JMIR Research Protocols最新文献

{"title":"Interventions to Counter Health Misinformation Among Older People: Protocol for a Scoping Review.","authors":"Maryline Vivion, Valérie Reid, Valérie Trottier, Frédéric Bergeron, Isabelle Savard, Emilie Dionne, André Tourigny","doi":"10.2196/74138","DOIUrl":"10.2196/74138","url":null,"abstract":"<p><strong>Background: </strong>In contemporary society, misinformation and disinformation have emerged as significant challenges, impacting various aspects of public health and societal cohesion. Some authors argue that older adults are particularly vulnerable to the effects of misinformation due to potential digital health literacy challenges. A previous review identified pedagogical approaches most commonly adopted in interventions aiming to improve the digital literacy of older adults but did not specifically address digital health literacy.</p><p><strong>Objective: </strong>This scoping review protocol aims to explore digital health literacy interventions targeting health misinformation and designed specifically for older adults.</p><p><strong>Methods: </strong>Following the methodology outlined by Arksey and O'Malley and the PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) checklist, this protocol delineates a systematic approach encompassing 5 stages: identification of research questions, identification of relevant studies, selection of studies, data charting, and collation of findings. Our scoping review will include peer-reviewed literature on interventions targeting misinformation for older adults. Research will be conducted on the MEDLINE (Ovid), Embase (Elsevier), PsycINFO (Ovid), CINAHL, and Web of Science databases. Gray literature will also be surveyed by performing a Google search to identify interventions and tools employed by public or private organizations, institutes, groups, or agencies. The databases and gray literature will be searched to identify relevant publications. Two members of our team will independently select publications to include in the review by using the Covidence review software (Veritas Health Innovation). The publications included will specifically address our research questions, be peer-reviewed, evidence-based, and published from January 1, 2005, in full-text English or French version. Data will be extracted from the included publications to mainly chart the intervention's objectives, types, target age groups, effectiveness, and risks reported. A thematic analysis will be conducted to categorize the study findings.</p><p><strong>Results: </strong>The funding for this project was provided in March 2024. The research questions were identified in January 2024. The databases and gray literature search strategies were developed in February 2024. The final selection of the publications; the charting, collating, and summarizing of data; along with the reporting of findings are planned for August to September 2025. The findings of this scoping review will be shared through publication in an open access journal and presentations scheduled between September and December 2025.</p><p><strong>Conclusions: </strong>This protocol will enable us to contribute to the advancement of knowledge in combating health misinformation among older adults. The results wil","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e74138"},"PeriodicalIF":1.4,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144608391","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Conversational Systems for Social Care in Older Adults: Protocol for a Scoping Review.","authors":"Rosiered Brownson-Smith, Ananya Ananthakrishnan, Oksana Hagen, Cen Cong, Amir Aly, Ray B Jones, Edward Meinert","doi":"10.2196/72310","DOIUrl":"10.2196/72310","url":null,"abstract":"<p><strong>Background: </strong>Social care systems worldwide face increasing demographic and financial pressures. This necessitates exploring innovative technological solutions to enhance service delivery without substantially increasing costs. Conversational interfaces, including interactive voice response, chatbots, and voice assistants, have gained traction as a means to improve accessibility and efficiency in social care. The rapid development of large language models such as ChatGPT has further accelerated interest in conversational artificial intelligence (AI). These technologies can offer intuitive interactions, particularly for individuals with limited digital literacy. However, their real-world impact, usability, and ethical considerations in social care remain underexplored.</p><p><strong>Objective: </strong>This scoping review aims to synthesize existing literature on the implementation, evaluation, and impact of conversational AI systems within social care settings for older adults. The review will identify best practices, current gaps, and future directions for research and implementation. Key research questions include the following: how are conversational systems implemented on a technical level, and how do older adults and their support systems use them in a social care context? What methods are used to evaluate acceptability, usability, and the impact of broad well-being in the context of older adults' social care? and What are conversational technologies' acceptability, usability, and well-being impact in the context of older adults' social care?</p><p><strong>Methods: </strong>The review will follow the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) and Population, Concept, and Context (PCC) frameworks. A systematic search will be conducted across five databases (IEEE, Web of Science, PubMed, ACM, and Scopus) for English-language articles published from 2019 onward. Studies will be included if they empirically examine conversational systems' implementation, evaluation, or impact for older adults (aged ≥55 years) within a social care context. Two independent reviewers will screen articles and extract data. A descriptive analysis will then categorize findings across key domains such as accessibility, usability, ethical considerations, and well-being outcomes.