@Article{info:doi/10.2196/68093, author="Harry, Christiana and Goodday, Sarah and Chapman, Carol and Karlin, Emma and Damian, Joy April and Brooks, Alexa and Boch, Adrien and Lugo, Nelly and McMillan, Rebecca and Tempero, Jonell and Swanson, Ella and Peabody, Shannon and McKenzie, Diane and Friend, Stephen", title="Using Social Media to Engage and Enroll Underrepresented Populations: Longitudinal Digital Health Research", journal="JMIR Form Res", year="2025", month="Apr", day="15", volume="9", pages="e68093", keywords="digital health research", keywords="digital health technology", keywords="recruitment", keywords="research subject", keywords="participant", keywords="pregnancy", keywords="maternal health", keywords="underrepresented populations", keywords="health equity", keywords="diversity", keywords="marginalized", keywords="advertisement", keywords="social media", keywords="retention", keywords="attrition", keywords="dropout", abstract="Background: Emerging digital health research poses roadblocks to the inclusion of historically marginalized populations in research. Exclusion of underresourced communities in digital health research is a result of multiple factors (eg, limited technology access, decreased digital literacy, language barriers, and historical mistrust of research and research institutions). Alternative methods of access and engagement may aid in achieving long-term sustainability of diversified participation in digital health research, ensuring that developed technologies and research outcomes are effective and equitable. Objective: This study aims to (1) characterize socioeconomic and demographic differences in individuals who enrolled and engaged with different remote, digital, and traditional recruitment methods in a digital health pregnancy study and (2) determine whether social media outreach is an efficient way of recruiting and retaining specific underrepresented populations (URPs) in digital health research. Methods: The Better Understanding the Metamorphosis of Pregnancy (BUMP) study was used as a case example. This is a prospective, observational, cohort study using digital health technology to increase understanding of pregnancy among 524 women, aged 18-40 years, in the United States. The study used different recruitment strategies: patient portal for genetic testing results, paid/unpaid social media ads, and a community health organization providing care to pregnant women (Moses/Weitzman Health System). Results: Social media as a recruitment tool to engage URPs in a digital health study was overall effective, with a 23.6\% (140/594) enrollment rate of those completing study interest forms across 25 weeks. Community-based partnerships were less successful, however, resulting in 53.3\% (57/107) engagement with recruitment material and only 8.8\% (5/57) ultimately enrolling in the study. Paid social media ads provided access to and enrollment of a diverse potential participant pool of race- or ethnicity-based URPs in comparison to other digital recruitment channels. Of those that engaged with study materials, paid recruitment had the highest percentage of non-White (non-Hispanic) respondents (85/321, 26.5\%), in comparison to unpaid ads (Facebook and Reddit; 37/167, 22.2\%). Of the enrolled participants, paid ads also had the highest percentage of non-White (non-Hispanic) participants (14/70, 20\%), compared to unpaid ads (8/52, 15.4\%) and genetic testing service subscribers (72/384, 18.8\%). Recruitment completed via paid ads (Instagram) had the highest study retention rate (52/70, 74.3\%) across outreach methods, whereas recruitment via community-based partnerships had the lowest (2/5, 40\%). Retention of non-White (non-Hispanic) participants was low across recruitment methods: paid (8/52, 15.4\%), unpaid (3/35, 14.3\%), and genetic testing service subscribers (50/281, 17.8\%). Conclusions: Social media recruitment (paid/unpaid) provides access to URPs and facilitates sustained retention similar to other methods, but with varying strengths and weaknesses. URPs showed lower retention rates than their White counterparts across outreach methods. Community-based recruitment showed lower engagement, enrollment, and retention. These findings highlight social media's potential for URP engagement and enrollment, illuminate potential roadblocks of traditional methods, and underscore the need for tailored research to improve URP enrollment and retention. ", doi="10.2196/68093", url="https://formative.jmir.org/2025/1/e68093" } @Article{info:doi/10.2196/70852, author="Mackey, Tim and Cuomo, E. Raphael and Xu, Qing and McMann, J. Tiana and Li, Zhuoran and Cai, Mingxiang and Wenzel, Christine and Yang, S. Joshua", title="Approach to Design and Evaluate Digital Tools to Enhance Young Adult Participation in Clinical Trials: Co-Design and Controlled Intercept Study", journal="J Med Internet Res", year="2025", month="Apr", day="11", volume="27", pages="e70852", keywords="health", keywords="clinical trials", keywords="COVID-19", keywords="digital health", keywords="coronavirus disease", abstract="Background: Certain populations are underrepresented in clinical trials, limiting the generalizability of new treatments and their efficacy and uptake in these populations. It is essential to identify and understand effective strategies for enrolling young adults in clinical trials, as they represent a vital and key demographic for future clinical trial participation. Objective: This study aimed to develop, test, and evaluate digital tools designed to encourage the participation of young adults in the clinical trial process. An interdisciplinary approach, incorporating social listening, qualitative focus groups, and co-design workshops, was used to achieve this goal. Methods: Digital tools were designed and evaluated using a 4-phase approach that included: (1) social listening to characterize lived experiences with COVID-19 trials as self-reported by online users, (2) qualitative focus groups with young adults to explore specific lived attitudes and experiences related to COVID-19 clinical research hesitancy and engagement, (3) a series of cocreation and co-design workshops to build digital tools aimed at encouraging clinical trial participation, and (4) a controlled intercept study to assess the usability and specific outcome measures of the co-designed digital tools among young adults. Results: A significantly higher change in the likelihood of participating in a clinical trial post exposure was observed among study participants when exposed to prototypes of a mobile app ($\Delta$=0.74 on a 10-point scale, P<.01) and website ($\Delta$=0.93, P<.01) compared to those exposed to a Facebook ad ($\Delta$=0.21) but not a digital flyer ($\Delta$=0.58). Furthermore, those exposed to the mobile app (x?=5.76, P=.04) and electronic flier (x?=5.72, P=.04), but not the website (x?=5.55), exhibited significantly higher postexposure interest in learning about clinical trials when compared to participants exposed to the Facebook (Meta) ad (x?=5.06). Participants in the intercept study were more likely to consider joining a clinical trial after seeing a mobile app ($\Delta$=0.74, P<.01) or website ($\Delta$=0.93, P<.001) compared to a Facebook ad ($\Delta$=0.21), but the digital flyer ($\Delta$=0.58) did not show a significant difference. In addition, those who saw the mobile app (x?=5.76, P=.04) or the digital flyer (x?=5.72, P=.04) showed more interest in learning about clinical trials than those who saw the Facebook ad (x?=5.06), though the website (x?= 5.55) did not significantly impact interest. Conclusions: Mobile apps and web pages co-designed with young diverse adults may represent effective digital tools to advance shared goals of encouraging inclusive clinical trials. ", doi="10.2196/70852", url="https://www.jmir.org/2025/1/e70852" } @Article{info:doi/10.2196/58916, author="Francis, M. Jackson and Neti, S. Sitapriya and Polavarapu, Dhatri and Atem, Folefac and Xie, Luyu and Kapera, Olivia and Mathew, S. Matthew and Marroquin, Elisa and McAdams, Carrie and Schellinger, Jeffrey and Ngenge, Sophia and Kukreja, Sachin and Schneider, E. Benjamin and Almandoz, P. Jaime and Messiah, E. Sarah", title="Association of Social Media Recruitment and Depression Among Racially and Ethnically Diverse Metabolic and Bariatric Surgery Candidates: Prospective Cohort Study", journal="JMIR Form Res", year="2025", month="Apr", day="10", volume="9", pages="e58916", keywords="social media", keywords="social media recruitment", keywords="depression", keywords="depressed", keywords="major depressive disorder", keywords="MDD", keywords="depressive disorder", keywords="depressive", keywords="race", keywords="racial", keywords="racial differences", keywords="ethnic", keywords="ethnic differences", keywords="ethnicity", keywords="metabolic surgery", keywords="bariatric surgery", keywords="obesity", keywords="obese", keywords="online health", keywords="ethics", keywords="mental health", keywords="eHealth", keywords="internet", keywords="digital health", keywords="digital mental health", keywords="online interventions", keywords="public engagement", keywords="public health", abstract="Background: Due to the widespread use of social media and the internet in today's connected world, obesity and depression rates are increasing concurrently on a global scale. This study investigated the complex dynamics involving social media recruitment for scientific research, race, ethnicity, and depression among metabolic and bariatric surgery (MBS) candidates. Objective: This study aimed to determine (1) the association between social media recruitment and depression among MBS candidates and (2) racial and ethnic differences in social media recruitment engagement. Methods: The analysis included data from 380 adult MBS candidates enrolled in a prospective cohort study from July 2019 to December 2022. Race and ethnicity, recruitment method (social media: yes or no), and depression status were evaluated using $\chi$2 tests and logistic regression models. Age, sex, and ethnicity were adjusted in multivariable logistic regression models. Results: The mean age of the candidates was 47.35 (SD 11.6) years, ranging from 18 to 78 years. Participants recruited through social media (n=41, 38.32\%) were more likely to report past or current episodes of depression compared to nonsocial media--recruited participants (n=74, 27.11\%; P=.03), with a 67\% increased likelihood of depression (odds ratio [OR] 1.67, 95\% CI 1.04?2.68, P=.03). Further analysis showed that participants with a history of depression who were below the mean sample age were 2.26 times more likely to be recruited via social media (adjusted OR [aOR] 2.26, 95\% CI 1.03?4.95; P=.04) compared to those above the mean age. Hispanic (n=26, 38.81\%) and non-Hispanic White (n=53, 35.10\%) participants were significantly more likely to be recruited via social media than non-Hispanic Black (n=27, 18.37\%) participants (P<.001). After adjusting for covariates, non-Hispanic Black participants were 60\% less likely than non-Hispanic White participants to be recruited via social media (aOR 0.40, 95\% CI 0.22?0.71; P=.002). Conclusions: We found that individuals recruited through social media channels, especially younger participants, were more likely to report past or current episodes of depression compared to those recruited through nonsocial media. The study also showed that non-Hispanic Black individuals are less likely to engage in social media recruitment for scientific research versus other racial and ethnic groups. Future mental health--related studies should consider strategies to mitigate potential biases introduced by recruitment methods to ensure the validity and generalizability of research findings. ", doi="10.2196/58916", url="https://formative.jmir.org/2025/1/e58916" } @Article{info:doi/10.2196/70149, author="Ajayi, Toluwalase and Kueper, Jacqueline and Ariniello, Lauren and Ho, Diana and Delgado, Felipe and Beal, Matthew and Waalen, Jill and Baca Motes, Katie and Ramos, Edward", title="Digital Health Platform for Maternal Health: Design, Recruitment Strategies, and Lessons Learned From the PowerMom Observational Cohort Study", journal="JMIR Form Res", year="2025", month="Apr", day="7", volume="9", pages="e70149", keywords="maternal health research", keywords="digital health platforms", keywords="pregnancy monitoring", keywords="decentralized clinical trials", keywords="participant engagement", keywords="health disparities", abstract="Background: Maternal health research faces challenges in participant recruitment, retention, and data collection, particularly among underrepresented populations. Digital health platforms like PowerMom (Scripps Research) offer scalable solutions, enabling decentralized, real-world data collection. Using innovative recruitment and multimodal techniques, PowerMom engages diverse cohorts to gather longitudinal and episodic data during pregnancy and post partum. Objective: This study aimed to evaluate the design, implementation, and outcomes of the PowerMom research platform, with a focus on participant recruitment, engagement, and data collection across diverse populations. Secondary objectives included identifying challenges encountered during implementation and deriving lessons to inform future digital maternal health studies. Methods: Participants were recruited via digital advertisements, pregnancy apps, and the PowerMom Consortium of more than 15 local and national organizations. Data collection included self-reported surveys, wearable devices, and electronic health records. Anomaly detection measures were implemented to address fraudulent enrollment activity. Recruitment trends and descriptive statistics from survey data were analyzed to summarize participant characteristics, assess engagement metrics, and quantify missing data to identify gaps. Results: Overall, 5617 participants were enrolled from 2021 to 2024, with 69.8\% (n=3922) providing demographic data. Of these, 48.5\% (2723/5617) were younger than 35 years, 14\% (788/5617) identified as Hispanic or Latina, and 13.7\% (770/5617) identified as Black or African American. Geographic representation spanned all 50 US states, Puerto Rico, and Guam, with 58.3\% (3276/5617) residing in areas with moderate access to maternity care and 16.4\% (919/5617) in highly disadvantaged neighborhoods based on the Area Deprivation Index. Enrollment rates increased substantially over the study period, from 55 participants in late 2021 to 3310 in 2024, averaging 99.4 enrollments per week in 2024. Participants completed a total of 17,123 surveys, with 71.8\% (4033/5617) completing the Intake Survey and 12.4\% (697/5617) completing the Postpartum Survey. Wearable device data were shared by 1168 participants, providing more than 378,000 daily biometric measurements, including activity levels, sleep, and heart rate. Additionally, 96 participants connected their electronic health records, contributing 276 data points such as diagnoses, medications, and laboratory results. Among pregnancy-related characteristics, 28.1\% (1578/5617) enrolled during the first trimester, while 15.1\% (849/5617) reported information about the completion of their pregnancies during the study period. Among the 913 participants who shared delivery information, 56.1\% (n=512) had spontaneous vaginal deliveries and 17.9\% (n=163) underwent unplanned cesarean sections. Conclusions: The PowerMom platform demonstrates the feasibility of using digital tools to recruit and engage diverse populations in maternal health research. Its ability to integrate multimodal data sources showcases its potential to provide comprehensive maternal-fetal health insights. Challenges with data completeness and survey attrition underscore the need for sustained participant engagement strategies. These findings offer valuable lessons for scaling digital health platforms and addressing disparities in maternal health research. Trial Registration: ClinicalTrials.gov NCT03085875; https://clinicaltrials.gov/study/NCT03085875 ", doi="10.2196/70149", url="https://formative.jmir.org/2025/1/e70149" } @Article{info:doi/10.2196/50225, author="Jiang, Xinrui and Timmons, Michelle and Boroda, Elias and Onakomaiya, Marie", title="Impact of Platform Design and Usability on Adherence and Retention: Randomized Web- and Mobile-Based Longitudinal Study", journal="J Particip Med", year="2025", month="Mar", day="27", volume="17", pages="e50225", keywords="behavioral science", keywords="electronic patient-reported outcomes", keywords="ePROs", keywords="retention", keywords="adherence", keywords="patient engagement", keywords="clinical trials", keywords="mobile phone", abstract="Background: Low retention and adherence increase clinical trial costs and timelines. Burdens associated with participating in a clinical trial contribute to early study termination. Electronic patient-reported outcome (ePRO) tools reduce participant burden by allowing remote participation, and facilitate communication between researchers and participants. The Datacubed Health (DCH) mobile app is unique among ePRO platforms in its application of behavioral science principles (reward, motivation, identity, etc) in clinical trials to promote engagement, adherence, and retention. Objective: We evaluated the impact of platform design and usability on adherence and retention with a longitudinal study involving repeated patient-facing study instruments. We expected participants assigned to complete instruments in the DCH mobile app to stay in this study longer (increased retention) and complete more surveys while in this study (increased adherence) due to the enhanced motivational elements unique to the participant experience in the DCH app group, and this group's overall lower burden of participation. Methods: A total of 284 adult participants completed 24 weekly surveys via 1 of 4 modalities (DCH app vs DCH website vs third-party website vs paper) in a web-based and mobile longitudinal study. Participants were recruited from open access websites (eg, Craigslist or Facebook [Meta]), and a closed web-based user group. All participation occurred remotely. Study staff deliberately limited communications with participants to directly assess the main effects of survey administration modality; enrollment and study administration were largely automated. Participants assigned to the DCH app group experienced behavioral science--driven motivational elements related to reward and identity formation throughout their study journey. There was no homolog to this feature in any other tested platform. Participants assigned to the DCH app group accessed study measures using passcodes or smartphone biometrics (face or touch ID). Participants in the DCH website group logged into a website using a username and password. Participants in the third-party website group accessed web-based surveys via personalized emailed links with no need for password authentication. Paper arm participants received paper surveys in the mail. Results: Mode of survey administration (DCH app vs DCH website vs third-party website vs paper) predicted study retention (F9,255=4.22, P<.001) and adherence (F9,162=5.5, P<.001). The DCH app group had greater retention than the paper arm (t=?3.80, P<.001), and comparable retention to the DCH website group. The DCH app group had greater adherence than all other arms (DCH web: t=?2.42, P=.02; third-party web: t=?3.56, P<.001; and paper arm: t=?4.53, P<.001). Conclusions: Using an ePRO platform in a longitudinal study increased retention and adherence in comparison to paper instruments. Incorporating behavioral science design in an ePRO platform resulted in further increase in adherence in a longitudinal study. ", doi="10.2196/50225", url="https://jopm.jmir.org/2025/1/e50225" } @Article{info:doi/10.2196/63822, author="Cardwell, T. Ethan and Ludwick, Teralynn and Chang, Shanton and Walsh, Olivia and Lim, Megan and Podbury, Rachel and Evans, David and Fairley, K. Christopher and Kong, S. Fabian Y. and Hocking, S. Jane", title="Engaging End Users to Inform the Design and Social Marketing Strategy for a Web-Based Sexually Transmitted Infection/Blood-Borne Virus (STI/BBV) Testing Service for Young People in Victoria, Australia: Qualitative Study", journal="J Med Internet Res", year="2025", month="Mar", day="27", volume="27", pages="e63822", keywords="web-based STI/HIV testing", keywords="social marketing", keywords="sexual health", keywords="participatory design", keywords="codesign", keywords="sexually transmitted infections", keywords="STI", keywords="HIV", keywords="Australia", keywords="social media", keywords="survey", keywords="blood-borne viruses", abstract="Background: The rates of sexually transmitted infections (STIs) continue to rise across Australia among 16- to 29-year-olds. Timely testing is needed to reduce transmission, but sexual health clinics are at capacity. This demand, coupled with barriers to getting tested faced by young people, has led to web-based services as a pragmatic solution. However, for young people to use these services, they must be acceptable, attractive, and usable. Social marketing principles combined with end user engagement can be used to guide the development of a web-based service and create a marketing strategy to attract them to the service. Objective: Working closely with end users and guided by social marketing, this project explored messaging, design elements (imagery), and promotional strategies that will support high usage of a web-based STI/blood-borne virus (BBV) testing service for young people in Victoria, Australia. Methods: Young people were recruited to participate in half-day workshops via youth organizations and targeted Meta (Facebook/Instagram) advertisements. An initial web-based survey was deployed to inform workshop content. Workshops were held in metropolitan, outer metropolitan, and regional Victoria. Young people were presented with a range of ``image territories'' developed by a social marketing firm and social marketing messages that were informed by the literature on communicating health messages. Participants discussed the feelings and reactions evoked by the content. Data collected through mixed methods (transcribed notes, audio recording, and physical outputs) were thematically analyzed to understand features of messaging and imagery that would attract young people to use the service. Results: A total of 45 people completed the initial survey with 17 participating in focus group workshops (metropolitan: n=8, outer metropolitan: n=6, and regional: n=3). Young people preferred messages that highlight the functional benefits (confidential, affordable, and accessible) of a web-based service and include professional imagery and logos that elicit trust. Young people indicated that the service should be promoted through digital communications (eg, dating apps and social media), with endorsement from government or other recognized institutions, and via word-of-mouth communications. Conclusions: This study has highlighted the value of applying social marketing theory with end user engagement in developing a web-based STI/BBV testing service. Through the voices of young people, we have established the foundations to inform the design and marketing for Victoria's first publicly funded web-based STI/BBV testing clinic. Future research will measure the reach and efficacy of social marketing, and how this service complements existing services in increasing STI/BBV testing uptake among young Victorians. ", doi="10.2196/63822", url="https://www.jmir.org/2025/1/e63822" } @Article{info:doi/10.2196/56803, author="Yadav, Vijay and Neto, Chaibub Elias and Doerr, Megan and Pratap, Abhishek and Omberg, Larsson", title="Long-Term Engagement of Diverse Study Cohorts in Decentralized Research: Longitudinal Analysis of ``All of Us'' Research Program Data", journal="Interact J Med Res", year="2025", month="Mar", day="19", volume="14", pages="e56803", keywords="digital health", keywords="engagement behavior", keywords="All of Us Research Program", keywords="retention", keywords="decentralized research cohorts", abstract="Background: The generalizability of clinical research hinges on robust study designs, which include the recruitment and maintenance of a representative study population. This study examines the evolution of the demographic characteristics of 329,038 participants who enrolled and participated in The All of Us Research Program (AoURP), a decentralized study aimed at representing the diversity of the United States. Objective: The primary objectives of this study were to assess alterations in the demographic composition of the cohort at different protocol stages within AoURP, while analyzing completion rates and timeframes for survey and substudy completion. Additionally, we examined how participant interactions with the program impacted engagement and survey responses. Methods: We conducted a longitudinal analysis of the AoURP data, tracking changes in demographic composition, completion rates, and completion times for surveys and substudies. Comparative analyses were performed to assess differences in engagement and survey completion based on sociodemographic characteristics of participants involved in postenrollment study components. Results: The sociodemographic composition of the cohort that participated in the postenrollment study (eg, optional components) differed significantly from that of the recruited population. The proportion of self-identified White participants increased by 21.2\%, whereas the proportion of Black or African American participants decreased by 12.18\% (P=.02). Participants who identified as White (n=93,614, 52.7\%) and NonHispanic (n=109,279, 42.21\%) were more engaged compared to those identifying as Black or African American (n=10,887, 15.76\%), Asian (n=4274, 38.72\%), or Hispanic (n=12,530, 20.7\%; P=.006). Participants' response times to study surveys and completeness varied across all demographic groups (P<.001). Furthermore, those identifying as White skipped fewer survey questions (1.19) compared to those identifying as Black or African American (1.40) or other racial and ethnic identities (P<.001). Conclusions: The AoURP dataset serves as an exceptional resource for investigating diverse public health concerns. However, the longitudinal analysis of participant-level data underscores a significant skew in population diversity, suggesting the need for targeted strategies to enhance engagement and retention across all groups. Ensuring diversity in the cohort is essential for maintaining the study's representativeness and the broad applicability of its findings. ", doi="10.2196/56803", url="https://www.i-jmr.org/2025/1/e56803" } @Article{info:doi/10.2196/63252, author="MacKinnon, Ross Kinnon and Khan, Naail and Newman, M. Katherine and Gould, Ariel Wren and Marshall, Gin and Salway, Travis and Pullen Sansfa{\c{c}}on, Annie and Kia, Hannah and Lam, SH June", title="Introducing Novel Methods to Identify Fraudulent Responses (Sampling With Sisyphus): Web-Based LGBTQ2S+ Mixed-Methods Study", journal="J Med Internet Res", year="2025", month="Mar", day="17", volume="27", pages="e63252", keywords="sampling", keywords="bots", keywords="transgender", keywords="nonbinary", keywords="detransition", keywords="lesbian, gay, bisexual, and transgender", keywords="mobile phone", abstract="Background: The myth of Sisyphus teaches about resilience in the face of life challenges. Detransition after an initial gender transition is an emerging experience that requires sensitive and community-driven research. However, there are significant complexities and costs that researchers must confront to collect reliable data to better understand this phenomenon, including the lack of a uniform definition and challenges with recruitment. Objective: This paper presents the sampling and recruitment methods of a new study on detransition-related phenomena among lesbian, gay, bisexual, transgender, queer, and 2-spirit (LGBTQ2S+) populations. It introduces a novel protocol for identifying and removing bot, scam, and ineligible responses from survey datasets and presents preliminary descriptive sociodemographic results of the sample. This analysis does not present gender-affirming health care outcomes. Methods: To attract a large and heterogeneous sample, 3 different study flyers were created in English, French, and Spanish. Between December 1, 2023, and May 1, 2024, these flyers were distributed to >615 sexual and gender minority organizations and gender care providers in the United States and Canada, and paid advertisements totaling >CAD \$7400 (US \$5551) were promoted on 5 different social media platforms. Although many social media promotions were rejected or removed, the advertisements reached >7.7 million accounts. Study website visitors were directed from 35 different traffic sources, with the top 5 being Facebook (3,577,520/7,777,218, 46\%), direct link (2,255,393/7,777,218, 29\%), Reddit (1,011,038/7,777,218, 13\%), Instagram (466,633/7,777,218, 6\%), and X (formerly known as Twitter; 233,317/7,777,218, 3\%). A systematic protocol was developed to identify scam, nonsense, and ineligible responses and to conduct web-based Zoom video platform screening with select participants. Results: Of the 1377 completed survey responses, 957 (69.5\%) were deemed eligible and included in the analytic dataset after applying the exclusion protocol and conducting 113 virtual screenings. The mean age of the sample was 25.87 (SD 7.77; median 24, IQR 21-29 years). A majority of the participants were White (Canadian, American, or of European descent; 748/950, 78.7\%), living in the United States (704/957, 73.6\%), and assigned female at birth (754/953, 79.1\%). Many participants reported having a sexual minority identity, with more than half the sample (543/955, 56.8\%) indicating plurisexual orientations, such as bisexual or pansexual identities. A minority of participants (108/955, 11.3\%) identified as straight or heterosexual. When asked about their gender-diverse identities after stopping or reversing gender transition, 33.2\% (318/957) reported being nonbinary, 43.2\% (413/957) transgender, and 40.5\% (388/957) identified as detransitioned. Conclusions: Despite challenges encountered during the study promotion and data collection phases, a heterogeneous sample of >950 eligible participants was obtained, presenting opportunities for future analyses to better understand these LGBTQ2S+ experiences. This study is among the first to introduce an innovative strategy to sample a hard-to-reach and equity-deserving group, and to present an approach to remove fraudulent responses. ", doi="10.2196/63252", url="https://www.jmir.org/2025/1/e63252" } @Article{info:doi/10.2196/60548, author="Donkin, Liesje and Henry, Nathan and Kercher, Amy and Pedersen, Mangor and Wilson, Holly and Chan, Yan Amy Hai", title="Effective Recruitment or Bot Attack? The Challenge of Internet-Based Research Surveys and Recommendations to Reduce Risk and Improve Robustness", journal="Interact J Med Res", year="2025", month="Mar", day="14", volume="14", pages="e60548", keywords="internet-based research", keywords="research methodology", keywords="surveys", keywords="data integrity", keywords="bot attacks", keywords="technology", keywords="data manipulation", keywords="spam", keywords="false", keywords="falsification", keywords="fraudulent", keywords="fraud", keywords="bots", keywords="research methods", keywords="data collection", keywords="verify", keywords="verification", keywords="participants", doi="10.2196/60548", url="https://www.i-jmr.org/2025/1/e60548" } @Article{info:doi/10.2196/59955, author="Sophus, I. Amber and Mitchell, W. Jason", title="Assessment of Fraud Deterrence and Detection Procedures Used in a Web-Based Survey Study With Adult Black Cisgender Women: Description of Lessons Learned and Recommendations", journal="JMIR Form Res", year="2025", month="Mar", day="12", volume="9", pages="e59955", keywords="Black women", keywords="HIV", keywords="fraud deterrence", keywords="fraud detection", keywords="web-based research", keywords="online research", keywords="data integrity", keywords="data collection", keywords="survey", abstract="Background: Online research studies enable engagement with more Black cisgender women in health-related research. However, fraudulent data collection responses in online studies raise important concerns about data integrity, particularly when incentives are involved. Objective: The purpose of this study was to assess the strengths and limitations of fraud deterrence and detection procedures implemented in an incentivized, cross-sectional, online study about HIV prevention and sexual health with Black cisgender women living in Texas. Methods: Data for this study came from a cross-sectional web-based survey that examined factors associated with potential pre-exposure prophylaxis use among a convenience sample of adult Black cisgender women from 3 metropolitan areas in Texas. Each eligibility screener and associated survey entry was evaluated using 4 fraud deterrence features and 7 fraud detection benchmarks with corresponding decision rules. Results: A total of 5862 respondents provided consent and initiated the eligibility screener, of whom 2150 (36.68\%) were ineligible for not meeting the inclusion criteria, and 131 (2.23\%) completed less than 80\% of the survey and were removed from further consideration. Other entries were removed for not passing level 1 fraud deterrent safeguards: duplicate entries with the same IP address (388/5862, 6.62\%), same telephone number (69/5862, 1.18\%), same email address (114/5862, 1.94\%), and same telephone number and email address (17/5862, 0.29\%). Of the remaining 2993 entries, 1652 entries were removed for not passing the first 2 items of the level 2 fraud detection benchmarks: screeners and surveys with latitude and longitude coordinates outside of the United States (347/2993, 11.59\%) and survey completion time of less than 10 minutes (1305/2993, 43.6\%). Of the remaining 1341 entries, 130 (9.69\%) passed all 5 of the remaining level 2 data validation benchmarks, and 763 (56.89\%) entries were removed due to passing less than 3. An additional 33.4\% (423/1341) entries were removed after passing 4 of the 5 remaining validation benchmarks, being contacted to verify survey information, and not providing legitimate contact information or being unable to confirm personal information. The final enrolled sample in this online study consisted of 155 respondents who provided consent, were deemed eligible, and passed fraud deterrence features and fraud detection benchmarks. In this paper, we discuss the lessons learned and provide recommendations for leveraging available features in survey software programs to help deter bots and enhance fraud detection procedures beyond relying on survey software options. Conclusions: Effectively identifying fraudulent responses in online surveys is an ongoing challenge. The data validation approach used in this study establishes a robust protocol for identifying genuine participants, thereby contributing to the removal of false data from study findings. By sharing experiences and implementing thorough fraud deterrence and detection protocols, researchers can maintain data validity and contribute to best practices in web-based research. ", doi="10.2196/59955", url="https://formative.jmir.org/2025/1/e59955" } @Article{info:doi/10.2196/63473, author="Khairat, Saif and Ottmar, Paige and Chourasia, Prabal and Obeid, Jihad", title="Effectiveness of Telehealth Versus In-Person Informed Consent: Randomized Study of Comprehension and Decision-Making", journal="J Med Internet Res", year="2025", month="Mar", day="5", volume="27", pages="e63473", keywords="telehealth", keywords="informed", keywords="consent", keywords="comprehension", keywords="decision-making", keywords="cross-sectional study", keywords="cross-section", keywords="telemedicine", keywords="eHealth", keywords="health care services", keywords="mHealth", keywords="effectiveness", keywords="informed consent", keywords="statistical analysis", keywords="feasibility", abstract="Background: Obtaining informed consent (IC) is vital for ethically and effectively recruiting participants in research projects. However, traditional in-person IC approaches encounter notable obstacles, such as geographic barriers, transportation expenses, and literacy challenges, which can lead to delays in enrollment and increased costs. Telehealth, especially teleconsent, offers a potential way to overcome these obstacles by facilitating the IC process in a digital setting. Nonetheless, there are concerns about whether teleconsent can achieve levels of understanding and involvement that are equivalent to those of in-person IC meetings. Objective: This study aims to evaluate comprehension and decision-making in participants undergoing teleconsent versus traditional in-person IC. We used validated assessments to determine whether teleconsent is a viable alternative that maintains participants' understanding and decision-making abilities. Methods: A randomized comparative study design was used, recruiting potential participants for a parent study assessing patient experiences with patient portals. Participants were randomly assigned to 2 groups: teleconsent and in-person consent. The teleconsent group used Doxy.me software, allowing real-time interaction between researchers and participants while reviewing and electronically signing the IC documents. Recruitment involved using an institutional web-based platform to identify interested individuals, who were then contacted to assess eligibility and gather demographic information. The Decision-Making Control Instrument (DMCI) survey was used to assess the perceived voluntariness, trust, and decision self-efficacy. The Quality of Informed Consent (QuIC) was used to measure the comprehension level of the consent form. The validated Short Assessment of Health Literacy-English tool