JMIR Research Protocols最新文献

Background: Patellofemoral pain syndrome is a highly prevalent overuse knee injury in athletic populations associated with pain and functional limitations, exacerbated by activities such as running, pivoting, cycling, and jumping. Self-management programs empowering athletes to take an active role in controlling their symptoms for chronic musculoskeletal conditions such as patellofemoral pain syndrome have grown in popularity. However, the efficacy of self-management programs specifically for athletes with patellofemoral pain syndrome is unclear due to limited and heterogeneous evidence.

Objective: The systematic review study will evaluate the effectiveness of self-management programs on pain and function, in athletes with patellofemoral pain syndrome.

Methods: PubMed/MEDLINE, Cochrane Library, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and PsycINFO databases will be systematically searched using terms related to "patellofemoral pain syndrome," "self-management," and "athletes." Interventional studies that are randomized and nonrandomized controlled trials will be included, comparing self-management programs to other treatments or control conditions among athletes with patellofemoral pain syndrome. Four reviewers will independently screen studies, extract data using the COVIDENCE software, and assess the quality of the study and evidence using the Pedro scale of risk of bias tool and GRADE approach, respectively. If feasible, a meta-analysis will be performed using the RevMan (version 5.4; the Cochrane Collaboration).

Results: The systematic review is currently in the search phase, with the authors refining search strings for the selected databases. The final search strings are expected to be ready by March 2024, and the review is projected to be completed by July 2024.

Conclusions: This systematic review protocol outlines a rigorous methodology for evaluating the effectiveness of self-management programs among athletes with patellofemoral pain syndrome. The findings will inform clinical practice and guide the development of tailored interventions to optimize outcomes for athletes with patellofemoral pain syndrome.

Trial registration: PROSPERO CRD42023492746; https://tinyurl.com/c5jze9ca.

International registered report identifier (irrid): PRR1-10.2196/58340.

Background: Digital microscopy combined with artificial intelligence (AI) is increasingly being implemented in health care, predominantly in advanced laboratory settings. However, AI-supported digital microscopy could be especially advantageous in primary health care settings, since such methods could improve access to diagnostics via automation and lead to a decreased need for experts on site. To our knowledge, no scoping or systematic review had been published on the use of AI-supported digital microscopy within primary health care laboratories when this scoping review was initiated. A scoping review can guide future research by providing insights to help navigate the challenges of implementing these novel methods in primary health care laboratories.

Objective: The objective of this scoping review is to map peer-reviewed studies on AI-supported digital microscopy in primary health care laboratories to generate an overview of the subject.

Methods: A systematic search of the databases PubMed, Web of Science, Embase, and IEEE will be conducted. Only peer-reviewed articles in English will be considered, and no limit on publication year will be applied. The concept inclusion criteria in the scoping review include studies that have applied AI-supported digital microscopy with the aim of achieving a diagnosis on the subject level. In addition, the studies must have been performed in the context of primary health care laboratories, as defined by the criteria of not having a pathologist on site and using simple sample preparations. The study selection and data extraction will be performed by 2 independent researchers, and in the case of disagreements, a third researcher will be involved. The results will be presented in a table developed by the researchers, including information on investigated diseases, sample collection, preparation and digitization, AI model used, and results. Furthermore, the results will be described narratively to provide an overview of the studies included. The proposed methodology is in accordance with the JBI methodology for scoping reviews.

Results: The scoping review was initiated in January 2023, and a protocol was published in the Open Science Framework in January 2024. The protocol was completed in March 2024, and the systematic search will be performed after the protocol has been peer reviewed. The scoping review is expected to be finalized by the end of 2024.

Conclusions: A systematic review of studies on AI-supported digital microscopy in primary health care laboratories is anticipated to identify the diseases where these novel methods could be advantageous, along with the shared challenges encountered and approaches taken to address them.

International registered report identifier (irrid): PRR1-10.2196/58149.

Background: Sexual minority men are disproportionately affected by methamphetamine use, with recent studies suggesting an increase in use specifically among Black sexual minority men. Black sexual minority men face unique structural barriers to achieving optimal health. Given its harmful effects, and in light of existing health disparities, an increase in methamphetamine use among Black sexual minority men poses a significant public health concern.

Objective: The Health Impacts and Struggles to Overcome the Racial Discrimination of Yesterday (HISTORY) study is investigating the potential impacts of exposure to the census tract-level structural racism and discrimination (SRD) on methamphetamine use among Black sexual minority men in Atlanta, Georgia, and will identify intervention targets to improve prevention and treatment of methamphetamine use in this population.

Methods: This study uses a mixed methods and multilevel design over a 5-year period and incorporates participatory approaches. Individual-level quantitative data will be collected from a community-based cohort of Black sexual minority men (N=300) via periodic assessment surveys, ecological momentary assessments, and medical record abstractions. Census tract-level measures of SRD will be constructed using publicly available administrative data. Qualitative data collection will include longitudinal, repeated in-depth interviews with a subset (n=40) of study participants. Finally, using a participatory group model-building process, we will build on our qualitative and quantitative data to generate causal maps of SRD and methamphetamine use among Black sexual minority men, which in turn will be translated into actionable recommendations for structural intervention.

