Journal of Clinical Epidemiology

OBJECTIVE: To generate a bank of items describing application and interpretation errors that can arise in pairwise meta-analyses in systematic reviews of interventions. STUDY DESIGN AND SETTING: Medline, Embase and Scopus were searched to identify studies describing types of errors in meta-analyses. Descriptions of errors and supporting quotes were extracted by multiple authors. Errors were reviewed at team meetings to determine if they should be excluded, reworded, or combined with other errors, and were categorised into broad categories of errors and subcategories within...

OBJECTIVE: Given the key role that pilot and feasibility (PAF) trials play in addressing the challenges of surgical trials, adequate reporting completeness is essential. Our aim was to assess completeness of reporting and evaluate if the items of the CONSORT extension for PAF trials have been reported in surgical PAF trials. STUDY DESIGN: This is a meta-research study reported according to PRISMA guidelines. Studies were included if they were pilot or feasibility randomized trials evaluating a surgical intervention...

BACKGROUND: Successful implementation of stroke rehabilitation guidelines demands high-quality practice standards tailored to targeted sociodemographic contexts. OBJECTIVE: To conduct a scoping review to determine the quality differences in post-stroke rehabilitation practice guidelines (PGs), when comparing high-income countries (HIC) and low or middle-income countries (LMIC). ELIGIBILITY CRITERIA: PGs available in English or Spanish between 2012 and 2021, providing recommendations on post-stroke rehabilitation...

OBJECTIVE: The involvement of consumers (people with lived experience of disease) in guidelines is widely advocated to improve their relevance and uptake. However, the approaches to consumer involvement in guidelines vary and are not well documented. We describe the consumer involvement framework of Caring for Australians and New ZealandeRs with kidney Impairment (CARI) Guidelines. STUDY DESIGN AND SETTING: We used a descriptive document analysis to collate all relevant policies, documents, emails, and presentations on consumer involvement in our organisations...

OBJECTIVE: The proliferation of evidence synthesis methods makes it challenging for reviewers to select the ''right'' method. This study aimed to update the Right Review tool (a web-based decision support tool that guides users through a series of questions for recommending evidence synthesis methods) and establish a common set of questions for the synthesis of both quantitative and qualitative studies (https://rightreview.knowledgetranslation.net/). STUDY DESIGN AND SETTING: A two-round modified international e-Delphi was conducted (2022) with researchers, health care providers, patients and policy makers...

OBJECTIVE: Health administrative data can be used to improve the health of people who inject drugs by informing public health surveillance and program planning, monitoring, and evaluation. However, methodological gaps in the use of these data persist due to challenges in accurately identifying injection drug use at the population level. In this study, we validated case-ascertainment algorithms for identifying people who inject drugs using health administrative data in Ontario, Canada...

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INTRODUCTION: The conduct of systematic reviews (SRs) and overviews share several similarities. However, because the unit of analysis for overviews is the SRs, there are some unique challenges. One of the most critical issues to manage when conducting an overview is the overlap of data across the primary studies included in the SRs. OBJECTIVE: This meta-research study aimed to describe the frequency of strategies to manage the overlap in overviews of exercise-related interventions...

OBJECTIVE: To apply a hierarchical model (HM) that addresses measurement error in regression of the treatment effect on the control group event rate (CR). We compare HM to weighted linear regression (WLR) which is subject to measurement error and mathematical coupling. STUDY DESIGN AND SETTING: We reviewed published hierarchical models that address measurement error and implemented a Bayesian version in open-source code to facilitate adoption by meta-analysts. We compared WLR and HM across a very large convenience sample of meta-analyses published in the Cochrane Database of Systematic Reviews...

OBJECTIVE: To develop a simple, practical methodology to equate or link equivalent domains of the 36-item Short-Form Health Survey (SF-36) and the Patient-Reported Outcomes Measurement Information System 29-item questionnaire (PROMIS-29) using the Rasch framework. STUDY DESIGN AND SETTING: In April 2016, the PROMIS-29 and SF-36 were completed by 1,501 individuals selected to be representative of the French population. For each domain common to the two questionnaires, a Partial Credit Model was fitted to the items related to that dimension in the two questionnaires...

OBJECTIVE: The minimal important change (MIC) reflects what patients, on average, consider the smallest improvement in a score that is important to them. MIC thresholds may vary across patient populations, interventions used, post-treatment time points and derivation methods. We determine and compare MIC thresholds for the Oxford Knee and Hip Score (OKS/OHS) at 3 months postoperatively to 12- and 24-month thresholds in patients undergoing knee or hip arthroplasty. STUDY DESIGN AND SETTING: This cohort study used data from patients undergoing total knee arthroplasty (TKA), unicompartmental knee arthroplasty (UKA), or total hip arthroplasty (THA) at a public hospital between February 2016 and February 2023...

