2020/12/9 TI - App-Controlled Treatment Monitoring and Support for Head and Neck Cancer Patients (APCOT): Protocol for a Prospective Randomized Controlled Trial JO - JMIR Res Protoc SP - e21693 VL - 9 IS - 12 KW - mHealth KW - head and neck cancer KW - HNSCC KW - radiotherapy KW - mobile app KW - quality of life KW - patient-reported outcome measures N2 - Background: Head and neck cancers (HNCs) are among the most common malignancies, which often require multimodal treatment that includes radiation therapy and chemotherapy. Patients with HNC have a high burden of symptoms due to both the damaging effects of the tumor and the aggressive multimodal treatment. Close symptom monitoring over the course of the disease may help to identify patients in need of medical interventions. Objective: This APCOT (App-Controlled Treatment Monitoring and Support for Head and Neck Cancer Patients) trial is designed to assess the feasibility of monitoring HNC patients during the course of (chemo)radiation therapy daily using a mobile app. Additionally, symptom patterns, patient satisfaction, and quality of life will be measured in app-monitored patients in comparison to a patient cohort receiving standard-of-care physician appointments, and health economy aspects of app monitoring will be analyzed. Methods: This prospective randomized single-center trial will evaluate the feasibility of integrating electronic patient-reported outcome measures (ePROMs) into the treatment workflow of HNC patients. Patients undergoing definitive or adjuvant (chemo)radiation therapy as part of their HNC treatment at the Department of Radiation Oncology, University Medical Center Freiburg (Freiburg, Germany) will receive weekly physician appointments and additional appointments as requested to monitor and potentially treat symptoms during the course of treatment. Patients in the experimental arm will additionally be monitored daily using a dedicated app regarding their disease- and treatment-related symptoms, quality of life, and need for personal physician appointments. The feasibility of ePROM monitoring will be tested as the primary endpoint and will be defined if ?80% of enrolled patients have answered ?80% of their daily app-based questions. Quality of life will be assessed using the validated European Organisation for Research and Treatment of Cancer questionnaires, and patient satisfaction will be measured by the validated Patient Satisfaction Questionnaire Short Form at the initiation, in the middle, and at completion of radiation therapy, as well as at follow-up examinations. Additionally, the number and duration of physician appointments during the course of radiation therapy will be quantified for both ePROM-monitored and standard-of-care patients. Results: This trial will enroll 100 patients who will be randomized (1:1) between the experimental arm with ePROM monitoring and the control arm with standard patient care. Recruitment will take 18 months, and trial completion is planned at 24 months after enrollment of the last patient. Conclusions: This trial will establish the feasibility of close ePROM monitoring of HNC patients undergoing (chemo)radiation therapy. The results can form the basis for further trials investigating potential clinical benefits of detailed symptom monitoring and patient-centered care in HNC patients regarding oncologic outcomes and quality of life. Trial Registration: German Clinical Trials Register DRKS00020491; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00020491 International Registered Report Identifier (IRRID): PRR1-10.2196/21693 UR - https://www.researchprotocols.org/2020/12/e21693 UR - http://dx.doi.org/10.2196/21693 UR - http://www.ncbi.nlm.nih.gov/pubmed/33295291 ID - info:doi/10.2196/21693 ER - TY - JOUR AU - Buitenweg, David AU - van de Mheen, Dike AU - Grund, Jean-Paul AU - van Oers, Hans AU - van Nieuwenhuizen, Chijs PY - 2020/12/3 TI - Visual and Personalized Quality of Life Assessment App for People With Severe Mental Health Problems: Qualitative Evaluation JO - JMIR Ment Health SP - e19593 VL - 7 IS - 12 KW - quality of life KW - qualitative evaluation KW - visual assessment KW - e-mental health KW - assessment app N2 - Background: QoL-ME is a digital visual personalized quality of life assessment app for people with severe mental health problems. Research reveals that e-mental health apps frequently suffer from low engagement and fall short of expectations regarding their impact on patients? daily lives. Studies often indicate that e-mental health apps ought to respect the needs and preferences of end users to achieve optimal user engagement. Objective: The aim of this study was to explore the experiences of users regarding the usability and functionality of QoL-ME and whether the app is actionable and beneficial for patients. Methods: End users (n=8) of QoL-ME contributed to semistructured interviews. An interview guide was used to direct the interviews. All interviews were audiorecorded and transcribed verbatim. Transcriptions were analyzed and coded thematically. Results: Analysis revealed 3 main themes: (1) benefit, (2) actionability, and (3) characteristics of the QoL-ME. The first theme reveals that the QoL-ME app was beneficial for the majority of respondents, primarily by prompting them to reflect on their quality of life. The current version is not yet actionable; the actionability of the QoL-ME app may be improved by enabling users to view their scores over time and by supplying practical advice for quality of life improvements. Overall, participants had positive experiences with the usability, design, and content of the app. Conclusions: The QoL-ME app can be beneficial to users as it provides them with insight into their quality of life and elicits reflection. Incorporating more functionalities that facilitate self-management, such as advice and strategies for improving areas that are lacking, will likely make the app actionable. Patients positively regarded the usability, design, and contents of the QoL-ME app. UR - https://mental.jmir.org/2020/12/e19593 UR - http://dx.doi.org/10.2196/19593 UR - http://www.ncbi.nlm.nih.gov/pubmed/33270036 ID - info:doi/10.2196/19593 ER - TY - JOUR AU - Richter, Frederike Maike AU - Storck, Michael AU - Blitz, Rogério AU - Goltermann, Janik AU - Seipp, Juliana AU - Dannlowski, Udo AU - Baune, T. Bernhard AU - Dugas, Martin AU - Opel, Nils PY - 2020/12/1 TI - Repeated Digitized Assessment of Risk and Symptom Profiles During Inpatient Treatment of Affective Disorder: Observational Study JO - JMIR Ment Health SP - e24066 VL - 7 IS - 12 KW - affective disorders KW - digital data collection KW - psychiatry KW - P4 medicine N2 - Background: Predictive models have revealed promising results for the individual prognosis of treatment response and relapse risk as well as for differential diagnosis in affective disorders. Yet, in order to translate personalized predictive modeling from research contexts to psychiatric clinical routine, standardized collection of information of sufficient detail and temporal resolution in day-to-day clinical care is needed. Digital collection of self-report measures by patients is a time- and cost-efficient approach to gain such data throughout treatment. Objective: The objective of this study was to investigate whether patients with severe affective disorders were willing and able to participate in such efforts, whether the feasibility of such systems might vary depending on individual patient characteristics, and if digitally acquired assessments were of sufficient diagnostic validity. Methods: We implemented a system for longitudinal digital collection of risk and symptom profiles based on repeated self-reports via tablet computers throughout inpatient treatment of affective disorders at the Department of Psychiatry at the University of Münster. Tablet-handling competency and the speed of data entry were assessed. Depression severity was additionally assessed by a clinical interviewer at baseline and before discharge. Results: Of 364 affective disorder patients who were approached, 242 (66.5%) participated in the study; 88.8% of participants (215/242) were diagnosed with major depressive disorder, and 27 (11.2%) had bipolar disorder. During the duration of inpatient treatment, 79% of expected assessments were completed, with an average of 4 completed assessments per participant; 4 participants (4/242, 1.6%) dropped out of the study prematurely. During data entry, 89.3% of participants (216/242) did not require additional support. Needing support with tablet handling and slower data entry pace were predicted by older age, whereas depression severity at baseline did not influence these measures. Patient self-reporting of depression severity showed high agreement with standardized external assessments by a clinical interviewer. Conclusions: Our results indicate that digital collection of self-report measures is a feasible, accessible, and valid method for longitudinal data collection in psychiatric routine, which will eventually facilitate the identification of individual risk and resilience factors for affective disorders and pave the way toward personalized psychiatric care. UR - https://mental.jmir.org/2020/12/e24066 UR - http://dx.doi.org/10.2196/24066 UR - http://www.ncbi.nlm.nih.gov/pubmed/33258791 ID - info:doi/10.2196/24066 ER - TY - JOUR AU - Kling, MR Samantha AU - Harris, A. Holly AU - Marini, Michele AU - Cook, Adam AU - Hess, B. Lindsey AU - Lutcher, Shawnee AU - Mowery, Jacob AU - Bell, Scott AU - Hassink, Sandra AU - Hayward, B. Shannon AU - Johnson, Greg AU - Franceschelli Hosterman, Jennifer AU - Paul, M. Ian AU - Seiler, Christopher AU - Sword, Shirley AU - Savage, S. Jennifer AU - Bailey-Davis, Lisa PY - 2020/11/24 TI - Advanced Health Information Technologies to Engage Parents, Clinicians, and Community Nutritionists in Coordinating Responsive Parenting Care: Descriptive Case Series of the Women, Infants, and Children Enhancements to Early Healthy Lifestyles for Baby (WEE Baby) Care Randomized Controlled Trial JO - JMIR Pediatr Parent SP - e22121 VL - 3 IS - 2 KW - early obesity prevention KW - responsive parenting KW - health information technology KW - coordination of care KW - clinical care KW - pragmatic intervention KW - data sharing N2 - Background: Socioeconomically disadvantaged newborns receive care from primary care providers (PCPs) and Women, Infants, and Children (WIC) nutritionists. However, care is not coordinated between these settings, which can result in conflicting messages. Stakeholders support an integrated approach that coordinates services between settings with care tailored to patient-centered needs. Objective: This analysis describes the usability of advanced health information technologies aiming to engage parents in self-reporting parenting practices, integrate data into electronic health records to inform and facilitate documentation of provided responsive parenting (RP) care, and share data between settings to create opportunities to coordinate care between PCPs and WIC nutritionists. Methods: Parents and newborns (dyads) who were eligible for WIC care and received pediatric care in a single health system were recruited and randomized to a RP intervention or control group. For the 6-month intervention, electronic systems were created to facilitate documentation, data sharing, and coordination of provided RP care. Prior to PCP visits, parents were prompted to respond to the Early Healthy Lifestyles (EHL) self-assessment tool to capture current RP practices. Responses were integrated into the electronic health record and shared with WIC. Documentation of RP care and an 80-character, free-text comment were shared between WIC and PCPs. A care coordination opportunity existed when the dyad attended a WIC visit and these data were available from the PCP, and vice versa. Care coordination was demonstrated when WIC or PCPs interacted with data and documented RP care provided at the visit. Results: Dyads (N=131) attended 459 PCP (3.5, SD 1.0 per dyad) and 296 WIC (2.3, SD 1.0 per dyad) visits. Parents completed the EHL tool prior to 53.2% (244/459) of PCP visits (1.9, SD 1.2 per dyad), PCPs documented provided RP care at 35.3% (162/459) of visits, and data were shared with WIC following 100% (459/459) of PCP visits. A WIC visit followed a PCP visit 50.3% (231/459) of the time; thus, there were 1.8 (SD 0.8 per dyad) PCP to WIC care coordination opportunities. WIC coordinated care by documenting RP care at 66.7% (154/231) of opportunities (1.2, SD 0.9 per dyad). WIC visits were followed by a PCP visit 58.9% (116/197) of the time; thus, there were 0.9 (SD 0.8 per dyad) WIC to PCP care coordination opportunities. PCPs coordinated care by documenting RP care at 44.0% (51/116) of opportunities (0.4, SD 0.6 per dyad). Conclusions: Results support the usability of advanced health information technology strategies to collect patient-reported data and share these data between multiple providers. Although PCPs and WIC shared data, WIC nutritionists were more likely to use data and document RP care to coordinate care than PCPs. Variability in timing, sequence, and frequency of visits underscores the need for flexibility in pragmatic studies. Trial Registration: ClinicalTrials.gov NCT03482908; https://clinicaltrials.gov/ct2/show/NCT03482908 International Registered Report Identifier (IRRID): RR2-10.1186/s12887-018-1263-z UR - http://pediatrics.jmir.org/2020/2/e22121/ UR - http://dx.doi.org/10.2196/22121 UR - http://www.ncbi.nlm.nih.gov/pubmed/33231559 ID - info:doi/10.2196/22121 ER - TY - JOUR AU - Edwards, Colin AU - Costello, Eamonn AU - Cassidy, Nicola AU - Vick, Bill AU - Russell, Anne-Marie PY - 2020/11/20 TI - Use of the patientMpower App With Home-Based Spirometry to Monitor the Symptoms and Impact of Fibrotic Lung Conditions: Longitudinal Observational Study JO - JMIR Mhealth Uhealth SP - e16158 VL - 8 IS - 11 KW - idiopathic pulmonary fibrosis KW - pulmonary fibrosis KW - eHealth KW - mHealth KW - patient-reported outcome measure KW - spirometry KW - home spirometry KW - patient experience KW - digital health KW - patient advocacy N2 - Background: Daily home-based spirometry in idiopathic pulmonary fibrosis (IPF) has been shown to be feasible and clinically informative. The patientMpower app facilitates home-based spirometry along with home-based monitoring of IPF-related symptoms. The patientMpower app can be downloaded to the user?s mobile phone or tablet device, enabling the recording of objective and subjective data. Objective: The aim of this paper is to report on the 1-year experience of using patientMpower with home-based spirometry by 36 participants with self-reported pulmonary fibrosis (PF) treated with usual care. Methods: Self-selecting participants enrolled in this community-based participatory research program through a patient advocacy group in their country: Irish Lung Fibrosis Association in Ireland and PF Warriors in the United States. Disease severity was comparable with a baseline mean predicted forced vital capacity (FVC) of 64% and 62% in the Irish and US participants, respectively. Both groups of participants were allocated to identical, in-country, open-label, single-group observational studies and were provided with a Bluetooth-active Spirobank Smart spirometer integrated directly with patientMpower. Data collected via patientMpower included seated FVC (daily), breathlessness grade (modified Medical Research Council scale score), step count, medication adherence, and symptoms and impact of IPF on daily life, which were measured by a patient-reported outcome measure (PROM) scale that was specifically developed for IPF. Longitudinal patient-reported data on oximetry and oxygen consumption were also collected. Results: A large majority of the 36 participants reported that their experience using patientMpower was positive, and they wanted to continue its use after the initial 6-week observation. Out of 36 participants, 21 (58%) recorded home-based spirometry without prompting for ?180 days, and 9 (25%) participants continued with recording home-based spirometry for ?360 days. Conclusions: The patientMpower app with associated Bluetooth-connected devices (eg, spirometer and pulse oximeter) offers an acceptable and accessible approach to collecting patient-reported objective and subjective data in fibrotic lung conditions. UR - http://mhealth.jmir.org/2020/11/e16158/ UR - http://dx.doi.org/10.2196/16158 UR - http://www.ncbi.nlm.nih.gov/pubmed/33216007 ID - info:doi/10.2196/16158 ER - TY - JOUR AU - Biran, Noa AU - Anthony Kouyaté, Robin AU - Yucel, Emre AU - McGovern, E. Gillian AU - Schoenthaler, M. Antoinette AU - Durling, G. Olivia AU - Unawane, Rashmi AU - Schutt, Andrew AU - Panjabi, Sumeet PY - 2020/11/17 TI - Adaptation and Evaluation of a Symptom-Monitoring Digital Health Intervention for Patients With Relapsed and Refractory Multiple Myeloma: Pilot Mixed-Methods Implementation Study JO - JMIR Form Res SP - e18982 VL - 4 IS - 11 KW - mHealth KW - digital health KW - electronic patient-reported outcome KW - ePRO KW - patient-reported outcome KW - PRO KW - mobile KW - app KW - implementation science KW - multiple myeloma KW - relapsed refractory multiple myeloma N2 - Background: Relapsed and refractory multiple myeloma (RRMM) is a bone marrow cancer that requires systemic treatment, which often results in severe symptom burden. Recent studies have found that electronic patient-reported outcome (ePRO) interventions implemented in the clinic setting have had positive outcomes for other oncology populations. Evidence of the efficacy of a similar approach is lacking for patients with RRMM. Objective: Recent recommendations for digital health interventions call for the publication of descriptions of iterative development processes in order to improve reproducibility and comparability. This study is an implementation pilot aiming to evaluate the acceptability and appropriateness of an ePRO intervention for patients with RRMM and to explore its impact on clinic workflow. Methods: A total of 11 patients with RRMM were recruited from the John Theurer Cancer Center in Hackensack, New Jersey. Patients used a mobile app to report on 17 symptoms at 4 sessions, each a week apart. Patients could also report symptoms ad hoc. When reports met predefined thresholds, the clinic was alerted and patients received automated guidance. Study end points were assessed using qualitative and quantitative methods. Results: A total of 9 patients (mean age 69.7 years) completed the study. Overall, 83% (30/36) of weekly sessions were completed. Patients found the frequency and time required to complete reporting acceptable. All patients agreed that the app was easy to use and understand. Providers felt the alerts they received required refinement. Patients and providers agreed it would be beneficial for patients to report for longer than 4 weeks. Patients felt that the training they received was adequate but contained too much information for a single session. All patients found the symptoms tracked to be appropriate; providers suggested shortening the list. All patients understood how to use the app for weekly reporting but had confusion about using it ad hoc. Providers felt the ad hoc feature could be removed. Neither patients nor providers viewed the in-app data reports but agreed on their potential value. Patients reported benefitting from symptom reporting through increased awareness of their symptoms. Clinic staff reported that app alerts were too numerous and redundant. They had difficulty responding to alerts within their existing workflow, partially because the data were not integrated into the electronic medical record system. Conclusions: Overall, the intervention was found to be acceptable and appropriate for patients with RRMM. Points of friction integrating the intervention into the clinic workflow were identified. Clinic staff provided recommendations for addressing these issues. Once such modifications are implemented, ePRO data from patients with RRMM could be used to inform and improve clinical research and care. This study underlines the importance of an iterative approach to implementation that includes all stakeholders in order to ensure successful adoption. UR - http://formative.jmir.org/2020/11/e18982/ UR - http://dx.doi.org/10.2196/18982 UR - http://www.ncbi.nlm.nih.gov/pubmed/33200997 ID - info:doi/10.2196/18982 ER - TY - JOUR AU - Maguire, Roma AU - Connaghan, John AU - Arber, Anne AU - Klepacz, Naomi AU - Blyth, G. Kevin AU - McPhelim, John AU - Murray, Paul AU - Rupani, Hitasha AU - Chauhan, Anoop AU - Williams, Peter AU - McNaughton, Laura AU - Woods, Kirstie AU - Moylan, Anne PY - 2020/11/12 TI - Advanced Symptom Management System for Patients with Malignant Pleural Mesothelioma (ASyMSmeso): Mixed Methods Study JO - J Med Internet Res SP - e19180 VL - 22 IS - 11 KW - malignant pleural mesothelioma KW - patient reported outcome measures KW - cancer KW - mobile health KW - telemedicine, symptom monitoring N2 - Background: Patients with malignant pleural mesothelioma (MPM) have a life-limiting illness and short prognosis and experience many debilitating symptoms from early in the illness. Innovations such as remote symptom monitoring are needed to enable patients to maintain wellbeing and manage symptoms in a proactive and timely manner. The Advanced Symptom Management System (ASyMS) has been successfully used to monitor symptoms associated with cancer. Objective: This study aimed to determine the feasibility and acceptability of using an ASyMS adapted for use by patients with MPM, called ASyMSmeso, enabling the remote monitoring of symptoms using a smartphone. Methods: This was a convergent mixed methods study using patient-reported outcome measures (PROMs) at key time points over a period of 2-3 months with 18 patients. The Sheffield Profile for Assessment and Referral for Care (SPARC), Technology Acceptance Model (TAM) measure for eHealth, and Lung Cancer Symptom Scale-Mesothelioma (LCSS-Meso) were the PROMs used in the study. Patients were also asked to complete a daily symptom questionnaire on a smartphone throughout the study. At the end of the study, semistructured interviews with 11 health professionals, 8 patients, and 3 carers were conducted to collect their experience with using ASyMSmeso. Results: Eighteen patients with MPM agreed to participate in the study (33.3% response rate). The completion rates of study PROMs were high (97.2%-100%), and completion rates of the daily symptom questionnaire were also high, at 88.5%. There were no significant changes in quality of life, as measured by LCSS-Meso. There were statistically significant improvements in the SPARC psychological need domain (P=.049) and in the ?Usefulness? domain of the TAM (P=.022). End-of-study interviews identified that both patients and clinicians found the system quick and easy to use. For patients, in particular, the system provided reassurance about symptom experience and the feeling of being listened to. The clinicians largely viewed the system as feasible and acceptable, and areas that were mentioned included the early management of symptoms and connectivity between patients and clinicians, leading to enhanced communication. Conclusions: This study demonstrates that remote monitoring and management of symptoms of people with MPM using a mobile phone are feasible and acceptable. The evidence supports future trials using remote symptom monitoring to support patients with MPM at home. UR - https://www.jmir.org/2020/11/e19180 UR - http://dx.doi.org/10.2196/19180 UR - http://www.ncbi.nlm.nih.gov/pubmed/33180025 ID - info:doi/10.2196/19180 ER - TY - JOUR AU - Weerts, M. Zsa Zsa R. AU - Heinen, E. Koert G. AU - Masclee, M. Ad A. AU - Quanjel, A. Amber B. AU - Winkens, Bjorn AU - Vork, Lisa AU - Rinkens, M. Paula E. L. AU - Jonkers, E. Daisy M. A. AU - Keszthelyi, Daniel PY - 2020/11/2 TI - Smart Data Collection for the Assessment of Treatment Effects in Irritable Bowel Syndrome: Observational Study JO - JMIR Mhealth Uhealth SP - e19696 VL - 8 IS - 11 KW - irritable bowel syndrome KW - digital diary KW - smartphone application KW - mobile phone application KW - mhealth KW - e-health KW - compliance KW - electronic case report file KW - patient reported outcome measures KW - peppermint oil KW - PERSUADE study. N2 - Background: End-of-day symptom diaries are recommended by drug regulatory authorities to assess treatment response in patients with irritable bowel syndrome. We developed a smartphone app to measure treatment response. Objective: Because the employment of an app to measure treatment response in irritable bowel syndrome is relatively new, we aimed to explore patients? adherence to diary use and characteristics associated with adherence. Methods: A smartphone app was developed to serve as a symptom diary. Patients with irritable bowel syndrome (based on Rome IV criteria) were instructed to fill out end-of-day diary questionnaires during an 8-week treatment. Additional online questionnaires assessed demographics, irritable bowel syndrome symptom severity, and psychosocial comorbidities. Adherence rate to the diary was defined as the percentage of days completed out of total days. Adherence to the additional web-based questionnaires was also assessed. Results: Overall, 189 patients were included (age: mean 34.0 years, SD 13.3 years; female: 147/189, 77.8%; male: 42/189, 22.2%). The mean adherence rate was 87.9% (SD 9.4%). However, adherence to the diary decreased over time (P<.001). No significant association was found between adherence and gender (P=.84), age (P=.22), or education level (lower education level: P=.58, middle education level: P=.46, versus high education level), while higher anxiety scores were associated with lower adherence (P=.03). Adherence to the online questionnaires was also high (>99%). Missing data due to technical issues were limited. Conclusions: The use of a smartphone app as a symptom diary to assess treatment response resulted in high patient adherence. The data-collection framework described led to standardized data collection with excellent completeness and can be used for future randomized controlled trials. Due to the slight decrease in adherence to diary use throughout the study, this method might be less suitable for longer trials. UR - https://mhealth.jmir.org/2020/11/e19696 UR - http://dx.doi.org/10.2196/19696 UR - http://www.ncbi.nlm.nih.gov/pubmed/33030150 ID - info:doi/10.2196/19696 ER - TY - JOUR AU - Harrison, Conrad AU - Loe, Sheng Bao AU - Lis, Przemys?aw AU - Sidey-Gibbons, Chris PY - 2020/10/29 TI - Maximizing the Potential of Patient-Reported Assessments by Using the Open-Source Concerto Platform With Computerized Adaptive Testing and Machine Learning JO - J Med Internet Res SP - e20950 VL - 22 IS - 10 KW - computerized adaptive testing KW - computerized adaptive test KW - CAT KW - machine learning KW - patient reported outcome measures KW - outcome assessment KW - Concerto UR - http://www.jmir.org/2020/10/e20950/ UR - http://dx.doi.org/10.2196/20950 UR - http://www.ncbi.nlm.nih.gov/pubmed/33118937 ID - info:doi/10.2196/20950 ER - TY - JOUR AU - Girgis, Afaf AU - Durcinoska, Ivana AU - Arnold, Anthony AU - Descallar, Joseph AU - Kaadan, Nasreen AU - Koh, Eng-Siew AU - Miller, Andrew AU - Ng, Weng AU - Carolan, Martin AU - Della-Fiorentina, A. Stephen AU - Avery, Sandra AU - Delaney, P. Geoff PY - 2020/10/29 TI - Web-Based Patient-Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care): Multicenter Pragmatic Nonrandomized Trial JO - J Med Internet Res SP - e19685 VL - 22 IS - 10 KW - patient-reported outcomes (PROs) KW - eHealth KW - patient-centered care KW - electronic health record KW - nonrandomized controlled trial KW - emergency department presentations KW - pragmatic trial KW - symptom screening N2 - Background: Despite the acceptability and efficacy of e?patient-reported outcome (ePRO) systems, implementation in routine clinical care remains challenging. Objective: This pragmatic trial implemented the PROMPT-Care (Patient Reported Outcome Measures for Personalized Treatment and Care) web-based system into existing clinical workflows and evaluated its effectiveness among a diverse population of patients with cancer. Methods: Adult patients with solid tumors receiving active treatment or follow-up care in four cancer centers were enrolled. The PROMPT-Care intervention supported patient management through (1) monthly off-site electronic PRO physical symptom and psychosocial well-being assessments, (2) automated electronic clinical alerts notifying the care team of unresolved clinical issues following two consecutive assessments, and (3) tailored online patient self-management resources. Propensity score matching was used to match controls with intervention patients in a 4:1 ratio for patient age, sex, and treatment status. The primary outcome was a reduction in emergency department presentations. Secondary outcomes were time spent on chemotherapy and the number of allied health service referrals. Results: From April 2016 to October 2018, 328 patients from four public hospitals received the intervention. Matched controls (n=1312) comprised the general population of patients with cancer, seen at the participating hospitals during the study period. Emergency department visits were significantly reduced by 33% (P=.02) among patients receiving the intervention compared with patients in the matched controls. No significant associations were found in allied health referrals or time to end of chemotherapy. At baseline, the most common patient reported outcomes (above-threshold) were fatigue (39%), tiredness (38.4%), worry (32.9%), general wellbeing (32.9%), and sleep (24.1%), aligning with the most frequently accessed self-management domain pages of physical well-being (36%) and emotional well-being (23%). The majority of clinical feedback reports were reviewed by nursing staff (729/893, 82%), largely in response to the automated clinical alerts (n=877). Conclusions: Algorithm-supported web-based systems utilizing patient reported outcomes in clinical practice reduced emergency department presentations among a diverse population of patients with cancer. This study also highlighted the importance of (1) automated triggers for reviewing above-threshold results in patient reports, rather than passive manual review of patient records; (2) the instrumental role nurses play in managing alerts; and (3) providing patients with resources to support guided self-management, where appropriate. Together, these factors will inform the integration of web-based PRO systems into future models of routine cancer care. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12616000615482; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370633 International Registered Report Identifier (IRRID): RR2-10.1186/s12885-018-4729-3 UR - http://www.jmir.org/2020/10/e19685/ UR - http://dx.doi.org/10.2196/19685 UR - http://www.ncbi.nlm.nih.gov/pubmed/33118954 ID - info:doi/10.2196/19685 ER - TY - JOUR AU - Collado-Borrell, Roberto AU - Escudero-Vilaplana, Vicente AU - Ribed, Almudena AU - Gonzalez-Anleo, Cristina AU - Martin-Conde, Maite AU - Romero-Jimenez, Rosa AU - Iglesias-Peinado, Irene AU - Herranz-Alonso, Ana AU - Sanjurjo-Saez, Maria PY - 2020/10/16 TI - Effect of a Mobile App for the Pharmacotherapeutic Follow-Up of Patients With Cancer on Their Health Outcomes: Quasi-Experimental Study JO - JMIR Mhealth Uhealth SP - e20480 VL - 8 IS - 10 KW - e-OncoSalud KW - app KW - smartphone KW - oral antineoplastic agent KW - oncology N2 - Background: Oral antineoplastic agents (OAAs) have revolutionized cancer management. However, they have been reported with adverse side effects and drug-drug interactions. Moreover, patient adherence to OAA treatment is critical. Mobile apps can enable remote and real-time pharmacotherapeutic monitoring of patients, while also promoting patient autonomy in their health care. Objective: The primary objective was to analyze the effect of using a mobile app for the follow-up of patients with oncohematological malignancies undergoing treatment with OAAs on their health outcomes. The secondary objectives were to analyze the role of the app in communication with health care professionals and patient satisfaction with the app. Methods: We performed a comparative, quasi-experimental study based on a prepost intervention with 101 patients (control group, n=51, traditional pharmacotherapeutic follow-up vs intervention group, n=50, follow-up through e-OncoSalud, a custom-designed app that promotes follow-up at home and the safety of patients receiving OAAs). The effect of this app on drug safety, adherence to treatment, and quality of life was evaluated. Results: With regard to drug safety, 73% (37/51) of the patients in the control group and 70% (35/50) of the patients in the intervention group (P=.01) presented with drug-related problems. The probability of detecting an insufficiently treated health problem in the intervention group was significantly higher than that in the control group (P=.04). The proportion of patients who presented with side effects in the intervention group was significantly lower than that in the control group (P>.99). In the control group, 49% (25/51) of the patients consumed some health resources during the first 6 months of treatment compared with 36% (18/50) of the patients in the intervention group (P=.76). Adherence to treatment was 97.6% (SD 7.9) in the intervention group, which was significantly higher than that in the control group (92.9% [SD 10.0]; P=.02). The EuroQol-5D in the intervention group yielded a mean (SD) index of 0.875 (0.156), which was significantly higher than that in the control group (0.741 [0.177]; P<.001). Approximately 60% (29/50) of the patients used the messaging module to communicate with pharmacists. The most frequent types of messages were acknowledgments (77/283, 27.2%), doubts about contraindications and interactions with OAAs (70/283, 24.7%), and consultations for adverse reactions to treatment (39/283, 13.8%). The satisfaction with the app survey conducted in the intervention group yielded an overall mean (SD) score of 9.1 (0.4) out of 10. Conclusions: Use of e-OncoSalud for the real-time follow-up of patients receiving OAAs facilitated the optimization of some health outcomes. The intervention group had significantly higher health-related quality of life and adherence to treatment than the control group. Further, the probability of the intervention group presenting with side effects was significantly lower than that of the control group. UR - http://mhealth.jmir.org/2020/10/e20480/ UR - http://dx.doi.org/10.2196/20480 UR - http://www.ncbi.nlm.nih.gov/pubmed/33064100 ID - info:doi/10.2196/20480 ER - TY - JOUR AU - Brusniak, Katharina AU - Arndt, Maria Hannah AU - Feisst, Manuel AU - Haßdenteufel, Kathrin AU - Matthies, Maria Lina AU - Deutsch, Maximilian Thomas AU - Hudalla, Hannes AU - Abele, Harald AU - Wallwiener, Markus AU - Wallwiener, Stephanie PY - 2020/10/14 TI - Challenges in Acceptance and Compliance in Digital Health Assessments During Pregnancy: Prospective Cohort Study JO - JMIR Mhealth Uhealth SP - e17377 VL - 8 IS - 10 KW - eHealth KW - compliance KW - pregnancy KW - digital assessments N2 - Background: Pregnant women are increasingly using mobile apps to access health information during the antenatal period. Therefore, digital health solutions can potentially be used as monitoring instruments during pregnancy. However, a main factor of success is high user engagement. Objective: The aim of this study was to analyze engagement and factors influencing compliance in a longitudinal study targeting pregnant women using a digital health app with self-tracking. Methods: Digitally collected data concerning demographics, medical history, technical aspects, and mental health from 585 pregnant women were analyzed. Patients filling out ?80% of items at every study visit were considered to be highly compliant. Factors associated with high compliance were identified using logistic regression. The effect of a change in mental and physical well-being on compliance was assessed using a one-sample t test. Results: Only 25% of patients could be considered compliant. Overall, 63% left at least one visit blank. Influential variables for higher engagement included higher education, higher income, private health insurance, nonsmoking, and German origin. There was no relationship between a change in the number of physical complaints or depressive symptoms and study dropout. Conclusions: Maintaining high engagement with digital monitoring devices over a long time remains challenging. As cultural and socioeconomic background factors had the strongest influence, more effort needs to be directed toward understanding the needs of patients from different demographic backgrounds to ensure high-quality care for all patients. More studies need to report on compliance to disclose potential demographic bias. UR - https://mhealth.jmir.org/2020/10/e17377 UR - http://dx.doi.org/10.2196/17377 UR - http://www.ncbi.nlm.nih.gov/pubmed/33052134 ID - info:doi/10.2196/17377 ER - TY - JOUR AU - Kwan, Heng Yu AU - Weng, Dun Si AU - Loh, Fang Dionne Hui AU - Phang, Kie Jie AU - Oo, Yi Livia Jia AU - Blalock, V. Dan AU - Chew, Hui Eng AU - Yap, Zhen Kai AU - Tan, Koon Corrinne Yong AU - Yoon, Sungwon AU - Fong, Warren AU - Řstbye, Truls AU - Low, Leng Lian AU - Bosworth, Barry Hayden AU - Thumboo, Julian PY - 2020/10/9 TI - Measurement Properties of Existing Patient-Reported Outcome Measures on Medication Adherence: Systematic Review JO - J Med Internet Res SP - e19179 VL - 22 IS - 10 KW - systematic review KW - reliability and validity KW - medication adherence KW - patient reported outcome measures N2 - Background: Medication adherence is essential for improving the health outcomes of patients. Various patient-reported outcome measures (PROMs) have been developed to measure medication adherence in patients. However, no study has summarized the psychometric properties of these PROMs to guide selection for use in clinical practice or research. Objective: This study aims to evaluate the quality of the PROMs used to measure medication adherence. Methods: This study was guided by the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) guidelines. Relevant articles were retrieved from the EMBASE, PubMed, Cochrane Library, Web of Science, and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases. The PROMs were then evaluated based on the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines. Results: A total of 121 unique medication adherence PROMs from 214 studies were identified. Hypotheses testing for construct validity and internal consistency were the most frequently assessed measurement properties. PROMs with at least a moderate level of evidence for ?5 measurement properties include the Adherence Starts with Knowledge 20, Compliance Questionnaire-Rheumatology, General Medication Adherence Scale, Hill-Bone Scale, Immunosuppressant Therapy Barrier Scale, Medication Adherence Reasons Scale (MAR-Scale) revised, 5-item Medication Adherence Rating Scale (MARS-5), 9-item MARS (MARS-9), 4-item Morisky Medication Adherence Scale (MMAS-4), 8-item MMAS (MMAS-8), Self-efficacy for Appropriate Medication Adherence Scale, Satisfaction with Iron Chelation Therapy, Test of Adherence to Inhalers, and questionnaire by Voils. The MAR-Scale revised, MMAS-4, and MMAS-8 have been administered electronically. Conclusions: This study identified 121 PROMs for medication adherence and provided synthesized evidence for the measurement properties of these PROMs. The findings from this study may assist clinicians and researchers in selecting suitable PROMs to assess medication adherence. UR - https://www.jmir.org/2020/10/e19179 UR - http://dx.doi.org/10.2196/19179 UR - http://www.ncbi.nlm.nih.gov/pubmed/33034566 ID - info:doi/10.2196/19179 ER - TY - JOUR AU - Kwan, Heng Yu AU - Oo, Yi Livia Jia AU - Loh, Fang Dionne Hui AU - Phang, Kie Jie AU - Weng, Dun Si AU - Blalock, V. Dan AU - Chew, Hui Eng AU - Yap, Zhen Kai AU - Tan, Koon Corrinne Yong AU - Yoon, Sungwon AU - Fong, Warren AU - Řstbye, Truls AU - Low, Leng Lian AU - Bosworth, Barry Hayden AU - Thumboo, Julian PY - 2020/10/8 TI - Development of an Item Bank to Measure Medication Adherence: Systematic Review JO - J Med Internet Res SP - e19089 VL - 22 IS - 10 KW - systematic review KW - patient-reported outcome measures KW - item bank KW - adherence N2 - Background: Medication adherence is important in managing the progression of chronic diseases. A promising approach to reduce cognitive burden when measuring medication adherence lies in the use of computer?adaptive tests (CATs) or in the development of shorter patient-reported outcome measures (PROMs). However, the lack of an item bank currently hampers this progress. Objective: We aim to develop an item bank to measure general medication adherence. Methods: Using the preferred reporting items for systematic review and meta-analysis (PRISMA), articles published before October 2019 were retrieved from PubMed, Embase, CINAHL, the Cochrane Library, and Web of Science. Items from existing PROMs were classified and selected (?binned? and ?winnowed?) according to standards published by the Patient-Reported Outcomes Measurement Information System (PROMIS) Cooperative Group. Results: A total of 126 unique PROMs were identified from 213 studies in 48 countries. Items from the literature review (47 PROMs with 579 items for which permission has been obtained) underwent binning and winnowing. This resulted in 421 candidate items (77 extent of adherence and 344 reasons for adherence). Conclusions: We developed an item bank for measuring general medication adherence using items