%0 Journal Article
        
%@ 1929-0748
%I JMIR Publications
%V 13
%N 
%P e51351
%T A Comparison of Conventional Root Canal Sealers With Ones That Use Green Synthesized Nanoparticles for Antimicrobial Activity: Protocol for a Systematic Review
%A Mohamed,Abubaker
%A Ismail,Enas
%A Adam,Razia Z
%+ Department of Prosthodontics, Faculty of Dentistry, University of the Western Cape, Private Bag X1, Belville, Cape Town, 7535, South Africa, 27 0219373095, rzadam@uwc.ac.za
%K root-canal sealers
%K nanoparticles
%K antimicrobial activity
%K root canal
%K antimicrobial
%K dentistry
%D 2024

%7 11.10.2024
%9 Protocol
%J JMIR Res Protoc
%G English
                
%X Background: Root canal failure and secondary endodontic infection are frequent clinical scenarios in dentistry. The main microorganisms implicated in root canal therapy failure are persistent Enterococcus faecalis, Candida albicans, and Staphylococcus aureus. To combat the impact of disease resistance, scientists are concentrating on alternative antimicrobial root canal sealers. Nanomaterials are a recent development in endodontic materials that exhibit great antimicrobial properties, making them an ideal material choice for root canal sealers. Objective: This systematic review aims to compare the antimicrobial properties of conventional root canal sealers to those incorporating green synthesized nanoparticles between 2010 and 2024. Methods: A well-constructed protocol was established and registered with PROSPERO (CRD42021286373). Ethics approval was obtained from the Biomedical Research and Ethics Committee from the University of the Western Cape (UWC; BM22/1/4). PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) reporting guidelines were followed. The included criteria demonstrate the green synthesized nanoparticles studies where the nanoparticles (NPs) are incorporated in root canal sealers. MeSH (Medical Subject Headings) terms were used for the search strategy of the systematic electronic databases for articles published in English between 2010 and 2024. The selected databases included Scopus, PubMed, Web of Science, Science Direct, EBSCOhost, SpringerLink, and Wiley Online. A quality assessment tool for laboratory studies will be used to critically appraise the included studies. If applicable, statistical measures (mean, SD, etc) will be used for data analysis and presentation of the results. Results: The protocol is registered with PROSPERO. A preliminary search was conducted using a determined search strategy across 8 electronic databases, and the review is now complete. Conclusions: It is anticipated that the results of this systematic review may reveal the increased interest and application for nanoparticle-enhanced root canal sealers. This will aid in the future development of root canal sealants and mitigate the risk of endodontic failure. Trial Registration: PROSPERO CRD42021286373; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=286373 International Registered Report Identifier (IRRID): DERR1-10.2196/51351 
%M 39393053
%R 10.2196/51351
%U https://www.researchprotocols.org/2024/1/e51351
%U https://doi.org/10.2196/51351
%U http://www.ncbi.nlm.nih.gov/pubmed/39393053

%0 Journal Article
        
%@ 2291-5222
%I 
%V 12
%N 
%P e53596
%T User Experience of Persons Using Ingestible Sensor–Enabled Pre-Exposure Prophylaxis to Prevent HIV Infection: Cross-Sectional Survey Study
%A Browne,Sara
%A Umlauf,Anya
%A Moore,David J
%A Benson,Constance A
%A Vaida,Florin
%K ingestible sensor
%K sensor
%K sensors
%K oral
%K UX
%K user experience
%K HIV prevention
%K medication adherence
%K HIV
%K prevention
%K prophylaxis
%K STI
%K STD
%K sexually transmitted
%K sexual transmission
%K drug
%K drugs
%K pharmacy
%K pharmacies
%K pharmacology
%K pharmacotherapy
%K pharmaceutic
%K pharmaceutics
%K pharmaceuticals
%K pharmaceutical
%K medication
%K medications
%K adherence
%K compliance
%K sexually transmitted infection
%K sexually transmitted disease
%D 2024

%7 3.5.2024
%9 
%J JMIR Mhealth Uhealth
%G English
                
%X Background: A digital health technology’s success or failure depends on how it is received by users. Objectives: We conducted a user experience (UX) evaluation among persons who used the Food and Drug Administration–approved Digital Health Feedback System incorporating ingestible sensors (ISs) to capture medication adherence, after they were prescribed oral pre-exposure prophylaxis (PrEP) to prevent HIV infection. We performed an association analysis with baseline participant characteristics, to see if “personas” associated with positive or negative UX emerged. Methods: UX data were collected upon exit from a prospective intervention study of adults who were HIV negative, prescribed oral PrEP, and used the Digital Health Feedback System with IS-enabled tenofovir disoproxil fumarate plus emtricitabine (IS-Truvada). Baseline demographics; urine toxicology; and self-report questionnaires evaluating sleep (Pittsburgh Sleep Quality Index), self-efficacy, habitual self-control, HIV risk perception (Perceived Risk of HIV Scale 8-item), and depressive symptoms (Patient Health Questionnaire–8) were collected. Participants with ≥28 days in the study completed a Likert-scale UX questionnaire of 27 questions grouped into 4 domain categories: overall experience, ease of use, intention of future use, and perceived utility. Means and IQRs were computed for participant total and domain subscores, and linear regressions modeled baseline participant characteristics associated with UX responses. Demographic characteristics of responders versus nonresponders were compared using the Fisher exact and Wilcoxon rank-sum tests. Results: Overall, 71 participants were enrolled (age: mean 37.6, range 18-69 years; n=64, 90% male; n=55, 77% White; n=24, 34% Hispanic; n=68, 96% housed; and n=53, 75% employed). No demographic differences were observed in the 63 participants who used the intervention for ≥28 days. Participants who completed the questionnaire were more likely to be housed (52/53, 98% vs 8/10, 80%; P=.06) and less likely to have a positive urine toxicology (18/51, 35% vs 7/10, 70%; P=.08), particularly methamphetamine (4/51, 8% vs 4/10, 40%; P=.02), than noncompleters. Based on IQR values, ≥75% of participants had a favorable UX based on the total score (median 3.78, IQR 3.17-4.20), overall experience (median 4.00, IQR 3.50-4.50), ease of use (median 3.72, IQR 3.33-4.22), and perceived utility (median 3.72, IQR 3.22-4.25), and ≥50% had favorable intention of future use (median 3.80, IQR 2.80-4.40). Following multipredictor modeling, self-efficacy was significantly associated with the total score (0.822, 95% CI 0.405-1.240; P<.001) and all subscores (all P<.05). Persons with more depressive symptoms reported better perceived utility (P=.01). Poor sleep was associated with a worse overall experience (−0.07, 95% CI −0.133 to −0.006; P=.03). Conclusions: The UX among persons using IS-enabled PrEP (IS-Truvada) to prevent HIV infection was positive. Association analysis of baseline participant characteristics linked higher self-efficacy with positive UX, more depressive symptoms with higher perceived utility, and poor sleep with negative UX. Trial Registration: ClinicalTrials.gov NCT03693040; https://clinicaltrials.gov/study/NCT03693040 
%R 10.2196/53596
%U https://mhealth.jmir.org/2024/1/e53596
%U https://doi.org/10.2196/53596

