This scoping review identifies existing registries collecting data on Klinefelter’s syndrome (KS) patients and what data are collected, with the purpose of identifying any KS-specific registries. Findings to be used to inform future registry development.

A comprehensive scoping review was conducted. Multiple sources were reviewed and articles screened based on inclusion criteria and exclusion criteria.

Searches performed across multiple sources including PubMed, Embase, the Cochrane Library, WHO International Clinical Trials Registry Platform, Orphanet, EU Clinical Trials Register, King’s College London Library and charity organisation webpages.

The included studies were required to focus on KS patients with reported data from an active registry that routinely collects data on KS patients.

Basic information about registries identified in included articles was extracted. Registries identified were contacted with a standardised set of questions to collect additional contextual information. Findings are presented in tables.

The scoping review included 18 articles. From those, 10 registries storing KS patient data were identified. Only one of those registries was KS-specific. Only three out of 10 registries collected data that encompassed genetic, clinical and social variables. Most data included in registries were collected exclusively from medical records, although some registries included data from patient surveys. Registries that received government funding had more KS participants than those that did not.

With only one KS-specific registry existing worldwide and none within the UK, this review has identified a need for the development of further KS-specific registries. Data collected could be used to develop an accurate KS phenotype and therefore lead to increased diagnosis of the disorder, improving the lives of people with KS.

Approximately one-third of people with epilepsy (PWE) experience resistance to treatment, including pharmacological therapies, epilepsy surgery, vagus nerve stimulation (VNS) and dietary interventions such as the ketogenic diet (KD). Emerging evidence suggests that the gut microbiota may influence seizure susceptibility and treatment response through the microbiota-gut-brain axis, potentially contributing to treatment resistance. The MiCrobiota-gut-brain Axis in Resistant Epilepsy project investigates how gut microbial features and associated host epigenetic signatures affect clinical outcomes in PWE undergoing diverse treatment strategies.

This is a multicentre, prospective, longitudinal study involving four clinical centres in Italy and one self-financing partner. Participants aged 3–50 years will be enrolled and stratified into four intervention cohorts: newly diagnosed drug-naïve epilepsy scheduled to start anti-seizure medications, focal drug-resistant epilepsy (DRE) undergoing epilepsy surgery, DRE receiving VNS, and DRE initiating KD. Clinical assessments (including body mass index calculation, self-reported monthly seizure count, dietary evaluation, quality of life scale and gastrointestinal symptoms scale), electroencephalography, MRI and biological sample collection (stool and blood) will be obtained at baseline and longitudinally at two or three timepoints over a 12-month observation period. Gut microbiota changes over time will be assessed via metagenomics (using 16S ribosomal RNA sequencing) and metaproteomics; the associated host DNA methylation profiles will be obtained from blood using Illumina EPIC arrays. Primary endpoints include identification of microbial or host methylation changes predictive of therapeutic response (ie, reduction from baseline in monthly seizure count) to the intervention. Data will be analysed using multivariate models and mixed-effect regression. Further, omics data and corresponding metadata will be integrated using multi-omics approaches to identify molecular signatures biomarkers predictive of treatment response and prognosis in PWE.

The study received ethical approval from the Research Ethic Board (Comitato Etico Territoriale Lombardia 3, ID 4896 – parere numero 4896_17.07.2024_N_bis). All participants or their legal guardians will provide written informed consent. Results will be disseminated through peer-reviewed publications, conference presentations or lay summaries targeting patient organisations.

ClinicalTrials.gov Identifier NCT07010445, registered on 2 May 2025.

To evaluate the association between non-steroidal anti-inflammatory drugs (NSAIDs) and miscarriage, which remains elusive in the actual literature, using modelling approaches to mitigate time-related bias.

Nationwide, population-based retrospective cohort study.

The study used data from the French National Mother-Child Register (EPI-MERES), developed from the French National Health Data System containing the health information (hospital admissions, drug dispensing, comorbidities, etc.) of about 99% French population.

4 857 907 pregnancies ended in a live birth, a stillbirth or a miscarriage from 2013 to 2019.

Exposure to NSAIDs from 2 weeks before conception to the 20th week of pregnancy.

Miscarriage (ie, spontaneous abortion before the 20th week of pregnancy) from the sixth week of pregnancy. The Cox regression with a time-dependent exposure that incorporated a 3-day lag was used to estimate HRs and their 95% CIs adjusted for maternal characteristics. The 3-day lag period allows for addressing protopathic bias.

