Determinants of enrolment rate in 397 clinical trials for healing diabetic foot ulcers: a systematic review

Objectives
Diabetes mellitus (DM) affects over 422 million individuals globally. Diabetic foot ulcers (DFUs) stand out as a challenging complication of DM, affecting up to 34% of individuals with DM. Despite the prevalence of DFUs, clinical trials for DFUs often face slow and insufficient patient recruitment. We aimed to identify key determinants that impact subject recruitment rates in DFU clinical trials.

Design
Systematic review.

Data sources
ClinicalTrials.gov and PubMed were searched to identify DFU clinical studies published from 1 January 1990 to 9 April 2025.

Eligibility criteria
We included English-language publications of clinical trials aimed at healing DFUs that reported enrolment numbers, duration of enrolment and number of study centres.

Data extraction and synthesis
Records were extracted and subjected to two independent rounds of review by five authors (LZ, SP, RN, HL-T, and RK). Data were pooled and analysed using negative binomial regression, Kaplan-Meier methods and Cox proportional hazards models. Study enrolment and site enrolment rates, as well as time to complete study enrolment, were analysed. Between-study heterogeneity was assessed using the likelihood ratio test.

Results
397 trials involving 31 955 participants were included. On average, DFU studies enrolled 4.24 patients per month (median: 1.65). US-based studies had slower recruitment than non-US studies, with a mean enrolment rate of 1.51 patients per site per month (median: 0.58). The average time to complete enrolment was 1.28 years. Studies that employed a higher number of study sites, were conducted outside the USA, studied behavioural or dietary supplement interventions, and began enrolment more recently, were more likely to have a higher enrolment rate. Longer time to complete enrolment was associated with a larger number of study sites, trials involving at least one US site, earlier starting enrolment year, and longer follow-up duration.

Conclusions
These findings have potential practical implications for the design and conduct of future DFU trials.

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Investigating the long-term public health and co-benefit impacts of an urban greenway intervention in the UK: a natural experiment evaluation – study protocol

Introduction
Urban green and blue space (UGBS) interventions, such as the development of an urban greenway, have the potential to provide public health benefits and multiple co-benefits in the realms of the environment, economy and society. This paper presents the protocol for a 5-year follow-up evaluation of the public health benefits and co-benefits of an urban greenway in Belfast, UK.

Methods and analysis
The natural experiment evaluation uses a range of systems-oriented and mixed-method approaches. First, using group model building methods, we codeveloped a causal loop diagram with stakeholders to inform the evaluation framework. We will use other systems methods including viable systems modelling and soft systems methodology to understand the context of the system (ie, the intervention) and the stakeholders involved in the development, implementation and maintenance phases. The effectiveness evaluation includes a repeat cross-sectional household survey with a random sample of 1200 local residents (adults aged ≥16 years old) who live within 1 mile of the greenway. The survey is complemented with administrative data from the National Health Service. For the household survey, outcomes include physical activity, mental well-being, quality of life, social capital, perceptions of environment and biodiversity. From the administrative data, outcomes include prescription medications for a range of non-communicable diseases such as cardiovascular disease, type II diabetes mellitus, chronic respiratory and mental health conditions. We also investigate changes in infectious disease rates, including COVID-19, and maternal and child health outcomes such as birth weight and gestational diabetes. A range of economic evaluation methods, including a cost-effectiveness analysis and social return on investment (SROI), will be employed. Findings from the household survey and administrative data analysis will be further explored in focus groups with a subsample of those who complete the household survey and the local community to explore possible mechanistic pathways and other impacts beyond those measured. Process evaluation methods include intercept surveys and direct observation of the number and type of greenway visitors using the Systems for Observing Play and Recreation in Communities tool. Finally, we will use methods such as weight of evidence, simulation and group model building, each embedding participatory engagement with stakeholders to help us interpret, triangulate and synthesise the findings.

Ethics and dissemination
To our knowledge, this is one of the first natural experiments with a 5-year follow-up evaluation of an UGBS intervention. The findings will help inform future policy and practice on UGBS interventions intended to bring a range of public health benefits and co-benefits. Ethics approval was obtained from the Medicine, Health and Life Sciences Research Ethics Committee prior to the commencement of the study. All participants in the household survey and focus group workshops will provide written informed consent before taking part in the study. Findings will be reported to (1) participants and stakeholders; (2) funding bodies supporting the research; (3) local, regional and national governments to inform policy; (4) presented at local, national and international conferences and (5) disseminated by peer-review publications.

