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☐ ☆ ✇ BMJ Open

Support-t, an online training and peer support platform to accompany youth living with type 1 diabetes transitioning to adult healthcare: protocol of an effectiveness-implementation trial

Por: Roy-Fleming · A. · Nakhla · M. · Mok · E. · Vanasse · A. · Cianci · L. · Kichler · J. · Simoneau-Roy · J. · Couture · Y. · Gagne · J. · Dupont · M. · Brazeau · A.-S. — Octubre 7th 2025 at 08:15
Introduction

Type 1 diabetes (T1D) demands self-management skills, knowledge and confidence to prevent medical complications. Adolescents living with T1D have distinct developmental challenges resulting in a worsening in glycaemic stability, irregular care and an increased risk for complications all while transitioning to adult healthcare. Age-specific online platforms could facilitate transition by fostering self-management education and support. The Support online self-guided training platform has been shown to increase the confidence of adults with T1D in managing their glycaemia. We aim to test the effectiveness of Support-t (ie, adapted for youth), compared with usual care, in improving haemoglobin A1c (HbA1c) and to understand the context of its implementation.

Methods

We will conduct a multisite, assessor-blinded, randomised controlled, parallel group, two-arm, superiority trial, evaluating effectiveness and implementation of Support-t versus usual care in 200 adolescents (14–16 years old) living with T1D. The active arm will have an 18-month access to Support-t, and their healthcare team will be trained on the platform’s content. The control arm will receive usual care. The primary outcome is HbA1c at 18 months. Secondary outcomes include self-efficacy for diabetes self-management, transition readiness, diabetes-specific quality of life, diabetes distress, continuous glucose monitoring metrics, number of severe hypoglycaemic events, diabetic ketoacidosis, T1D-related emergency department visits and hospitalisations as well as engagement and satisfaction. A subgroup of participants in the active arm and of healthcare providers will be interviewed assessing barriers, facilitators, engagement and fidelity of the intervention. Primary analysis will be by intention-to-treat. The difference in mean HbA1c at 18 months (with a 95% CI) will be calculated between both arms. A cost-effectiveness analysis is also planned.

Ethics and dissemination

December 8, 2024 version of the protocol was approved by the McGill University Health Centre Research Ethics Board (MP-37-2024-9734). Results will be disseminated through peer-reviewed publications and patient-partners’ network.

Trial registration number

ClinicalTrials.gov (NCT05910840).

☐ ☆ ✇ BMJ Open

Incorporating behavioural and psychological factors into cardiovascular disease risk prediction models: protocol for a systematic review

Por: Tang · C. · Ng · N. C.-S. · Ming · L. C. · Wong · R. S.-Y. — Octubre 3rd 2025 at 06:32
Objectives

This systematic review aims to: (1) evaluate how behavioural and psychological factors have been incorporated into cardiovascular disease (CVD) risk prediction models; (2) assess their impact on model performance metrics such as area under the curve (AUC) and net reclassification index (NRI); and (3) identify which specific variables are most consistently associated with predictive improvements. This protocol is reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses protocols (PRISMA-P) 2015, and the systematic review will follow the Cochrane Handbook and report findings based on PRISMA 2020.

Design

A systematic review protocol developed in accordance with the (PRISMA-P) 2015 guidelines.

Data sources

Systematic searches will be carried out in PubMed, Scopus, Web of Science and Google Scholar, limited to studies published from 2019 to 2024.

Eligibility criteria

Peer-reviewed original studies involving adult populations (≥18 years) at risk of CVD, incorporating at least one behavioural or psychological variable into a CVD risk prediction model. Studies must report model performance metrics such as AUC or NRI. Studies focusing solely on biochemical or demographic factors, paediatric populations, or non-CVD outcomes will be excluded.

Data extraction and synthesis

Two independent reviewers will screen eligible studies, extract data and assess study quality using the Newcastle-Ottawa Scale and Quality in Prognostic Studies tool. A narrative synthesis will be performed, with meta-analysis conducted if feasible.

Ethics and dissemination

Ethical approval is not required for this study. Findings will be disseminated through peer-reviewed publication and conference presentations.

PROSPERO registration number

CRD420251014218.

