Journal of Clinical Epidemiology

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OBJECTIVE: To investigate the frequency, determinants, stages, and barriers of patient and public involvement (PPI) in systematic reviews, and to explore its association with the dissemination of reviews. STUDY DESIGN AND SETTING: We examined systematic reviews that required the inclusion of a PPI declaration, published in The BMJ between January 1, 2015, and December 31, 2022. Multivariable analysis was used to assess the association between PPI and key variables...

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Scoping reviews can identify a large number of evidence sources. This commentary describes and provides guidance on planning, conducting, and reporting large scoping reviews. This guidance is informed by experts in scoping review methodology, including JBI Scoping Review Methodology group members, who have also conducted and reported large scoping reviews. We propose a working definition for large scoping reviews that includes approximately 100 sources of evidence but must also consider the volume of data to be extracted, the complexity of the analyses and purpose...

BACKGROUND: Prognostic models incorporate multiple prognostic factors to estimate the likelihood of future events for individual patients based on their prognostic factor values. Evaluating these models crucially involves conducting studies to assess their predictive performance, like discrimination. Systematic reviews and meta-analyses of these evaluation studies play an essential role in selecting models for clinical practice. METHODS: In this paper, we outline three thresholds to determine the target for certainty rating in the discrimination of prognostic models, as observed across a body of validation studies...

OBJECTIVES: Data-driven decision support tools have been increasingly recognised to transform healthcare. However, such tools are often developed on predefined research datasets without adequate knowledge of the origin of this data and how it was selected. How a dataset is extracted from a clinical database can profoundly impact the validity, interpretability and interoperability of the dataset and downstream analyses, yet is rarely reported. Therefore, we present a case study illustrating how a definitive patient list was extracted from a clinical source database and how this can be reported...

IMPORTANCE: The restricted Net Treatment Benefit (rNTB) is a clinically meaningful and tractable estimand of the overall treatment effect assessed in randomized trials when at least one survival endpoint with time restriction is used. Its interpretation does not rely on parametric assumptions such as proportional hazards, can be estimated without bias even in presence of independent right-censoring and can include a pre-specified threshold of minimal clinically relevant difference. OBJECTIVE: To demonstrate that the rNTB, corresponding to the NTB during a predefined time interval, is a meaningful and adaptable measure of treatment effect in clinical trials...

OBJECTIVE: Film mammography has replaced digital mammography in breast screening programs globally. This led to a small increase in the rate of detection, but whether the detection of clinically important cancers increased is uncertain. We aimed to assess the impact on tumour characteristics of screen-detected and interval breast cancers. STUDY DESIGN AND SETTING: We searched seven databases from inception to 08 October 2023 for publications comparing film and digital mammography within the same population of asymptomatic women at population (average) risk of breast cancer...

Causal inference methods for observational data represent an alternative to randomised controlled trials when they are not feasible or when real-world evidence is sought. Inverse-probability-of-treatment weighting (IPTW) is one of the most popular approaches to account for confounding in observational studies. In medical research, IPTW is mainly applied to estimate the causal effect of a binary treatment, even when the treatment has in fact multiple categories, despite the availability of IPTW estimators for multiple treatment categories...

The automation of a wide variety of laboratory equipment and analyses has generated large amounts of laboratory data that can be used for research purposes. It is therefore increasingly important to support researchers, in particular those with no or limited laboratory background, in identifying and handling potential biases and pitfalls associated with use of these data. This commentary reviews five central considerations for researchers who extract and analyze routine biochemical laboratory-generated data from registers, with the aim of improving the quality, accuracy, and transparency of future studies...

OBJECTIVES: Observational studies are not subject to the same requirements as randomised controlled trials such as as registration or publishing a protocol. The aim of this scoping review was to estimate the registration rate of observational studies in leading peer-reviewed medicine journals and to evaluate whether protocols were available in the public domain. STUDY DESIGN AND SETTING: In March 2023, we searched OVID Medline for observational studies published in 2022 in the top five general medicine journals according to impact factor (The Lancet, The British Medical Journal, The Journal of the American Medical Association, The New England Journal of Medicine and Annals of Internal Medicine)...

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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...