%0 Journal Article
        
%@ 1438-8871
%I JMIR Publications
%V 26
%N 
%P e54645
%T Factor Analysis of Patients Who Find Tablets or Capsules Difficult to Swallow Due to Their Large Size: Using the Personal Health Record Infrastructure of Electronic Medication Notebooks
%A Asano,Masaki
%A Imai,Shungo
%A Shimizu,Yuri
%A Kizaki,Hayato
%A Ito,Yukiko
%A Tsuchiya,Makoto
%A Kuriyama,Ryoko
%A Yoshida,Nao
%A Shimada,Masanori
%A Sando,Takanori
%A Ishijima,Tomo
%A Hori,Satoko
%+ Division of Drug Informatics, Faculty of Pharmacy and Graduate School of Pharmaceutical Sciences, Keio University, 1-5-30 Shibakoen, Minato-ku, Tokyo, 105-8512, Japan, 81 354002650, satokoh@keio.jp
%K tablet
%K tablets
%K capsules
%K capsule
%K size
%K personal health record
%K electronic medication notebook
%K patient preference
%K drug
%K drugs
%K pharmacy
%K pharmacies
%K pharmacology
%K pharmacotherapy
%K pharmaceutic
%K pharmaceutics
%K pharmaceuticals
%K pharmaceutical
%K medication
%K medications
%K preference
%K preferences
%K pill
%K pills
%K machine learning
%K decision tree
%K swallow
%K swallowing
%K throat
%K pharynx
%K risk
%K risks
%K dysphagia
%K speech
%K mobile phone
%D 2024

%7 24.4.2024
%9 Original Paper
%J J Med Internet Res
%G English
                
%X Background: Understanding patient preference regarding taking tablet or capsule formulations plays a pivotal role in treatment efficacy and adherence. Therefore, these preferences should be taken into account when designing formulations and prescriptions. Objective: This study investigates the factors affecting patient preference in patients who have difficulties swallowing large tablets or capsules and aims to identify appropriate sizes for tablets and capsules. Methods: A robust data set was developed based on a questionnaire survey conducted from December 1, 2022, to December 7, 2022, using the harmo smartphone app operated by harmo Co, Ltd. The data set included patient input regarding their tablet and capsule preferences, personal health records (including dispensing history), and drug formulation information (available from package inserts). Based on the medication formulation information, 6 indices were set for each of the tablets or capsules that were considered difficult to swallow owing to their large size and concomitant tablets or capsules (used as controls). Receiver operating characteristic (ROC) analysis was used to evaluate the performance of each index. The index demonstrating the highest area under the curve of the ROC was selected as the best index to determine the tablet or capsule size that leads to swallowing difficulties. From the generated ROCs, the point with the highest discriminative performance that maximized the Youden index was identified, and the optimal threshold for each index was calculated. Multivariate logistic regression analysis was performed to identify the risk factors contributing to difficulty in swallowing oversized tablets or capsules. Additionally, decision tree analysis was performed to estimate the combined risk from several factors, using risk factors that were significant in the multivariate logistic regression analysis. Results: This study analyzed 147 large tablets or capsules and 624 control tablets or capsules. The “long diameter + short diameter + thickness” index (with a 21.5 mm threshold) was identified as the best indicator for causing swallowing difficulties in patients. The multivariate logistic regression analysis (including 132 patients with swallowing difficulties and 1283 patients without) results identified the following contributory risk factors: aged <50 years (odds ratio [OR] 1.59, 95% CI 1.03-2.44), female (OR 2.54, 95% CI 1.70-3.78), dysphagia (OR 3.54, 95% CI 2.22-5.65), and taking large tablets or capsules (OR 9.74, 95% CI 5.19-18.29). The decision tree analysis results suggested an elevated risk of swallowing difficulties for patients with taking large tablets or capsules. Conclusions: This study identified the most appropriate index and threshold for indicating that a given tablet or capsule size will cause swallowing difficulties, as well as the contributory risk factors. Although some sampling biases (eg, only including smartphone users) may exist, our results can guide the design of patient-friendly formulations and prescriptions, promoting better medication adherence. 
%M 38657229
%R 10.2196/54645
%U https://www.jmir.org/2024/1/e54645
%U https://doi.org/10.2196/54645
%U http://www.ncbi.nlm.nih.gov/pubmed/38657229

%0 Journal Article
        
%@ 1438-8871
%I JMIR Publications
%V 24
%N 4
%P e35178
%T Accuracy of Wearable Transdermal Alcohol Sensors: Systematic Review
%A Brobbin,Eileen
%A Deluca,Paolo
%A Hemrage,Sofia
%A Drummond,Colin
%+ Department of Addictions, King's College London, Addiction Science Building, 4 Windsor Walk, London, SE5 8BB, United Kingdom, 44 0207 836 5454, eileen.brobbin@kcl.ac.uk
%K alcohol consumption
%K alcohol detection
%K alcohol monitoring
%K alcohol treatment
%K digital technology
%K ecologic momentary assessment
%K transdermal alcohol sensors
%K wearables
%K mobile phone
%D 2022