In total, there were 163 666 (3,37%) miscarriage cases, and 349 294 (7.19%) pregnancies were exposed to NSAIDs. Unexposed pregnancies were used as the reference category in all analyses. In the main analysis, exposure to NSAIDs increased the risk of miscarriage (HR, 1.83; 95% CI 1.81 to 1.86). The effect of individual drugs was heterogeneous, with 7 of the 19 drugs evaluated shown to increase the risk (flurbiprofen had the highest risk (HR, 3.28; 95% CI 3.15 to 3.41) and naproxen the lowest (HR, 1.09; 95% CI 1.01 to 1.18)). In the sensitivity analyses, increasing the lag time decreased the estimated HR (from HR, 2.25; 95% CI 2.21 to 2.28 with no lag to HR, 1.56; 95% CI 1.54 to 1.59 with a 7-day lag). Overall, the risk of miscarriage remained statistically significant in all the analyses.

Our study found that early exposure to NSAIDs could increase the risk of miscarriage. This finding contributes to the body of evidence on their safety profile and may help inform future recommendations for their use in pregnant women.

Limited male engagement in HIV prevention and care is a global challenge more pronounced in sub-Saharan Africa (SSA) contributing to ongoing transmission. However, peer network interventions show promise in improving engagement.

To map and synthesise evidence on peer network interventions for HIV prevention and care among men in SSA, with a focus on the types of strategies used, populations reached and how these interventions address cultural, social and structural barriers across the HIV care cascade.

Scoping review of peer-reviewed literature, conducted and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.

Community and facility-based HIV prevention and care settings across multiple countries in SSA.

Populations included men having sex with men, men in key occupational groups (fishermen, truck drivers), adolescents and young people, and men living with HIV. Studies not conducted in SSA, not peer-reviewed or not focused on male peer networks were excluded.

Peer network interventions included peer education, peer navigation, HIV self-testing (HIVST) distribution, adherence support groups, disclosure and stigma-reduction counselling, technology-enabled peer support (SMS and social media) and community-based antiretroviral therapy (ART) delivery. Intervention duration and intensity varied across studies.

Primary outcomes included HIV testing uptake, linkage to care, ART initiation, adherence, retention in care and viral suppression. Secondary outcomes included stigma reduction, disclosure and engagement among hard-to-reach male populations.

We conducted a review of literature published between November 2013 and November 2024, searching PubMed, Web of Science, Scopus and Cochrane databases. Studies were included if they examined peer network approaches in HIV prevention and care among men in SSA.

A total of 905 records were identified, of which 75 studies met the inclusion criteria. Peer network interventions were implemented across diverse SSA contexts and male populations. Strategies such as peer-led education, social diffusion models, HIVST distribution and technology-enabled peer support consistently improved HIV testing uptake, linkage to care, ART initiation and adherence. Contextually tailored interventions such as community-based outreach addressing occupational risk environments and economic vulnerabilities were particularly effective in engaging men traditionally underserved by facility-based services. However, challenges persisted, including variable linkage to care following HIVST and sensitivity to user costs.

Peer-led interventions in HIV care for men in SSA effectively address cultural, social and structural barriers, improving testing, ART adherence and viral suppression. Tailored, technology-enhanced and community-based approaches ensure equitable HIV prevention and treatment outcomes, despite challenges like linkage to care.

Unplanned hospital readmissions within 30 days of discharge measure the quality of healthcare. This study aims to identify the characteristics of patients at higher risk of readmission.

Retrospective cohort study.

North-east Italy (Marca Trevigiana Local Health Authority).

The study examined a total of 39 467 index admissions from hospital discharges (SDO) in the 890 000-inhabitant area during 2022.

Readmission rates and 95% CIs were computed by risk factor, age and type of admission (surgical or medical). A logistic mixed-effects model was used to estimate readmission OR, adjusting for potential confounders.