Results: Enrollment in the HISTORY study commenced in March 2023 and is anticipated to be completed by November 2024.

Conclusions: The HISTORY study will serve as a crucial background upon which future structural interventions can be built, to mitigate the effects of methamphetamine use and SRD among Black sexual minority men.

International registered report identifier (irrid): DERR1-10.2196/63761.

Background: The US Preventive Services Task Force recommends providers offer individualized healthy behavior interventions for all adults, independent of their risk of cardiovascular disease. While strong evidence exists to support disease-specific programs designed to improve multiple lifestyle behaviors, approaches to adapting these interventions for a broader population are not well established. Digital behavior change interventions (DBCIs) hold promise as a more generalizable and scalable approach to overcome the resource and time limitations that traditional behavioral intervention programs face, especially within an occupational setting.

Objective: We aimed to evaluate the efficacy of a multimodal DBCI on (1) self-reported behaviors of physical activity, nutrition, sleep, and mindfulness; (2) cardiometabolic biomarkers; and (3) chronic disease-related medical expenditure.

Methods: We conducted a 2-arm randomized controlled trial for 12 months among employees of an academic health care facility in the United States. The intervention arm received a scale, a smartphone app, an activity tracker, a video library for healthy behavior recommendations, and an on-demand health coach. The control arm received standard employer-provided health and wellness benefits. The primary outcomes of the study included changes in self-reported lifestyle behaviors, cardiometabolic biomarkers, and chronic disease-related medical expenditure. We collected health behavior data via baseline and quarterly web-based surveys, biometric measures via clinic visits at baseline and 12 months, and identified relevant costs through claims datasets.

Results: A total of 603 participants were enrolled and randomized to the intervention (n=300, 49.8%) and control arms (n=303, 50.2%). The average age was 46.7 (SD 11.2) years, and the majority of participants were female (80.3%, n=484), White (85.4%, n=504), and non-Hispanic (90.7%, n=547), with no systematic differences in baseline characteristics observed between the study arms. We observed retention rates of 86.1% (n=519) for completing the final survey and 77.9% (n=490) for attending the exit visit.

Conclusions: This study represents the largest and most comprehensive evaluation of DBCIs among participants who were not selected based on their underlying condition to assess its impact on behavior, cardiometabolic biomarkers, and medical expenditure.

Trial registration: ClinicalTrials.gov NCT04712383; https://clinicaltrials.gov/study/NCT04712383.

International registered report identifier (irrid): RR1-10.2196/50378.

Background: Initiated in 2021, a Brazilian project aims to establish a national injury registry, compiling comprehensive data on events and individuals across the country, irrespective of injury severity. The registry integrates information from prehospital and hospital care, diverse health systems lacking interoperability, and sectors such as firefighters and the police. Its primary goal is to enhance health surveillance by providing timely, high-quality information, guiding prevention strategies, and informing policy making. The project still aims to reduce long-term morbidity and mortality associated with injuries.

Objective: A knowledge gap remains regarding the effects of injury registries in relation to policies and injury outcomes. This protocol outlines a systematic review and meta-analysis to answer "What is the effect of implementation and use of injury registry data on policy making, hospitalization, and mortality?"

Methods: The systematic review follows PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, focusing on studies reporting results related to the implementation and use of injury registries, including trauma registries. Outcomes of interest include policy making, hospitalization rates or duration, and mortality. Registries within well-defined administrative boundaries will be included. Data will be collected from PubMed, Embase, Scopus, Web of Science, Lilacs, and references. Records will be independently screened by 2 reviewers, with any disagreements resolved through arbitration by a third reviewer. Homogeneous studies, with 3 or more evaluating the same outcome, may undergo meta-analysis. Subgroup analyses by registry type, injury groups, and other selected variables of interest will be conducted. Sensitivity analysis, risk of bias assessment, publication bias evaluation, and quality appraisal will also be performed.

Results: This systematic review will run from November 2023 to June 2024. No identical review was found. Search strategies were finalized, the bibliographic search started, duplicates were eliminated, and title and abstract screening began. Of 35 studies retrieved, 85 were excluded due to duplication, leaving 50 for selection.

Conclusions: This study is timely, aligning with ongoing national efforts to implement an injury registry. By synthesizing available evidence, we will identify the potential of injury registries to guide the decisions of Brazilian policy makers.

Trial registration: PROSPERO CRD42023481528; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=481528.

International registered report identifier (irrid): PRR1-10.2196/55029.

Background: Childhood obesity has become a significant public health concern over the past 2 decades, posing multifactorial challenges, including modifiable factors like dietary habits, physical activity, screen time, and sleeping habits. Prevention efforts require a comprehensive approach comprising educational interventions, collaboration among multidisciplinary teams, and community engagement. Since schools play a central role in children's lives, they are the ideal setting for promoting healthy habits.

Objective: The LIVELY (Multidimensional School-Based and Family-Involved Interventions to Promote a Healthy and Sustainable Lifestyle) study will assess the prevalence of overweight and obesity in primary school children and identify contributing factors within families. Additionally, it aims to implement and evaluate a multidimensional, multidisciplinary intervention to foster a sustainable and healthy lifestyle, ultimately working toward preventing obesity in school-aged children.

