JMIR Research Protocols最新文献

{"title":"Pharmacological and Nonpharmacological Interventions to Address Insomnia Symptoms and Poor Sleep Quality Among People With HIV: Protocol for a Scoping Review.","authors":"Elliott R Weinstein, Meghan J Linder, Jessie Y Liu, Carol Mita, Peter R Chai","doi":"10.2196/98894","DOIUrl":"10.2196/98894","url":null,"abstract":"<p><strong>Background: </strong>HIV-related research has increasingly focused on addressing long-term comorbidities affecting health-related quality of life for people with HIV. Sleep-related conditions, such as insomnia, are highly prevalent among people with HIV and are associated with a variety of health challenges, including immune dysregulation, increased mental health burden, and reduced antiretroviral therapy adherence. Although there are several evidence-based pharmacological (eg, hypnotics) and nonpharmacological interventions (eg, cognitive behavioral therapy) to treat insomnia, few have been specifically tested among people with HIV.</p><p><strong>Objective: </strong>The objective of this scoping review is to characterize the current state of the field regarding pharmacological and nonpharmacological interventions for treating insomnia symptoms and poor sleep quality among adults (aged 18 years or older) with HIV.</p><p><strong>Methods: </strong>Eligible studies are those that (1) are focused on adults with HIV (aged ≥18 years), (2) examine the effects of an intervention (pharmacological or nonpharmacological) within this population, and (3) have a primary outcome dedicated to sleep quality and/or insomnia symptoms. All published manuscripts, abstracts, conference proceedings, and currently registered studies in the clinical trials registry will be considered. The review will follow the JBI scoping review methodology and adhere to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) reporting standards. A comprehensive literature search will be conducted by searching MEDLINE, Embase, PsycInfo, CINAHL, Web of Science Core Collection, Cochrane CENTRAL, and ProQuest Dissertations & Theses Global databases in July 2026. Two reviewers will independently screen abstracts and titles using Covidence, with a third reviewer resolving any conflicts via consensus meetings. Full-text reviews of selected studies will then be conducted to determine final study eligibility. Data from included studies will then be independently extracted using a pilot-tested extraction form that captures participant characteristics, study details, intervention design, and sleep-related outcomes. A thorough narrative review with a summary table of study characteristics and findings will be generated at the end of the scoping review process.</p><p><strong>Results: </strong>The scoping review process began in April 2026. The authors anticipate identifying relevant full-text articles by December 2026 and completing the initial review of all eligible manuscripts by January 2027. Final results are expected to be consolidated and submitted for publication in the spring or summer of 2027.</p><p><strong>Conclusions: </strong>The results of this scoping review will help to contextualize the current landscape of potentially helpful interventions to improve insomnia symptoms and poor sleep quality among people with HIV t","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e98894"},"PeriodicalIF":1.6,"publicationDate":"2026-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13664994/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149181473","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":"Memory B Cells and Antibody Responses to Vaccines in Infected Children (MARVIC) With Recurrent Infections: Protocol for a Prospective Observational Study.","authors":"Jalilah Jamaluddin, Siti Mardhiana Mohamad, Mohd Azri Zainal Abidin, Khairoon Nisa Mohamed Nashrudin, Malina Osman, Intan Hakimah Ismail","doi":"10.2196/101835","DOIUrl":"https://doi.org/10.2196/101835","url":null,"abstract":"<p><strong>Background: </strong>Recurrent infections are a common concern in pediatric practice and may prompt evaluation for an underlying inborn error of immunity, particularly when infections are severe, persistent, unusual, or recurrent. Recurrent sinopulmonary infections such as pneumonia, sinusitis, and otitis media may indicate a humoral immune defect, as antibody deficiencies are among the most common inborn errors of immunity. Laboratory tests typically include measurement of serum immunoglobulins (immunoglobulin G [IgG], immunoglobulin A [IgA], and immunoglobulin M [IgM]) and IgG subclasses (IgG1, IgG2, IgG3, and IgG4), assessment of vaccine-specific antibody responses, and enumeration of B-cell subsets. Together, these tests assess the quantitative and functional components of humoral immunity. However, pediatric reference intervals for these immunological parameters have not been established in Malaysia.</p><p><strong>Objective: </strong>This study aims to characterize humoral immune parameters among Malaysian children with recurrent infections, compare these parameters with those of healthy children, and establish age-specific reference values in a healthy pediatric population.