%7 14.4.2022
%9 Review
%J J Med Internet Res
%G English
                
%X Background: There are a range of wearable transdermal alcohol sensors that are available and are being developed. These devices have the potential to monitor alcohol consumption continuously over extended periods in an objective manner, overcoming some of the limitations of other alcohol measurement methods (blood, breath, and urine). Objective: The objective of our systematic review was to assess wearable transdermal alcohol sensor accuracy. Methods: A systematic search of the CINAHL, Embase, Google Scholar, MEDLINE, PsycINFO, PubMed, and Scopus bibliographic databases was conducted in February 2021. In total, 2 team members (EB and SH) independently screened studies for inclusion, extracted data, and assessed the risk of bias. The methodological quality of each study was appraised using the Mixed Methods Appraisal Tool. The primary outcome was transdermal alcohol sensor accuracy. The data were presented as a narrative synthesis. Results: We identified and analyzed 32 studies. Study designs included laboratory, ambulatory, and mixed designs, as well as randomized controlled trials; the length of time for which the device was worn ranged from days to weeks; and the analyzed sample sizes ranged from 1 to 250. The results for transdermal alcohol concentration data from various transdermal alcohol sensors were generally found to positively correlate with breath alcohol concentration, blood alcohol concentration, and self-report (moderate to large correlations). However, there were some discrepancies between study reports; for example, WrisTAS sensitivity ranged from 24% to 85.6%, and specificity ranged from 67.5% to 92.94%. Higher malfunctions were reported with the BACtrack prototype (16%-38%) and WrisTAS (8%) than with SCRAM (2%); however, the former devices also reported a reduced time lag for peak transdermal alcohol concentration values when compared with SCRAM. It was also found that many companies were developing new models of wearable transdermal alcohol sensors. Conclusions: As shown, there is a lack of consistency in the studies on wearable transdermal alcohol sensor accuracy regarding study procedures and analyses of findings, thus making it difficult to draw direct comparisons between them. This needs to be considered in future research, and there needs to be an increase in studies directly comparing different transdermal alcohol sensors. There is also a lack of research investigating the accuracy of transdermal alcohol sensors as a tool for monitoring alcohol consumption in clinical populations and use over extended periods. Although there is some preliminary evidence suggesting the accuracy of these devices, this needs to be further investigated in clinical populations. Trial Registration: PROSPERO CRD42021231027; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=231027 
%M 35436239
%R 10.2196/35178
%U https://www.jmir.org/2022/4/e35178
%U https://doi.org/10.2196/35178
%U http://www.ncbi.nlm.nih.gov/pubmed/35436239

%0 Journal Article
        
%@ 1438-8871
%I JMIR Publications
%V 24
%N 2
%P e25597
%T Acceptability of and Willingness to Take Digital Pills by Patients, the Public, and Health Care Professionals: Qualitative Content Analysis of a Large Online Survey
%A Chevance,Astrid
%A Fortel,Axel
%A Jouannin,Adeline
%A Denis,Faustine
%A Mamzer,Marie-France
%A Ravaud,Philippe
%A Sidorkiewicz,Stephanie
%+ Center for Research in Epidemiology and Statistics, Université de Paris-French National Institute for Health and Medical Research, 1, place du pravis de Notre Dame, Paris, 75004, France, 33 142348987, astrid.chevance@gmail.com
%K acceptability
%K health technology assessment
%K clinical effectiveness research
%K ethics
%K digital pill
%K digital health
%K digital therapeutics
%K ingestible sensor
%K adherence
%D 2022

%7 18.2.2022
%9 Original Paper
%J J Med Internet Res
%G English
                
%X Background: Digital pills are pills combined with a sensor, which sends a signal to a patch connected to a smartphone when the pills are ingested. Health care professionals can access patient data from digital pills online via their own interface, thus allowing them to check whether a patient took the drug. Digital pills were developed for the stated goal of improving treatment adherence. The US Food and Drug Administration approved the first digital pills in November 2017, but the manufacturer withdrew its application to the European Medicines Agency in July 2020 because of insufficient evaluation. Objective: As recommended for the evaluation of health technologies, this study assesses the prospective acceptability of and willingness to take digital pills among patients, the public, and health care professionals. Methods: Participants were patients who were receiving long-term treatment for a chronic condition, public participants (both groups recruited from a representative sample), and health care professionals. Participants answered 5 open-ended questions regarding the acceptability of digital pills and 1 close-ended question regarding the willingness to take digital pills, which were developed in a preliminary qualitative study. We explored the 5 theoretical dimensions of acceptability by performing an abductive qualitative content analysis of all free-text responses. We assessed data saturation with mathematical models. We fitted a multivariate logistic regression model to identify the sociodemographic and health characteristics associated with the willingness to take digital pills. Results: Between January 29, 2020, and April 18, 2020, 767 patients, 1238 public participants, and 246 health care professionals provided 11,451 free-text responses. We identified 98 codes related to the acceptability of digital pills: 29 codes on perceived clinical effectiveness (eg, sensor safety cited by 66/2251 participants, 29.5%), 6 on perceived burden (eg, increased doctors’ workload, 164/2251 participants, 7.3%), 25 on perceived ethicality (eg, policing, 345/2251 participants, 15.3%), 30 codes on perceived opportunity (eg, exclusively negative perception, 690/2251 participants, 30.7%), and 8 on affective attitude (eg, anger, 541/2251, 24%). Overall, 271/767 (35.3%) patients, 376/1238 (30.4%) public participants, and 39/246 (15.8%) health care professionals reported willingness to take digital pills. This willingness was associated with male sex (odds ratio 1.98, 95% CI 1.62-2.43) and current use of a connected device to record health settings (with a dose–response relationship). Conclusions: The prospective acceptability of and willingness to take digital pills were limited by clinical and ethical concerns both at the individual and societal level. Our results suggest that digital pills should not be considered a mere change in the form of drug administration but a complex intervention requiring specific evaluation before extended use in clinical routine practice as well as an ethical and legal framework to ensure safe and ethical collection and use of health data through a patient-centered approach. 
%M 35179509
%R 10.2196/25597
%U https://www.jmir.org/2022/2/e25597
%U https://doi.org/10.2196/25597
%U http://www.ncbi.nlm.nih.gov/pubmed/35179509

%0 Journal Article
        
%@ 2292-9495
%I JMIR Publications
%V 8
%N 4
%P e30786
%T A Novel Digital Pill System for Medication Adherence Measurement and Reporting: Usability Validation Study
%A Baumgartner,Susan L
%A Buffkin Jr,D Eric
%A Rukavina,Elise
%A Jones,Jason
%A Weiler,Elizabeth
%A Carnes,Tony C
%+ etectRx, Inc., 747 SW 2nd Avenue, Suite 365T, IMB 24, Gainesville, FL, 32601, United States, 1 678 602 5701, susan.baumgartner@etectrx.com
%K digital pills
%K digital medication
%K ingestible event marker
%K ingestible sensor
%K human factors
%K usability
%K validation study
%K medication adherence
%K medication nonadherence
%K remote patient monitoring
%K mobile phone
%D 2021

