JMIR Research Protocols最新文献

{"title":"Noninvasive, Multimodal Inflammatory Biomarker Discovery for Systemic Inflammation (NOVA Study): Protocol for a Cross-Sectional Study.","authors":"Jinjoo Shim, Sinziana Muraru, Rucsandra Dobrota, Elgar Fleisch, Oliver Distler, Filipe Barata","doi":"10.2196/62877","DOIUrl":"https://doi.org/10.2196/62877","url":null,"abstract":"<p><strong>Background: </strong>Prolonged systemic inflammation is recognized as a major contributor to the development of various chronic inflammatory diseases. Daily measurements of inflammatory biomarkers can significantly improve disease monitoring of systemic inflammation, thus contributing to reducing the burden on patients and the health care system. There exists, however, no scalable, cost-efficient, and noninvasive biomarker for remote assessment of systemic inflammation. To this end, we propose a novel, multimodal, and noninvasive approach for measuring inflammatory biomarkers.</p><p><strong>Objective: </strong>This study aimed to evaluate the relationship between the levels of inflammatory biomarkers in serum (gold standard) and those measured noninvasively in urine, sweat, saliva, exhaled breath, stool, and core body temperature in patients with systemic inflammation.</p><p><strong>Methods: </strong>This study is a single-center, cross-sectional study and includes a total of 20 participants (10 patients with systemic inflammation and 10 control patients). Eligible participants provide serum, urine, sweat, saliva, exhaled breath, and stool samples for biomarker analyses. Core body temperature is measured using a sensor. The primary end point is the level of C-reactive protein (CRP). The secondary end points are interleukin (IL)-1β, IL-6, IL-8, IL-10, and tumor necrosis factor-α levels. The tertiary end points are fractional exhaled nitric oxide, calprotectin, and core body temperature. Samples will be collected in 2 batches, enabling preliminary analysis of the first batch (patients 1-5 from each group). The full analysis will include both batches. CRP and cytokine levels will be measured using enzyme-linked immunosorbent assay and electrochemiluminescence immunoassay. For statistical analysis, the Shapiro-Wilk test will be used to evaluate the normality of the distribution in each variable. We will perform the 2-tailed t test or Wilcoxon rank sum test to compare the levels of inflammatory biomarkers between patients with systemic inflammations and control patients. Pearson and Spearman correlation coefficients will assess the relationship between inflammatory biomarkers from noninvasive methods and serum biomarkers. Using all-subset regression analysis, we will determine the combination of noninvasive methods yielding the highest predictive accuracy for serum CRP levels. Participants' preferences for sampling methods will be assessed through a questionnaire.</p><p><strong>Results: </strong>The study received ethics approval from the independent research ethics committee of Canton Zurich on October 28, 2022. A total of 20 participants participated in the study measurements. Data collection started on February 22, 2023, and was completed on September 22, 2023. Participants were on average 52.8 (SD 14.4; range 24-82) years of age, and 70% (14/20) of them were women. The analysis results reporting findings are expected to be published in ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142580945","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":"Influence of Distraction Factors on Performance in Laparoscopic Surgery in Immersive Virtual Reality: Study Protocol of a Cross-Over Trial in Medical Students and Residents-DisLapVR.","authors":"Laura Hanke, Richard Schulte, Christian Boedecker, Florentine Huettl, Patrick Saalfeld, Vuthea Chheang, Marlene Wessels, Christoph von Castell, Heiko Hecht, Christian Hansen, Hauke Lang, Tobias Huber","doi":"10.2196/59014","DOIUrl":"https://doi.org/10.2196/59014","url":null,"abstract":"<p><strong>Background: </strong>Working in an operating room (OR) is physically and mentally challenging: the operation itself demands the surgeon's full attention, while time and cost efficiency constraints, daily planning, and emergency care interfere with the procedure. Thus, multitasking becomes an integral surgical competence. This study aims to examine the effect of disruptions during surgery in a highly immersive virtual reality (IVR) operation environment combined with a virtual reality (VR) laparoscopy simulator.</p><p><strong>Objective: </strong>This study aims to identify distractions in the OR and their importance in the clinical setting.