JMIR Research Protocols最新文献

{"title":"Preventing Premature Pre-Exposure Prophylaxis Discontinuation and Sexually Transmitted Infections Among Men Who Have Sex With Men (Project PEACH): Protocol for a Prospective Cohort Study.","authors":"Amalia Aldredge, Derrius Carter, Candice A DeCree, Elliot V Gardner, Gina Bailey Herring, Oumaima Kaabi, Rebecca Moges-Banks, Rachel Valencia, Colleen Frances Kelley, Patrick Sean Sullivan","doi":"10.2196/56096","DOIUrl":"10.2196/56096","url":null,"abstract":"<p><strong>Background: </strong>There is an ongoing syndemic of HIV and sexually transmitted infections (STIs) in the United States, particularly among men who have sex with men (MSM). We have increasingly effective and diverse measures of prevention, including various types of pre-exposure prophylaxis (PrEP) for HIV prevention and doxycycline postexposure prophylaxis (doxyPEP) for STI prevention. As options expand, we need to understand how to use a combination of these strategies and other supports for MSM to best curb the syndemic.</p><p><strong>Objective: </strong>We designed a patient-preference trial to understand patient preferences for PrEP and doxyPEP, how preferences may change over time, and methods for preventing premature discontinuation of PrEP.</p><p><strong>Methods: </strong>We enrolled HIV-negative MSM in metropolitan Atlanta, Georgia. Participants could elect to take PrEP (daily or on-demand), doxyPEP, both, or neither, along with app-based support to evaluate for risk factors of discontinuation or behavioral changes that might affect their choice of prevention methods. Participants were able to switch prevention methods at any time. Oral PrEP and doxyPEP users are currently being offered quarterly in-person or at-home HIV, syphilis, gonorrhea, and chlamydia testing along with opportunities for motivational interviewing.</p><p><strong>Results: </strong>We enrolled individuals from November 2021 to September 2023. Among 240 participants, the median age was 30 (IQR 25-35), 63% (n=150) self-identified as non-Hispanic Black, and 69% (n=166) were insured. Most participants (n=144, 60%) elected to take daily PrEP plus doxyPEP, with a smaller proportion taking on-demand PrEP plus doxyPEP (n=34, 14%) or daily PrEP without doxyPEP (n=33, 14%).</p><p><strong>Conclusions: </strong>We designed an ongoing study to evaluate the preferences for PrEP and doxyPEP among MSM in metropolitan Atlanta. Enrollment was completed in 22 months and included a diverse cohort of MSM that will be followed longitudinally to evaluate prevention preferences over time. At baseline, most participants preferred to take a combination of daily PrEP and doxyPEP for HIV and STI prevention.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov NCT05072093; https://clinicaltrials.gov/study/NCT05072093.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/56096.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e56096"},"PeriodicalIF":1.4,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12059491/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144018209","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":"Physical Activity Measurement Reactivity Among Midlife Adults With Elevated Risk for Cardiovascular Disease: Protocol for Coordinated Analyses Across Six Studies.","authors":"Kiri Baga, Gabrielle M Salvatore, Iris Bercovitz, Amanda L Folk, Ria Singh, Laura M König, Meghan L Butryn, Jacqueline A Mogle, Danielle Arigo","doi":"10.2196/67438","DOIUrl":"https://doi.org/10.2196/67438","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Cardiovascular disease (CVD) remains the leading cause of death in the United States, and adults aged 40-60 years with specific health conditions are at particularly elevated risk for developing CVD. Physical activity (PA) is a key cardioprotective behavior and many interventions exist to promote PA in this group. Effective promotion requires accurate assessment of PA behavior; as PA is often estimated by averaging across multiple days, a threat to accurate assessment is measurement reactivity, or an atypical increase in PA behavior at the start of measurement periods that may bias conclusions. Evidence for PA measurement reactivity is equivocal, though concern has resulted in recommendations to add or drop PA measurement days from inclusion, which may introduce undue burden on participants. At present, the extent of PA measurement reactivity and the behaviors most likely to be affected (eg, steps vs minutes of exercise) among those at risk for CVD are unclear, as are participant characteristics such as gender and study expectations (eg, intervention vs observation only) that may contribute to differences in these patterns.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The goal of this study is to improve on the current understanding of the extent of PA measurement reactivity and potential moderators among US adults aged 40-60 years with CVD risk factors.