</p><p><strong>Results: </strong>The results will be included in the scoping review, which began in March 2025. The analysis is underway and is expected to be completed and submitted for publication by September 2025.</p><p><strong>Conclusions: </strong>This scoping review will provide an overview of the role of conversational AI in social care, highlighting both opportunities and challenges in implementation. By synthesizing existing research, the review will inform future developments in the use of conversational agents to improve social inclusion, engagement, and well-being among older adults.</p><p><strong>In","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e72310"},"PeriodicalIF":1.4,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144608389","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Digital Health Applications (DiGA) for Treating Depression and Generalized Anxiety Disorder: Protocol for a Systematic Health App Review and Systematic Review of Published Evidence.","authors":"Annika Schmitz, Lucas Kueppers, Jacob Klein, Silke Frey, Arian Karimzadeh, Ana Luísa Neves, Birgitta Weltermann","doi":"10.2196/63380","DOIUrl":"10.2196/63380","url":null,"abstract":"<p><strong>Background: </strong>Depression and generalized anxiety disorder (GAD) are widespread mental health diseases with significant individual and societal consequences. Psychotherapy, particularly cognitive behavioral therapy (CBT), is a common treatment approach, but its application is limited due to costs and staff shortages. Germany has been the first country to integrate and reimburse digital health applications (DiGAs) as an easily accessible treatment option since 2020. Despite regulatory processes, skepticism among physicians regarding clinical relevance and evidence persists.</p><p><strong>Objective: </strong>This protocol aims to describe the methodology of the planned systematic review. Using expert ratings, the app review will assess the guideline conformity, functions, and usability of German DiGAs for depression and GAD listed at the Federal Institute for Drugs and Medical Devices (BfArM). The additional systematic review will synthesize the effectiveness and quality of these DiGAs based on randomized controlled trials.</p><p><strong>Methods: </strong>The study protocol follows the 2015 PRISMA (Preferred Reporting Items for Systematic Reviews) guideline and was registered in the international Prospective Register of Systematic Reviews (PROSPERO). The review consists of 2 parts: (1) a systematic health app review of DiGAs addressing depression or GAD and (2) a systematic review of published evidence on these DiGAs. The systematic health app review comprises a summary of the DiGA features including the Institute for Healthcare Informatics (IMS) App Functionality Scoring System, a guideline conformity check, and the Mobile Application Rating Scale (MARS) assessment. The systematic review of published evidence is based on a systematic literature search in electronic databases (MEDLINE via PubMed, Cochrane Central Register of Controlled Trials [CENTRAL], Web of Science), as well as relevant websites. The approach includes an effectiveness evaluation, a risk of bias assessment using the Cochrane tool, Risk of Bias 2 (RoB2), and an overall quality evaluation using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) method.</p><p><strong>Results: </strong>The systematic literature search was conducted in July 2024 and August 2024, and an updated search is planned for November 2025. Data extraction, narrative synthesis, and evaluation of DiGA and corresponding studies are expected to be completed in spring 2026. The results will be presented using a PRISMA flow diagram and tables to display general information, risk of bias, and overall quality.</p><p><strong>Conclusions: </strong>The review will influence both the actual use and future developments of DiGAs. Good quality characteristics will enhance transparency and trust among physicians, while quality deficits provide options for improvement by manufacturers and governing institutions. Consequently, patients' care with DiGAs may improve.</p><p><strong>Trial","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e63380"},"PeriodicalIF":1.4,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144608390","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Higher-Than-Standard-Intensity International Normalized Ratio Goal for Patients Undergoing Mechanical Aortic Valve Replacement With Additional Thrombotic Risk Factors: Protocol for a Systematic Review and Meta-Analysis.","authors":"Myung-Rho Kim, Taha Shaikh, Shawn Wang, Spencer Taylor, Vidhani Goel, Banveet Kaur Khetarpal, Chowdhury Ahsan, Kavita Batra","doi":"10.2196/73389","DOIUrl":"10.2196/73389","url":null,"abstract":"<p><strong>Background: </strong>Lifelong anticoagulation therapy with vitamin K antagonists is recommended following mechanical aortic valve replacement (MAVR) to prevent valve thrombosis. Current guidelines recommend a standard international normalized ratio (INR) of 2.5 for patients with MAVR without additional thromboembolic risk factors, and a higher INR goal of 3.0 for those with conditions such as atrial fibrillation, prior thromboembolism, or left ventricular dysfunction. However, limited clinical evidence exists to guide anticoagulation intensity in this high-risk subgroup, necessitating a systematic review.