JMIR Research Protocols最新文献

Background: The researchers have used mobile phones to assist in monitoring, analyzing, and managing moods to acquire insight into mood patterns. There is a lack of evidence in their use as clinical tools and interventions, which necessitates a comprehensive review and quality assessment to understand barriers and facilitators for app implementation as an impactful clinical intervention.

Objective: This review aims to (1) provide an overview of the recent evidence on mobile mood-monitoring apps that are intended for facilitating self-management and support of mental health in children, adolescents, and young people; and (2) investigate the quality of publicly available apps.

Methods: The study will first involve a scoping review of the literature on mood-monitoring apps for children, adolescents, and young people followed by an evaluation of features of the apps available in the marketplace. The scoping review will follow the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines and search 6 databases- Embase, CINAHL, PubMed, ACM Digital Library, Scopus, and Springer LNCS-for relevant studies and reviews published in the last 3 years. The author will then screen the references, extract data from the included studies, and analyze them to synthesize the evidence on mood apps. Next, the Apple App Store and Google Play Store will be searched for mood apps. A total of 2 independent reviewers will screen the apps based on eligibility criteria, and disagreements will be resolved through consensus. The features of the selected apps will then be evaluated using the Mobile Health Index and Navigation framework, and descriptive analysis will be used to synthesize the findings.

Results: Literature search and screening began soon after submission of the protocol and is expected to be completed by September 2024. The app evaluation will be completed by October 2024.

Conclusions: Combined, the scoping literature review and app evaluation will provide an in-depth overview of the most recent scientific evidence related to mood apps and the quality of apps actually available for use.

International registered report identifier (irrid): PRR1-10.2196/56400.

Background: There is an increasing need for evidence-based postoperative rehabilitation strategies to optimize patient outcome. Knowledge of potential prognostic factors could steer the development of rehabilitation protocols and could result in better treatment outcomes and higher patient satisfaction.

Objective: This study aimed to investigate which potential prognostic factors predict baseline shoulder pain and function and its evolution in the first 2 years following surgery, in patients with total shoulder arthroplasty. The secondary objective is to investigate which potential prognostic factors predict baseline quality of life and its evolution in the first two years following surgery.

Methods: To reach the aims of this project, a prospective longitudinal study, running from January 2020 to March 2025, will be carried out with a follow-up of 48 months. Patients will be randomized based on sling wear. We will study factors such as shoulder function, patient expectations, psychosocial factors, lifestyle factors, sling wear, soft tissue integrity, and physiotherapy treatment. Test moments will take place preoperatively, at 6 weeks, 12 weeks, 6 months, 12 months, and 24 months. Descriptive statistics will be used to describe the patient population characteristics. Based on literature review, expert opinion, and univariate analyses, potential prognostic factors will be chosen as covariates. A mixed regression model for repeated measures will be used to assess both the evolution of the Shoulder Pain and Disability Index within persons from baseline over time and the differences in evolution between participants. Correlation analyses will be used to investigate associations between the other outcome measures such as the Constant and Murley Score, shoulder range of motion, shoulder muscle strength, and proprioception, and the primary outcome measure, the Shoulder Pain and Disability Index score. Potential prognostic factors not included in the model will be presented in a descriptive manner.

Results: Data collection started in January 2020. In April 2023 the sample size was reached. Data collection will end in April 2025. Analyses will follow when data collection is completed.

Conclusions: Knowledge of potential prognostic factors will have implications toward better rehabilitation strategies of patients after total shoulder arthroplasty.

Trial registration: ClinicalTrials.gov NCT04258267; https://clinicaltrials.gov/study/NCT04258267.

International registered report identifier (irrid): DERR1-10.2196/56522.

Background: Human trafficking is a human rights violation in every region of the world. The African continent is not spared. Every year, millions of people experience significant health and social consequences. International organizations and governments combating human trafficking are hindered by a lack of knowledge about what factors influence domestic (within-country) human trafficking.

Objective: This study aims to conduct a scoping review to collate and synthesize literature on factors influencing domestic trafficking in Africa.

Methods: We will follow Arksey and O'Malley's framework to answer the question about reported influences on domestic human trafficking and their relative weight. The search strategy will explore PubMed, CINAHL, Web of Science, and Scopus. A total of 2 independent researchers will select quantitative, qualitative, or mixed methods studies that examine relationships influencing domestic human trafficking. We will document our results by following the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. We will extract a list of all reported relationships between identified factors influencing domestic human trafficking in each study. Based on a discourse analysis approach, we will weigh the strengths of the relationships based on how frequently they are reported across the included studies. We will summarize the findings as fuzzy cognitive maps depicting the relationships reported in the literature. The maps represent the influences between concepts (nodes) linked by arrows (edges) going from each cause to its outcomes. These maps are helpful visual summaries of the factors associated with domestic human trafficking, allowing a comparison with maps to be created by stakeholder groups.