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;To achieve this goal, we will conduct coordinated multilevel analyses across 6 studies. Data are from nationally representative, publicly available datasets (observation only: 2 studies) and baseline weeks of observation from behavioral weight loss clinical trials (4 studies), all collected in the United States. The publicly available datasets National Health and Nutrition Examination Survey (NHANES; 2013-2014) and the Midlife in the United States (MIDUS) Study (2004-2009; total n=1385) were used, which are available from the Inter-university Consortium for Political and Social Research website. Behavioral weight loss trials were conducted by the Drexel University Weight Eating and Lifestyle (WELL) Center (2011-2023; total n=444), in person or remotely via Zoom. Relevant data from each study were extracted for adults aged 40-60 years who have ≥1 risk factor for CVD (total n=1832; 11,707 total days of PA measurement with 6-7 days per person). Changes in PA behavior across the measurement period will be examined at the day level, using 2-level multilevel models (days nested within persons) and cross-level interactions (for moderation effects).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This project was funded in August 2022 and received supplementary funding in September 2023. Dataset acquisition and data cleaning were completed in October 2024. Analyses are expected to be completed in April 2025, and findings are anticipated to be shared in July 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Results from this coordinated analysis project will provide the first ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e67438"},"PeriodicalIF":1.4,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12059496/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143993499","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":"Paving the Road for More Ethical and Equitable Policies and Practices in Telerehabilitation in Psychology and Neuropsychology: Protocol for a Rapid Review.","authors":"Dorothée Morand-Grondin, Jeanne Berthod, Jennifer Sigouin, Simon Beaulieu-Bonneau, Dahlia Kairy","doi":"10.2196/66639","DOIUrl":"https://doi.org/10.2196/66639","url":null,"abstract":"<p><strong>Background: </strong>Virtual rehabilitation, or telerehabilitation (TR), has exponentially evolved in the last few years, gaining particular momentum since the COVID-19 pandemic. In response to a new reality of strict restrictions of physical contact necessitating the shift from in-person health services to tele-health visits, TR has seen widespread adoption. In this context, ensuring ethical and equitable TR services is crucial for establishing sustainable TR models for psychology and neuropsychology into health care systems. This requires complete and consistent guidance for clinicians and patients involved.</p><p><strong>Objective: </strong>The objective of this study is to synthesize existing evidence to provide timely insights on potential ethical and equitable benefits and pitfalls associated with the use of TR in a psychological and neuropsychological framework.</p><p><strong>Methods: </strong>A rapid review of TR practices will be conducted specifically within the context of neuropsychology and psychology rehabilitation. We will include review articles published between 2010 and 2020 as well as original articles published between 2020 and 2023, all addressing TR issues with a main focus on neuropsychological and/or psychological rehabilitation activities. This research protocol describes the methodology, including search strategy, screening process, data extraction, and analysis methods.</p><p><strong>Results: </strong>Guided by an experienced librarian, the search strategy was designed and performed in 3 relevant databases. Articles were screened in accordance with the inclusion and exclusion criteria, and data were collected by 2 independent reviewers. Data extraction is underway, and we expect to complete the rapid review in January 2025.</p><p><strong>Conclusions: </strong>This study is part of a broader cross-Canadian initiative aimed at informing policy development and clinical practices in TR. By evaluating the ethical and equitable considerations specific to psychology and neuropsychology, this review aims to contribute to help shape future TR practices to ensure access to high-quality, accessible TR services supporting diverse patient needs in psychology and neuropsychology.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/66639.