Prenatal exposure to antibiotics and the risk of orofacial clefts: a protocol for a systematic review and meta-analysis

Introduction
Orofacial clefts (OFCs), including cleft lip, cleft palate and combined cleft lip and palate, are among the most common craniofacial malformations in newborns and present significant healthcare challenges. Emerging evidence has raised concerns regarding the potential impact of prenatal exposure to antibiotics on fetal development. Antibiotics prescribed during pregnancy—particularly those that cross the placental barrier—may pose teratogenic risks. Previous studies investigating the association between prenatal antibiotic exposure and the risk of OFCs have yielded inconsistent results. However, no studies have yet attempted to summarise this evidence, highlighting the need for a comprehensive evaluation. This report describes a systematic review and meta-analysis protocol to retrospectively analyse the relationship between prenatal antibiotic exposure and the risk of developing OFCs, focusing on the role of antibiotic type and timing of exposure. The results of such a review will hopefully provide a comprehensive synthesis of the available evidence, helping to inform clinical practice and guide patient counselling regarding the use of antibiotics during pregnancy.

Methods and analysis
The planned systematic review and meta-analysis will adhere to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines to ensure a comprehensive and systematic approach to summarising the available evidence on the topic. This study will include longitudinal cohort studies, case–control studies, and interventional trials that investigate the association between prenatal antibiotic exposure and OFCs. The search strategy will cover major databases, including CINAHL, Cochrane Library, ClinicalTrials.gov, EMBASE, PubMed, Scopus and Web of Science, using tailored search terms. A team of independent assessors will screen article titles, abstracts and full texts. Any discrepancies will be resolved through discussions. Quality assessment will use the Newcastle-Ottawa Scale and Grading of Recommendations Assessment, Development and Evaluation criteria. Data extraction will focus on the study characteristics, participant details, exposure specifics and outcome measures. A random-effects meta-analysis will aggregate summary effect sizes, and heterogeneity will be assessed using I2 and Q statistics.

Ethics and dissemination
Ethical approval is not required for this systematic review, as it relies on already published data. The findings will be disseminated through peer-reviewed journals and conference presentations, providing critical insights into clinical practice and public health policies regarding antibiotic use during pregnancy.

PROSPERO registration number
CRD42024565064

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Novembre 2024

Exploring the role of health applications in promoting health among older adults: a scoping review protocol

Introduction
Evidence on the use of health apps to support healthcare and promote the health of individuals aged 55 and older is limited. Older adults face challenges with literacy, usability and accessibility of digital tools. This scoping review aims to explore how digital health apps promote healthy living and self-empowerment while identifying successful applications for older adults

Methods and analysis
This study will adopt the JBI methodology for scoping reviews, guided by the (Population, Concept, Context) framework. The results will be comprehensively reported in the final scoping review and illustrated using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. The inclusion criteria include studies from 2016 to 2024 that investigate the use of health applications within healthcare services for older adults.

Ethics and dissemination
Ethical approval is not required for this scoping review. The findings will highlight potential directions for future research and improve knowledge among professionals, researchers and the public. The results will be published in a peer-reviewed journal and disseminated through professional networks. Data will be available from the Open Science Framework.

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Novembre 2024

Enablers and barriers to the implementation of breast self-examination (BSE) education programmes among adolescent girls in Sub-Saharan Africa (SSA): an integrative systematic review protocol

Background
Breast cancer is emerging as a leading cause of mortality among women and adolescent girls in Sub-Saharan Africa (SSA). However, there is a lack of clarity on the enablers and barriers associated with the implementation of preventive strategies, such as breast self-examination (BSE), particularly among adolescent girls.

Objective
This paper presents a protocol for conducting a systematic review aiming to synthesise studies on the enablers and barriers to implementing BSE education programmes among adolescent girls in SSA.

