Definition and key concepts of high-performing health systems: a scoping review

Objectives
To determine how high performing is defined in relation to a health system and chart the literature on the definitions and key concepts of high-performing healthcare systems.

Design
Scoping review.

Data sources
MEDLINE, EMBASE, CINAHL and the Cochrane Central Register of Controlled Trials were searched from inception to July 2024. The grey literature was also searched.

Eligibility criteria
Included studies reported on health systems and high performance to identify explicit definitions, research outcomes and knowledge gaps.

Results
Two reviewers independently screened 5721 citations and 507 full-text articles, resulting in the inclusion of 35 primary articles and 47 companion documents in the review. Three independent definitions for a high-performance health system were identified. 24 research studies reported outcomes on the elements of a high-performing health system (58%), system evaluation (32%) and tool development or validation (10%). Knowledge gaps identified were the lack of a common definition, a lack of common indicators, strategies for moving evidence into policy and practice, and difficulties with comparisons across health systems.

Conclusions
We found limited definitions and a lack of empirical evidence on our topic. There is an opportunity for primary research in the area of health systems and high performance.

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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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Construction of a quality evaluation indicator system for extended care in patients with chronic obstructive pulmonary disease: a cross-sectional study

Objective
The aim of this study was to construct a quality evaluation indicator system for extended care in patients with chronic obstructive pulmonary disease (COPD), provide beneficial references for quality evaluation and practice standardisation of extended care.

Design
This study was conducted from April to November 2023. Based on the three-dimensional quality structure model of ‘structure–process–result’, we used literature review and Delphi method to form the quality evaluation indicator system for extended care in patients with COPD and determined the weight of each indicator by analytic hierarchy process (AHP).

Setting
Zhengzhou Central Hospital Affiliated to Zhengzhou University and School of Nursing and Health, Zhengzhou University, Zhengzhou, Henan, China.

Participants
20 experts from different universities and hospitals in China participated in the study. They all had profound attainments in clinical treatment, nursing and extended care of COPD.

Primary outcome measures
Effective questionnaire response rate, coefficient of expert authority, arithmetic mean, proportion of maximum score, Kendall harmony coefficient, scores of importance, variation coefficient and weight were used to evaluate the quality evaluation indicator system for extended care.

Results
In the two rounds of Delphi expert consultation, the effective questionnaire response rates were both 100%. The coefficients of expert authority were 0.83 and 0.89, respectively. Kendall harmony coefficients were 0.088 and 0.215, respectively. The final formed quality evaluation indicator system for extended care included 3 primary indicators, 10 secondary indicators and 40 tertiary indicators. For each indicator, the variation coefficient was 0.063–0.151 and the weight was 0.001–0.065.

Conclusion
The quality evaluation indicator system for extended care based on mature theoretical basis and scientific method is scientific and reliable. And the weight of each indicator is set reasonably and accurately, which could provide a basis for quality evaluation and continuous quality improvement of extended care.

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Systematic mapping review of statistical methods applied to the relationships between cancer diagnosis and geographical level factors in UK

Objectives
We examined studies that analysed the spatial association of cancers with demographic, environmental, behavioural and/or socioeconomic factors and the statistical methods applied.

Design
Systematic mapping review.

Data sources
Web of Science (SSCI) (search on 28 July 2022), MEDLINE, SocINDEX and CINAHL (search on 4 August 2022), additional searches included grey literature.

Eligibility criteria for selecting studies
(1) Focused on the constituent countries of the UK (England, Wales, Scotland and Northern Ireland) and its major regions (eg, the North West); (2) compared cancer(s) outcomes with demographic, environmental, behavioural and socioeconomic characteristics by applying methods to identify their spatial association; (3) reported cancer prevalence, incidence rates, relative risk or ORs for a risk factor or to an average level of cancer.

Data extraction and synthesis
A standardised data extraction form was developed and for all studies, core data were extracted including bibliographic information, study design, geographical factors analysed, data aggregation level, methods applied and main findings. We described and synthesised the characteristics of the studies using summary tables, charts and graphs.

Results
52 studies were included covering a variety of objectives and geographical scales. These studies considered different types of cancer, with the most common cancer types analysed being blood and lymphoid cell cancers. The most common methods used to assess the association between cancers and geographical level factors were regression analyses, with the majority being Poisson regression, then logistic and linear regression. Studies were usually conducted at ward and local authority level, or by exact point location when distances from putative risk sources were considered. The results were usually presented in plots or as tables, instead of maps.

Conclusion
Our results highlight the lack of consideration of spatially explicit models in the analysed studies, with the risk of having failed the assumption of independence in the data.

PROSPERO registration number
CRD42022349165.

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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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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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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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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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[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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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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Cognitive deficits in treatment-resistant depression: protocol for a systematic review and meta-analysis

Introduction
Major depressive disorder (MDD) is a major global healthcare challenge. This is, in part, due to the lack of treatment response and chronic course of MDD. Such a course of illness is often termed treatment-resistant depression (TRD) and is seen in over one-third of people with MDD. Reasons for treatment resistance are not well established, nor is the definition of TRD. Duration and severity of depression, however, are associated with TRD and are also associated with cognitive deficits. Thus, TRD could be particularly prone to cognitive deficits and at heightened risk for neuroprogression. While the cognitive profile of MDD has been investigated in several systematic reviews, no systematic review of cognition in TRD exists to date. The present study will fill this gap in the literature. It is expected that TRD will show more severe cognitive deficits than generally reported in MDD and deficits in all cognitive functions are expected.

Methods and Analysis
A systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be performed of the databases Embase, Pubmed/MEDLINE, PsychINFO and Cochrane including peer-reviewed studies on humans using standardised cognitive tests. Pilot searching was performed in January 2025 and the full search will be commenced in June 2025, with additional searches following completion. Where sufficient data are reported, a meta-analysis comparing deficits in TRD with MDD and healthy control participants will be performed; alternatively, effects based on norms will be calculated. Meta-regression, subgroup and sensitivity analyses will be conducted to explore moderators that are sufficiently reported in the literature. The quality of studies will be assessed by the Newcastle-Ottawa Scale.

Ethics and dissemination
Ethical approval is not necessary to perform the study, and results will be presented at a suitable conference and published in a peer-reviewed journal.

Prospero registration number
CRD42024538898.

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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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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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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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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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