JMIR Research Protocols最新文献

{"title":"Evaluating Diversity in Open Photoplethysmography Datasets: Protocol for a Systematic Review.","authors":"Vedha Penmetcha, Lekaashree Rambabu, Brandon G Smith, Orla Mantle, Thomas Edmiston, Laura Hobbs, Shobhana Nagraj, Peter H Charlton, Tom Bashford","doi":"10.2196/73040","DOIUrl":"10.2196/73040","url":null,"abstract":"<p><strong>Background: </strong>Photoplethysmography (PPG) is an optical method for measuring blood volume changes in microcirculation through noninvasive photodetection. It has become a widespread and essential clinical tool, used in pulse oximeters and wearable devices. However, technical aspects of PPG make it susceptible to intrinsic bias, with the potential to adversely affect particular patient and consumer populations. Developments in PPG technology, increasingly driven by openly accessible datasets as opposed to de novo experimentation, have the potential to help monitor an array of physiological variables. However, some populations may be underrepresented in PPG datasets. We describe a protocol for a systematic review to assess the biases within open access PPG datasets.</p><p><strong>Objective: </strong>This review aims to evaluate the underlying reporting patterns and structure of openly accessible PPG datasets. We will provide insight into the measured biosignals and demographic variables included in the datasets in the hope of shedding light on what PPG data parameters are being used to develop medical devices. Therefore, we can elucidate current gaps and areas for improvement to reduce bias in medical device development.</p><p><strong>Methods: </strong>This review will be reported in accordance with the standard PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. We will include primary studies that mention PPG and specifically reference openly accessible datasets since 2000. The datasets must contain physiological parameters such as heart rate, blood pressure, or respiratory rate, as well as the PPG waveform data, collected from humans. Searches will be conducted in literature databases and data repositories, including MedLine OVID, IEEE Xplore, Scopus, and PhysioNet. Studies will be evaluated in accordance with the Standing Together Initiative recommendations, which are urging for health care technologies supported by representative data. Biosignal and demographic variables will be extracted from the PPG datasets, with steps taken to harmonize and store this information. Statistical analysis will be performed, including descriptive statistics and the chi-square test for comparisons. Additional statistical analyses will be performed after data extraction is completed and the level of heterogeneity is characterized.</p><p><strong>Results: </strong>We will analyze the dataset diversity and the structural basis of PPG datasets. This includes statistically analyzing the demographic and biosignal variables in the datasets. By using statistical test fit for nominal variable comparisons, we will evaluate the frequencies of characteristics like the devices used, biosignals collected, clinical parameters, demographic characteristics, and geographic information. This systematic review is expected to be completed by September 2025. The screening and review of the articles is currently being conducted.</p><p","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e73040"},"PeriodicalIF":1.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12488168/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145206443","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":"Culturally Tailored Diabetes Self-Management Education and Support Programs in Black African and Caribbean Adults With Type 2 Diabetes (HEAL-D): Protocol for a Multicenter, Pragmatic Randomized Controlled Trial.","authors":"Louise M Goff, Drusus A Johnson, Vicky Bell, Susan Blyden, Peter Bower, Jeremy Dale, Tess Harris, Andrew Healey, Eleanor Hoverd, Huajie Jin, Tony Kelly, Carol Rivas, Clare Robinson, Jayne Thorpe, Sandra Tomlinson, Michael Ussher, Charlotte Wahlich, Barbara McGowan","doi":"10.2196/71861","DOIUrl":"https://doi.org/10.2196/71861","url":null,"abstract":"<p><strong>Background: </strong>People of Black African and Black Caribbean ethnicity experience higher rates and poorer outcomes of type 2 diabetes (T2D) than people of White European ethnicity; these inequalities are compounded by poor healthcare access. Cultural tailoring of diabetes self-management education and support (DSMES) programs has the potential to improve healthcare engagement and clinical outcomes for ethnic minority groups. Healthy Eating & Active Lifestyles for Diabetes (HEAL-D) is a co-designed, culturally tailored group-based DSMES program for adults of Black African and Black Caribbean ethnicity.</p><p><strong>Objective: </strong>This trial aims to evaluate the clinical and cost effectiveness of the HEAL-D intervention, compared to standard DSMES programs, in Black African and Black Caribbean adults living with T2D.