@Article{info:doi/10.2196/65733, author="Munce, P. Sarah E. and Jarrett, Clementine and Senthilnathan, Vjura and Luong, Dorothy and Allemang, Brooke and Bailey, Katherine and Biddiss, Elaine and Britto, T. Maria and Buchanan, Francine and Cassidy, Christine and Cross, Andrea and Cunningham, Jessie and Dimitropoulos, Gina and Hadland, E. Scott and Kastner, Monika and Killackey, Tieghan and Kokorelias, Kristina and Macarthur, Colin and Micsinszki, Samantha and Niles, Chavon and Wright, Virginia F. and Toulany, Alene", title="Development of a Framework for Youth- and Family-Specific Engagement in Research: Proposal for a Scoping Review and Qualitative Descriptive Study", journal="JMIR Res Protoc", year="2025", month="Mar", day="28", volume="14", pages="e65733", keywords="youth and family engagement", keywords="frameworks", keywords="implementation science", keywords="scoping review", keywords="qualitative", abstract="Background: Youth and families play an indispensable role in health research, given their unique lived experiences and expertise. Aligning research with patients' needs, values, and preferences can significantly enhance its relevance and impact; however, recent research has highlighted various challenges and risks associated with youth and family engagement in health research. These challenges encompass the perils of tokenism, power imbalances and dynamics, questioning the motives behind engagement, and limited accessibility to patient-friendly training for patient partners, as well as inadequate training on patient engagement for researchers and the absence of equitable engagement tools. To address these risks and challenges, different patient engagement models, theories, frameworks, and guiding principles have been developed and adopted; to date, however, their transferability to youth- and family-specific engagement in research has been limited. Objective: The objectives of this project are (1) to determine the extent of the literature on the application of patient engagement models, theories, frameworks, and guiding principles in the context of youth-specific research; and (2) to determine how meaningful the key components and constructs of these models, theories, frameworks, and guiding principles are to youth and their family members. Methods: This project will use an integrated knowledge translation approach and consists of 2 phases: (1) a scoping review to identify patient engagement models, theories, frameworks and guiding principles in youth research; and (2) a qualitative descriptive study using one-on-one semistructured interviews with youth and family members to understand their conceptualization of meaningful engagement in health research. For phase 1, the following databases were searched: Medline, CINAHL, EMBASE, PsycINFO, and the Cochrane Central Register of Controlled Trials. Literature from 2013 to August 28, 2024, was captured. Primary studies using a patient engagement in research model, theory, or framework, or guiding principles, in youth will be included. The risk of bias of included studies will not be assessed. Extracted data will be quantitatively summarized using numerical counts and qualitatively using content analysis. For phase 2, we will recruit 9 to 17 youth and 9 to 17 family members. Transcripts will be analyzed using an inductive approach outlined by Braun and Clarke. Results: The project has received funding from the Canadian Institutes of Health Research. A 9-member integrated knowledge translation panel consisting of 6 youth and 3 family members has been established. Conclusions: The findings from this study will identify what is currently known about the application of patient engagement models, theories, frameworks, and guiding principles in youth-specific research and the important components of these models, theories, frameworks, and guiding principles from the perspective of youth and their families. These findings will be instrumental to developing a youth- and family-specific engagement in research framework called the UNITE framework and subsequently, a validated measure. International Registered Report Identifier (IRRID): PRR1-10.2196/65733 ", doi="10.2196/65733", url="https://www.researchprotocols.org/2025/1/e65733" } @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/10.2196/58410, author="Hernandez-Spalding, Kaitlyn and Farinu, Oluyemi and Clarke, Lasha and Lewis, Tamiah and Suarez, Angie and Bugg, Kimarie and Strickland, Kieauna and Molleti, Ashley and Maxy, Sherry and Hernandez-Green, Natalie", title="Centering Birthing Experiences of Women of Color: Protocol for a Qualitative Maternal Near Miss Study", journal="JMIR Res Protoc", year="2025", month="Mar", day="27", volume="14", pages="e58410", keywords="maternal health disparities", keywords="maternal near miss", keywords="minority health", keywords="mental health", keywords="narrative-based medicine", keywords="experiences", keywords="birthing experience", keywords="women", keywords="Black women", keywords="United States", keywords="maternal morbidity", keywords="patient-centered", keywords="racial", keywords="ethnic", keywords="disparities", keywords="socioeconomically", keywords="pregnancy", keywords="childbirth", keywords="postpartum", keywords="antenatal", abstract="Background: In the United States, Black women are 3-4 times more likely to experience maternal near miss (MNM) or severe maternal morbidity (SMM) than non-Hispanic White women. However, there is a limited narrative-based investigation into Black and other marginalized women's MNM experiences. Additionally, limited extant research on the impact of MNM and SMM on birthing women's families or support persons and health care providers precludes the development of multilevel, patient-centered methods to eliminate these racial or ethnic disparities. Objective: This paper presents the protocol for a study that aims to draw insights from the experiences of racially and socioeconomically diverse mothers with MNM and SMM, their family or support persons (eg, partners), and health care providers to inform legislation, clinical practice, and infrastructure for optimal social support using PRISMA-P (Preferred Reporting Items for Systematic review and Meta-Analysis Protocols) guidelines. Using a storytelling approach to assess participants' risk factors, document underlying causes, and research clinical causes of MNM, researchers hypothesize these data will inform policies to improve maternal conditions and provide safe and effective prevention and treatment options for birthing persons. Methods: Morehouse School of Medicine (MSM) will partner with health services and community-based organizations to promote inclusive participant recruitment for this multiphase study. In phase 1, qualitative interviews were conducted with birthing women (n?87) who have experienced MNM and SMM. In phase 2, we will conduct qualitative interviews with the following groups: birthing women's partners or support persons (n?50), health care providers serving birthing women (n?50), and adults who lost their mothers to pregnancy-related complications (n?50). In each phase, the total number of participants interviewed will be based on theoretical saturation, that is, the point in iterative data collection and analysis when all important insights have been exhausted from the data already available. Results: Recruitment for phase 1 started in July 2021. As of March 2024, we have recruited 87 racially and socioeconomically diverse birthing women. Of those, 74\% (64/87) self-identified as Black or African American, 20\% (17/87) as Hispanic or Latina, and 9\% (8/87) as Native American or Alaska Native. Severe preeclampsia accounted for 46\% (40/87) of participants' pregnancy-related adverse experiences. Qualitative interviews grounded in narrative-based medicine are ongoing. Recruitment for phase 2 will occur between July 2023 and December 2024. Study results will be published in peer-reviewed scientific journals. Conclusions: The findings from this research will deepen the understanding of how severe obstetric complications (1) are experienced by birthing women; (2) are perceived by their partners, support persons, and health providers; and (3) impact the lives of bereaved family and community members. ", doi="10.2196/58410", url="https://www.researchprotocols.org/2025/1/e58410" } @Article{info:doi/10.2196/52121, author="Daniels, Joseph and van der Merwe, Leigh-Ann Leonashia and Portle, Sarah and Bongo, Cikizwa and Nadkarni, Shiv and Petrus Peters, Remco", title="Tailoring a Skills-Based Serostatus Disclosure Intervention for Transgender Women in South Africa: Protocol for a Usability and Feasibility Study", journal="JMIR Res Protoc", year="2025", month="Mar", day="26", volume="14", pages="e52121", keywords="transgender women", keywords="intervention development", keywords="relationships", keywords="HIV treatment", keywords="South Africa", keywords="mobile phones, smartphones", keywords="skills-based", keywords="serostatus disclosure", keywords="HIV", keywords="HIV prevention", keywords="transgender", keywords="treatment outcomes", keywords="transmission", keywords="HIV-discordant partnerships", keywords="behavioral intervention", keywords="safe sex", keywords="human-centered design", keywords="viral suppression", keywords="Speaking Out and Allying Relationships", keywords="LGBTQ2S", keywords="LGBTQ", keywords="2SILGBTQ", abstract="Background: Transgender women have few interventions to support their HIV prevention and treatment outcomes in South Africa. Further, increased focus should be on intervention development that will reduce HIV transmission within HIV-discordant partnerships, especially for transgender women who navigate gender, sexuality, and relationship stigma. The Speaking Out and Allying Relationships (SOAR) intervention has been developed for sexual minority men to address these outcomes in South Africa. It is a behavioral intervention that is delivered in groups via videoconference to develop coping skills to manage HIV-related stress, assist with disclosure to partners, and establish and maintain safer sex practices with partners. Tailoring SOAR may be feasible for transgender women to support their HIV care while reducing transmission within their relationships. Objective: This study aims to (1) adapt SOAR for transgender women and test its usability, then (2) assess its feasibility. Methods: To achieve aim 1, we will use a human-centered design approach to tailor the existing SOAR intervention for transgender women. Interviews and a survey will be administered to transgender women (N=15) to assess intervention preferences. Findings will be used to tailor content like roleplays, scenarios, and media to align with transgender women's lived experiences navigating HIV and relationships. Afterward, we will conduct a usability test with 7 (47\%) of the 15 participants to determine intervention understanding and satisfaction. Participants will be transgender women living with HIV and in a relationship with a man who has unknown HIV status or is HIV-negative. All participants will be recruited using community-based approaches. In aim 2, we will examine SOAR feasibility using a 1-arm pilot study. Transgender women (N=20) will be recruited using aim 1 methods and eligibility criteria, with participants completing feasibility surveys and interviews, as well as behavioral and biomedical assessments. Results: Intervention adaptation began in May 2023 with interviews. Feasibility pilot testing was conducted with 14 transgender women, with study completion in January 2025. Conclusions: Transgender women need more intervention options that engage their relationships since these can present barriers to HIV treatment outcomes like hindering viral suppression in South Africa. Delivering an existing yet tailored intervention via videoconference expands its reach to transgender women and allows them to engage with others and learn new skills in a secure setting like their homes. SOAR has the potential to improve relationship dynamics and reduce violence, which will in turn enhance HIV treatment and prevention engagement. International Registered Report Identifier (IRRID): PRR1-10.2196/52121 ", doi="10.2196/52121", url="https://www.researchprotocols.org/2025/1/e52121" } @Article{info:doi/10.2196/57821, author="Govender, Samantha and Cochrane, Elizabeth Maria and Mogale, Mabina and Gordon, Reno and Tshephe, Tjodwapi", title="Establishing a Digital Health Care Ecosystem in a Health Sciences University in South Africa: Protocol for a Mixed Methods Study", journal="JMIR Res Protoc", year="2025", month="Mar", day="25", volume="14", pages="e57821", keywords="health sciences", keywords="digital ecosystem", keywords="curriculum", keywords="community engagement", keywords="tertiary education institutions", abstract="Background: Comprehensive and formalized digital health care ecosystems in health sciences tertiary education in South Africa do not currently exist, but they have the potential to influence teaching and learning, research, and community engagement. Objective: A total of 3 key objectives underpin the study, that is, determining the health care curriculum needs and required content for the development of a formalized digital health ecosystem, determining the level of readiness of staff and students to participate in a digital health care ecosystem, and determining whether community engagement and strategic partnerships can contribute to the sustainability of a digital health care ecosystem. Methods: A multipronged approach will be used to address the objectives, with a mixed methods design being undertaken. The qualitative phases will be phenomenological in nature, and triangulation of information along with thematic analysis will be conducted on the collected data. Quantitative data will be collected prospectively and cross-sectionally and analyzed using descriptive analysis. Sampling will include subject experts for the Delphi technique, staff and students at the University, clinical training and education partners, and community leaders. This study has received ethical approval from the Sefako Makgatho Health Sciences University Research and Ethics Committee (SMUREC/H/260/2023:PG). Results: Data collection for the first phase will begin in January 2024 and conclude in December 2024. Phase 2 and 3 of the study will be conducted concurrently, with data collection starting in January 2025 and concluding in December 2026. Conclusions: The establishment of a digital health care ecosystem has the potential to benefit staff, students, and communities through stakeholder collaboration, educational opportunities, research projects, and improved service delivery. International Registered Report Identifier (IRRID): DERR1-10.2196/57821 ", doi="10.2196/57821", url="https://www.researchprotocols.org/2025/1/e57821" } @Article{info:doi/10.2196/60296, author="Lazo-Porras, Maria and Tateishi-Serruto, Jose Francisco and Butler, Christopher and Cuba-Fuentes, Sof{\'i}a Mar{\'i}a and Rossini-Vilchez, Daniela and Perez-Leon, Silvana and L{\'u}car-Flores, Miriam and Miranda, Jaime J. and Bernabe-Ortiz, Antonio and Diez-Canseco, Francisco and Moore, Graham and Landeiro, Filipa and Cardenas, Kathia Maria and Vera Tudela, Carlos Juan and White, Lee and Calvo, A. Rafael and Whiteley, William and Hawkins, Jemma and ", title="Assessment of Health System Readiness and Quality of Dementia Services in Peru: Protocol for a Qualitative Study With Stakeholder Interviews and Documentation Review", journal="JMIR Res Protoc", year="2025", month="Mar", day="21", volume="14", pages="e60296", keywords="dementia", keywords="health system readiness", keywords="caregiver", keywords="comorbidities", keywords="Peru", keywords="study protocol", keywords="quality of care", keywords="comorbidity", keywords="patient journey", keywords="mHealth", abstract="Background: Dementia is a global health priority with significant challenges due to its complex nature and increasing prevalence. Health systems worldwide struggle to address chronic conditions like dementia, often providing fragmented care. However, information about how health systems respond to the needs of people with dementia and their carers, and the quality of care provided, is scarce in low- and middle-income countries. Objective: This study aims to assess the quality of the health system to provide diagnosis and care for people with dementia and their carers in Peru. In order to do this, the study will explore the response of the Peruvian health system to people with dementia and their carers, and explore the experiences of people with dementia of receiving their diagnosis, management, and quality of care for this condition. Methods: This study is part of a research program called ``IMPACT Salud: Innovations using Mhealth for people with dementia and Co-morbidities,'' aimed at strengthening health systems to provide care for people with dementia and their carers. The study has a descriptive, cross-sectional design that uses a qualitative methodology, including stakeholder interviews and documentation review, and consists of 2 substudies, a health system assessment (HSA) and an exploration of the patient journey. The first substudy uses an HSA methodology suitable for low- and middle-income countries, conducting 160 structured interviews with 12 different stakeholder types across 3 levels of the health system (micro, meso, and macro) in 4 Peruvian regions, each with distinct geographical and urbanization profiles. The second substudy uses a patient journey methodology, which involves conducting 40 in-depth interviews with people with dementia, carers, and health care workers from the same 4 regions. The insights into the people with dementia patient and caregiver experience within the health system from the interviews will be used to produce a patient journey map. The analysis will be guided by the high-quality health system framework, and the findings from the HSA and patient journey will be structured using the domains included in the framework through the lens of quality of services. Results: Data collection began in March 2024. As of the end of September 2024, a total of 156 interviews from the HSA and 38 interviews from the patient journey study have been conducted across 4 regions. Conclusions: This study will provide a national, multilevel insight into the current operation of the Peruvian health system, including an analysis of the quality of services provided with regard to dementia diagnosis, management, and care from the perspectives of stakeholders, patients, and their carers. International Registered Report Identifier (IRRID): DERR1-10.2196/60296 ", doi="10.2196/60296", url="https://www.researchprotocols.org/2025/1/e60296" } @Article{info:doi/10.2196/64813, author="Nijhawan, E. Ank and Kholy, Jana and Marcus, L. Julia and Hogan, P. Timothy and Higashi, T. Robin and Naeem, Jacqueline and Hansen, Laura and Torres, Brynn and Harris, Barry-Lewis and Zhang, Song and Krakower, Douglas", title="A Multicomponent Strategy to Improve HIV Pre-Exposure Prophylaxis in a Southern US Jail: Protocol for a Type 3 Hybrid Implementation-Effectiveness Trial", journal="JMIR Res Protoc", year="2025", month="Mar", day="18", volume="14", pages="e64813", keywords="pre-exposure prophylaxis", keywords="PrEP", keywords="HIV", keywords="HIV prevention", keywords="jail", keywords="incarceration", keywords="health disparity", keywords="electronic health records", keywords="EHR", keywords="southern United States", abstract="Background: Pre-exposure prophylaxis (PrEP) is an effective approach for preventing HIV infection, but it is underutilized by populations who may benefit the most, including people living in the Southern United States and those involved in the criminal legal (CL) system. Improving the access and use of PrEP for these groups could decrease HIV-related health disparities. Beyond individual outcomes, HIV prevention for CL-involved people can have a significant public health impact on HIV incidence due to a high turnover between jails and the community. Objective: We will develop, implement, and evaluate a multicomponent PrEP implementation strategy for the Dallas County Jail (DCJ) to increase the initiation of this HIV-preventive intervention for CL-involved individuals. Methods: This is a type 3 hybrid implementation-effectiveness study that takes a combined approach by assessing the implementation of a strategy to identify candidates for PrEP at the DCJ and linking them to PrEP providers upon community re-entry while also gathering information about clinical outcomes. The approach is guided by the EPIS (exploration, preparation, implementation, sustainment) framework. Initial formative work (exploration) involves qualitative interviews of diverse key stakeholders to identify factors that may influence linkage to PrEP after jail release. These findings will undergo rapid qualitative analysis (preparation) to inform the adaptation of a multicomponent jail PrEP implementation strategy protocol. This approach, which will include an electronic health record (EHR) prediction model and integration of a PrEP patient navigator into the jail health team, will allow medical providers and the navigator at the DCJ to engage individuals most likely to benefit in shared decision-making about PrEP and navigate them to community PrEP care (implementation) in a process that begins before release from jail and ends with successful care linkage. Regular quantitative and qualitative evaluations of this approach will allow for ongoing stakeholder input, refinement of the implementation strategy, and maintenance of the program (sustainment). Results: Findings from 26 qualitative interviews (9 formerly incarcerated individuals, 9 county jail staff, and 8 employees of community organizations) have been obtained, analyzed, and mapped to an implementation strategy formalized in a jail PrEP protocol. An HIV risk prediction model based on EHR data to identify individuals most likely to benefit from PrEP has been developed and internally validated and is ready to be deployed. We anticipate the availability of preliminary study findings in 2026. Conclusions: This study will provide key insights into the feasibility and effectiveness of a PrEP implementation strategy among people at increased risk of HIV acquisition in an urban jail in Southern United States. This practical and scalable strategy can be used as a model for other urban jails to address HIV-related inequities. International Registered Report Identifier (IRRID): DERR1-10.2196/64813 ", doi="10.2196/64813", url="https://www.researchprotocols.org/2025/1/e64813" } @Article{info:doi/10.2196/58976, author="Sohail, Maira and Matthews, Lynn and Williams, Audra and Kempf, Mirjam-Colette and Phillips, Desiree and Goymer, Hannah and Johnson,, Bernadette and Mugavero, Michael and Elopre, Latesha", title="Improving Pre-Exposure Prophylaxis Provision as Part of Routine Gynecologic Care Among Black Cisgender Women (Project PrEP4Her): Protocol for the Implementation of an Intervention", journal="JMIR Res Protoc", year="2025", month="Mar", day="14", volume="14", pages="e58976", keywords="Black", keywords="cis-Gender women", keywords="PrEP", keywords="pre-exposure prophylaxis", keywords="South", keywords="HIV", keywords="gynecology", abstract="Background: Although HIV pre-exposure prophylaxis (PrEP) has been proven to be an effective prevention tool in decreasing HIV transmission, achieving adequate PrEP uptake has remained a challenge among Black cisgender women living in the Southern United States. Gynecology clinics, which provide primary health care services for many cisgender women, have the potential to be an ideal setting for the integration of PrEP services. Objective: We designed an intervention, PrEP4Her, which aims to implement PrEP service delivery at gynecology clinics in Alabama, the United States, as part of routine reproductive and sexual health care visits to improve PrEP engagement rates among Black cisgender women. Methods: Guided by the information gathered on (1) factors impacting PrEP implementation at gynecology clinics, including key barriers and facilitators to PrEP implementation and potential strategies to address the identified barriers (in-depth interviews with the gynecology care team), (2) structural barriers and provider-level barriers to PrEP implementation (cross-sectional study among gynecologists), and (3) implementation strategies on how to integrate PrEP services into routine gynecology care (in-depth interviews and focus groups with Black cisgender women), a multicomponent implementation strategy, tailored for Black cisgender women, was developed to integrate PrEP in routine women's health visits (ie, PrEP4Her). To determine the efficacy of the program, we will measure implementation outcomes, reach (increase in the absolute number of Black cisgender women receiving PrEP prescriptions), effectiveness (increase in the proportion of PrEP prescriptions over time), and adoption (proportion of team members willing to implement PrEP4Her) using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework. In addition, acceptability (the extent to which providers and Black cisgender women feel PrEP4Her to be acceptable---in-depth interviews); Feasibility (appropriateness of PrEP4Her for a larger, full-scale trial---the Feasibility of Intervention Measure scale); and fidelity (the degree to which PrEP4Her program was implemented as designed---electronic survey with patients) will also be assessed. Results: The qualitative and quantitative data from the gynecology care team and the qualitative data from Black cisgender women were collected from August 9, 2022, to April 19, 2023, and were integrated through joint displays to identify major themes. The combined findings provided a comprehensive understanding of factors that were fundamental in the development and refinement of PrEP4Her implementation. The PrEP4Her was implemented from January 29, 2024, to August 16, 2024. The information gathered is being used to assess PrEP4Her efficacy (based on reach, effectiveness, adoption, acceptability, feasibility, and fidelity). Conclusions: Upon completion of our research, our interdisciplinary team, which includes experts in infectious diseases, implementation science, community-engaged research, and psychology, will be primed to lead a multisite type III implementation trial for PrEP service delivery at gynecology clinics across the Southern United States. International Registered Report Identifier (IRRID): DERR1-10.2196/58976 ", doi="10.2196/58976", url="https://www.researchprotocols.org/2025/1/e58976", url="http://www.ncbi.nlm.nih.gov/pubmed/40085134" } @Article{info:doi/10.2196/63481, author="Fu, Guojing and Chen, Yunmeng and Liang, Xiao and Guo, Chunli and Fan, Xueming and Gong, Xiao and Chen, Wenjie and Teng, Jing and Tang, Jun and Liao, Xing and Wei, Jingjing and Zhang, Yunling", title="Core Outcome Set Development for Tension-Type Headache Treatment Using Traditional Chinese Medicine: Protocol for a Delphi Consensus Study", journal="JMIR Res Protoc", year="2025", month="Feb", day="5", volume="14", pages="e63481", keywords="tension-type headache", keywords="core outcome set", keywords="traditional Chinese medicine", keywords="systematic review", keywords="Delphi", keywords="protocol", abstract="Background: Tension-type headache (TTH) is the most common type of headache and the second most common health-related complaint among children and adults. Traditional Chinese medicine (TCM) offers unique therapeutic benefits in treating TTH. However, the lack of standardized evidence---such as inconsistencies in outcome selection and reporting in clinical studies, a lack of consensus on outcomes and measures, high risks of selective reporting bias, and missing data---has limited the development of robust evidence supporting the efficacy of TCM in treating TTH. Therefore, establishing a core outcome set (COS) is crucial for standardizing TCM clinical studies for TTH, thereby enhancing the quality and comparability of research findings. Objective: This study aims to develop a COS for future clinical studies on the treatment of TTH with TCM. Methods: The COS will be developed through the following 3 stages. First, systematic reviews and semistructured interviews will be conducted to identify potential essential outcomes, which will be evaluated by the steering committee to finalize a preliminary list of outcomes. Data will be processed using thematic analysis to ensure comprehensive coverage of relevant outcomes. Second, a 2-round Delphi survey will be conducted, inviting stakeholders, including health care experts and patients with tension-type headaches, to determine the importance of each outcome. Statistical analysis will be used to assess the level of consensus and prioritize outcomes based on predefined criteria. Third, a face-to-face consensus meeting will be held to finalize the COS and recommend measurement times for each outcome. Key outcomes will be interpreted based on their clinical relevance and feasibility of measurement, ensuring the COS is comprehensive and applicable in clinical settings. Results: The protocol has been registered in PROSPERO, with the review commencing on October 1, 2024, and anticipated results by November 15, 2024. The systematic reviews will be finalized, followed by the Delphi survey and consensus conference in late 2024 and early 2025. The COS findings will be reported per COS-STAR (Core Outcome Set--STAndards for Reporting) guidelines, published in an international journal, presented at conferences, and disseminated to participants for clinical application. Conclusions: This study is necessary as developing a COS for future TCM clinical studies in the treatment of TTH can maximize the value of data from individual trials and provide high-quality research evidence. Trial Registration: Core Outcome Measures in Effectiveness Trials Initiative 1473; https://tinyurl.com/3ts62s2p International Registered Report Identifier (IRRID): PRR1-10.2196/63481 ", doi="10.2196/63481", url="https://www.researchprotocols.org/2025/1/e63481" } @Article{info:doi/10.2196/60255, author="Nykiel-Bailey, Sydney and Burrows, Kathryn and Szafarowicz, E. Bianca and Moquin, Rachel", title="Faculty Perceptions on the Roles of Mentoring, Advising, and Coaching in an Anesthesiology Residency Program: Mixed Methods Study", journal="JMIR Med Educ", year="2025", month="Jan", day="21", volume="11", pages="e60255", keywords="coaching", keywords="faculty perceptions", keywords="mentoring", keywords="perception", keywords="medical education", keywords="anesthesia", keywords="modality", keywords="support", keywords="Washington University", keywords="university", keywords="coaching skills", keywords="training", keywords="culture change", keywords="culture", keywords="flexibility", keywords="systematic framework", abstract="Background: Mentoring, advising, and coaching are essential components of resident education and professional development. Despite their importance, there is limited literature exploring how anesthesiology faculty perceive these practices and their role in supporting residents. Objective: This study aims to investigate anesthesiology faculty perspectives on the significance, implantation strategies, and challenges associated with mentorship, advising, and coaching in resident education. Methods: A comprehensive survey was administrated to 93 anesthesiology faculty members at Washington University School of Medicine. The survey incorporated quantitative Likert-scale questions and qualitative short-answer responses to assess faculty perceptions of the value, preferred formats, essential skills, and capacity for fulfilling multiple roles in these support practices. Additional areas of focus included the impact of staffing shortages, training requirements, and the potential of these practices to enhance faculty recruitment and retention. Results: The response rate was 44\% (n=41). Mentoring was identified as the most important aspect, with 88\% (n=36) of faculty respondents indicating its significance, followed by coaching, which was highlighted by 78\% (n=32) of respondents. The majority felt 1 faculty member can effectively hold multiple roles for a given trainee. The respondents desired additional training for roles and found roles to be rewarding. All roles were seen as facilitating recruitment and retention. Barriers included faculty burnout; confusion between roles; time constraints; and desire for specialized training, especially in coaching skills. Conclusions: Implementing structured mentoring, advising, and coaching can profoundly impact resident education but requires role clarity, protected time, culture change, leadership buy-in, and faculty development. Targeted training and operational investments could enable programs to actualize immense benefits from high-quality resident support modalities. Respondents emphasized that resident needs evolve over time, necessitating flexibility in appropriate faculty guidance. While coaching demands unique skills, advising hinges on expertise and mentoring depends on relationship-building. Systematic frameworks of coaching, mentoring, and advising programs could unlock immense potential. However, realizing this vision demands surmounting barriers such as burnout, productivity pressures, confusion about logistics, and culture change. Ultimately, prioritizing resident support through high-quality personalized guidance can recenter graduate medical education. ", doi="10.2196/60255", url="https://mededu.jmir.org/2025/1/e60255" } @Article{info:doi/10.2196/58271, author="Savaria, Virginie and Queenton, Johanne and Carrier, Annie", title="Decentralized Management of Home Care Services for Seniors: Protocol for a Participatory Action Research", journal="JMIR Res Protoc", year="2025", month="Jan", day="17", volume="14", pages="e58271", keywords="health system", keywords="decentralization", keywords="management", keywords="home care services", keywords="seniors", keywords="collaboration", abstract="Background: The centralization of decision-making power in the public health care system has a negative impact on the practice of professionals and the quality of home care services (HCS) for seniors. To improve HCS, decentralized management could be a particularly promising approach. To be effective, strategies designed to incorporate this management approach require attention to 3 elements: autonomy of local stakeholders, individual and organizational capacities, and accountability for actions and decisions. Not many studies have focused on strategies for integrating decentralized and collaborative management at the local level in HCS. Objective: The overall aim of this study is to coconstruct HCS management strategies and explore decentralized practices in the day-to-day work of low-level managers and professionals. The specific objectives, in collaboration with local HCS stakeholders, are to (1) identify concrete and achievable strategies for decentralized management, and (2) describe factors (facilitators and obstacles) that could potentially influence their integration. Methods: This participatory action research involves a cyclical process. Before initiating the cycles, a preliminary stage consists of forming a steering committee composed of managers (n=3), professionals (n=3), seniors (n=3), informal caregivers (n=3), and the research team (n=3). This committee will facilitate multistakeholder consultation to coconstruct local management strategies based on a real-life problem