JMIR Research Protocols最新文献

{"title":"Supporting Physical and Mental Health in Rural Veterans Living With Heart Failure: Protocol for a Nurse-Led Telephone Intervention Study.","authors":"Lucinda J Graven, Laurie Abbott, Josef V Hodgkins, Thomas Ledermann, M Bryant Howren","doi":"10.2196/63498","DOIUrl":"https://doi.org/10.2196/63498","url":null,"abstract":"<p><strong>Background: </strong>Heart failure (HF) remains a disease of notable disparity for rural veterans, despite recent advancements in clinical treatment. Managing HF in the home is stressful and complex for rural veterans who experience unique barriers to optimal physical and mental health, necessitating adequate support and problem-solving skills.</p><p><strong>Objective: </strong>This study aims to (1) adapt, to the rural sociocultural context, a culturally sensitive, tailored, telephone support and problem-solving intervention (CARE-HF [Supporting Physical and Mental Health in Rural Veterans With Heart Failure]) using findings from preliminary qualitative research and (2) evaluate the effects of CARE-HF on problem-solving and physical and mental health outcomes among rural veterans with HF.</p><p><strong>Methods: </strong>This study involves a repeated-measures, single-group design. The intervention content was adapted and tailored to the rural sociocultural context using preliminary qualitative data and guided by the Theories of Social Problem-Solving and Stress, Appraisal, and Coping. Veterans are recruited from Veterans Administration home-based cardiac rehabilitation clinics, cardiology clinics that serve veterans, veterans-based community resource centers, and social media campaigns. Veterans with HF (N=100) receive the CARE-HF intervention. This nurse-led intervention comprises 8 telephone sessions that use a five-step, problem-solving process to manage common HF problems in the home: (1) identifying the problem and viewing it in a positive manner, (2) goal setting, (3) generating potential strategies for problem management, (4) choosing and implementing strategies to manage the problem, and (5) evaluating strategy effectiveness. Veterans receive initial problem-solving training during the first session, with follow-up sessions focusing on problem-solving skill reinforcement and assisting veterans in applying these principles to manage self-identified, HF-related problems experienced in the home. Data are collected at baseline and 3, 6, 12, and 18 months from baseline on problem-solving and outcomes of interest (ie, HF self-care; HF symptoms; health care utilization; depressive symptoms; anxiety; HF-specific, health-related quality of life; stress; resilience; and coping). Demographic data will be analyzed using descriptive statistics and multilevel growth curve modeling with restricted maximum likelihood estimation to compare a series of models using Akaike information criteria and Bayesian information criteria fit indices while controlling for covariates.</p><p><strong>Results: </strong>Recruitment started in April 2023. As of December 2024, we have enrolled 56 veterans. Recruitment is anticipated to end in June 2025, with data collection continuing until all enrolled veterans have completed the 18-month follow-up period.</p><p><strong>Conclusions: </strong>Adapting and testing a culturally sensitive, tailored, telephone interve","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e63498"},"PeriodicalIF":1.4,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143729972","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":"Theory-Based Social Media Intervention for Nonmedical Use of Prescription Opioids in Young Adults: Protocol for a Randomized Controlled Trial.","authors":"Cheuk Chi Tam, Sean D Young, Sayward Harrison, Xiaoming Li, Alain H Litwin","doi":"10.2196/65847","DOIUrl":"https://doi.org/10.2196/65847","url":null,"abstract":"<p><strong>Background: </strong>The nonmedical use of prescription opioids (NMUPO) in young adults in the United States is concerning and is robustly influenced by many psychosocial factors. Given the advantages of flexibility, wide coverage, and real-time responses and assessment, using social media appears to be a promising and innovative approach to delivering psychosocial intervention to young adults. However, few theory-based social media interventions are available for NMUPO targeting this at-risk population.</p><p><strong>Objective: </strong>Guided by the information-motivation-behavioral skills model, the proposed research aims to address critical gaps by theoretically exploring psychosocial content associated with NMUPO among young adults via formative assessment. These findings will then be used to develop and evaluate the feasibility and preliminary efficacy of a peer-led social media intervention to reduce NMUPO among young adults.