JMIR Research Protocols最新文献

{"title":"Efficacy and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Poststroke Dysphagia: Protocol for a Randomized, Sham-Controlled Clinical Trial.","authors":"Luming Gao, Jin Li, Miao Xie, Canyi Xu, Changying Zhang, Weichuan Kuang, Xi Wen, Xiaoyin Wang, Yue Liu, Yu Wang, Tong Liu","doi":"10.2196/95182","DOIUrl":"https://doi.org/10.2196/95182","url":null,"abstract":"<p><strong>Background: </strong>Dysphagia is a common complication following stroke. While current management strategies for poststroke dysphagia (PSD) range from nutritional support to neurostimulation techniques, an optimal treatment regimen remains elusive. As a promising noninvasive neuromodulation approach, transcutaneous auricular vagus nerve stimulation (taVNS) requires further validation in rigorously designed trials to establish robust evidence of its efficacy and mechanisms of action.</p><p><strong>Objective: </strong>This study aims to validate the efficacy of taVNS in treating PSD and to elucidate its underlying mechanisms, thereby supporting the development of a novel, noninvasive therapeutic strategy for improving swallowing function in stroke survivors.</p><p><strong>Methods: </strong>This study will use a prospective, randomized, double-blind, controlled trial design. A total of 40 patients with PSD will be enrolled and randomly allocated to either a taVNS group or a sham taVNS group. Both groups will receive conventional swallowing rehabilitation therapy as the baseline intervention. The taVNS group will receive bilateral electrical stimulation at the cymba conchae and cavum conchae of the auricle. These sites correspond to the \"Heart\" and \"Kidney\" auricular acupoints, selected in accordance with traditional Chinese medicine theory. In contrast, the sham taVNS group will receive stimulation at regions of the auricle not innervated by the vagus nerve. The primary outcome measure will be the Penetration-Aspiration Scale score. Secondary outcomes will include the Yale Pharyngeal Residue Severity Rating Scale, hyoid bone displacement and hyoid-thyroid approximation distance assessed via B-mode ultrasonography, and motor-evoked potentials of the suprahyoid muscles elicited by transcranial magnetic stimulation. All outcome measures will be evaluated at baseline and after the 2-week intervention period.</p><p><strong>Results: </strong>This paper describes the protocol for a study evaluating the efficacy and mechanisms of taVNS in patients with PSD. The study was funded in January 2025. Participant recruitment began in March 2025 and is projected to conclude by October 2026. Data collection began in March 2025 and is projected to be completed by October 2026. Primary study results are expected to be submitted for publication in winter 2026.</p><p><strong>Conclusions: </strong>This study aims to validate the efficacy of taVNS in treating PSD and to elucidate its underlying mechanisms, thereby supporting the development of a novel, noninvasive therapeutic strategy for improving swallowing function in stroke survivors.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e95182"},"PeriodicalIF":1.6,"publicationDate":"2026-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149286908","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":"Mapping the Literature on Self-Efficacy Levels Among Medical Students in Higher Education: Protocol for a Scoping Review to Guide Educational Strategies.","authors":"Alex Bertolazzo Quitério, Emerson Roberto Dos Santos, João Daniel de Souza Menezes, Matheus Querino da Silva, Clarissa Albuquerque Vaz Nunes, Denise Iglesias Lima Silvestrini, Alana Clara Santos Rocha, Pedro Belchior da Silveira Junior, Andressa Karina Stefani, Thiago Sivieri, Gustavo Gouveia Macedo, Camila Bortoluci de Lima, Janaína Aparecida de Sales Floriano, Marina Ottoboni Rossi, Giovana Viecili Rossi, Ana Paula Bernardes da Rosa, Luís Cesar Fava Spessoto, Gerardo Maria de Araújo Filho, Antônio Hélio Oliani, Denise Cristina Móz Vaz, Izaura Dos Santos Ramos, Fabiana de Souza Orlandi, Samila Bernardi do Vale Lopes, Julio César André","doi":"10.2196/95032","DOIUrl":"https://doi.org/10.2196/95032","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Self-efficacy significantly influences medical students' academic performance. Rooted in Albert Bandura's social cognitive theory, self-efficacy is defined as an individual's subjective judgment of their capability to organize and execute courses of action required to attain designated types of performances. Unlike general self-esteem, self-efficacy is task- and context-specific. In undergraduate medical education, self-efficacy operates across three interdependent subdomains: (1) academic self-efficacy, encompassing cognitive confidence to master biomedical curricula; (2) clinical skills self-efficacy, reflecting perceived competence in procedural tasks and clinical reasoning; and (3) interpersonal and communication self-efficacy, denoting confidence in empathetic history taking and interprofessional collaboration. These subdomains are presented as a provisional analytical heuristic informed by Bandura's social cognitive theory and prior reviews of self-efficacy in medical education.