JMIR Research Protocols最新文献

{"title":"Efficacy and Safety of Murivenna Anal Infiltration Compared to Diltiazem Topical Application in Chronic Anal Fissure: Protocol for a Prospective, Randomized, Open-Label Clinical Trial.","authors":"Pratap Shankar Km, Indu Puthan Purayil, Palengara Binitha, Amit Kumar Rai, Sophia Jameela, Azeem Ahmad, Chandra Sekhara Rao Bhogavalli, Narayanam Srikanth, Rabinarayan Acharya","doi":"10.2196/63063","DOIUrl":"https://doi.org/10.2196/63063","url":null,"abstract":"<p><strong>Background: </strong>Anal fissure is a common proctologic condition that causes significant pain and anguish to patients, significantly impacting their quality of life and well-being. There are various treatment options for anal fissure, ranging from pharmacological agents that reduce anal sphincter tone to surgical interventions for cases resistant to medical management. Ayurvedic treatments have shown potential for the therapeutic management of anal fissure.</p><p><strong>Objective: </strong>This clinical study aims to analyze the efficacy and safety of murivenna anal infiltration compared to diltiazem topical application in chronic anal fissure.</p><p><strong>Methods: </strong>This is an open-labeled, randomized, controlled parallel group clinical trial with a sample size of 66 participants to be randomized and allocated in a 1:1 ratio to 2 groups. The intervention group will be treated with murivenna anal infiltration, and the control group will be treated with topical application of diltiazem for a period of 4 weeks. The primary outcome will be the proportion of participants demonstrating complete healing after 4 weeks of treatment. The secondary outcomes will be the proportion of participants demonstrating complete healing after 7 days and 14 days of treatment, change in pain at or after defecation, cessation of bleeding, and any recurrence during the study period. Any adverse events will also be recorded during the trial period.</p><p><strong>Results: </strong>The project was funded in July 2023, and the study period is 24 months. Participant recruitment started in December 2023. As of August 2024, we have enrolled 50 participants. The data analysis will be complete by June 2025, and the results are expected to be published by August 2025.</p><p><strong>Conclusions: </strong>High recurrence rates, adverse effects, incomplete healing, and the negative impact on patients' daily activities and quality of life underscore the need for alternative therapeutic options. Ayurveda offers potential for more sustainable relief with fewer adverse effects. Murivenna oil is a time-tested medicated oil effectively used by Ayurvedic physicians for various ulcers of traumatic and pathological origin. This study will provide scientific evidence on the efficacy and safety of murivenna anal infiltration; further, it can be incorporated into the cost-effective management of chronic anal fissure.</p><p><strong>Trial registration: </strong>Clinical Trials Registry India CTRI/2023/09/057330; https://tinyurl.com/y4ut9e8p.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/63063.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e63063"},"PeriodicalIF":1.4,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143122786","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":"Effectiveness of Gastric Cancer Endoscopic Screening in Intermediate-Risk Countries: Protocol for a Systematic Review and Meta-Analysis.","authors":"Maria Beatriz Mourato, Nuno Pratas, Andreia Branco Pereira, Filipa Taré, Raphael Chança, Inês Fronteira, Rui Dinis, Miguel Areia","doi":"10.2196/56791","DOIUrl":"10.2196/56791","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Gastric cancer (GC) is the fifth most prevalent neoplasm worldwide and the fourth with the highest mortality, and its geographical distribution is not homogeneous with high-risk, intermediate-risk (IR), and low-risk areas. Advanced stages at diagnosis are related to high mortality, but early detection greatly increases the chances of survival. Upper endoscopy with biopsy is the gold standard for GC diagnosis. Several studies have investigated the relevance of endoscopic screening and how to implemente it in IR countries. However, most Western societies recommend screening only in selected populations with high-risk factors for GC. No systematic reviews on GC endoscopic screening in IR countries exist.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;We aimed to determine the effectiveness of endoscopic GC screening in IR countries.