Methods: During the school year, each class will be individually involved in a multidimensional educational intervention covering the topics of healthy, sustainable nutrition and lifestyle. Children will also participate in a multimedia lab where they will create an animated cartoon. The lectures will engage them through various methods, including direct instructions, games, and drawing activities, to stimulate and enhance their learning and involvement.

Results: Data collection began in October 2023 and will last until the end of October 2024. A sample of 227 children from 14 classes was included in the study. The mean age was 8.9 (SD 1.2) years, and 48% (n=110) were males. Among the overall sample, 18.1% (n=41; 95% CI 13.7%-23.7%) were overweight, while 5.3% (n=12; 95% CI 3%-9%) had obesity. Males had a higher prevalence of obesity than females (9.1%, n=10 vs 1.7%, n=3, P=.03, respectively). Otherwise, the prevalence of central obesity was similar between the two (P=.329). Data analysis and the presentation of the complete results will be available after the end of 2024.

Conclusions: The study could lead to the structuring of an educational intervention model in school settings aimed at preventing childhood obesity. Moreover, it could help raise awareness of childhood obesity and help prevent this public health issue.

Trial registration: ClinicalTrials.gov NCT05966051; https://clinicaltrials.gov/study/NCT05966051.

International registered report identifier (irrid): DERR1-10.2196/57509.

Background: Midlife and older women who experience intimate partner violence (IPV) often have less access to supports and services than younger women. There is far less focus on research and supports for midlife and older women compared to younger women experiencing IPV, and often, neither elder abuse nor IPV services meet their needs. Few interventions are available to meet the needs of midlife and older women.

Objective: The goal of this randomized controlled trial is to test the effectiveness of an advocacy intervention for midlife and older women who experience IPV and to learn from the experiences of those who implement and participate in the program.

Methods: This trial is a 2-arm, unblinded, parallel, pragmatic randomized controlled trial with a qualitative component. Eligible participants will be women who live in the Maritime provinces of Canada (New Brunswick, Nova Scotia, and Prince Edward Island), who are in midlife and older (aged approximately ≥50 years), and who are currently in a relationship with an abusive partner or have recently left an abusive partner. Facilitators will be trained to deliver the intervention. The intervention will be entirely virtual and will consist of 2 components: (1) an empowerment component, which will involve sharing resources and information with the women; and (2) a social support component, which will include providing support and encouragement to women for 12 weeks. Quantitative effectiveness data will be collected from all trial participants at baseline, 3 months after the intervention, and 9 months after the intervention about the incidence and severity of IPV, physical and mental health, and safety behaviors and strategies. Qualitative interviews will be conducted with the facilitators and intervention group participants. Control group participants will receive a static, nontailored version of the advocacy intervention for midlife and older women (AIM) intervention materials after baseline data collection.

Results: A total of 12 facilitators have been trained to deliver the AIM intervention to trial participants. Participant recruitment and data collection will be completed in January 2025. Data analysis will continue throughout the data collection period, and the results will be disseminated by December 2025.

Conclusions: This research will result in the adaptation and testing of a program to support and empower midlife and older women in the Maritime provinces of Canada who experience IPV.

Trial registration: International Standard Randomized Controlled Trial Registry ISRCTN30646991; https://doi.org/10.1186/ISRCTN30646991.

International registered report identifier (irrid): DERR1-10.2196/57886.

Background: Hypospadias is a common congenital anomaly characterized by the displacement of the urethral opening to the ventral side of the penis. Surgical correction is often necessary for functional and psychological reasons. The etiology involves genetic and environmental factors, and chordee, a downward curvature of the penis, is a common complication. Proteins such as fibulin-1, elastin, matrix metalloproteinase-1, basic fibroblast growth factor, and α-smooth muscle actin play roles in hypospadias development.

Objective: The study's aim is to investigate the differences in messenger RNA (mRNA) expression of fibulin-1, elastin, matrix metalloproteinase-1, basic fibroblast growth factor, and α-smooth muscle actin between the ventral and dorsal tunica dartos in patients with hypospadias and chordee.

Methods: This prospective cohort study aims to investigate differences in mRNA expression of the abovementioned proteins between the ventral and dorsal tunica dartos in patients with hypospadias and chordee. Ethics approval has been obtained, and consent from parents will be obtained before data collection. Eligible participants are aged 6-18 months, diagnosed with hypospadias and chordee, and planned for urethroplasty. Tissue samples will be collected from both aspects of the tunica dartos and analyzed using real-time quantitative reverse transcription-polymerase chain reaction. Data analysis will involve statistical tests and normalization of housekeeping genes.

Results: This study is at the protocol development stage. A pilot study regarding its feasibility has been ongoing as of August 2023. The study results are expected to be available by the end of 2024.

Conclusions: The study of mRNA expressions of various proteins in the tunica dartos of patients with hypospadias and chordee is expected to improve the understanding and expand the knowledge of the pathophysiology of hypospadias and chordee.

International registered report identifier (irrid): DERR1-10.2196/52282.