%7 8.11.2021
%9 Original Paper
%J JMIR Hum Factors
%G English
                
%X Background: Medication nonadherence is a costly problem that is common in clinical use and clinical trials alike, with significant adverse consequences. Digital pill systems have proved to be effective and safe solutions to the challenges of nonadherence, with documented success in improving adherence and health outcomes. Objective: The aim of this human factors validation study is to evaluate a novel digital pill system, the ID-Cap System from etectRx, for usability among patient users in a simulated real-world use environment. Methods: A total of 17 patients with diverse backgrounds who regularly take oral prescription medications were recruited. After training and a period of training decay, the participants were asked to complete 12 patient-use scenarios during which errors or difficulties were logged. The participants were also interviewed about their experiences with the ID-Cap System. Results: The participants ranged in age from 27 to 74 years (mean 51 years, SD 13.8 years), and they were heterogeneous in other demographic factors as well, such as education level, handedness, and sex. In this human factors validation study, the patient users completed 97.5% (196/201) of the total use scenarios successfully; 75.1% (151/201) were completed without any failures or errors. The participants found the ID-Cap System easy to use, and they were able to accurately and proficiently record ingestion events using the device. Conclusions: The participants demonstrated the ability to safely and effectively use the ID-Cap System for its intended use. The ID-Cap System has great potential as a useful tool for encouraging medication adherence and can be easily implemented by patient users. 
%M 34747709
%R 10.2196/30786
%U https://humanfactors.jmir.org/2021/4/e30786
%U https://doi.org/10.2196/30786
%U http://www.ncbi.nlm.nih.gov/pubmed/34747709

%0 Journal Article
        
%@ 2561-326X
%I JMIR Publications
%V 5
%N 4
%P e26213
%T A Brief Training Program to Support the Use of a Digital Pill System for Medication Adherence: Pilot Descriptive Study
%A Chai,Peter R
%A Bustamante,Maria J
%A Goodman,Georgia
%A Mohamed,Yassir
%A Najarro,Jesse
%A Sullivan,Matthew C
%A Castillo-Mancilla,Jose
%A Coyle,Ryan P
%A Mayer,Kenneth H
%A Rosen,Rochelle K
%A Baumgartner,Susan L
%A Alpert,Pamela E
%A Boyer,Edward W
%A O'Cleirigh,Conall
%+ Department of Emergency Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA, 02411, United States, 1 617 732 5640, pchai@bwh.harvard.edu
%K digital pill system
%K technology training
%K HIV prevention
%K PrEP
%K ingestible sensors
%K mobile phone
%D 2021

%7 23.4.2021
%9 Original Paper
%J JMIR Form Res
%G English
                
%X Background: Digital pill systems (DPSs), which comprise ingestible radiofrequency sensors integrated into a gelatin capsule that overencapsulates a medication, can directly measure ingestion events. Objective: Teaching users to operate a DPS is vital to ensure the collection of actionable ingestion and adherence data. In this study, we aim to develop and pilot a training program, grounded in the Technology Acceptance Model, to instruct individuals on DPS operation. Methods: A two-part training program, comprising in-person and text message–based components, was used with HIV-negative men who have sex with men with nonalcohol substance use, who had enrolled in a 90-day pilot demonstration study using the DPS to measure adherence to pre-exposure prophylaxis. We assessed the number of responses to text check-ins, the number and types of episodes where technical support was requested, the resolutions of such issues, and engagement with the program over the study period. Participant feedback on the program was evaluated through qualitative user experience interviews. Results: A total of 15 participants were enrolled in and completed the program. Seven technical challenges related to DPS operations were reported across 5 participants. Most commonly, participants requested support connecting the wearable Reader device with their smartphone, charging the Reader, and operating the mobile app. A total of 6 issues were resolved asynchronously or in real time via phone; 1 required in-person evaluation and resolution. Preliminary qualitative findings indicate that both the in-person and remote follow-up components of the training program were perceived as acceptable. Suggested improvements included repeated DPS refresher sessions at in-person follow-up visits and enhanced written materials for the independent resolution of technological issues. Conclusions: A brief two-part DPS training program, drawing from individuals’ experiences and from the Technology Acceptance Model, can provide valuable insights for users. The program also identifies and addresses several areas of actual or potential challenges related to operating a DPS and allows for the resolution of such issues within the first week of DPS use. 
%M 33890863
%R 10.2196/26213
%U https://formative.jmir.org/2021/4/e26213
%U https://doi.org/10.2196/26213
%U http://www.ncbi.nlm.nih.gov/pubmed/33890863

%0 Journal Article
        
%@ 2561-326X
%I JMIR Publications
%V 5
%N 3
%P e17993
%T A Rest Quality Metric Using a Cluster-Based Analysis of Accelerometer Data and Correlation With Digital Medicine Ingestion Data: Algorithm Development
%A Heidary,Zahra
%A Cochran,Jeffrey M
%A Peters-Strickland,Timothy
%A Knights,Jonathan
%+ Otsuka Pharmaceutical Development & Commercialization, Inc, 508 Carnegie Center Dr, Princeton, NJ, 08540, United States, 1 609 524 6788, jeffrey.cochran@otsuka-us.com
%K serious mental illness
%K rest quality
%K actimetry
%K behavioral health
%K digital medicine
%K accelerometer
%K medication adherence
%D 2021

%7 2.3.2021
%9 Original Paper
%J JMIR Form Res
%G English
                
%X Background: Adherence to medication regimens and patient rest are two important factors in the well-being of patients with serious mental illness. Both of these behaviors are traditionally difficult to record objectively in unsupervised populations. Objective: A digital medicine system that provides objective time-stamped medication ingestion records was used by patients with serious mental illness. Accelerometer data from the digital medicine system was used to assess rest quality and thus allow for investigation into correlations between rest and medication ingestion. Methods: Longest daily rest periods were identified and then evaluated using a k-means clustering algorithm and distance metric to quantify the relative quality of patient rest during these periods. This accelerometer-derived quality-of-rest metric, along with other accepted metrics of rest quality, such as duration and start time of the longest rest periods, was compared to the objective medication ingestion records. Overall medication adherence classification based on rest features was not performed due to a lack of patients with poor adherence in the sample population. Results: Explorations of the relationship between these rest metrics and ingestion did seem to indicate that patients with poor adherence experienced relatively low quality of rest; however, patients with better adherence did not necessarily exhibit consistent rest quality. This sample did not contain sufficient patients with poor adherence to draw more robust correlations between rest quality and ingestion behavior. The correlation of temporal outliers in these rest metrics with daily outliers in ingestion time was also explored. Conclusions: This result demonstrates the ability of digital medicine systems to quantify patient rest quality, providing a framework for further work to expand the participant population, compare these rest metrics to gold-standard sleep measurements, and correlate these digital medicine biomarkers with objective medication ingestion data. 
%M 33650981
%R 10.2196/17993
%U https://formative.jmir.org/2021/3/e17993
%U https://doi.org/10.2196/17993
%U http://www.ncbi.nlm.nih.gov/pubmed/33650981