</p><p><strong>Objective: </strong>We aimed to assess the safety and efficacy of higher-intensity INR goals (>3.0) compared to standard-intensity goals (approximately 2.5) in patients with MAVR with additional thromboembolic risk factors.</p><p><strong>Methods: </strong>This protocol describes a systematic review and meta-analysis following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 guidelines. A comprehensive literature search will be conducted across PubMed, Embase, and the Cochrane Library for studies published before December 18, 2024. Eligible studies include randomized controlled trials (RCTs), cohort studies, and follow-up studies involving adult patients with MAVR on warfarin therapy, stratified by the presence of additional thromboembolic risk factors. Non-English-language studies, case reports, editorials, and animal studies will be excluded.</p><p><strong>Results: </strong>The review will synthesize existing data to compare the risks and benefits of intensified anticoagulation in patients with MAVR with additional thromboembolic risk factors. Data analysis and manuscript preparation are scheduled for July-August 2025.</p><p><strong>Conclusions: </strong>This study will provide critical evidence on INR management in high-risk patients with MAVR, potentially informing future updates to clinical guidelines and optimizing the balance between thromboembolic prevention and bleeding risk.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/73389.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e73389"},"PeriodicalIF":1.4,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144608388","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Stress Management Among Caregivers of Detained Youth: Protocol for Randomized Controlled Trial of the RAISE Web-Based mHealth App.","authors":"Johanna B Folk, Adrian Aguilera, Tara M Chaplin, Marina Tolou-Shams","doi":"10.2196/67511","DOIUrl":"10.2196/67511","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Detained adolescents exhibit high rates of behavioral health needs, yet few receive treatment during detention or community re-entry. Once adolescents are released into the community, caregivers must mobilize significant resources and overcome barriers to facilitate their treatment engagement. Parenting stress is often heightened during this forced separation and the re-entry transition. Parenting stress is associated with greater perceived barriers to treatment and, for adolescents who begin treatment, less therapeutic change and premature treatment dropout. Interventions designed to support caregivers of detained adolescents in managing their stress while navigating the juvenile legal system are urgently needed, and mobile health (mHealth) interventions offer promising, scalable approaches. RAISE (Reducing pArentIng StrEss) is a web-based application co-designed with caregivers of detained adolescents to reduce caregiver stress and promote postrelease adolescent behavioral health services use.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study will evaluate the effectiveness of RAISE in reducing caregiver stress and promoting adolescent behavioral health services use following release from detention.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A randomized controlled trial with 60 caregivers of detained adolescents (ages 12-17 years) across the United States will be conducted. Caregivers will be recruited through passive and active techniques and randomized to receive RAISE (intervention) or an informational brochure (comparison). Self-assessment questionnaires will be completed at baseline and 3- and 6-month follow-up timepoints. The fully automated RAISE intervention includes an 8-week stress reduction intervention, self-monitoring and affirmational SMS text messaging, and resources related to navigating the juvenile legal system. Assessments include empirically validated measures of parenting stress, mindful parenting, parenting self-efficacy, adolescent services use, motivation for youth treatment, caregiver behavioral health, sociodemographics, and RAISE usability (intervention only). Caregivers will also participate in a semistructured qualitative exit interview at the 3-month (postintervention) timepoint. Descriptive statistics will examine recruitment, randomization, assessment, retention, and application usability. Independent samples t tests and chi-square analyses will determine whether randomization was successful based on multiple background variables; group differences will be accounted for in outcome analyses. Regression analyses will be used for outcome analyses, with an intent-to-treat design; analyses will include intervention group as a predictor and control for the baseline level of the outcome, application usage, and demographic characteristics. Potential moderators and mediators of intervention effects will be explored.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;We propose the enrollment of 60 caregivers by April 2025, ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e67511"},"PeriodicalIF":1.4,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144608392","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Training and Education Programs for Health Care Professionals on Video and Text-Based Meetings in Ensuring Health Care Quality: Protocol for a Scoping Review.","authors":"Md Shafiqur Rahman Jabin, Aneekah Ashfaq, Nussrat Bi, Evalill Nilsson","doi":"10.2196/69963","DOIUrl":"10.2196/69963","url":null,"abstract":"<p><strong>Background: </strong>The use of video meetings and text-based meetings has surged and emerged as a critical tool in health care. These tools offer many benefits, such as patient prescreening, counseling services, remote patient tracking, and monitoring. With the increasing demand for technologies, health care professionals require training and educational competency development to sustain in the modern digital age. This necessitates synthesizing evidence about the existing training programs in arranging and regulating such meetings, the implementation, and reassurance about the effectiveness of these digital health meetings.