</p><p><strong>Methods: </strong>A 24-month, multicenter, pragmatic, open-label, 2-arm, parallel-group, individually randomized group treatment trial will be conducted, with primary end point (glycated hemoglobin [HbA<sub>1c</sub>]) assessment at 12 months. Black African and Black Caribbean adults with T2D (n=300), recruited from 3 to 5 centers in the United Kingdom (including London, West Midlands, and Greater Manchester), will be randomized in a 1:1 ratio to HEAL-D (intervention) or a standard DSMES program (control). HbA<sub>1c</sub>, blood lipids, anthropometric outcomes, blood pressure, physical activity, and patient-reported outcome measures relating to psychological well-being and self-management support, lifestyle behaviors, and health economics will be collected at baseline and follow-up visits (6, 12, and 24 months). Cost-effectiveness will be assessed through a cost-utility analysis conducted from a health and social care perspective. A mixed methods process evaluation will provide a formative evaluation of delivery, intervention fidelity, and implementation of HEAL-D, and an embedded study within a project will assess the impact of multiple long-term conditions on uptake of, and engagement with HEAL-D, and the impact of HEAL-D on multiple long-term conditions. The trial received Research Authority and Research Ethics Council approval on April 22, 2024.</p><p><strong>Results: </strong>Funding began in August 2023. Site \"green light\" was received on August 15, 2024, for London; November 29, 2024, for Manchester; and January 31, 2025, for the West Midlands. Recruitment commenced in August 2024 and is due to run for 11 months. As of March 26, 2025, a total of 76 participants have consented. Last patient, last visit is expected in June 2027; primary data analysis is expected to begin in July 2027. Final results are anticipated to be available in September 2027, and publication is expected by the end of 2027.</p><p><strong>Conclusions: </strong>The HEAL-D trial will address whether a culturally tailored DSMES program, provided in-person or via videoconferencing, is clinically and cost-effective compared to sta","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e71861"},"PeriodicalIF":1.5,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145199341","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 Stage of Change Theory-Based, Stage-Matched Intervention for Healthy Dietary Intake Among Office Workers in a Low- to Middle-Income Country: Protocol for a Cluster Randomized Trial.","authors":"Janaka Godevithana, Champa Jayalakshmie Wijesinghe, Millawage Supun Dilara Wijesinghe","doi":"10.2196/70293","DOIUrl":"https://doi.org/10.2196/70293","url":null,"abstract":"<p><strong>Background: </strong>An unhealthy diet is a well-established risk factor for the development of noncommunicable diseases, and office workers are at a higher risk of noncommunicable diseases due to their sedentary work style. Stage of change (SOC) theory-based and stage-matched interventions effectively influence dietary and behavior changes. The effectiveness of such interventions in the context of low- and middle-income countries is yet to be assessed.</p><p><strong>Objective: </strong>This protocol describes a cluster randomized trial planned to evaluate the effectiveness of an intervention for changing dietary behavior among government office workers in the Galle district in Sri Lanka.</p><p><strong>Methods: </strong>A cluster randomized trial was conducted in 20 clusters divided into intervention and control arms. A cluster was an office with 30 clerical-type workers who were sedentary at work. A stage-matched intervention based on behavior change processes was implemented in the intervention clusters for 3 months. Participants were provided with an intervention matched to their SOC at baseline. Precontemplators and contemplators received awareness-raising and emotional arousal interventions. Others received goal setting and self-monitoring interventions. The SOC and dietary intake were assessed at baseline and the postintervention stage through a staging algorithm, and 24-hour dietary recall was supplemented with a picture guide and computer software. Adherence to the intervention was assessed monthly. We hypothesized that participants would achieve a progressive change in the SOC and healthy dietary intake in the intervention clusters compared to the control clusters.</p><p><strong>Results: </strong>By December 2024, the planned intervention was completed. Data analysis on the effectiveness of the intervention is to be completed and published in 2025.</p><p><strong>Conclusions: </strong>This protocol reports a stage-matched intervention based on SOC theory, enriching the current knowledge base with new evidence from office workers in a low- to middle-income country.</p><p><strong>Trial registration: </strong>Sri Lanka Clinical Trials Registry SLCTR/2020/025; https://slctr.lk/trials/slctr-2020-025.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/70293.