Tools, techniques, methods, and processes for the detection and mitigation of fraudulent or erroneous data in evidence synthesis: a scoping review protocol.

OBJECTIVE: This scoping review aims to identify, catalogue, and characterize previously reported tools, techniques, methods, and processes that have been recommended or used by evidence synthesizers to detect fraudulent or erroneous data and mitigate its impact. INTRODUCTION: Decision-making for policy and practice should always be underpinned by the best available evidence-typically peer-reviewed scientific literature. Evidence synthesis literature should be collated and organized using the appropriate evidence synthesis methodology, best exemplified by the role systematic reviews play in evidence-based health care. However, with the rise of "predatory journals," fraudulent or erroneous data may be invading this literature, which may negatively affect evidence syntheses that use this data. This, in turn, may compromise decision-making processes. INCLUSION CRITERIA: This review will include peer-reviewed articles, commentaries, books, and editorials that describe at least 1 tool, technique, method, or process with the explicit purpose of identifying or mitigating the impact of fraudulent or erroneous data for any evidence synthesis, in any topic area. Manuals, handbooks, and guidance from major organizations, universities, and libraries will also be considered. METHODS: This review will be conducted using the JBI methodology for scoping reviews and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). Databases and relevant organizational websites will be searched for eligible studies. Title and abstract, and subsequently full-text screening will be conducted in duplicate using Covidence. Data from identified full texts will be extracted using a pre-determined checklist, while the findings will be summarized descriptively and presented in tables. THIS SCOPING REVIEW PROTOCOL WAS REGISTERED IN OPEN SCIENCE FRAMEWORK: https://osf.io/u8yrn.

An Umbrella Review of Meta-Analyses Evaluating Associations between Human Health and Exposure to Major Classes of Plastic-Associated Chemicals.

Background: Epidemiological research investigating the impact of exposure to plastics, and plastic-associated chemicals, on human health is critical, especially given exponentially increasing plastic production. In parallel with increasing production, academic research has also increased exponentially both in terms of the primary literature and ensuing systematic reviews with meta-analysis. However, there are few overviews that capture a broad range of chemical classes to present a state of play regarding impacts on human health. Methods: We undertook an umbrella review to review the systematic reviews with meta-analyses. Given the complex composition of plastic and the large number of identified plastic-associated chemicals, it was not possible to capture all chemicals that may be present in, and migrate from, plastic materials. We therefore focussed on a defined set of key exposures related to plastics. These were microplastics, due to their ubiquity and potential for human exposure, and the polymers that form the matrix of consumer plastics. We also included plasticisers and flame retardants as the two classes of functional additive with the highest concentration ranges in plastic. In addition, we included bisphenols and per- and polyfluoroalkyl substances (PFAS) as two other major plastic-associated chemicals with significant known exposure through food contact materials. Epistemonikos and PubMed were searched for systematic reviews with meta-analyses, meta-analyses, and pooled analyses evaluating the association of plastic polymers, particles (microplastics) or any of the selected groups of high-volume plastic-associated chemicals above, measured directly in human biospecimens, with human health outcomes. Results: Fifty-two systematic reviews were included, with data contributing 759 meta-analyses. Most meta-analyses (78%) were from reviews of moderate methodological quality. Across all the publications retrieved, only a limited number of plastic-associated chemicals within each of the groups searched had been evaluated in relevant meta-analyses, and there were no meta-analyses evaluating polymers, nor microplastics. Synthesised estimates of the effects of plastic-associated chemical exposure were identified for the following health outcome categories in humans: birth, child and adult reproductive, endocrine, child neurodevelopment, nutritional, circulatory, respiratory, skin-related and cancers. Bisphenol A (BPA) is associated with decreased anoclitoral distance in infants, type 2 diabetes (T2D) in adults, insulin resistance in children and adults, polycystic ovary syndrome, obesity and hypertension in children and adults and cardiovascular disease (CVD); other bisphenols have not been evaluated. Phthalates, the only plasticisers identified, are associated with spontaneous pregnancy loss, decreased anogenital distance in boys, insulin resistance in children and adults, with additional associations between certain phthalates and decreased birth weight, T2D in adults, precocious puberty in girls, reduced sperm quality, endometriosis, adverse cognitive development and intelligence quotient (IQ) loss, adverse fine motor and psychomotor development and elevated blood pressure in children and asthma in children and adults. Polychlorinated biphenyls (PCBs), polybrominated diphenyl ethers (PBDEs) but not other flame retardants, and some PFAS were identified and are all associated with decreased birth weight. In general populations, PCBs are associated with T2D in adults and endometriosis, bronchitis in infants, CVD, non-Hodgkin's lymphoma (NHL) and breast cancer. In PCB-poisoned populations, exposure is associated with overall mortality, mortality from hepatic disease (men), CVD (men and women) and several cancers. PBDEs are adversely associated with children's cognitive development and IQ loss. PBDEs and certain PFAS are associated with changes in thyroid function. PFAS exposure is associated with increased body mass index (BMI) and overweight in children, attention deficit hyperactive disorder (ADHD) in girls and allergic rhinitis. Potential protective associations were found, namely abnormal pubertal timing in boys being less common with higher phthalate exposure, increased high-density lipoprotein (HDL) with exposure to mono(2-ethyl-5-oxohexyl) phthalate (MEOHP) and reduced incidence of chronic lymphocytic lymphoma (a subtype of NHL) with PCB exposure. Conclusions: Exposure to plastic-associated chemicals is associated with adverse outcomes across a wide range of human health domains, and every plastic-associated chemical group is associated with at least one adverse health outcome. Large gaps remain for many plastic-associated chemicals. Recommendations: For research, we recommend that efforts are harmonised globally to pool resources and extend beyond the chemicals included in this umbrella review. Priorities for primary research, with ensuing systematic reviews, could include micro- and nanoplastics as well as emerging plastic-associated chemicals of concern such as bisphenol analogues and replacement plasticisers and flame retardants. With respect to chemical regulation, we propose that safety for plastic-associated chemicals in humans cannot be assumed at market entry. We therefore recommend that improved independent, systematic hazard testing for all plastic-associated chemicals is undertaken before market release of products. In addition because of the limitations of laboratory-based testing for predicting harm from plastic in humans, independent and systematic post-market bio-monitoring and epidemiological studies are essential to detect potential unforeseen harms.