identified by the committee. The steering committee will also guide the research process. The first cycle will consist of establishing an initial plan of decentralized management strategies. During the observation phase, meetings of 4 homogeneous focus groups, including managers, professionals, seniors, and informal caregivers, will be held. During the reflection phase, a thematic analysis will be carried out, and data will be interpreted and validated by the steering committee. Then, in the action phase, results will be presented to managers and professionals so that they can coconstruct a plan of decentralized management strategies to prioritize. The second cycle will explore the factors involved. The observation, reflection, and action phases will be repeated. Ultimately, the results of the 2 cycles will be integrated in a model coconstructed by the steering committee. Results: Data collection is in progress; the partnership officially began on February 1, 2024, and the plan is to continue data collection through 2025. The steering committee will validate the data to ensure that they are accurate and that the results reflect the reality of local stakeholders. Conclusions: By identifying decentralized and collaborative management strategies at the local level as well as factors to facilitate their integration in HCS, this approach can be used for other decentralized management projects in different areas of the health care system. This study will give decision makers insight into strategies aimed at improving the management of their institution, which will enhance seniors' well-being and the quality of their health care services. International Registered Report Identifier (IRRID): DERR1-10.2196/58271 ", doi="10.2196/58271", url="https://www.researchprotocols.org/2025/1/e58271" } @Article{info:doi/10.2196/63949, author="von Bosse, Alexa and K{\"o}nig, Peter and Jansen, Eva", title="Influence of Partnership Relationships on Long-Term Neurological Rehabilitation in Germany: Protocol for a Qualitative Retrospective Study", journal="JMIR Res Protoc", year="2025", month="Jan", day="13", volume="14", pages="e63949", keywords="neurological rehabilitation", keywords="neurological injury", keywords="therapeutic alliance", keywords="relationship building", keywords="caregivers", keywords="family", keywords="partnership", keywords="health professionals", keywords="neurological", keywords="therapeutic", keywords="Germany", keywords="retrospective study", keywords="narrative interview", keywords="biopsychosocial", keywords="family-centered", abstract="Background: Acquired neurological diseases entail significant changes and influence the relationship between a patient and their significant other. In the context of long-term rehabilitation, those affected collaborate with health care professionals who are expected to have a positive impact on the lives of the affected individuals. Objective: This study aims to examine the changes in the relationship between the patient and their loved ones due to acquired neurological disorders and the influence of health care professionals on this relationship. Methods: Through sociogenetic type building, we will identify different types of patient-caregiver dyads and their effects on health care professionals and vice versa. The results will then be integrated into a model based on the theory of symbolic interactionism and Baxter's Relational Dialectics Theory. Results: This study is not funded and was approved by the ethics committee of the German Society for Nursing Science, and it complies with the Declaration of Helsinki. The data collection started in June 2024 based on narrative couple interviews and is running. We assume that patients and their relatives will demonstrate heterogeneity as individuals, as well as in their interactions within the dyad, regarding certain orientations such as coping with illness, motivation for therapy, and coping strategies. Conclusions: Our findings address a biopsychosocial perspective that enhances treatment approaches in neurological long-term care. Understanding the influence of professionals on dyadic couple relationships can improve rehabilitation effectiveness by tailoring therapeutic approaches to various patient types, relatives, and dyadic relationship constellations. This fosters patient- and family-centered therapy in line with holistic care. International Registered Report Identifier (IRRID): DERR1-10.2196/63949 ", doi="10.2196/63949", url="https://www.researchprotocols.org/2025/1/e63949", url="http://www.ncbi.nlm.nih.gov/pubmed/39804683" } @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/10.2196/58285, author="Smoyer, B. Amy", title="Impact of Changes in Criminal-Legal Practices During the COVID-19 Pandemic on the HIV Risk Behaviors of Women Who Use Drugs: Protocol for a Multimethods Qualitative Study", journal="JMIR Res Protoc", year="2024", month="Dec", day="20", volume="13", pages="e58285", keywords="HIV", keywords="corrections", keywords="women", keywords="substance use", keywords="COVID-19", keywords="criminal-legal systems", keywords="carceral", keywords="qualitative", keywords="SARS-Cov-2", keywords="coronavirus", keywords="pandemic", keywords="drug", keywords="women who use drugs", keywords="psychosocial", keywords="HIV risk", keywords="health care", keywords="qualitative method", keywords="socio-demographic", keywords="audio-recorded", keywords="thematic analysis", abstract="Background: HIV risk behavior in women who use drugs is related to myriad psychosocial issues, including incarceration. The experience of incarceration elevates women's HIV risk by disrupting social networks, housing, employment, and access to health care. During the COVID-19 pandemic, changes in criminal-legal practices resulted in decreased incarceration, especially among women. These changes may have largely altered HIV risk among women who use drugs, depending on their access to care in the community. Objective: This study seeks to build knowledge about the impact of shifts in criminal-legal practices during the COVID-19 pandemic on HIV risk behaviors of justice-involved women who use drugs. Methods: Qualitative methods are used to gather and analyze women's narratives about their life experiences before and during the COVID-19 pandemic, with a focus on individual and structural determinants of HIV risk behaviors. Thirty formerly incarcerated women with a history of substance use are being recruited through collaboration with community partners. Each participant completes a sociodemographic survey and two interviews. The first interview uses a life history instrument that invites participants to reflect on key turning points in their lives. The second interview uses a calendar approach to gather information about participants' lives during the first year of the COVID-19 pandemic (March 2020-March 2021). The interviews (1 hour each) are audio-recorded and transcribed for analysis. Rapid Qualitative Inquiry and thematic analysis are being used to manage, organize, and interpret the data. The study team will collaborate with a subset of participants to develop digital stories about their COVID-19 experiences, a process that allows for member-checking and triangulation. Findings will be disseminated to program and policy makers in academic venues, community settings, and social service agencies. Results: To date, 10 women's data have been collected. In total, two themes have been identified in this preliminary data: (1)the chaos and instability of participants' lives increased during the COVID-19 pandemic: participants reported a wide range of psychosocial and health problems and limited engagement with social service systems. Interaction with criminal-legal systems was rife with uncertainty; participants described living in a state of limbo, which was extremely stressful. (2) When asked to describe a ``turning point'' in their lives, many participants attributed their substance use to the traumatic loss of a child due to death, incarceration, or termination of parental rights. During the COVID-19 pandemic, participants' struggles to cope with these unresolved experiences of grief and loss were intensified by the widespread death and dying of the pandemic. Conclusions: Preliminary findings suggest that HIV risk factors increased for participants during the COVID-19 pandemic and invite further investment in community-based harm reduction programs, especially housing, that support women who use drugs. Interventions that address experiences of maternal grief and loss may reduce women's substance use. International Registered Report Identifier (IRRID): DERR1-10.2196/58285 ", doi="10.2196/58285", url="https://www.researchprotocols.org/2024/1/e58285" } @Article{info:doi/10.2196/57819, author="R{\aa}destad, Monica and Kanfj{\"a}ll, Torkel and Lindstr{\"o}m, Veronica", title="Real-Time Triage, Position, and Documentation (TriPoD) During Medical Response to Major Incidents: Protocol for an Action Research Study", journal="JMIR Res Protoc", year="2024", month="Dec", day="19", volume="13", pages="e57819", keywords="action research", keywords="decision support technique", keywords="information technology", keywords="medical response", keywords="major incident", keywords="management", abstract="Background: There is a need to address the implementation of technological innovation into emergency medical services to facilitate and improve information exchange between prehospital emergency care providers, command centers, and hospitals during major incidents to enable better allocation of resources and minimize loss of life. At present, there is a lack of technology supporting real-time information sharing in managing major incidents to optimize the use of resources available. Objective: The aim of this protocol is to develop, design, and evaluate information technology innovations for use in medical response to major incidents. Methods: This study has a qualitative action research design. This research approach is suitable for developing and changing practice in health care settings since it is cyclical in nature and involves development, evaluation, redevelopment, and replanning. The qualitative data collection will include workshops, structured meetings, semistructured interviews, questionnaires, observations, and focus group interviews. This study assesses the use of a digital solution for real-time information sharing by involving 3 groups of indented users: prehospital emergency care personnel, hospital personnel, and designated duty officers with experience and specific knowledge in managing major incidents. This study will explore end users' experiences and needs, and a digital solution for prehospital and hospital settings will be developed in collaboration with technology producers. Results: The trial implementation and evaluation phase for this study is from April 2024 to May 2026. Interviews and questionnaires with end users were conducted during the planning phase. We have performed observations in connection with 2 major exercises in April 2024 and November 2024. The outcome of this analysis will form the basis for the design and development of a new information technology system. We aim to complete the observations in training sessions and exercises (phase 3) by September 2025, followed by modification of the technology solutions tested (phase 4) before dissemination in a scientific journal. Conclusions: This protocol includes several methods for data collection that will form the basis for the design and development process of a digital solution for real-time information sharing to support efficient management in major incidents based on the experiences and requirements of end users. The findings from this study will contribute to the limited research on users' perspectives and the development of digital solutions for real-time information during major incidents. International Registered Report Identifier (IRRID): PRR1-10.2196/57819 ", doi="10.2196/57819", url="https://www.researchprotocols.org/2024/1/e57819" } @Article{info:doi/10.2196/59372, author="Taylor, V. Kayla and Garchitorena, Laurent and Scaramutti-Gladfelter, Carolina and Wyrick, Mykayla and Grill, B. Katherine and Seixas, A. Azizi", title="A Digital Mental Health Solution to Improve Social, Emotional, and Learning Skills for Youth: Protocol for an Efficacy and Usability Study", journal="JMIR Res Protoc", year="2024", month="Dec", day="19", volume="13", pages="e59372", keywords="mental health", keywords="digital health", keywords="mHealth", keywords="usability", keywords="pilot study", keywords="United States", keywords="mental health crisis", keywords="Science Technology Engineering Math and Social and Emotional Learning", keywords="STEMSEL", keywords="efficacy", keywords="well-being", keywords="barriers", keywords="facilitators", keywords="resources", keywords="youth", keywords="adolescents", keywords="teenagers", keywords="students", keywords="feasibility", keywords="adoption", keywords="evidence-based", keywords="intervention", keywords="anxiety", keywords="depression", keywords="Neolth", keywords="digital app", abstract="Background: The COVID-19 pandemic has exposed a devastating youth mental health crisis in the United States, characterized by an all-time high prevalence of youth mental illness. This crisis is exacerbated by limited access to mental health services and the reduction of mental health support in schools. Mobile health platforms offer a promising avenue for delivering tailored and on-demand mental health care. Objective: To address the lack of youth mental health services, we created the Science Technology Engineering Math and Social and Emotional Learning (STEMSEL) study. Our aim was to investigate the efficacy of a digital mental health intervention, Neolth, in enhancing social and emotional well-being, reducing academic stress, and increasing mental health literacy and life skills among adolescents. Methods: The STEMSEL study will involve the implementation and evaluation of Neolth across 4 distinct phases. In phase 1, a comprehensive needs assessment will be conducted across 3 diverse schools, each using a range of teaching methods, including in-person, digital, and hybrid modalities. Following this, in phase 2, school administrators and teachers undergo intensive training sessions on Neolth's functionalities and intervention processes as well as understand barriers and facilitators of implementing a digital mental health program at their respective schools. Phase 3 involves recruiting middle and high school students aged 11-18 years from the participating schools, with parental consent and student assent obtained, to access Neolth. Students will then be prompted to complete an intake questionnaire, enabling the customization of available modules to address their specific needs. Finally, phase 4 will include a year-long pre- and posttest pilot study to rigorously evaluate the usability and effectiveness of Neolth in addressing the mental health concerns of students across the selected schools. Results: Phase 1 was successfully completed in August 2022, revealing significant deficits in mental health resources within the participating schools. The needs assessment identified critical gaps in available mental health support services. We are currently recruiting a diverse group of middle and high school students to participate in the study. The study's completion is scheduled for 2024, with data expected to provide insights into the real-world use of Neolth among the adolescent population. It is designed to deliver findings regarding the intervention's efficacy in addressing the mental health needs of students. Conclusions: The STEMSEL study plays a crucial role in assessing the feasibility and adoption of digital mental health interventions within the school-aged youth population in the United States. The findings generated from this study have the potential to dismantle obstacles to accessing mental health assistance and broaden the availability of care through evidence-based strategies. International Registered Report Identifier (IRRID): DERR1-10.2196/59372 ", doi="10.2196/59372", url="https://www.researchprotocols.org/2024/1/e59372" } @Article{info:doi/10.2196/58860, author="Al-Jayyousi, Fakhri Ghadir and Alsayed Hassan, Diana and Abdul Rahim, Hanan and E Abdel-Rahman, Manar and Ferreira, Isabel and Mukhalalati, Banan and O'Hara, Lily and Khalil, Hanan and Tayyem, Reema and S Abu Alhaija, Elham and Abidia, Randa and Zolezzi, Monica and El-Awaisi, Alla and Al-Wattary, Noor and Mahmood Al Saady, Rafif and Saffouh El Hajj, Maguy and Shraim, Mujahed and K Abouhanian, Arpi and Saeb, Hatoun and Mohammed, Mustapha and ", title="Health and Well-Being in the Context of Health-Promoting University Initiatives: Protocol for a Mixed Methods Needs Assessment Study at Qatar University", journal="JMIR Res Protoc", year="2024", month="Dec", day="18", volume="13", pages="e58860", keywords="college students", keywords="needs assessment", keywords="qualitative", keywords="lifestyle behaviors", keywords="environmental scan", abstract="Background: Health-promoting universities are dedicated to fostering learning environments and organizational cultures that support the physical and mental well-being of students, faculty, and staff. As students constitute the largest group within the university community, any policy intervention targeting them is likely to have a significant impact on the university as a whole. Objective: This study aims to assess the health status and needs of Qatar University (QU) students using a comprehensive and holistic definition of health, informed by the perspectives of students, faculty members, and key informants. The ultimate goal is to inform evidence-based policies and services designed to improve students' physical and mental well-being. Methods: An explanatory sequential mixed-methods research design will be used to conduct a comprehensive assessment of students' health status and needs. This assessment will consist of a quantitative component (a web-based health survey) administered to a convenience sample of students, and a qualitative component, including focus groups with students and faculty members, as well as interviews with key informants. Priority health issues and their determinants, identified through the quantitative assessment, will inform and guide the qualitative assessment to provide a deeper understanding of the various contexts and factors shaping them. Descriptive analyses (eg, proportions or means with SDs), comparative analyses (eg, t tests or chi-square tests), and association analyses (eg, linear, logistic, or Poisson regression models) will be used to analyze the quantitative data. Thematic analysis will be used in the qualitative assessments. Additionally, an environmental scan will be conducted to assess relevant facilities, services, and programs at the QU campus and the QU Primary Healthcare Corporation Center, as well as to review university policies and regulations that may affect students' health and well-being. Together, the needs assessment and environmental scan will inform the design of multilevel interventions, including health education and promotion programs, health services orientation, and proposed policy changes. Results: Between March and December 2022, 812 students completed the web-based health survey. Data have been extracted, cleaned, and harmonized. Analyses to assess the extent of selection bias and the calculation of weights to account for this in all subsequent analyses have been completed (by December 2023). Following the completion of all quantitative data analyses (expected by the end of 2024), focus groups, interviews, and the environmental scan will begin in January-December 2025. Conclusions: This project will help identify and prioritize the health needs of QU students and their determinants, and inform relevant services and policies targeting these needs. By using comprehensive and context-appropriate methods, this project will contribute to QU's strategic efforts to become a Health-Promoting University. International Registered Report Identifier (IRRID): DERR1-10.2196/58860 ", doi="10.2196/58860", url="https://www.researchprotocols.org/2024/1/e58860", url="http://www.ncbi.nlm.nih.gov/pubmed/39693145" } @Article{info:doi/10.2196/63068, author="Norberg, L{\o}nnebakke B{\o}rge and Austad, Bjarne and Kristiansen, Eli and Zanaboni, Paolo and Getz, Okkenhaug Linn", title="The Impact and Wider Implications of Remote Consultations for General Practice in Norway: Qualitative Study Among Norwegian Contract General Practitioners", journal="JMIR Form Res", year="2024", month="Dec", day="17", volume="8", pages="e63068", keywords="remote consultations", keywords="e-health", keywords="digital medicine", keywords="telemedicine", keywords="impact", keywords="downsides", keywords="disadvantages", keywords="pitfalls", keywords="safety", keywords="general practice", keywords="family medicine", keywords="practice organization", keywords="ecology of healthcare", keywords="remote consultation", keywords="monitoring", keywords="teleconsultation", keywords="social determinants of health", abstract="Background: The digital shift toward remote consultations in general practice needs ongoing monitoring to understand its impact on general practice organizations and the wider health care system. Objective: This study aimed to explore how remote consultations impact on contracted general practitioner (GP) practices and how GPs perceive the implications of this uptake for the overall health care system. Methods: In total, 5 focus groups were conducted with a total of 18 GPs from all 4 health regions of Norway in 2022. The material was subjected to Braun and Clarke's thematic analysis. Results: The analysis yielded six themes: (1) the design of novel effective clinical pathways: remote consultations empower GPs to tailor new effective clinical trajectories, blending modalities to address diverse needs across clinical episodes---from initial triage, through investigations to case closure; (2) increased workday flexibility: remote consultations introduce variability into daily work, allowing GPs to adjust patient contact intensity, and leading to a less stressful work-home balance; (3) erosion of organizational boundaries: easy remote access to GPs appears to reduce patients' tolerance for minor illness and self-care, hindering effective gatekeeping and shifting GPs' focus from proactive to more reactive work, increasing work-related stress; (4) degradation of clinical shrewdness: confronted with an increasing amount of unsorted and trivial remote inquiries, GPs observe challenges in detecting and prioritizing serious cases; (5) dilemmas related to responsibility, ethics, and legislation: remote consultations highlight a tension for contract GPs between legal responsibilities and ethical obligations, with implications for patients with limited health literacy; this may entail suboptimal evaluation or delayed treatment---potentially contributing to increased health care inequity; and (6) retaining clinical core values in a changing world. Overall, GPs affirm that remote consultations have come to stay and describe efforts to effectively manage the advantages and disadvantages inherent in such interactions to safeguard clinical effectiveness and organizational sustainability of primary health care. Conclusions: The widespread adoption of remote consultations in the Norwegian contract GP scheme fundamentally reshapes the dynamics of GP work and the overall health care system. Awareness and proactive management of these changes are essential for maintaining sustainable, high-quality primary health care. ", doi="10.2196/63068", url="https://formative.jmir.org/2024/1/e63068", url="http://www.ncbi.nlm.nih.gov/pubmed/39688890" } @Article{info:doi/10.2196/62761, author="Harrison Ginsberg, Kristin and Babbott, Katie and Serlachius, Anna", title="Exploring Participants' Experiences of Digital Health Interventions With Qualitative Methods: Guidance for Researchers", journal="J Med Internet Res", year="2024", month="Nov", day="28", volume="26", pages="e62761", keywords="qualitative methods", keywords="content analysis", keywords="thematic analysis", keywords="digital health evaluation", keywords="user engagement", keywords="user experience", keywords="digital health intervention", keywords="innovation", keywords="patient experience", keywords="health care", keywords="researcher", keywords="technology", keywords="mobile health", keywords="mHealth", keywords="telemedicine", keywords="digital health", keywords="behavior change", keywords="usability", keywords="tutorial", keywords="research methods", keywords="qualitative research", keywords="study design", doi="10.2196/62761", url="https://www.jmir.org/2024/1/e62761" } @Article{info:doi/10.2196/56844, author="M{\o}rk, Gry and Bonsaksen, Tore and Larsen, S{\o}nnik Ole and Kunnikoff, Martin Hans and Lie, Stangeland Silje", title="Virtual Reality Simulation in Undergraduate Health Care Education Programs: Usability Study", journal="JMIR Med Educ", year="2024", month="Nov", day="19", volume="10", pages="e56844", keywords="360{\textdegree} videos", keywords="health professions education", keywords="virtual reality", keywords="usability study", keywords="undergraduates", keywords="university", keywords="students", keywords="simulation", abstract="Background: Virtual reality (VR) is increasingly being used in higher education for clinical skills training and role-playing among health care students. Using 360{\textdegree} videos in VR headsets, followed by peer debrief and group discussions, may strengthen students' social and emotional learning. Objective: This study aimed to explore student-perceived usability of VR simulation in three health care education programs in Norway. Methods: Students from one university participated in a VR simulation program. Of these, students in social education (n=74), nursing (n=45), and occupational therapy (n=27) completed a questionnaire asking about their perceptions of the usability of the VR simulation and the related learning activities. Differences between groups of students were examined with Pearson chi-square tests and with 1-way ANOVA. Qualitative content analysis was used to analyze data from open-ended questions. Results: The nursing students were most satisfied with the usability of the VR simulation, while the occupational therapy students were least satisfied. The nursing students had more often prior experience from using VR technology (60\%), while occupational therapy students less often had prior experience (37\%). Nevertheless, high mean scores indicated that the students experienced the VR simulation and the related learning activities as very useful. The results also showed that by using realistic scenarios in VR simulation, health care students can be prepared for complex clinical situations in a safe environment. Also, group debriefing sessions are a vital part of the learning process that enhance active involvement with peers. Conclusions: VR simulation has promise and potential as a pedagogical tool in health care education, especially for training soft skills relevant for clinical practice, such as communication, decision-making, time management, and critical thinking. ", doi="10.2196/56844", url="https://mededu.jmir.org/2024/1/e56844" } @Article{info:doi/10.2196/55874, author="Widianti, Dini and Mahardhika, Pribadi Zwasta and Modjo, Robiana", title="Development of a Mobile App for Occupational Stress Screening Among Female Workers: Protocol for an Exploratory Sequential Design Study", journal="JMIR Res Protoc", year="2024", month="Nov", day="14", volume="13", pages="e55874", keywords="mobile app", keywords="study protocol", keywords="occupational stress", keywords="female workers", keywords="stress", keywords="screening", keywords="worker", keywords="app", keywords="safety hazards", keywords="technological innovation", keywords="ergonomic", keywords="psychological hazards", keywords="mobile health", keywords="digital platform", keywords="algorithm", abstract="Background: Occupational safety hazards include physical, chemical, ergonomic, biological, and psychological hazards. Technological innovation in screening for occupational stress, especially among female workers, is needed to improve their health and productivity. Objective: This research is being conducted to obtain a prediction model of work stress through a questionnaire instrument that includes stressors and symptoms based on the transactional model, as well as measurement of work stress through a mobile app that can be used anywhere. Methods: The research is conducted in 3 stages: qualitative research, quantitative research (cross-sectional), and mobile app development. Data were collected from companies located in Jakarta, Indonesia. The sample was chosen based on purposive sampling. For the quantitative research (n=430), logistic regression analysis was used. Results: We are developing a work stress screening instrument for female workers, which includes stressors and symptoms based on the transactional model, in the form of a digital platform so that female workers can undertake the examination anywhere without interfering with working hours or home duties. This research was funded in January 2024 and qualitative data collection began in February 2024. Quantitative data were obtained in March 2024; the number of respondents in the qualitative stage was 6, and in the quantitative stage it was 430. The work stress screening app is in the development stage and will be launched at the same time as the data collection is performed so we can examine the respondents' perspectives on the use of the app. Conclusions: This study analyzes the prediction of work stress to help female workers screen for work stress. Workers who are detected as experiencing work stress will be educated using an algorithm programmed in the app. International Registered Report Identifier (IRRID): PRR1-10.2196/55874 ", doi="10.2196/55874", url="https://www.researchprotocols.org/2024/1/e55874" } @Article{info:doi/10.2196/55643, author="Meyer, B. Kathe and Rohde, Gudrun and Frivold, Gro", title="Relatives' and Intensive Care Unit Personnel's Perspectives of Care in Organ Donation: Protocol for a Multiple Methods Study", journal="JMIR Res Protoc", year="2024", month="Nov", day="11", volume="13", pages="e55643", keywords="organ procurement", keywords="qualitative research", keywords="public health", keywords="patient-reported outcome", keywords="organ donation", keywords="organ care", keywords="perspectives", keywords="donors", keywords="intensive care personnel", keywords="Scandinavia", keywords="donor relatives", keywords="family satisfaction", keywords="descriptive analysis", keywords="comparative analysis", keywords="organ harvesting", abstract="Background: In organ donation from deceased donors, the interaction between the donor's relatives and intensive care personnel is an important factor. The organ donation (OD) process is complex, and patients' relatives play a vital role. Intensive care professionals need knowledge about how relatives perceive and experience the process to create a caring environment and support them throughout. Therefore, this collaborative project aims to explore both relatives' and intensive care personnel's perspectives of care in deceased organ donation in Scandinavia. Objective: This study aims to (1) investigate donor relatives' satisfaction and ICU personnel's perception of their own professional competence and (2) explore donor relatives' and ICU personnel's experiences in the OD process to design for care and support in OD. Methods: This protocol outlines a Scandinavian (Norway, Sweden, and Denmark) project, including 4 work packages. Work package 1 started in 2023 with the translation and validation of the Family Satisfaction in the Intensive Care Unit questionnaire into a Danish version and the translation of the Professional Competence in Organ Donation Questionnaire into a Swedish and Danish version. A cross-sectional survey measuring Scandinavian relatives' perception of support in and satisfaction with the organ donation process and a cross-sectional survey measuring Scandinavian intensive care personnel's competence in organ donation are the foundation for work package 2 (2024). The data from both surveys will be analyzed using descriptive and comparative analysis. The results will inform the interview guides in qualitative studies (work packages 3 and 4). Participants in the quantitative study will be invited to participate in in-depth interviews. In work package 3, in-depth interviews will be conducted to illuminate relatives' experiences in the organ donation process. The interviews will be analyzed using thematic analysis, according to Braun and Clarke. In work package 4 (2025-2026), 1 qualitative design study will be conducted to illuminate ICU personnel's experiences. Furthermore, the results from work packages 2 and 3 will inform the development of specific programs for care, support, and communication in the organ donation process. Results: The project was funded by the Norwegian Organ Donor Foundation in 2022 and Scandiatransplant in 2023. The Norwegian Nurses Organisation supports the project by funding a PhD student. The PhD student was employed by the University in Agder in May 2024. Conclusions: This project will provide new knowledge that will assist us in designing and establishing programs for care, support, and donor relatives' involvement in OD processes. International Registered Report Identifier (IRRID): PRR1-10.2196/55643 ", doi="10.2196/55643", url="https://www.researchprotocols.org/2024/1/e55643" } @Article{info:doi/10.2196/54022, author="Naicker, Sundresan and Tariq, Amina and Donovan, Raelene and Magon, Honor and White, Nicole and Simmons, Joshua and McPhail, M. Steven", title="Patterns and Perceptions of Standard Order Set Use Among Physicians Working Within a Multihospital System: Mixed Methods Study", journal="JMIR Form Res", year="2024", month="Nov", day="8", volume="8", pages="e54022", keywords="medical informatics", keywords="adoption and implementation", keywords="behavior", keywords="health systems", keywords="testing", keywords="electronic medical records", keywords="behavioral model", keywords="quantitative data", keywords="semistructured interview", keywords="clinical practice", keywords="user preference", keywords="user", keywords="user experience", abstract="Background: Electronic standard order sets automate the ordering of specific treatment, testing, and investigative protocols by physicians. These tools may help reduce unwarranted clinical variation and improve health care efficiency. Despite their routine implementation within electronic medical records (EMRs), little is understood about how they are used and what factors influence their adoption in practice. Objective: This study aims to (1) describe the patterns of use of standard order sets implemented in a widely used EMR (PowerPlans and Cerner Millennium) within a multihospital digital health care system; (2) explore the experiences and perceptions of implementers and users regarding the factors contributing to the use of these standard order sets; and (3) map these findings to the Capability, Opportunity, and Motivation Behavior (COM-B) model of behavior change to assist those planning to develop, improve, implement, and iterate the use of standard order sets in hospital settings. Methods: Quantitative data on standard order set usage were captured from 5 hospitals