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e70293"},"PeriodicalIF":1.5,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145199286","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":"Vascular and Cardiovascular Outcomes of Smoking Cessation and Switching to Electronic Cigarette Use: Protocol for a Systematic Review of Prospective Studies.","authors":"Giusy Rita Maria La Rosa, Jacqueline Yu, Giulio Geraci, Davide Capodanno, Takao Ohki, Jacob George, Riccardo Polosa","doi":"10.2196/74949","DOIUrl":"10.2196/74949","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Despite the well-documented adverse health effects of tobacco smoking, it remains prevalent worldwide. Chronic tobacco smoking is associated with significant cardiovascular effects, including an increased risk of cardiovascular disease and vascular dysfunction. In recent years, the use of electronic cigarettes (ECs) has increased, with many former tobacco cigarette smokers switching to ECs to aid in smoking cessation. To date, no systematic review has synthesized prospective evidence on key vascular and cardiovascular outcomes among adult smokers who quit or switch to ECs, with the specific aim of identifying early and clinically meaningful indicators of vascular recovery.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This systematic review aims to summarize the current prospective studies on the vascular effects of switching to exclusive EC use and the overall effects of smoking cessation on regular tobacco cigarette smokers. The review will focus, in particular, on early indicators of vascular improvement, such as measures of vascular function, including arterial stiffness and endothelial function, as well as on heart rate, blood pressure, nonfatal myocardial infarction, nonfatal stroke, sudden cardiovascular death, and acute heart failure.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The review will be reported following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. A comprehensive search was performed in PubMed and Scopus on January 12, 2025, without restrictions on the publication date. Studies will be included if they focus on cardiovascular outcomes, with study designs, including clinical trials (randomized controlled trials, observational studies), prospective cohort studies, and case-control studies. Studies involving regular smokers, aged 18 years and older, and those reporting on smoking cessation or switching to ECs will be considered. Data will be extracted using a standardized form and synthesized qualitatively. Risk of bias will be assessed using Joanna Briggs Institute's critical appraisal tools, with results informing sensitivity analyses and interpretation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;As of January 2025, the preliminary search retrieved 1479 records across PubMed and Scopus. At the time of this protocol's publication, the first manuscript on vascular function outcomes was completed in July 2025 and is currently under peer review. Each subsequent review will include an updated search before completion.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This review will provide a comprehensive landscape of current literature on the long-term vascular effects of smoking cessation and switching to exclusive EC use. The findings will help identify early indicators of vascular damage reversal, gaps in the current evidence base, and inform future research directions. By disseminating the results through peer-reviewed journals, conferences, and digital platforms, the review aims to enhance the u","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e74949"},"PeriodicalIF":1.5,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145191836","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":"Integrating a Combination HIV Prevention Intervention Into a Widely Used Geosocial App for Chinese Men Who Have Sex With Men: Protocol for a Single-Arm Pilot and Repeated Cross-Sectional Study.","authors":"Wenting Huang, Kunru Ning, Shi Hao Ernest Koh, Guodong Mi, Fei Yu, Yufen Liu, Daniel Stegmueller, Kimberly A Powers, Stefan Baral, Patrick S Sullivan, Aaron J Siegler","doi":"10.2196/69536","DOIUrl":"https://doi.org/10.2196/69536","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;HIV disproportionately affects men who have sex with men in China. However, HIV prevention services use among this population remains limited, in part due to concerns of privacy and sexual identity disclosure. These concerns might be addressed through telehealth services.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study was designed to assess the feasibility and acceptability of Blued+, which integrates an HIV prevention services package into a geosocial networking app commonly used by Chinese men who have sex with men.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The study design was a single-arm pilot of the Blued+ intervention among men who have sex with men, using repeated cross-sectional surveys of an external population for comparison. For the pilot study, men were recruited from Beijing and Chengdu. A 3-month standard-of-care period with measurement at enrollment and month 0 (baseline) was followed by a 12-month intervention period with measurement at months 3, 6, 9, and 12. During the intervention period, participants received the enhanced version of the Blued app (Blued+) with HIV testing, linkage to care as needed, choice of condoms and condom-compatible lubricants, and pre-exposure prophylaxis (PrEP) services. PrEP was provided through in-app counseling and prescription, followed by lab tests at local clinics and mailed medication. Three cross-sectional surveys in months 0, 6, and 12 were administered to men in Beijing and Chengdu who were not enrolled in another HIV prevention study. These participants had access to the standard Blued geosocial networking app and local health services. The primary outcome of feasibility was the uptake of home HIV testing and PrEP. The coprimary outcome of intervention acceptability was measured with the System Usability Scale.