was used to measure participants' health literacy levels. Results: A total of 64 participants were enrolled in the study, with 32 in the teleconsent group and 32 in the in-person group. Of 64 participants, 32 (50\%) were in the teleconsent group, 54 (84.4\%) were females, 44 (68.7\%) were aged 18-34 years, 50 (78.1\%) were White, and 31 (48.4\%) had a bachelor degree. The mean SAHL-E scores were different between the teleconsent and in-person groups (16.72, SD 1.88 vs 17.38, SD 0.95; P=.03). No significant differences were found between the average scores at baseline and follow-up for QuIC part A (P=.29), QuIC part B (P=.25), and DMCI (P=.38) within the teleconsent and in-person groups. Additionally, there were no significant differences in QuIC or DMCI between subgroups based on age, sex, and ethnicity. Conclusions: This study assessed the effectiveness of IC processes through telehealth compared to traditional in-person visits. Findings indicate that telehealth offers similar participant understanding and engagement while overcoming geographic and accessibility barriers. As health care adopts digital solutions, these results highlight telehealth's potential to improve recruitment and retention in clinical research, suggesting that policy makers should integrate telehealth practices into regulations for better access and health outcomes. ", doi="10.2196/63473", url="https://www.jmir.org/2025/1/e63473", url="http://www.ncbi.nlm.nih.gov/pubmed/40053795" } @Article{info:doi/10.2196/66821, author="El Kababji, Samer and Mitsakakis, Nicholas and Jonker, Elizabeth and Beltran-Bless, Ana-Alicia and Pond, Gregory and Vandermeer, Lisa and Radhakrishnan, Dhenuka and Mosquera, Lucy and Paterson, Alexander and Shepherd, Lois and Chen, Bingshu and Barlow, William and Gralow, Julie and Savard, Marie-France and Fesl, Christian and Hlauschek, Dominik and Balic, Marija and Rinnerthaler, Gabriel and Greil, Richard and Gnant, Michael and Clemons, Mark and El Emam, Khaled", title="Augmenting Insufficiently Accruing Oncology Clinical Trials Using Generative Models: Validation Study", journal="J Med Internet Res", year="2025", month="Mar", day="5", volume="27", pages="e66821", keywords="generative models", keywords="study accrual", keywords="recruitment", keywords="clinical trial replication", keywords="oncology", keywords="validation", keywords="simulated patient", keywords="simulation", keywords="retrospective", keywords="dataset", keywords="patient", keywords="artificial intelligence", keywords="machine learning", abstract="Background: Insufficient patient accrual is a major challenge in clinical trials and can result in underpowered studies, as well as exposing study participants to toxicity and additional costs, with limited scientific benefit. Real-world data can provide external controls, but insufficient accrual affects all arms of a study, not just controls. Studies that used generative models to simulate more patients were limited in the accrual scenarios considered, replicability criteria, number of generative models, and number of clinical trials evaluated. Objective: This study aimed to perform a comprehensive evaluation on the extent generative models can be used to simulate additional patients to compensate for insufficient accrual in clinical trials. Methods: We performed a retrospective analysis using 10 datasets from 9 fully accrued, completed, and published cancer trials. For each trial, we removed the latest recruited patients (from 10\% to 50\%), trained a generative model on the remaining patients, and simulated additional patients to replace the removed ones using the generative model to augment the available data. We then replicated the published analysis on this augmented dataset to determine if the findings remained the same. Four different generative models were evaluated: sequential synthesis with decision trees, Bayesian network, generative adversarial network, and a variational autoencoder. These generative models were compared to sampling with replacement (ie, bootstrap) as a simple alternative. Replication of the published analyses used 4 metrics: decision agreement, estimate agreement, standardized difference, and CI overlap. Results: Sequential synthesis performed well on the 4 replication metrics for the removal of up to 40\% of the last recruited patients (decision agreement: 88\% to 100\% across datasets, estimate agreement: 100\%, cannot reject standardized difference null hypothesis: 100\%, and CI overlap: 0.8-0.92). Sampling with replacement was the next most effective approach, with decision agreement varying from 78\% to 89\% across all datasets. There was no evidence of a monotonic relationship in the estimated effect size with recruitment order across these studies. This suggests that patients recruited earlier in a trial were not systematically different than those recruited later, at least partially explaining why generative models trained on early data can effectively simulate patients recruited later in a trial. The fidelity of the generated data relative to the training data on the Hellinger distance was high in all cases. Conclusions: For an oncology study with insufficient accrual with as few as 60\% of target recruitment, sequential synthesis can enable the simulation of the full dataset had the study continued accruing patients and can be an alternative to drawing conclusions from an underpowered study. These results provide evidence demonstrating the potential for generative models to rescue poorly accruing clinical trials, but additional studies are needed to confirm these findings and to generalize them for other diseases. ", doi="10.2196/66821", url="https://www.jmir.org/2025/1/e66821", url="http://www.ncbi.nlm.nih.gov/pubmed/40053790" } @Article{info:doi/10.2196/59954, author="Newman, E. Jamie and Clarke, Leslie and Athimuthu, Pranav and Dhawan, Megan and Owen, Sharon and Beiersdorfer, Traci and Parlberg, M. Lindsay and Bangdiwala, Ananta and McMillan, Taya and DeMauro, B. Sara and Lorch, Scott and Peralta-Carcelen, Myriam and Wilson-Costello, Deanne and Ambalavanan, Namasivayam and Merhar, L. Stephanie and Poindexter, Brenda and Limperopoulos, Catherine and Davis, M. Jonathan and Walsh, Michele and Bann, M. Carla", title="Supplementing Consent for a Prospective Longitudinal Cohort Study of Infants With Antenatal Opioid Exposure: Development and Assessment of a Digital Tool", journal="JMIR Form Res", year="2025", month="Mar", day="4", volume="9", pages="e59954", keywords="informed consent digital tool", keywords="avatars", keywords="video-assisted consent", keywords="MRI", keywords="antenatal opioid exposure", keywords="infant", keywords="antenatal", keywords="opioid exposure", keywords="caregiver", keywords="survey", keywords="magnetic resonance imaging", keywords="Outcomes of Babies With Opioid Exposure", abstract="Background: The Outcomes of Babies With Opioid Exposure (OBOE) study is an observational cohort study examining the impact of antenatal opioid exposure on outcomes from birth to 2 years of age. COVID-19 social distancing measures presented challenges to research coordinators discussing the study at length with potential participants during the birth hospitalization, which impacted recruitment, particularly among caregivers of unexposed (control) infants. In response, the OBOE study developed a digital tool (consenter video) to supplement the informed consent process, make it more engaging, and foster greater identification with the research procedures among potential participants. Objective: We aim to examine knowledge of the study, experiences with the consent process, and perceptions of the consenter video among potential participants of the OBOE study. Methods: Analyses included 129 caregivers who were given the option to view the consenter video as a supplement to the consent process. Participants selected from 3 racially and ethnically diverse avatars to guide them through the 11-minute video with recorded voice-overs. After viewing the consenter video, participants completed a short survey to assess their knowledge of the study, experiences with the consent process, and perceptions of the tool, regardless of their decision to enroll in the main study. Chi-square tests were used to assess differences between caregivers of opioid-exposed and unexposed infants in survey responses and whether caregivers who selected avatars consistent with their racial or ethnic background were more likely to enroll in the study than those who selected avatars that were not consistent with their background. Results: Participants demonstrated good understanding of the information presented, with 95\% (n=123) correctly identifying the study purpose and 88\% (n=112) correctly indicating that their infant would not be exposed to radiation during the magnetic resonance imaging. Nearly all indicated they were provided ``just the right amount of information'' (n=123, 98\%) and that they understood the consent information well enough to decide whether to enroll (n=125, 97\%). Survey responses were similar between caregivers of opioid-exposed infants and unexposed infants on all items except the decision to enroll. Those in the opioid-exposed group were more likely to enroll in the main study compared to the unexposed group (n=49, 89\% vs n=38, 51\%; P<.001). Of 81 caregivers with known race or ethnicity, 35 (43\%) chose avatars to guide them through the video that matched their background. Caregivers selecting avatars consistent with their racial or ethnic background were more likely to enroll in the main study (n=29, 83\% vs n=43, 57\%; P=.01). Conclusions: This interactive digital tool was helpful in informing prospective participants about the study. The consenter tool enhanced the informed consent process, reinforced why caregivers of unexposed infants were being approached, and was particularly helpful as a resource for families to understand magnetic resonance imaging procedures. Trial Registration: ClinicalTrials.gov NCT04149509; https://clinicaltrials.gov/study/NCT04149509 ", doi="10.2196/59954", url="https://formative.jmir.org/2025/1/e59954" } @Article{info:doi/10.2196/56098, author="Sommers, Jonathan and Dizon, S. Don and Lewis, A. Mark and Stone, Erik and Andreoli, Richard and Henderson, Vida", title="Assessing Health Information Seeking Behaviors Among Targeted Social Media Users Using an Infotainment Video About a Cancer Clinical Trial: Population-Based Descriptive Study", journal="JMIR Cancer", year="2025", month="Mar", day="3", volume="11", pages="e56098", keywords="cancer clinical trials", keywords="digital media", keywords="social media", keywords="infotainment", keywords="recruitment", keywords="education and awareness", keywords="edutainment", keywords="public engagement", keywords="cancer", keywords="lack of information", keywords="health information", keywords="medical awareness", keywords="video series", keywords="public audience", keywords="low cost", keywords="research participants", abstract="Background: The lack of information and awareness about clinical trials, as well as misconceptions about them, are major barriers to cancer clinical trial participation. Digital and social media are dominant sources of health information and offer optimal opportunities to improve public medical awareness and education by providing accurate and trustworthy health information from reliable sources. Infotainment, material intended to both entertain and inform, is an effective strategy for engaging and educating audiences that can be easily disseminated using social media and may be a novel way to improve awareness of and recruitment in clinical trials. Objective: The purpose of this study was to evaluate whether an infotainment video promoting a clinical trial, disseminated using social media, could drive health information seeking behaviors. Methods: As part of a video series, we created an infotainment video focused on the promotion of a specific cancer clinical trial. We instituted a dissemination and marketing process on Facebook to measure video engagement and health information seeking behaviors among targeted audiences who expressed interest in breast cancer research and organizations. To evaluate video engagement, we measured reach, retention, outbound clicks, and outbound click-through rate. Frequencies and descriptive statistics were used to summarize each measure. Results: The video substantially increased health information seeking behavior by increasing viewership from 1 visitor one month prior to launch to 414 outbound clicks from the video to the clinical trial web page during the 21-day social media campaign period. Conclusions: Our study shows that digital and social media tools can be tailored for specific target audiences, are scalable, and can be disseminated at low cost, making it an accessible educational, recruitment, and retention strategy focused on improving the awareness of clinical trials. Trial Registration: ClinicalTrials.gov NCT03418961; https://clinicaltrials.gov/study/NCT03418961 ", doi="10.2196/56098", url="https://cancer.jmir.org/2025/1/e56098" } @Article{info:doi/10.2196/67981, author="Sebo, Paul and Tudrej, Benoit and Bernard, Augustin and Delaunay, Bruno and Dupuy, Alexandra and Malavergne, Claire and Maisonneuve, Hubert", title="Increasing Participation and Completion Rates in Questionnaire Surveys of Primary Care Patients: Cluster-Randomized Study", journal="Interact J Med Res", year="2025", month="Feb", day="25", volume="14", pages="e67981", keywords="completion rate", keywords="missing data", keywords="mixed mode", keywords="web-based", keywords="participation rate", keywords="primary care", keywords="questionnaire", keywords="QR code", keywords="tablet", keywords="survey", keywords="primary care patients", keywords="randomized study", abstract="Background: Participation and completion rates in questionnaire-based surveys are often low. Objective: This study aims to assess participation and completion rates for a survey using paper and mixed mode questionnaires with patients recruited by research assistants in primary care waiting rooms. Methods: This cluster-randomized study, conducted in 2023 in France, involved 974 patients from 39 practices randomized into 4 groups: ``paper with incentive'' (n=251), ``paper without incentive'' (n=368), ``mixed mode with tablet'' (n=187), and ``mixed mode with QR code'' (n=168). Analyses compared the combined paper group with the 2 mixed mode groups and the ``paper with incentive'' and ``paper without incentive'' groups. Logistic regressions were used to analyze participation and completion rates. Results: Of the 974 patients recruited, 822 (women: 536/821, 65.3\%; median age 52, IQR 37-68 years) agreed to participate (participation rate=84.4\%), with no significant differences between groups. Overall, 806 patients (98.1\%) answered all 48 questions. Completion rates were highest in the combined paper group (99.8\%) compared to mixed mode groups (96.8\% for paper or tablet, 93.3\% for paper or QR code; P<.001). There was no significant difference in completion rates between the ``paper with incentive'' and ``paper without incentive'' groups (100\% vs 99.7\%). Conclusions: Recruiting patients in waiting rooms with research assistants resulted in high participation and completion rates across all groups. Mixed mode options did not enhance participation or completion rates but may offer logistical advantages. Future research should explore incentives and mixed-mode strategies in diverse settings. ", doi="10.2196/67981", url="https://www.i-jmr.org/2025/1/e67981" } @Article{info:doi/10.2196/55082, author="Min, Deborah and Yun, Ji-Young and Parslow, Chad and Jajodia, Anushka and Han, Hae-Ra", title="Online-Based Recruitment Methods for Community-Dwelling Older Adults: Scoping Review and Lessons Learned From the PLAN Trial", journal="J Med Internet Res", year="2025", month="Feb", day="25", volume="27", pages="e55082", keywords="older adults", keywords="online", keywords="online recruitment", keywords="community-dwelling", keywords="strategies", keywords="America", keywords="Americans", keywords="technology adoption", keywords="digital technologies", keywords="COVID-19", keywords="pandemic", keywords="digital health", keywords="dementia", keywords="caregivers", keywords="healthcare system", keywords="community health workers", keywords="consultants", keywords="mobile phone", abstract="Background: Despite rapid technological advancement and a considerably aging US population, there remains a gap in the literature pertaining to online-based recruitment strategies for older adults. Objective: This study aimed to describe the lessons learned from the authors' experience of recruiting a sample for PLAN (Preparing successful aging through dementia Literacy education And Navigation), an ongoing, community-based randomized controlled trial designed to promote the transition of community-dwelling Korean American older adults with probable dementia and their caregivers into the health care system. The authors also present online-based recruitment strategies focused on older adults reported in relevant published studies to compare with their experiences. Methods: Data sources included PLAN recruitment tracking files, study team meeting minutes, and interviews with community consultants. We also conducted a scoping review of published studies, searching PubMed in July 2021, and updated our search in September 2023. Eligibility criteria included (1) focus on older adults aged more than 65 years, (2) sample recruited from a community setting, and (3) inclusion and description of online-based recruitment strategies. Exclusion criteria (1) did not focus on adults older than 65 years in a community setting, (2) did not include or describe online-based recruitment strategies, or (3) used online-based methods but not for the purpose of recruitment. The review followed the PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews). Information was extracted using a data charting table and synthesized by conducting a thematic analysis. Results: In total, 8 articles were included in the scoping review and primarily addressed health promotion and recruitment strategy evaluation. When compared with PLAN data sources, five key themes emerged as relevant to the online-based recruitment of community-dwelling older adults: (1) unfamiliarity with technology---limited digital literacy, (2) differences in internet access and use across older age groups, (3) providing technological support to promote recruitment, (4) successful and unsuccessful recruitment using social media, and (5) other diverse online-based methods of recruitment. In particular, direct quotes from multiple sources for the PLAN trial revealed technological challenges that were common among immigrant older adults as the study team used various online-based recruitment activities. Conclusions: The literature was limited in the discussion of online-based recruitment among older participants. Data sources revealed the digital divide and limited digital literacy, particularly among non--English-speaking immigrant older adults and their caregivers. The usefulness of online-based recruitment of older adults is uncertain due, in large part, to limited sociodemographic diversity noted in the samples recruited in the included studies. Future research should explore the role of race and ethnicity and other characteristics, such as socioeconomic status, sex, education, access to technology, and digital literacy, in relation to online-based recruitment for adequate representation of diverse older adults in research. Trial Registration: ClinicalTrials.gov NCT03909347; https://clinicaltrials.gov/study/NCT03909347 ", doi="10.2196/55082", url="https://www.jmir.org/2025/1/e55082", url="http://www.ncbi.nlm.nih.gov/pubmed/39998873" } @Article{info:doi/10.2196/66718, author="Gardner, Leslie Leah and Raeisian Parvari, Pezhman and Seidman, Mark and Holden, J. Richard and Fowler, R. Nicole and Zarzaur, L. Ben and Summanwar, Diana and Barboi, Cristina and Boustani, Malaz", title="Improving the User Interface and Guiding the Development of Effective Training Material for a Clinical Research Recruitment and Retention Dashboard: Usability Testing Study", journal="JMIR Form Res", year="2025", month="Feb", day="24", volume="9", pages="e66718", keywords="recruitment strategies", keywords="clinical research", keywords="research subject recruitment", keywords="agile science", keywords="agile implementation", keywords="human-computer interaction", abstract="Background: Participant recruitment and retention are critical to the success of clinical trials, yet challenges such as low enrollment rates and high attrition remain ongoing obstacles. RecruitGPS is a scalable dashboard with integrated control charts to address these issues by providing real-time data monitoring and analysis, enabling researchers to better track and improve recruitment and retention. Objective: This study aims to identify the challenges and inefficiencies users encounter when interacting with the RecruitGPS dashboard. By identifying these issues, the study aims to inform strategies for improving the dashboard's user interface and create targeted, effective instructional materials that address user needs. Methods: Twelve clinical researchers from the Midwest region of the United States provided feedback through a 10-minute, video-recorded usability test session, during which participants were instructed to explore the various tabs of the dashboard, identify challenges, and note features that worked well while thinking aloud. Following the video session, participants took a survey on which they answered System Usability Scale (SUS) questions, ease of navigation questions, and a Net Promoter Score (NPS) question. Results: A quantitative analysis of survey responses revealed an average SUS score of 61.46 (SD 23.80; median 66.25) points, indicating a need for improvement in the user interface. The NPS was 8, with 4 of 12 (33\%) respondents classified as promoters and 3 of 12 (25\%) as detractors, indicating a slightly positive satisfaction. When participants compared RecruitGPS to other recruitment and study management tools they had used, 8 of 12 (67\%) of participants rated RecruitGPS as better or much better. Only 1 of 12 (8\%) participants rated RecruitGPS as worse but not much worse. A qualitative analysis of participants' interactions with the dashboard diagnosed a confusing part of the dashboard that could be eliminated or made optional and provided valuable insight for the development of instructional videos and documentation. Participants liked the dashboard's data visualization capabilities, including intuitive graphs and trend tracking; progress indicators, such as color-coded status indicators and comparison metrics; and the overall dashboard's layout and design, which consolidated relevant data on a single page. Users also valued the accuracy and real-time updates of data, especially the integration with external sources like Research Electronic Data Capture (REDCap). Conclusions: RecruitGPS demonstrates significant potential to improve the efficiency of clinical trials by providing researchers with real-time insights into participant recruitment and retention. This study offers valuable recommendations for targeted refinements to enhance the user experience and maximize the dashboard's effectiveness. Additionally, it highlights navigation challenges that can be addressed through the development of clear and focused instructional videos. ", doi="10.2196/66718", url="https://formative.jmir.org/2025/1/e66718" } @Article{info:doi/10.2196/66681, author="Wyse, Rebecca and Forbes, Erin and Norton, Grace and Viana Da Silva, Priscilla and Fakes, Kristy and Johnston, Ann Sally and Smith, R. Stephen and Zucca, Alison", title="Effect on Response Rates of Adding a QR Code to Patient Consent Forms for Qualitative Research in Patients With Cancer: Pilot Randomized Controlled Trial", journal="JMIR Form Res", year="2025", month="Feb", day="21", volume="9", pages="e66681", keywords="QR code", keywords="qualitative research", keywords="cancer", keywords="randomized controlled trial", keywords="RCT", keywords="patient recruitment", keywords="consent forms", keywords="response rates", abstract="Background: The successful conduct of health and medical research is largely dependent on participant recruitment. Effective, yet inexpensive methods of increasing response rates for all types of research are required. QR codes are now commonplace, and despite having been extensively used to recruit study participants, a search of the literature failed to reveal any randomized trial investigating the effect of adding a QR code on qualitative research response rates. Objective: This study aimed to collect data on rates of response, consent, and decline among patients with cancer, and the average time taken to respond following randomization to receive either a QR code or no QR code on the patient consent form for a qualitative research study. Methods: This was a pilot randomized controlled trial (RCT) embedded within a qualitative research study. In total, 40 eligible patients received a recruitment pack for the qualitative study, which included an information statement, a consent form, and an addressed, stamped envelope to return their consent form. Patients were randomized 1:1 to the control (standard recruitment pack only) or intervention group (standard recruitment pack including modified consent form with a QR code). Results: In total, 27 out of 40 patients (age: mean 63.0, SD 14.8 years; 45\% female) responded to the consent form. A lower proportion of the QR code group (60\%) responded (odd ratio [OR] 0.57, 95\% CI 0.14-2.37; P=.44), compared to 75\% of the standard recruitment group. However, a higher proportion of the QR group (35\%) consented (OR 1.84, 95\% CI 0.41-8.29; P=.43), compared to the standard recruitment group (20\%). A lower proportion of the QR group (25\%) declined (OR 0.34, 95\% CI 0.09-1.38; P=.13) relative to the standard recruitment group (55\%). The mean response time of the QR code group was 16 days (rate ratio [RR] 0.79, 95\% CI 0.47-1.35; P=.39) compared to 19 days for the standard recruitment group. None of the age-adjusted analyses were statistically significant. Conclusions: This underpowered pilot study did not find any evidence that offering an option to respond through a QR code on a patient consent form for a qualitative study increased the overall patient response rate (combined rate of consent and decline). However, there was a nonsignificant trend, indicating that more patients who received the QR code consented compared to those who did not receive the QR code. This study provides useful preliminary data on the potential impact of QR codes on patient response rates to invitations to participate in qualitative research and can be used to inform fully powered RCTs. Trial Registration: OSF Registries 10.17605/OSF.IO/PJ25X; https://doi.org/10.17605/OSF.IO/PJ25X ", doi="10.2196/66681", url="https://formative.jmir.org/2025/1/e66681" } @Article{info:doi/10.2196/55316, author="Dauber-Decker, L. Katherine and Feldstein, David and Hess, Rachel and Mann, Devin and Kim, Ji Eun and Gautam-Goyal, Pranisha and Solomon, Jeffrey and Khan, Sundas and Malik, Fatima and Xu, Lynn and Huffman, Ainsley and Smith, D. Paul and Halm, Wendy and Yuroff, Alice and Richardson, Safiya", title="Snowball Group Usability Testing for Rapid and Iterative Multisite Tool Development: Method Development Study", journal="JMIR Form Res", year="2025", month="Feb", day="18", volume="9", pages="e55316", keywords="clinical decision support", keywords="CDS", keywords="decision aid", keywords="clinical aid", keywords="cough", keywords="sore throat", keywords="strep pharyngitis", keywords="snowball group usability testing", keywords="snowball group", keywords="usability testing", abstract="Background: Usability testing is valuable for assessing a new tool or system's usefulness and ease-of-use. Several established methods of usability testing exist, including think-aloud testing. Although usability testing has been shown to be crucial for successful clinical decision support (CDS) tool development, it is often difficult to conduct across multisite development projects due to its time- and labor-intensiveness, cost, and the skills required to conduct the testing. Objective: Our objective was to develop a new method of usability testing that would enable efficient acquisition and dissemination of results among multiple sites. We sought to address the existing barriers to successfully completing usability testing during CDS tool development. Methods: We combined individual think-aloud testing and focus groups into one session and performed sessions serially across 4 sites (snowball group usability testing) to assess the usability of two CDS tools designed for use by nurses in primary and urgent care settings. We recorded each session and took notes in a standardized format. Each site shared feedback from their individual sessions with the other sites in the study so that they could incorporate that feedback into their tools prior to their own testing sessions. Results: The group testing and snowballing components of our new usability testing method proved to be highly beneficial. We identified 3 main benefits of snowball group usability testing. First, by interviewing several participants in a single session rather than individuals over the course of weeks, each site was able to quickly obtain their usability feedback. Second, combining the individualized think-aloud component with a focus group component in the same session helped study teams to more easily notice similarities in feedback among participants and to discuss and act upon suggestions efficiently. Third, conducting usability testing in series across sites allowed study teams to incorporate feedback based on previous sites' sessions prior to conducting their own testing. Conclusions: Snowball group usability testing provides an efficient method of obtaining multisite feedback on newly developed tools and systems, while addressing barriers typically associated with traditional usability testing methods. This method can be applied to test a wide variety of tools, including CDS tools, prior to launch so that they can be efficiently optimized. Trial Registration: Clinicaltrials.gov NCT04255303; https://clinicaltrials.gov/study/NCT04255303 ", doi="10.2196/55316", url="https://formative.jmir.org/2025/1/e55316" } @Article{info:doi/10.2196/58451, author="Draucker, Burke Claire and Carri{\'o}n, Andr{\'e}s and Ott, A. Mary and Hicks, I. Ariel and Knopf, Amelia", title="A 4-Site Public Deliberation Project on the Acceptability of Youth Self-Consent in Biomedical HIV Prevention Trials: Assessment of Facilitator Fidelity to Key Principles", journal="JMIR Form Res", year="2025", month="Feb", day="13", volume="9", pages="e58451", keywords="public deliberation", keywords="deliberative democracy", keywords="bioethics", keywords="ethical conflict", keywords="biomedical", keywords="HIV prevention", keywords="HIV research", keywords="group facilitation", keywords="fidelity assessment", keywords="content analysis", abstract="Background: Public deliberation is an approach used to engage persons with diverse perspectives in discussions and decision-making about issues affecting the public that are controversial or value laden. Because experts have identified the need to evaluate facilitator performance, our research team developed a framework to assess the fidelity of facilitator remarks to key principles of public deliberation. Objective: This report describes how the framework was used to assess facilitator fidelity in a 4-site public deliberation project on the acceptability of minor self-consent in biomedical HIV prevention research. Methods: A total of 88 individuals participated in 4 deliberation sessions held in 4 cities throughout the United States. The sessions, facilitated by 18 team members, were recorded and transcribed verbatim. Facilitator remarks were highlighted, and predetermined coding rules were used to code the remarks to 1 of 6 principles of quality deliberations. A variety of display tables were used to organize the codes and calculate the number of facilitator remarks that were consistent or inconsistent with each principle during each session across all sites. A content analysis was conducted on the remarks to describe how facilitator remarks aligned or failed to align with each principle. Results: In total, 735 remarks were coded to one of the principles; 516 (70.2\%) were coded as consistent with a principle, and 219 (29.8\%) were coded as inconsistent. A total of 185 remarks were coded to the principle of equal participation (n=138, 74.6\% as consistent; n=185, 25.4\% as inconsistent), 158 were coded to expression of diverse opinions (n=110, 69.6\% as consistent; n=48, 30.4\% as inconsistent), 27 were coded to respect for others (n=27, 100\% as consistent), 24 were coded to adoption of a societal perspective (n=11, 46\% as consistent; n=13, 54\% as inconsistent), 99 were coded to reasoned justification of ideas (n=81, 82\% as consistent; n=18, 18\% as inconsistent), and 242 were coded to compromise or movement toward consensus (n=149, 61.6\% as consistent; n=93, 38.4\% as inconsistent). Therefore, the counts provided affirmation that most of the facilitator remarks were aligned with the principles of deliberation, suggesting good facilitator fidelity. By considering how the remarks aligned or failed to align with the principles, areas where facilitator fidelity can be strengthened were identified. The results indicated that facilitators should focus more on encouraging quieter members to participate, refraining from expressing personal opinions, promoting the adoption of a societal perspective and reasoned justification of opinions, and inviting deliberants to articulate their areas of common ground. Conclusions: The results provide an example of how a framework for assessing facilitator fidelity was used in a 4-site deliberation project. The framework will be refined to better address issues related to balancing personal and public perspectives, managing plurality, and mitigating social inequalities. ", doi="10.2196/58451", url="https://formative.jmir.org/2025/1/e58451" } @Article{info:doi/10.2196/58628, author="Koh, Jodie and Caron, Stacey and Watters, N. Amber and Vaidyanathan, Mahesh and Melnick, David and Santi, Alyssa and Hudson, Kenneth and Arguelles, Catherine and Mathur, Priyanka and Etemadi, Mozziyar", title="Technological Adjuncts to Streamline Patient Recruitment, Informed Consent, and Data Management Processes in Clinical Research: Observational Study", journal="JMIR Form Res", year="2025", month="Jan", day="29", volume="9", pages="e58628", keywords="digital health", keywords="patient recruitment", keywords="consent", keywords="technological adjuncts", keywords="data management", keywords="clinical research processes", keywords="automation", keywords="digital platforms", keywords="data warehouse", keywords="patient data", keywords="imaging data", keywords="pregnancy", keywords="clinical research methods", abstract="Background: Patient recruitment and data management are laborious, resource-intensive aspects of clinical research that often dictate whether the successful completion of studies is possible. Technological advances present opportunities for streamlining these processes, thus improving completion rates for clinical research studies. Objective: This paper aims to demonstrate how technological adjuncts can enhance clinical research processes via automation and digital integration. Methods: Using one clinical research study as an example, we highlighted the use of technological adjuncts to automate and streamline research processes across various digital platforms, including a centralized database of electronic medical records (enterprise data warehouse [EDW]); a clinical research data management tool (REDCap [Research Electronic Data Capture]); and a locally managed, Health Insurance Portability and Accountability Act--compliant server. Eligible participants were identified through automated queries in the EDW, after which they received personalized email invitations with digital consent forms. After digital consent, patient data were transferred to a single Health Insurance Portability and Accountability Act--compliant server where each participant was assigned a unique QR code to facilitate data collection and integration. After the research study visit, data obtained were associated with existing electronic medical record data for each participant via a QR code system that collated participant consent, imaging data, and associated clinical data according to a unique examination ID. Results: Over a 19-month period, automated EDW queries identified 20,988 eligible patients, and 10,582 patients received personalized email invitations. In total, 1000 (9.45\%) patients signed consents to participate in the study. Of the consented patients, 549 unique patients completed 779 study visits; some patients consented to the study at more than 1 time period during their pregnancy. Conclusions: Technological adjuncts in clinical research decrease human labor while increasing participant reach and minimizing disruptions to clinic operations. Automating portions of the clinical research process benefits clinical research efforts by expanding and optimizing participant reach while reducing the limitations of labor and time in completing research studies. ", doi="10.2196/58628", url="https://formative.jmir.org/2025/1/e58628", url="http://www.ncbi.nlm.nih.gov/pubmed/39879093" } @Article{info:doi/10.2196/66384, author="Kezbers, M. Krista and Robertson, C. Michael and H{\'e}bert, T. Emily and Montgomery, Audrey and Businelle, S. Michael", title="Detecting Deception and Ensuring Data Integrity in a Nationwide mHealth Randomized Controlled Trial: Factorial Design Survey Study", journal="J Med Internet