☐ ☆ ✇ BMJ Open

Use of an innovative electronic communications platform (912Rwanda) to improve prehospital transport of injured people in Rwanda: protocol for a type 2 hybrid effectiveness-implementation interrupted time series study

Por: Rwanda912 RIGHT Group · Quinn · Assuman · Nishimwe · Sheferaw · Alayande · Munyura · Bagahirwa · Hagenimana · Ignatowicz · D'Ambruoso · Muhire · Jayaraman · Belli · Bojke · Rickard · Ajisola · Hemming · Byiringiro · Davies — Agosto 14th 2025 at 04:49
Introduction

Injury is a major cause of death in Rwanda, with many deaths occurring before hospital admission. Timely transport of injured patients to appropriate hospitals is crucial, ideally within an hour for severely injured patients. However, delays in reaching treatment facilities are common, with ambulance services using inefficient mobile phone communication. This project aims to evaluate the effectiveness and implementation of an innovative electronic communication platform (912Rwanda).

Methods and analysis

The study will be conducted through the public ambulance service, Service d’Aide Médicale d’Urgence (SAMU), and receiving health facilities in Kigali city and Musanze district in Rwanda. The 912Rwanda intervention will be rolled out in the two locations at different times. The primary effectiveness outcome is the time from ambulance deployment to patient arrival at the health facility. Secondary effectiveness outcomes include disaggregated times of the primary outcome and clinical outcomes, such as length of stay and requirement for intensive care. These outcomes will be evaluated using an interrupted time series analysis, accounting for non-homogeneous variances, auto-regressive errors and non-linear trends where appropriate. Implementation outcomes will be evaluated using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) Qualitative Evaluation for Systematic Translation (QuEST) framework. Cost-effectiveness will be evaluated using a cost-consequence analysis with consequences as determined by the interrupted time series analysis.

Ethics and dissemination

Ethical approval was obtained from the Rwanda National Research Ethics Committee (Ref No: 99/RNEC/2023). Dissemination will occur through open-access peer-reviewed publications, relevant national and international conferences.

Trial registration number

ISRCTN97674565.

☐ ☆ ✇ BMJ Open

Pragmatic, multicentre, factorial, randomised controlled trial of sepsis electronic prompting for timely intervention and care (SEPTIC trial): a protocol

Por: Ranard · B. L. · Qian · M. · Cummings · M. J. · Zhang · D. Y. · Lee · S. M. · Beitler · J. R. · Applebaum · J. R. · Schenck · E. J. · Mohamed · H. · Trepp · R. · Hsu · H. · Scofi · J. · Southern · W. N. · Rossetti · S. C. · Yip · N. H. · Brodie · D. · Sharma · M. · Fertel · B. S. · Adelman — Agosto 12th 2025 at 03:13
Introduction

Sepsis is a major cause of death both globally and in the United States. Early identification and treatment of sepsis are crucial for improving patient outcomes. International guidelines recommend hospital sepsis screening programmes, which are commonly implemented in the electronic health record (EHR) as an interruptive sepsis screening alert based on systemic inflammatory response syndrome (SIRS) criteria. Despite widespread use, it is unknown whether these sepsis screening and alert tools improve the delivery of high-quality sepsis care.

Methods and analysis

The Sepsis Electronic Prompting for Timely Intervention and Care (SEPTIC) master protocol will study two distinct populations in separate trials: emergency department (ED) patients (SEPTIC-ED) and inpatients (SEPTIC-IP). The SEPTIC trials are pragmatic, multicentre, blinded, randomised controlled trials, with equal allocation to compare four SIRS-based sepsis screening alert groups: no alerts (control), nurse alerts only, prescribing clinician alerts only, or nurse and prescribing clinician alerts. Randomisation will be at the patient level. SEPTIC will be performed at eight acute-care hospitals in the greater New York City area and enrol patients at least 18 years old. The primary outcome is the percentage of patients with completion of a modified Surviving Sepsis Campaign (SSC) hour-1 bundle within 3 hours of the first SIRS alert. Secondary outcomes include time from first alert to completion of a modified SSC hour-1 bundle, time from first alert to individual bundle component order and completion, intensive care unit (ICU) transfer, hospital discharge disposition, inpatient mortality at 90 days, positive blood cultures (bacteraemia), adverse antibiotic events, sepsis diagnoses and septic shock diagnoses.