Results: This project received financial support in March 2023. We expect to start the project in March 2024. We recruited 2 research staff members to conduct the scoping review and expect to publish the results in March 2025.

Conclusions: The review will provide a comprehensive understanding of factors influencing domestic human trafficking in Africa. The overlap of human trafficking with other forms of exploitation, the limited literature on domestic human trafficking, and the likely diversity of factors are challenges for the review. We propose strategies to address these challenges.

International registered report identifier (irrid): PRR1-10.2196/56392.

Background: Approximately 100,000 patients undergo fecal ostomy operations annually across the United States. This patient population experiences high surgical complication rates and poor biopsychosocial outcomes. Surgical teams are not trained to address the psychosocial needs that often arise during recovery after fecal ostomy surgery.

Objective: This study aims to refine and establish the acceptability and usability of the Communication Intervention for fecal ostomy Surgery (CI-oSurg), a web-based communication intervention aimed at reducing distress among patients recovering from ostomy surgery.

Methods: We describe the proposed study design, methodology, and training protocol. We will conduct an open pilot (n=24 patients and n=8 clinicians) of video-based training to first identify the level and types of distress patients are experiencing. Next, patients will view web videos that address frequent challenges faced by ostomy patients, considering practical management and emotional and adaptation concerns. Qualitative one-to-one semistructured interviews will be conducted with participants to explore the acceptability and feasibility of the program and refine the intervention and study procedures.

Results: This study has been approved by the Mass General Brigham Institutional Review Board. Study funding has been obtained, and recruitment is planned for the fall of 2024.

Conclusions: Through this study, we will refine CI-oSurg, a web-based communication intervention focused on reducing distress after ostomy surgery, to improve intervention acceptability and usability. These improvements will allow us to establish the usability and acceptability of the intervention before efficacy testing to determine the ability of this intervention to reduce distress after fecal ostomy surgery.

Trial registration: ClinicalTrials.gov NCT06320002; https://clinicaltrials.gov/study/NCT06320002.

International registered report identifier (irrid): PRR1-10.2196/60575.

Background: Antimicrobial resistance (AMR) is a major global public health concern, particularly in low- and middle-income countries where resources and infrastructure for an adequate response are limited. The World Health Organization (WHO) Global Antimicrobial Resistance Surveillance System (GLASS) was introduced in 2016 to address these challenges, outlining recommendations for priority pathogen-antibiotic combinations. Despite this initiative, implementation in Africa remains understudied. This scoping review aims to assess the current state of implementing WHO GLASS recommendations on antimicrobial sensitivity testing (AST) in Africa.

Objective: The primary objective of this study is to determine the current state of implementing the WHO GLASS recommendations on AST for priority pathogen-antimicrobial combinations. The review will further document if the reporting of AST results is according to "susceptible," "intermediate," and "resistant" recommendations according to GLASS.

Methods: Following the methodological framework by Arksey and O'Malley, studies published between January 2016 and November 2023 will be included. Search strategies will target electronic databases, including MEDLINE, Scopus, CINAHL, and Embase. Eligible studies will document isolates tested for antimicrobial sensitivity, focusing on WHO-priority specimens and pathogens. Data extraction will focus on key study characteristics, study context, population, and adherence to WHO GLASS recommendations on AST. Descriptive statistics involving summarizing the quantitative data extracted through measures of central tendency and variation will be used. Covidence and Microsoft Excel software will be used. This study will systematically identify, collate, and analyze relevant studies and data sources based on clear inclusion criteria to provide a clear picture of the progress achieved in the implementation of the WHO GLASS recommendations. Areas for further improvement will be documented to inform future efforts to strengthen GLASS implementation for enhanced AMR surveillance in Africa.

Results: The study results are expected in August 2024.

Conclusions: To our knowledge, this scoping review will be the first to comprehensively examine the implementation of WHO GLASS recommendations in Africa, shedding light on the challenges and successes of AMR surveillance in the region. Addressing these issues aims to contribute to global efforts to combat AMR.

International registered report identifier (irrid): PRR1-10.2196/58140.

Background: Research in the developmental origins of health and disease provides compelling evidence that adverse events during the first 1000 days of life from conception can impact life course health. Despite many decades of research, we still lack a complete understanding of the mechanisms underlying some of these associations. The Newcastle 1000 Study (NEW1000) is a comprehensive, prospective population-based pregnancy cohort study based in Newcastle, New South Wales, Australia, that will recruit pregnant women and their partners at 11-14 weeks' gestation, with assessments at 20, 28, and 36 weeks; birth; 6 weeks; and 6 months, in order to provide detailed data about the first 1000 days of life to investigate the developmental origins of noncommunicable diseases.