Res", year="2025", month="Jan", day="28", volume="27", pages="e66384", keywords="ecological momentary assessment", keywords="enrollment", keywords="fraud", keywords="mHealth", keywords="randomized controlled trial", keywords="recruitment", keywords="deception", keywords="data integrity", keywords="behavior", keywords="social", keywords="RCT", keywords="factorial design", keywords="mobile phone", abstract="Background: Social behavioral research studies have increasingly shifted to remote recruitment and enrollment procedures. This shifting landscape necessitates evolving best practices to help mitigate the negative impacts of deceptive attempts (eg, fake profiles and bots) at enrolling in behavioral research. Objective: This study aimed to develop and implement robust deception detection procedures during the enrollment period of a remotely conducted randomized controlled trial. Methods: A 32-group (2{\texttimes}2{\texttimes}2{\texttimes}2{\texttimes}2) factorial design study was conducted from November 2021 to September 2022 to identify mobile health (mHealth) survey design features associated with the highest completion rates of smartphone-based ecological momentary assessments (n=485). Participants were required to be at least 18 years old, live in the United States, and own an Android smartphone that was compatible with the Insight app that was used in the study. Recruitment was conducted remotely through Facebook advertisements, a 5-minute REDCap (Research Electronic Data Capture) prescreener, and a screening and enrollment phone call. The research team created and implemented a 12-step checklist (eg, address verification and texting a copy of picture identification) to identify and prevent potentially deceptive attempts to enroll in the study. Descriptive statistics were calculated to understand the prevalence of various types of deceptive attempts at study enrollment. Results: Facebook advertisements resulted in 5236 initiations of the REDCap prescreener. A digital deception detection procedure was implemented for those who were deemed pre-eligible (n=1928). This procedure resulted in 26\% (501/1928) of prescreeners being flagged as potentially deceptive. Completing multiple prescreeners (301/501, 60.1\%) and providing invalid addresses (156/501, 31.1\%) were the most common reasons prescreeners were flagged. An additional 1\% (18/1928) of prescreeners were flagged as potentially deceptive during the subsequent study screening and enrollment phone call. Reasons for exclusion at the screening and enrollment phone call level included having an invalid phone type (6/18, 33.3\%), completing multiple prescreeners (6/18, 33.3\%), and providing an invalid address (5/18, 27.7\%). This resulted in 1409 individuals being eligible after all deception checks were completed. Postenrollment social security number checks revealed that 3 (0.6\%) fully enrolled participants out of 485 provided erroneous social security numbers during the screening process. Conclusions: Implementation of a deception detection procedure in a remotely conducted randomized controlled trial resulted in a substantial proportion of cases being flagged as potentially engaging in deceptive attempts at study enrollment. The results of the deception detection procedures in this study confirmed the need for vigilance in conducting remote behavioral research in order to maintain data integrity. Implementing systematic deception detection procedures may support study administration, data quality, and participant safety in remotely conducted behavioral research. Trial Registration: ClinicalTrials.gov NCT05194228; https://clinicaltrials.gov/study/NCT05194228 ", doi="10.2196/66384", url="https://www.jmir.org/2025/1/e66384" } @Article{info:doi/10.2196/52043, author="Engelke, Lara and Calvano, Claudia and Pohl, Steffi and Winter, Maria Sibylle and Renneberg, Babette", title="Parental Mental Health and Child Maltreatment in the COVID-19 Pandemic: Importance of Sampling in a Quantitative Statistical Study", journal="J Med Internet Res", year="2025", month="Jan", day="24", volume="27", pages="e52043", keywords="COVID-19", keywords="parental stress", keywords="parental mental health", keywords="child maltreatment", keywords="data collection methods", keywords="web-based surveys", keywords="convenience sample", keywords="sampling methods", abstract="Background: Results on parental burden during the COVID-19 pandemic are predominantly available from nonrepresentative samples. Although sample selection can significantly influence results, the effects of sampling strategies have been largely underexplored. Objective: This study aimed to investigate how sampling strategy may impact study results. Specifically, we aimed to (1) investigate if outcomes on parental health and child maltreatment during the COVID-19 pandemic from a convenience sample differ from those of a specific representative sample and (2) investigate reasons for differences in the results. Methods: In 2020, we simultaneously conducted 2 studies: (1) a web-based survey using a convenience sample of 4967 parents of underage children, primarily recruited via social media, and (2) a study using a quota sample representative of the German adult population with underage children (N=1024), recruited through a combination of telephone interviews and computer-assisted web interviews. In both studies, the same questionnaire was used. To evaluate the impact of sampling, we compared the results on outcomes (parental stress, subjective health, parental mental health, general stress, pandemic-related stress, and the occurrence of child maltreatment) between the 2 samples. To explain differences in the results between the 2 studies, we controlled for sociodemographic data, parent-related risk factors, and COVID-19--related experiences. Results: Compared to parents from the quota sample, parents from the convenience sample reported significantly more parental stress ($\eta$2=0.024); decreased subjective health ($\eta$2=0.016); more anxiety and depression symptoms ($\eta$2=0.055); more general stress ($\eta$2=0.044); more occurrences of verbal emotional abuse (VEA; $\phi$=0.12), witnessing domestic violence (WDV; $\phi$=0.13), nonverbal emotional abuse (NEA; $\phi$=0.03), physical abuse ($\phi$=0.10), and emotional neglect ($\phi$=0.06); and an increase of child maltreatment (VEA: exp(B)=2.95; WDV: exp(B)=3.19; NEA: exp(B)=1.65). Sociodemographic data, parent-related risk factors, and COVID-19--related experiences explained the differences in parental stress (remaining difference between samples after controlling for covariates: $\eta$2=0.002) and subjective health (remaining difference between samples after controlling for covariates: $\eta$2=0.004) and partially explained differences in parental mental health (remaining: $\eta$2=0.016), general stress (remaining: $\eta$2=0.014), and child maltreatment (remaining: VEA: exp(B)=2.05 and WDV: exp(B)=2.02) between the 2 samples. The covariates could not explain the difference in NEA (exp(B)=1.70). We discuss further factors that may explain the unexplained differences. Conclusions: Results of studies can be heavily impacted by the sampling strategy. Scientists are advised to collect relevant explaining variables (covariates) that are possibly related to sample selection and the outcome under investigation. This approach enables us to identify the individuals to whom the results apply and to combine findings from different studies. Furthermore, if data on the distribution of these explanatory variables in the population are available, it becomes possible to adjust for sample selection bias. ", doi="10.2196/52043", url="https://www.jmir.org/2025/1/e52043" } @Article{info:doi/10.2196/63349, author="McInnis, J. Brian and Pindus, Ramona and Kareem, Daniah and Vital, G. Daniela and Hekler, B. Eric and Nebeker, Camille", title="Factors Influencing Informed Consent Preferences in Digital Health Research: Survey Study of Prospective Participants", journal="J Med Internet Res", year="2025", month="Jan", day="23", volume="27", pages="e63349", keywords="digital health", keywords="research ethics", keywords="informed consent", keywords="readability", keywords="health literacy", keywords="human-centered approach", keywords="consent communication", keywords="text snippet", keywords="qualitative analysis", keywords="effectiveness", keywords="health information", keywords="health informatics", abstract="Background: Readability is important to consider when developing informed consent communications for prospective research participants, but not the most important consideration. Other factors to consider relate to learning preferences and literacy needs of people recruited to participate in research, as these factors can influence understanding of consent communications. To promote understanding among prospective participants, researchers should take a human-centered approach to develop consent communications. Objective: This study aims to explore how factors related to readability, topic, and participant demographic characteristics play into preferences for digital health research consent material. These factors are important to consider as not attending to some details that matter to a specific subgroup of prospective participants may systematically exclude people from research. Methods: People eligible to participate in a digital health study were recruited to review 31 paragraph length sections of a consent form, referred to as ``text snippets,'' for an existing institutional review board--approved digital health study. Participants (N=79) were surveyed and asked to choose between 2 variations of the text snippets, either indicating a preference for the institutional review board--approved original or a version that was modified to improve readability. Results: A slim majority of participants provided feedback about the snippets (n=44; 55\%). Our qualitative analysis of the feedback found that participants preferred shorter snippets, in general, but the snippets also elicited new questions not addressed by the original consent material. This observation is supported by our quantitative analysis, which found that when the character length of the original was longer, participants were less likely to prefer the original (P<.001) and more likely to prefer the modified text by a factor of 1.20 times (P=.04), and particularly for snippets explaining study risks (P=.03). Our analysis also found significant differences in participant demographic characteristics. For example, older participants tended to prefer the original more than younger participants, by a factor of 1.95 times (P=.004). The results present illustrative examples of how factors related to sex, age, physical activity, and ethnicity all play into preference for consent communication. Conclusions: The findings point toward new ways of evaluating informed consent communication: (1) for responsiveness to specific prospective participant populations, and (2) effectiveness at eliciting informed questions from people considering participation. We discuss how creating partnerships with prospective participants to prototype informed consent materials, specifically study procedures and risks, can be a way to identify those details before launching a study. Furthermore, future research should go beyond ``readability'' to explore alternate measures of evaluating consent materials, such as the likelihood that the consent material and communication procedures will elicit ``informed questions'' for the research team. ", doi="10.2196/63349", url="https://www.jmir.org/2025/1/e63349", url="http://www.ncbi.nlm.nih.gov/pubmed/39847412" } @Article{info:doi/10.2196/59291, author="Ko, Eunjung and Gao, Ye and Wang, Peng and Wijayasingha, Lahiru and Wright, D. Kathy and Gordon, C. Kristina and Wang, Hongning and Stankovic, A. John and Rose, M. Karen", title="Recruitment Challenges and Strategies in a Technology-Based Intervention for Dementia Caregivers: Descriptive Study", journal="JMIR Form Res", year="2025", month="Jan", day="17", volume="9", pages="e59291", keywords="recruitment challenges and strategies", keywords="technology-based intervention", keywords="dementia caregivers", keywords="dementia", keywords="mobile phone", keywords="Alzheimer disease", keywords="smart health", abstract="Background: Researchers have encountered challenges in recruiting unpaid caregivers of people living with Alzheimer disease and related dementias for intervention studies. However, little is known about the reasons for nonparticipation in in-home smart health interventions in community-based settings. Objective: This study aimed to (1) assess recruitment rates in a smart health technology intervention for caregivers of people living with Alzheimer disease and related dementias and reasons for nonparticipation among them and (2) discuss lessons learned from recruitment challenges and strategies to improve recruitment. Methods: The smart health intervention was a 4-month, single-arm trial designed to evaluate an in-home, technology-based intervention that monitors stressful moments for caregiving dyads through acoustic signals and to provide the caregivers with real-time stress management strategies. The recruitment involved two main methods: on-site engagement by a recruiter from a memory clinic and social media advertising. Caregivers were screened for eligibility by phone between January 2021 and September 2023. The recruitment rates, reasons for nonparticipation, and participant demographics were analyzed using descriptive statistics. Results: Of 201 caregivers contacted, 11 were enrolled in this study. Eighty-two caregivers did not return the screening call, and others did not participate due to privacy concerns (n=30), lack of interest (n=29), and burdensome study procedures (n=26). Our recruitment strategies included addressing privacy concerns, visualizing collected data through a dashboard, boosting social media presence, increasing the recruitment budget, updating advertisements, and preparing and deploying additional study devices. Conclusions: This study highlighted barriers to participation in the smart health intervention. Despite several recruitment strategies, enrollment rates remained below expectations. These findings underscore the need for future research to explore alternative methods for increasing the recruitment of informal dementia caregivers in technology-based intervention studies. Trial Registration: ClinicalTrials.gov NCT04536701; https://clinicaltrials.gov/study/NCT04536701 International Registered Report Identifier (IRRID): RR2-10.1111/jan.14714 ", doi="10.2196/59291", url="https://formative.jmir.org/2025/1/e59291" } @Article{info:doi/10.2196/52385, author="Mumtaz, Shahzad and McMinn, Megan and Cole, Christian and Gao, Chuang and Hall, Christopher and Guignard-Duff, Magalie and Huang, Huayi and McAllister, A. David and Morales, R. Daniel and Jefferson, Emily and Guthrie, Bruce", title="A Digital Tool for Clinical Evidence--Driven Guideline Development by Studying Properties of Trial Eligible and Ineligible Populations: Development and Usability Study", journal="J Med Internet Res", year="2025", month="Jan", day="16", volume="27", pages="e52385", keywords="multimorbidity", keywords="clinical practice guideline", keywords="gout", keywords="Trusted Research Environment", keywords="National Institute for Health and Care Excellence", keywords="Scottish Intercollegiate Guidelines Network", keywords="clinical practice", keywords="development", keywords="efficacy", keywords="validity", keywords="epidemiological data", keywords="epidemiology", keywords="epidemiological", keywords="digital tool", keywords="tool", keywords="age", keywords="gender", keywords="ethnicity", keywords="mortality", keywords="feedback", keywords="availability", abstract="Background: Clinical guideline development preferentially relies on evidence from randomized controlled trials (RCTs). RCTs are gold-standard methods to evaluate the efficacy of treatments with the highest internal validity but limited external validity, in the sense that their findings may not always be applicable to or generalizable to clinical populations or population characteristics. The external validity of RCTs for the clinical population is constrained by the lack of tailored epidemiological data analysis designed for this purpose due to data governance, consistency of disease or condition definitions, and reduplicated effort in analysis code. Objective: This study aims to develop a digital tool that characterizes the overall population and differences between clinical trial eligible and ineligible populations from the clinical populations of a disease or condition regarding demography (eg, age, gender, ethnicity), comorbidity, coprescription, hospitalization, and mortality. Currently, the process is complex, onerous, and time-consuming, whereas a real-time tool may be used to rapidly inform a guideline developer's judgment about the applicability of evidence. Methods: The National Institute for Health and Care Excellence---particularly the gout guideline development group---and the Scottish Intercollegiate Guidelines Network guideline developers were consulted to gather their requirements and evidential data needs when developing guidelines. An R Shiny (R Foundation for Statistical Computing) tool was designed and developed using electronic primary health care data linked with hospitalization and mortality data built upon an optimized data architecture. Disclosure control mechanisms were built into the tool to ensure data confidentiality. The tool was deployed within a Trusted Research Environment, allowing only trusted preapproved researchers to conduct analysis. Results: The tool supports 128 chronic health conditions as index conditions and 161 conditions as comorbidities (33 in addition to the 128 index conditions). It enables 2 types of analyses via the graphic interface: overall population and stratified by user-defined eligibility criteria. The analyses produce an overview of statistical tables (eg, age, gender) of the index condition population and, within the overview groupings, produce details on, for example, electronic frailty index, comorbidities, and coprescriptions. The disclosure control mechanism is integral to the tool, limiting tabular counts to meet local governance needs. An exemplary result for gout as an index condition is presented to demonstrate the tool's functionality. Guideline developers from the National Institute for Health and Care Excellence and the Scottish Intercollegiate Guidelines Network provided positive feedback on the tool. Conclusions: The tool is a proof-of-concept, and the user feedback has demonstrated that this is a step toward computer-interpretable guideline development. Using the digital tool can potentially improve evidence-driven guideline development through the availability of real-world data in real time. ", doi="10.2196/52385", url="https://www.jmir.org/2025/1/e52385" } @Article{info:doi/10.2196/60189, author="Klein, Dave and Montgomery, Aisha and Begale, Mark and Sutherland, Scott and Sawyer, Sherilyn and McCauley, L. Jacob and Husbands, Letheshia and Joshi, Deepti and Ashbeck, Alan and Palmer, Marcy and Jain, Praduman", title="Building a Digital Health Research Platform to Enable Recruitment, Enrollment, Data Collection, and Follow-Up for a Highly Diverse Longitudinal US Cohort of 1 Million People in the All of Us Research Program: Design and Implementation Study", journal="J Med Internet Res", year="2025", month="Jan", day="15", volume="27", pages="e60189", keywords="longitudinal studies", keywords="cohort studies", keywords="health disparities", keywords="minority populations", keywords="vulnerable populations", keywords="precision medicine", keywords="biomedical research", keywords="decentralization", keywords="digital health technology", keywords="database management system", abstract="Background: Longitudinal cohort studies have traditionally relied on clinic-based recruitment models, which limit cohort diversity and the generalizability of research outcomes. Digital research platforms can be used to increase participant access, improve study engagement, streamline data collection, and increase data quality; however, the efficacy and sustainability of digitally enabled studies rely heavily on the design, implementation, and management of the digital platform being used. Objective: We sought to design and build a secure, privacy-preserving, validated, participant-centric digital health research platform (DHRP) to recruit and enroll participants, collect multimodal data, and engage participants from diverse backgrounds in the National Institutes of Health's (NIH) All of Us Research Program (AOU). AOU is an ongoing national, multiyear study aimed to build a research cohort of 1 million participants that reflects the diversity of the United States, including minority, health-disparate, and other populations underrepresented in biomedical research (UBR). Methods: We collaborated with community members, health care provider organizations (HPOs), and NIH leadership to design, build, and validate a secure, feature-rich digital platform to facilitate multisite, hybrid, and remote study participation and multimodal data collection in AOU. Participants were recruited by in-person, print, and online digital campaigns. Participants securely accessed the DHRP via web and mobile apps, either independently or with research staff support. The participant-facing tool facilitated electronic informed consent (eConsent), multisource data collection (eg, surveys, genomic results, wearables, and electronic health records [EHRs]), and ongoing participant engagement. We also built tools for research staff to conduct remote participant support, study workflow management, participant tracking, data analytics, data harmonization, and data management. Results: We built a secure, participant-centric DHRP with engaging functionality used to recruit, engage, and collect data from 705,719 diverse participants throughout the United States. As of April 2024, 87\% (n=613,976) of the participants enrolled via the platform were from UBR groups, including racial and ethnic minorities (n=282,429, 46\%), rural dwelling individuals (n=49,118, 8\%), those over the age of 65 years (n=190,333, 31\%), and individuals with low socioeconomic status (n=122,795, 20\%). Conclusions: We built a participant-centric digital platform with tools to enable engagement with individuals from different racial, ethnic, and socioeconomic backgrounds and other UBR groups. This DHRP demonstrated successful use among diverse participants. These findings could be used as best practices for the effective use of digital platforms to build and sustain cohorts of various study designs and increase engagement with diverse populations in health research. ", doi="10.2196/60189", url="https://www.jmir.org/2025/1/e60189" } @Article{info:doi/10.2196/60413, author="Zheng, Yi Wu and Shvetcov, Artur and Slade, Aimy and Jenkins, Zoe and Hoon, Leonard and Whitton, Alexis and Logothetis, Rena and Ravindra, Smrithi and Kurniawan, Stefanus and Gupta, Sunil and Huckvale, Kit and Stech, Eileen and Agarwal, Akash and Funke Kupper, Joost and Cameron, Stuart and Rosenberg, Jodie and Manoglou, Nicholas and Senadeera, Manisha and Venkatesh, Svetha and Mouzakis, Kon and Vasa, Rajesh and Christensen, Helen and Newby, M. Jill", title="Recruiting Young People for Digital Mental Health Research: Lessons From an AI-Driven Adaptive Trial", journal="J Med Internet Res", year="2025", month="Jan", day="14", volume="27", pages="e60413", keywords="recruitment", keywords="Facebook", keywords="retention, COVID-19", keywords="artificial intelligence", abstract="Background: With increasing adoption of remote clinical trials in digital mental health, identifying cost-effective and time-efficient recruitment methodologies is crucial for the success of such trials. Evidence on whether web-based recruitment methods are more effective than traditional methods such as newspapers, media, or flyers is inconsistent. Here we present insights from our experience recruiting tertiary education students for a digital mental health artificial intelligence--driven adaptive trial---Vibe Up. Objective: We evaluated the effectiveness of recruitment via Facebook and Instagram compared to traditional methods for a treatment trial and compared different recruitment methods' retention rates. With recruitment coinciding with COVID-19 lockdowns across Australia, we also compared the cost-effectiveness of social media recruitment during and after lockdowns. Methods: Recruitment was completed for 2 pilot trials and 6 minitrials from June 2021 to May 2022. To recruit participants, paid social media advertising on Facebook and Instagram was used, alongside mailing lists of university networks and student organizations or services, media releases, announcements during classes and events, study posters or flyers on university campuses, and health professional networks. Recruitment data, including engagement metrics collected by Meta (Facebook and Instagram), advertising costs, and Qualtrics data on recruitment methods and survey completion rates, were analyzed using RStudio with R (version 3.6.3; R Foundation for Statistical Computing). Results: In total, 1314 eligible participants (aged 22.79, SD 4.71 years; 1079, 82.1\% female) were recruited to 2 pilot trials and 6 minitrials. The vast majority were recruited via Facebook and Instagram advertising (n=1203; 92\%). Pairwise comparisons revealed that the lead institution's website was more effective in recruiting eligible participants than Facebook (z=3.47; P=.003) and Instagram (z=4.23; P<.001). No differences were found between recruitment methods in retaining participants at baseline, at midpoint, and at study completion. Wilcoxon tests found significant differences between lockdown (pilot 1 and pilot 2) and postlockdown (minitrials 1-6) on costs incurred per link click (lockdown: median Aus \$0.35 [US \$0.22], IQR Aus \$0.27-\$0.47 [US \$0.17-\$0.29]; postlockdown: median Aus \$1.00 [US \$0.62], IQR Aus \$0.70-\$1.47 [US \$0.44-\$0.92]; W=9087; P<.001) and the amount spent per hour to reach the target sample size (lockdown: median Aus \$4.75 [US \$2.95], IQR Aus \$1.94-6.34 [US \$1.22-\$3.97]; postlockdown: median Aus \$13.29 [US \$8.26], IQR Aus \$4.70-25.31 [US \$2.95-\$15.87]; W=16044; P<.001). Conclusions: Social media advertising via Facebook and Instagram was the most successful strategy for recruiting distressed tertiary students into this artificial intelligence--driven adaptive trial, providing evidence for the use of this recruitment method for this type of trial in digital mental health research. No recruitment method stood out in terms of participant retention. Perhaps a reflection of the added distress experienced by young people, social media recruitment during the COVID-19 lockdown period was more cost-effective. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12621001092886; https://tinyurl.com/39f2pdmd; Australian New Zealand Clinical Trials Registry ACTRN12621001223820; https://tinyurl.com/bdhkvucv ", doi="10.2196/60413", url="https://www.jmir.org/2025/1/e60413" } @Article{info:doi/10.2196/60324, author="Fang, Heping and Xian, Ruoling and Li, Juan and Li, Yingcun and Liu, Enmei and Zhao, Yan and Hu, Yan", title="Urban-Suburban Differences in Public Perspectives on Digitalizing Pediatric Research: Cross-Sectional Survey Study", journal="J Med Internet Res", year="2025", month="Jan", day="7", volume="27", pages="e60324", keywords="pediatrics", keywords="pediatric research", keywords="digital health", keywords="public opinion", keywords="research", keywords="patient participation", keywords="urban", keywords="rural", keywords="caregiver attitudes", keywords="social media", keywords="mobile phone", abstract="Background: Recruiting and retaining participants in pediatric research has always been challenging, particularly in healthy populations and remote areas, leading to selection bias and increased health disparities. In the digital age, medical research has been transformed by digital tools, offering new opportunities to enhance engagement in clinical research. However, public perspectives on digitalizing pediatric research and potential differences between urban and suburban areas remain unclear. Objective: This study aimed to investigate public perspectives on digitalizing pediatric research and compare differences between urban and suburban areas to help diversify participants and address health disparities. Methods: A cross-sectional web-based survey targeting caregivers of kindergarten children (aged 2-7 years) in Chongqing was conducted between June and December 2023. A total of 4231 valid questionnaires were analyzed, with 25.1\% (n=1064) of the children residing in urban areas and 74.9\% (n=3167) in suburban areas. Descriptive statistics and intergroup comparisons were used for data analysis. Results: Approximately 59.8\% (n=2531) of the caregivers had first impressions of pediatric research, with 36.9\% (n=1561) being positive and 22.9\% (n=970) being negative. A total of 38.3\% (n=1621) of caregivers recognized the growing popularity of digital tools, and 36.7\% (n=1552) supported their use in pediatric research, but only 25.2\% (n=1068) favored online-only research methods. The main concerns regarding the use of software in pediatric research were privacy issues (n=3273, 77.4\%) and potential addiction (n=2457, 58.1\%). Public accounts of research institutions (n=3400, 80.4\%) were the most favored for online recruitment. Telephones (1916/3076, 62.3\%) and social media apps (1801/3076, 58.6\%) were the most popular for regular contact. Intergroup comparisons revealed that suburban caregivers had more positive first impressions of pediatric research (38.6\% vs 32\%; P<.001; adjusted odds ratio [aOR] 1.27, 95\% CI 1.09-1.47) and faced fewer participation barriers: ``worry about being an experimental subject'' (70.9\% vs 76.6\%; P<.001; aOR 0.79, 95\% CI 0.67-0.93), ``pose a risk to children's health'' (58.6\% vs 67.8\%; P<.001; aOR 0.71, 95\% CI 0.61-0.83), ``do not have enough background information'' (55.2\% vs 61.6\%; P<.001; aOR 0.78, 95\% CI 0.67-0.89), and ``worry about recommending other products'' (48.2\% vs 55\%; P<.001; aOR 0.78, 95\% CI 0.67-0.89). They also showed greater support for online-only research methods (26\% vs 22.9\%; P=.045; aOR 1.19, 95\% CI 1.01-1.41) and greater openness to unofficial online recruitment sources (social media friends: 24.7\% vs 18.9\%; P<.001; aOR 1.33, 95\% CI 1.11-1.59; moments on social media: 15.5\% vs 11.1\%; P<.001; aOR 1.35, 95\% CI 1.09-1.67). Conclusions: In the digital age, enhancing recruitment and retention in pediatric research can be achieved by integrating both official and unofficial social media strategies, implementing a hybrid online-offline follow-up approach, and addressing privacy concerns. ", doi="10.2196/60324", url="https://www.jmir.org/2025/1/e60324" } @Article{info:doi/10.2196/66800, author="Klein, Augustus and Golub, A. Sarit and Berke, Danielle and Castle, Elijah", title="Developing Guidelines for Conducting Stigma Research With Transgender and Nonbinary Individuals: Protocol for Creation of a Trauma-Informed Approach to Research", journal="JMIR Res Protoc", year="2025", month="Jan", day="6", volume="14", pages="e66800", keywords="transgender", keywords="non-binary", keywords="HIV prevention and treatment", keywords="stigma research", keywords="trauma-informed", abstract="Background: Transgender and nonbinary individuals have received increasing attention within HIV research, with studies documenting the pervasive role stigma plays in creating and sustaining health inequities. However, the proliferation of HIV stigma research with this population has also raised concerns about research practices that may unintentionally stigmatize or retraumatize the very communities they are designed to benefit. Conducting stigma research is critical for generating accurate information about HIV epidemiology, risk and protective factors, and intervention strategies for transgender and nonbinary individuals. Yet, little research has directly examined the experiences of transgender and nonbinary individuals when participating in these studies or identified specific research practices (eg, recruitment materials or study framing, choice of specific survey measures, data collection protocols, and researcher behaviors) that may influence study participation, retention, and data quality. Equally important, research has not adequately examined the potential for unintended harm due to emotional distress experienced by participating in such research and what specific strategies might mitigate against potential distressful research experiences. Objective: This study aimed to develop a set of empirically based trauma-informed guidelines for conducting HIV-related stigma research with transgender and nonbinary individuals to increase researchers' capacity to recruit and retain transgender and nonbinary individuals in HIV-related stigma research, enhance the quality of data collected, and reduce unintentional harm in stigma research methodology. Methods: The study will engage in primary data collection using both qualitative and quantitative methodology. First, we will use in-depth qualitative interviews with 60 participants representing 3 participant groups: researchers, mental health clinicians, and transgender and nonbinary individuals who have participated in HIV-related and sexual health research. Second, the qualitative findings will be used to develop an initial set of survey items representing a preliminary set of guidelines. Third, we will engage 75 participants in a 3-round modified Delphi method, to refine the guidelines and promote their acceptability among key stakeholders. Results: The study is funded by the National Institute of Mental Health starting in July 2022 and data collection began January 2023. The study's findings underscore the critical importance of adopting a trauma-informed approach to HIV stigma research with transgender and nonbinary individuals. Conclusions: To make meaningful strides in stigma research, it is imperative to examine experiences of stigma that may happen within the research context and identify strategies for improving data quality and reducing unintentional harm in study recruitment, methodology, implementation, and dissemination. International Registered Report Identifier (IRRID): DERR1-10.2196/66800 ", doi="10.2196/66800", url="https://www.researchprotocols.org/2025/1/e66800" } @Article{info:doi/10.2196/65099, author="Terceiro, Luciana and Mustafa, Imran Mudassir and H{\"a}gglund, Maria and Kharko, Anna", title="Research Participants' Engagement and Retention in Digital Health Interventions Research: Protocol for Mixed Methods Systematic Review", journal="JMIR Res Protoc", year="2025", month="Jan", day="3", volume="14", pages="e65099", keywords="clinical research informatics", keywords="participant engagement", keywords="participant retention", keywords="clinical research", keywords="mobile application", keywords="digital platforms", keywords="mobile phone", abstract="Background: Digital health interventions have become increasingly popular in recent years, expanding the possibilities for treatment for various patient groups. In clinical research, while the design of the intervention receives close attention, challenges with research participant engagement and retention persist. This may be partially due to the use of digital health platforms, which may lack adequacy for participants. Objective: This systematic literature review aims to investigate the relationship between digital health platforms and participant engagement and retention in clinical research. It will map and analyze key definitions of engagement and retention, as well as identify design characteristics that influence them. Methods: We will carry out a mixed methods systematic literature review, analyzing qualitative and quantitative studies. The search strategy includes the electronic databases PubMed, IEEE Xplore, CINAHL, Scopus, Web of Science, APA PsycINFO, and the ACM Digital Library. The review will encompass studies published between January 2018 and June 2024. Criteria for inclusion will be the presence of digital health care interventions conducted through digital health platforms like websites, web and mobile apps used by patients, and informal caregivers as research participants. The main outcome will be a narrative analysis with key findings on the definitions of participant engagement and retention and critical factors that affect them. Quality assessment and appraisal will be done through the Mixed-Methods Assessment Tool. Data analysis and synthesis will follow the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 flow diagram. Quantitative data will be qualified and integrated into qualitative data, which will be analyzed using thematic analysis and synthesis. Results: The study expects to map and summarize critical definitions of participant engagement and retention, and the characteristics of digital health platforms that influence them. The systematic review is expected to be completed in June 2025. Conclusions: This systematic review will contribute to the growing discussion on how the design of digital health intervention platforms can promote participant engagement and retention in clinical research. Trial Registration: PROSPERO CRD42024561650; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=561650 International Registered Report Identifier (IRRID): PRR1-10.2196/65099 ", doi="10.2196/65099", url="https://www.researchprotocols.org/2025/1/e65099" } @Article{info:doi/10.2196/64668, author="Marshall, J. Daniel and Gower, L. Amy and Katz, L. Mira and Bauermeister, A. Jos{\'e} and Shoben, B. Abigail and Reiter, L. Paul", title="Recruitment of Young Gay, Bisexual, and Other Men Who Have Sex With Men for a Web-Based Human Papillomavirus Vaccination Intervention: Differences in Participant Characteristics and Study Engagement by Recruitment Source in a Randomized Controlled Trial", journal="J Med Internet Res", year="2025", month="Jan", day="3", volume="27", pages="e64668", keywords="study recruitment", keywords="gay and bisexual men", keywords="human papillomavirus", keywords="vaccination promotion", keywords="digital intervention", keywords="social media", keywords="dating apps", keywords="recruitment", keywords="young adults", keywords="adolescents", keywords="gay", keywords="bisexual", keywords="men who have sex with men", abstract="Background: Young gay, bisexual, and other men who have sex with men have been referred to as a ``hard-to-reach'' or ``hidden'' community in terms of recruiting for research studies. With widespread internet use among this group and young adults in general, web-based avenues represent an important approach for reaching and recruiting members of this community. However, little is known about how participants recruited from various web-based sources may differ from one another. Objective: This study aimed to determine how young gay, bisexual, and other men who have sex with men recruited from various web-based sources differ from one another in terms of participant characteristics and study engagement. Methods: Data were collected as part of a randomized controlled trial of Outsmart HPV, a web-based human papillomavirus?