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Protocols, grant proposals, registered reports (RR1)

Latest Submissions Open for Peer Review

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Titles/Abstracts of Articles Currently Open for Review:

  • Background: Loneliness is increasingly recognized as a major public health concern in higher education with nearly one in four students feeling lonely most or all of the time, with 80% reporting moderate-to-severe loneliness. Compassion from others, defined as receiving warmth, care, and understanding, may buffer loneliness. Yet, many students may struggle with receiving compassion due to shame, self criticism, and fear of compassion, which hinder their capacity to engage in supportive relationships. Objective: The proposed scoping review (ScR) aims to map the existing literature on compassion from others and its relationship to loneliness among university students, clarify conceptual boundaries, identify psychological and institutional influences, and highlight gaps to inform future research and intervention development. Methods: This protocol for the scoping review follows PRISMA ScR guidance. Eligibility criteria are structured using the PI(E)COS framework. Searches in the final scoping review (ScR) will be conducted in PsycINFO, PubMed, Scopus, Web of Science, ERIC, ProQuest, CINAHL and Google Scholar. This protocol proposes the methodological framework of Arksey and O’Malley with enhancements from the Joanna Briggs Institute (JBI) for use in the anticipated scoping review. Jointly and consistent with Joanne Briggs Institute (JBI) guidance for ScR, we will aim to map the breadth and nature of existing research; therefore, no critical appraisal or risk of bias assessment will be undertaken, as these are not required for scoping reviews unless justified by specific objectives Results: The ScR protocol will document the predicted tools for mapping definitions and measures of compassion from others; the prevalence and correlates of loneliness; psychological barriers, such as shame and threat sensitivity; and institutional contributors, such as academic culture and supervisory relationships. Conclusions: This ScR protocol provides the initial outline of the future ScR methods of compassion from others research in higher education. Findings will support the development of compassionate academic environments that foster students’ sense of belonging and reduce their loneliness. Clinical Trial: OSF portal with access from the link https://osf.io/4tnqc/overview

  • Technical Approaches to Predicting Acute Deterioration in Pediatric Inpatients: Protocol for a Scoping Review

    Date Submitted: May 2, 2026
    Open Peer Review Period: May 3, 2026 - Jun 28, 2026

    Background: Early warning systems are widely used to detect acute clinical deterioration, which may be defined as a significant worsening in health over a few hours that may lead to adverse outcomes such as code blue activation, unplanned intensive care unit admission, or death. These systems rely on regular measurement of physiological parameters, such as heart rate and blood pressure, which are converted into warning scores using deterioration prediction algorithms (DPAs). A range of DPAs are currently in use, most commonly simple track-and-trigger tools or summative scoring systems. More complex machine learning approaches have been proposed that may improve prediction accuracy. However, heterogeneity in outcome definitions and reported model performance metrics hinders evidence synthesis needed to support deployment of proposed models in clinical contexts. Objective: This scoping review aims to identify the range of DPAs developed for use in pediatric inpatient early warning systems, as well as operational definitions of deterioration and reported performance metrics. Methods: The review will follow the Joanna Briggs Institute methodology for scoping reviews and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) reporting guidelines. The population of interest is hospitalized children. The concept under review is deterioration prediction algorithms, defined as decision-support tools that use routinely monitored physiological parameters to alert clinicians to worsening clinical status. The context will be inpatient ward settings, excluding emergency departments, neonatal units, and intensive care environments. Studies will be identified from searches on the MEDLINE (Ovid), Scopus, Web of Science, Cochrane, and ACM DL databases. Studies will be screened by two independent reviewers against the inclusion and exclusion criteria. A broad range of study types, including prospective and retrospective analyses, will be eligible for inclusion. Data on the choice of algorithmic approach, definition of deterioration, and reported performance metrics will be collated and analyzed. The results will be presented descriptively in tabular and narrative formats. Results: At the time of submission, the protocol has been registered and the search strategy finalized. A formal database search has been carried out in April 2026. Screening and data extraction are expected to occur over the following 6 months, after which the findings will be published. Conclusions: This protocol describes the planned scoping review of deterioration prediction algorithms for pediatric inpatient care. The completed review will summarize the types of algorithms evaluated, the outcomes used to define deterioration, and the performance metrics reported. These findings will support further evidence synthesis in this emerging field. Clinical Trial: Registered on Open Science Framework at https://osf.io/eg9cs(DOI: 10.17605/OSF.IO/EG9CS)

  • IMMERSE-2 IMpleMenting Effective infection prevention and control in ReSidential aged carE through Communities of Practice: protocol for a before-and-after study

    Date Submitted: Apr 30, 2026
    Open Peer Review Period: Apr 30, 2026 - Jun 25, 2026

    Background: In Australian residential aged care, infection prevention and control (IPC) lead nurses are a key part of the IPC program. IPC Leads are often the main IPC contact and provide support to staff to improve IPC and resident outcomes. To enhance their competence and self-efficacy, IPC Leads need to engage in ongoing role development. Connecting with others IPC Leads, learning together and sharing ideas and resources could also be beneficial. Communities of practice (CoPs) have been shown to improve self-efficacy and job satisfaction by fostering belonging, peer learning and problem-solving. Drawing on social learning theory, CoPs encourage learning with and from one another to explore and iteratively develop practice. This study draws on the CoP literature and builds on our previous pilot of a CoP for IPC lead nurses in one state of Australia, which found promising impacts on confidence and practice change. Objective: This study will evaluate CoPs for IPC Leads working in Australian residential aged care. Primarily the study will assess for change in IPC Leads’ self-efficacy. It will also explore job satisfaction, IPC practice improvement and assess the acceptability and feasibility of CoPs. Methods: A before-and-after study design using multi-methods. We will recruit IPC Leads from across Australia to participate in the CoPs. The CoPs will be implemented over 12 months, with online sessions held monthly for 30-60 minutes each. Baseline and 12-month follow-up surveys of IPC Leads’ self-efficacy and job satisfaction, and audits of IPC practice will be conducted. At 12-months follow-up, surveys and interviews with IPC Leads will be assess acceptability and feasibility of the CoPs and explore case examples of IPC Leads facilitating practice change. Researcher notes and costings data collected will be used to further evaluate the feasibility and fidelity of the CoPs. Results: This project was funded in October 2024 and commenced in February 2025. Recruitment of IPC Leads began in March 2026. The CoPs are expected to commence in June-July 2026. Data collection will commence in June 2026 and is expected to be completed by January 2028. Conclusions: Findings will create new research knowledge in the field of CoPs and knowledge translation in the aged care sector and will inform the sustainability and potential for future scale-up of this collaborative social learning approach. Clinical Trial: Not applicable

  • Background: Transcutaneous auricular vagus nerve stimulation (taVNS) is an emerging neuromodulation technique in rehabilitation research. While implanted vagus nerve stimulation is used clinically for epilepsy and treatment-resistant depression, its non-invasive form has mainly been explored in experimental settings, including physiotherapy and neuropsychiatry. Very few studies have investigated taVNS in speech-language pathology. However, given the vagus nerve's role in motor and sensory swallowing control, taVNS may offer a promising approach for dysphagia management - a frequent and severe complication in elderly stroke patients. Therefore, the development of an innovative protocol integrating taVNS appears pertinent in the context of swallowing rehabilitation. Objective: This protocol aims to evaluate the efficacy of taVNS combined with standard speech-language therapy for improving pharyngolaryngeal swallowing function and quality of life in elderly patients (≥70 years) with acute post-stroke dysphagia. Methods: This single-center, two-arm, randomized controlled clinical trial is conducted in a single-blind design. A total of 20 participants are expected to be enrolled. Eligible patients will be randomly allocated to receive either standard speech-language therapy combined with an inactive tVNS-E device, or standard speech-language therapy combined with non-invasive auricular vagus nerve stimulation via an active tVNS-E device. Both groups will undergo four rehabilitation sessions per week over three weeks. Clinical assessments (GUSS, SWAL-QoL, food trial) will be conducted at baseline T0 (inclusion) and at the end of the protocol at T3 (Week 3 – Day 4). Results: The study is currently in the participant recruitment phase. Recruitment began in April 2026. Baseline and post-test data collection is expected to continue until February 2028. Data analysis is planned for March 2028, and study results are expected to be published in April 2028. Conclusions: This will be the first randomized controlled trial evaluating taVNS for post-stroke dysphagia rehabilitation in patients aged ≥70 years. If effective, taVNS could provide a non-invasive adjunct to conventional speech-language therapy. Clinical Trial: ClinicalTrials.gov (NCT07428590)

  • Background: Cancer is a significant public health challenge in India, contributing to 8.3% of deaths and 5.0% of DALYs in 2016—nearly double its burden in 1990. Fragmented service delivery, limited specialist availability, late presentation, and significant financial hardship continue to hinder access to timely and effective cancer care, particularly in rural and underserved regions. National initiatives such as the NP-NCD and Ayushman Bharat have expanded diagnostic and treatment coverage; however, critical gaps remain in infrastructure, human resources, and quality of care. A comprehensive, system-level assessment is essential to inform evidence-based planning and strengthen cancer services nationwide. Objective: This study aims to evaluate the availability, readiness, and geographic distribution of cancer care services in India and to identify disparities across rural–urban settings and healthcare sectors. A secondary objective is to develop a framework to strengthen cancer service delivery across the continuum of care. Methods: A cross-sectional, descriptive study will be conducted across 32 States/UTs over three years. Using proportionate sampling, districts will be selected based on rural and urban population distribution. Nodal hospitals—preferably those hosting Hospital-Based Cancer Registries—will coordinate data collection from primary, secondary, and tertiary cancer care facilities. A structured electronic pro forma will capture data across six quality-of-care domains: equitable, effective, patient-centred, safe, efficient, and timely. Data will be entered through an online portal and monitored centrally. Descriptive statistics will summarise service availability, while Chi-square tests will assess differences across facility types, sectors, and geographic strata. Results: Ethical approval was obtained from the ICMR-NCDIR Institutional Ethics Committee (NCDIR/IEC/3058/2022); no individual patient data will be collected, all responses will be anonymised, and participation will be voluntary Conclusions: This situational analysis will generate critical evidence on India’s cancer care landscape, highlighting disparities and system gaps. Findings will support policymakers and programme managers in strengthening infrastructure, workforce deployment, and service delivery to advance equitable and comprehensive cancer care nationwide.