Methodological components, structure and quality assessment tools for evidence summaries: a scoping review.

OBJECTIVE: The objective of this review was to identify and map the available information related to the definition, structure, and core methodological components of evidence summaries, as well as to identify any indicators of quality. INTRODUCTION: Evidence summaries offer a practical solution to overcoming some of the barriers present in evidence-based health care, such as lack of access to evidence at the point of care, and the knowledge and expertise to evaluate the quality and translate the evidence into clinical decision-making. However, lack of transparency in reporting and inconsistencies in the methodology of evidence summary development have previously been cited and pose problems for end-users (eg, clinicians, policymakers). INCLUSION CRITERIA: Any English-language resource that described the methodological development or appraisal of an evidence summary was included. METHODS: PubMed, Embase, and CINAHL (EBSCOhost) were systematically searched in November 2019, with no limits on the search. The search was updated in June 2021 and January 2023. Gray literature searches and pearling of references of included sources were also conducted at the same time as the database searches. All resources (ie, articles, papers, books, dissertations, reports, and websites) were eligible for inclusion in the review if they evaluated or described the development or appraisal of an evidence summary methodology within a point-of-care context and were published in English. Literature reviews (eg, systematic reviews, rapid reviews), including summaries of evidence on interventions or health care activities that either measure effects, a phenomena of interest, or where the objective was the development, description or evaluation of methods without a clear point-of-care target, were excluded from the review. RESULTS: A total of 76 resources (n=56 articles from databases and n=20 reports from gray literature sources) were included in the review. The most common type/name included critically appraised topic (n=18) and evidence summary (n=17). A total of 25 resources provided a definition of an evidence summary: commonalities included a clinical question; a structured, systematic literature search; a description of literature selection; and appraisal of evidence. Of these 25, 16 included descriptors such as brief, concise, rapid, short, succinct and snapshot. The reported methodological components closely reflected the definition results, with the most reported methodological components being a systematic, multi-database search, and critical appraisal. Evidence summary examples were mostly presented as narrative summaries and usually included a reference list, background or clinical context, and recommendations or implications for practice or policy. Four quality assessment tools and a systematic review of tools were included. CONCLUSIONS: The findings of this study highlight the wide variability in the definition, language, methodological components and structure used for point-of-care resources that met our definition of an evidence summary. This scoping review is one of the first steps aimed at improving the credibility and transparency of evidence summaries in evidence-based health care, with further research required to standardize the definitions and methodologies associated with point-of-care resources and accepted tools for quality assessment. SUPPLEMENTAL DIGITAL CONTENT: A Chinese-language version of the abstract of this review is available at http://links.lww.com/SRX/A59, studies ineligible following full-text review http://links.lww.com/SRX/A60.