from validated PROMs. This will allow researchers to create new PROMs from selected items and provide the foundation to develop CATs. UR - https://www.jmir.org/2020/10/e19089 UR - http://dx.doi.org/10.2196/19089 UR - http://www.ncbi.nlm.nih.gov/pubmed/33030441 ID - info:doi/10.2196/19089 ER - TY - JOUR AU - Middleton, M. Rod AU - Pearson, R. Owen AU - Ingram, Gillian AU - Craig, M. Elaine AU - Rodgers, J. William AU - Downing-Wood, Hannah AU - Hill, Joseph AU - Tuite-Dalton, Katherine AU - Roberts, Christopher AU - Watson, Lynne AU - Ford, V. David AU - Nicholas, Richard AU - PY - 2020/9/23 TI - A Rapid Electronic Cognitive Assessment Measure for Multiple Sclerosis: Validation of Cognitive Reaction, an Electronic Version of the Symbol Digit Modalities Test JO - J Med Internet Res SP - e18234 VL - 22 IS - 9 KW - cognition KW - multiple sclerosis KW - eHealth KW - electronic assessment KW - patient reported outcomes KW - neurology N2 - Background: Incorporating cognitive testing into routine clinical practice is a challenge in multiple sclerosis (MS), given the wide spectrum of both cognitive and physical impairments people can have and the time that testing requires. Shortened paper and verbal assessments predominate but still are not used routinely. Computer-based tests are becoming more widespread; however, changes in how a paper test is implemented can impact what exactly is being assessed in an individual. The Symbol Digit Modalities Test (SDMT) is one validated test that forms part of the cognitive batteries used in MS and has some computer-based versions. We developed a tablet-based SDMT variant that has the potential to be ultimately deployed to patients? own devices. Objective: This paper aims to develop, validate, and deploy a computer-based SDMT variant, the Cognition Reaction (CoRe) test, that can reliably replicate the characteristics of the paper-based SDMT. Methods: We carried out analysis using Pearson and intraclass correlations, as well as a Bland-Altman comparison, to examine consistency between the SDMT and CoRe tests and for test-retest reliability. The SDMT and CoRe tests were evaluated for sensitivity to disability levels and age. A novel metric in CoRe was found: question answering velocity could be calculated. This was evaluated in relation to disability levels and age for people with MS and compared with a group of healthy control volunteers. Results: SDMT and CoRe test scores were highly correlated and consistent with 1-month retest values. Lower scores were seen in patients with higher age and some effect was seen with increasing disability. There was no learning effect evident. Question answering velocity demonstrated a small increase in speed over the 90-second duration of the test in people with MS and healthy controls. Conclusions: This study validates a computer-based alternative to the SDMT that can be used in clinics and beyond. It enables accurate recording of elements of cognition relevant in MS but offers additional metrics that may offer further value to clinicians and people with MS. UR - http://www.jmir.org/2020/9/e18234/ UR - http://dx.doi.org/10.2196/18234 UR - http://www.ncbi.nlm.nih.gov/pubmed/32965240 ID - info:doi/10.2196/18234 ER - TY - JOUR AU - Heidel, Alexandra AU - Hagist, Christian PY - 2020/9/23 TI - Potential Benefits and Risks Resulting From the Introduction of Health Apps and Wearables Into the German Statutory Health Care System: Scoping Review JO - JMIR Mhealth Uhealth SP - e16444 VL - 8 IS - 9 KW - health apps KW - wearables KW - digital health application KW - mHealth N2 - Background: Germany is the first country worldwide that has introduced a digital care act as an incentive system to enhance the use of digital health devices, namely health apps and wearables, among its population. The act allows physicians to prescribe statutory financed and previously certified health apps and wearables to patients. This initiative has the potential to improve treatment quality through better disease management and monitoring. Objective: The aim of this paper was to outline the key concepts related to the potential risks and benefits discussed in the current literature about health apps and wearables. Furthermore, this study aimed to answer the research question: Which risks and benefits may result from the implementation of the digital care act in Germany? Methods: We conducted the scoping study by searching the databases PubMed, Google Scholar, and JMIR using the keywords health apps and wearables. We discussed 55 of 136 identified articles published in the English language from 2015 to March 2019 in this paper using a qualitative thematic analysis approach. Results: We identified four key themes within the articles: Effectivity of health apps and wearables to improve health; users of health apps and wearables; the potential of bring-your-own, self-tracked data; and concerns and data privacy risks. Within these themes, we identified three main stages of benefits for the German health care system: Usage of health apps and wearables; continuing to use health apps and wearables; and sharing bring-your-own; self-tracked data with different agents in the health care sector. Conclusions: The digital care act could lead to an improvement in treatment quality through better patient monitoring, disease management, personalized therapy, and better health education. However, physicians should play an active role in recommendingand supervising health app use to reach digital-illiterate or health-illiterate people. Age must not be an exclusion criterion. Yet, concerns about data privacy and security are very strong in Germany. Transparency about data processing should be provided at all times for continuing success of the digital care act in Germany. UR - http://mhealth.jmir.org/2020/9/e16444/ UR - http://dx.doi.org/10.2196/16444 UR - http://www.ncbi.nlm.nih.gov/pubmed/32965231 ID - info:doi/10.2196/16444 ER - TY - JOUR AU - Rolland, Benjamin AU - Haesebaert, Frédéric AU - Zante, Elodie AU - Benyamina, Amine AU - Haesebaert, Julie AU - Franck, Nicolas PY - 2020/9/18 TI - Global Changes and Factors of Increase in Caloric/Salty Food Intake, Screen Use, and Substance Use During the Early COVID-19 Containment Phase in the General Population in France: Survey Study JO - JMIR Public Health Surveill SP - e19630 VL - 6 IS - 3 KW - COVID-19 KW - containment KW - eating behaviors KW - screen use KW - internet use KW - substance use KW - public health KW - mental health KW - pandemic KW - lifestyle KW - online survey KW - addiction N2 - Background: The international outbreak of coronavirus disease (COVID-19) has led many countries to enforce drastic containment measures. It has been suggested that this abrupt lockdown of populations will foster addiction-related habits such as caloric/salty food intake, screen use, and substance use. Objective: Our aim was to assess the global changes and factors of increase in addiction-related habits during the early COVID-19 containment phase in France. Methods: A web-based survey was provided from day 8 to day 13 of the containment and was completed by 11,391 participants. The questions explored sociodemographic features, psychiatric/addiction history, material conditions of lockdown, general stress, mental well-being, and reported changes in several addiction-related behaviors. Global changes were described and factors of increase were explored using population-weighted and adjusted logistic regression models, providing adjusted odds ratios (aORs) and their 95% confidence intervals. Results: Overall, the respondents reported more increases in addiction-related habits than decreases, specifically 28.4% (caloric/salty food intake), 64.6% (screen use), 35.6% (tobacco use), 24.8% (alcohol use), and 31.2% (cannabis use). Reduced well-being scores and increased stress scores were general factors of increase in addiction-related habits (P<.001 for all habits). Factors of increase in caloric/salty food intake (n=10,771) were female gender (aOR 1.62, 95% CI 1.48-1.77), age less than 29 years (P<.001), having a partner (aOR 1.19, 95% CI 1.06-1.35), being locked down in a more confined space (per 1 square meter/person decrease: aOR 1.02, 95% CI 1.01-1.03), being locked down alone (aOR 1.29, 95% CI 1.11-1.49), and reporting current (aOR 1.94, 95% CI 1.62-2.31) or past (aOR 1.27, 95% CI 1.09-1.47) psychiatric treatment. Factors of increase in screen use (n=11,267) were female gender (aOR 1.31, 95% CI 1.21-1.43), age less than 29 years (P<.001), having no partner (aOR 1.18, 95% CI 1.06-1.32), being employed (P<.001), intermediate/high education level (P<.001), being locked down with no access to an outdoor space (aOR 1.16, 95% CI 1.05-1.29), being locked down alone (aOR 1.15, 95% CI 1.01-1.32), living in an urban environment (P<.01), and not working (P<.001). Factors of increase in tobacco use (n=2787) were female gender (aOR 1.31, 95% CI 1.11-1.55), having no partner (aOR 1.30, 95% CI 1.06-1.59), intermediate/low education level (P<.01), and still working in the workplace (aOR 1.47, 95% CI 1.17-1.86). Factors of increase in alcohol use (n=7108) were age 30-49 years (P<.05), a high level of education (P<.001), and current psychiatric treatment (aOR 1.44, 95% CI 1.10-1.88). The only significant factor of increase in cannabis use (n=620) was intermediate/low level of education (P<.001). Conclusions: The early phase of COVID-19 containment in France led to widespread increases in addiction-related habits in the general population. Reduced well-being and increased stress were universal factors of increase. More specific factors were associated with increases in each of the explored habits. UR - http://publichealth.jmir.org/2020/3/e19630/ UR - http://dx.doi.org/10.2196/19630 UR - http://www.ncbi.nlm.nih.gov/pubmed/32589149 ID - info:doi/10.2196/19630 ER - TY - JOUR AU - Boumans, Roel AU - van Meulen, Fokke AU - van Aalst, William AU - Albers, Joyce AU - Janssen, Marčse AU - Peters-Kop, Marieke AU - Huisman - de Waal, Getty AU - van de Poll, Alexandra AU - Hindriks, Koen AU - Neerincx, Mark AU - Olde Rikkert, Marcel PY - 2020/9/9 TI - Quality of Care Perceived by Older Patients and Caregivers in Integrated Care Pathways With Interviewing Assistance From a Social Robot: Noninferiority Randomized Controlled Trial JO - J Med Internet Res SP - e18787 VL - 22 IS - 9 KW - integrated care pathway KW - social robot KW - quality of care KW - noninferiority randomized controlled trial N2 - Background: Society is facing a global shortage of 17 million health care workers, along with increasing health care demands from a growing number of older adults. Social robots are being considered as solutions to part of this problem. Objective: Our objective is to evaluate the quality of care perceived by patients and caregivers for an integrated care pathway in an outpatient clinic using a social robot for patient-reported outcome measure (PROM) interviews versus the currently used professional interviews. Methods: A multicenter, two-parallel-group, nonblinded, randomized controlled trial was used to test for noninferiority of the quality of care delivered through robot-assisted care. The randomization was performed using a computer-generated table. The setting consisted of two outpatient clinics, and the study took place from July to December 2019. Of 419 patients who visited the participating outpatient clinics, 110 older patients met the criteria for recruitment. Inclusion criteria were the ability to speak and read Dutch and being assisted by a participating health care professional. Exclusion criteria were serious hearing or vision problems, serious cognitive problems, and paranoia or similar psychiatric problems. The intervention consisted of a social robot conducting a 36-item PROM. As the main outcome measure, the customized Consumer Quality Index (CQI) was used, as reported by patients and caregivers for the outpatient pathway of care. Results: In total, 75 intermediately frail older patients were included in the study, randomly assigned to the intervention and control groups, and processed: 36 female (48%) and 39 male (52%); mean age 77.4 years (SD 7.3), range 60-91 years. There was no significant difference in the total patient CQI scores between the patients included in the robot-assisted care pathway (mean 9.27, SD 0.65, n=37) and those in the control group (mean 9.00, SD 0.70, n=38): P=.08, 95% CI ?0.04 to 0.58. There was no significant difference in the total CQI scores between caregivers in the intervention group (mean 9.21, SD 0.76, n=30) and those in the control group (mean 9.09, SD 0.60, n=35): P=.47, 95% CI ?0.21 to 0.46. No harm or unintended effects occurred. Conclusions: Geriatric patients and their informal caregivers valued robot-assisted and nonrobot-assisted care pathways equally. Trial Registration: ClinicalTrials.gov NCT03857789; https://clinicaltrials.gov/ct2/show/NCT03857789 UR - http://www.jmir.org/2020/9/e18787/ UR - http://dx.doi.org/10.2196/18787 UR - http://www.ncbi.nlm.nih.gov/pubmed/32902387 ID - info:doi/10.2196/18787 ER - TY - JOUR AU - Schoenthaler, Antoinette AU - Cruz, Jocelyn AU - Payano, Leydi AU - Rosado, Marina AU - Labbe, Kristen AU - Johnson, Chrystal AU - Gonzalez, Javier AU - Patxot, Melissa AU - Patel, Smit AU - Leven, Eric AU - Mann, Devin PY - 2020/8/31 TI - Investigation of a Mobile Health Texting Tool for Embedding Patient-Reported Data Into Diabetes Management (i-Matter): Development and Usability Study JO - JMIR Form Res SP - e18554 VL - 4 IS - 8 KW - patient-reported outcome measures KW - mobile health KW - type 2 diabetes N2 - Background: Patient-reported outcomes (PROs) are increasingly being used in the management of type 2 diabetes (T2D) to integrate data from patients? perspective into clinical care. To date, the majority of PRO tools have lacked patient and provider involvement in their development, thus failing to meet the unique needs of end users, and lack the technical infrastructure to be integrated into the clinic workflow. Objective: This study aims to apply a systematic, user-centered design approach to develop i-Matter (investigating a mobile health [mHealth] texting tool for embedding patient-reported data into diabetes management), a theory-driven, mobile PRO system for patients with T2D and their primary care providers. Methods: i-Matter combines text messaging with dynamic data visualizations that can be integrated into electronic health records (EHRs) and personalized patient reports. To build i-Matter, we conducted semistructured group and individual interviews with patients with T2D and providers, a design thinking workshop to refine initial ideas and design the prototype, and user testing sessions of prototypes using a rapid-cycle design (ie, design-test-modify-retest). Results: Using an iterative user-centered process resulted in the identification of 6 PRO messages that were relevant to patients and providers: medication adherence, dietary behaviors, physical activity, sleep quality, quality of life, and healthy living goals. In user testing, patients recommended improvements to the wording and timing of the PRO text messages to increase clarity and response rates. Patients also recommended including motivational text messages to help sustain engagement with the program. The personalized report was regarded as a key tool for diabetes self-management by patients and providers because it aided in the identification of longitudinal patterns in the PRO data, which increased patient awareness of their need to adopt healthier behaviors. Patients recommended adding individualized tips to the journal on how they can improve their behaviors. Providers preferred having a separate tab built into the EHR that included the personalized report and highlighted key trends in patients? PRO data over the past 3 months. Conclusions: PRO tools that capture patients? well-being and the behavioral aspects of T2D management are important to patients and providers. A clinical trial will test the efficacy of i-Matter in 282 patients with uncontrolled T2D. Trial Registration: ClinicalTrials.gov NCT03652389; https://clinicaltrials.gov/ct2/show/NCT03652389 UR - https://formative.jmir.org/2020/8/e18554 UR - http://dx.doi.org/10.2196/18554 UR - http://www.ncbi.nlm.nih.gov/pubmed/32865505 ID - info:doi/10.2196/18554 ER - TY - JOUR AU - Lee, Joon PY - 2020/8/26 TI - Is Artificial Intelligence Better Than Human Clinicians in Predicting Patient Outcomes? JO - J Med Internet Res SP - e19918 VL - 22 IS - 8 KW - patient outcome prediction KW - artificial intelligence KW - machine learning KW - human-generated predictions KW - human-AI symbiosis UR - http://www.jmir.org/2020/8/e19918/ UR - http://dx.doi.org/10.2196/19918 UR - http://www.ncbi.nlm.nih.gov/pubmed/32845249 ID - info:doi/10.2196/19918 ER - TY - JOUR AU - Loo, Stephanie AU - Grasso, Chris AU - Glushkina, Jessica AU - McReynolds, Justin AU - Lober, William AU - Crane, Heidi AU - Mayer, H. Kenneth PY - 2020/8/19 TI - Capturing Relevant Patient Data in Clinical Encounters Through Integration of an Electronic Patient-Reported Outcome System Into Routine Primary Care in a Boston Community Health Center: Development and Implementation Study JO - J Med Internet Res SP - e16778 VL - 22 IS - 8 KW - information technology in health KW - primary care KW - technology adoption KW - technology diffusion N2 - Background: Electronic patient-reported outcome (ePRO) systems can improve health outcomes by detecting health issues or risk behaviors that may be missed when relying on provider elicitation. Objective: This study aimed to implement an ePRO system that administers key health questionnaires in an urban community health center in Boston, Massachusetts. Methods: An ePRO system that administers key health questionnaires was implemented in an urban community health center in Boston, Massachusetts. The system was integrated with the electronic health record so that medical providers could review and adjudicate patient responses in real-time during the course of the patient visit. This implementation project was accomplished through careful examination of clinical workflows and a graduated rollout process that was mindful of patient and clinical staff time and burden. Patients responded to questionnaires using a tablet at the beginning of their visit. Results: Our program demonstrates that implementation of an ePRO system in a primary care setting is feasible, allowing for facilitation of patient-provider communication and care. Other community health centers can learn from our model in terms of applying technological innovation to streamline clinical processes and improve patient care. Conclusions: Our program demonstrates that implementation of an ePRO system in a primary care setting is feasible, allowing for facilitation of patient-provider communication and care. Other community health centers can learn from our model for application of technological innovation to streamline clinical processes and improve patient care. UR - http://www.jmir.org/2020/8/e16778/ UR - http://dx.doi.org/10.2196/16778 UR - http://www.ncbi.nlm.nih.gov/pubmed/32554372 ID - info:doi/10.2196/16778 ER - TY - JOUR AU - Gra?i? Kuhar, Cvetka AU - Gortnar Cepeda, Tja?a AU - Kova?, Timotej AU - Kukar, Matja? AU - Ru?i? Gorenjec, Nina PY - 2020/8/4 TI - Mobile App for Symptom Management and Associated Quality of Life During Systemic Treatment in Early Stage Breast Cancer: Nonrandomized Controlled Prospective Cohort Study JO - JMIR Mhealth Uhealth SP - e17408 VL - 8 IS - 8 KW - breast cancer KW - systemic therapy KW - mobile application KW - patient-reported outcome KW - quality of life N2 - Background: Providing patients with cancer who are undergoing systemic therapy with useful information about symptom management is essential to prevent unnecessary deterioration of quality of life. Objective: The aim was to evaluate whether use of an app for symptom management was associated with any change in patient quality of life or use of health resources. Methods: Outpatients with early stage breast cancer receiving systemic therapy were recruited at the Institute of Oncology in Ljubljana, Slovenia. Patients who received systemic therapy between December 2017 and March 2018 (control group) and between April 2018 and September 2018 (intervention group) were eligible. All patients received standard care, but only those in the intervention group were asked to use mPRO Mamma, an Android-based smartphone app, in addition. The app supported daily tracking of 50 symptoms, allowed users to grade their symptom severity (as mild, moderate, or severe), and also provided in-depth descriptions and recommendations based on reported symptom level. Patient-reported outcomes in both groups were assessed through the European Organisation for Research and Treatment of Cancer (EORTC) core (C-30) and breast cancer (BR-23) questionnaires, as well as a questionnaire about health resources use. The primary outcomes were the difference in the global quality of life between groups and the difference in summary score of the EORTC C-30 questionnaire between groups after 3 time periods (the first week of treatment, the first treatment cycle, and the entire treatment). The secondary outcome was the use of health resources (doctor visits and hospitalizations) in each time period. Other scales were used for exploratory analysis. Results: The mean difference between the intervention group (n=46) and the control group (n=45) in global quality of life (adjusted for baseline and type of surgery) after the first week was 10.1 (95% CI 1.8 to 18.5, P=.02). The intervention group summary scores were significantly higher than those of the control group after the first week (adjusted mean difference: 8.9, 95% CI 3.1 to 14.7, P=.003) and at the end of treatment (adjusted mean difference: 10.6, 95% CI 3.9 to 17.3, P=.002). Use of health resources was not statistically significant between the groups in either the first week (P=.12) or the first treatment cycle (P=.13). Exploratory analysis findings demonstrated clinically important improvements (indicated by EORTC C-30 or BR-23 scale scores)?social, physical, role, and cognitive function were improved while pain, appetite loss, and systemic therapy side effects were reduced. Conclusions: Use of the app enabled patients undergoing systemic therapy for early stage breast cancer to better cope with symptoms which was demonstrated by a better global quality of life and summary score after the first week and by a better summary score at the end of treatment in the intervention group compared to those of the control group, but no change in the use of health resources was demonstrated. UR - https://mhealth.jmir.org/2020/8/e17408 UR - http://dx.doi.org/10.2196/17408 UR - http://www.ncbi.nlm.nih.gov/pubmed/32427567 ID - info:doi/10.2196/17408 ER - TY - JOUR AU - Steele Gray, Carolyn PY - 2020/7/29 TI - Seeking Meaningful Innovation: Lessons Learned Developing, Evaluating, and Implementing the Electronic Patient-Reported Outcome Tool JO - J Med Internet Res SP - e17987 VL - 22 IS - 7 KW - digital health KW - implementation KW - meaningfulness UR - http://www.jmir.org/2020/7/e17987/ UR - http://dx.doi.org/10.2196/17987 UR - http://www.ncbi.nlm.nih.gov/pubmed/32723725 ID - info:doi/10.2196/17987 ER - TY - JOUR AU - Anthony, A. Chris AU - Rojas, Octavio Edward AU - Keffala, Valerie AU - Glass, Ann Natalie AU - Shah, S. Apurva AU - Miller, J. Benjamin AU - Hogue, Matthew AU - Willey, C. Michael AU - Karam, Matthew AU - Marsh, Lawrence John PY - 2020/7/29 TI - Acceptance and Commitment Therapy Delivered via a Mobile Phone Messaging Robot to Decrease Postoperative Opioid Use in Patients With Orthopedic Trauma: Randomized Controlled Trial JO - J Med Internet Res SP - e17750 VL - 22 IS - 7 KW - acceptance and commitment therapy KW - opioid crisis KW - patient-reported outcome measures KW - postoperative pain KW - orthopedics KW - text messaging KW - chatbot KW - conversational agents KW - mHealth N2 - Background: Acceptance and commitment therapy (ACT) is a pragmatic approach to help individuals decrease avoidable pain. Objective: This study aims to evaluate the effects of ACT delivered via an automated mobile messaging robot on postoperative opioid use and patient-reported outcomes (PROs) in patients with orthopedic trauma who underwent operative intervention for their injuries. Methods: Adult patients presenting to a level 1 trauma center who underwent operative fixation of a traumatic upper or lower extremity fracture and who used mobile phone text messaging were eligible for the study. Patients were randomized in a 1:1 ratio to either the intervention group, who received twice-daily mobile phone messages communicating an ACT-based intervention for the first 2 weeks after surgery, or the control group, who received no messages. Baseline PROs were completed. Two weeks after the operative intervention, follow-up was performed in the form of an opioid medication pill count and postoperative administration of PROs. The mean number of opioid tablets used by patients was calculated and compared between groups. The mean PRO scores were also compared between the groups. Results: A total of 82 subjects were enrolled in the study. Of the 82 participants, 76 (38 ACT and 38 controls) completed the study. No differences between groups in demographic factors were identified. The intervention group used an average of 26.1 (SD 21.4) opioid tablets, whereas the control group used 41.1 (SD 22.0) tablets, resulting in 36.5% ([41.1-26.1]/41.1) less tablets used by subjects receiving the mobile phone?based ACT intervention (P=.004). The intervention group subjects reported a lower postoperative Patient-Reported Outcome Measure Information System Pain Intensity score (mean 45.9, SD 7.2) than control group subjects (mean 49.7, SD 8.8; P=.04). Conclusions: In this study, the delivery of an ACT-based intervention via an automated mobile messaging robot in the acute postoperative period decreased opioid use in selected patients with orthopedic trauma. Participants receiving the ACT-based intervention also reported lower pain intensity after 2 weeks, although this may not represent a clinically important difference. Trial Registration: ClinicalTrials.gov NCT03991546; https://clinicaltrials.gov/ct2/show/NCT03991546 UR - https://www.jmir.org/2020/7/e17750 UR - http://dx.doi.org/10.2196/17750 UR - http://www.ncbi.nlm.nih.gov/pubmed/32723723 ID - info:doi/10.2196/17750 ER - TY - JOUR AU - Schrage, Theresa AU - Görlach, Mirja AU - Betz, Stephan Christian AU - Bokemeyer, Carsten AU - Kröger, Nicolaus AU - Mueller, Volkmar AU - Petersen, Cordula AU - Krüll, Andreas AU - Schulz, Holger AU - Bleich, Christiane PY - 2020/7/29 TI - Development of a Short Instrument for Measuring Health-Related Quality of Life in Oncological Patients for Clinical Use: Protocol for an Observational Study JO - JMIR Res Protoc SP - e17854 VL - 9 IS - 7 KW - patient-reported outcomes KW - health-related quality of life KW - oncology KW - psychometric validation KW - mixed methods study N2 - Background: Cancer patients often suffer from the physical and psychological burden of their disease and its treatment. This is frequently insufficiently identified and addressed in clinical practice. In the context of improving patient-centered care in oncological patients, patient-reported outcomes (PROs) represent an important addition to current routine care. So far, available PRO questionnaires for cancer patients are unsuitable for routine procedures due to their length and complexity. Objective: This study aimed to develop and psychometrically test a short questionnaire to measure health-related quality of life (HrQoL) in cancer patients for use in routine care. Methods: This observational study consists of two parts: (1) a qualitative study to develop a short questionnaire measuring HrQoL and (2) a quantitative study to psychometrically test this questionnaire in five oncological departments of a comprehensive cancer center. In part 1 of the study, semistructured interviews with 28 cancer patients, as well as five focus groups with 22 clinicians and nurses, were conducted to identify clinically relevant dimensions of HrQoL. The identified dimensions were complemented with related dimensions from empirical studies and reviewed via expert discussion. Based on this, a short instrument was developed. In part 2 of the study, the developed questionnaire was tested in cancer in- and outpatients at five participating oncological clinics using additional standardized questionnaires assessing HrQoL and other important PROs. The questionnaire was presented to more than 770 patients twice during treatment. Results: The project started in May 2017 with recruitment for study phase I beginning in December 2017. Recruitment for study phases I and II ended in April 2018 and February 2019, respectively. After study phase II and psychometrical analyses, the newly developed questionnaire measuring the HrQoL of all cancer entities in routine care was finalized. Conclusions: With five to six dimensions and one item per dimension, the developed questionnaire is short enough to not disrupt routine procedures during treatment and is profound enough to inform clinicians about the patient?s HrQoL impairments and status. Trial Registration: Open Science Framework Registries 10.17605/OSF.IO/Y7XCE; https://osf.io/y7xce/ International Registered Report Identifier (IRRID): RR1-10.2196/17854 UR - https://www.researchprotocols.org/2020/7/e17854 UR - http://dx.doi.org/10.2196/17854 UR - http://www.ncbi.nlm.nih.gov/pubmed/32726289 ID - info:doi/10.2196/17854 ER - TY - JOUR AU - Dimaguila, Luis Gerardo AU - Gray, Kathleen AU - Merolli, Mark PY - 2020/7/28 TI - Enabling Better Use of Person-Generated Health Data in Stroke Rehabilitation Systems: Systematic Development of Design Heuristics JO - J Med Internet Res SP - e17132 VL - 22 IS - 7 KW - person-generated health data KW - patient-reported outcome measures KW - heuristics KW - stroke rehabilitation KW - consumer health informatics KW - evidence-based practice KW - information technology N2 - Background: An established and well-known method for usability assessment of various human-computer interaction technologies is called heuristic evaluation (HE). HE has been adopted for evaluations in a wide variety of specialized contexts and with objectives that go beyond usability. A set of heuristics to evaluate how health information technologies (HITs) incorporate features that enable effective patient use of person-generated health data (PGHD) is needed in an era where there is a growing demand and variety of PGHD-enabled technologies in health care and where a number of remote patient-monitoring technologies do not yet enable patient use of PGHD. Such a set of heuristics would improve the likelihood of positive effects from patients? use of PGHD and lower the risk of negative effects. Objective: This study aims to describe the development of a set of heuristics for the design and evaluation of how well remote patient therapeutic technologies enable patients to use PGHD (PGHD enablement). We used the case of Kinect-based stroke rehabilitation systems (K-SRS) in this study. Methods: The development of a set of heuristics to enable better use of PGHD was primarily guided by the R3C methodology. Closer inspection of the methodology reveals that neither its development nor its application to a case study were described in detail. Thus, where relevant, each step was grounded through best practice activities in the literature and by using Nielsen?s heuristics as a basis for determining the new set of heuristics. As such, this study builds on the R3C methodology, and the implementation of a mixed process is intended to result in a robust and credible set of heuristics. Results: A total of 8 new heuristics for PGHD enablement in K-SRS were created. A systematic and detailed process was applied in each step of heuristic development, which bridged the gaps described earlier. It is hoped that this would aid future developers of specialized heuristics, who could apply the detailed process of heuristic development for other domains of technology, and additionally for the case of PGHD enablement for other health conditions. The R3C methodology was also augmented through the use of qualitative studies with target users and domain experts, and it is intended to result in a robust and credible set of heuristics, before validation and refinement. Conclusions: This study is the first to develop a new set of specialized heuristics to evaluate how HITs incorporate features that enable effective patient use of PGHD, with K-SRS as a key case study. In addition, it is the first to describe how the identification of initial HIT features and concepts to enable PGHD could lead to the development of a specialized set of heuristics. UR - http://www.jmir.org/2020/7/e17132/ UR - http://dx.doi.org/10.2196/17132 UR - http://www.ncbi.nlm.nih.gov/pubmed/32720901 ID - info:doi/10.2196/17132 ER - TY - JOUR AU - Jiwani, Rozmin AU - Wang, Jing AU - Berndt, Andrea AU - Ramaswamy, Padmavathy AU - Mathew Joseph, Nitha AU - Du, Yan AU - Ko, Jisook AU - Espinoza, Sara PY - 2020/7/24 TI - Changes in Patient-Reported Outcome Measures With a Technology-Supported Behavioral Lifestyle Intervention Among Patients With Type 2 Diabetes: Pilot Randomized Controlled Clinical Trial JO - JMIR Diabetes SP - e19268 VL - 5 IS - 3 KW - Patient-Reported Outcome Measurement Information System KW - patient-reported outcomes KW - patient-reported outcome measures KW - type 2 diabetes KW - self-management KW - self-monitoring KW - behavioral lifestyle interventions N2 - Background: In the United States, more than one-third of the adult population is obese, and approximately 25.2% of those aged ?65 years have type 2 diabetes (T2D), which is the seventh leading cause of death. It is important to measure patient-reported outcomes and monitor progress or challenges over time when managing T2D to understand patients? perception of health and quantify the impact of disease processes or intervention effects. The evaluation of patient-reported outcome measures (PROMs) is especially important among patients with multiple chronic conditions in which clinical measures do not provide a complete picture of health. Objective: This study examined the feasibility of collecting Patient-Reported Outcome Measurement Information System (PROMIS) measures, and preliminarily evaluated changes in PROMIS scores and compared the scores with standard scores of the general US population. The parent study is a pilot randomized controlled clinical trial testing three different modes (mobile health [mHealth], paper diary, and control) of self-monitoring in a behavioral lifestyle intervention among overweight or obese patients with T2D. Methods: Patients with comorbid overweight or obesity and a diagnosis of T2D for at least 6 months were recruited from a diabetes education program. Participants were randomized to the following three groups: mHealth, paper diary, and control (standard of care) groups. Paper diary and mHealth experimental groups received additional behavioral lifestyle intervention education sessions, as well as tools to self-monitor weight, physical activity, diet, and blood glucose. All participants completed PROMIS-57 and PROMIS-Global Health (GH) version 1.0 questionnaires during visits at baseline, 3 months, and 6 months. The PROMIS-57 includes the following seven domains: anxiety, depression, fatigue, pain interference, physical function, satisfaction with participation in social roles, and sleep disturbance. The PROMIS-GH is composed of the following two domains: global mental health and global physical health. Results: A total of 26 patients (mHealth, 11; paper diary, 9; control, 6) were included in our analysis. The study sample was predominantly African American (68%) and female (57%), with a mean age of 54.7 years and a mean BMI of 37.5 kg/m2. All patients completed the PROMIS-57 and PROMIS-GH questionnaires, and we compared the mean scores of the three groups to investigate potential differences. No relevant differences were noted across the groups. However, positive trends were noted in both intervention (mHealth and paper diary) groups in the middle (month 3) and end (month 6) of the study. Conclusions: Our pilot study provides evidence for the feasibility of using PROMIS questionnaires to record important components of T2D-related symptoms among overweight or obese individuals. The results from our study support the use of PROMIS questionnaires to provide clinicians and researchers with a benchmark for assessing the overall need for symptom management and determining the success or challenges of an intervention. Trial Registration: ClinicalTrials.gov NCT02858648; https://clinicaltrials.gov/ct2/show/NCT02858648 UR - http://diabetes.jmir.org/2020/3/e19268/ UR - http://dx.doi.org/10.2196/19268 UR - http://www.ncbi.nlm.nih.gov/pubmed/32706652 ID - info:doi/10.2196/19268 ER - TY - JOUR AU - Springer, Michael Jason AU - Kermani, A. Tanaz AU - Sreih, Antoine AU - Shaw, G. Dianne AU - Young, Kalen AU - Burroughs, M. Cristina AU - Merkel, A. Peter PY - 2020/7/20 TI - Clinical Characteristics of an Internet-Based Cohort of Patient-Reported Diagnosis of Granulomatosis With Polyangiitis and Microscopic Polyangiitis: Observational Study JO - J Med Internet Res SP - e17231 VL - 22 IS - 7 KW - granulomatosis with polyangiitis KW - microscopic polyangiitis KW - vasculitis KW - patient-reported outcomes KW - patient registry KW - electronic health records KW - questionnaire KW - online cohort N2 - Background: Utilizing the traditional centers of excellence approach to conduct clinical trials involving rare diseases remains challenging. Patient-based registries have been shown to be both feasible and valid in several other diseases. Objective: This report outlines the clinical characteristics of a large internet registry cohort of participants with a self-reported diagnosis of granulomatosis with polyangiitis or microscopic polyangiitis. Methods: Patients with a self-reported diagnosis of granulomatosis with polyangiitis or microscopic polyangiitis in an internet-based prospective longitudinal cohort (from the Vasculitis Patient-Powered Research Network) were included. Data on symptoms, diagnostic testing, and treatment were collected using standardized questionnaires. Results: The study compared patients with granulomatosis with polyangiitis (n=762) and patients with microscopic polyangiitis (n=164). Of the cohort, 97.7% (904/925) reported the diagnosis had been confirmed by a physician. Compared to microscopic polyangiitis, patients with granulomatosis with polyangiitis reported significantly more ear, nose, and throat manifestations (granulomatosis with polyangiitis: 641/723, 88.7%; microscopic polyangiitis: 89/164, 54.3%; z=10.42, P<.001), fevers (granulomatosis with polyangiitis: 325/588, 55.3%; microscopic polyangiitis: 64/139, 46.0%; z=1.96, P=.05), joint involvement (granulomatosis with polyangiitis: 549/688, 79.8%; microscopic polyangiitis: 106/154, 68.8%; z=2.96, P=.003), and pulmonary involvement (granulomatosis with polyangiitis: 523/734, 71.3%; microscopic polyangiitis: 90/154, 58.4%; z=3.13, P=.002). Compared to microscopic polyangiitis, patients with granulomatosis with polyangiitis reported significantly less renal involvement (granulomatosis with polyangiitis: 457/743, 61.5%; microscopic polyangiitis: 135/163, 82.8%; z=?5.18, P<.001) and renal transplantation (granulomatosis with polyangiitis: 10/721, 1.4%; microscopic polyangiitis: 7/164, 4.3%; z=?2.43, P=.02). Antineutrophil cytoplasmic antibody positivity was reported in 94.2% (652/692) of patients with granulomatosis with polyangiitis and 96.1% (147/153) of patients with microscopic polyangiitis. A biopsy showing vasculitis was reported in 77.0% (562/730) of patients with granulomatosis with polyangiitis and 81.9% (131/160) of patients with microscopic polyangiitis. Conclusions: In this large, internet-based cohort of patients with a self-reported diagnosis of granulomatosis with polyangiitis or microscopic polyangiitis, disease manifestations were consistent with expectations for each type of vasculitis. Given the rarity of these and other vasculitides, conducting some types of research through internet-based registries may provide an efficient alternative to inperson, center-of-excellence clinical trials. UR - https://www.jmir.org/2020/7/e17231 UR - http://dx.doi.org/10.2196/17231 UR - http://www.ncbi.nlm.nih.gov/pubmed/32459634 ID - info:doi/10.2196/17231 ER - TY - JOUR AU - Krusche, Martin AU - Klemm, Philipp AU - Grahammer, Manuel AU - Mucke, Johanna AU - Vossen, Diana AU - Kleyer, Arnd AU - Sewerin, Philipp AU - Knitza, Johannes PY - 2020/7/20 TI - Acceptance, Usage, and Barriers of Electronic Patient-Reported Outcomes Among German Rheumatologists: Survey Study JO - JMIR Mhealth Uhealth SP - e18117 VL - 8 IS - 7 KW - electronic patient-reported outcome measures KW - eHealth KW - rheumatology KW - rheumatoid arthritis KW - patient perspective KW - mobile phone N2 - Background: The use of patient-reported outcomes (PROs) allows for patient-centered, measurable, and transparent care. Electronic PROs (ePROs) have many benefits and hold great potential to improve current usage of PROs, yet limited evidence exists regarding their acceptance, usage, and barriers among rheumatologists. Objective: This study aims to evaluate the current level of acceptance, usage, and barriers among German rheumatologists regarding the use of ePROs. The importance of different ePRO features for rheumatologists was investigated. Additionally, the most frequently used PROs for patients with rheumatoid arthritis (RA) were identified. Methods: Data were collected