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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[Articles] The impact of biological interventions on health-related quality of life in adults with Crohn's disease: a systematic review with meta-analysis

Methodological issues in HRQoL measurement, including the need for larger sample sizes, standardized reporting, and uniform participant characteristics, contribute to the low methodological quality of current evidence on the impact of biological agents on HRQoL in CD. There is a large unmet need to investigate the association between clinical outcomes and HRQoL outcomes more thoroughly.

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Azithromycin as adjunctive treatment for uncomplicated severe acute malnutrition (AMOUR): study protocol for a double-masked randomised controlled trial

Introduction
Amoxicillin is recommended for children with uncomplicated severe acute malnutrition (SAM). However, some trials have shown no difference in amoxicillin for nutritional recovery in children with SAM compared with placebo. In addition, amoxicillin treatment requires two times per day dosing for 7 days, which may influence adherence. Azithromycin is a broad-spectrum antibiotic that can be provided as a single dose and has reduced mortality in children aged 1–59 months when provided by mass drug administration. The AMOUR trial is designed to assess amoxicillin, azithromycin and placebo as part of outpatient treatment of uncomplicated SAM.

Methods and analysis
This double-masked randomised controlled trial will enrol 3000 children over 3 years in an individually randomised 1:1:1 allocation to azithromycin, amoxicillin or placebo arms and follow them for 12 months. Children eligible to enrol in the study will be aged 6–59 months and have uncomplicated non-oedematous SAM as defined by weight-for-height Z-score

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Methods of assessment of diabetic retinopathy in low- and middle-income countries: a protocol for scoping review

Introduction
Globally, over a hundred million people are estimated to suffer from diabetic retinopathy (DR), which is a major complication of diabetes mellitus (DM). The prevalence of DM is projected to increase from the current 537 million by almost 50%, to 783 million by 2045. As a result, DR is one of the fastest rising causes of preventable blindness. Three out of four people suffering from DM live in low- and middle-income countries (LMICs), where resources for both diagnosis and treatment are lacking. There has been a reduction in the rate of blindness from DR in high-income countries, while an opposite trend has been noted in LMICs, contributing to this massive morbidity burden. This scoping review aims to ascertain the methods used to assess DR in LMICs.

Methods and analysis
The scoping review will adhere to the Preferred Reporting Items for Systematic Review and Meta-Analysis extension for Scoping Review (PRISMA-ScR) guidelines and the Arksey and O’Malley (2005) methodology framework. A systematic search of peer-reviewed literature will be carried out for all papers up to 15 May 2025 by identifying studies from electronic databases, including Embase, Medline and CENTRAL (Cochrane Library). A hand search of the associated reference lists of included studies and grey literature will also be conducted. The identified studies will be screened based on agreed eligibility (inclusion/exclusion) criteria by two independent reviewers, with any disagreements resolved via arbitration from a third reviewer. The data will be thematically summarised according to different aspects of DR assessment methods, and key findings will be elicited. The key findings will provide a comprehensive and clear understanding of the assessment methods used to identify DR in LMICs.

Ethics and dissemination
Ethical approval was not sought for this work as only publicly available information is used. The results will be disseminated through a peer-reviewed publication, conference presentations and meetings with stakeholders.

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Epistemologies, methodologies and theories used in qualitative Global North health and social care research: a scoping review protocol

Introduction
In qualitative research, there are different approaches to defining and engaging with social reality. Epistemology, as the study of knowledge and knowledge creation, influences the methodologies and theories used by researchers. A growing literature questions the universality of Western-centric and Global North research methodologies and theories and highlights their Western epistemological roots. While Western frameworks are appropriate for Western contexts, it is a fallacy to assume that they represent global realities, thereby marginalising Global South knowledge systems. Thus, the aim of this scoping review is to analyse the underlying epistemologies, methodologies or theories that are evident in qualitative research conducted by researchers from the Global North in their research on, for or with people from the Global South.

Methods and analysis
The review will be conducted using the Joanna Briggs Institute framework for scoping reviews. A search strategy will be developed to identify published and unpublished literature in CINAHL, Embase, Google Scholar, MEDLINE, ProQuest, PsycINFO and Web of Science. All potential papers will be exported to the reference manager Zotero, and the results will be uploaded to Rayyan. Studies are selected using a three-step process and documented using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses flowchart. The abstracted studies will then be collated using the PAGER framework to identify the patterns, advances, gaps, evidence and recommendations that help to understand the review question.

Ethics and dissemination
As this is a secondary analysis, our research does not require ethical approval, but we will scrutinise all included studies for inclusion of an ethical approval statement. We intend to share our findings through peer-reviewed international journals and presentations at conferences, as well as collaborating with colleagues in related fields.

Study registration
The protocol for this scoping review has been registered with the Open Science Framework (https://doi.org/10.17605/OSF.IO/5BUZX).