</p><p><strong>Methods: </strong>The proposed study will comprise serial research activities. First, formative research will be conducted through semistructured interviews among 30 young adults engaged in NMUPO. Qualitative data will be synthesized using a pragmatic approach for identifying psychosocial content associated with NMUPO. Second, qualitative findings will be used for developing a peer-led social media intervention to reduce NMUPO among young adults by integrating promising psychotherapy principles and incorporating them with well-trained recovery coaches. Third, the social media intervention will be evaluated through a 12-week randomized controlled trial among 70 young adults (n=35, 50% in the intervention group and control group) engaged in NMUPO via mixed methods, including pre- and postintervention surveys, social media paradata (eg, time-series reactions to posts) collection, and ecological momentary assessment during the intervention. The control group will not receive an intervention but will complete the pre- and postintervention surveys. The primary outcomes will be feasibility, usability, and acceptability, while the secondary outcomes will be psychosocial and behavioral measures, such as past-3-month NMUPO, intention, psychological distress, self-efficacy, resilience, and coping strategies.</p><p><strong>Results: </strong>The proposed study was funded in May 2024. Social media campaigns have received responses from a total of 379 individuals, with 24 (6.3%) identified as eligible. As of February 10, 2025, we have completed formative interviews with 8 eligible participants.</p><p><strong>Conclusions: </strong>The proposed study will be one of the first efforts to develop and deliver a theory-based peer-led intervention on social media, incorporating empirical findings on the psychosocial mechanism of NMUPO. The findings of the proposed study will provide valuable insights into opioid risk reduction for young adults through an innovative approach. If the tested trial is found to be feasib","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e65847"},"PeriodicalIF":1.4,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143729983","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":"Predicting Therapy Outcomes in Patients With Stress-Related Disorders: Protocol for a Predictive Modeling Study.","authors":"Ludwig Franke Föyen, Victoria Sennerstam, Evelina Kontio, Oskar Flygare, Magnus Boman, Elin Lindsäter","doi":"10.2196/65790","DOIUrl":"https://doi.org/10.2196/65790","url":null,"abstract":"<p><strong>Background: </strong>While cognitive behavioral therapy has shown efficacy in treating stress-related disorders, such as adjustment disorder and exhaustion disorder, knowledge about factors contributing to treatment response is limited. Improved identification of such factors could enhance assessment procedures and treatment strategies. In addition, evaluating how traditional prediction methods and machine learning can complement each other may help bridge gaps in understanding and predicting treatment response.</p><p><strong>Objective: </strong>This study aims to (1) evaluate putative predictors of treatment response in patients with stress-related disorders using traditional prediction methods and (2) model treatment outcomes using a machine learning approach. This design combines the interpretability of traditional methods with the ability of machine learning to identify complex patterns.</p><p><strong>Methods: </strong>We will analyze data from a randomized controlled trial comparing 2 internet-delivered treatments, cognitive behavioral therapy versus an active control treatment, for patients diagnosed with adjustment disorder or exhaustion disorder (N=300). Prediction models will be based on pooled data from both treatment arms due to the limited sample size and lack of knowledge on predictors of treatment effects. Putative predictors include sociodemographic and clinical information, clinician-assessed data, self-rated symptoms, and cognitive test scores. The primary outcome of interest is responder status on the Perceived Stress Scale-10, evaluated based on the reliable change index posttreatment. For the traditional approach, univariate logistic regressions will be conducted for each predictor, followed by an ablation study for significant predictors. For the machine learning approach, 4 classifiers (logistic regression with elastic net, random forest, support vector machine, and AdaBoost) will be trained and evaluated. The dataset will be split into training (70%) and testing (30%) sets. Hyperparameter tuning will be conducted using 5-fold cross-validation with randomized search. Model performance will be assessed using balanced accuracy, precision, recall, and area under the curve.</p><p><strong>Results: </strong>All data were collected between April 2021 and September 2022. We hypothesize that key predictors will include younger age, education level, baseline symptom severity, treatment credibility, and history of sickness absence. We anticipate that the machine learning models will outperform a dummy model predicting the majority class and achieve a balanced accuracy of ≥67%, thus indicating clinical usefulness.