</p><p><strong>Methods: </strong>The MARVIC (Memory B Cells and Antibody Responses to Vaccines in Infected Children) study is a prospective observational comparative study incorporating a vaccine challenge follow-up in children with recurrent infections and age-matched healthy controls. Eligible participants will undergo baseline assessment of serum immunoglobulins and IgG subclass concentrations using nephelometry, B-cell subsets using flow cytometry, and vaccine-specific antibody responses using enzyme-linked immunosorbent assays. They will then receive the tetanus toxoid and 23-valent pneumococcal polysaccharide vaccines, followed by repeat blood sampling 28 to 30 days later to evaluate functional antibody responses. The co-primary outcomes are between-group differences in IgG subclass concentrations, vaccine-specific antibody responses, and B-cell subsets between children with recurrent infections and healthy controls. The secondary outcome is the establishment of age-specific reference intervals for these immunological parameters among healthy children.</p><p><strong>Results: </strong>This study was funded in December 2024, and participant recruitment and data collection are ongoing. As of May 2026, a total of 145 participants had been recruited, comprising 60 (41.4%) children with recurrent infections and 85 (58.6%) healthy controls, all of whom had completed postvaccination follow-up sampling. Data collection and analysis are expected to be completed by December 2026, with publication of the findings anticipated in May 2027.</p><p><strong>Conclusions: </strong>This study will provide a comprehensive evaluation of the humoral immune profile of Malaysian children with recurrent infections. The findings may improve the identification of clinically relevant ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e101835"},"PeriodicalIF":1.6,"publicationDate":"2026-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13660582/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149181219","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":"Mapping the Evidence on Vitamin D, Vitamin B12, and Folate Deficiencies and Their Potential Impact on Treatment Outcomes in Patients With Cancer in Sub-Saharan Africa: Protocol for a Scoping Review.","authors":"Olufunmilayo Olukemi Akapo, Olubunmi Margaret Ogbodu, Teke Apalata","doi":"10.2196/91276","DOIUrl":"https://doi.org/10.2196/91276","url":null,"abstract":"<p><strong>Background: </strong>Micronutrient deficiencies, particularly of vitamin D, vitamin B12, and folate, are increasingly recognized as important, yet underexplored contributors to adverse outcomes in oncology care. These micronutrients are essential for immune regulation, DNA synthesis and repair, cell proliferation, and metabolic homeostasis, all of which are frequently disrupted in patients with cancer. Deficiencies may arise due to cancer-related metabolic changes, malabsorption, anorexia, and treatment-related toxicities, potentially influencing therapeutic response, treatment tolerance, survival, and quality of life. Despite growing evidence, findings remain fragmented across cancer types, treatment modalities, and geographical settings.</p><p><strong>Objective: </strong>This scoping review aims to systematically map the available evidence on the prevalence, determinants, and reported clinical associations of vitamin D, vitamin B12, and folate deficiencies among adult patients with cancer. The review will also explore how these deficiencies are associated with treatment-related outcomes, including toxicity, therapeutic response, survival, hospitalization, and quality of life, and will identify reported screening, supplementation, and nutritional management practices in oncology care.</p><p><strong>Methods: </strong>The review protocol follows the Joanna Briggs Institute methodology for scoping reviews and will be reported according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews). A comprehensive search of PubMed and MEDLINE, Scopus, ScienceDirect, and relevant gray literature sources will be conducted for studies published between 2000 and 2025. Eligible studies will include observational, interventional, mixed methods, and qualitative studies examining vitamin D, vitamin B12, and/or folate deficiencies in adult oncology populations. Two reviewers will independently screen studies, extract data, and chart findings, whereas a third reviewer will resolve disagreements. Extracted data will include prevalence estimates, determinants of deficiencies, clinical outcomes, and nutritional management strategies. Findings will be synthesized descriptively and presented using thematic mapping, summary tables, and evidence charts.</p><p><strong>Results: </strong>A preliminary search was conducted in May 2026. Study selection commenced on June 30, 2026, following the completion of database searches and removal of duplicate records and was finalized within 8 weeks by August 30, 2026. The anticipated timelines for each stage of the review are presented in the Results section below. Preliminary search outputs from the PubMed database demonstrate the feasibility of the proposed search strategy. The final review will report the number of studies identified, screened, included, and excluded at each stage using a PRISMA-ScR flow diagram.