CONSORT 2025 Statement
Abstract
Importance: Well-designed and properly executed randomized trials are considered the most reliable evidence on the benefits of health care 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 randomized trial. CONSORT was first published in 1996, then updated in 2001 and 2010. Herein, we present the updated CONSORT 2025 statement, which aims to account for recent methodological advancements and feedback from end users. Observations: 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, nonpharmacological treatment), other related reporting guidelines (Template for Intervention Description and Replication [TIDieR]), and recommendations from other sources (eg, personal communications). The list of potential changes to the checklist was assessed in a large, international, online, 3-round Delphi survey involving 317 participants and discussed at a 2-day online expert consensus meeting of 30 invited international experts. We have made substantive changes to the CONSORT checklist. We added 7 new checklist items, revised 3 items, deleted 1 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 randomized 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. Conclusions and Relevance: Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomized trials to ensure that trial reports are clear and transparent.
Cite this
Sally Hopewell, An‐Wen Chan, Professor Gary S. Collins, Asbjørn Hróbjartsson, David Moher, Kenneth F. Schulz, … Isabelle Boutron (2025). CONSORT 2025 Statement. JAMA. https://doi.org/10.1001/jama.2025.4347
@article{sally2025consort,
title = {CONSORT 2025 Statement},
author = {Hopewell, Sally and Chan, An‐Wen and Collins, Professor Gary S. and Hróbjartsson, Asbjørn and Moher, David and Schulz, Kenneth F. and Aggarwal, Rakesh and Berkwits, Michael and Berlin, Jesse A. and Bhandari, Nita and Butcher, Nancy J. and Campbell, Marion and Chidebe, Runcie C.W. and Elbourne, Diana R. and Farmer, Andrew A. and Fergusson, Dean A. and Goodman, Steven N. and Hoffmann, Tammy and Ioannidis, John P. A. and Kahan, Brennan C and Knowles, Rachel Louise and Lamb, Sarah E and Lewis, Steff C. and Loder, Elizabeth and Offringa, Martin and Ravaud, Philippe and Richards, Dawn P. and Rockhold, Frank W. and Schriger, David L. and Siegfried, Nandi and Staniszewska, Sophie H. and Taylor, Rod Stephen and Thabane, Lehana and Torgerson, David John and Vohra, Sunita and White, Ian R. and Boutron, Isabelle},
year = {2025},
journal = {JAMA},
doi = {10.1001/jama.2025.4347}
}Citations in this library
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