%0 Journal Article
        
%@ 2561-326X
%I JMIR Publications
%V 5
%N 1
%P e13888
%T Identifying Health Economic Considerations to Include in the Research Protocol of a Randomized Controlled Trial (the REDUCE-RISK Trial): Systematic Literature Review and Assessment
%A Neyt,Mattias
%A Christiaens,Annick
%A Aloi,Marina
%A de Ridder,Lissy
%A Croft,Nicholas M
%A Koletzko,Sibylle
%A Levine,Arie
%A Turner,Dan
%A Russell,Richard K
%A Ruemmele,Frank M
%A Veereman,Gigi
%+ Medical Evaluation and Technology Assessment (ME-TA), Jan Burssensstraat 23, Merendree, 9850, Belgium, 32 477901317, mattias.neyt@me-ta.eu
%K Crohn disease
%K cost-benefit analysis
%K adalimumab
%K clinical trial
%K protocol
%K technology assessment, biomedical
%D 2021

%7 25.1.2021
%9 Review
%J JMIR Form Res
%G English
                
%X Background: The REDUCE-RISK trial was set up to compare the effectiveness of weekly subcutaneously administered methotrexate with daily oral azathioprine or 6-mercaptopurine in low-risk Crohn disease (CD) or subcutaneously administered adalimumab (ADA) in high-risk CD in a pediatric population (age 6-17 years). Objective: The aim of this study is to perform a systematic review to provide input into the research protocol to gather the necessary information to improve the performance of an evidence-based economic evaluation when the trial is finished. Methods: The Centre for Reviews and Dissemination (CRD) Health Technology Assessment (HTA) database, websites of HTA institutes, CRD’s National Health Service Economic Evaluation Database, MEDLINE (OVID), and Embase databases were consulted to retrieve (reviews of) relevant economic evaluations. Studies were eligible if they included a pediatric or adult population with inflammatory bowel diseases (CD and ulcerative colitis [UC]) treated with ADA (Humira). There were no restrictions on the comparator. Only economic evaluations expressing outcomes in life years gained or quality-adjusted life years gained were selected. Results: A total of 12 primary studies were identified. None of these studies included a pediatric population because of a lack of supporting trials. The economic evaluations identified in our systematic review indicate that ADA is an appropriate intervention for inclusion in such a trial. From a health economic point of view, it is important to make an incremental analysis comparing such an intervention with standard care and not immediately versus another (expensive) biological treatment. Information on the impact of children’s school attendance and parents’ productivity is currently lacking in economic evaluations, and none of the underlying trials measured quality of life (QoL) using a generic utility instrument. Conclusions: The review of the economic literature on ADA for the treatment of patients with CD supports the performance of a trial with biologicals in pediatric patients, including making a distinction according to disease severity. Conducting an economic literature review enabled us to decide which variables should be added to the research protocol from an economic point of view. Measurements for children’s and parents’ QoL (EuroQol 5-Dimension questionnaires), children’s school attendance, and parents’ productivity (WPAI-CD-CG questionnaire) were added to the research protocol. This will provide support for the calculation of the cost-effectiveness of the interventions evaluated in the REDUCE-RISK trial. Trial Registration: ClinicalTrials.gov NCT02852694; https://clinicaltrials.gov/ct2/show/NCT02852694 
%M 33492239
%R 10.2196/13888
%U http://formative.jmir.org/2021/1/e13888/
%U https://doi.org/10.2196/13888
%U http://www.ncbi.nlm.nih.gov/pubmed/33492239

%0 Journal Article
        
%@ 2368-7959
%I JMIR Publications
%V 7
%N 9
%P e21378
%T Detection of Behavioral Anomalies in Medication Adherence Patterns Among Patients With Serious Mental Illness Engaged With a Digital Medicine System
%A Knights,Jonathan
%A Heidary,Zahra
%A Cochran,Jeffrey M
%+ Otsuka Pharmaceutical Development & Commercialization, 508 Carnegie Center Drive, Princeton, NJ, 08540, United States, 1 6095246788, jonathan.knights@otsuka-us.com
%K digital medicine
%K mobile phone
%K entropy rate
%K Markov chains
%K medication adherence
%K contextual anomaly
%K psychiatric disorders
%D 2020

%7 10.9.2020
%9 Original Paper
%J JMIR Ment Health
%G English
                
%X Background: Adherence to medication is often represented in the form of a success percentage over a period of time. Although noticeable changes to aggregate adherence levels may be indicative of unstable medication behavior, a lack of noticeable changes in aggregate levels over time does not necessarily indicate stability. The ability to detect developing changes in medication-taking behavior under such conditions in real time would allow patients and care teams to make more timely and informed decisions. Objective: This study aims to develop a method capable of identifying shifts in behavioral (medication) patterns at the individual level and subsequently assess the presence of such shifts in retrospective clinical trial data from patients with serious mental illness. Methods: We defined the term adherence volatility as “the degree to which medication ingestion behavior fits expected behavior based on historically observed data” and defined a contextual anomaly system around this concept, leveraging the empirical entropy rate of a stochastic process as the basis for formulating anomaly detection. For the presented methodology, each patient’s evolving behavior is used to dynamically construct the expectation bounds for each future interval, eliminating the need to rely on model training or a static reference sequence. Results: Simulations demonstrated that the presented methodology identifies anomalous behavior patterns even when aggregate adherence levels remain constant and highlight the temporal dependence inherent in these anomalies. Although a given sequence of events may present as anomalous during one period, that sequence should subsequently contribute to future expectations and may not be considered anomalous at a later period—this feature was demonstrated in retrospective clinical trial data. In the same clinical trial data, anomalous behavioral shifts were identified at both high- and low-adherence levels and were spread across the whole treatment regimen, with 77.1% (81/105) of the population demonstrating at least one behavioral anomaly at some point in their treatment. Conclusions: Digital medicine systems offer new opportunities to inform treatment decisions and provide complementary information about medication adherence. This paper introduces the concept of adherence volatility and develops a new type of contextual anomaly detection, which does not require an a priori definition of normal and allows expectations to evolve with shifting behavior, removing the need to rely on training data or static reference sequences. Retrospective analysis from clinical trial data highlights that such an approach could provide new opportunities to meaningfully engage patients about potential shifts in their ingestion behavior; however, this framework is not intended to replace clinical judgment, rather to highlight elements of data that warrant attention. The evidence provided here identifies new areas for research and seems to justify additional explorations in this area. 
%M 32909950
%R 10.2196/21378
%U https://mental.jmir.org/2020/9/e21378
%U https://doi.org/10.2196/21378
%U http://www.ncbi.nlm.nih.gov/pubmed/32909950