Methods and analysis
The systematic review will be conducted from December 2024 to August 2025, following the predefined methodological framework outlined in the PRISMA guidelines. To gather relevant studies, a comprehensive search will be conducted across four main online databases, namely PubMed, Scopus, Cochrane Library and EMBASE, along with other relevant grey literature sources, such as Google Scholar, to identify pertinent literature on this topic. The screening process will involve an initial review of titles and abstracts to quickly identify relevant studies, followed by a thorough assessment of the full-text versions of selected studies. Two reviewers, working independently, will extract data and evaluate the risk of bias in the included studies using either the Joana Briggs Institute’s Critical Appraisal tool or Cochrane’s Risk of Bias tool V.2 (RoB 2). The focus of the included studies will be on BSE among adolescents aged 10 to 19 years of age. Depending on the results of the literature search and the characteristics of the findings in the selected studies, we will conduct a meta-analysis if possible. Alternatively, a narrative synthesis will be conducted. The review will provide empirical evidence to inform health promoters and policymakers in advocating for BSE, particularly, among adolescent girls in SSA, with the ultimate goal of mitigating the risk of breast cancer.

Ethics and dissemination
Since this study is based on the analysis of already published research articles, ethical approval is not required. The results will be disseminated through peer-reviewed academic publications and presentations, informing further research and practice regarding BSE education programmes.

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Novembre 2024

Scoping review of review methodologies used for guiding evidence-based practice in critical care: a protocol

Introduction
A literature review provides a synthesis on a selection of papers about a specific topic. This is used by health practitioners in critical care as in other specialities when making clinical practice decisions. The task of knowledge transfer through the review process of scientific papers involves a variety of methodologies with differing expectations on the quality and rigour that is applied. Exploration on the types of review methodologies selected by the authors of critical care literature may reveal the extent that choice of methodology has on how papers are selected and appraised may influence evidence-based practice recommendations. This scoping review aims to systematically map the breadth of current literature with the objective of identifying the types of review methodologies used by interdisciplinary authors synthesising the literature in adult critical care.

Methods and analysis
Arksey and O’Malley’s approach in conducting a scoping review will be followed and use of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Review guidelines in the reporting of findings. Papers with diverse review methodologies will be identified by searching four electronic databases (CINAHL/EBSCO, MEDLINE/PubMed, Scopus and Embase). Grey literature will be excluded due to the clinical nature of the review question. Search results will be reviewed independently by two researchers based on title and abstract followed by full-text papers that meet inclusion criteria. Characteristics of review methodologies will be collected and analysed using a tool developed by the interdisciplinary research team.

Ethics and dissemination
This scoping review will provide an overview of the types of review methodologies most often undertaken with the interdisciplinary research team synthesising the quality of critical care literature. Scrutiny will be applied to the review methodologies selected, the challenges faced and current trends in the transfer of knowledge towards evidence-based practice. The results will be disseminated by publication through a peer-reviewed journal and by presentation as a part of conference proceedings. Ethics approval is not applicable for this scoping review.

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Novembre 2024

[Articles] Public health, policy, and clinical interventions to improve perinatal care for migrant women and infants in high-income countries: a systematic review

The findings suggest that multicomponent interventions comprising multidisciplinary teams, in-person interpreting, maternal education, and social welfare support can improve perinatal outcomes for migrant women and their infants. Removing financial barriers to care may improve perinatal outcomes and be cost saving to healthcare systems. However, these findings should be interpreted with caution given that most included studies were of poor quality and that sensitivity analysis restricting to interventional studies only did not demonstrate any effect on the main outcomes of interest.

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Novembre 2024

Economic effects of priority setting in healthcare: a scoping review of current evidence

Objectives
Study objective was to map the current literature on the economic effects of priority setting at the system level in healthcare.

Design
The study was conducted as a scoping review.

Data sources
Scopus electronic database was searched in June 2023.

Eligibility criteria
We included peer-reviewed articles published 1 January 2020–1 January 2023. All study designs that contained empirical evidence on the financial effects or opportunity costs of healthcare priority setting were included excluding disease, condition, treatment, or patient group-specific studies.