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This scoping review aims to map and analyze the literature on self-efficacy among medical students, identifying factors in its construction and influence on academic performance. The review also aims to catalog the instruments used to measure self-efficacy and examine changes in self-efficacy over time and across stages of medical training.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Following the frameworks of Arksey and O'Malley, Levac et al, and the Joanna Briggs Institute, this review addresses the question, \"What has been published about self-efficacy levels in higher education among medical students?\" Comprehensive searches across major electronic databases and gray literature will include studies from January 2019 to September 2026, in English, Portuguese, or Spanish, focusing on undergraduate medical students. Searches will be conducted in the Embase, Cochrane Library, PubMed, Scopus, Virtual Health Library, Web of Science databases and in the education- and psychology-focused databases ERIC and PsycInfo using an expanded search strategy incorporating controlled vocabulary (MeSH [Medical Subject Headings], Emtree, and DeCS [Descritores em Ciências da Saúde]) and free-text synonyms. Screening will be performed using Covidence software (Veritas Health Innovation), with discrepancies resolved by a third senior reviewer. Data will be narratively synthesized through descriptive qualitative mapping and structured tabular summaries, without quantitative statistical pooling.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This protocol was registered prospectively on the Open Science Framework before manuscript submission. This research has not received specific funding from any agency in the public, commercial, or not-for-profit sectors. No data have been collected as of September 2026. Each of the 4 review phases is estimated to take 2 months. Results are expected to be published approximately 9 to 12 months following the init","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e95032"},"PeriodicalIF":1.6,"publicationDate":"2026-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149267655","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":"Assessing Pandemic Response Implementation and the Workforce Impact Among Nurses and Midwives Internationally: Protocol for an Exploratory, Pragmatic, Online Descriptive Study.","authors":"Allison Squires, Hillary J Dutton, Amal Mobarki, Simon Andrew Jones","doi":"10.2196/94179","DOIUrl":"https://doi.org/10.2196/94179","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The COVID-19 pandemic placed unprecedented demands on nurses and midwives worldwide, exacerbating existing workforce shortages and contributing to high rates of mental health issues and altered labor market dynamics. Nurses and midwives in low- and middle-income countries remain underrepresented in the literature.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The aim of this study is to describe and compare the impact of pandemic response implementation across countries and contexts on the global nursing and midwifery workforce who worked and delivered care between March 2020 and December 2023.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A pragmatic design guides this multinational, online, descriptive study. Eligible participants are nurses and midwives who cared for at least 1 patient with suspected or confirmed COVID-19. Country teams use opt-in convenience and network sampling, targeting 300 participants per country, or 60 participants for small island states. The self-administered 79-question instrument, hosted on Qualtrics XM software and available in 27 languages, was developed with country teams. It includes 8 open-ended free-text questions; 46 questions examining the impact of pandemic response implementation on mental health, career mobility, economics, and occupational exposures; and 25 demographic questions. After pilot-testing, data collection took place between July 2022 and June 2026. Summative content analysis combined with natural language processing techniques analyzed the qualitative data. Descriptive and bivariate analyses analyzed quantitative responses. Cross-country comparative analyses of quantitative data use funnel plots with binomial control limits to compare country responses and can accommodate unequal sample sizes. Psychometric evaluation of instruments developed and tested in this study is planned. Funding and ethics approval for the study were provided by the lead author's university.