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Asthma self-knowledge patient-reported outcome measures for the paediatric population with asthma: a systematic review protocol

Introduction
Asthma is a major personal and public health problem worldwide, with a significant impact on patients’ quality of life and health systems. The prevalence of asthma in children is 9.1% and in adolescents is 11%. Greater literacy among children is related to better asthma control. There are many validated Patient-Reported Outcome Measures (PROMs) related to asthma, but there are only a few, and no gold standard, to measure children and adolescents’ knowledge of asthma. Therefore, the purpose of this systematic review is to evaluate the most suitable asthma self-knowledge PROMs for the paediatric population with asthma.

Methods and analysis
The inclusion criteria will be children and adolescents diagnosed with asthma (population), validated PROMs about asthma self-knowledge (intervention), between each PROM (comparison) and measurement properties (outcome) (validity, reliability, interpretability and responsiveness). The search process will be conducted in PubMed, Web of Science, EMBASE and SCOPUS. The risk of bias evaluation will be done independently by two authors with the COnsensus-based Standards for the selection of health Measurement INstruments risk of bias checklist, and the quality of evidence will be evaluated based on the Grading of Recommendations Assessment, Development and Evaluation approach.

Ethics and dissemination
Ethics approval is not applicable for this study since the data that will be collected are secondary data and are already in the public domain. The results will be disseminated through peer-reviewed publication and conference presentations.

PROSPERO registration number
CRD42024577500.

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Achieving impactful treatment for paediatric endocrine disorders in low- to middle-income countries (LMICs): a scoping review

Objectives
Endocrine disorders, such as hypo/hyperthyroidism and diabetes, affect over 5% of the world’s population, with an additional 5% of cases remaining undiagnosed. Despite the increasing prevalence of endocrine disorders, especially in low- to middle-income countries (LMICs), limited research offers comprehensive guidance on treating this complex medical field. This scoping review aims to provide evidence-based recommendations for efficient, effective and accessible treatment of paediatric thyroid conditions and diabetes in LMICs.

Design
Scoping review guidelines outlined by the Preferred Reporting Items for Systematic and Meta-Analysis Extension for Scoping Reviews, using the Joanna Briggs Institute (JBI) methodology to analyse healthcare administration approaches in LMICs.

Data sources
PubMed, Google Scholar, MEDLINE, EconLit, Science Direct and Scopus were searched using a set of search terms from 19 December 2023 to 16 January 2024. An additional high-level search was performed in May 2025.

Eligibility criteria
Selection of a variety of peer-reviewed publications with a setting in LMICs. Articles were included if they described an intervention strategy related to select paediatric chronic diseases, endocrine conditions or non-communicable diseases. The treatment strategies in question were government initiatives, mobile health, specialised programmes and primary care.

Data extraction and synthesis
One reviewer manually reviewed articles and documented findings on Microsoft Excel. In accordance with JBI methodological guidelines, no risk of bias assessment or quality appraisal of included studies was conducted.

Results
After reviewing primary care, specialised care, government intervention programmes and mobile care initiatives within developing countries, primary care with an emphasis on task shifting emerged as the best approach for treating paediatric endocrine disorders.

Conclusion
Despite recommendations favouring specialised care or government interventions, primary care proves to be the optimal method for treating endocrine conditions. Given limited healthcare funding in LMICs, implementing primary care initiatives can achieve significant health outcomes while maximising resources.

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Perceptions of human papillomavirus vaccination among adolescent boys and their parents in high-income countries: a scoping review protocol

Background
Human papillomavirus (HPV) is the most common cause of cervical cancer in women. However, among adolescent boys, initial exposure to HPV is associated with a higher risk of developing oropharyngeal and oral cancers compared with girls. Notably, the incidence of oropharyngeal cancer has been rising sharply in high-income countries, yet HPV vaccination coverage among adolescent boys remains suboptimal. Therefore, understanding the perceptions of adolescent boys and their parents regarding HPV vaccination in high-income countries is crucial for the development of effective public health strategies.

Objectives
This scoping review aims to explore the perceptions of adolescent boys and their parents regarding HPV vaccination and investigate the facilitating factors and barriers influencing HPV vaccination.

Methods and analysis
The method framework of Arksey and O’Malley, the Joanna Briggs Institute, as well as the recommendations of Levac will be used to conduct the scoping review. This scoping review will be reported in accordance with the PRISMA extension for scoping reviews checklist. A systematic literature search will be performed on Ovid-MEDLINE, CINAHL, Cochrane CENTRAL, Ovid-Embase, PsycINFO and Web of Science. Two reviewers will independently perform the study selection and data extraction. Identified studies will be extracted using a customised extraction template on Covidence and analysed descriptively using narrative synthesis. The review commenced in April 2024 and will be completed in July 2025.

Ethics and dissemination
Formal ethical approval is not required, as primary data will not be collected for this study. The findings will be disseminated through publication in a peer-reviewed journal.

Registration
This protocol has been registered with the Open Science Framework (https://doi.org/10.17605/OSF.IO/M5NH2).