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The run-in period was launched on July 15, 2022, with recruitment completed on August 24, 2022. The baseline period concluded in November 2022, and all follow-up assessments were completed by December 2023. At baseline, the pilot study enrolled 423 participants, and the cross-sectional comparison enrolled 1314 participants. Participants in the pilot were young (mean age 30, SD 7 years) and educated (324/423, 76.6% reported a college degree or higher), and most (302/423, 71.4%) reported HIV testing in the prior 3 months. Most participants (404/423, 95.5%) had heard of PrEP, and over a quarter had used PrEP (114/423, 27%). Participants in the comparison population had comparable sociodemographic characteristics, reporting HIV testing (501/857, 58.5%) in the prior 3 months, PrEP awareness (723/857, 84.4%), and PrEP use in the last 3 months (182/857, 15.4%).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This pilot study will provide preliminary evidence regarding the feasibility and acceptability of the Blued+ intervention. The study findings will provide evidence setting the foundation for future research that involves embedding prevention platf","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e69536"},"PeriodicalIF":1.5,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145191733","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":"Efficacy and Safety of a Digital Tapering Intervention for Patients Prescribed Opioids After Surgery: Protocol for a Prospective Exploratory Cohort Study.","authors":"Bergdís Elsa Hjaltadottir, Anna Bryndís Blöndal","doi":"10.2196/72317","DOIUrl":"10.2196/72317","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;More than 300 million surgical procedures are performed worldwide each year, and opioids remain a primary approach for managing acute postoperative pain. Studies have demonstrated that a significant number of patients do not discontinue opioid treatment and continue to use opioids for months or even years after surgery. Tapering and management of prescription opioids is a well-known practice and is a part of the current clinical guidelines on safe prescribing. Every patient should receive thorough monitoring, education, and a tapering plan when prescribed opioids or receiving refills after a prolonged treatment. There are challenges associated with tapering, including close follow-up, patient education, clinician time, and withdrawal safety. The evolution of smartphone app use for follow-up has shown promising results in some fields of medicine, and patients are increasingly interested in this approach.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The objective of this study is to investigate the efficacy and safety of Prescriby services, comprising clinician management augmented with digital support, as a tapering intervention in patients after knee or hip replacement surgery.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Efficacy will be measured in tapers successfully completed, doses successfully lowered during tapering, number of active users, satisfaction with the intervention, and patients successfully remaining off opioid medication at 6 and 12 months after the intervention. Participant safety will be monitored by assessing adverse effects during tapering using the numeric pain rating scale to assess the severity of pain. Participants are recruited via referrals from orthopedic clinics and orthopedic departments in the hospital after surgery during the 6-month study period to the Prescriby clinic, where they will receive a personalized tapering treatment and follow-up with a clinical pharmacist. Despite the existence of numerous clinical guidelines on tapering off dependence-inducing medications, there is limited knowledge of the outcomes of such tapering.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study received funding in February 2024. Data collection for secondary outcomes started in November 2024 and ended in July 2025. Data collection for primary outcomes will start in June 2026 and finish in July 2026. As of manuscript submission in August 2025, 75 patients had been recruited into the study. Analysis of secondary data started in August 2025, and results will be published in the fourth quarter of 2025. Analysis of primary data will start in July 2026, and results will be published in the fourth quarter of 2026.