Ethics and dissemination

Ethics approval was obtained from the Columbia University Institutional Review Board (IRB) serving as a single IRB. Results will be disseminated in peer-reviewed journal(s), scientific meeting(s) and via social media.

Trial registration number

ClinicalTrials.gov: NCT06117605 and NCT06117618.

☐ ☆ ✇ BMJ Open

Hotspotters Project: a study protocol for a stepped wedge cluster RCT on the cost-effectiveness of 12-month proactive, integrated and personalised care for patients with problems on multiple life domains and high acute care use

Por: Tiemes · V. · Leming · K. A. · Borgdorff · H. · Bruijnzeels · M. A. · van Gestel · L. C. · Adriaanse · M. A. · van der Wel · M. · van den Akker-van Marle · E. M. · Numans · M. E. · Vos · R. C. — Agosto 11th 2025 at 03:13
Introduction

‘Hotspotters’ are patients with complex care needs, defined by problems in multiple life domains and high acute care use. These patients often receive mismatched care, resulting in overuse of care and increased healthcare costs. As reliable data on effective interventions for this population are scarce, the goal of this study is to assess the cost-effectiveness of proactive, personalised, integrated care for this group.

Methods and analysis

The Hotspotters Project is planned as a stepped wedge cluster randomised controlled trial in 20 primary care practices in the Netherlands. All practices and participants will begin with standard care during the control period (2–8 months), followed by an intervention (12 months) consisting of a positive health intake with goal setting, multidisciplinary meetings, a personalised care plan and proactive care management. The study will conclude with a follow-up (2–8 months), resulting in a total study duration of 22 months. We plan to include 200 patients with (a) problems on two or more life domains and (b) at least two acute care encounters in the previous year. Possible Hotspotters are identified using an Adjusted Clinical Groups-based algorithm or via a local primary healthcare team.

Outcomes

Questionnaires and routine care data will be used to gather data on cost-effectiveness, which will then be assessed using multilevel analysis, with levels for the individual, cluster and duration of control period. Secondary outcomes will include psychological outcomes on self-regulation (proactive coping, patient activation, self-efficacy and intention), experience of care (satisfaction, perceived autonomy support and qualitative data from focus groups) and quality of life, qualitative analysis of the Positive Health approach, implementation outcomes and process evaluation including integration of care.

Ethics and dissemination

The Ethics Committee of Leiden University Medical Centre granted approval (METC-LDD, P21.123). Results will be shared through peer-reviewed publication and (inter)national conference presentations.

Trial registration number

NCT05878054.

☐ ☆ ✇ BMJ Open

Athletes access to, attitudes towards and experiences of help-seeking for mental health: a scoping review

Por: Brown · K. R. · Quinton · M. L. · Tidmarsh · G. · Cumming · J. — Agosto 8th 2025 at 01:15
Objectives

Athletes have been found to experience a similar prevalence of mental health issues to non-athletes. However, they are subjected to a greater array of barriers to help-seeking for mental health, including sport-specific factors. This scoping review synthesised the literature on athletes’ access to, attitudes towards and experiences of help-seeking for mental health from formal (mental health professionals such as psychiatrists) and semiformal sources (those who are not mental health professionals but are a service provider such as a coach).

Design

The Joanna Briggs Institute framework and recommendations were used alongside the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Protocols checklist for scoping reviews. This scoping review was predominantly informed by Arksey and O’Malley’s framework for scoping reviews, supplemented by Levac et al’s additional recommendations. Rickwood and colleagues’ help-seeking frameworks informed the research question, inclusion/exclusion criteria and analysis.

Data sources

The search terms and synonyms of "athlete" AND "mental health" AND "help-seeking" were searched in PsychINFO, Embase, MEDLINE, APA PsychArticles Full Text, Web of Science Core Collection, Scopus, Sport Discus, CINAHL and Proquest (Education Database, Health & Medical Collection, Nursing & Allied Health database, Psychology Database, Public Health Database, Education Collection, and Medicine & Education). These searches were conducted at three time points between April 2022 and 2024.