A total of 2197 readmissions occurred within 30 days of the index admission, resulting in an overall rate of 30-day readmissions of 6.7% (CI 6.4% to 7.0%). The median time to readmission was 11 days (IQR 5 to 20). In the multivariate analysis, after adjusting for age and sex, the following clinical conditions were associated with a higher risk of readmission: alcohol-related disease (OR=2.06, CI 1.36 to 3.13), metastatic cancer (OR=1.98, CI 1.57 to 2.50), epilepsy (OR=1.93, CI 1.36 to 2.75), dialysis or end-stage kidney disease (OR=1.92, CI 1.39 to 2.66), chronic obstructive pulmonary disease (OR=1.88, CI 1.49 to 2.36), stoma (OR=1.72, CI 1.22 to 2.44), transplant (OR=1.62, CI 1.03 to 2.55), being bedridden (OR=1.57, CI 1.28 to 1.93), anaemia (OR=1.57, CI 1.35 to 1.83), urinary tract infection (OR=1.54, CI 1.30 to 1.83), pneumonia (OR=1.52, CI 1.31 to 1.75), dementia (OR=1.49, CI 1.24 to 1.79), diabetes (OR=1.37, CI 1.17 to 1.61) and transfusion (OR=1.34, CI 1.03 to 1.73).

Several chronic and acute conditions at index admission significantly increased the risk of readmission. Strengthening transitional care, outpatient services and palliative care could mitigate readmissions.

Urgent and emergency care in Germany is delivered across multiple, loosely connected sectors. In the absence of coherent, time-resolved data on patient movements between emergency medical services (EMS), out-of-hours ambulatory care, emergency departments (EDs) and inpatient care, inefficiencies and coordination gaps remain difficult to quantify. A process-centric, trans-sectoral analysis is required to characterise real-world patient pathways and identify actionable levers for improvement. The study aims to reconstruct, model and analyse patient pathways for urgent health complaints across all relevant sectors of the healthcare system in a German model region.

We will employ a mixed-methods observational study design. Routine data from EMS, out-of-hours ambulatory care, EDs and subsequent inpatient care will be pseudonymised at source, linked via a trusted third party and analysed within a trusted research environment. Time-stamped event logs will support process mining for discovery, conformance and performance analysis alongside descriptive statistics with stratification by context, such as setting, time of day, urgency and patient cohorts. Anonymous cross-sectional surveys of patients and front-line professionals, complemented by quarterly snapshot surveys in out-of-hours ambulatory care and interviews, will provide convergent evidence on the motives, barriers and coordination of utilisation behaviour. Enrolment for surveys is anticipated from the fourth quarter of 2025; routine data capture covers 1 January–31 December 2026; analyses and dissemination run until 31 December 2027.

The study received ethical approval from the Ethics Committee of the Medical Faculty at RWTH Aachen University (EK 25-351). Survey modules are conducted anonymously with voluntary participation and without collection of direct identifiers; routine care data are processed in pseudonymised form and analysed within a trusted research environment. Stakeholder interviews will be conducted with informed consent. Results will be disseminated through peer-reviewed publications, conference presentations and summary reports for participating institutions and stakeholders, complemented by plain-language materials to support patient-centred navigation.

DRKS00035916.

More than 300 million major surgical procedures are carried out under general anaesthesia each year worldwide, and advanced airway management remains one of the leading daily challenges for clinicians. Data from large international prospective cohort studies on adverse events such as cardiovascular collapse, cardiac arrest and severe hypoxaemia during advanced airway management to facilitate anaesthesia are lacking.

The International obServational sTudy on AiRway manaGement in operAting room and non-operaTing room anaEsthesia (STARGATE) study will be an international prospective observational cohort study describing the incidence of major adverse events associated with advanced airway management (tracheal intubation or supraglottic airway device placement) for general anaesthesia in the operating and non-operating room for surgery and medical procedures. The secondary aim will be to describe the practice of airway management in a large international cohort. Critically ill patients will be excluded from this study. Data on patients’ characteristics, type of procedure and the adopted airway management strategy, post-procedure adverse events, operator characteristics and in-hospital mortality will be prospectively collected. The study aims to enrol 10 500 patients.

The study has been approved by the Ethics Committee of the coordinating centre (Comitato Etico Interaziendale AOU San Luigi Gonzaga, N° 25/2023). Each of the participating centres will then seek approval of their local Ethics Committee before enrolment. Data will be disseminated to the scientific community by original articles submitted to international peer-reviewed journals.

NCT05759299.