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;We anticipate that persistent opioid use in standard treatment could be somewhere in the range of 10% to 15%. We hypothesize that the intervention group will have a lower rate of persistent opioid use. With regard to the secondary outcomes, we estimate that more than 85% of the participant","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e72317"},"PeriodicalIF":1.5,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145185998","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":"Caring Text Messages for Suicide Prevention in Urban American Indian Youth: Protocol for a Randomized Controlled Trial.","authors":"Erin Renee Morgan, Marija Bogic, Luciana Hebert, Erin Poole, Nichole Tsosie, Nathania Tsosie, Kandyce Garcia, Marcia O'Leary, Raeann Mettler, Gina Johnson, Linda Son-Stone, Tassy Parker, Dedra Buchwald, Spero Manson","doi":"10.2196/71344","DOIUrl":"10.2196/71344","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;American Indian (AI) young adults in urban areas have many cultural strengths but also face unique challenges. Cultural norms within their communities strongly emphasize relationships. Previous research has found that receiving occasional positive and nondemanding messages-caring text messages-can be beneficial among people experiencing suicidality.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To ameliorate increasing rates of suicide and suicidality among AI young adults, we implemented a caring text message intervention designed to increase social connectedness.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This 2-arm, double-blinded, randomized controlled trial is being implemented at 2 clinical sites with large AI populations. Partnering with clinics in Albuquerque, New Mexico, and Rapid City, South Dakota, we are recruiting AI adults aged 18-34 years to participate in a caring text message study. During the baseline visit, participants complete several surveys and an interview with study staff to understand their history of suicidal behavior. After completion of the baseline visit, participants are randomized to receive the intervention-approximately 30 caring text messages-or treatment as usual. The text messaging platform selected for this study allows bidirectional messaging; while there is no expectation that participants respond, they can provide feedback or seek additional resources. Participants are followed up at 6 and 12 months postbaseline. At the final 12-month follow-up visit, they complete many of the same surveys and participate in an interview to ascertain suicidality since their initial visit. The primary outcomes of interest are suicide-related behaviors-suicidal ideation, suicide planning, suicide attempt, or thoughts and actions requiring hospitalization. Secondary outcomes include social connectedness and other measures of mental health. We will use an intention-to-treat analysis with logistic and linear regression to calculate odds ratios and risk differences (95% CIs) for binary and continuous outcomes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;As of June 2025, the New Mexico site has finished recruitment and follow-up assessments. The South Dakota site is still enrolling participants and has conducted the first follow-up assessments. The project has been well-received by participants.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This randomized controlled trial will evaluate whether a caring text message intervention is effective in reducing suicidality among AI young adults in urban areas. Participants have received the culturally tailored caring text messages. This trial will help establish whether caring text messages are an effective strategy for reducing suicidal behaviors and promoting feelings of connectedness among AI young adults.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;ClinicalTrials.gov NCT03136094; http://clinicaltrials.gov/show/NCT03136094.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;International registered report identifier (irrid): &lt;/strong&gt;","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e71344"},"PeriodicalIF":1.5,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12514422/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145175630","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":"Developing Recommendations to Improve Crisis Line Supports for Public Safety Personnel in Canada: Protocol for a Multimethod National Study.","authors":"Gisell Castillo, Chantalle Clarkin, Thiyake Rajaratnam, Fatima Ahmad, Susan Anderson, Gil Angela Dela Cruz, Nadia Aleem, R Nicholas Carleton, Matthew Charbonneau, Adam Crewdson, Danielle Dubé, Max Gomez, Jenny Hardy, Chris Hargreaves, Simon Hatcher, Fardous Hosseiny, Brian Mishara, Eva Serhal, Daisy R Singla, Mark Sinyor, Caitlin Tavares, Karen VanderSluis, Yolanda Wolfgram, Juveria Zaheer, Allison Crawford","doi":"10.2196/75285","DOIUrl":"10.2196/75285","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Public Safety Personnel (PSP) in Canada experience disproportionately high rates of mental distress and suicidal thoughts and behaviors. PSP mental health is a critical public health issue with far-reaching implications for both individual well-being and the effectiveness of emergency response systems. Crisis lines are an evidence-based public health intervention; however, knowledge gaps remain regarding PSP crisis line use, barriers to accessing services, and the appropriateness of crisis line service models for meeting PSP mental health needs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to address these knowledge gaps using a participatory approach to better understand the crisis line needs and preferences of PSP communities. We also aim to apply our learnings and co-design actionable recommendations for crisis line service improvements and to support PSP who may wish to contact a crisis line.