(HPV) vaccination intervention for young gay, bisexual, and other men who have sex with men. From 2019 to 2021, we recruited young gay, bisexual, and other men who have sex with men in the United States who were aged 18-25 years and not vaccinated against HPV (n=1227) through various web-based avenues. We classified each participant as being recruited from either (1) social media (eg, Facebook, Instagram, Snapchat), (2) a dating app (eg, Grindr, Scruff), or (3) some other digital recruitment source (eg, existing research panel, university-based organization). Analyses compared participants from these 3 groups on demographic and health-related characteristics and metrics involving study engagement. Results: Most demographic and health-related characteristics differed by web-based recruitment source, including race or ethnicity (P<.001), relationship status (P<.001), education level (P<.001), employment status (P<.001), sexual self-identity (P<.001), health insurance status (P<.001), disclosure of sexual orientation (P=.048), and connectedness to the LGBTQ (lesbian, gay, bisexual, transgender, queer) community (P<.001) The type of device used by participants during study enrollment also differed across groups, with smartphone use higher among participants recruited via dating apps (n=660, 96.6\%) compared to those recruited via social media (n=318, 78.9\%) or other digital sources (n=85, 60.3\%; P<.001). Participants recruited via social media were more likely than those recruited via dating apps to complete follow-up surveys at 3 different timepoints (odds ratios 1.52-2.09, P=.001-.008). These participants also spent a longer amount of time viewing intervention content about HPV vaccination (3.14 minutes vs 2.67 minutes; P=.02). Conclusions: We were able to recruit a large national sample of young gay, bisexual, and other men who have sex with men for a web-based HPV vaccination intervention via multiple methodologies. Participants differed on a range of demographic and health-related characteristics, as well as metrics related to study engagement, based on whether they were recruited from social media, a dating app, or some other digital recruitment source. Findings highlight key issues and considerations that can help researchers better plan and customize future web-based recruitment efforts of young gay, bisexual, and other men who have sex with men. Trial Registration: ClinicalTrials.gov NCT04032106; https://clinicaltrials.gov/study/NCT04032106 International Registered Report Identifier (IRRID): RR2-10.2196/16294 ", doi="10.2196/64668", url="https://www.jmir.org/2025/1/e64668" } @Article{info:doi/10.2196/64636, author="Rong, Jian and Pathiravasan, H. Chathurangi and Zhang, Yuankai and Faro, M. Jamie and Wang, Xuzhi and Schramm, Eric and Borrelli, Belinda and Benjamin, J. Emelia and Liu, Chunyu and Murabito, M. Joanne", title="Baseline Smartphone App Survey Return in the Electronic Framingham Heart Study Offspring and Omni 1 Study: eCohort Study", journal="JMIR Aging", year="2024", month="Dec", day="31", volume="7", pages="e64636", keywords="mHealth", keywords="mobile health", keywords="mobile application", keywords="smartphone", keywords="digital health", keywords="digital technology", keywords="digital intervention", keywords="gerontology", keywords="geriatric", keywords="older adult", keywords="aging", keywords="eFHS", keywords="eCohort", keywords="smartphone app", keywords="baseline app surveys", keywords="Framingham Heart Study", keywords="health information", keywords="information collection", keywords="mobile phone", abstract="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. ", doi="10.2196/64636", url="https://aging.jmir.org/2024/1/e64636" } @Article{info:doi/10.2196/52448, author="Matthes, Nina and Willem, Theresa and Buyx, Alena and Zimmermann, M. Bettina", title="Social Media Recruitment as a Potential Trigger for Vulnerability: Multistakeholder Interview Study", journal="JMIR Hum Factors", year="2024", month="Dec", day="30", volume="11", pages="e52448", keywords="vulnerability", keywords="social media", keywords="clinical study enrollment", keywords="clinical study recruitment", keywords="clinical trials", keywords="stigma", keywords="discrimination", keywords="injustice", keywords="recruitment", keywords="clinical study", keywords="hepatitis B", keywords="TherVacB", keywords="clinical research", keywords="attitudes", keywords="patient privacy", keywords="utilization", abstract="Background: More clinical studies use social media to increase recruitment accrual. However, empirical analyses focusing on the ethical aspects pertinent when targeting patients with vulnerable characteristics are lacking. Objective: This study aims to explore expert and patient perspectives on vulnerability in the context of social media recruitment and seeks to explore how social media can reduce or amplify vulnerabilities. Methods: As part of an international consortium that tests a therapeutic vaccine against hepatitis B (TherVacB), we conducted 30 qualitative interviews with multidisciplinary experts in social media recruitment (from the fields of clinical research, public relations, psychology, ethics, philosophy, law, and social sciences) about the ethical, legal, and social challenges of social media recruitment. We triangulated the expert assessments with the perceptions of 6 patients with hepatitis B regarding social media usage and attitudes relative to their diagnosis. Results: Experts perceived social media recruitment as beneficial for reaching hard-to-reach populations and preserving patient privacy. Features that may aggravate existing vulnerabilities are the acontextual point of contact, potential breaches of user privacy, biased algorithms disproportionately affecting disadvantaged groups, and technological barriers such as insufficient digital literacy skills and restricted access to relevant technology. We also report several practical recommendations from experts to navigate these triggering effects of social media recruitment, including transparent communication, addressing algorithm bias, privacy education, and multichannel recruitment. Conclusions: Using social media for clinical study recruitment can mitigate and aggravate potential study participants' vulnerabilities. Researchers should anticipate and address the outlined triggering effects within this study's design and proactively define strategies to overcome them. We suggest practical recommendations to achieve this. ", doi="10.2196/52448", url="https://humanfactors.jmir.org/2024/1/e52448" } @Article{info:doi/10.2196/51786, author="Craig, S. Leslie and Evans, L. Christina and Taylor, D. Brittany and Patterson, Jace and Whitfield, Kaleb and Hill, Mekhi and Nwagwu, Michelle and Mubasher, Mohamed and Bednarczyk, A. Robert and McCray, G. Gail and Gaddis, R. Cheryl L. and Taylor, Natasha and Thompson, Emily and Douglas, Ursula and Latimer, K. Saundra and Spivey, G. Sedessie and Henry Akintobi, Tabia and Quarells, Collins Rakale", title="Challenges and Lessons Learned in Managing Web-Based Survey Fraud for the Garnering Effective Outreach and Research in Georgia for Impact Alliance--Community Engagement Alliance Survey Administrations", journal="JMIR Public Health Surveill", year="2024", month="Dec", day="24", volume="10", pages="e51786", keywords="web-based survey research", keywords="data quality", keywords="data integrity", keywords="COVID-19", keywords="Georgia", keywords="data collection", keywords="scientists", keywords="integrity", keywords="transparency", keywords="public health", keywords="deception", keywords="disinformation", keywords="survey fraud", keywords="legitimate data", abstract="Background: Convenience, privacy, and cost-effectiveness associated with web-based data collection have facilitated the recent expansion of web-based survey research. Importantly, however, practical benefits of web-based survey research, to scientists and participants alike, are being overshadowed by the dramatic rise in suspicious and fraudulent survey submissions. Misinformation associated with survey fraud compromises data quality and data integrity with important implications for scientific conclusions, clinical practice, and social benefit. Transparency in reporting on methods used to prevent and manage suspicious and fraudulent submissions is key to protecting the veracity of web-based survey data; yet, there is limited discussion on the use of antideception strategies during all phases of survey research to detect and eliminate low-quality and fraudulent responses. Objective: This study aims to contribute to an evolving evidence base on data integrity threats associated with web-based survey research by describing study design strategies and antideception tools used during the web-based administration of the Garnering Effective Outreach and Research in Georgia for Impact Alliance--Community Engagement Alliance (GEORGIA CEAL) Against COVID-19 Disparities project surveys. Methods: GEORGIA CEAL was established in response to the COVID-19 pandemic and the need for rapid, yet, valid, community-informed, and community-owned research to guide targeted responses to a dynamic, public health crisis. GEORGIA CEAL Surveys I (April 2021 to June 2021) and II (November 2021 to January 2022) received institutional review board approval from the Morehouse School of Medicine and adhered to the CHERRIES (Checklist for Reporting Results of Internet E-Surveys). Results: A total of 4934 and 4905 submissions were received for Surveys I and II, respectively. A small proportion of surveys (Survey I: n=1336, 27.1\% and Survey II: n=1024, 20.9\%) were excluded due to participant ineligibility, while larger proportions (Survey I: n=1516, 42.1\%; Survey II: n=1423, 36.7\%) were flagged and removed due to suspicious activity; 2082 (42.2\%) and 2458 (50.1\%) of GEORGIA CEAL Surveys I and II, respectively, were retained for analysis. Conclusions: Suspicious activity during GEORGIA CEAL Survey I administration prompted the inclusion of additional security tools during Survey II design and administration (eg, hidden questions, Completely Automated Public Turing Test to Tell Computers and Humans Apart verification, and security questions), which proved useful in managing and detecting fraud and resulted in a higher retention rate across survey waves. By thorough discussion of experiences, lessons learned, and future directions for web-based survey research, this study outlines challenges and best practices for designing and implementing a robust defense against survey fraud. Finally, we argue that, in addition to greater transparency and discussion, community stakeholders need to be intentionally and mindfully engaged, via approaches grounded in community-based participatory research, around the potential for research to enable scientific discoveries in order to accelerate investment in quality, legitimate survey data. ", doi="10.2196/51786", url="https://publichealth.jmir.org/2024/1/e51786" } @Article{info:doi/10.2196/53187, author="Lopez-Alcalde, Jesus and Wieland, Susan L. and Yan, Yuqian and Barth, J{\"u}rgen and Khami, Reza Mohammad and Shivalli, Siddharudha and Lokker, Cynthia and Rai, Kaur Harleen and Macharia, Paul and Yun, Sergi and Lang, Elvira and Bwanika Naggirinya, Agnes and Campos-Asensio, Concepci{\'o}n and Ahmadian, Leila and Witt, M. Claudia", title="Methodological Challenges in Randomized Controlled Trials of mHealth Interventions: Cross-Sectional Survey Study and Consensus-Based Recommendations", journal="J Med Internet Res", year="2024", month="Dec", day="19", volume="26", pages="e53187", keywords="digital health", keywords="eHealth", keywords="mobile health", keywords="mHealth", keywords="randomized controlled trial", keywords="survey", keywords="recommendations", keywords="intervention integrity", keywords="adherence", keywords="consensus", keywords="mobile phone", abstract="Background: Mobile health (mHealth) refers to using mobile communication devices such as smartphones to support health, health care, and public health. mHealth interventions have their own nature and characteristics that distinguish them from traditional health care interventions, including drug interventions. Thus, randomized controlled trials (RCTs) of mHealth interventions present specific methodological challenges. Identifying and overcoming those challenges is essential to determine whether mHealth interventions improve health outcomes. Objective: We aimed to identify specific methodological challenges in RCTs testing mHealth interventions' effects and develop consensus-based recommendations to address selected challenges. Methods: A 2-phase participatory research project was conducted. First, we sent a web-based survey to authors of mHealth RCTs. Survey respondents rated on a 5-point scale how challenging they found 21 methodological aspects in mHealth RCTs compared to non-mHealth RCTs. Nonsystematic searches until June 2022 informed the selection of the methodological challenges listed in the survey. Second, a subset of survey respondents participated in an online workshop to discuss recommendations to address selected methodological aspects identified in the survey. Finally, consensus-based recommendations were developed based on the workshop discussion and email interaction. Results: We contacted 1535 authors of mHealth intervention RCTs, of whom 80 (5.21\%) completed the survey. Most respondents (74/80, 92\%) identified at least one methodological aspect as more or much more challenging in mHealth RCTs. The aspects most frequently reported as more or much more challenging were those related to mHealth intervention integrity, that is, the degree to which the study intervention was implemented as intended, in particular managing low adherence to the mHealth intervention (43/77, 56\%), defining adherence (39/79, 49\%), measuring adherence (33/78, 42\%), and determining which mHealth intervention components are used or received by the participant (31/75, 41\%). Other challenges were also frequent, such as analyzing passive data (eg, data collected from smartphone sensors; 24/58, 41\%) and verifying the participants' identity during recruitment (28/68, 41\%). In total, 11 survey respondents participated in the subsequent workshop (n=8, 73\% had been involved in at least 2 mHealth RCTs). We developed 17 consensus-based recommendations related to the following four categories: (1) how to measure adherence to the mHealth intervention (7 recommendations), (2) defining adequate adherence (2 recommendations), (3) dealing with low adherence rates (3 recommendations), and (4) addressing mHealth intervention components (5 recommendations). Conclusions: RCTs of mHealth interventions have specific methodological challenges compared to those of non-mHealth interventions, particularly those related to intervention integrity. Following our recommendations for addressing these challenges can lead to more reliable assessments of the effects of mHealth interventions on health outcomes. ", doi="10.2196/53187", url="https://www.jmir.org/2024/1/e53187" } @Article{info:doi/10.2196/60504, author="Bikou, Georgia Alexia and Deligianni, Elena and Dermiki-Gkana, Foteini and Liappas, Nikolaos and Teri{\'u}s-Padr{\'o}n, Gabriel Jos{\'e} and Beltr{\'a}n Jaunsar{\'a}s, Eugenia Maria and Cabrera-Umpi{\'e}rrez, Fernanda Maria and Kontogiorgis, Christos", title="Improving Participant Recruitment in Clinical Trials: Comparative Analysis of Innovative Digital Platforms", journal="J Med Internet Res", year="2024", month="Dec", day="18", volume="26", pages="e60504", keywords="clinical research", keywords="e-recruitment", keywords="patient matching", keywords="clinical trials", keywords="digital platforms", keywords="enrollment", keywords="electronic consent", abstract="Background: Pharmaceutical product development relies on thorough and costly clinical trials. Participant recruitment and monitoring can be challenging. The incorporation of cutting-edge technologies such as blockchain and artificial intelligence has revolutionized clinical research (particularly in the recruitment stage), enhanced secure data storage and analysis, and facilitated participant monitoring while protecting their personal information. Objective: This study aims to investigate the use of novel digital platforms and their features, such as e-recruitment, e-consent, and matching, aiming to optimize and expedite clinical research. Methods: A review with a systematic approach was conducted encompassing literature from January 2000 to October 2024. The MEDLINE, ScienceDirect, Scopus, and Google Scholar databases were examined thoroughly using a customized search string. Inclusion criteria focused on digital platforms involving clinical trial recruitment phases that were in English and had international presence, scientific validation, regulatory approval, and no geographic limitations. Literature reviews and unvalidated digital platforms were excluded. The selected studies underwent meticulous screening by the research team, ensuring a thorough analysis of novel digital platforms and their use and features for clinical trials. Results: A total of 24 digital platforms were identified that supported clinical trial recruitment phases. In general, most of them (n=22, 80\%) are headquartered and operating in the United States, providing a range of functionalities including electronic consent (n=14, 60\% of the platforms), participant matching, and monitoring of patients' health status. These supplementary features enhance the overall effectiveness of the platforms in facilitating the recruitment process for clinical trials. The analysis and digital platform findings refer to a specific time frame when the investigation took place, and a notable surge was observed in the adoption of these novel digital tools, particularly following the COVID-19 outbreak. Conclusions: This study underscores the vital role of the identified digital platforms in clinical trials, aiding in recruitment, enhancing patient engagement, accelerating procedures, and personalizing vital sign monitoring. Despite their impact, challenges in accessibility, compatibility, and transparency require careful consideration. Addressing these challenges is crucial for optimizing digital tool integration into clinical research, allowing researchers to harness the benefits while managing the associated risks effectively. ", doi="10.2196/60504", url="https://www.jmir.org/2024/1/e60504" } @Article{info:doi/10.2196/60231, author="Silvey, Scott and Liu, Jinze", title="Sample Size Requirements for Popular Classification Algorithms in Tabular Clinical Data: Empirical Study", journal="J Med Internet Res", year="2024", month="Dec", day="17", volume="26", pages="e60231", keywords="medical informatics", keywords="machine learning", keywords="sample size", keywords="research design", keywords="decision trees", keywords="classification algorithm", keywords="clinical research", keywords="learning-curve analysis", keywords="analysis", keywords="analyses", keywords="guidelines", keywords="ML", keywords="decision making", keywords="algorithm", keywords="curve analysis", keywords="dataset", abstract="Background: The performance of a classification algorithm eventually reaches a point of diminishing returns, where the additional sample added does not improve the results. Thus, there is a need to determine an optimal sample size that maximizes performance while accounting for computational burden or budgetary concerns. Objective: This study aimed to determine optimal sample sizes and the relationships between sample size and dataset-level characteristics over a variety of binary classification algorithms. Methods: A total of 16 large open-source datasets were collected, each containing a binary clinical outcome. Furthermore, 4 machine learning algorithms were assessed: XGBoost (XGB), random forest (RF), logistic regression (LR), and neural networks (NNs). For each dataset, the cross-validated area under the curve (AUC) was calculated at increasing sample sizes, and learning curves were fit. Sample sizes needed to reach the observed full--dataset AUC minus 2 points (0.02) were calculated from the fitted learning curves and compared across the datasets and algorithms. Dataset--level characteristics, minority class proportion, full--dataset AUC, number of features, type of features, and degree of nonlinearity were examined. Negative binomial regression models were used to quantify relationships between these characteristics and expected sample sizes within each algorithm. A total of 4 multivariable models were constructed, which selected the best-fitting combination of dataset--level characteristics. Results: Among the 16 datasets (full-dataset sample sizes ranging from 70,000-1,000,000), median sample sizes were 9960 (XGB), 3404 (RF), 696 (LR), and 12,298 (NN) to reach AUC stability. For all 4 algorithms, more balanced classes (multiplier: 0.93-0.96 for a 1\% increase in minority class proportion) were associated with decreased sample size. Other characteristics varied in importance across algorithms---in general, more features, weaker features, and more complex relationships between the predictors and the response increased expected sample sizes. In multivariable analysis, the top selected predictors were minority class proportion among all 4 algorithms assessed, full--dataset AUC (XGB, RF, and NN), and dataset nonlinearity (XGB, RF, and NN). For LR, the top predictors were minority class proportion, percentage of strong linear features, and number of features. Final multivariable sample size models had high goodness-of-fit, with dataset--level predictors explaining a majority (66.5\%-84.5\%) of the total deviance in the data among all 4 models. Conclusions: The sample sizes needed to reach AUC stability among 4 popular classification algorithms vary by dataset and method and are associated with dataset--level characteristics that can be influenced or estimated before the start of a research study. ", doi="10.2196/60231", url="https://www.jmir.org/2024/1/e60231" } @Article{info:doi/10.2196/51536, author="Jones, Tamara and Edbrooke, Lara and Rawstorn, C. Jonathan and Denehy, Linda and Hayes, Sandra and Maddison, Ralph and Sverdlov, L. Aaron and Koczwara, Bogda and Kiss, Nicole and Short, E. Camille", title="Demographics and Health Characteristics Associated With the Likelihood of Participating in Digitally Delivered Exercise Rehabilitation for Improving Heart Health Among Breast Cancer Survivors: Cross-Sectional Survey Study", journal="JMIR Cancer", year="2024", month="Dec", day="16", volume="10", pages="e51536", keywords="digital health", keywords="breast cancer", keywords="exercise", keywords="rehabilitation", keywords="cardiotoxicity", keywords="demographic", keywords="cancer survivor", keywords="exercise rehabilitation", keywords="home-based program", keywords="pathologic process", keywords="radiation", keywords="physical phenomena", keywords="heart care", keywords="cardiovascular disease", keywords="diagnosis", keywords="cross-sectional study", keywords="chronic disease", keywords="statistics", abstract="Background: Strong evidence supports the benefits of exercise following both cardiovascular disease and cancer diagnoses. However, less than one-third of Australians who are referred to exercise rehabilitation complete a program following a cardiac diagnosis. Technological advances make it increasingly possible to embed real-time supervision, tailored exercise prescription, behavior change, and social support into home-based programs. Objective: This study aimed to explore demographic and health characteristics associated with the likelihood of breast cancer survivors uptaking a digitally delivered cardiac exercise rehabilitation program and to determine whether this differed according to intervention timing (ie, offered generally, before, during, or after treatment). Secondary aims were to explore the knowledge of cardiac-related treatment side-effects, exercise behavior, additional intervention interests (eg, diet, fatigue management), and service fee capabilities. Methods: This cross-sectional study involved a convenience sample of breast cancer survivors recruited via social media. A self-reported questionnaire was used to collect outcomes of interests, including the likelihood of uptaking a digitally delivered cardiac exercise rehabilitation program, and demographic and health characteristics. Descriptive statistics were used to summarize sample characteristics and outcomes. Ordered logistic regression models were used to examine associations between demographic and health characteristics and likelihood of intervention uptake generally, before, during, and after treatment, with odds ratios (ORs) <0.67 or >1.5 defined as clinically meaningful and statistical significance a priori set at P?.05. Results: A high proportion (194/208, 93\%) of the sample (mean age 57, SD 11 years; median BMI=26, IQR 23?31 kg/m2) met recommended physical activity levels at the time of the survey. Living in an outer regional area (compared with living in a major city) was associated with higher odds of uptake in each model (OR 3.86?8.57, 95\% CI 1.04-68.47; P=.01?.04). Receiving more cardiotoxic treatments was also associated with higher odds of general uptake (OR 1.42, 95\% CI 1.02-1.96; P=.04). There was some evidence that a higher BMI, more comorbid conditions, and lower education (compared with university education) were associated with lower odds of intervention uptake, but findings differed according to intervention timing. Respondents identified the need for better education about the cardiotoxic effects of breast cancer treatment, and the desire for multifaceted rehabilitation interventions that are free or low cost (median Aus \$10, IQR 10-15 per session; Aus \$1=US \$0.69 at time of study). Conclusions: These findings can be used to better inform future research and the development of intervention techniques that are critical to improving the delivery of a digital service model that is effective, equitable, and accessible, specifically, by enhancing digital inclusion, addressing general exercise barriers experienced by chronic disease populations, incorporating multidisciplinary care, and developing affordable delivery models. ", doi="10.2196/51536", url="https://cancer.jmir.org/2024/1/e51536" } @Article{info:doi/10.2196/62919, author="Raeside, Rebecca and Todd, R. Allyson and Barakat, Sarah and Rom, Sean and Boulet, Stephanie and Maguire, Sarah and Williams, Kathryn and Mihrshahi, Seema and Hackett, L. Maree and Redfern, Julie and Partridge, R. Stephanie and ", title="Recruitment of Adolescents to Virtual Clinical Trials: Recruitment Results From the Health4Me Randomized Controlled Trial", journal="JMIR Pediatr Parent", year="2024", month="Dec", day="16", volume="7", pages="e62919", keywords="adolescents", keywords="clinical trial", keywords="recruitment", keywords="digital health", keywords="prevention", keywords="adolescent health", keywords="health behavior change", keywords="health promotion", keywords="social media", abstract="Background: Preventive interventions are needed to provide targeted health support to adolescents to improve health behaviors. Engaging adolescents in preventive interventions remains a challenge, highlighting the need for innovative recruitment strategies. Given adolescents' lives are intertwined with digital technologies, attention should be focused on these avenues for recruitment. The evolving nature of clinical trials, including the emergence of virtual clinical trials, requires new recruitment approaches, which must be evaluated. Objective: This study aimed to examine the effectiveness and cost of various digital recruitment strategies for recruiting adolescents to a virtual clinical trial, evaluate the progression of participants from screening to enrollment, and explore factors associated with nonparticipation. This was conducted using data from the Health4Me Study, a preventive digital health intervention to improve physical activity and nutrition behaviors among adolescents aged 12 to 18 years. Methods: Participants were recruited into the Health4Me Study via social media advertisements on various contemporary platforms, emails to schools, emails to contacts within known networks, and emails to relevant youth organizations. Data were collected from social media advertisements, screening, and recruitment logs. Data analysis included summary and descriptive statistics, as well as chi-square tests to explore factors associated with nonparticipation. Results: From 2369 expressions of interest, 390 (16.4\%) participants were enrolled. A total of 19 advertisements were placed on social media, and 385 promotional emails were sent to schools, contacts within known networks, and relevant youth organizations. Social media advertisements reached 408,077 unique accounts. Advertisements mostly reached those living in populous states in Australia (306,489/408,077, 75.11\% of unique accounts) and those identifying as female (177,698/408,077, 43.55\% of unique accounts). A total of 24.97\% (101,907/408,077) of advertisements were delivered to accounts with uncategorized genders. The total cost per participant enrolled was Aus \$3.89 (approximately US \$2.58). Most participants (1980/2305, 85.90\%) found out about this study through Instagram. Differences in screening characteristics between eligible participants who did and did not enroll were found to be statistically significant for gender (P=.02), with fewer males and more individuals reporting their gender as ``other'' enrolling than expected by chance alone. The recruitment method also differed (P<.001), with fewer participants enrolling through Instagram and more enrolling through other methods (eg, known networks or word of mouth) than expected by chance alone. Conclusions: This study found that virtual clinical trial recruitment was found to be low-cost, with the potential to increase trial participation. Social media was the most effective recruitment method, reaching all states and territories, including hard-to-reach populations. Future action is needed to explore recruitment methods that are more effective for males and to build trust among adolescents regarding clinical trial recruitment via social media. Trial Registration: Australia New Zealand Clinical Trials Registry ACTRN12622000949785; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383576\&isReview=true ", doi="10.2196/62919", url="https://pediatrics.jmir.org/2024/1/e62919" } @Article{info:doi/10.2196/60193, author="Linden-Carmichael, Ashley and Stull, W. Samuel and Wang, Danny and Bhandari, Sandesh and Lanza, T. Stephanie", title="Impact of Providing a Personalized Data Dashboard on Ecological Momentary Assessment Compliance Among College Students Who Use Substances: Pilot Microrandomized Trial", journal="JMIR Form Res", year="2024", month="Dec", day="5", volume="8", pages="e60193", keywords="ecological momentary assessment", keywords="data dashboard", keywords="study compliance", keywords="substance use", keywords="substance use behavior", keywords="college student", keywords="alcohol", keywords="cannabis", keywords="cannabis use", keywords="personalized data dashboard", keywords="EMA protocol", keywords="EMA", keywords="health behaviors", keywords="survey", keywords="compliance", keywords="self-reported", abstract="Background: The landscape of substance use behavior among young adults has observed rapid changes over time. Intensive longitudinal designs are ideal for examining and intervening in substance use behavior in real time but rely on high participant compliance in the study protocol, representing a significant challenge for researchers. Objective: This study aimed to evaluate the effect of including a personalized data dashboard (DD) in a text-based survey prompt on study compliance outcomes among college students participating in a 21-day ecological momentary assessment (EMA) study. Methods: Participants (N=91; 61/91, 67\% female and 84/91, 92\% White) were college students who engaged in recent alcohol and cannabis use. Participants were randomized to either complete a 21-day EMA protocol with 4 prompts/d (EMA Group) or complete the same EMA protocol with 1 personalized message and a DD indicating multiple metrics of progress in the study, delivered at 1 randomly selected prompt/d (EMA+DD Group) via a microrandomized design. Study compliance, completion time, self-reported protocol experiences, and qualitative responses were assessed for both groups. Results: Levels of compliance were similar across groups. Participants in the EMA+DD Group had overall faster completion times, with significant week-level differences in weeks 2 and 3 of the study (P=.047 and P=.03, respectively). Although nonsignificant, small-to-medium effect sizes were observed when comparing the groups in terms of compensation level (P=.08; Cohen w=0.19) and perceived burden (P=.09; Cohen d=-0.36). Qualitative findings revealed that EMA+DD participants perceived that seeing their progress facilitated engagement. Within the EMA+DD Group, providing a DD at the moment level did not significantly impact participants' likelihood of completing the EMA or completion time at that particular prompt (all P>.05), with the exception of the first prompt of the day (P=.01 and P<.001). Conclusions: Providing a DD may be useful to increase engagement, particularly for researchers aiming to assess health behaviors shortly after a survey prompt is deployed to participants' mobile devices. International Registered Report Identifier (IRRID): RR2-10.2196/57664 ", doi="10.2196/60193", url="https://formative.jmir.org/2024/1/e60193" } @Article{info:doi/10.2196/51877, author="Ma, Chunxuan and Adler, H. Rachel and Neidre, B. Daria and Chen, C. Ronald and Northouse, L. Laurel and Rini, Christine and Tan, Xianming and Song, Lixin", title="Challenges and Approaches to Recruitment for and Retention in a Dyad-Focused eHealth Intervention During COVID-19: Randomized Controlled Trial", journal="J Med Internet Res", year="2024", month="Dec", day="3", volume="26", pages="e51877", keywords="randomized controlled trials", keywords="RCT", keywords="prostate cancer", keywords="accrual", keywords="retention", keywords="COVID-19 pandemic", keywords="family-based research", abstract="Background: Family-based randomized controlled trials (RCTs) encounter recruitment and retention challenges. Cancer-focused RCTs typically recruit convenience samples from local cancer centers and hospitals. Objective: This study aimed to examine the recruitment and retention of a population-based, patient-partner dyad cohort in an RCT testing a dyadic eHealth intervention to improve the quality of life in patients with prostate cancer and their partners. Methods: In this 2-arm, parallel-group RCT, men who recently completed treatment for localized prostate cancer statewide were recruited through North Carolina Central Cancer Registry rapid case ascertainment between April 2018 and April 2021, coinciding with the COVID-19 pandemic. Patient-partner dyads underwent baseline assessments and were randomly assigned to either the intervention or control groups. Follow-up surveys were conducted at 4, 8, and 12 months after baseline. Descriptive and logistic regression analyses were used to achieve the study's aims. Results: Of the 3078 patients referred from rapid case ascertainment, 2899 were screened. A total of 357 partners were approached after obtaining the eligible patients' permission, 280 dyads completed baseline assessments and were randomized (dyad enrollment rate: 85.11\%, 95\% CI 81.3\%-88.9\%), and 221 dyads completed the 12-month follow-up (retention rate: 78.93\%, 95\% CI 74.2\%-83.7\%). Regarding the factors associated with retention, compared with White participants, people self-reporting as ``other races'' (including American Indian, Asian, and multiracial) were more likely to drop out of the study (odds ratio 2.78, 95\% CI 1.10-7.04), and older participants were less likely to withdraw (odds ratio 0.96, 95\% CI 0.92-0.99). Conclusions: Despite the negative impact of the pandemic, we successfully recruited enough patient-partner dyads to test our RCT hypotheses. Our recruitment and retention rates were equivalent to or higher than those in most dyadic intervention studies. A well-functioning research team and specific strategies (eg, eHealth intervention, internet phone, and online surveys) facilitated the recruitment and retention of patients with prostate cancer and their partners during the unprecedented