Data extraction and synthesis
Two independent researchers screened the articles, and two additional researchers reviewed the full texts and extracted data. We used Joanna Briggs Institute checklists to assess the quality of qualitative, quasi-experimental and economic evaluations and the mixed methods appraisal tool for the mixed method studies. Synthesis was done qualitatively and through descriptive statistics.

Results
8869 articles were screened and 15 fulfilled the inclusion criteria. The most common study focus was health technology assessment (7/15). Other contexts were opportunity costs, effects of programme budgeting and marginal analysis, and disinvestment initiatives. Priority setting activities analysed in the studies did not achieve cost savings or cost containment (4/15) or have mixed findings at best (8/15). Only five studies found some indication of cost savings, cost containment or increased efficiency. Also, many of the studies consider costs only indirectly or qualitatively.

Conclusions
All in all, there is very little research addressing the pressing question of whether explicit priority setting and priority-setting methods can support cost containment on a health service system level (regional or national). There is limited evidence of the economic effects of priority setting.

Leggi
Novembre 2024

Inappropriate antibiotic prescription for acute tonsillitis in low- and middle-income countries (LMICs): a systematic review and meta-analysis protocol

Introduction
Tonsillitis is a self-limiting inflammatory process of the tonsils. In high-income countries, guidelines have been developed to decide if a patient needs an antibiotic or not. These guidelines help to reduce unnecessary antibiotic prescriptions and prevent the development of antimicrobial resistance (AMR). In low- and middle-income countries (LMICs), medical practitioners have the tendency to prescribe antibiotics in all cases of tonsillitis; there is an overprescription of antibiotics. These prescriptions are probably unjustified and seem to be responsible for the increased AMR seen in developing countries. The aim of this review will be to estimate the proportion of unjustified antibiotic prescriptions in LMICs.

Methods and analysis
We will conduct a systematic review of all observational studies on the diagnosis and treatment of tonsillitis in LMICs. The selected database will include PubMed, Web of Sciences Global Index Medicus and the Grey literature. The search will include studies published from January 2012 until December 2024. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, and bias will be assessed by a Risk of Bias Assessment Tool for observational studies by Hoy et al. A meta-analysis will be conducted for homogeneous studies, eventually using the random effect model. Subgroup analysis will include a period of study, study quality, countries and/or subregions of LMICs involved, study setting, age of participants, tools and definition used.

Ethics and dissemination
Formal ethical approval is not required, as primary data will not be collected. The results will be disseminated through peer-reviewed publications and presented at scientific conferences.

PROSPERO registration number
CRD 42022384957

Leggi
Novembre 2024

Exploring patient involvement in obstetrics and gynaecology education for medical students: a scoping review protocol

Introduction
It is important to incorporate the patient perspective into healthcare education, as we know that patients are experts in their own conditions. The expertise gained through lived experience serves to complement the theoretical knowledge that healthcare educators can provide. This scoping review aims to explore patient involvement in medical education within obstetrics and gynaecology, a specialty that can provide unique challenges and complexities to patient involvement due to its potentially highly sensitive and intimate nature. The goal of this study is to map the available literature on this topic which will allow for the identification of potential gaps in the provision of training for medical students in this field. The research also aims to highlight challenges that may be associated with patient involvement in this specialty in order to guide future initiatives.

Methods and analysis
The Joanna Briggs Institute scoping review framework and methodology will be used to guide and conduct this scoping review. A systematic search of electronic databases MEDLINE, CINAHL, Embase, Scopus, PsycINFO, ERIC, Google Scholar, Web of Science, African Journals Online, Cochrane Library and SciVerse will be carried out. Articles will be limited to the English language. No geographical limitations will be placed on the search. Literature from 1960 to 2023 will be considered for inclusion which corresponds with the first reports of patient educators used to assist with the demonstration of clinical skills in obstetrics and gynaecology. Relevant academic journals will be hand-searched for the previous 5 years. Identified studies will be screened by two independent reviewers and data extraction carried out by the primary researcher. Key findings will be presented in tables and summarised in narrative form. Findings from the review will be reported according to the PRISMA Extension for Scoping Reviews reporting checklist.