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We will include randomized and nonrandomized controlled trials, cohort studies, case-control studies, cross-sectional studies, and economic studies focusing on endoscopic screening of GC in the asymptomatic population of IR countries. The search will be conducted in MEDLINE, SCOPUS, Embase, and Web of Science. Other gray literature sources will be additionally searched. Studies published in English, Portuguese, or Spanish until September 2024 will be included. Two independent reviewers will screen the titles and abstracts of all search results. The selected studies will then be fully analyzed, and the data will be collected and coded in a database. To minimize the risk of bias, the included studies will undergo a quality analysis according to Cochrane risk of bias tools, RoB 2 of randomized trials and ROBINS-I for nonrandomized trials; Newcastle-Ottawa Quality Assessment Scale for case-control and cohort studies; and National Heart, Lung and Blood Institute study quality assessment tools for cross-sectional studies. The data collected will be cataloged in 2 categories: efficacy or effectiveness data and economic data, and separate meta-analyses will be performed for each category if appropriate.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study is expected to provide results on the efficacy, effectiveness, and cost-effectiveness of endoscopic screening in an IR population. To date, 969 studies were screened for title and abstract, 75 were selected for full-text screening, and 44 were retained for data analysis. Additionally, 2 studies were selected from our manual search. Currently, the study is in the early stages of data extraction and risk of bias assessment and is expected to be published in the first quarter of 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;To our knowledge, this review will be the first to provide evidence on the effectiveness of endoscopic GC screening in IR countries. In doing so, we believe we will help guide future research, inform health care decisions and assist policy makers in this area, and support future decisions to implement GC screening programs i","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":" ","pages":"e56791"},"PeriodicalIF":1.4,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142638775","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":"Effect of an Internet-Based Pilates Telerehabilitation Intervention in People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial.","authors":"Andrea Tacchino, Michela Ponzio, Paolo Confalonieri, Letizia Leocani, Matilde Inglese, Diego Centonze, Eleonora Cocco, Paolo Gallo, Damiano Paolicelli, Marco Rovaris, Loredana Sabattini, Gioacchino Tedeschi, Luca Prosperini, Francesco Patti, Edoardo Sessa, Elisabetta Pedrazzoli, Mario Alberto Battaglia, Giampaolo Brichetto","doi":"10.2196/58026","DOIUrl":"https://doi.org/10.2196/58026","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Physical activity (PA) has been recommended in multiple sclerosis (MS) to maintain good physical fitness and mental health, reduce the severity of symptoms and risk of relapse, and improve quality of life. Pilates has been suggested as an ideal PA to manage physical, cognitive, and psychological symptoms of MS and a useful method to maintain and improve balance and gait.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This paper presents the protocol for a study that aims to evaluate the efficacy on the physical domain (specifically balance and gait) of a home-based, self-managed PA intervention delivered through the MS-FIT exergame (HELAGLOBE Società a responsabilità limitata). In addition, measures of cognitive performance, quality of life, and well-being will be considered.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This is a 2-arm, multicenter, randomized controlled trial with 3 assessment points (baseline, 12 weeks postintervention, and 6 weeks follow-up). People with MS with mild disability, low risk of falling, preserved cognitive functions, and low anxiety and depression are potential eligible participants. The experimental group (MS-FIT) will self-administer the MS-FIT exergame at home in addition to their leisure-time physical activities. MS-FIT is an internet- and Pilates-based tool that uses the Microsoft Kinect Sensor V2. Participants in the control group will only have access to their leisure-time physical activities. Participants in the MS-FIT group will train at home with MS-FIT for 12 weeks and will be required to perform the exercises for a total of 30 minutes/day for at least 3 days/week. The primary outcome is the Timed Up and Go, a test designed to assess walking. We will also administer additional tests for motor function (visual analog scale 0-10, Timed 25-Foot Walk, Ambulation Index, 2-minute walk test, Twelve Item Multiple Sclerosis Walking Scale, Nine-Hole Peg Test), cognition (Brief International Cognitive Assessment for Multiple Sclerosis), fatigue (Modified Fatigue Impact Scale), quality of life (Multiple Sclerosis Quality of Life-54), well-being (Psychological Well-Being Scales), and PA (International Physical Activity Questionnaire and Minnesota Leisure Time Physical Activity Questionnaire). Acceptance and satisfaction with the intervention received (Client Satisfaction Questionnaire and an adapted version of the Tele-healthcare Satisfaction Questionnaire - Wearable Technology) and subjective impressions of changes