BACKGROUND: An emerging body of randomized controlled trials (RCTs) on COVID-19 vaccines has served as the evidence base for public health decision-making. While it is recommended that RCTs report results by health equity stratifiers to reduce bias in healthcare and gaps in research, it is unknown whether this was done in COVID-19 vaccine trials. OBJECTIVE: To critically examine the use of health equity stratifiers in COVID-19 vaccine trials. STUDY DESIGN: We conducted a methodological review of published COVID-19 vaccine trials available in the COVID-NMA systematic review database through February 8, 2023...

OBJECTIVE: This study aims to assess the quality, risk of bias, and conflicts of interest of clinical trials conducted on the effects of fortified infant formula. STUDY DESIGN: Systematic review including all randomized clinical trials targeting healthy children and using three arms: fortified infant formula; standard formula; and breastfeeding. We performed a descriptive analysis of the studies reviewed, assessed their quality using the "Risk-of-Bias 2" tool, and identified conflicts of interest...

OBJECTIVE: In this study we evaluate how to estimate diagnostic test accuracy (DTA) correctly in the presence of longitudinal patient data (i.e., repeated test applications per patient). STUDY DESIGN AND SETTING: We used a nonparametric approach to estimate sensitivity and specificity of three tests for different target conditions with varying characteristics (i.e., episode length and disease-free intervals between episodes): 1) systemic inflammatory response syndrome (n = 36), 2) depression (n = 33), and 3) epilepsy (n = 30)...

OBJECTIVE: Our aims were to, first, identify and summarise the use of methods, frameworks, and tools as a conceptual basis for investigating dimensions of equity impacts of public health interventions in systematic reviews including an equity focus. These include PROGRESS-Plus, which identifies key sociodemographic characteristics that determine health outcomes. Second, we aimed to document challenges and opportunities encountered in the application of such methods, as reported in systematic reviews...

IMPORTANCE: Ceiling effect may lead to misleading conclusions when using patient-reported outcome measure (PROM) scores as an outcome. OBJECTIVE: The aim of this study was to investigate the potential source of ceiling effect related errors in randomized controlled trials (RCTs) reporting no differences in patient-reported outcome measure (PROM) scores between study groups. DESIGN: A review of RCTs published in the top 10 orthopedic journals was conducted, focusing on studies that reported no significant differences in outcomes between two study groups...

OBJECTIVE: To systematically evaluate the reproducibility of primary data and, the reproducibility and correctness of pooled sensitivity and specificity estimates reported in a sample of diagnostic meta-analyses. STUDY DESIGN AND SETTING: We conducted an exemplary systematic review of diagnostic meta-analyses comparing coronary computed tomography angiography to invasive coronary angiography in patients with suspected coronary artery disease. The objectives were to assess 1) the reproducibility of contingency tables, 2) the reproducibility of pooled sensitivity and specificity, and 3) differences to reported results when applying a recommended bivariate binomial model for pooling sensitivity and specificity...

OBJECTIVES: In 2019, only 7% of Cochrane systematic reviews (SRs) cited a core outcome set (COS) in relation to choosing outcomes, even though a relevant COS existed but was not mentioned (or cited) for a further 29% of SRs. Our objectives for the current work were to (1) examine the extent to which authors are currently considering COS to inform outcome choice in Cochrane protocols and completed SRs, and (2) understand author facilitators and barriers to using COS. STUDY DESIGN AND SETTING: We examined all completed Cochrane SRs published in the last 3 months of 2022 and all Cochrane protocols published in 2022 for the extent to which they: (a) cited a COS, (b) searched for COS, (c) used outcomes from existing COS, and (d) reported outcome inconsistency among included studies and/or noted the need for COS...

BACKGROUND: In current core outcome set (COS) development practice, there seems to be variation regarding the level of granularity of outcome domains within the same and between different COS. The chosen granularity of domains has consequences for definitions and interpretation of domains and instrument development. OBJECTIVE: To determine what guidance can be given to (COS) developers regarding the granularity of outcome domain extraction and presentation during COS development...

OBJECTIVE: To describe, and explain the rationale for, the methods used and decisions made during development of the updated SPIRIT 2024 and CONSORT 2024 reporting guidelines. METHODS: We developed SPIRIT 2024 and CONSORT 2024 together to facilitate harmonisation of the two guidelines, and incorporated content from key extensions. We conducted a scoping review of comments suggesting changes to SPIRIT 2013 and CONSORT 2010, and compiled a list of other possible revisions based on existing SPIRIT and CONSORT extensions, other reporting guidelines and personal communications...