over 5-month intervals for 3 years (2019, 2020, and 2021). Qualitative data, comprising unstructured and semistructured interviews (n=15), were collected and analyzed using a reflexive thematic approach. Interview themes were then mapped to a theory-informed model of behavior change (COM-B) to identify determinants of standard order set usage in routine clinical practice. The COM-B model is an evidence-based, multicomponent framework that posits that human actions result from multiple contextual influences, which can be categorized across 3 dimensions: capability, opportunity, and motivation, all of which intersect. Results: The total count of standard order set usage across the health system during the 2019 observation period was 267,253, increasing to 293,950 in 2020 and 335,066 in 2021. There was a notable shift toward using specialty order sets that received upgrades during the study period. Four emergent themes related to order set use were derived from clinician interviews: (1) Knowledge and Skills; (2) Perceptions; (3) Technical Dependencies; and (4) Unintended Consequences, all of which were mapped to the COM-B model. Findings indicate a user preference for customized order sets that respond to local context and user experience. Conclusions: The study findings suggest that ongoing investment in the development and functionality of specialty order sets has the potential to enhance usage as these sets continue to be customized in response to local context and user experience. Sustained and continuous uptake of appropriate Computerized Provider Order Entry use may require implementation strategies that address the capability, opportunity, and motivational influencers of behavior. ", doi="10.2196/54022", url="https://formative.jmir.org/2024/1/e54022" } @Article{info:doi/10.2196/57065, author="Nicholls, Jane Melanie and Almeida, Alexandra and Castello, Justin and Grelotti, David and Daugherty, Bianca and Gann Jr, Donny and Lenyoun, Karen and Trillo-Park, Sharon and Borquez, Annick", title="Assessing the Safety, User Acceptability, Dissemination, and Reach of a Comprehensive Web-Based Resource on Medications for Opioid Use Disorder (MOUD Hub): Protocol for a Development and Usability Study", journal="JMIR Res Protoc", year="2024", month="Nov", day="7", volume="13", pages="e57065", keywords="opioid use disorder", keywords="medications for opioid use disorder", keywords="digital health", keywords="digital intervention", keywords="substance use", keywords="motivational interviewing", keywords="stages of change", abstract="Background: Medications for opioid use disorder (MOUD), such as methadone and buprenorphine, are the gold standard for opioid use disorder (OUD) treatment. Owing to various barriers, MOUD access and retention are low in the United States. The internet presents a digital solution to mitigate barriers, but a comprehensive and reliable resource is lacking. We present a user-friendly, web-based resource, the MOUD Hub, that provides reliable information on MOUD. Objective: This study aims to assess the safety, acceptability, feasibility of dissemination, and reach of the MOUD Hub using focus groups and advertising on 1 key search engine and 1 social media platform. Methods: This protocol describes the development of the MOUD Hub and the descriptive observational feasibility study that will be undertaken. The MOUD Hub uses motivational interviewing principles to guide users through the stages of change. The website provides evidence-based information from national health and substance use agencies, harm reduction organizations, and peer-reviewed literature. First, pilot focus groups with 10 graduate students who have lived experience with OUD will be conducted to provide feedback on safety concerns. Then, focus groups with 20-30 potential MOUD Hub users (eg, people with OUD with and without MOUD experience, friends and family, and health care providers) will be conducted to assess safety, acceptability, reach, and usability. Data will be analyzed using inductive thematic analysis. The website will be advertised on Google and MOUD-specific Reddit forums to assess dissemination, reach, and user acceptability based on the total user volume, sociodemographic characteristics, pop-up survey responses, and 1-year engagement patterns. This information will be collected through Google Analytics. Potential differences between users from Google and Reddit will be assessed. Results: The MOUD Hub will be launched in January 2025. Data collected from 5 focus groups (approximately 30-40 participants) will be used to improve the website before launching it. There is no target sample size for the second stage of the study as it aims to assess dissemination feasibility and reach. Data will be collected for a year, analyzed every 3 months, and used to improve the website. Conclusions: The MOUD Hub offers an innovative theory-based approach, tailored to people with OUD and their family and friends, to increase access to and retention in MOUD treatment in the United States and provides broader harm reduction resources for those not currently in a position to receive treatment or those at risk of resuming illicit opioid use. Findings from this feasibility phase will serve to better tailor the MOUD Hub. After modifying the website based on our findings, we will use a randomized controlled trial to assess its efficacy in increasing MOUD access and retention, contributing to growing research on web-based interventions for OUD. International Registered Report Identifier (IRRID): PRR1-10.2196/57065 ", doi="10.2196/57065", url="https://www.researchprotocols.org/2024/1/e57065" } @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/10.2196/57685, author="Knox, Liam and Coates, Elizabeth and Griffiths, Alys and Ali, Yasmin and Hobson, Esther and McDermott, Christopher", title="Development and Evaluation of the Telehealth in Motor Neuron Disease System: The TIME Study Protocol", journal="JMIR Res Protoc", year="2024", month="Oct", day="8", volume="13", pages="e57685", keywords="motor neuron disease", keywords="amyotrophic lateral sclerosis", keywords="telehealth", keywords="digital health", keywords="process evaluation", keywords="implementation", keywords="co-production", keywords="digital technology", keywords="mhealth", keywords="eHealth", keywords="virtual medicine", abstract="Background: For more responsive care provision for motor neuron disease and caregivers, a digital system called Telehealth in MND-Care (TiM-C) was created. TiM-C sends regular symptom questionnaires to users; their responses are sent to health care professionals (HCPs). To enable people with motor neuron disease to participate in research studies more easily, a parallel platform was developed from TiM-C, called Telehealth in MND-Research (TiM-R). TiM-R can advertise studies, collect data, and make them available to MND researchers. Objective: This study has 4 work packages (WPs) to facilitate service approval, codevelop the TiM systems, and evaluate the service. Each WP aims to understand (1) what helps and hinders the approval of the TiM-C system as a National Health Service; (2) what aspects of MND care and research are currently unmet and can be addressed through the TiM-C and TiM-R systems; (3) how TiM-C influences MND care, from the perspective of people with motor neuron disease, their caregivers, and HCPs; and (4) the costs and benefits associated with TiM-C. Methods: WP1 will use semistructured interviews with 10-15 people involved in the approval of TiM-C to understand the barriers and facilitators to governance processes. WP2 will use individual and group interviews with 25-35 users (people with motor neuron disease, caregivers, HCPs, MND researchers, and industry) of TiM-C and TiM-R to understand the current unmet needs of these user groups and how TiM services can be developed to meet these needs. WP3 will use a process evaluation involving 5 elements; local context, engagement, user experiences, service impact, and mechanisms of action. A range of methods, including audits, analysis of routine data, questionnaires, interviews, and observations will be used with people with motor neuron disease, caregivers, and HCPs, both those using the system and those who declined the service when invited. WP4 will use data collected through the process evaluation and known costs to conduct a cost-consequence and budget impact analysis to explore the cost-benefit of the TiM-C service. Most data collected will be qualitative, with thematic and framework analysis used to develop themes from transcripts and observations. Descriptive statistics or t tests and chi-square tests will be used to describe and analyze quantitative data. Results: This study has received ethical approval and has begun recruitment in 1 site. Further, 13 specialist MND centers will adopt TiM-C and the TIME study, beginning in July 2024. The study will conclude in November 2026 and a final report will be produced 3 months after the completion date. Conclusions: This study will facilitate the implementation and development of TiM-C and TiM-R and fully evaluate the TiM-C service, enabling informed decision-making among health care providers regarding continued involvement and contribute to the wider literature relating to how technology-enabled care services can affect clinical care. International Registered Report Identifier (IRRID): DERR1-10.2196/57685 ", doi="10.2196/57685", url="https://www.researchprotocols.org/2024/1/e57685" } @Article{info:doi/10.2196/57596, author="Alexandrova-Karamanova, Anna and Lauri Korajlija, Anita and Halama, Peter and Baban, Adriana", title="Long-Term Post--COVID-19 Health and Psychosocial Effects and Coping Resources Among Survivors of Severe and Critical COVID-19 in Central and Eastern Europe: Protocol for an International Qualitative Study", journal="JMIR Res Protoc", year="2024", month="Sep", day="30", volume="13", pages="e57596", keywords="COVID-19 survivors", keywords="severe COVID-19", keywords="COVID-19 hospitalization", keywords="long-term COVID-19 effects", keywords="post--COVID-19 condition", keywords="posttraumatic growth", keywords="coping resources", keywords="qualitative", keywords="international", keywords="Central and Eastern Europe", abstract="Background: There is a strong need to determine pandemic and postpandemic challenges and effects at the individual, family, community, and societal levels. Post--COVID-19 health and psychosocial effects have long-lasting impacts on the physical and mental health and quality of life of a large proportion of survivors, especially survivors of severe and critical COVID-19, extending beyond the end of the pandemic. While research has mostly focused on the negative short- and long-term effects of COVID-19, few studies have examined the positive effects of the pandemic, such as posttraumatic growth. It is essential to study both negative and positive long-term post--COVID-19 effects and to acknowledge the role of the resources available to the individual to cope with stress and trauma. This knowledge is especially needed in understudied regions hit hard by the pandemic, such as the region of Central and Eastern Europe. A qualitative approach could provide unique insights into the subjective perspectives of survivors on their experiences with severe COVID-19 disease and its lingering impact on their lives. Objective: The aim of the study is to qualitatively explore the experiences of adult survivors of severe or critical COVID-19 throughout the acute and postacute period in 5 Central and Eastern European countries (Bulgaria, Slovakia, Croatia, Romania, and Poland); gain insight into negative (post--COVID-19 condition and quality of life) and positive (posttraumatic growth) long-term post--COVID effects; and understand the role of survivors' personal, social, and other coping resources and local sociocultural context and epidemic-related situations. Methods: This is a qualitative thematic analysis study with an experiential reflexive perspective and inductive orientation. The analytical approach involves 2-stage data analysis: national analyses in stage 1 and international analysis in stage 2. Data are collected from adult survivors of severe and critical COVID-19 through in-depth semistructured interviews conducted in the period after hospital discharge. Results: As of the publication of this paper, data collection is complete. The total international sample includes 151 survivors of severe and critical COVID-19: Bulgaria (n=33, 21.8\%), Slovakia (n=30, 19.9\%), Croatia (n=30, 19.9\%), Romania (n=30, 19.9\%), and Poland (n=28, 18.5\%). National-level qualitative thematic analysis is currently underway, and several papers based on national results have been published. Cross-national analysis has started in 2024. The results will be submitted for publication in the third and fourth quarters of 2024. Conclusions: This research emphasizes the importance of a deeper understanding of the ongoing health and psychosocial challenges survivors face and what helps them cope with these challenges and, in some cases, thrive. It has implications for informing holistic care and improving the health and psychosocial outcomes of survivors of COVID-19 and will be crucial for evaluating the overall impact and multifaceted implications of the pandemic and for informing future pandemic preparedness. International Registered Report Identifier (IRRID): DERR1-10.2196/57596 ", doi="10.2196/57596", url="https://www.researchprotocols.org/2024/1/e57596", url="http://www.ncbi.nlm.nih.gov/pubmed/39348673" } @Article{info:doi/10.2196/59050, author="Bijker, Rimke and Merkouris, S. Stephanie and Dowling, A. Nicki and Rodda, N. Simone", title="ChatGPT for Automated Qualitative Research: Content Analysis", journal="J Med Internet Res", year="2024", month="Jul", day="25", volume="26", pages="e59050", keywords="ChatGPT", keywords="natural language processing", keywords="qualitative content analysis", keywords="Theoretical Domains Framework", abstract="Background: Data analysis approaches such as qualitative content analysis are notoriously time and labor intensive because of the time to detect, assess, and code a large amount of data. Tools such as ChatGPT may have tremendous potential in automating at least some of the analysis. Objective: The aim of this study was to explore the utility of ChatGPT in conducting qualitative content analysis through the analysis of forum posts from people sharing their experiences on reducing their sugar consumption. Methods: Inductive and deductive content analysis were performed on 537 forum posts to detect mechanisms of behavior change. Thorough prompt engineering provided appropriate instructions for ChatGPT to execute data analysis tasks. Data identification involved extracting change mechanisms from a subset of forum posts. The precision of the extracted data was assessed through comparison with human coding. On the basis of the identified change mechanisms, coding schemes were developed with ChatGPT using data-driven (inductive) and theory-driven (deductive) content analysis approaches. The deductive approach was informed by the Theoretical Domains Framework using both an unconstrained coding scheme and a structured coding matrix. In total, 10 coding schemes were created from a subset of data and then applied to the full data set in 10 new conversations, resulting in 100 conversations each for inductive and unconstrained deductive analysis. A total of 10 further conversations coded the full data set into the structured coding matrix. Intercoder agreement was evaluated across and within coding schemes. ChatGPT output was also evaluated by the researchers to assess whether it reflected prompt instructions. Results: The precision of detecting change mechanisms in the data subset ranged from 66\% to 88\%. Overall $\kappa$ scores for intercoder agreement ranged from 0.72 to 0.82 across inductive coding schemes and from 0.58 to 0.73 across unconstrained coding schemes and structured coding matrix. Coding into the best-performing coding scheme resulted in category-specific $\kappa$ scores ranging from 0.67 to 0.95 for the inductive approach and from 0.13 to 0.87 for the deductive approaches. ChatGPT largely followed prompt instructions in producing a description of each coding scheme, although the wording for the inductively developed coding schemes was lengthier than specified. Conclusions: ChatGPT appears fairly reliable in assisting with qualitative analysis. ChatGPT performed better in developing an inductive coding scheme that emerged from the data than adapting an existing framework into an unconstrained coding scheme or coding directly into a structured matrix. The potential for ChatGPT to act as a second coder also appears promising, with almost perfect agreement in at least 1 coding scheme. The findings suggest that ChatGPT could prove useful as a tool to assist in each phase of qualitative content analysis, but multiple iterations are required to determine the reliability of each stage of analysis. ", doi="10.2196/59050", url="https://www.jmir.org/2024/1/e59050" } @Article{info:doi/10.2196/54951, author="Lakew, Nathan and Jonsson, Jakob and Lindner, Philip", title="Probing the Role of Digital Payment Solutions in Gambling Behavior: Preliminary Results From an Exploratory Focus Group Session With Problem Gamblers", journal="JMIR Hum Factors", year="2024", month="Jul", day="23", volume="11", pages="e54951", keywords="digital payment solutions", keywords="online gambling behavior", keywords="sociotechnical", keywords="subjective experience", keywords="focus group", abstract="Background: Technology has significantly reshaped the landscape and accessibility of gambling, creating uncharted territory for researchers and policy makers involved in the responsible gambling (RG) agenda. Digital payment solutions (DPS) are the latest addition of technology-based services in gambling and are now prominently used for deposit and win withdrawal. The seamless collaboration between online gambling operators and DPS, however, has raised concerns regarding the potential role of DPS platforms in facilitating harmful behavior. Objective: Using a focus group session with problem gamblers, this study describes a preliminary investigation of the role of DPS in the online gambling context and its influence on players' gambling habits, financial behavior, choices of gambling environment, and the overall outcome of gambling subjective experiences. Methods: A total of 6 problem gamblers participated in a one-and-half-hour focus group session to discuss how DPSs are integrated into their everyday gambling habits, what motivates them to use DPS, and what shifts they observe in their gambling behavior. Thematic analysis was used to analyze the empirical evidence with a mix of inductive and deductive research approaches as a knowledge claim strategy. Results: Our initial findings revealed that the influence of DPSs in online gambling is multifaced where, on the one hand, their ability to integrate with players' existing habits seamlessly underscores the facilitating role they play in potentially maximizing harm. On the other hand, we find preliminary evidence that DPSs can have a direct influence on gambling outcomes in both subtle and pervasive ways---nudging, institutionalizing, constraining, or triggering players' gambling activities. This study also highlights the increasingly interdisciplinary nature of online gambling, and it proposes a preliminary conceptual framework to illustrate the sociotechnical interplay between DPS and gambling habits that ultimately capture the outcome of gambling's subjective experience. Conclusions: Disguised as a passive payment enabler, the role of DPS has so far received scant attention; however, this exploratory qualitative study demonstrates that given the technological advantage and access to customer financial data, DPS can become a potent platform to enable and at times trigger harmful gambling. In addition, DPS's bird's-eye view of cross-operator gambling behavior can open up an opportunity for researchers and policy makers to explore harm reduction measures that can be implemented at the digital payment level for gambling customers. Finally, more interdisciplinary studies are needed to formulate the sociotechnical nature of online gambling and holistic harm minimization strategy. ", doi="10.2196/54951", url="https://humanfactors.jmir.org/2024/1/e54951" } @Article{info:doi/10.2196/58318, author="Mallakin, Maryam and Langley, Joe and Harvey, Gillian and Walker, Sarah and Raber, Caylee and Beyzaei, Nadia and Paczka Giorgi, A. Luz and Holyoke, Paul and Sellen, Kate", title="Recovery and Renewal of Co-Design Approaches in Health: Protocol for a Realist Synthesis", journal="JMIR Res Protoc", year="2024", month="Jul", day="17", volume="13", pages="e58318", keywords="participatory design", keywords="co-design", keywords="realist synthesis", keywords="equity, diversity, and inclusion", keywords="EDI", keywords="community of practice", keywords="online co-design", keywords="virtual platform", keywords="internet research ethics", keywords="health communication", keywords="health design", keywords="COVID-19", keywords="virtual health", keywords="digital health", abstract="Background: The COVID-19 pandemic significantly transformed the landscape of work and collaboration, impacting design research methodologies and techniques. Co-design approaches have been both negatively and positively affected by the pandemic, prompting a need to investigate and understand the extent of these impacts, changes, and adaptations, specifically in the health sector. Despite the challenges that the pandemic imposed on conducting co-design and related projects, it also encouraged a re-evaluation of co-design practices, leading to innovative solutions and techniques. Designers and researchers have explored alternative ways to engage stakeholders and end users, leveraging digital workshops and participatory digital platforms. These adaptations have the potential to enhance inclusivity, allowing for a wider range of individuals to contribute their perspectives and insights through co-design and thus contribute to healthcare change. Objective: This study aims to explore the impacts of the pandemic on co-design and related practices, focusing on co-design practices in healthcare that have been gained, adapted, or enhanced, with a specific focus on issues of equity, diversity, and inclusion. Methods: The study uses a realist synthesis methodology to identify and analyze the effects of the pandemic on co-design approaches in health, drawing on a range of sources including first-person experiences, gray literature, and academic literature. A community of practice in co-design in health will be engaged to support this process. Results: By examining the experiences and insights of professionals, practitioners, and communities who were actively involved in co-design and have navigated the challenges and opportunities of the pandemic, we can gain a deeper understanding of the strategies, tools, and techniques that have facilitated effective co-design during the pandemic, contributing to building resilience and capacity in co-design in health beyond the pandemic. Conclusions: By involving community partners, community of practice (research), and design practitioners, we expect closer proximity to practice with capacity building occurring through the realist process, thus enabling rapid adoption and refinement of new techniques or insights that emerge. Ultimately, this research will contribute to the advancement of co-design methodologies and inform the future of co-design in health. International Registered Report Identifier (IRRID): DERR1-10.2196/58318 ", doi="10.2196/58318", url="https://www.researchprotocols.org/2024/1/e58318" } @Article{info:doi/10.2196/52998, author="Squire, M. Claudia and Giombi, C. Kristen and Rupert, J. Douglas and Amoozegar, Jacqueline and Williams, Peyton", title="Determining an Appropriate Sample Size for Qualitative Interviews to Achieve True and Near Code Saturation: Secondary Analysis of Data", journal="J Med Internet Res", year="2024", month="Jul", day="9", volume="26", pages="e52998", keywords="saturation", keywords="sample size", keywords="web-based data collection", keywords="semistructured interviews", keywords="qualitative", keywords="research methods", keywords="research methodology", keywords="data collection", keywords="coding", keywords="interviews", keywords="interviewing", keywords="in-depth", abstract="Background: In-depth interviews are a common method of qualitative data collection, providing rich data on individuals' perceptions and behaviors that would be challenging to collect with quantitative methods. Researchers typically need to decide on sample size a priori. Although studies have assessed when saturation has been achieved, there is no agreement on the minimum number of interviews needed to achieve saturation. To date, most research on saturation has been based on in-person data collection. During the COVID-19 pandemic, web-based data collection became increasingly common, as traditional in-person data collection was possible. Researchers continue to use web-based data collection methods post the COVID-19 emergency, making it important to assess whether findings around saturation differ for in-person versus web-based interviews. Objective: We aimed to identify the number of web-based interviews needed to achieve true code saturation or near code saturation. Methods: The analyses for this study were based on data from 5 Food and Drug Administration--funded studies conducted through web-based platforms with patients with underlying medical conditions or with health care providers who provide primary or specialty care to patients. We extracted code- and interview-specific data and examined the data summaries to determine when true saturation or near saturation was reached. Results: The sample size used in the 5 studies ranged from 30 to 70 interviews. True saturation was reached after 91\% to 100\% (n=30-67) of planned interviews, whereas near saturation was reached after 33\% to 60\% (n=15-23) of planned interviews. Studies that relied heavily on deductive coding and studies that had a more structured interview guide reached both true saturation and near saturation sooner. We also examined the types of codes applied after near saturation had been reached. In 4 of the 5 studies, most of these codes represented previously established core concepts or themes. Codes representing newly identified concepts, other or miscellaneous responses (eg, ``in general''), uncertainty or confusion (eg, ``don't know''), or categorization for analysis (eg, correct as compared with incorrect) were less commonly applied after near saturation had been reached. Conclusions: This study provides support that near saturation may be a sufficient measure to target and that conducting additional interviews after that point may result in diminishing returns. Factors to consider in determining how many interviews to conduct include the structure and type of questions included in the interview guide, the coding structure, and the population under study. Studies with less structured interview guides, studies that rely heavily on inductive coding and analytic techniques, and studies that include populations that may be less knowledgeable about the topics discussed may require a larger sample size to reach an acceptable level of saturation. Our findings also build on previous studies looking at saturation for in-person data collection conducted at a small number of sites. ", doi="10.2196/52998", url="https://www.jmir.org/2024/1/e52998", url="http://www.ncbi.nlm.nih.gov/pubmed/38980711" } @Article{info:doi/10.2196/57341, author="Tyagi, Pranjal and Bouldin, D. Erin and Hathaway, A. Wendy and D'Arcy, Derek and Nasr, Zacharia Samer and Intrator, Orna and Dang, Stuti", title="Preimplementation Evaluation of a Self-Directed Care Program in a Veterans Health Administration Regional Network: Protocol for a Mixed Methods Study", journal="JMIR Res Protoc", year="2024", month="Jun", day="14", volume="13", pages="e57341", keywords="long-term institutional care", keywords="self-directed care", keywords="veteran directed care", keywords="veteran", keywords="veterans", keywords="institutional care", keywords="long term care", keywords="mixed-methods", keywords="caregivers", keywords="caregiver", keywords="United States", keywords="nursing home", keywords="homecare", keywords="community-based", keywords="home-based", keywords="unmet", keywords="pre-implementation", keywords="barriers", keywords="barrier", keywords="facilitators", keywords="facilitator", keywords="quantitative data", abstract="Background: The Veteran-Directed Care (VDC) program serves to assist veterans at risk of long-term institutional care to remain at home by providing funding to hire veteran-selected caregivers. VDC is operated through partnerships between Department of Veterans Affairs (VA) Medical Centers (VAMCs) and third-party Aging and Disability Network Agency providers. Objective: We aim to identify facilitators, barriers, and adaptations in VDC implementation across 7 VAMCs in 1 region: Veterans Integrated Service Network (VISN) 8, which covers Florida, South Georgia, Puerto Rico, and the US Virgin Islands. We also attempted to understand leadership and stakeholder perspectives on VDC programs' reach and implementation and identify veterans served by VISN 8's VDC programs and describe their home- and community-based service use. Finally, we want to compare veterans served by VDC programs in VISN 8 to the veterans served in VDC programs across the VA. This information is intended to be used to identify strategies and propose recommendations to guide VDC program expansion in VISN 8. Methods: The mixed methods study design encompasses electronically delivered surveys, semistructured interviews, and administrative data. It is guided by the Consolidated Framework for Implementation Research (CFIR version 2.0). Participants included the staff of VAMCs and partnering aging and disability network agencies across VISN 8, leadership at these VAMCs and VISN 8, veterans enrolled in VDC, and veterans who declined VDC enrollment and their caregivers. We interviewed selected VAMC site leaders in social work, Geriatrics and Extended Care, and the Caregiver Support Program. Each interviewee will be asked to complete a preinterview survey that includes information about their personal characteristics, experiences with the VDC program, and perceptions of program aspects according to the CFIR (version 2.0) framework. Participants will complete a semistructured interview that covers constructs relevant to the respondent and facilitators, barriers, and adaptations in VDC implementation at their site. Results: We will calculate descriptive statistics including means, SDs, and percentages for survey responses. Facilitators, barriers, number of patients enrolled, and staffing will also be presented. Interviews will be analyzed using rapid qualitative techniques guided by CFIR domains and constructs. Findings from VISN 8 will be collated to identify strategies for VDC expansion. We will use administrative data to describe veterans served by the programs in VISN 8. Conclusions: The VA has prioritized VDC rollout nationwide and this study will inform these expansion efforts. The findings from this study will provide information about the experiences of the staff, leadership, veterans, and caregivers in the VDC program and identify program facilitators and barriers. These results may be used to improve program delivery, facilitate growth within VISN 8, and inform new program establishment at other sites nationwide as the VDC program expands. International Registered Report Identifier (IRRID): DERR1-10.2196/57341 ", doi="10.2196/57341", url="https://www.researchprotocols.org/2024/1/e57341", url="http://www.ncbi.nlm.nih.gov/pubmed/38875003" } @Article{info:doi/10.2196/53362, author="?erne, Tina and Turk, Eva and Mirosevic, Spela and Rotar Pavli{\v c}, Danica", title="Needs and Experiences With Health Care Providers of Adult Rare Disease Patients and Caregivers of People With Rare Diseases: Protocol for a Qualitative Study", journal="JMIR Res Protoc", year="2024", month="Apr", day="22", volume="13", pages="e53362", keywords="rare diseases", keywords="patients", keywords="caregivers", keywords="needs", keywords="barriers", keywords="access to health care", abstract="Background: Rare diseases in Europe are defined as diseases with a prevalence of less than 5 per 10,000 people. Despite their individual rarity, the total number of rare diseases is considerable. Rare diseases are often chronic and complex, affecting physical, mental, and neurological health. People with rare diseases face challenges such as delayed diagnosis, limited medical support, and financial burden. Caregivers, usually family members, bear significant physical and emotional burdens. Understanding the experiences of patients with rare disease and their caregivers is critical to effective care, but this is still underresearched. Better support and understanding of the challenges faced by both patients and caregivers is clearly needed. Our study will explore the experiences and needs of people with rare diseases and caregivers of people with rare diseases in relation to accessing health services. Objective: This study aims to explore the experiences of patients with rare disease and their caregivers with Slovenian health care providers and to create a theoretical model of needs and experiences. Methods: This is a qualitative thematic analysis study, using the codebook approach. The study will conduct semi--open-ended interviews to understand the experiences and needs of people with rare diseases and caregivers of people with rare diseases in relation to accessing health services. The interview questions will be based on an extensive literature review. Data from the interviews will be analyzed using thematic analysis to identify patterns and build a thematic map. Data will be analyzed by at least 2 coders. To ensure reliability, respondent validation will be conducted and negative cases investigated. Any discrepancies will be resolved by consulting the entire research team until a consensus is reached. Results: This study was not specifically funded. However, author T? is supported by grant number P3-0339 from the Slovenian Agency for Research and Innovation. This study was approved by the Medical Ethics Committee of the Republic of Slovenia (0120-47/2022/3), and recruitment is expected to begin in May 2024, with data analysis results anticipated by the end of 2025. Conclusions: This study will fill an important research gap in Slovenia by exploring the needs and experiences of people living with rare diseases and their caregivers. The results will contribute to the broader field of rare diseases and add knowledge that can inform future research processes and intervention strategies. It also aims to identify neglected areas that have a significant impact on the lives of people with rare diseases. This study is important not only because it addresses the immediate needs of the Slovenian rare disease community, but also because it contributes to a discussion on patient-centered care, health policy design, and the inclusion of psychosocial components in health care. International Registered Report Identifier (IRRID): PRR1-10.2196/53362 ", doi="10.2196/53362", url="https://www.researchprotocols.org/2024/1/e53362", url="http://www.ncbi.nlm.nih.gov/pubmed/38648088" } @Article{info:doi/10.2196/51779, author="Robertson, Ciara and Hibberd, Carina and Shepherd, Ashley and Johnston, Gordon", title="How a National Organization Works in Partnership With People Who Have Lived Experience in Mental Health Improvement Programs: Protocol for an Exploratory Case Study", journal="JMIR Res Protoc", year="2024", month="Apr", day="19", volume="13", pages="e51779", keywords="partnership", keywords="engagement", keywords="case study", keywords="mental health", keywords="improvement", keywords="national program", keywords="quality improvement", abstract="Background: This is a research proposal for a case study to explore how a national organization works in partnership with people with lived experience in national mental health improvement programs. Quality improvement is considered a key solution to addressing challenges within health care, and in Scotland, there are significant efforts to use quality improvement as a means of improving health and social care delivery. In 2016, Healthcare Improvement Scotland (HIS) established the improvement hub, whose purpose is to lead national improvement programs that use a range of approaches to support teams and services. Working in partnership with people with lived experience is recognized as a key component of such improvement work. There is, however, little understanding of how this is manifested in practice in national organizations. To address gaps in evidence and strengthen a consistent approach, a greater understanding is required to improve partnership working. Objective: The aim of this study is to better understand how a national organization works in partnership with people who have lived experience with improvement programs in mental health services, exploring people's experiences of partnership working in a national organization. An exploratory case study approach will be used to address the research questions in relation to the Personality Disorder (PD) Improvement Programme: (1) How is partnership working described in the PD Improvement Programme? (2) How is partnership working manifested in practice in the PD Improvement Programme? and (3) What factors influence partnership working in the PD Improvement Programme? Methods: An exploratory case study approach will be used in relation to the PD Improvement Programme, led by HIS. This research will explore how partnership working with people with lived experience is described and manifested in practice, outlining factors influencing partnership working. Data will be gathered from various qualitative sources, and analysis will deepen an understanding of partnership working. Results: This study is part of a clinical doctorate program at the University of Stirling and is unfunded. Data collection was completed in October 2023; analysis is expected to be completed and results will be published in January 2025. Conclusions: This study will produce new knowledge on ways of working with people with lived experience and will have practical implications for all improvement-focused interventions. Although the main focus of the study is on national improvement programs, it is anticipated that this study will contribute to the understanding of how all national public service organizations work in partnership with people with lived experience of mental health care. International Registered Report Identifier (IRRID): DERR1-10.2196/51779 ", doi="10.2196/51779", url="https://www.researchprotocols.org/2024/1/e51779", url="http://www.ncbi.nlm.nih.gov/pubmed/38640479" } @Article{info:doi/10.2196/56346, author="Jabin, Rahman Md Shafiqur and Samuriwo, Ray and Chilaka, Marcus and Yaroson, Vann Emilia", title="Effectiveness and Experiences of Quality Improvement Interventions in Older Adult Care: Protocol for a Mixed Methods Systematic Review", journal="JMIR Res Protoc", year="2024", month="Apr", day="18", volume="13", pages="e56346", keywords="patient safety", keywords="acceptability", keywords="accessibility", keywords="appropriateness", keywords="timeliness", keywords="equitability", keywords="social care", abstract="Background: Quality improvement (QI) interventions are designed to resolve the recurring challenges of care for older individuals, such as working conditions for staff, roles of older individuals in their own care and their families, and relevant stakeholders. Therefore, there is a need to map the impacts of QI interventions in older adult care settings and further improve health and social care systems associated with older adults. Objective: This review aims to compile and synthesize the best available evidence regarding the effectiveness of policy and practice QI interventions in older adult care. The secondary aim is to understand the care of older individuals and QI intervention-related experiences and perspectives of stakeholders, care providers, older individuals, and their families. Methods: The mixed methods review will follow the standard methodology used by Joanna Briggs Institute. The published studies will be searched through CINAHL, MEDLINE, PsycINFO, ASSIA, and Web of Science, and the unpublished studies through Mednar, Trove, OCLC WorldCat, and Dissertations and Theses. This review included both qualitative and quantitative analyses of patients undergoing older adult care and any health and care professionals involved in the care delivery for older adults; a broad range of QI interventions, including assistive technologies, effects of training and education, improved reporting, safety programs, and medical devices; the experiences and perspectives of staff and patients; the context of older adult care setting; and a broad range of outcomes, including patient safety. The standard procedure for reporting, that is, PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, will be followed. Results: A result-based convergent synthesis design will be used in which both quantitative and qualitative studies will be analyzed separately, and the results of both syntheses will be then integrated during a final (convergent) synthesis. The integration will compare the findings of quantitative and qualitative evidence using tables in light of the results of both syntheses. Conclusions: This comprehensive review is expected to reflect on the insights into some QI interventions and their impact, outline some common challenges of quality for older adult care, and benefit both the practical usefulness of care service activities and the society at large. International Registered Report Identifier (IRRID): PRR1-10.2196/56346 ", doi="10.2196/56346", url="https://www.researchprotocols.org/2024/1/e56346", url="http://www.ncbi.nlm.nih.gov/pubmed/38635311" } @Article{info:doi/10.2196/50568, author="Macdonald, Trystan and Dinnes, Jacqueline and Maniatopoulos, Gregory and Taylor-Phillips, Sian and Shinkins, Bethany and Hogg, Jeffry and Dunbar, Kevin John and Solebo, Lola Ameenat and Sutton, Hannah and Attwood, John and Pogose, Michael and Given-Wilson, Rosalind and Greaves, Felix and Macrae, Carl and Pearson, Russell and Bamford, Daniel and Tufail, Adnan and Liu, Xiaoxuan and Denniston, K. Alastair", title="Target Product Profile for a Machine Learning--Automated Retinal Imaging Analysis Software for Use in English Diabetic Eye Screening: Protocol for a Mixed Methods Study", journal="JMIR Res Protoc", year="2024", month="Mar", day="27", volume="13", pages="e50568", keywords="artificial intelligence", keywords="design", keywords="developers", keywords="diabetes mellitus", keywords="diabetic eye screening", keywords="diabetic retinopathy", keywords="diabetic", keywords="DM", keywords="England", keywords="eye screening", keywords="imaging analysis software", keywords="implementation", keywords="machine learning", keywords="retinal imaging", keywords="study protocol", keywords="target product profile", abstract="Background: Diabetic eye screening (DES) represents a significant opportunity for the application of machine learning (ML) technologies, which may improve clinical and service outcomes. However, successful integration of ML into DES requires careful product development, evaluation, and implementation. Target product profiles (TPPs) summarize the requirements necessary for successful implementation so these can guide product development and evaluation. Objective: This study aims to produce a TPP for an ML-automated retinal imaging analysis software (ML-ARIAS) system for use in DES in England. Methods: This work will consist of 3 phases. Phase 1 will establish the characteristics to be addressed in the TPP. A list of candidate characteristics will be generated from the following sources: an overview of systematic reviews of diagnostic test TPPs; a systematic review of digital health TPPs; and the National Institute for Health and Care Excellence's Evidence Standards Framework for Digital Health Technologies. The list of characteristics will be refined and validated by a study advisory group (SAG) made up of representatives from key stakeholders in DES. This includes people with diabetes; health care professionals; health care managers and leaders; and regulators and policy makers. In phase 2, specifications for these characteristics will be drafted following a series of semistructured interviews with participants from these stakeholder groups. Data collected from these interviews will be analyzed using the shortlist of characteristics as a framework, after which specifications will be drafted to create a draft TPP. Following approval by the SAG, in phase 3, the draft will enter an internet-based Delphi consensus study with participants sought from the groups previously identified, as well as ML-ARIAS developers, to ensure feasibility. Participants will be invited to score characteristic and specification pairs on a scale from ``definitely exclude'' to ``definitely include,'' and suggest edits. The document will be iterated between rounds based on participants' feedback. Feedback on the draft document will be sought from a group of ML-ARIAS developers before its final contents are agreed upon in an in-person consensus meeting. At this meeting, representatives from the stakeholder groups previously identified (minus ML-ARIAS developers, to avoid bias) will be presented with the Delphi results and feedback of the user group and asked to agree on the final contents by vote. Results: Phase 1 was completed in November 2023. Phase 2 is underway and expected to finish in March 2024. Phase 3 is expected to be complete in July 2024. Conclusions: The multistakeholder development of a TPP for an ML-ARIAS for use in DES in England will help developers produce tools that serve the needs of patients, health care providers, and their staff. The TPP development process will also provide methods and a template to produce similar documents in other disease areas. International Registered Report Identifier (IRRID): DERR1-10.2196/50568 ", doi="10.2196/50568", url="https://www.researchprotocols.org/2024/1/e50568", url="http://www.ncbi.nlm.nih.gov/pubmed/38536234" } @Article{info:doi/10.2196/51562, author="Ames, L. Meghan and Karlsen, C. Micaela and Sundermeir, M. Samantha and Durrwachter, Neve and Hemmingson, A. Tyler and Reznar, M. Melissa and Staffier, Livingston Kara and Weeks, Bruce and Gittelsohn, Joel", title="Lifestyle Medicine Implementation in 8 Health Systems: Protocol for a Multiple Case Study Investigation", journal="JMIR Res Protoc", year="2024", month="Mar", day="13", volume="13", pages="e51562", keywords="healthy lifestyle", keywords="implementation science", keywords="lifestyle medicine", keywords="multiple case study", keywords="noncommunicable diseases", keywords="prevention", keywords="qualitative methods", abstract="Background: Lifestyle medicine (LM) is the use of therapeutic lifestyle changes (including a whole-food, plant-predominant eating pattern; regular physical activity; restorative sleep; stress management; avoidance of risky substances; and positive social connection) to prevent and treat chronic illness. Despite growing evidence, LM is still not widely implemented in health care settings. Potential challenges to LM implementation include lack of clinician training, staffing concerns, and misalignment of LM services with fee-for-service reimbursement, but the full range of factors facilitating or obstructing its implementation and long-term success are not yet understood. To learn important lessons for success and failure, it is crucial to understand the experiences of different LM programs. Objective: This study aims to describe in depth the protocol used to identify barriers and facilitators impacting the implementation of LM in health systems. Methods: The study team comprises team members at the American College of Lifestyle Medicine (ACLM), including staff and researchers with expertise in public health, LM, and qualitative research. We recruited health systems that were members of the ACLM Health Systems Council. From among 15 self-nominating health systems, we selected 7 to represent a diversity of geographic location, type, size, expertise, funding, patients, and LM services. Partway through the study, we recruited 1 additional contrasting health system to serve as a negative case. For each case, we conducted in-depth interviews, document reviews, site visits (limited due to the COVID-19 pandemic), and study team debriefs. Interviews lasted 45-90 minutes and followed a semistructured interview guide, loosely based on the Consolidated Framework for Implementation Research (CFIR) model. We are constructing detailed case narrative reports for each health system that are subsequently used in cross-case analyses to develop a contextually rich and detailed understanding of various predetermined and emergent topics. Cross-case analyses will draw on a variety of methodologies, including in-depth case familiarization, inductive or deductive coding, and thematic analysis, to identify cross-cutting themes. Results: The study team has completed data collection for all 8 participating health systems, including 68 interviews and 1 site visit. We are currently drafting descriptive case narratives, which will be disseminated to participating health systems for member checking and shared broadly as applied vignettes. We are also conducting cross-case analyses to identify critical facilitators and barriers, explore clinician training strategies to facilitate LM implementation, and develop an explanatory model connecting practitioner adoption of LM and experiences of burnout. Conclusions: This protocol paper offers real-world insights into research methods and practices to identify barriers and facilitators to the implementation of LM in health systems. Findings can advise LM implementation across various health system contexts. Methodological limitations and lessons learned can guide the execution of other studies with similar methodologies. International Registered Report Identifier (IRRID): DERR1-10.2196/51562 ", doi="10.2196/51562", url="https://www.researchprotocols.org/2024/1/e51562", url="http://www.ncbi.nlm.nih.gov/pubmed/38320320" } @Article{info:doi/10.2196/48894, author="Worthington, A. Michelle and Christie, H. Richard and Masino, J. Aaron and Kark, M. Sarah", title="Identifying Unmet Needs in Major Depressive Disorder Using a Computer-Assisted Alternative to Conventional Thematic Analysis: Qualitative Interview Study With Psychiatrists", journal="JMIR Form Res", year="2024", month="Mar", day="1", volume="8", pages="e48894", keywords="consumer health informatics", keywords="interview", keywords="major depressive disorder", keywords="medical informatics applications", keywords="needs assessment", keywords="psychiatry and psychology", abstract="Background: The development of digital health tools that are clinically relevant requires a deep understanding of the unmet needs of stakeholders, such as clinicians and patients. One way to reveal unforeseen stakeholder needs is through qualitative research, including stakeholder interviews. However, conventional qualitative data analytical approaches are time-consuming and resource-intensive, rendering them untenable in many industry settings where digital tools are conceived of and developed. Thus, a more time-efficient process for identifying clinically relevant target needs for digital tool development is needed. Objective: The objective of this study was to address the need for an accessible, simple, and time-efficient alternative to conventional thematic analysis of qualitative research data through text analysis of semistructured interview transcripts. In addition, we sought to identify important themes across expert psychiatrist advisor interview transcripts to efficiently reveal areas for the development of digital tools that target unmet clinical needs. Methods: We conducted 10 (1-hour-long) semistructured interviews with US-based psychiatrists treating major depressive disorder. The interviews were conducted using an interview guide that comprised open-ended questions predesigned to (1) understand the clinicians' experience of the care management process and (2) understand the clinicians' perceptions of the patients' experience of the care management process. We then implemented a hybrid analytical approach that combines computer-assisted text analyses with deductive analyses as an alternative to conventional qualitative thematic analysis to identify word combination frequencies, content categories, and broad themes characterizing unmet needs in the care management process. Results: Using this hybrid computer-assisted analytical approach, we were able to identify several key areas that are of interest to clinicians in the context of major depressive disorder and would be appropriate targets for digital tool development. Conclusions: A hybrid approach to qualitative research combining computer-assisted techniques with deductive techniques provides a time-efficient approach to identifying unmet needs, targets, and relevant themes to inform digital tool development. This can increase the likelihood that useful and practical tools are built and implemented to ultimately improve health outcomes for patients. ", doi="10.2196/48894", url="https://formative.jmir.org/2024/1/e48894", url="http://www.ncbi.nlm.nih.gov/pubmed/38427407" } @Article{info:doi/10.2196/47700, author="Mukherjee, Joyeeta and Rawat, Shruta and ul Hadi, Saif and Aggarwal, Pritha and Chakrapani, Venkatesan and Rath, Pratyasha and Manchi, Pallavi and Aylur, Srikrishnan and Malhotra, Shelly and Keane, Margaret and Gangaramany, Alok", title="Understanding the Acceptability of Broadly Neutralizing Antibodies for HIV Prevention Among At-Risk Populations and Feasibility Considerations for Product Introduction in India: Protocol for a Qualitative Study", journal="JMIR Res Protoc", year="2024", month="Feb", day="7", volume="13", pages="e47700", keywords="HIV", keywords="key populations", keywords="acceptability", keywords="feasibility", keywords="product attributes", keywords="end-user preferences", keywords="broadly neutralizing antibodies", keywords="simulated behavioral experiments", keywords="qualitative study", abstract="Background: Acceptability and preference research play a crucial role in the design, evaluation, and implementation of any new prevention product in any geographical setting. They also play a critical role in the development of clinical guidelines and policies. A wide range of acceptability studies have been conducted in diverse general and key populations for various new HIV prevention products worldwide. As clinical development strategies are being developed for clinical studies of broadly neutralizing antibodies (bNAbs) as potential HIV prevention products, appropriately tailoring them to address the type of HIV epidemic at hand would be critical for efficient uptake within in-country public health systems and decrease adoption and adherence challenges. Accomplishing this will require comprehensive acceptability and feasibility studies to inform multisectoral efforts that increase access to these products and national policies supportive of access to health care for those in most need. Thus, it is both opportune and important to undertake focused efforts toward informing product development strategies. Objective: This study aims to understand preferences for product attributes and key behavioral factors influencing adoption and uptake of bNAb prevention products among end-users including female sex workers, men who have sex with men, transgender women, people who inject drugs, and adolescent girls and young women in India and understand the key health system and programmatic perspectives toward the introduction of bNAb prevention products from health service providers and policy makers in India. Methods: A multisite study will be conducted in Delhi, Mumbai, and Chennai to capture the differences in perspectives among diverse end-users and key informants across the country. The study will use a multimethods design using focus group discussions, in-depth interviews, simulated behavioral experiments, and key informant interviews. A total of 30 focus group discussions, 45 in-depth interviews, 15 simulated behavioral experiments sessions, and 15 key informant interviews will be conducted across 3 sites. Results: The data collected and analyzed will enable insights on which specific product attributes matter the most to the populations and why some attributes are less preferred; contextual drivers of preferences and choices at individual, interpersonal, social, and structural levels; and relative positioning of bNAb products among other potential HIV prevention products. Insights from the health service providers and policy makers will provide a critical understanding of the need perception of the potential product in the existing product landscape and what additional efforts and resources are required for potential introduction, delivery, and uptake of the bNAb products in the Indian context. Conclusions: Insights generated from the abovementioned objectives will represent perspectives of populations of interest across geographies in India, will provide an overview of the acceptability of bNAb products and the feasibility of their introduction in this region, and will inform product development strategies. International Registered Report Identifier (IRRID): DERR1-10.2196/47700 ", doi="10.2196/47700", url="https://www.researchprotocols.org/2024/1/e47700", url="http://www.ncbi.nlm.nih.gov/pubmed/38324364" } @Article{info:doi/10.2196/48601, author="Kepplinger, Anja and Braun, Alexander and Fringer, Andr{\'e} and Roes, Martina", title="Understanding Employee Voice Behavior Through the Use of Digital Voice Channel in Long-Term Care: Protocol for an Embedded Multiple-Case Study", journal="JMIR Res Protoc", year="2024", month="Feb", day="2", volume="13", pages="e48601", keywords="digital voice channel", keywords="employee participation", keywords="employee voice", keywords="health care provider", keywords="home care facilities", keywords="long-term care", keywords="nursing home", abstract="Background: Specific challenges in the health care sector, such as hierarchical structures, shortages of nursing staff, and high turnover of nursing staff, can be addressed by a change process of organizational culture into shared governance. Data from business organizations show that the use of digital voice channels provides employee voice. This approach makes concrete the opportunity for employees to raise their voices by answering surveys and making comments in an anonymous forum, which subsequently positively influences staff turnover and sick leave. Since there is no clear understanding of how a digital voice channel can be used in long-term care to address employee voice, a research gap has been identified. Objective: The purpose of ADVICE (Understanding Employee Voice Behavior; the acronym for this study) is to understand how the use of a digital voice channel performs in long-term care (residential long-term care and home care facilities). The aim of this study is to understand how the digital voice channel can support staff in making their voices heard and to see what managers need to use the voice channel to change the work environment. Methods: An embedded multiple-case study will be used to explore the experiences of 2 health care providers who have already implemented a digital voice channel. ADVICE is organized into two main phases: (1) a scoping review and (2) an embedded multiple-case study. For this purpose, focus group interviews with employees, discursive-dialogical interviews with managers, meeting protocols, and data from the digital voice channel will be analyzed. First, all units of analysis from every embedded unit will be separately analyzed and then comprehensively analyzed to obtain a case vignette from every embedded unit (within-analysis). In the second stage, the analyzed data from the embedded units will be compared with each other in a comparative analysis (cross-analysis). Results: The results will provide insight into how digital voice channels can be used in long-term care to address employee voice. We expect to find how the digital voice channel can empower nurses to speak up and, consequently, create a better work environment. Data collection began in August 2023, and from a current perspective, the first results are expected in summer 2024. Conclusions: In summary, the results may help to better understand the use of a digital voice channel in the health care sector and its transformative potential for leadership. At the organizational level, research can help to improve the attractiveness of the workplace by understanding how to give employees a voice. International Registered Report Identifier (IRRID): PRR1-10.2196/48601 ", doi="10.2196/48601", url="https://www.researchprotocols.org/2024/1/e48601", url="http://www.ncbi.nlm.nih.gov/pubmed/38306164" } @Article{info:doi/10.2196/54213, author="Sowan, Azizeh and Chinman, Matthew", title="Model for Doctor of Nursing Practice Projects Based on Cross-Fertilization Between Improvement and Implementation Sciences: Protocol for Quality Improvement and Program Evaluation Studies", journal="JMIR Res Protoc", year="2024", month="Jan", day="31", volume="13", pages="e54213", keywords="quality improvement", keywords="implementation", keywords="Doctor of Nursing Practice", keywords="model", keywords="methodology", keywords="Nursing", keywords="Doctor of Nursing", keywords="hybrid approach", keywords="implementation sciences", keywords="scholarship", keywords="scholars", keywords="Nursing Practice Program", keywords="nursing program", abstract="Background: Hundreds of nursing professionals graduate each year from Doctor of Nursing Practice (DNP) programs, entrusted with roles as practice scholars and leaders. Graduates are tasked to lead multidisciplinary knowledge implementation projects to improve safety, quality, and key performance metrics. Nevertheless, there is a continued lack of agreement and faculty dissatisfaction with the format, focus, and results of the DNP graduation projects. The use of a wide range of models and methodologies from different sciences for knowledge implementation introduces challenges to DNP students; affects the scientific rigor of the projects; and results in the overuse, superficial use, or misuse of the models. Quality improvement (QI) and program evaluation studies are substantial investments that may lead to waste and even harm if not well conducted. Traditional QI methodologies, commonly used in DNP projects, were found to be uncertain in improving health care outcomes. The complexity of health care systems calls for cross-fertilization between improvement and implementation sciences to improve health care outcomes. Objective: This study describes the development, implementation, and evaluation of a hybrid model for QI and program evaluation studies to guide scholarship in the DNP program. Methods: The hybrid model was based on cross-fertilization between improvement and implementation sciences. The model adapted the Getting to Outcome (GTO) and Knowledge to Action (KTA) models as the overarching process models for knowledge implementation. Within each phase of the GTO and KTA models, expected barriers and facilitators for the implementation and adoption of innovation were identified based on the CFIR (Consolidated Framework for Implementation Research). Accordingly, strategies to facilitate the implementation and adoption of innovations were identified based on a refined list of implementation strategies and QI tools. The choice of these models was based on the top 5 criteria for selecting implementation science theories and frameworks. Seven DNP students used the hybrid model to conduct QI projects. Students evaluated their experiences by responding to a Qualtrics survey. Results: The hybrid model encouraged a comprehensive systematic way of thinking, provided tools essential to implementation success, emphasized the need for adaptability in implementation, maintained rigor in QI, and guided the sustainability of change initiatives. Some of the challenges faced by students included finding reliable and valid measures, attaining and maintaining staff buy-in, and competing organizational priorities. Conclusions: Cross-fertilization between improvement and implementation sciences provided a roadmap and systematic thinking for successful QI projects in the DNP program. The integration of the CFIR with the GTO or KTA process models, enforced by the use of evidence-based implementation strategies and QI tools, reflected the complexity of health care systems and emphasized the need for adaptability in implementation. International Registered Report Identifier (IRRID): RR1-10.2196/54213 ", doi="10.2196/54213", url="https://www.researchprotocols.org/2024/1/e54213", url="http://www.ncbi.nlm.nih.gov/pubmed/38294860" } @Article{info:doi/10.2196/47528, author="H{\aa}kansson, Anders and Tjernberg, Johanna and Hansson, Helena", title="Effects and Limitations of a Unique, Nationwide, Self-Exclusion Service for Gambling Disorder and Its Self-Perceived Effects and Harms in Gamblers: Protocol for a Qualitative Interview Study", journal="JMIR Res Protoc", year="2023", month="Nov", day="14", volume="12", pages="e47528", keywords="gambling disorder", keywords="problem gambling", keywords="behavioral addiction", keywords="self-exclusion", keywords="Spelpaus", keywords="gambling", keywords="management", keywords="data", keywords="online gambling", keywords="harm", keywords="harm reduction tool", keywords="recruitment", keywords="qualitative interview study", keywords="gambler", abstract="Background: Voluntary self-exclusion from gambling is a common but underdeveloped harm reduction tool in the management of gambling problems or gambling disorders. Large-scale, multi-operator, and operator-independent self-exclusion services are needed. A recent nationwide multi-operator self-exclusion service in Sweden (Spelpaus), involving both land- and web-based gambling sites, is promising, but recent data have revealed limitations to this system and possibilities to breach one's self-exclusion through overseas web-based gambling. More knowledge is needed about the benefits and challenges of such an extensive self-exclusion service, and its effects as perceived by gamblers. Objective: This study protocol describes the rationale and design of a qualitative interview study addressing the effects and limitations perceived by individuals with gambling problems and their concerned significant others. The study aims to provide an in-depth experience of this novel self-exclusion service and to inform stakeholders and policymakers in order to further improve harm reduction tools against gambling problems. Methods: Individuals with gambling problems will be recruited primarily through social media and also from a treatment unit, if needed, for a qualitative interview study. Recorded interview material will be analyzed through content analysis, and recruitment will continue until saturation in the material is reached. This study will provide in-depth information about a harm reduction tool that is promising and commonly used, but which has proven to be breached by a significant number of users, potentially limiting its efficiency. The aim is to interview a sufficient number of gamblers until saturation has been obtained in the interview material. Saturation will be considered through a continuous analysis, comparing recently collected data to previously collected data. Results: Results will be reported as the themes and subthemes identified after the thorough analysis and coding of the transcribed text material and will be accompanied by citations representing relevant themes and subthemes. Results are planned to be provided before the end of 2023. Conclusions: This study will likely provide new insights into user perspectives on a multi-operator self-exclusion service that involves both web- and land-based gambling operators, and which according to previous literature attracts many gamblers but also appears to have limitations and challenges in the target group of individuals with gambling problems. Policy and legislation implications, as well as clinical implications for treatment providers, will be discussed. Results and conclusions will be disseminated to policy makers in Sweden and internationally, as well as to peer organizations, treatment providers, and the research community. Trial Registration: ClinicalTrials.gov NCT05693155; https://clinicaltrials.gov/study/NCT05693155 International Registered Report Identifier (IRRID): PRR1-10.2196/47528 ", doi="10.2196/47528", url="https://www.researchprotocols.org/2023/1/e47528", url="http://www.ncbi.nlm.nih.gov/pubmed/37962917" } @Article{info:doi/10.2196/41836, author="Amick, Erick and Naanyu, Violet and Bucher, Sherri and Henry, W. Beverly", title="Perceptions of Global Health Engagements in Relation to the COVID-19 Pandemic Among Health Care Workers and Administrators in Western Kenya: Protocol for a Multistage Qualitative Study", journal="JMIR Res Protoc", year="2023", month="Jul", day="19", volume="12", pages="e41836", keywords="global health", keywords="global health engagements", keywords="GHEs", keywords="health care workers", keywords="local perspectives", keywords="low- and middle-income countries", keywords="LMICs", abstract="Background: There has been significant interest in global health in low- and middle-income countries (LMICs) among individuals living in high-income countries (HICs) over the past 30 years. Much of the literature on global health engagements (GHEs) has been presented from the perspective of individuals from high-income countries. Local stakeholders such as health care workers and health care administrators represent critical constituencies for global health activities, yet their perspectives are underrepresented in the literature. The purpose of this study is to examine the experiences of local health care workers and administrators with GHEs in Kenya. We will explore the perceived role GHEs play in preparing the health system to address a public health crisis, as well as their role in pandemic recovery and its aftermath. Objective: The aims of this study are to (1) examine how Kenyan health care workers and administrators interpret experiences with GHEs as having advantaged or hindered them and the local health system to provide care during an acute public health crisis and (2) to explore recommendations to reimagine GHEs in a postpandemic Kenya. Methods: This study will be conducted at a large teaching