Characteristics of non-randomised studies of drug treatments: cross sectional study.

Objective: To examine the characteristics of comparative non-randomised studies that assess the effectiveness or safety, or both, of drug treatments.

Design: Cross sectional study.

Data Sources: Medline (Ovid), for reports published from 1 June 2022 to 31 August 2022.

A cross-sectional study assessing visual abstracts of randomized trials revealed inadequate reporting and high prevalence of spin.

Objectives: Visual abstracts (VAs) lack study-specific reporting guidelines and are increasingly used as stand-alone sources in medical research dissemination although not designed for this purpose. Therefore, our objectives were to describe 1) completeness of reporting in VAs and corresponding written abstracts (WAs) of randomized controlled trials (RCTs), and 2) the extent and type of spin (ie, any reporting pattern that could distort result interpretation and mislead readers) in VAs and WAs of RCTs with a statistically nonsignificant primary outcome.

Study Design And Setting: We conducted a cross-sectional study evaluating VAs and WAs of RCTs published between January 1, 2021, and March 3, 2023.

Preferred study designs to support a comparative therapeutic strategy question in oncology: a vignette study.

Objectives: Some therapeutic strategy questions in oncology could be answered with studies using observational data. Target trial emulation is the application of design principles from randomized controlled trials (RCTs) to the analysis of observational data, to reduce design-induced biases. Our objective was to determine which type of study physicians would preferably plan to answer a comparative effectiveness question lacking evidence in oncology.

A novel framework to assess haematology and oncology registration trials: The THEOREMM project.

Background: Methodological limitations affect a significant number of oncology and haematology trials, raising concerns about the applicability of their results. For example, a suboptimal control arm or limited access to best care upon progression may skew the trial results toward a benefit in the experimental arm. Beyond the fact that such limitations do not prevent drugs reaching the market, other assessment tools, such as those developed by professional societies-ESMO-MCBS and ASCO Value Framework-do not integrate these important shortcomings.

Sensitivity and Specificity of Using GPT-3.5 Turbo Models for Title and Abstract Screening in Systematic Reviews and Meta-analyses.

Background: Systematic reviews are performed manually despite the exponential growth of scientific literature.

Objective: To investigate the sensitivity and specificity of GPT-3.5 Turbo, from OpenAI, as a single reviewer, for title and abstract screening in systematic reviews.

Psychometric properties and domains covered by patient-reported outcome measures used in trials assessing interventions for chronic pain.

Objectives: To identify the patient-reported outcome measures (PROMs) used in clinical trials assessing interventions for chronic pain, describe their psychometric properties, and the clinical domains they cover.

Study Design And Setting: We identified phase 3 or 4 interventional trials: on adult participants (aged >18 years), registered in clinicaltrials.gov between January 1, 2021 and December 31, 2022, and which provided "chronic pain" as a keyword condition.

Methods used to develop the SPIRIT 2024 and CONSORT 2024 Statements.

Objectives: 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 harmonization 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.

Synthesis methods used to combine observational studies and randomised trials in published meta-analyses.

Background: This study examined the synthesis methods used in meta-analyses pooling data from observational studies (OSs) and randomised controlled trials (RCTs) from various medical disciplines.

Methods: We searched Medline via PubMed to identify reports of systematic reviews of interventions, including and pooling data from RCTs and OSs published in 110 high-impact factor general and specialised journals between 2015 and 2019. Screening and data extraction were performed in duplicate.

Protocol for a living evidence synthesis on variants of concern and COVID-19 vaccine effectiveness.

Background: It is evident that COVID-19 will remain a public health concern in the coming years, largely driven by variants of concern (VOC). It is critical to continuously monitor vaccine effectiveness as new variants emerge and new vaccines and/or boosters are developed. Systematic surveillance of the scientific evidence base is necessary to inform public health action and identify key uncertainties.

No evidence of important difference in summary treatment effects between COVID-19 preprints and peer-reviewed publications: a meta-epidemiological study.

Objectives: Preprints became a major source of research communication during the COVID-19 pandemic. We aimed to evaluate whether summary treatment effect estimates differ between preprint and peer-reviewed journal trials.

Study Design And Setting: A meta-epidemiological study.

A structured approach to information retrieval improved identification of funding and researchers' conflicts of interest in trials included in Cochrane reviews.

Objectives: To compare the contemporary Cochrane review approach for retrieving information on trial funding and researchers' conflicts of interest with a structured approach for information retrieval.