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e66639"},"PeriodicalIF":1.4,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12056424/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143998851","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":"The Comprehensive Adaptive Multisite Prevention of University Student Suicide Trial: Protocol for a Randomized Controlled Trial.","authors":"Kyla Blalock, Jacqueline Pistorello, Shireen L Rizvi, John R Seeley, Francesca Kassing, James Sinclair, Linda A Oshin, Robert J Gallop, Cassidy M Fry, Ted Snyderman, David A Jobes, Jennifer Crumlish, Hannah R Krall, Susan Stadelman, Filiz Gözenman-Sapin, Kate Davies, David Steele, David B Goldston, Scott N Compton","doi":"10.2196/68441","DOIUrl":"https://doi.org/10.2196/68441","url":null,"abstract":"<p><strong>Background: </strong>Suicidal ideation is increasing among university students. Despite growing demand for services, university counseling centers (UCCs) face limited resources to meet the complex needs of students who are suicidal.</p><p><strong>Objective: </strong>The Comprehensive Adaptive Multisite Prevention of University Student Suicide (CAMPUS) Trial evaluates 4 treatment sequences within UCCs to develop evidence-based treatment guidelines.</p><p><strong>Methods: </strong>The CAMPUS Trial consists of a feasibility study followed by a sequential multiple-assignment randomized trial (SMART). The original CAMPUS protocol was modified during the COVID-19 pandemic to accommodate new UCC tele-mental health services, including remote treatment, assessments, and monitoring. A smaller-scale feasibility study was conducted to (1) evaluate implementation of hybrid telehealth and in-person interventions and (2) fine-tune online procedures. Following the feasibility study, university students (aged 18-25 years) seeking UCC services with moderate to severe suicidal ideation will enroll in the CAMPUS Trial. Student participants are randomly assigned to 1 of 4 treatment sequences with 2 stages of intervention. In stage 1, students receive 4 to 6 weeks of either (1) a suicide-focused treatment-Collaborative Assessment and Management of Suicidality-or (2) enhanced treatment as usual. Treatment responders enter the maintenance phase. In stage 2, nonresponders are rerandomized for an additional 1 to 8 weeks of (1) Collaborative Assessment and Management of Suicidality or (2) an intensive skills-based treatment-dialectical behavior therapy for UCC settings. UCC counselors will enroll in the CAMPUS Trial to complete measures about their experience working with students who are suicidal. CAMPUS Trial administration includes representation from all sites to facilitate cross-site coordination and an advisory board of stakeholders from all UCCs to facilitate treatment implementation.</p><p><strong>Results: </strong>Student participant recruitment began on October 25, 2022, and ended on May 16, 2024. As of November 2024, data collection for the SMART was ongoing with active study participants. Data collection was completed in November 2024, and as of April 2025, data analysis is underway. Full results will be available in 2025.</p><p><strong>Conclusions: </strong>The CAMPUS Trial offers a model for future SMARTs for the treatment of suicidal thoughts or behaviors (or both) across various settings. The results will inform treatment guidelines for students presenting with suicidality at UCCs.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT04707066; http://clinicaltrials.gov/ct2/show/NCT04707066.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/68441.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e68441"},"PeriodicalIF":1.4,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12056417/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144019068","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":"The Fire Fighter Cancer Cohort Study: Protocol for a Longitudinal Occupational Cohort Study.","authors":"Jefferey L Burgess, Shawn C Beitel, Miriam M Calkins, Melissa A Furlong, Paola Louzado Feliciano, Jamie Kolar Gabriel, Casey Grant, Jaclyn M Goodrich, Judith M Graber, Olivia Healy, James Hollister, Jeff Hughes, Sara Jahnke, Krystal Kern, Frank A Leeb, Alberto J Caban-Martinez, Alexander C Mayer, Russell Osgood, Cynthia Porter, Sreenivasan Ranganathan, Heather M Stapleton, Natasha Schaefer Solle, Christine Toennis, Derek J Urwin, Michelle Valenti, John J Gulotta","doi":"10.2196/70522","DOIUrl":"https://doi.org/10.2196/70522","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Firefighters are at an increased risk of cancer and other health conditions compared with the general population. However, the specific exposures and mechanisms contributing to these risks are not fully understood. This information is critical to formulate and test protective interventions.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The purpose of the Fire Fighter Cancer Cohort Study (FFCCS) is to conduct community-engaged research with the fire service to advance the evaluation and reduction of firefighter exposures, along with understanding and mitigating effects leading to an increased risk of cancer and other health conditions. This involves establishing a long-term (&gt;30 years) firefighter multicenter prospective cohort study.