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Recommendations for the use of biomarkers for the management of adults with sepsis: a scoping review and critical appraisal

Objective
A synthesis and appraisal of the recommendations for biomarkers in practice guidelines concerning sepsis is required to consolidate evidence-based practice. We generated an evidence gap map (EGM) on the use of biomarkers for managing adults with sepsis.

Design
Scoping review.

Data sources
MEDLINE, Guidelines International Network, Pan American Health Organization, Trip Database and UpToDate were searched from 2016 to March 2025.

Eligibility criteria
Guidance documents (GD) that searched at least one literature source and provided clinical recommendations for the use of biomarkers for the management (diagnosis and prognosis, including treatment response) of adults with sepsis.

Data extraction and synthesis
Two reviewers independently applied the eligibility criteria and extracted data. We used the AGREE-II (Appraisal of Guidelines for Research and Evaluation) tool to assess the GD quality. GDs that scored ≥50% on the AGREE-II ‘Rigour of development’ domain were considered robust. We also applied the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system to evaluate if the recommendations were strong or conditional.

Results
We found 10 GDs, with only half (4/8) having a robust methodology. There were 31 recommendations concerning biomarkers. Among these, 24 (77.4%) recommendations were about single biomarkers, with lactate (23; 74.2%) and procalcitonin (8; 25.8%) most frequently recommended. Biomarker testing focused on prognosis in 28 (90.3%) recommendations. Overall, 16 (51.6%) recommendations were graded strong and 13 (42.0%) were conditional, which we displayed in an EGM.

Conclusions
The methodology of GDs concerning adult sepsis was poor. Our review calls for more prudent use of biomarkers in specific prognostic scenarios and in combination with standard clinical assessments. Enhancing the methodological quality of future GDs is essential to generate more valid and robust recommendations for optimising patient care.

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Role of statins in non-small cell lung cancer treatment: a systematic review and meta-analysis

Objectives
This systematic review and meta-analysis investigates the association between statin use and clinical outcomes in non-small cell lung cancer (NSCLC) patients, focusing on the therapeutic potential of statins and their impact on patient prognosis.

Design
The review includes a mix of prospective and retrospective cohort studies and randomised controlled trials to assess the relationship between statin use and NSCLC outcomes. ROBINS-I tool was used for assessing risk of bias, ensuring methodological rigour.

Data sources
A literature search was conducted across several databases, including MEDLINE (PubMed), EMBASE, Web of Science and the Cochrane Central Register of Controlled Trials. The databases were searched from inception to June 2024.

Eligibility criteria
Participants included adult NSCLC patients prescribed statins before or after diagnosis, with no restrictions on sex, age or disease stage. Interventions of interest were statin medications, typically used for hypercholesterolemia, and also investigated for anticancer properties. The primary outcome was overall survival (OS), with secondary outcomes including progression-free survival (PFS), cancer-specific survival and NSCLC recurrence.

Data extraction and synthesis
Data extraction was performed independently by two reviewers. Results were synthesised via a random-effects model, with forest plots illustrating HRs for OS and PFS.

Results
The meta-analysis included 25 studies with 51 536 NSCLC patients. Statin use was associated with improved OS (HR 0.77, 95% CI 0.70 to 0.85). A trend towards improved PFS was observed but did not reach statistical significance (HR 0.87, 95% CI 0.71 to 1.07).

Conclusions
Statin use may improve survival outcomes in NSCLC patients. These findings support the potential therapeutic role of statins in NSCLC management and call for further clinical trials.

PROSPERO registration number
CRD42016047524.

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OptiNeoCare: optimisation of routine care in the management of severe perinatal asphyxia in full-term or near-term newborns – study protocol for analysis of suboptimal care by confidential inquiries and e-self report

Introduction
Severe perinatal asphyxia at term or near term remains a critical public health issue, associated with high risks of neonatal death and hypoxic-ischaemic encephalopathy (HIE). Despite improved clinical guidelines, suboptimal care persists in many cases, and previous audits have demonstrated that up to 50% of asphyxia cases could be associated with suboptimal care. OptiNeoCare is a French study which aims to assess the prevalence and determinants of suboptimal obstetric and neonatal care and evaluate its potential impact on neonatal outcomes.