Ethics and dissemination
Ethical approval is not required for this study. The findings from the study will be submitted for publication in peer-reviewed journals and at medical education conferences.

Leggi
Novembre 2024

Exploring influential components and indicators in hospital resilience assessment: a scoping review protocol

Introduction
Hospitals are vital infrastructures that provide health services during emergencies and disasters. However, in recent years, disasters have led to hospital losses and interruptions in medical services. Consequently, the concept of resilience has garnered significant attention. Despite extensive research, the lack of clarity in explaining hospital resilience poses challenges in effective assessment and identifying key priorities for enhancing disaster risk management. Recently, the WHO’s Eastern Mediterranean Regional Office (EMRO) introduced a conceptual framework for the conceptualisation of hospital resilience, defining it through six interconnected components and four resilience capacities. Identifying specific indicators and characteristics for hospital resilience components based on the EMRO framework. This protocol outlines the method for conducting a scoping review to identify such indicators and characteristics to develop a comprehensive hospital resilience assessment tool.

Methods and analysis
This scoping review will adhere to the six-step protocol proposed by Arksey and O’Malley. It aims to comprehensively understand current knowledge about resilient hospital characteristics and identify effective components and indicators for assessing hospital resilience. The review will encompass available articles indexed in PubMed, Scopus and Web of Science. Additionally, searches will explore the grey literature on Google Scholar, the WHO’s website and regional offices. There will be no publication date restrictions applied to the search. Quantitative and qualitative content analyses will assess and categorise the study results. Our protocol was drafted using the Preferred Reporting Items for Systematic Reviews and Meta-analysis Protocols extension for scoping reviews.

Ethics and dissemination
This protocol describes a scoping review within a doctoral thesis focused on health in emergencies and disasters, specifically hospital resilience. The study, associated with ethics code number (IR.USWR.REC.1402.120), aims to develop a comprehensive assessment tool for hospital resilience. Once peer-reviewed and published, the findings will inform experts, policymakers and relevant organisations in emergency and disaster management.

Leggi
Novembre 2024

Non-surgical treatment for tandem spinal stenosis: a systematic review protocol

Background
Tandem Spinal Stenosis (TSS) is a disease characterised by the narrowing of the spinal canal in two or more non-adjacent areas of the spine, often affecting both the cervical and lumbar vertebrae. Doctors and patients increasingly favour non-surgical treatments that have the function of relieving symptoms and improving outcomes. This systematic review aims to evaluate the effectiveness and safety of non-surgical therapies for TSS and comprehensively summarise existing evidence.

Methods and analysis
We will conduct comprehensive searches, both manual and electronic, of literature published up to 30 September 2024; database searches will commence after the publication of this agreement, with an estimated commencement date of 1 December 2024, and the end date is 31 May 2025, without language restrictions. Key databases such as MEDLINE, PubMed, EMBASE, Web of Science, Cochrane Library, WHO International Clinical Trial Registration Platform, China National Knowledge Infrastructure, China Biomedical Literature Database, China Scientific Journal Database and Wan-Fang Database will be explored. In addition, we will include resources such as library journals and conference abstracts. Following the identification and screening of all randomised controlled trials focusing on non-surgical treatments for TSS, two investigators will perform a meta-analysis of the included studies. The findings will be summarised as the risk ratio for binary data and the standardised or weighted mean difference for continuous data.

Ethics and dissemination
Ethical approval is not required, as the review does not involve individual patient data. The review’s findings will provide clinicians with evidence on using non-surgical treatments for TSS, disseminated through peer-reviewed publications or conferences.

PROSPERO registration number
CRD42024496634.

Leggi
Novembre 2024

Surveillance of carbapenem resistance in Asian countries: a systematic review and meta-analysis

Introduction
Carbapenems are used to treat multidrug-resistant organisms as last-resort antibiotics. Resistance to carbapenems is an emerging public health threat worldwide, with alarming reported rates in Asian countries. To minimise further spread of resistant strains and guide interventions, it is important to understand the prevalence rates and causative molecular determinants. Therefore, the systematic review and meta-analysis arising from this protocol will aim to comprehensively describe the available surveillance data on carbapenem resistance in Asian countries to provide an in-depth overview of the carbapenem resistance status in this region.