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;At the conclusion of data collection in June 2026, a total of more than 23,000 nurses and midwives from 108 countries engaged with this study's online instrument, with over 14,000 completing more than 50% of all the questions. Descriptive analyses of partial samples have been published, as have the pilot tests of the methodology. The analyses specified here will use the complete dataset and are underway, with the first multinational analyses expected in 2027. Country teams will lead analyses specific to their country.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Upon completion, this study will identify the common and unique factors that influenced pandemic response implementation relative to nurses and midwives during the COVID-19 pandemic, from low-resource to high-resource settings. Data may provide multilevel insights into the postpandemic workforce. Finally, this study will provide data that can inform country-level preparation to meet key articles of the World Health Organization Pandemic Agreement","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e94179"},"PeriodicalIF":1.6,"publicationDate":"2026-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13712254/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149286929","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Resilient Together Dyadic Intervention for Persons With Dementia and Their Partners: Protocol for a Feasibility Randomized Controlled Trial.","authors":"Sarah M Bannon, Sydney M McCage, Renata Elizalde Carrillo, Stephan A Brandt, Grace O Allison, Aida Aminpour, Kristin Walker, Talea Cornelius, Robert A Parker, Kristen Dams-O'Connor, Bradford Dickerson, Christine Ritchie, Ana-Maria Vranceanu","doi":"10.2196/106005","DOIUrl":"https://doi.org/10.2196/106005","url":null,"abstract":"<p><strong>Background: </strong>Alzheimer disease and related dementias can impact emotional distress and individual and relational health among persons living with dementia and their romantic partners. There are limited skill-based interventions that can help couples build resilience while navigating dementia-related challenges.</p><p><strong>Objective: </strong>We aim to assess the feasibility, acceptability, and preliminary signal of improvement of Resilient Together for Alzheimer's Disease and Related Dementia (RT-ADRD), a novel dyadic skills-based intervention aimed at preventing chronic emotional distress early after diagnosis.</p><p><strong>Methods: </strong>Couples are randomized to complete either (1) six weekly conjoint intervention sessions of RT-ADRD or (2) a minimally enhanced usual care condition involving a self-guided pamphlet. Both partners must demonstrate capacity to consent to research participation, and at least 1 partner must exhibit clinically elevated emotional distress. Partners living with dementia must have received their diagnosis in the past 6 months. Participants complete baseline and posttest assessments of resiliency skills, emotional distress, relationship functioning, and quality of life and assessments of treatment satisfaction at posttest only.</p><p><strong>Results: </strong>This is aim 3 of a 5-year funded study that initially began in July 2022. Participant recruitment and data collection for this phase began in October 2024 and will continue until 40 couples (80 individuals) are randomized and complete the posttest. As of manuscript submission (July 2026), 25 couples have been enrolled and 25 couples have been randomized. Data collection is currently underway, and study completion is expected by early 2027.</p><p><strong>Conclusions: </strong>This study will gather comprehensive information on the feasibility and acceptability of RT-ADRD relative to minimally enhanced usual care and assess the preliminary signal of improvement in proximal outcomes. Findings will directly inform plans for a larger efficacy trial.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e106005"},"PeriodicalIF":1.6,"publicationDate":"2026-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13712169/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149286959","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk-of-Bias Assessment of Target Trial Emulation Studies at Regulatory and Policy Decision Points Along the Medical Product Life Cycle: Protocol for a Scoping Review and Stakeholder Survey.","authors":"Anni Kokolahti, Saara Puustinen, Martin Russek, Christoph Röthlein, Cornelia Becker, Jonas Peltner, Ines Costa, Sirpa Hartikainen, Britta Haenisch, Cláudia Furtado, Anna-Maija Tolppanen, Christina Tikka","doi":"10.2196/107499","DOIUrl":"https://doi.org/10.2196/107499","url":null,"abstract":"<p><strong>Background: </strong>Target trial emulation (TTE) studies are increasingly important for regulatory decision‑making and health technology assessments (HTAs), but current risk-of-bias (RoB) tools are not specifically tailored to assess biases central to TTE studies-such as immortal time bias, misaligned eligibility criteria, and prevalent user bias. RoB assessment for TTE studies thus remains difficult, and it is unclear which tools and adaptations researchers currently use or how well they work.