</p><p><strong>Conclusions: </strong>The scoping r","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e91276"},"PeriodicalIF":1.6,"publicationDate":"2026-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13660966/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149181956","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":"Cochlear Implant Referrals in Adults With Severe-to-Profound Hearing Loss in the United Kingdom (CIRCA-2): Protocol for a Repeat National Multicenter Retrospective Observational Study.","authors":"Alexander Scott North, Chloe Swords, Petrina Checkland, Jessica Daniels, Oliver George Denton, Amir Habeeb, Kim Hui Lim, Isaac Jarratt-Barnham, Amar Rajgor, Bhavesh Vijay Tailor, Jeremy Wong, Jameel Muzaffar","doi":"10.2196/94888","DOIUrl":"https://doi.org/10.2196/94888","url":null,"abstract":"<p><strong>Background: </strong>Cochlear implantation (CI) is a highly effective intervention for adults with severe-to-profound hearing loss, yet uptake across the United Kingdom remains low despite clear National Institute for Health and Care Excellence (NICE 2019) guidance and well-established clinical benefits. The original Cochlear Implant Referral Criteria Audit (CIRCA-1) identified marked inequities in access to CIs in 2022, with lower referral rates among older adults, males, and individuals from socioeconomically deprived areas, alongside individuals from minority ethnic backgrounds being less likely to be informed of their eligibility for referral. Since then, national awareness initiatives and the expansion of the existing local \"CI Champions\" scheme have aimed to address these inequities, improve awareness of CI candidacy, and improve the quality of discussions with patients about options for CI referral. This repeat assessment aims to assess the success of these interventions to identify improvements in access to CIs as well as persisting barriers.</p><p><strong>Objective: </strong>CIRCA-2 is a national, multicenter, retrospective observational audit designed to re-evaluate adult CI referral pathways and measure progress since the first audit cycle.</p><p><strong>Methods: </strong>The study will include adults assessed in secondary-care ear, nose, throat, and audiology departments between July and December 2025 whose audiometric thresholds meet NICE TA566 criteria. Participating centers will identify eligible patients using the British Cochlear Implant Group Crystal Report within Auditbase, and anonymized demographic, audiometric, and service-level data will be extracted. The primary outcomes are the proportions of patients meeting NICE TA566 criteria who were informed of their eligibility and referred for CI assessment, with comparisons made to CIRCA-1 data. Secondary analyses will examine adherence to national standards and predictors of discussion and referral using multivariable modeling. In addition, the study will assess the number of patients within criteria for the Comparing Cochlear Implants With Hearing Aids in Adults (COACH) trial and those meeting CI criteria in one ear only.</p><p><strong>Results: </strong>Retrospective data for the period July 1 to December 31, 2025, were collected between January and March 2026. Eighty-three sites submitted data relating to 15,060 patients. Data analysis is projected to be complete by October 2026, with publication of final results expected in early 2027.</p><p><strong>Conclusions: </strong>By quantifying change over time, CIRCA-2 will provide an updated national picture of CI referral practice, highlight any persisting barriers, and inform future strategies to promote equitable access to CIs.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e94888"},"PeriodicalIF":1.6,"publicationDate":"2026-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13660863/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149181969","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":"A Human-Centered Framework to Capture the Holistic Pain Story in Chronic Pain: Protocol for a Multicenter Observational Feasibility Study.","authors":"Jodi Townsley Dubuclet, Krishna Badhiwala, David Page, Scott DeBates, Vivek Kumar Tyagi, Binesh Balasingh, Eric Carpenter, Kiran V Patel","doi":"10.2196/95222","DOIUrl":"10.2196/95222","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Standardized metrics such as the numeric rating scale (NRS) provide essential quantitative pain benchmarks but can be augmented by capturing the functional and emotional context of a patient's lived experience. Adding surveys creates a \"contextual disconnect\" (increasing data yield with diminishing insights) and adds patient burden. The CONNECT (Collecting Communication Data to Enhance Patient-Physician Interaction) study proposes a structured, multimodal framework integrating patient narratives, drawings, and mobility assessments to capture each patient's holistic \"pain story\" and create a comprehensive ground truth dataset for developing digital health tools.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to (1) evaluate the feasibility of capturing multimodal communication data (narratives, drawings, and mobility) from patients with chronic pain, (2) quantify gaps between standard clinical metrics (eg, the NRS) and patient-defined key functional limitations, and (3) evaluate the usability and perceived communication value of software prototypes (myStory).