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.

The revised JBI critical appraisal tool for the assessment of risk of bias for cohort studies.

Cohort studies are a robust analytical observational study design that explore the difference between two different cohorts on an outcome, differentiated by their exposure status. Despite being observational in nature, they are often included in systematic reviews of effectiveness, particularly when randomized controlled trials are limited or not feasible. Like all studies included in a systematic review, cohort studies must undergo a critical appraisal process to assess the extent to which a study has considered potential bias in its design, conduct, or analysis. Critical appraisal tools facilitate this evaluation. This paper introduces the revised critical appraisal tool for cohort studies, completed by the JBI Effectiveness Methodology Group (EMG), who are currently revising the suite of JBI critical appraisal tools for quantitative study designs. The revised tool responds to updates in methodological guidance from the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Working Group and reporting guidance from PRISMA 2020, providing a robust framework for evaluating risk of bias in a cohort study. Transparent and rigorous assessment using this tool will assist reviewers in understanding the validity and relevance of the results and conclusions drawn from a systematic review that includes cohort studies. This may contribute to better evidence-based decision-making in health care. This paper discusses the key changes made to the tool, justifications for these changes, and provides practical guidance on how this tool should be interpreted and applied by systematic reviewers.

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.

Prophylactic embolization versus observation for high-grade blunt trauma splenic injury: a systematic review with meta-analysis.

OBJECTIVE: The objective of this systematic review was to compare the effectiveness of prophylactic angioembolization with observation as primary management strategies for patients with high-grade (grades 3-5) blunt trauma splenic injury. INTRODUCTION: The spleen is frequently injured in abdominal trauma. Historical management practices involved splenectomy, but more recent evidence suggests an increased risk of severe infections and sepsis associated with this approach. Accordingly, non-operative management strategies, including prophylactic splenic artery embolization and clinical observation, have gained prominence. This systematic review with meta-analysis directly compares angioembolization with clinical observation for high-grade splenic injuries only, aiming to provide clarity on this matter amid ongoing debates and variations in clinical practice. INCLUSION CRITERIA: This review included adult patients aged 15 years or older with high-grade splenic injuries (grade 3-5) due to blunt trauma. Outcomes of interest include the need for further intervention (failure of management), mortality, complications, red blood cell transfusion requirements, hospital length of stay, and intensive care unit length of stay. METHODS: A comprehensive search of PubMed, Embase, and CINAHL (EBSCOhost), was performed with no restrictions on language or publication date. Gray literature was searched, including trial registries and relevant conference proceedings. After deduplication, 2 reviewers independently assessed titles and abstracts, and, subsequently, full-text articles for eligibility. Methodological quality of the included studies was assessed using standardized instruments from JBI. Data was extracted using predefined templates, and statistical meta-analysis was performed, where possible, using a random effects model. Heterogeneity was assessed using statistical methods, and potential publication bias was tested with a funnel plot. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach was used to evaluate the certainty of evidence. RESULTS: Sixteen studies were included in this review. Methodological quality assessment indicated some risk of bias in most studies, with concerns primarily related to differences in injury severity and potential confounding factors. Meta-analysis revealed that prophylactic angioembolization significantly reduced risk of management failure by 57% (OR 0.43, 95% CI 0.28-0.68, I2=53%, 15 studies) and decreased patient mortality by 37% (OR 0.63, 95% CI 0.43-0.93, I2=0%, 9 studies) compared with clinical observation alone. There was a 47% reduction in risk of complications associated with prophylactic embolization compared with clinical observation (OR 0.53, 95% CI 0.29-0.95, I2=0%, 4 studies). Some statistical heterogeneity was observed, with I2 ranging from 0% to 53%. No significant differences were observed between the 2 management strategies for red blood cell transfusion requirements and hospital length of stay. CONCLUSIONS: The results of this study support the use of prophylactic embolization for high-grade blunt trauma splenic injuries, indicated by lower failure of management rates, reduced need for additional interventions, lower mortality, and fewer complications. REVIEW REGISTRATION: PROSPERO CRD42023420220.

Experiences of informal caregivers of people with dementia in low- and middle-income countries: a systematic review protocol.