and referral hospital in western Kenya with a long history of hosting GHEs in support of its tripartite mission of providing care, training, and research. This qualitative study will be conducted in 3 phases. In phase 1, in-depth interviews will be conducted to capture participants' lived experience in relation to their unique understandings of the pandemic, GHEs, and the local health system. In phase 2, group discussions using nominal group techniques will be conducted to determine potential priority areas to reimagine future GHEs. In phase 3, in-depth interviews will be conducted to explore these priority areas in greater detail to explore recommendations for potential strategies, policies, and other actions that might be used to achieve the priorities determined to be of highest importance. Results: The study activities commenced in late summer 2022, with findings to be published in 2023. It is anticipated that the findings from this study will provide insight into the role GHEs play in a local health system in Kenya and provide critical stakeholder and partner input from persons hitherto ignored in the design, implementation, and management of GHEs. Conclusions: This qualitative study will examine the perspectives of GHEs in relation to the COVID-19 pandemic among Kenyan health care workers and health care administrators in western Kenya using a multistage protocol. Using a combination of in-depth interviews and nominal group techniques, this study aims to shed light on the roles global health activities are perceived to play in preparing health care professionals and the health system to address an acute public health crisis. International Registered Report Identifier (IRRID): PRR1-10.2196/41836 ", doi="10.2196/41836", url="https://www.researchprotocols.org/2023/1/e41836", url="http://www.ncbi.nlm.nih.gov/pubmed/37315197" } @Article{info:doi/10.2196/47255, author="Boone, Robert Eli and Tai, Heiley and Raich, Ali and Vatsavai, Amulya and Qin, Annie and Thompson, Kayla and Johri, Mohini and Hu, Ruitian and Golla, Vishnukamal and Harris-Gersten, Melissa", title="Financial Health of People Living With Dementia and Their Informal Care Partners: Protocol for a Mixed Methods Study", journal="JMIR Res Protoc", year="2023", month="Jul", day="11", volume="12", pages="e47255", keywords="avoiding care due to cost", keywords="care rationing", keywords="cost", keywords="delayed care due to cost", keywords="dementia", keywords="economic strain", keywords="financial burden", keywords="financial distress", keywords="financial hardship", keywords="financial strain", keywords="financial stress", keywords="financial toxicity", keywords="MCI", keywords="mild cognitive impairment", keywords="out-of-pocket costs", keywords="out-of-pocket spending", abstract="Background: There is a growing body of academic literature focusing on the significant financial burdens placed on people living with cancer, but little evidence exists on the impact of rising costs of care in other vulnerable populations. This financial strain, also known as financial toxicity, can impact behavioral, psychosocial, and material domains of life for people diagnosed with chronic conditions and their care partners. New evidence suggests that populations experiencing health disparities, including those with dementia, face limited access to health care, employment discrimination, income inequality, higher burdens of disease, and exacerbating financial toxicity. Objective: The three study aims are to (1) adapt a survey to capture financial toxicity in people living with dementia and their care partners; (2) characterize the degree and magnitude of different components of financial toxicity in this population; and (3) empower the voice of this population through imagery and critical reflection on their perceptions and experiences relating to financial toxicity. Methods: This study uses a mixed methods approach to comprehensively characterize financial toxicity among people living with dementia and their care partners. To address aim 1, we will adapt elements from previously validated and reliable instruments, including the Comprehensive Score for Financial Toxicity and Patient-Reported Outcomes Measurement Information System, to develop a financial toxicity survey specific to dyads of people living with dementia and their care partners. A total of 100 dyads will complete the survey, and data will be analyzed using descriptive statistics and regression models to address aim 2. Aim 3 will be addressed using the process of ``photovoice,'' which is a qualitative, participatory research method that combines photography, verbal narratives, and critical reflection by groups of individuals to capture aspects of their environment and experiences with a certain topic. Quantitative results and qualitative findings will be integrated using a validated, joint display table mixed methods approach called the pillar integration process. Results: This study is ongoing, with quantitative findings and qualitative results anticipated by December 2023. Integrated findings will enhance the understanding of financial toxicity in individuals living with dementia and their care partners by providing a comprehensive baseline assessment. Conclusions: As one of the first studies on financial toxicity related to dementia care, findings from our mixed methods approach will support the development of new strategies for improving the costs of care. While this work focuses on those living with dementia, this protocol could be replicated for people living with other diseases and serve as a blueprint for future research efforts in this space. International Registered Report Identifier (IRRID): DERR1-10.2196/47255 ", doi="10.2196/47255", url="https://www.researchprotocols.org/2023/1/e47255", url="http://www.ncbi.nlm.nih.gov/pubmed/37432718" } @Article{info:doi/10.2196/47461, author="Yelton, Brooks and Rumthao, Rachel Jancham and Sakhuja, Mayank and Macauda, M. Mark and Donelle, Lorie and Arent, A. Michelle and Yang, Xueying and Li, Xiaoming and Noblet, Samuel and Friedman, B. Daniela", title="Assessment and Documentation of Social Determinants of Health Among Health Care Providers: Qualitative Study", journal="JMIR Form Res", year="2023", month="Jul", day="3", volume="7", pages="e47461", keywords="social determinants of health", keywords="SDOH", keywords="health equity", keywords="Healthy People 2030", keywords="interviews", keywords="thematic analysis", keywords="health care worker", keywords="health care provider", keywords="barrier", keywords="facilitator", keywords="qualitative study", keywords="web-based", keywords="patient health", keywords="well-being", keywords="community health status", abstract="Background: Research clearly demonstrates social determinants of health (SDOH) impact health outcomes. Provider consideration of patient SDOH in prevention and treatment planning is critical for improved health care quality and health equity. Despite awareness of the connections between SDOH and improved population health, research demonstrates few providers document patient SDOH. Objective: This qualitative study aimed to better understand the barriers and facilitators of SDOH assessment, documentation, and referral in different health care settings and roles. Methods: Individual semistructured interviews were conducted with practicing health care providers in South Carolina between August 25, 2022, and September 2, 2022. Participants were recruited via community partners' web-based newsletters or listservs using a purposive sampling design. An interview guide with 19 questions was used to explore the following research question: How do SDOH impact patient health and what are the facilitators and barriers experienced by multidisciplinary health care providers assessing and documenting patient SDOH? Results: Participants (N=5) included a neonatal intensive care unit registered nurse, a nurse practitioner, a certified nurse midwife, a family and preventive medicine physician, and a counselor (licensed clinical social worker) with careers spanning 12 to 32 years. Participant responses are presented according to the following 5 themes: participants' understanding of SDOH for the patient population, assessment and documentation practices, referrals to other providers and community-based resources, barriers and facilitators of SDOH assessment and documentation, and SDOH assessment and documentation training preferences. Overall, participants were aware of the importance of including patient SDOH in assessment and intervention but noted a variety of institutional and interpersonal barriers to assessment and documentation, including time constraints, perceptions of stigma around discussion of SDOH, and limited referral protocols. Conclusions: Incentivizing inclusion of patient SDOH in health care must be facilitated from the top down, so assessment and documentation can be universally implemented in a pragmatic way that works for providers in a variety of roles and settings for the betterment of health care quality, health equity, and improved population health outcomes. Partnering with community organizations can serve to augment health care organizations' resource and referral availability for addressing patients' social needs. ", doi="10.2196/47461", url="https://formative.jmir.org/2023/1/e47461", url="http://www.ncbi.nlm.nih.gov/pubmed/37399064" } @Article{info:doi/10.2196/41436, author="H{\"o}rold, Madlen and Apfelbacher, Christian and Gerhardinger, Katharina and Rohr, Magdalena and Schimmelpfennig, Maria and Weigt, Julia and Brandstetter, Susanne", title="Parents' and Health Care Professionals' Perspectives on Prevention and Prediction of Food Allergies in Children: Protocol for a Qualitative Study", journal="JMIR Res Protoc", year="2023", month="Mar", day="22", volume="12", pages="e41436", keywords="parents", keywords="health care professionals", keywords="content analysis", keywords="grounded theory", keywords="food allergy", keywords="children", keywords="allergic reaction", keywords="information needs", keywords="information seeking", keywords="prevention", keywords="prediction", keywords="risk factors", abstract="Background: Food allergy in children is increasing in prevalence in the western world and appears to become an important health problem. Parents of children at risk of food allergy live with the fear of allergic reaction, especially when the children are very young. The paradigm shift in allergy prevention in the last decade---away from allergen avoidance toward a tolerance induction approach---challenges both parents and health care professionals, as they have to deal with changing information and new evidence that often contradicts previous assumptions. Yet, research on health information--seeking behavior and needs of parents on primary prevention of food allergy in children as well as on prediction and prevention strategies of German health care professionals is lacking. Objective: The aim of the study is to explore and understand parents' and health care professionals' perspectives on the prediction and prevention of food allergies. We are particularly interested in information needs, information seeking, and health care usage and place a special focus on families' experiences when their child is at risk or diagnosed with food allergies. Furthermore, food allergy prediction and prevention strategies of health care professionals will be explored. Methods: This study is part of the NAMIBIO (food allergy biomarker) app consortium, which aims to identify early predictors for the development of food allergy in children and develop apps to guide health care professionals and parents of children with a high risk of food allergy toward prevention and timely tolerance induction. The study uses a qualitative approach with topic-guided interviews and focus groups with parents of children (0-3 years) and health care professionals. Data collection will continue until theoretical saturation is reached. The qualitative content analysis will be used according to Kuckartz to identify overarching themes toward information needs and seeking behavior as well as usage of health care and health care professionals' predictive and preventive strategies. In addition, a constructivist grounded theory approach will be used to explore and understand parents' experiences, interactions, and social processes in families in daily life. Results: Recruitment and data collection started in February 2022 and is still ongoing. Conclusions: The qualitative study will provide insight into parents' information-seeking behavior and needs regarding the prevention of food allergy in children, parents' use of pediatric primary care, and health care professionals strategies for the prediction and prevention of food allergies in children. We assume that our results will highlight the challenges associated with the paradigm shift in allergy prevention for both parents and health care professionals. The results will be used to make practical recommendations from the user's perspective and inform the development of the NAMIBIO apps. International Registered Report Identifier (IRRID): DERR1-10.2196/41436 ", doi="10.2196/41436", url="https://www.researchprotocols.org/2023/1/e41436", url="http://www.ncbi.nlm.nih.gov/pubmed/36947117" } @Article{info:doi/10.2196/44172, author="Horton, Anna and Loban, Katya and Nugus, Peter and Fortin, Marie-Chantal and Gunaratnam, Lakshman and Knoll, Greg and Mucsi, Istvan and Chaudhury, Prosanto and Landsberg, David and Paquet, Michel and Cantarovich, Marcelo and Sandal, Shaifali", title="Health System--Level Barriers to Living Donor Kidney Transplantation: Protocol for a Comparative Case Study Analysis", journal="JMIR Res Protoc", year="2023", month="Mar", day="7", volume="12", pages="e44172", keywords="transplantation", keywords="living donor kidney transplantation", keywords="health systems", keywords="barriers", keywords="resource based theory", keywords="complex adaptive systems", abstract="Background: Living donor kidney transplantation (LDKT) is the best treatment option for patients with kidney failure and offers significant medical and economic advantages for both patients and health systems. Despite this, rates of LDKT in Canada have stagnated and vary significantly across Canadian provinces, the reasons for which are not well understood. Our prior work has suggested that system-level factors may be contributing to these differences. Identifying these factors can help inform system-level interventions to increase LDKT. Objective: Our objective is to generate a systemic interpretation of LDKT delivery across provincial health systems with variable performance. We aim to identify the attributes and processes that facilitate the delivery of LDKT to patients, and those that create barriers and compare these across systems with variable performance. These objectives are contextualized within our broader goal of increasing rates of LDKT in Canada, particularly in lower-performing provinces. Methods: This research takes the form of a qualitative comparative case study analysis of 3 provincial health systems in Canada that have high, moderate, and low rates of LDKT performance (the percentage of LDKT to all kidney transplantations performed). Our approach is underpinned by an understanding of health systems as complex adaptive systems that are multilevel and interconnected, and involve nonlinear interactions between people and organizations, operating within a loosely bounded network. Data collection will comprise semistructured interviews, document reviews, and focus groups. Individual case studies will be conducted and analyzed using inductive thematic analysis. Following this, our comparative analysis will operationalize resource-based theory to compare case study data and generate explanations for our research question. Results: This project was funded from 2020 to 2023. Individual case studies were carried out between November 2020 and August 2022. The comparative case analysis will begin in December 2022 and is expected to conclude in April 2023. Submission of the publication is projected for June 2023. Conclusions: By investigating health systems as complex adaptive systems and making comparisons across provinces, this study will identify how health systems can improve the delivery of LDKT to patients with kidney failure. Our resource-based theory framework will provide a granular analysis of the attributes and processes that facilitate or create barriers to LDKT delivery across multiple organizations and levels of practice. Our findings will have practice and policy implications and help inform transferrable competencies and system-level interventions conducive to increasing LDKT. International Registered Report Identifier (IRRID): DERR1-10.2196/44172 ", doi="10.2196/44172", url="https://www.researchprotocols.org/2023/1/e44172", url="http://www.ncbi.nlm.nih.gov/pubmed/36881454" } @Article{info:doi/10.2196/37827, author="Brodbeck, Jeannette and Jacinto, Sofia and Gouveia, Afonso and Mendon{\c{c}}a, Nuno and Mad{\"o}rin, Sarah and Brandl, Lena and Schokking, Lotte and Rodrigues, Maria Ana and Gon{\c{c}}alves, Judite and Mooser, Bettina and Marques, M. Marta and Isaac, Joana and Nogueira, Vasco and Matos Pires, Ana and van Velsen, Lex", title="A Web-Based Self-help Intervention for Coping With the Loss of a Partner: Protocol for Randomized Controlled Trials in 3 Countries", journal="JMIR Res Protoc", year="2022", month="Nov", day="30", volume="11", number="11", pages="e37827", keywords="bereavement", keywords="cognitive behavioral therapy", keywords="CBT", keywords="cost-effectiveness", keywords="electronic mental health", keywords="grief", keywords="technology acceptance", abstract="Background: The death of a partner is a critical life event in later life, which requires grief work as well as the development of a new perspective for the future. Cognitive behavioral web-based self-help interventions for coping with prolonged grief have established their efficacy in decreasing symptoms of grief, depression, and loneliness. However, no study has tested the efficacy for reducing grief after losses occurring less than 6 months ago and the role of self-tailoring of the content. Objective: This study aims to evaluate the clinical efficacy and acceptance of a web-based self-help intervention to support the grief process of older adults who have lost their partner. It will compare the outcomes, adherence, and working alliance in a standardized format with those in a self-tailored delivery format and investigate the effects of age, time since loss, and severity of grief at baseline as predictors. Focus groups to understand user experience and a cost-effectiveness analysis will complement the study. Methods: The study includes 3 different randomized control trials. The trial in Switzerland comprises a waitlist control group and 2 active arms consisting of 2 delivery formats, standardized and self-tailored. In the Netherlands and in Portugal, the trials follow a 2-arm design that will be, respectively, complemented with focus groups on technology acceptance and cost-effectiveness analysis. The main target group will consist of adults aged >60 years from the general population in Switzerland (n?85), the Netherlands (n?40), and Portugal (n?80) who lost their partner and seek help for coping with grief symptoms, psychological distress, and adaptation problems in daily life. The trials will test the intervention's clinical efficacy for reducing grief (primary outcome) and depression symptoms and loneliness (secondary outcomes) after the intervention. Measurements will take place at baseline (week 0), after the intervention (week 10), and at follow-up (week 20). Results: The trials started in March 2022 and are expected to end in December 2022 or when the needed sample size is achieved. The first results are expected by January 2023. Conclusions: The trials will provide insights into the efficacy and acceptance of a web-based self-help intervention among older adults who have recently lost a partner. Results will extend the knowledge on the role of self-tailoring, working alliance, and satisfaction in the effects of the intervention. Finally, the study will suggest adaptations to improve the acceptance of web-based self-help interventions for older mourners and explore the cost-effectiveness of this intervention. Limitations include a self-selective sample and the lack of cross-cultural comparisons. Trial Registration: Switzerland: ClinicalTrials.gov NCT05280041; https://clinicaltrials.gov/ct2/show/NCT05280041; Portugal: ClinicalTrials.gov NCT05156346; https://clinicaltrials.gov/ct2/show/NCT05156346 International Registered Report Identifier (IRRID): PRR1-10.2196/37827 ", doi="10.2196/37827", url="https://www.researchprotocols.org/2022/11/e37827", url="http://www.ncbi.nlm.nih.gov/pubmed/36449341" } @Article{info:doi/10.2196/40041, author="Padilla, Mabel and Gutierrez, Mariana and Fagan, Jennifer", title="Using Semistructured Telephone Interviews to Collect Qualitative Data From People With HIV Who Are Not in Medical Care: Implementation Study", journal="JMIR Res Protoc", year="2022", month="Nov", day="28", volume="11", number="11", pages="e40041", keywords="qualitative research", keywords="methods", keywords="telephone interviews", keywords="HIV", keywords="semistructured interviews", keywords="recruitment", abstract="Background: The Medical Monitoring Qualitative (MMP-Qual) Project was designed to collect qualitative data from people with HIV not engaged in medical care that would complement quantitative data collected by the Medical Monitoring Project (MMP)---a national surveillance system---and inform the MMP's recruitment and data collection methods. Objective: Our objectives were to describe the methodology of this project, reflect on the challenges and lessons learned from conducting qualitative telephone interviews at a national level, and describe how we used and plan to use the qualitative data to evaluate our recruitment procedures and quantitative data collection instrument as well as knowledge of HIV care engagement. Methods: We used stratified purposive sampling to identify and recruit participants who had participated in the structured MMP interview into the MMP-Qual Project. To be eligible, participants must have had an HIV diagnosis, be aged ?18 years, have lived in an MMP jurisdiction, and have not been engaged in HIV medical care. From August 1, 2018, to May 31, 2019, we conducted semistructured telephone interviews with 36 people with HIV across the United States about several topics (eg, facilitators and barriers to care and experience with surveys). Four trained interviewers conducted semistructured 60-minute telephone interviews with 36 participants. Data collection lasted from August 1, 2018, to May 31, 2019. Results: From 2018 to 2019, 113 people were eligible to participate in the MMP-Qual Project. Of the people recruited, 28\% (22/79) refused to participate. Of those who agreed to participate, 63\% (36/57) were interviewed, and 37\% (21/57) were no-shows. Of the 34 participants for whom we had complete data, 15 (44\%) were aged ?50 years, 26 (76\%) identified as male, 22 (65\%) were Black or African American, and 12 (35\%) lived in the Southern United States. Conclusions: We learned that it is possible to obtain rich qualitative data from people with HIV who are not in care via telephone interviews and that this mode might be conducive to talking about sensitive topics. We also learned the importance of flexibility, communication, and coordination because we relied on health department staff to perform recruitment and had difficulty implementing our original sampling strategy. We hope that other projects will learn from our experience conducting qualitative telephone interviews with people with HIV on a national level. International Registered Report Identifier (IRRID): RR1-10.2196/40041 ", doi="10.2196/40041", url="https://www.researchprotocols.org/2022/11/e40041", url="http://www.ncbi.nlm.nih.gov/pubmed/36441569" } @Article{info:doi/10.2196/42577, author="Gu{\'e}nette, Line and Kr{\"o}ger, Edeltraut and Bonnan, Dylan and Maheu, Anne and Morin, Mich{\`e}le and B{\'e}langer, Laurianne and Vedel, Isabelle and Wilchesky, Machelle and Sirois, Caroline and Durand, Etienne and Couturier, Yves and Sourial, Nadia and Dallaire, Cl{\'e}mence", title="Reorganizing Pharmaceutical Care in Family Medicine Groups for Older Adults With or at Risk of Major Neurocognitive Disorders: Protocol for a Mixed Methods Study", journal="JMIR Res Protoc", year="2022", month="Nov", day="17", volume="11", number="11", pages="e42577", keywords="primary care", keywords="older adults", keywords="neurocognitive disorders", keywords="pharmaceutical care", keywords="mixed method study", abstract="Background: The latest global figures show that 55 million persons lived with major neurocognitive disorders (MNCDs) worldwide in 2021. In Quebec, Canada, most of these older adults are cared for by family physicians in interdisciplinary primary care clinics such as family medicine groups (FMG). When a person has a MNCD, taking potentially inappropriate medications or polypharmacy (5 different medications or more) increases their vulnerability to serious adverse events. With the recent arrival of pharmacists working in FMGs and their expanded scope of practice and autonomy, new possibilities for optimizing older adults' pharmacotherapy are opening. Objective: This project aims to evaluate the impact of involving these pharmacists in the care trajectory of older adults living with MNCD, in an interdisciplinary collaboration with the FMG team, as well as home care nurses and physicians. Pharmacists will provide medication reviews, interventions, and recommendations to improve the pharmacotherapy and support offered to these patients and their caregivers. Methods: This 2-step mixed methods study will include a quasi-experimental controlled trial (step 1) and semistructured interviews (step 2). Older adults undergoing cognitive assessment, recently diagnosed with MNCD, or receiving care for this at home will be identified and recruited in FMGs in 2 Quebec regions. FMGs implementing the intervention will involve pharmacists in these patients' care trajectory. Training and regular mentoring will be offered to these FMGs, especially to pharmacists. In control FMGs, no FMG pharmacist will be involved with these patients, and usual care will be provided. Results: Medication use (including appropriateness) and burden, satisfaction of care received, and quality of life will be assessed at study beginning and after 6 months of follow-up and compared between groups. At the end of the intervention study, we will conduct semistructured interviews with FMG care team members (pharmacists, nurses, and physicians) who have experienced the intervention. We will ask about the feasibility of integrating the intervention into practice and their satisfaction with and their perception of the intervention's impacts for older adults and their families. We will assess the effect of improved pharmaceutical care for older adults with or at risk of MNCDs through the involvement of FMG pharmacists and a reorganization of pharmaceutical care. Conclusions: The inclusion of pharmacists in interdisciplinary care teams is recent and rising, strengthened by more substantial pharmacist practice roles. Results will inform the processes required to successfully involve pharmacists and implement developed tools and procedures transposable to other care settings to improve patient care. Trial Registration: ClinicalTrials.gov NCT04889794; https://clinicaltrials.gov/ct2/show/NCT04889794 International Registered Report Identifier (IRRID): DERR1-10.2196/42577 ", doi="10.2196/42577", url="https://www.researchprotocols.org/2022/11/e42577", url="http://www.ncbi.nlm.nih.gov/pubmed/36264995" } @Article{info:doi/10.2196/38126, author="Leung, I. Tiffany and Wang, H. Karen and Lin, L. Tammy and Gin, T. Geneen and Pendharkar, S. Sima and Chen, Angie Chwen-Yuen", title="Women Physicians in Transition Learning to Navigate the Pipeline from Early to Mid-Career: Protocol for a Qualitative Study", journal="JMIR Res Protoc", year="2022", month="Jun", day="2", volume="11", number="6", pages="e38126", keywords="gender equity", keywords="women physician", keywords="female physicians", keywords="career development", keywords="professional development", keywords="career pipeline", keywords="leaky pipeline", keywords="mid-career physicians", keywords="early-career physicians", keywords="physician", keywords="healthcare profession", keywords="peer support", keywords="physician perspective", keywords="physician experience", keywords="professional learning", keywords="healthcare", keywords="health care", keywords="healthcare education", keywords="career support", keywords="gender equality", keywords="gender bias", keywords="healthcare learning", abstract="Background: Women physicians face unique obstacles while progressing through their careers, navigating career advancement and seeking balance between professional and personal responsibilities. Systemic changes, along with individual and institutional changes, are needed to overcome obstacles perpetuating physician gender inequities. Developing a deeper understanding of women physicians' experiences during important transition points could reveal both barriers and opportunities for recruitment, retention, and promotion, and inform best practices developed based on these experiences. Objective: The aim is to learn from the experiences and perspectives of women physicians as they transition from early to mid-career, then develop best practices that can serve to support women physicians as they advance through their careers. Methods: Semistructured interviews were conducted with women physicians in the United States in 2020 and 2021. Eligibility criteria included self-identification as a woman who is in the process of transitioning or who recently transitioned from early to mid-career stage. Purposeful sampling facilitated identification of participants who represented diversity in career pathway, practice setting, specialty, and race/ethnicity. Each participant was offered compensation for their participation. Interviews were audio-recorded and professionally transcribed. Interview questions were open-ended, exploring participants' perceptions of this transition. Qualitative thematic analysis will be performed. We will use an open coding and grounded theory approach on interview transcripts. Results: The Ethics Review Committee of the Faculty of Health, Medicine, and Life Sciences at Maastricht University approved the study; Stanford University expedited review approved the study; and the University of California, San Diego certified the study as exempt from review. Twelve in-depth interviews of 50-100 minutes in duration were completed. Preliminary analyses indicate one key theme is a tension resulting from finite time divided between demands from a physician career and demands from family needs. In turn, this results in constant boundary control between these life domains that are inextricable and seemingly competing against each other within a finite space; family needs impinge on planned career goals, if the boundary between them is not carefully managed. To remedy this, women sought resources to help them redistribute home responsibilities, freeing themselves to have more time, especially for children. Women similarly sought resources to help with career advancement, although not with regard to time directly, but to first address foundational knowledge gaps about career milestones and how to achieve them. Conclusions: Preliminary results provide initial insights about how women identify or activate a career shift and how they marshaled resources and support to navigate barriers they faced. Further analyses are continuing as of March 2022 and are expected to be completed by June 2022. The dissemination plan includes peer-reviewed open-access journal publication of the results and presentation at the annual meeting of the American Medical Association's Women Physicians Section. ", doi="10.2196/38126", url="https://www.researchprotocols.org/2022/6/e38126", url="http://www.ncbi.nlm.nih.gov/pubmed/35653172" } @Article{info:doi/10.2196/31189, author="Wagman, A. Jennifer and Amabile, Claire and Sumstine, Stephanie and Park, Eunhee and Boyce, Sabrina and Silverman, Jay and Fielding-Miller, Rebecca and Oaks, Laury and Swendeman, Dallas", title="Student, Staff, and Faculty Perspectives on Intimate Partner and Sexual Violence on 3 Public University Campuses: Protocol for the UC Speaks Up Study and Preliminary Results", journal="JMIR Res Protoc", year="2022", month="Apr", day="5", volume="11", number="4", pages="e31189", keywords="campus-based violence prevention", keywords="intimate partner violence", keywords="sexual violence", keywords="mixed methods research", keywords="public health approach", keywords="prevention", keywords="student-led", keywords="trauma-informed research", keywords="University of California", abstract="Background: Intimate partner and sexual violence are pervasive public health issues on college and university campuses in the United States. Research is recommended for creating and maintaining effective, relevant, and acceptable prevention programs and response services for student survivors. Objective: The University of California (UC) Speaks Up study aims to examine factors contributing to intimate partner and sexual violence on 3 UC campuses and use the findings to develop and test interventions and policies to prevent violence, promote health, and lay the groundwork for subsequent large-scale quantitative research. Methods: A mixed methods study was conducted at UC Los Angeles, UC San Diego, and UC Santa Barbara. Phase I (2017-2020) involved a resource audit; cultural consensus modeling of students' perceptions of sexual consent; in-depth interviews (IDIs) and focus group discussions with students to understand perceptions of campus environment related to experiences as well as prevention of and responses to violence; and IDIs with faculty, staff, and community stakeholders to investigate institutional and community arrangements influencing students' lives and experiences. Phase II (2020-ongoing) involves IDIs with student survivors to assess the use and perceptions of campus and community services. Qualitative content analysis is used to generate substantive codes and subthemes that emerge, using a thematic analysis approach. Results: In January 2019, we conducted 149 free-listing interviews and 214 web-based surveys with undergraduate and graduate and professional students for the cultural consensus modeling. Between February 2019 and June 2019, 179 IDIs were conducted with 86 (48\%) undergraduate students, 21 (11.7\%) graduate and professional students, 34 (19\%) staff members, 27 (15.1\%) faculty members, and 11 (6.1\%) community stakeholders, and 35 focus group discussions (27/35, 77\% with undergraduate students and 8/35, 23\% with graduate and professional students) were conducted with 201 participants. Since September 2020, 50\% (15/30) of the planned student survivor interviews have been conducted. This segment of data collection was disrupted by the COVID-19 pandemic. Recruitment is ongoing. Conclusions: Data analysis and phase II data collection are ongoing. The findings will be used to develop and test interventions for preventing violence, promoting health and well-being, and ensuring that survivor