  • Background: Medical record review (MRR) is a common research method that uses information recorded in patient health records to answer health-related questions. MRRs help researchers learn about disease prevalence and practice patterns, treatment variation, outcomes, and healthcare quality and safety. It is relatively inexpensive and can be conducted efficiently. However, challenges such as missing data, inaccurate terminology, and inconsistent documentation are potential sources of bias, undermining the validity of MRRs. Prior MRR checklists are limited due to being outdated, incomplete, or not designed for newer approaches such as those involving electronic health records (EHRs). Objective: To develop expert-approved recommendations and a checklist for the conduct and reporting of MRRs addressing both traditional chart reviews and contemporary EHR-based research. Methods: We will conduct an expert consensus study using a modified Delphi approach following the ACCORD guideline for consensus methods in biomedicine. The process will be informed by a systematic review of the literature on the conduct, reporting, and quality assessment of MRR studies, registered on the Open Science Framework website (https://osf.io/9yj8r/overview). A multidisciplinary panel of 27 experts, primarily drawn from but not restricted to the Pediatric Emergency Research Canada (PERC) network and was selected purposefully to ensure diversity in expertise, background, and experience. Candidate checklist items identified through the literature review and an initial meeting will be evaluated over up to three rounds of anonymous online Delphi surveys using 5-point Likert scales. Items not reaching consensus (<75% approval) will be revised iteratively. A steering committee will oversee the process, and an in-person consensus meeting will be held to refine draft guidelines. Approval of the final version of the recommendations by at least 90% of the experts will be required. The final version will be tested with a broader group of patient partners, international researchers and stakeholders to ensure it is practical and useful. Based on institutional policies, this project was considered outside the mandate of the Research Ethics Board and therefore did not require ethics approval. Results: This project received financial support from the Canadian Institutes of Health Research (Planning and Dissemination Grant# 204652) in November 2025. The first three rounds of Delphi surveys were conducted in December 2025 to March 2026. The recommendations are expected to be completed in the Spring of 2026 and be externally evaluated in the summer of 2026. Conclusions: This project will lead to more rigorously designed MRR studies, thereby improving the quality of healthcare research to inform patient care.

  • Background: Rheumatoid arthritis (RA) disease activity during disease-modifying antirheumatic drug (DMARD) tapering is commonly monitored using in-person clinical assessment and the 28-joint Disease Activity Score with C-reactive protein (DAS28-CRP). Although effective, this approach is resource intensive and may be inconvenient for patients. Remote monitoring using patient-reported outcome measures and wearable sensors may offer a practical way to detect flare earlier and support safer tapering pathways. Prior pilot work suggests that accelerometery-derived physical activity, mobility, and sleep metrics are associated with RA disease activity and are acceptable to patients. Objective: This protocol aims to evaluate the feasibility and diagnostic accuracy of remote monitoring for detecting RA flare during DMARD tapering. The study will (1) continuously measure physical activity using wrist-worn accelerometers, (2) collect weekly Rheumatoid Arthritis Flare Questionnaire (RA-FQ) scores, (3) develop a joint modelling framework to estimate flare risk from longitudinal activity data, and (4) retrospectively assess prediction accuracy against patient- and clinician-defined flare onset. Methods: This is a prospective observational cohort study embedded within the ROADMAP DMARD tapering clinic at the Freeman Hospital, Newcastle upon Tyne, United Kingdom. Adults with clinician-confirmed RA in remission (DAS28-CRP <2.4) who are undergoing or about to start DMARD tapering and can walk independently will be recruited. The target sample size is 100 patients. Study visits are aligned with routine ROADMAP appointments and include baseline and week 12 assessments, with an optional 12-week extension (week 24) and ad hoc visits for suspected flare. Patients will wear wrist-worn Axivity AX6 devices continuously for 12 weeks (three devices worn sequentially for 28 days each), with an optional further 12 weeks in the extension phase. Weekly RA-FQ data will be collected via REDCap or paper questionnaires if needed. Clinical assessments include tender and swollen joint counts, patient and physician visual analogue scales, C-reactive protein, DAS28-CRP, and Health Assessment Questionnaire Disability Index scores. Flare status will be defined using clinician assessment supported by DAS28-CRP and/or swollen joint count criteria. A joint modelling framework combining longitudinal accelerometery-derived metrics and time-to-event analysis will generate daily flare-risk predictions. Model performance will be evaluated using area under the receiver operating characteristic curve, sensitivity, specificity, predictive values, and lead time to flare detection. Results: As of April 2026, 16 patients have been recruited. This protocol reports the study design, procedures, and planned analyses; outcome analyses will be reported after follow-up completion. Conclusions: This study will provide pilot evidence on the feasibility and accuracy of multimodal remote monitoring for RA flare detection during DMARD tapering in routine care. Findings will inform model refinement, external validation, and future larger multicentre studies evaluating clinical utility and service impact.

  • Background: Despite being a major burden in low- and middle-income countries in India, the understanding of cancer and its treatment remains limited. Adverse drug reactions (ADRs) from chemotherapy, polypharmacy, drug interactions and the cost of care also pose challenges for patient safety and health economics. Objective: This protocol describes the design of a prospective, observational, cross-sectional study that will evaluate chemotherapy drugs based on their usage, ADRs, and drug interactions, as well as undertake pharmacoeconomic analyses, including cost-effectiveness analysis, cost-utility analysis, and budget impact analysis to guide safe and cost-effective cancer treatment. Methods: The research will involve 67 adult cancer patients on chemotherapy in the oncology department of a tertiary care hospital in India for eight months. The Case Record Form will be used for data collection. Pharmacovigilance estimates will be done using standardised instruments (WHO-UMC scale, Naranjo algorithm, Hartwig and Siegel scale, Schumock and Thornton criteria). Economic analyses will include cost analysis, cost-effectiveness analysis (ICER), cost-utility analysis (ICUR) and budget impact analysis. Polypharmacy (use of >=5 drugs) and drug-drug interactions will also be assessed. Results: The study will confirm a high burden of ADRs, polypharmacy, and financial toxicity with chemotherapy. Results will demonstrate the link between prescription complexity, safety and cost. Conclusions: Linking pharmacovigilance with pharmacoeconomics will support rational prescribing, encourage generic and biosimilar uptake, and ultimately improve safety, affordability, and access to cancer treatment. Clinical Trial: CTRI/2025/10/096700 (Registered on: 31/10/2025)

  • Integrative Prevention at Work: Protocol for the Development of an Assessment Tool

    Date Submitted: Apr 27, 2026
    Open Peer Review Period: Apr 28, 2026 - Jun 23, 2026

    Background: In a changing world of work, integrative prevention at work represents a promising avenue for addressing contemporary health, safety and well-being issues. However, for organizations to deploy and benefit from this approach, developing an assessment tool for integrative prevention appears to be the first required step. No existing assessment tool can assess all its key characteristics on a unified scale, limiting the operationalization of this approach in organizations. Objective: The general objective of this project is to develop an assessment tool for integrative prevention at work intended for organizations in the health and social services sector. Specifically, this project aims to: 1) to generate items, rating scales and instructions; 2) to validate the content of the tool; 3) to pre-test the tool in organizational settings and 4) to evaluate its psychometric properties. Methods: A four-phase methodological study will be carried out for each research objective. The assessment tool will be developed and tested in the health and social services organizations in Quebec, Canada. Results: Phase 1 is complete: A total of 96 items were created and distributed relatively evenly across five subscales, each reflecting one attribute of integrative prevention at work. Phase 2 will be finalized by the end of 2026. Phases 3 and 4 will be completed by the end of 2028 to provide a validated tool to assess the key characteristics of integrative prevention at work. Conclusions: From an organizational perspective, this tool will provide health and social services organizations with a validated, context-adapted measure of integrative prevention at work, enabling baseline assessment, targeted improvements, and longitudinal monitoring, thereby strengthening prevention practices. From a research perspective, this project will deepen the understanding of integrative prevention at work through its empirical validation.

  • Background: Outdoor free play is associated with benefits for children’s health, yet opportunities have declined and intervention approaches remain heterogeneous. A clearer understanding is needed of which interventions are effective and under what implementation conditions. Objective: This systematic review aims to synthesize interventions related to outdoor free play in children aged 0–12 years, evaluate their effects on child health and developmental outcomes, and characterize intervention components, delivery strategies, and implementation features.  Methods: We will search MEDLINE, Embase, CINAHL, Scopus, CENTRAL, and Web of Science. Eligible studies will use experimental or quasi-experimental designs to examine interventions related to outdoor free play, defined as child-directed play outdoors that is not structured by adults. Interventions will include but not be limited to modifications to environments, policies, supervision, or resources. The primary outcome will be any quantitative child health or developmental outcome. Studies must provide sufficient detail to identify core components, delivery format, target population, and setting. Two reviewers will independently screen studies, extract data, and assess risk of bias using Cochrane Risk of Bias 2 tool and ROBINS-I. Intervention characteristics and implementation factors will be synthesized descriptively using TIDieR and RE-AIM. Where appropriate, meta-analyses will be conducted using random-effects models, with subgroup analyses by age and setting, and sensitivity analyses restricted to studies at low risk of bias. Results: Funded in Decembre 2025, search strategy ran in April 2026 and title and abstracts screening started as of April 2026. Conclusions: This review will identify which outdoor free play interventions are effective and feasible. By clarifying key components and implementation features, it will support decisions on selecting, adapting, and scaling interventions within local contexts. Clinical Trial: PROSPERO no CRD420261376414; https://www.crd.york.ac.uk/PROSPERO/view/CRD420261376414

  • Automated Digital Wellness Coaching for Working-Age Adults: Protocol for a Cluster Randomized Controlled Trial

    Date Submitted: Apr 28, 2026
    Open Peer Review Period: Apr 28, 2026 - Jun 23, 2026

    Background: Digital interventions provide a scalable, resource-saving approach to promote well-being and health and prevent lifestyle-related chronic health conditions, but their ability to engage and benefit diverse audiences remains a challenge. Objective: This study aims to evaluate a 6-month web-based wellness coaching program among working-age adults. The program is theory- and evidence-based, co-designed, and targets three behavioral domains (physical activity, diet, sleep) with an overarching focus on stress–recovery balance. Methods: The study follows a 2-arm parallel cluster randomized controlled design and lasts 12 months. Participants with age 18–65, proficiency in Finnish, and access to Internet were recruited from diverse worksites (n=13) in Central and Southwestern Finland. The sites were allocated 1:1 to intervention (coaching program) or waitlist control arm (general information on well-being). Data collection comprises fitness tests (handgrip strength, heart rate variability, body composition, waist circumference, BMI) and questionnaires conducted at months 0, 6, and 12, together with continuous monitoring of implementation costs, study uptake, dropout, and engagement (eg, visits to and time spent on the coaching platform). The primary outcome is the participant-level change in self-reported well-being (WHO-5 Well-Being Index) from baseline to 12 months. Secondary outcomes include changes in measures reflecting physical fitness, anthropometrics, lifestyle behaviors, health, and functional capacity. Further evaluation domains include health economic impact (eg, changes in well-being-, productivity-, and quality-adjusted life years), feasibility (study uptake, dropout, and engagement), and user experiences (acceptability, overall evaluation, and readiness to recommend the coaching program). Planned analyses will be conducted on the intention-to-treat principle and include linear mixed-effects models and health economic modelling. Results: The study received ethical approval in May 2025. Participant registration was open in September–October 2025, informed consents were collected in October–November 2025, and baseline assessments were conducted in October–December 2025. Consents were obtained from 294 and complete baseline data from 268 participants. Data collection will be completed within 2026, data analysis is planned for 2026–2027, and the dissemination of results will begin in 2027. The study is conducted as a part of the European Union’s Joint Action on Cardiovascular Diseases and Diabetes (JACARDI) that has received funding from the EU4Health Programme 2021–2027. Conclusions: The study contributes to evidence on the potential of fully automated digital tools to enhance workforce well-being and save societal costs. Clinical Trial: ISRCTN Registry ISRCTN12097902 https://doi.org/10.1186/ISRCTN12097902 (date of registration: 06/08/2025)