</p><p><strong>Objective: </strong>This study aims to analyze the RoB assessment of TTE studies at regulatory and policy decision points along the medical product life cycle by providing a systematic overview of tools developed, used, adapted, or evaluated for TTE studies and the perceived importance and feasibility of assessing TTE studies by HTA assessors, regulators, systematic reviewers, and methods experts.</p><p><strong>Methods: </strong>This is a protocol for a scoping review and online survey among systematic reviewers, methods experts, European HTA organizations, and regulators. We will collect data on the name, description, and feasibility of RoB tools used, adapted, and developed for TTE studies, as well as RoB assessment results and the RoB sources relevant for TTE studies. Two authors will use qualitative content analysis to analyze the data independently. The systematic search for published and gray literature in 4 electronic databases (PubMed, Scopus, Web of Science, and the Cochrane Library), on relevant websites (eg, Cochrane, HTA and regulatory agencies), and through reference list checking was conducted in May to June 2026.</p><p><strong>Results: </strong>As of August 25, 2026, screening is ongoing, and 78 references have been preliminarily included in the scoping review. We will analyze the scoping review and survey data and provide an overview of the types, feasibility, and assessment results of RoB tools currently used, adapted, or developed for TTE studies, as well as the RoB sources considered relevant for TTE studies by HTA assessors, regulators, systematic reviewers, and methods experts. Analysis results of the literature review and survey are expected in September 2026 and November 2026, respectively.</p><p><strong>Conclusions: </strong>The analysis of the scoping review and survey data will inform users of TTE evidence about the feasibility of RoB tools; future development and training needs; and the perceived value of assessing the RoB in HTAs, regulatory decisions, and systematic reviews.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/107499.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e107499"},"PeriodicalIF":1.6,"publicationDate":"2026-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149286962","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":"Multimodal Characterization of Postmortem Pink Teeth in Indonesian Forensic Practice: Protocol for a Retrospective Laboratory Case Series.","authors":"Alfin Fardeni Harahap, Eriska Riyanti, Fahmi Oscandar, Erli Sarilita","doi":"10.2196/107436","DOIUrl":"https://doi.org/10.2196/107436","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Postmortem pink teeth are an uncommon finding produced by color changes within dental tissues. They have been reported in several death contexts, including drowning, but neither their presence nor their intensity is specific for a cause of death. Inconsistent photographic, radiological, and histological methods have limited comparison across studies.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to describe a reproducible multimodal workflow for postmortem pink teeth and to estimate the feasibility, measurement reliability, and exploratory associations of protocol-specified photographic scores, cone beam computed tomography (CBCT) structural measurements, and histological distribution scores.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This is a retrospective laboratory case series using existing specimens and records from Indonesian forensic practice. Candidate teeth will undergo outcome-blind eligibility assessment for applicable ethics coverage, provenance, medicolegal custody, anonymous decedent linkage, and technical evaluability. Photography will be scored with the 3-level Score of Pink Teeth Color and Score of Pink Teeth Region scales. CBCT will quantify dentin thickness and pulp-to-tooth area ratio after long-axis reorientation; CBCT gray values will not be interpreted as tissue density. Hematoxylin-eosin sections will be scored by the farthest dentinal zone containing recognizable erythrocytes or blood-compatible pigmented material, without claiming chemical identification of hemoglobin. Two blinded raters will evaluate each modality. Analyses will emphasize descriptive estimates, weighted kappa, intraclass correlation coefficients, and exploratory Spearman correlations with bootstrap 95% confidence intervals. Multiple teeth from one decedent will be handled by decedent-level clustering when linkage is available. No diagnostic accuracy or cause-of-death prediction analysis is planned.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The working catalog contains 25 candidate teeth with existing photographic and CBCT records and available histopathological source materials. The Research Ethics Approval was renewed under No. 004123/KEP Ladokgi R.E. Martadinata/2026, valid from July 29, 2026 to July 29, 2027. The renewed approval describes the study as involving 25 postmortem pink-teeth samples. All candidate teeth will undergo outcome-blind eligibility assessment based on ethics coverage, provenance, medicolegal custody, decedent linkage, and technical evaluability. Protocol-locked remeasurement and blinded histological re-review will be completed only for eligible specimens before the final dataset is frozen. Reliability assessment and integrated analysis will be performed using the frozen analytic dataset.