</p><p><strong>Methods: </strong>An IVR environment was created using a high-resolution, stereoscopic 360° video of the OR. Different distractions were identified, classified as auditory, visual, or audio-visual, and recorded accordingly. The surrounding was combined with a VR laparoscopic simulator. Participants-medical students and surgical residents-received proficiency-based training in basic laparoscopic skills and were blinded to the aim of the experiment. Following a cross-over design, each participant received a unique order of virtual distraction factors while performing tasks on the laparoscopic simulator. During the experiment, subjective passing of time, stress, heart rate, and visually induced motion sickness are recorded. After the experiment, validated questionnaires for usability, immersion, and stress were completed, as well as subjective evaluation of the distractions. The questionnaires used included the system usability scale, Self-Assessment Manikin score, National Aeronautics and Space Administration Task Load Index, and the immersion rating scale as described by Nichols. Performance in the laparoscopic tasks in relation to distractions will be evaluated by the Wilcoxon test and ANOVA for continuous variables. Subgroup analyses in regard to age, gender, and expertise (medical students vs surgical residents) are planned.</p><p><strong>Results: </strong>The described trial started in August 2022 and is ongoing. By July 2024, a total of 30 medical students and 9 surgeons have completed the study.</p><p><strong>Conclusions: </strong>We present a study protocol aiming to identify the impact of different disruptions in OR during laparoscopic training in IVR. Hence, it may lead to an improved awareness of distractions and facilitate accommodations toward an improved work environment. Prior research leads to the hypothesis that the performance of a more experienced surgeon is less impacted by distractions than the performance of inexperienced surgeons and medical students. Furthermore, we investigate which type of distraction has the largest impact on performance. With this knowledge, specific multitasking training can be devised, which may be particularly useful in medical education, for which VR might play a leading role. Additionally, workplace surroundings in the OR can be optimized ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583296","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 COSMOS Registry of CytoSorb Hemoadsorption Therapy in Critically Ill Patients: Protocol for an International, Prospective Registry.","authors":"Fabio Silvio Taccone, Frank Martin Brunkhorst, Gabriella Bottari, Jorge Hidalgo, Andreas Kribben, Jean-Louis Teboul, Dana Tomescu, Teresa Klaus, Joerg Scheier, Efthymios Deliargyris, Ricard Ferrer","doi":"10.2196/55880","DOIUrl":"https://doi.org/10.2196/55880","url":null,"abstract":"<p><strong>Background: </strong>Extracorporeal blood purification with CytoSorb has been increasingly used as an adjunctive therapy in several hyperinflammatory critical care conditions, as well as to remove elevated levels of myoglobin or bilirubin in patients with rhabdomyolysis or liver failure. Despite the increasing worldwide use of hemoadsorption, data from large international multicenter studies are still lacking.</p><p><strong>Objective: </strong>The COSMOS (CytoSorb Treatment Of Critically Ill Patients) registry is a company-sponsored registry by CytoSorbents Corporation and CytoSorbents Medical Inc. and will provide a data repository and reporting infrastructure for the surveillance of CytoSorb use in real-world critical care settings in an unselected, critically ill patient population. The gathered data will serve as a comprehensive resource to assess the effects of such therapy on patients' management.</p><p><strong>Methods: </strong>The international COSMOS registry is collecting prospective data for patients treated with CytoSorb during routine care in various critical care indications, based on the decision of the treating physicians. Data are collected at baseline, during CytoSorb therapy, 24 hours thereafter, at discharge from the intensive care unit and the hospital, and on day 90. Key outcomes assessed include change in inflammatory biomarkers, vasopressor requirements, fluid balance, organ function and organ support, length of intensive care unit and hospital stay, occurrence of adverse events, and mortality.</p><p><strong>Results: </strong>The COSMOS registry started with the inclusion of the first patient on July 15, 2022, and is now actively enrolling in 4 countries (Germany, Spain, Portugal, and Italy), with plans to expand to other countries outside of Europe. An initial readout is planned for presentation at an international Critical Care conference in 2024.</p><p><strong>Conclusions: </strong>The COSMOS registry is intended to provide comprehensive real-world data on patient outcomes with CytoSorb in various critical care indications, thereby contributing to optimization of patient selection, timing of initiation, and dosing of hemoadsorption treatment.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05146336; https://clinicaltrials.gov/study/NCT05146336.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/55880.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142581394","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 CHALO! 