Materials and methods
This prospective, population-based observational study will include newborns ≥36 weeks’ gestation with severe perinatal asphyxia across 12 French perinatal networks (213 maternity units). Inclusion criteria comprise neonatal death or moderate/severe HIE with confirmed biochemical markers of asphyxia. Data will be collected prospectively from labour wards, transport teams and neonatal intensive care units using an electronic case report form, and the in-situ team will be invited to complete a morbi-mortality review (MMR). Approximately 336 cases will be included over 12 months, with 25% randomly selected for confidential enquiry by two experts. The quality of care will be assessed based on a structured classification of medical errors (diagnostic, therapeutic, preventive and systemic) by a panel of experts including an obstetrician or midwife and a paediatrician. Root cause analysis will identify determinants of suboptimal care. A concordance analysis will compare findings from MMRs and confidential enquiries. Statistical analysis will include multivariable logistic regression to explore associations between care quality and neonatal outcomes.

Ethics and dissemination
Ethical approval was granted by the Ethics Committee for Research in Obstetrics and Gynaecology. Informed non-opposition is required from participants. Results will be shared with participating centres, healthcare professionals and through scientific dissemination.

Trial registration number
ClinicalTrials.gov ID: NCT06322732.

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Effect of strategies to improve interhospital transports of critically ill patients on safety and costs: protocol for a systematic review and meta-analysis

Introduction
Transporting critically ill patients between medical facilities can be hazardous and costly. Whether by road, fixed-wing aircraft or helicopter, many professional associations have proposed strategies to efficiently and safely transport patients at high risk of instability. Although these strategies have been assessed in some studies, no comprehensive synthesis of their benefits has been conducted to date. The aim of this study is to assess the effect of strategies to improve the safety and costs of interhospital transports for critically ill patients.

Methods and analysis
We will conduct a systematic review according to the Cochrane guidelines. The review will include randomised controlled trials (RCTs), cohort studies and case-control studies assessing the effect of interventions to improve interhospital transports of critically ill patients on safety and costs. We will search multiple electronic databases (PubMed, EMBASE, CINAHL, Web of Science, Cochrane Library) from inception to 6 months prior to the submission of the final manuscript. Screening by title and abstract, full-text screening, data extraction and quality assessment will be performed by two independent reviewers. We will assess the risk of bias with the Cochrane revised tool for RCTs and with the risk of bias in non-randomised studies of interventions tool. If possible, we will calculate pooled effect estimates and 95% CIs to assess the effect of the interventions. We will also assess heterogeneity using the I2 index and rate the certainty of evidence with the Grading of Recommendations Assessment, Development and Evaluation tool and trial sequential analysis.

Ethics and dissemination
Ethics approval is not required for this review. The results of this systematic review will be shared through publication in a peer-reviewed journal, conference presentations and our network of knowledge user collaborators.

PROSPERO registration number
International Prospective Register of Systematic Reviews (CRD42024595080).

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Coronary atherosclerosis screening in asymptomatic adults using coronary artery calcium for cardiovascular prevention: a systematic review of randomised controlled trials and prospective cohorts

Objectives
To review the available evidence of screening for atherosclerosis in adults in a primary prevention setting with coronary artery calcium scoring (CACS) on the impact on cardiovascular (CV) risk factor control, health behaviour and clinical events.

Design
Systematic review, reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Data sources
We searched MEDLINE, Embase and Cochrane Central Register of Controlled Trials through 22 January 2025.

Eligibility criteria
We included randomised controlled trials (RCTs) and prospective cohorts, without language restrictions, comparing adults without cardiovascular diseases undergoing CACS to a control group that either did not undergo CACS or where the participants and physicians were blinded to its result. Outcomes included changes in CV risk factor control, CV therapy, changes in health behaviour at follow-up and clinical events (all-cause and CV mortality and non-fatal CV events).

Data extraction and synthesis
Two independent reviewers extracted data and assessed the risk of bias. Due to substantial heterogeneity among the included studies, a quantitative analysis was not possible.

Results
We identified seven RCTs and one observational study, with participants ranging from 56 to 43 447 with a total of 51 554. Populations were heterogeneous with a mean age range of 42–64 years, % women ranging from 21% to 100% and mean baseline CACS from 1.37 to >100 Agatston units. Interventions following CACS were also heterogeneous, ranging from simply communicating results to participants to initiating statin therapy for detectable CACS. One RCT demonstrated improvement regarding blood pressure (BP) (n=2137; change in systolic BP: CACS: –5 mm Hg; control: –7 mm Hg; p=0.02), several an improvement in blood lipids between groups (five studies, n=3693; eg, low-density lipoprotein (LDL) cholesterol: range –6.0 to –4.9 mg/dL). Results regarding CV medication (seven studies, n=51 104) were more discrepant, with some studies showing a decrease and others an increase in indication for or usage of CV medication. Three trials (n=3338) investigated adherence to CV medication, with only one showing increased adherence to statins (CACS: 63.3%; control: 45.6%; p=0.03). Five trials (n=3692) investigated behavioural changes, with one showing an increased motivation to change lifestyle (CACS: 94%; control: 62.8%; p=0.002) and another a higher adherence in self-reported physical activity (CACS: 96%; control: 59%; p