Objective: The study aims to provide a longitudinal multisystem approach to phenotyping, supported by robust clinical data and collection of biological samples in NEW1000.

Methods: This manuscript describes in detail the large variety of samples collected in the study and the method of collection, storage, and utility of the samples in the biobank, with a particular focus on incorporation of the samples into emerging and novel large-scale "-omics" platforms, including the genome, microbiome, epigenome, transcriptome, fragmentome, metabolome, proteome, exposome, and cell-free DNA and RNA. Specifically, this manuscript details the methods used to collect, process, and store biological samples, including maternal, paternal, and fetal blood, microbiome (stool, skin, vaginal, oral), urine, saliva, hair, toenail, placenta, colostrum, and breastmilk.

Results: Recruitment for the study began in March 2021. As of July 2024, 1040 women and 684 partners were enrolled, with 922 infants born. The NEW1000 biobank contains 24,357 plasma aliquots from ethylenediaminetetraacetic acid (EDTA) tubes, 5284 buffy coat aliquots, 4000 plasma aliquots from lithium heparin tubes, 15,884 blood serum aliquots, 2977 PAX RNA tubes, 26,595 urine sample aliquots, 2280 fecal swabs, 17,687 microbiome swabs, 2356 saliva sample aliquots, 1195 breastmilk sample aliquots, 4007 placental tissue aliquots, 2680 hair samples, and 2193 nail samples.

Conclusions: NEW1000 will generate a multigenerational, deeply phenotyped cohort with a comprehensive biobank of samples relevant to a large variety of analyses, including multiple -omics platforms.

International registered report identifier (irrid): DERR1-10.2196/63562.

Background: Syphilis is a systemic, preventable, and curable infection caused by the bacterium Treponema pallidum. Despite being treatable, syphilis continues to have a high incidence, with a resurgence observed even in countries with strong health surveillance systems. This highlights the need to understand the various strategies used globally to improve access to care for individuals with syphilis.

Objective: This scoping review aims to identify and map the barriers and facilitators affecting access to health care for people with syphilis.

Methods: This scoping review will follow the methodology outlined by the Joanna Briggs Institute. The search will be conducted across several databases, including PubMed/MEDLINE, Scopus, Embase, LILACS (Virtual Health Library), and CINAHL (EBSCO). In addition, sources of unpublished studies or gray literature will be explored. Studies focusing on access to health care for individuals with syphilis will be included, regardless of geographic location, country, or language. Two independent reviewers will assess the results, and data will be extracted using a tool specifically developed for this review. The extracted quantitative data will be presented in tables and analyzed using descending hierarchical classification, represented by a class dendrogram. Barriers and facilitators will be categorized into dimensions of access.

Results: Database searching began in October 2024. Full-text screening and review are expected to be completed in December 2024. Data extraction and analysis are expected to be completed by February 2025, and the final report will be completed in March 2025.

Conclusions: The findings of this scoping review, guided by this protocol, will elucidate the main barriers and facilitators that affect access to syphilis treatment. This study may contribute to the practices of health professionals, managers, and the academic community, and provide relevant information for the population.

Trial registration: Open Science Framework Registries osf.io/kpsab; https://osf.io/kpsab.

International registered report identifier (irrid): PRR1-10.2196/63561.

Background: Occupational safety hazards include physical, chemical, ergonomic, biological, and psychological hazards. Technological innovation in screening for occupational stress, especially among female workers, is needed to improve their health and productivity.

Objective: This research is being conducted to obtain a prediction model of work stress through a questionnaire instrument that includes stressors and symptoms based on the transactional model, as well as measurement of work stress through a mobile app that can be used anywhere.

Methods: The research is conducted in 3 stages: qualitative research, quantitative research (cross-sectional), and mobile app development. Data were collected from companies located in Jakarta, Indonesia. The sample was chosen based on purposive sampling. For the quantitative research (n=430), logistic regression analysis was used.

Results: We are developing a work stress screening instrument for female workers, which includes stressors and symptoms based on the transactional model, in the form of a digital platform so that female workers can undertake the examination anywhere without interfering with working hours or home duties. This research was funded in January 2024 and qualitative data collection began in February 2024. Quantitative data were obtained in March 2024; the number of respondents in the qualitative stage was 6, and in the quantitative stage it was 430. The work stress screening app is in the development stage and will be launched at the same time as the data collection is performed so we can examine the respondents' perspectives on the use of the app.

Conclusions: This study analyzes the prediction of work stress to help female workers screen for work stress. Workers who are detected as experiencing work stress will be educated using an algorithm programmed in the app.

International registered report identifier (irrid): PRR1-10.2196/55874.