Diagnostic errors in primary care are common, particularly in the interpretation and follow-up of abnormal haemoglobin (Hgb) and estimated glomerular filtration rate (eGFR) results. These errors frequently result in missed or delayed diagnoses of serious conditions such as anaemia and chronic kidney disease. This protocol describes a stepped-wedge cluster randomised controlled trial designed to evaluate a novel, evidence-based, team-based intervention aimed at improving diagnostic safety and efficiency.

The study will be conducted across 12 University of Texas Physicians (UTPs) primary care clinics in Houston, Texas, USA. Adult patients (≥18 years) with newly identified abnormal Hgb or eGFR results will be eligible for inclusion. The intervention integrates automated tracking of abnormal laboratory results, nurse navigators to support patient follow-up and engagement, and clinical pathologists to provide diagnostic guidance to primary care providers. The primary outcome is diagnostic safety, defined as the proportion of patients who receive a correct diagnosis within 6 months. Secondary outcomes include diagnostic efficiency, appropriate test utilisation, cost-effectiveness, patient activation and implementation metrics such as acceptability, fidelity and sustainability. The study will also explore barriers and facilitators to successful implementation using mixed-methods evaluation.

This trial has been approved by the Institutional Review Board at The University of Texas Health Science Center at Houston. Study results will be disseminated through peer-reviewed publications and conference presentations, and findings will be reported to UTP leadership to inform potential system-wide implementation.

NCT05735314.

Atrial Fibrillation (AF) is the most common arrhythmia worldwide affecting an estimated 5% of people over the age of 65 and is a leading cause of stroke and heart failure. Identification of patients at risk allows preventative measures and treatment before these complications occur. Conventional risk prediction models are static, do not have flexibility to incorporate dynamic risk factors and possess only modest predictive value. Artificial intelligence and machine learning-powered health virtual twin technology offer transformative methods for risk prediction and guiding clinical decisions.

In this prospective observational study, 1200 patients will be recruited in two tertiary centres. Patients hospitalised with acute illnesses (sepsis, heart failure, respiratory failure, stroke or critical illness) and patients having undergone high-risk surgery (major vascular surgery, upper gastrointestinal surgery and emergency surgery) will be monitored with a patch-based remote wireless monitoring system for up to 14 days. Clinical and electrocardiographic data will be used for modelling the risk of new-onset AF. The primary outcome is episodes of AF >30 s and will be described as ratio of episodes/patient and as percentage of patients having episodes of AF. Secondary outcomes include 30-day and 90-day readmission rates and complications of AF.

The aim of this study is to generate data for the development and validation of health virtual twins predicting onset of AF in an at-risk population. The intelligent monitoring to predict atrial fibrillation (NOTE-AF) study is part of the TARGET project, a Horizon Europe funded programme which includes risk prediction, diagnosis and management of AF-related stroke (https://target-horizon.eu/).

The study has received approval by the Health Research Authority and the National Research Ethics Service (REC reference 24/NW/0170, IRAS project ID: 342528) in the UK and has been registered on clinicaltrials.gov (NCT06600620). Results will be disseminated as outlined in the TARGET protocol to communicate project ideas, activities and results to diverse audiences.

NCT06600620.

Childhood cancer survivors (CCSs) experience educational disruptions during and following treatment, yet robust, longitudinal evidence on educational performance remains limited. We will investigate differences in educational outcomes between CCSs and non-cancer peers during primary and secondary school. We will also explore how sociodemographic factors and age at diagnosis contribute to potential differences in General Certificate of Secondary Education (GCSE) examinations, a critical indicator of future academic and employment prospects.

We will use the Education and Child Health Insights from Linked Data (ECHILD) to capture linked health and education data for children born in National Health Service (NHS)-funded hospitals in England. We will generate birth cohorts spanning September 1997 to August 2015 (estimated sample size: ~10 million), formed of pupils expected to have undertaken national curriculum assessments between academic years 2004/2005 and 2021/2022 including Key Stage (KS) 1, 2 and 4, corresponding to ages 7, 11 and 16 respectively. Cancer diagnosis will be identified from inpatient hospital records, using International Classification of Diseases, 10th Revision codes (ICD-10). We will investigate differences between CCS and their non-cancer peers in terms of their sociodemographic characteristics and describe trends in educational performances at all KSs, recorded Special Educational Needs and Disabilities (SEND) and school absences. Differences in KS4 (GCSE) performances between CCS and non-cancer peers will be quantified, according to and accounting for geographic region, sex, deprivation, ethnicity and birth characteristics. To assess whether cancer diagnosis disrupts academic trajectories, we will restrict analysis to those with KS2 attainment data and investigate KS4 performance. We will finally explore the influence of age at diagnosis on educational performance at KS4.