pandemic. Trial Registration: ClinicalTrials.gov NCT03489057; https://clinicaltrials.gov/study/NCT03489057 International Registered Report Identifier (IRRID): RR2-https://doi.org/10.1186/s13063-021-05948-5 ", doi="10.2196/51877", url="https://www.jmir.org/2024/1/e51877", url="http://www.ncbi.nlm.nih.gov/pubmed/39625741" } @Article{info:doi/10.2196/63032, author="Herman, M. Patricia and Slaughter, E. Mary and Qureshi, Nabeel and Azzam, Tarek and Cella, David and Coulter, D. Ian and DiGuiseppi, Graham and Edelen, Orlando Maria and Kapteyn, Arie and Rodriguez, Anthony and Rubinstein, Max and Hays, D. Ron", title="Comparing Health Survey Data Cost and Quality Between Amazon's Mechanical Turk and Ipsos' KnowledgePanel: Observational Study", journal="J Med Internet Res", year="2024", month="Nov", day="29", volume="26", pages="e63032", keywords="data collection", keywords="probability panel", keywords="convenience sample", keywords="data quality", keywords="weighting", keywords="back pain", keywords="misrepresentation", keywords="Amazon", keywords="Mechanical Turk", keywords="MTurk", keywords="convenience panel", keywords="KnowledgePanel", abstract="Background: Researchers have many options for web-based survey data collection, ranging from access to curated probability-based panels, where individuals are selectively invited to join based on their membership in a representative population, to convenience panels, which are open for anyone to join. The mix of respondents available also varies greatly regarding representation of a population of interest and in motivation to provide thoughtful and accurate responses. Despite the additional dataset-building labor required of the researcher, convenience panels are much less expensive than probability-based panels. However, it is important to understand what may be given up regarding data quality for those cost savings. Objective: This study examined the relative costs and data quality of fielding equivalent surveys on Amazon's Mechanical Turk (MTurk), a convenience panel, and KnowledgePanel, a nationally representative probability-based panel. Methods: We administered the same survey measures to MTurk (in 2021) and KnowledgePanel (in 2022) members. We applied several recommended quality assurance steps to enhance the data quality achieved using MTurk. Ipsos, the owner of KnowledgePanel, followed their usual (industry standard) protocols. The survey was designed to support psychometric analyses and included >60 items from the Patient-Reported Outcomes Measurement Information System (PROMIS), demographics, and a list of health conditions. We used 2 fake conditions (``syndomitis'' and ``chekalism'') to identify those more likely to be honest respondents. We examined the quality of each platform's data using several recommended metrics (eg, consistency, reliability, representativeness, missing data, and correlations) including and excluding those respondents who had endorsed a fake condition and examined the impact of weighting on representativeness. Results: We found that prescreening in the MTurk sample (removing those who endorsed a fake health condition) improved data quality but KnowledgePanel data quality generally remained superior. While MTurk's unweighted point estimates for demographics exhibited the usual mismatch with national averages (younger, better educated, and lower income), weighted MTurk data matched national estimates. KnowledgePanel's point estimates better matched national benchmarks even before poststratification weighting. Correlations between PROMIS measures and age and income were similar in MTurk and KnowledgePanel; the mean absolute value of the difference between each platform's 137 correlations was 0.06, and 92\% were <0.15. However, correlations between PROMIS measures and educational level were dramatically different; the mean absolute value of the difference across these 17 correlation pairs was 0.15, the largest difference was 0.29, and the direction of more than half of these relationships in the MTurk sample was the opposite from that expected from theory. Therefore, caution is needed if using MTurk for studies where educational level is a key variable. Conclusions: The data quality of our MTurk sample was often inferior to that of the KnowledgePanel sample but possibly not so much as to negate the benefits of its cost savings for some uses. International Registered Report Identifier (IRRID): RR2-10.1186/s12891-020-03696-2 ", doi="10.2196/63032", url="https://www.jmir.org/2024/1/e63032" } @Article{info:doi/10.2196/57747, author="Afolabi, Aliyyat and Cheung, Elaine and Lyu, Chen Joanne and Ling, M. Pamela", title="Short-Form Video Informed Consent Compared With Written Consent for Adolescents and Young Adults: Randomized Experiment", journal="JMIR Form Res", year="2024", month="Nov", day="22", volume="8", pages="e57747", keywords="health communication", keywords="video informed consent", keywords="randomized experiment", keywords="informed consent", keywords="adolescent", keywords="video", keywords="consent", keywords="e-cigarette", keywords="vaping", keywords="health research", keywords="social media", keywords="vaping cessation", keywords="smoking cessation", abstract="Background: Adolescents and young adults have the highest prevalence of e-cigarette use (``vaping''), but they are difficult to enroll in health research studies. Previous studies have found that video consent can improve comprehension and make informed consent procedures more accessible, but the videos in previous studies are much longer than videos on contemporary social media platforms that are popular among young people. Objective: This study aimed to examine the effectiveness of a short-form (90-second) video consent compared with a standard written consent for a vaping cessation study for adolescents and young adults. Methods: We conducted a web-based experiment with 435 adolescents and young adults (aged 13-24 years) recruited by a web-based survey research provider. Each participant was randomly assigned to view either a short-form video consent or a written consent form describing a behavioral study of a social media--based vaping cessation program. Participants completed a postexposure survey measuring three outcomes: (1) comprehension of the consent information, (2) satisfaction with the consent process, and (3) willingness to participate in the described study. Independent sample 2-tailed t tests and chi-square tests were conducted to compare the outcomes between the 2 groups. Results: In total, 435 cases comprised the final analytic sample (video: n=215, 49.4\%; written: n=220, 50.6\%). There was no significant difference in characteristics between the 2 groups (all P>.05). Participants who watched the short-form video completed the consent review and postconsent survey process in less time (average 4.5 minutes) than those in the written consent group (5.1 minutes). A total of 83.2\% (179/215) of the participants in the video consent condition reported satisfaction with the overall consent process compared with 76.3\% (168/220) in the written consent condition (P=.047). There was no difference in the ability to complete consent unassisted and satisfaction with the amount of time between study conditions. There was no difference in the composite measure of overall comprehension, although in individual measures, participants who watched the short-form video consent performed better in 4 measures of comprehension about risk, privacy, and procedures, while participants who read the written document consent had better comprehension of 2 measures of study procedures. There was no difference between the groups in willingness to participate in the described study. Conclusions: Short-form informed consent videos had similar comprehension and satisfaction with the consent procedure among adolescents and young adults. Short-form informed consent videos may be a feasible and acceptable alternative to the standard written consent process, although video and written consent forms have different strengths with respect to comprehension. Because they match how young people consume media, short-form videos may be particularly well suited for adolescents and young adults participating in research. ", doi="10.2196/57747", url="https://formative.jmir.org/2024/1/e57747", url="http://www.ncbi.nlm.nih.gov/pubmed/39576682" } @Article{info:doi/10.2196/58771, author="Qureshi, Nabeel and Hays, D. Ron and Herman, M. Patricia", title="Dropout in a Longitudinal Survey of Amazon Mechanical Turk Workers With Low Back Pain: Observational Study", journal="Interact J Med Res", year="2024", month="Nov", day="11", volume="13", pages="e58771", keywords="chronic low back pain", keywords="Mechanical Turk", keywords="MTurk", keywords="survey attrition", keywords="survey weights", keywords="Amazon", keywords="occupational health", keywords="manual labor", abstract="Background: Surveys of internet panels such as Amazon's Mechanical Turk (MTurk) are common in health research. Nonresponse in longitudinal studies can limit inferences about change over time. Objective: This study aimed to (1) describe the patterns of survey responses and nonresponse among MTurk members with back pain, (2) identify factors associated with survey response over time, (3) assess the impact of nonresponse on sample characteristics, and (4) assess how well inverse probability weighting can account for differences in sample composition. Methods: We surveyed adult MTurk workers who identified as having back pain. We report participation trends over 3 survey waves and use stepwise logistic regression to identify factors related to survey participation in successive waves. Results: A total of 1678 adults participated in wave 1. Of those, 983 (59\%) participated in wave 2 and 703 (42\%) in wave 3. Participants who did not drop out took less time to complete previous surveys (30 min vs 35 min in wave 1, P<.001; 24 min vs 26 min in wave 2, P=.02) and reported having fewer health conditions (5.88 vs 6.6, P<.001). In multivariate models predicting responding at wave 2, lower odds of participation were associated with more time to complete the baseline survey (odds ratio [OR] 0.98, 95\% CI 0.97-0.99), being Hispanic (compared with non-Hispanic, OR 0.69, 95\% CI 0.49-0.96), having a bachelor's degree as their terminal degree (compared with all other levels of education, OR 0.58, 95\% CI 0.46-0.73), having more pain interference and intensity (OR 0.75, 95\% CI 0.64-0.89), and having more health conditions. In contrast, older respondents (older than 45 years age compared with 18-24 years age) were more likely to respond to the wave 2 survey (OR 2.63 and 3.79, respectively) and those whose marital status was divorced (OR 1.81) and separated (OR 1.77) were also more likely to respond to the wave 2 survey. Weighted analysis showed slight differences in sample demographics and conditions and larger differences in pain assessments, particularly for those who responded to wave 2. Conclusions: Longitudinal studies on MTurk have large, differential dropouts between waves. This study provided information about the individuals more likely to drop out over time, which can help researchers prepare for future surveys. ", doi="10.2196/58771", url="https://www.i-jmr.org/2024/1/e58771" } @Article{info:doi/10.2196/57165, author="Xiong, Eddy and Bonner, Carissa and King, Amanda and Bourne, Maxwell Zoltan and Morgan, Mark and Tolosa, Ximena and Stanton, Tony and Greaves, Kim", title="Insights From the Development of a Dynamic Consent Platform for the Australians Together Health Initiative (ATHENA) Program: Interview and Survey Study", journal="JMIR Form Res", year="2024", month="Nov", day="6", volume="8", pages="e57165", keywords="dynamic consent", keywords="research", keywords="clinical trials", keywords="consumer engagement", keywords="digital consent", keywords="development", keywords="decision making", keywords="decision", keywords="feedback", keywords="user platform", keywords="users", keywords="communication", abstract="Background: Dynamic consent has the potential to address many of the issues facing traditional paper-based or electronic consent, including enrolling informed and engaged participants in the decision-making process. The Australians Together Health Initiative (ATHENA) program aims to connect participants across Queensland, Australia, with new research opportunities. At its core is dynamic consent, an interactive and participant-centric digital platform that enables users to view ongoing research activities, update consent preferences, and have ongoing engagement with researchers. Objective: This study aimed to describe the development of the ATHENA dynamic consent platform within the framework of the ATHENA program, including how the platform was designed, its utilization by participants, and the insights gained. Methods: One-on-one interviews were undertaken with consumers, followed by a workshop with health care staff to gain insights into the dynamic consent concept. Five problem statements were developed, and solutions were posed, from which a dynamic consent platform was constructed, tested, and used for implementation in a clinical trial. Potential users were randomly recruited from a pre-existing pool of 615 participants in the ATHENA program. Feedback on user platform experience was gained from a survey hosted on the platform. Results: In the 13 consumer interviews undertaken, participants were positive about dynamic consent, valuing privacy, ease of use, and adequate communication. Motivators for registration were feedback on data usage and its broader community benefits. Problem statements were security, trust and governance, ease of use, communication, control, and need for a scalable platform. Using the newly constructed dynamic consent platform, 99 potential participants were selected, of whom 67 (68\%) were successfully recontacted. Of these, 59 (88\%) agreed to be sent the platform, 44 (74\%) logged on (indicating use), and 22 (57\%) registered for the clinical trial. Survey feedback was favorable, with an average positive rating of 78\% across all questions, reflecting satisfaction with the clarity, brevity, and flexibility of the platform. Barriers to implementation included technological and health literacy. Conclusions: This study describes the successful development and testing of a dynamic consent platform that was well-accepted, with users recognizing its advantages over traditional methods of consent regarding flexibility, ease of communication, and participant satisfaction. This information may be useful to other researchers who plan to use dynamic consent in health care research. ", doi="10.2196/57165", url="https://formative.jmir.org/2024/1/e57165" } @Article{info:doi/10.2196/58136, author="Ackermann, Deonna and Hersch, Jolyn and Jordan, Dana and Clinton-Gray, Emily and Bracken, Karen and Janda, Monika and Turner, Robin and Bell, Katy", title="Participant Motivators and Expectations in the MEL-SELF Randomized Clinical Trial of Patient-Led Surveillance for Recurrent Melanoma: Content Analysis of Survey Responses", journal="JMIR Dermatol", year="2024", month="Oct", day="17", volume="7", pages="e58136", keywords="teledermatology", keywords="melanoma", keywords="randomized controlled trial", keywords="trial recruitment and retention", keywords="studies within a trial", keywords="SWATs", keywords="dermatology", keywords="cancer", keywords="early detection", keywords="dermatology clinical trials", keywords="clinical trials", keywords="mobile phone", abstract="Background: Limited data exist on the motivations and expectations of participants when enrolling in dermatology clinical trials, including melanoma early detection trials. Understanding participant motivators for research engagement has been identified as a prioritized area for trial methodology research. Objective: The study aimed to determine motivators of participation and expectations from trial involvement among patients enrolled in the MEL-SELF randomized clinical trial of patient-led surveillance for new or recurrent melanoma. Methods: The MEL-SELF trial is recruiting patients previously treated for localized melanoma, who own a smartphone, have a partner to assist with skin self-examination (SSE), and attend routinely scheduled follow-up at specialist and primary care skin clinics in Australia. We evaluated responses from the first 100 randomized participants to 2 open-ended questions about their motivations and expectations for participating in the trial, administered through the internet-based baseline questionnaire. A total of 3 coders independently coded the free-text responses and resolved discrepancies through consensus. Qualitative content analysis by an iterative process was used to group responses into themes. Responses from potential participants who were not randomized and the 404 participants randomized subsequently into the trial, were also checked for new themes. Coding and analysis were conducted in Microsoft Excel. Results: Out of the 100 survey participants, 98 (98\%) answered at least 1 of the 2 questions. Overall, responses across the motivation and expectation items indicated 3 broad themes: community benefit, perceived personal benefit, and trusting relationship with their health care provider. The most common motivators for participation were related to community benefit. These included progressing medical research, benefitting future melanoma patients who may have similar experiences, and broader altruistic sentiments such as ``helping others'' or ``giving back.'' The most common expectations from the trial related to personal benefit. These included perceived improved outcomes such as earlier diagnosis and treatment, access to additional care, and increased self-empowerment to take actions themselves that benefit their health. Patients expressed a desire to gain health-related knowledge and skills and were interested in the potential advantages of teledermatology. There were no new themes in responses from those who were not randomized or were randomized subsequent to the first 100. Conclusions: We report a tailorable, patient-focused approach to identify drivers of research engagement in clinical research. Clinical trials offer an opportunity to collate a substantial evidence base on determinants of research participation and to identify context-specific factors. Results from the MEL-SELF trial emphasized notable altruism, self-empowerment, and perceived advantages of teledermatology as specific motivators. These findings informed consent processes, recruitment, retention, response to trial tasks, and intervention adherence for the MEL-SELF host trial. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000176864.https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379527\& ", doi="10.2196/58136", url="https://derma.jmir.org/2024/1/e58136" } @Article{info:doi/10.2196/51751, author="Wright, L. Amy and Willett, Jayne Ysabella and Ferron, Mae Era and Kumarasamy, Vithusa and Lem, M. Sarah and Ahmed, Ossaid", title="Using Social Media to Recruit Participants in Health Care Research: Case Study", journal="J Med Internet Res", year="2024", month="Oct", day="11", volume="26", pages="e51751", keywords="social media", keywords="qualitative methods", keywords="recruitment strategies", keywords="healthcare research", keywords="digital health", keywords="internet", keywords="", doi="10.2196/51751", url="https://www.jmir.org/2024/1/e51751" } @Article{info:doi/10.2196/49546, author="Agmon, Shunit and Singer, Uriel and Radinsky, Kira", title="Leveraging Temporal Trends for Training Contextual Word Embeddings to Address Bias in Biomedical Applications: Development Study", journal="JMIR AI", year="2024", month="Oct", day="2", volume="3", pages="e49546", keywords="natural language processing", keywords="NLP", keywords="BERT", keywords="word embeddings", keywords="statistical models", keywords="bias", keywords="algorithms", keywords="gender", abstract="Background: Women have been underrepresented in clinical trials for many years. Machine-learning models trained on clinical trial abstracts may capture and amplify biases in the data. Specifically, word embeddings are models that enable representing words as vectors and are the building block of most natural language processing systems. If word embeddings are trained on clinical trial abstracts, predictive models that use the embeddings will exhibit gender performance gaps. Objective: We aim to capture temporal trends in clinical trials through temporal distribution matching on contextual word embeddings (specifically, BERT) and explore its effect on the bias manifested in downstream tasks. Methods: We present TeDi-BERT, a method to harness the temporal trend of increasing women's inclusion in clinical trials to train contextual word embeddings. We implement temporal distribution matching through an adversarial classifier, trying to distinguish old from new clinical trial abstracts based on their embeddings. The temporal distribution matching acts as a form of domain adaptation from older to more recent clinical trials. We evaluate our model on 2 clinical tasks: prediction of unplanned readmission to the intensive care unit and hospital length of stay prediction. We also conduct an algorithmic analysis of the proposed method. Results: In readmission prediction, TeDi-BERT achieved area under the receiver operating characteristic curve of 0.64 for female patients versus the baseline of 0.62 (P<.001), and 0.66 for male patients versus the baseline of 0.64 (P<.001). In the length of stay regression, TeDi-BERT achieved a mean absolute error of 4.56 (95\% CI 4.44-4.68) for female patients versus 4.62 (95\% CI 4.50-4.74, P<.001) and 4.54 (95\% CI 4.44-4.65) for male patients versus 4.6 (95\% CI 4.50-4.71, P<.001). Conclusions: In both clinical tasks, TeDi-BERT improved performance for female patients, as expected; but it also improved performance for male patients. Our results show that accuracy for one gender does not need to be exchanged for bias reduction, but rather that good science improves clinical results for all. Contextual word embedding models trained to capture temporal trends can help mitigate the effects of bias that changes over time in the training data. ", doi="10.2196/49546", url="https://ai.jmir.org/2024/1/e49546" } @Article{info:doi/10.2196/56048, author="Hoadley, Ariel and Fleisher, Linda and Kenny, Cassidy and Kelly, JA Patrick and Ma, Xinrui and Wu, Jingwei and Guerra, Carmen and Leader, E. Amy and Alhajji, Mohammed and D'Avanzo, Paul and Landau, Zoe and Bass, Bauerle Sarah", title="Exploring Racial Disparities in Awareness and Perceptions of Oncology Clinical Trials: Cross-Sectional Analysis of Baseline Data From the mychoice Study", journal="JMIR Cancer", year="2024", month="Sep", day="30", volume="10", pages="e56048", keywords="oncology clinical trial", keywords="cancer", keywords="decision-making", keywords="racial disparity", keywords="medical mistrust", abstract="Background: Black/African American adults are underrepresented in oncology clinical trials in the United States, despite efforts at narrowing this disparity. Objective: This study aims to explore differences in how Black/African American oncology patients perceive clinical trials to improve support for the clinical trial participation decision-making process. Methods: As part of a larger randomized controlled trial, a total of 244 adult oncology patients receiving active treatment or follow-up care completed a cross-sectional baseline survey on sociodemographic characteristics, clinical trial knowledge, health literacy, perceptions of cancer clinical trials, patient activation, patient advocacy, health care self-efficacy, decisional conflict, and clinical trial intentions. Self-reported race was dichotomized into Black/African American and non--Black/African American. As appropriate, 2-tailed t tests and chi-square tests of independence were used to examine differences between groups. Results: Black/African American participants had lower clinical trial knowledge (P=.006), lower health literacy (P<.001), and more medical mistrust (all P values <.05) than non--Black/African American participants. While intentions to participate in a clinical trial, if offered, did not vary between Black/African American and non--Black/African American participants, Black/African American participants indicated lower awareness of clinical trials, fewer benefits of clinical trials, and more uncertainty around clinical trial decision-making (all P values <.05). There were no differences for other variables. Conclusions: Despite no significant differences in intent to participate in a clinical trial if offered and high overall trust in individual health care providers among both groups, beliefs persist about barriers to and benefits of clinical trial participation among Black/African American patients. Findings highlight specific ways that education and resources about clinical trials could be tailored to better suit the informational and decision-making needs and preferences of Black/African American oncology patients. ", doi="10.2196/56048", url="https://cancer.jmir.org/2024/1/e56048" } @Article{info:doi/10.2196/56872, author="Stein, Alexandra and Blasini, Romina and Strantz, Cosima and Fitzer, Kai and Gulden, Christian and Leddig, Torsten and Hoffmann, Wolfgang", title="User Requirements for an Electronic Patient Recruitment System: Semistructured Interview Analysis After First Implementation in 3 German University Hospitals", journal="JMIR Hum Factors", year="2024", month="Sep", day="27", volume="11", pages="e56872", keywords="patient recruitment system", keywords="clinical trial recruitment support system", keywords="clinical trials", keywords="recruit", keywords="recruitment", keywords="recruiting", keywords="participant", keywords="participants", keywords="research", keywords="digital health", keywords="usability", keywords="interview", keywords="interviews", keywords="qualitative", keywords="experience", keywords="experiences", keywords="attitude", keywords="attitudes", keywords="opinion", keywords="perception", keywords="perceptions", keywords="perspective", keywords="perspectives", keywords="database", keywords="databases", keywords="information system", keywords="information systems", keywords="search", keywords="searches", keywords="searching", keywords="retrieval", abstract="Background: Clinical trials are essential for medical research and medical progress. Nevertheless, trials often fail to reach their recruitment goals. Patient recruitment systems aim to support clinical trials by providing an automated search for eligible patients in the databases of health care institutions like university hospitals. To integrate patient recruitment systems into existing workflows, previous works have assessed user requirements for these tools. In this study, we tested patient recruitment systems KAS+ and recruIT as part of the MIRACUM (Medical Informatics in Research and Care in University Medicine) project. Objective: Our goal was to investigate whether and to what extent the 2 different evaluated tools can meet the requirements resulting from the first requirements analysis, which was performed in 2018-2019. A user survey was conducted to determine whether the tools are usable in practice and helpful for the trial staff. Furthermore, we investigated whether the test phase revealed further requirements for recruitment tools that were not considered in the first place. Methods: We performed semistructured interviews with 10 participants in 3 German university hospitals who used the patient recruitment tools KAS+ or recruIT for at least 1 month with currently recruiting trials. Thereafter, the interviews were transcribed and analyzed by Meyring method. The identified statements of the interviewees were categorized into 5 groups of requirements and sorted by their frequency. Results: The evaluated recruIT and KAS+ tools fulfilled 7 and 11 requirements of the 12 previously identified requirements, respectively. The interviewed participants mentioned the need for different notification schedules, integration into their workflow, different patient characteristics, and pseudonymized screening lists. This resulted in a list of new requirements for the implementation or enhancement of patient recruitment systems. Conclusions: Trial staff report a huge need of support for the identification of eligible trial participants. Moreover, the workflows in patient recruitment differ across trials. For better suitability of the recruitment systems in the workflow of different kinds of trials, we recommend the implementation of an adjustable notification schedule for screening lists, a detailed workflow analysis, broad patient filtering options, and the display of all information needed to identify the persons on the list. Despite criticisms, all participants confirmed to use the patient recruitment systems again. ", doi="10.2196/56872", url="https://humanfactors.jmir.org/2024/1/e56872" } @Article{info:doi/10.2196/58578, author="Chen, David and Cao, Christian and Kloosterman, Robert and Parsa, Rod and Raman, Srinivas", title="Trial Factors Associated With Completion of Clinical Trials Evaluating AI: Retrospective Case-Control Study", journal="J Med Internet Res", year="2024", month="Sep", day="23", volume="26", pages="e58578", keywords="artificial intelligence", keywords="clinical trial", keywords="completion", keywords="AI", keywords="cross-sectional study", keywords="application", keywords="intervention", keywords="trial design", keywords="logistic regression", keywords="Europe", keywords="clinical", keywords="trials testing", keywords="health care", keywords="informatics", keywords="health information", abstract="Background: Evaluation of artificial intelligence (AI) tools in clinical trials remains the gold standard for translation into clinical settings. However, design factors associated with successful trial completion and the common reasons for trial failure are unknown. Objective: This study aims to compare trial design factors of complete and incomplete clinical trials testing AI tools. We conducted a case-control study of complete (n=485) and incomplete (n=51) clinical trials that evaluated AI as an intervention of ClinicalTrials.gov. Methods: Trial design factors, including area of clinical application, intended use population, and intended role of AI, were extracted. Trials that did not evaluate AI as an intervention and active trials were excluded. The assessed trial design factors related to AI interventions included the domain of clinical application related to organ systems; intended use population for patients or health care providers; and the role of AI for different applications in patient-facing clinical workflows, such as diagnosis, screening, and treatment. In addition, we also assessed general trial design factors including study type, allocation, intervention model, masking, age, sex, funder, continent, length of time, sample size, number of enrollment sites, and study start year. The main outcome was the completion of the clinical trial. Odds ratio (OR) and 95\% CI values were calculated for all trial design factors using propensity-matched, multivariable logistic regression. Results: We queried ClinicalTrials.gov on December 23, 2023, using AI keywords to identify complete and incomplete trials testing AI technologies as a primary intervention, yielding 485 complete and 51 incomplete trials for inclusion in this study. Our nested propensity-matched, case-control results suggest that trials conducted in Europe were significantly associated with trial completion when compared with North American trials (OR 2.85, 95\% CI 1.14-7.10; P=.03), and the trial sample size was positively associated with trial completion (OR 1.00, 95\% CI 1.00-1.00; P=.02). Conclusions: Our case-control study is one of the first to identify trial design factors associated with completion of AI trials and catalog study-reported reasons for AI trial failure. We observed that trial design factors positively associated with trial completion include trials conducted in Europe and sample size. Given the promising clinical use of AI tools in health care, our results suggest that future translational research should prioritize addressing the design factors of AI clinical trials associated with trial incompletion and common reasons for study failure. ", doi="10.2196/58578", url="https://www.jmir.org/2024/1/e58578", url="http://www.ncbi.nlm.nih.gov/pubmed/39312296" } @Article{info:doi/10.2196/55354, author="Sturgiss, Elizabeth and Advocat, Jenny and Barton, Christopher and Walker, N. Emma and Nielsen, Suzanne and Wright, Annemarie and Lam, Tina and Gunatillaka, Nilakshi and Oad, Symrin and Wood, Christopher", title="Using Text Messaging Surveys in General Practice Research to Engage With People From Low-Income Groups: Multi-Methods Study", journal="JMIR Mhealth Uhealth", year="2024", month="Sep", day="5", volume="12", pages="e55354", keywords="SMS", keywords="data collection", keywords="research methods", keywords="disadvantaged population", keywords="priority populations", keywords="message", keywords="messages", keywords="messaging", keywords="disadvantaged", keywords="underserved", keywords="survey", keywords="surveys", keywords="digital divide", keywords="marginalized", keywords="access", keywords="accessibility", keywords="barrier", keywords="barriers", keywords="smartphone", keywords="smartphones", keywords="digital health", keywords="underrepresented", keywords="mobile phone", keywords="short message service", abstract="Background: SMS text messages through mobile phones are a common means of interpersonal communication. SMS text message surveys are gaining traction in health care and research due to their feasibility and patient acceptability. However, challenges arise in implementing SMS text message surveys, especially when targeting marginalized populations, because of barriers to accessing phones and data as well as communication difficulties. In primary care, traditional surveys (paper-based and online) often face low response rates that are particularly pronounced among disadvantaged groups due to financial limitations, language barriers, and time constraints. Objective: This study aimed to investigate the potential of SMS text message--based patient recruitment and surveys within general practices situated in lower socioeconomic areas. This study was nested within the Reducing Alcohol-Harm in General Practice project that aimed to reduce alcohol-related harm through screening in Australian general practice. Methods: This study follows a 2-step SMS text message data collection process. An initial SMS text message with an online survey link was sent to patients, followed by subsequent surveys every 3 months for consenting participants. Interviews were conducted with the local primary health network organization staff, the participating practice staff, and the clinicians. The qualitative data were analyzed using constructs from the Consolidated Framework for Implementation Research. Results: Out of 6 general practices, 4 were able to send SMS text messages to their patients. The initial SMS text message was sent to 8333 patients and 702 responses (8.2\%) were received, most of which were not from a low-income group. This low initial response was in contrast to the improved response rate to the ongoing 3-month SMS text message surveys (55/107, 51.4\% at 3 months; 29/67, 43.3\% at 6 months; and 44/102, 43.1\% at 9 months). We interviewed 4 general practitioners, 4 nurses, and 4 administrative staff from 5 of the different practices. Qualitative data uncovered barriers to engaging marginalized groups including limited smartphone access, limited financial capacity (telephone, internet, and Wi-Fi credit), language barriers, literacy issues, mental health conditions, and physical limitations such as manual dexterity and vision issues. Practice managers and clinicians suggested strategies to overcome these barriers, including using paper-based surveys in trusted spaces, offering assistance during survey completion, and offering honoraria to support participation. Conclusions: While SMS text message surveys for primary care research may be useful for the broader population, additional efforts are required to ensure the representation and involvement of marginalized groups. More intensive methods such as in-person data collection may be more appropriate to capture the voice of low-income groups in primary care research. International Registered Report Identifier (IRRID): RR2-10.3399/BJGPO.2021.0037 ", doi="10.2196/55354", url="https://mhealth.jmir.org/2024/1/e55354", url="http://www.ncbi.nlm.nih.gov/pubmed/39235843" } @Article{info:doi/10.2196/54621, author="Yang, Meicheng and Zhuang, Jinqiang and Hu, Wenhan and Li, Jianqing and Wang, Yu and Zhang, Zhongheng and Liu, Chengyu and Chen, Hui", title="Enhancing Patient Selection in Sepsis Clinical Trials Design Through an AI Enrichment Strategy: Algorithm Development and Validation", journal="J Med Internet Res", year="2024", month="Sep", day="4", volume="26", pages="e54621", keywords="sepsis", keywords="enrichment strategy", keywords="disease progression trajectories", keywords="artificial intelligence", keywords="predictive modeling", keywords="conformal prediction", abstract="Background: Sepsis is a heterogeneous syndrome, and enrollment of more homogeneous patients is essential to improve the efficiency of clinical trials. Artificial intelligence (AI) has facilitated the identification of homogeneous subgroups, but how to estimate the uncertainty of the model outputs when applying AI to clinical decision-making remains unknown. Objective: We aimed to design an AI-based model for purposeful patient enrollment, ensuring that a patient with sepsis recruited into a trial would still be persistently ill by the time the proposed therapy could impact patient outcome. We also expected that the model could provide interpretable