  • Background: ADHD affects over 366 million adults and 139 million children worldwide, yet diagnosis remains fundamentally subjective, relying on clinical interviews, behavioral observations, and rating scales that yield inconsistent results across practitioners and settings. Artificial intelligence (AI), machine learning (ML), and deep learning (DL) offer a paradigm shift toward objective, data-driven diagnosis by detecting complex patterns across neuroimaging, electrophysiology, and digital biomarkers that elude conventional assessment. Although AI-based ADHD research has grown exponentially, no comprehensive synthesis examines the full spectrum of data modalities, validation practices, and clinical translation readiness. This gap limits our understanding of which approaches are most promising for real-world implementation. Objective: This scoping review will visually map the current evidence on the AI-based ADHD classification with respect to predictive accuracy, data forms, data features, generalizability, and interpretability of models. Methods: This scoping review will use the Joanna Briggs Institute (JBI) approach to scoping reviews and follow the Preferred Reporting Items of Systematic Reviews and Meta-Analyses Extension Scoping Reviews (PRISMA-ScR) guidelines. Five electronic databases such as IEEE Xplore, Scopus, PubMed, Web of Science, and ACM Digital Library will be systematically searched for peer-reviewed studies published between January 2019 and April 2026. Empirical studies in English involving the use of AI, ML, DL or explainable AI (XAI) to diagnose ADHD with a sample size of greater than 100 individuals, and a control group (typically developing or healthy group) will be included. Two independent reviewers will screen the titles, abstracts and full texts, and any conflicts will either be resolved through discussion or through arbitration. A standardized template of Excel will be used to extract data that will include the following: bibliographic data, data modalities, data models, data validation approaches, performance metrics, and explainability approaches. Thematic and narrative analysis will be used to synthesize findings in four research questions that will address model performance, data modality contributions, data characteristics, and interpretability methods. Results: The results will be included in the scoping review, which began in December 2025. Analysis and screening is in progress, with the scoping review expected to be completed and submitted for publication in June 2026. Conclusions: This scoping review will provide the first comprehensive synthesis of AI-, ML-, and DL-based ADHD diagnostic classification studies, mapping the evidence across data modalities, validation practices, interpretability methods, and clinical translation readiness. Findings will inform future methodological standards and support the translation of AI-based diagnostic tools into clinical practice.

  • Background: Preschool children suffering from oral diseases have high levels of visible plaque is found on tooth surfaces signify the importance of oral hygiene maintenance for good oral health. Literature indicates that preschool children, specifically those aged 3 to 6 years, lack the fine motor skills and cognitive coordination required to perform effective plaque removal independently. Supervised Toothbrushing (STB), have demonstrated superior efficacy in reducing plaque scores and improving health. Older children will perform the task independently, But still they need assistance whereas younger children may need more support and supervision during brushing. Every month, children will participate in supervised toothbrushing programs where they brush their teeth at school using fluoridated toothpaste while being watched over by staff and peers. Despite the availability of various school health initiatives, the implementation of supervised brushing programmes in preschool settings is often limited. This paper presents the study protocol for newly introduced BrushYen Supervised Tooth Brushing Programme aims to promote ideal brushing technique, enhance children's motivation and establish consistent oral hygiene habits. However, there is limited evidence regarding its effectiveness among preschool children. Objective: To evaluate the reduction in plaque scores among preschool children at 1, 3, and 6 months following the implementation of the "Brushyen" program. And to assess the improvement in gingival health status at the same intervals. Another objective of the study is to determine the improvement in toothbrushing skills (dexterity) and parental awareness regarding oral hygiene. Methods: This study is a Quasi-experimental study. A total of 120 preschoolers studying in montessari of The Yenepoya school. The Monthly supervised toothbrushing sessions will be conducted post-lunch, where the BrushYen Champions will assist the teachers in monitoring the preschoolers. Clinical parameters will be recorded using the identical set of indices Visible Plaque Index, Modified Gingival Index, and Modified OHI-S to allow for a direct statistical comparison against baseline values, Participants will be followed up at 1, 3, and 6 months. Results: Enrollment started in June 2026. It is estimated that the enrollment period will be 12 months. Data collection is planned to be completed in 2027. Conclusions: The BrushYen Supervised Tooth Brushing Programme aims to promote ideal brushing technique, enhance children's motivation and establish consistent oral hygiene habits. However, there is limited evidence regarding its effectiveness among preschool children Clinical Trial: Trial Acknowledgement Number is: CTRI/2026/03/107144

  • Development And Feature Analysis of YenQuit App: A Smoking Cessation Tool Amongst Health Care Professional Students: Protocol for a cross-sectional study

    Date Submitted: Apr 21, 2026
    Open Peer Review Period: Apr 22, 2026 - Jun 17, 2026

    Background: Health care professional students represent as important target group for tobacco control interventions, as the behaviour established during their training years may influence both their future personal health practice and also their role in cessation counselling to patients. In recent years, mobile health (mHealth) has emerged as promising tool in tobacco cessation by providing accessible, personalized support, progress tracking and real time interventions. However, there is limited evidence on the specific design, personalized support. The Yenquit Application was developed based on 5As and 5Rs to address this gap by integrating user engagement feature aim to facilitate tobacco cessation. Objective: The objective of this study is to develop the YenQuit mobile/web-based application and aims to evaluate its features, effectiveness in promoting smoking cessation, and user engagement and experience among healthcare professional students. Methods: This study is a cross-sectional study. A total of 97 health care professional students that meet the inclusion criteria will have access to application, where they will fill the baseline questionnaire followed by Fagerström Test for Nicotine Dependence (FTND), Usage of application is monitored and end of 30 days of on boarding, the participants will fill the feedback on the effectiveness of the application. Results: : Enrollment started in March 2026. It is estimated that the enrollment period will be 12 months. Data collection is planned to be completed in 2027 Conclusions: The Yenquit mobile application is been developed as a user -friendly, evidence-based digital tool to support smoking cessation among health care professional students. By integrating behavioral counselling approach such as the 5As and 5Rs models, the application has the potential to enhance accessibility to cessation support in academic health settings. Further evaluation will provide insights into its effectiveness, user engagement, and acceptability as a mobile-based cessation intervention Clinical Trial: Trial Acknowledgement Number is: REF/2026/03/127126

  • Sex differences in the association of dietary pattern with type 2 diabetes mellitus: a systematic review protocol

    Date Submitted: Apr 21, 2026
    Open Peer Review Period: Apr 22, 2026 - Jun 17, 2026

    Background: Diabetes mellitus encompasses disorders characterized by hyperglycemia due to pancreatic B-cell dysfunction. Type 2 diabetes (T2D) constitutes over 90% of cases, on a background of genetic, metabolic, and environmental factors. Knowing that sex differences impact insulin resistance and glycemic control, this review aims to identify differences in adherence to dietary patterns between women and men with T2D. Objective: This systematic review aims to evaluate sex differences in dietary pattern adherence among individuals with type 2 diabetes and their implications for glycemic control. Methods: The protocol was developed using the Prepared Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Studies published until April 2026 will be identified by searching the following electronic databases: Medline, Scopus, Cochrane Library, and Web of Science. Three investigators will independently screen articles based on title and abstract, followed by a thorough analysis of selected full-text articles of interest. Articles on T2D and dietary pattern scores that include biological sex data will be included. The estimation of risk of bias will be performed using the Standard Quality Assessment Criteria for Evaluating Primary Research Papers from a Variety of Fields. In order to synthesize the results, a narrative analysis will be performed based on Grading of Recommendations Assessment, Development and Evaluation. Results: This study will synthesize available evidence on sex-specific differences in dietary adherence among individuals with T2D. It is anticipated that most included studies will report higher dietary pattern scores among women compared to men, suggesting greater adherence to dietary recommendations. Findings will be summarized descriptively, including study characteristics, sample sizes, and key outcomes related to dietary adherence and glycemic control. Conclusions: This systematic review will provide a comprehensive overview of the role of sex in dietary adherence among individuals with T2D. Identifying sex-specific differences may inform the development of tailored nutritional strategies and interventions aimed at improving glycemic outcomes. Ultimately, this work highlights the importance of incorporating sex-based approaches in the management of T2D to optimize long-term health outcomes. Clinical Trial: PROSPERO – CRD42024340213.

  • Navigating Fentanyl With the Community Use and Testing Study: A Cohort Study Protocol

    Date Submitted: Apr 21, 2026
    Open Peer Review Period: Apr 21, 2026 - Jun 16, 2026

    Background: The United States (U.S.) drug supply rapidly fluctuates, distinguished by synthetic substances such as illicitly manufactured fentanyl (IMF). IMF drives overdose risk and frustrates treatment induction and retention, leaving few options for patients with opioid use disorder and motivating adaptations to medications for opioid use disorder (MOUD) such as injectable formulations and dosing changes. A recent innovation that shows promise for addressing drug supply challenges and that is being implemented in state and local jurisdictions is community drug checking. Objective: The Community Use and Testing Study (CUTS) will inform how IMF’s presence, form, and potency in the illicit drug supply influence ongoing use, overdose risk, and clinical severity of health consequences; and how the presence of IMF and other novel substances in the drug supply impact MOUD treatment uptake and experiences. Methods: This prospective, observational community-based longitudinal study in Rhode Island, USA conducts repeated surveys with 600 people who use drugs, alongside community drug checking programming using both field- and laboratory-based testing. Results: This research was funded by the National Institute on Drug Abuse (UG3/UH3DA056881) in 2023 and is projected to end December 2027. Enrollment (N=600) was completed in March 2026 and data collection is scheduled to end in September 2027. Conclusions: Findings from CUTS will help inform prevention and intervention approaches to the drug supply in fentanyl endemic areas, determine engagement in and clinical utility of community drug checking, and help identify factors influencing poor MOUD treatment experience and retention.