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The structure of the FFCCS includes a fire service oversight and planning board to provide guidance and foster communication between researchers and fire organizations; a data coordinating center overseeing survey data collection and data management; an exposure assessment center working with quantitative exposure data to construct a firefighter job exposure matrix; and a biomarker analysis center, including a biorepository. Together, the centers evaluate the association between firefighter exposures and toxic health effects. Firefighter research liaisons are involved in all phases of the research. The FFCCS research design primarily uses a set of core and project-specific survey questions accompanied by a collection of biological samples (blood and urine) for the analysis of biomarkers of exposure and effect. Data and samples are collected upon entry into the study, with subsequent collection after eligible exposures, and at intervals (eg, 1-2 years) after enrollment. FFCCS data collection and analysis have been developed to evaluate unique exposures for specific firefighter groups; cancer risks; and end points in addition to cancer, such as reproductive outcomes. Recruitment is carried out with coordination from partnering fire departments and eligible participants, including active career and volunteer firefighters in the United States.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The FFCCS protocol development was first funded by the US Federal Emergency Management Agency in 2016, with enrollment beginning in February 2018. As of September 2024, &gt;6200 participants from &gt;275 departments across 31 states have enrolled, including recruit and incumbent firefighters. Biological samples have been analyzed for measures of exposure and effect. Specific groups enrolled in the FFCCS include career and volunteer structural firefighters, women firefighters, trainers, fire investigators, wildland firefighters, firefighters responding to wildland-urban interface fires, and airport firefighters. Peer-reviewed published results include measurement of exposures and the toxic effects of firefighting exposure. Whenever possible, research results are provided back to individual participants.&lt;/p","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e70522"},"PeriodicalIF":1.4,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12056432/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143990424","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":"Patient-Related Metadata Reported in Sequencing Studies of SARS-CoV-2: Protocol for a Scoping Review and Bibliometric Analysis.","authors":"Karen O'Connor, Davy Weissenbacher, Amir Elyaderani, Ebbing Lautenbach, Matthew Scotch, Graciela Gonzalez-Hernandez","doi":"10.2196/58567","DOIUrl":"10.2196/58567","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;There has been an unprecedented effort to sequence the SARS-CoV-2 virus and examine its molecular evolution. This has been facilitated by the availability of publicly accessible databases, such as the GISAID (Global Initiative on Sharing All Influenza Data) and GenBank, which collectively hold millions of SARS-CoV-2 sequence records. Genomic epidemiology, however, seeks to go beyond phylogenetic (the study of evolutionary relationships among biological entities) analysis by linking genetic information to patient characteristics and disease outcomes, enabling a comprehensive understanding of transmission dynamics and disease impact. While these repositories include fields reflecting patient-related metadata for a given sequence, the inclusion of these demographic and clinical details is scarce. The current understanding of patient-related metadata in published sequencing studies and its quality remains unexplored.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;Our review aims to quantitatively assess the extent and quality of patient-reported metadata in papers reporting original whole genome sequencing of the SARS-CoV-2 virus and analyze publication patterns using bibliometric analysis. Finally, we will evaluate the efficacy and reliability of a machine learning classifier in accurately identifying relevant papers for inclusion in the scoping review.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The National Institutes of Health's LitCovid collection will be used for the automated classification of papers reporting having deposited SARS-CoV-2 sequences in public repositories, while an independent search will be conducted in MEDLINE and PubMed Central for validation. Data extraction will be conducted using Covidence (Veritas Health Innovation Ltd). The extracted data will be synthesized and summarized to quantify the availability of patient metadata in the published literature of SARS-CoV-2 sequencing studies. For the bibliometric analysis, relevant data points, such as author affiliations, citation metrics, author keywords, and Medical Subject Headings terms will be extracted.