</p><p><strong>Conclusions: </strong>This study will contribute to the limited research on predictors of treatment outcome in stress-related disorders. The findings could support the development of more personalized and effective treatments for individuals diagnosed with adjustment disorder or exhaustion disorder, po","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e65790"},"PeriodicalIF":1.4,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143709730","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":"The Utility of a Smartphone-Based Retinal Imaging Device as a Screening Tool in an Outpatient Clinic Setting: Protocol for an Observational Study.","authors":"Ajay Mittal, Victor Sanchez, Navjot Singh Azad, Yaroslav Zuyev, Rafael Robles, Mark Sherwood","doi":"10.2196/52650","DOIUrl":"https://doi.org/10.2196/52650","url":null,"abstract":"<p><strong>Background: </strong>Glaucoma, a disease leading to the degeneration of retinal ganglion cells, results in changes to the optic nerve head that are often diagnosed late when visual problems arise. With the prevalence of glaucoma surpassing 76 million adults worldwide and with glaucoma being the leading cause of irreversible blindness in the world, the early detection and management of glaucoma is imperative. Digital ophthalmoscopes, such as the D-EYE (D-EYE, Srl), have emerged as a technology that uses smartphone cameras with an attachment on the lens to visualize the retina and optic nerve head without the need for dilation. The purpose of this pilot study is to examine the acceptability and feasibility of a D-EYE digital ophthalmoscope to screen for ocular pathology involving the optic nerve, particularly glaucoma.</p><p><strong>Objective: </strong>This study aimed to demonstrate the effect of a smartphone-based ophthalmoscope as a potential vision screening tool for optic nerve head pathology in participants enrolled in this study. The first specific aim was to determine the ability of the D-EYE smartphone ophthalmoscope to gather high-quality imaging to be used for grading the fundus into low- and high-risk categories for eye pathology. The second specific aim was to determine the difference in the quality of data capture between still retinal images and 30-second retinal video recordings produced by D-EYE smartphone ophthalmoscopes.</p><p><strong>Methods: </strong>This observational pilot study enrolled 110 patients receiving routine eye care at the University of Florida Health from February 2019 to February 2022 to assess the use of the D-EYE device in capturing still images and 30-second videos of the bilateral retina and optic nerves of each participant. Study participants completed a survey to gather demographics and past medical history data with a particular focus on previous eye health history. Images were reviewed by 5 ophthalmology residents with interrater reliability analysis performed to assess findings.</p><p><strong>Results: </strong>Ophthalmology resident review indicated greater visualizability and clarity of the bilateral retina and optic nerves with 30-second videos of retinal imaging compared with still-image ophthalmic capture. Furthermore, an increase in visualizability and clarity allowed for a more accurate measurement of the cup-to-disc ratio, a diagnostic marker for glaucoma. In addition, the likelihood of referral of the glaucomatous and healthy sample groups to ophthalmologists indicated a greater sensitivity of digital ophthalmoscopes in being able to detect retinal abnormalities requiring early intervention and management, supporting the technology's use as a screening tool.</p><p><strong>Conclusions: </strong>This investigation suggests that the use of smartphone-based digital ophthalmoscopes can be more effectively applied as a screening tool by capturing 30-second videos compared with still images a","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e52650"},"PeriodicalIF":1.4,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143709748","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":"Examining the Efficacy of the Telehealth Assessment and Skill-Building Kit (TASK III) Intervention for Stroke Caregivers: Protocol for a Randomized Controlled Clinical Trial.","authors":"Tamilyn Bakas, Elaine Miller, Heidi Sucharew, Natalie Kreitzer, Jahmeel Israel, Matthew Rota, Brett Harnett, Kari Dunning, Holly Jones, Michael McCarthy, Bonnie Brehm, Joan K Austin, Pamela H Mitchell","doi":"10.2196/67219","DOIUrl":"10.2196/67219","url":null,"abstract":"<p><strong>Background: </strong>Stroke is a leading cause of serious, long-term disability and has a sudden onset. Upon discharge to the home setting, families are thrust into providing care, often without sufficient training from health care providers. Aligned with current patient and caregiver guidelines, the Telehealth Assessment and Skill-Building Kit (TASK III) is a nurse-led intervention designed to empower caregivers to address their own needs and those of the survivor using innovative skill-building strategies.</p><p><strong>Objective: </strong>This study aims to test the short-term (immediately after the intervention at 8 wk) and long-term (12, 24, and 52 wk) efficacy of the TASK III intervention, compared with an information, support, and referral (ISR) group, to improve caregiver life changes (ie, changes in physical health, physical functioning, emotional well-being, and general health) as a result of providing care.</p><p><strong>Methods: </strong>A randomized controlled clinical trial design will be used with baseline data collection from 296 family caregivers by telephone after the stroke survivor is discharged home. Caregivers randomly assigned to the ISR group (n=148, 50%) will receive information from the American Heart Association about stroke family caregiving. Caregivers randomly assigned to the TASK III group (n=148, 50%) will receive a TASK III resource guide and information from the American Heart Association. Both groups will receive 8 weekly calls from a nurse, with a booster call a month later. Outcomes will be assessed by blinded data collectors at 8, 12, 24, and 52 weeks. The primary outcome (at 8 wk) is caregiver life changes measured by the Bakas Caregiving Outcomes Scale. Secondary outcomes are depressive symptoms; other symptoms (eg, stress, fatigue, sleep, pain, and shortness of breath); unhealthy days; diet; exercise; and self-reported health care use. Mediators are task difficulty, threat appraisal, and self-efficacy. Program evaluation outcomes (satisfaction and technology ratings) will also be analyzed.