  • Effects of two telerehabilitation programs on the health status of people with knee osteoarthritis: protocol for a randomized controlled trial

    Date Submitted: Apr 20, 2026
    Open Peer Review Period: Apr 21, 2026 - Jun 16, 2026

    Background: Knee osteoarthritis is a prevalent chronic condition associated with pain, functional limitations, and reduced quality of life. Exercise is the cornerstone of nonpharmacological management; however, long-term adherence to exercise programs remains challenging. Telerehabilitation has emerged as a promising strategy to improve access to supervised exercise, yet evidence comparing synchronous and asynchronous delivery formats, particularly in developing countries, is limited. This study protocol describes a randomized clinical trial designed to compare the effects of synchronous and asynchronous telerehabilitation exercise programs on pain, physical function, quality of life, and exercise adherence in individuals with knee osteoarthritis. Objective: Therefore, this study protocol describes a randomized clinical trial designed to evaluate the effects of two telerehabilitation exercise programs—synchronous (online) and asynchronous—on pain, functional capacity, and quality of life in individuals with knee osteoarthritis over a six-week intervention period. Methods: This single-center randomized clinical trial will include individuals aged 40–75 years with clinical and/or radiographic knee osteoarthritis. Participants will be randomly allocated to a synchronous or asynchronous telerehabilitation exercise program delivered over six weeks. Both groups will follow an identical, structured exercise protocol, differing only in delivery mode. Outcomes will be assessed at baseline and post-intervention. The primary outcome is pain and physical function. Secondary outcomes include quality of life, functional performance, and exercise adherence. The study protocol was adjusted following a preliminary feasibility study to optimize intervention delivery and monitoring procedures. Results: This study did not receive specific funding. The authors received individual scholarships and research support from CAPES and FUNDECT. Data collection began in August 2024, and by October 2025, a total of 30 participants had been recruited. Data analysis is currently ongoing. Manuscript preparation is expected to begin in May 2026, with submission planned for December 2026. Conclusions: This trial will provide evidence regarding the feasibility, adherence, and potential effectiveness of different telerehabilitation delivery formats for individuals with knee osteoarthritis. Findings may inform the development of accessible, low-cost rehabilitation strategies in settings with limited access to in-person care. Clinical Trial: Brazilian Registry of Clinical Trials (REBEC): RBR-3kzr42p; https://ensaiosclinicos.gov.br/rg/RBR-3kzr42p

  • ADHD Pharmacotherapy in the Context of Coexisting Eating Disorders: A Scoping Review Protocol

    Date Submitted: Apr 17, 2026
    Open Peer Review Period: Apr 21, 2026 - Jun 16, 2026

    Background: Eating disorders (EDs) and attention-deficit/hyperactivity disorder (ADHD) co-occur at rates substantially exceeding chance, potentially due to shared neurodevelopmental, genetic, and reward-processing mechanisms. Despite growing clinical recognition of this overlap, no comprehensive synthesis of the effects of ADHD pharmacotherapy on ED outcomes in individuals with co-occurring ADHD and EDs currently exists. Clinicians prescribing ADHD medications to this population must balance potential risks, including appetite suppression, weight loss, and misuse, against possible benefits, including improved impulse control, improved engagement in ED treatment, and reduced binge-eating frequency, all in the absence of astructured evidence base to draw upon. Objective: This scoping review aims to: (1) map existing evidence on the effects of ADHD pharmacotherapy on ED symptom outcomes in individuals with co-occurring ADHD and EDs; (2) characterise the safety and tolerability profile of ADHD medications in this population; (3) describe the range of study designs, populations, medication types, and outcome measures re- ported in the literature; and (4) identify key methodological gaps to inform future research priorities. Methods: The review will follow the PRISMA Extension for Scoping Reviews methodology. Eligible studies will include individuals with a formal diagnosis of ADHD or clinically significant ADHD symptoms, alongside a diagnosed ED or clinically significant ED pathology, across all ED diagnoses and age groups. Any pharmacological agent approved or used off-label for ADHD, including stimulants and non-stimulants, will be eligible as the primary intervention. All study designs will be included, from randomised controlled trials to case reports, consistent with the anticipated sparsity of controlled trial data in this population. Seven electronic databases will be searched (MEDLINE, Embase, PsycINFO, PubMed, CENTRAL, Web of Science, SCOPUS), alongside trial registries and manual searches. Title/abstract and full-text screening will be conducted independently by two reviewers, with discrepancies resolved by a senior reviewer. Findings will be synthesised narratively, structured by population group, medication class, and outcome domain. Results: Ethics & Dissemination Ethical approval is not required as this review involves secondary analysis of publicly available data. Findings will be disseminated via peer-reviewed publication and are intended to inform prescribing practice, highlight evidence gaps, and provide a foundation for future controlled research at the intersection of ADHD and EDs. Conclusions: Ethics & Dissemination: Ethical approval is not required as this review involves secondary analysis of publicly available data. Findings will be disseminated via peer-reviewed publication and are intended to inform prescribing practice, highlight evidence gaps, and provide a foundation for future controlled research at the intersection of ADHD and EDs.

  • Determinants of Post-Injury Employment Trajectories Among Nurses Aged 50 and Over: A Life‑Story Mixed‑Methods Study Protocol

    Date Submitted: Apr 17, 2026
    Open Peer Review Period: Apr 21, 2026 - Jun 16, 2026

    Background: Workforce aging is accelerating, particularly among women aged 50 and over. In the healthcare sector, older nurses face increased exposure to occupational injuries, including musculoskeletal disorders and burnout, which may result in work disability. Following an occupational injury, nurses must navigate complex decisions involving return to work or retirement. These decisions occur within interacting personal, organizational, healthcare, and compensation systems. The determinants of these post-injury employment trajectories remain insufficiently documented, which limits the development of targeted interventions to support reintegration in employment or retirement transitions. Objective: This study aims to identify the factors that influence employment trajectories of nurses aged 50 and over following an occupational injury. Methods: This study uses a two-stage qualitative design. Stage 1 consists of a life‑story study based on semi‑structured interviews with approximately 20 nurses aged 50 and over who have experienced an occupational injury. Interviews will explore factors related to the worker, the work environment, the healthcare system, and the compensation system. Data will be analyzed using thematic analysis. This stage will generate preliminary recommendations to support return to work or transition to retirement. Stage 2 consists of a nominal group process to validate and refine these recommendations. Four nominal groups will be formed, each including four participants representing nurses, healthcare professionals, employer representatives, and insurer representatives. Participants will assess the relevance, clarity, and completeness of the recommendations. Data will be analyzed using descriptive statistics and qualitative content analysis. Results: Participant recruitment and data collection began in September 2025 and are expected to continue until October 2026. Conclusions: This study will identify key facilitators and barriers shaping post-injury employment trajectories of nurses aged 50 and over. The findings will inform actionable recommendations to support sustainable return to work or structured transition to retirement in this growing segment of the healthcare workforce.

  • Background: Despite significant advancements in HIV care, all components of the care continuum from diagnosis to antiretroviral treatment (ART) uptake and sustained virologic suppression (VS) are worse for adolescents and young adults with HIV (AHIV) (ages 12-30). ART adherence remains elusive for ≈60% of AHIV, impeding the goal of the Ending the HIV Epidemic in the United States Initiative (EHE). Even when AHIV are suppressed, medication fatigue and other factors threaten sustained virologic control. Long-acting injectable ART (LAI-ART) has the potential to improve the care continuum for AHIV. Objective: The Strategies to Achieve Viral Suppression for Youth with HIV Study (SAVVY) aims to evaluate the impact and implementation of an informed choice-counseling intervention on ART options, including its impact on intervention acceptability, participants’ ART selection and later facilitated access, and the clinical outcome of VS rates among AHIV. We also aim to assess determinants influencing LAI-ART implementation outcomes, guided by the Consolidated Framework for Implementation Research. Methods: SAVVY is a preference-guided, observational, type-1 effectiveness implementation study, investigating the efficacy of precision engagement approaches to patient counselling on options for ART that are approved for patients with viral load (VL) <50 copies/mL. Patients eligible for enrollment are AHIV (ages 12-30) engaged in clinical care and prescribed ART (N=288). All participants undergo CHOICE counseling (CC), where they are presented with and decide on their preferred ART options (oral ART [oART] or LAI-ART) using a computer-assisted precision engagement tool (HIV-ASSIST). The SAVVY LAI-ART Access Team facilitates [EW1.1][EO1.2]access and logistics for those who qualify for and choose LAI-ART. At entry, enrollees are divided into two cohorts: those with HIV RNA PCR VL ≥50 copies/mL (Cohort 1a) and those with VL <50 copies/mL (Cohort 1b). Cohort 1a participants are informed of VL requirements to qualify for LAI-ART, receive supportive messages and biweekly VL measurements [EW2.1][EW2.2]for three months, and are re-offered CC upon achieving VL<50 copies/mL. Enrollees with persistent VL ≥50 copies/mL at 3 months continue standard oART with the option of referral for LAI-ART once VL is <50 copies/mL. Cohort 1b participants undergo CC and can proceed to LAI-ART or maintain oART. The primary outcome is VS (VL<20 copies/mL), comparing the oART and LAI-ART groups. SAVVY is JHU IRB-approved and registered on clinicaltrials.gov (NCT06886971). The first participant was enrolled in November 2024 with full accrual anticipated in 36 months. Results: n/a Conclusions: SAVVY represents a pragmatic, feasible implementation strategy towards informed, personalized ART decision-making among AHIV, which could expand access to beneficial novel technologies. It aims to use the proven approach of youth-centered care, where treatment choices are self-driven by youth, to improve LAI-ART uptake and persistence[EW3.1], increase VS, and improve overall outcomes for AHIV.

  • Background: Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by limited and repetitive behaviors and disturbances in social communication and interactions. Currently, there is no fundamental treatment for ASD, with only a few medications available for use on a limited basis to manage concomitant neuropsychiatric symptoms. The primary therapeutic goal of such treatments is to alleviate symptoms while maximizing the functional independence and quality of life of affected individuals. Many complementary and alternative medicine (CAM) therapies have been reported to have effects on ASD symptoms; however, evidence is insufficient to confirm their clinical effectiveness. Acupuncture has traditionally been used as a complementary intervention to manage various neurological and neuropsychiatric diseases, including ASD, in East Asia. However, how acupuncture stimulation modulates neural activity at the macroscale level in individuals with ASD remains largely unknown. Objective: This study aims to elucidate the acute neural mechanisms underlying acupuncture stimulation in patients with autism spectrum disorder (ASD) and typically developing individuals using a multimodal neuroimaging approach. Methods: This study was designed as a randomized placebo-controlled trial. Seventy participants, including individuals with ASD (n=35) and typically developing (TD) controls (n=35), will be randomly assigned to either the verum or sham acupuncture group. The verum acupuncture group will receive stimulation at specific acupoints clinically indicated for ASD and gain a deqi sensation. The sham acupuncture group will receive superficial needling at non-acupoints unrelated to the ASD symptoms. Each group will undergo clinical assessments and multimodal neuroimaging measurements, including functional near-infrared spectroscopy (fNIRS) and electroencephalography (EEG), before and after acupuncture stimulation. The primary outcomes include differences in resting brain connectivity, network metrics, and power spectrum densities associated with disease status, as well as changes in these neural markers following acupuncture stimulation between the two groups. Secondary outcomes will focus on identifying neural markers and specific brain regions that correlate with clinical indicators of autism spectrum disorder. Results: Recruitment began in April 2025. To date, 20 ASD and 12 TD individuals have participated in this study. The recruitment process is expected to continue until December 2026. Conclusions: ASD presents a significant socioeconomic burden, with no definitive treatment established to date. Although acupuncture is a widely applied intervention for various neurological conditions, including ASD, its macroscale neural mechanisms remain poorly understood. By employing multimodal neuroimaging, the present study aims to elucidate the immediate neural substrates underlying acupuncture stimulation in patients with ASD. These findings should provide a robust neurobiological foundation for future longitudinal research and development of evidence-based integrative treatment strategies. Clinical Trial: Clinical Research Information Service of the Republic of Korea (CRIS), one of the WHO ICTRP Primary Registries; KCT0010437 (https://cris.nih.go.kr/cris/search/detailSearch.do/31192)

  • Creating Pathways for Change to Increase Modern Contraceptive Uptake in Rural Indonesia: Protocol for a Feminist Qualitative Study

    Date Submitted: Apr 10, 2026
    Open Peer Review Period: Apr 10, 2026 - Jun 5, 2026