Methodology and analysis
A systematic review and meta-analysis will be conducted via PubMed, ScienceDirect, Cochrane Library and Web of Science databases. Additional articles and grey literature will be searched in Google Scholar, OpenGrey and Google Chrome by manually searching the reference lists of selected studies. The review question was designed according to components in the ECLIPSE (E-expectations, C-client, L-location, I-impact, P-profile and S-service) framework. Studies conducted with samples other than clinical samples will be excluded. Only original articles published in the English language will be included. The Joanna Briggs Institute critical appraisal tool will be used to assess the quality of the included studies. A random-effects meta-analysis will be performed if the data are sufficiently homogenous. Heterogeneity between studies will be assessed via the I² statistic. The subgroup analysis will be performed considering the type of sample, pathogen type, region/country where the studies were conducted and genetic determinants.

Ethics and dissemination
As this study is conducted on the basis of published data, ethical approval is exempt. The findings of this study will be disseminated in a peer-reviewed journal with the intention of providing summarised data on the globally emerging threat of carbapenem resistance and emphasising the need to introduce alternative, more effective treatment options.

PROSPERO registration number
CRD42024515806.

Leggi
Novembre 2024

Association between life satisfaction and health behaviours among older adults: a systematic review and meta-analysis protocol

Introduction
Life satisfaction is a key indicator of successful ageing and reflects well-being. There is evidence of the association between life satisfaction and health behaviours among older adults. Therefore, this systematic review and meta-analysis protocol seeks to determine the strength and direction of the association between life satisfaction and health behaviours among older adults.

Methods and analysis
This protocol followed the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will search the electronic databases (MEDLINE, APA PsycINFO, Web of Science, CINAHL and Global Health) from inception to date. Only observational studies that described the association between life satisfaction and health behaviours—smoking, alcohol drinking, physical activity, diet/nutrition and sleep—will be included. Two independent reviewers will conduct screening, data extraction and risk of bias assessment of the articles. The risk of bias will be assessed using the Joanna Briggs Institute critical appraisal tools for cohort and analytical cross-sectional studies. Studies will be included in the meta-analysis if they report zero-order associations between life satisfaction and health behaviours; otherwise, a narrative synthesis will be presented.

Ethics and dissemination
This study does not require ethics approval, as it involves analysing secondary data from published studies. The completed review will be published in a peer-reviewed journal and presented at conferences.

Trial registration number
PROSPERO (CRD42023441386).

Leggi
Novembre 2024

Extended-duration work shifts among care workers: a scoping review protocol

Introduction
The available literature reviews of shift work among care workers are almost exclusively focused on 8-hour shifts and 12-hour shifts or 24-hour on-call shifts for physicians. We do not yet know the scope of evidence regarding extended-duration work shifts (defined as on-duty shifts of 16 or more hours per shift) in diverse healthcare settings, such as the impact on care workers and recipients of care. In this proposed scoping review, we aim to provide an overview of the current research regarding extended-duration work shifts among care workers in various healthcare settings.

Methods and analysis
We will conduct this scoping review in accordance with the Joanna Briggs Institute scoping review methodology. Comprehensive searches will be conducted in PubMed, Embase, MEDLINE, Web of Science and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases and grey literature sources. We will include empirical studies that focus on extended-duration work shifts among care workers working in different healthcare settings, including home care, community, acute care settings, long-term care homes and assisted living facilities. We will not apply language restrictions. We will conduct searches in August 2024, followed by screening of records. We will exclude research on on-call work shifts and investigations that solely focus on interns. The included literature will be screened independently by pairs of reviewers at the title and abstract review phase, followed by a full-text review for relevant literature. Any disagreement will be resolved by consensus or discussion with a third reviewer. The results will be extracted and summarised in the final report in tabular form, when possible, along with narrative synthesis.