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[Articles] Effectiveness and safety of strategies to optimise antimicrobial use in solid organ transplant recipients. Systematic review and meta-analyses

Strategies to optimise antimicrobial use are safe, with no negative impact on mortality or transplant-related complications, and appear to improve some clinical outcomes in SOTr, particularly when using perioperative antimicrobial prophylaxis in kidney SOTr and when implementing AMS programmes. No difference in the rate of surgical site infection was found between short and extended duration of antimicrobial prophylaxis for kidney and liver SOTr. This suggests that a shorter duration of antimicrobial surgical prophylaxis may be safe for transplant recipients.

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Scoping review of guidance on safe non-consultant medical staffing recommendations for UK acute hospitals

Objectives
Modern healthcare is delivered by an increasingly multidisciplinary team, complicating workforce management. Patient safety inquiries have led to reports such as the Francis and Berwick reports (2013), which consistently emphasise the need for proper staffing to ensure patient safety. While nursing has seen progress with safe staffing guidelines, there remains a significant gap in guidance for medical staff. In the UK, consultants are the senior members of the medical profession who have achieved a Certification of Completion of Training (CCT) and are able to practice independently. The number of required consultants is based on population needs, and future consultant numbers are used to determine the number of doctor training positions. However, this approach often overlooks the specific staffing needs of individual hospitals, particularly regarding patient safety. Although a named consultant is responsible for patient care, the medical workforce that handles day-to-day operations in acute hospitals consists of a diverse group of staff who require varying degrees of supervision based on their competency and seniority. This group includes medical associates, such as physician associates, and resident doctors (formerly known as junior doctors) who themselves are a heterogeneous group needing different levels of oversight. As a result, the previous focus solely on consultant staffing requirements must be broadened to address the realities of patient care. At present, no single resource provides a comprehensive summary of staffing recommendations that includes all groups within the non-consultant medical workforce. This research aims to identify existing guidance for this part of the medical workforce to support healthcare management. The objectives of this study are, therefore, to identify guidance and recommendations for safe staffing levels from a patient safety perspective for non-consultant medical staff in UK acute hospitals.

Design
A scoping literature review was conducted and is reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.

Data sources
This used five search strategies: internal website searches, Google Scholar searches, general Google searches, medical database searches via Ovid and a snowballing strategy.

Eligibility criteria
English-language resources published from 2015 to 2024 that provide specific guidance on safe medical staffing levels for National Health Service acute hospitals in the UK.

Data extraction and synthesis
Thematic analysis was employed to identify patterns in the diverse guidance discovered, using a hybrid approach that combined human and AI methods. The benefits and limitations of this method are discussed.

Results
The review yielded 10 703 resources, of which 10 met all eligibility criteria for analysis. Identified themes include staffing requirements, staffing recommendations and a tiered system approach.

Conclusions
Medical staffing is complex due to the varying roles and competencies involved. While some guidance exists, there is a clear need for more comprehensive recommendations that go beyond specific specialities. Future research should focus on developing a medical safe staffing tool and addressing the barriers to comprehensive guidance, both of which would enhance patient care.

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Effect of zinc supplementation on diarrhoea in HIV infection: a protocol for systematic review and meta-analysis of controlled clinical trials

Introduction
Diarrhoea is a common problem in people living with HIV. Some trials have demonstrated the effectiveness of zinc supplementation in the prevention and treatment of diarrhoea; however, several studies employing the effectiveness of zinc supplementation for reducing diarrhoea in HIV infection have reported heterogeneous outcomes, necessitating a systematic review to provide an exhaustive summary of current evidence. This review aims to pool the available evidence on the effectiveness of zinc supplementation on diarrhoea in HIV infection.

Methods and analysis
This systematic review protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. A systematic literature search will be conducted in Chinese and English databases, including PubMed, Scopus, Google Scholar, Cochrane Library, EMBASE, Web of Science, China National Knowledge Infrastructure, Chinese Scientific Journal Database, SinoMed and Wanfang, as part of our search strategy from inception to 17 May 2025. Two reviewers will independently identify eligible studies and extract data. The risk of bias in included studies will be assessed using version 2 of the Cochrane risk-of-bias tool for randomised trials. The risk ratio and 95% CIs will be used to estimate the efficacy of treatment and evaluation approach to rate the certainty of evidence. Cochran’s Q and the I2 will be used to evaluate statistical heterogeneity. Data will be analysed using Stata version 13.0.