    Background: Family planning program has been globally shown to reduce maternal mortality by reducing both total and high-risk pregnancies. Despite the national implementation of this program since the 1970s, Indonesia still faces many challenges in achieving family planning goals. Low modern contraceptive prevalence rate (mCPR) remains a problem that impacts public health, population growth, economy, and welfare issues. It should be tackled, especially in rural areas, with multifactorial causes and diverse needs. Various programs have been developed globally to overcome this problem; however, each region has different characteristics and demands that should be understood. Objective: This study aims to develop a theory of change by understanding rural women’s needs and actively collaborating with multiple participant groups to increase modern contraceptive uptake. The theory of change will also be informed by the views of four distinct stakeholders who is responsible for providing contraceptive services (i.e. policy makers at regency and provincial level) in order to make informed recommendations. Methods: This feminist qualitative study embedding participatory action research principles adapts the first three steps of the six essential steps for quality intervention development. The target location is West Sumba Regency, one of Indonesia’s 100 lowest mCPR regencies and located in East Nusa Tenggara, which has the highest total fertility rate in Indonesia. Consisting of two rounds of data collection, this study includes different participant groups (i.e. rural women and men, mothers-in-law, religious figures, cultural leaders, midwives, family planning educators, and policymakers) with different strategies. To ensure data saturation and trustworthiness, we aim to recruit up to 45 participants through purposeful sampling, selecting participants based on the criteria for each group. The data collection methods are focus groups and semi-structured interviews. We will analyze the data using reflexive thematic analysis. Results: The theory of change development focuses on women’s voices and incorporates various perspectives from rural communities, including the service providers and policymakers. Ethics approval has been obtained by the College of Medical, Veterinary, and Life Sciences (MVLS) Research Ethics Committee, University of Glasgow, UK, and the Public Health Faculty, University of Nusa Cendana, Indonesia. We anticipate that we will complete all data collections and analysis by December 2026. Conclusions: The ultimate goal of this study is to develop a theory of change to create a meaningful change in contraceptive services in rural areas. This study will contribute to encourage rural communities to collaborate and empower rural women to overcome their reproductive health problems. By understanding the diverse contexts and specific needs of the rural population, the results will be essential to transforming family planning programs. In doing so, it will significantly enhance women’s reproductive health while also addressing and reducing health inequalities in rural areas.

  • Background: Bone invasion in Oral Squamous Cell Carcinoma (OSCC) is a significant prognostic variable whose association with other important histopathological variables like Depth of Invasion (DOI) and Worst Pattern of Invasion (WPOI) has not been carefully examined. DOI is implemented in exsisting staging systems, and WPOI is acknowledged to predict tumor aggressiveness. Limited literature has been conducted to determine their collaborative relationship with bone involvement. Understanding these correlations will enhance histopathological assessment, which leads to better clinical decisions. Objective: This study will help to assess the presence of bone invasion in OSCC patients. It will also help in determining DOI and WPOI. Further, a comparative study will be carried out between the occurrence and degree of bone invasion with DOI and WPOI in OSCC patients. Methods: Histopathologically confirmed 80 cases of OSCC, which have been through surgical resection, will be included in this observational study. DOI will be evaluated based on hematoxylin and eosin-stained sections using standardized guidelines. WPOI will be measured in types 1-5 according to the set criteria and will be graded accordingly. Bone invasion will be evaluated histopathologically following decalcification, which will be categorized as either present or absent. Statistical tests will include chi-square analysis and logistic regression to establish the relationship between DOI, WPOI and bone invasion. Results: It is expected that the increased values of DOI and improved grades of WPOI (Types 4 and 5) will have a strong correlation with bone invasion. The cases exhibiting infiltrative patterns of invasion and a deeper depth of the tumor are likely to show more aggressive biological behavior and more chance of bone infiltration. These findings are expected to support the use of DOI, WPOI and bone invasion as predictive markers in OSCC. By March 6, 2026 data of 50 patients are collected, and the remaining 30 patient’s data will be collected during the study. Conclusions: It is anticipated that the study will emphasize the importance of DOI and WPOI evaluation and assessment of bone invasion to increase accuracy and prognosis in OSCC cases. Establishing significant correlations between these parameters can lead to better histopathological assessment and improved treatment planning, leading to better patient outcomes. Clinical Trial: not required

  • Menstrual Cycle Phase, Hamstrings-to-Quadriceps Ratio, and Injury Risk Markers: Protocol for a Repeated-Measures Study in Physically Active Women

    Date Submitted: Apr 6, 2026
    Open Peer Review Period: Apr 6, 2026 - Jun 1, 2026

    Background: The relationship between female physical performance and menstrual cycle (MC) phases is widely discussed in applied sports science and clinical kinesiology. However, current evidence remains inconsistent, particularly regarding muscle strength and biomechanical risk factors for injury. Objective: This study aims to examine the relationship between MC phases and lower limb injury risk factors, with a particular focus on the hamstrings-to-quadriceps strength ratio (H/Q ratio). Methods: Following an initial session, participants will monitor their MC over 3 months using a mobile application, urinary ovulation tests, and self-reported symptoms, while also recording perceived readiness for physical activity. Each participant will then complete two laboratory assessments: the early follicular phase (days 1–3 of menstrual bleeding) and the peri-ovulatory phase. Testing will include isokinetic strength assessment, evaluation of muscle–tendon mechanical properties, and body composition analysis. Results: Recruitment will begin in June 2026. A total of 32 participants will be enrolled in two waves (June–July 2026 and June–July 2027). Preliminary results are expected by 06/2028. Conclusions: This study may improve understanding of MC–related changes in neuromuscular function and support individualized, non-invasive approaches to training and injury prevention in women. Associating objectively estimated MC phases with a mobile application, urinary ovulation tests and subjective perceptions of performance will provide insights into the agreement between perceived and physiological indicators of performance readiness. Clinical Trial: NCT07462286

  • Background: Asymptomatic bacteriuria (ASB) has been associated with preterm birth and pyelonephritis, and until recently, screening for ASB was recommended for all women in first trimester of pregnancy. Recent divergence between NICE guidelines (which do not recommend routine screening) and NHS initiatives such as the Saving Babies’ Lives Care Bundle (which recommends screening in high-risk women) may have led to inconsistencies in UK clinical practice. Objective: To describe the protocol for a national multicentre study evaluating variation in ASB screening practices across UK maternity units and examining associated maternal and neonatal outcomes. Methods: The TU(L)IPS study is a national, multicentre observational study conducted through the UK Audit and Research Collaborative in Obstetrics and Gynaecology (UKARCOG) network. The study comprises two components: (1) a structured survey of UK maternity units to characterise local ASB screening guidelines and practices, and (2) a retrospective cohort study using routinely collected clinical data to assess adherence to local and national guidance and to describe maternal and neonatal outcomes. Participating sites contribute data via a standardised REDCap-based data collection platform using predefined variables and harmonised outcome definitions. Analyses will be descriptive, including frequencies and proportions, with comparisons stratified by screening status, urine culture result categories, and preterm birth risk groups. Results: The study was launched nationally in January 2025. Recruitment closed with 28 NHS Trusts participating across the United Kingdom. Stage 1 data collection was completed in December 2025. Stage 2 data collection is scheduled to conclude in March 2026, with the database lock planned for March 2026. Data cleaning and analysis will commence following the database lock. The anticipated study completion date is May 2026. Conclusions: This study will provide a comprehensive national evaluation of variation in ASB screening practices and associated outcomes in pregnancy. By using a standardised, protocolised approach across multiple sites, the TU(L)IPS study aims to generate contemporary evidence to inform clinical practice and national policy.

  • Background: Renal fibrosis is the final common pathway of chronic kidney disease progression and a critical histological predictor of renal function decline and allograft failure. Routine clinical monitoring with estimated glomerular filtration rate (eGFR) and albuminuria is insensitive to the development of fibrosis. Renal biopsy is invasive, which limits repeated assessment and suffers from sampling bias. Consequently, non-invasive imaging biomarkers that can accurately quantify fibrosis, monitor disease progression, and predict outcomes are highly desirable. Multiparametric magnetic resonance imaging (mpMRI) offers extensive characterization of renal structural and functional properties. Previous work has indicated that MRI measures are associated with fibrosis development and with declining renal function. However, there remains a sparsity of longitudinal data and comprehensive validation of MRI measures against histology and measured glomerular filtration rate (mGFR). Objective: Our ongoing longitudinal study aims to validate mpMRI against reference standard kidney biopsy in kidney transplant recipients (KTR) and to compare the time-dependent trajectories of imaging and functional markers across living kidney donors (LKD), KTR and healthy control (HC) cohorts to assess their prognostic value for mGFR decline. Methods: Participants: 32 living kidney donors (LKD), 32 KTR, and 32 healthy controls (HC). Inclusion criteria: LKD and KTR who have been approved for transplant. HC must show no evidence of renal disease and have normal blood pressure. Exclusion criteria: Contraindications to MRI or severe claustrophobia. Time points: Baseline investigations prior to transplant surgery, with follow-up assessments at 3-, 12-, and 24-months post-transplant. Data collection: mpMRI is performed at 3T. The MRI protocol includes structural T1-weighted and T2-weighted imaging, T1 mapping, T2 mapping, T2* mapping, DWI, pseudo-continuous ASL, non-contrast-enhanced angiography, and phase-contrast measurement of renal artery flow. Glomerular filtration rate will be measured by [99mTc]Tc-DTPA clearance. A baseline allograft biopsy is performed in all KTR during the transplantation surgery. Subsequent protocol biopsies are planned at 3, 12, and 24 months in KTR. Extent of fibrosis is quantified using quantitative stereology. Primary outcome: Longitudinal association between quantitative MRI measures and histologically determined renal fibrosis. Secondary outcomes: Longitudinal divergence of MRI and functional markers across cohorts; diagnostic performance for fibrosis; and predictive value for mGFR decline in KTR and LKD. Linear mixed models will be used to study longitudinal associations. Receiver operating characteristic curve analysis will assess diagnostic performance. Results: Recruitment for the MPRENAL study commenced in November 2024. As of March 2026, enrolment is ongoing with 42 participants recruited. Full data analysis and results are projected for December 2029. Conclusions: Successful completion of this study is expected to provide robust histological validation of mpMRI and establish its utility as a non-invasive tool for monitoring renal health. Clinical Trial: ClinicalTrials.gov NCT06210555; https://clinicaltrials.gov/ct2/show/NCT06210555