2.0 mHealth-Based Multilevel Intervention to Promote HIV Testing and Linkage-to-Care Among Men Who Have Sex with Men in Mumbai, India: Protocol for a Randomized Controlled Trial.","authors":"Jatin Chaudary, Shruta Rawat, Alpana Dange, Sarit A Golub, Ryung S Kim, Venkatesan Chakrapani, Kenneth H Mayer, Julia Arnsten, Viraj V Patel","doi":"10.2196/59873","DOIUrl":"10.2196/59873","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Current programs to engage marginalized populations such as gay and bisexual individuals and other men who have sex with men (MSM) in HIV prevention interventions do not often reach all MSM who may benefit from them. To reduce the global burden of HIV, far-reaching strategies are needed to engage MSM in HIV prevention and treatment. Globally, including low- and middle-income countries, MSM are now widely using internet-based social and mobile technologies (SMTs; eg, dating apps, social media, and WhatsApp [Meta]), which provides an unprecedented opportunity to engage unreached and underserved groups, such as MSM for HIV prevention and care.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aimed to assess the effectiveness of a multilevel mobile health (mHealth)-based intervention to improve HIV testing uptake and status neutral linkage-to-care among sexually active MSM reached through internet-based platforms in Mumbai, India.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;In this randomized controlled trial, we will determine whether CHALO! 2.0 (a theory-based multilevel intervention delivered in part through WhatsApp) results in increased HIV testing and linkage-to-care (prevention or treatment). This study is being conducted among 1000 sexually active MSM who are unaware of their HIV status (never tested or tested &gt;6 months ago) and are recruited through SMTs in Mumbai, India. We will conduct a 12-week, 3-arm randomized trial comparing CHALO! 2.0 to 2 control conditions-an attention-matched SMT-based control (also including a digital coupon for free HIV testing) and a digital coupon-only control. The primary outcomes will be HIV testing and status neutral linkage-to-care by 6 months post enrollment. Participants will be followed up for a total of 18 months to evaluate the long-term impact.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The study was funded in 2020, with recruitment having started in April 2022 due to delays from the COVID-19 pandemic. Baseline survey data collection began in April 2022, with follow-up surveys starting in July 2022. As of April 2022, we enrolled 1004 participants in the study. The completion of follow-up data collection is expected in January 2025, with results to be published thereafter.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;While global health agencies have called for internet-based interventions to engage populations vulnerable to HIV who are not being reached, few proven effective and scalable models exist and none is in India, which has one of the world's largest HIV epidemics. This study will address this gap by testing a multicomponent mHealth intervention to reach and engage MSM at high priority for HIV interventions and link them to HIV testing and prevention or treatment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;ClinicalTrials.gov NCT04814654; https://clinicaltrials.gov/study/NCT04814654. Clinical Trial Registry of India CTRI/2021/03/032280.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;International registered report identifier (irri","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142581161","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 Effect of Effort During a Resistance Exercise Session on Glycemic Control in Individuals Living With Prediabetes or Type 2 Diabetes: Protocol for a Crossover Randomized Controlled Trial.","authors":"Marissa Ramirez, Maja Gebauer, Christine Mermier, Jonathan Peter Little, Luotao Lin, Gabriel Palley, Yu Yu Hsiao, Roberto Ivan Mota Alvidrez, Zach A Mang, Fabiano Trigueiro Amorim, Valmor Tricoli, Flavio De Castro Magalhaes","doi":"10.2196/63598","DOIUrl":"https://doi.org/10.2196/63598","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Type 2 diabetes (T2D) is preceded by prediabetes, and these conditions place a great burden on patients and society. These conditions are significantly associated with poor glycemic control, which is improved by resistance exercise. It has been suggested that resistance exercise should be performed with a high degree of effort to improve glucose metabolism, but this is associated with negative psychological responses that might lead to lower long-term adherence.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aimed to investigate the effect of the degree of effort during a resistance exercise session on glycemic control and psychological responses in individuals living with prediabetes or T2D.