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;CONNECT is a multiphase, multicenter, exploratory feasibility study using human-centered design. Up to 3 tertiary care interventional pain practices in the United States will enroll 2 mutually exclusive cohorts (up to 40 patients each). Phase 1 conceptualizes the patient narrative as a \"clinical sensor,\" collecting a foundational ground truth dataset via video-recorded pain narratives, guided drawings, standardized mobility assessments, and validated surveys. Phase 2 uses phase 1 learnings to develop and evaluate up to 5 myStory prototypes, assessing utility, usability, and perceived communication value via task-based evaluation and think-aloud protocols. Exploratory analyses include dual-coder thematic analysis, pose estimation mobility assessments, and AI-assisted narrative summarization.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Recruitment began in May 2026. As of September 2026, one site is active, with 37 participants enrolled. Anticipated outcomes include (1) a rich, multimodal dataset establishing a ground truth of patient-derived functional limitations, goals, and expectations; (2) characterization of pain story gaps missed by the NRS via the contextual disconnect rate (defined as NRS ≤6 with ≥1 key functional limitation); (3) evaluation of at least one feasible prototype concept (mean score of 3.0 on a 5-point Likert scale); and (4) initial user testing of new communication assessment scales. Results are anticipated in late 2026 and will be disseminated through peer-reviewed publications and conferences.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This protocol establishes a reproducible framework for understanding the holistic \"pain story\" by capturing narrative, visual, and functional dimensions of chronic pain. Findings will inform new communication tools intended to enhance patient-provider communication and align care with outcom","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e95222"},"PeriodicalIF":1.6,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13651979/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149147793","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":"Multidimensional Evaluation of the Efficacy of a Comprehensive Ayurveda Approach as an Add-On to Conventional Therapy in Children With Autism Spectrum Disorder: Protocol for a Randomized, Open-Label, Parallel-Group, Active-Controlled Clinical Trial.","authors":"Vidyashree Anchan, Thejaswini C, Srinibash Sahoo, Sonam Chandhok, B C S Rao, Renu Singh, Meghna P P, Sindhu C V, Rakshitha Kotian, N Srikanth","doi":"10.2196/99910","DOIUrl":"10.2196/99910","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Autism spectrum disorder (ASD) is a heterogeneous neurodevelopmental disorder characterized by impairments in social communication, restricted and repetitive behaviors, and deficits across multiple developmental domains. Although conventional interventions, including speech, behavioral, and occupational therapies, improve functional outcomes, many children continue to experience persistent cognitive and adaptive impairments. Ayurvedic formulations such as &lt;i&gt;Saraswata Ghrita&lt;/i&gt; and &lt;i&gt;Ayush Manas&lt;/i&gt; possess neuroprotective, anti-inflammatory, antioxidant, and cognition-enhancing properties, but robust clinical evidence supporting their adjunctive use in ASD is limited.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The study aims to evaluate the efficacy of a comprehensive Ayurveda intervention as an adjunct to conventional therapy in children with ASD by assessing changes in behavioral symptoms, intellectual functioning, adaptive behavior, parental quality of life, and exploratory inflammatory biomarkers.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This randomized, open-label, parallel-group, active-controlled clinical trial will enroll 80 children aged 6 to 15 years diagnosed with ASD according to &lt;i&gt;DSM-5&lt;/i&gt; (&lt;i&gt;Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition&lt;/i&gt;) criteria at the Central Ayurveda Research Institute (CARI), Bengaluru, in collaboration with selected autism therapy centers. Participants will be randomized in a 1:1 ratio to receive either conventional therapy alone or conventional therapy combined with &lt;i&gt;Saraswata Ghrita&lt;/i&gt; and &lt;i&gt;Ayush Manas&lt;/i&gt; for 6 months. Outcome assessments will be performed at predefined intervals using the Autism Treatment Evaluation Checklist (ATEC), Indian Scale for Assessment of Autism (ISAA), Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV), Vineland Adaptive Behavior Scales, Third Edition (VABS-III), and Quality of Life in Autism (QoLA) questionnaire. Exploratory laboratory assessments include high-sensitivity C-reactive protein, interleukin-6, and tumor necrosis factor-alpha (TNF-α). Safety will be evaluated through adverse event monitoring and laboratory investigations. Statistical analysis will be performed after data verification. Data normality will be assessed using the Shapiro-Wilk test. Variables will be represented as frequencies (%), mean (SD), or median with IQR. Preintervention and postintervention comparisons will use repeated-measures ANOVA or the Friedman test, as appropriate, with significance set at &lt;i&gt;P&lt;/i&gt;&lt;.05, using STATA software (version 18.0; StataCorp LLC).