  • Background: Osteoporotic vertebral fractures are a leading cause of pain, disability, and reduced quality of life in the elderly population. Although vertebroplasty is widely used to relieve pain and stabilize fractures, postoperative rehabilitation remains suboptimal, with limited functional recovery. Seated Baduanjin, a modified form of traditional Baduanjin exercise tailored for frail elderly patients, has been successfully applied in the rehabilitation of knee osteoarthritis, cervical spondylosis, and sarcopenia. However, its application in patients after vertebroplasty has not yet been systematically synthesized. Objective: This systematic review and meta-analysis aims to evaluate the efficacy and safety of seated Baduanjin exercise compared with usual care in terms of pain, physical function, and quality of life among elderly patients with osteoporotic vertebral fractures following vertebroplasty. Methods: This protocol has been registered in PROSPERO (CRD420261344980). We will search PubMed, Cochrane Library, EMBASE, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang Data, and VIP Database from inception to July 2026, with no language or date restrictions. Only randomized controlled trials evaluating seated Baduanjin in elderly patients (aged ≥60 years) after vertebroplasty will be included. Two reviewers will independently screen the literature, extract data, assess the risk of bias using the Cochrane RoB 2.0 tool, and evaluate the quality of evidence using the GRADE system. The primary outcome is pain intensity. Secondary outcomes include physical function, quality of life, and balance function. Meta-analysis will be performed using RevMan 5.4. Heterogeneity will be assessed using the I² statistic and Cochran’s Q test: a fixed-effects model will be used when I² < 50% and P ≥ 0.1; if I² ≥ 50% or P < 0.1, subgroup analyses will be conducted. If heterogeneity persists, sensitivity analyses or exploratory subgroup analyses will be performed. Should the heterogeneity remain unexplained, a random-effects model will be adopted, and the GRADE evidence level will be downgraded. Results: As of January 2026, the preliminary screening of titles and abstracts for 241 studies has been completed. Full-text screening is expected to be finalized by May 2026, and data analysis is planned for completion by August 2026. Approximately two-thirds of the relevant studies have been published since 2020. In terms of geographic distribution, the study samples are highly concentrated in Asia. The results will be comprehensively presented around the core outcomes: the primary outcome will be presented as changes in the Visual Analogue Scale (VAS). Secondary outcomes will be assessed using physical function measures such as the Oswestry Disability Index and quality of life scales such as the SF-36 and EQ-5D. The pooled effect sizes with 95% confidence intervals for the corresponding outcome measures will be reported. Additionally, the incidence of adverse events will be statistically analyzed. Conclusions: If the findings of this study confirm the efficacy and safety of seated Baduanjin exercise, it may provide a viable approach for non-pharmacological rehabilitation in elderly patients following vertebroplasty. However, some studies may have a risk of bias, such as insufficient standardization of intervention protocols and difficulty in implementing blinding. Due to variations in intervention protocols, outcome measures, and patient cultural backgrounds, substantial heterogeneity is anticipated. Moreover, the limited number of available original randomized controlled trials and the high geographic concentration of the study samples may restrict the generalizability of the conclusions. Future research should focus on optimizing intervention protocols and supplementing the evidence with high-quality, multicenter, large-sample randomized controlled trials to enhance the reliability of the findings. PROSPERO registration number: CRD 420261344980 Clinical Trial: This systematic review protocol was developed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA-P) guidelines. It has been registered on the International Prospective Register of Systematic Reviews (PROSPERO) platform (CRD420261344980). Any methodological changes during the research process will be recorded and updated in the PROSPERO record.

  • Background: Chronic pain is a leading cause of disability and requires multidimensional assessment of pain intensity and functioning, yet electronic health records (EHRs) rarely capture these measures systematically. By contrast, surveys collecting patient-reported outcomes can assess pain over multiple dimensions but remain resource-intensive and difficult to scale for continuous population-level monitoring. Objective: The objective of this study is to develop and validate a domain-informed natural language processing (NLP) framework to derive pain severity and functional interference outcomes from unstructured clinical narratives. Using a benchmark dataset of 3,726 Veterans with longitudinal survey measures, we aim to demonstrate that NLP-derived outcomes can serve as a reliable, scalable surrogate for resource-intensive patient-reported surveys. Methods: This study utilizes a retrospective cohort of 3,726 Veterans with chronic musculoskeletal pain initiating Complementary and Integrative Health (CIH) therapies across 18 Veterans Health Administration (VA) Whole Health Flagship sites (2021–2023). The dataset encompasses longitudinal patient-reported outcome surveys serving as the benchmark, linked with both structured and unstructured data from the VA EHR. To guide extraction and enable scalable processing, we developed a seed lexicon and annotation guidelines based on established psychometric instruments and input from subject matter experts (SMEs). Currently, SMEs are annotating clinical notes in iterative batches. Upon completion, a large language model (LLM) will annotate additional notes. These annotations will be used to fine-tune a lightweight language model capable of processing the entire cohort. The study employs a three-stage validation process, assessing: (1) documentation completeness; (2) inference accuracy, evaluating agreement between model outputs and SME annotations at both the LLM and fine-tuned model levels; and (3) concordance with patient-reported outcomes captured independently from the EHR. Results: To date, a cohort of 3,726 Veterans has been identified. The longitudinal survey data have been linked to clinical notes corresponding to the survey time period. The seed lexicon and annotation guidelines have been developed. Annotation is underway in iterative batches to drive the subsequent LLM adaptation and three-stage validation. Conclusions: This protocol outlines a framework for identifying severe pain interference from clinical narratives, addressing a critical gap in health care system surveillance. To our knowledge, this is the first study to validate clinical text-based pain outcome extraction against patient-reported outcomes in a nationwide longitudinal cohort. If successful, this approach will enable health care systems to continuously monitor pain-related functional interference and support more holistic, patient-centered pain management at scale.

  • Background: Post-acute intervention is pivotal to preventing functional disability among stroke patients. Nurse-led rehabilitation intervention can be an effective way to improve functional ability and reintegration into society of post-stroke patients. Objective: This study aims to evaluate the effectiveness of a structured nurse-led multidisciplinary post-acute rehabilitation program to improve the self-care functional disability among stroke patients. Methods: This is a parallel (1:1), open-label, prospective randomized controlled trial that has been conducted at the National Institute of Neurosciences and Hospital (NINS&H), Dhaka, Bangladesh. We include participants who are 18 years old and above, both males and females, regardless of stroke type or time, modified Rankin Scale (mRS) 2-4 with disability on upper and/or lower limb(s), physician advice for rehabilitation, require assistive devices for activities of daily living (ADL), possess a smartphone, and are willing to provide consent and participate in the study. We exclude individuals who are involved in other clinical trials, those planning to undertake institutional rehabilitation services, and those with communication difficulties (speech impairments). The intervention group receives rehabilitative education, assistive devices, and teleservices for biweekly follow-up after hospital discharge. The control group receives usual discharge education and advice on routine follow-up at discharge. The primary outcome measures functional independence after 6 months of rehabilitation. Secondary outcomes include the evaluation of 1) rehabilitation adherence, 2) motor function, 3) self-efficacy, 4) emotional status, and 5) activity participation of post-stroke disabled patients after 6 months of rehabilitation. Researchers evaluate patients at baseline, at midline after 3 months, and at endline after 6 months of intervention. Results: The patient's enrolment started in February 2026, and follow-up will be completed in October 2026. A total of 166 patients will be recruited in the intervention (n = 83) and control (n = 83) groups. This study was approved by the institutional review board of NINS&H, Dhaka, Bangladesh, on January 18, 2026. Conclusions: The results can contribute to a scalable, culturally appropriate nurse-led rehabilitation intervention to ensure smooth post-stroke daily living activities with disabilities. Clinical Trial: ClinicalTrials.gov NCT07384650; https://clinicaltrials.gov/search?id= NCT07384650

  • Association between cardiovascular disease and cataract: A protocol for systematic review and meta-analysis

    Date Submitted: Mar 29, 2026
    Open Peer Review Period: Mar 29, 2026 - May 29, 2026

    Background: Emerging evidence suggests shared pathophysiological mechanisms between cataracts and cardiovascular disease (CVD), indicating a potential link between these two prevalent non-communicable diseases. Oxidative stress, resulting from an imbalance between reactive oxygen species production and the body's antioxidant defenses, contributes to lens protein aggregation in cataracts and lipid oxidation in atherosclerosis, a key feature of several CVD subtypes. This shared pathophysiology implies that systemic vascular health may influence cataractogenesis. However, the epidemiological evidence supporting this relationship remains inconclusive. Objective: The main objective of this systematic review aims to synthesize existing evidence on the risk of developing cataracts in adults with underlying CVD. Methods: This systematic review follows the guidelines outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and its extension for protocols (PRISMA-P) guidelines. Using the Population, Exposure, Comparator, Outcome (PECO) framework, this review attempts to identify the association between established CVD and the risk of cataract development or the need for cataract surgery. Systematic literature searches are conducted in PubMed, Scopus, Web of Science, and Embase using Medical Subject Headings terms, from database inception to 31 December 2024. Original research articles involving adults (≥18 years) that assess the statistical relationship between CVD and cataracts are included. Two independent reviewers screen studies, extract data, and appraise studies’ quality using the Newcastle-Ottawa Scale. Meta-analyses are conducted using random-effects models to calculate pooled effect estimates, with heterogeneity assessed using the I² statistic. Results: By October 2025, the systematic review had been successfully completed in accordance with PRISMA guidelines. Comprehensive database searches identified relevant studies examining the association between cardiovascular disease (CVD) and cataract development or the need for cataract surgery. Conclusions: This systematic review provides a consolidated and up-to-date evaluation of the relationship between CVD and cataracts. The findings highlight the potential importance of integrating cardiovascular risk assessment into routine ophthalmologic care. Continued refinement of study methodologies and standardisation of outcome measures are needed to address observed heterogeneity and strengthen future evidence, ultimately supporting more holistic management of patients with coexisting cardiovascular and ocular conditions. Clinical Trial: This systematic review has been registered with PROSPERO (CRD42025629907) and the Ministry of Health Malaysia (NMRR ID-24-03414-99G).

  • Background: Antimicrobial resistance (AMR) poses a growing and serious threat to patient safety worldwide. Nurses, as the largest professional group in the global health workforce, play a central role in antimicrobial management. However, their contributions to antimicrobial stewardship (AMS) programmes remain poorly characterised and inconsistently measured. To date, no systematic review has combined a meta-analysis of the clinical effectiveness of nurse-led or nurse-involved AMS interventions with an implementation-focused synthesis to inform policy, practice, or future research. This gap is particularly relevant for the Gulf Cooperation Council and the Middle East and North Africa (GCC/MENA) healthcare systems, where the burden of AMR is high, and evidence of nursing contributions to AMS is limited. Objective: This protocol describes a convergent, parallel-streams mixed-methods systematic review to determine: (1) the effectiveness of nurse-led or nurse-involved antimicrobial stewardship (AMS) interventions on patient and antimicrobial outcomes in hospital and primary care settings globally; (2) the barriers and facilitators to implementing nurse-led AMS interventions or programmes; and (3) synthesis GCC/MENA evidence via sub-group analysis Methods: The review will follow the JBI convergent, parallel-streams mixed-methods methodology. Eleven databases will be searched from January 2000 to April 2026. The review will include primary research comprising: (1) quantitative studies (Stream 1), including randomised controlled trials, quasi-experimental studies, interrupted time series, and controlled before-and-after studies reporting clinical or process outcomes of nurse-led or nurse-involved AMS interventions. Where appropriate, meta-analysis will be conducted using a random-effects model. Outcomes will include antibiotic consumption, prescribing appropriateness, mortality, hospital length of stay, time to first antibiotic dose, and blood culture collection rates. (2) qualitative studies (Stream 2), which will be synthesised using thematic analysis guided by the Consolidated Framework for Implementation Research (CFIR 2.0) to identify barriers and facilitators of implementation. Findings from both streams will be integrated using a convergent joint display. Eight pre-specified subgroup analyses are planned, including comparisons between GCC/MENA countries and the rest of the world, and between intensive care and general ward settings. The certainty of evidence for quantitative outcomes will be assessed using GRADE. The review is registered with PROSPERO (CRD420261341653). Results: The protocol was registered with PROSPERO. Database searches are scheduled to commence in April 2026. Full-text screening is expected to be completed by June 2026, with data extraction and synthesis anticipated by October 2026. The completed systematic review to be submitted for publication in January 2027. Conclusions: This review will provide the first meta-analytic synthesis of the clinical effectiveness of nurse-led AMS, alongside a structured implementation analysis using CFIR 2.0. The findings will inform antimicrobial stewardship programme design, nursing education, and health policy, with particular relevance for GCC/MENA healthcare systems. Clinical Trial: PROSPERO: CRD420261341653; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=1341653