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This study will be a crossover, 3-arm, randomized controlled trial. A total of 15 participants living with prediabetes or T2D will be thoroughly familiarized with 7 resistance exercises; afterward, they will perform 3 randomized experimental sessions, each lasting approximately 48 hours each, separated by at least 4 washout days. In 2 of these sessions, supervised resistance exercise will be performed, but the sessions will differ in the degree of effort in each set (high vs low) and will be equalized in terms of total weight lifted and session duration. For this, proximity to failure will be manipulated by changing the number of sets per exercise, the number of repetitions per set, and the resting interval between sets and exercises. Participants will also complete a sedentary (control) session, where they will not perform any exercise. In response to each session, psychological responses will be assessed (exertion, affect, enjoyment, self-efficacy, and discomfort). Glycemic control will be assessed by a continuous glucose monitoring device every 5 minutes, throughout the approximately 48 hours of each experimental session. Food and drink will be individually prescribed by a registered dietitian nutritionist and provided to participants, in order to control for the confounding effect of energy intake and diet composition. Physical activity levels will be assessed by accelerometry. Randomization will be done using the opaque, sequentially numbered envelopes technique. Participants and researchers will be blinded for continuous glucose monitoring and accelerometry data, and data will be analyzed by a blinded statistician.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study has been funded, and data collection is expected to take place between June 2024 and May 2025. Final manuscript submission should happen by August 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The results of this project might encourage individuals living with prediabetes and T2D to engage in resistance exercise while better informing exercise specialists on how to best incorporate resistance exercise in their client's or patient's routine.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;ClinicalTrials.gov NCT06208189; https://clinicaltrials.gov/s","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142581491","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 Computer-Based Psychoeducational Self-Help Platforms for Eating Disorders (With or Without an Associated App): Protocol for a Systematic Review.","authors":"Alessandra Gentile, Yosua Yan Kristian, Erica Cini","doi":"10.2196/60165","DOIUrl":"10.2196/60165","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Access to psychological health care is extremely difficult, especially for individuals with severely stigmatized disorders such as eating disorders (EDs). There has been an increase in children, adolescents, and adults with ED symptoms and ED, especially following the COVID-19 pandemic. Computer-based self-help platforms (± associated apps) allow people to bridge the treatment gap and receive support when in-person treatment is unavailable or not preferred.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The aim of this systematic review is to evaluate the effectiveness of computer-based self-help platforms for EDs, some of which may have associated apps.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The proposed systematic review will follow the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. This review will report and evaluate the literature concerning the efficacy of self-help platforms for EDs. Articles were obtained from the Ovid MEDLINE, Embase, Global Health, and APA PsycInfo. The inclusion criteria included research with original data and gray literature; research evaluating the efficacy of web-based psychoeducational self-help platforms for EDs; people with an ED diagnosis, ED symptoms, at risk of developing EDs, or from the general population without ED-related behaviors; pre- and post-computer-based ± associated apps intervention clinical outcome of ED symptoms; pre- and post-computer-based ± associated apps intervention associated mental health difficulties; and literature in English. The exclusion criteria were solely guided self-help platforms, only in-person interventions with no computer-based ± associated apps comparison group, only in-person-delivered CBT, self-help platforms for conditions other than eating disorders, systematic reviews, meta-analyses, posters, leaflets, books, reviews, and research that only reported physical outcomes. Two independent authors used the search terms to conduct the initial search. The collated articles then were screened by their titles and abstracts, and finally, full-text screenings were conducted. The Cochrane Risk of Bias 2 tool will be used to assess the risks of bias in the included studies. Data extraction will be conducted, included studies will undergo narrative synthesis, and results will be presented in tables. The systematic review will be submitted to a peer-reviewed journal.