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study is expected to be completed in early 2025. Our classification model has been developed and we have classified publications in LitCovid published through February 2023. As of September 2024, papers through August 2024 are being prepared for processing. Screening is underway for validated papers from the classifier. Direct literature searches and screening of the results began in October 2024. We will summarize and narratively describe our findings using tables, graphs, and charts where applicable.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This scoping review will report findings on the extent and types of patient-related metadata reported in genomic viral sequencing studies of SARS-CoV-2, identify gaps in the reporting of patient metadata, and make recommendations for improving the quality and consistency of reporting in this area. T","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e58567"},"PeriodicalIF":1.4,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12056431/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143993427","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":"Italian Medical Professionals' Practices, Attitudes, and Knowledge in Travel Medicine: Protocol for a National Survey.","authors":"Francesco Baglivo, Luigi De Angelis, Federico Vannini, Antonello Agostini, Antonio Todaro, Eleonora Torri, Giulio Alberto Gianolio Lopez, Margherita Fui, Alberto Tomasi, Caterina Rizzo","doi":"10.2196/59511","DOIUrl":"https://doi.org/10.2196/59511","url":null,"abstract":"<p><strong>Background: </strong>The evolving global health landscape highlights the importance of travel medicine, making it necessary for health care professionals to understand the epidemiologic profiles among varied traveler populations and keep themselves updated in this rapidly changing field. However, in Italy, travel medicine clinics have significant gaps in resource allocation, staff training, and infrastructure.</p><p><strong>Objective: </strong>This protocol of a cross-sectional study aims to create and validate a questionnaire to assess the knowledge, attitudes, and practices of health care professionals in travel medicine in Italy. The final goal is to provide a tool to evaluate the state of travel medicine, guide training initiatives, and be able to monitor trends over time.</p><p><strong>Methods: </strong>The study population consists of health care professionals who practice travel medicine in Italy. The questionnaire will be developed by adapting an existing English survey and conducting a scoping review to align the questionnaire with contemporary scientific discourse. The validation process includes face validity, content validity, and expert evaluation. The sample size, determined through power analysis, ranges from 218 to 278 participants. The questionnaire will undergo a pilot test on a smaller sample size (10% of the total) to identify and address any issues. Statistical analysis will include central tendency and dispersion measures, categorical summaries, group comparisons, and regressions. This research received ethical approval, and informed consent will be obtained from all participants.</p><p><strong>Results: </strong>As of July 2024, we completed the questionnaire validation involving 9 experts. The validated version of the questionnaire includes 86 items. Furthermore, we conducted a pilot test on 53 individuals during the SIMVIM (Italian Society of Travel Medicine and Migrations) course on travel medicine held in Lucca, Italy, on June 14, 2024.</p><p><strong>Conclusions: </strong>This cross-sectional study will guide strategic planning and targeting training and awareness activities in areas deemed most critical or lacking. The study's structured approach and periodic assessments will facilitate the identification of educational gaps, the dissemination of best practices, and the overall improvement of health care services for travelers in Italy.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/59511.