Effectiveness and safety of enhanced postoperative care units for non-cardiac, non-neurological surgery: a systematic review protocol.

OBJECTIVE: The proposed systematic review will evaluate the evidence on the effectiveness and safety of enhanced post-operative care (EPC) units on patient and health service outcomes in adult patients following non-cardiac, non-neurological surgery. INTRODUCTION: The increase in surgical procedures globally has placed a significant economic and societal burden on health care systems. Recognizing this challenge, EPC units have emerged as a model of care, bridging the gap between traditional, ward-level care and intensive care. EPC offers benefits such as higher staff-to-patient ratios, close patient monitoring (eg, invasive monitoring), and access to critical interventions (eg, vasopressor support). However, there is a lack of well-established guidelines and empirical evidence regarding the safety and effectiveness of EPC units for adult patients following surgery. INCLUSION CRITERIA: This review will include studies involving adult patients (≥18 years) undergoing any elective or emergency non-cardiac, non-neurological surgery, who have been admitted to an EPC unit. Experimental, quasi-experimental, and observational study designs will be eligible. METHODS: This review will follow the JBI methodology for systematic reviews of effectiveness. The search strategy will identify published and unpublished studies from the Cochrane Library, MEDLINE (Ovid), Embase (Ovid), and Scopus, as well as gray literature sources, from 2010 to the present. Two independent reviewers will screen studies, extract data, and critically appraise selected studies using standardized JBI assessment tools. Where feasible, a statistical meta-analysis will be performed to combine study findings. The certainty of evidence will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology. REVIEW REGISTRATION: PROSPERO CRD42023455269.

Predatory journals and their practices present a conundrum for systematic reviewers and evidence synthesisers of health research: A qualitative descriptive study.

Predatory journals are a blemish on scholarly publishing and academia and the studies published within them are more likely to contain data that is false. The inclusion of studies from predatory journals in evidence syntheses is potentially problematic due to this propensity for false data to be included. To date, there has been little exploration of the opinions and experiences of evidence synthesisers when dealing with predatory journals in the conduct of their evidence synthesis. In this paper, the thoughts, opinions, and attitudes of evidence synthesisers towards predatory journals and the inclusion of studies published within these journals in evidence syntheses were sought. Focus groups were held with participants who were experienced evidence synthesisers from JBI (previously the Joanna Briggs Institute) collaboration. Utilising qualitative content analysis, two generic categories were identified: predatory journals within evidence synthesis, and predatory journals within academia. Our findings suggest that evidence synthesisers believe predatory journals are hard to identify and that there is no current consensus on the management of these studies if they have been included in an evidence synthesis. There is a critical need for further research, education, guidance, and development of clear processes to assist evidence synthesisers in the management of studies from predatory journals.

Effectiveness of suture button fixation versus screw fixation for the management of acute distal tibiofibular syndesmotic injuries: a systematic review protocol.

OBJECTIVE: The aim of this review is to determine whether suture button fixation is more effective than traditional screw fixation for the management of acute distal tibiofibular syndesmotic injuries. INTRODUCTION: Syndesmotic injuries are common and require surgical management to avoid chronic pain and instability, and to improve long-term functional outcomes. Screw fixation and suture button fixation are the 2 techniques of choice for treatment; however, there remains ongoing debate surrounding which treatment modality delivers the best outcomes, leading to significant variability in practice. The suture button is a relatively new technique; therefore, there is a need for an updated, high-quality systematic review to help guide best practice in syndesmosis injury management. INCLUSION CRITERIA: This review will consider studies comparing suture button versus screw fixation of acute (<6 weeks) distal tibiofibular syndesmotic injuries. Patients aged 18 or over, with syndesmotic injuries requiring surgical stabilization, with or without an associated fracture, will be included. The primary outcome of interest will be composite functional ankle scores. Secondary outcomes will include range of motion, pain, joint malreduction, complications rates, re-operation rates, and return to work/sport. METHODS: This review will be conducted in accordance with the JBI guidelines for systematic reviews of effectiveness. The following electronic databases will be searched: PubMed, Embase, Scopus, The Cochrane Register of Controlled Trials, and Web of Science, in addition to gray literature databases. No publication date or language limits will be applied. Two independent reviewers will screen titles, abstracts, and full-text studies, assessing methodological quality using the JBI critical appraisal tools. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach will be used to assess certainty in the findings. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42022331211.