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The authors conducted a database search for articles published by May 31, 2024. In total, 14 studies were included in the systematic review. Data charting, synthesis, and analysis were completed in Microsoft Excel by the end of July 2024. Results will be grouped based on the intervention stages. The results are expected to be published by the end of 2024. Overall, the systematic review found that computer-based self-help platforms are effective in reducing global ED psychopathology and ED-related behaviors.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142568931","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of Electroacupuncture in the Treatment of Mild to Moderate Female Stress Urinary Incontinence: Protocol for a Systematic Review and Network Meta-Analysis.","authors":"JiaNi Shi, Peiqi Li, Yifan Wu, Jiawei Li, Yuchen Zhang, Bin Xiao","doi":"10.2196/55870","DOIUrl":"https://doi.org/10.2196/55870","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Stress urinary incontinence (SUI), the most common form of urinary incontinence, is a condition that affects many women. It is characterized by involuntary urine leakage during activities that increase abdominal pressure, such as sneezing, coughing, or physical exertion, according to the International Continence Society. SUI affects patients' quality of life and causes depression and emotional disorders, which negatively influences physical and mental health. The participants in the studies in this review comprised women with mild to moderate SUI, because there are more female patients than male patients, and most patients with severe SUI are treated surgically. Moreover, after retrieval, there were no systematic reviews or network meta-analyses (NMAs) of conservative treatments, such as electroacupuncture (EA), in women with mild to moderate SUI.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to investigate the efficacy of electroacupuncture among women with mild to moderate SUI using an NMA.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Randomized clinical trials related to conservative treatments for SUI will be searched in 5 English and 3 Chinese literature databases: EMBASE, PubMed, Cochrane, Web of Science, ClinicalTrials.gov, Chinese National Knowledge Infrastructure (CNKI), WanFang, and the Chinese BioMedical Literature Database. The search period for these 8 electronic databases will be from 2002 to 2022. The PROSPERO database and the International Platform of Registered Systematic Review and Meta-Analysis Protocols (INPLASY) database will also be searched. Two reviewers will independently complete the research selection. After screening the studies, 2 other researchers will extract the data, and the quality of the included studies will be evaluated according to the quality standards specified in the Cochrane Collaboration Tool (version 2). The primary outcomes will be the change in urine leakage determined by a 1-hour pad test and International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) scores at baseline and at the conclusion of the follow-up. The secondary outcomes will be 72-hour incontinence episodes, residual bladder volume, effective rate, urodynamic indexes, and other reported measurements. Stata (version 14.0; StataCorp) and Review Manager (RevMan version 5.3; Cochrane) will be implemented for data synthesis and meta-analysis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The results are not yet accessible because this is a protocol for a systematic review and meta-analysis. The protocol was registered on INPLASY on February 22, 2023. By April 6, 2023, we had completed the literature search of the 8 databases and completed the selection and data extraction of the articles.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The results of this systematic review will demonstrate the efficacy of EA among women with mild to moderate SUI. The results will provide evidence for clinicians and guideline makers to choose sui","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142575924","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Combined Telemedicine and Ambulatory Wound Care Team Intervention for Improving Cross-Sector Outpatient Chronic Wound Management: Protocol for the Mixed Methods TELE-AMBUS Research Project.","authors":"Sindre Aske Høyland, Kari Anne Holte, Olaug Øygarden, Kamrul Islam, Egil Kjerstad, Ragnhild Gjerstad-Sørensen, Synnøve Aske Høyland, Hanne Rusten Wærnes, Pascale Carayon, Maureen Fallon, Sarah Bradbury, Marcus Gürgen, Sissel Eikeland Husebø, Eirin Rødseth","doi":"10.2196/55502","DOIUrl":"https://doi.org/10.2196/55502","url":null,"abstract":"<p><strong>Background: </strong>There is a growing prevalence of nonhealing wounds and chronic diseases in society, and there is an associated need for wound management solutions that include the use of telemedicine. A broad spectrum of factors influences the planning and execution of interventions within telemedicine in chronic wound management, spanning organizations, technologies, and individuals, including professionals and patients. The Telemedicine and Ambulatory Wound Care Team (TELE-AMBUS) project applies a whole-system research approach to account for this spectrum of factors.