services are relevant and acceptable to and meet the needs of all individuals in the campus community, including those who are typically understudied. The findings will also be used to prepare for rigorous, UC--system-wide public health prevention research. International Registered Report Identifier (IRRID): DERR1-10.2196/31189 ", doi="10.2196/31189", url="https://www.researchprotocols.org/2022/4/e31189", url="http://www.ncbi.nlm.nih.gov/pubmed/35380114" } @Article{info:doi/10.2196/36201, author="Hirsch, Annemarie and Durden, Elizabeth T. and Silva, Jennifer", title="Linking Electronic Health Records and In-Depth Interviews to Inform Efforts to Integrate Social Determinants of Health Into Health Care Delivery: Protocol for a Qualitative Research Study", journal="JMIR Res Protoc", year="2022", month="Mar", day="11", volume="11", number="3", pages="e36201", keywords="electronic health records", keywords="social determinants of health", keywords="poverty", keywords="rural", keywords="qualitative", keywords="health system", abstract="Background: Health systems are attempting to capture social determinants of health (SDoH) in electronic health records (EHR) and use these data to adjust care plans. To date, however, methods for identifying social needs, which are the SDoH prioritized by patients, have been underexplored, and there is little guidance as to how clinicians should act on SDoH data when caring for patients. Moreover, the unintended consequences of collecting and responding to SDoH are poorly understood. Objective: The objective of this study is to use two data sources, EHR data and patient interviews, to describe divergences between the EHR and patient experiences that could help identify gaps in the documentation of SDoH in the EHR; highlight potential missed opportunities for addressing social needs, and identify unintended consequences of efforts to integrate SDoH into clinical care. Methods: We are conducting a qualitative study that merges discrete and free-text data from EHRs with in-depth interviews with women residing in rural, socioeconomically deprived communities in the Mid-Atlantic region of the United States. Participants had to confirm that they had at least one visit with the large health system that serves the region. Interviews with the women included questions regarding health, interaction with the health system, and social needs. Next, with consent, we extracted discrete data (eg, diagnoses and medication orders) for each participant and free-text clinician notes from this health system's EHRs between 1996 and the year of the interview. We used a standardized protocol to create an EHR narrative, a free-text summary of the EHR data. We used NVivo to identify themes in the interviews and the EHR narratives. Results: To date, we have interviewed 88 women, including 51 White women, 19 Black women, 14 Latina women, 2 mixed Black and Latina women, and 2 Asian Pacific women. We have completed the EHR narratives on 66 women. The women range in age from 18 to 90 years. We found corresponding EHR data on all but 4 of the interview participants. Participants had contact with a wide range of clinical departments (eg, psychiatry, neurology, and infectious disease) and received care in various clinical settings (eg, primary care clinics, emergency departments, and inpatient hospitalizations). A preliminary review of the EHR narratives revealed that the clinician notes were a source of data on a range of SDoH but did not always reflect the social needs that participants described in the interviews. Conclusions: This study will provide unique insight into the demands and consequences of integrating SDoH into clinical care. This work comes at a pivotal point in time, as health systems, payors, and policymakers accelerate attempts to deliver care within the context of social needs. International Registered Report Identifier (IRRID): DERR1-10.2196/36201 ", doi="10.2196/36201", url="https://www.researchprotocols.org/2022/3/e36201", url="http://www.ncbi.nlm.nih.gov/pubmed/35275090" } @Article{info:doi/10.2196/31795, author="Oberschmidt, Kira and Gr{\"u}nloh, Christiane and Nijboer, Femke and van Velsen, Lex", title="Best Practices and Lessons Learned for Action Research in eHealth Design and Implementation: Literature Review", journal="J Med Internet Res", year="2022", month="Jan", day="28", volume="24", number="1", pages="e31795", keywords="action research", keywords="eHealth", keywords="best practices", keywords="lessons learned", abstract="Background: Action research (AR) is an established research framework to introduce change in a community following a cyclical approach and involving stakeholders as coresearchers in the process. In recent years, it has also been used for eHealth development. However, little is known about the best practices and lessons learned from using AR for eHealth development. Objective: This literature review aims to provide more knowledge on the best practices and lessons learned from eHealth AR studies. Additionally, an overview of the context in which AR eHealth studies take place is given. Methods: A semisystematic review of 44 papers reporting on 40 different AR projects was conducted to identify the best practices and lessons learned in the research studies while accounting for the particular contextual setting and used AR approach. Results: Recommendations include paying attention to the training of stakeholders' academic skills, as well as the various roles and tasks of action researchers. The studies also highlight the need for constant reflection and accessible dissemination suiting the target group. Conclusions: This literature review identified room for improvements regarding communicating and specifying the particular AR definition and applied approach. ", doi="10.2196/31795", url="https://www.jmir.org/2022/1/e31795", url="http://www.ncbi.nlm.nih.gov/pubmed/35089158" } @Article{info:doi/10.2196/33525, author="Ferrari, Manuela and Fazeli, Sahar and Mitchell, Claudia and Shah, Jai and Iyer, N. Srividya", title="Exploring Empathy and Compassion Using Digital Narratives (the Learning to Care Project): Protocol for a Multiphase Mixed Methods Study", journal="JMIR Res Protoc", year="2022", month="Jan", day="13", volume="11", number="1", pages="e33525", keywords="digital narratives", keywords="fundraising campaigns", keywords="mixed methods", keywords="randomized controlled trial", keywords="stigma and discrimination", abstract="Background: Digital stories---first-person, self-made, 2- to 3-minute videos---generate awareness, impart knowledge, and promote understanding on topics such as mental illness. Digital stories are a narrative-based art form often created by individuals without formal training in filmmaking to relate personal experiences. Somewhat like digital narratives, video testimonies created within the social marketing or fundraising campaigns of government agencies and private or public corporations aim to reduce the stigma of mental illness while supporting research and services. In video testimonies, personal stories are captured on camera by professional filmmakers. Sharing critical life events greatly benefits tellers and listeners alike, supporting catharsis, healing, connectiveness, and citizenship. Objective: This study explores digital stories and video testimonies featuring mental illness and recovery in their ability to elicit empathy and compassion while reducing stigma among viewers. Methods: Using mixed methods, phase 1 will involve a search of Canadian social marketing activities and fundraising campaigns concerning mental illness and recovery. Phase 2 will involve the organization of digital storytelling workshops in which participants will create digital stories about their own experiences of mental illness and recovery. In phase 3, a pilot randomized controlled trial will be undertaken to compare marketing and fundraising campaigns with digital stories for their impact on viewers, whereas phase 4 will focus on knowledge dissemination. Results: Ethics approval for this study was received in March 2021. Data on the feasibility of the study design and the results of the controlled trial will be generated. This study will produce new knowledge on effective ways of promoting mental health awareness and decreasing stigma, with practical importance for future social marketing and fundraising campaigns. The anticipated time for completion within the 2-year study period includes 9 months for phase 1 (knowledge synthesis activities identifying social marketing and fundraising campaigns) and phase 2 (storytelling workshops), 11 months for phase 3 (feasibility assessment and data collection: randomized controlled trial), and 2 months for phase 4 (knowledge dissemination). Conclusions: The knowledge generated will have practical implications for the public and for future social marketing and fundraising campaigns promoted by government agencies as well as nonprofit and for-profit organizations by enhancing our understanding of how individuals and societies respond to stories of mental distress and what prompts citizens to help others. Trial Registration: ClinicalTrials.gov NCT04881084; https://clinicaltrials.gov/ct2/show/NCT04881084 International Registered Report Identifier (IRRID): PRR1-10.2196/33525 ", doi="10.2196/33525", url="https://www.researchprotocols.org/2022/1/e33525", url="http://www.ncbi.nlm.nih.gov/pubmed/35023844" } @Article{info:doi/10.2196/30663, author="Ariff, Shabina and Maznani, Ikram and Bhura, Maria and Memon, Zahid and Arshad, Tayyaba and Samejo, Ahmed Tariq and Zaidi, Shujaat and Umer, Muhammad and Ahmed, Imran and Habib, Atif Muhammad and Soofi, Bashir Sajid and Bhutta, A. Zulfiqar", title="Understanding Perceptions and Practices for Designing an Appropriate Community-Based Kangaroo Mother Care Implementation Package: Qualitative Exploratory Study", journal="JMIR Form Res", year="2022", month="Jan", day="7", volume="6", number="1", pages="e30663", keywords="kangaroo mother care", keywords="low birth weight", keywords="neonatal mortality formative research", keywords="Pakistan", keywords="newborn care", abstract="Background: Low birth weight (LBW) is a common outcome of preterm birth, which increases the risk of an infant's morbidity and mortality. Approximately 20 million infants are born with LBW globally per year. Since a significant number of births in Pakistan take place at home, it is important to focus on the use of kangaroo mother care (KMC), the practice of skin-to-skin contact, in communities to prevent neonatal mortality and morbidity. Objective: We employed a formative research approach to understand the context of communities and facilities with regard to neonatal care and KMC practice. The broader aims were to inform the design and delivery of culturally appropriate platforms to introduce KMC in communities, and develop effective recruitment and retention strategies of KMC in rural areas of the Dadu district in the Sindh province of Pakistan. Methods: We conducted focus group discussions, in-depth interviews, and key informant interviews with families of LBW babies, community members, health care providers, and hospital administrators to identify barriers, enablers, and a knowledge base for KMC interventions. Results: Newborn care practices in communities were found to be suboptimal. The community was generally unaware of the KMC intervention for the care of LBW babies. However, facility health care providers, the community, and family members were willing to provide KMC to improve outcomes. We found significant support from the community members and health care providers for KMC practices. Mothers were also ready to provide intermittent KMC. The administrative staff at the hospitals accepted the introduction of KMC practices for LBW babies. Conclusions: KMC as a method of treating LBW babies is widely accepted in the community. This formative research provides strategically valuable information that will be helpful for developing effective implementation strategies by identifying common community practices for LBW babies, along with identifying the barriers and enablers to KMC practice. ", doi="10.2196/30663", url="https://formative.jmir.org/2022/1/e30663", url="http://www.ncbi.nlm.nih.gov/pubmed/34994692" } @Article{info:doi/10.2196/26002, author="Alodhayani, A. Abdulaziz and Hassounah, Mazen Marwah and Qadri, R. Fatima and Abouammoh, A. Noura and Ahmed, Zakiuddin and Aldahmash, M. Abdullah", title="Culture-Specific Observations in a Saudi Arabian Digital Home Health Care Program: Focus Group Discussions With Patients and Their Caregivers", journal="J Med Internet Res", year="2021", month="Dec", day="8", volume="23", number="12", pages="e26002", keywords="connected health", keywords="digital health", keywords="telehealth", keywords="telemedicine", keywords="culture", keywords="Islam", keywords="Arab", keywords="mobile phone", abstract="Background: There is growing evidence of the need to consider cultural factors in the design and implementation of digital health interventions. However, there is still inadequate knowledge pertaining to the aspects of the Saudi Arabian culture that need to be considered in the design and implementation of digital health programs, especially in the context of home health care services for patients who are chronically and terminally ill. Objective: This study aims to explore the specific cultural factors related to patients and their caregivers from the perspective of physicians, nurses, and trainers that have influenced the pilot implementation of Remotely Accessible Healthcare At Home, a connected health program in the Home Health Care department at King Saud University Medical City, Riyadh, Saudi Arabia. Methods: A qualitative study design was adopted to conduct a focus group discussion in July 2019 using a semistructured interview guide with 3 female and 4 male participants working as nurses, family physicians, and information technologists. Qualitative data obtained were analyzed using a thematic framework analysis. Results: A total of 2 categories emerged from the focus group discussion that influenced the experiences of digital health program intervention: first, culture-related factors including language and communication, cultural views on using cameras during consultation, nonadherence to web-based consultations, and family role and commitment and second, caregiver characteristics in telemedicine that includes their skills and education and electronic literacy. Participants of this study revealed that indirect contact with patients and their family members may work as a barrier to proper communication through the Remotely Accessible Healthcare At Home program. Conclusions: We recommend exploring the use of interpreters in digital health, creating awareness among the local population regarding privacy in digital health, and actively involving direct family members with the health care providers. ", doi="10.2196/26002", url="https://www.jmir.org/2021/12/e26002", url="http://www.ncbi.nlm.nih.gov/pubmed/34889740" } @Article{info:doi/10.2196/24643, author="Dehghani, Mohammad and Kahouei, Mehdi and Akhondzadeh, Shahin and Mesgarpour, Bita and Ferdousi, Reza", title="Expectations of Health Researchers From Academic Social Network Sites: Qualitative Study", journal="J Med Internet Res", year="2021", month="Dec", day="7", volume="23", number="12", pages="e24643", keywords="research", keywords="social network", keywords="academic social network", keywords="research network", keywords="academic", keywords="researcher", keywords="literature", keywords="qualitative", keywords="content analysis", abstract="Background: Today, academic social network sites' role in improving the quality of education and how investigators conduct their research has become more critical. Objective: This study aimed to investigate Iranian health researchers' requirements for academic social network sites from a low-income country perspective. Methods: This qualitative study with a phenomenological approach was done in 2020. In this study, 23 researchers in the health system were selected by purposive sampling. Semistructured interviews were used to collect data. Data were analyzed by MaxQDA-10 software and the content analysis method. Results: We identified 2 categories of functional and technical characteristics in the study participants' expectations. Functional characteristics included facilitating communication and team activities, managing scientific publications, enhancing the process of conducting research, being informative, and sharing and trading laboratory materials and equipment. Technical characteristics of an academic social network include user management capabilities, high security and privacy, being user-friendly, and other technical features. Conclusions: Health researchers emphasized 2 functional and technical characteristics required to meet academic social network sites' expectations. ", doi="10.2196/24643", url="https://www.jmir.org/2021/12/e24643", url="http://www.ncbi.nlm.nih.gov/pubmed/34878993" } @Article{info:doi/10.2196/25170, author="Rauwerdink, Anneloek and Kasteleyn, J. Marise and Chavannes, H. Niels and Schijven, P. Marlies", title="Successes of and Lessons From the First Joint eHealth Program of the Dutch University Hospitals: Evaluation Study", journal="J Med Internet Res", year="2021", month="Nov", day="25", volume="23", number="11", pages="e25170", keywords="CSIRO framework", keywords="evaluation strategy", keywords="eHealth", keywords="telemedicine", keywords="qualitative research", keywords="formative evaluation", keywords="digital health", abstract="Background: A total of 8 Dutch university hospitals are at the forefront of contributing meaningfully to a future-proof health care system. To stimulate nationwide collaboration and knowledge-sharing on the topic of evidence-based eHealth, the Dutch university hospitals joined forces from 2016 to 2019 with the first Citrien Fund (CF) program eHealth; 29 eHealth projects with various subjects and themes were selected, supported, and evaluated. To determine the accomplishment of the 10 deliverables for the CF program eHealth and to contribute to the theory and practice of formative evaluation of eHealth in general, a comprehensive evaluation was deemed essential. Objective: The first aim of this study is to evaluate whether the 10 deliverables of the CF program eHealth were accomplished. The second aim is to evaluate the progress of the 29 eHealth projects to determine the barriers to and facilitators of the development of the CF program eHealth projects. Methods: To achieve the first aim of this study, an evaluation study was carried out using an adapted version of the Commonwealth Scientific and Industrial Research Organization framework. A mixed methods study, consisting of a 2-part questionnaire and semistructured interviews, was conducted to analyze the second aim of the study. Results: The 10 deliverables of the CF program eHealth were successfully achieved. The program yielded 22 tangible eHealth solutions, and significant knowledge on the development and use of eHealth solutions. We have learned that the patient is enthusiastic about accessing and downloading their own medical data but the physicians are more cautious. It was not always possible to implement the Dutch set of standards for interoperability, owing to a lack of information technology (IT) capacities. In addition, more attention needed to be paid to patients with low eHealth skills, and education in such cases is important. The eHealth projects' progress aspects such as planning, IT services, and legal played an important role in the success of the 29 projects. The in-depth interviews illustrated that a novel eHealth solution should fulfill a need, that partners already having the knowledge and means to accelerate development should be involved, that clear communication with IT developers and other stakeholders is crucial, and that having a dedicated project leader with sufficient time is of utmost importance for the success of a project. Conclusions: The 8 Dutch university hospitals were able to collaborate successfully and stimulate through a bottom-up approach, nationwide eHealth development and knowledge-sharing. In total, 22 tangible eHealth solutions were developed, and significant eHealth knowledge about their development and use was shared. The eHealth projects' progress aspects such as planning, IT services, and legal played an important role in the successful progress of the projects and should therefore be closely monitored when developing novel eHealth solutions. International Registered Report Identifier (IRRID): RR2-10.1016/j.ceh.2020.12.002 ", doi="10.2196/25170", url="https://www.jmir.org/2021/11/e25170", url="http://www.ncbi.nlm.nih.gov/pubmed/34842536" } @Article{info:doi/10.2196/29207, author="Alessa, Tourkiah and Hawley, Mark and de Witte, Luc", title="Identification of the Most Suitable App to Support the Self-Management of Hypertension: Systematic Selection Approach and Qualitative Study", journal="JMIR Mhealth Uhealth", year="2021", month="Nov", day="17", volume="9", number="11", pages="e29207", keywords="app", keywords="hypertension", keywords="self-management", keywords="mHealth", keywords="blood pressure", keywords="support", keywords="Saudi Arabia", keywords="cardiology", keywords="heart", keywords="effective", keywords="security", abstract="Background: Smartphone apps are increasingly being used to aid in hypertension self-management, and a large and ever-growing number of self-management apps have been commercially released. However, very few of these are potentially effective and secure, and researchers have yet to establish the suitability of specific hypertension apps to particular contexts. Objective: The aim of this study is to identify the most suitable hypertension app in the context of Saudi Arabia and its health system. Methods: This study used a 2-stage approach to selecting the most suitable app for hypertension self-management. First, a systematic selection approach was followed to identify a shortlist of the most suitable apps according to the criteria of potential effectiveness, theoretical underpinning, and privacy and security. Second, an exploratory qualitative study was conducted to select the most suitable from the shortlist: 12 doctors were interviewed, and 22 patients participated in 4 focus groups. These explored participants' attitudes towards self-management apps in general, and their views towards the apps identified via the systematic selection process. The qualitative data were analyzed using framework analysis. Results: In the first stage, only 5 apps were found to be potentially effective while also having a theoretical underpinning and protecting users' data. In the second stage, both doctors and patients were generally interested in using hypertension apps, but most had no experience with these apps due to a lack of awareness of their availability and suitability. Patients and doctors liked apps that combine intuitive interfaces with a pleasant and clear visual design, in-depth features (eg, color-coded feedback accompanied with textual explanations), activity-specific reminders, and educational content regarding hypertension and potential complications. When the pros and cons of the 5 apps were discussed, 3 apps were identified as being more suitable, with Cora Health rated the highest by the participants. Conclusions: Only 5 apps were deemed potentially effective and secure. Patients' and doctors' discussions of the pros and cons of these 5 apps revealed that 3 out of the 5 are clearly more suitable, with the Cora Health app being judged most suitable overall. ", doi="10.2196/29207", url="https://mhealth.jmir.org/2021/11/e29207", url="http://www.ncbi.nlm.nih.gov/pubmed/34787586" } @Article{info:doi/10.2196/22140, author="Su, Zhaohui and Li, Xiaoshan and McDonnell, Dean and Fernandez, A. Andrea and Flores, E. Bertha and Wang, Jing", title="Technology-Based Interventions for Cancer Caregivers: Concept Analysis", journal="JMIR Cancer", year="2021", month="Nov", day="16", volume="7", number="4", pages="e22140", keywords="concept analysis", keywords="caregivers", keywords="cancer", keywords="oncology", keywords="technology-based interventions", keywords="mobile phone", abstract="Background: Cancer is a taxing chronic disease that demands substantial care, most of which is shouldered by informal caregivers. As a result, cancer caregivers often have to manage considerable challenges that could result in severe physical and psychological health consequences. Technology-based interventions have the potential to address many, if not all, of the obstacles caregivers encounter while caring for patients with cancer. However, although the application of technology-based interventions is on the rise, the term is seldom defined in research or practice. Considering that the lack of conceptual clarity of the term could compromise the effectiveness of technology-based interventions for cancer caregivers, timely research is needed to bridge this gap. Objective: This study aims to clarify the meaning of technology-based interventions in the context of cancer caregiving and provide a definition that can be used by cancer caregivers, patients, clinicians, and researchers to facilitate evidence-based research and practice. Methods: The 8-step concept analysis method by Walker and Avant was used to analyze the concept of technology-based interventions in the context of cancer caregiving. PubMed, PsycINFO, CINAHL, and Scopus were searched for studies that examined technology-based interventions for cancer caregivers. Results: The defining attributes of technology-based interventions were recognized as being accessible, affordable, convenient, and user-friendly. On the basis of insights gained on the defining attributes, antecedents to, and consequences of technology-based interventions through the concept analysis process, technology-based interventions were defined as the use of technology to design, develop, and deliver health promotion contents and strategies aimed at inducing or improving positive physical or psychological health outcomes in cancer caregivers. Conclusions: This study clarified the meaning of technology-based interventions in the context of cancer caregiving and provided a clear definition that can be used by caregivers, patients, clinicians, and researchers to facilitate evidence-based oncology practice. A clear conceptualization of technology-based interventions lays foundations for better intervention design and research outcomes, which in turn have the potential to help health care professionals address the needs and preferences of cancer caregivers more cost-effectively. ", doi="10.2196/22140", url="https://cancer.jmir.org/2021/4/e22140", url="http://www.ncbi.nlm.nih.gov/pubmed/34783664" } @Article{info:doi/10.2196/24460, author="Abdullahi Yari, Imrana and Dehling, Tobias and Kluge, Felix and Geck, Juergen and Sunyaev, Ali and Eskofier, Bjoern", title="Security Engineering of Patient-Centered Health Care Information Systems in Peer-to-Peer Environments: Systematic Review", journal="J Med Internet Res", year="2021", month="Nov", day="15", volume="23", number="11", pages="e24460", keywords="patient-centered", keywords="health care", keywords="information infrastructures", keywords="decentralization", keywords="mobile health", keywords="peer-to-peer", keywords="COVID-19 proximity trackers", keywords="edge computing", keywords="security", keywords="vulnerabilities", keywords="attacks", keywords="threats", keywords="mobile phone", abstract="Background: Patient-centered health care information systems (PHSs) enable patients to take control and become knowledgeable about their own health, preferably in a secure environment. Current and emerging PHSs use either a centralized database, peer-to-peer (P2P) technology, or distributed ledger technology for PHS deployment. The evolving COVID-19 decentralized Bluetooth-based tracing systems are examples of disease-centric P2P PHSs. Although using P2P technology for the provision of PHSs can be flexible, scalable, resilient to a single point of failure, and inexpensive for patients, the use of health information on P2P networks poses major security issues as users must manage information security largely by themselves. Objective: This study aims to identify the inherent security issues for PHS deployment in P2P networks and how they can be overcome. In addition, this study reviews different P2P architectures and proposes a suitable architecture for P2P PHS deployment. Methods: A systematic literature review was conducted following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) reporting guidelines. Thematic analysis was used for data analysis. We searched the following databases: IEEE Digital Library, PubMed, Science Direct, ACM Digital Library, Scopus, and Semantic Scholar. The search was conducted on articles published between 2008 and 2020. The Common Vulnerability Scoring System was used as a guide for rating security issues. Results: Our findings are consolidated into 8 key security issues associated with PHS implementation and deployment on P2P networks and 7 factors promoting them. Moreover, we propose a suitable architecture for P2P PHSs and guidelines for the provision of PHSs while maintaining information security. Conclusions: Despite the clear advantages of P2P PHSs, the absence of centralized controls and inconsistent views of the network on some P2P systems have profound adverse impacts in terms of security. The security issues identified in this study need to be addressed to increase patients' intention to use PHSs on P2P networks by making them safe to use. ", doi="10.2196/24460", url="https://www.jmir.org/2021/11/e24460", url="http://www.ncbi.nlm.nih.gov/pubmed/34779788" } @Article{info:doi/10.2196/30332, author="Leese, Jenny and MacDonald, Graham and Backman, L. Catherine and Townsend, Anne and Nimmon, Laura and Li, C. Linda", title="Experiences of Wearable Technology by Persons with Knee Osteoarthritis Participating in a Physical Activity Counseling Intervention: Qualitative Study Using a Relational Ethics Lens", journal="JMIR Mhealth Uhealth", year="2021", month="Nov", day="12", volume="9", number="11", pages="e30332", keywords="relational ethics", keywords="physical activity", keywords="wearable", keywords="arthritis", keywords="qualitative", abstract="Background: Current evidence indicates physical activity wearables could support persons with knee osteoarthritis (OA) to be more physically active. However, recent evidence also identifies some persons with arthritis experience guilt or worry while using a wearable if they are not as active as they feel they should be. Questions remain around how persons with knee OA experience benefits or downsides using a wearable in their everyday lives. Better understanding is needed if wearables are to be incorporated in arthritis self-management in ethically aware ways. Objective: Using an ethics lens, we aimed to describe a range of experiences from persons with knee OA who used a wearable during a physical activity counseling intervention study. Methods: This is a secondary analysis of qualitative interviews nested within a randomized controlled trial. Guided by phenomenography, we explored the experiences of persons with knee OA following participation in a physical activity counseling intervention that involved using a Fitbit Flex and biweekly phone calls with a study physiotherapist (PT) in an 8-week period. Benefits or downsides experienced in participants' relationships with themselves or the study PT when using the wearable were identified using a relational ethics lens. Results: Interviews with 21 participants (12 females and 9 males) aged 40 to 82 years were analyzed. Education levels ranged from high school graduates (4/21, 19\%) to bachelor's degrees or above (11/21, 52\%). We identified 3 categories of description: (1) participants experienced their wearable as a motivating or nagging influence to be more active, depending on how freely they were able to make autonomous choices about physical activity in their everyday lives; (2) some participants felt a sense of accomplishment from seeing progress in their wearable data, which fueled their motivation; (3) for some participants, sharing wearable data helped to build mutual trust in their relationship with the study PT. However, they also expressed there was potential for sharing wearable data to undermine this trust, particularly if this data was inaccurate. Conclusions: Findings provide an early glimpse into positive and negative emotional impacts of using a wearable that can be experienced by participants with knee OA when participating in a randomized controlled trial to support physical activity. To our knowledge, this is the first qualitative study that uses a relational ethics lens to explore how persons with arthritis experienced changes in their relationship with a health professional when using a wearable during research participation. ", doi="10.2196/30332", url="https://mhealth.jmir.org/2021/11/e30332", url="http://www.ncbi.nlm.nih.gov/pubmed/34766912" } @Article{info:doi/10.2196/30125, author="Mulgund, Pavankumar and Sharman, Raj and Purao, Sandeep and Thimmanayakanapalya, Suresh Sagarika and Winkelstein, Peter", title="Mapping Information Needs of Patients With Sexually Transmitted Infections Using Web-Based Data Sources: Grounded Theory Investigation", journal="J Med Internet Res", year="2021", month="Nov", day="10", volume="23", number="11", pages="e30125", keywords="information needs", keywords="sexually transmitted diseases", keywords="patient journey maps", keywords="health information seeking", keywords="stigmatizing disorders", keywords="online forum", keywords="sexually transmitted infection", keywords="American Sexual Health Association", keywords="grounded theory", keywords="stigma", abstract="Background: According to the World health organization (WHO), more than 1 million sexually transmitted infections (STIs) are acquired each day across the world. The incidence rates of STIs in the United States are at a record high for the fourth consecutive year. Owing to the stigma associated with the incidence of STI, there is a general reluctance to seek information in person. Instead, web-based information sources remain the primary avenues of information-seeking. However, these sources are designed without a comprehensive understanding of the information needs of individuals who have contracted STIs. Objective: This study aimed to investigate the information needs of individuals who have or suspect they have contracted an STI. A better understanding of their information needs can drive the design of more effective digital interventions. Methods: This is a qualitative and analytical study of 549 transcripts (consisting of queries posted over the last 10 years) from web-based forums of the American Sexual Health Association (ASHA), which allows patients, volunteers, and health care providers connect anonymously. The analysis follows a grounded theory (GT) approach with multiple coding stages to uncover categories and themes. Results: Three categories of information needs emerged. The first two, clinical and logistical, are similar to other contexts. However, our analysis shows that there is a significant need for the last category---psychosocial information. Approximately 59\% of instances are linked to concerns such as confusion, discretion, remorse, and others. These needs vary across the stages of a patient's journey