via an online survey consisting of 18 questions. The survey was completed by members of the Working Group Young Rheumatology of the German Society for Rheumatology (Arbeitsgemeinschaft Junge Rheumatologie der Deutschen Gesellschaft für Rheumatologie [DGRh]) at the 2019 annual DGRh conference. Only members currently working in clinical adult rheumatology were eligible to complete the survey. Results: A total of 119 rheumatologists completed the survey, of which 107 (89.9%) reported collecting PROs in routine practice and 28 (25.5%) already used ePROs. Additionally, 44% (43/97) were planning to switch to ePROs in the near future. The most commonly cited reason for not switching was the unawareness of suitable software solutions. Respondents were asked to rate the features of ePROs on a scale of 0 to 100 (0=unimportant, 100=important). The most important features were automatic score calculation and display (mean 77.50) and simple data transfer to medical reports (mean 76.90). When asked about PROs in RA, the respondents listed pain, morning stiffness, and patient global assessment as the most frequently used PROs. Conclusions: The potential of ePROs is widely seen and there is great interest in them. Despite this, only a minority of physicians use ePROs, and the main reason for not implementing them was cited as the unawareness of suitable software solutions. Developers, patients, and rheumatologists should work closely together to help realize the full potential of ePROs and ensure a seamless integration into clinical practice. UR - http://mhealth.jmir.org/2020/7/e18117/ UR - http://dx.doi.org/10.2196/18117 UR - http://www.ncbi.nlm.nih.gov/pubmed/32390592 ID - info:doi/10.2196/18117 ER - TY - JOUR AU - Schleimer, Erica AU - Pearce, Jennifer AU - Barnecut, Andrew AU - Rowles, William AU - Lizee, Antoine AU - Klein, Arno AU - Block, J. Valerie AU - Santaniello, Adam AU - Renschen, Adam AU - Gomez, Refujia AU - Keshavan, Anisha AU - Gelfand, M. Jeffrey AU - Henry, G. Roland AU - Hauser, L. Stephen AU - Bove, Riley PY - 2020/7/6 TI - A Precision Medicine Tool for Patients With Multiple Sclerosis (the Open MS BioScreen): Human-Centered Design and Development JO - J Med Internet Res SP - e15605 VL - 22 IS - 7 KW - human-centered design KW - mobile phone KW - personal health record KW - participatory medicine KW - visualization in eHealth KW - human factors N2 - Background: Patients with multiple sclerosis (MS) face several challenges in accessing clinical tools to help them monitor, understand, and make meaningful decisions about their disease course. The University of California San Francisco MS BioScreen is a web-based precision medicine tool initially designed to be clinician facing. We aimed to design a second, openly available tool, Open MS BioScreen, that would be accessible, understandable, and actionable by people with MS. Objective: This study aimed to describe the human-centered design and development approach (inspiration, ideation, and implementation) for creating the Open MS BioScreen platform. Methods: We planned an iterative and cyclical development process that included stakeholder engagement and iterative feedback from users. Stakeholders included patients with MS along with their caregivers and family members, MS experts, generalist clinicians, industry representatives, and advocacy experts. Users consisted of anyone who wants to track MS measurements over time and access openly available tools for people with MS. Phase I (inspiration) consisted of empathizing with users and defining the problem. We sought to understand the main challenges faced by patients and clinicians and what they would want to see in a web-based app. In phase II (ideation), our multidisciplinary team discussed approaches to capture, display, and make sense of user data. Then, we prototyped a series of mock-ups to solicit feedback from clinicians and people with MS. In phase III (implementation), we incorporated all concepts to test and iterate a minimally viable product. We then gathered feedback through an agile development process. The design and development were cyclical?many times throughout the process, we went back to the drawing board. Results: This human-centered approach generated an openly available, web-based app through which patients with MS, their clinicians, and their caregivers can access the site and create an account. Users can enter information about their MS (basic level as well as more advanced concepts), visualize their data longitudinally, access a series of algorithms designed to empower them to make decisions about their treatments, and enter data from wearable devices to encourage realistic goal setting about their ambulatory activity. Agile development will allow us to continue to incorporate precision medicine tools, as these are validated in the clinical research arena. Conclusions: After engaging intended users into the iterative human-centered design of the Open MS BioScreen, we will now monitor the adaptation and dissemination of the tool as we expand its functionality and reach. The insights generated from this approach can be applied to the development of a number of self-tracking, self-management, and user engagement tools for patients with chronic conditions. UR - https://www.jmir.org/2020/7/e15605 UR - http://dx.doi.org/10.2196/15605 UR - http://www.ncbi.nlm.nih.gov/pubmed/32628124 ID - info:doi/10.2196/15605 ER - TY - JOUR AU - Lawitschka, Anita AU - Buehrer, Stephanie AU - Bauer, Dorothea AU - Peters, Konrad AU - Silbernagl, Marisa AU - Zubarovskaya, Natalia AU - Brunmair, Barbara AU - Kayali, Fares AU - Hlavacs, Helmut AU - Mateus-Berr, Ruth AU - Riedl, David AU - Rumpold, Gerhard AU - Peters, Christina PY - 2020/6/30 TI - A Web-Based Mobile App (INTERACCT App) for Adolescents Undergoing Cancer and Hematopoietic Stem Cell Transplantation Aftercare to Improve the Quality of Medical Information for Clinicians: Observational Study JO - JMIR Mhealth Uhealth SP - e18781 VL - 8 IS - 6 KW - mobile app KW - adolescents KW - cancer KW - stem cell transplant KW - self-reported heath status KW - medical information exchange KW - mobile phone N2 - Background: A growing number of cancer and hematopoietic stem cell transplant (HSCT) survivors require long-term follow-up with optimal communication schemes, and patients' compliance is crucial. Adolescents have various unmet needs. Regarding self-report of symptoms and health status, users of mobile apps showed enhanced compliance. Currently, HSCT aftercare at the HSCT outpatient clinic of the St. Anna Children?s Hospital in Vienna, Austria, is based on handwritten diaries, carrying various disadvantages. Recently, we developed the prototype of a web-based, self-monitoring gamified mobile app tailored for adolescents: the INTERACCT (Integrating Entertainment and Reaction Assessment into Child Cancer Therapy) app. Objective: This observational, prospective study evaluated the usability of the INTERACCT app for tracking real-time self-reported symptoms and health status data in adolescent HSCT patients and a healthy matched control group. The primary outcome of the study was the quality of the self-reported medical information. We hypothesized that the mobile app would provide superior medical information for the clinicians than would the handwritten diaries. Methods: Health data were reported via paper diary and mobile app for 5 consecutive days each. The quality of medical information was rated on a 5-point scale independently and blinded by two HSCT clinicians, and the duration of use was evaluated. A total of 52 participant questionnaires were assessed for gaming patterns and device preferences, self-efficacy, users? satisfaction, acceptability, and suggestions for improvement of the mobile app. Interrater reliability was calculated with the intraclass correlation coefficient, based on a two-way mixed model; one-way repeated-measures analysis of variance and t tests were conducted post hoc. Descriptive methods were used for correlation with participants? demographics. For users? satisfaction and acceptability of the mobile app, the median and the IQR were calculated. Results: Data from 42 participants?15 patients and 27 healthy students?with comparable demographics were evaluated. The results of our study indicated a superiority of the quality of self-reported medical data in the INTERACCT app over traditional paper-and-pencil assessment (mobile app: 4.14 points, vs paper-based diary: 3.77 points, P=.02). The mobile app outperformed paper-and-pencil assessments mainly among the patients, in particular among patients with treatment-associated complications (mobile app: 4.43 points, vs paper-based diary: 3.73 points, P=.01). The mobile app was used significantly longer by adolescents (?14 years: 4.57 days, vs ?13 years: 3.14 days, P=.03) and females (4.76 days for females vs 2.95 days for males, P=.004). This corresponds with a longer duration of use among impaired patients with comorbidities. User satisfaction and acceptability ratings for the mobile app were high across all groups, but adherence to entering a large amount of data decreased over time. Based on our results, we developed a case vignette of the target group. Conclusions: Our study was the first to show that the quality of patient-reported medical information submitted via the INTERACCT app embedded in a serious game is superior to that submitted via a handwritten diary. In light of these results, a refinement of the mobile app supported by a machine learning approach is planned within an international research project. UR - http://mhealth.jmir.org/2020/6/e18781/ UR - http://dx.doi.org/10.2196/18781 UR - http://www.ncbi.nlm.nih.gov/pubmed/32602847 ID - info:doi/10.2196/18781 ER - TY - JOUR AU - Pryss, Rüdiger AU - Schlee, Winfried AU - Hoppenstedt, Burkhard AU - Reichert, Manfred AU - Spiliopoulou, Myra AU - Langguth, Berthold AU - Breitmayer, Marius AU - Probst, Thomas PY - 2020/6/30 TI - Applying Machine Learning to Daily-Life Data From the TrackYourTinnitus Mobile Health Crowdsensing Platform to Predict the Mobile Operating System Used With High Accuracy: Longitudinal Observational Study JO - J Med Internet Res SP - e15547 VL - 22 IS - 6 KW - mHealth KW - crowdsensing KW - tinnitus KW - machine learning KW - mobile operating system differences KW - ecological momentary assessment KW - mobile phone N2 - Background: Tinnitus is often described as the phantom perception of a sound and is experienced by 5.1% to 42.7% of the population worldwide, at least once during their lifetime. The symptoms often reduce the patient?s quality of life. The TrackYourTinnitus (TYT) mobile health (mHealth) crowdsensing platform was developed for two operating systems (OS)?Android and iOS?to help patients demystify the daily moment-to-moment variations of their tinnitus symptoms. In all platforms developed for more than one OS, it is important to investigate whether the crowdsensed data predicts the OS that was used in order to understand the degree to which the OS is a confounder that is necessary to consider. Objective: In this study, we explored whether the mobile OS?Android and iOS?used during user assessments can be predicted by the dynamic daily-life TYT data. Methods: TYT mainly applies the paradigms ecological momentary assessment (EMA) and mobile crowdsensing to collect dynamic EMA (EMA-D) daily-life data. The dynamic daily-life TYT data that were analyzed included eight questions as part of the EMA-D questionnaire. In this study, 518 TYT users were analyzed, who each completed at least 11 EMA-D questionnaires. Out of these, 221 were iOS users and 297 were Android users. The iOS users completed, in total, 14,708 EMA-D questionnaires; the number of EMA-D questionnaires completed by the Android users was randomly reduced to the same number to properly address the research question of the study. Machine learning methods?a feedforward neural network, a decision tree, a random forest classifier, and a support vector machine?were applied to address the research question. Results: Machine learning was able to predict the mobile OS used with an accuracy up to 78.94% based on the provided EMA-D questionnaires on the assessment level. In this context, the daily measurements regarding how users concentrate on the actual activity were particularly suitable for the prediction of the mobile OS used. Conclusions: In the work at hand, two particular aspects have been revealed. First, machine learning can contribute to EMA-D data in the medical context. Second, based on the EMA-D data of TYT, we found that the accuracy in predicting the mobile OS used has several implications. Particularly, in clinical studies using mobile devices, the OS should be assessed as a covariate, as it might be a confounder. UR - http://www.jmir.org/2020/6/e15547/ UR - http://dx.doi.org/10.2196/15547 UR - http://www.ncbi.nlm.nih.gov/pubmed/32602842 ID - info:doi/10.2196/15547 ER - TY - JOUR AU - Bruce, R. Courtenay AU - Harrison, Patricia AU - Nisar, Tariq AU - Giammattei, Charlie AU - Tan, M. Neema AU - Bliven, Caitlin AU - Shallcross, Jamie AU - Khleif, Aroub AU - Tran, Nhan AU - Kelkar, Sayali AU - Tobias, Noreen AU - Chavez, E. Ana AU - Rivera, Dana AU - Leong, Angela AU - Romano, Angela AU - Desai, Nicholas S. AU - Sol, R. Josh AU - Gutierrez, Kayla AU - Rappel, Christopher AU - Haas, Eric AU - Zheng, Feibi AU - Park, J. Kwan AU - Jones, Stephen AU - Barach, Paul AU - Schwartz, Roberta PY - 2020/6/26 TI - Assessing the Impact of Patient-Facing Mobile Health Technology on Patient Outcomes: Retrospective Observational Cohort Study JO - JMIR Mhealth Uhealth SP - e19333 VL - 8 IS - 6 KW - mHealth KW - patient-centered care KW - patient satisfaction KW - length of stay KW - patient activation KW - patient empowerment KW - patient engagement KW - patient involvement KW - hospital stay KW - communication programs N2 - Background: Despite the growth of and media hype about mobile health (mHealth), there is a paucity of literature supporting the effectiveness of widespread implementation of mHealth technologies. Objective: This study aimed to assess whether an innovative mHealth technology system with several overlapping purposes can impact (1) clinical outcomes (ie, readmission rates, revisit rates, and length of stay) and (2) patient-centered care outcomes (ie, patient engagement, patient experience, and patient satisfaction). Methods: We compared all patients (2059 patients) of participating orthopedic surgeons using mHealth technology with all patients of nonparticipating orthopedic surgeons (2554 patients). The analyses included Wilcoxon rank-sum tests, Kruskal-Wallis tests for continuous variables, and chi-square tests for categorical variables. Logistic regression models were performed on categorical outcomes and a gamma-distributed model for continuous variables. All models were adjusted for patient demographics and comorbidities. Results: The inpatient readmission rates for the nonparticipating group when compared with the participating group were higher and demonstrated higher odds ratios (ORs) for 30-day inpatient readmissions (nonparticipating group 106/2636, 4.02% and participating group 54/2048, 2.64%; OR 1.48, 95% CI 1.03 to 2.13; P=.04), 60-day inpatient readmissions (nonparticipating group 194/2636, 7.36% and participating group 85/2048, 4.15%; OR 1.79, 95% CI 1.32 to 2.39; P<.001), and 90-day inpatient readmissions (nonparticipating group 261/2636, 9.90% and participating group 115/2048, 5.62%; OR 1.81, 95% CI 1.40 to 2.34; P<.001). The length of stay for the nonparticipating cohort was longer at 1.90 days, whereas the length of stay for the participating cohort was 1.50 days (mean 1.87, SD 2 vs mean 1.50, SD 1.37; P<.001). Patients treated by participating surgeons received and read text messages using mHealth 83% of the time and read emails 84% of the time. Patients responded to 60% of the text messages and 53% of the email surveys. Patients were least responsive to digital monitoring questions when the hospital asked them to do something, and they were most engaged with emails that did not require action, including informational content. A total of 96% (558/580) of patients indicated high satisfaction with using mHealth technology to support their care. Only 0.40% (75/2059) patients opted-out of the mHealth technology program after enrollment. Conclusions: A novel, multicomponent, pathway-driven, patient-facing mHealth technology can positively impact patient outcomes and patient-reported experiences. These technologies can empower patients to play a more active and meaningful role in improving their outcomes. There is a deep need, however, for a better understanding of the interactions between patients, technology, and health care providers. Future research is needed to (1) help identify, address, and improve technology usability and effectiveness; (2) understand patient and provider attributes that support adoption, uptake, and sustainability; and (3) understand the factors that contribute to barriers of technology adoption and how best to overcome them. UR - http://mhealth.jmir.org/2020/6/e19333/ UR - http://dx.doi.org/10.2196/19333 UR - http://www.ncbi.nlm.nih.gov/pubmed/32589161 ID - info:doi/10.2196/19333 ER - TY - JOUR AU - Haun, N. Jolie AU - Alman, C. Amy AU - Melillo, Christine AU - Standifer, Maisha AU - McMahon-Grenz, Julie AU - Shin, Marlena AU - Lapcevic, A. W. AU - Patel, Nitin AU - Elwy, Rani A. PY - 2020/6/26 TI - Using Electronic Data Collection Platforms to Assess Complementary and Integrative Health Patient-Reported Outcomes: Feasibility Project JO - JMIR Med Inform SP - e15609 VL - 8 IS - 6 KW - integrative medicine KW - health information technology KW - health services research KW - mobile phone KW - patient-reported outcomes KW - veteran N2 - Background: The Veteran Administration (VA) Office of Patient-Centered Care and Cultural Transformation is invested in improving veteran health through a whole-person approach while taking advantage of the electronic resources suite available through the VA. Currently, there is no standardized process to collect and integrate electronic patient-reported outcomes (ePROs) of complementary and integrative health (CIH) into clinical care using a web-based survey platform. This quality improvement project enrolled veterans attending CIH appointments within a VA facility and used web-based technologies to collect ePROs. Objective: This study aimed to (1) determine a practical process for collecting ePROs using patient email services and a web-based survey platform and (2) conduct analyses of survey data using repeated measures to estimate the effects of CIH on patient outcomes. Methods: In total, 100 veterans from one VA facility, comprising 11 cohorts, agreed to participate. The VA patient email services (Secure Messaging) were used to manually send links to a 16-item web-based survey stored on a secure web-based survey storage platform (Qualtrics). Each survey included questions about patient outcomes from CIH programs. Each cohort was sent survey links via Secure Messaging (SM) at 6 time points: weeks 1 through 4, week 8, and week 12. Process evaluation interviews were conducted with five primary care providers to assess barriers and facilitators to using the patient-reported outcome survey in usual care. Results: This quality improvement project demonstrated the usability of SM and Qualtrics for ePRO collection. However, SM for ePROs was labor intensive for providers. Descriptive statistics on health competence (2-item Perceived Health Competence Scale), physical and mental health (Patient-Reported Outcomes Measurement Information System Global-10), and stress (4-item Perceived Stress Scale) indicated that scores did not significantly change over time. Survey response rates varied (18/100, 18.0%-42/100, 42.0%) across each of the 12 weekly survey periods. In total, 74 of 100 participants provided ?1 survey, and 90% (66/74) were female. The majority, 62% (33/53) of participants, who reported the use of any CIH modality, reported the use of two or more unique modalities. Primary care providers highlighted specific challenges with SM and offered solutions regarding staff involvement in survey implementation. Conclusions: This quality improvement project informs our understanding of the processes currently available for using SM and web-based data platforms to collect ePROs. The study results indicate that although it is possible to use SM and web-based survey platforms for ePROs, automating scheduled administration will be necessary to reduce provider burden. The lack of significant change in ePROs may be due to standard measures taking a biomedical approach to wellness. Future work should focus on identifying ideal ePRO processes that would include standardized, whole-person measures of wellness. UR - http://medinform.jmir.org/2020/6/e15609/ UR - http://dx.doi.org/10.2196/15609 UR - http://www.ncbi.nlm.nih.gov/pubmed/32589163 ID - info:doi/10.2196/15609 ER - TY - JOUR AU - Jibb, A. Lindsay AU - Khan, S. James AU - Seth, Puneet AU - Lalloo, Chitra AU - Mulrooney, Lauren AU - Nicholson, Kathryn AU - Nowak, A. Dominik AU - Kaur, Harneel AU - Chee-A-Tow, Alyssandra AU - Foster, Joel AU - Stinson, N. Jennifer PY - 2020/6/16 TI - Electronic Data Capture Versus Conventional Data Collection Methods in Clinical Pain Studies: Systematic Review and Meta-Analysis JO - J Med Internet Res SP - e16480 VL - 22 IS - 6 KW - electronic KW - data collection KW - pain KW - efficiency KW - systematic review KW - meta-analysis N2 - Background: The most commonly used means to assess pain is by patient self-reported questionnaires. These questionnaires have traditionally been completed using paper-and-pencil, telephone, or in-person methods, which may limit the validity of the collected data. Electronic data capture methods represent a potential way to validly, reliably, and feasibly collect pain-related data from patients in both clinical and research settings. Objective: The aim of this study was to conduct a systematic review and meta-analysis to compare electronic and conventional pain-related data collection methods with respect to pain score equivalence, data completeness, ease of use, efficiency, and acceptability between methods. Methods: We searched the Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica Database (EMBASE), and Cochrane Central Register of Controlled Trials (CENTRAL) from database inception until November 2019. We included all peer-reviewed studies that compared electronic (any modality) and conventional (paper-, telephone-, or in-person?based) data capture methods for patient-reported pain data on one of the following outcomes: pain score equivalence, data completeness, ease of use, efficiency, and acceptability. We used random effects models to combine score equivalence data across studies that reported correlations or measures of agreement between electronic and conventional pain assessment methods. Results: A total of 53 unique studies were included in this systematic review, of which 21 were included in the meta-analysis. Overall, the pain scores reported electronically were congruent with those reported using conventional modalities, with the majority of studies (36/44, 82%) that reported on pain scores demonstrating this relationship. The weighted summary correlation coefficient of pain score equivalence from our meta-analysis was 0.92 (95% CI 0.88-0.95). Studies on data completeness, patient- or provider-reported ease of use, and efficiency generally indicated that electronic data capture methods were equivalent or superior to conventional methods. Most (19/23, 83%) studies that directly surveyed patients reported that the electronic format was the preferred data collection method. Conclusions: Electronic pain-related data capture methods are comparable with conventional methods in terms of score equivalence, data completeness, ease, efficiency, and acceptability and, if the appropriate psychometric evaluations are in place, are a feasible means to collect pain data in clinical and research settings. UR - https://www.jmir.org/2020/6/e16480 UR - http://dx.doi.org/10.2196/16480 UR - http://www.ncbi.nlm.nih.gov/pubmed/32348259 ID - info:doi/10.2196/16480 ER - TY - JOUR AU - Desai, Sonali AU - Stevens, Emma AU - Emani, Srinivas AU - Meyers, Peter AU - Iversen, Maura AU - Solomon, H. Daniel PY - 2020/5/27 TI - Improving Quality of Care in Rheumatoid Arthritis Through Mobile Patient-Reported Outcome Measurement: Focus Group Study JO - JMIR Form Res SP - e15158 VL - 4 IS - 3 KW - quality improvement KW - rheumatoid arthritis N2 - Background: Patient-reported outcomes (PROs) for chronic disease management can be integrated into the routine workflow by leveraging mobile technology. Objective: The objective of our study was to describe the process of our quality improvement (QI) efforts using tablets for PRO collection in a busy, academic rheumatology practice to support a treat-to-target (TTT) approach for rheumatoid arthritis (RA) management. Methods: Our QI team designed a process for routine collection of PROs for RA patients at the Arthritis Center, employing information technology and an electronic medical record (EMR) system. Patients received a tablet at the clinic check-in desk to complete the Routine Assessment of Patient Index Data 3 (RAPID3) survey, a validated RA PRO. RAPID3 scores were uploaded to the EMR in real time and available for use in shared decision making during routine office visits. Weekly data were collected on RAPID3 completion rates and shared with front desk staff and medical assistants to drive improvement. Patients in our patient family advisory council and focus groups provided informal feedback on the process. Results: From May 1, 2017, to January 31, 2019, a total of 4233 RAPID3 surveys were completed by 1691 patients. The mean age of patients was 63 (SD 14) years; 84.00% (1420/1691) of the patients were female, and 83.00% (1403/1691) of the patients were white. The rates of RAPID3 completion increased from 14.3% (58/405) in May 2017 to 68.00% (254/376) in September 2017 and were sustained over time through January 2019. Informal feedback from patients was positive and negative, relating to the usability of the tablet and the way rheumatologists used and explained the RAPID3 data in shared decision making during the office visit. Conclusions: We designed a sustainable and reliable process for collecting PROs from patients with RA in the waiting room and integrated these data through the EMR during office visits. UR - http://formative.jmir.org/2020/3/e15158/ UR - http://dx.doi.org/10.2196/15158 UR - http://www.ncbi.nlm.nih.gov/pubmed/32459179 ID - info:doi/10.2196/15158 ER - TY - JOUR AU - Ratnayake, Irushi AU - Ahern, Susannah AU - Ruseckaite, Rasa PY - 2020/5/6 TI - Patient-Reported Outcome Measures in Cystic Fibrosis: Protocol for a Systematic Review JO - JMIR Res Protoc SP - e15467 VL - 9 IS - 5 KW - patient-reported outcome measure KW - PROM KW - cystic fibrosis KW - health-related quality of life N2 - Background: Patients with cystic fibrosis (CF) can struggle with burdensome symptoms and treatment regimens that negatively affect every aspect of their life. As physiological parameters can fail to capture these complications, the assessment of health-related quality of life (HRQOL) has gained prominence. HRQOL can be measured using standardized patient questionnaires called patient-reported outcome measures (PROMs). The Australian Cystic Fibrosis Data Registry (ACFDR) collects clinical data on adult and pediatric patients with CF. The incorporation of PROMs into the ACFDR would enable monitoring of HRQOL trends, benchmarking of HRQOL outcomes, and support of HRQOL research in CF. Objective: Prior to incorporation of a PROM in the ACFDR, this systematic review was planned to evaluate whether any suitable PROMs are currently being used for CF. Methods: This systematic review will be conducted in compliance with the PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols) guidelines. MEDLINE, EMBASE, Scopus, CINAHL (Cumulative Index of Nursing and Allied Health Literature), PsycINFO, and Cochrane Library databases were searched for articles published between January 2009 and February 2019 on the use of PROMs to measure HRQOL in adult and pediatric patients with CF. Study designs such as observational studies, reviews and validation studies were included. Studies describing randomized controlled trials, dissertations, books, guideline statements, and abstracts were excluded. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) risk of bias checklist was used to assess the methodological quality of included studies. A descriptive synthesis of the results will be undertaken in line with the outcomes of this study. Results: As of July 2019, the search has been conducted and 4530 records were screened. After two phases of screening, 97 studies were included in the final review and subjected to data extraction. Reviewers are currently in the process of critical appraisal. Conclusions: This review will identify any PROM(s) that may be used to measure HRQOL in the ACFDR. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42019126931; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=126931 UR - https://www.researchprotocols.org/2020/5/e15467 UR - http://dx.doi.org/10.2196/15467 UR - http://www.ncbi.nlm.nih.gov/pubmed/32374269 ID - info:doi/10.2196/15467 ER - TY - JOUR AU - Jung, Miyeon AU - Lee, SaeByul AU - Kim, Jisun AU - Kim, HeeJeong AU - Ko, BeomSeok AU - Son, Ho Byung AU - Ahn, Sei-Hyun AU - Park, Rang Yu AU - Cho, Daegon AU - Chung, Haekwon AU - Park, Jin Hye AU - Lee, Minsun AU - Lee, Won Jong AU - Chung, Seockhoon AU - Chung, Yong Il PY - 2020/5/4 TI - A Mobile Technology for Collecting Patient-Reported Physical Activity and Distress Outcomes: Cross-Sectional Cohort Study JO - JMIR Mhealth Uhealth SP - e17320 VL - 8 IS - 5 KW - telemedicine KW - breast neoplasms KW - mobile apps KW - quality of life KW - validation KW - patient-reported outcome measures (PROMs) KW - questionnaire N2 - Background: Electronic patient-reported outcome (PROs) provides a fast and reliable assessment of a patient?s health-related quality of life. Nevertheless, using PRO in the traditional paper format is not practical for clinical practice due to the limitations associated with data analysis and management. A questionnaire app was developed to address the need for a practical way to group and use distress and physical activity assessment tools. Objective: The purpose of this study was to assess the level of agreement between electronic (mobile) and paper-and-pencil questionnaire responses. Methods: We validated the app version of the distress thermometer (DT), International Physical Activity Questionnaire (IPAQ), and Patient Health Questionnaire?9 (PHQ-9). A total of 102 participants answered the paper and app versions of the DT and IPAQ, and 96 people completed the PHQ-9. The study outcomes were the correlation of the data between the paper-and-pencil and app versions. Results: A total of 106 consecutive breast cancer patients were enrolled and analyzed for validation of paper and electronic (app) versions. The Spearman correlation values of paper and app surveys for patients who responded to the DT questionnaire within 7 days, within 3 days, and on the same day were .415 (P<.001), .437 (P<.001), and .603 (P<.001), respectively. Similarly, the paper and app survey correlation values of the IPAQ total physical activity metabolic equivalent of task (MET; Q2-6) were .291 (P=.003), .324 (P=.005), and .427 (P=.01), respectively. The correlation of the sum of the Patient Health Questionnaire?9 (Q1-9) according to the time interval between the paper-based questionnaire and the app-based questionnaire was .469 for 14 days (P<.001), .574 for 7 days (P<.001), .593 for 3 days (P<.001), and .512 for the same day (P=.03). These were all statistically significant. Similarly, the correlation of the PHQ (Q10) value according to the time interval between the paper-based questionnaire and the app-based questionnaire was .283 for 14 days (P=.005), .409 for 7 days (P=.001), .415 for 3 days (P=.009), and .736 for the same day (P=.001). These were all statistically significant. In the overall trend, the shorter the interval between the paper-and-pencil questionnaire and the app-based questionnaire, the higher the correlation value. Conclusions: The app version of the distress and physical activity questionnaires has shown validity and a high level of association with the paper-based DT, IPAQ (Q2-6), and PHQ-9. The app-based questionnaires were not inferior to their respective paper versions and confirm the feasibility for their use in clinical practice. The high correlation between paper and mobile app data allows the use of new mobile apps to benefit the overall health care system. Trial Registration: ClinicalTrials.gov NCT03072966; https://clinicaltrials.gov/ct2/show/NCT03072966 UR - https://mhealth.jmir.org/2020/5/e17320 UR - http://dx.doi.org/10.2196/17320 UR - http://www.ncbi.nlm.nih.gov/pubmed/32364508 ID - info:doi/10.2196/17320 ER - TY - JOUR AU - Morton, Emma AU - Hou, HJ Sharon AU - Fogarty, Oonagh AU - Murray, Greg AU - Barnes, Steven AU - Depp, Colin AU - AU - Michalak, Erin PY - 2020/4/27 TI - A Web-Based Adaptation of the Quality of Life in Bipolar Disorder Questionnaire: Psychometric Evaluation Study JO - JMIR Ment Health SP - e17497 VL - 7 IS - 4 KW - bipolar disorder KW - survey methodology KW - patient reported outcomes KW - psychometrics KW - questionnaire design KW - quality of life KW - validation studies N2 - Background: Quality of life (QoL) is considered a key treatment outcome in bipolar disorder (BD) across research, clinical, and self-management contexts. Web-based assessment of patient-reported outcomes offer numerous pragmatic benefits but require validation to ensure measurement equivalency. A web-based version of the Quality of Life in Bipolar Disorder (QoL.BD) questionnaire was developed (QoL Tool). Objective: This study aimed to evaluate the psychometric properties of a web-based QoL self-report questionnaire for BD (QoL Tool). Key aims were to (1) characterize the QoL of the sample using the QoL Tool, (2) evaluate the internal consistency of the web-based measure, and (3) determine whether the factor structure of the original version of the QoL.BD instrument was replicated in the web-based instrument. Methods: Community-based participatory research methods were used to inform the development of a web-based adaptation of the QoL.BD instrument. Individuals with BD who registered for an account with the QoL Tool were able to opt in to sharing their data for research purposes. The distribution of scores and internal consistency estimates, as indicated by Cronbach alpha, were inspected. An exploratory factor analysis using maximum likelihood and oblique rotation was conducted. Inspection of the scree plot, eigenvalues, and minimum average partial correlation were used to determine the optimal factor structure to extract. Results: A total of 498 people with BD (349/498, 70.1% female; mean age 39.64, SD 12.54 years; 181/498, 36.3% BD type I; 195/498, 39.2% BD type II) consented to sharing their QoL Tool data for the present study. Mean scores across the 14 QoL Tool domains were, in general, significantly lower than that of the original QoL.BD validation sample. Reliability estimates for QoL Tool domains were comparable with that observed for the QoL.BD instrument (Cronbach alpha=.70-.93). Exploratory factor analysis supported the extraction of an 11-factor model, with item loadings consistent with the factor structure suggested by the original study. Findings for the sleep and physical domains differed from the original study, with this analysis suggesting one shared latent construct. Conclusions: The psychometric properties of the web-based QoL Tool are largely concordant with the original pen-and-paper QoL.BD, although some minor differences in the structure of the sleep and physical domains were observed. Despite this small variation from the factor structure identified in the QoL.BD instrument, the latent factor structure of the QoL Tool largely reproduced the original findings and theoretical structure of QoL areas relevant to people with BD. These findings underscore the research and clinical utility of this instrument, but further comparison of the psychometric properties of the QoL Tool relative to the QoL.BD instrument is warranted. Future adaptations of the QoL Tool, including the production of an app-based version of the QoL Tool, are also discussed. UR - http://mental.jmir.org/2020/4/e17497/ UR - http://dx.doi.org/10.2196/17497 UR - http://www.ncbi.nlm.nih.gov/pubmed/32338620 ID - info:doi/10.2196/17497 ER - TY - JOUR AU - Tolstrup, K. Lćrke AU - Pappot, Helle AU - Bastholt, Lars AU - Zwisler, Ann-Dorthe AU - Dieperink, B. Karin PY - 2020/4/9 TI - Patient-Reported Outcomes During Immunotherapy for Metastatic Melanoma: Mixed Methods Study of Patients? and Clinicians? Experiences JO - J Med Internet Res SP - e14896 VL - 22 IS - 4 KW - side effects, adverse events, patient-reported outcomes, PRO-CTCAE, melanoma, eHealth, immunotherapy, patient satisfaction KW - CPIs, interviews N2 - Background: The benefits of electronic patient reported outcomes (PRO) questionnaires have been demonstrated in many settings, including in hospitals and patient homes. However, it remains to be investigated how melanoma patients and their treating clinicians experience the electronic self-reporting of side effects and the derived communication. Objective: The primary objective of this study was to examine patients? and clinicians? experiences with an eHealth intervention for weekly monitoring of side effects during treatment with immunotherapy. Methods: An eHealth intervention based on questions from the PRO-Common Terminology Criteria for Adverse Events (CTCAE) library was used and tested in a randomized clinical trial with patients receiving immunotherapy for malignant melanoma and clinicians at a university hospital in Denmark. On a weekly basis, patients reported their symptoms from home during the treatment via a provided tablet. The electronic patient reports were available to clinicians in the outpatient clinic. A mixed methods approach was applied to investigate the patients? and clinicians? experiences with the intervention. Data from patient experiences were collected in a short survey, the Patient Feedback Form. Moreover, a subset of the patients participating in the survey was interviewed about their experience. Furthermore, one focus group interview with clinicians was carried out to elucidate their views. Results: A total of 57 patients completed the Patient Feedback Form, and 14 patients were interviewed. The focus group interview included 5 clinicians. Overall, patients and clinicians were satisfied with the tool. They believed it enhanced patients? awareness of side effects and increased their feeling of involvement. The patients reported that it was easy to fill out the questionnaire and that it made sense to do so. However, a minority of the patients expressed in the interviews that they did not believe that the health care professionals had seen their reports when they came to the clinic, and that the reporting did not lead to increased contact with the department. Conclusions: Overall, satisfaction with the eHealth intervention was high among patients and their treating clinicians. The tool was easy to use and contributed to greater symptom awareness and patient involvement. Thus, in terms of patient and clinician satisfaction with the tool, it makes sense to continue using the tool beyond the project period. Trial Registration: ClinicalTrials.gov NCT03073031; https://tinyurl.com/tjx3gtu UR - https://www.jmir.org/2020/4/e14896 UR - http://dx.doi.org/10.2196/14896 UR - http://www.ncbi.nlm.nih.gov/pubmed/32271150 ID - info:doi/10.2196/14896 ER - TY - JOUR AU - Meirte, Jill AU - Hellemans, Nick AU - Anthonissen, Mieke AU - Denteneer, Lenie AU - Maertens, Koen AU - Moortgat, Peter AU - Van Daele, Ulrike PY - 2020/4/3 TI - Benefits and Disadvantages of Electronic Patient-reported Outcome Measures: Systematic Review JO - JMIR Perioper Med SP - e15588 VL - 3 IS - 1 KW - electronic patient-reported outcome measures KW - paper-based patient-reported outcome measures KW - systematic review KW - advantages KW - pitfalls N2 - Background: Patient-reported outcome measures (PROMs) are important in clinical practice and research. The growth of electronic health technologies provides unprecedented opportunities to systematically collect information via PROMs. Objective: The aim of this study was to provide an objective and comprehensive overview of the benefits, barriers, and disadvantages of the digital collection of qualitative electronic patient-reported outcome measures (ePROMs). Methods: We performed a systematic review of articles retrieved from PubMED and Web of Science. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed during all stages. The search strategy yielded a total of 2333 records, from which 32 met the predefined inclusion and exclusion criteria. The relevant ePROM-related information was extracted from each study. Results: Results were clustered as benefits and disadvantages. Reported benefits of ePROMs were greater patient preference and acceptability, lower costs, similar or faster completion time, higher data quality and response rates, and facilitated symptom management and patient-clinician communication. Tablets were the most used ePROM modality (14/32, 44%), and, as a platform, Web-based systems were used the most (26/32, 81%). Potential disadvantages of ePROMs include privacy protection, a possible large initial financial investment, and exclusion of certain populations or the ?digital divide.? Conclusions: In conclusion, ePROMs offer many advantages over paper-based collection of patient-reported outcomes. Overall, ePROMs are preferred over paper-based methods, improve data quality, result in similar or faster completion time, decrease costs, and facilitate clinical decision making and symptom management. Disadvantages regarding ePROMs have been outlined, and suggestions are provided to overcome the barriers. We provide a path forward for researchers and clinicians interested in implementing ePROMs. Trial Registration: PROSPERO CRD42018094795; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=94795 UR - http://periop.jmir.org/2020/1/e15588/ UR - http://dx.doi.org/10.2196/15588 UR - http://www.ncbi.nlm.nih.gov/pubmed/33393920 ID - info:doi/10.2196/15588 ER - TY - JOUR AU - Tran, Christine AU - Dicker, Adam AU - Leiby, Benjamin AU - Gressen, Eric AU - Williams, Noelle AU - Jim, Heather PY - 2020/3/25 TI - Utilizing Digital Health to Collect Electronic Patient-Reported Outcomes in Prostate Cancer: Single-Arm Pilot Trial JO - J Med Internet Res SP - e12689 VL - 22 IS - 3 KW - eHealth KW - mHealth KW - smartphone KW - mobile phone KW - mobile apps KW - health promotion KW - chronic disease KW - health-related quality of life KW - cancer KW - patient-reported outcome measures KW - health information technology KW - patient-centered care N2 - Background: Measuring patient-reported outcomes (PROs) requires an individual?s perspective on their symptoms, functional status, and quality of life. Digital health enables remote electronic PRO (ePRO) assessments as a clinical decision support tool to facilitate meaningful provider interactions and personalized treatment. Objective: This study explored the feasibility and acceptability of collecting ePROs using validated health-related quality of life (HRQoL) questionnaires for prostate cancer. Methods: Using Apple ResearchKit software, the Strength Through Insight app was created with content from validated HRQoL tools 26-item Expanded Prostate Cancer Index Composite (EPIC) or EPIC for Clinical Practice and 8-item Functional Assessment of Cancer Therapy Advanced Prostate Symptom Index. In a single-arm pilot study with patients receiving prostate cancer treatment at Thomas Jefferson University Hospital and affiliates, participants were recruited, and instructed to download Strength Through Insight and complete ePROs once a week over 12 weeks. A mixed methods approach, including qualitative pre- and poststudy interviews, was used to evaluate the feasibility and acceptability of Strength Through Insight for the collection and care management of cancer treatment. Results: Thirty patients consented to the study; 1 patient failed to complete any of the questionnaires and was left out of the analysis of the intervention. Moreover, 86% (25/29) reached satisfactory questionnaire completion (defined as completion of 60% of weekly questions over 12 weeks). The lower bound of the exact one-sided 95% CI was 71%, exceeding the 70% feasibility threshold. Most participants self-identified with having a high digital literacy level (defined as the ability to use, understand, evaluate, and analyze information from multiple formats from a variety of digital sources), and only a few participants identified with having a low digital literacy level (defined as only having the ability to gather information on the Web). Interviews were thematically analyzed to reveal the following: (1) value of emotional support and wellness in cancer treatment, (2) rise of social patient advocacy in online patient communities and networks, (3) patient concerns over privacy, and (4) desire for personalized engagement tools. Conclusions: Strength Through Insight was demonstrated as a feasible and acceptable method of data collection for ePROs. A high compliance rate confirmed the app as a reliable tool for patients with localized and advanced prostate cancer. Nearly all participants reported that using the smartphone app is easier than or equivalent to the traditional paper-and-pen approach, providing evidence of acceptability and support for the use of remote PRO monitoring. This study expands on current research involving the value of digital health, as a social and behavioral science, augmented with technology, can begin to contribute to population health management, as it shapes psychographic segmentation by demographic, socioeconomic, health condition, or behavioral factors to group patients by their distinct personalities and motivations, which influence their choices. Trial Registration: ClinicalTrials.gov NC03197948; http://clinicaltrials.gov/ct2/show/NC03197948 UR - https://www.jmir.org/2020/3/e12689 UR - http://dx.doi.org/10.2196/12689 UR - http://www.ncbi.nlm.nih.gov/pubmed/32209536 ID - info:doi/10.2196/12689 ER - TY - JOUR AU - Ness, Nils-Henning AU - Haase, Rocco AU - Kern, Raimar AU - Schriefer, Dirk AU - Ettle, Benjamin AU - Cornelissen, Christian AU - Akguen, Katja AU - Ziemssen, Tjalf PY - 2020/3/17 TI - The Multiple Sclerosis Health Resource Utilization Survey (MS-HRS): Development and Validation Study JO - J Med Internet Res SP - e17921 VL - 22 IS - 3 KW - multiple sclerosis KW - patient-reported outcome measures KW - resource utilization KW - validation KW - questionnaire development N2 - Background: Survey-based studies are frequently used to describe the economic impact of multiple sclerosis (MS). However, there is no validated health resource survey available, preventing comparison of study results and meaningful conclusions regarding the efficiency of long-term treatments. Objective: The aim of this study was to develop and validate a tablet- and paper-based MS health resource utilization survey. Methods: We developed and validated the Multiple Sclerosis Health Resource Utilization Survey (MS-HRS), consisting of 24 cost items for paper and tablet users. Data for validation came from two large German observational studies. Survey practicability was assessed according to the response rate. Reliability was described using test-retest reliability as well as Guttman lambda. Construct validity was assessed as convergent and discriminant validity via correlations with associated patient-reported outcomes and known-group analyses. Results: In total, 2207 out of 2388 (response rate: 92.4%) patients completed the survey and were included to determine psychometric properties. The test-retest reliability had an intraclass correlation coefficient of 0.828 over a course of 3 months. Convergent validity analyses showed that total costs correlated positively with increased disability (r=0.411, P<.001). For discriminant validity, correlations of total costs with the Treatment Satisfaction Questionnaire for Medication ranged from ?0.006 (convenience) to ?0.216 (effectiveness). The mean annual cost was ?28,203 (SD ?14,808) (US $39,203; SD US $20,583) with disease-modifying therapies. Conclusions: The MS-HRS is a multilingual, reliable, valid, electronically available, and easy-to-administer questionnaire providing a holistic cross-sectional and longitudinal assessment of resource utilization in patients with MS. UR - http://www.jmir.org/2020/3/e17921/ UR - http://dx.doi.org/10.2196/17921 UR - http://www.ncbi.nlm.nih.gov/pubmed/32181745 ID - info:doi/10.2196/17921 ER - TY - JOUR AU - Lewinson, Elizabeth Rebecca AU - Katz, D. Joel PY - 2020/3/9 TI - Influencing Pain Inferences Using Random Numerical Anchoring: Randomized Controlled Trial JO - JMIR Hum Factors SP - e17533 VL - 7 IS - 1 KW - pain KW - heuristics KW - chronic pain KW - pain inference KW - numerical anchoring KW - anchoring effect KW - mechanical Turk N2 - Background: Numerical anchoring occurs when exposure to a numeric quantity influences a person?s subsequent judgment involving other quantities. This could be applicable to the evaluation of pain, where exposure to an unrelated number before the evaluation of pain could influence pain ratings. Objective: This study aimed to determine whether exposure to a random numeric anchor influences subsequent pain intensity ratings of a hypothetical patient. Methods: In this study, 385 participants read a vignette describing a patient with chronic pain before being randomly assigned to one of four groups. Groups 1 and 2 spun an 11-wedge number wheel (0-10), which was, unbeknown to the participants, programmed to stop on a high number (8) or a low number (2), respectively. Group 3 spun a similar letter wheel (A-K), which was programmed to stop on either the letter C or I (control 1). Group 4 did not spin a wheel (control 2). Participants were then asked to rate the patient?s pain intensity using a 0 to 10 numeric rating scale. Results: The high-number group rated the patient?s pain (median 8, IQR 2) significantly higher than the letter wheel control (median 7, IQR 2; P=.02) and the low-number group (median 6, IQR 2; P<.001). The low-number group rated the pain significantly lower than controls 1 and 2 (median 7, IQR 2; both P=.045). Conclusions: Pain ratings were influenced by prior exposure to a random number with no relevant information about the patient?s pain, indicating anchoring had occurred. However, contrary to the traditional definition of anchoring where anchoring occurs even when participants are unaware of the anchor?s influence, in this study, the anchoring effect was seen only in participants who believed that the anchor had influenced them. This suggests that anchoring effects could potentially occur among health care providers tasked with evaluating a patient?s pain and should be evaluated further. UR - http://humanfactors.jmir.org/2020/1/e17533/ UR - http://dx.doi.org/10.2196/17533 UR - http://www.ncbi.nlm.nih.gov/pubmed/32149719 ID - info:doi/10.2196/17533 ER - TY - JOUR AU - Gomis-Pastor, Mar AU - Roig, Eulalia AU - Mirabet, Sonia AU - T De Pourcq, Jan AU - Conejo, Irene AU - Feliu, Anna AU - Brossa, Vicens AU - Lopez, Laura AU - Ferrero-Gregori, Andreu AU - Barata, Anna AU - Mangues, Antonia M. PY - 2020/2/4 TI - A Mobile App (mHeart) to Detect Medication Nonadherence in the Heart Transplant Population: Validation Study JO - JMIR Mhealth Uhealth SP - e15957 VL - 8 IS - 2 KW - self-report KW - patient-reported outcome measures KW - behavioral sciences KW - treatment adherence and compliance KW - transplantation KW - early medical intervention KW - telemedicine KW - mobile health KW - validation studies KW - patient satisfaction N2 - Background: Medication nonadherence in heart transplant recipients (HTxR) is related to graft loss and death. mHeart is a mobile app that uses electronic patient-reported outcome measures (ePROMs) to identify and manage medication nonadherence in the outpatient heart transplant (HTx) population. Objective: The study primarily aimed to validate mHeart to measure medication nonadherence in early stage HTxR by assessing the psychometric properties of ePROMs. The secondary aims were to (1) measure patient satisfaction with the mHeart tool and its usability and (2) explore the impact of a theory-based treatment on medication nonadherence rates to determine its scalability to larger research. Methods: A prospective study was conducted in the outpatient clinic of a tertiary hospital. All consecutive early stage HTxR (<1.5 years from HTx) were included. The ePROM psychometric properties assessed were validity, reliability, responsiveness, interpretability, and burden. ePROMs comprised the 4-item Morisky-Green-Levine questionnaire and an adapted version of the Haynes-Sackett questionnaire. The Simplified Medication Adherence Questionnaire (SMAQ) was also applied on-site. Three consecutive medication nonadherence assessments were performed by a transplant pharmacist. To improve medication nonadherence, theory-based interventions were delivered in a 1-month period. Patient satisfaction was assessed by a semiquantitative Web-based survey at the end of the study. Results: We included 31 early stage HTxR (age: mean 54 years, SD 12 years), and 71% (22/31) of them were men. The HTxR were taking a mean 13 (SD 4; range 7-18) drugs per day. A total of 42% (13/31) of patients were unaware of the consequences of medication nonadherence, and 39% (12/31) of patients were nonadherent to immunosuppressive treatment. The content validity measure showed excellent levels of expert panel agreement for the Haynes-Sacket (14/14, 100%) and Morisky-Green-Levine (13/14, 93%) questionnaires. SMAQ and Morisky-Green-Levine ePROMs showed similar measurement domains (convergent validity, phi=0.6, P<.001), which, as expected, differed from Haynes-Sackett ePROMs (divergent validity, phi=0.3, P=.12). Reliability assessment revealed a very strong association between ePROM and on-site PROMs (phi>0.7, P<.001). Reproducibility was moderate (Haynes-Sackett ?=0.6, P<.002) or poor (Morisky-Green-Levine ?=0.3, P=.11) because of unexpected improved medication adherence rates during the test-retest period. According to responsiveness, the theory-based multifaceted intervention program improved medication nonadherence by 16% to 26% (P<.05). A burden analysis showed that ePROMs could potentially overcome traditional on-site limitations (eg, automatic recording of ePROM responses in the hospital information system). The mean score for overall patient satisfaction with the mHeart approach was 9 (SD 2; score range: 0-10). All 100% (29/29) of patients surveyed reported that they would recommend the mHeart platform to other HTxR. Conclusions: ePROMs adhered to the quality standards and successfully identified medication nonadherence in the HTx population, supporting their widespread use. The theory-based intervention program showed a promising improvement in medication adherence rates and produced excellent patient satisfaction and usability scores in HTxR. UR - https://mhealth.jmir.org/2020/2/e15957 UR - http://dx.doi.org/10.2196/15957 UR - http://www.ncbi.nlm.nih.gov/pubmed/32014839 ID - info:doi/10.2196/15957 ER - TY - JOUR AU - Lee, Rachael Rebecca AU - Shoop-Worrall, Stephanie AU - Rashid, Amir AU - Thomson, Wendy AU - Cordingley, Lis PY - 2020/1/30 TI - ?Asking Too Much??: Randomized N-of-1 Trial Exploring Patient Preferences and Measurement Reactivity to Frequent Use of Remote Multidimensional Pain Assessments in Children and Young People With Juvenile Idiopathic Arthritis JO - J Med Internet Res SP - e14503 VL - 22 IS - 1 KW - mHealth KW - pain KW - pain assessment KW - juvenile idiopathic arthritis KW - patient reported outcomes KW - pediatrics N2 - Background: Remote monitoring of pain using multidimensional mobile health (mHealth) assessment tools is increasingly being adopted in research and care. This assessment method is valuable because it is challenging to capture pain histories, particularly in children and young people in diseases where pain patterns can be complex, such as juvenile idiopathic arthritis (JIA). With the growth of mHealth measures and more frequent assessment, it is important to explore patient preferences for the timing and frequency of administration of such tools and consider whether certain administrative patterns can directly impact on children?s pain experiences. Objective: This study aimed to explore the feasibility and influence (in terms of objective and subjective measurement reactivity) of several time sampling strategies in remote multidimensional pain reporting. Methods: An N-of-1 trial was conducted in a subset of children and young people with JIA and their parents recruited to a UK cohort study. Children were allocated to 1 of 4 groups. Each group followed a different schedule of completion of MPT for 8 consecutive weeks. Each schedule included 2 blocks, each comprising 4 different randomized time sampling strategies, with each strategy occurring once within each 4-week block. Children completed MPT according to time sampling strategies: once-a-day, twice-a-day, once-a-week, and as-and-when pain was experienced. Adherence to each strategy was calculated. Participants completed the Patient-Reported Outcomes Measurement Information System Pain Interference Scale at the end of each week to explore objective reactivity. Differences in pain interference scores between time sampling strategies were assessed graphically and using Friedman tests. Children and young people and their parents took part in a semistructured interview about their preferences for different time sampling strategies and to explore subjective reactivity. Results: A total of 14 children and young people (aged 7-16 years) and their parents participated. Adherence to pain reporting was higher in less intense time sampling strategies (once-a-week=63% [15/24]) compared with more intense time sampling strategies (twice-a-day=37.8% [127/336]). There were no statistically significant differences in pain interference scores between sampling strategies. Qualitative findings from interviews suggested that children preferred once-a-day (6/14, 43%) and as-and-when pain reporting (6/14, 43%). Creating routine was one of the most important factors for successful reporting, while still ensuring that comprehensive information about recent pain was captured. Conclusions: Once-a-day pain reporting provides rich contextual information. Although patients were less adherent to this preferred sampling strategy, once-a-day reporting still provides more frequent assessment opportunities compared with other less intense or overburdensome schedules. Important issues for the design of studies and care incorporating momentary assessment techniques were identified. We demonstrate that patient reporting preferences are key to accommodate and are important where data capture quality is key. Our findings support frequent administration of such tools, using daily reporting methods where possible. UR - http://www.jmir.org/2020/1/e14503/ UR - http://dx.doi.org/10.2196/14503 UR - http://www.ncbi.nlm.nih.gov/pubmed/32012051 ID - info:doi/10.2196/14503 ER - TY - JOUR AU - Beukenhorst, L. Anna AU - Howells, Kelly AU - Cook, Louise AU - McBeth, John AU - O'Neill, W. Terence AU - Parkes, J. Matthew AU - Sanders, Caroline AU - Sergeant, C. Jamie AU - Weihrich, S. Katy AU - Dixon, G. William PY - 2020/1/29 TI - Engagement and Participant Experiences With Consumer Smartwatches for Health Research: Longitudinal, Observational Feasibility Study JO - JMIR Mhealth Uhealth SP - e14368 VL - 8 IS - 1 KW - medical informatics computing KW - mHealth KW - patient-reported outcomes KW - musculoskeletal diseases KW - mobile phone KW - smartwatch/wearable KW - self-tracking N2 - Background: Wearables provide opportunities for frequent health data collection and symptom monitoring. The feasibility of using consumer cellular smartwatches to provide information both on symptoms and contemporary sensor data has not yet been investigated. Objective: This study aimed to investigate the feasibility and acceptability of using cellular smartwatches to capture multiple patient-reported outcomes per day alongside continuous physical activity data over a 3-month period in people living with knee osteoarthritis (OA). Methods: For the KOALAP (Knee OsteoArthritis: Linking Activity and Pain) study, a novel cellular smartwatch app for health data collection was developed. Participants (age ?50 years; self-diagnosed knee OA) received a smartwatch (Huawei Watch 2) with the KOALAP app. When worn, the watch collected sensor data and prompted participants to self-report outcomes multiple times per day. Participants were invited for a baseline and follow-up interview to discuss their motivations and experiences. Engagement with the watch was measured using daily watch wear time and the percentage completion of watch questions. Interview transcripts were analyzed using grounded thematic analysis. Results: A total of 26 people participated in the study. Good use and engagement were observed over 3 months: most participants wore the watch on 75% (68/90) of days or more, for a median of 11 hours. The number of active participants declined over the study duration, especially in the final week. Among participants who remained active, neither watch time nor question completion percentage declined over time. Participants were mainly motivated to learn about their symptoms and enjoyed the self-tracking aspects of the watch. Barriers to full engagement were battery life limitations, technical problems, and unfulfilled expectations of the watch. Participants reported that they would have liked to report symptoms more than 4 or 5 times per day. Conclusions: This study shows that capture of patient-reported outcomes multiple times per day with linked sensor data from a smartwatch is feasible over at least a 3-month period. International Registered Report Identifier (IRRID): RR2-10.2196/10238 UR - https://mhealth.jmir.org/2020/1/e14368 UR - http://dx.doi.org/10.2196/14368 UR - http://www.ncbi.nlm.nih.gov/pubmed/32012078 ID - info:doi/10.2196/14368 ER - TY - JOUR AU - Ramsey, Imogen AU - Corsini, Nadia AU - Hutchinson, D. Amanda AU - Marker, Julie AU - Eckert, Marion PY - 2020/1/28 TI - Development of a Core Set of Patient-Reported Outcomes for Population-Based Cancer Survivorship Research: Protocol for an Australian Consensus Study JO - JMIR Res Protoc SP - e14544 VL - 9 IS - 1 KW - cancer survivorship KW - quality of life KW - patient-reported outcomes KW - core outcome set KW - Delphi study KW - consensus N2 - Background: Core outcome sets seek to improve the consistency and quality of research by providing agreed-upon recommendations regarding what outcomes should be measured as a minimum for a population and setting. The problems arising from a lack of outcome standardization in population-based cancer survivorship research indicate the need for agreement on a core set of patient-reported outcomes (PROs) to enhance data quality, consistency, and comparability. Objective: This study aims to identify a core set of PROs, representing the most important issues impacting on cancer survivors' long-term health, functioning and quality of life, to inform population-based research on cancer survivorship. Methods: In Phase I, a list of all potentially important outcomes will be generated through focus group discussions with cancer survivors and a review of measures for assessing quality of life in cancer survivorship. The consolidated list will be advanced to Phase II, where a stakeholder consensus process will be conducted with national experts in cancer survivorship to refine and prioritize the outcomes into a core outcome set. The process will consist of a two-round Delphi survey and a consensus meeting. Cancer survivors, oncology health care professionals, and potential end users of the core outcome set with expertise in cancer survivorship research or policy will be invited to participate. In Phase III, recommended measures for assessment of the core outcome set will be selected with advice from experts on the assessment, analysis, and interpretation of PROs. Results: As of April 2019, data collection for Phase I is complete and data analysis is underway. These data will inform the list of outcomes to be advanced into Phase II. Recruitment for Phase II will commence in June 2019, and it is anticipated that it will take 6 months to complete the three-step consensus process and identify a provisional core outcome set. The study results are expected to be published in early 2020. Conclusions: Expert consensus-driven recommendations on outcome measurement will facilitate the inclusion of survivorship outcomes considered important by cancer survivors and health professionals in future research. Adoption of the core outcome set will enable comparison and synthesis of evidence across studies and enhance the quality of PRO data collected in cancer survivorship research, particularly when applied to address macro-level questions. International Registered Report Identifier (IRRID): DERR1-10.2196/14544 UR - http://www.researchprotocols.org/2020/1/e14544/ UR - http://dx.doi.org/10.2196/14544 UR - http://www.ncbi.nlm.nih.gov/pubmed/32012089 ID - info:doi/10.2196/14544 ER - TY - JOUR AU - Abdolkhani, Robab AU - Gray, Kathleen AU - Borda, Ann AU - DeSouza, Ruth PY - 2020/1/22 TI - Quality Assurance of Health Wearables Data: Participatory Workshop on Barriers, Solutions, and Expectations JO - JMIR Mhealth Uhealth SP - e15329 VL - 8 IS - 1 KW - remote sensing technology KW - data quality assurance KW - patient-generated health data KW - wearable devices KW - participatory research N2 - Background: The ubiquity of health wearables and the consequent production of patient-generated health data (PGHD) are rapidly escalating. However, the utilization of PGHD in routine clinical practices is still low because of data quality issues. There is no agreed approach to PGHD quality assurance; therefore, realizing the promise of PGHD requires in-depth discussion among diverse stakeholders to identify the data quality assurance challenges they face and understand their needs for PGHD quality assurance. Objective: This paper reports findings from a workshop aimed to explore stakeholders? data quality challenges, identify their needs and expectations, and offer practical solutions. Methods: A qualitative multi-stakeholder workshop was conducted as a half-day event on the campus of an Australian University located in a major health care precinct, namely the Melbourne Parkville Precinct. The 18 participants had experience of PGHD use in clinical care, including people who identified as health care consumers, clinical care providers, wearables suppliers, and health information specialists. Data collection was done by facilitators capturing written notes of the proceedings as attendees engaged in participatory design activities in written and oral formats, using a range of whole-group and small-group interactive methods. The collected data were analyzed thematically, using deductive and inductive coding. Results: The participants? discussions revealed a range of technical, behavioral, operational, and organizational challenges surrounding PGHD, from the time when data are collected by patients to the time data are used by health care providers for clinical decision making. PGHD stakeholders found consensus on training and engagement needs, continuous collaboration among stakeholders, and development of technical and policy standards to assure PGHD quality. Conclusions: Assuring PGHD quality is a complex process that requires the contribution of all PGHD stakeholders. The variety and depth of inputs in our workshop highlighted the importance of co-designing guidance for PGHD quality guidance. UR - https://mhealth.jmir.org/2020/1/e15329 UR - http://dx.doi.org/10.2196/15329 UR - http://www.ncbi.nlm.nih.gov/pubmed/32012090 ID - info:doi/10.2196/15329 ER - TY - JOUR AU - Goodday, M. Sarah AU - Atkinson, Lauren AU - Goodwin, Guy AU - Saunders, Kate AU - South, Matthew AU - Mackay, Clare AU - Denis, Mike AU - Hinds, Chris AU - Attenburrow, Mary-Jane AU - Davies, Jim AU - Welch, James AU - Stevens, William AU - Mansfield, Karen AU - Suvilehto, Juulia AU - Geddes, John PY - 2020/1/15 TI - The True Colours Remote Symptom Monitoring System: A Decade of Evolution JO - J Med Internet Res SP - e15188 VL - 22 IS - 1 KW - symptom assessment KW - signs and symptoms KW - digital health KW - ecological momentary assessment KW - mood disorders UR - https://www.jmir.org/2020/1/e15188 UR - http://dx.doi.org/10.2196/15188 UR - http://www.ncbi.nlm.nih.gov/pubmed/31939746 ID - info:doi/10.2196/15188 ER - TY - JOUR AU - Barger, Diana AU - Leleux, Olivier AU - Conte, Valérie AU - Sapparrart, Vincent AU - Gapillout, Marie AU - Crespel, Isabelle AU - Erramouspe, Marie AU - Delveaux, Sandrine AU - Wittkop, Linda AU - Dabis, François AU - Bonnet, Fabrice PY - 2019/12/18 TI - Web-Based Module for the Collection of Electronic Patient-Reported Outcomes in People Living With HIV in Nouvelle Aquitaine, France: Usability Evaluation JO - JMIR Form Res SP - e15013 VL - 3 IS - 4 KW - patient reported outcome measures KW - patient generated health data KW - quality of life N2 - Background: Patient-reported outcomes (PROs) can be of great value for both research and chronic disease management. We developed a new module of the ANRS CO3 Aquitaine cohort study?s Web-based data capture and visualization solution (APPEGE 2.0) for the collection of electronic PROs among people living with HIV cared for in Nouvelle Aquitaine, France. Objective: This study aimed to evaluate the usability of 2 successively developed prototypes of ARPEGE 2.0?s electronic PROs module before launching a pilot study, owing to the novelty of the proposed data collection method for our setting and specific characteristics of the target population. Methods: A total of 2 sequential rounds of empirical, task-based usability evaluations were conducted, involving 8 research staff and then 7 people living with HIV. Evaluators provided written feedback during round 1 and oral feedback during round 2. Evaluators who completed the full set of tasks responded to the System Usability Scale (SUS). We assessed changes in SUS scores between rounds and concluded usability testing when SUS scores reached a ceiling effect, defining good usability a priori as a usability score of 70. Results: Insights were generated regarding the visibility of system status and the match between the system and the real world that improved the module?s usability. Research staff evaluators reported mean SUS scores of 65 (SD 18.87) and patient evaluators reported mean SUS scores of 85 (SD 5.4; P=.032). Conclusions: Software modifications, informed by successive rounds of usability testing, resulted in sufficient gains in usability to undertake piloting. Insights generated during evaluations prompted us to find the appropriate balance between optimal security and ease of use. Trial Registration: ClinicalTrials.gov NCT03296202; https://clinicaltrials.gov/ct2/show/NCT03296202 International Registered Report Identifier (IRRID): RR2-10.2196/10.2196/resprot.9439 UR - http://formative.jmir.org/2019/4/e15013/ UR - http://dx.doi.org/10.2196/15013 UR - http://www.ncbi.nlm.nih.gov/pubmed/31850847 ID - info:doi/10.2196/15013 ER - TY - JOUR AU - Morton, Emma AU - Hole, Rachelle AU - Murray, Greg AU - Buzwell, Simone AU - Michalak, Erin PY - 2019/12/4 TI - Experiences of a Web-Based Quality of Life Self-Monitoring Tool for Individuals With Bipolar Disorder: A Qualitative Exploration JO - JMIR Ment Health SP - e16121 VL - 6 IS - 12 KW - bipolar disorder KW - self-monitoring KW - self-management KW - qualitative KW - recovery KW - quality of life KW - eHealth N2 - Background: Self-monitoring of symptoms is a cornerstone of psychological interventions in bipolar disorder (BD), but individuals with lived experience also value tracking holistic outcomes, such as quality of life (QoL). Importantly, self-monitoring is not always experienced positively by people with BD and may have lower than expected rates of engagement. Therefore, before progressing into QoL tracking tools, it is important to explore user perspectives to identify possible risks and benefits, optimal methods to support engagement, and possible avenues to integrate QoL self-monitoring practices into clinical work. Objective: This study aimed to conduct a qualitative exploration of how individuals with BD engaged with a Web-based version of a BD-specific QoL self-monitoring instrument, the QoL tool. Methods: A total of 43 individuals with BD engaged with a self-management intervention with an optional Web-based QoL self-assessment tool as part of an overarching mixed method study. Individuals were later interviewed about personal experiences of engagement with the intervention, including experiences of gauging their own QoL. A thematic analysis was used to identify salient aspects of the experience of QoL self-monitoring in BD. Results: In total, 4 categories describing people?s experiences of QoL self-monitoring were identified: (1) breadth of QoL monitoring, (2) highlighting the positive, (3) connecting self-monitoring to action, and (4) self-directed patterns of use. Conclusions: The findings of this research generate novel insights into ways in which individuals with BD experience the Web-based QoL self-assessment tool. The value of tracking the breadth of domains was an overarching aspect, facilitating the identification of both areas of strength and life domains in need of intervention. Importantly, monitoring QoL appeared to have an inherently therapeutic quality, through validating flourishing areas and reinforcing self-management efforts. This contrasts the evidence suggesting that symptom tracking may be distressing because of its focus on negative experiences and positions QoL as a valuable adjunctive target of observation in BD. Flexibility and personalization of use of the QoL tool were key to engagement, informing considerations for health care providers wishing to support self-monitoring and future research into Web- or mobile phone?based apps. UR - https://mental.jmir.org/2019/12/e16121 UR - http://dx.doi.org/10.2196/16121 UR - http://www.ncbi.nlm.nih.gov/pubmed/31799936 ID - info:doi/10.2196/16121 ER - TY - JOUR AU - Timimi, Farris AU - Ray, Sara AU - Jones, Erik AU - Aase, Lee AU - Hoffman, Kathleen PY - 2019/11/28 TI - Patient-Reported Outcomes in Online Communications on Statins, Memory, and Cognition: Qualitative Analysis Using Online Communities JO - J Med Internet Res SP - e14809 VL - 21 IS - 11 KW - social media KW - hydroxymethylglutaryl-CoA reductase inhibitors KW - drug-related side effects and adverse reactions KW - memory loss KW - PROMs KW - pharmacovigilance KW - infodemiology KW - infoveillance KW - peer-support groups N2 - Background: In drug development clinical trials, there is a need for balance between restricting variables by setting eligibility criteria and representing the broader patient population that may use a product once it is approved. Similarly, although recent policy initiatives focusing on the inclusion of historically underrepresented groups are being implemented, barriers still remain. These limitations of clinical trials may mask potential product benefits and side effects. To bridge these gaps, online communication in health communities may serve as an additional population signal for drug side effects. Objective: The aim of this study was to employ a nontraditional dataset to identify drug side-effect signals. The study was designed to apply both natural language processing (NLP) technology and hands-on linguistic analysis to a set of online posts from known statin users to (1) identify any underlying crossover between the use of statins and impairment of memory or cognition and (2) obtain patient lexicon in their descriptions of experiences with statin medications and memory changes. Methods: Researchers utilized user-generated content on Inspire, looking at over 11 million posts across Inspire. Posts were written by patients and caregivers belonging to a variety of communities on Inspire. After identifying these posts, researchers used NLP and hands-on linguistic analysis to draw and expand upon correlations among statin use, memory, and cognition. Results: NLP analysis of posts identified statistical correlations between statin users and the discussion of memory impairment, which were not observed in control groups. NLP found that, out of all members on Inspire, 3.1% had posted about memory or cognition. In a control group of those who had posted about TNF inhibitors, 6.2% had also posted about memory and cognition. In comparison, of all those who had posted about a statin medication, 22.6% (P<.001) also posted about memory and cognition. Furthermore, linguistic analysis of a sample of posts provided themes and context to these statistical findings. By looking at posts from statin users about memory, four key themes were found and described in detail in the data: memory loss, aphasia, cognitive impairment, and emotional change. Conclusions: Correlations from this study point to a need for further research on the impact of statins on memory and cognition. Furthermore, when using nontraditional datasets, such as online communities, NLP and linguistic methodologies broaden the population for identifying side-effect signals. For side effects such as those on memory and cognition, where self-reporting may be unreliable, these methods can provide another avenue to inform patients, providers, and the Food and Drug Administration. UR - http://www.jmir.org/2019/11/e14809/ UR - http://dx.doi.org/10.2196/14809 UR - http://www.ncbi.nlm.nih.gov/pubmed/31778117 ID - info:doi/10.2196/14809 ER - TY - JOUR AU - Roberts, Anne Natasha AU - Alexander, Kimberly AU - Wyld, David AU - Janda, Monika PY - 2019/11/26 TI - Factors in Randomized Controlled Trials Reported to Impact the Implementation of Patient-Reported Outcome Measures Into Routine Care: Protocol for a Systematic Review JO - JMIR Res Protoc SP - e14579 VL - 8 IS - 11 KW - patient reported outcomes KW - PROs KW - PROMs KW - clinical practice KW - implementation KW - implementation science KW - iPARIHS N2 - Background: Patient-reported outcome measures (PROMs) are tools that enable patients to directly report their own assessments of well-being, or symptoms, in a structured and consistent way. Despite the usefulness of PROMs in optimizing health outcomes, their use in clinical practice is not routine. PROMs are complex to integrate into the clinical setting, with many elements potentially impacting on the success of implementation. For this reason, a protocol has been developed to guide a systematic review to collate information on implementation as presented in the randomized controlled trials (RCTs) to date. Objective: The primary objective of this systematic review is to identify and synthesize factors available from RCT data about the fidelity of PROM interventions in clinical practice. The secondary objective will be an assessment of how implementation factors impact fidelity outcomes. Methods: Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting standards will be followed. MEDLINE, EMBASE, and the Cumulative Index to Nursing and Allied Health Literature via OvidSP will be accessed using a defined search strategy. Grey literature and ClinicalTrials.gov will be reviewed for unpublished studies. Data extraction will be done to identify fidelity and factors impacting implementation, summarized using a narrative synthesis. An evidence-based implementation science framework will assist in identifying potential elements of importance and their effect on the process and outcomes of implementation. A meta-analysis to assess the impact of implementation factors will be attempted. A Cochrane risk of bias tool will be used. Results: This protocol has received funding, and searches of databases will commence at the end of May 2019. It is planned that this systematic review will be finalized for publication in (December) 2019. Conclusions: Applying an implementation science evidence-based framework to the published literature may identify factors present in the data that impact on the implementation of PROMs into routine clinical care. This systematic review aims to improve understanding of how these factors impact the fidelity of this intervention, so that PROMs can be more effectively used in the care of patients. This systematic review can also offer more detailed information about the process and outcomes of successful implementation of PROMs. International Registered Report Identifier (IRRID): PRR1-10.2196/14579 UR - http://www.researchprotocols.org/2019/11/e14579/ UR - http://dx.doi.org/10.2196/14579 UR - http://www.ncbi.nlm.nih.gov/pubmed/31769763 ID - info:doi/10.2196/14579 ER - TY - JOUR AU - Mundy, R. Lily AU - Klassen, Anne AU - Grier, Jordan AU - Carty, J. Matthew AU - Pusic, L. Andrea AU - Hollenbeck, T. Scott AU - Gage, J. Mark PY - 2019/10/17 TI - Development of a Patient-Reported Outcome Instrument for Patients With Severe Lower Extremity Trauma (LIMB-Q): Protocol for a Multiphase Mixed Methods Study JO - JMIR Res Protoc SP - e14397 VL - 8 IS - 10 KW - amputation KW - limb salvage KW - lower extremity KW - trauma KW - survey KW - questionnaire KW - patient reported outcome measures KW - quality of life KW - patient satisfaction N2 - Background: A current limitation in the care of patients with severe lower extremity traumatic injuries is the lack of a rigorously developed patient-reported outcome (PRO) instrument specific to lower extremity trauma patients. Objective: This mixed methods protocol aims to describe phases I and II of the development of a PRO instrument for lower extremity trauma patients, following international PRO development guidelines. Methods: The phase I study follows an interpretive description approach. Development of the PRO instrument begins with identifying the concepts that are important to patients, after which a preliminary conceptual framework is devised from a systematic literature review and used to generate an interview guide. Patients aged 18 years or above with limb-threatening lower extremity traumatic injuries resulting in reconstruction, amputation, or amputation after failed reconstruction will be recruited. The subjects will participate in semistructured, in-depth qualitative interviews to identify all important concepts of interest. The qualitative interview data will be coded with top-level domains, themes, and subthemes. The codes will then be utilized to refine the conceptual framework and generate preliminary items and a set of scales. The preliminary scales will be further refined via a process of conducting cognitive debriefing interviews with lower extremity trauma patients and soliciting expert opinions. Phase III will include a large-scale field test, using Rasch measurement theory to analyze the psychometric properties