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Ethical approval was obtained before study initiation, and the trial was registered with the Clinical Trials Registry-India (CTRI/2025/04/085035). Participant recruitment commenced on December 3, 2025. As of July 17, 2026, 20 participants had been enrolled and completed baseline assessments; 14 had completed the 90-day follow-up, and 2 had comp","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e99910"},"PeriodicalIF":1.6,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13652383/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149147879","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":"Geriatric Assessment-Based Stratification to Evaluate Treatment Intensity, Quality of Life, and Survival in Older Patients With Metastatic Colorectal Cancer: Protocol for a Prospective Observational Study.","authors":"Takako Hiramatsu, Izumi Okazaki, Kyoko Hosokawa, Kazuhiko Yoshimatsu, Takeshi Nagasaka","doi":"10.2196/94561","DOIUrl":"10.2196/94561","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Older patients with metastatic colorectal cancer (mCRC) are a heterogeneous population with wide variability in functional status, frailty, cognition, nutritional reserve, and comorbidity burden. Treatment decisions are often guided primarily by chronological age and performance status, which may not adequately capture vulnerability or patient-centered outcomes in this population.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The primary aim of this study is to prospectively evaluate the association of baseline geriatric assessment (GA)-derived frailty with overall survival in older patients with mCRC receiving first-line systemic therapy in routine clinical practice; secondary aims are to evaluate the associations of frailty with initial treatment intensity and early changes in quality of life (QOL).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Baseline GA includes activities of daily living, instrumental activities of daily living, the Clinical Frailty Scale, the Mini-Cog, nutritional assessment, the Charlson Comorbidity Index (excluding cancer-related items), and the Eastern Cooperative Oncology Group (ECOG) performance status. Blood-based prognostic biomarkers, including the prognostic nutritional index and neutrophil-to-lymphocyte ratio, are also collected. Initial treatment intensity is defined according to the first-line systemic regimen selected at baseline, whereas subsequent local therapies are recorded separately. QOL is assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) at baseline and 8 to 12 weeks after treatment initiation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study was registered in the UMIN Clinical Trials Registry (UMIN000060489) on April 1, 2026. This study received no external funding. Participant recruitment began on April 1, 2026 (the first participant enrolled in June 2026) and is planned to continue for approximately 2.5 years (projected completion: October 2028), with an anticipated sample size of approximately 100 participants; an early QOL follow-up is scheduled for 8 to 12 weeks after treatment initiation for each participant. As of the submission of this revised manuscript (August 2026), 4 participants had been enrolled, baseline QOL assessments had been completed for all 4 participants, and the 8- to 12-week follow-up QOL assessments had been completed for 3 participants; no outcome data were available. Analysis of the primary outcome will be conducted after final survival follow-up, with the main results anticipated for publication in 2030.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This protocol describes a pragmatic GA-based observational framework to examine associations between pretreatment vulnerability, initial treatment intensity, survival outcomes, and patient-reported QOL in older patients with mCRC. Given the exploratory, hypothesis-generating design, the study is expected to generate clinically relevant hypotheses for individ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e94561"},"PeriodicalIF":1.6,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13694998/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149147371","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":"Nurse-Led and Nurse-Involved Antimicrobial Stewardship in Hospitals and Primary Care: Protocol for a Mixed Methods Systematic Review and Meta-Analysis With Gulf Cooperation Council and Middle East and North Africa Subgroup Analysis.","authors":"Suthan Pandarakutty, Brenda Poku, Shanthi Ramasubramaniam, Sylivia Nalubega, Mansour Mansour, Manju Varghese, Lakshmi Renganathan, Vijith Chandu, Virgina Varghese, Faiza Al Zadjali, Vishnu Renjith","doi":"10.2196/96342","DOIUrl":"10.2196/96342","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Antimicrobial resistance poses a growing threat to patient safety worldwide. Nurses are central to antimicrobial management; however, their contribution to formal antimicrobial stewardship (AMS) programs remains poorly characterized. To our knowledge, no previous review has combined evidence on the effectiveness and implementation of nurse-led and nurse-involved AMS interventions, including Gulf Cooperation Council and Middle East and North Africa (GCC/MENA) subgroup analysis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This protocol describes a mixed methods systematic review that aims to determine (1) the effectiveness of nurse-led or nurse-involved AMS interventions on patient and antimicrobial outcomes in hospital and primary care settings and (2) the barriers and facilitators influencing this implementation using the Consolidated Framework for Implementation Research (CFIR 2.0).