</p><p><strong>Objective: </strong>The primary objective of this study was to explore and analyze the implementation and consequences of an outpatient wound management model, comprising 2 interconnected quality improvement interventions (ie, telemedicine and ambulatory wound care team) aimed at older and vulnerable patients with chronic wounds, across the specialist and primary health care sectors. Embedded in this objective is the aim to improve the competence levels of health care providers and, consequently, the service quality of outpatient wound management across specialist and primary health care services.</p><p><strong>Methods: </strong>This project examines the implementation and consequences of an outpatient wound management model through a combined process and economic evaluation research strategy. A sociotechnical system theory approach and multiple work package design support the examination. The project uses observations, conversations, interviews, and economic assessments to gather rich, in-depth insights and understanding on why and how the new wound management model contributes to a change or not compared with the traditional treatment model.</p><p><strong>Results: </strong>The project has been funded from 2021 to 2025. Baseline interviews have been conducted since April 2022 and concluded in January 2024. Fieldwork, including nonparticipant observations, semistructured interviews, and informal conversations, has been conducted since November 2022 and is expected to conclude in March 2025. In parallel and as part of the cost-effectiveness analyses, time usage data on the outpatient and regular clinical models are being gathered during the fieldwork.</p><p><strong>Conclusions: </strong>We applied a whole-system approach in multiple ways, that is, to design or inform our fieldwork and to explore, evaluate, and translate project findings into practice across services. To our knowledge, this approach has not been undertaken in telemedicine in chronic wound management literature and associated human factors and ergonomics research. Thus, our approach can produce both original and novel research and theoretical results internationally.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/55502.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142575978","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":"Accuracy Standards of Wearable Technologies for Assessment of Soccer Kicking: Protocol for a Systematic Literature Review.","authors":"Luiz H Palucci Vieira, Filipe Manuel Clemente, Felipe Armando Chang Marquez, Walter Manuel Rea Olivares, Kelly R Vargas Villafuerte, Felipe P Carpes","doi":"10.2196/57433","DOIUrl":"https://doi.org/10.2196/57433","url":null,"abstract":"<p><strong>Background: </strong>Wearable technology is widely applied in performance monitoring, an integral part of sports and exercise sciences. The kick movement in soccer exemplifies a sports technique that could benefit from appropriate biomechanics assessment methodologies. However, the accuracy of wearables in quantifying soccer kick mechanics, particularly under field conditions, remains unclear.</p><p><strong>Objective: </strong>This study aims to present a protocol for a systematic review to discuss the measurement properties (validity, reliability, and/or accuracy aspects) of wearable technology systems explicitly used to measure ball-kicking features in soccer.</p><p><strong>Methods: </strong>This review protocol was preregistered in the Open Science Framework. A total of 2 authors will perform searches in major electronic databases using specific keyword combinations in PubMed, Physical Therapy and Sports Medicine, Web of Science, ProQuest, IEEE Xplore, EBSCOHost, and Scopus. Following a specific population, intervention, comparison, outcome framework (population: soccer players and/or collected human data in a football-related environment; intervention: at least 1 wearable used; comparator: criterion measures, repeated testing sessions and/or actual values; outcome: ball kicking data), studies will be screened based on predetermined inclusion and exclusion criteria. The methodological quality of the included studies will be assessed using the \"consensus-based standards for the selection of health measurement instruments\" checklist (in studies concerning validity or reliability) or the \"quality assessment of diagnostic accuracy studies\" tool (in studies concerning accuracy). Data extraction will be conducted to determine the level of evidence according to the \"best evidence synthesis method,\" and an evidence gap map will be constructed. The Cohen κ coefficient will be used to estimate the interevaluator agreement.