</p><p><strong>Results: </strong>The trial was registered on March 10, 2022. Enrollment and random assignment of the first participant was on November 30, 2022, with an anticipated completion of recruitment by November 30, 2025. Completion of the primary end point data analysis is anticipated by August 31, 2026, with results expected to be reported on ClinicalTrials.gov by April 1, 2027. As of October 9, 2024, a total of 198 (66.9% of the proposed total sample of 296) family caregivers have been enrolled and randomly assigned to the TASK III group (n=98, 49.5%) or the ISR group (n=100, 50.5%). The last update was performed on January 25, 2024.</p><p><strong>Conclusions: </strong>If the TASK III intervention is shown to be efficacious in the proposed randomized controlled clinical trial, our next goal will be to translate TASK III into ongoing stroke systems of care, providing a tremendous public health impact.<","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":" ","pages":"e67219"},"PeriodicalIF":1.4,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143408025","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":"Exploring Climate Change's Impact on the Cardiopulmonary Health of Adults Living in the Canton of Valais, Switzerland: Protocol for a Development and Usability Pilot Study.","authors":"Omar Portela Dos Santos, Paulo Jorge Pereira Alves, Henk Verloo","doi":"10.2196/67128","DOIUrl":"https://doi.org/10.2196/67128","url":null,"abstract":"<p><strong>Background: </strong>Climate change is affecting public health and well-being. In 2016, Swiss emergency departments (EDs) treated 1,722,000 cases, with 4718 daily admissions. In 2023, the ED of Sion Regional Hospital recorded 75,000 consultations. The links between climate change and health are complex, necessitating urgent research on its impact on cardiopulmonary health in Valais, Switzerland. Raising awareness among frontline professionals is crucial for developing health promotion and disease prevention strategies.</p><p><strong>Objective: </strong>This study explores the preliminary effects of climate change on cardiopulmonary health in Valais and assesses adult patients' knowledge of its health consequences. Findings will inform adaptations in patient care, health promotion, and disease prevention at Sion Hospital's ED. The feasibility of patient selection and data collection will also be evaluated.</p><p><strong>Methods: </strong>Using a convergent, parallel, mixed methods design, data will be collected from September 21, 2024, to September 20, 2025, with a target sample of 60 patients. The quantitative phase will examine patient recruitment feasibility, consultation reasons, and triage levels, correlating them with climate variables (temperature, nitrogen dioxide, particulate matter, sulfur dioxide, and ozone). It will also analyze sociodemographic profiles. The qualitative phase will explore patients' knowledge of climate change and its potential links to their ED visits. The feasibility and acceptability of the study process will be assessed. The protocol follows the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Extension for Pilot and Feasibility Trials.</p><p><strong>Results: </strong>Data collection started on September 21, 2024, following the approval by the ethical commission. Data collection will take place over 1 year, until September 20, 2025.</p><p><strong>Conclusions: </strong>This study will test the feasibility of a larger investigation and examine potential associations between Valais' changing microclimate and population health. Findings will establish patient profiles and explore their perceptions and knowledge of climate change, informing future health interventions.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/67128.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e67128"},"PeriodicalIF":1.4,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143709729","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":"Establishing a Digital Health Care Ecosystem in a Health Sciences University in South Africa: Protocol for a Mixed Methods Study.","authors":"Samantha Govender, Maria Elizabeth Cochrane, Mabina Mogale, Reno Gordon, Tjodwapi Tshephe","doi":"10.2196/57821","DOIUrl":"https://doi.org/10.2196/57821","url":null,"abstract":"<p><strong>Background: </strong>Comprehensive and formalized digital health care ecosystems in health sciences tertiary education in South Africa do not currently exist, but they have the potential to influence teaching and learning, research, and community engagement.</p><p><strong>Objective: </strong>A total of 3 key objectives underpin the study, that is, determining the health care curriculum needs and required content for the development of a formalized digital health ecosystem, determining the level of readiness of staff and students to participate in a digital health care ecosystem, and determining whether community engagement and strategic partnerships can contribute to the sustainability of a digital health care ecosystem.