  • Check, Monitor, Control Hypertension in Older African American Adults (#Check, Monitor, Control): Protocol for a Randomized Clinical Trial

    Date Submitted: Mar 26, 2026
    Open Peer Review Period: Mar 27, 2026 - May 22, 2026

    Background: African Americans (AAs) experience higher rates of hypertension (HTN) and related cardiovascular and stroke mortality compared with the general U.S. population. Interestingly, studies have shown that AAs take more antihypertensive medications but are less likely to adhere to the prescribed medication regimens compared to the general population. Additionally, participants in qualitative studies have expressed that HTN self-management, particularly lifestyle modifications, should receive more attention than increasing medications. Objective: The objectives of this study are: 1) to evaluate the synergistic effect of a pharmacist and community health worker (Pharm+CHW) intervention compared to a Pharmacist alone (Pharm control group) to improve blood pressure (BP) control in a predominantly AA cohort aged ≥ 55 years in a prospective randomized trial (n=480); 2) to identify factors correlated with clinical BP outcomes. Methods: This is a randomized clinical trial to investigate novel behavioral intervention strategies targeting HTN self-management (e.g., medication management, blood pressure monitoring) and lifestyle modifications. The study has two components: a pharmacist-led medication management component (Pharm) and a community health worker support component (CHW). In the Pharm component, pharmacists will provide virtual Medication Therapy Management (MTM) services, which include: a comprehensive medication review, recommendations for lifestyle modifications, blood pressure self-monitoring education, and medication management app education. In the CHW component, CHW will support participants’ self-initiation of behavioral change(s), address challenges to lifestyle modification, and provide health education through workshops. The study intervention will be guided by a Community Advisory Board (CAB) consisting of six members. The study will recruit a cohort of 480 predominantly AA adults 55 years or older with HTN through community-and faith-based organizations and clinics in Houston, Texas, U.S. Participants will be prospectively randomized to one of the two parallel groups: 1) Pharmacist alone (control group; n=240); or 2) Pharmacist and CHW interventions (Pharm+CHW; n=240) for 24 months. Computer-generated randomization, with 1:1 allocation stratified by age, recruitment site, and HTN stage, will be applied. The primary self-monitoring BP outcome will be measured at 0-, 6-, 12-, 18-, and 24-months to evaluate the effectiveness of the proposed interventions. The secondary outcomes will include medication adherence, hypertension knowledge, perceived competency, body mass index, and physical activity. Results: The study was funded by the National Institute on Minority Health and Health Disparities of the National Institutes of Health under award number 2U54MD007605 in September 2025. The CAB has convened and offered support for recruitment efforts. Recruitment is ongoing, and the intervention is expected to begin in summer 2026. Conclusions: This project will fill an important knowledge gap regarding the synergistic effect of CHWs working in collaboration with pharmacists to help older adults use technologies (e.g., virtual visits, mobile medication management apps) and initiate lifestyle modifications for HTN self-management in older adult AAs. Clinical Trial: NCT07413159

  • Imaging-Confirmed Epidemiology of Age-Related Macular Degeneration in Rural Central India: A Hospital-Based Cross-Sectional Study Protocol

    Date Submitted: Mar 18, 2026
    Open Peer Review Period: Mar 25, 2026 - May 20, 2026

    Background: Age-related macular degeneration (AMD) is the leading cause of irreversible central vision loss in adults aged 50 years and above. In rural India, its true burden remains substantially underestimated because prior prevalence data relied exclusively on fundoscopy, without confirmatory imaging. The Central India Eye and Medical Study (CIEMS, 2011) reported early AMD in 8.3% of adults aged 60 years and above in rural Wardha, yet no subsequent OCT- or FFA-confirmed estimate exists for this population. Objective: This study has three primary objectives: (1) To estimate the imaging-confirmed prevalence of AMD among adults aged 50 years and above attending a rural tertiary care hospital in Central India; (2) To identify demographic, behavioural, and systemic factors independently associated with AMD in this population; and (3) To characterise patterns of diagnostic delay and barriers to eye care in patients with AMD. Methods: A hospital-based cross-sectional study will be conducted at the Department of Ophthalmology, Acharya Vinoba Bhave Rural Hospital, Wardha, Maharashtra. Participant recruitment will begin on 20 March 2026 and continue until 19 March 2027, providing a 12-month enrolment period. A minimum of 126 participants will be enrolled through consecutive sampling supplemented by community screening camps. AMD will be graded by two masked retinal specialists using AREDS criteria, with spectral-domain OCT (Cirrus HD-OCT 5000, Carl Zeiss Meditec, Dublin, CA, USA) and fundus fluorescein angiography as confirmatory modalities. The primary outcome is age- and sex-adjusted AMD prevalence. Secondary outcomes include risk factor associations (multivariable logistic regression), diagnostic delay (median delay with nonparametric comparison between recruitment pathways), and visual acuity at first presentation. Inter-grader agreement will be quantified using Cohen's kappa. Results: The study was registered with the Clinical Trials Registry of India (CTRI/2026/03/106075) on 12 March 2026. Participant recruitment will begin on 20 March 2026 and continue until 19 March 2027 at Acharya Vinoba Bhave Rural Hospital, Wardha, Maharashtra, India. As this manuscript describes the study protocol, no participants have yet been enrolled. Data analysis is expected to begin in mid-2027, with dissemination of results anticipated in late 2027. Conclusions: This study will generate the first imaging-confirmed AMD prevalence data for rural Central India since 2011. Systematic quantification of smokeless tobacco exposure, occupational sunlight, and diagnostic delay will provide actionable evidence for integrating AMD screening into India's National Programme for Control of Blindness and Visual Impairment. Clinical Trial: Clinical Trials Registry of India - CTRI/2026/03/106075 (registered 12 March 2026)

  • Background: Cigarette smoking remains highly prevalent among people living with type 2 diabetes mellitus (T2DM) and is independently associated with accelerated cardiovascular disease, worsened microvascular complications, and premature mortality. Despite strong evidence supporting pharmacological and behavioural cessation interventions, the integration of structured tobacco treatment into routine diabetes care remains inconsistent across healthcare systems. Furthermore, ongoing controversies surround the potential role of tobacco harm reduction (THR) strategies—including electronic nicotine delivery systems (ENDS)—for individuals who are unable or unwilling to achieve complete abstinence from tobacco. Objective: This protocol describes an international, modified Delphi study designed to generate expert consensus on optimising smoking cessation care and on the place of THR approaches in the management of T2DM, and to prioritise pragmatic, evidence-informed recommendations for clinical practice and future research. Methods: A multidisciplinary Steering Committee will develop a structured set of consensus statements informed by the DiaSmokeFree evidence base and framed using PICO-oriented questions across eight clinical domains. We will recruit 30–50 international experts from relevant scientific societies and clinical disciplines. Participants will complete two to three anonymous online rating rounds over approximately two to three months. Each statement will be rated on a 6-point Likert scale (1 = strongly disagree to 6 = strongly agree). Consensus will be defined a priori as ≥85% of respondents rating within a single agreement category (1–2, 3–4, or 5–6). Statements not reaching consensus will be revised on the basis of quantitative feedback and free-text comments and re-rated in subsequent rounds. Ethics and dissemination: Ethical approval will be sought where required by local regulations. Participation is voluntary with informed consent. Results will be reported in accordance with the Conducting and REporting DElphi Studies (CREDES) guidance and disseminated as an open-access consensus statement, a suite of practical clinical tools, and a prioritised research agenda to support the integration of evidence-based tobacco treatment and harm reduction into T2DM care.

  • Background: Reviewing the prescription drug monitoring program (PDMP) before signing a controlled medication prescription is a best practice to improve opioid safety and is legislatively mandated in most states. Mandating provider actions have unintended costs including workflow interruptions and misapplying provider time. The evidence supporting PDMP effectiveness is mixed, exacerbating the knowledge gap regarding mandating PDMP use. Prior PDMP evaluations have been limited by low rates of PDMP use and an inability to link encounter level PDMP review with patient outcomes. Clinical decision support (CDS) is an effective implementation strategy which is advantageous in collecting clinical data on PDMP use and prescribing decisions. Objective: This study aims to evaluate if user-centered CDS, which imports PDMP data into existing workflows, improves PDMP use and patient safety while reducing provider work. Methods: This is an electronic health record (EHR)-embedded, randomized control trial of 2 clinician-facing active choice CDS alerts to facilitate mandatory PDMP review vs usual care. One CDS, “mandated alert,” interrupts providers when prescribing an opioid or benzodiazepine with a link suggesting providers open the EHR-integrated state PDMP interface. Results: Utilizing user-centered design, we developed a second “smart” mandated CDS with the same rules-based logic and suggestion to check the PDMP, but also displays patient-specific data imported from the PDMP (number of active narcotic, sedative, and stimulant filled prescriptions). The aim of adding PDMP data to CDS is to facilitate PDMP utilization while decreasing unnecessary provider work when additional PDMP information is not needed. Providers were randomized and balanced by setting (349 inpatient, 354 emergency department and 751 outpatient). Both CDS alerts will be implemented within a single health system with a shared EHR and compared to usual care (no CDS). The primary outcome will be PDMP use. Secondary outcomes will be evaluated relative to encounter level PDMP use and include time spent prescribing, controlled medication prescription completion, and future opioid use by patients. Conclusions: This is a study protocol for a pragmatic, EHR-embedded randomized clinical trial optimizing a CDS implementation strategy to improve PDMP utilization while decreasing provider work. Implementation and effectiveness outcomes will be examined using the RE-AIM framework. Clinical Trial: NCT06215560 registered 5/6/24

  • Background: Chronic liver disease (CLD) is a major public health burden, particularly among middle-aged men with metabolic risk factors such as obesity and type 2 diabetes. Although sustained lifestyle modification is critical for preventing disease progression, long-term self-management in this population is often suboptimal. Mobile health interventions show promise for supporting self-management; however, most are patient-centered and rarely incorporate structured family engagement despite evidence highlighting the importance of social support. Objective: This study aims to develop and formalize a protocol for a family-supported digital health coaching intervention for middle-aged men with CLD and metabolic risk factors and to evaluate its feasibility and acceptability prior to effectiveness testing. Methods: This parallel-group randomized controlled trial, approved by the Institutional Review Board of Y University Health System (Approval No. 4-2025-0117) and sponsored by Y University Health System, will be conducted in Seoul, Republic of Korea. Eligible participants are men aged 40–64 years with CLD for ≥6 months and at least one metabolic risk factor; key exclusions include decompensated cirrhosis and active malignancy within 5 years. A total of 82 patient–family dyads (164 participants) will be randomized (1:1) to either a 12-week smartphone-based intervention grounded in the Information–Motivation–Behavioral Skills model or usual care. The primary outcome is change in Nonalcoholic Fatty Liver Disease Self-Management Questionnaire score from baseline to 12 weeks. Secondary outcomes include perceived social support (MSPSS), depressive symptoms (PHQ-9), family experience (FIES:CI), sleep quality (PSQI-K), and clinical indicators derived from electronic medical records, including body mass index, waist circumference, aspartate aminotransferase, alanine aminotransferase, bilirubin, albumin, triglycerides, high-density lipoprotein cholesterol, and glycated hemoglobin as applicable. Data will be analyzed using repeated-measures analysis to evaluate group-by-time effects under an intention-to-treat framework. Results: Expert content validation demonstrated excellent validity (Content Validity Index = 1.00). Usability testing indicated high acceptability (System Usability Scale mean 86.88, standard deviation 7.58). The finalized protocol operationalizes information, motivation, and behavioral skills within a structured digital platform incorporating dyadic family involvement. Enrollment began in May 2025 and is expected to be completed by March 2026. Conclusions: This protocol describes the development of a family-supported digital intervention for CLD management and provides a framework for evaluating family-centered self-management strategies in middle-aged men with metabolic risk factors. Clinical Trial: Clinical Research Information Service (KCT0010494), registered on March 25, 2025. Secondary identifiers: none. Individual participant data will be available upon reasonable request following publication.