</p><p><strong>Results: </strong>This ongoing systematic review has completed database searches and is currently in the screening phase. Depending on the number and consistency of studies, results may be presented by meta-analysis or qualitative synthesis, with subgroup analyses considering factors such as gender, age, and playing level. The final results are expected by July 2024, with manuscript submission anticipated by November 2024.</p><p><strong>Conclusions: </strong>Our study will provide a comprehensive summary of the highest level of evidence available on the use of wearables for the assessment of soccer kick mechanics, providing practical guidance for athletes and sports sciences professionals regarding the validity and reliability aspects of using wearable technology to measure ball-kicking features in soccer.</p><p><strong>Trial registration: </strong>OSF registries https://osf.io/zm3j6.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/57433.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142575981","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":"Fostering Shared Decision-Making Between Patients and Health Care Professionals in Clinical Practice Guidelines: Protocol for a Project to Develop and Test a Tool for Guideline Developers.","authors":"Lena Fischer, Fülöp Scheibler, Corinna Schaefer, Torsten Karge, Thomas Langer, Leon Vincent Schewe, Ivan D Florez, Andrew Hutchinson, Sheyu Li, Marta Maes-Carballo, Zachary Munn, Lilisbeth Perestelo-Perez, Livia Puljak, Anne Stiggelbout, Dawid Pieper","doi":"10.2196/57611","DOIUrl":"10.2196/57611","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Clinical practice guidelines (CPGs) are designed to assist health care professionals in medical decision-making, but they often lack effective integration of shared decision-making (SDM) principles to reflect patient values and preferences, particularly in the context of preference-sensitive CPG recommendations. To address this shortcoming and foster SDM through CPGs, the integration of patient decision aids (PDAs) into CPGs has been proposed as an important strategy. However, methods for systematically identifying and prioritizing CPG recommendations relevant to SDM and related decision support tools are currently lacking.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The aim of the project is to develop (1) a tool for systematically identifying and prioritizing CPG recommendations for which SDM is considered particularly relevant and (2) a platform for PDAs to support practical SDM implementation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The project consists of 6 work packages (WPs). It is embedded in the German health care context but has an international focus. In WP 1, we will conduct a scoping review in bibliographic databases and gray literature sources to identify methods used to foster SDM via PDAs in the context of CPGs. In WP 2, we will conduct semistructured interviews with CPG experts to better understand the concepts of preference sensitivity and identify strategies for fostering SDM through CPGs. WP 3, a modified Delphi study including surveys and focus groups with SDM experts, aims to define and operationalize preference sensitivity. Based on the results of the Delphi study, we will develop a methodology for prioritizing key questions in CPGs. In WP 4, the tool will be developed. A list of relevant items to identify CPG recommendations for which SDM is most relevant will be created, tested, and iteratively refined, accompanied by the development of a user manual. In WP 5, a platform for creating and digitizing German-language PDAs will be developed to support the practical application of SDM during clinical encounters. WP 6 will conclude the project by testing the tool with newly developed and revised CPGs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The Brandenburg Medical School Ethics Committee approved the project (165122023-ANF). An international multidisciplinary advisory board is involved to guide the tool development on CPGs and SDM. Patient partners are involved throughout the project, considering the essential role of the patient perspective in SDM. As of February 20, 2024, we are currently assessing literature references to determine eligibility for inclusion in the scoping review (WP 1). We expect the project to be completed by December 31, 2026.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The tool will enable CPG developers to systematically incorporate aspects of SDM into CPG development, thereby providing guideline-based support for the patient-practitioner interaction. Together, the tool for CPGs and the platform for PDAs w","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142568932","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}