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The protocol prioritizes traceable acquisition, conservative biological interpretation, and reliability over diagnostic claims. It is intended to standardize documentation of a rare forensic fi","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2026-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149286951","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":"Algorithmic Noise Adjacency in Cantonese-Language Dementia Education on YouTube: Protocol for a Sociotechnical Audit of Recommendation Environments.","authors":"Benjamin K P Woo","doi":"10.2196/101949","DOIUrl":"https://doi.org/10.2196/101949","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Older Chinese American adults with limited English proficiency frequently rely on culturally and linguistically tailored online media platforms for dementia education and health literacy. Existing digital health evaluation frameworks primarily assess the internal quality and accuracy of educational materials while overlooking the recommendation environments through which users encounter health information. Commercial recommendation systems may expose users to medically unverified or commercially motivated health content adjacent to evidence-based dementia education resources.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This protocol establishes a reproducible computational framework for auditing recommendation environments surrounding Cantonese-language dementia education videos on YouTube. The study introduces the concept of algorithmic noise adjacency, defined operationally as the concentration of recommendation nodes whose informational utility diverges from evidence-based dementia education objectives within local recommendation neighborhoods.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The protocol uses an automated sociotechnical audit framework centered on 2 Cantonese-language dementia education videos previously examined in longitudinal digital outreach research. A Selenium WebDriver pipeline with a headless Chromium browser architecture and fingerprinting mitigations will simulate 1200 independent browsing sessions distributed uniformly across a 100-day window. Sessions will be routed through a rotating residential proxy infrastructure localized to Southern California Chinese American communities. During each session, the top 10 sidebar recommendation videos adjacent to the source clinical asset (the anchor video) will be extracted. Recommendation metadata will undergo structured semantic classification into 5 mutually exclusive categories: category A, verified public health and clinical infrastructure, category B, diaspora culture and entertainment, category C, commercially motivated health content lacking established clinical validation, category D, unverified alternative medicine, and category E, ambiguous or unclassified baseline noise. Double-coding and consensus adjudication of a random 10% sample will be used to establish interrater reliability. Generalized linear mixed-effects models with logit link functions, session-level random intercepts, and reciprocal rank slot position weighting will evaluate recommendation characteristics while accounting for clustering within browsing sessions. Primary outcome measures include the noise adjacency ratio, slot-weighted noise adjacency ratio, recommendation recurrence density, and neighborhood entropy. Secondary analyses will evaluate temporal recommendation drift and cross-session recommendation variability.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Protocol development and pilot automation testing were finalized in September 2026. Automation stress testing, semantic calibration, and proxy","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e101949"},"PeriodicalIF":1.6,"publicationDate":"2026-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149267699","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":"Feasibility and Acceptability of Videoconference-Based Family Psychoeducation for Young Adult Caregivers of Family Members With Major Depressive Disorder: Protocol for a Pilot Randomized Controlled Trial.","authors":"Hideki Nakamura, Sho Okawa, Hiroki Tanoue, Yoshihiro Goto, Akari Matsuzawa, Keiko Ito","doi":"10.2196/105182","DOIUrl":"10.2196/105182","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Young adult caregivers of a family member with major depressive disorder (MDD) constitute a vulnerable population. They have substantial support needs because they often experience psychological distress and daily burdens during a developmental period in which education, partnership formation, and parenting frequently overlap with caregiving responsibilities. Consequently, the burden associated with caring for a family member with MDD may adversely affect young adult caregivers' mental health and life stability. Despite these needs, support programs and intervention studies specifically targeting young adult caregivers remain scarce. Videoconference-based family psychoeducation (vFPE) may help address this gap, improving access for individuals facing time and geographic barriers. However, the feasibility of conducting a randomized controlled trial (RCT) of vFPE in this population has not yet been established.