OBJECTIVE: This review aims to synthesize the experiences of informal caregivers of people with dementia in low- and middle-income countries (LMICs). INTRODUCTION: Globally, the burden of dementia is increasing disproportionately in LMICs. Informal caregivers play a vital role and face multiple challenges in LMICs, even though they also often lack the awareness and skills to provide adequate care for people living with dementia. Many LMICs have limited resources and caregivers lack support services. Understanding their experiences and perceptions may improve interventions, helping caregivers to better support those living with dementia. INCLUSION CRITERIA: Studies from all settings in LMICs will be considered. Qualitative data from qualitative or mixed methods studies that explore caregivers' experiences and perceptions will be included in this review. Participants are informal caregivers of people diagnosed with dementia at any stage, regardless of age, gender, or their relationship with people living with dementia. METHODS: This review will follow the JBI methodology for a qualitative systematic reviews, with meta-aggregation as the synthesis method. The review will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A 3-step search strategy will be used to locate published and unpublished studies in MEDLINE, CINAHL, Embase, PsycINFO, AgeLine, LILACS, African Index Medicus, ProQuest Dissertations and Theses, Open Dissertations, Web of Science Core Collection, and Google Scholar. There will be no date or language limitations. All studies will be screened against the inclusion criteria and data will be extracted and critically appraised for methodological quality by 2 independent reviewers using JBI tools. Confidence in the final synthesized findings will be assessed using the ConQual approach. REVIEW REGISTRATION: PROSPERO CRD42023453814.

Common tool structures and approaches to risk of bias assessment: implications for systematic reviewers.

There are numerous tools available to assess the risk of bias in individual studies in a systematic review. These tools have different structures, including scales and checklists, which may or may not separate their items by domains. There are also various approaches and guides for the process, scoring, and interpretation of risk of bias assessments, such as value judgments, quality scores, and relative ranks. The objective of this commentary, which is part of the JBI Series on Risk of Bias, is to discuss some of the distinctions among different tool structures and approaches to risk of bias assessment and the implications of these approaches for systematic reviewers.

Implementing GRADE in systematic reviews that adhere to JBI methodological conduct.

GRADE is a methodological approach used to establish certainty in a body of evidence and is now widely adopted among the evidence synthesis and guideline development community. JBI is an international evidence-based health care organization that provides guidance for a range of evidence synthesis approaches. The GRADE approach is currently endorsed for use in a subset of JBI systematic reviews; however, there is some uncertainty regarding when (and how) GRADE may be implemented in reviews that follow JBI methodology.

Comparison of bias adjustment in meta-analysis using data-based and opinion-based methods.

INTRODUCTION: Several methods exist for bias adjustment of meta-analysis results, but there has been no comprehensive comparison with unadjusted methods. We compare 6 bias-adjustment methods with 2 unadjusted methods to examine how these different methods perform. METHODS: We re-analyzed a meta-analysis that included 10 randomized controlled trials. Two data-based methods (Welton's data-based approach and Doi's quality effects model) and 4 opinion-informed methods (opinion-based approach, opinion-based distributions combined statistically with data-based distributions, numerical opinions informed by data-based distributions, and opinions obtained by selecting areas from data-based distributions) were used to incorporate methodological quality information into the meta-analytical estimates. The results of these 6 methods were compared with 2 unadjusted models: the DerSimonian-Laird random effects model and Doi's inverse variance heterogeneity model. RESULTS: The 4 opinion-based methods returned the random effects model estimates with wider uncertainty. The data-based and quality effects methods returned different results and aligned with the inverse variance heterogeneity method with some minor downward bias adjustment. CONCLUSION: Opinion-based methods seem to only add uncertainty rather than bias adjust.

The revised JBI critical appraisal tool for the assessment of risk of bias for quasi-experimental studies.

Systematic reviews of effectiveness offer a rigorous synthesis of the best evidence available regarding the effects of interventions or treatments. Randomized controlled trials are considered the optimal study design for evaluating the effectiveness of interventions and are the ideal study design for inclusion in a systematic review of effectiveness. In the absence of randomized controlled trials, quasi-experimental studies may be relied on to provide information on treatment or intervention effectiveness. However, such studies are subject to unique considerations regarding their internal validity and, consequently, the assessment of the risk of bias of these studies needs to consider these features of design and conduct. The JBI Effectiveness Methodology Group has recently commenced updating the suite of JBI critical appraisal tools for quantitative study designs to align with the latest advancements in risk of bias assessment. This paper presents the revised critical appraisal tool for risk of bias assessment of quasi-experimental studies; offers practical guidance for its use; provides examples for interpreting the results of risk of bias assessment; and discusses major changes from the previous version, along with the justifications for those changes.

Non-operative management of high-grade splenic injury: a systematic review protocol.