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e59511"},"PeriodicalIF":1.4,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12053279/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144005622","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":"Efficacy And Safety of Acupoint Catgut Embedding for Perennial Allergic Rhinitis: Protocol for a Randomized Clinical Trial.","authors":"Zijie Cai, ChunXue Meng, Fei Wang, ChunZhi Tang, Jing Zhang, Qian Zhang, Bin Guo","doi":"10.2196/63933","DOIUrl":"https://doi.org/10.2196/63933","url":null,"abstract":"<p><strong>Background: </strong>Allergic rhinitis (AR) is a noninfectious chronic inflammatory disease of the nasal mucosa characterized mainly by itching, sneezing, nasal congestion, and rhinorrhea. It is mediated by immunoglobulin E (IgE). AR is one of the most common allergic diseases globally, affecting 10% to 20% of the population worldwide, with some regions even reaching rates as high as 50%, posing a global health issue. The prevalence of AR has been increasing since the 1960s, with a significant increase in recent years. At present, modern medicine-including desensitization therapy, the use of antiallergic drugs, antihistamines, hormones, and other treatments-can improve symptoms or regulate the immune system. However, both short- and long-term efficacy remain limited, as symptoms often recur after treatment cessation, and long-term drug use is associated with toxicity and side effects.</p><p><strong>Objective: </strong>Acupoint catgut embedding (ACE) therapy is widely used to treat AR in China. ACE therapy has been reported to be effective in managing the symptoms of AR, but the evidence faces methodological limitations. Therefore, we designed a parallel-arm, randomized controlled, multicentered, placebo-controlled, and single-blinded trial to evaluate the efficacy and safety of ACE therapy for AR.</p><p><strong>Methods: </strong>This study will be a parallel-group, patient-blind, placebo-controlled randomized controlled trial conducted in the Third Affiliated Hospital of Sun Yat-sen University, Ningxia Chinese Medicine Research Center, and the Affiliated Hospital of Shanxi University of Traditional Chinese Medicine. The trial consists of a 4-week treatment period, along with a 3-month follow-up. After providing written informed consent, eligible participants will be randomized at a ratio of 1: 1 into one of 2 groups: the ACE group receiving treatment and the sham ACE group. Both groups will receive conventional loratadine treatment.</p><p><strong>Results: </strong>The funding began in January 2022. The study was initiated on February 1, 2025, and will end in February 2026. Patient recruitment has already started, and the study results will be released in March 2026.</p><p><strong>Conclusions: </strong>We expect that this research will provide important insights into the efficacy of ACE treatment for AR and generate robust data for the foundation of future research in this field.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry ChiCTR2500095634; https://www.chictr.org.cn/historyversionpubEN.html?regno=ChiCTR2500095634.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/63933.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e63933"},"PeriodicalIF":1.4,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12053070/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143990037","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":"Technical Requirements, Design, and Automation Process for a Statewide Registry-Based Tailored Text Messaging System: Protocol for a Longitudinal Observational Study.","authors":"Deborah Ogunsanmi, Jerica Chambers, Asos Mahmood, Avinash Reddy Pakker, Anusha Kompalli, Umar Kabir, Satya Surbhi, Justin Gatwood, Md Sultan Mahmud, James E Bailey","doi":"10.2196/62874","DOIUrl":"https://doi.org/10.2196/62874","url":null,"abstract":"<p><strong>Background: </strong>Tailored text messaging is a low-cost mobile health intervention approach shown to effectively improve self-care behaviors and clinical outcomes for patients with chronic cardiometabolic conditions. Given the ubiquitous nature of mobile phones, text messages have the potential to reach a large audience. However, automating and disseminating tailored text messages to large populations at low cost presents major logistical challenges that serve as barriers to implementation.</p><p><strong>Objective: </strong>This study aimed to describe the protocol for a longitudinal observational study designed to assess the feasibility of an innovative approach for automating and disseminating personalized and tailored text messages to large populations at risk of cardiovascular events using a low-cost registry-based tailored text messaging system known as the Heart Health Messages (HHM) program. Further, it describes the technical requirements, architectural design, automation process, and challenges associated with program implementation.