%0 Journal Article
        
%@ 1438-8871
%I JMIR Publications
%V 22
%N 7
%P e16904
%T Understanding the Acceptability of Subdermal Implants as a Possible New HIV Prevention Method: Multi-Stage Mixed Methods Study
%A Rael,Christine Tagliaferri
%A Lentz,Cody
%A Carballo-Diéguez,Alex
%A Giguere,Rebecca
%A Dolezal,Curtis
%A Feller,Daniel
%A D'Aquila,Richard T
%A Hope,Thomas J
%+ HIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute, Columbia University, 1051 Riverside Dr, New York, NY, 10032, United States, 1 6467746967, cr2857@cumc.columbia.edu
%K PrEP implant
%K YouTube
%K acceptability
%K long-acting PrEP
%K systemic PrEP
%K human-centered design
%K HIV prevention
%K removable implant
%K long-acting HIV prevention
%K gay and bisexual men
%D 2020

%7 27.7.2020
%9 Original Paper
%J J Med Internet Res
%G English
                
%X Background: A long-acting implant for HIV pre-exposure prophylaxis (PrEP) is in development in the Sustained Long-Action Prevention Against HIV (SLAP-HIV) trial. This could provide an alternative to oral PrEP. Objective: Our mixed methods study aimed to understand (1) users’ experiences with a similar subdermal implant for contraception and (2) factors influencing the likelihood that gay and bisexual men (GBM) would use a proposed PrEP implant. Methods: Work was completed in 4 stages. In stage 1, we conducted a scientific literature review on existing subdermal implants, focusing on users’ experiences with implant devices. In stage 2, we reviewed videos on YouTube, focusing on the experiences of current or former contraceptive implant users (as these implants are similar to those in development in SLAP-HIV). In stage 3, individuals who indicated use of a subdermal implant for contraception in the last 5 years were recruited via a web-based questionnaire. Eligible participants (n=12 individuals who liked implants a lot and n=12 individuals who disliked implants a lot) completed in-depth phone interviews (IDIs) about their experiences. In stage 4, results from IDIs were used to develop a web-based survey for HIV-negative GBM to rate their likelihood of using a PrEP implant on a scale (1=very unlikely and 5=very likely) based on likely device characteristics and implant concerns identified in the IDIs. Results: In the scientific literature review (stage 1), concerns about contraceptive implants that could apply to the PrEP implants in development included potential side effects (eg, headache), anticipated high cost of the device, misconceptions about PrEP implants (eg, specific contraindications), and difficulty accessing PrEP implants. In the stage 2 YouTube review, individuals who had used contraceptive implants reported mild side effects related to their device. In stage 3, implant users reported that devices were comfortable, unintrusive, and presented only minor discomfort (eg, bruising) before or after insertion and removal. They mainly reported removing or disliking the device due to contraceptive-related side effects (eg, prolonged menstruation). Participants in the stage 4 quantitative survey (N=304) were mainly gay (204/238, 85.7%), white (125/238, 52.5%), cisgender men (231/238, 97.1%), and 42.0% (73/174) of them were on oral PrEP. Not having to take a daily pill increased the likelihood of using PrEP implants (mean 4.13). Requiring >1 device to achieve 1 year of protection (mean range 1.79-2.94) mildly discouraged PrEP implant use. Participants did not mind moderate bruising, a small scar, tenderness, or bleeding after insertion or removal, and an implant with a size slightly larger than a matchstick (mean ratings 3.18-3.69). Conclusions: PrEP implants are promising among GBM. Implant features and insertion or removal-related concerns do not seem to discourage potential users. To ensure acceptability, PrEP implants should require the fewest possible implants for the greatest protection duration. 
%M 32348277
%R 10.2196/16904
%U https://www.jmir.org/2020/7/e16904
%U https://doi.org/10.2196/16904
%U http://www.ncbi.nlm.nih.gov/pubmed/32348277

%0 Journal Article
        
%@ 1438-8871
%I JMIR Publications
%V 19
%N 7
%P e246
%T Effectiveness of Digital Medicines to Improve Clinical Outcomes in Patients with Uncontrolled Hypertension and Type 2 Diabetes: Prospective, Open-Label, Cluster-Randomized Pilot Clinical Trial
%A Frias,Juan
%A Virdi,Naunihal
%A Raja,Praveen
%A Kim,Yoona
%A Savage,George
%A Osterberg,Lars
%+ Proteus Digital Health, 2600 Bridge Parkway, Redwood City, CA, 94065, United States, 1 4158285009, nvirdi@proteus.com
%K digital medicine
%K hypertension
%K type 2 diabetes
%K patient engagement, medication adherence
%K therapeutic inertia
%D 2017