from symptom manifestation to treatment maintenance. Conclusions: Responding to the needs of individuals who have or suspect they have contracted an STI requires compassionate and personalized responses (beyond factual clinical and logistical information). Web-based forums provide anonymity but do not adequately incorporate mechanisms, practices, or incentives to respond to diverse psychosocial concerns. Innovative approaches to add such support can make the digital interventions more effective for this group of individuals. ", doi="10.2196/30125", url="https://www.jmir.org/2021/11/e30125", url="http://www.ncbi.nlm.nih.gov/pubmed/34757326" } @Article{info:doi/10.2196/27896, author="Noorbergen, J. Tyler and Adam, P. Marc T. and Teubner, Timm and Collins, E. Clare", title="Using Co-design in Mobile Health System Development: A Qualitative Study With Experts in Co-design and Mobile Health System Development", journal="JMIR Mhealth Uhealth", year="2021", month="Nov", day="10", volume="9", number="11", pages="e27896", keywords="co-design", keywords="mHealth", keywords="guidelines", keywords="qualitative study", keywords="mobile phone", abstract="Background: The proliferation of mobile devices has enabled new ways of delivering health services through mobile health systems. Researchers and practitioners emphasize that the design of such systems is a complex endeavor with various pitfalls, including limited stakeholder involvement in design processes and the lack of integration into existing system landscapes. Co-design is an approach used to address these pitfalls. By recognizing users as experts of their own experience, co-design directly involves users in the design process and provides them an active role in knowledge development, idea generation, and concept development. Objective: Despite the existence of a rich body of literature on co-design methodologies, limited research exists to guide the co-design of mobile health (mHealth) systems. This study aims to contextualize an existing co-design framework for mHealth applications and construct guidelines to address common challenges of co-designing mHealth systems. Methods: Tapping into the knowledge and experience of experts in co-design and mHealth systems development, we conducted an exploratory qualitative study consisting of 16 semistructured interviews. Thereby, a constructivist ontological position was adopted while acknowledging the socially constructed nature of reality in mHealth system development. Purposive sampling across web-based platforms (eg, Google Scholar and ResearchGate) and publications by authors with co-design experience in mHealth were used to recruit co-design method experts (n=8) and mHealth system developers (n=8). Data were analyzed using thematic analysis along with our objectives of contextualizing the co-design framework and constructing guidelines for applying co-design to mHealth systems development. Results: The contextualized framework captures important considerations of the mHealth context, including dedicated prototyping and implementation phases, and an emphasis on immersion in real-world contexts. In addition, 7 guidelines were constructed that directly pertain to mHealth: understanding stakeholder vulnerabilities and diversity, health behavior change, co-design facilitators, immersion in the mHealth ecosystem, postdesign advocates, health-specific evaluation criteria, and usage data and contextual research to understand impact. Conclusions: System designers encounter unique challenges when engaging in mHealth systems development. The contextualized co-design framework and constructed guidelines have the potential to serve as a shared frame of reference to guide the co-design of mHealth systems and facilitate interdisciplinary collaboration at the nexus of information technology and health research. ", doi="10.2196/27896", url="https://mhealth.jmir.org/2021/11/e27896", url="http://www.ncbi.nlm.nih.gov/pubmed/34757323" } @Article{info:doi/10.2196/20046, author="Busse, Sophie Theresa and Kernebeck, Sven and Nef, Larissa and Rebacz, Patrick and Kickbusch, Ilona and Ehlers, Peter Jan", title="Views on Using Social Robots in Professional Caregiving: Content Analysis of a Scenario Method Workshop", journal="J Med Internet Res", year="2021", month="Nov", day="10", volume="23", number="11", pages="e20046", keywords="social robots", keywords="robotics", keywords="health care sector", keywords="health personnel", keywords="ethics", keywords="forecasting", keywords="trends", keywords="technology", keywords="digital transformation", keywords="professional caregiving", abstract="Background: Interest in digital technologies in the health care sector is growing and can be a way to reduce the burden on professional caregivers while helping people to become more independent. Social robots are regarded as a special form of technology that can be usefully applied in professional caregiving with the potential to focus on interpersonal contact. While implementation is progressing slowly, a debate on the concepts and applications of social robots in future care is necessary. Objective: In addition to existing studies with a focus on societal attitudes toward social robots, there is a need to understand the views of professional caregivers and patients. This study used desired future scenarios to collate the perspectives of experts and analyze the significance for developing the place of social robots in care. Methods: In February 2020, an expert workshop was held with 88 participants (health professionals and educators; [PhD] students of medicine, health care, professional care, and technology; patient advocates; software developers; government representatives; and research fellows) from Austria, Germany, and Switzerland. Using the scenario methodology, the possibilities of analog professional care (Analog Care), fully robotic professional care (Robotic Care), teams of robots and professional caregivers (Deep Care), and professional caregivers supported by robots (Smart Care) were discussed. The scenarios were used as a stimulus for the development of ideas about future professional caregiving. The discussion was evaluated using qualitative content analysis. Results: The majority of the experts were in favor of care in which people are supported by technology (Deep Care) and developed similar scenarios with a focus on dignity-centeredness. The discussions then focused on the steps necessary for its implementation, highlighting a strong need for the development of eHealth competence in society, a change in the training of professional caregivers, and cross-sectoral concepts. The experts also saw user acceptance as crucial to the use of robotics. This involves the acceptance of both professional caregivers and care recipients. Conclusions: The literature review and subsequent workshop revealed how decision-making about the value of social robots depends on personal characteristics related to experience and values. There is therefore a strong need to recognize individual perspectives of care before social robots become an integrated part of care in the future. ", doi="10.2196/20046", url="https://www.jmir.org/2021/11/e20046", url="http://www.ncbi.nlm.nih.gov/pubmed/34757318" } @Article{info:doi/10.2196/26424, author="Kim, Jihae Agnes and Yang, Jisun and Jang, Yihyun and Baek, Sang Joon", title="Acceptance of an Informational Antituberculosis Chatbot Among Korean Adults: Mixed Methods Research", journal="JMIR Mhealth Uhealth", year="2021", month="Nov", day="9", volume="9", number="11", pages="e26424", keywords="tuberculosis", keywords="chatbot", keywords="technology acceptance model", keywords="mobile phone", abstract="Background: Tuberculosis (TB) is a highly infectious disease. Negative perceptions and insufficient knowledge have made its eradication difficult. Recently, mobile health care interventions, such as an anti-TB chatbot developed by the research team, have emerged in support of TB eradication programs. However, before the anti-TB chatbot is deployed, it is important to understand the factors that predict its acceptance by the population. Objective: This study aims to explore the acceptance of an anti-TB chatbot that provides information about the disease and its treatment to people vulnerable to TB in South Korea. Thus, we are investigating the factors that predict technology acceptance through qualitative research based on the interviews of patients with TB and homeless facility personnel. We are then verifying the extended Technology Acceptance Model (TAM) and predicting the factors associated with the acceptance of the chatbot. Methods: In study 1, we conducted interviews with potential chatbot users to extract the factors that predict user acceptance and constructed a conceptual framework based on the TAM. In total, 16 interviews with patients with TB and one focus group interview with 10 experts on TB were conducted. In study 2, we conducted surveys of potential chatbot users to validate the extended TAM. Survey participants were recruited among late-stage patients in TB facilities and members of web-based communities sharing TB information. A total of 123 responses were collected. Results: The results indicate that perceived ease of use and social influence were significantly predictive of perceived usefulness (P=.04 and P<.001, respectively). Perceived usefulness was predictive of the attitude toward the chatbot (P<.001), whereas perceived ease of use (P=.88) was not. Behavioral intention was positively predicted by attitude toward the chatbot and facilitating conditions (P<.001 and P=.03, respectively). The research model explained 55.4\% of the variance in the use of anti-TB chatbots. The moderating effect of TB history was found in the relationship between attitude toward the chatbot and behavioral intention (P=.01) and between facilitating conditions and behavioral intention (P=.02). Conclusions: This study can be used to inform future design of anti-TB chatbots and highlight the importance of services and the environment that empower people to use the technology. ", doi="10.2196/26424", url="https://mhealth.jmir.org/2021/11/e26424", url="http://www.ncbi.nlm.nih.gov/pubmed/34751667" } @Article{info:doi/10.2196/30704, author="Bickmore, W. Timothy and {\'O}lafsson, Stef{\'a}n and O'Leary, K. Teresa", title="Mitigating Patient and Consumer Safety Risks When Using Conversational Assistants for Medical Information: Exploratory Mixed Methods Experiment", journal="J Med Internet Res", year="2021", month="Nov", day="9", volume="23", number="11", pages="e30704", keywords="conversational assistant", keywords="conversational interface", keywords="dialogue system", keywords="medical error", keywords="patient safety", keywords="risk mitigation", keywords="warnings", keywords="disclaimers", keywords="grounding", keywords="explainability", keywords="mobile phone", abstract="Background: Prior studies have demonstrated the safety risks when patients and consumers use conversational assistants such as Apple's Siri and Amazon's Alexa for obtaining medical information. Objective: The aim of this study is to evaluate two approaches to reducing the likelihood that patients or consumers will act on the potentially harmful medical information they receive from conversational assistants. Methods: Participants were given medical problems to pose to conversational assistants that had been previously demonstrated to result in potentially harmful recommendations. Each conversational assistant's response was randomly varied to include either a correct or incorrect paraphrase of the query or a disclaimer message---or not---telling the participants that they should not act on the advice without first talking to a physician. The participants were then asked what actions they would take based on their interaction, along with the likelihood of taking the action. The reported actions were recorded and analyzed, and the participants were interviewed at the end of each interaction. Results: A total of 32 participants completed the study, each interacting with 4 conversational assistants. The participants were on average aged 42.44 (SD 14.08) years, 53\% (17/32) were women, and 66\% (21/32) were college educated. Those participants who heard a correct paraphrase of their query were significantly more likely to state that they would follow the medical advice provided by the conversational assistant ($\chi$21=3.1; P=.04). Those participants who heard a disclaimer message were significantly more likely to say that they would contact a physician or health professional before acting on the medical advice received ($\chi$21=43.5; P=.001). Conclusions: Designers of conversational systems should consider incorporating both disclaimers and feedback on query understanding in response to user queries for medical advice. Unconstrained natural language input should not be used in systems designed specifically to provide medical advice. ", doi="10.2196/30704", url="https://www.jmir.org/2021/11/e30704", url="http://www.ncbi.nlm.nih.gov/pubmed/34751661" } @Article{info:doi/10.2196/27748, author="Javier, J. Sarah and Wu, Justina and Smith, L. Donna and Kanwal, Fasiha and Martin, A. Lindsey and Clark, Jack and Midboe, M. Amanda", title="A Web-Based, Population-Based Cirrhosis Identification and Management System for Improving Cirrhosis Care: Qualitative Formative Evaluation", journal="JMIR Form Res", year="2021", month="Nov", day="9", volume="5", number="11", pages="e27748", keywords="cirrhosis", keywords="informatics", keywords="care coordination", keywords="implementation", keywords="Consolidated Framework for Implementation Research (CFIR)", keywords="quality improvement", abstract="Background: Cirrhosis, or scarring of the liver, is a debilitating condition that affects millions of US adults. Early identification, linkage to care, and retention of care are critical for preventing severe complications and death from cirrhosis. Objective: The purpose of this study is to conduct a preimplementation formative evaluation to identify factors that could impact implementation of the Population-Based Cirrhosis Identification and Management System (P-CIMS) in clinics serving patients with cirrhosis. P-CIMS is a web-based informatics tool designed to facilitate patient outreach and cirrhosis care management. Methods: Semistructured interviews were conducted between January and May 2016 with frontline providers in liver disease and primary care clinics at 3 Veterans Health Administration medical centers. A total of 10 providers were interviewed, including 8 physicians and midlevel providers from liver-related specialty clinics and 2 primary care providers who managed patients with cirrhosis. The Consolidated Framework for Implementation Research guided the development of the interview guides. Inductive consensus coding and content analysis were used to analyze transcribed interviews and abstracted coded passages, elucidated themes, and insights. Results: The following themes and subthemes emerged from the analyses: outer setting: needs and resources for patients with cirrhosis; inner setting: readiness for implementation (subthemes: lack of resources, lack of leadership support), and implementation climate (subtheme: competing priorities); characteristics of individuals: role within clinic; knowledge and beliefs about P-CIMS (subtheme: perceived and realized benefits; useful features; suggestions for improvement); and perceptions of current practices in managing cirrhosis cases (subthemes: preimplementation process for identifying and linking patients to cirrhosis care; structural and social barriers to follow-up). Overall, P-CIMS was viewed as a powerful tool for improving linkage and retention, but its integration in the clinical workflow required leadership support, time, and staffing. Providers also cited the need for more intuitive interface elements to enhance usability. Conclusions: P-CIMS shows promise as a powerful tool for identifying, linking, and retaining care in patients living with cirrhosis. The current evaluation identified several improvements and advantages of P-CIMS over current care processes and provides lessons for others implementing similar population-based identification and management tools in populations with chronic disease. ", doi="10.2196/27748", url="https://formative.jmir.org/2021/11/e27748", url="http://www.ncbi.nlm.nih.gov/pubmed/34751653" } @Article{info:doi/10.2196/33653, author="Spitale, Giovanni and Merten, Sonja and Jafflin, Kristen and Schwind, Bettina and Kaiser-Grolimund, Andrea and Biller-Andorno, Nikola", title="A Novel Risk and Crisis Communication Platform to Bridge the Gap Between Policy Makers and the Public in the Context of the COVID-19 Crisis (PubliCo): Protocol for a Mixed Methods Study", journal="JMIR Res Protoc", year="2021", month="Nov", day="1", volume="10", number="11", pages="e33653", keywords="disease outbreaks", keywords="coronavirus", keywords="COVID-19 surveys", keywords="COVID-19 questionnaires", keywords="qualitative methods", keywords="health literacy", keywords="policy making", keywords="risk and crisis communication", keywords="COVID-19", abstract="Background: Since the end of 2019, COVID-19 has had a significant impact on people around the globe. As governments institute more restrictive measures, public adherence could decrease and discontent may grow. Providing high-quality information and countering fake news are important. However, we also need feedback loops so that government officials can refine preventive measures and communication strategies. Policy makers need information---preferably based on real-time data---on people's cognitive, emotional, and behavioral reactions to public health messages and restrictive measures. PubliCo aims to foster effective and tailored risk and crisis communication as well as provide an assessment of the risks and benefits of prevention and control measures, since their effectiveness depends on public trust and cooperation. Objective: Our project aims to develop a tool that helps tackle the COVID-19 infodemic, with a focus on enabling a nuanced and in-depth understanding of public perception. The project adopts a transdisciplinary multistakeholder approach, including participatory citizen science. Methods: We aim to combine a literature and media review and analysis as well as empirical research using mixed methods, including an online survey and diary-based research, both of which are ongoing and continuously updated. Building on real-time data and continuous data collection, our research results will be highly adaptable to the evolving situation. Results: As of September 2021, two-thirds of the proposed tool is operational. The current development cycles are focusing on analytics, user experience, and interface refinement. We have collected a total of 473 responses through PubliCo Survey and 22 diaries through PubliCo Diaries. Conclusions: Pilot data show that PubliCo is a promising and efficient concept for bidirectional risk and crisis communication in the context of public health crises. Further data are needed to assess its function at a larger scale or in the context of an issue other than COVID-19. International Registered Report Identifier (IRRID): DERR1-10.2196/33653 ", doi="10.2196/33653", url="https://www.researchprotocols.org/2021/11/e33653", url="http://www.ncbi.nlm.nih.gov/pubmed/34612823" } @Article{info:doi/10.2196/26886, author="Yadav, Lalit and Gill, K. Tiffany and Taylor, Anita and De Young, Jennifer and Chehade, J. Mellick", title="Identifying Opportunities, and Motivation to Enhance Capabilities, Influencing the Development of a Personalized Digital Health Hub Model of Care for Hip Fractures: Mixed Methods Exploratory Study", journal="J Med Internet Res", year="2021", month="Oct", day="28", volume="23", number="10", pages="e26886", keywords="digital health", keywords="mixed-methods", keywords="hip fractures", keywords="behavior change", keywords="patient education", keywords="model of care", keywords="mobile phone", keywords="patient networked units", abstract="Background: Most older people after a hip fracture injury never return to their prefracture status, and some are admitted to residential aged care facilities. Advancement of digital technology has helped in optimizing health care including self-management and telerehabilitation. Objective: This study aims to understand the perspectives of older patients with hip fracture and their family members and residential aged caregivers on the feasibility of developing a model of care using a personalized digital health hub. Methods: We conducted a mixed methods study in South Australia involving patients aged 50 years and older, their family members, and residential aged caregivers. Quantitative data analysis included basic demographic characteristics, and access to digital devices was analyzed using descriptive statistics. Spearman rank-order correlation was used to examine correlations between the perceived role of a personalized digital health hub in improving health and the likelihood of subsequent use. Findings from qualitative analysis were interpreted using constructs of capability, opportunity, and motivation to help understand the factors influencing the likelihood of potential personalized digital health hub use. Results: This study recruited 100 participants---55 patients, 13 family members, and 32 residential aged caregivers. The mean age of the patients was 76.4 (SD 8.4, range 54-88) years, and 60\% (33/55) of the patients were female. Approximately 50\% (34/68) of the patients and their family members had access to digital devices, despite less than one-third using computers as part of their occupation. Approximately 72\% (72/100) of the respondents thought that personalized digital health hub could improve health outcomes in patients. However, a moderate negative correlation existed with increasing age and likelihood of personalized digital health hub use (Spearman $\rho$=--0.50; P<.001), and the perceived role of the personalized digital health hub in improving health had a strong positive correlation with the likelihood of personalized digital health hub use by self (Spearman $\rho$=0.71; P<.001) and by society, including friends and family members (Spearman $\rho$=0.75; P<.001). Most patients (54/55, 98\%) believed they had a family member, friend, or caregiver who would be able to help them use a personalized digital health hub. Qualitative analysis explored capability by understanding aspects of existing knowledge, including willingness to advance digital navigation skills. Access could be improved through supporting opportunities, and factors influencing intrinsic motivation were considered crucial for designing a personalized digital health hub--enabled model of care. Conclusions: This study emphasized the complex relationship between capabilities, motivation, and opportunities for patients, their family members, and formal caregivers as a patient networked unit. The next stage of research will continue to involve a cocreation approach followed by iterative processes and understand the factors influencing the development and successful integration of complex digital health care interventions in real-world scenarios. ", doi="10.2196/26886", url="https://www.jmir.org/2021/10/e26886", url="http://www.ncbi.nlm.nih.gov/pubmed/34709183" } @Article{info:doi/10.2196/25646, author="Cohen Rodrigues, R. Talia and de Buisonj{\'e}, R. David and Keesman, Mike and Reijnders, Thomas and van der Geer, E. Jessica and Janssen, R. Veronica and Kraaijenhagen, A. Roderik and Atsma, E. Douwe and Evers, M. Andrea W.", title="Facilitators of and Barriers to Lifestyle Support and eHealth Solutions: Interview Study Among Health Care Professionals Working in Cardiac Care", journal="J Med Internet Res", year="2021", month="Oct", day="15", volume="23", number="10", pages="e25646", keywords="eHealth", keywords="digital health", keywords="cardiovascular disease", keywords="cardiac care", keywords="lifestyle change", keywords="lifestyle support", keywords="intervention", keywords="health care professionals", keywords="implementation", keywords="interview", keywords="facilitators", keywords="barriers", abstract="Background: Cardiovascular diseases (CVDs) pose a significant health threat and reduce both people's life expectancy and quality of life. Healthy living is a key component in the effective prevention and treatment of CVD. However, health care professionals (HCPs) experience difficulties in supporting lifestyle changes among their patients. eHealth can provide a solution to these barriers. Objective: This study aims to provide insights into the factors HCPs find important in the support of patients with CVD in the uptake of and adherence to a healthy lifestyle and the perceived facilitators of and barriers to using eHealth to provide lifestyle support to patients with CVD. Methods: In-depth interviews were conducted with 16 Dutch HCPs specializing in lifestyle support in cardiac care. Results: We identified 13 themes, of which the first 12 concerned lifestyle support in general and were related to intervention, patient, or health care. Throughout these themes, the use of eHealth reoccurred as a potential facilitator of or solution to barriers to lifestyle support. Our final theme specifically concerned barriers to the adoption and usability of eHealth. Conclusions: HCPs do recognize the potential advantages of eHealth while experiencing barriers to using digital tools. Incorporating their needs and values in the development of lifestyle support programs, especially eHealth, could increase their use and lead to a more widespread adoption of eHealth into health care. ", doi="10.2196/25646", url="https://www.jmir.org/2021/10/e25646", url="http://www.ncbi.nlm.nih.gov/pubmed/34652280" } @Article{info:doi/10.2196/26623, author="Sarkar, Urmimala and Lee, E. Jane and Nguyen, H. Kim and Lisker, Sarah and Lyles, R. Courtney", title="Barriers and Facilitators to the Implementation of Virtual Reality as a Pain Management Modality in Academic, Community, and Safety-Net Settings: Qualitative Analysis", journal="J Med Internet Res", year="2021", month="Sep", day="22", volume="23", number="9", pages="e26623", keywords="virtual reality", keywords="medical informatics", keywords="information technology", keywords="implementation science", keywords="qualitative research", abstract="Background: Prior studies have shown that virtual reality (VR) is an efficacious treatment modality for opioid-sparing pain management. However, the majority of these studies were conducted among primarily White, relatively advantaged populations and in well-resourced settings. Objective: We conducted a qualitative, theory-informed implementation science study to assess the readiness for VR in safety-net settings. Methods: Using the theoretical lens of the Consolidated Framework for Implementation Research (CFIR) framework, we conducted semistructured interviews with current VR users and nonusers based in safety-net health systems (n=15). We investigated barriers and facilitators to a commercially available, previously validated VR technology platform AppliedVR (Los Angeles, CA, USA). We used deductive qualitative analysis using the overarching domains of the CFIR framework and performed open, inductive coding to identify specific themes within each domain. Results: Interviewees deemed the VR intervention to be useful, scalable, and an appealing alternative to existing pain management approaches. Both users and nonusers identified a lack of reimbursement for VR as a significant challenge for adoption. Current users cited positive patient feedback, but safety-net stakeholders voiced concern that existing VR content may not be relevant or appealing to diverse patients. All respondents acknowledged the challenge of integrating and maintaining VR in current pain management workflows across a range of clinical settings, and this adoption challenge was particularly acute, given resource and staffing constraints in safety-net settings. Conclusions: VR for pain management holds interest for frontline pain management clinicians and leadership in safety-net health settings but will require significant tailoring and adaption to address the needs of diverse populations. Integration into complex workflows for pain management is a significant barrier to adoption, and participants cited structural cost and reimbursement concerns as impediments to initial implementation and scaling of VR use. ", doi="10.2196/26623", url="https://www.jmir.org/2021/9/e26623", url="http://www.ncbi.nlm.nih.gov/pubmed/34550074" } @Article{info:doi/10.2196/26869, author="Dharanikota, Spurthy and LeRouge, M. Cynthia and Lyon, Victoria and Durneva, Polina and Thompson, Matthew", title="Identifying Enablers of Participant Engagement in Clinical Trials of Consumer Health Technologies: Qualitative Study of Influenza Home Testing", journal="J Med Internet Res", year="2021", month="Sep", day="14", volume="23", number="9", pages="e26869", keywords="consumer health care technologies", keywords="CHTs", keywords="smartphone-supported home tests", keywords="Smart-HT", keywords="premarket clinical trials", keywords="trial engagement", keywords="at-home diagnostic testing", keywords="mobile phone", abstract="Background: A rise in the recent trend of self-managing health using consumer health technologies highlights the importance of efficient and successful consumer health technology trials. Trials are particularly essential to support large-scale implementations of consumer health technologies, such as smartphone-supported home tests. However, trials are generally fraught with challenges, such as inadequate enrollment, lack of fidelity to interventions, and high dropout rates. Understanding the reasons underlying individuals' participation in trials can inform the design and execution of future trials of smartphone-supported home tests. Objective: This study aims to identify the enablers of potential participants' trial engagement for clinical trials of smartphone-supported home tests. We use influenza home testing as our instantiation of a consumer health technology subject to trial to investigate the dispositional and situational enablers that influenced trial engagement. Methods: We conducted semistructured interviews with 31 trial participants using purposive sampling to facilitate demographic diversity. The interviews included a discussion of participants' personal characteristics and external factors that enabled their trial engagement with a smartphone-supported home test for influenza. We performed both deductive and inductive thematic analyses to analyze the interview transcripts and identify enabler themes. Results: Our thematic analyses revealed a structure of dispositional and situational enablers that enhanced trial engagement. Situationally, clinical affiliation, personal advice, promotional recruitment strategies, financial incentives, and insurance status influenced trial engagement. In addition, digital health literacy, motivation to advance medical research, personal innovativeness, altruism, curiosity, positive attitude, and potential to minimize doctors' visits were identified as the dispositional enablers for trial engagement in our study. Conclusions: We organized the identified themes for dispositional and situational enablers of trial engagement with a smartphone-supported home test into a research framework that can guide future research as well as the trial design and execution of smartphone-supported home tests. We suggest several trial design and engagement strategies to enhance the financial and scientific viability of these trials that pave the way for advancements in patient care. Furthermore, our study also offers practical strategies to trial organizers to enhance participants' enrollment and engagement in clinical trials of these home tests. ", doi="10.2196/26869", url="https://www.jmir.org/2021/9/e26869", url="http://www.ncbi.nlm.nih.gov/pubmed/34519664" } @Article{info:doi/10.2196/28349, author="Keyworth, Chris and O'Connor, Rory and Quinlivan, Leah and Armitage, J. Christopher", title="Acceptability of a Brief Web-Based Theory-Based Intervention to Prevent and Reduce Self-harm: Mixed Methods Evaluation", journal="J Med Internet Res", year="2021", month="Sep", day="14", volume="23", number="9", pages="e28349", keywords="self-harm", keywords="implementation intentions", keywords="acceptability", keywords="online", keywords="volitional help sheet", keywords="digital health", keywords="mental health", abstract="Background: The volitional help sheet (VHS) for self-harm equips people with a means of responding automatically to triggers for self-harm with coping strategies. Although there is some evidence of its efficacy, improving acceptability and making the intervention available in a web-based format may be crucial to increasing effectiveness and reach. Objective: This study aims to use the Theoretical Framework of Acceptability (TFA) to explore the acceptability of the VHS, examine for whom and under what circumstances this intervention is more or less acceptable, and develop a series of recommendations for how the VHS can be used to support people in reducing repeat self-harm. Methods: We explored acceptability in two phases. First, our patient and public involvement partners evaluated the original VHS from a lived experience perspective, which was subsequently translated into a web-based format. Second, a representative sample of adults in the United Kingdom who had previously self-harmed were recruited via a YouGov survey (N=514) and were asked to rate the acceptability of the VHS based on the seven constructs of the TFA, namely, affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy. Data were analyzed using descriptive statistics, one-tailed t tests, and binary logistic regression. A directed content analysis approach was used to analyze qualitative data. Results: Participants in the web-based survey rated the VHS as positive (affective attitude; t457=4.72; P<.001); were confident using it (self-efficacy; t457=9.54; P<.001); felt they did not have to give up any benefits, profits, or values when using it (opportunity costs; t439=?15.51; P<.001); understood it and how it worked (intervention coherence; t464=11.90; P<.001); and were confident that it would achieve its purpose (perceived effectiveness; t466=2.04; P=.04). The TFA domain burden appeared to be an important indicator of acceptability. Lower levels of perceived burden when using the VHS tool were more prevalent among younger adults aged 18-24 years (OR 3.63, 95\% CI 1.50-8.78), people of White ethnic background (OR 3.02, 95\% CI 1.06-8.613), and people without a long-term health condition (OR 1.53, 95\% CI 1.01-2.30). Perceived modifications to further improve acceptability included improved formatting (burden), the feature to add new situations and responses or amend existing ones (ethicality), and clearer instructions and further detail about the purpose of the VHS (intervention coherence). Conclusions: Our findings show high levels of acceptability among some people who have previously self-harmed, particularly among younger adults, people of White ethnic backgrounds, and people without long-term health conditions. Future research should aim to improve acceptability among older adults, people from minority ethnic groups, and people with long-term health conditions. ", doi="10.2196/28349", url="https://www.jmir.org/2021/9/e28349", url="http://www.ncbi.nlm.nih.gov/pubmed/34518153" } @Article{info:doi/10.2196/28878, author="Katiri, Roulla