</p><p><strong>Objective: </strong>The synthesis will also uncover what training programs for health care professionals to conduct video and text-based meetings are available, and if so, how they were implemented and their impacts from the perspectives of the organization, the staff, and the patients.</p><p><strong>Methods: </strong>The review will follow the Joanna Briggs Institute (JBI) methodology. The published studies will be searched in APA PsycInfo, PubMed, and CINAHL, and the unpublished studies through Mednar, Trove, OCLC WorldCat, Dissertations, and Theses. Studies published in English from 2003 will be considered. This review will include studies of health care professionals trained to communicate online with patients or service users, health care professionals, and health care organizations. The concept will involve online communication, such as conducting video and text-based meetings (emails, chats, and web portals), and the context will consider studies based on health care, hospitals or clinics, and primary care. A broad scope of evidence, including quantitative, qualitative, text, and opinion studies, will be considered. A total of 2 independent reviewers will screen the titles and abstracts and review the full text. Data will be extracted from the included studies using a data extraction tool developed for this study.</p><p><strong>Results: </strong>The results will be presented in a PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) flow diagram. A draft charting table will be developed as a data extraction tool. The results will be presented as a \"map\" of the data in a logical, diagrammatic, or tabular form and a descriptive format. This protocol was first developed by the principal author at Linnaeus University in April 2022; however, a full search was undertaken in August 2024 as part of research development at the University of Bradford.</p><p><strong>Conclusions: </strong>The review will identify the knowledge gaps, clarify the concepts, examine emerging evidence, and thus make recommendations for future research on video consultation and text-based meetings.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/69963.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e69963"},"PeriodicalIF":1.4,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144600428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sustained Virological Response as a Surrogate Marker for Mortality, Decompensated Cirrhosis, or Hepatocellular Carcinoma in People With Chronic Hepatitis C Virus Infection Treated With Direct-Acting Antivirals: Protocol for a Bayesian and Causal Mediation Analysis.","authors":"Kurinchi Selvan Gurusamy, Christian Gluud","doi":"10.2196/68113","DOIUrl":"10.2196/68113","url":null,"abstract":"<p><strong>Background: </strong>Sustained virological response (SVR) is commonly used as a marker of treatment success in people with chronic hepatitis C virus (HCV) infection. However, there is uncertainty on whether SVR is a validated surrogate marker of successful chronic HCV infection treatment.</p><p><strong>Objective: </strong>This research project aims to evaluate whether SVR is a good surrogate for all-cause mortality, decompensated cirrhosis, any specific aspect of liver decompensation (jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage), or hepatocellular carcinoma in people with chronic HCV infection eligible to receive direct-acting antiviral drugs.</p><p><strong>Methods: </strong>We will use two ongoing systematic reviews on the effectiveness of direct-acting antiviral drugs in chronic HCV infection as our data sources. The analysis plan is to estimate the regression coefficients or between-studies correlation between SVR and an event using three different Bayesian approaches with OpenBUGS, as outlined in the guidance by the evidence synthesis unit, and estimate the average proportion of the effect mediated through SVR by causal mediation analysis using R.</p><p><strong>Results: </strong>As of June 19, 2025, the two systematic reviews (one on randomized clinical trials and one on observational studies) on the effectiveness of direct-acting antiviral drugs in chronic HCV infection are ongoing.</p><p><strong>Conclusions: </strong>We will use the German Institute of Quality and Efficiency in Health Care criterion for surrogacy for cancer, with at least 50% of the treatment effect mediated through SVR, but the information will be reported in a way that allows people to interpret the information using their own criteria.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e68113"},"PeriodicalIF":1.4,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144600430","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ethical Implications of Artificial Intelligence in Vaccine Equity: Protocol for Exploring Vaccine Distribution Planning and Scheduling in Pandemics in Low- and Middle-Income Countries.","authors":"Ifeanyichukwu Akuma, Vina Vaswani, Elif Perihan Ekmekci","doi":"10.2196/76634","DOIUrl":"https://doi.org/10.2196/76634","url":null,"abstract":"<p><strong>Background: </strong>The COVID-19 pandemic highlighted significant disparities in vaccine distribution, particularly in low- and middle-income countries (LMICs). Artificial intelligence (AI) has emerged as a potential tool to optimize vaccine distribution planning and scheduling. However, its ethical implications, including equity, transparency, bias, and accessibility, remain underexplored. Ensuring ethical AI implementation in vaccine distribution is crucial to addressing health equity challenges worldwide.