Study Design And Setting: Methodological study of 100 Cochrane reviews from August to December 2020 and one randomly selected trial from each review. Reporting of trial funding and researchers' conflicts of interest in reviews was compared with information identified using a structured retrieval process, and time to retrieve information was noted.

Reminding Peer Reviewers of Reporting Guideline Items to Improve Completeness in Published Articles: Primary Results of 2 Randomized Trials.

Importance: Numerous studies have shown that adherence to reporting guidelines is suboptimal.

Objective: To evaluate whether asking peer reviewers to check if specific reporting guideline items were adequately reported would improve adherence to reporting guidelines in published articles.

Design, Setting, And Participants: Two parallel-group, superiority randomized trials were performed using manuscripts submitted to 7 biomedical journals (5 from the BMJ Publishing Group and 2 from the Public Library of Science) as the unit of randomization, with peer reviewers allocated to the intervention or control group.

Interleukin-6 blocking agents for treating COVID-19: a living systematic review.

Background: It has been reported that people with COVID-19 and pre-existing autoantibodies against type I interferons are likely to develop an inflammatory cytokine storm responsible for severe respiratory symptoms. Since interleukin 6 (IL-6) is one of the cytokines released during this inflammatory process, IL-6 blocking agents have been used for treating people with severe COVID-19.

Objectives: To update the evidence on the effectiveness and safety of IL-6 blocking agents compared to standard care alone or to a placebo for people with COVID-19.

Completeness of reporting in abstracts of randomized controlled trials assessing interventional radiology for liver disease.

Purpose: To assess the completeness of reporting in abstracts of published randomized controlled trials (RCTs) assessing interventional radiology (IR) for liver disease; to assess whether publication of the 2017 CONSORT update for nonpharmacological treatments (NPT) resulted in changes in abstract reporting; and to identify factors associated with better reporting.

Material And Methods: MEDLINE and Embase were searched to identify RCTs of IR for liver disease (January 2015-September 2020). Two reviewers assessed the completeness of abstract reporting according to the CONSORT-NPT-2017-update.

Empirical evaluation of the methods used in systematic reviews including observational studies and randomized trials.

Objectives: To examine the methodological characteristics of systematic reviews and meta-analyses including observational studies (OSs) and randomized controlled trials (RCTs), in various medical disciplines.

Study Design And Setting: We searched Medline via PubMed to identify systematic reviews of interventions including RCTs and OSs published in 110 journals from 2015 to 2019. We extracted in duplicate general and methodological characteristics of the systematic review.

metaCOVID: A web-application for living meta-analyses of COVID-19 trials.

Outputs from living evidence syntheses projects have been used widely during the pandemic by guideline developers to form evidence-based recommendations. However, the needs of different stakeholders cannot be accommodated by solely providing pre-defined non amendable numerical summaries. Stakeholders also need to understand the data and perform their own exploratory analyses.

Conceptualizing the reporting of living systematic reviews.

Objectives: As part of an effort to develop an extension of the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 statement for living systematic reviews (LSRs), we discuss conceptual issues relevant to the reporting of LSRs and highlight a few challenges.

Methods: Discussion of conceptual issues based on a scoping review of the literature and discussions among authors.

Results: We first briefly describe aspects of the LSR production process relevant to reporting.

Using Risk of Bias 2 to assess results from randomised controlled trials: guidance from Cochrane.

A systematic review identifies, appraises and synthesises all the empirical evidence from studies that meet prespecified eligibility criteria to answer a specific research question. As part of the appraisal, researchers use explicit methods to assess risk of bias in the results' from included studies that contribute to the review's findings, to improve our confidence in the review's conclusions. Randomised controlled trials included in Cochrane Reviews have used a specific risk of bias tool to assess these included studies since 2008.

A scoping review identifies multiple comments suggesting modifications to SPIRIT 2013 and CONSORT 2010.

Objectives: To identify, summarize, and analyse comments on the core reporting guidelines for protocols of randomized trials (Standard Protocol Items: Recommendations for Interventional Trials [SPIRIT] 2013) and for completed trials (Consolidated Standards of Reporting Trials [CONSORT] 2010), with special emphasis on suggestions for guideline modifications.

Methods: We included documents written in English and published after 2010 that explicitly commented on SPIRIT 2013 or CONSORT 2010. We searched four bibliographic databases (Embase and MEDLINE to June 2022; Web of Science and Google Scholar to April 2022) and other sources (e.