in performance (Patients' Global Impression of Change) will also be assessed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Recruitment for the trial started on March 16, 2022, and the first participant was randomized the same day. Data analysis and results are expected to be published in 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Pilates has proven beneficial in several neurological diseases such as MS. With this study, we will provide evidence for the use in clinical practice of a digital tool for self-administ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e58026"},"PeriodicalIF":1.4,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143122778","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":"Evaluating the Benefit of Home Support Provider Services for Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea: Protocol for an Ambispective International Real-World Study.","authors":"Sarah Alami, Manuella Schaller, Sylvie Blais, Henry Taupin, Marta Hernández González, Frédéric Gagnadoux, Paula Pinto, Irene Cano-Pumarega, Lieven Bedert, Ben Braithwaite, Hervé Servy, Stéphane Ouary, Céline Fabre, Fabienne Bazin, Joëlle Texereau","doi":"10.2196/65840","DOIUrl":"10.2196/65840","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Adherence and persistence to positive airway pressure (PAP) therapy are key factors for positive health outcomes. Home support providers participate in the home implementation and follow-up of PAP therapy for patients with obstructive sleep apnea (OSA). In Europe, home support provider service levels are country (or area) specific, resulting in differences in content and frequency of patient interactions. However, no robust evaluation of the impact of these differences on clinical and patient outcomes has been performed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The AWAIR study aims to evaluate and compare the impact of different home support provider service levels on PAP adherence and persistence in 4 European countries.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This real-world, ambispective, cohort study-conducted in France, Belgium, Spain, and Portugal-will recruit adults with OSA who started PAP therapy between 2019 and 2023 and were followed by an Air Liquide Healthcare home support provider. Given the large number of eligible participants (around 150,000), the study will use a decentralized and digital approach. A patient video will present the study objectives and the participation process. A secure electronic solution will be used to manage patient information and consent, as well as to administer a web-based questionnaire. Retrospective data, collected during routine patient follow-up by home support providers, include the level of service and device data, notably PAP use. Prospective data collected using an electronic patient-reported outcome tool include health status, OSA-related factors, patient-reported outcomes including quality of life and symptoms, OSA and PAP literacy, patient-reported experience, and satisfaction with PAP therapy and service. Hierarchical models, adjusted for preidentified confounding factors, will be used to assess the net effect of home support provider services on PAP adherence and persistence while minimizing real-world study biases and considering the influence of country-level contextual factors. We hypothesize that higher levels of home support provider services will be positively associated with adherence and persistence to PAP therapy.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;As of December 2024, the study has received approval in France, Portugal, and 2 regions of Spain. The study began enrollment in France in October 2024. Results are expected in the second quarter of 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The AWAIR study has a unique design, leveraging an unprecedented number of eligible participants, decentralized technologies, and a real-world comparative methodology across multiple countries. This approach will highlight intercountry differences in terms of patient characteristics, PAP adherence, and persistence, as well as patient-reported outcomes, patient-reported experiences, and satisfaction with the home service provider. By assessing the added value of home support provider servic","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":" ","pages":"e65840"},"PeriodicalIF":1.4,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813275","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":"Challenges and Strategies Adopted for Remote Teaching of Biochemistry During the COVID-19 Pandemic: Protocol for a Scoping Review.","authors":"Tatiane Iembo, Helena Landim Gonçalves Cristóvão, Emerson Roberto Dos Santos, André Bavaresco Gonçalves Cristóvão, Nathália Bavaresco Gonçalves Cristóvão, Cíntia Canato Martins, Natália Almeida de Arnaldo Silva Rodrigues Castro, Fernando Nestor Facio Júnior, Antônio Hélio Oliani, Alba Regina de Abreu Lima, Vânia Maria Sabadoto Brienze, Doroteia Rossi Silva Souza, Júlio César André","doi":"10.2196/59552","DOIUrl":"https://doi.org/10.2196/59552","url":null,"abstract":"<p><strong>Background: </strong>In March 2020, the global landscape witnessed widespread upheavals in both socioeconomic and educational spheres due to the onset of the COVID-19 pandemic. With measures imposed to control the virus's spread, educational institutions around the world embraced digital learning, introducing challenges in the adaptation to virtual education. This shift proved especially daunting in resource-limited nations with limited digital infrastructure.