</p><p><strong>Objective: </strong>This study aims to assess the ethical implications of AI-assisted vaccine distribution planning and scheduling in LMICs during pandemics. It seeks to evaluate AI's role in ensuring equitable vaccine access, analyze ethical concerns associated with its deployment, and propose an ethical framework to guide AI-based vaccine distribution strategies.</p><p><strong>Methods: </strong>Our multiphase qualitative research approach will combine a systematic scoping review, a witness seminar with key stakeholders (health care professionals, AI developers, policymakers, and bioethicists), and a meta-synthesis of findings. The scoping review will follow PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses Extension for Scoping Reviews) guidelines, focusing on studies from 2019 to 2023. The witness seminar will provide firsthand insights into AI's ethical impact on vaccine equity. Thematic content analysis and qualitative coding will be used for data interpretation, with findings integrated into a policy-driven ethical framework.</p><p><strong>Results: </strong>This study received institutional ethical approval in October 2023. Recruitment commenced in mid-August 2024 through email requests to prospective participants, and recruitment for the witness seminar (focus group discussion) is still ongoing, with 7 expert participants confirmed. Data collection is projected to conclude by August 2025. Preliminary literature analysis from the scoping review is ongoing, and qualitative data analysis from the witness seminar is scheduled for September 2025. The final results and proposed ethical framework are expected to be published in early 2026.</p><p><strong>Conclusions: </strong>By examining the ethical implications of AI in vaccine distribution, this research will provide actionable recommendations for policymakers, health care organizations, and AI developers. The findings will contribute to the discourse on responsible AI deployment in health care worldwide, ensuring transparency, fairness, and inclusivity in pandemic response strategies.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/76634.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e76634"},"PeriodicalIF":1.4,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144600427","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry): Protocol for an Open-Label Prospective Randomized Trial.","authors":"Ann-Kristine Mandøe Svendsen, Søren Hagstrøm, Konstantinos Kamperis, Anna Elizabeth Andersen, Nanna Celina Henneberg, Jason Van Batavia, Anne Estrup Olesen, Luise Borch","doi":"10.2196/63226","DOIUrl":"10.2196/63226","url":null,"abstract":"<p><strong>Background: </strong>To the best of our knowledge, no studies have investigated the withdrawal strategy of pharmacological treatment with solifenacin or mirabegron in children diagnosed with urinary incontinence who have achieved continence on pharmacotherapy.</p><p><strong>Objective: </strong>The primary objective is to investigate if abrupt withdrawal versus gradual withdrawal of pharmacotherapy (solifenacin or mirabegron) influences the risk of recurrence of incontinence, assessed by a self-reported 14-day calendar of incontinence episodes.</p><p><strong>Methods: </strong>Children aged 5-14 years diagnosed with urinary incontinence, treated with pharmacotherapy of solifenacin or mirabegron and ready for withdrawal, will be randomized 1:1 to either abrupt or gradual withdrawal, according to the medical treatment that the child is receiving. The primary outcome measure is the recurrence of incontinence after withdrawal, 1 month after initiation of withdrawal of the physician-prescribed medication, assessed by a self-reported 14-day calendar of incontinence episodes. In addition, recurrence of incontinence after 3, 6, and 12 months after initiation of withdrawal will be measured. The hypothesis that gradual withdrawal is superior to abrupt withdrawal regarding the risk of recurrence of incontinence will be analyzed by logistic regression.</p><p><strong>Results: </strong>Recruitment began at the end of May 2024 and will continue until 216 patients are included, which is expected by December 2027. As of February 2025, a total of 25 participants are included.</p><p><strong>Conclusions: </strong>The results are expected to influence the withdrawal strategy of pharmacological treatment with solifenacin or mirabegron in children with daytime urinary incontinence.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06465576; https://clinicaltrials.gov/search?term=NCT06465576.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/63226.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e63226"},"PeriodicalIF":1.4,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144600429","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Optimizing a Personalized Health Approach for Virtually Treating High-Risk Caregivers of Children With Neurogenetic Conditions (Project WellCAST): Protocol for a Randomized Controlled Trial.","authors":"Bridgette Kelleher, Kaleb Emerson, Lyndsey N Graham, Veronika Vozka, Anne Wheeler, William Fadel, Daniel Foti, Isha Metzger, Mandy Rispoli, Wendy Machalicek, Laurie McLay, Sean Lane, Wei Siong Neo, Allie Carter, Lisa Brown, Jennifer Brown, Laura Lee McIntyre, Elizabeth Salwitz, Gloria Dietz, Riley Naughton, Katlyn Peek, Nicole Hollins, Emma Woodford","doi":"10.2196/80023","DOIUrl":"https://doi.org/10.2196/80023","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.2196/64360.].</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e80023"},"PeriodicalIF":1.4,"publicationDate":"2025-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144591287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}