Ethics and dissemination
Because no patients were involved, ethical approval was not required. The final results of this research will be submitted to a peer-reviewed journal or presented at relevant conferences, and any deviations from this protocol will be recorded and explained in the final report.

PROSPERO registration number
CRD42022328098.

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Triangular perspectives of healthcare providers, patients and their families on ICU palliative care: a protocol for a systematic review of qualitative studies

Introduction
In the intensive care unit (ICU), palliative care encounters obstacles such as decision conflicts, psychological stress and cultural differences among patients, families and healthcare providers. The well-being and the care quality of patients are influenced by these factors. The highly technical and curative-focused environment of the ICU presents a challenge for palliative care without appropriate integration. Certainly, it is imperative to comprehend these issues and devise strategies to reconcile curative and palliative needs. This paper employs qualitative metaintegration to appraise the experiences and perspectives of palliative care in the ICU, emphasising its outcomes, barriers and the necessity of balanced care and treatment.

Methods and analysis
This study conducted a comprehensive search of both the published and unpublished literature (such as grey literature) from a variety of databases, concerning PubMed, Google Scholar, Cochrane Library, CINAHL, Web of Science, Embase, Scopus, PsycINFO, CNKI, Wanfang, CBM and VIP, up to 10 July 2024. The articles will be retrieved and incorporated into EndNote X9 to facilitate organisation. Two independent researchers will evaluate the studies using the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Qualitative Research, and a third researcher will resolve all discrepancies. Data extraction and results synthesis will be performed independently based on the JBI qualitative data extraction tool. Finally, the ConQual method will be employed to estimate the calibre of the compiled results.

Ethics and dissemination
The systematic review was conducted without the necessity of obtaining ethical clearance from a research committee, as it analysed previously published studies that did not contain any personal identifying information of participants. The review’s findings were presented to key stakeholders and submitted for consideration in peer-reviewed journals.

PROSPERO registration number
CRD42024571594.

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Engagement of Indigenous peoples in commercial tobacco reform strategies: a scoping review protocol

Introduction
The tobacco and nicotine industry fuels tobacco-related addiction, disease and death. Indigenous peoples experience a disproportionate burden of commercial tobacco-related morbidity and mortality. Over the past two decades, significant progress has been made in reducing smoking prevalence among Indigenous peoples; however, smoking remains a leading contributor to the burden of death and disease. This review will summarise evidence on commercial tobacco resistance and/or eradication strategies, including policy reforms, in relation to Indigenous peoples across Oceania, the Pacific Islands and North America.

Methods and analysis
This review will follow guidelines from the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews and will be conducted in accordance with the Joanna Briggs Institute (JBI) methodology for scoping reviews. This review will consider academic and grey literature published since 1 January 2000. The following electronic databases will be searched for relevant primary research articles and commentaries: PubMed, Scopus, Informit, Web of Science and PsycINFO. Additional searches will be conducted in ProQuest to identify relevant grey literature. Papers will be screened by two reviewers to determine eligibility, followed by full-text data extraction. Findings will be synthesised descriptively for each review question and by region. Studies included in the review will be assessed against criteria for Indigenous engagement in research.

Ethics and dissemination
This protocol was led by Indigenous interests, needs and rights of Indigenous peoples, consistent with the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP), the WHO’s Framework Convention on Tobacco Control and ethical practice. This review was conceptualised with Indigenous leadership and through engagement, including but not limited to the Indigenous lived experience of the authors (MK, E-ST, HC, PNH, PH, SAM, AW, SW and RM). This review supports the global goal of eradicating commercial tobacco-related harms – reframing commercial tobacco use as a structurally imposed harm sustained by colonial and commercial forces rather than personal choice. Findings from this review will be shared with Indigenous partners and communities who requested this work and will be submitted for peer-reviewed publication.