and Hall, A. Deborah and Hoare, J. Derek and Fackrell, Kathryn and Horobin, Adele and Buggy, N{\'o}ra and Hogan, Nicholas and Kitterick, T. P{\'a}draig and ", title="Redesigning a Web-Based Stakeholder Consensus Meeting About Core Outcomes for Clinical Trials: Formative Feedback Study", journal="JMIR Form Res", year="2021", month="Aug", day="19", volume="5", number="8", pages="e28878", keywords="COVID-19", keywords="nominal group technique", keywords="formative research", keywords="patient participation", keywords="persons with hearing impairments", keywords="mobile phone", abstract="Background: Clinical trials that assess the benefits and harms of an intervention do so by measuring and reporting outcomes. Inconsistent selection and diversity in the choice of outcomes make it challenging to directly compare interventions. To achieve an agreed core set of outcomes, a consensus methodology is recommended, comprising a web-based Delphi survey and a face-to-face consensus meeting. However, UK government regulations to control the pandemic prohibited plans for a face-to-face consensus meeting as part of the Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) study. Objective: This study aims to evaluate the modifications made by the CROSSSD study team to achieve consensus using web-based methods, but with minimal deviation from the original study protocol. Methods: The study team worked with health care users and professionals to translate the planned face-to-face consensus meeting in a web-based format, preserving the key elements of the nominal group technique. A follow-up survey gathered evaluation feedback on the experiences of the 22 participating members. Feedback covered premeeting preparation, the process of facilitated discussions and voting, ability to contribute, and perceived fairness of the outcome. Results: Overall, 98\% (53/54) of feedback responses agreed or strongly agreed with the statements given, indicating that the web-based meeting achieved its original goals of open discussion, debate, and voting to agree with a core outcome set for single-sided deafness. Hearing-impaired participants were fully engaged, but there were some methodological challenges. For the participants, challenges included building rapport, understanding, and delivering the tasks in hand. For the study team, challenges included the need for thorough preparation and management of the unpredictability of tasks on the day. Conclusions: Sharing our experiences and lessons learned can benefit future core outcome set developers. Overcoming the challenges of delivering a web-based consensus exercise in the face of the pandemic can be applied more generally to maximize inclusiveness, enhance geographical access, and reduce research costs. ", doi="10.2196/28878", url="https://formative.jmir.org/2021/8/e28878", url="http://www.ncbi.nlm.nih.gov/pubmed/34420915" } @Article{info:doi/10.2196/25767, author="Afrashtehfar, Ian Kelvin and Bryant, Ross Stephen", title="Understanding the Lived Experience of North American Dental Patients With a Single-Tooth Implant in the Upper Front Region of the Mouth: Protocol for a Qualitative Study", journal="JMIR Res Protoc", year="2021", month="Jun", day="18", volume="10", number="6", pages="e25767", keywords="esthetic dentistry", keywords="esthetics", keywords="implant dentistry", keywords="patient perception", keywords="patient-reported outcome measures", keywords="personal satisfaction", keywords="phenomenology", keywords="single-tooth dental implants", keywords="single-unit implant-supported restoration", abstract="Background: Assessment of the subjective experiences of individuals with maxillary anterior (ie, the upper front region of the mouth) single-tooth implants is limited mainly to quantitative measurements of satisfaction with appearance. Interestingly, there is unexplained variability in the relationship between satisfaction and appearance. Objective: This qualitative study protocol aims to explore and better understand the satisfaction with appearance and function in a Canadian population with maxillary anterior single-tooth implants treated at a postgraduate university clinic. Thus, we aim to obtain diversity among participants relating to the identification of esthetically pleasing and displeasing cases from a clinician perspective. Methods: A qualitative research design using interpretative phenomenology analysis (IPA) will provide an adaptable inductive research approach. The participants will be recruited, and consent documents, photographs, digital intraoral scans, and self-administered questionnaire responses will be obtained from them. The transcribed verbatim data from audio-recorded, in-depth, semistructured, one-to-one interviews of the participants will be managed, coded, and analyzed thematically with computer-assisted qualitative data analysis software. The IPA will consider the COnsolidated criteria for REporting Qualitative (COREQ) guidelines when applicable. Results: For the qualitative interview, we plan to include at least eight patients to conduct up to 1.5 hours of open-ended interviews with each participant aided by an interview guide. Ethical approval was granted by the University of British Columbia Behavioral Research Ethics Board (H19-00107) in May 2019. Two American dental foundations funded this study. Conclusions: The analysis in this study will elucidate the aspects (including their value) that influence participant satisfaction at different dental implant treatment stages. This will be the first qualitative study on this group of the population to explore and obtain a better understanding of their satisfaction with appearance and function, as well as any other patient-reported outcome measures that could be identified. International Registered Report Identifier (IRRID): DERR1-10.2196/25767 ", doi="10.2196/25767", url="https://www.researchprotocols.org/2021/6/e25767", url="http://www.ncbi.nlm.nih.gov/pubmed/33886491" } @Article{info:doi/10.2196/20300, author="Brown, Poppy and Waite, Felicity and Lambe, Sin{\'e}ad and Rosebrock, Laina and Freeman, Daniel", title="Virtual Reality Cognitive Therapy in Inpatient Psychiatric Wards: Protocol for a Qualitative Investigation of Staff and Patient Views Across Multiple National Health Service Sites", journal="JMIR Res Protoc", year="2020", month="Aug", day="20", volume="9", number="8", pages="e20300", keywords="virtual reality", keywords="therapy", keywords="inpatient psychiatric care", keywords="implementation", abstract="Background: Patients in psychiatric wards typically have very limited access to individual psychological therapy. Inpatients often have significant time available, and an important transition back to everyday life to prepare for---but historically, there have been few trained therapists available on wards for the delivery of evidence-based therapy. Automated virtual reality (VR) therapy may be one route to increase the provision of powerful psychological treatments in psychiatric hospitals. The gameChange automated VR cognitive therapy is targeted at helping patients overcome anxious avoidance and re-engage in everyday situations (such as walking down the street, taking a bus, or going to a shop). This treatment target may fit well for many patients preparing for discharge. However, little is known about how VR therapy may be viewed in this setting. Objective: The objectives of the study are to explore psychiatric hospital staff and patients' initial expectations of VR therapy, to gather patient and staff views of an automated VR cognitive therapy (gameChange) after briefly experiencing it, and to identify potential differences across National Health Service (NHS) mental health trusts for implementation. Guided by an implementation framework, the knowledge gained from this study will be used to assess the feasibility of VR treatment adoption into psychiatric hospitals. Methods: Focus groups will be conducted with NHS staff and patients in acute psychiatric wards at 5 NHS mental health trusts across England. Staff and patients will be interviewed in separate groups. Individual interviews will also be conducted when preferred by a participant. Within each of the 5 trusts, 1 to 2 wards will be visited. A total of 8-15 staff and patients per ward will be recruited, with a minimum total of 50 staff and patients recruited across all sites. Focus group questions have been derived from the nonadoption, abandonment, and challenges to the scale-up, spread, and sustainability (NASSS) framework. Focus groups will discuss expectations of VR therapy before participants are given the opportunity to briefly try the gameChange VR therapy. Questions will then focus on opinions about the therapy and investigate feasibility of adoption, with particular consideration given to site specific issues. A thematic analysis will be conducted. Results: As of May 15, 2020, 1 patient focus group has been conducted. Conclusions: The study will provide unique insight from patients and staff into the potential for implementing automated VR therapy in psychiatric wards. Perspectives will be captured both on the use of immersive technology hardware and therapy-specific issues in such settings. International Registered Report Identifier (IRRID): DERR1-10.2196/20300 ", doi="10.2196/20300", url="http://www.researchprotocols.org/2020/8/e20300/", url="http://www.ncbi.nlm.nih.gov/pubmed/32667897" } @Article{info:doi/10.2196/14997, author="Marques, S. Sandra C. and Doetsch, Julia and Br{\o}dsgaard, Anne and Cuttini, Marina and Draper, S. Elizabeth and Kajantie, Eero and Lebeer, Jo and van der Pal, Sylvia and Pedersen, Pernille and and Barros, Henrique", title="Improving Understanding of Participation and Attrition Phenomena in European Cohort Studies: Protocol for a Multi-Situated Qualitative Study", journal="JMIR Res Protoc", year="2020", month="Jul", day="15", volume="9", number="7", pages="e14997", keywords="European cohorts", keywords="VPT", keywords="VLBW", keywords="preterm", keywords="participation", keywords="attrition", keywords="multi-situated qualitative study", keywords="collaborative visual methods", keywords="triangulation", abstract="Background: Cohort studies represent a strong methodology for increasing one's understanding of human life-course development and etiological mechanisms. Retention of participants, especially during long follow-up periods, is, however, a major challenge. A better understanding of the motives for participation and attrition in cohort studies in diverse sociogeographic and cultural settings is needed, as this information is most useful in developing effective retention strategies. Objective: This study aims to improve our understanding of participation and attrition phenomena in a European cohort study of very preterm/very-low-birth-weight (VPT/VLBW) infants from various sociogeographic and cultural settings to better understand variability and ultimately contribute to developing novel and more ``in-context'' strategies to improve retention. Methods: This study uses a triangulation of multisituated methods to collect data on various cohorts in the Research on European Children and Adults Born Preterm (RECAP) network, which include focus group discussions, individual semidriven interviews, and a collaborative, reflexive visual methodology (participant-generated VideoStories) with relevant key actors involved with these cohort studies such as adult participants, parents (caregivers), cohort staff, health care professionals, and academic researchers. The methodological strategy aims to provide a shared flexible framework of various qualitatively driven methods to collect data on VPT/VLBW adult and child cohorts, from which research partners may choose and combine those most pertinent to apply in their own specific contexts. Data from all sources and sites will be submitted to a triangulation of phenomenological thematic analysis with discourse analysis. Results: As of January 2020, in this study, we enrolled 92 participants variously involved with child and adult RECAP partnering cohorts from six countries. Multisite enrollment and data collection are expected to be completed in all seven study settings by June 2020. Findings will be reported in future publications. Conclusions: Qualitative research methods are a useful complement for enriching and illuminating quantitative results. We expect that opting for a multisituated study approach addressing the interplay of the lived experience of individuals in both researcher and researched stances of particular cohort study settings will contribute to filling some gaps in the understanding of participation variability and effectiveness of different implemented strategies in context. Moreover, health research subjects have traditionally been positioned as passive objects of study rather than active participants, even though they have the greatest stake in improving health care policies and practices. Including collaborative methods allows us to counteract the ``top-down'' model by handing over some research control to the very people who are providing the data on which research findings will be based while also acknowledging the value of their involvement. International Registered Report Identifier (IRRID): DERR1-10.2196/14997 ", doi="10.2196/14997", url="https://www.researchprotocols.org/2020/7/e14997", url="http://www.ncbi.nlm.nih.gov/pubmed/32667901" } @Article{info:doi/10.2196/16827, author="Dimaguila, Luis Gerardo and Gray, Kathleen and Merolli, Mark", title="Patient-Reported Outcome Measures of Utilizing Person-Generated Health Data in the Case of Simulated Stroke Rehabilitation: Development Method", journal="JMIR Res Protoc", year="2020", month="May", day="7", volume="9", number="5", pages="e16827", keywords="patient monitoring", keywords="patient reported outcome measures", keywords="patient generated health data", keywords="person generated health data", keywords="questionnaire design", keywords="telemedicine", abstract="Background: Person-generated health data (PGHD) are health data that people generate, record, and analyze for themselves. Although the health benefits of PGHD use have been reported, there is no systematic way for patients to measure and report the health effects they experience from using their PGHD. Patient-reported outcome measures (PROMs) allow patients to systematically self-report their outcomes of a health care service. They generate first-hand evidence of the impact of health care services and are able to reflect the real-world diversity of actual patients and management approaches. Therefore, this paper argues that a PROM of utilizing PGHD, or PROM-PGHD, is necessary to help build evidence-based practice in clinical work with PGHD. Objective: This paper aims to describe a method for developing PROMs for people who are using PGHD in conjunction with their clinical care---PROM-PGHD, and the method is illustrated through a case study. Methods: The five-step qualitative item review (QIR) method was augmented to guide the development of a PROM-PGHD. However, using QIR as a guide to develop a PROM-PGHD requires additional socio-technical consideration of the PGHD and the health technologies from which they are produced. Therefore, the QIR method is augmented for developing a PROM-PGHD, resulting in the PROM-PGHD development method. Results: A worked example was used to illustrate how the PROM-PGHD development method may be used systematically to develop PROMs applicable across a range of PGHD technology types used in relation to various health conditions. Conclusions: This paper describes and illustrates a method for developing a PROM-PGHD, which may be applied to many different cases of health conditions and technology categories. When applied to other cases of health conditions and technology categories, the method could have broad relevance for evidence-based practice in clinical work with PGHD. ", doi="10.2196/16827", url="https://www.researchprotocols.org/2020/5/e16827", url="http://www.ncbi.nlm.nih.gov/pubmed/32379052" } @Article{info:doi/10.2196/15399, author="Porthun, Jan and Manschel, Jonas", title="Characteristics, Opportunities, and Challenges of Osteopathy (COCO) in the Perceptions of Osteopaths in Germany, Austria, and Switzerland: Protocol for a Comprehensive Mixed Methods Study", journal="JMIR Res Protoc", year="2019", month="Dec", day="18", volume="8", number="12", pages="e15399", keywords="osteopath", keywords="osteopathic medicine", keywords="health occupations", keywords="occupational profile", keywords="mixed methods", abstract="Background: Currently, the importance of osteopathy within the health care system is controversial. The training structures and the acknowledgment of the occupational profile strongly differ in the German-speaking territory. Objective: This study aims to examine the characteristics of the osteopathic profession as well as the possibilities and challenges for osteopaths in Germany, Austria, and Switzerland. Methods: This study adopted a mixed methods design. The research topic will be examined based on qualitative and quantitative partial studies that will be conducted in parallel as well as sequentially. By applying different research methods and sample testing and by using standardized, validated measurement methods, we expect to be able to gain new insights into the work area of osteopathy. Results: In November 2018, we started the research and data collection. Currently, we are conducting the first two partial studies. The planned duration of each of the partial study is 6-9 months. The project is scheduled to be completed in 2021. Conclusions: This study will examine how osteopaths define themselves in comparison with professionals from other occupational profiles and how they describe the characteristics of their work. The identification of central issues is expected to help clarify the issues and define the profession. As such, the results might contribute to the conservation and improvement of the quality of osteopathic treatment. International Registered Report Identifier (IRRID): PRR1-10.2196/15399 ", doi="10.2196/15399", url="http://www.researchprotocols.org/2019/12/e15399/", url="http://www.ncbi.nlm.nih.gov/pubmed/31850852" } @Article{info:doi/10.2196/jmir.9702, author="Guetterman, C. Timothy and Chang, Tammy and DeJonckheere, Melissa and Basu, Tanmay and Scruggs, Elizabeth and Vydiswaran, Vinod V. G.", title="Augmenting Qualitative Text Analysis with Natural Language Processing: Methodological Study", journal="J Med Internet Res", year="2018", month="Jun", day="29", volume="20", number="6", pages="e231", keywords="qualitative research", keywords="natural language processing", keywords="text data", keywords="methodology", keywords="coding", abstract="Background: Qualitative research methods are increasingly being used across disciplines because of their ability to help investigators understand the perspectives of participants in their own words. However, qualitative analysis is a laborious and resource-intensive process. To achieve depth, researchers are limited to smaller sample sizes when analyzing text data. One potential method to address this concern is natural language processing (NLP). Qualitative text analysis involves researchers reading data, assigning code labels, and iteratively developing findings; NLP has the potential to automate part of this process. Unfortunately, little methodological research has been done to compare automatic coding using NLP techniques and qualitative coding, which is critical to establish the viability of NLP as a useful, rigorous analysis procedure. Objective: The purpose of this study was to compare the utility of a traditional qualitative text analysis, an NLP analysis, and an augmented approach that combines qualitative and NLP methods. Methods: We conducted a 2-arm cross-over experiment to compare qualitative and NLP approaches to analyze data generated through 2 text (short message service) message survey questions, one about prescription drugs and the other about police interactions, sent to youth aged 14-24 years. We randomly assigned a question to each of the 2 experienced qualitative analysis teams for independent coding and analysis before receiving NLP results. A third team separately conducted NLP analysis of the same 2 questions. We examined the results of our analyses to compare (1) the similarity of findings derived, (2) the quality of inferences generated, and (3) the time spent in analysis. Results: The qualitative-only analysis for the drug question (n=58) yielded 4 major findings, whereas the NLP analysis yielded 3 findings that missed contextual elements. The qualitative and NLP-augmented analysis was the most comprehensive. For the police question (n=68), the qualitative-only analysis yielded 4 primary findings and the NLP-only analysis yielded 4 slightly different findings. Again, the augmented qualitative and NLP analysis was the most comprehensive and produced the highest quality inferences, increasing our depth of understanding (ie, details and frequencies). In terms of time, the NLP-only approach was quicker than the qualitative-only approach for the drug (120 vs 270 minutes) and police (40 vs 270 minutes) questions. An approach beginning with qualitative analysis followed by qualitative- or NLP-augmented analysis took longer time than that beginning with NLP for both drug (450 vs 240 minutes) and police (390 vs 220 minutes) questions. Conclusions: NLP provides both a foundation to code qualitatively more quickly and a method to validate qualitative findings. NLP methods were able to identify major themes found with traditional qualitative analysis but were not useful in identifying nuances. Traditional qualitative text analysis added important details and context. ", doi="10.2196/jmir.9702", url="http://www.jmir.org/2018/6/e231/", url="http://www.ncbi.nlm.nih.gov/pubmed/29959110" } @Article{info:doi/10.2196/10312, author="Nielsen, Bettina and Slinning, Kari and Weie Oddli, Hanne and Drozd, Filip", title="Identification of Implementation Strategies Used for the Circle of Security-Virginia Family Model Intervention: Concept Mapping Study", journal="JMIR Res Protoc", year="2018", month="Jun", day="14", volume="7", number="6", pages="e10312", keywords="implementation strategies", keywords="Circle of Security Virginia-Family Model", keywords="Expert Recommendations for Implementing Change taxonomy", keywords="methodology", keywords="reproducibility", keywords="knowledge transfer", abstract="Background: A reoccurring finding from health and clinical services is the failure to implement theory and research into practice and policy in appropriate and efficient ways, which is why it is essential to develop and identify implementation strategies, as they constitute the how-to component of translating and changing health practices. Objective: The aim of this study was to provide a systematic and comprehensive review of the implementation strategies that have been applied for the Circle of Security-Virginia Family (COS-VF) model by developing an implementation protocol. Methods: First, informal interviews and documents were analyzed using concept mapping to identify implementation strategies. All documentation from the Network for Infant Mental Health's work with COS-VF was made available and included for analysis, and the participants were interviewed to validate the findings and add information not present in the archives. To avoid lack of clarity, an existing taxonomy of implementation strategies, the Expert Recommendations for Implementing Change, was used to conceptualize (ie, name and define) strategies. Second, the identified strategies were specified according to Proctor and colleagues' recommendations for reporting in terms of seven dimensions: actor, the action, action targets, temporality, dose, implementation outcomes, and theoretical justification. This ensures a full description of the implementation strategies and how these should be used in practice. Results: Ten implementation strategies were identified: (1) develop educational materials, (2) conduct ongoing training, (3) audit and feedback, (4) make training dynamic, (5) distribute educational materials, (6) mandate change, (7) obtain formal commitments, (8) centralize technical assistance, (9) create or change credentialing and licensure standards, and (10) organize clinician implementation team meetings. Conclusions: This protocol provides a systematic and comprehensive overview of the implementation of the COS-VF in health services. It constitutes a blueprint for the implementation of COS-VF that supports the interpretation of subsequent evaluation studies, facilitates knowledge transfer and reproducibility of research results in practice, and eases the replication and comparison of implementation strategies in COS-VF and other interventions. ", doi="10.2196/10312", url="http://www.researchprotocols.org/2018/6/e10312/", url="http://www.ncbi.nlm.nih.gov/pubmed/29903703" } @Article{info:doi/10.2196/resprot.6452, author="Sieverink, Floor and Kelders, Saskia and Poel, Mannes and van Gemert-Pijnen, Lisette", title="Opening the Black Box of Electronic Health: Collecting, Analyzing, and Interpreting Log Data", journal="JMIR Res Protoc", year="2017", month="Aug", day="07", volume="6", number="8", pages="e156", keywords="eHealth", keywords="black box", keywords="evaluation", keywords="log data analysis", doi="10.2196/resprot.6452", url="http://www.researchprotocols.org/2017/8/e156/", url="http://www.ncbi.nlm.nih.gov/pubmed/28784592" } @Article{info:doi/10.2196/resprot.6766, author="Blijleven, Vincent and Koelemeijer, Kitty and Jaspers, Monique", title="Exploring Workarounds Related to Electronic Health Record System Usage: A Study Protocol", journal="JMIR Res Protoc", year="2017", month="Apr", day="28", volume="6", number="4", pages="e72", keywords="electronic health records", keywords="qualitative research", keywords="workarounds", keywords="unintended consequences", keywords="physicians", keywords="nurses", keywords="administrative personnel", abstract="Background: Health care providers resort to informal temporary practices known as workarounds for handling exceptions to normal workflow that are unintentionally imposed by electronic health record (EHR) systems. Although workarounds may seem favorable at first sight, they are generally suboptimal and may jeopardize patient safety, effectiveness, and efficiency of care. Identifying workarounds and understanding their motivations, scope, and impact is pivotal to support the design of user-friendly EHRs and achieve closer alignment between EHRs and work contexts. Objective: We propose a study protocol to identify EHR workarounds and subsequently determine their scope and impact on health care providers' workflows, patient safety, effectiveness, and efficiency of care. First, knowing whether a workaround solely affects the health care provider who devised it, or whether its effects extends beyond the EHR user to the work context of other health care providers, is key to accurately assessing its degree of influence on the overall patient care workflow. Second, knowing whether the consequence of an EHR workaround is favorable or unfavorable provides insights into how to address EHR-related safety, effectiveness, and efficiency concerns. Knowledge of both perspectives can provide input on optimizing EHR designs. Methods: In the study, a combination of direct observations, semistructured interviews, and qualitative coding techniques will be used to identify, analyze, and classify EHR workarounds. The research project will be conducted within three distinct pediatric care processes and settings at a large university hospital. Results: Data was collected using the described approach from January 2016 to March 2017. Data analysis is underway and is expected to be completed in May 2017. We aim to report the results of this study in a follow-up publication. Conclusions: This study protocol provides a grounded framework to explore EHR workarounds from a holistic and integral perspective. Insights from this study can inform the design and redesign of EHRs to further align with work contexts of healthcare professionals, and subsequently lead to better organization and safer provision of care. ", doi="10.2196/resprot.6766", url="http://www.researchprotocols.org/2017/4/e72/", url="http://www.ncbi.nlm.nih.gov/pubmed/28455273" } @Article{info:doi/10.2196/resprot.5467, author="Garne, Kristina and Br{\o}dsgaard, Anne and Zachariassen, Gitte and Clemensen, Jane", title="Telemedicine in Neonatal Home Care: Identifying Parental Needs Through Participatory Design", journal="JMIR Res Protoc", year="2016", month="Jul", day="08", volume="5", number="3", pages="e100", keywords="preterm infant", keywords="telemedicine", keywords="participatory design", keywords="neonatal home care", abstract="Background: For the majority of preterm infants, the last weeks of hospital admission mainly concerns tube feeding and establishment of breastfeeding. Neonatal home care (NH) was developed to allow infants to remain at home for tube feeding and establishment of breastfeeding with regular home visits from neonatal nurses. For hospitals covering large regions, home visits may be challenging, time consuming, and expensive and alternative approaches must be explored. Objective: To identify parental needs when wanting to provide neonatal home care supported by telemedicine. Methods: The study used participatory design and qualitative methods. Data were collected from observational studies, individual interviews, and focus group interviews. Two neonatal units participated. One unit was experienced in providing neonatal home care with home visits, and the other planned to offer neonatal home care with telemedicine support. A total of 9 parents with preterm infants assigned to a neonatal home care program and 10 parents with preterm infants admitted to a neonatal unit participated in individual interviews and focus group interviews, respectively. Results: Three overall themes were identified: being a family, parent self-efficacy, and nurse-provided security. Parents expressed desire for the following: (1) a telemedicine device to serve as a ``bell cord'' to the neonatal unit, giving 24-hour access to nurses, (2) video-conferencing to provide security at home, (3) timely written email communication with the neonatal unit, and (4) an online knowledge base on preterm infant care, breastfeeding, and nutrition. Conclusions: Our findings highlight the importance of neonatal home care. NH provides parents with a feeling of being a family, supports their self-efficacy, and gives them a feeling of security when combined with nursing guidance. Parents did not request hands-on support for infant care, but instead expressed a need for communication and guidance, which could be met using telemedicine. ", doi="10.2196/resprot.5467", url="http://www.researchprotocols.org/2016/3/e100/", url="http://www.ncbi.nlm.nih.gov/pubmed/27392576" } @Article{info:doi/10.2196/resprot.4591, author="Stellefson, Michael and Alber, Julia and Paige, Samantha and Castro, Daniela and Singh, Briana", title="Evaluating Comparative Effectiveness Research Priorities for Care Coordination in Chronic Obstructive Pulmonary Disease: A Community-Based eDelphi Study", journal="JMIR Res Protoc", year="2015", month="Aug", day="12", volume="4", number="3", pages="e103", keywords="capacity building", keywords="community engagement", keywords="comparative effectiveness research", keywords="Internet", keywords="patient-centered care", keywords="patient-centered outcomes research", keywords="pulmonary disease", keywords="Web-based collaboration", abstract="Background: Despite research supporting the use of care coordination in chronic obstructive pulmonary disease (COPD), there is relatively little known about the comparative effectiveness of different strategies used to organize care for patients. To investigate the most important COPD care coordination strategies, community-based stakeholder input is needed, especially from medically underserved populations. Web-based platforms are electronic tools now being used to bring together individuals from underrepresented populations to share input and obtain clarification on comparative effectiveness research (CER) ideas, questions, and hypotheses. Objective: Use low computer-literate, collaborative survey technology to evaluate stakeholder priorities for CER in COPD care coordination. Methods: A mixed-method, concurrent triangulation design was used to collect survey data from a virtual advisory board of community-based stakeholders including medically underserved patients with COPD, informal caregivers, clinicians, and research scientists. The eDelphi method was used to conduct 3 iterative rounds of Web-based surveys. In the first 2 survey rounds, panelists viewed a series of ``mini research prospectus'' YouTube video presentations and rated their level of agreement with the importance of 10 COPD care coordination topics using 7-point Likert scales. In the final third-round survey, panelists ranked (1=most important, 8=least important) and commented on 8 remaining topics that panelists favored most throughout the first 2 survey rounds. Following the third-round survey, panelists were asked to provide feedback on the potential impact of a Web-based stakeholder engagement network dedicated to improving CER in COPD. Results: Thirty-seven panelists rated the following care coordination topics as most important (lower means indicate greater importance): (1) measurement of quality of care (mean 2.73, SD 1.95); (2) management of COPD with other chronic health issues (mean 2.92, SD 1.67); (3) pulmonary rehabilitation as a model for care (mean 3.72; SD 1.93); (4) quality of care coordination (mean 4.12, SD 2.41); and (5) comprehensive COPD patient education (mean 4.27, SD 2.38). Stakeholder comments on the relative importance of these care coordination topics primarily addressed the importance of comparing strategies for COPD symptom management and evaluating new methods for patient-provider communication. Approximately one half of the virtual panel assembled indicated that a Web-based stakeholder engagement network could enable more online community meetings (n=19/37, 51\%) and facilitate more opportunities to suggest, comment on, and vote for new CER ideas in COPD (n=18/37, 49\%). Conclusions: Members of this unique virtual advisory board engaged in a structured Web-based communication process that identified the most important community-specific COPD care coordination research topics and questions. Findings from this study support the need for more CER that evaluates quality of care measures used to assess the delivery of treatments and interventions among medically underserved patients with COPD. ", doi="10.2196/resprot.4591", url="http://www.researchprotocols.org/2015/3/e103/", url="http://www.ncbi.nlm.nih.gov/pubmed/26268741" } @Article{info:doi/10.2196/resprot.4404, author="Avis, LS Jillian and van Mierlo, Trevor and Fournier, Rachel and Ball, DC Geoff", title="Lessons Learned From Using Focus Groups to Refine Digital Interventions", journal="JMIR Res Protoc", year="2015", month="Jul", day="31", volume="4", number="3", pages="e95", keywords="data collection", keywords="digital interventions", keywords="focus groups", keywords="health care", keywords="Internet", keywords="qualitative research", doi="10.2196/resprot.4404", url="http://www.researchprotocols.org/2015/3/e95/", url="http://www.ncbi.nlm.nih.gov/pubmed/26232313" }