Eligibility criteria

The inclusion and exclusion criteria were initially predetermined and specified in the protocol paper published in BMJ Open. Primary research articles, interventions and systematic reviews that referred to semiformal and formal sources of support were included.

Data extraction and synthesis

The lead reviewer (KRB) screened all titles and abstracts, and full texts, and extracted data from all included studies. A second reviewer was involved in screening and extracting 20%–30% of studies at each stage. Findings were synthesised descriptively (eg, study population, data collection method and location of studies) and by content (eg, access, attitudes and experiences, sources of support, use of theory and the validity of quantitative measures used).

Results

After screening 4954 titles and abstracts and 275 full texts in Covidence, 104 papers were included in the review. This comprised of 87 primary research articles, 13 interventions and 4 systematic reviews. Most of the primary articles and interventions were published in the USA (50%). 49.4% of the primary articles used quantitative methods, 34.5% used qualitative methods and 16.1% used mixed methods. Attitudes towards mental health help-seeking were investigated in 78.8% of the included studies, experiences of help-seeking in 53.8% and access to sources of support in 31.7% of studies. Of the primary articles and interventions, formal sources were investigated in 55% of studies, semiformal sources in 2% and both in 26% of studies.

Conclusions

This scoping review of 104 papers showed the benefit of using help-seeking frameworks to shape and analyse a review. Analysing the results using these frameworks provided a novel contribution to the literature, showing where the athlete help-seeking literature base is currently focused and identified gaps for further research. For example, there is a need for further research on athletes in less developed nations, more qualitative and mixed methods studies, and further research on athletes’ access to mental health support and their interactions with semiformal sources. The results have applied implications in public health and sport by highlighting the different factors that impact athlete help-seeking, and therefore areas where they require support.

☐ ☆ ✇ BMJ Open

Systematic review protocol for effectiveness and cost-effectiveness of non-surgical interventions to prevent diabetes progression in adults with prediabetes

Por: Sui · C. F. · Ming · L. C. · Soh · Y. C. · Ng · C. H. · Al-Worafi · Y. M. · Hussain · Z. — Julio 23rd 2025 at 04:48
Introduction

Prediabetes (PD), defined by impaired glucose tolerance or impaired fasting glucose, represents a growing global health challenge, with a prevalence projected to increase substantially. PD is a critical intervention target because of its high annual progression rate (5–10%) to type 2 diabetes mellitus (T2DM) and elevated cardiovascular disease (CVD) risk. Non-surgical interventions (NSIs), particularly lifestyle modifications (LMs) and pharmacological therapies, are the cornerstone of PD management, demonstrating efficacy and cost efficiency over surgical options. However, despite LM’s ability to reduce T2DM incidence by 40–70% in trials such as the Diabetes Prevention Program, real-world implementation faces barriers, including resource intensity and complex delivery requirements, which increase upfront costs. We aim to review scientific literature reporting on the effectiveness and cost-effectiveness of NSIs for preventing the progression of PD to T2DM among adults.

Methods and analysis

A comprehensive systematic search will be conducted across major biomedical databases (PubMed, Scopus, Cochrane Library, Web of Science) for records published up to July 2024. We will include studies involving adults diagnosed with PD according to the American Diabetes Association (ADA) or WHO criteria, focusing on LM and pharmacological treatments. Observational and interventional study designs, including economic evaluations, will be considered. Primary outcome: diabetes incidence (ADA or WHO glycaemic criteria). Secondary outcomes: (1) CVD risk factors, (2) health utilities and (3) healthcare cost analyses. The protocol adheres to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 guidelines and is registered with PROSPERO (CRD42024561294). Data extraction and quality assessment will be performed by two reviewers, with discrepancies resolved by the consensus of a third reviewer. Data will be narratively synthesised; if the data allow, a meta-analysis will be conducted.

Ethics and dissemination

This systematic review was exempt from ethical approval as it involved no collection of individual patient data and posed no confidentiality risks. The findings will be shared via publication in a peer-reviewed journal or presentation at relevant conferences.

PROSPERO registration number

CRD42024561294.

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