factors and estimate the uncertainty of the model outputs at a customized confidence level. Methods: In this retrospective study, 9135 patients with sepsis requiring vasopressor treatment within 24 hours after sepsis onset were enrolled from Beth Israel Deaconess Medical Center. This cohort was used for model development, and 10-fold cross-validation with 50 repeats was used for internal validation. In total, 3743 patients with sepsis from the eICU Collaborative Research Database were used as the external validation cohort. All included patients with sepsis were stratified based on disease progression trajectories: rapid death, recovery, and persistent ill. A total of 148 variables were selected for predicting the 3 trajectories. Four machine learning algorithms with 3 different setups were used. We estimated the uncertainty of the model outputs using conformal prediction (CP). The Shapley Additive Explanations method was used to explain the model. Results: The multiclass gradient boosting machine was identified as the best-performing model with good discrimination and calibration performance in both validation cohorts. The mean area under the receiver operating characteristic curve with SD was 0.906 (0.018) for rapid death, 0.843 (0.008) for recovery, and 0.807 (0.010) for persistent ill in the internal validation cohort. In the external validation cohort, the mean area under the receiver operating characteristic curve (SD) was 0.878 (0.003) for rapid death, 0.764 (0.008) for recovery, and 0.696 (0.007) for persistent ill. The maximum norepinephrine equivalence, total urine output, Acute Physiology Score III, mean systolic blood pressure, and the coefficient of variation of oxygen saturation contributed the most. Compared to the model without CP, using the model with CP at a mixed confidence approach reduced overall prediction errors by 27.6\% (n=62) and 30.7\% (n=412) in the internal and external validation cohorts, respectively, as well as enabled the identification of more potentially persistent ill patients. Conclusions: The implementation of our model has the potential to reduce heterogeneity and enroll more homogeneous patients in sepsis clinical trials. The use of CP for estimating the uncertainty of the model outputs allows for a more comprehensive understanding of the model's reliability and assists in making informed decisions based on the predicted outcomes. ", doi="10.2196/54621", url="https://www.jmir.org/2024/1/e54621" } @Article{info:doi/10.2196/47882, author="Copland, R. Rachel and Hanke, Sten and Rogers, Amy and Mpaltadoros, Lampros and Lazarou, Ioulietta and Zeltsi, Alexandra and Nikolopoulos, Spiros and MacDonald, M. Thomas and Mackenzie, S. Isla", title="The Digital Platform and Its Emerging Role in Decentralized Clinical Trials", journal="J Med Internet Res", year="2024", month="Sep", day="3", volume="26", pages="e47882", keywords="decentralized clinical trials", keywords="digital platform", keywords="digitalization", keywords="clinical trials", keywords="mobile phone", doi="10.2196/47882", url="https://www.jmir.org/2024/1/e47882" } @Article{info:doi/10.2196/54450, author="Conley, C. Claire and Rodriguez, D. Jennifer and McIntyre, McKenzie and Niell, L. Bethany and O'Neill, C. Suzanne and Vadaparampil, T. Susan", title="Strategies for Identifying and Recruiting Women at High Risk for Breast Cancer for Research Outside of Clinical Settings: Observational Study", journal="J Med Internet Res", year="2024", month="Sep", day="2", volume="26", pages="e54450", keywords="breast cancer", keywords="high-risk populations", keywords="risk management", keywords="recruitment", keywords="woman", keywords="women", keywords="high risk", keywords="observational study", keywords="cross-sectional", keywords="Facebook", keywords="Twitter", keywords="flyer", keywords="flyers", keywords="community events", keywords="community event", keywords="genetic mutation", abstract="Background: Research is needed to understand and address barriers to risk management for women at high (?20\% lifetime) risk for breast cancer, but recruiting this population for research studies is challenging. Objective: This paper compares a variety of recruitment strategies used for a cross-sectional, observational study of high-risk women. Methods: Eligible participants were assigned female at birth, aged 25-85 years, English-speaking, living in the United States, and at high risk for breast cancer as defined by the American College of Radiology. Individuals were excluded if they had a personal history of breast cancer, prior bilateral mastectomy, medical contraindications for magnetic resonance imaging, or were not up-to-date on screening mammography per American College of Radiology guidelines. Participants were recruited from August 2020 to January 2021 using the following mechanisms: targeted Facebook advertisements, Twitter posts, ResearchMatch (a web-based research recruitment database), community partner promotions, paper flyers, and community outreach events. Interested individuals were directed to a secure website with eligibility screening questions. Participants self-reported method of recruitment during the eligibility screening. For each recruitment strategy, we calculated the rate of eligible respondents and completed surveys, costs per eligible participant, and participant demographics. Results: We received 1566 unique responses to the eligibility screener. Participants most often reported recruitment via Facebook advertisements (724/1566, 46\%) and ResearchMatch (646/1566, 41\%). Community partner promotions resulted in the highest proportion of eligible respondents (24/46, 52\%), while ResearchMatch had the lowest proportion of eligible respondents (73/646, 11\%). Word of mouth was the most cost-effective recruitment strategy (US \$4.66 per completed survey response) and paper flyers were the least cost-effective (US \$1448.13 per completed survey response). The demographic characteristics of eligible respondents varied by recruitment strategy: Twitter posts and community outreach events resulted in the highest proportion of Hispanic or Latina women (1/4, 25\% and 2/6, 33\%, respectively), and community partner promotions resulted in the highest proportion of non-Hispanic Black women (4/24, 17\%). Conclusions: Although recruitment strategies varied in their yield of study participants, results overall support the feasibility of identifying and recruiting women at high risk for breast cancer outside of clinical settings. Researchers must balance the associated costs and participant yield of various recruitment strategies in planning future studies focused on high-risk women. ", doi="10.2196/54450", url="https://www.jmir.org/2024/1/e54450", url="http://www.ncbi.nlm.nih.gov/pubmed/39222344" } @Article{info:doi/10.2196/54034, author="Willem, Theresa and Zimmermann, M. Bettina and Matthes, Nina and Rost, Michael and Buyx, Alena", title="Acceptance of Social Media Recruitment for Clinical Studies Among Patients With Hepatitis B: Mixed Methods Study", journal="J Med Internet Res", year="2024", month="Aug", day="26", volume="26", pages="e54034", keywords="Facebook", keywords="Twitter", keywords="social media", keywords="clinical trial", keywords="enrollment", keywords="health technology acceptance", keywords="ethics", keywords="infectious diseases", keywords="privacy", keywords="data protection", keywords="stigma", keywords="discrimination", abstract="Background: Social media platforms are increasingly used to recruit patients for clinical studies. Yet, patients' attitudes regarding social media recruitment are underexplored. Objective: This mixed methods study aims to assess predictors of the acceptance of social media recruitment among patients with hepatitis B, a patient population that is considered particularly vulnerable in this context. Methods: Using a mixed methods approach, the hypotheses for our survey were developed based on a qualitative interview study with 6 patients with hepatitis B and 30 multidisciplinary experts. Thematic analysis was applied to qualitative interview analysis. For the cross-sectional survey, we additionally recruited 195 patients with hepatitis B from 3 clinical centers in Germany. Adult patients capable of judgment with a hepatitis B diagnosis who understood German and visited 1 of the 3 study centers during the data collection period were eligible to participate. Data analysis was conducted using SPSS (version 28; IBM Corp), including descriptive statistics and regression analysis. Results: On the basis of the qualitative interview analysis, we hypothesized that 6 factors were associated with acceptance of social media recruitment: using social media in the context of hepatitis B (hypothesis 1), digital literacy (hypothesis 2), interest in clinical studies (hypothesis 3), trust in nonmedical (hypothesis 4a) and medical (hypothesis 4b) information sources, perceiving the hepatitis B diagnosis as a secret (hypothesis 5a), attitudes toward data privacy in the social media context (hypothesis 5b), and perceived stigma (hypothesis 6). Regression analysis revealed that the higher the social media use for hepatitis B (hypothesis 1), the higher the interest in clinical studies (hypothesis 3), the more trust in nonmedical information sources (hypothesis 4a), and the less secrecy around a hepatitis B diagnosis (hypothesis 5a), the higher the acceptance of social media as a recruitment tool for clinical hepatitis B studies. Conclusions: This mixed methods study provides the first quantitative insights into social media acceptance for clinical study recruitment among patients with hepatitis B. The study was limited to patients with hepatitis B in Germany but sets out to be a reference point for future studies assessing the attitudes toward and acceptance of social media recruitment for clinical studies. Such empirical inquiries can facilitate the work of researchers designing clinical studies as well as ethics review boards in balancing the risks and benefits of social media recruitment in a context-specific manner. ", doi="10.2196/54034", url="https://www.jmir.org/2024/1/e54034" } @Article{info:doi/10.2196/38189, author="Milliken, Tabitha and Beiler, Donielle and Hoffman, Samantha and Olenginski, Ashlee and Troiani, Vanessa", title="Recruitment in Appalachian, Rural and Older Adult Populations in an Artificial Intelligence World: Study Using Human-Mediated Follow-Up", journal="JMIR Form Res", year="2024", month="Aug", day="22", volume="8", pages="e38189", keywords="telecommunication", keywords="enrollment rate", keywords="Northern Appalachia", keywords="web-based", keywords="aging", keywords="recruitment", keywords="rural", abstract="Background: Participant recruitment in rural and hard-to-reach (HTR) populations can present unique challenges. These challenges are further exacerbated by the need for low-cost recruiting, which often leads to use of web-based recruitment methods (eg, email, social media). Despite these challenges, recruitment strategy statistics that support effective enrollment strategies for underserved and HTR populations are underreported. This study highlights how a recruitment strategy that uses email in combination with follow-up, mostly phone calls and email reminders, produced a higher-than-expected enrollment rate that includes a diversity of participants from rural, Appalachian populations in older age brackets and reports recruitment and demographic statistics within a subset of HTR populations. Objective: This study aims to provide evidence that a recruitment strategy that uses a combination of email, telephonic, and follow-up recruitment strategies increases recruitment rates in various HTR populations, specifically in rural, older, and Appalachian populations. Methods: We evaluated the overall enrollment rate of 1 recruitment arm of a larger study that aims to understand the relationship between genetics and substance use disorders. We evaluated the enrolled population's characteristics to determine recruitment success of a combined email and follow-up recruitment strategy, and the enrollment rate of HTR populations. These characteristics included (1) enrollment rate before versus after follow-up; (2) zip code and county of enrollee to determine rural or urban and Appalachian status; (3) age to verify recruitment in all eligible age brackets; and (4) sex distribution among age brackets and rural or urban status. Results: The email and follow-up arm of the study had a 17.4\% enrollment rate. Of the enrolled participants, 76.3\% (4602/6030) lived in rural counties and 23.7\% (1428/6030) lived in urban counties in Pennsylvania. In addition, of patients enrolled, 98.7\% (5956/6030) were from Appalachian counties and 1.3\% (76/6030) were from non-Appalachian counties. Patients from rural Appalachia made up 76.2\% (4603/6030) of the total rural population. Enrolled patients represented all eligible age brackets from ages 20 to 75 years, with the 60-70 years age bracket having the most enrollees. Females made up 72.5\% (4371/6030) of the enrolled population and males made up 27.5\% (1659/6030) of the population. Conclusions: Results indicate that a web-based recruitment method with participant follow-up, such as a phone call and email follow-up, increases enrollment numbers more than web-based methods alone for rural, Appalachian, and older populations. Adding a humanizing component, such as a live person phone call, may be a key element needed to establish trust and encourage patients from underserved and rural areas to enroll in studies via web-based recruitment methods. Supporting statistics on this recruitment strategy should help researchers identify whether this strategy may be useful in future studies and HTR populations. ", doi="10.2196/38189", url="https://formative.jmir.org/2024/1/e38189" } @Article{info:doi/10.2196/49600, author="Hu, Sisi and Kirkpatrick, E. Ciera and Lee, Namyeon and Hong, Yoorim and Lee, Sungkyoung and Hinnant, Amanda", title="Using Short-Form Videos to Get Clinical Trial Newcomers to Sign Up: Message-Testing Experiment", journal="J Med Internet Res", year="2024", month="Aug", day="15", volume="26", pages="e49600", keywords="clinical trial recruitment", keywords="TikTok", keywords="source credibility", keywords="framing", keywords="psychological barriers", keywords="logistical barriers", keywords="integrated behavioral model", keywords="short-form videos", keywords="social media use", keywords="clinical trial", keywords="recruitment", abstract="Background: Recruiting participants for clinical trials poses challenges. Major barriers to participation include psychological factors (eg, fear and mistrust) and logistical constraints (eg, transportation, cost, and scheduling). The strategic design of clinical trial messaging can help overcome these barriers. While strategic communication can be done through various channels (eg, recruitment advertisements), health care providers on the internet have been found to be key sources for communicating clinical trial information to US adults in the social media era. Objective: This study aims to examine how communication source (ie, medical doctors and peers) and message framing of TikTok videos (ie, psychological and logistical framing) influence clinical trial--related attitudes, perceptions, and sign-up behaviors under the guidance of the integrated behavioral model. Methods: This study used a 2 (source: doctor vs peer) {\texttimes} 2 (framing: psychological vs logistical) between-participant factorial design web-based experiment targeting adults in the United States who had never participated in clinical trials (ie, newcomers). A Qualtrics panel was used to recruit and compensate the study respondents (n=561). Participants viewed short-form videos with doctors or peers, using psychological or logistical framing. The main outcome measures included perceived source credibility, self-efficacy, attitude toward clinical trial participation, behavioral intention, and sign-up behavior. Structural equation modeling was used to analyze the direct and indirect effects of message factors on the outcome variables. Source (doctor=1; peer=0) and framing (psychological=1; logistical=0) were dummy-coded. Results: Doctor-featured messages led to greater perceived source credibility ($\beta$=.31, P<.001), leading to greater self-efficacy (95\% CI 0.13-0.30), which in turn enhanced behavioral intention (95\% CI 0.12-0.29) and clinical trial sign-up behavior (95\% CI 0.02-0.04). Logistical barrier--framed messages led to greater self-efficacy ($\beta$=--.09, P=.02), resulting in higher intention to participate in clinical trials (95\% CI --0.38 to --0.03) and improved sign-up behavior (95\% CI --0.06 to --0.004). Logistical barrier--framed messages were also directly associated with an increased likelihood of signing up for a clinical trial ($\beta$=--.08, P=.03). The model accounted for 21\% of the variance in clinical trial sign-up behavior. Attitude did not significantly affect behavioral intention in this study ($\beta$=.08, P=.14), and psychological and logistical barrier--framed messages did not significantly differ in attitudes toward clinical trial participation ($\beta$=--.04, P=.09). Conclusions: These findings advance our understanding of how people process popular message characteristics in short-form videos and lend practical guidance for communicators. We encourage medical professionals to consider short-form video sites (eg, TikTok and Instagram Reels) as effective tools for discussing clinical trials and participation opportunities. Specifically, featuring doctors discussing efforts to reduce logistical barriers is recommended. Our measuring of actual behavior as an outcome is a rare and noteworthy contribution to this research. ", doi="10.2196/49600", url="https://www.jmir.org/2024/1/e49600" } @Article{info:doi/10.2196/48516, author="Bowers, M. Jennifer and Huelsnitz, O. Chloe and Dwyer, A. Laura and Gibson, P. Laurel and Agurs-Collins, Tanya and Ferrer, A. Rebecca and Acevedo, M. Amanda", title="Measuring Relationship Influences on Romantic Couples' Cancer-Related Behaviors During the COVID-19 Pandemic: Protocol for a Longitudinal Online Study of Dyads and Cancer Survivors", journal="JMIR Res Protoc", year="2024", month="Jul", day="31", volume="13", pages="e48516", keywords="cancer prevention", keywords="COVID-19", keywords="risk perceptions", keywords="dyads", keywords="romantic relationships", keywords="cancer", keywords="oncology", keywords="survivor", keywords="survivors", keywords="dyad", keywords="spouse", keywords="spousal", keywords="partner", keywords="health behavior", keywords="health behaviors", keywords="cohabiting", keywords="cohabit", keywords="study design", keywords="recruit", keywords="recruitment", keywords="methodology", keywords="methods", keywords="enrol", keywords="enrolment", keywords="enroll", keywords="enrollment", abstract="Background: Research has established the effects of romantic relationships on individuals' morbidity and mortality. However, the interplay between relationship functioning, affective processes, and health behaviors has been relatively understudied. During the COVID-19 pandemic, relational processes may influence novel health behaviors such as social distancing and masking. Objective: We describe the design, recruitment, and methods of the relationships, risk perceptions, and cancer-related behaviors during the COVID-19 pandemic study. This study was developed to understand how relational and affective processes influence romantic partners' engagement in cancer prevention behaviors as well as health behaviors introduced or exacerbated by the COVID-19 pandemic. Methods: The relationships, risk perceptions, and cancer-related behaviors during the COVID-19 pandemic study used online survey methods to recruit and enroll 2 cohorts of individuals involved in cohabiting romantic relationships, including 1 cohort of dyads (n=223) and 1 cohort of cancer survivors (n=443). Survey assessments were completed over 2 time points that were 5.57 (SD 3.14) weeks apart on average. Health behaviors assessed included COVID-19 vaccination and social distancing, physical activity, diet, sleep, alcohol use, and smoking behavior. We also examined relationship factors, psychological distress, and household chaos. Results: Data collection occurred between October 2021 and August 2022. During that time, a total of 926 participants were enrolled, of which about two-thirds were from the United Kingdom (n=622, 67.8\%) and one-third were from the United States (n=296, 32.2\%); about two-thirds were married (n=608, 66.2\%) and one-third were members of unmarried couples (n=294, 32\%). In cohorts 1 and 2, the mean age was about 34 and 50, respectively. Out of 478 participants in cohort 1, 19 (4\%) identified as Hispanic or Latino/a, 79 (17\%) as non-Hispanic Asian, 40 (9\%) as non-Hispanic Black or African American, and 306 (64\%) as non-Hispanic White; 62 (13\%) participants identified their sexual orientation as bisexual or pansexual, 359 (75.1\%) as heterosexual or straight, and 53 (11\%) as gay or lesbian. In cohort 2, out of 440 participants, 13 (3\%) identified as Hispanic or Latino/a, 8 (2\%) as non-Hispanic Asian, 5 (1\%) as non-Hispanic Black or African American, and 398 (90.5\%) as non-Hispanic White; 41 (9\%) participants identified their sexual orientation as bisexual or pansexual, 384 (87.3\%) as heterosexual or straight, and 13 (3\%) as gay or lesbian. The overall enrollment rate for individuals was 66.14\% and the overall completion rate was 80.08\%. Conclusions: We discuss best practices for collecting online survey data for studies examining relationships and health, challenges related to the COVID-19 pandemic, recruitment of underrepresented populations, and enrollment of dyads. Recommendations include conducting pilot studies, allowing for extra time in the data collection timeline for marginalized or underserved populations, surplus screening to account for expected attrition within dyads, as well as planning dyad-specific data quality checks. International Registered Report Identifier (IRRID): DERR1-10.2196/48516 ", doi="10.2196/48516", url="https://www.researchprotocols.org/2024/1/e48516" } @Article{info:doi/10.2196/54867, author="Zondag, M. Anna G. and Hollestelle, J. Marieke and van der Graaf, Rieke and Nathoe, M. Hendrik and van Solinge, W. Wouter and Bots, L. Michiel and Vernooij, M. Robin W. and Haitjema, Saskia and ", title="Comparison of the Response to an Electronic Versus a Traditional Informed Consent Procedure in Terms of Clinical Patient Characteristics: Observational Study", journal="J Med Internet Res", year="2024", month="Jul", day="11", volume="26", pages="e54867", keywords="informed consent", keywords="learning health care system", keywords="e-consent", keywords="cardiovascular risk management", keywords="digital health", keywords="research ethics", abstract="Background: Electronic informed consent (eIC) is increasingly used in clinical research due to several benefits including increased enrollment and improved efficiency. Within a learning health care system, a pilot was conducted with an eIC for linking data from electronic health records with national registries, general practitioners, and other hospitals. Objective: We evaluated the eIC pilot by comparing the response to the eIC with the former traditional paper-based informed consent (IC). We assessed whether the use of eIC resulted in a different study population by comparing the clinical patient characteristics between the response categories of the eIC and former face-to-face IC procedure. Methods: All patients with increased cardiovascular risk visiting the University Medical Center Utrecht, the Netherlands, were eligible for the learning health care system. From November 2021 to August 2022, an eIC was piloted at the cardiology outpatient clinic. Prior to the pilot, a traditional face-to-face paper-based IC approach was used. Responses (ie, consent, no consent, or nonresponse) were assessed and compared between the eIC and face-to-face IC cohorts. Clinical characteristics of consenting and nonresponding patients were compared between and within the eIC and the face-to-face cohorts using multivariable regression analyses. Results: A total of 2254 patients were included in the face-to-face IC cohort and 885 patients in the eIC cohort. Full consent was more often obtained in the eIC than in the face-to-face cohort (415/885, 46.9\% vs 876/2254, 38.9\%, respectively). Apart from lower mean hemoglobin in the full consent group of the eIC cohort (8.5 vs 8.8; P=.0021), the characteristics of the full consenting patients did not differ between the eIC and face-to-face IC cohorts. In the eIC cohort, only age differed between the full consent and the nonresponse group (median 60 vs 56; P=.0002, respectively), whereas in the face-to-face IC cohort, the full consent group seemed healthier (ie, higher hemoglobin, lower glycated hemoglobin [HbA1c], lower C-reactive protein levels) than the nonresponse group. Conclusions: More patients provided full consent using an eIC. In addition, the study population remained broadly similar. The face-to-face IC approach seemed to result in a healthier study population (ie, full consenting patients) than the patients without IC, while in the eIC cohort, the characteristics between consent groups were comparable. Thus, an eIC may lead to a better representation of the target population, increasing the generalizability of results. ", doi="10.2196/54867", url="https://www.jmir.org/2024/1/e54867", url="http://www.ncbi.nlm.nih.gov/pubmed/38990640" } @Article{info:doi/10.2196/51520, author="Teano, L. Anthony and Scott, Ashley and Gipson, Cassandra and Albert, Marilyn and Pettigrew, Corinne", title="Social Media Programs for Outreach and Recruitment Supporting Aging and Alzheimer Disease and Related Dementias Research: Longitudinal Descriptive Study", journal="JMIR Aging", year="2024", month="Jul", day="9", volume="7", pages="e51520", keywords="education", keywords="social media", keywords="outreach", keywords="recruitment", keywords="Alzheimer's disease", keywords="Alzheimer disease", abstract="Background: Social media may be a useful method for research centers to deliver health messages, increase their visibility in the local community, and recruit study participants. Sharing examples of social media--based community outreach and educational programs, and evaluating their outcomes in this setting, is important for understanding whether these efforts have a measurable impact. Objective: The aim of this study is to describe one center's social media activities for community education on topics related to aging, memory loss, and Alzheimer disease and related dementias, and provide metrics related to recruitment into clinical research studies. Methods: Several social media platforms were used, including Facebook, X (formerly Twitter), and YouTube. Objective assessments quantified monthly, based on each platform's native dashboard, included the number of followers, number of posts, post reach and engagement, post impressions, and video views. The number of participants volunteering for research during this period was additionally tracked using a secure database. Educational material posted to social media most frequently included content developed by center staff, content from partner organizations, and news articles or resources featuring center researchers. Multiple educational programs were developed, including social media series, web-based talks, Twitter chats, and webinars. In more recent years, Facebook content was occasionally boosted to increase visibility in the local geographical region. Results: Up to 4 years of page metrics demonstrated continuing growth in reaching social media audiences, as indicated by increases over time in the numbers of likes or followers on Facebook and X/Twitter and views of YouTube videos (growth trajectories). While Facebook reach and X/Twitter impression rates were reasonable, Facebook engagement rates were more modest. Months that included boosted Facebook posts resulted in a greater change in page followers and page likes, and higher reach and engagement rates (all P?.002). Recruitment of participants into center-affiliated research studies increased during this time frame, particularly in response to boosted Facebook posts. Conclusions: These data demonstrate that social media activities can provide meaningful community educational opportunities focused on Alzheimer disease and related dementias and have a measurable impact on the recruitment of participants into research studies. Additionally, this study highlights the importance of tracking outreach program outcomes for evaluating return on investment. ", doi="10.2196/51520", url="https://aging.jmir.org/2024/1/e51520" } @Article{info:doi/10.2196/50240, author="Sobolewski, Jessica and Rothschild, Allie and Freeman, Andrew", title="The Impact of Incentives on Data Collection for Online Surveys: Social Media Recruitment Study", journal="JMIR Form Res", year="2024", month="Jul", day="4", volume="8", pages="e50240", keywords="social media", keywords="online survey recruitment", keywords="incentive", keywords="experiment", keywords="online surveys", keywords="Facebook", keywords="Instagram", keywords="data collection", keywords="users", keywords="cost", keywords="social media recruitment", keywords="survey", abstract="Background: The use of targeted advertisements on social media platforms (eg, Facebook and Instagram) has become increasingly popular for recruiting participants for online survey research. Many of these surveys offer monetary incentives for survey completion in the form of gift cards; however, little is known about whether the incentive amount impacts the cost, speed, and quality of data collection. Objective: This experiment addresses this gap in the literature by examining how different incentives in paid advertising campaigns on Instagram for completing a 10-minute online survey influence the response rate, recruitment advertising cost, data quality, and length of data collection. Methods: This experiment tested three incentive conditions using three Instagram campaigns that were each allocated a US \$1400 budget to spend over a maximum of 4 days; ads targeted users aged 15-24 years in three nonadjacent designated market areas of similar size to avoid overlapping audiences. Four ad creatives were designed for each campaign; all ads featured the same images and text, but the incentive amount varied: no incentive, US \$5 gift card, and US \$15 gift card. All ads had a clickable link that directed users to an eligibility screener and a 10-minute online survey, if eligible. Each campaign ran for either the full allotted time (4 days) or until there were 150 total survey completes, prior to data quality checks for fraud. Results: The US \$15 incentive condition resulted in the quickest and cheapest data collection, requiring 17 hours and ad spending of US \$338.64 to achieve 142 survey completes. The US \$5 condition took more than twice as long (39 hours) and cost US \$864.33 in ad spending to achieve 148 survey completes. The no-incentive condition ran for 60 hours, spending nearly the full budget (US \$1398.23), and achieved only 24 survey completes. The US \$15 and US \$5 incentive conditions had similar levels of fraudulent respondents, whereas the no-incentive condition had no fraudulent respondents. The completion rate for the US \$15 and US \$5 incentive conditions were 93.4\% (155/166) and 89.8\% (149/166), respectively, while the completion rate for the no-incentive condition was 43.6\% (24/55). Conclusions: Overall, we found that a higher incentive resulted in quicker data collection, less money spent on ads, and higher response rates, despite some fraudulent cases that had to be dropped from the sample. However, when considering the total incentive amounts in addition to the ad spending, a US \$5 incentive appeared to be the most cost-effective data collection option. Other costs associated with running a campaign for a longer period should also be considered. A longer experiment is warranted to determine whether fraud varies over time across conditions. ", doi="10.2196/50240", url="https://formative.jmir.org/2024/1/e50240" } @Article{info:doi/10.2196/52281, author="Reed, D. Nicole and Bull, Sheana and Shrestha, Umit and Sarche, Michelle and Kaufman, E. Carol", title="Combating Fraudulent Participation in Urban American Indian and Alaska Native Virtual Health Research: Protocol for Increasing Data Integrity in Online Research (PRIOR)", journal="JMIR Res Protoc", year="2024", month="Jun", day="13", volume="13", pages="e52281", keywords="fraudulent survey participation", keywords="online survey research", keywords="American Indian and Alaska Native", keywords="data integrity", keywords="health research", keywords="research trust", keywords="online survey", keywords="case study", keywords="randomized control trial", keywords="RCT", keywords="social media", keywords="recruitment", keywords="young women", keywords="women", keywords="American Indian", keywords="Native Americans", keywords="Native American", keywords="fraudulent", keywords="data privacy", abstract="Background: While the advantages of using the internet and social media for research recruitment are well documented, the evolving online environment also enhances motivations for misrepresentation to receive incentives or to ``troll'' research studies. Such fraudulent assaults can compromise data integrity, with substantial losses in project time; money; and especially for vulnerable populations, research trust. With the rapid advent of new technology and ever-evolving social media platforms, it has become easier for misrepresentation to occur within online data collection. This perpetuation can occur by bots or individuals with malintent, but careful planning can help aid in filtering out fraudulent data. Objective: Using an example with urban American Indian and Alaska Native young women, this paper aims to describe PRIOR (Protocol for Increasing Data Integrity in Online Research), which is a 2-step integration protocol for combating fraudulent participation in online survey research. Methods: From February 2019 to August 2020, we recruited participants for formative research preparatory to an online randomized control trial of a preconceptual health program. First, we described our initial protocol for preventing fraudulent participation, which proved to be unsuccessful. Then, we described modifications we made in May 2020 to improve the protocol performance and the creation of PRIOR. Changes included transferring data collection platforms, collecting embedded geospatial variables, enabling timing features within the screening survey, creating URL links for each method or platform of data collection, and manually confirming potentially eligible participants' identifying information. Results: Before the implementation of PRIOR, the project experienced substantial fraudulent attempts at study enrollment, with less than 1\% (n=6) of 1300 screened participants being identified as truly eligible. With the modified protocol, of the 461 individuals who completed a screening survey, 381 did not meet the eligibility criteria assessed on the survey. Of the 80 that did, 25 (31\%) were identified as ineligible via PRIOR. A total of 55 (69\%) were identified as eligible and verified in the protocol and were enrolled in the formative study. Conclusions: Fraudulent surveys compromise study integrity, validity of the data, and trust among participant populations. They also deplete scarce research resources including respondent compensation and personnel time. Our approach of PRIOR to prevent online misrepresentation in data was successful. This paper reviews key elements regarding fraudulent data participation in online research and demonstrates why enhanced protocols to prevent fraudulent data collection are crucial for building trust with vulnerable populations. Trial Registration: ClinicalTrials.gov NCT04376346; https://www.clinicaltrials.gov/study/NCT04376346 International Registered Report Identifier (IRRID): DERR1-10.2196/52281 ", doi="10.2196/52281", url="https://www.researchprotocols.org/2024/1/e52281", url="http://www.ncbi.nlm.nih.gov/pubmed/38869930" } @Article{info:doi/10.2196/50650, author="Jackson, Kristina and Meisel, Matthew and Sokolovsky, Alexander and Chen, Katie and Barnett, Nancy", title="Detecting and Understanding Social Influence During Drinking Situations: Protocol for a Bluetooth-Based Sensor Feasibility and Acceptability Study", journal="JMIR Res Protoc", year="2024", month="Jun", day="6", volume="13", pages="e50650", keywords="Bluetooth technology", keywords="passive sensing", keywords="social influence", keywords="alcohol use", keywords="ecological momentary assessment", keywords="social network", keywords="feasibility", keywords="acceptability", keywords="mobile phone", abstract="Background: High-risk alcohol consumption among young adults frequently occurs in the presence of peers who are also drinking. A high-risk drinking situation may consist of particular social network members who have a primary association with drinking. Fine-grained approaches such as ecological momentary assessment (EMA) are growing in popularity for studying real-time social influence, but studies using these approaches exclusively rely on participant self-report. Passive indicators of peer presence using Bluetooth-based technology to detect real-time interactions have the potential to assist in the development of just-in-time interventions. Objective: This study seeks to examine the feasibility and acceptability of using a Bluetooth-based sensor and smartphone app to measure social contact in real-world drinking situations. Methods: Young adults (N=20) who drink heavily and report social drinking will be recruited from the community to participate in a 3-week EMA study. Using a social network interview, index participants will identify