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This Canada-wide study uses multiple methods across three iterative phases. Phase 1 involves community engagement with PSP to better understand their crisis needs and existing supports. Instrumental to our engagement ethic is the formation of a co-researcher group, composed of PSP with lived experience, who will guide the research process. We will review deidentified crisis line interactions to identify patterns in service use and call outcomes to identify possible points of intervention to enhance service efficacy. We will launch a national web-based anonymous survey to understand the crisis line needs, barriers, and preferences of PSP. Phase 2 focuses on deepening our understanding of PSP experiences with crisis lines through in-depth interviews with those who have accessed or thought about accessing crisis lines and those without crisis line experience who wish to share their views. We will conduct focus groups with crisis sector staff to learn about desired training and resources for improving service delivery to PSP. Phase 3 focuses on developing and conducting co-design workshops to generate evidence-based recommendations with PSP, crisis line responders, researchers, and clinicians. Collaborating across sectors will allow us to codevelop feasible strategies for improving crisis line services to better meet the needs of PSP in crisis who may be inclined to access crisis lines for support.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;As of December 2024, the crisis line dataset has been identified and study recruitment for the national survey was completed. Data collection for all other research activities is expected to conclude by May 2025. We anticipate that study findings will be available by the end of 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;By identifying barriers to crisis line use and codeveloping solutions, this research will inform policy, service design, and training to enhance services. Ensuring PSP can access crisis line supports that are equitable, evidence-based, and integrated","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e75285"},"PeriodicalIF":1.5,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12514416/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145175633","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":"Digitally Mediated Occupational Therapy to Increase Physical Activity in Urban and Rural Breast Cancer Survivors: Protocol for a Single-Arm Feasibility Trial.","authors":"Tara C Klinedinst, Zachary C Pope, Michael C Robertson, Nadia Stanley, Audrey Wint, Christina Henson, Darla E Kendzor","doi":"10.2196/73554","DOIUrl":"10.2196/73554","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The 5-year survival rate for breast cancer (BC) has increased in recent years. However, functional limitations associated with BC treatment (eg, loss of strength, fatigue, and lymphedema) often have far-reaching effects on survivors' physical and mental health. Aerobic physical activity (PA) and muscle-strengthening exercise (MSE) can reduce functional limitations, and occupational therapy (OT) can support these health-promoting behaviors after treatment. Yet, barriers to access among BC survivors (eg, time burden and distance to the OT clinic) limit participation in OT programing. This is particularly true in Oklahoma, where 33% of residents live in rural counties. Digital technologies (eg, telehealth) can help urban and rural BC survivors circumvent these barriers.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;We are investigating the feasibility of a novel OT program among urban and rural BC survivors that features (1) 8 once-weekly telehealth OT sessions targeting constructs grounded in Self-Determination Theory (SDT), and (2) self-regulatory strategies known to support aerobic PA and MSE in BC survivors including self-monitoring via a wearable PA tracker, goal setting, and the provision of timely feedback.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This is a single-arm feasibility trial. We are recruiting 38 BC survivors using community-based recruitment approaches and via referral from collaborating oncologists. Participants include individuals who have undergone primary treatment and/or breast-conserving surgery or mastectomy for BC in the last 24 months and who do not meet recommended PA levels at the time of enrollment. We will assess self-reported program acceptability and feasibility via recruitment rates, study retention, and protocol adherence. We will also evaluate program safety by tracking BC-related lymphedema events, musculoskeletal injuries, and other adverse events. Finally, we will assess changes in aerobic PA, MSE, and health-related quality of life during the program period using accelerometry and self-report measurement tools.