Ethics and dissemination
All data for this study will come from published literature, so an ethics review is not necessary. The findings will be disseminated through conference presentations and publication in peer-reviewed journals, with the expectation that they will guide future research and inform future management of work shifts in care workers.

Leggi
Novembre 2024

Uses of private health provider data for governance in low-income and middle-income countries: results from a scoping review

This work grew from an interest in understanding how private data are used for health system governance in low-income and middle-income countries (LMICs).
Objective
We conducted a scoping review to understand how the public sector collects routine data from the private health sector and uses it for governance purposes. The private health sector was defined to include both formal and informal, for-profit or non-profit, actors delivering healthcare services.

Findings
We identified 4014 individual English language studies published between 2010 and 2021. We reviewed titles and abstracts of all, with 50% reviewed by two authors to ensure a common application of inclusion criteria. 89 studies were selected for review in full; following this, 26 articles were included in the final selection as they directly report on the use of routine private sector data for governance in LMICs. Only English language studies were included, limiting the scope of possible conclusions.

Results
Data were most commonly collected by the Ministry of Health or a subministerial office, with extraction from District Health Information System 2 specifically cited for three studies. 16 studies collected data on infrastructure and distribution, 15 on service delivery, 12 on health financing, 7 on pharmaceuticals and other consumables, 4 on health workforce, 4 on quality of care and 4 on epidemic surveillance.

Conclusion
The studies identified provide examples of the public sector’s capacity to collect and use data routinely collected from the private sector to perform essential governance functions. The paucity of studies identified is an indication that more attention is needed to ensure that this key area of health system governance is undertaken and that lessons learnt are shared. This review provides insights to understanding private sector health data collection and use for governance in LMICs, and for guiding activities to assess and improve this according to country context and capacity.

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Novembre 2024

Variability of quality-of-life measurements and reporting in randomised controlled trials of pancreatic cancer: a systematic review

Objectives
This systematic review aims to evaluate the methodology used in pancreatic cancer (PC) randomised controlled trials (RCTs) measuring quality of life (QOL) and focuses on the type, frequency, survey compliance and duration of these assessments.

Design
Systematic review of PC RCTs measuring QOL.

Data sources
A search of PubMed.gov and ClinicalTrials.gov was conducted for PC RCTs measuring QOL from inception to 21 March 2023. Only phase III RCTs were included. Studies were excluded if QOL was not measured, the study was phase I/II, in the second-line setting or unavailable in English. Data were independently extracted by two reviewers in a standardised fashion.

Primary and secondary outcome measures
Primary outcomes included the type of QOL instrument used, the timing and frequency of assessments, methods of analysis and survey completion rates (SCRs) over time. Secondary outcomes included patient demographics, significant QOL improvements and the frequency of trials measuring QOL.

Results
Out of 269 studies screened, 54 RCTs were identified, and 24 measured QOL (involving 11 229 patients). Instruments used included the EORTC QLQ-C30 (n=15), FACT-HEP (n=3), Spitzer-QOL-Index (n=2), EQ-5D (n=2), LASA (n=1) and FACT-PA (n=1). Most trials assessed QOL until disease progression or death (10/24), with 4-week intervals being the most common (7/24). SCRs were reported in 15/24 trials, with disease stage influencing SCRs over time. In trials with metastatic, locally advanced/metastatic, and resectable disease, the median times to reach a 50% response rate—defined as the point where the number of surveys completed was half of the enrolled participants—were 12.41 weeks (n=2), 14.14 weeks (n=10), and 54.2 weeks (n=3), respectively.” Only 2/24 trials reported significant QOL improvements between treatment arms. Patient age was reported in all trials, while race/ethnicity was only reported in 4/24 trials.

Conclusions
Significant variability exists in the timing, methods and reporting of QOL assessments in PC trials. There is a need for further research to assess the implications of missing data and consider the temporality of QOL assessment in patients with advanced cancers and poor prognosis.

Leggi
Novembre 2024