</p><p><strong>Objective: </strong>This scoping review aims to explore the experiences of biochemistry educators during the COVID-19 pandemic, focusing on successful pedagogical strategies used to overcome challenges in remote teaching. The goal is to compile valuable information applicable to health-related undergraduate and postgraduate courses.</p><p><strong>Methods: </strong>This review considers studies and experiences related to the transition to remote biochemistry education during the pandemic. It encompasses a variety of pedagogical approaches, including online teaching tools, interactive methods, and alternatives to practical laboratory classes. The search spans databases such as MEDLINE, the Cochrane Database of Systematic Reviews, and Joanna Briggs Institute (JBI) Evidence Synthesis, with a focus on identifying systematic or scoping reviews; however, none were identified in the preliminary search.</p><p><strong>Results: </strong>Starting in February 2022, the scoping review protocol was scheduled for completion by July 2024. From an initial pool of 1171 results, 85 articles were selected, with duplicate verification pending for the subsequent phase of the project. The findings from this review on biochemistry teaching strategies will be communicated using a combination of descriptive narrative, graphical, and tabular formats, emphasizing diverse pedagogical approaches pertinent to the subject. Dissemination will occur through regional and national scientific conference presentations, alongside publication in a peer-reviewed journal.</p><p><strong>Conclusions: </strong>This review aims to generate innovative pedagogical approaches and pinpoint learning activities, materials, and tools that support social and collaborative learning across various subjects, including biochemistry. Moreover, it will offer perspectives from students and educators on the implemented activities, with the intention of integrating them as supplementary methods to boost student participation, and thereby, improve learning outcomes and skill development.</p><p><strong>Trial registration: </strong>Open Science Framework VZSA7; https://osf.io/VZSA7/.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/59552.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e59552"},"PeriodicalIF":1.4,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143070889","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":"An mHealth Intervention With Financial Incentives to Promote Smoking Cessation and Physical Activity Among Black Adults: Protocol for a Feasibility Randomized Controlled Trial.","authors":"Adam Alexander, Michael Businelle, Marshall Cheney, Amy Cohn, Lorna McNeill, Kevin Short, Summer Frank-Pearce, David Bradley, Kimberly Estrada, Iván Flores, Jack Fronheiser, Darla Kendzor","doi":"10.2196/69771","DOIUrl":"https://doi.org/10.2196/69771","url":null,"abstract":"<p><strong>Background: </strong>Black adults in the United States experience disproportionately high rates of tobacco- and obesity-related diseases, driven in part by disparities in smoking cessation and physical activity. Smartphone-based interventions with financial incentives offer a scalable solution to address these health disparities.</p><p><strong>Objective: </strong>This study aims to assess the feasibility and preliminary efficacy of a mobile health intervention that provides financial incentives for smoking cessation and physical activity among Black adults.</p><p><strong>Methods: </strong>A total of 60 Black adults who smoke (≥5 cigarettes/d) and are insufficiently physically active (engaging in <150 min of weekly moderate-intensity physical activity) will be randomly assigned to either HealthyCells intervention (incentives for smoking abstinence only) or HealthyCells+ intervention (incentives for both smoking abstinence and daily step counts). Participants will use study-provided smartphones, smartwatches, and carbon monoxide monitors for 9 weeks (1 wk prequit date through 8 wk postquit date). Feasibility will be evaluated based on recruitment rates, retention, and engagement. The primary outcomes include carbon monoxide-verified, 7-day smoking abstinence at 8 weeks postquit date and changes in average daily step count. Feasibility benchmarks include a recruitment rate of ≥5 participants per month, a retention rate of ≥75%, and a smoking abstinence rate of ≥20% at 8 weeks postquit date. Expected increases in physical activity include a net gain of 500 to 1500 steps per day compared to baseline.