Review registration
Open Science Framework https://osf.io/wxqcb

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Evaluation of a virtual reality-directed brain-gut behavioural treatment inpatient program for patients with inflammatory bowel disease: protocol for a pilot feasibility trial

Introduction
Pain is one of the most bothersome symptoms that affects patients with inflammatory bowel disease (IBD) but is often inadequately treated. Inadequate pain control in the inpatient setting not only impacts patients’ experience but increases opioid use and hospital length of stay. Opioids are often considered first-line treatment for severe pain but are associated with significant morbidity and mortality in IBD. Non-steroidal anti-inflammatory drugs are a non-opioid analgesic option, but concerns regarding their contribution to IBD flares have limited their use. Brain-gut behavioural therapies (BGBT), such as cognitive behavioural therapy, meditation and gut-directed hypnotherapy, are effective for pain management and have a role in the treatment of IBD symptoms. However, the use of BGBT in IBD is challenging, given limited access to behavioural health specialists, especially in the inpatient setting. Virtual reality (VR)-directed BGBT programmes can bridge this gap and enhance pain treatment for inpatients with IBD. Therefore, in this study, we aim to establish feasibility and acceptability for a VR-directed BGBT inpatient programme for patients with IBD.

Methods and analysis
We will recruit 40 patients with IBD who are hospitalised at Michigan Medicine and who endorse IBD-related pain. We will assess patient-reported outcomes (pain rating, IBD-specific symptoms, perceived stress, mood) before and after treatment, cumulative inpatient analgesic requirements and hospital length of stay. Our primary objective will be to establish intervention feasibility defined by the frequency and percentage of enrolled participants that use the VR-directed BGBT inpatient intervention in any capacity. Our secondary objective will be to evaluate intervention acceptability by conducting semistructured interviews with study participants. We will also explore the preliminary effectiveness of VR-directed BGBT on patient-reported outcomes and healthcare utilisation as compared with historic controls.

Ethics and dissemination
The study was approved by the institutional review board of the University of Michigan Medical School on 10 October 2023 (HUM00240999). All human subjects will be required to sign an informed consent document prior to study participation. Study findings will be reported through peer-reviewed publication.

Trial registration number
NCT06188793.

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Gender disparities in COVID-19 vaccine hesitancy in high-income countries: an umbrella review protocol

Introduction
Vaccine hesitancy remains a critical public health challenge, especially in high-income countries. Gender differences in vaccine hesitancy can significantly affect vaccination rates and public health outcomes. The aim of this research is performing an umbrella review and meta-analysis to systematically investigate gender disparities in vaccine hesitancy for COVID-19 in high-income countries, as well as the quality, potential biases and dependability of epidemiological evidence.

Methods and analysis
The study will systematically search, extract and analyse data from reported systematic reviews and meta-analyses that focus specifically on gender differences in vaccine hesitancy. The search will include CINAHL, Cochrane Library, PubMed/MEDLINE, EMBASE and Epistemonikos for studies published from 2019 onward. The inclusion criteria will encompass systematic reviews and meta-analyses of non-interventional studies conducted in high-income countries. The identified factors contributing to vaccine hesitancy will be categorised based on demographic, psychological, social and economic dimensions. The methodological quality of the included meta-analyses will be assessed using the “Joanna Briggs Institute Critical Appraisal Checklist for Systematic Reviews and Research Syntheses” tool.

Ethics and dissemination
Ethical approval is not required for this umbrella review. These results will be published in a peer-reviewed journal.

PROSPERO registration number
CRD42024572978.

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Characterising socially accountable research: a scoping review protocol paper

Introduction
Social accountability is a key value and aspirational goal of many medical institutions. While much has been studied on social accountability in the context of medical education and institutions, less research has examined how social accountability influences research. In light of this absence, the objective of our scoping review is to research the following questions: (1) What characterises socially accountable research (SAR), and how is it expressed and experienced? (2) How do language, positionality, and worldview influence SAR?, and (3) What structures and considerations are necessary to support successful SAR in local and global contexts?

Methods and analysis
To answer the above research questions, the Arksey and O’Malley, Levac et al, Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews and Joanna Briggs Institute (JBI) guidelines will be followed. The search strategy was adapted and applied to MEDLINE, Embase, ERIC, and CINAHL databases. A total of n=5289 eligible articles were identified. Articles were excluded if they were published before 1995, were in a language other than English, or were duplicates, leaving n=2840 articles for title/abstract screening.

Ethics and dissemination
Ethical approval is not required to complete this study. We will take an integrated knowledge translation approach. Throughout the project, results will be disseminated to knowledge users (ie, consultations, following Arksey and O’Malley). Our findings will be presented to the larger academic community, policymakers, and healthcare practitioners through presentations, reports, newsletters, and an online repository.

Trial registration number
Open Science Framework 16 July 2024. osf.io/mvhnu.

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