and recruit 3 of their friends to carry a Bluetooth beacon. Participants will complete a series of EMA reports on their own personal Android devices including random reports; morning reports; first-drink reports; and signal-contingent reports, which are triggered following the detection of a beacon carried by a peer participant. EMA will assess alcohol use and characteristics of the social environment, including who is nearby and who is drinking. For items about peer proximity and peer drinking, a customized peer list will be presented to participants. Feedback about the study protocol will be ascertained through weekly contact with both index and peer participants, followed by a qualitative interview at the end of the study. We will examine the feasibility and acceptability of recruitment, enrollment of participants and peers, and retention. Feasibility will be determined using indexes of eligibility, enrollment, and recruitment. Acceptability will be determined through participant enrollment and retention, protocol compliance, and participant-reported measures of acceptability. Feasibility and acceptability for peer participants will be informed by enrollment rates, latency to enrollment, compliance with carrying the beacon, and self-reported reasons for compliance or noncompliance with beacon procedures. Finally, EMA data about peer proximity and peer drinking will support the validity of the peer selection process. Results: Participant recruitment began in February 2023, and enrollment was completed in December 2023. Results will be reported in 2025. Conclusions: The protocol allows us to examine the feasibility and acceptability of a Bluetooth-based sensor for the detection of social contact between index participants and their friends, including social interactions during real-world drinking situations. Data from this study will inform just-in-time adaptive interventions seeking to address drinking in the natural environment by providing personalized feedback about a high-risk social context and alerting an individual that they are in a potentially unsafe situation. International Registered Report Identifier (IRRID): DERR1-10.2196/50650 ", doi="10.2196/50650", url="https://www.researchprotocols.org/2024/1/e50650", url="http://www.ncbi.nlm.nih.gov/pubmed/38842927" } @Article{info:doi/10.2196/51530, author="Kumarasamy, Vithusa and Goodfellow, Nicole and Ferron, Mae Era and Wright, L. Amy", title="Evaluating the Problem of Fraudulent Participants in Health Care Research: Multimethod Pilot Study", journal="JMIR Form Res", year="2024", month="Jun", day="4", volume="8", pages="e51530", keywords="fraudulent participants", keywords="threats to data integrity", keywords="online recruitment", keywords="multimethod study", keywords="health care research", keywords="bots", keywords="social media", abstract="Background: The shift toward online recruitment methods, accelerated by the COVID-19 pandemic, has brought to the forefront the growing concern of encountering fraudulent participants in health care research. The increasing prevalence of this issue poses a serious threat to the reliability and integrity of research data and subsequent findings. Objective: This study aims to explore the experiences of health care researchers (HCRs) who have encountered fraudulent participants while using online recruitment methods and platforms. The primary objective was to gain insights into how researchers detect and mitigate fraudulent behavior in their work and provide prevention recommendations. Methods: A multimethod sequential design was used for this pilot study, comprising a quantitative arm involving a web-based survey followed by a qualitative arm featuring semistructured interviews. The qualitative description approach framed the qualitative arm of the study. Sample sizes for the quantitative and qualitative arms were based on pragmatic considerations that in part stemmed from encountering fraudulent participants in a concurrent study. Content analysis was used to analyze open-ended survey questions and interview data. Results: A total of 37 HCRs participated, with 35\% (13/37) of them engaging in qualitative interviews. Online platforms such as Facebook, email, Twitter (subsequently rebranded X), and newsletters were the most used methods for recruitment. A total of 84\% (31/37) of participants indicated that fraudulent participation occurred in studies that mentioned incentives in their recruitment communications, with 71\% (26/37) of HCRs offering physical or electronic gift cards as incentives. Researchers identified several indicators of suspicious behavior, including email surges, discrepancies in contact or personal information, geographical inconsistencies, and suspicious responses to survey questions. HCRs emphasized the need for a comprehensive screening protocol that extends beyond eligibility checks and is seamlessly integrated into the study protocol, grant applications, and research ethics board submissions. Conclusions: This study sheds light on the intricate and pervasive problem of fraudulent participation in health care research using online recruitment methods. The findings underscore the importance of vigilance and proactivity among HCRs in identifying, preventing, and addressing fraudulent behavior. To effectively tackle this challenge, researchers are encouraged to develop a comprehensive prevention strategy and establish a community of practice, facilitating real-time access to solutions and support and the promotion of ethical research practices. This collaborative approach will enable researchers to effectively address the issue of fraudulent participation, ensuring the conduct of high-quality and ethically sound research in the digital age. ", doi="10.2196/51530", url="https://formative.jmir.org/2024/1/e51530", url="http://www.ncbi.nlm.nih.gov/pubmed/38833292" } @Article{info:doi/10.2196/56218, author="Tran, D. Amanda and White, E. Alice and Torok, R. Michelle and Jervis, H. Rachel and Albanese, A. Bernadette and Scallan Walter, J. Elaine", title="Lessons Learned From a Sequential Mixed-Mode Survey Design to Recruit and Collect Data From Case-Control Study Participants: Formative Evaluation", journal="JMIR Form Res", year="2024", month="May", day="27", volume="8", pages="e56218", keywords="case-control studies", keywords="mixed-mode design", keywords="epidemiologic study methods", keywords="web-based survey", keywords="telephone interview", keywords="public health", keywords="outbreak preparedness", keywords="COVID-19", keywords="survey", keywords="recruitment", keywords="epidemiology", keywords="methods", abstract="Background: Sequential mixed-mode surveys using both web-based surveys and telephone interviews are increasingly being used in observational studies and have been shown to have many benefits; however, the application of this survey design has not been evaluated in the context of epidemiological case-control studies. Objective: In this paper, we discuss the challenges, benefits, and limitations of using a sequential mixed-mode survey design for a case-control study assessing risk factors during the COVID-19 pandemic. Methods: Colorado adults testing positive for SARS-CoV-2 were randomly selected and matched to those with a negative SARS-CoV-2 test result from March to April 2021. Participants were first contacted by SMS text message to complete a self-administered web-based survey asking about community exposures and behaviors. Those who did not respond were contacted for a telephone interview. We evaluated the representativeness of survey participants to sample populations and compared sociodemographic characteristics, participant responses, and time and resource requirements by survey mode using descriptive statistics and logistic regression models. Results: Of enrolled case and control participants, most were interviewed by telephone (308/537, 57.4\% and 342/648, 52.8\%, respectively), with overall enrollment more than doubling after interviewers called nonresponders. Participants identifying as female or White non-Hispanic, residing in urban areas, and not working outside the home were more likely to complete the web-based survey. Telephone participants were more likely than web-based participants to be aged 18-39 years or 60 years and older and reside in areas with lower levels of education, more linguistic isolation, lower income, and more people of color. While there were statistically significant sociodemographic differences noted between web-based and telephone case and control participants and their respective sample pools, participants were more similar to sample pools when web-based and telephone responses were combined. Web-based participants were less likely to report close contact with an individual with COVID-19 (odds ratio [OR] 0.70, 95\% CI 0.53-0.94) but more likely to report community exposures, including visiting a grocery store or retail shop (OR 1.55, 95\% CI 1.13-2.12), restaurant or cafe or coffee shop (OR 1.52, 95\% CI 1.20-1.92), attending a gathering (OR 1.69, 95\% CI 1.34-2.15), or sport or sporting event (OR 1.05, 95\% CI 1.05-1.88). The web-based survey required an average of 0.03 (SD 0) person-hours per enrolled participant and US \$920 in resources, whereas the telephone interview required an average of 5.11 person-hours per enrolled participant and US \$70,000 in interviewer wages. Conclusions: While we still encountered control recruitment challenges noted in other observational studies, the sequential mixed-mode design was an efficient method for recruiting a more representative group of participants for a case-control study with limited impact on data quality and should be considered during public health emergencies when timely and accurate exposure information is needed to inform control measures. ", doi="10.2196/56218", url="https://formative.jmir.org/2024/1/e56218", url="http://www.ncbi.nlm.nih.gov/pubmed/38801768" } @Article{info:doi/10.2196/53646, author="Glayzer, E. Jennifer and Bray, C. Bethany and Kobak, H. William and Steffen, D. Alana and Schlaeger, M. Judith", title="Lack of Diversity in Research on Females with Ehlers-Danlos Syndromes: Recruitment Protocol for a Quantitative Online Survey", journal="JMIR Res Protoc", year="2024", month="May", day="2", volume="13", pages="e53646", keywords="Ehlers-Danlos syndrome", keywords="hypermobility", keywords="social media", keywords="recruitment", keywords="Facebook", keywords="hereditary disease", keywords="connective tissue disorders", keywords="racial", keywords="ethnic", keywords="diversity", keywords="challenges", keywords="strategies", keywords="strategy", keywords="online", keywords="information seeking", keywords="cross-sectional survey", keywords="dyspareunia", keywords="painful sex", keywords="United States", abstract="Background: Ehlers-Danlos syndromes (EDS) are a group of connective tissue disorders caused by fragile lax collagen. Current EDS research lacks racial and ethnic diversity. The lack of diversity may be associated with the complexities of conducting a large international study on an underdiagnosed condition and a lack of EDS health care providers who diagnose and conduct research outside of the United States and Europe. Social media may be the key to recruiting a large diverse EDS sample. However, studies that have used social media to recruit have not been able to recruit diverse samples. Objective: This study aims to discuss challenges, strategies, outcomes, and lessons learned from using social media to recruit a large sample of females with EDS. Methods: Recruitment on social media for a cross-sectional survey examining dyspareunia (painful sexual intercourse) in females was examined. Inclusion criteria were (1) older than 18 years of age, (2) assigned female at birth, and (3) diagnosed with EDS. Recruitment took place on Facebook and Twitter (now X), from June 1 to June 25, 2019. Results: A total of 1178 females with EDS were recruited from Facebook (n=1174) and X (n=4). On Facebook, participants were recruited via support groups. A total of 166 EDS support groups were identified, 104 permitted the principal investigator to join, 90 approved posting, and the survey was posted in 54 groups. Among them, 30 of the support groups posted in were globally focused and not tied to any specific country or region, 21 were for people in the United States, and 3 were for people outside of the United States. Recruitment materials were posted on X with the hashtag \#EDS. A total of 1599 people accessed the survey and 1178 people were eligible and consented. The average age of participants was 38.6 (SD 11.7) years. Participants were predominantly White (n=1063, 93\%) and non-Hispanic (n=1046, 92\%). Participants were recruited from 29 countries, with 900 (79\%) from the United States and 124 (11\%) from Great Britain. Conclusions: Our recruitment method was successful at recruiting a large sample. The sample was predominantly White and from North America and Europe. More research needs to be conducted on how to recruit a diverse sample. Areas to investigate may include connecting with more support groups from outside the United States and Europe, researching which platforms are popular in different countries, and translating study materials into different languages. A larger obstacle to recruiting diverse samples may be the lack of health care providers that diagnose EDS outside the United States and Europe, making the pool of potential participants small. There needs to be more health care providers that diagnose and treat EDS in countries that are predominantly made up of people of color as well as research that specifically focuses on these populations. International Registered Report Identifier (IRRID): RR1-10.2196/53646 ", doi="10.2196/53646", url="https://www.researchprotocols.org/2024/1/e53646", url="http://www.ncbi.nlm.nih.gov/pubmed/38696252" } @Article{info:doi/10.2196/48767, author="Nwosu, Chinonyelum and Khan, Hamda and Masese, Rita and Nocek, M. Judith and Gollan, Siera and Varughese, Taniya and Bourne, Sarah and Clesca, Cindy and Jacobs, R. Sara and Baumann, Ana and Klesges, M. Lisa and Shah, Nirmish and Hankins, S. Jane and Smeltzer, P. Matthew", title="Recruitment Strategies in the Integration of Mobile Health Into Sickle Cell Disease Care to Increase Hydroxyurea Utilization Study (meSH): Multicenter Survey Study", journal="JMIR Form Res", year="2024", month="Apr", day="16", volume="8", pages="e48767", keywords="sickle cell", keywords="recruitment", keywords="eHealth", keywords="multicenter", keywords="utilization", keywords="strategy", keywords="hydroxyurea", keywords="mobile health", keywords="mhealth", keywords="intervention", abstract="Background: Hydroxyurea is an evidence-based disease-modifying therapy for sickle cell disease (SCD) but is underutilized. The Integration of Mobile Health into Sickle Cell Disease Care to Increase Hydroxyurea Utilization (meSH) multicenter study leveraged mHealth to deliver targeted interventions to patients and providers. SCD studies often underenroll; and recruitment strategies in the SCD population are not widely studied. Unanticipated events can negatively impact enrollment, making it important to study strategies that ensure adequate study accrual. Objective: The goal of this study was to evaluate enrollment barriers and the impact of modified recruitment strategies among patients and providers in the meSH study in response to a global emergency. Methods: Recruitment was anticipated to last 2 months for providers and 6 months for patients. The recruitment strategies used with patients and providers, new recruitment strategies, and recruitment rates were captured and compared. To document recruitment adaptations and their reasons, study staff responsible for recruitment completed an open-ended 9-item questionnaire eliciting challenges to recruitment and strategies used. Themes were extrapolated using thematic content analysis. Results: Total enrollment across the 7 sites included 89 providers and 293 patients. The study acceptance rate was 85.5\% (382/447) for both patients and providers. The reasons patients declined participation were most frequently a lack of time and interest in research, while providers mostly declined because of self-perceived high levels of SCD expertise, believing they did not need the intervention. Initially, recruitment involved an in-person invitation to participate during clinic visits (patients), staff meetings (providers), or within the office (providers). We identified several important recruitment challenges, including (1) lack of interest in research, (2) lack of human resources, (3) unavailable physical space for recruitment activities, and (4) lack of documentation to verify eligibility. Adaptive strategies were crucial to alleviate enrollment disruptions due to the COVID-19 pandemic. These included remote approaching and consenting (eg, telehealth, email, and telephone) for patients and providers. Additionally, for patients, recruitment was enriched by simplification of enrollment procedures (eg, directly approaching patients without a referral from the provider) and a multitouch method (ie, warm introductions with flyers, texts, and patient portal messages). We found that patient recruitment rates were similar between in-person and adapted (virtual with multitouch) approaches (167/200, 83.5\% and 126/143, 88.1\%, respectively; P=.23). However, for providers, recruitment was significantly higher for in-person vs remote recruitment (48/50, 96\% and 41/54, 76\%, respectively, P<.001). Conclusions: We found that timely adaptation in recruitment strategies secured high recruitment rates using an assortment of enriched remote recruitment strategies. Flexibility in approach and reducing the burden of enrollment procedures for participants aided enrollment. It is important to continue identifying effective recruitment strategies in studies involving patients with SCD and their providers and the impact and navigation of recruitment challenges. Trial Registration: ClinicalTrials.Gov NCT03380351; https://clinicaltrials.gov/study/NCT03380351 International Registered Report Identifier (IRRID): RR2-10.2196/16319 ", doi="10.2196/48767", url="https://formative.jmir.org/2024/1/e48767", url="http://www.ncbi.nlm.nih.gov/pubmed/38625729" } @Article{info:doi/10.2196/48823, author="Beatty, R. Jessica and Zelenak, Logan and Gillon, Spencer and McGoron, Lucy and Goyert, Gregory and Ondersma, J. Steven", title="Risk Identification in Perinatal Health Care Settings via Technology-Based Recruitment Methods: Comparative Study", journal="JMIR Form Res", year="2024", month="Mar", day="4", volume="8", pages="e48823", keywords="participant recruitment", keywords="engagement", keywords="health care screening", keywords="mobile phone", abstract="Background: Digital screening and intervention tools have shown promise in the identification and reduction of substance use in health care settings. However, research in this area is impeded by challenges in integrating recruitment efforts into ongoing clinical workflows or staffing multiple study clinics with full-time research assistants, as well as by the underreporting of substance use. Objective: The aim of the study is to evaluate pragmatic methods for facilitating study recruitment in health care settings by examining recruitment rates and participant characteristics using in-person--based versus flyer approaches. Methods: This study compared recruitment rates at a Women's Health clinic in the Midwest under 2 different recruitment strategies: in person versus via a flyer with a QR code. We also examined the disclosure of substance use and risk screener positivity for the 2 strategies. We also obtained information about the current use of technology and willingness to use it for study participation. Results: A greater percentage of patients recruited in person participated than those recruited via flyers (57/63, 91\% vs 64/377, 17\%). However, the final number recruited in each group was roughly equal (n=57 vs n=64). Additionally, participants recruited via flyers were more likely to screen positive for alcohol use risk on the Tolerance, Annoyed, Cut Down, Eye-Opener alcohol screen than those recruited at the clinic (24/64, 38\% vs 11/57, 19\%; $\chi$21=4.9; P=.03). Participants recruited via flyers were also more likely to screen positive for drug use risk on the Wayne Indirect Drug Use Screener than those recruited at the clinic (20/64, 31\% vs 9/57, 16\%; $\chi$21=4.0; P=.05). Furthermore, of the 121 pregnant women, 117 (96.7\%) reported owning a smartphone, 111 (91.7\%) had an SMS text message plan on their phone, and 94 (77.7\%) reported being willing to receive SMS text messages or participate in a study if sent a link to their phone. Conclusions: The distribution of flyers with a QR code by medical staff appears to be an efficient and cost-effective method of recruitment that also facilitates disclosure while reducing the impact on clinic workflows. This method of recruitment can be useful for data collection at multiple locations and lead to larger samples across and between health systems. Participant recruitment via technology in perinatal health care appears to facilitate disclosure, particularly when participants can learn about the research and complete screening using their own device at a place and time convenient for them. Pregnant women in an urban Midwestern hospital had access to and were comfortable using technology. ", doi="10.2196/48823", url="https://formative.jmir.org/2024/1/e48823", url="http://www.ncbi.nlm.nih.gov/pubmed/38437004" } @Article{info:doi/10.2196/47984, author="Weisblum, Margaret and Trussell, Emma and Schwinn, Traci and Pacheco, R. Andrea and Nurkin, Paige", title="Screening and Retaining Adolescents Recruited Through Social Media: Secondary Analysis from a Longitudinal Clinical Trial", journal="JMIR Pediatr Parent", year="2024", month="Feb", day="28", volume="7", pages="e47984", keywords="adolescents", keywords="attrition prevention", keywords="Instagram", keywords="LGBQ", keywords="online recruitment", keywords="retention", keywords="screening", keywords="sexual minority", keywords="social media", keywords="youth", abstract="Background: Social media has become a popular method to recruit participants, particularly for studies with hard-to-reach populations. These studies still face challenges in data quality and, for longitudinal studies, sample retention. However, in addition to aiding in recruitment, social media platforms can help researchers with participant verification and tracking procedures during the study. There is limited previous research describing how longitudinal studies can use social media to screen and retain participants. Objective: This paper describes strategies implemented to screen and retain a nationwide sample of sexual minority youth who were recruited through social media platforms for a longitudinal study testing a drug abuse prevention program. Methods: Our screening strategies for participants included collecting necessary demographic information (name, phone, email, and social media accounts), verifying this information using publicly available web-based records, and sending confirmation emails to ensure working email addresses and correct dates of birth. Retention strategies included communications designed to develop positive participant relationships, incentives for survey completion, regular updating of participant contact information, targeting hard-to-reach participants, and using social media as an alternative means of contacting participants. Results: During enrollment, although the only demographic data required were a phone number and an email address, 87.58\% (1065/1216) of participants provided their Instagram as an alternative means of contact. This form of alternative communication remains the most preferred with 87.40\% (1047/1198) of participants continuing to provide an Instagram username as of January 2023, about 3 years after recruitment began. In comparison, other alternative means of contact (eg, Facebook and alternative email) were provided by only 6.43\% (77/1198) to 56.18\% (673/1198) of participants. Direct messaging on Instagram was used to successfully confirm participant identity, remind participants to take annual follow-up surveys, and update lost participant contact information. Screening and retention strategies used in the study have helped achieve 96.30\% (1171/1216) to 96.79\% (1177/1216) sample retention across 3 waves of data collection. Conclusions: Though social media can be a helpful tool to recruit participants, attrition and participant authenticity difficulties may be associated with this method. Screening and retention strategies can be implemented to improve retention. Internet searches are effective for screening youth to ensure they meet eligibility requirements. Additionally, social media---Instagram in this study---can help to track and locate participants who do not respond to traditional contact methods. Trial Registration: ClinicalTrials.gov NCT03954535; https://clinicaltrials.gov/study/NCT03954535 ", doi="10.2196/47984", url="https://pediatrics.jmir.org/2024/1/e47984", url="http://www.ncbi.nlm.nih.gov/pubmed/38416559" } @Article{info:doi/10.2196/48538, author="Stoffel, T. Sandro and Law, Hui Jing and Kerrison, Robert and Brewer, R. Hannah and Flanagan, M. James and Hirst, Yasemin", title="Testing Behavioral Messages to Increase Recruitment to Health Research When Embedded Within Social Media Campaigns on Twitter: Web-Based Experimental Study", journal="JMIR Form Res", year="2024", month="Feb", day="5", volume="8", pages="e48538", keywords="advertise", keywords="advertisement", keywords="advertisements", keywords="advertising", keywords="behavior change", keywords="behavioral", keywords="behaviour change", keywords="behavioural", keywords="campaign", keywords="campaigns", keywords="experimental design", keywords="message", keywords="messages", keywords="messaging", keywords="recruit", keywords="recruiting", keywords="recruitment", keywords="social media", keywords="social norms", keywords="Twitter", abstract="Background: Social media is rapidly becoming the primary source to disseminate invitations to the public to consider taking part in research studies. There is, however, little information on how the contents of the advertisement can be communicated to facilitate engagement and subsequently promote intentions to participate in research. Objective: This paper describes an experimental study that tested different behavioral messages for recruiting study participants for a real-life observational case-control study. Methods: We included 1060 women in a web-based experiment and randomized them to 1 of 3 experimental conditions: standard advertisement (n=360), patient endorsement advertisement (n=345), and social norms advertisement (n=355). After seeing 1 of the 3 advertisements, participants were asked to state (1) their intention to take part in the advertised case-control study, (2) the ease of understanding the message and study aims, and (3) their willingness to be redirected to the website of the case-control study after completing the survey. Individuals were further asked to suggest ways to improve the messages. Intentions were compared between groups using ordinal logistic regression, reported in percentages, adjusted odds ratio (aOR), and 95\% CIs. Results: Those who were in the patient endorsement and social norms--based advertisement groups had significantly lower intentions to take part in the advertised study compared with those in the standard advertisement group (aOR 0.73, 95\% CI 0.55-0.97; P=.03 and aOR 0.69, 95\% CI 0.52-0.92; P=.009, respectively). The patient endorsement advertisement was perceived to be more difficult to understand (aOR 0.65, 95\% CI 0.48-0.87; P=.004) and to communicate the study aims less clearly (aOR 0.72, 95\% CI 0.55-0.95; P=.01). While the patient endorsement advertisement had no impact on intention to visit the main study website, the social norms advertisement decreased willingness compared with the standard advertisement group (157/355, 44.2\% vs 191/360, 53.1\%; aOR 0.74, 95\% CI 0.54-0.99; P=.02). The majority of participants (395/609, 64.8\%) stated that the messages did not require changes, but some preferred clearer (75/609, 12.3\%) and shorter (59/609, 9.7\%) messages. Conclusions: The results of this study indicate that adding normative behavioral messages to simulated tweets decreased participant intention to take part in our web-based case-control study, as this made the tweet harder to understand. This suggests that simple messages should be used for participant recruitment through Twitter (subsequently rebranded X). ", doi="10.2196/48538", url="https://formative.jmir.org/2024/1/e48538", url="http://www.ncbi.nlm.nih.gov/pubmed/38315543" } @Article{info:doi/10.2196/51238, author="Ng, Y. Madelena and Olgin, E. Jeffrey and Marcus, M. Gregory and Lyles, R. Courtney and Pletcher, J. Mark", title="Email-Based Recruitment Into the Health eHeart Study: Cohort Analysis of Invited Eligible Patients", journal="J Med Internet Res", year="2023", month="Dec", day="22", volume="25", pages="e51238", keywords="digital health study", keywords="recruitment", keywords="research participants", keywords="campaign evaluation", keywords="email", keywords="advertisement", keywords="enrollment", keywords="registration", keywords="consent", keywords="participation", keywords="engagement", keywords="eHealth", abstract="Background: Web- or app-based digital health studies allow for more efficient collection of health data for research. However, remote recruitment into digital health studies can enroll nonrepresentative study samples, hindering the robustness and generalizability of findings. Through the comprehensive evaluation of an email-based campaign on recruitment into the Health eHeart Study, we aim to uncover key sociodemographic and clinical factors that contribute to enrollment. Objective: This study sought to understand the factors related to participation, specifically regarding enrollment, in the Health eHeart Study as a result of a large-scale remote email recruitment campaign. Methods: We conducted a cohort analysis on all invited University of California, San Francisco (UCSF) patients to identify sociodemographic and clinical predictors of enrollment into the Health eHeart Study. The primary outcome was enrollment, defined by account registration and consent into the Health eHeart Study. The email recruitment campaign was carried out from August 2015 to February 2016, with electronic health record data extracted between September 2019 and December 2019. Results: The email recruitment campaign delivered at least 1 email invitation to 93.5\% (193,606/206,983) of all invited patients and yielded a 3.6\% (7012/193,606) registration rate among contacted patients and an 84.1\% (5899/7012) consent rate among registered patients. Adjusted multivariate logistic regression models analyzed independent sociodemographic and clinical predictors of (1) registration among contacted participants and (2) consent among registered participants. Odds of registration were higher among patients who are older, women, non-Hispanic White, active patients with commercial insurance or Medicare, with a higher comorbidity burden, with congestive heart failure, and randomized to receive up to 2 recruitment emails. The odds of registration were lower among those with medical conditions such as dementia, chronic pulmonary disease, moderate or severe liver disease, paraplegia or hemiplegia, renal disease, or cancer. Odds of subsequent consent after initial registration were different, with an inverse trend of being lower among patients who are older and women. The odds of consent were also lower among those with peripheral vascular disease. However, the odds of consent remained higher among patients who were non-Hispanic White and those with commercial insurance. Conclusions: This study provides important insights into the potential returns on participant enrollment when digital health study teams invest resources in using email for recruitment. The findings show that participant enrollment was driven more strongly by sociodemographic factors than clinical factors. Overall, email is an extremely efficient means of recruiting participants from a large list into the Health eHeart Study. Despite some improvements in representation, the formulation of truly diverse studies will require additional resources and strategies to overcome persistent participation barriers. ", doi="10.2196/51238", url="https://www.jmir.org/2023/1/e51238", url="http://www.ncbi.nlm.nih.gov/pubmed/38133910" } @Article{info:doi/10.2196/49354, author="Crespi, Elizabeth and Heller, Johanna and Hardesty, J. Jeffrey and Nian, Qinghua and Sinamo, K. Joshua and Welding, Kevin and Kennedy, David Ryan and Cohen, E. Joanna", title="Exploring Different Incentive Structures Among US Adults Who Use e-Cigarettes to Optimize Retention in Longitudinal Web-Based Surveys: Case Study", journal="J Med Internet Res", year="2023", month="Dec", day="13", volume="25", pages="e49354", keywords="incentive", keywords="conditional incentive", keywords="web-based survey", keywords="longitudinal study", keywords="follow-up", keywords="nicotine", keywords="e-cigarettes", keywords="tobacco", keywords="survey", keywords="retention", keywords="demographics", keywords="case study", keywords="optimization", keywords="adults", abstract="Background: Longitudinal cohort studies are critical for understanding the evolution of health-influencing behaviors, such as e-cigarette use, over time. Optimizing follow-up rates in longitudinal studies is necessary for ensuring high-quality data with sufficient power for analyses. However, achieving high rates of follow-up in web-based longitudinal studies can be challenging, even when monetary incentives are provided. Objective: This study compares participant progress through a survey and demographics for 2 incentive structures (conditional and hybrid unconditional-conditional) among US adults using e-cigarettes to understand the optimal incentive structure. Methods: The data used in this study are from a web-based longitudinal cohort study (wave 4; July to September 2022) of US adults (aged 21 years or older) who use e-cigarettes ?5 days per week. Participants (N=1804) invited to the follow-up survey (median completion time=16 minutes) were randomly assigned into 1 of 2 incentive structure groups (n=902 each): (1) conditional (US \$30 gift code upon survey completion) and (2) hybrid unconditional-conditional (US \$15 gift code prior to survey completion and US \$15 gift code upon survey completion). Chi-square tests assessed group differences in participant progress through 5 sequential stages of the survey (started survey, completed screener, deemed eligible, completed survey, and deemed valid) and demographics. Results: Of the 902 participants invited to the follow-up survey in each group, a higher proportion of those in the conditional (662/902, 73.4\%) than the hybrid (565/902, 62.6\%) group started the survey (P<.001). Of those who started the survey, 643 (97.1\%) participants in the conditional group and 548 (97\%) participants in the hybrid group completed the screener (P=.89), which was used each wave to ensure participants remained eligible. Of those who completed the screener, 555 (86.3\%) participants in the conditional group and 446 (81.4\%) participants in the hybrid group were deemed eligible for the survey (P=.02). Of those eligible, 514 (92.6\%) participants from the conditional group and 401 (89.9\%) participants from the hybrid group completed the survey and were deemed valid after data review (P=.14). Overall, more valid completions were yielded from the conditional (514/902, 57\%) than the hybrid group (401/902, 44.5\%; P<.001). Among those who validly completed the survey, no significant differences were found by group for gender, income, race, ethnicity, region, e-cigarette use frequency, past 30-day cigarette use, or number of waves previously completed. Conclusions: Providing a US \$30 gift code upon survey completion yielded higher rates of survey starts and completions than providing a US \$15 gift code both before and after survey completion. These 2 methods yielded participants with similar demographics, suggesting that one approach is not superior in obtaining a balanced sample. Based on this case study, future web-based surveys examining US adults using e-cigarettes could consider providing the full incentive upon completion of the survey. International Registered Report Identifier (IRRID): RR2-10.2196/38732 ", doi="10.2196/49354", url="https://www.jmir.org/2023/1/e49354", url="http://www.ncbi.nlm.nih.gov/pubmed/38090793" } @Article{info:doi/10.2196/51089, author="Zhang, Xupin and Wang, Jingjing and Lane, M. Jamil and Xu, Xin and S{\"o}rensen, Silvia", title="Investigating Racial Disparities in Cancer Crowdfunding: A Comprehensive Study of Medical GoFundMe Campaigns", journal="J Med Internet Res", year="2023", month="Dec", day="12", volume="25", pages="e51089", keywords="crowdfunding", keywords="racial discrimination", keywords="GoFundMe", abstract="Background: In recent years, there has been growing concern about prejudice in crowdfunding; however, empirical research remains limited, particularly in the context of medical crowdfunding. This study addresses the pressing issue of racial disparities in medical crowdfunding, with a specific focus on cancer crowdfunding on the GoFundMe platform. Objective: This study aims to investigate racial disparities in cancer crowdfunding using average donation amount, number of donations, and success of the fundraising campaign as outcomes. Methods: Drawing from a substantial data set of 104,809 campaigns in the United States, we used DeepFace facial recognition technology to determine racial identities and used regression models to examine racial factors in crowdfunding performance. We also examined the