</p><p><strong>Results: </strong>Recruitment is expected to begin in February 2025 and conclude by September 2025, with data analysis completed by October 2025.</p><p><strong>Conclusions: </strong>This study will evaluate the feasibility of a culturally tailored mobile health intervention combining financial incentives for smoking cessation and physical activity promotion. Findings will inform the design of larger-scale trials to address health disparities through scalable, technology-based approaches.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05188287; https://clinicaltrials.gov/ct2/show/NCT05188287.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/69771.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e69771"},"PeriodicalIF":1.4,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143065563","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":"Access to Health Care and Use of Health Care Services Among Males in Africa: Protocol for a Scoping Review.","authors":"Nkoleleng Johannah Mashilo, Kelechi Elizabeth Oladimeji, Siphamandla Gumede, Samanta Tresha Lalla-Edward","doi":"10.2196/52351","DOIUrl":"https://doi.org/10.2196/52351","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;There is a scarcity of data on males' health-seeking behavior, as well as their access to and use of health care services, in Africa. According to some studies, men are less likely than women to seek medical help for issues such as communicable and noncommunicable diseases, depression, substance abuse, physical disabilities, and stressful life events. The study of males' health-seeking behaviors is important, because it allows us to learn about male health, how masculinity encourages underuse of health care services, how this affects males' overall health and well-being, and how cultural values and backgrounds may impact older men's health-seeking behaviors.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The objective of this review is to assess evidence on how males access and use health care services and their health knowledge, attitudes, and perceptions to identify gaps for targeted, context-specific strategies to improve males' health and outcomes, particularly in Africa.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The scoping review process will be guided by the methodology frameworks of the Joanna Briggs Institute and Arksey and O'Malley and will follow the Preferred Reporting Items for Systematic reviews and Meta-analysis Protocols Extension for Scoping Reviews guidelines. The following electronic databases will be systematically searched for evidence published between January 2010 and 2023: PubMed, Scopus, Web of Science, African Journals Online, and Google Scholar. Two reviewers will independently screen full texts and chart the data; a third reviewer will be engaged in the event of disagreement between the 2 independent reviewers. The results of this scoping review will be summarized quantitatively through numerical counts and qualitatively through a narrative synthesis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The electronic database search was conducted between March and April 2023 and redone in April 2024 to include the most recent articles. A total of 114,737 articles were retrieved and 4258 removed as duplicates. After title screening, 337 results remained, and after abstract selection, 140 results remained. As of December 2024, the scoping review was in the full-text screening phase. We plan to complete data extraction, synthesis, and writing of the entire manuscript of the review in January 2025, and then submit it to a journal for peer review and publication in February 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The scoping review results will advance the current knowledge about health-seeking behavior and access to and uptake of health care services among African males. To our knowledge, this scoping review is the first on this topic, and it will identify vital information on the barriers to and facilitators of African males' health care access and uptake. It will also provide information on successful health care programs for males that may be tailored and adopted across different African contexts.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registratio","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e52351"},"PeriodicalIF":1.4,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143070887","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":"Migration of Health Workers and Its Impacts on the Nigerian Health Care Sector: Protocol for a Scoping Review.","authors":"David Omiyi, Ebenezer Arubuola, Marcus Chilaka, Md Shafiqur Rahman Jabin","doi":"10.2196/62726","DOIUrl":"https://doi.org/10.2196/62726","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Health worker migration from Nigeria poses significant challenges to the Nigerian health care sector and has far-reaching implications for health care systems globally. Understanding the factors driving migration, its effects on health care delivery, and potential policy interventions is critical for addressing this complex issue.