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This review follows the Joanna Briggs Institute convergent, parallel-streams mixed methods methodology. Eligible studies report a nurse-led or nurse-involved AMS intervention among adults receiving antimicrobial therapy in hospital or primary care settings; pediatric-only and long-term care settings are excluded. Eleven databases will be searched from January 2000 to the calendar month of searching. Two reviewers will independently screen records in 2 rounds, with agreement quantified by Cohen κ (target ≥0.70). The quantitative stream will include randomized, quasi-experimental, interrupted time series, and controlled before-and-after studies, with effect measures matched to outcome type. Risk of bias will be independently assessed using design-matched tools. Random-effects meta-analysis will be the primary approach, with prediction intervals supplementing &lt;i&gt;I&lt;/i&gt;² to quantify heterogeneity. The qualitative stream will synthesize implementation data through hybrid deductive-inductive CFIR 2.0 thematic synthesis. Both streams will be integrated through a convergent joint display classifying findings as convergent, complementary, expansive, or discordant. Three primary subgroup analyses will compare GCC/MENA vs the rest of the world, hospital vs primary care, and levels of nursing involvement. GRADE (Grading of Recommendations Assessment, Development and Evaluation) will be applied to all primary quantitative outcomes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Database searches, Covidence import, and deduplication were completed in March 2026. Title and abstract screening, including pilot calibration, was completed by June 2026. Full-text screening was planned for completion by August 2026, followed by parallel quantitative and qualitative data extraction from August to September 2026. Meta-analysis, CFIR thematic synthesis, and GRADE assessment are expected by November 2026, with mixed methods integration planned for November to December 2026. Manuscript writing is planned for January to February 2027, with submission targe","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e96342"},"PeriodicalIF":1.6,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13649170/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149136620","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":"Game-Based Intervention for Adolescent Pregnancy Prevention: Protocol for a Multisite Randomized Controlled Trial Evaluation.","authors":"Brittany Rosen, Sydney Hineline, Andrea Meisman, Bin Zhang, Caitlin Holden, Christi Esquivel, Whitney Garney, Kelly Wilson","doi":"10.2196/88047","DOIUrl":"10.2196/88047","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Existing adolescent pregnancy prevention programs have demonstrated modest effects. Evaluation is needed for interventions aimed at improving intermediary outcomes linked to behaviors associated with adolescent pregnancy prevention, including intentions, communication skills, decision-making skills, access to information, and supportive adult relationships. These intermediary outcomes often serve as mechanisms that decrease sexual behaviors associated with unintended pregnancy and sexually transmitted infection risk and enhance understanding of how interventions influence behavior. The US federal government announced a funding cycle aimed at assessing innovative programs for underserved youth. As 1 of the 12 grantees, we will evaluate Using the Connect (UTC), a novel game-based learning intervention offering opportunities to improve participants' intention to delay sex, skills related to communication, decision-making, and accessing information, and strengthen their connection to a trusted adult.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study describes the clustered randomized controlled trial protocol to assess the effectiveness of UTC on middle school youth's intention to delay sex, individual-level skills (communication, decision-making, and accessing information), and perception of connection to a trusted adult.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This multisite trial had planned enrollment for 1150 youth aged 10-14 years from 46 community-based organizations in Texas, Alabama, and Illinois. Sites will be randomized to either UTC or business-as-usual control consisting of routine youth programming (eg, physical activity, career education, and mental health awareness). UTC consists of 4 interactive games, 1 wrap-up activity, and 1 take-home activity focused on communication, decision-making, accessing sexual health information and resources, and strengthening connections with trusted adults. Participants will complete electronic surveys at baseline, immediate post-survey, 3-month follow-up, and 9-month follow-up. Outcomes will be assessed using adapted survey measures of intention to delay sexual intercourse, communication skills, decision-making skills, skills to access sexual health information and resources, and perceived connection to trusted adults. To decrease attrition, we will use an evidence-based retention model. We will conduct sensitivity analyses to assess the robustness of findings.