OBJECTIVE: The objective of this review is to establish whether embolization is more effective than clinical observation for adult patients with grade III-V splenic injuries. The findings will be used to guide future practice and, if necessary, inform future research design and conduct. INTRODUCTION: The spleen is one of the most frequently injured intra-abdominal organs, with a reported adult mortality of 7% to 18% following trauma. Non-operative management has become a standard of care for hemodynamically stable patients. In clinical practice, the decision whether to prophylactically embolize or manage high-grade injuries with observation alone remains controversial. INCLUSION CRITERIA: Sources including adult patients with grade III-V splenic injuries secondary to blunt trauma will be included in this review. Eligible studies must include comparisons between 2 cohorts of patients undergoing either prophylactic embolization or clinical observation only. Outcomes will include mortality rate, failure of treatment, intensive care unit admission, length of hospital stay, blood transfusion requirements, and patient satisfaction. METHODS: A systematic review with meta-analysis will be conducted. PubMed, Embase, and CINAHL will be searched for eligible studies, as will trial registries and sources of gray literature. Study selection, quality appraisal, and data extraction of outcomes will be performed in duplicate. Methodological quality will be evaluated using JBI critical appraisal tools. Studies will, where possible, be pooled in statistical meta-analysis. A random effects model will be used and statistical analysis will be performed. The certainty of the findings will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. REVIEW REGISTRATION: PROSPERO CRD42023420220.

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.

Oncological and functional outcomes of transoral surgery compared with non-surgical management in small-volume oropharyngeal cancer: a systematic review protocol.

OBJECTIVE: The objective of this systematic review is to investigate oncological and functional outcomes following primary transoral surgery compared with non-surgical management in patients with small-volume (T1-2, N0-2) oropharyngeal cancer. INTRODUCTION: The incidence of oropharyngeal cancer is rising. Transoral surgery was introduced to provide a minimally invasive treatment option for patients with small-volume oropharyngeal cancer and to avoid the morbidity that results from open surgery and the potential acute and late toxicities of chemoradiotherapy. INCLUSION CRITERIA: The review will include all studies on adult patients with small-volume oropharyngeal cancer managed by transoral surgery or non-surgical management with radiotherapy and/or chemotherapy. All patients must have undergone treatment with curative intent. Participants who underwent palliative treatment will be excluded. METHODS: This review will follow the JBI methodology for systematic reviews of effectiveness. Eligible study designs will include randomized controlled trials, quasi-experimental studies, and prospective or retrospective cohort studies. Databases to be searched will include PubMed, Embase, CINAHL, Cochrane CENTRAL, and multiple trial registries from 1972. Titles and abstracts will be reviewed, and full-text articles will be retrieved if they meet the inclusion criteria. All eligible studies will be critically appraised by 2 independent reviewers using the appropriate JBI tools for experimental and observational designs. Where possible, outcome data from studies will be pooled with statistical meta-analysis to compare both oncological and functional outcomes between the two groups. All time to event to data will be converted to a common metric for oncological outcomes. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach will be followed to assess the certainty of findings. REVIEW REGISTRATION: PROSPERO CRD4202235209.

From critical appraisal to risk of bias assessment: clarifying the terminology for study evaluation in JBI systematic reviews.

The foundations for critical appraisal of literature have largely progressed through the development of epidemiologic research methods and the use of research to inform medical teaching and practice. This practical application of research is referred to as evidence-based medicine and has delivered a standard for the health care profession where clinicians are equally as engaged in conducting scientific research as they are in the practice of delivering treatments. Evidence-based medicine, now referred to as evidence-based health care, has generally been operationalized through empirically supported treatments, whereby the choice of treatments is substantiated by scientific support, usually by means of an evidence synthesis. As evidence synthesis methodology has advanced, guidance for the critical appraisal of primary research has emphasized a distinction from the assessment of internal validity required for synthesized research. This assessment is conceptualized and branded in various ways in the literature, such as risk of bias, critical appraisal, study validity, methodological quality, and methodological limitations. This paper provides a discussion of the definitions and characteristics of these terms, concluding with a recommendation for JBI to adopt the term "risk of bias" assessment.

The revised JBI critical appraisal tool for the assessment of risk of bias for randomized controlled trials.

JBI recently began the process of updating and revising its suite of critical appraisal tools to ensure that these tools remain compatible with recent developments within risk of bias science. Following a rigorous development process led by the JBI Effectiveness Methodology Group, this paper presents the revised critical appraisal tool for the assessment of risk of bias for randomized controlled trials. This paper also presents practical guidance on how the questions of this tool are to be interpreted and applied by systematic reviewers, while providing topical examples. We also discuss the major changes made to this tool compared to the previous version and justification for why these changes facilitate best-practice methodologies in this field.