of the instrument; shortening and finalizing the scales; and determining the reliability, validity, and responsiveness of the instrument. Results: Phases I and II of this study have been funded. Phase I of this study has been completed, and phase II began in January 2019 and is expected to be completed in November 2019. Phase III will begin following the completion of phase II. Conclusions: This protocol describes the initial phases of development of a novel PRO instrument for use in lower extremity trauma patients. International Registered Report Identifier (IRRID): DERR1-10.2196/14397 UR - http://www.researchprotocols.org/2019/10/e14397/ UR - http://dx.doi.org/10.2196/14397 UR - http://www.ncbi.nlm.nih.gov/pubmed/31625944 ID - info:doi/10.2196/14397 ER - TY - JOUR AU - Jin, Haomiao AU - Wu, Shinyi PY - 2019/10/1 TI - Use of Patient-Reported Data to Match Depression Screening Intervals With Depression Risk Profiles in Primary Care Patients With Diabetes: Development and Validation of Prediction Models for Major Depression JO - JMIR Form Res SP - e13610 VL - 3 IS - 4 KW - patient-reported data KW - patient-centered decision making KW - depression screening KW - depression KW - diabetes KW - health information technology KW - data analytics KW - predictive modeling KW - machine learning KW - data mining N2 - Background: Clinical guidelines recommend screening for depression in the general adult population but recognizes that the optimum interval for screening is unknown. Ideal screening intervals should match the patient risk profiles. Objective: This study describes a predictive analytics approach for mining clinical and patient-reported data from a large clinical study for the identification of primary care patients at high risk for depression to match depression screening intervals with patient risk profiles. Methods: This paper analyzed data from a large safety-net primary care study for diabetes and depression. A regression-based data mining technique was used to examine 53 demographics, clinical variables, and patient-reported variables to develop three prediction models for major depression at 6, 12, and 18 months from baseline. Predictors with the strongest predictive power that require low information collection efforts were selected to develop the prediction models. Predictive accuracy was measured by the area under the receiver operating curve (AUROC) and was evaluated by 10-fold cross-validation. The effectiveness of the prediction algorithms in supporting clinical decision making for six ?typical? types of patients was demonstrated. Results: The analysis included 923 patients who were nondepressed at the study baseline. Five patient-reported variables were selected in the prediction models to predict major depression at 6, 12, and 18 months: (1) Patient Health Questionnaire 2-item score; (2) the Sheehan Disability Scale; (3) previous problems with depression; (4) the diabetes symptoms scale; and (5) emotional burden of diabetes. All three depression prediction models had an AUROC>0.80, comparable with published depression prediction studies. Among the 6 ?typical? types of patients, the algorithms suggest that patients who reported impaired daily functioning by health status are at an elevated risk for depression in all three periods. Conclusions: This study demonstrated that leveraging patient-reported data and prediction models can help improve identification of high-risk patients and clinical decisions about the depression screening interval for diabetes patients. Implementation of this approach can be coupled with application of modern technologies such as telehealth and mobile health assessment for collecting patient-reported data to improve privacy, reducing stigma and costs, and promoting a personalized depression screening that matches screening intervals with patient risk profiles. UR - https://formative.jmir.org/2019/4/e13610 UR - http://dx.doi.org/10.2196/13610 UR - http://www.ncbi.nlm.nih.gov/pubmed/31573900 ID - info:doi/10.2196/13610 ER - TY - JOUR AU - Hjollund, I. Niels Henrik PY - 2019/9/30 TI - Fifteen Years? Use of Patient-Reported Outcome Measures at the Group and Patient Levels: Trend Analysis JO - J Med Internet Res SP - e15856 VL - 21 IS - 9 KW - patient-reported outcome KW - questionnaires KW - chronic disease KW - outpatient follow-up KW - patient involvement KW - resource reallocation N2 - Background: Since 2004, we have collected patient-reported outcome (PRO) data from several Danish patient populations for use at the group and patient levels. Objective: The aim of this paper is to highlight trends during the last 15 years with respect to patient inclusion, the methods for collection of PRO data, the processing of the data, and the actual applications and use of the PRO measurements. Methods: All PRO data have been collected using the AmbuFlex/WestChronic PRO system, which was developed by the author in 2004 and has been continuously updated since. The analysis of trends was based on a generic model applicable for any kind of clinical health data, according to which any application of clinical data may be divided into four processes: patient identification, data collection, data aggregation, and the actual data use. Data for analysis were generated by a specific application in the system and transferred for analysis to the R package. Results: During the 15-year period, 78,980 patients within 28 different groups of chronic and malignant illnesses have answered 260,433 questionnaires containing a total of 13,538,760 responses. Several marked changes have taken place: (1) the creation of cohorts for clinical epidemiological research purposes has shifted towards cohorts defined by clinical use of PRO data at the patient level; (2) the development of AmbuFlex, where PRO data are used as the entire basis for outpatient follow-up instead of fixed appointments, has undergone exponential growth and the system is currently in use in 47 International Statistical Classification of Diseases and Related Health Problems groups, covering 16,000 patients and 94 departments throughout Denmark; (3) response rates (up to 92%) and low attrition rates have been reached in group level projects, and there are even higher response rates in AmbuFlex where the patients are individually referred; (4) The answering method has shifted, as while in 2005 a total of 66.5% of questionnaires were paper based, this is the case for only 4.3% in 2019; and (5) the approach methods for questionnaires and reminders have changed dramatically from letter, emails, and short message service text messaging to a national, secure electronic mail system through which 93.2% of the communication to patients took place in 2019. The combination of secure email and web-based answering has resulted in a low turnaround time in which half of responses are now received within 5 days. Conclusions: The demand for clinical use of PRO measurements has increased, driven by a wish among patients as well as clinicians to use PRO to promote better symptom assessment, more patient-centered care, and more efficient use of resources. Important technological changes have occurred, creating new opportunities, and making PRO collection and use cheaper and more feasible. Several legal changes may constitute a barrier for further development as well as a barrier for better utilization of patients? questionnaire data. The current legal restrictions on the joint use of health data imposed by the European Union?s General Data Protection Regulation makes no distinction between use and misuse, and steps should be taken to alleviate these restrictions on the joint use of PRO data. UR - https://www.jmir.org/2019/9/e15856 UR - http://dx.doi.org/10.2196/15856 UR - http://www.ncbi.nlm.nih.gov/pubmed/31573943 ID - info:doi/10.2196/15856 ER - TY - JOUR AU - Engler, Kim AU - Ahmed, Sara AU - Lessard, David AU - Vicente, Serge AU - Lebouché, Bertrand PY - 2019/08/02 TI - Assessing the Content Validity of a New Patient-Reported Measure of Barriers to Antiretroviral Therapy Adherence for Electronic Administration in Routine HIV Care: Proposal for a Web-Based Delphi Study JO - JMIR Res Protoc SP - e12836 VL - 8 IS - 8 KW - HIV KW - antiretroviral therapy, highly active KW - patient-reported outcome measure KW - medication adherence KW - Delphi technique KW - stakeholder participation KW - Canada KW - France N2 - Background: Adherence to lifesaving antiretroviral therapy (ART) for HIV infection remains a challenge for many patients. Routine screening for barriers to ART adherence could help make HIV care more patient-centered and prevent virologic rebound or failure. Our team is currently developing a new HIV-specific patient-reported outcome measure (PROM) of these barriers for use in Canada and France along with a digital app for its electronic administration. In our previous work, we developed the PROM?s multidimensional conceptual framework and generated 100 English items, which have been translated to French. Objective: This study aims to use a Web-based Delphi to help validate and select the content of this new HIV-specific PROM, based on the perspective of anglophone and francophone patients and providers in Canada and France. Here, we present the proposal for this Delphi. Methods: This modified Delphi will involve a diverse panel of patients (n=32) and providers (n=52) recruited especially from the 9 sites of the PROM development study (site locations in Canada: Montreal, Toronto, Vancouver; in France: Paris, Nantes, Clermont-Ferrand, Saint-Martin, Cayenne). Overall, 2 rounds of Web-based questionnaires will be conducted. The threshold for consensus is set at 60% and will determine which items are carried forward to the second round. Per item, 3 aspects will be rated: importance as a barrier to ART adherence, relevance for HIV care, and clarity. In both rounds, space will be available for free text comments. Overall comprehensiveness will be assessed in the second round. Results: This study has undergone a methodological review by experts in patient-oriented research. It has received approval from a research ethics board of the McGill University Health Centre. It is financially supported, in part, by the Canadian Institutes of Health Research?s Strategy for Patient-Oriented Research-Quebec Support Unit (M006). As of May 21, 2019, 15 people living with HIV and 25 providers completed the first round of the Delphi (24 from Canada and 16 from France). Conclusions: To our knowledge, this is the first Delphi to seek consensus on the most relevant and clinically actionable barriers to ART adherence, collecting opinions on an extensive list of barriers. Drawing on a relatively large and diverse panel of HIV patients and providers, it essentially engages key stakeholders in decision making about the PROM?s final content, helping to ensure its utility and adoption. International Registered Report Identifier (IRRID): PRR1-10.2196/12836 UR - https://www.researchprotocols.org/2019/8/e12836/ UR - http://dx.doi.org/10.2196/12836 UR - http://www.ncbi.nlm.nih.gov/pubmed/31376275 ID - info:doi/10.2196/12836 ER - TY - JOUR AU - Hauth, Franziska AU - Bizu, Verena AU - App, Rehan AU - Lautenbacher, Heinrich AU - Tenev, Alina AU - Bitzer, Michael AU - Malek, Peter Nisar AU - Zips, Daniel AU - Gani, Cihan PY - 2019/07/24 TI - Electronic Patient-Reported Outcome Measures in Radiation Oncology: Initial Experience After Workflow Implementation JO - JMIR Mhealth Uhealth SP - e12345 VL - 7 IS - 7 KW - mHealth KW - eHealth KW - radiation oncology KW - patient reported outcome measures N2 - Background: Mobile health (mHealth) technologies are increasingly used in various medical fields. However, the potential of mHealth to improve patient care in radiotherapy by acquiring electronic patient reported outcome measures (ePROMs) during treatment has been poorly studied so far. Objective: The aim of this study was to develop and implement a novel Web app (PROMetheus) for patients undergoing radiotherapy. Herein, we have reported our experience with a focus on feasibility, patient acceptance, and a correlation of ePROMs with the clinical course of the patients. Methods: In the period between January and June 2018, 21 patients used PROMetheus to score side effects, symptoms, and quality of life?related parameters during and after their treatment. Items of the Patient Reported Outcome version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) were chosen based on the primary site of disease, 27 items for head and neck tumors, 21 items for thoracic tumors, and 24 items for pelvic tumors. Results: In total, 17 out of the 21 patients (81%) regularly submitted ePROMs and more than 2500 data points were acquired. An average of 5.2, 3.5, and 3.3 min was required to complete the head and neck, thorax, and pelvis questionnaires, respectively. ePROMS were able to detect the occurrence of both expected and unexpected side effects during the treatment. In addition, a gradual increase in the severity of side effects over the course the treatment and their remission afterward could be observed with ePROMs. In total, 9 out of the 17 patients (53%), mostly those with head and neck and thoracic cancers, reported PRO-CTCAE grade III or IV fatigue with severe impairments of activities of daily life. Conclusions: This study shows the successful implementation of an ePROM system and a high patient acceptance. ePROMs have a great potential to improve patient care in radiotherapy by providing a comprehensive documentation of symptoms and side effects, especially of ones that are otherwise underreported. UR - http://mhealth.jmir.org/2019/7/e12345/ UR - http://dx.doi.org/10.2196/12345 UR - http://www.ncbi.nlm.nih.gov/pubmed/31342906 ID - info:doi/10.2196/12345 ER - TY - JOUR AU - Geerards, Daan AU - Pusic, Andrea AU - Hoogbergen, Maarten AU - van der Hulst, René AU - Sidey-Gibbons, Chris PY - 2019/07/11 TI - Computerized Quality of Life Assessment: A Randomized Experiment to Determine the Impact of Individualized Feedback on Assessment Experience JO - J Med Internet Res SP - e12212 VL - 21 IS - 7 KW - quality of life KW - outcome assessment KW - patient-reported outcome measures KW - computer-adaptive testing KW - WHOQOL KW - psychometrics KW - feedback N2 - Background: Quality of life (QoL) assessments, or patient-reported outcome measures (PROMs), are becoming increasingly important in health care and have been associated with improved decision making, higher satisfaction, and better outcomes of care. Some physicians and patients may find questionnaires too burdensome; however, this issue could be addressed by making use of computerized adaptive testing (CAT). In addition, making the questionnaire more interesting, for example by providing graphical and contextualized feedback, may further improve the experience of the users. However, little is known about how shorter assessments and feedback impact user experience. Objective: We conducted a controlled experiment to assess the impact of tailored multimodal feedback and CAT on user experience in QoL assessment using validated PROMs. Methods: We recruited a representative sample from the general population in the United Kingdom using the Oxford Prolific academic Web panel. Participants completed either a CAT version of the World Health Organization Quality of Life assessment (WHOQOL-CAT) or the fixed-length WHOQOL-BREF, an abbreviated version of the WHOQOL-100. We randomly assigned participants to conditions in which they would receive no feedback, graphical feedback only, or graphical and adaptive text-based feedback. Participants rated the assessment in terms of perceived acceptability, engagement, clarity, and accuracy. Results: We included 1386 participants in our analysis. Assessment experience was improved when graphical and tailored text-based feedback was provided along with PROMs (?=0.22, P<.001). Providing graphical feedback alone was weakly associated with improvement in overall experience (?=0.10, P=.006). Graphical and text-based feedback made the questionnaire more interesting, and users were more likely to report they would share the results with a physician or family member (?=0.17, P<.001, and ?=0.17, P<.001, respectively). No difference was found in perceived accuracy of the graphical feedback scores of the WHOQOL-CAT and WHOQOL-BREF (?=0.06, P=.05). CAT (stopping rule [SE<0.45]) resulted in the administration of 25% fewer items than the fixed-length assessment, but it did not result in an improved user experience (P=.21). Conclusions: Using tailored text-based feedback to contextualize numeric scores maximized the acceptability of electronic QoL assessment. Improving user experience may increase response rates and reduce attrition in research and clinical use of PROMs. In this study, CAT administration was associated with a modest decrease in assessment length but did not improve user experience. Patient-perceived accuracy of feedback was equivalent when comparing CAT with fixed-length assessment. Fixed-length forms are already generally acceptable to respondents; however, CAT might have an advantage over longer questionnaires that would be considered burdensome. Further research is warranted to explore the relationship between assessment length, feedback, and response burden in diverse populations. UR - http://www.jmir.org/2019/7/e12212/ UR - http://dx.doi.org/10.2196/12212 UR - http://www.ncbi.nlm.nih.gov/pubmed/31298217 ID - info:doi/10.2196/12212 ER - TY - JOUR AU - Burns, Kara AU - McBride, A. Craig AU - Patel, Bhaveshkumar AU - FitzGerald, Gerard AU - Mathews, Shane AU - Drennan, Judy PY - 2019/6/13 TI - Creating Consumer-Generated Health Data: Interviews and a Pilot Trial Exploring How and Why Patients Engage JO - J Med Internet Res SP - e12367 VL - 21 IS - 6 KW - patient generated health data KW - patient engagement KW - patient participation KW - mHealth KW - photography N2 - Background: Consumer-generated health data (CGHD) are any clinically relevant data collected by patients or their carers (consumers) that may improve health care outcomes. Like patient experience measures, these data reflect the consumer perspective and is part of a patient-centric agenda. The use of CGHD is believed to enhance diagnosis, patient engagement, and thus foster an improved therapeutic partnership with health care providers. Objective: The aim of this study was to further identify how these data were used by consumers and how it influences engagement via a validated framework. In addition, carer data has not been explored for the purpose of engagement. Methods: Study 1 used interviews with CGHD-experienced patients, carers, and doctors to understand attitudes about data collection and use, developing an ontological framework. Study 2 was a pilot trial with carers (parents) of children undergoing laparoscopic appendectomy. For 10 days carers generated and emailed surgical site photographs to a tertiary children?s hospital. Subsequently, carers were interviewed about the engagement framework. In total, 60 interviews were analyzed using theme and content analysis. Results: This study validates a framework anchored in engagement literature, which categorizes CGHD engagement outcomes into 4 domains: physiological, cognitive, emotional, and behavioral. CGHD use is complex, interconnected, and can be organized into 10 themes within these 4 domains. Conclusions: CGHD can instigate an ecosystem of engagement and provide clinicians with an enhanced therapeutic relationship through an extended view into the patient?s world. In addition to clinical diagnosis and efficient use of health care resources, data offer another tool to manage consumers service experience, especially the emotions associated with the health care journey. Collection and use of data increases consumers sense of reassurance, improves communication with providers, and promotes greater personal responsibility, indicating an empowering consumer process. Finally, it can also improve confidence and satisfaction in the service. UR - http://www.jmir.org/2019/6/e12367/ UR - http://dx.doi.org/10.2196/12367 UR - http://www.ncbi.nlm.nih.gov/pubmed/31199312 ID - info:doi/10.2196/12367 ER - TY - JOUR AU - Lindskrog, Signe AU - Christensen, Bang Karl AU - Osborne, H. Richard AU - Vingtoft, Sřren AU - Phanareth, Klaus AU - Kayser, Lars PY - 2019/6/2 TI - Relationship Between Patient-Reported Outcome Measures and the Severity of Chronic Obstructive Pulmonary Disease in the Context of an Innovative Digitally Supported 24-Hour Service: Longitudinal Study JO - J Med Internet Res SP - e10924 VL - 21 IS - 6 KW - health literacy KW - empowerment KW - patient reported outcome measures KW - self-reported mental and physical health KW - health literacy questionnaire KW - health education impact questionnaire KW - SF-36 KW - epital living lab KW - chronic obstructive pulmonary disease N2 - Background: Individuals with chronic obstructive pulmonary disease (COPD) live with the burden of a progressive life-threatening condition that is often accompanied by anxiety and depression. The severity of the condition is usually considered from a clinical perspective and characterized according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification of severity (1-4) and a risk assessment (A through D) that focuses on the patient?s symptoms and number of exacerbations, but information about perceived health or ability to manage the condition are rarely included. Objective: We evaluated 3 patient-reported outcome measurements (PROMs) to examine how these can be used to report on individuals with COPD who were supported by a digitally assisted intervention that aims to increase the patient?s management of their condition to improve their well-being. Methods: A total of 93 individuals with COPD were enrolled. At baseline and after 6 and 12 months, we measured self-reported self-management (Health Education Impact Questionnaire, heiQ) and health literacy (Health Literacy Questionnaire, HLQ), and physical and mental health (Short Form-36, SF-36) PROMs were collected. The scores of the 19 PROM dimensions were related to COPD severity, that is, GOLD risk assessment, pulmonary function at entry, and number of exacerbations of a period up to 12 months. The initial PROM scores were also compared with pulmonary function, exacerbations, and GOLD risk assessment to predict the number of contacts within the first 90 days. Results: At baseline, 2 dimensions from heiQ and SF-36 Physical health differed significantly between GOLD risk factor groups, indicating more distress and poorer attitudes and health status with increasing severity (GOLD risk assessment). Pulmonary function (FEV1) was negatively associated with the severity of the condition. After 6 months, we observed an increase in heiQ6 (skill and technique acquisition) and a reduction in emotional distress. The latter effect persisted after 12 months, where heiQ4 (self-monitoring and insight) also increased. HLQ3 (actively managing my health) decreased after 6 and 12 months. The number of exacerbations and the GOLD risk factor assessment predicted the number of contacts during the first 90 days. Furthermore, 2 of the PROMS heiQ6 (skill and technique acquisition) and HLQ8 (ability to find good health information) evaluated at baseline were associated with the number of contacts within the first 90 after enrollment. The pulmonary function was not associated with the number of contacts. Conclusions: Our data suggest that selected dimensions from HLQ, heiQ, and SF-36 can be used as PROMs in relation to COPD to provide researchers and clinicians with greater insight into how this condition affects individuals? ability to understand and manage their condition and perception of their physical and mental health. The PROMs add to the information obtained with the clinical characteristics including the GOLD risk factor assessment. International Registered Report Identifier (IRRID): RR2-10.2196/resprot.6506 UR - https://www.jmir.org/2019/6/e10924/ UR - http://dx.doi.org/10.2196/10924 UR - http://www.ncbi.nlm.nih.gov/pubmed/31199320 ID - info:doi/10.2196/10924 ER - TY - JOUR AU - Hjollund, Ingvar Niels Henrik AU - Valderas, Maria José AU - Kyte, Derek AU - Calvert, Jane Melanie PY - 2019/05/21 TI - Health Data Processes: A Framework for Analyzing and Discussing Efficient Use and Reuse of Health Data With a Focus on Patient-Reported Outcome Measures JO - J Med Internet Res SP - e12412 VL - 21 IS - 5 KW - medical informatics KW - patient-reported outcome KW - patient-physician relationship KW - data collection UR - https://www.jmir.org/2019/5/e12412/ UR - http://dx.doi.org/10.2196/12412 UR - http://www.ncbi.nlm.nih.gov/pubmed/31115347 ID - info:doi/10.2196/12412 ER - TY - JOUR AU - Rothrock, E. Nan AU - Bass, Michael AU - Blumenthal, Andrea AU - Gershon, C. Richard AU - Hanson, Beate AU - Joeris, Alexander AU - Kaat, Aaron AU - Morrison, Suzanne AU - O'Toole, V. Robert AU - Patel, Shalini AU - Stover, Michael AU - Weaver, J. Michael AU - White, Raymond AU - Varela Diaz, Maria AU - Vrahas, S. Mark PY - 2019/04/12 TI - AO Patient Outcomes Center: Design, Implementation, and Evaluation of a Software Application for the Collection of Patient-Reported Outcome Measures in Orthopedic Outpatient Clinics JO - JMIR Form Res SP - e10880 VL - 3 IS - 2 KW - orthopedics KW - patient reported outcome measures KW - tablet computers N2 - Background: Patient-reported outcomes are increasingly utilized in routine orthopedic clinical care. Computer adaptive tests (CATs) from the Patient-Reported Outcomes Measurement Information System (PROMIS) offer a brief and precise assessment that is well suited for collection within busy clinical environments. However, software apps that support the administration and scoring of CATs, provide immediate access to patient-reported outcome (PRO) scores, and minimize clinician burden are not widely available. Objective: Our objective was to design, implement, and test the feasibility and usability of a Web-based system for collecting CATs in orthopedic clinics. Methods: AO Patient Outcomes Center (AOPOC) was subjected to 2 rounds of testing. Alpha testing was conducted in 3 orthopedic clinics to evaluate ease of use and feasibility of integration in clinics. Patients completed an assessment of PROMIS CATs and a usability survey. Clinicians participated in a brief semistructured interview. Beta-phase testing evaluated system performance through load testing and usability of the updated version of AOPOC. In both rounds of testing, user satisfaction, bugs, change requests, and performance of PROMIS CATs were captured. Results: Patient feedback supported the ease of use in completing an assessment in AOPOC. Across both phases of testing, clinicians rated AOPOC as easy to use but noted difficulties in integrating a Web-based software application within their clinics. PROMIS CATs performed well; the default assessment of 2 CATs was completed quickly (mean 9.5 items) with a satisfactory range of measurement. Conclusion: AOPOC was demonstrated to be an easy-to-learn and easy-to-use software application for patients and clinicians that can be integrated into orthopedic clinical care. The workflow disruption in integrating any type of PRO collection must be addressed if patients? voices are to be better integrated in clinical care. UR - https://formative.jmir.org/2019/2/e10880/ UR - http://dx.doi.org/10.2196/10880 UR - http://www.ncbi.nlm.nih.gov/pubmed/30977735 ID - info:doi/10.2196/10880 ER - TY - JOUR AU - Hartmann, Ralf AU - Sander, Christian AU - Lorenz, Noah AU - Böttger, Daniel AU - Hegerl, Ulrich PY - 2019/04/03 TI - Utilization of Patient-Generated Data Collected Through Mobile Devices: Insights From a Survey on Attitudes Toward Mobile Self-Monitoring and Self-Management Apps for Depression JO - JMIR Ment Health SP - e11671 VL - 6 IS - 4 KW - mHealth KW - depression KW - adherence KW - mobile applications, self-management N2 - Background: Depression is a severe psychiatric disease with high prevalence and an elevated risk for recurrence and chronicity. A substantial proportion of individuals with a diagnosis of unipolar depressive disorder do not receive treatment as advised by national guidelines. Consequently, self-monitoring and self-management become increasingly important. New mobile technologies create unique opportunities to obtain and utilize patient-generated data. As common adherence rates to mobile technologies are scarce, a profound knowledge of user behavior and attitudes and preferences is important throughout any developmental process of mobile technologies and apps. Objective: The aim of this survey was to provide descriptive data upon usage and anticipated usage of self-monitoring and self-management of depression and preferences of potential users in terms of documented parameters and data-sharing options. Methods: A Web-based survey comprising 55 questions was conducted to obtain data on the usage of mobile devices, app usage, and participant?s attitudes and preferences toward mobile health apps for the self-monitoring and self-management of depression. Results: A total of 825 participants provided information. Moreover, two-thirds of the sample self-reported to be affected by depressive symptoms, but only 12.1% (81/668) of those affected by depression have ever used any mobile self-monitoring or self-management app. Analysis showed that people want personally relevant information and feedback but also focus on handling sensitive data. Conclusions: New mobile technologies and smartphone apps, especially in combination with mobile sensor systems, offer unique opportunities to overcome challenges in the treatment of depression by utilizing the potential of patient-generated data. Focus on patient-relevant information, security and safe handling of sensitive personal data, as well as options to share data with self-selected third parties should be considered mandatory throughout any development process. UR - https://mental.jmir.org/2019/4/e11671/ UR - http://dx.doi.org/10.2196/11671 UR - http://www.ncbi.nlm.nih.gov/pubmed/30942693 ID - info:doi/10.2196/11671 ER - TY - JOUR AU - Manini, Matthew Todd AU - Mendoza, Tonatiuh AU - Battula, Manoj AU - Davoudi, Anis AU - Kheirkhahan, Matin AU - Young, Ellen Mary AU - Weber, Eric AU - Fillingim, Benton Roger AU - Rashidi, Parisa PY - 2019/03/26 TI - Perception of Older Adults Toward Smartwatch Technology for Assessing Pain and Related Patient-Reported Outcomes: Pilot Study JO - JMIR Mhealth Uhealth SP - e10044 VL - 7 IS - 3 KW - smartwatch KW - focus group KW - ecological momentary assessment (EMA) KW - patient-reported outcomes (PRO) N2 - Background: Chronic pain, including arthritis, affects about 100 million adults in the United States. Complexity and diversity of the pain experience across time and people and its fluctuations across and within days show the need for valid pain reports that do not rely on patient?s long-term recall capability. Smartwatches can be used as digital ecological momentary assessment (EMA) tools for real-time collection of pain scores. Smartwatches are generally less expensive than smartphones, are highly portable, and have a simpler user interface, providing an excellent medium for continuous data collection and enabling a higher compliance rate. Objective: The aim of this study was to explore the attitudes and perceptions of older adults towards design and technological aspects of a smartwatch framework for measuring patient report outcomes (PRO) as an EMA tool. Methods: A focus group session was conducted to explore the perception of participants towards smartwatch technology and its utility for PRO assessment. Participants included older adults (age 65+), with unilateral or bilateral symptomatic knee osteoarthritis. A preliminary user interface with server communication capability was developed and deployed on 10 Samsung Gear S3 smartwatches and provided to the users during the focus group. Pain was designated as the main PRO, while fatigue, mood, and sleep quality were included as auxiliary PROs. Pre-planned topics included participants? attitude towards the smartwatch technology, usability of the custom-designed app interface, and suitability of the smartwatch technology for PRO assessment. Discussions were transcribed, and content analysis with theme characterization was performed to identify and code the major themes. Results: We recruited 19 participants (age 65+) who consented to take part in the focus group study. The overall attitude of the participants toward the smartwatch technology was positive. They showed interest in the direct phone-call capability, availability of extra apps such as the weather apps and sensors for tracking health and wellness such as accelerometer and heart rate sensor. Nearly three-quarters of participants showed willingness to participate in a one-year study to wear the watch daily. Concerns were raised regarding usability, including accessibility (larger icons), notification customization, and intuitive interface design (unambiguous icons and assessment scales). Participants expressed interest in using smartwatch technology for PRO assessment and the availability of methods for sharing data with health care providers. Conclusions: All participants had overall positive views of the smartwatch technology for measuring PROs to facilitate patient-provider communications and to provide more targeted treatments and interventions in the future. Usability concerns were the major issues that will require special consideration in future smartwatch PRO user interface designs, especially accessibility issues, notification design, and use of intuitive assessment scales. UR - http://mhealth.jmir.org/2019/3/e10044/ UR - http://dx.doi.org/10.2196/10044 UR - http://www.ncbi.nlm.nih.gov/pubmed/30912756 ID - info:doi/10.2196/10044 ER - TY - JOUR AU - Steele Gray, Carolyn AU - Gravesande, Janelle AU - Hans, Kaur Parminder AU - Nie, X. Jason AU - Sharpe, Sarah AU - Loganathan, Mayura AU - Lyons, Renee AU - Cott, Cheryl PY - 2019/02/27 TI - Using Exploratory Trials to Identify Relevant Contexts and Mechanisms in Complex Electronic Health Interventions: Evaluating the Electronic Patient-Reported Outcome Tool JO - JMIR Form Res SP - e11950 VL - 3 IS - 1 KW - eHealth KW - mHealth KW - multiple chronic conditions KW - clinical trial, phase III KW - health care evaluation mechanisms KW - quantitative evaluation KW - qualitative evaluation KW - narrative analysis N2 - Background: Designing appropriate studies for evaluating complex interventions, such as electronic health solutions to support integrated care, remains a methodological challenge. With the many moving parts of complex interventions, it is not always clear how program activities are connected to anticipated and unanticipated outcomes. Exploratory trials can be used to uncover determinants (or mechanisms) to inform content theory that underpins complex interventions before designing a full evaluation plan. Objective: A multimethod exploratory trial of the electronic patient-reported outcome (ePRO) tool was conducted to uncover contexts, processes and outcome variables, and the mechanisms that link these variables before full-scale evaluation. ePRO is a mobile app and portal designed to support goal-oriented care in interdisciplinary primary health care practices (clinical-level integration). This paper offers evaluation findings and methodological insight on how to use exploratory trial data to identify relevant context, process, and outcome variables, as well as central (necessary to achieving outcomes) versus peripheral (less critical and potentially context dependent) mechanisms at play. Methods: The 4-month trial was conducted in 2 primary health care practices in Toronto, Canada. The patients were randomized into control and intervention groups and compared pre and post on quality of life and activation outcome measures. Semistructured interviews were conducted with providers and patients in the intervention group. Narrative analysis was used to uncover dominant mechanisms that inform the intervention?s content theory (how context and process variables are linked to outcomes). Results: Overall, 7 providers, 1 administrator, and 16 patients (7-control, 9-intervention) participated in the study. This study uncovered many complex and nuanced context, process, and outcome variables at play in the intervention. Narrative analysis of patient and provider interviews revealed dominant story lines that help to tease apart central and peripheral mechanisms driving the intervention. Provider and patient story lines centered around fitting the new intervention into everyday work and life of patients and providers and meaningfulness of the intervention. These themes were moderated by patient-provider relationships going into and throughout the intervention, their comfort with technology, and the research process. Conclusions: Identifying dominant story lines using narrative analysis helps to identify the most relevant context and process variables likely to influence study outcomes. Normalization process theory emerges as a useful theory to uncover underlying mechanisms because of its emphasis on the social production and normalization of technological, processual, and social aspects of work; all found to be critical to our intervention. The number of complex, overlapping influencing variables suggests that complex interventions such as ePRO require us to pay careful attention to central versus peripheral mechanisms that will influence study outcomes. The narrative methods presented here are shown to be useful in uncovering these mechanisms and help to guide subsequent larger evaluation studies. UR - http://formative.jmir.org/2019/1/e11950/ UR - http://dx.doi.org/10.2196/11950 UR - http://www.ncbi.nlm.nih.gov/pubmed/30810532 ID - info:doi/10.2196/11950 ER - TY - JOUR AU - Wicks, Paul AU - McCaffrey, Stacey AU - Goodwin, Kim AU - Black, Ryan AU - Hoole, Michael AU - Heywood, James PY - 2019/01/25 TI - A Modular Health-Related Quality of Life Instrument for Electronic Assessment and Treatment Monitoring: Web-Based Development and Psychometric Validation of Core Thrive Items JO - J Med Internet Res SP - e12075 VL - 21 IS - 1 KW - personal health records KW - health-related quality of life KW - patient reported outcome measures N2 - Background: Patient-reported outcome (PRO) measures describe natural history, manage disease, and measure the effects of interventions in trials. Patients themselves increasingly use Web-based PRO tools to track their progress, share their data, and even self-experiment. However, existing PROs have limitations such as being: designed for paper (not screens), long and burdensome, negatively framed, under onerous licensing restrictions, either too generic or too specific. Objective: This study aimed to develop and validate the core items of a modular, patient-centric, PRO system (Thrive) that could measure health status across a range of chronic conditions with minimal burden. Methods: Thrive was developed in 4 phases, largely consistent with Food and Drug Administration guidance regarding PRO development. First, preliminary core items (common across multiple conditions: core Thrive items) were developed through literature review, analysis of approximately 20 existing PROs on PatientsLikeMe, and feedback from psychometric and content experts. Second, 2 rounds of cognitive interviews were iteratively conducted with patients (N=14) to obtain feedback on the preliminary items. Third, core Thrive items were administered electronically along with comparator measures, including 20-item Short-Form General Health Survey (SF)-20 and Patient Health Questionnaire (PHQ)-9, to a large sample (N=2002) of adults with chronic diseases through the PatientsLikeMe platform. On the basis of theoretical and empirical rationale, items were revised or removed. Fourth, the revised core Thrive items were administered to another sample of patients (N=704) with generic and condition-specific comparator measures. A psychometric evaluation, which included both modern and classical test theory approaches, was conducted on these items, and several more items were removed. Results: Cognitive interviews helped to remove confusing or redundant items. Empirical testing of subscales revealed good internal consistency (Cronbach alpha=.712-.879), test-retest reliability (absolute intraclass correlations=.749-.912), and convergent validity with legacy PRO scales (eg, Pearson r=.5-.75 between Thrive subscales and PHQ-9 total). The finalized instrument consists of a 19-item core including 5 multi-item subscales: Core symptoms, Abilities, Mobility, Sleep, and Thriving. Results provide evidence of construct (content, convergent) validity, high levels of test-retest and internal consistency reliability, and the ability to detect change over time. The items did not exhibit bias based on gender or age, and the items generally functioned similarly across conditions. These results support the use of Thrive Core items across diverse chronic patient populations. Conclusions: Thrive appears to be a useful approach for capturing important domains for patients with chronic conditions. This core set serves as a foundation to begin developing modular condition-specific versions in the near future. Cross-walking against traditional PROs from the PatientsLikeMe platform is underway, in addition to clinical validation and comparison with biomarkers. Thrive is licensed under Creative Commons Attribution ShareAlike 4.0. UR - http://www.jmir.org/2019/1/e12075/ UR - http://dx.doi.org/10.2196/12075 UR - http://www.ncbi.nlm.nih.gov/pubmed/30681962 ID - info:doi/10.2196/12075 ER - TY - JOUR AU - Warrington, Lorraine AU - Absolom, Kate AU - Conner, Mark AU - Kellar, Ian AU - Clayton, Beverly AU - Ayres, Michael AU - Velikova, Galina PY - 2019/01/24 TI - Electronic Systems for Patients to Report and Manage Side Effects of Cancer Treatment: Systematic Review JO - J Med Internet Res SP - e10875 VL - 21 IS - 1 KW - oncology KW - chemotherapy KW - patient reported outcomes KW - patient centered KW - medical informatics N2 - Background: There has been a dramatic increase in the development of electronic systems to support cancer patients to report and manage side effects of treatment from home. Systems vary in the features they offer to patients, which may affect how patients engage with them and how they improve patient-centered outcomes. Objective: This review aimed to (1) describe the features and functions of existing electronic symptom reporting systems (eg, symptom monitoring, tailored self-management advice), and (2) explore which features may be associated with patient engagement and patient-centered outcomes. Methods: The review was registered with the International Prospective Register of Systematic Reviews (PROSPERO) and followed guidelines from the Centre for Reviews and Dissemination (University of York, United Kingdom). Primary searches were undertaken of MEDLINE, Embase, PsycInfo, Web of Science, Cochrane Central Register of Controlled Trials, and the Health Technology Assessment databases. Secondary searches were undertaken by screening reference lists and citations. Two researchers applied broad inclusion criteria to identify and select relevant records. Data were extracted and summarized using Microsoft Excel. In order to meet the aims, the study selection, data extraction, and data synthesis comprised two stages: (1) identifying and characterizing available systems and (2) summarizing data on patient engagement and patient-centered outcomes. Results: We identified 77 publications relating to 41 distinct systems. In Stage 1, all publications were included (N=77). The features identified that supported clinicians and care were facility for health professionals to remotely access and monitor patient-reported data (24/41, 58%) and function to send alerts to health professionals for severe symptoms (17/41, 41%). Features that supported patients were facility for patients to monitor/review their symptom reports over time (eg, graphs) (19/41, 46%), general patient information about cancer treatment and side effects (17/41, 41%), tailored automated patient advice on symptom management (12/41, 29%), feature for patients to communicate with the health care team (6/41, 15%), and a forum for patients to communicate with one another (4/41, 10%). In Stage 2, only publications that included some data on patient engagement or patient-centered outcomes were included (N=29). A lack of consistency between studies in how engagement was defined, measured, or reported, and a wide range of methods chosen to evaluate systems meant that it was not possible to compare across studies or make conclusions on relationships with system features. Conclusions: Electronic systems have the potential to help patients manage side effects of cancer treatment, with some evidence to suggest a positive effect on patient-centered outcomes. However, comparison across studies is difficult due to the wide range of assessment tools used. There is a need to develop guidelines for assessing and reporting engagement with systems, and a set of core outcomes for evaluation. We hope that this review will contribute to the field by introducing a taxonomy for characterizing system features. Trial Registration: PROSPERO CRD42016035915; www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42016035915 UR - http://www.jmir.org/2019/1/e10875/ UR - http://dx.doi.org/10.2196/10875 UR - http://www.ncbi.nlm.nih.gov/pubmed/30679145 ID - info:doi/10.2196/10875 ER - TY - JOUR AU - Matthies, Maria Lina AU - Taran, Florin-Andrei AU - Keilmann, Lucia AU - Schneeweiss, Andreas AU - Simoes, Elisabeth AU - Hartkopf, D. Andreas AU - Sokolov, N. Alexander AU - Walter, B. Christina AU - Sickenberger, Nina AU - Wallwiener, Stephanie AU - Feisst, Manuel AU - Gass, Paul AU - Lux, P. Michael AU - Schuetz, Florian AU - Fasching, A. Peter AU - Sohn, Christof AU - Brucker, Y. Sara AU - Graf, Joachim AU - Wallwiener, Markus PY - 2019/01/22 TI - An Electronic Patient-Reported Outcome Tool for the FACT-B (Functional Assessment of Cancer Therapy-Breast) Questionnaire for Measuring the Health-Related Quality of Life in Patients With Breast Cancer: Reliability Study JO - J Med Internet Res SP - e10004 VL - 21 IS - 1 KW - breast cancer KW - ePRO measurement KW - FACT-B KW - HRQoL KW - patient-reported outcomes KW - reliability of ePRO N2 - Background: The most frequent malignant disease in women is breast cancer. In the metastatic setting, quality of life is the primary therapeutic goal, and systematic treatment has only a limited effect on survival rates; therefore, the concept of the health-related quality of life (HRQoL) and measurement of patient-reported outcomes (PROs) are gaining more and more importance in the therapy setting of diseases such as breast cancer. One of the frequently used questionnaires for measuring the HRQoL in patients with breast cancer is the Functional Assessment of Cancer Therapy-Breast (FACT-B). Currently, paper-based surveys still predominate, as only a few reliable and validated electronic-based questionnaires are available. ePRO tools for the FACT-B questionnaire with proven reliability are missing so far. Objective: The aim of this study was to analyze the reliability of tablet-based measurement of FACT-B in the German language in adjuvant (curative) and metastatic breast cancer patients. Methods: Paper- and tablet-based questionnaires were completed by a total of 106 female adjuvant and metastatic breast cancer patients. All patients were required to complete the electronically based (ePRO) and paper-based version of the FACT-B. A frequency analysis was performed to determine descriptive sociodemographic characteristics. Both dimensions of reliability (parallel forms reliability using Wilcoxon test and test of internal consistency using Spearman ?) and agreement rates for single items, Kendall tau for each subscale, and total score were analyzed. Results: High correlations were shown for both dimensions of reliability (parallel forms reliability and internal consistency) in the patients? response behavior between paper-based and electronically based questionnaires. Regarding the reliability test of parallel forms, no significant differences were found in 35 of 37 single items, while significant correlations in the test for consistency were found in all 37 single items, in all 5 sum individual item subscale scores, as well as in total FACT-B score. Conclusions: The ePRO version of the FACT-B questionnaire is reliable for patients with breast cancer in both adjuvant and metastatic settings, showing highly significant correlations with the paper-based version in almost all questions all subscales and the total score. UR - http://www.jmir.org/2019/1/e10004/ UR - http://dx.doi.org/10.2196/10004 UR - http://www.ncbi.nlm.nih.gov/pubmed/30668517 ID - info:doi/10.2196/10004 ER - TY - JOUR AU - McCaffrey, Stacey AU - Black, A. Ryan AU - Nagao, Mitchell AU - Sepassi, Marjan AU - Sharma, Gaurav AU - Thornton, Susan AU - Kim, H. Youn AU - Braverman, Julia PY - 2019/01/07 TI - Measurement of Quality of Life in Patients with Mycosis Fungoides/Sézary Syndrome Cutaneous T-Cell Lymphoma: Development of an Electronic Instrument JO - J Med Internet Res SP - e11302 VL - 21 IS - 1 KW - quality of life KW - Rasch KW - patient-reported outcome KW - cutaneous T-cell lymphoma KW - mycosis fungoides KW - Sézary syndrome N2 - Background: Although the quality of life (QoL) plays an important role in treatment decision making and clinical management of mycosis fungoides (MF) or Sézary syndrome (SS) subtypes of cutaneous T-cell lymphomas (MF/SS-CTCLs), an MF- or SS-specific measure of QoL does not exist. Objective: The objective of this research was to develop and validate the first QoL instrument for MF/SS-CTCL using a patient-centered approach. Methods: A conceptual framework for the MF/SS-CTCL QoL was developed through a literature review and interviews with key opinion leaders. Concept elicitation with patients was utilized to refine the conceptual model and generate preliminary items. The items were then revised based on qualitative and quantitative feedback obtained through cognitive debriefing surveys and interviews with patients. Next, participants (N=126) completed the preliminary MF/SS-CTCL QoL and a comparator measure of health-related QoL (Skindex-29) through the PatientsLikeMe Open Research Exchange. The MF/SS-CTCL QoL was completed again 5 days later by 66 participants for the purposes of evaluating test-retest reliability. The MF/SS-CTCL QoL was finalized based on results from an empirical evaluation, which included both classical and modern test theory approaches. Specifically, this included evaluation of (1) the optimal item response theory measurement model; (2) item fit; (3) unidimensionality; (4) rating scale performance; (5) reliability; (6) test information (precision); (7) person-to-item map; (8) convergent and discriminant validity; and (9) presence of bias via differential item function. Results: Results from the comprehensive psychometric evaluation utilizing a Rasch-Grouped Rating Scale model yielded a final 12-item instrument. The rating scale functioned as expected, and the instrument exhibited adequate person reliability (.87), good to excellent test-retest reliability (r=.89, P<.001), high levels of measurement precision, and good person-to-item targeting. The correlation between the MF/SS-CTCL QoL and the Skindex-29 (r=.852, P<.001) was significantly greater than the correlation between the MF/SS-CTCL QoL and syndrome stage (r=.260, P<.001), providing support for convergent and discriminant validity. Items did not show significant bias based on gender, age, or race. Rasch scores were converted to scaled scores with qualitative descriptive categories for ease of interpretation. Conclusions: Empirical evaluation demonstrated strong evidence of excellent psychometric properties. Utilizing a patient-centered measure development approach ensures that this QoL instrument captures the information that is most meaningful and clinically relevant to patients. UR - https://www.jmir.org/2019/1/e11302/ UR - http://dx.doi.org/10.2196/11302 UR - http://www.ncbi.nlm.nih.gov/pubmed/30617041 ID - info:doi/10.2196/11302 ER - TY - JOUR AU - Taylor, Sara AU - Ferguson, Craig AU - Peng, Fengjiao AU - Schoeneich, Magdalena AU - Picard, W. Rosalind PY - 2019/01/03 TI - Use of In-Game Rewards to Motivate Daily Self-Report Compliance: Randomized Controlled Trial JO - J Med Internet Res SP - e11683 VL - 21 IS - 1 KW - self-reports KW - protocol compliance KW - recreational games N2 - Background: Encouraging individuals to report daily information such as unpleasant disease symptoms, daily activities and behaviors, or aspects of their physical and emotional state is difficult but necessary for many studies and clinical trials that rely on patient-reported data as primary outcomes. Use of paper diaries is the traditional method of completing daily diaries, but digital surveys are becoming the new standard because of their increased compliance; however, they still fall short of desired compliance levels. Objective: Mobile games using in-game rewards offer the opportunity to increase compliance above the rates of digital diaries and paper diaries. We conducted a 5-week randomized control trial to compare the completion rates of a daily diary across 3 conditions: a paper-based participant-reported outcome diary (Paper PRO), an electronic-based participant-reported outcome diary (ePRO), and a novel ePRO diary with in-game rewards (Game-Motivated ePRO). Methods: We developed a novel mobile game that is a combination of the idle and pet collection genres to reward individuals who complete a daily diary with an in-game reward. Overall, 197 individuals aged 6 to 24 years (male: 100 and female: 97) were enrolled in a 5-week study after being randomized into 1 of the 3 methods of daily diary completion. Moreover, 157 participants (male: 84 and female: 69) completed at least one diary and were subsequently included in analysis of compliance rates. Results: We observed a significant difference (F2,124=6.341; P=.002) in compliance to filling out daily diaries, with the Game-Motivated ePRO group having the highest compliance (mean completion 86.4%, SD 19.6%), followed by the ePRO group (mean completion 77.7%, SD 24.1%), and finally, the Paper PRO group (mean completion 70.6%, SD 23.4%). The Game-Motivated ePRO (P=.002) significantly improved compliance rates above the Paper PRO. In addition, the Game-Motivated ePRO resulted in higher compliance rates than the rates of ePRO alone (P=.09). Equally important, even though we observed significant differences in completion of daily diaries between groups, we did not observe any statistically significant differences in association between the responses to a daily mood question and study group, the average diary completion time (P=.52), or the System Usability Scale score (P=.88). Conclusions: The Game-Motivated ePRO system encouraged individuals to complete the daily diaries above the compliance rates of the Paper PRO and ePRO without altering the participants? responses. Trial Registration: ClinicalTrials.gov NCT03738254; http://clinicaltrials.gov/ct2/show/NCT03738254 (Archived by WebCite at http://www.webcitation.org/74T1p8u52) UR - https://www.jmir.org/2019/1/e11683/ UR - http://dx.doi.org/10.2196/11683 UR - http://www.ncbi.nlm.nih.gov/pubmed/30609986 ID - info:doi/10.2196/11683 ER - TY - JOUR AU - Weitzman, R. Elissa AU - Magane, M. Kara AU - Wisk, E. Lauren PY - 2018/12/21 TI - How Returning Aggregate Research Results Impacts Interest in Research Engagement and Planned Actions Relevant to Health Care Decision Making: Cohort Study JO - J Med Internet Res SP - e10647 VL - 20 IS - 12 KW - aggregate research results KW - decision making KW - juvenile idiopathic arthritis KW - patient engagement KW - patient-reported outcome measures KW - rheumatic disease N2 - Background: Collection of patient-reported outcomes measures (PROs) may augment clinical data and inform health research, improving care, yet approaches to sustaining interest among patient cohorts in research participation are needed. One approach may involve returning aggregate research results (ARRs), which may help patients contextualize personal experiences, prompt conversations with providers or family, and encourage information seeking. This model has been demonstrated for Web-based patient-centered registries. Studies with clinical cohorts may further elucidate the model, its impacts on interest in research participation and planned actions, and potential for participants to experience this as helpful or harmful?gap areas. Objective: We sought to investigate the impacts of returning ARRs comprising summaries of PROs and clinical metrics to parents of children with rheumatic disease, assessing interest in future research participation among parents who viewed ARRs and plans for acting on returned information. Further, we sought to investigate reactions to viewing ARRs and how these reactions impacted planned actions. Methods: Clinical and PRO data were obtained about children in a national clinical disease registry, summarized, and processed into annotated infographics, comprising ARRs for children?s parents. Parents who viewed ARRs (n=111) were surveyed about the information?s perceived value and their reactions. Reaction patterns were summarized using principal components analysis (PCA), and associations among reaction patterns and interest in research participation and planned actions were estimated using multivariate logistic regression. Results: Parental endorsement of the value of ARRs for understanding their child?s condition and making care decisions was high (across 10 topics for which ARRs were shared, 42.2%-77.3% of the parents reported information was ?very valuable?). Most (58/111, 52.3%) parents reported being more interested in participating in research after viewing ARRs, with the remainder reporting that their interest levels were unchanged. Reactions to viewing ARRs reflected experiencing validation/affirmation and information burden based on PCA. Reactions were not associated with child demographic or clinical characteristics and PROs, except that parents from households with less education reported greater information burden than those from more educated households (P=.007). In adjusted models, parents with higher validation/affirmation scores had increased odds of reporting heightened interest in research participation (adjusted odds ratio [AOR] 1.97, 95% CI 1.18-3.30), while higher information burden scores were associated with decreased odds of planned discussions with their child (AOR 0.59, 95% CI 0.36-0.95) and increased odds of planned discussions with providers (AOR 1.75, 95% CI 1.02-3.00). Conclusions: Returning ARRs may foster a ?virtuous cycle? of research engagement, especially where ARRs are experienced favorably and affect plans to share and discuss ARRs in support of a child?s chronic disease care and treatment. Reactions to ARRs vary with education level, underscoring the need for attention to equity for this model. UR - http://www.jmir.org/2018/12/e10647/ UR - http://dx.doi.org/10.2196/10647 UR - http://www.ncbi.nlm.nih.gov/pubmed/30578228 ID - info:doi/10.2196/10647 ER - TY - JOUR AU - Karsten, M. Maria AU - Speiser, Dorothee AU - Hartmann, Claudia AU - Zeuschner, Nele AU - Lippold, Kai AU - Kiver, Verena AU - Gocke, Peter AU - Kirchberger, Valerie AU - Blohmer, Jens-Uwe PY - 2018/12/20 TI - Web-Based Patient-Reported Outcomes Using the International Consortium for Health Outcome Measurement Dataset in a Major German University Hospital: Observational Study JO - JMIR Cancer SP - e11373 VL - 4 IS - 2 KW - breast cancer KW - International Council Health Outcome Measurement KW - mobile phone KW - patient-reported outcomes N2 - Background: Collecting patient-reported outcome (PRO) data systematically enables objective evaluation of treatment and its related outcomes. Using disease-specific questionnaires developed by the International Consortium for Health Outcome Measurement (ICHOM) allows for comparison between physicians, hospitals, and even different countries. Objective: This pilot project aimed to establish a digital system to measure PROs for new patients with breast cancer who attended the Charité Breast Center This approach should serve as a blueprint to further expand the PRO measurement to other disease entities and departments. Methods: In November 2016, we implemented a Web-based system to collect PRO data at Charité Breast Center using the ICHOM dataset. All new patients at the Breast Center were enrolled and answered a predefined set of questions using a tablet computer. Once they started their treatment at Charité, automated emails were sent to the patients at predefined treatment points. Those emails contained a Web-based link through which they could access and answer questionnaires. Results: By now, 541 patients have been enrolled and 2470 questionnaires initiated. Overall, 9.4% (51/541) of the patients were under the age of 40 years, 49.7% (269/541) between 40 and 60 years, 39.6% (214/541) between 60 and 80 years, and 1.3% (7/541) over the age of 80 years. The average return rate of questionnaires was 67.0%. When asked about the preference regarding paper versus Web-based questionnaires, 6.0% (8/134) of the patients between 50 and 60 years, 6.0% (9/150) between 60 and 70 years, and 12.7% (9/71) over the age of 70 years preferred paper versions. Conclusions: Measuring PRO in patients with breast cancer in an automated electronic version is possible across all age ranges while simultaneously achieving a high return rate. UR - http://cancer.jmir.org/2018/2/e11373/ UR - http://dx.doi.org/10.2196/11373 UR - http://www.ncbi.nlm.nih.gov/pubmed/30573450 ID - info:doi/10.2196/11373 ER - TY - JOUR AU - Lancaster, Karla AU - Abuzour, Aseel AU - Khaira, Manmeet AU - Mathers, Annalise AU - Chan, April AU - Bui, Vivian AU - Lok, Annie AU - Thabane, Lehana AU - Dolovich, Lisa PY - 2018/12/18 TI - The Use and Effects of Electronic Health Tools for Patient Self-Monitoring and Reporting of Outcomes Following Medication Use: Systematic Review JO - J Med Internet Res SP - e294 VL - 20 IS - 12 KW - eHealth KW - mHealth KW - electronic health record KW - telemedicine KW - self-report KW - patient portals KW - patient-centered care KW - drug monitoring KW - adverse effects N2 - Background: Electronic health (eHealth) tools are becoming increasingly popular for helping patients? self-manage chronic conditions. Little research, however, has examined the effect of patients using eHealth tools to self-report their medication management and use. Similarly, there is little evidence showing how eHealth tools might prompt patients and health care providers to make appropriate changes to medication use. Objective: The objective of this systematic review was to determine the impact of patients? use of eHealth tools on self-reporting adverse effects and symptoms that promote changes to medication use. Related secondary outcomes were also evaluated. Methods: MEDLINE, EMBASE, and CINAHL were searched from January 1, 2000, to April 25, 2018. Reference lists of relevant systematic reviews and included articles from the literature search were also screened to identify relevant studies. Title, abstract, and full-text review as well as data extraction and risk of bias assessment were performed independently by 2 reviewers. Due to high heterogeneity, results were not meta-analyzed and instead presented as a narrative synthesis. Results: A total of 14 studies, including 13 randomized controlled trials (RCTs) and 1 open-label intervention, were included, from which 11 unique eHealth tools were identified. In addition, 14 RCTs found statistically significant increases in positive medication changes as a result of using eHealth tools, as did the single open-label study. Moreover, 8 RCTs found improvement in patient symptoms following eHealth tool use, especially in adolescent asthma patients. Furthermore, 3 RCTs showed that eHealth tools might improve patient self-efficacy and self-management of chronic disease. Little or no evidence was found to support the effectiveness of eHealth tools at improving medication recommendations and reconciliation by clinicians, medication-use behavior, health service utilization, adverse effects, quality of life, or patient satisfaction. eHealth tools with multifaceted functionalities and those allowing direct patient-provider communication may be more effective at improving patient self-management and self-efficacy. Conclusions: Evidence suggests that the use of eHealth tools may improve patient symptoms and lead to medication changes. Patients generally found eHealth tools useful in improving communication with health care providers. Moreover, health-related outcomes among frequent eHealth tool users improved in comparison with individuals who did not use eHealth tools frequently. Implementation issues such as poor patient engagement and poor clinician workflow integration were identified. More high-quality research is needed to explore how eHealth tools can be used to effectively manage use of medications to improve medication management and patient outcomes. UR - https://www.jmir.org/2018/12/e294/ UR - http://dx.doi.org/10.2196/jmir.9284 UR - http://www.ncbi.nlm.nih.gov/pubmed/30563822 ID - info:doi/10.2196/jmir.9284 ER - TY - JOUR AU - Dibble, R. Emily AU - Iott, E. Bradley AU - Flynn, J. Allen AU - King, P. Darren AU - MacEachern, P. Mark AU - Friedman, P. Charles AU - Caverly, J. Tanner PY - 2018/11/27 TI - A Rapid Process for Identifying and Prioritizing Technology-Based Tools for Health System Implementation JO - JMIR Cancer SP - e11195 VL - 4 IS - 2 KW - patient reported outcome measures KW - evidence-based practice KW - decision support systems, clinical KW - medical informatics applications KW - practice guidelines as topic KW - evidence review KW - expert panel KW - health information technology KW - oncology care model KW - clinical decision support N2 - Background: Health system decisions to put new technologies into clinical practice require a rapid and trustworthy decision-making process informed by best evidence. Objective: This study aimed to present a rapid evidence review process that can be used to inform health system leaders and clinicians seeking to implement new technology tools to improve patient-clinician decision making and patient-oriented outcomes. Methods: The rapid evidence review process we pioneered involved 5 sequential subprocesses: (1) environmental scan, (2) expert panel recruitment, (3) host evidence review panel, (4) analysis, and (5) local validation panel. We conducted an environmental scan of health information technology (IT) literature to identify relevant digital tools in oncology care. We synthesized the recent literature using current evidence review methods, creating visual summaries for use by a national panel of experts. Panelists were taken through a 6-hour modified Delphi process to prioritize tools for implementation. Findings from the rapid evidence review panel were taken to a local validation panel for further rapid review during a 3-hour session. Results: Our rapid evidence review process shows promise for informing decision making by reducing the amount of time and resources needed to identify and prioritize adoption of IT tools. Despite evidence of improved patient outcomes, panelists had substantial concerns about implementing patient-reported outcome tracking tools, voicing concerns about liability, lack of familiarity with new technology, and additional time and workflow changes such tools would require. Instead, clinicians favored technologies that did not require clinician involvement. Conclusions: Health system leaders can use the rapid evidence review process presented here to usefully inform local technology adoption, implementation, and use in practice. UR - http://cancer.jmir.org/2018/2/e11195/ UR - http://dx.doi.org/10.2196/11195 UR - http://www.ncbi.nlm.nih.gov/pubmed/30482740 ID - info:doi/10.2196/11195 ER - TY - JOUR AU - Meyer, Robert AU - Spittel, Susanne AU - Steinfurth, Laura AU - Funke, Andreas AU - Kettemann, Dagmar AU - Münch, Christoph AU - Meyer, Thomas AU - Maier, André PY - 2018/11/12 TI - Patient-Reported Outcome of Physical Therapy in Amyotrophic Lateral Sclerosis: Observational Online Study JO - JMIR Rehabil Assist Technol SP - e10099 VL - 5 IS - 2 KW - ALS KW - amyotrophic lateral sclerosis KW - physical therapy KW - MYMOP KW - net promoter score KW - NPS KW - online self-assessment N2 - Background: Physical therapy is an essential component of multidisciplinary treatment in amyotrophic lateral sclerosis (ALS). However, the meaning of physical therapy beside preservation of muscular strength and functional maintenance is not fully understood. Objective: The purpose of this study was to examine patients? perception of physical therapy during symptom progression using an internet assessment approach. Methods: A prospective, longitudinal, observational study was performed. Recruitment took place in an ALS center in Berlin, Germany. Online self-assessment was established on a case management platform over 6 months. Participants self-assessed the progression of the disease with the ALS Functional Rating Scale-Revised (ALSFRS-R) and tracked the efficacy of targeted physical therapy using Measure Yourself Medical Outcome Profile (MYMOP). We used the net promoter score (NPS) to inquire into recommendation levels of physical therapy. Results: Forty-five participants with ALS were included in the study. Twenty-seven (60.0%) started the online assessment. The mean duration of physical therapy sessions per week was 142.7 minutes (SD 60.4) with a mean frequency of 2.9 (SD 1.2) per week. As defined by MYMOP input, the most concerning symptoms were reported in the legs (62.2%), arms (31.1%), and less frequently in the torso (6.7%). As expected for a progressive disease, there was a functional decline of 3 points in the ALSFRS-R at the end of the observation period (n=20). Furthermore, the MYMOP showed a significant loss of 0.8 in the composite score, 0.9 in the activity score and 0.8 in the targeted symptom. In spite of functional decline, the recommendation for physical therapy jumped from a baseline value of 20 NPS points to a very high 50 points at the end of study (P=.05). Conclusions: Physical therapy is perceived as an important treatment method by patients with ALS. Despite functional deterioration, patients are satisfied with physical therapy and recommend this intervention. The results also underline how the meaning of physical therapy changes throughout the disease. Physical therapy in ALS has to be regarded as a supportive and palliative health care intervention beyond functional outcome parameters. UR - http://rehab.jmir.org/2018/2/e10099/ UR - http://dx.doi.org/10.2196/10099 UR - http://www.ncbi.nlm.nih.gov/pubmed/30425026 ID - info:doi/10.2196/10099 ER - TY - JOUR AU - Froud, Robert AU - Fawkes, Carol AU - Foss, Jonathan AU - Underwood, Martin AU - Carnes, Dawn PY - 2018/10/24 TI - Responsiveness, Reliability, and Minimally Important and Minimal Detectable Changes of 3 Electronic Patient-Reported Outcome Measures for Low Back Pain: Validation Study JO - J Med Internet Res SP - e272 VL - 20 IS - 10 KW - electronic patient-reported outcome measures KW - validation KW - responsiveness KW - reliability KW - minimally important change KW - minimal detectable change KW - Roland Morris Disability Questionnaire KW - visual analog scale KW - numerical rating scale N2 - Background: The Roland Morris Disability Questionnaire (RMDQ), visual analog scale (VAS) of pain intensity, and numerical rating scale (NRS) are among the most commonly used outcome measures in trials of interventions for low back pain. Their use in paper form is well established. Few data are available on the metric properties of electronic counterparts. Objective: The goal of our research was to establish responsiveness, minimally important change (MIC) thresholds, reliability, and minimal detectable change at a 95% level (MDC95) for electronic versions of the RMDQ, VAS, and NRS as delivered via iOS and Android apps and Web browser. Methods: We recruited adults with low back pain who visited osteopaths. We invited participants to complete the eRMDQ, eVAS, and eNRS at baseline, 1 week, and 6 weeks along with a health transition question at 1 and 6 weeks. Data from participants reporting recovery were used in MIC and responsiveness analyses using receiver operator characteristic (ROC) curves and areas under the ROC curves (AUCs). Data from participants reporting stability were used for analyses of reliability (intraclass correlation coefficient [ICC] agreement) and MDC95. Results: We included 442 participants. At 1 and 6 weeks, ROC AUCs were 0.69 (95% CI 0.59 to 0.80) and 0.67 (95% CI 0.46 to 0.87) for the eRMDQ, 0.69 (95% CI 0.58 to 0.80) and 0.74 (95% CI 0.53 to 0.95) for the eVAS, and 0.73 (95% CI 0.66 to 0.80) and 0.81 (95% CI 0.69 to 0.92) for the eNRS, respectively. Associated MIC thresholds were estimated as 1 (0 to 2) and 2 (?1 to 5), 13 (9 to 17) and 7 (?12 to 26), and 2 (1 to 3) and 1 (0 to 2) points, respectively. Over a 1-week period in participants categorized as ?stable? and ?about the same? using the transition question, ICCs were 0.87 (95% CI 0.66 to 0.95) and 0.84 (95% CI 0.73 to 0.91) for the eRMDQ with MDC95 of 4 and 5, 0.31 (95% CI ?0.25 to 0.71) and 0.61 (95% CI 0.36 to 0.77) for the eVAS with MDC95 of 39 and 34, and 0.52 (95% CI 0.14 to 0.77) to 0.67 (95% CI 0.51 to 0.78) with MDC95 of 4 and 3 for the eNRS. Conclusions: The eRMDQ was reliable with borderline adequate responsiveness. The eNRS was responsive with borderline reliability. While the eVAS had adequate responsiveness, it did not have an attractive reliability profile. Thus, the eNRS might be preferred over the eVAS for measuring pain intensity. The observed electronic outcome measures? metric properties are within the ranges of values reported in the literature for their paper counterparts and are adequate for measuring changes in a low back pain population. UR - http://www.jmir.org/2018/10/e272/ UR - http://dx.doi.org/10.2196/jmir.9828 UR - http://www.ncbi.nlm.nih.gov/pubmed/30355556 ID - info:doi/10.2196/jmir.9828 ER - TY - JOUR AU - Lucas, R. Alexander AU - Bass, B. Michael AU - Rothrock, E. Nan AU - O'Connor, L. Mary AU - Sorkin, R. Mia AU - Nawyn, Jason AU - Albinali, Fahd AU - Wagner, I. Lynne PY - 2018/10/22 TI - Development of an eHealth System to Capture and Analyze Patient Sensor and Self-Report Data: Mixed-Methods Assessment of Potential Applications to Improve Cancer Care Delivery JO - JMIR Med Inform SP - e46 VL - 6 IS - 4 KW - cancer KW - care delivery KW - decision support KW - eHealth KW - mobile phone KW - survivorship KW - symptom monitoring N2 - Background: Capturing and Analyzing Sensor and Self-Report Data for Clinicians and Researchers (COMPASS) is an electronic health (eHealth) platform designed to improve cancer care delivery through passive monitoring of patients? health status and delivering customizable reports to clinicians. Based on data from sensors and context-driven administration of patient-reported outcome (PRO) measures, key indices of patients? functional status can be collected between regular clinic visits, supporting clinicians in the delivery of patient care. Objective: The first phase of this project aimed to systematically collect input from oncology providers and patients on potential clinical applications for COMPASS to refine the system. Methods: Ten clinicians representing various oncology specialties and disciplines completed semi-structured interviews designed to solicit clinician input on how COMPASS can best support clinical care delivery. Three cancer patients tested a prototype of COMPASS for 7 days and provided feedback. Interview data were tabulated using thematic content analysis to identify the most clinically relevant objective and PRO domains. Results: Thematic content analysis revealed that clinicians were most interested in monitoring vital statistics, symptoms, and functional status, including the physical activity level (n=9), weight (n=5), fatigue (n=9), sleep quality (n=8), and anxiety (n=7). Patients (2 in active treatment and 1 in remission) reported that they would use such a device, were enthusiastic about their clinicians monitoring their health status, especially the tracking of symptoms, and felt knowing their clinicians were monitoring and reviewing their health status provided valuable reassurance. Patients would, however, like to provide some context to their data. Conclusions: Clinicians and patients both articulated potential benefits of the COMPASS system in improving cancer care. From a clinician standpoint, data need to be easily interpretable and actionable. The fact that patients and clinicians both see potential value in eHealth systems suggests wider adoption and utilization could prove to be a useful tool for improving care delivery. UR - http://medinform.jmir.org/2018/4/e46/ UR - http://dx.doi.org/10.2196/medinform.9525 UR - http://www.ncbi.nlm.nih.gov/pubmed/30348634 ID - info:doi/10.2196/medinform.9525 ER - TY - JOUR AU - Sturt, Jackie AU - Dliwayo, Rebecca Thandiwe AU - Forjaz, Vera AU - Hamilton, Kathryn AU - Bryce, Carol AU - Fraser, Joseph AU - Griffiths, Frances PY - 2018/10/11 TI - Eliciting the Impact of Digital Consulting for Young People Living With Long-Term Conditions (LYNC Study): Cognitive Interviews to Assess the Face and Content Validity of Two Patient-Reported Outcome Measures JO - J Med Internet Res SP - e268 VL - 20 IS - 10 KW - communication KW - referral and consultation KW - electronic mail KW - text messaging KW - chronic disease KW - young adult KW - patient-reported outcome measures N2 - Background: Digital consulting, using email, text, and Skype, is increasingly offered to young people accessing specialist care for long-term conditions. No patient-reported outcome measures (PROMs) have been evaluated for assessing outcomes of digital consulting. Systematic and scoping reviews, alongside patient involvement, revealed 2 candidate PROMs for this purpose: the patient activation measure (PAM) and the physician?s humanistic behaviors questionnaire (PHBQ). PAM measures knowledge, beliefs, and skills that enable people to manage their long-term conditions. PHBQ assesses the presence of behaviors that are important to patients in their physician-patient interactions. Objective: This study aimed to assess the face and content validity of PAM and PHBQ to explore whether they elicit important outcomes of digital consulting and whether the PROMs can isolate the digital consultation component of care. Methods: Participants were drawn from 5 clinics providing specialist National Health Service care to 16- to 24-year-olds with long-term health conditions participating in the wider LYNC (Long-Term Conditions, Young People, Networked Communications) study. Overall, 14 people undertook a cognitive interview in this substudy. Of these, 7 participants were young people with either inflammatory bowel disease, cystic fibrosis, or cancer. The remaining 7 participants were clinicians who were convenience sampled. These included a clinical psychologist, 2 nurses, 3 consultant physicians, and a community youth worker practicing in cancer, diabetes, cystic fibrosis, and liver disease. Cognitive interviews were transcribed and analyzed, and a spreadsheet recorded the participants? PROM item appraisals. Illustrative quotes were extracted verbatim from the interviews for all participants. Results: Young people found 11 of the PAM 13 items and 7 of the additional 8 PAM 22 items to be relevant to digital consulting. They were only able to provide spontaneous examples of digital consulting for 50% (11/22) of the items. Of the 7 clinicians, 4 appraised all PAM 13 items and 20 of the PAM 22 items to be relevant to evaluating digital consulting and articulated operationalization of the items with reference to their own digital consulting practice with greater ease than the young people. Appraising the PHBQ, in 14 of the 25 items, two-thirds of the young people?s appraisals offered digital consulting examples with ease, suggesting that young people can detect and discern humanistic clinician behaviors via digital as well as face-to-face communication channels. Moreover, 17 of the 25 items were appraised as relevant by the young people. This finding was mirrored in the clinician appraisals. Both young people and the clinicians found the research task complex. Young participants required considerably more researcher prompting to elicit examples related to digital consulting rather than their face-to-face care. Conclusions: PAM and PHBQ have satisfactory face and content validity for evaluating digital consulting to warrant proceeding to psychometric evaluation. Completion instructions require revision to differentiate between digital and face-to-face consultations. UR - https://www.jmir.org/2018/10/e268/ UR - http://dx.doi.org/10.2196/jmir.9786 UR - http://www.ncbi.nlm.nih.gov/pubmed/30309832 ID - info:doi/10.2196/jmir.9786 ER - TY - JOUR AU - Crouthamel, Michelle AU - Quattrocchi, Emilia AU - Watts, Sarah AU - Wang, Sherry AU - Berry, Pamela AU - Garcia-Gancedo, Luis AU - Hamy, Valentin AU - Williams, E. Rachel PY - 2018/9/13 TI - Using a ResearchKit Smartphone App to Collect Rheumatoid Arthritis Symptoms From Real-World Participants: Feasibility Study JO - JMIR Mhealth Uhealth SP - e177 VL - 6 IS - 9 KW - rheumatoid arthritis KW - smartphone KW - mobile phone KW - patient-reported outcome measures KW - mobile applications N2 - Background: Using smartphones to enroll, obtain consent, and gather self-reported data from patients has the potential to enhance our understanding of disease burden and quantify physiological impact in the real world. It may also be possible to harness integral smartphone sensors to facilitate remote collection of clinically relevant data. Objective: We conducted the Patient Rheumatoid Arthritis Data From the Real World (PARADE) observational study using a customized ResearchKit app with a bring-your-own-device approach. Our objective was to assess the feasibility of using an entirely digital approach (social media and smartphone app) to conduct a real-world observational study of patients with rheumatoid arthritis. Methods: We conducted this observational study using a customized ResearchKit app with a bring-your-own-device approach. To recruit patients, the PARADE app, designed to guide patients through a series of tasks, was publicized via social media platforms and made available for patients in the United States to download from the Apple App Store. We collected patient-reported data, such as medical history, rheumatoid arthritis-related medications (past and present), and a range of patient-reported outcome measures. We included in the assessment a joint-pain map and a novel objective assessment of wrist range of movement, measured by the smartphone-embedded gyroscope and accelerometer. Results: Within 1 month of recruitment via social media campaigns, 399 participants self-enrolled, self-consented, and provided complete demographic data. Joint pain was the most frequently reported rheumatoid arthritis symptom to bother study participants (344/393, 87.5%). Severe patient-reported wrist pain appeared to be inversely linked with the range of