</p><p><strong>Methods: </strong>A multipronged approach will be used to address the objectives, with a mixed methods design being undertaken. The qualitative phases will be phenomenological in nature, and triangulation of information along with thematic analysis will be conducted on the collected data. Quantitative data will be collected prospectively and cross-sectionally and analyzed using descriptive analysis. Sampling will include subject experts for the Delphi technique, staff and students at the University, clinical training and education partners, and community leaders. This study has received ethical approval from the Sefako Makgatho Health Sciences University Research and Ethics Committee (SMUREC/H/260/2023:PG).</p><p><strong>Results: </strong>Data collection for the first phase will begin in January 2024 and conclude in December 2024. Phase 2 and 3 of the study will be conducted concurrently, with data collection starting in January 2025 and concluding in December 2026.</p><p><strong>Conclusions: </strong>The establishment of a digital health care ecosystem has the potential to benefit staff, students, and communities through stakeholder collaboration, educational opportunities, research projects, and improved service delivery.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/57821.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e57821"},"PeriodicalIF":1.4,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143709728","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":"Student Acceptance of Digital Entrustable Professional Activities: Protocol for a Cohort Study.","authors":"Maximilian Domann, Constanze Richters, Matthias Stadler","doi":"10.2196/59326","DOIUrl":"https://doi.org/10.2196/59326","url":null,"abstract":"<p><strong>Background: </strong>Integrating digital entrustable professional activities (EPAs) and simulations in medical education represents a substantial shift toward competency-based learning. This approach focuses on developing specific skills through manageable units and enhancing proficiency in high-stakes environments. The technology acceptance model provides a framework to evaluate the adoption of these educational technologies, emphasizing the roles of perceived usefulness and ease of use.</p><p><strong>Objective: </strong>This cohort study aims to investigate the acceptance of digital EPAs among medical students within simulated training environments. It seeks to understand how perceived usefulness and ease of use influence this acceptance, guided by the principles of the technology acceptance model.</p><p><strong>Methods: </strong>The cohort study will involve medical students in the clinical phase of their education at Ludwig Maximilians University Munich. The survey, distributed through the Module-6 distributor, will capture their perceptions of digital EPAs. The data will be analyzed using regression analysis.</p><p><strong>Results: </strong>Data collection is anticipated to be complete by April 2025, with analysis concluded by May 2025. The results will provide insights into students' attitudes toward digital EPAs and their willingness to integrate these tools into their learning.</p><p><strong>Conclusions: </strong>This study will contribute to the understanding of digital EPAs' role in medical education, potentially guiding future design and implementation of these tools. While highlighting the importance of perceived usefulness and ease of use, the study also acknowledges limitations in sample size and recruitment methodology, indicating the need for further research with more diverse and larger groups. This research is poised to shape future medical training programs, aligning with the evolving landscape of medical education.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/59326.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e59326"},"PeriodicalIF":1.4,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143709731","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":"Unintended Prolonged Opioid Use: Protocol for a Case-Controlled Trial.","authors":"W Michael Hooten, Darin J Erickson, Marek Chawarski, Natalie A Scholz, Jennifer F Waljee, Chad M Brummett, Molly M Jeffery","doi":"10.2196/72032","DOIUrl":"10.2196/72032","url":null,"abstract":"<p><strong>Background: </strong>Misuse of prescription opioids remains a public health problem. Appropriate short-term use of these medications in opioid-naive patients is indicated in selected settings but can result in unintended prolonged opioid use (UPOU), defined as the continuation of opioid therapy beyond the period by which acute pain would have been expected to resolve. Clinical strategies aimed at preventing UPOU are lacking due to the absence of information about how this poorly understood clinical phenomenon actually develops.</p><p><strong>Objective: </strong>In this research project, 3 Clinical and Translational Science Awards (CTSA) programs (Mayo Clinic, University of Michigan, and Yale University) leveraged the conceptual framework for UPOU to investigate how patient characteristics, practice environment characteristics, and opioid prescriber characteristics facilitate or impede UPOU. All data management and analyses were conducted at a fourth CTSA program (University of Minnesota). This work was accomplished by pursuing 3 specific aims.