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The objective of this study is to examine the feasibility of conducting a waitlist-controlled pilot RCT of vFPE and the acceptability of the vFPE intervention among young adult caregivers of a family member with MDD.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This study is a waitlist-controlled pilot RCT. Young adult caregivers (aged 18-39 y) will be randomly assigned in a 1:1 ratio to either the intervention group or a waitlist control group. Participants in the intervention group will receive 4 weekly 40-minute vFPE sessions. The primary outcomes are feasibility and acceptability. Feasibility will be assessed by recruitment, randomization, intervention completion, dropout rates, and safety. Acceptability will be assessed using the Client Satisfaction Questionnaire-8 Japanese version. Exploratory outcomes, including anxiety and depressive symptoms, mental well-being, psychological distress, caregiver burden, self-efficacy, and health-related quality of life, will be assessed at baseline, postintervention, and 1-month follow-up via online self-administered questionnaires. Exploratory outcomes will be used to inform the design of a future definitive RCT rather than to draw conclusions about intervention effectiveness.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This paper describes the study protocol. Ethical approval was obtained from the Research Ethics Committee, Faculty of Nursing, Toho University, on December 18, 2025. Recruitment commenced on January 10, 2026, with the first participant enrolled on February 20, 2026. As of May 2026, 8 participants had been enrolled. Intervention delivery and data collection are expected to continue until March 2028. Study findings will be disseminated through presentations at academic conferences and publication in peer-reviewed journals.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study will clarify the feasibility of conducting an RCT of vFPE among young adult caregivers of a family member with MDD, providing foundational data to inform the design of a future de","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e105182"},"PeriodicalIF":1.6,"publicationDate":"2026-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13693828/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149244763","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of a Simulation-Based Training Program on Cup Detachment During Vacuum-Assisted Vaginal Birth: Protocol for a Multicenter Quasi-Experimental Before-and-After Study.","authors":"Maria Rosa Vila Hernandez, Sara Tameish, Ivan Hurtado, Maria Del Mar Goya Canino, Alicia Carrera I Boix, Oscar Martinez Perez","doi":"10.2196/100242","DOIUrl":"10.2196/100242","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Safe vacuum-assisted vaginal birth depends on appropriate case selection, accurate cup placement, controlled traction, recognition of technical difficulty, and timely abandonment of an unsuccessful attempt. Simulation-based education can improve procedural performance, but evidence that vacuum-specific simulation changes patient-level clinical practice remains limited.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to estimate the change in the occurrence of cup detachment (known as \"pop off\") following implementation of a standardized simulation-based training program for vacuum-assisted vaginal birth. Cup detachment was designated as the single primary outcome after evaluation of the preintervention cohort but before any postintervention versus preintervention comparative analysis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This multicenter quasi-experimental before-and-after study is being conducted in 19 Spanish maternity hospitals participating in the Registro Español de Morbimortalidad Materna y Perinatal. The implemented preintervention observation period ran from November 28, 2024, through February 28, 2026. The training and washout phase was conducted during March and April 2026, followed by postintervention data collection from May through October 2026. Preintervention clinical variables are ascertained retrospectively from medical records, whereas postintervention data collection is prospective. The intervention combines preparatory theoretical material, a 1-hour face-to-face simulation workshop using a PROMPT FLEX obstetric simulator and vacuum devices, checklist-based assessment, supervised practice, feedback, and debriefing. The primary outcome will be analyzed using modified Poisson regression to estimate risk ratios and 95% CIs, accounting for hospital and protocol-defined calendar time trends. Sequential instrumentation and conversion to cesarean birth will be analyzed separately as key secondary clinical outcomes. Ethical approval was granted by the Clinical Research Ethics Committee of Girona (code 2024.070) on August 5, 2024.