Ethics approval was granted by NHS Health Research Authority Research Ethics Committee (20/EE/0180). Findings will be shared with academics, policymakers, children and families affected by childhood cancer, and published in journals. Code/metadata will be shared on ECHILD GitHub repository.

Rheumatological diseases represent a widespread heterogeneous group of disorders, united by chronic musculoskeletal inflammatory processes. Despite the increasing effectiveness of new therapies, the lack of adequate treatments for certain conditions and the occurrence of adverse drug reactions have led to the need for alternative strategies, including food supplements. These products are perceived by the patient as a valuable aid without adverse effects. However, adverse reactions to food supplements have been reported, although their incidence cannot be established due to the lack of consumption data. In this context, the IntegraRE project aims at collecting information on the use of food supplements in rheumatology, considering both physicians and patients.

A survey-based cross-sectional study has been designed into two consecutive phases: Phase 1 aims to investigate rheumatologists’ knowledge, attitudes and recommendations to patients regarding food supplements, while Phase 2 focuses on estimating patients’ intake of food supplements, including the specific products used, unit consumed and reasons for their consumption. Questionnaires will be collected from at least 287 rheumatologists and 2000 patients, geographically distributed in proportion to the Italian population. These will gather information on sociodemographic variables, lifestyle factors, knowledge, clinical practices and supplement consumption.

The study protocol has been approved by the Ethics Committee of the Italian National Institute of Health (approval no. AOO 0032395 on 24 July 2024). The results, which will be widely disseminated through conference presentations, peer-reviewed publications and dedicated project webpage, will provide an understanding of the use of food supplements in rheumatology and allow guidelines to be drawn up on their correct use in the clinical practice of rheumatological diseases. Overall, this survey will increase people’s awareness of the effects of food supplements and encourage their safe and conscious use.

Post-surgical care following cochlear implantation is a pivotal part of the rehabilitation journey for cochlear implant (CI) recipients. However, frequent in-clinic visits, particularly in the first year following CI activation, can place a significant burden on CI recipients. Moreover, the growing number of CI recipients may pose a challenge for CI clinics to provide consistent and lifelong care. Cochlear Remote Care is a platform that enables the delivery of post-surgical care through remote hearing assessments and remote video appointments, offering an opportunity to enhance clinic efficiency, eliminate geographical barriers, reduce financial burdens and provide flexible post-surgical options. The primary objective of this study is to compare self-reported hearing ability in daily life among CI recipients who receive post-surgical care through Remote Care with those receiving routine in-clinic care during the first year following CI activation. Additionally, the study will assess the time and costs associated with these care models for both the clinic and patients.

This multi-centre randomised controlled trial is set to be conducted across 11 clinics in the United Kingdom, Italy, the Netherlands, Belgium and Australia, with an anticipated sample size of 148 participants. All participants will be adults with post-lingual deafness and unilateral CIs. Following baseline measurements at 3 months post-activation, participants will be randomly assigned to either in-clinic visits or Remote Care appointments. At six and 12 months after activation, participants will complete a comprehensive battery of audiometric tests and questionnaires on patient-reported outcomes, usability and resource utilisation.

Ethics approval has been obtained for each clinical site. Study findings will be disseminated widely through peer-reviewed publications, lay language summaries and conference presentations.

NCT05552118.

Lower gastrointestinal symptoms attributed to colorectal disease are common. Early diagnosis of serious colorectal disease such as colorectal cancer (CRC), precancerous growths (polyps) and inflammation is important to ensure the best possible outcomes for a patient. The current ‘gold standard’ diagnostic test is colonoscopy. Colonoscopy is an invasive procedure. Some people struggle to cope with it and require intravenous sedation and/or analgesia. It is also resource-intensive, needing to be performed in specialist endoscopy units by a trained team. Across the UK, the demand for colonoscopy is outstripping capacity and the diagnosis of colorectal disease is being delayed. A colon capsule endoscope (CCE) is an alternative colorectal diagnostic. It is a ‘camera in a pill’ that can be swallowed and which passes through the gastrointestinal tract, obtaining visual images on the colon. There is now established experience of CCE in the UK. CCE might provide a less invasive method to diagnose colorectal disease if found to be accurate and effective and provide a means by which to increase the National Health Service (NHS) diagnostic capacity.