</p><p><strong>Methods: </strong>In aim 1, opioid-naive adults receiving an initial opioid prescription were recruited for study participation. Opioid prescriptions were identified longitudinally, and patterns of use were categorized as short-term, episodic, or long-term use using established criteria. Using a prospective case-control design, patients progressing to UPOU were matched 1:1 with patients who did not develop UPOU, and differences in patient characteristics were assessed. In aim 2, clinicians who prescribed opioids to patients in aim 1 were identified and recruited for prospective assessments. Institutional and individual practice environments were assessed using a validated self-report survey. In aim 3, structural equation modeling was used to evaluate data collected in aims 1 and 2, and identified interactions were further evaluated in a large national administrative claims database.</p><p><strong>Results: </strong>Patient recruitment began on August 1, 2019. However, due to the COVID-19 pandemic, patient recruitment was slowed and intermittently interrupted over the ensuing 3-year period. As a result of regional variations in the impact of the COVID-19 pandemic on research activities, the majority of patient and clinician recruitment occurred at the Mayo Clinic site.</p><p><strong>Conclusions: </strong>Following complete data analyses, it is anticipated that electronic health record systems will be leveraged to help clinicians identify at risk patients and to develop direct-to-patient educational materials to raise awareness of the risk factors for developing UPOU.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT04024397; https://clinicaltrials.gov/study/NCT04024397.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/72032.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":" ","pages":"e72032"},"PeriodicalIF":1.4,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143483256","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":"Measuring Adult Health and Well-Being Outcomes Associated With Nature Contact in Parks and Other Forms of Protected Areas: Protocol for a Scoping Review.","authors":"Jill Bueddefeld, Catherine E Reining, Loraine Lavallee, Ryan Brady, Mark W Groulx, Christopher James Lemieux","doi":"10.2196/63338","DOIUrl":"10.2196/63338","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Growing evidence shows various health and well-being benefits from nature contact in parks and other forms of protected areas. However, the methods to measure these outcomes lack systematic identification, critical appraisal, and synthesis. Researchers working in this area would benefit from a clear framework highlighting key considerations when selecting measurement tools, along with a summary of the measures used, and insights into the limitations of generalizing existing research findings.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The objectives of this scoping review are 2-fold. First, we aim to identify the instruments used to measure mental health and well-being outcomes of adults associated with direct nature contact in parks and other forms of protected areas. Second, we aim to evaluate the psychometric properties associated with the validity of these instruments to better understand the strengths and weaknesses of current measurement approaches.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Following PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines, 8 scholarly databases were searched (PubMed, Web of Science, PsycINFO [via ProQuest], ERIC [via EBSCOhost], CINAHL [via EBSCOhost], GreenFILE [via EBSCOhost], OVID, and GEOBASE) on January 4, 2023, for literature measuring the mental health and well-being outcomes associated with nature contact in protected areas. Sources were screened by reviewers based on clear inclusion or exclusion criteria relevant to the research questions: peer-reviewed English language studies measuring mental health and well-being focused on adults (aged 18+ years) with direct, in-person nature contact in parks and protected areas. Data will be extracted, analyzed, and represented according to 3 domains. This includes study details, characteristics of the measurement instruments, and their validity.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The results of the study and submission of a manuscript for peer review are expected in April 2025. The results of the scoping review are expected to contribute to an understanding of the diverse methods used to measure mental health and well-being related to nature contact in protected areas. Expected findings will include an organized summary of existing quantitative and qualitative instruments for measuring mental health and well-being outcomes, including appraisal of the instrument's psychometric properties.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;To the authors' knowledge, this will be the first scoping review undertaken on measures used to assess mental health and well-being outcomes related to nature contact in parks and protected areas context, offering a starting point from which to critically examine the validity and consistency of such methods. Findings will aid in identifying the strengths and weaknesses of current measurement approaches to mental health and well-being outcomes of nature contact and ma","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e63338"},"PeriodicalIF":1.4,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143692037","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}