wrist movement measured objectively by the app. At study entry, 292 of 399 participants (73.2%) indicated a preference for participating in a mobile app?based study. The number of participants in the study declined to 45 of 399 (11.3%) at week 12. Conclusions: Despite the declining number of participants over time, the combination of social media and smartphone app with sensor integration was a feasible and cost-effective approach for the collection of patient-reported data in rheumatoid arthritis. Integral sensors within smartphones can be harnessed to provide novel end points, and the novel wrist range of movement test warrants further clinical validation. UR - http://mhealth.jmir.org/2018/9/e177/ UR - http://dx.doi.org/10.2196/mhealth.9656 UR - http://www.ncbi.nlm.nih.gov/pubmed/30213779 ID - info:doi/10.2196/mhealth.9656 ER - TY - JOUR AU - Irfan Khan, Anum AU - Gill, Ashlinder AU - Cott, Cheryl AU - Hans, Kaur Parminder AU - Steele Gray, Carolyn PY - 2018/08/28 TI - mHealth Tools for the Self-Management of Patients With Multimorbidity in Primary Care Settings: Pilot Study to Explore User Experience JO - JMIR Mhealth Uhealth SP - e171 VL - 6 IS - 8 KW - primary care KW - mHealth KW - self-management KW - multimorbidity N2 - Background: Given the complex and evolving needs of individuals with multimorbidity, the adoption of mHealth tools to support self-management efforts is increasingly being explored, particularly in primary care settings. The electronic patient-reported outcomes (ePRO) tool was codeveloped with patients and providers in an interdisciplinary primary care team in Toronto, Canada, to help facilitate self-management in community-dwelling adults with multiple chronic conditions. Objective: The objective of study is to explore the experience and expectations of patients with multimorbidity and their providers around the use of the ePRO tool in supporting self-management efforts. Methods: We conducted a 4-week pilot study of the ePRO tool. Patients? and providers? experiences and expectations were explored through focus groups that were conducted at the end of the study. In addition, thematic analyses were used to assess the shared and contrasting perspectives of patients and providers on the role of the ePRO tool in facilitating self-management. Coded data were then mapped onto the Individual and Family Self-Management Theory using the framework method. Results: In this pilot study, 12 patients and 6 providers participated. Both patients and providers emphasized the need for a more explicit recognition of self-management context, including greater customizability of content to better adapt to the complexity and fluidity of self-management in this particular patient population. Patients and providers highlighted gaps in the extent to which the tool enables self-management processes, including how limited progress toward self-management goals and the absence of direct provider engagement through the ePRO tool inhibited patients from meeting their self-management goals. Providers highlighted proximal outcomes based on their experience of the tool and specifically, they indicated that the tool offered valuable insights into the broader patient context, which helps to inform the self-management approach and activities they recommend to patients, whereas patients recognized the tool?s potential in helping to improve access to different providers in a team-based primary care setting. Conclusions: This study identifies a more explicit recognition of the contextual factors that influence patients? ability to self-manage and greater adaptability to accommodate patient complexity and provider workflow as next steps in refining the ePRO tool to better support self-management efforts in primary care ahead of its application in a full-scale randomized pragmatic trial. UR - http://mhealth.jmir.org/2018/8/e171/ UR - http://dx.doi.org/10.2196/mhealth.8593 UR - http://www.ncbi.nlm.nih.gov/pubmed/30154073 ID - info:doi/10.2196/mhealth.8593 ER - TY - JOUR AU - Brajovic, Sonja AU - Blaser, A. David AU - Zisk, Meaghan AU - Caligtan, Christine AU - Okun, Sally AU - Hall, Marni AU - Pamer, A. Carol PY - 2018/08/21 TI - Validating a Framework for Coding Patient-Reported Health Information to the Medical Dictionary for Regulatory Activities Terminology: An Evaluative Study JO - JMIR Med Inform SP - e42 VL - 6 IS - 3 KW - adverse drug events KW - Food and Drug Administration KW - MedDRA KW - patient-generated health data KW - PatientsLikeMe KW - vocabulary, controlled KW - data curation N2 - Background: The availability of and interest in patient-generated health data (PGHD) have grown steadily. Patients describe medical experiences differently compared with how clinicians or researchers would describe their observations of those same experiences. Patients may find nonserious, known adverse drug events (ADEs) to be an ongoing concern, which impacts the tolerability and adherence. Clinicians must be vigilant for medically serious, potentially fatal ADEs. Having both perspectives provides patients and clinicians with a complete picture of what to expect from drug therapies. Multiple initiatives seek to incorporate patients? perspectives into drug development, including PGHD exploration for pharmacovigilance. The Food and Drug Administration (FDA) Adverse Event Reporting System contains case reports of postmarketing ADEs. To facilitate the analysis of these case reports, case details are coded using the Medical Dictionary for Regulatory Activities (MedDRA). PatientsLikeMe is a Web-based network where patients report, track, share, and discuss their health information. PatientsLikeMe captures PGHD through free-text and structured data fields. PatientsLikeMe structured data are coded to multiple medical terminologies, including MedDRA. The standardization of PatientsLikeMe PGHD enables electronic accessibility and enhances patient engagement. Objective: The aim of this study is to retrospectively review PGHD for symptoms and ADEs entered by patients on PatientsLikeMe and coded by PatientsLikeMe to MedDRA terminology for concordance with regulatory-focused coding practices. Methods: An FDA MedDRA coding expert retrospectively reviewed a data file containing verbatim patient-reported symptoms and ADEs and PatientsLikeMe-assigned MedDRA terms to determine the medical accuracy and appropriateness of the selected MedDRA terms, applying the International Council for Harmonisation MedDRA Term Selection: Points to Consider (MTS:PTC) guides. Results: The FDA MedDRA coding expert reviewed 3234 PatientsLikeMe-assigned MedDRA codes and patient-reported verbatim text. The FDA and PatientsLikeMe were concordant at 97.09% (3140/3234) of the PatientsLikeMe-assigned MedDRA codes. The 2.91% (94/3234) discordant subset was analyzed to identify reasons for differences. Coding differences were attributed to several reasons but mostly driven by PatientsLikeMe?s approach of assigning a more general MedDRA term to enable patient-to-patient engagement, while the FDA assigned a more specific medically relevant term. Conclusions: PatientsLikeMe MedDRA coding of PGHD was generally comparable to how the FDA would code similar data, applying the MTS:PTC principles. Discordant coding resulted from several reasons but mostly reflected a difference in purpose. The MTS:PTC coding principles aim to capture the most specific reported information about an ADE, whereas PatientsLikeMe may code patient-reported symptoms and ADEs to more general MedDRA terms to support patient engagement among a larger group of patients. This study demonstrates that most verbatim reports of symptoms and ADEs collected by a PGHD source, such as the PatientsLikeMe platform, could be reliably coded to MedDRA terminology by applying the MTS:PTC guide. Regarding all secondary use of novel data, understanding coding and standardization principles applied to these data types are important. UR - http://medinform.jmir.org/2018/3/e42/ UR - http://dx.doi.org/10.2196/medinform.9878 UR - http://www.ncbi.nlm.nih.gov/pubmed/30131314 ID - info:doi/10.2196/medinform.9878 ER - TY - JOUR AU - Rosner, I. Benjamin AU - Gottlieb, Marc AU - Anderson, N. William PY - 2018/07/20 TI - Accuracy of Internet-Based Patient Self-Report of Postdischarge Health Care Utilization and Complications Following Orthopedic Procedures: Observational Cohort Study JO - J Med Internet Res SP - e10405 VL - 20 IS - 7 KW - patient-generated health data KW - patient reported outcome measures KW - patient self-report KW - complications KW - utilization KW - patient readmission KW - emergency room KW - hospital economics N2 - Background: The accuracy of patient self-report of health care utilization and complications has yet to be determined. If patients are accurate and engaged self-reporters, collecting this information in a manner that is temporally proximate to the health care utilization events themselves may prove valuable to health care organizations undertaking quality improvement initiatives for which such data are often unavailable. Objective: The objective of this study was to measure the accuracy of patient self-report of health care utilization and complications in the 90 days following orthopedic procedures using an automated digital patient engagement platform. Methods: We conducted a multicenter real-world observational cohort study across 10 orthopedic practices in California and Nevada. A total of 371 Anthem members with claims data meeting inclusion criteria who had undergone orthopedic procedures between March 1, 2015, and July 1, 2016, at participating practices already routinely using an automated digital patient engagement platform for asynchronous remote guidance and telemonitoring were sent surveys through the platform (in addition to the other materials being provided to them through the platform) regarding 90-day postencounter health care utilization and complications. Their self-reports to structured survey questions of health care utilization and complications were compared to claims data as a reference. Results: The mean age of the 371 survey recipients was 56.5 (SD 15.7) years, 48.8% (181/371) of whom were female; 285 individuals who responded to 1 or more survey questions had a mean age of 56.9 (SD 15.4) years and a 49.5% (141/285) female distribution. There were no significant differences in demographics or event prevalence rates between responders and nonresponders. With an overall survey completion rate of 76.8% (285/371), patients were found to have accuracy of self-report characterized by a kappa of 0.80 and agreement of 0.99 and a kappa of 1.00 and agreement of 1.00 for 90-day hospital admissions and pulmonary embolism, respectively. Accuracy of self-report of 90-day emergency room/urgent care visits and of surgical site infection were characterized by a kappa of 0.45 and agreement of 0.96 and a kappa of 0.53 and agreement of 0.97, respectively. Accuracy for other complications such as deep vein thrombosis, hemorrhage, severe constipation, and fracture/dislocation was lower, influenced by low event prevalence rates within our sample. Conclusions: In this multicenter observational cohort study using an automated internet-based digital patient engagement platform, we found that patients were most accurate self-reporters of 90-day hospital admissions and pulmonary embolism, followed by 90-day surgical site infection and emergency room/urgent care visits. They were less accurate for deep vein thrombosis and least accurate for hemorrhage, severe constipation, and fracture/dislocation. A total of 76.8% (285/371) of patients completed surveys without the need for clinical staff to collect responses, suggesting the acceptability to patients of internet-based survey dissemination from and collection by clinical teams. While our methods enabled detection of events outside of index institutions, assessment of accuracy of self-report for presence and absence of events and nonresponse bias analysis, low event prevalence rates, particularly for several of the complications, limit the conclusions that may be drawn for some of the findings. Nevertheless, this investigation suggests the potential that engaging patients in self-report through such survey modalities may offer for the timely and accurate measurement of matters germane to health care organizations engaged in quality improvement efforts post discharge. UR - http://www.jmir.org/2018/7/e10405/ UR - http://dx.doi.org/10.2196/10405 UR - http://www.ncbi.nlm.nih.gov/pubmed/30030212 ID - info:doi/10.2196/10405 ER - TY - JOUR AU - Schoen, W. Martin AU - Basch, Ethan AU - Hudson, L. Lori AU - Chung, E. Arlene AU - Mendoza, R. Tito AU - Mitchell, A. Sandra AU - St. Germain, Diane AU - Baumgartner, Paul AU - Sit, Laura AU - Rogak, J. Lauren AU - Shouery, Marwan AU - Shalley, Eve AU - Reeve, B. Bryce AU - Fawzy, R. Maria AU - Bhavsar, A. Nrupen AU - Cleeland, Charles AU - Schrag, Deborah AU - Dueck, C. Amylou AU - Abernethy, P. Amy PY - 2018/07/16 TI - Software for Administering the National Cancer Institute?s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events: Usability Study JO - JMIR Hum Factors SP - e10070 VL - 5 IS - 3 KW - usability KW - patient-reported outcomes KW - symptoms KW - adverse events KW - PRO-CTCAE KW - cancer clinical trials N2 - Background: The US National Cancer Institute (NCI) developed software to gather symptomatic adverse events directly from patients participating in clinical trials. The software administers surveys to patients using items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) through Web-based or automated telephone interfaces and facilitates the management of survey administration and the resultant data by professionals (clinicians and research associates). Objective: The purpose of this study was to iteratively evaluate and improve the usability of the PRO-CTCAE software. Methods: Heuristic evaluation of the software functionality was followed by semiscripted, think-aloud protocols in two consecutive rounds of usability testing among patients with cancer, clinicians, and research associates at 3 cancer centers. We conducted testing with patients both in clinics and at home (remotely) for both Web-based and telephone interfaces. Furthermore, we refined the software between rounds and retested. Results: Heuristic evaluation identified deviations from the best practices across 10 standardized categories, which informed initial software improvement. Subsequently, we conducted user-based testing among 169 patients and 47 professionals. Software modifications between rounds addressed identified issues, including difficulty using radio buttons, absence of survey progress indicators, and login problems (for patients) as well as scheduling of patient surveys (for professionals). The initial System Usability Scale (SUS) score for the patient Web-based interface was 86 and 82 (P=.22) before and after modifications, respectively, whereas the task completion score was 4.47, which improved to 4.58 (P=.39) after modifications. Following modifications for professional users, the SUS scores improved from 71 to 75 (P=.47), and the mean task performance improved significantly (4.40 vs 4.02; P=.001). Conclusions: Software modifications, informed by rigorous assessment, rendered a usable system, which is currently used in multiple NCI-sponsored multicenter cancer clinical trials. Trial Registration: ClinicalTrials.gov NCT01031641; https://clinicaltrials.gov/ct2/show/NCT01031641 (Archived by WebCite at http://www.webcitation.org/708hTjlTl) UR - http://humanfactors.jmir.org/2018/3/e10070/ UR - http://dx.doi.org/10.2196/10070 UR - http://www.ncbi.nlm.nih.gov/pubmed/30012546 ID - info:doi/10.2196/10070 ER - TY - JOUR AU - Barger, Diana AU - Leleux, Olivier AU - Conte, Valérie AU - Sapparrart, Vincent AU - Gapillout, Marie AU - Crespel, Isabelle AU - Erramouspe, Marie AU - Delveaux, Sandrine AU - Dabis, Francois AU - Bonnet, Fabrice PY - 2018/06/07 TI - Integrating Electronic Patient-Reported Outcome Measures into Routine HIV Care and the ANRS CO3 Aquitaine Cohort?s Data Capture and Visualization System (QuAliV): Protocol for a Formative Research Study JO - JMIR Res Protoc SP - e147 VL - 7 IS - 6 KW - patient-reported outcomes KW - HIV KW - patient-centered care KW - health-related quality of life KW - patient-generated health data N2 - Background: Effective antiretroviral therapy has greatly reduced HIV-related morbidity and mortality, dramatically changing the demographics of the population of people living with HIV. The majority of people living with HIV in France are well cared for insofar as their HIV infection is concerned but remain at risk for age-associated comorbidities. Their long-term, potentially complex, and growing care needs make the routine, longitudinal assessment of health-related quality of life and other patient-reported outcomes of relevance in the current treatment era. Objective: We aim to describe the development of a Web-based electronic patient-reported outcomes system for people living with HIV linked to the ANRS CO3 Aquitaine cohort?s data capture and visualization system (ARPEGE) and designed to facilitate the electronic collection of patient-reported data and ultimately promote better patient-physician communication and quality of care (both patient satisfaction and health outcomes). Methods: Participants who meet the eligibility criteria will be invited to engage with the Web-based electronic patient-reported outcomes system and provided with the information necessary to create a personal patient account. They will then be able to access the electronic patient-reported outcomes system and complete a set of standardized validated questionnaires covering health-related quality of life (World Health Organization's Quality of Life Instrument in HIV infection, named WHOQOL-HIV BREF) and other patient-reported outcomes. The information provided via questionnaires will ultimately be presented in a summary format for clinicians, together with the patient?s HIV care history. Results: The prototype of the Web-based electronic patient-reported outcome system will be finalized and the first 2 formative research phases of the study (prototyping and usability testing) will be conducted from December 2017 to May 2018. We describe the sequential processes planned to ensure that the proposed electronic patient-reported outcome system is ready for formal pilot testing, referred to herein as phases 1a and 1b. We also describe the planned pilot-testing designed to evaluate the acceptability and use of the system from the patient?s perspective (phase 2). Conclusions: As the underlying information technology solution, ARPEGE, has being developed in-house, should the feasibility study presented here yield promising results, the panel of services provided via the proposed portal could ultimately be expanded and used to experiment with health-promoting interventions in aging people living with HIV in hospital-based care or adapted for use in other patient populations. Trial Registration: ClinicalTrials.gov NCT03296202; https://clinicaltrials.gov/ct2/show/NCT03296202 (Archived by WebCite at http://www.webcitation.org/6zgOBArps) Registered Report Identifier: RR1-10.2196/9439 UR - http://www.researchprotocols.org/2018/6/e147/ UR - http://dx.doi.org/10.2196/resprot.9439 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/resprot.9439 ER - TY - JOUR AU - Li, Jing AU - Yazdany, Jinoos AU - Trupin, Laura AU - Izadi, Zara AU - Gianfrancesco, Milena AU - Goglin, Sarah AU - Schmajuk, Gabriela PY - 2018/05/09 TI - Capturing a Patient-Reported Measure of Physical Function Through an Online Electronic Health Record Patient Portal in an Ambulatory Clinic: Implementation Study JO - JMIR Med Inform SP - e31 VL - 6 IS - 2 KW - electronic health record KW - patient-reported outcomes KW - rheumatoid arthritis N2 - Background: Despite significant interest in the collection of patient-reported outcomes to make care more patient-centered, few studies have evaluated implementation efforts to collect patient-reported outcomes from diverse patient populations Objective: We assessed the collection of patient-reported outcomes from rheumatoid arthritis patients in an academic rheumatology clinic, using a paper and an online form through the electronic health record patient portal. Methods: We identified patients seen between 2012-2016 with ?2 face-to-face encounters with a rheumatology provider and International Classification of Diseases codes for RA, ?30 days apart. In 2013, our clinic implemented a paper version of the Patient Reported Outcome Measurement Information System (PROMIS) physical function form that was administered to patients upon their check-in at the clinic. In 2015, an online version of the form became available by way of the electronic health record patient portal to patients with active portal accounts. We compared the proportion of visits with documented PROMIS scores across age, race and ethnicity, and language and examined trends over time using a control chart. Results: We included 1078 patients with rheumatoid arthritis with 7049 in-person encounters at the rheumatology clinic over 4 years, with an average of 168 visits per month. Of the included patients, 80.4% of patients (867/1078) were female and the mean age was 58 (SD 16) years. The overall PROMIS physical function score documentation increased from 60.4% (1081/1791) of visits in 2013 to 74.4% (905/1217) of visits in 2016. Online score documentation increased from 10.0% (148/1473) in 2015 to 19.3% (235/1217) in 2016. African American patients were least likely to have a PROMIS physical function score recorded (55/88, 62.5% compared to 792/990, 80.0% for other racial or ethnic groups; P<.001). Compared with white patients, both African American and Hispanic patients were less likely to have active online electronic health record portal accounts (44/88, 50% and 90/157, 57.3% respectively, compared to 437/521, 83.9% of white patients; P<.001) and, once activated, less likely to use the online survey (6/44, 13.6% and 16/90, 17.8% respectively, compared to 135/437, 30.9% of white patients; P=.02). There was no significant difference in the proportion of any PROMIS physical function forms recorded between non-English vs English preferred patients. No significant differences were found across age or gender. Conclusions: PROMIS physical function form completion improved overall from 2012-2016 but lagged among racial and ethnic minorities and non-English preferred patients. Future studies should address issues of portal access, enrollment, satisfaction, and persistence and focus on developing PRO implementation strategies that accommodate the needs and preferences of diverse populations. UR - http://medinform.jmir.org/2018/2/e31/ UR - http://dx.doi.org/10.2196/medinform.8687 UR - http://www.ncbi.nlm.nih.gov/pubmed/29743158 ID - info:doi/10.2196/medinform.8687 ER - TY - JOUR AU - El Shafie, A. Rami AU - Bougatf, Nina AU - Sprave, Tanja AU - Weber, Dorothea AU - Oetzel, Dieter AU - Machmer, Timo AU - Huber, E. Peter AU - Debus, Jürgen AU - Nicolay, H. Nils PY - 2018/03/06 TI - Oncologic Therapy Support Via Means of a Dedicated Mobile App (OPTIMISE-1): Protocol for a Prospective Pilot Trial JO - JMIR Res Protoc SP - e70 VL - 7 IS - 3 KW - mHealth KW - radiotherapy KW - mobile application KW - quality of life KW - cancer KW - Patient-Reported Outcome Measures (PROMs) N2 - Background: The increasing role of consumer electronics and Web-enabled mobile devices in the medical sector opens up promising possibilities for integrating novel technical solutions into therapy and patient support for oncologic illnesses. A recent survey carried out at Heidelberg University Hospital suggested a high acceptance among patients for an additional approach to patient care during radiotherapy based on patient-reported outcomes by a dedicated mobile app. Objective: The aim of this trial (OPTIMISE-1: Oncologic Therapy Support Via Means of a Dedicated Mobile App ? A Prospective Feasibility Evaluation) is to prospectively evaluate the feasibility of employing a mobile app for the systematic support of radiooncological patients throughout the course of their radiotherapy by monitoring symptoms and patient performance, and facilitating the background-exchange of relevant information between patient and physician. Methods: The present single-center, prospective, exploratory trial, conducted at Heidelberg University Hospital, assesses the feasibility of integrating an app-based approach into patient-care during radiotherapy. Patients undergoing curative radiotherapy for thoracic or pelvic tumors will be surveyed regarding general performance, treatment-related quality of life (QoL) and symptoms, and their need to personally consult a physician by means of a mobile app during treatment. The primary endpoint of feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day. Furthermore, treatment-related patient satisfaction and health-related QoL is assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) and the European Organization for Research and Treatment of Cancer (EORTC) questionnaires at the beginning (baseline) and end of radiotherapy, and at the first follow-up. Results: This trial will recruit 50 patients over a period of 12 months. Follow-up will be completed after 18 months, and publication of results is planned at 24 months after trial initiation. Conclusions: This study will serve as a basis for future studies aiming to exploit the constant innovation in mobile medical appliances and integrate novel patient-centered concepts into patient care in the context of radiotherapy. Trial Registration: ClinicalTrials.gov NCT03168048; https://clinicaltrials.gov/ct2/show/NCT03168048 (Archived at WebCite http://www.webcitation.org/6wtWGgi0X) UR - https://www.researchprotocols.org/2018/3/e70/ UR - http://dx.doi.org/10.2196/resprot.8915 UR - http://www.ncbi.nlm.nih.gov/pubmed/29510971 ID - info:doi/10.2196/resprot.8915 ER - TY - JOUR AU - Teixeira Neto, Cavalcante Nestor AU - Lima, Lopes Yuri AU - Almeida, Leăo Gabriel Peixoto AU - Bezerra, Almeida Márcio AU - Lima, Paula Pedro Olavo De AU - de Oliveira, Ribeiro Rodrigo PY - 2018/02/23 TI - Physiotherapy Questionnaires App to Deliver Main Musculoskeletal Assessment Questionnaires: Development and Validation Study JO - JMIR Rehabil Assist Technol SP - e1 VL - 5 IS - 1 KW - mobile phone KW - Foot and Ankle Outcome Score KW - American Orthopaedic Foot and Ankle Society KW - musculoskeletal assessment questionnaires KW - health survey N2 - Background: Patient-reported outcomes (PROs) translate subjective outcomes into objective data that can be quantified and analyzed. Nevertheless, the use of PROs in their traditional paper format is not practical for clinical practice due to limitations associated with the analysis and management of the data. To address the need for a viable way to group and utilize the main functioning assessment tools in the field of musculoskeletal disorders, the Physiotherapy Questionnaires app was developed. Objective: This study aims to explain the development of the app, to validate it using two questionnaires, and to analyze whether participants prefer to use the app or the paper version of the questionnaires. Methods: In the first stage, the app for an Android operational system was developed. In the second stage, the aim was to select questionnaires that were most often used in musculoskeletal clinical practice and research. The Foot and Ankle Outcome Score (FAOS) and American Orthopaedic Foot and Ankle Society (AOFAS) questionnaire were selected to validate the app. In total, 50 participants completed the paper and app versions of the AOFAS and 50 completed the FAOS. The study?s outcomes were the correlation of the data between the paper and app versions as well as the preference of the participants between the two versions. Results: The app was approved by experts after the adaptations of the layout for mobile phones and a total of 18 questionnaires were included in the app. Moreover, the app allows the generation of PDF and Excel files with the patients? data. In regards to validity, the mean of the total scores of the FAOS were 91.54% (SD 8.86%) for the paper version and 91.74% (SD 9.20%) for the app. There was no statistically significant differences in the means of the total scores or the subscales (P=.11-.94). The mean total scores for the AOFAS were 93.94 (SD 8.47) for the paper version and 93.96 (SD 8.48) for the app. No statistically significant differences were found for the total scores for the AOFAS or the subscales (P>.99). The app showed excellent agreement with the paper version of the FAOS, with an ICC value of 0.98 for the total score (95% CI 0.98-0.99), which was also found for the AOFAS with the ICC for the total score of 0.99 (95% CI 0.98-0.99). For compliance, 72% (36/50) of the participants in the FAOS group and 94% (47/50) in the AOFAS group preferred the app version. Conclusions: The Physiotherapy Questionnaires app showed validity and high levels of compliance for the FAOS and AOFAS, which indicates it is not inferior to the paper version of these two questionnaires and confirms its viability and feasibility for use in clinical practice. UR - http://rehab.jmir.org/2018/1/e1/ UR - http://dx.doi.org/10.2196/rehab.9247 UR - http://www.ncbi.nlm.nih.gov/pubmed/29475827 ID - info:doi/10.2196/rehab.9247 ER - TY - JOUR AU - Mastboom, Josephine Monique AU - Planje, Rosa AU - van de Sande, Adreanus Michiel PY - 2018/02/23 TI - The Patient Perspective on the Impact of Tenosynovial Giant Cell Tumors on Daily Living: Crowdsourcing Study on Physical Function and Quality of Life JO - Interact J Med Res SP - e4 VL - 7 IS - 1 KW - synovitis KW - pigmented villonodular KW - giant cell tumor of tendon sheath KW - rare diseases KW - crowdsourcing KW - social media KW - patient-reported outcome measures KW - quality of life KW - health-related quality of life KW - social participation KW - surveys and questionnaires N2 - Background: Tenosynovial giant cell tumor (TGCT) is a rare, benign lesion affecting the synovial lining of joints, bursae, and tendon sheaths. It is generally characterized as a locally aggressive and often recurring tumor. A distinction is made between localized- and diffuse-type. The impact of TGCT on daily living is currently ill-described. Objective: The aim of this crowdsourcing study was to evaluate the impact of TGCT on physical function, daily activities, societal participation (work, sports, and hobbies), and overall quality of life from a patient perspective. The secondary aim was to define risk factors for deteriorated outcome in TGCT. Methods: Members of the largest known TGCT Facebook community, PVNS is Pants!!, were invited to an e-survey, partially consisting of validated questionnaires, for 6 months. To confirm disease presence and TGCT-type, patients were requested to share histological or radiological proof of TGCT. Unpaired t tests and chi-square tests were used to compare groups with and without proof and to define risk factors for deteriorated outcome. Results: Three hundred thirty-seven questionnaires, originating from 30 countries, were completed. Median age at diagnosis was 33 (interquartile range [IQR]=25-42) years, majority was female (79.8% [269/337]), diffuse TGCT (70.3% [237/337]), and affected lower extremities (knee 70.9% [239/337] and hip 9.5% [32/337]). In 299 lower-extremity TGCT patients (32.4% [97/299]) with disease confirmation, recurrence rate was 36% and 69.5% in localized and diffuse type, respectively. For both types, pain and swelling decreased after treatment; in contrast, stiffness and range of motion worsened. Patients were limited in their employment (localized 13% [8/61]; diffuse 11.0% [21/191]) and sport-activities (localized 58% [40/69]; diffuse 63.9% [147/230]). Compared with general US population, all patients showed lower Patient-Reported Outcomes Measurements Information System-Physical Function (PROMIS-PF), Short Form-12 (SF-12), and EuroQoL 5 Dimensions 5 Levels (EQ5D-5L) scores, considered clinically relevant, according to estimated minimal important difference (MID). Diffuse versus localized type scored almost 0.5 standard deviation lower for PROMIS-PF (P<.001) and demonstrated a utility score of 5% lower for EQ-5D-5L (P=.03). In localized TGCT, recurrent disease and ?2 surgeries negatively influenced scores of Visual Analog Scale (VAS)-pain/stiffness, SF-12, and EQ-5D-5L (P<.05). In diffuse type, recurrence resulted in lower score for VAS, PROMIS-PF, SF-12, and EQ-5D-5L (P<.05). In both types, patients with treatment ?1year had significantly lower SF-12. Conclusions: TGCT has a major impact on daily living in a relatively young and working population. Patients with diffuse type, recurrent disease, and ?2 surgeries represent lowest functional and quality of life outcomes. Physicians should be aware that TGCT patients frequently continue to experience declined health-related quality of life and physical function and often remain limited in daily life, even after treatment(s). UR - http://www.i-jmr.org/2018/1/e4/ UR - http://dx.doi.org/10.2196/ijmr.9325 UR - http://www.ncbi.nlm.nih.gov/pubmed/29475829 ID - info:doi/10.2196/ijmr.9325 ER - TY - JOUR AU - Lloyd, Helen AU - Wheat, Hannah AU - Horrell, Jane AU - Sugavanam, Thavapriya AU - Fosh, Benjamin AU - Valderas, M. Jose AU - Close, James PY - 2018/02/14 TI - Patient-Reported Measures for Person-Centered Coordinated Care: A Comparative Domain Map and Web-Based Compendium for Supporting Policy Development and Implementation JO - J Med Internet Res SP - e54 VL - 20 IS - 2 KW - patient reported outcome measures KW - quality of life N2 - Background: Patient-reported measure (PRM) questionnaires were originally used in research to measure outcomes of intervention studies. They have now evolved into a diverse family of tools measuring a range of constructs including quality of life and experiences of care. Current health and social care policy increasingly advocates their use for embedding the patient voice into service redesign through new models of care such as person-centered coordinated care (P3C). If chosen carefully and used efficiently, these tools can help improve care delivery through a variety of novel ways, including system-level feedback for health care management and commissioning. Support and guidance on how to use these tools would be critical to achieve these goals. Objective: The objective of this study was to develop evidence-based guidance and support for the use of P3C-PRMs in health and social care policy through identification of PRMs that can be used to enhance the development of P3C, mapping P3C-PRMs against an existing model of domains of P3C, and integration and organization of the information in a user-friendly Web-based database. Methods: A pragmatic approach was used for the systematic identification of candidate P3C-PRMs, which aimed at balancing comprehensiveness and feasibility. This utilized a number of resources, including existing compendiums, peer-reviewed and gray literature (using a flexible search strategy), and stakeholder engagement (which included guidance for relevant clinical areas). A subset of those candidate measures (meeting prespecified eligibility criteria) was then mapped against a theoretical model of P3C, facilitating classification of the construct being measured and the subsequent generation of shortlists for generic P3C measures, specific aspects of P3C (eg, communication or decision making), and condition-specific measures (eg, diabetes, cancer) in priority areas, as highlighted by stakeholders. Results: In total, 328 P3C-PRMs were identified, which were used to populate a freely available Web-based database. Of these, 63 P3C-PRMs met the eligibility criteria for shortlisting and were classified according to their measurement constructs and mapped against the theoretical P3C model. We identified tools with the best coverage of P3C, thereby providing evidence of their content validity as outcome measures for new models of care. Transitions and medications were 2 areas currently poorly covered by existing measures. All the information is currently available at a user-friendly web-based portal (p3c.org.uk), which includes all relevant information on each measure, such as the constructs targeted and links to relevant literature, in addition to shortlists according to relevant constructs. Conclusions: A detailed compendium of P3C-PRMs has been developed using a pragmatic systematic approach supported by stakeholder engagement. Our user-friendly suite of tools is designed to act as a portal to the world of PRMs for P3C, and have utility for a broad audience, including (but not limited to) health care commissioners, managers, and researchers. UR - http://www.jmir.org/2018/2/e54/ UR - http://dx.doi.org/10.2196/jmir.7789 UR - http://www.ncbi.nlm.nih.gov/pubmed/29444767 ID - info:doi/10.2196/jmir.7789 ER - TY - JOUR AU - Rincon, Esther AU - Monteiro-Guerra, Francisco AU - Rivera-Romero, Octavio AU - Dorronzoro-Zubiete, Enrique AU - Sanchez-Bocanegra, Luis Carlos AU - Gabarron, Elia PY - 2017/12/04 TI - Mobile Phone Apps for Quality of Life and Well-Being Assessment in Breast and Prostate Cancer Patients: Systematic Review JO - JMIR Mhealth Uhealth SP - e187 VL - 5 IS - 12 KW - cancer KW - mHealth KW - app KW - mobile phone KW - quality of life KW - well-being N2 - Background: Mobile phone health apps are increasingly gaining attention in oncological care as potential tools for supporting cancer patients. Although the number of publications and health apps focusing on cancer is increasing, there are still few specifically designed for the most prevalent cancers diagnosed: breast and prostate cancers. There is a need to review the effect of these apps on breast and prostate cancer patients? quality of life (QoL) and well-being. Objective: The purposes of this study were to review the scientific literature on mobile phone apps targeting breast or prostate cancer patients and involving QoL and well-being (anxiety and depression symptoms) and analyze the clinical and technological characteristics, strengths, and weaknesses of these apps, as well as patients? user experience with them. Methods: We conducted a systematic review of peer-reviewed literature from The Cochrane Library, Excerpta Medica Database, PsycINFO, PubMed, Scopus, and MEDLINE to identify studies involving apps focused on breast and/or prostate cancer patients and QoL and/or well-being published between January 1, 2000, and July 12, 2017. Only trial studies which met the inclusion criteria were selected. The systematic review was completed with a critical analysis of the apps previously identified in the health literature research that were available from the official app stores. Results: The systematic review of the literature yielded 3862 articles. After removal of duplicates, 3229 remained and were evaluated on the basis of title and abstract. Of these, 3211 were discarded as not meeting the inclusion criteria, and 18 records were selected for full text screening. Finally, 5 citations were included in this review, with a total of 644 patients, mean age 52.16 years. Four studies targeted breast cancer patients and 1 focused on prostate cancer patients. Four studies referred to apps that assessed QoL. Only 1 among the 5 analyzed apps was available from the official app store. In 3 studies, an app-related intervention was carried out, and 2 of them reported an improvement on QoL. The lengths of the app-related interventions varied from 4 to 12 weeks. Because 2 of the studies only tracked use of the app, no effect on QoL or well-being was found. Conclusions: Despite the existence of hundreds of studies involving cancer-focused mobile phone apps, there is a lack of rigorous trials regarding the QoL and/or well-being assessment in breast and/or prostate cancer patients. A strong and collective effort should be made by all health care providers to determine those cancer-focused apps that effectively represent useful, accurate, and reliable tools for cancer patients? disease management. Trial Registration: PROSPERO CRD42017073069; https://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID= CRD42017073069 (Archived by WebCite at http://www.webcitation.org/6v38Clb9T) UR - http://mhealth.jmir.org/2017/12/e187/ UR - http://dx.doi.org/10.2196/mhealth.8741 UR - http://www.ncbi.nlm.nih.gov/pubmed/29203459 ID - info:doi/10.2196/mhealth.8741 ER - TY - JOUR AU - Rutherford, Claudia AU - King, T. Madeleine AU - Smith, P. David AU - Costa, SJ Daniel AU - Tait, Margaret-Ann AU - Patel, I. Manish AU - PY - 2017/11/08 TI - Psychometric Evaluation of a Patient-Reported Symptom Index for Nonmuscle Invasive Bladder Cancer: Field Testing Protocol JO - JMIR Res Protoc SP - e216 VL - 6 IS - 11 KW - quality of life KW - patient reported outcome measures KW - cancer KW - bladder cancer KW - surveys and questionnaires N2 - Background: Nonmuscle invasive bladder cancer (NMIBC) is a chronic condition requiring intensive follow-up, repeated endoscopic examinations, tumor resections, and intravesical treatments that can occur every 3 months for life. In this clinical context, patient-reported outcomes (PROs) are a critical concern for patients and their managing clinicians. PROs have enormous potential to be integral to treatment assessment and recommendations for NMIBC; however, current PRO measures are inadequate for NMIBC because they lack key NMIBC-specific symptoms and side effects associated with contemporary treatments. Objective: The overarching aim of this study was to develop and evaluate a patient-reported symptom index (SI) for individuals with NMIBC (the NMIBC-SI) that is acceptable to patients; reliable, valid, and responsive to differences between contemporary