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Prognostic factors associated with failure of total elbow replacement: a protocol for analysis of National Joint Registry data in England

Introduction
Understanding the prognostic factors associated with the failure of total elbow replacement (TER) is crucial for informing patients about risks and enabling shared decision-making regarding TER as a definitive management option. This protocol outlines the planned analysis of National Joint Registry (NJR) data to investigate prognostic factors for TER failure.

Methods and analysis
The primary analysis will use the NJR elbow dataset, including all eligible patients who underwent TER surgery between April 2012 and December 2023. To incorporate ethnicity and comorbidities as potential prognostic factors, the NJR will be linked to the National Health Service (NHS) England Hospital Episode Statistics-Admitted Patient Care (HES-APC) data for a secondary analysis. The analysis will adhere to the REporting recommendations for tumour MARKer prognostic studies guidelines. The primary outcome under investigation is TER failure, defined as requiring revision surgery. Initially, the overall prognosis of TER will be examined using unadjusted net implant failure via the Kaplan-Meier method. The list of potential prognostic factors to be investigated in this study has been informed by a systematic review on this topic, input from patient and public involvement and engagement (PPIE) groups and a survey shared with healthcare professionals providing TER services. The relationship between each potential prognostic factor and failure will be assessed using univariable regression methods. Based on the findings from our systematic review, the univariable association will also be adjusted for age, sex and indication for TER surgery using multivariable regression methods. The extent of missing data will be reported, and the reasons for missing data will be explored. A very high degree of data completeness is expected, and a complete case analysis will be performed as the primary analysis. Multiple imputations will be considered as a sensitivity analysis.

Ethics and dissemination
The NJR research committee approved this analysis, and the NHS Health Research Authority tool guidance dictates that the secondary use of such data for research does not require approval from a research ethics committee. The results from this analysis will be published in a peer-reviewed journal and presented at scientific conferences.

Trial registration number
NCT06760585.

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Consensus-based development and practice testing of a generic quality indicator set for parenteral medication administration at home: a RAND appropriateness method study

Objectives
Due to nursing shortages, an ageing population and increasing care demand, there is a growing interest in parenteral medication administration at home (PMAaH), comprising the administration of parenteral medication in the home situation of patients. The operational design of such PMAaH care pathways is complex, resulting in many variations of adoptions, showing a need for a quality framework. Although quality indicators (QIs) have been proposed to monitor the quality of specific care pathways, a generic quality framework for all types of PMAaH is lacking. Therefore, this study proposes a generic quality set for PMAaH, which includes structure and process QIs, to benchmark and redesign PMAaH care pathways to ensure high quality.

Design
A generic QI set was developed for PMAaH using a systematic RAND appropriateness method adapted at the third phase. This method consisted of a scoping review to identify indicators, an expert panel rating phase including an online questionnaire and subsequent panel meeting to assess the appropriateness of the indicators and a retrospective practice testing to evaluate the feasibility, clarity and measurability of the indicators. After the practice testing, which consisted of an online questionnaire where experts could indicate the implementation state of all indicators in their hospital, a third expert panel adjusted the set to increase the likelihood of implementation in practice.

Setting
The experts, all healthcare professionals involved in PMAaH processes, were recruited using the snowball sampling technique from three large Dutch, teaching hospitals. Subsequently, a practice testing by self-assessment was conducted in seven large Dutch teaching hospitals.

Participants
17 and seven healthcare professionals with diverse backgrounds participated in the online questionnaire and panel meeting, respectively.

Results
The scoping review resulted in 36 QIs for PMAaH. After two expert panel rating rounds (online questionnaire and panel meeting), two indicators were removed: a QI related to travel distance policy since it was irrelevant and redundant, and a QI stating that a clinician should take the lead in a PMAaH-team, which was deemed too restrictive. After the practice testing, two QIs were removed: a QI related to clinical response documentation, which was unclear for the practice testing respondents and already covered by other QIs, and a QI related to survival documentation, which was deemed infeasible and undesirable to measure this differently than other patients by the third expert panel.
The final set consists of 32 indicators (of which 15 were structure indicators and 17 were process indicators). The final set predominately includes QIs that are aimed at patient safety but also QIs focusing on the working conditions of the healthcare workers. 17.6% of the QIs are currently fully implemented in general in all seven hospitals. The practice testing revealed that operational QIs are more frequently implemented in practice than systemic QIs and that a structured quality assurance programme is needed in the hospitals.

Conclusions
This study proposes a generic quality set for PMAaH that hospitals can use to redesign and benchmark PMAaH care pathways to assure high quality. The practice testing confirmed that there is a need for this structured quality set.

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[Review] Advocating for the recognition of underlying immunosuppression in critical illness

Immunosuppression, characterised by impaired immune function, significantly influences infection risk and ICU admissions in critically ill patients. This manuscript highlights the need for grading criteria to assess pre-existing immunosuppression, considering factors like underlying diseases, immunosuppressive therapies, and clinical outcomes variability. We propose a grading system categorising immunosuppression as mild, moderate, or severe. These criteria, while preliminary, offer a foundation for future refinement.

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