%7 11.07.2017
%9 Original Paper
%J J Med Internet Res
%G English
                
%X Background: Hypertension and type 2 diabetes mellitus are major modifiable risk factors for cardiac, cerebrovascular, and kidney diseases. Reasons for poor disease control include nonadherence, lack of patient engagement, and therapeutic inertia. Objective: The aim of this study was to assess the impact on clinic-measured blood pressure (BP) and glycated hemoglobin (HbA1c) using a digital medicine offering (DMO) that measures medication ingestion adherence, physical activity, and rest using digital medicines (medication taken with ingestible sensor), wearable sensor patches, and a mobile device app. Methods: Participants with elevated systolic BP (SBP ≥140 mm Hg) and HbA1c (≥7%) failing antihypertensive (≥2 medications) and oral diabetes therapy were enrolled in this three-arm, 12-week, cluster-randomized study. Participants used DMO (includes digital medicines, the wearable sensor patch, and the mobile device app) for 4 or 12 weeks or received usual care based on site randomization. Providers in the DMO arms could review the DMO data via a Web portal. In all three arms, providers were instructed to make medical decisions (medication titration, adherence counseling, education, and lifestyle coaching) on all available clinical information at each visit. Primary outcome was change in SBP at week 4. Other outcomes included change in SBP and HbA1c at week 12, and low-density lipoprotein cholesterol (LDL-C) and diastolic blood pressure (DBP) at weeks 4 and 12, as well as proportion of patients at BP goal (<140/90 mm Hg) at weeks 4 and 12, medical decisions, and medication adherence patterns. Results: Final analysis included 109 participants (12 sites; age: mean 58.7, SD years; female: 49.5%, 54/109; Hispanic: 45.9%, 50/109; income ≤ US $20,000: 56.9%, 62/109; and ≤ high school education: 52.3%, 57/109). The DMO groups had 80 participants (7 sites) and usual care had 29 participants (5 sites). At week 4, DMO resulted in a statistically greater SBP reduction than usual care (mean –21.8, SE 1.5 mm Hg vs mean –12.7, SE 2.8 mmHg; mean difference –9.1, 95% CI –14.0 to –3.3 mm Hg) and maintained a greater reduction at week 12. The DMO groups had greater reductions in HbA1c, DBP, and LDL-C, and a greater proportion of participants at BP goal at weeks 4 and 12 compared with usual care. The DMO groups also received more therapeutic interventions than usual care. Medication adherence was ≥80% while using the DMO. The most common adverse event was a self-limited rash at the wearable sensor site (12%, 10/82). Conclusions: For patients failing hypertension and diabetes oral therapy, this DMO, which provides dose-by-dose feedback on medication ingestion adherence, can help lower BP, HbA1c, and LDL-C, and promote patient engagement and provider decision making. Trial Registration: Clinicaltrials.gov NCT02827630; https://clinicaltrials.gov/show/NCT02827630 (Archived by WebCite at http://www.webcitation.org/6rL8dW2VF) 
%M 28698169
%R 10.2196/jmir.7833
%U http://www.jmir.org/2017/7/e246/
%U https://doi.org/10.2196/jmir.7833
%U http://www.ncbi.nlm.nih.gov/pubmed/28698169

%0 Journal Article
        
%@ 2291-5222
%I JMIR Publications
%V 5
%N 6
%P e76
%T Direct Adherence Measurement Using an Ingestible Sensor Compared With Self-Reporting in High-Risk Cardiovascular Disease Patients Who Knew They Were Being Measured: A Prospective Intervention
%A Thompson,David
%A Mackay,Teresa
%A Matthews,Maria
%A Edwards,Judith
%A Peters,Nicholas S
%A Connolly,Susan B
%+ National Heart and Lung Institute, Imperial College London, 4th Floor Imperial Centre for Translational and Experimental Medicine, Du Cane Road, London, W12 0NN, United Kingdom, 44 2075941880, n.peters@imperial.ac.uk
%K cardiac prevention and rehabilitation
%K adherence
%K mHealth
%K remote monitoring
%K cardiovascular diseases
%K primary prevention
%K medication adherence
%K telemedicine
%D 2017

%7 12.06.2017
%9 Original Paper
%J JMIR Mhealth Uhealth
%G English
                
%X Background: Use of appropriate cardioprotective medication is a cornerstone of cardiovascular disease prevention, but less-than-optimal patient adherence is common. Thus, strategies for improving adherence are recommended to adopt a multifaceted approach. Objective: The objective of our study was to test a system comprising a biodegradable, ingestible sensor for direct measurement of medication ingestion in a group of patients at elevated cardiovascular risk attending a cardiac prevention and rehabilitation program. Methods: In this prospective intervention trial in a single group of 21 patients running from April 2014 to June 2015, we measured adherence by self-report and adherence determined objectively by the system. The sensor emits a signal when it encounters the acidic environment of the stomach, detectable by an externally worn patch and linked software app. Longitudinal adherence data in the form of daily progress charts for sensed dosing events as compared with scheduled dosing are visible to patients on their tablet computer’s medication dosing app, thus providing patients with continuous medication adherence feedback. We sought feedback on patient acceptability by questionnaire assessment. Participants used the system for the 12-week period of their cardiac prevention and rehabilitation program. Results: Only 1 patient at initial assessment and 1 patient at end-of-program assessment reported often missing medication. The remaining patients reported never missing medication or had missing data. Only 12 (57%) of patients overall achieved system-determined adherence of 80% or more, and 3 patients had scores below 40%. Participants reported high levels of acceptability. Conclusions: This integrated system was well tolerated in a group of 21 patients over an appreciable time frame. Its ability to measure adherence reveals the sizeable disconnect between patient self-reported adherence and actual medication taking and has promising potential for clinical use as a tool to encourage better medication-taking behavior due to its ability to provide continuous patient-level feedback. 
%M 28606895
%R 10.2196/mhealth.6998
%U http://mhealth.jmir.org/2017/6/e76/
%U https://doi.org/10.2196/mhealth.6998
%U http://www.ncbi.nlm.nih.gov/pubmed/28606895

%0 Journal Article
        
%@ 1438-8871
%I JMIR Publications
%V 19
%N 1
%P e19
%T Digital Pills to Measure Opioid Ingestion Patterns in Emergency Department Patients With Acute Fracture Pain: A Pilot Study
%A Chai,Peter R
%A Carreiro,Stephanie
%A Innes,Brendan J
%A Rosen,Rochelle K
%A O'Cleirigh,Conall
%A Mayer,Kenneth H
%A Boyer,Edward W
%+ Division of Medical Toxicology, Department of Emergency Medicine, Brigham and Women's Hospital, 75 Francis St, Boston, MA, 02115, United States, 1 617 732 5640, peterchai@gmail.com
%K medication adherence
%K opioid
%K digital pills
%K digital health
%K emergency medicine
%K pain management
%D 2017