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to comprehensively examine the factors encouraging the emigration of Nigerian health workers, map out the effects of health worker migration on the Nigerian health system, document the loss of investment in health training and education resulting from migration, identify relevant policy initiatives addressing migration, determine the effects of Nigerian health worker migration on destination countries, and identify the benefits and demerits to Nigeria of health worker migration.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This study will follow the Joanna Briggs Institute methodology. A search strategy will retrieve published studies from MEDLINE, CINAHL, Embase, Global Health, Academic Search Premiere, and Web of Science. Unpublished studies will be sourced from dissertations and theses. A comprehensive search will involve keyword scans and citation searches. Exclusion criteria will filter out irrelevant studies, such as studies unrelated to the international migration of health workers and non-English language studies. A total of 2 independent reviewers will screen the titles and abstracts and then review the full text. Data will be extracted from the included studies using a data extraction tool developed for this study. The study selection process will be shown using a PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) flowchart. While the traditional risk of bias assessments is not applied to scoping reviews, the quality of included studies will be evaluated based on methodological transparency.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The process of selecting studies will be shown using a PRISMA ScR flowchart, and information gathering will be done through a charting table that has been prepared in advance. We plan to collect data from January 2025 to March 2025 and present the results to examine publication patterns and study details. The final summary is expected to be released by the summer of 2025. It will provide an in-depth look at how health worker migration impacts the health care sector in Nigeria.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study holds immense potential to contribute to understanding health worker migration from Nigeria and inform policy and practice interventions to address its challenges. By synthesizing existing evidence, the scoping review will guide future research and policy efforts to mitigate the adverse effects of migration on health care systems and workforce sustainability. Furthermore, the results will aid in recognizing deficiencies in the existing literature;","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e62726"},"PeriodicalIF":1.4,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143065644","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":"Increasing Access to Mental Health Supports for 18- to 25-Year-Old Indigenous Youth With the JoyPop Mobile Mental Health App: Study Protocol for a Randomized Controlled Trial.","authors":"Angela MacIsaac, Teagan Neufeld, Ishaq Malik, Elaine Toombs, Janine V Olthuis, Fred Schmidt, Crystal Dunning, Kristine Stasiuk, Tina Bobinski, Arto Ohinmaa, Sherry H Stewart, Amanda S Newton, Aislin R Mushquash","doi":"10.2196/64745","DOIUrl":"https://doi.org/10.2196/64745","url":null,"abstract":"<p><strong>Background: </strong>Transitional-aged youth have a high burden of mental health difficulties in Canada, with Indigenous youth, in particular, experiencing additional circumstances that challenge their well-being. Mobile health (mHealth) approaches hold promise for supporting individuals in areas with less access to services such as Northern Ontario.</p><p><strong>Objective: </strong>The primary objective of this study is to evaluate the effectiveness of the JoyPop app in increasing emotion regulation skills for Indigenous transitional-aged youth (aged 18-25 years) on a waitlist for mental health services when compared with usual practice (UP). The secondary objectives are to (1) evaluate the impact of the app on general mental health symptoms and treatment readiness and (2) evaluate whether using the app is associated with a reduction in the use (and therefore cost) of other services while one is waiting for mental health services.</p><p><strong>Methods: </strong>The study is a pragmatic, parallel-arm randomized controlled superiority trial design spanning a 4-week period. All participants will receive UP, which involves waitlist monitoring practices at the study site, which includes regular check-in phone calls to obtain any updates regarding functioning. Participants will be allocated to the intervention (JoyPop+UP) or control (UP) condition in a 1:1 ratio using stratified block randomization. Participants will complete self-report measures of emotion regulation (primary outcome), mental health, treatment readiness, and service use during 3 assessments (baseline, second [after 2 weeks], and third [after 4 weeks]). Descriptive statistics pertaining to baseline variables and app usage will be reported. Linear mixed modeling will be used to analyze change in outcomes over time as a function of condition assignment, while a cost-consequence analysis will be used to evaluate the association between app use and service use.