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;We received funding in March 2024 and institutional review board approval in September 2024. We began recruiting in November 2024. We anticipate completing data collection in early 2026. We hypothesize that the SDT-grounded OT program will be acceptable, feasible, and safe. We also expect pre- to post-program improvements in (1) SDT-informed determinants of PA, (2) levels of aerobic PA and MSE engagement, and (3) health-related quality of life.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The novel OT program under investigation is designed to decrease barriers to engaging in aerobic PA and MSE among people who have undergone various BC treatments. It is centered on facilitating a successful transition from active treatment to the posttreatment period and combines OT with the benefits of telehealth delivery and health behavior change theory. This program is amenable to","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e73554"},"PeriodicalIF":1.5,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12514410/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145175661","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":"Comparison of Ketorolac at 3 Doses in Children With Acute Pain: Protocol for A Randomized Controlled Trial.","authors":"Mohamed Eltorki, Redjana Carciumaru, Samina Ali, Anne Holbrook, Michael Livingston, Samira Samiee-Zafarghandy, Karen Beattie, Lehana Thabane, Lucia Giglia","doi":"10.2196/76554","DOIUrl":"10.2196/76554","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Intravenous ketorolac is a potent nonopioid analgesic commonly used to treat vigorous pain in children and adults. Despite its widespread use in pediatric emergency settings, ketorolac dosing in children remains \"off-label,\" with limited high-quality evidence to guide practice. Pharmacokinetic differences between children and adults suggest that lower ceiling doses adopted from adult practice may lead to suboptimal analgesia in pediatric populations. Inconsistent ketorolac dosing practices across centers reflect substantial clinical uncertainty. Amid efforts to reduce opioid use and provide effective nonopioid alternatives, rigorous pediatric trials evaluating ketorolac dosing are urgently needed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The primary objective is to determine whether 2 lower-dose intravenous ketorolac strategies (0.25 mg/kg-30 mg or 0.5 mg/kg-10 mg) are noninferior to the standard dosing regimen (0.5 mg/kg-30 mg) in reducing mean pain scores at 60 minutes postadministration in children aged 6-17 years presenting with vigorous pain. The secondary hypothesis is that ketorolac 0.5 mg/kg up to 10 mg will be superior to 0.25 mg/kg up to 30 mg by at least the minimally important difference of 2.0 points on the verbal Numerical Rating Scale (vNRS).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The KETODOSE trial is a single-center, randomized, double-blind, double-dummy, noninferiority trial conducted at McMaster Children's Hospital. Eligible participants aged 6 to &lt;18 years with vigorous pain (vNRS &gt;4) are randomized in a 1:1:1 ratio to standard dosing or one of 2 low-dose ketorolac regimens. Study drugs are administered via intravenous push over 5 minutes. Pain scores are assessed at baseline, 30, 60, 90, and 120 minutes. The primary endpoint is the mean change in vNRS score at 60 minutes. Secondary outcomes include pain scores at other time points, time to effective analgesia, rescue analgesia requirements, opioid consumption, and adverse events. Caregiver perceptions regarding analgesic use are evaluated using a mixed-methods semistructured survey. A sample size of 180 participants (60 per group) provides 80% power to detect noninferiority within a margin of 1.0 on the vNRS, assuming an SD of 1.5. Intention-to-treat and per-protocol analyses will be performed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Recruitment is ongoing. Final analyses will be performed once follow-up is completed for all participants. Results will be disseminated through peer-reviewed publications, conference presentations, caregiver- and clinician-facing educational tools, and national knowledge mobilization networks.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The KETODOSE trial will provide urgently needed evidence to guide ketorolac dosing for acute pain in children. If lower-dose regimens are shown to be noninferior to standard dosing, this may promote safer prescribing practices, reduce adverse events, and support efforts to minimize pediatric opioid use, thereby","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e76554"},"PeriodicalIF":1.5,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145251157","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}