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study was funded in November 2024. During the preintervention phase, 1155 cases were recorded in 19 hospitals; 12 were excluded according to the selection criteria, leaving 1143 eligible cases. At the verified July 2026 project update, 144 postintervention cases had been collected. Postintervention data collection is scheduled to close in October 2026; the protocol-defined comparative analysis will be performed after database lock, with publication of the main results planned for summer 2027.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The current analysis plan was fixed before database lock and before any formal comparative postintervention versus preintervention effectiveness analysis. The protocol also defines assessment of contamination, intervention fidelity, secular trends, and the limitations inherent to a nonrandomized before-and-after evaluatio","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e100242"},"PeriodicalIF":1.6,"publicationDate":"2026-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13693959/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149244468","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Auditory Biofeedback Gait Training in Individuals With Chronic Ankle Instability: Protocol for a Randomized Controlled Trial.","authors":"Danielle Marie Torp, Ji Yeon Choi, Alexandra Edison, Matthew Hoch, Kyle Kosik, Amelia Bruce Leicht, Ilana Patlan, Stacey Slone, Abbey Thomas, Jennifer Xu, Luke Donovan","doi":"10.2196/107775","DOIUrl":"10.2196/107775","url":null,"abstract":"<p><strong>Background: </strong>Chronic ankle instability (CAI) develops in a large majority of patients with lateral ankle sprain (LAS), who often experience recurring injuries, residual feelings of instability, and abnormal neuromuscular patterns. Specifically, gait alterations are common in those with CAI and considered a contributing factor to poor long-term ankle joint health. Yet, there are no evidence-based gait-training protocols targeted to improve biomechanics, which may improve long-term outcomes related to ankle joint health and patient satisfaction.</p><p><strong>Objective: </strong>This study protocol introduces a progressive auditory biofeedback (ABF) gait-training program aimed to improve short- and long-term lower extremity biomechanics and talar cartilage outcomes and reduce the frequency of ankle-giving-way episodes and recurring injuries.</p><p><strong>Methods: </strong>This study is a multisite randomized controlled trial (RCT) with a target enrollment of 100 patients with CAI into a control group (n=50, 50%) or an ABF gait-training program (n=50, 50%). Both groups will complete a progressive 6-week (12-session) protocol comprising walking, ruck marching, and running on a treadmill. Lower extremity kinematics and kinetics, talar cartilage characteristics (via ultrasonography), self-perceived dysfunction and instability, and number of recurring sprains will be assessed prior to intervention, immediately after intervention, and 6 and 12 months postintervention. Finally, the frequency of ankle-giving-way episodes in the 6 months prior to intervention will be compared to the frequency of episodes at the 6- and 12-month time points to determine a longitudinal difference in ankle-giving-way episodes.</p><p><strong>Results: </strong>The study was funded in September 2024 and prospectively registered through ClinicalTrials.gov on March 10, 2025. The first participant was enrolled in May 2025. As of August 2026, 118 individuals had been recruited and 19 participants enrolled. Recruitment will remain open until September 2027, and study completion is expected in September 2028. Data processing is projected to continue through September 2028, with the final report published in June 2029.</p><p><strong>Conclusions: </strong>This study will be the first RCT of ABF gait training to assess the immediate and long-term effects on lower extremity biomechanics, ankle joint health, and patient-reported outcomes in patients with CAI. Results from this study will advance the knowledge of long-term joint health that may be associated with poor outcomes post-LAS.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06868316; https://clinicaltrials.gov/study/NCT06868316.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/107775.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e107775"},"PeriodicalIF":1.6,"publicationDate":"2026-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149244850","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}