The aim of this study is to determine the diagnostic accuracy of CCE when compared with colonoscopy in representative and clinically meaningful cohorts of patients. An evaluation of the experiences of CCE for the patient and clinical team and an assessment of cost effectiveness will be undertaken.

We will undertake three research workstreams (WS). In WS1, we shall perform a paired (back-to-back) study. Each participant will swallow the CCE and then later on the same day they will have a colonoscopy. The study has been designed in collaboration with our Patient Advisory Group and as closely mirrors standard care as is possible. 973 participants will be recruited from three representative clinical contexts; suspected CRC, suspected inflammatory bowel disease and postpolypectomy surveillance. Up to 30 sites across the UK will be involved to maximise inclusivity. Measures of diagnostic accuracy will be reported along with CCE completion rates, number of colonoscopy procedures potentially prevented and adverse events, such as capsule retention. A nested substudy of intraobserver and interobserver agreement will be performed. WS2 will develop models of cost-effectiveness and WS3 will evaluate the patient and clinician experience, with reference to acceptability and choice.

The study findings will provide the evidence base to inform future colorectal diagnostic services.

The study has approval from the North East—Tyne and Wear South research ethics committee (REC reference 24/NE/0178, IRAS 331349). The findings will be disseminated to the NHS, National Institute for Health and Care Excellence, other clinical stakeholders and participants, patients and the public.

ISRCTN16126290.

Health advocacy (HA) is acknowledged as a core competence in medical education. However, varying and sometimes conflicting conceptualisations of HA exist, making it challenging to integrate the competence consistently. While this diversity highlights the need for a deeper understanding of HA conceptualisations, a comprehensive analysis across the continuum of medical education is absent in the literature. This protocol has been developed to clarify the conceptual dimensions of the HA competence in literature as applied to medical education.

The review will be conducted in line with the JBI (formerly Joanna Briggs Institute) methodology for scoping reviews. A comprehensive literature search was developed and already carried out in eight academic databases and Google Scholar, without restrictions on publication date, geography or language. Articles that describe the HA role among students and physicians who receive or provide medical education will be eligible for inclusion. Two independent reviewers will independently complete title and abstract screening prior to full-text review of selected articles and data extraction on the final set. A descriptive-analytical approach will be applied for summarising the data.

This scoping review does not involve human participants, as all evidence is sourced from publicly available databases. Therefore, ethical approval is not required for this study. The findings from this scoping review will be disseminated through submission to a high-quality peer-reviewed journal and presented at academic conferences. By clarifying the conceptualisations of HA, this review aims to contribute to a shared narrative that will strengthen the foundation for integrating the HA role into medical education.

A preliminary version of this protocol was registered on the Open Science Framework on 9 December 2024, and can be accessed at the following link: https://osf.io/ed2br. We have also registered our scoping review protocol as a preprint at medRxiv: https://doi.org/10.1101/2024.12.09.24318699.

Preoperative exercise training is recommended, when feasible, for people undergoing resection for lung cancer and has been shown to reduce the risk of postoperative pulmonary complications and improve preoperative exercise capacity. However, preoperative exercise training programmes are not commonly available in the Australian clinical practice setting due to a range of factors including resource and time restrictions. We aim to describe the protocol to evaluate the implementation of an existing preoperative exercise training programme in people undergoing lung cancer resection in an Australian setting.

This is an evaluation of a secondary objective of a study examining the effect of lung cancer resection on exercise capacity, lung function and symptoms of dyspnoea and quality of life. Participants will be prospectively recruited at the time of lung cancer diagnosis and planned surgical treatment through the lung cancer multidisciplinary team of a metropolitan hospital in Sydney, Australia. All participants will be offered the choice of participating in the preoperative exercise training programme which encompasses a hybrid gym and telerehabilitation programme of up to five sessions/week from baseline until surgical date. The programme will be evaluated using the Reach, Effectiveness, Adoption, Implementation, Maintenance Framework including both quantitative and qualitative measures which will be analysed using descriptive statistics and qualitative analysis coded inductively.

The study has received ethical approval through the Northern Sydney Local Health District reference 2023/ETH01643 and has been registered prospectively. Findings will be disseminated through peer-reviewed publication and scientific conference presentation.

ACTRN12624000359538.