Mapping Clinical Barriers and Evidence-Based Implementation Strategies in Low-to-Middle Income Countries (LMICs).

BACKGROUND: Low-to-middle income countries (LMICs) experience a high burden of disease from both non-communicable and communicable diseases. Addressing these public health concerns requires effective implementation strategies and localization of translation of knowledge into practice. AIM: To identify and categorize barriers and strategies to evidence implementation in LMICs from published evidence implementation studies. METHODS: A descriptive analysis of key characteristics of evidence implementation projects completed as part of a 6-month, multi-phase, intensive evidence-based clinical fellowship program, conducted in LMICs and published in the JBI Database of Systematic Reviews and Implementation Reports was undertaken. Barriers were identified and categorized to the Donabedian dimensions of care (structure, process, and outcome), and strategies were mapped to the Cochrane effective practice and organization of care taxonomy. RESULTS: A total of 60 implementation projects reporting 58 evidence-based clinical audit topics from LMICs were published between 2010 and 2018. The projects included diverse populations and were predominantly conducted in tertiary care settings. A total of 279 barriers to implementation were identified. The most frequently identified groupings of barriers were process-related and associated predominantly with staff knowledge. A total of 565 strategies were used across all projects, with every project incorporating more than one strategy to address barriers to implementation of evidence-based practice; most strategies were categorized as educational meetings for healthcare workers. LINKING EVIDENCE TO ACTION: Context-specific strategies are required for successful evidence implementation in LMICs, and a number of common barriers can be addressed using locally available, low-cost resources. Education for healthcare workers in LMICs is an effective awareness-raising, workplace culture, and practice-transforming strategy for evidence implementation.

Accuracy of core needle biopsy compared to fine needle biopsy for the diagnosis of neoplasm in patients with suspected head and neck cancers: a systematic review protocol of diagnostic test accuracy.

OBJECTIVE: The objective of this review is to determine the difference in diagnostic accuracy of core needle biopsy and fine needle aspiration for patients with a head and neck mass using surgical histopathology as a reference test. The risks and adverse events associated with each technique will also be compared. INTRODUCTION: Tissue diagnosis is critical in evaluation of head and neck lesions to guide management. Options for tissue biopsy include surgical biopsy, fine needle aspiration and core needle biopsy. INCLUSION CRITERIA: Studies that compare ultrasound-guided core needle biopsy and/or fine needle aspiration to investigate lumps in the thyroid, cervical lymph nodes, or salivary glands for malignancy in adult patients will be included. The comparator test will be definitive histology in form of surgical biopsy/excision. METHODS: MEDLINE, Emcare, Embase, Web of Science and Cochrane Register of Diagnostic Accuracy Studies will be searched. Studies will be critically appraised by two independent reviewers for methodological quality, using the modified critical appraisal instrument QUADAS-2 and JBI SUMARI software. Two independent reviewers will extract data from papers included in the review using the standardized data extraction tool available in the JBI Reviewer's Manual. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42020140005.

Methodological components and quality of evidence summaries: a scoping review protocol.

OBJECTIVE: The objective of this review is to identify and map the available evidence related to evidence summary methodologies and indicators of quality. INTRODUCTION: It can be challenging for clinicians and policy makers to keep up-to-date with current evidence and best practice. An evidence summary is a way to provide health care decision makers with the most recent, highest quality evidence available on a particular topic in an easily digestible format to facilitate evidence-based clinical decisions. However, objectively evaluating the methodological quality of these types of evidence reviews is challenging. INCLUSION CRITERIA: Articles, papers, books, dissertations, reports and websites will be included if they evaluate, or describe the development or appraisal of, an evidence summary methodology. METHODS: A three-step search strategy will be used to find both published and unpublished literature. The following databases will be searched: US National Library of Medicine Database (PubMed) Cumulative Index to Nursing and Allied Health Literature (CINAHL), Scopus, ProQuest Dissertations and Theses, and Embase. The gray literature search will include relevant government and university websites, the Health Evidence Network website, the World Health Organization (WHO) Health Evidence Network website, the McMaster Health Systems Evidence website, and relevant websites included in the Canadian Agency for Drugs and Technologies in Health (CADTH) Grey Matters Handbook. Sources published in English will be considered, with no date limitation.