moderating effect of the proportion of White residents on crowdfunding bias and used 2-tailed t tests to measure the influence of racial anonymity on crowdfunding success. Owing to the large sample size, we set the cutoff for significance at P<.001. Results: In the regression and supplementary analyses, the racial identity of the fundraiser significantly predicted average donations (P<.001), indicating that implicit bias may play a role in donor behavior. Gender (P=.04) and campaign description length (P=.62) did not significantly predict the average donation amounts. The race of the fundraiser was not significantly associated with the number of donations (P=.42). The success rate of cancer crowdfunding campaigns, although generally low (11.77\%), showed a significant association with the race of the fundraiser (P<.001). After controlling for the covariates of the fundraiser gender, fundraiser age, local White proportion, length of campaign description, and fundraising goal, the average donation amount to White individuals was 17.68\% higher than for Black individuals. Moreover, campaigns that did not disclose racial information demonstrated a marginally higher average donation amount (3.92\%) than those identified as persons of color. Furthermore, the racial composition of the fundraiser's county of residence was found to exert influence (P<.001); counties with a higher proportion of White residents exhibited reduced racial disparities in crowdfunding outcomes. Conclusions: This study contributes to a deeper understanding of racial disparities in cancer crowdfunding. It highlights the impact of racial identity, geographic context, and the potential for implicit bias in donor behavior. As web-based platforms evolve, addressing racial inequality and promoting fairness in health care financing remain critical goals. Insights from this research suggest strategies such as maintaining racial anonymity and ensuring that campaigns provide strong evidence of deservingness. Moreover, broader societal changes are necessary to eliminate the financial distress that drives individuals to seek crowdfunding support. ", doi="10.2196/51089", url="https://www.jmir.org/2023/1/e51089", url="http://www.ncbi.nlm.nih.gov/pubmed/38085562" } @Article{info:doi/10.2196/42123, author="Tsiouris, Angeliki and Mayer, Anna and Wiltink, J{\"o}rg and Ruckes, Christian and Beutel, E. Manfred and Zwerenz, R{\"u}diger", title="Recruitment of Patients With Cancer for a Clinical Trial Evaluating a Web-Based Psycho-Oncological Intervention: Secondary Analysis of a Diversified Recruitment Strategy in a Randomized Controlled Trial", journal="JMIR Cancer", year="2023", month="Nov", day="27", volume="9", pages="e42123", keywords="psycho-oncology", keywords="cancer", keywords="recruitment", keywords="social media", keywords="web-based interventions", keywords="web-based recruitment", abstract="Background: Participant recruitment poses challenges in psycho-oncological intervention research, such as psycho-oncological web-based intervention studies. Strict consecutive recruitment in clinical settings provides important methodological benefits but is often associated with low response rates and reduced practicability and ecological validity. In addition to preexisting recruitment barriers, the protective measures owing to the COVID-19 pandemic restricted recruitment activities in the clinical setting since March 2020. Objective: This study aims to outline the recruitment strategy for a randomized controlled trial evaluating the unguided emotion-based psycho-oncological online self-help (epos), which combined traditional and web-based recruitment. Methods: We developed a combined recruitment strategy including traditional (eg, recruitment in clinics, medical practices, cancer counseling centers, and newspapers) and web-based recruitment (Instagram, Facebook, and web pages). Recruitment was conducted between May 2020 and September 2021. Eligible participants for this study were adult patients with any type of cancer who were currently receiving treatment or in posttreatment care. They were also required to have a good command of the German language and access to a device suitable for web-based interventions, such as a laptop or computer. Results: We analyzed data from 304 participants who were enrolled in a 17-month recruitment period using various recruitment strategies. Web-based and traditional recruitment strategies led to comparable numbers of participants (151/304, 49.7\% vs 153/304, 50.3\%). However, web-based recruitment required much less effort. Regardless of the recruitment strategy, the total sample did not accurately represent patients with cancer currently undergoing treatment for major types of cancer in terms of various sociodemographic characteristics, including but not limited to sex and age. However, among the web-recruited study participants, the proportion of female participants was even higher (P<.001), the mean age was lower (P=.005), private internet use was higher (on weekdays: P=.007; on weekends: P=.02), and the number of those who were currently under treatment was higher (P=.048). Other demographic and medical characteristics revealed no significant differences between the groups. The majority of participants registered as self-referred (236/296, 79.7\%) instead of having followed the recommendation of or study invitation from a health care professional. Conclusions: The combined recruitment strategy helped overcome general and COVID-19--specific recruitment barriers and provided the targeted participant number. Social media recruitment was the most efficient individual recruitment strategy for participant enrollment. Differences in some demographic and medical characteristics emerged, which should be considered in future analyses. Implications and recommendations for social media recruitment based on personal experiences are presented. Trial Registration: German Clinical Trials Register DRKS00021144; https://drks.de/search/en/trial/DRKS00021144 International Registered Report Identifier (IRRID): RR2-10.1016/j.invent.2021.100410 ", doi="10.2196/42123", url="https://cancer.jmir.org/2023/1/e42123", url="http://www.ncbi.nlm.nih.gov/pubmed/38010774" } @Article{info:doi/10.2196/52877, author="Guetz, Bernhard and Bidmon, Sonja", title="Authors' Reply: ``The Problem of Investigating Causal Relationships Between Cognitive and Evaluative Variables''", journal="J Med Internet Res", year="2023", month="Nov", day="22", volume="25", pages="e52877", keywords="social influence", keywords="physician rating websites", keywords="patient satisfaction", keywords="eHealth literacy", doi="10.2196/52877", url="https://www.jmir.org/2023/1/e52877", url="http://www.ncbi.nlm.nih.gov/pubmed/37991815" } @Article{info:doi/10.2196/45570, author="Konerding, Uwe", title="The Problem of Investigating Causal Relationships Between Cognitive and Evaluative Variables", journal="J Med Internet Res", year="2023", month="Nov", day="22", volume="25", pages="e45570", keywords="social influence", keywords="physician rating websites", keywords="patient satisfaction", keywords="eHealth literacy", doi="10.2196/45570", url="https://www.jmir.org/2023/1/e45570", url="http://www.ncbi.nlm.nih.gov/pubmed/37991832" } @Article{info:doi/10.2196/46190, author="Wong, W. Kirstie H. T. and Lau, Y. Wallis C. and Man, C. Kenneth K. and Bilbow, Andrea and Ip, Patrick and Wei, Li", title="Effectiveness of Facebook Groups and Pages on Participant Recruitment Into a Randomized Controlled Trial During the COVID-19 Pandemic: Descriptive Study", journal="J Med Internet Res", year="2023", month="Oct", day="17", volume="25", pages="e46190", keywords="1-2-3 Magic, ADHD", keywords="attention deficit/hyperactivity disorder", keywords="behavioral parenting training", keywords="BPT", keywords="clinical trial", keywords="COVID-19", keywords="Facebook group", keywords="Facebook page", keywords="Facebook", keywords="pediatric", keywords="randomized controlled trial", keywords="recruitment", keywords="social media", keywords="youth", keywords="Zoom", abstract="Background: In response to the unprecedented challenges posed by the COVID-19 pandemic, conventional recruitment approaches were halted, causing the suspension of numerous clinical trials. Previously, Facebook (Meta Platforms, Inc) has emerged as a promising tool for augmenting participant recruitment. While previous research has explored the use of Facebook for surveys and qualitative studies, its potential for recruiting participants into randomized controlled trials (RCTs) remains underexplored. Objective: This study aimed to comprehensively examine the effectiveness of using Facebook groups and pages to facilitate participant recruitment during the COVID-19 pandemic for an RCT on the effectiveness of a remote parenting program, 1-2-3 Magic, in families who have children with attention-deficit/hyperactivity disorder (ADHD) in the United Kingdom. Methods: We disseminated 5 Facebook posts with an attached digital flyer across 4 prominent ADHD UK support groups and pages run by the National Attention Deficit Disorder Information and Support Services, reaching an audience of around 16,000 individuals over 2 months (January 7 to March 4, 2022). Eligibility criteria mandated participants to be parents or caregivers of a child with diagnosed ADHD aged 12 years or younger, be residing in the United Kingdom, have access to stable internet, and have a device with the Zoom (Zoom Video Communications) app. Participants were required to have never attended 1-2-3 Magic training previously. Prospective participants expressed their interest through Microsoft Forms (Microsoft Corporation). The trial aimed to recruit 84 parents. It is important to note that the term ``parent'' or ``caregiver'' in the RCT and in this study within a trial refers to anybody who has legal responsibility for the child. Results: Overall, 478 individuals registered their interest through Microsoft Forms within the stipulated 2-month window. After the eligibility check, 135 participants were contacted for a baseline meeting through Zoom. The first 84 participants who attended a baseline meeting and returned a completed consent form were enrolled. Subsequently, another 16 participants were added, resulting in a final sample of 100 participants. This recruitment strategy incurred negligible expenses and demanded minimal human resources. The approach yielded favorable outcomes by efficiently attracting eligible participants in a condensed time frame, transcending geographical barriers throughout the United Kingdom, which would have been tedious to achieve through traditional recruitment methods. Conclusions: Our experience demonstrated that digital flyers posted in the targeted Facebook groups were a cost-effective and quick method for recruiting for an RCT, which opened during the COVID-19 pandemic when lockdown restrictions were in place in the United Kingdom. Trialists should consider this low-cost recruitment intervention for trials going forward, and in the case of a global pandemic, this novel recruitment method enabled the trial to continue where many have failed. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 15281572; https://www.isrctn.com/ISRCTN15281572 ", doi="10.2196/46190", url="https://www.jmir.org/2023/1/e46190", url="http://www.ncbi.nlm.nih.gov/pubmed/37847536" } @Article{info:doi/10.2196/47705, author="Oudat, Qutaibah and Bakas, Tamilyn", title="Merits and Pitfalls of Social Media as a Platform for Recruitment of Study Participants", journal="J Med Internet Res", year="2023", month="Oct", day="11", volume="25", pages="e47705", keywords="recruitment", keywords="social media", keywords="review", keywords="study participant", keywords="methods", doi="10.2196/47705", url="https://www.jmir.org/2023/1/e47705", url="http://www.ncbi.nlm.nih.gov/pubmed/37819692" } @Article{info:doi/10.2196/49678, author="Haun, N. Jolie and Venkatachalam, H. Hari and Fowler, A. Christopher and Alman, C. Amy and Ballistrea, M. Lisa and Schneider, Tali and Benzinger, C. Rachel and Melillo, Christine and Alexander, B. Neil and Klanchar, Angelina S. and Lapcevic, William and French, D. Dustin", title="Mobile and Web-Based Partnered Intervention to Improve Remote Access to Pain and Posttraumatic Stress Disorder Symptom Management: Recruitment and Attrition in a Randomized Controlled Trial", journal="J Med Internet Res", year="2023", month="Oct", day="3", volume="25", pages="e49678", keywords="PTSD", keywords="pain", keywords="veteran", keywords="attrition", keywords="CIH", keywords="randomized controlled trial", keywords="chronic pain", keywords="remote intervention", keywords="dyad", keywords="mobile health", abstract="Background: Increasing access to nonpharmacological interventions to manage pain and posttraumatic stress disorder (PTSD) is essential for veterans. Complementary and integrative health (CIH) interventions can help individuals manage symptom burden with enhanced accessibility via remotely delivered health care. Mission Reconnect (MR) is a partnered, self-directed intervention that remotely teaches CIH skills. Objective: The purpose of this paper is to describe the recruitment, onboarding phase, and attrition of a fully remote randomized controlled trial (RCT) assessing the efficacy of a self-directed mobile and web-based intervention for veterans with comorbid chronic pain and PTSD and their partners. Methods: A total of 364 veteran-partner dyads were recruited to participate in a mixed methods multisite waitlist control RCT. Qualitative attrition interviews were conducted with 10 veterans with chronic pain and PTSD, and their self-elected partners (eg, spouse) who consented but did not begin the program. Results: At the point of completing onboarding and being randomized to the 2 treatment arms, of the 364 recruited dyads, 97 (26.6\%) failed to complete onboarding activities. Reported reasons for failure to complete onboarding include loss of self-elected partner buy-in (n=8, 8\%), difficulties with using remote data collection methods and interventions (n=30, 31\%), and adverse health experiences unrelated to study activities (n=23, 24\%). Enrolled veterans presented at baseline with significant PTSD symptom burden and moderate-to-severe pain severity, and represented a geographically and demographically diverse population. Attrition interviews (n=10) indicated that misunderstanding MR including the intent of the intervention or mistaking the surveys as the actual intervention was a reason for not completing the MR registration process. Another barrier to MR registration was that interviewees described the mailed study information and registration packets as too confusing and excessive. Competing personal circumstances including health concerns that required attention interfered with MR registration. Common reasons for attrition following successful MR registration included partner withdrawal, adverse health issues, and technological challenges relating to the MR and electronic data collection platform (Qualtrics). Participant recommendations for reducing attrition included switching to digital forms to reduce participant burden and increasing human interaction throughout the registration and baseline data collection processes. Conclusions: Challenges, solutions, and lessons learned for study recruitment and intervention delivery inform best practices of delivering remote self-directed CIH interventions when addressing the unique needs of this medically complex population. Successful recruitment and enrollment of veterans with chronic pain and PTSD, and their partners, to remote CIH programs and research studies requires future examination of demographic and symptom-associated access barriers. Accommodating the unique needs of this medically complex population is essential for improving the effectiveness of CIH programs. Disseminating lessons learned and improving access to remotely delivered research studies and CIH programs is paramount in the post--COVID-19 climate. Trial Registration: ClinicalTrials.gov NCT03593772; https://clinicaltrials.gov/ct2/show/NCT03593772 ", doi="10.2196/49678", url="https://www.jmir.org/2023/1/e49678", url="http://www.ncbi.nlm.nih.gov/pubmed/37788078" } @Article{info:doi/10.2196/43824, author="Fan, A. Carolyn and Upham, Michelle and Beaver, Kristine and Dashtestani, Krista and Skiby, M. Malachi and Pentel, Z. Kimberly and Rhew, C. Isaac and Kauth, R. Michael and Shipherd, C. Jillian and Kaysen, Debra and Simpson, Tracy and Lehavot, Keren", title="Recruiting Sexual and Gender Minority Veterans for Health Disparities Research: Recruitment Protocol of a Web-Based Prospective Cohort Study", journal="JMIR Res Protoc", year="2023", month="Oct", day="2", volume="12", pages="e43824", keywords="lesbian, gay, bisexual, transgender, queer, and other sexual and gender minority", keywords="LGBTQ+", keywords="veteran", keywords="recruitment", keywords="health disparities", abstract="Background: The Health for Every Veteran Study is the first Veterans Health Administration--funded, nationwide study on lesbian, gay, bisexual, transgender, queer, and other sexual and gender minority (LGBTQ+) veterans' health that relies exclusively on primary recruitment methods. This study aimed to recruit 1600 veterans with diverse sexual and gender identities to study the mental health and health risk behaviors of this population. A growing body of literature highlights the health inequities faced by LGBTQ+ veterans when compared with their heterosexual or cisgender peer groups. However, there is little to no guidance in the health disparities literature describing the recruitment of LGBTQ+ veterans. Objective: This paper provides an overview of the recruitment methodology of Health for Every Veteran Study. We describe the demographics of the enrolled cohort, challenges faced during recruitment, and considerations for recruiting LGBTQ+ veterans for health research. Methods: Recruitment for this study was conducted for 15 months, from September 2019 to December 2020, with the goal of enrolling 1600 veterans evenly split among 8 sexual orientation and gender identity subgroups: cisgender heterosexual women, cisgender lesbian women, cisgender bisexual women, cisgender heterosexual men, cisgender gay men, cisgender bisexual men, transgender women, and transgender men. Three primary recruitment methods were used: social media advertising predominantly through Facebook ads, outreach to community organizations serving veterans and LGBTQ+ individuals across the United States, and contracting with a research recruitment company, Trialfacts. Results: Of the 3535 participants screened, 1819 participants met the eligibility criteria, and 1062 completed the baseline survey to enroll. At baseline, 25.24\% (268/1062) were recruited from Facebook ads, 40.49\% (430/1062) from community outreach, and 34.27\% (364/1062) from Trialfacts. Most subgroups neared the target enrollment goals, except for cisgender bisexual men, women, and transgender men. An exploratory group of nonbinary and genderqueer veterans and veterans with diverse gender identities was included in the study. Conclusions: All recruitment methods contributed to significant portions of the enrolled cohort, suggesting that a multipronged approach was a critical and successful strategy in our study of LGBTQ+ veterans. We discuss the strengths and challenges of all recruitment methods, including factors impacting recruitment such as the COVID-19 pandemic, negative comments on Facebook ads, congressional budget delays, and high-volume surges of heterosexual participants from community outreach. In addition, our subgroup stratification offers important disaggregated insights into the recruitment of specific LGBTQ+ subgroups. Finally, the web-based methodology offers important perspectives not only for reaching veterans outside of the Veterans Health Administration but also for research studies taking place in the COVID-19-impacted world. Overall, this study outlines useful recruitment methodologies and lessons learned to inform future research that seeks to recruit marginalized communities. International Registered Report Identifier (IRRID): DERR1-10.2196/43824 ", doi="10.2196/43824", url="https://www.researchprotocols.org/2023/1/e43824", url="http://www.ncbi.nlm.nih.gov/pubmed/37782536" } @Article{info:doi/10.2196/47970, author="Billington, Olive Emma and Hasselaar, M. Charley and Kembel, Lorena and Myagishima, C. Rebecca and Arain, A. Mubashir", title="Effectiveness and Cost of Using Facebook Recruitment to Elicit Canadian Women's Perspectives on Bone Health and Osteoporosis: Cross-Sectional Survey Study", journal="J Med Internet Res", year="2023", month="Sep", day="29", volume="25", pages="e47970", keywords="osteoporosis", keywords="bone health", keywords="bone mineral density", keywords="fracture", keywords="survey", keywords="Facebook", keywords="advertisement", keywords="recruitment", keywords="women's health", keywords="social media", keywords="bone", keywords="perspective", abstract="Background: Surveys can help health researchers better understand the public's perspectives and needs regarding prevalent conditions such as osteoporosis, which affects more than two-thirds of postmenopausal women. However, recruitment of large cohorts for survey research can be time-consuming and expensive. With 2.9 billion active users across the globe and reasonable advertising costs, Facebook (Meta Platforms, Inc) has emerged as an effective recruitment tool for surveys, although previous studies have targeted young populations (<50 years of age) and none have focused on bone health. Objective: We assessed the effectiveness and cost of using Facebook to recruit Canadian women aged ?45 years to share their perspectives on bone health and osteoporosis via a web-based survey. Methods: We developed a 15-minute web-based survey with the goal of eliciting perspectives on bone health and osteoporosis. A Facebook advertisement was placed for 2 weeks in February 2022, during which time it was shown to women of age ?45 years who resided in Canada, inviting them to participate and offering a chance to win 1 of 5 CAD \$100 gift cards (at the time of this study [February 14, 2022], a currency exchange rate of CAD \$1=US \$0.79 was applicable). Those who clicked on the advertisement were taken to an eligibility screening question on the survey home screen. Individuals who confirmed eligibility were automatically directed to the first survey question. All individuals who answered the first survey question were considered participants and included in the analyses. We determined the survey reach, click rate, cooperation rate, completion rate, cost per click, and cost per participant. Sociodemographic characteristics of respondents were compared with data from the 2021 Canadian Census. Results: The Facebook advertisement was shown to 34,086 unique Facebook users, resulting in 2033 link clicks (click rate: 6.0\%). A total of 1320 individuals completed the eligibility screening question, 1195 started the survey itself (cooperation rate: 58.8\%), and 966 completed the survey (completion rate: 47.5\%). The cost of the advertising campaign was CAD \$280.12, resulting in a cost per click of CAD \$0.14 and a cost per participant of CAD \$0.23. The 1195 participants ranged in age from 45-89 years (mean 65, SD 7 years), 921 (93.7\%) were of White ethnicity, 854 (88.3\%) had completed some postsecondary education, and 637 (65.8\%) resided in urban areas. Responses were received from residents of all 10 Canadian provinces and 2 of 3 territories. When compared to 2021 Canadian Census data, postsecondary education and rural residence were overrepresented in our study population. Conclusions: Facebook advertising is an efficient, effective, and inexpensive way of recruiting large samples of older women for participation in web-based surveys for health research. However, it is important to recognize that this modality is a form of convenience sampling and the benefits of Facebook recruitment must be balanced with its limitations, which include selection bias and coverage error. ", doi="10.2196/47970", url="https://www.jmir.org/2023/1/e47970", url="http://www.ncbi.nlm.nih.gov/pubmed/37773625" } @Article{info:doi/10.2196/46415, author="Griggs, Stephanie and Ash, I. Garrett and Pignatiello, Grant and Papik, AnnMarie and Huynh, Johnathan and Leuchtag, Mary and Hickman Jr, L. Ronald", title="Internet-Based Recruitment and Retention of Young Adults With Type 1 Diabetes: Cross-Sectional Study", journal="JMIR Form Res", year="2023", month="Aug", day="22", volume="7", pages="e46415", keywords="type 1 diabetes", keywords="internet-based recruitment", keywords="young adult", keywords="diabetes", keywords="diabetic", keywords="type 1", keywords="recruit", keywords="research platform", keywords="T1D", keywords="social media", keywords="research subject", keywords="research participant", keywords="study participant", abstract="Background: Multiple research strategies are required to recruit and engage a representative cohort of young adults in diabetes research. In this report, we describe an approach for internet-based recruitment for a repeated-measures descriptive study. Objective: The objective of this cross-sectional study was to determine whether internet-based recruitment through multiple social media platforms, a clinical research platform, and cooperation with community partnerships---College Diabetes Network and Beyond Type 1---would serve as an effective way to recruit a representative sample of young adults aged 18-25 years with type 1 diabetes (T1D). Methods: We conducted a repeated-measures descriptive study. We captured enrollment rates and participant characteristics acquired from each social media platform through survey data and Facebook analytics. This study was advertised via paid postings across a combination of different social media platforms (eg, Facebook, Instagram, Twitter, and Reddit). We used quarterly application postings, quarterly newsletters, and participation in the ResearchMatch registry to identify potentially eligible participants from February 3, 2021, to June 6, 2022. Results: ResearchMatch proved to be the most cost-effective strategy overall, yielding the highest gender and racial diversity compared to other internet platforms (eg, Facebook, Instagram, Twitter, and Reddit), application postings (eg, Beyond Type 1), and newsletters (eg, College Diabetes Network and a local area college). However, we propose that the combination of these approaches yielded a larger, more diverse sample compared to any individual strategy. Our recruitment cost was US \$16.69 per eligible participant, with a 1.27\% conversion rate and a 30\% eligibility rate. Conclusions: Recruiting young adults with T1D across multiple internet-based platforms was an effective strategy to yield a moderately diverse sample. Leveraging various recruitment strategies is necessary to produce a representative sample of young adults with T1D. As the internet becomes a larger forum for study recruitment, participants from underrepresented backgrounds may continue engaging in research through advertisements on the internet and other internet-based recruitment platforms. ", doi="10.2196/46415", url="https://formative.jmir.org/2023/1/e46415", url="http://www.ncbi.nlm.nih.gov/pubmed/37606985" } @Article{info:doi/10.2196/44813, author="Raggatt, Michelle and Wright, C. Cassandra J. and Sacks-Davis, Rachel and Dietze, M. Paul and Hellard, E. Margaret and Hocking, S. Jane and Lim, C. Megan S.", title="Identifying the Most Effective Recruitment Strategy Using Financial Reimbursements for a Web-Based Peer Network Study With Young People Aged 16-18 Years: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2023", month="Aug", day="11", volume="12", pages="e44813", keywords="young adult", keywords="incentive reimbursement", keywords="research subject", keywords="study participant", keywords="financial", keywords="research subject recruitment", keywords="social network", keywords="peer network", keywords="web-based network", keywords="randomized", keywords="friend", keywords="recruit", keywords="incentive", keywords="reimburse", keywords="reward", keywords="incentivized", keywords="youth", keywords="adolescent", keywords="teenage", keywords="recruitment", keywords="reinforcing factor", keywords="enabling factor", keywords="disambiguation", keywords="intrinsic incentive", keywords="extrinsic incentive", keywords="motivation", keywords="reward system", keywords="positive reinforcement", keywords="compensation", keywords="monetary", keywords="remuneration", keywords="remunerative incentive", keywords="financial incentive", keywords="bonus", keywords="stipend", keywords="donation", abstract="Background: Peers are an important determinant of health and well-being during late adolescence; however, there is limited quantitative research examining peer influence. Previous peer network research with adolescents faced methodological limitations and difficulties recruiting young people. Objective: This study aims to determine whether a web-based peer network survey is effective at recruiting adolescent peer networks by comparing 2 strategies for reimbursement. Methods: This study will use a 2-group randomized trial design to test the effectiveness of reimbursements for peer referral in a web-based cross-sectional peer network survey. Young people aged 16-18 years recruited through Instagram, Snapchat, and a survey panel will be randomized to receive either scaled group reimbursement (the experimental group) or fixed individual reimbursement (the control group). All participants will receive a reimbursement of Aus \$5 (US \$3.70) for their own survey completion. In the experimental group (scaled group reimbursement), all participants within a peer network will receive an additional Aus \$5 (US \$3.70) voucher for each referred participant who completes the study, up to a maximum total value of Aus \$30 (US \$22.20) per participant. In the control group (fixed individual reimbursement), participants will only be reimbursed for their own survey completion. Participants' peer networks are assessed during the survey by asking about their close friends. A unique survey link will be generated to share with the participant's nominated friends for the recruitment of secondary participants. Outcomes are the proportion of a participant's peer network and the number of referred peers who complete the survey. The required sample size is 306 primary participants. Using a multilevel logistic regression model, we will assess the effect of the reimbursement intervention on the proportion of primary participants' close friends who complete the survey. The secondary aim is to determine participant characteristics that are associated with successfully recruiting close friends. Young people aged 16-18 years were involved in the development of the study design through focus groups and interviews (n=26). Results: Participant recruitment commenced in 2022. Conclusions: A longitudinal web-based social network study could provide important data on how social networks and their influence change over time. This trial aims to determine whether scaled group reimbursement can increase the number of peers referred. The outcomes of this trial will improve the recruitment of young people to web-based network studies of sensitive health issues. International Registered Report Identifier (IRRID): DERR1-10.2196/44813 ", doi="10.2196/44813", url="https://www.researchprotocols.org/2023/1/e44813", url="http://www.ncbi.nlm.nih.gov/pubmed/37566448" } @Article{info:doi/10.2196/41997, author="Weber, Matthew and Armour, L. Veronica and Lindstadt, Calandra and Yanovitzky, Itzhak", title="Testing Multiple Methods to Effectively Promote Use of a Knowledge Portal to Health Policy Makers: Quasi-Experimental Evaluation", journal="J Med Internet Res", year="2023", month="Jun", day="28", volume="25", pages="e41997", keywords="depression", keywords="depression screening", keywords="policy making", keywords="Google Ads", keywords="analytics", keywords="knowledge brokers", keywords="knowledge sharing", keywords="online", keywords="resources", keywords="teen", keywords="young adult", keywords="effectiveness", abstract="Background: Health policy makers and advocates increasingly utilize online resources for policy-relevant knowledge. Knowledge brokering is one potential mechanism to encourage the use of research evidence in policy making, but the mechanisms of knowledge brokerage in online spaces are understudied. This work looks at knowledge brokerage through the launch of Project ASPEN, an online knowledge portal developed in response to a New Jersey legislative act that established a pilot program for adolescent depression screening for young adults in grades 7-12. Objective: This study compares the ability to drive policy brief downloads by policy makers and advocates from the Project ASPEN knowledge portal using a variety of online methods to promote the knowledge portal. Methods: The knowledge portal was launched on February 1, 2022, and a Google Ad campaign was run between February 27, 2022, and March 26, 2022. Subsequently, a targeted social media campaign, an email campaign, and tailored research presentations were used to promote the website. Promotional activities ended on May 31, 2022. Website analytics were used to track a variety of actions including new users coming to the website, page views, and policy brief downloads. Statistical analysis was used to assess the efficacy of different approaches. Results: The campaign generated 2837 unique user visits to the knowledge portal and 4713 page views. In addition, the campaign generated 6.5 policy web page views/day and 0.7 policy brief downloads/day compared with 1.8 views/day and 0.5 downloads/day in the month following the campaign. The rate of policy brief page view conversions was significantly higher for Google Ads compared with other channels such as email (16.0 vs 5.4; P<.001) and tailored research presentations (16.0 vs 0.8; P<.001). The download conversion rate for Google Ads was significantly higher compared with social media (1.2 vs 0.1; P<.001) and knowledge brokering activities (1.2 vs 0.2; P<.001). By contrast, the download conversion rate for the email campaign was significantly higher than that for social media (1.0 vs 0.1; P<.001) and tailored research presentations (1.0 vs 0.2; P<.001). While Google Ads for this campaign cost an average of US \$2.09 per click, the cost per conversion was US \$11 per conversion to drive targeted policy web page views and US \$147 per conversion to drive policy brief downloads. While other approaches drove less traffic, those approaches were more targeted and cost-effective. Conclusions: Four tactics were tested to drive user engagement with policy briefs on the Project ASPEN knowledge portal. Google Ads was shown to be effective in driving a high volume of policy web page views but was ineffective in terms of relative costs. More targeted approaches such as email campaigns and tailored research presentations given to policy makers and advocates to promote the use of research evidence on the knowledge portal website are likely to be more effective when balancing goals and cost-effectiveness. ", doi="10.2196/41997", url="https://www.jmir.org/2023/1/e41997", url="http://www.ncbi.nlm.nih.gov/pubmed/37379073" } @Article{info:doi/10.2196/44252, author="Blake, V. Kathryn and Antal, Holly and Bunnell, Timothy H. and He, Jiaxian and Henderson, Robert and Holbrook, T. Janet and McCahan, M. Suzanne and Pennington, Chris and Rogers, Linda and Shade, David and Sugar, A. Elizabeth and Taylor, Alexandra and Wise, A. Robert and Wysocki, Tim", title="Comprehension by Caregivers and Adolescents of Clinical Trial Information Delivered via Multimedia Video Versus Conventional Practice: Nonrandomized Controlled Trial", journal="JMIR Pediatr Parent", year="2023", month="Jun", day="22", volume="6", pages="e44252", keywords="adolescent", keywords="clinical trial", keywords="comprehension", keywords="informed consent", keywords="internet", keywords="multimedia", abstract="Background: Research participants often misunderstand the required elements of informed consent information, whether provided in written or oral format. Informed consent instruments with embedded evidence-based learning theory principles administered in multimedia electronic formats may improve comprehension and retention. Objective: This study aims to determine whether study information comprehension and retention using an interactive multimedia video consent process was noninferior to comprehension and retention after an in-person face-to-face interaction with a conventional written consent document for caregivers and adolescents enrolled in a clinical trial. Methods: Participants were caregivers and children aged 12 to 17 years who were enrolled in a clinical trial of asthma treatment. Consent information was presented as a multimedia web-based video consent interaction or as a conventional written consent document with in-person interaction between the prospective participants and the study staff. The trial used a parallel nonrandomized noninferiority design that compared the 2 consent methods. Caregivers and adolescents completed a 17-item open-ended comprehension questionnaire (score range 17-51) at enrollment and at the end of the study 20 weeks later. Comprehension and retention were compared between the consent formats. Noninferiority was established if the 95\% CI upper bound of the difference in scores (conventional format minus web-based) was less than the noninferiority margin of 2.4; superiority was established if the upper bound of the CI was <0. Results: In total, 54 caregiver and adolescent dyads completed the interactive multimedia web-based video consent, and 25 dyads completed the conventional consent. Overall, 33\% (26/79) of all adolescents were Black, 57\% (45/79) were male, and 61\% (48/79) had a household income of