treatments for NMIBC; and fit for purpose as an endpoint in clinical trials. Methods: The NMIBC-SI will be evaluated in 2 field tests across a total of 3 years. Field test 1 is a cross-sectional study design involving 225 adult NMIBC patients recruited while undergoing active treatment or those who completed final treatment within the past week. Data collected include patient demographics, clinical features of the tumor, risk category, treatment type, comorbidity, and PROs. Field test 2 is a prospective longitudinal study involving 225 newly diagnosed NMIBC-SI patients. Clinical data and patient-completed questionnaires will be collected at 4 time points during treatment: before tumor resection, 1 week after resection, end-of-induction intravesical therapy, and 1-year follow-up. Standard psychometric tests will be performed to assess the reliability, validity, responsiveness, and clinical utility of the NMIBC-SI. Results: Participant recruitment to field test 1 commenced in February 2017. Recruitment for field test 2 is planned to commence in January 2018. Final results are expected to be published in 2019. The NMIBC-SI will be freely available for use via registration. Conclusions: This study protocol contains detailed methods that will be used across multiple international sites. Phase 2 in the development of the NMIBC-SI will enable a comprehensive evaluation of its reliability, validity, and responsiveness to ensure that the NMIBC-SI is fit for purpose in clinical research and provides an evidence base for the ongoing improvement of future therapies for NMIBC. Trial Registration: ClinicalTrials.gov NCT03091764; http://clinicaltrials.gov/ct2/showNCT03091764 (Archived by WebCite at http://www.webcitation.org/6umBhQeNX) UR - http://www.researchprotocols.org/2017/11/e216/ UR - http://dx.doi.org/10.2196/resprot.8761 UR - http://www.ncbi.nlm.nih.gov/pubmed/29117930 ID - info:doi/10.2196/resprot.8761 ER - TY - JOUR AU - Khetani, A. Mary AU - Lim, K. Heather AU - Corden, E. Marya PY - 2017/10/24 TI - Caregiver Input to Optimize the Design of a Pediatric Care Planning Guide for Rehabilitation: Descriptive Study JO - JMIR Rehabil Assist Technol SP - e10 VL - 4 IS - 2 KW - pediatrics KW - social participation KW - goals KW - patient-reported outcome KW - eHealth N2 - Background: Participation and Environment Measure Plus (PEM+) is a guide that is compatible with the YC-PEM and may expedite care plan development and strengthen a patient?s engagement in discussions and decisions about their values, needs, and desires that shape meaningful care (ie, patient-centered care). Objective: The objective of this study was to examine the feasibility of a stepwise process for building on a baseline assessment of young children's participation in activities to develop a care plan relevant to pediatric rehabilitation. Methods: A cross-sectional descriptive study design was employed using qualitative methods. Data were collected via Web-based technology and by telephone. Twenty-five caregivers of young children (9 with developmental delays, 16 without delays) and between 1 and 7 years were recruited from a subsample of parents who had previously enrolled in a Web-based validation of a PRO on children?s participation and provided consent for future contact. Each caregiver completed a demographic questionnaire and Young Children?s Participation and Environment Measure (YC-PEM) online, followed by a 20- to 60-min semistructured and audiotaped phone interview to review and build upon PRO results as summarized in an electronic report. Interview data were content coded to the interview guide and reviewed by multiple research staff to estimate feasibility according to stepwise completion rates, perceptions of difficulty in step completion, and perceptions of overall utility. Results: Half of the participants in the final study sample (N=25) fully completed a stepwise process of building on their baseline PRO assessment to develop an initial care plan for their child. In most cases, similar stepwise completion rates and trends in the approaches taken for step completion were found regardless of the child?s disability status. However, more parents of children with disabilities reported difficulties in rank ordering their priorities for change and identified child-focused strategies for goal attainment. Nearly 77% (19/25) of users were willing to use the process to develop and communicate intervention priorities and strategies with professionals, family, and friends. Conclusions: Results informed revisions to the care planning guide before usability and feasibility testing of an initial Web-based prototype that is now underway. UR - http://rehab.jmir.org/2017/2/e10/ UR - http://dx.doi.org/10.2196/rehab.7566 UR - http://www.ncbi.nlm.nih.gov/pubmed/29066421 ID - info:doi/10.2196/rehab.7566 ER - TY - JOUR AU - Rye Hanton, Cassia AU - Kwon, Yong-Jun AU - Aung, Thawda AU - Whittington, Jackie AU - High, R. Robin AU - Goulding, H. Evan AU - Schenk, Katrin A. AU - Bonasera, J. Stephen PY - 2017/10/03 TI - Mobile Phone-Based Measures of Activity, Step Count, and Gait Speed: Results From a Study of Older Ambulatory Adults in a Naturalistic Setting JO - JMIR Mhealth Uhealth SP - e104 VL - 5 IS - 10 KW - mobile phone KW - functional status KW - mobility KW - gait speed KW - mobility measures KW - LLFDI KW - SAFFE KW - PROMIS short KW - PROMIS Global KW - step count KW - behavioral classification KW - frailty phenotype KW - normal aging N2 - Background: Cellular mobile telephone technology shows much promise for delivering and evaluating healthcare interventions in cost-effective manners with minimal barriers to access. There is little data demonstrating that these devices can accurately measure clinically important aspects of individual functional status in naturalistic environments outside of the laboratory. Objective: The objective of this study was to demonstrate that data derived from ubiquitous mobile phone technology, using algorithms developed and previously validated by our lab in a controlled setting, can be employed to continuously and noninvasively measure aspects of participant (subject) health status including step counts, gait speed, and activity level, in a naturalistic community setting. A second objective was to compare our mobile phone-based data against current standard survey-based gait instruments and clinical physical performance measures in order to determine whether they measured similar or independent constructs. Methods: A total of 43 ambulatory, independently dwelling older adults were recruited from Nebraska Medicine, including 25 (58%, 25/43) healthy control individuals from our Engage Wellness Center and 18 (42%, 18/43) functionally impaired, cognitively intact individuals (who met at least 3 of 5 criteria for frailty) from our ambulatory Geriatrics Clinic. The following previously-validated surveys were obtained on study day 1: (1) Late Life Function and Disability Instrument (LLFDI); (2) Survey of Activities and Fear of Falling in the Elderly (SAFFE); (3) Patient Reported Outcomes Measurement Information System (PROMIS), short form version 1.0 Physical Function 10a (PROMIS-PF); and (4) PROMIS Global Health, short form version 1.1 (PROMIS-GH). In addition, clinical physical performance measurements of frailty (10 foot Get up and Go, 4 Meter walk, and Figure-of-8 Walk [F8W]) were also obtained. These metrics were compared to our mobile phone-based metrics collected from the participants in the community over a 24-hour period occurring within 1 week of the initial assessment. Results: We identified statistically significant differences between functionally intact and frail participants in mobile phone-derived measures of percent activity (P=.002, t test), active versus inactive status (P=.02, t test), average step counts (P<.001, repeated measures analysis of variance [ANOVA]) and gait speed (P<.001, t test). In functionally intact individuals, the above mobile phone metrics assessed aspects of functional status independent (Bland-Altman and correlation analysis) of both survey- and/or performance battery-based functional measures. In contrast, in frail individuals, the above mobile phone metrics correlated with submeasures of both SAFFE and PROMIS-GH. Conclusions: Continuous mobile phone-based measures of participant community activity and mobility strongly differentiate between persons with intact functional status and persons with a frailty phenotype. These measures assess dimensions of functional status independent of those measured using current validated questionnaires and physical performance assessments to identify functional compromise. Mobile phone-based gait measures may provide a more readily accessible and less-time consuming measure of gait, while further providing clinicians with longitudinal gait measures that are currently difficult to obtain. UR - http://mhealth.jmir.org/2017/10/e104/ UR - http://dx.doi.org/10.2196/mhealth.5090 UR - http://www.ncbi.nlm.nih.gov/pubmed/28974482 ID - info:doi/10.2196/mhealth.5090 ER - TY - JOUR AU - Girgis, Afaf AU - Durcinoska, Ivana AU - Levesque, V. Janelle AU - Gerges, Martha AU - Sandell, Tiffany AU - Arnold, Anthony AU - Delaney, P. Geoff AU - PY - 2017/10/02 TI - eHealth System for Collecting and Utilizing Patient Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care) Among Cancer Patients: Mixed Methods Approach to Evaluate Feasibility and Acceptability JO - J Med Internet Res SP - e330 VL - 19 IS - 10 KW - patient reported outcome measures KW - eHealth KW - self-management KW - medical oncology KW - patient-centered care KW - electronic health records N2 - Background: Despite accumulating evidence indicating that collecting patient-reported outcomes (PROs) and transferring results to the treating health professional in real time has the potential to improve patient well-being and cancer outcomes, this practice is not widespread. Objective: The aim of this study was to test the feasibility and acceptability of PROMPT-Care (Patient Reported Outcome Measures for Personalized Treatment and Care), a newly developed electronic health (eHealth) system that facilitates PRO data capture from cancer patients, data linkage and retrieval to support clinical decisions and patient self-management, and data retrieval to support ongoing evaluation and innovative research. Methods: We developed an eHealth system in consultation with content-specific expert advisory groups and tested it with patients receiving treatment or follow-up care in two hospitals in New South Wales, Australia, over a 3-month period. Participants were recruited in clinic and completed self-report Web-based assessments either just before their upcoming clinical consultation or every 4 weeks if in follow-up care. A mixed methods approach was used to evaluate feasibility and acceptability of PROMPT-Care; data collected throughout the study informed the accuracy and completeness of data transfer procedures, and extent of missing data was determined from participants? assessments. Patients participated in cognitive interviews while completing their first assessment and completed evaluation surveys and interviews at study-end to assess system acceptability and usefulness of patient self-management resources, and oncology staff were interviewed at study-end to determine the acceptability and perceived usefulness of real-time PRO reporting. Results: A total of 42 patients consented to the study; 7 patients were withdrawn before starting the intervention primarily because of changes in eligibility. Overall, 35 patients (13 on treatment and 22 in follow-up) completed 67 assessments during the study period. Mean completeness of patient-reported data was 93%, with 100% accuracy of data transfer. Ten patients completed cognitive interviews, 28 completed evaluation surveys, and 14 completed evaluation interviews at study-end. PROMPT-Care patient acceptability was high?100% (28/28) reported the time to complete the Web-based assessments (average 15 min) as about right, most willing to answer more questions (79%, 22/28 yes), 96% (27/28) found the Web-based assessment easier or same as completing a paper copy, and they valued the self-management resources . Oncology staff (n=5) also reported high acceptability and potential feasibility of the system. Conclusions: Patients and oncology staff found the PROMPT-Care system to be highly acceptable, and the results suggest that it would be feasible to implement it into an oncology setting. Suggested modifications to the patient assessment survey, clinician access to the reports, and system requirements will be made as part of the next stage of large-scale testing and future implementation of the system as part of routine care. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN1261500135294; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369299&isReview=true (Archived by WebCite at http://www.webcitation.org/6lzylG5A0). UR - https://www.jmir.org/2017/10/e330/ UR - http://dx.doi.org/10.2196/jmir.8360 UR - http://www.ncbi.nlm.nih.gov/pubmed/28970188 ID - info:doi/10.2196/jmir.8360 ER - TY - JOUR AU - van Lint, Céline AU - Wang, Wenxin AU - van Dijk, Sandra AU - Brinkman, Willem-Paul AU - Rövekamp, JM Ton AU - Neerincx, A. Mark AU - Rabelink, J. Ton AU - van der Boog, JM Paul PY - 2017/09/26 TI - Self-Monitoring Kidney Function Post Transplantation: Reliability of Patient-Reported Data JO - J Med Internet Res SP - e316 VL - 19 IS - 9 KW - self-care KW - kidney transplantation KW - creatinine KW - patient compliance KW - data accuracy KW - patient reported outcomes N2 - Background: The high frequency of outpatient visits after kidney transplantation is burdensome to both the recovering patient and health care capacity. Self-monitoring kidney function offers a promising strategy to reduce the number of these outpatient visits. Objective: The objective of this study was to investigate whether it is safe to rely on patients? self-measurements of creatinine and blood pressure, using data from a self-management randomized controlled trial. Methods: For self-monitoring creatinine, each participant received a StatSensor Xpress-i Creatinine Meter and related test material. For self-monitoring blood pressure, each participant received a Microlife WatchBP Home, an oscillometric device for blood pressure self-measurement on the upper arm. Both devices had a memory function and the option to download stored values to a computer. During the first year post transplantation, 54 patients registered their self-measured creatinine values in a Web-based Self-Management Support System (SMSS) which provided automatic feedback on the registered values (eg, seek contact with hospital). Values registered in the SMSS were compared with those logged automatically in the creatinine device to study reliability of registered data. Adherence to measurement frequency was determined by comparing the number of requested with the number of performed measurements. To study adherence to provided feedback, SMSS-logged feedback and information from the electronic hospital files were analyzed. Results: Level of adherence was highest during months 2-4 post transplantation with over 90% (42/47) of patients performing at least 75% of the requested measurements. Overall, 87.00% (3448/3963) of all registered creatinine values were entered correctly, although values were often registered several days later. If (the number of) measured and registered values deviated, the mean of registered creatinine values was significantly lower than what was measured, suggesting active selection of lower creatinine values. Adherence to SMSS feedback ranged from 53% (14/24) to 85% (33/39), depending on the specific feedback. Conclusions: Patients? tendency to postpone registration and to select lower creatinine values for registration and the suboptimal adherence to the feedback provided by the SMSS might challenge safety. This should be well considered when designing self-monitoring care systems, for example by ensuring that self-measured data are transferred automatically to an SMSS. UR - http://www.jmir.org/2017/9/e316/ UR - http://dx.doi.org/10.2196/jmir.7542 UR - http://www.ncbi.nlm.nih.gov/pubmed/28951385 ID - info:doi/10.2196/jmir.7542 ER - TY - JOUR AU - Fink, C. Jeffrey AU - Doerfler, M. Rebecca AU - Yoffe, R. Marni AU - Diamantidis, J. Clarissa AU - Blumenthal, B. Jacob AU - Siddiqui, Tariq AU - Gardner, F. James AU - Snitker, Soren AU - Zhan, Min PY - 2016/05/26 TI - Patient-Reported Safety Events in Chronic Kidney Disease Recorded With an Interactive Voice-Inquiry Dial-Response System: Monthly Report Analysis JO - J Med Internet Res SP - e125 VL - 18 IS - 5 KW - patient-reported outcomes KW - CKD KW - interactive voice-response system KW - patient safety N2 - Background: Monitoring patient-reported outcomes (PROs) may improve safety of chronic kidney disease (CKD) patients. Objective: Evaluate the performance of an interactive voice-inquiry dial-response system (IVRDS) in detecting CKD-pertinent adverse safety events outside of the clinical environment and compare the incidence of events using the IVDRS to that detected by paper diary. Methods: This was a 6-month study of Stage III-V CKD patients in the Safe Kidney Care (SKC) study. Participants crossed over from a paper diary to the IVDRS for recording patient-reported safety events defined as symptoms or events attributable to medications or care. The IVDRS was adapted from the SKC paper diary to record event frequency and remediation. Participants were auto-called weekly and permitted to self-initiate calls. Monthly reports were reviewed by two physician adjudicators for their clinical significance. Results: 52 participants were followed over a total of 1384 weeks. 28 out of 52 participants (54%) reported events using the IVDRS versus 8 out of 52 (15%) with the paper diary; hypoglycemia was the most common event for both methods. All IVDRS menu options were selected at least once except for confusion and rash. Events were reported on 121 calls, with 8 calls reporting event remediation by ambulance or emergency room (ER) visit. The event rate with the IVDRS and paper diary, with and without hypoglycemia, was 26.7 versus 4.7 and 18.3 versus 0.8 per 100 person weeks, respectively (P=.002 and P<.001). The frequent users (ie, >10 events) largely differed by method, and event rates excluding the most frequent user of each were 16.9 versus 2.5 per 100 person weeks, respectively (P<.001). Adjudicators found approximately half the 80 reports clinically significant, with about a quarter judged as actionable. Hypoglycemia was often associated with additional reports of fatigue and falling. Participants expressed favorable satisfaction with the IVDRS. Conclusions: Use of the IVDRS among CKD patients reveals a high frequency of clinically significant safety events and has the potential to be used as an important supplement to clinical care for improving patient safety. UR - http://www.jmir.org/2016/5/e125/ UR - http://dx.doi.org/10.2196/jmir.5203 UR - http://www.ncbi.nlm.nih.gov/pubmed/27230267 ID - info:doi/10.2196/jmir.5203 ER - TY - JOUR AU - Eichler, S. Gabriel AU - Cochin, Elisenda AU - Han, Jian AU - Hu, Sylvia AU - Vaughan, E. Timothy AU - Wicks, Paul AU - Barr, Charles AU - Devenport, Jenny PY - 2016/05/12 TI - Exploring Concordance of Patient-Reported Information on PatientsLikeMe and Medical Claims Data at the Patient Level JO - J Med Internet Res SP - e110 VL - 18 IS - 5 KW - feasibility of data linking KW - patient-powered research network N2 - Background: With the emergence of data generated by patient-powered research networks, it is informative to characterize their correspondence with health care system-generated data. Objectives: This study explored the linking of 2 disparate sources of real-world data: patient-reported data from a patient-powered research network (PatientsLikeMe) and insurance claims. Methods: Active patients within the PatientsLikeMe community, residing in the United States, aged 18 years or older, with a self-reported diagnosis of multiple sclerosis or Parkinson?s disease (PD) were invited to participate during a 2-week period in December 2014. Patient-reported data were anonymously matched and compared to IMS Health medical and pharmacy claims data with dates of service between December 2009 and December 2014. Patient-level match (identity), diagnosis, and usage of disease-modifying therapies (DMTs) were compared between data sources. Results: Among 603 consenting patients, 94% had at least 1 record in the IMS Health dataset; of these, there was 93% agreement rate for multiple sclerosis diagnosis. Concordance on the use of any treatment was 59%, and agreement on reports of specific treatment usage (within an imputed 5-year period) ranged from 73.5% to 100%. Conclusions: It is possible to match patient identities between the 2 data sources, and the high concordance at multiple levels suggests that the matching process was accurate. Likewise, the high degree of concordance suggests that these patients were able to accurately self-report their diagnosis and, to a lesser degree, their treatment usage. Further studies of linked data types are warranted to evaluate the use of enriched datasets to generate novel insights. UR - http://www.jmir.org/2016/5/e110/ UR - http://dx.doi.org/10.2196/jmir.5130 UR - http://www.ncbi.nlm.nih.gov/pubmed/27174602 ID - info:doi/10.2196/jmir.5130 ER - TY - JOUR AU - Hung, Man AU - Zhang, Weiping AU - Chen, Wei AU - Bounsanga, Jerry AU - Cheng, Christine AU - Franklin, D. Jeremy AU - Crum, B. Anthony AU - Voss, W. Maren AU - Hon, D. Shirley PY - 2015/09/23 TI - Patient-Reported Outcomes and Total Health Care Expenditure in Prediction of Patient Satisfaction: Results From a National Study JO - JMIR Public Health Surveill SP - e13 VL - 1 IS - 2 KW - health care quality KW - value KW - expenditure KW - cost KW - medical outcomes KW - patient satisfaction KW - Medical Expenditure Panel Survey KW - patient-reported outcomes KW - Affordable Care Act KW - big data analytics N2 - Background: Health care quality is often linked to patient satisfaction. Yet, there is a lack of national studies examining the relationship between patient satisfaction, patient-reported outcomes, and medical expenditure. Objective: The aim of this study is to examine the contribution of physical health, mental health, general health, and total health care expenditures to patient satisfaction using a longitudinal, nationally representative sample. Methods: Using data from the 2010-2011 Medical Expenditure Panel Survey, analyses were conducted to predict patient satisfaction from patient-reported outcomes and total health care expenditures. The study sample consisted of adult participants (N=10,157), with sampling weights representative of 233.26 million people in the United States. Results: The results indicated that patient-reported outcomes and total health care expenditure were associated with patient satisfaction such that higher physical and mental function, higher general health status, and higher total health care expenditure were associated with higher patient satisfaction. Conclusions: We found that patient-reported outcomes and total health care expenditure had a significant relationship with patient satisfaction. As more emphasis is placed on health care value and quality, this area of research will become increasingly needed and critical questions should be asked about what we value in health care and whether we can find a balance between patient satisfaction, outcomes, and expenditures. Future research should apply big data analytics to investigate whether there is a differential effect of patient-reported outcomes and medical expenditures on patient satisfaction across different medical specialties. UR - http://publichealth.jmir.org/2015/2/e13/ UR - http://dx.doi.org/10.2196/publichealth.4360 UR - http://www.ncbi.nlm.nih.gov/pubmed/27227131 ID - info:doi/10.2196/publichealth.4360 ER - TY - JOUR AU - Attai, J. Deanna AU - Cowher, S. Michael AU - Al-Hamadani, Mohammed AU - Schoger, M. Jody AU - Staley, C. Alicia AU - Landercasper, Jeffrey PY - 2015/07/30 TI - Twitter Social Media is an Effective Tool for Breast Cancer Patient Education and Support: Patient-Reported Outcomes by Survey JO - J Med Internet Res SP - e188 VL - 17 IS - 7 KW - breast cancer KW - education KW - social support KW - social media KW - patient outcome assessment N2 - Background: Despite reported benefits, many women do not attend breast cancer support groups. Abundant online resources for support exist, but information regarding the effectiveness of participation is lacking. We report the results of a Twitter breast cancer support community participant survey. Objective: The aim was to determine the effectiveness of social media as a tool for breast cancer patient education and decreasing anxiety. Methods: The Breast Cancer Social Media Twitter support community (#BCSM) began in July 2011. Institutional review board approval with a waiver of informed consent was obtained for a deidentified survey that was posted for 2 weeks on Twitter and on the #BCSM blog and Facebook page. Results: There were 206 respondents to the survey. In all, 92.7% (191/206) were female. Respondents reported increased knowledge about breast cancer in the following domains: overall knowledge (80.9%, 153/189), survivorship (85.7%, 162/189), metastatic breast cancer (79.4%, 150/189), cancer types and biology (70.9%, 134/189), clinical trials and research (66.1%, 125/189), treatment options (55.6%, 105/189), breast imaging (56.6%, 107/189), genetic testing and risk assessment (53.9%, 102/189), and radiotherapy (43.4%, 82/189). Participation led 31.2% (59/189) to seek a second opinion or bring additional information to the attention of their treatment team and 71.9% (136/189) reported plans to increase their outreach and advocacy efforts as a result of participation. Levels of reported anxiety before and after participation were analyzed: 29 of 43 (67%) patients who initially reported ?high or extreme? anxiety reported ?low or no? anxiety after participation (P<.001). Also, no patients initially reporting low or no anxiety before participation reported an increase to high or extreme anxiety after participation. Conclusions: This study demonstrates that breast cancer patients? perceived knowledge increases and their anxiety decreases by participation in a Twitter social media support group. UR - http://www.jmir.org/2015/7/e188/ UR - http://dx.doi.org/10.2196/jmir.4721 UR - http://www.ncbi.nlm.nih.gov/pubmed/26228234 ID - info:doi/10.2196/jmir.4721 ER - TY - JOUR AU - Merolli, Mark AU - Gray, Kathleen AU - Martin-Sanchez, Fernando AU - Lopez-Campos, Guillermo PY - 2015/01/22 TI - Patient-Reported Outcomes and Therapeutic Affordances of Social Media: Findings From a Global Online Survey of People With Chronic Pain JO - J Med Internet Res SP - e20 VL - 17 IS - 1 KW - social media KW - chronic disease KW - chronic pain KW - therapeutic affordances KW - patient-reported outcomes N2 - Background: Patient-reported outcomes (PROs) from social media use in chronic disease management continue to emerge. While many published articles suggest the potential for social media is positive, there is a lack of robust examination into mediating mechanisms that might help explain social media?s therapeutic value. This study presents findings from a global online survey of people with chronic pain (PWCP) to better understand how they use social media as part of self-management. Objective: Our aim is to improve understanding of the various health outcomes reported by PWCP by paying close attention to therapeutic affordances of social media. We wish to examine if demographics of participants underpin health outcomes and whether the concept of therapeutic affordances explains links between social media use and PROs. The goal is for this to help tailor future recommendations for use of social media to meet individuals? health needs and improve clinical practice of social media use. Methods: A total of 231 PWCP took part in a global online survey investigating PROs from social media use. Recruited through various chronic disease entities and social networks, participants provided information on demographics, health/pain status, social media use, therapeutic affordances, and PROs from use. Quantitative analysis was performed on the data using descriptive statistics, cross-tabulation, and cluster analysis. Results: The total dataset represented 218 completed surveys. The majority of participants were university educated (67.0%, 146/218) and female (83.9%, 183/218). More than half (58.7%, 128/218) were married/partnered and not working for pay (75.9%, 88/116 of these due to ill health). Fibromyalgia (46.6%, 55/118) and arthritis (27.1%, 32/118) were the most commonly reported conditions causing pain. Participants showed a clear affinity for social network site use (90.0%, 189/210), followed by discussion forums and blogs. PROs were consistent, suggesting that social media positively impact psychological, social, and cognitive health. Analysis also highlighted two strong correlations linking platform used and health outcomes (particularly psychological, social, and cognitive) to (1) the narrative affordance of social media and (2) frequency of use of the platforms. Conclusions: Results did not uncover definitive demographics or characteristics of PWCP for which health outcomes are impacted. However, findings corroborate literature within this domain suggesting that there is a typical profile of people who use social media for health and that social media are more suited to particular health outcomes. Exploration of the relationship between social media?s therapeutic affordances and health outcomes, in particular the narration affordance, warrants further attention by patients and clinicians. UR - http://www.jmir.org/2015/1/e20/ UR - http://dx.doi.org/10.2196/jmir.3915 UR - http://www.ncbi.nlm.nih.gov/pubmed/25616273 ID - info:doi/10.2196/jmir.3915 ER - TY - JOUR AU - Duracinsky, Martin AU - Lalanne, Christophe AU - Goujard, Cécile AU - Herrmann, Susan AU - Cheung-Lung, Christian AU - Brosseau, Jean-Paul AU - Schwartz, Yannick AU - Chassany, Olivier PY - 2014/04/25 TI - Electronic Versus Paper-Based Assessment of Health-Related Quality of Life Specific to HIV Disease: Reliability Study of the PROQOL-HIV Questionnaire JO - J Med Internet Res SP - e115 VL - 16 IS - 4 KW - HIV KW - quality of life KW - patient-reported outcomes KW - electronic records KW - reliability N2 - Background: Electronic patient-reported outcomes (PRO) provide quick and usually reliable assessments of patients? health-related quality of life (HRQL). Objective: An electronic version of the Patient-Reported Outcomes Quality of Life-human immunodeficiency virus (PROQOL-HIV) questionnaire was developed, and its face validity and reliability were assessed using standard psychometric methods. Methods: A sample of 80 French outpatients (66% male, 52/79; mean age 46.7 years, SD 10.9) were recruited. Paper-based and electronic questionnaires were completed in a randomized crossover design (2-7 day interval). Biomedical data were collected. Questionnaire version and order effects were tested on full-scale scores in a 2-way ANOVA with patients as random effects. Test-retest reliability was evaluated using Pearson and intraclass correlation coefficients (ICC, with 95% confidence interval) for each dimension. Usability testing was carried out from patients? survey reports, specifically, general satisfaction, ease of completion, quality and clarity of user interface, and motivation to participate in follow-up PROQOL-HIV electronic assessments. Results: Questionnaire version and administration order effects (N=59 complete cases) were not significant at the 5% level, and no interaction was found between these 2 factors (P=.94). Reliability indexes were acceptable, with Pearson correlations greater than .7 and ICCs ranging from .708 to .939; scores were not statistically different between the two versions. A total of 63 (79%) complete patients? survey reports were available, and 55% of patients (30/55) reported being satisfied and interested in electronic assessment of their HRQL in clinical follow-up. Individual ratings of PROQOL-HIV user interface (85%-100% of positive responses) confirmed user interface clarity and usability. Conclusions: The electronic PROQOL-HIV introduces minor modifications to the original paper-based version, following International Society for Pharmacoeconomics and Outcomes Research (ISPOR) ePRO Task Force guidelines, and shows good reliability and face validity. Patients can complete the computerized PROQOL-HIV questionnaire and the scores from the paper or electronic versions share comparable accuracy and interpretation. UR - http://www.jmir.org/2014/4/e115/ UR - http://dx.doi.org/10.2196/jmir.3330 UR - http://www.ncbi.nlm.nih.gov/pubmed/24769643 ID - info:doi/10.2196/jmir.3330 ER - TY - JOUR AU - Merolli, Mark AU - Gray, Kathleen AU - Martin-Sanchez, Fernando PY - 2013/08/08 TI - Developing a Framework to Generate Evidence of Health Outcomes From Social Media Use in Chronic Disease Management JO - Med 2.0 SP - e3 VL - 2 IS - 2 KW - chronic disease KW - social media KW - Internet KW - evidence-based practice, affordances KW - patient-reported outcomes N2 - Background: While there is an abundance of evidence-based practice (EBP) recommendations guiding management of various chronic diseases, evidence suggesting best practice for using social media to improve health outcomes is inadequate. The variety of social media platforms, multiple potential uses, inconsistent definitions, and paucity of rigorous studies, make it difficult to measure health outcomes reliably in chronic disease management. Most published investigations report on an earlier generation of online tools, which are not as user-centered, participatory, engaging, or collaborative, and thus may work differently for health self-management. Objective: The challenge to establish a sound evidence base for social media use in chronic disease starts with the need to define criteria and methods to generate and evaluate evidence. The authors? key objective is to develop a framework for research and practice that addresses this challenge. Methods: This paper forms part of a larger research project that presents a conceptual framework of how evidence of health outcomes can be generated from social media use, allowing social media to be utilized in chronic disease management more effectively. Using mixed methods incorporating a qualitative literature review, a survey and a pilot intervention, the research closely examines the therapeutic affordances of social media, people with chronic pain (PWCP) as a subset of chronic disease management, valid outcome measurement of patient-reported (health) outcomes (PRO), the individual needs of people living with chronic disease, and finally translation of the combined results to improve evidence-based decision making about social media use in this context. Results: Extensive review highlights various affordances of social media that may prove valuable to understanding social media?s effect on individual health outcomes. However, without standardized PRO instruments, we are unable to definitively investigate these effects. The proposed framework that we offer outlines how therapeutic affordances of social media coupled with valid and reliable PRO measurement may be used to generate evidence of improvements in health outcomes, as well as guide evidence-based decision making in the future about social media use as part of chronic disease self-management. Conclusions: The results will (1) inform a framework for conducting research into health outcomes from social media use in chronic disease, as well as support translating the findings into evidence of improved health outcomes, and (2) inform a set of recommendations for evidence-based decision making about social media use as part of chronic disease self-management. These outcomes will fill a gap in the knowledge and resources available to individuals managing a chronic disease, their clinicians and other researchers in chronic disease and the field of medicine 2.0. UR - http://www.medicine20.com/2013/2/e3/ UR - http://dx.doi.org/10.2196/med20.2717 UR - http://www.ncbi.nlm.nih.gov/pubmed/25075238 ID - info:doi/10.2196/med20.2717 ER - TY - JOUR AU - Baggott, Christina AU - Gibson, Faith AU - Coll, Beatriz AU - Kletter, Richard AU - Zeltzer, Paul AU - Miaskowski, Christine PY - 2012/12/11 TI - Initial Evaluation of an Electronic Symptom Diary for Adolescents with Cancer JO - JMIR Res Protoc SP - e23 VL - 1 IS - 2 KW - mHealth, eHealth, patient-reported outcomes, symptom assessment, adolescent, cancer N2 - Background: The delivery of optimal care depends on accurate communication between patients and clinicians regarding untoward symptoms. Documentation of patients? symptoms necessitates reliance on memory, which is often imprecise. We developed an electronic diary (eDiary) for adolescents and young adults (AYAs) with cancer to record symptoms. Objective: The purpose of this paper is to describe the utility of an eDiary designed for AYAs with cancer, including dependability of the mobile application, the reasons for any missing recorded data, patients? adherence rates to daily symptom queries, and patients? perceptions of the usefulness and acceptability of symptom data collection via mobile phones. Methods: Our team developed an electronic symptom diary based on interviews conducted with AYAs with cancer and their clinicians. This diary included daily severity ratings of pain, nausea, vomiting, fatigue, and sleep. The occurrence of other selected physical sequelae was assessed daily. Additionally, patients selected descriptors of their mood. A 3-week trial of the eDiary was conducted with 10 AYA cancer patients. Mobile phones with service plans were loaned to patients who were instructed to report their symptoms daily. Patients completed a brief questionnaire and were interviewed to elicit their perceptions of the eDiary and any technical difficulties encountered. Results: Overall adherence to daily symptom reports exceeded 90%. Young people experienced few technical difficulties and reported benefit from daily symptom reports. Symptom occurrence rates were high and considerable inter- and intra-patient variability was noted in symptom and mood reports. Conclusions: We demonstrated the utility of an eDiary that may contribute insight into patients? symptom patterns to promote effective symptom management. UR - http://www.researchprotocols.org/2012/2/e23/ UR - http://dx.doi.org/10.2196/resprot.2175 UR - http://www.ncbi.nlm.nih.gov/pubmed/23612521 ID - info:doi/10.2196/resprot.2175 ER - TY - JOUR AU - Cascade, Elisa AU - Marr, Paige AU - Winslow, Matthew AU - Burgess, Andrew AU - Nixon, Mark PY - 2012/10/11 TI - Conducting Research on the Internet: Medical Record Data Integration with Patient-Reported Outcomes JO - J Med Internet Res SP - e137 VL - 14 IS - 5 KW - Direct-to-patient study KW - patient-reported outcomes KW - observational research KW - medical record review KW - Internet recruitment KW - online patient communities N2 - Background: The growth in the number of patients seeking health information online has given rise to new direct-to-patient research methods, including direct patient recruitment and study conduct without use of physician sites. While such patient-centric designs offer time and cost efficiencies, the absence of physician-reported data is a key concern, with potential impact on both scientific rigor and operational feasibility. Objective: To (1) gain insight into the viability of collecting patient-reported outcomes and medical record information in a sample of gout patients through a direct-to-patient approach (ie, without the involvement of physician sites), and (2) evaluate the validity of patient-reported diagnoses collected during a patient-reported outcomes plus medical record (PRO+MR) direct-to-patient study. Methods: We invited a random sample of MediGuard.org members aged 18 to 80 years to participate via email based on a gout treatment or diagnosis in their online profiles. Interested members clicked on an email link to access study information, consent to participate electronically, and be screened for eligibility. The first 50 consenting participants completed an online survey and provided electronic and wet signatures on medical record release forms for us to obtain medical charts from their managing physicians. Results: A total of 108 of 1250 MediGuard.org members (8.64%) accessed study information before we closed the study at 50 completed surveys. Of these 108 members who took the screener, 50 (46.3%) completed the study, 19 (17.6%) did not pass the screening, 5 (4.6%) explicitly declined to participate due to the medical record requirement, and 34 (31.5%) closed the browser without completing the survey screener. Ultimately, we obtained 38 of 50 charts (76%): 28 collected using electronic signature and 10 collected based on wet signature on a paper form. Of the 38 charts, 37 cited a gout diagnosis (35 charts) or use of a gout medication (2 charts). Only 1 chart lacked any mention of gout. Conclusions: Patients can be recruited directly for observational study designs that include patient-reported outcomes and medical record data with over 75% data completeness. Although the validity of self-reported diagnosis is often a concern in Internet-based studies, in this PRO+MR study pilot, nearly all (37 of 38) charts confirmed patient-reported data. UR - http://www.jmir.org/2012/5/e137/ UR - http://dx.doi.org/10.2196/jmir.2202 UR - http://www.ncbi.nlm.nih.gov/pubmed/23060427 ID - info:doi/10.2196/jmir.2202 ER -