</p><p><strong>Methods: </strong>Patients at high risk of cardiovascular diseases are identified using a statewide population health registry known as the Tennessee Population Data Network. Tailored invitation messages and enrollment surveys are sent to eligible patients via Twilio. Upon completion of the receipt of consent and enrollment forms, participants receive tailored text messages from a library of generic messages based on participant-selected frequency of message delivery (daily or every other day). In addition, participants receive monthly text-based check-in survey messages designed to assess intervention adherence and improvement in self-care. Participants are also sent quarterly follow-up surveys to update enrollment information and preferences. All enrolled participants will receive tailored text messages for a 12-month intervention period.</p><p><strong>Results: </strong>Since the start of the program, 18,974 patients from 2 major health systems have met the inclusion criteria and were eligible for the HHM program. A total of 3 phases of HHM 1.0 have been implemented so far, reaching 225 eligible patients in phase 1, a total of 5288 patients in phase 2, and 13,461 patients in phase 3, with an enrollment of approximately 2% (n=4/225), 3% (n=137/5228), and 3% (n=350/13461), respectively. Efforts are underway to implement strategies in collaboration with the health systems to enhance the HHM program rollout and patient participation.</p><p><strong>Conclusions: </strong>The HHM program is a low-cost tailored text messaging intervention set for broader dissemination and potential replication. The program has the capacity to improve outcomes for people with chronic medical conditions.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/62874.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e62874"},"PeriodicalIF":1.4,"publicationDate":"2025-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12048783/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143967737","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":"The Effectiveness of a Race-Based Stress Reduction Intervention on Improving Stress-Related Symptoms and Inflammation in African American Women at Risk for Cardiometabolic Disease: Protocol for Recruitment and Intervention for a Randomized Controlled Trial.","authors":"Karen L Saban, Cara Joyce, Alexandria Nyembwe, Linda Janusek, Dina Tell, Paula de la Pena, Darnell Motley, Lamise Shawahin, Laura Prescott, Stephanie Potts-Thompson, Jacquelyn Y Taylor","doi":"10.2196/65649","DOIUrl":"https://doi.org/10.2196/65649","url":null,"abstract":"<p><strong>Background: </strong>In recent years, the prevalence of cardiometabolic disease (CMD) in African American women has risen; the risk also increases with age, in comparison to men. Evidence demonstrates that stressful life events, including experiences of racism and perceived discrimination, contribute substantially to inflammatory diseases, such as CMD. Despite this evidence, few evidence-based interventions are available to assist individuals from minoritized communities in coping with the chronic stress related to their racial or ethnic identity.</p><p><strong>Objective: </strong>Our proposed randomized controlled trial will test a novel, race-based intervention tailored to African American women, called Resilience, Stress, and Ethnicity (RiSE).</p><p><strong>Methods: </strong>In this randomized controlled trial, we will randomize participants 1:1 to the 8-week, group-based RiSE program (intervention) or a health education program (active control group). Both programs will consist of synchronous classes on Zoom and will be led by experts. The primary end point will be stress at 6 months after the intervention, and the efficacy of RiSE will be evaluated for improving stress-related symptoms (current perceived stress, depressive symptoms, fatigue, and sleep disturbance), improving coping strategies, and reducing inflammatory burden in African American women at risk for CMD. Validated survey measures and inflammatory biomarkers will be assessed at baseline, midintervention, intervention completion, and 6 months after the intervention, and differences over time by intervention will be evaluated using mixed effects models.</p><p><strong>Results: </strong>This study was funded by the National Institute on Aging on March 30, 2023, with recruitment and enrollment beginning in October 2023. The study is underway, with 120 participants enrolled as of March 2025.</p><p><strong>Conclusions: </strong>This study will be one of the first to examine a race-based stress reduction intervention in African American women and has the potential to improve the health of minoritized groups faced with chronic stress associated with experiencing racism and discrimination. We anticipate that RiSE will reduce stress-related symptoms, enhance adaptive coping, and reduce inflammation.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05902741; https://www.clinicaltrials.gov/study/NCT05902741.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e65649"},"PeriodicalIF":1.4,"publicationDate":"2025-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12048792/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143990039","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}