CONSORT 2025 statement: updated guideline for reporting randomised trials
Authors:
- Sally HopewellSHSally Hopewell
- An-Wen ChanACAn-Wen Chan
- Gary S CollinsGCGary S Collins
- Asbjørn HróbjartssonAHAsbjørn Hróbjartsson
- David MoherDMDavid Moher
- Kenneth F SchulzKSKenneth F Schulz
- Ruth TunnRTRuth Tunn
- Rakesh AggarwalRARakesh Aggarwal
- Michael BerkwitsMBMichael Berkwits
- Jesse A BerlinJBJesse A Berlin
- Nita BhandariNBNita Bhandari
- Nancy J ButcherNBNancy J Butcher
Top Cited Papers
Open Access
Abstract
Background Well designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT (Consolidated Standards of Reporting Trials) statement was designed to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomised trial. CONSORT was first published in 1996, then updated in 2001 and 2010. Here, we present the updated CONSORT 2025 statement, which aims to account for recent methodological advancements and feedback from end users. Methods We conducted a scoping review of the literature and developed a project-specific database of empirical and theoretical evidence related to CONSORT, to generate a list of potential changes to the checklist. The list was enriched with recommendations provided by the lead authors of existing CONSORT extensions (Harms, Outcomes, Non-pharmacological Treatment), other related reporting guidelines (TIDieR) and recommendations from other sources (eg, personal communications). The list of potential changes to the checklist was assessed in a large, international, online, three-round Delphi survey involving 317 participants and discussed at a two-day online expert consensus meeting of 30 invited international experts. Results We have made substantive changes to the CONSORT checklist. We added seven new checklist items, revised three items, deleted one item, and integrated several items from key CONSORT extensions. We also restructured the CONSORT checklist, with a new section on open science. The CONSORT 2025 statement consists of a 30-item checklist of essential items that should be included when reporting the results of a randomised trial and a diagram for documenting the flow of participants through the trial. To facilitate implementation of CONSORT 2025, we have also developed an expanded version of the CONSORT 2025 checklist, with bullet points eliciting critical elements of each item. Conclusion Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomised trials to ensure that trial reports are clear and transparent.Keywords
This publication has 48 references indexed in Scilit:
- Development of a topic‐specific bibliographic database supporting the updates of SPIRIT 2013 and CONSORT 2010Cochrane Evidence Synthesis and Methods, 2024
- Reporting of Factorial Randomized TrialsJAMA, 2023
- Guidelines for Reporting Outcomes in Trial ReportsJAMA, 2022
- Consolidated Standards of Reporting Trials (CONSORT) extensions covered most types of randomized controlled trials, but the potential workload for authors was highJournal of Clinical Epidemiology, 2019
- Reporting of Multi-Arm Parallel-Group Randomized TrialsJAMA, 2019
- Reporting of Patient-Reported Outcomes in Randomized TrialsJAMA, 2013
- Reporting of Noninferiority and Equivalence Randomized TrialsJAMA, 2012
- Use of the CONSORT Statement and Quality of Reports of Randomized TrialsJAMA, 2001
- The CONSORT Statement: Revised Recommendations for Improving the Quality of Reports of Parallel-Group Randomized TrialsJAMA, 2001
- Improving the Quality of Reporting of Randomized Controlled TrialsJAMA, 1996