</p><p><strong>Results: </strong>Recruitment began September 1, 2023, and is ongoing. In total, 2 participants have completed the study.</p><p><strong>Conclusions: </strong>This study will assess whether the JoyPop app is effective for Indigenous transitional-aged youth on a waitlist for mental health services. Positive findings may support the integration of the app into mental health services as a waitlist management tool.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05991154; https://clinicaltrials.gov/study/NCT05991154.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/64745.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e64745"},"PeriodicalIF":1.4,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143065642","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":"Clozapine for Treatment-Resistant Disruptive Behaviors in Youths With Autism Spectrum Disorder Aged 10-17 Years: Protocol for an Open-Label Trial.","authors":"André Luiz Schuh Teixeira da Rosa, Marina Ribeiro Barreto da Costa, Gabriela Bezerra Sorato, Felipe de Moura Manjabosco, Érica Bonganhi de Bem, Lucas Dellazari, Arthur Bezerra Falcão, Lucas de Oliveira Cia, Olivia Sorato Bezerra, Rogério Boff Borges, Luis Augusto Rohde, Ana Soledade Graeff-Martins","doi":"10.2196/58031","DOIUrl":"https://doi.org/10.2196/58031","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition emerging in early childhood, characterized by core features such as sociocommunicative deficits and repetitive, rigid behaviors, interests, and activities. In addition to these, disruptive behaviors (DB), including aggression, self-injury, and severe tantrums, are frequently observed in pediatric patients with ASD. The atypical antipsychotics risperidone and aripiprazole, currently the only Food and Drug Administration-approved treatments for severe DB in patients with ASD, often encounter therapeutic failure or intolerance. Given this, exploring pharmacological alternatives for more effective management of DB associated with ASD is essential. Clozapine, noted for its unique antiaggressive effects in schizophrenia and in various treatment-resistant neuropsychiatric disorders, independent from its antipsychotic efficacy, remains underexplored in youths with ASD facing severe and persistent DB.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aimed to evaluate the efficacy, tolerability, and safety of clozapine for treatment-resistant DB in youths with ASD.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This is a prospective, single-center, noncontrolled, open-label trial. After a cross-titration phase, 31 patients with ASD aged 10-17 years and with treatment-resistant DB received a flexible dosage regimen of clozapine (up to 600 mg/day) for 12 weeks. Standardized instruments were applied before, during, and after the treatment, and rigorous clinical monitoring was performed weekly. The primary outcome was assessed using the Irritability Subscale of the Aberrant Behavior Checklist. Other efficacy measures include the Clinical Global Impression Severity and Improvement, the Swanson, Nolan, and Pelham questionnaire-IV, the Childhood Autism Rating Scale, and the Vineland Adaptive Behavior Scale. Safety and tolerability measures comprised adverse events, vital signs, electrocardiography, laboratory tests, physical measurements, and extrapyramidal symptoms with the Simpsons-Angus Scale. Statistical analysis will include chi-square tests with Monte Carlo simulation for categorical variables, paired t tests or Wilcoxon tests for continuous variables, and multivariate linear mixed models to evaluate the primary outcome, adjusting for confounders.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Recruitment commenced in February 2023. Data collection was concluded by April 2024, with analysis ongoing. This article presents the protocol of the initially planned study to provide a detailed methodological description. The results of this trial will be published in a future paper.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The urgent need for effective pharmacological therapies in mitigating treatment-resistant DB in pediatric patients with ASD underscores the importance of this research. Our study represents the first open-label trial to explore the anti-aggressive effects of clozapine in this speci","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e58031"},"PeriodicalIF":1.4,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143065619","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}