  • Background: Type 2 diabetes mellitus (T2DM) has become a major health burden worldwide, therefore strategies to manage it in early stages are continuously being investigated. Excessive calorie consumption and sedentary lifestyles which are accompanied by the development of a low-grade inflammatory state, are one of the key risk factors for the development of prediabetes, metabolic syndrome and the subsequent T2DM. Lifestyle modifications like intermittent fasting (IF) have become an important aspect in the management of T2DM. Current evidence on the effects of IF on low-grade inflammation in individuals with either prediabetes, metabolic syndrome or T2DM is inconsistent. This systematic review protocol outlines the planned synthesis and evaluation of existing literature investigating the effectiveness of IF on inflammatory markers of adult patients with prediabetes T2DM or metabolic syndrome. Objective: The main objective of this review is to analyse data of previously published studies investigating effects of different IF regimens by assessing inflammatory markers of patients with prediabetes, metabolic syndrome or T2DM. Methods: This protocol is prepared in accordance with the Preferred Reporting Items for Systematic Review and Meta-analysis Protocol (PRISMA-P) 2020. Databases including PubMed/Medline, PubMed Central, Scopus and Google Scholar will be systematically searched for published randomized controlled trials and longitudinal studies, including cohort, case-control, cross-sectional, observational, retrospective and prospective studies involving all types of intermittent fasting in adult humans with prediabetes or T2DM OR metabolic syndrome. Eligible participants will be adults (≥18 years) diagnosed with metabolic syndrome, prediabetes or T2DM using the American Diabetes Association (ADA) or the World Health Organisation (WHO) criteria. Systematic reviews, conference abstracts, editorials and meta-analyses will be excluded. Additionally, studies without a control group will be excluded unless they provide baseline vs. follow-up inflammatory data. The control group in randomized controlled trials will consist of subjects on their usual diet, continuous energy restriction or standard diabetic care. Active comparators like Mediterranean diet will be allowed if inflammatory markers are reported. Data on changes in inflammatory markers between the intervention and control group, as well as between baseline and post intervention will be extracted. The extracted data will be verified by a second reviewer and disagreements will be resolved by a third reviewer. The risk of bias of the included randomized controlled trials will be assessed using the Cochrane Risk of Bias 2 (RoB 2), while for longitudinal studies the National Institutes of Health (NIH) quality assessment tool for Before-After (Pre-post) studies with no control group will be used. Review Manager (RevMan) will be used to perform a meta-analysis where sufficient data are available and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach will be used to assess the quality of evidence. Results: This review will only use publicly available published data. The findings of this review will provide a comprehensive synthesis of the current evidence regarding the effects of intermittent fasting regimens on inflammatory markers of adult patients with either T2DM, prediabetes or metabolic syndrome. Conclusions: The findings will highlight the current knowledge gaps and inform future clinical research, which may help to guide early intervention strategies to manage prediabetes or metabolic syndrome and to prevent the onset of T2DM. Clinical Trial: International Prospective Register of Systematic Reviews (PROSPERO) CRD420251133867, https://www.crd.york.ac.uk/PROSPERO/view/CRD420251133867

  • Background: Population aging is rapidly reshaping the Brazilian labor force, increasing the participation of adults aged 50 years and older and intensifying the need for safe, inclusive, and age‑friendly workplaces. Preventive behaviors at work play a vital role in protecting workers’ physical, social, and psychological health; however, no validated Brazilian Portuguese instrument is currently available to measure their frequency. The Preventive Behaviors at Work Frequency Scale (Échelle de Fréquence des Comportements Préventifs au Travail), developed in Canada, evaluates how often workers adopt six key preventive behaviors grounded in the Model of Preventive Behaviors at Work. A culturally adapted and psychometrically validated version is therefore needed to support occupational health research, surveillance, and evidence‑based interventions for Brazilian older workers. Objective: This study aims to describe the protocol for the cross-cultural adaptation and psychometric validation of the Brazilian Portuguese version of the Preventive Behaviors at Work Frequency Scale for workers aged 50 years and over. Methods: This methodological study will be conducted based on international guidelines for cross-cultural adaptation and questionnaire validation and will be completed in six steps: (1) forward translation, (2) forward translation synthesis, (3) back translation, (4) harmonization and expert appraisal of relevance, (5) pretesting with the target population, and (6) field testing and psychometric evaluation. Data collection will take place remotely with Brazilian workers aged 50 years and over during a 12‑month period, beginning in winter 2026. Results: Steps 1 and 2 were completed in February 2026, and step 3 (back‑translation) began in March 2026, alongside preparations for step 4. The study is progressing according to the established methodological timeline. Field testing and psychometric evaluation are expected to be carried out between spring–fall 2026, with preliminary results anticipated in winter 2026. Conclusions: This study will produce the first Brazilian Portuguese version of the Preventive Behaviors at Work Frequency Scale, enabling the assessment of preventive behaviors among older workers and strengthening occupational health research and practice in Brazil. The adapted instrument is expected to support cross‑national research, inform evidence‑based workplace interventions, and contribute to the promotion of safe, inclusive, and sustainable work participation among aging workers.

  • Oral versus intravenous fluid therapy in emergency department patients: protocol for a randomized controlled non-inferiority trial

    Date Submitted: Mar 16, 2026
    Open Peer Review Period: Mar 16, 2026 - May 11, 2026

    Background: Intravenous fluid therapy is widely used in emergency departments (ED) to treat hypovolemia but is invasive and associated with potential complications. Oral fluid therapy represents a non-invasive alternative; however, evidence regarding its feasibility and ability to achieve prescribed fluid volumes in ED patients remains limited. Objective: To evaluate the feasibility of oral fluid therapy in ED patients requiring fluid replacement and to determine whether oral fluid therapy is non-inferior to intravenous fluid therapy in achieving prescribed fluid volumes. Methods: This investigator-initiated, multicenter, open-label randomized controlled feasibility and non-inferiority trial will enroll 250 adult ED patients prescribed ≥1000 ml intravenous crystalloid therapy. Participants are randomized 1:1 to receive either oral fluids or intravenous crystalloid. The primary feasibility outcome is protocol adherence. The primary clinical outcome is the proportion of patients achieving the prescribed fluid volume during the ED stay, analyzed using a non-inferiority framework. Secondary outcomes include total fluid volume received, blood pressure changes, hospital-free days, peripheral intravenous catheter use, acute kidney injury, severe electrolyte imbalance, and additional feasibility measures. Analyses will follow the intention-to-treat principle. Results: Recruitment began in October 2025 at three Danish EDs and is ongoing. As of March 2026, we have enrolled 85 patients. Conclusions: This trial will evaluate whether oral fluid therapy is feasible in ED patients and whether it can achieve prescribed fluid volumes comparable to intravenous therapy. The findings will inform the design of a future definitive effectiveness trial. Clinical Trial: ClinicalTrials.gov ID NCT07361952

  • Background: Breast cancer surgical and reconstructive decision-making is a complex, preference-sensitive process that requires patients to balance oncologic safety, aesthetic outcomes, recovery burden, and long-term quality of life. Despite the growing emphasis on shared decision making (SDM), existing patient decision aids (PDAs) in breast reconstruction are often static, text-heavy, and insufficiently responsive to individual patient values and emotional needs. Artificial intelligence (AI) offers an opportunity to develop adaptive, patient-centered decision-support tools that integrate clinical evidence, patient narratives, and personalized feedback. Objective: This study protocol describes the development and early feasibility testing of an AI-supported, narrative-driven digital decision aid designed to facilitate shared decision-making for patients considering breast cancer surgery and reconstruction. Methods: A multiphase mixed-methods design will guide development and preliminary evaluation. Phase I involves qualitative semi-structured interviews with breast cancer patients and clinical stakeholders to identify key informational needs, emotional challenges, and experiential factors influencing decision-making. Interview transcripts will undergo inductive thematic analysis to inform the conceptual framework, content structure, and narrative integration of the decision aid. Phase II is a pilot mixed-methods feasibility study involving 50 patients with early-stage breast cancer considering surgical and reconstructive options. Participants will use the digital decision aid and complete validated measures including the Decisional Conflict Scale and Decision Regret Scale, along with investigator-developed usability and acceptability assessments. Semi-structured exit interviews will provide qualitative feedback on usability and perceived value. Results: Findings will inform refinement of the decision aid and guide the design of future effectiveness trials. Conclusions: This study outlines a rigorous, stakeholder-informed framework for developing an AI-supported decision aid for breast cancer surgical decision-making. If successful, this approach may enhance shared decision-making and serve as a model for ethically grounded AI-supported decision tools in other preference-sensitive clinical contexts.

  • Exit Interviews in Health Professions Education: a Scoping Review Protocol

    Date Submitted: Mar 13, 2026
    Open Peer Review Period: Mar 13, 2026 - May 8, 2026

    Background: The healthcare workforce is facing numerous challenges, with retaining skilled, qualified, and experienced practitioners being paramount. Exit interviews are a long-established practice with evidence of effectiveness across a range of settings, but are rarely implemented among health professionals. Research on the use of exit interviews mirrors this pattern. This scoping review will address this gap by systematically mapping the use of exit interviews in the literature on health professionals and trainees. Objective: This protocol describes the scoping review process, with a primary question: What is known about the use of exit interviews in health professions education? Methods: This review will follow the Joanna Briggs Institute methodology and will report using the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist. The review will involve systematic searches of academic and grey literature databases. The review will include any studies that utilise or describe exit interviews in the context of health professions education, broadly defined. No data limit will be applied. Titles, abstracts, and full texts will be screened in a two-stage process. At each stage, an initial pilot stage of 10% of identified sources will be reviewed by two independent screeners. A Kappa score indicating substantial agreement (0.61-0.80) will be required before the remaining screening can be completed by a single reviewer. This will be supported by the Rayyan systematic review management platform. Data extraction will be performed by one reviewer and checked by a second, with disagreements resolved by consensus. A further AI-powered verification of data extraction will be performed. The findings will map existing approaches, highlight research gaps and inform future research using exit interviews. Results: No results as this is a protocol. Conclusions: Ethics and Dissemination This scoping review will use publicly available data; therefore, no ethical approval is required. The findings from the completed review will be submitted for publication in a peer-reviewed journal and for presentation at relevant conferences. Clinical Trial: This protocol is registered on the Open Science Framework: https://doi.org/10.17605/OSF.IO/PT2RX