%7 13.01.2017
%9 Original Paper
%J J Med Internet Res
%G English
                
%X Background: Nonadherence to prescribed regimens for opioid analgesic agents contributes to increasing opioid abuse and overdose death. Opioids are frequently prescribed on an as-needed basis, placing the responsibility to determine opioid dose and frequency with the patient. There is wide variability in physician prescribing patterns because of the lack of data describing how patients actually use as-needed opioid analgesics. Digital pill systems have a radiofrequency emitter that directly measures medication ingestion events, and they provide an opportunity to discover the dose, timing, and duration of opioid therapy. Objective: The purpose of this study was to determine the feasibility of a novel digital pill system to measure as-needed opioid ingestion patterns in patients discharged from the emergency department (ED) after an acute bony fracture. Methods: We used a digital pill with individuals who presented to a teaching hospital ED with an acute extremity fracture. The digital pill consisted of a digital radiofrequency emitter within a standard gelatin capsule that encapsulated an oxycodone tablet. When ingested, the gastric chloride ion gradient activated the digital pill, transmitting a radiofrequency signal that was received by a hip-worn receiver, which then transmitted the ingestion data to a cloud-based server. After a brief, hands-on training session in the ED, study participants were discharged home and used the digital pill system to ingest oxycodone prescribed as needed for pain for one week. We conducted pill counts to verify digital pill data and open-ended interviews with participants at their follow-up appointment with orthopedics or at one week after enrollment in the study to determine the knowledge, attitudes, beliefs, and practices regarding digital pills. We analyzed open-ended interviews using applied thematic analysis. Results: We recruited 10 study participants and recorded 96 ingestion events (87.3%, 96/110 accuracy). Study participants reported being able to operate all aspects of the digital pill system after their training. Two participants stopped using the digital pill, reporting they were in too much pain to focus on the novel technology. The digital pill system detected multiple simultaneous ingestion events by the digital pill system. Participants ingested a mean 8 (SD 5) digital pills during the study period and four participants continued on opioids at the end of the study period. After interacting with the digital pill system in the real world, participants found the system highly acceptable (80%, 8/10) and reported a willingness to continue to use a digital pill to improve medication adherence monitoring (90%, 9/10). Conclusions: The digital pill is a feasible method to measure real-time opioid ingestion patterns in individuals with acute pain and to develop real-time interventions if opioid abuse is detected. Deploying digital pills is possible through the ED with a short instructional course. Patients who used the digital pill accepted the technology. 
%M 28087496
%R 10.2196/jmir.7050
%U http://www.jmir.org/2017/1/e19/
%U https://doi.org/10.2196/jmir.7050
%U http://www.ncbi.nlm.nih.gov/pubmed/28087496

%0 Journal Article
        
%@ 2291-5222
%I JMIR Publications Inc.
%V 3
%N 4
%P e108
%T Let Visuals Tell the Story: Medication Adherence in Patients with Type II Diabetes Captured by a Novel Ingestion Sensor Platform
%A Browne,Sara H
%A Behzadi,Yashar
%A Littlewort,Gwen
%+ University of California, San Diego, School of Medicine, 9500 Gilman Drive, Mail Code 0640, La Jolla, CA, 92093-0640, United States, 1 858 822 6563, shbrowne@ucsd.edu
%K ingestion sensor platform
%K data visualization
%K time domain methods
%K medication adherence
%K patient self-management
%D 2015

%7 31.12.2015
%9 Original Paper
%J JMIR mHealth uHealth
%G English
                
%X Background: Chronic diseases such as diabetes require high levels of medication adherence and patient self-management for optimal health outcomes. A novel sensing platform, Digital Health Feedback System (Proteus Digital Health, Redwood City, CA), can for the first time detect medication ingestion events and physiological measures simultaneously, using an edible sensor, personal monitor patch, and paired mobile device. The Digital Health Feedback System (DHFS) generates a large amount of data. Visual analytics of this rich dataset may provide insights into longitudinal patterns of medication adherence in the natural setting and potential relationships between medication adherence and physiological measures that were previously unknown. Objective: Our aim was to use modern methods of visual analytics to represent continuous and discrete data from the DHFS, plotting multiple different data types simultaneously to evaluate the potential of the DHFS to capture longitudinal patterns of medication-taking behavior and self-management in individual patients with type II diabetes. Methods: Visualizations were generated using time domain methods of oral metformin medication adherence and physiological data obtained by the DHFS use in 5 patients with type II diabetes over 37-42 days. The DHFS captured at-home metformin adherence, heart rate, activity, and sleep/rest. A mobile glucose monitor captured glucose testing and level (mg/dl). Algorithms were developed to analyze data over varying time periods: across the entire study, daily, and weekly. Following visualization analysis, correlations between sleep/rest and medication ingestion were calculated across all subjects. Results: A total of 197 subject days, encompassing 141,840 data events were analyzed. Individual continuous patch use varied between 87-98%. On average, the cohort took 78% (SD 12) of prescribed medication and took 77% (SD 26) within the prescribed ±2-hour time window. Average activity levels per subjects ranged from 4000-12,000 steps per day. The combination of activity level and heart rate indicated different levels of cardiovascular fitness between subjects. Visualizations over the entire study captured the longitudinal pattern of missed doses (the majority of which took place in the evening), the timing of ingestions in individual subjects, and the range of medication ingestion timing, which varied from 1.5-2.4 hours (Subject 3) to 11 hours (Subject 2). Individual morning self-management patterns over the study period were obtained by combining the times of waking, metformin ingestion, and glucose measurement. Visualizations combining multiple data streams over a 24-hour period captured patterns of broad daily events: when subjects rose in the morning, tested their blood glucose, took their medications, went to bed, hours of sleep/rest, and level of activity during the day. Visualizations identified highly consistent daily patterns in Subject 3, the most adherent participant. Erratic daily patterns including sleep/rest were demonstrated in Subject 2, the least adherent subject. Correlation between sleep /rest and medication ingestion in each individual subject was evaluated. Subjects 2 and 4 showed correlation between amount of sleep/rest over a 24-hour period and medication-taking the following day (Subject 2: r=.47, P<.02; Subject 4: r=.35, P<.05). With Subject 2, sleep/rest disruptions during the night were highly correlated (r=.47, P<.009) with missing doses the following day. Conclusions: Visualizations integrating medication ingestion and physiological data from the DHFS over varying time intervals captured detailed individual longitudinal patterns of medication adherence and self-management in the natural setting. Visualizing multiple data streams simultaneously, providing a data-rich representation, revealed information that would not have been shown by plotting data streams individually. Such analyses provided data far beyond traditional adherence summary statistics and may form the foundation of future personalized predictive interventions to drive longitudinal adherence and support optimal self-management in chronic diseases such as diabetes. 
%M 26721413
%R 10.2196/mhealth.4292
%U http://mhealth.jmir.org/2015/4/e108/
%U https://doi.org/10.2196/mhealth.4292
%U http://www.ncbi.nlm.nih.gov/pubmed/26721413