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Funding was received in September 2021 through the Personal Responsibility Education Innovative Strategies funding opportunity within the Personal Responsibility Education Program of the Department of Health and Human Services. Site recruitment and enrollment began in June 2023. Between June 15, 2023, and May 31, 2025, 1338 youth have been enrolled in the study. Follow-up data collection was completed in April 2026. As of July 2026, all study activities have concluded, and data from 1231 partic","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":" ","pages":"e88047"},"PeriodicalIF":1.6,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13691462/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148976746","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":"Novel Sensors and Data-Driven Approach to Support Prevention, Diagnosis, and Treatment Planning of Cerebrovascular Accidents: Protocol for a Multimodal Data Collection Study With Novel Sensors.","authors":"Milla Immonen, Hilkka Liedes, Aysen Degerli, Ilona Ruotsalainen, Juha Pajula, Mika Hilvo, Heidi Similä, Adil Umer, Mark van Gils, Miia Jansson, Kirsi Maaria Rasmus, Minna Pikkarainen, Petri Huhtinen, Mikko Kärppä, Julius Francis Gomes, Hany Ferdinando, Miguel Bordallo López, Teemu Myllylä, Vesa Kiviniemi, Mikael von Und Zu Fraunberg, Pekka Jäkälä","doi":"10.2196/86930","DOIUrl":"10.2196/86930","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Stroke is the second leading cause of death worldwide. Cerebrovascular diseases (CVDs), including strokes and transient ischemic attacks (TIAs), cause long-term disabilities and economic burdens. Strokes can be ischemic, caused by blood clots; or hemorrhagic, caused by bleeding in the brain. Immediate diagnosis and treatment are crucial. Proper management of TIAs is essential due to the high risk of subsequent strokes. Currently, wearable sensors, AI-based prediction, and automatic video analysis are not used in CVD diagnosis and recovery estimation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This paper describes the design, cohort characteristics, and multimodal dataset of the Stroke-Data study conducted at 2 university hospitals in Finland. Although findings from individual components of the study have been reported elsewhere, this paper provides the first comprehensive description of the overall study design, cohort, and multimodal data collection protocol. The study collected a unique multimodal dataset comprising sensor data, video recordings, clinical assessments, questionnaires, and health record data from healthy controls and patients with stroke and TIA to support the development of AI, sensor-based, and video-based methods for CVD diagnosis and recovery estimation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Stroke-Data was a prospective national multicenter study conducted at Oulu University Hospital and Kuopio University Hospital from October 2021 to December 2022. A rich multimodal dataset from patients with stroke and TIA and healthy controls was collected by study nurses and a research assistant. Inclusion criteria for patients were age &gt;18 years and a diagnosis of cerebrovascular accident or TIA within the previous 3 days. Healthy control participants were aged 18 years and older and had no major chronic diseases, although blood pressure and cholesterol medications were permitted. Data collection included electroencephalogram; electrocardiogram; near-infrared spectroscopy; accelerometers to analyze gait and balance; retinal fundus images; video recordings of neurological examinations to analyze the face, body movements, and speech; clinical assessments; questionnaires; and electronic health records.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;In total, 263 participants were recruited, of whom 123 were controls (median age 59, IQR 45-72 years; female: 84/123, 68.3%), 31 were patients with TIA (median age 71, IQR 60-80 years; female: 8/31, 25.8%), and 103 were patients with stroke (median age 70, IQR 59-76 years; female: 42/102, 41.2%, sex data missing from 1 participant). A total of 6 participants were excluded (5 had diagnoses other than TIA or stroke and 1 control participant had a previous CVD).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;We successfully conducted a multicenter multimodal data collection study on healthy controls and patients with stroke and TIA. This protocol paper provides a comprehensive methodological description of ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e86930"},"PeriodicalIF":1.6,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13691472/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149136597","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}