TY - JOUR
T1 - CONSORT 2025 statement
T2 - updated guideline for reporting randomised trials
AU - Hopewell, Sally
AU - Chan, An-Wen
AU - Collins, Gary S.
AU - Hróbjartsson, Asbjorn
AU - Moher, David
AU - Schulz, Kenneth F.
AU - Tunn, Ruth
AU - Aggarwal, Rakesh
AU - Berkwits, Michael
AU - Berlin, Jesse A.
AU - Bhandari, Nita
AU - Butcher, Nancy J.
AU - Campbell, Marion K.
AU - Chidebe, Runcie C. W.
AU - Elbourne, Diana
AU - Farmer, Andrew
AU - Fergusson, Dean A.
AU - Golub, Robert M.
AU - Goodman, Steven N.
AU - Hoffmann, Tammy C.
AU - Ioannidis, John P. A.
AU - Kahan, Brennan C.
AU - Knowles, Rachel L.
AU - Lamb, Sarah E.
AU - Lewis, Steff
AU - Loder, Elizabeth
AU - Offringa, Martin
AU - Ravaud, Philippe
AU - Richards, Dawn P.
AU - Rockhold, Frank W.
AU - Schriger, David L.
AU - Siegfried, Nandi L.
AU - Staniszewska, Sophie
AU - Taylor, Rod S.
AU - Thabane, Lehana
AU - Torgerson, David
AU - Vohra, Sunita
AU - White, Ian R.
AU - Boutron, Isabelle
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2025/4/14
Y1 - 2025/4/14
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/105002788708
U2 - 10.1136/bmj-2024-081123
DO - 10.1136/bmj-2024-081123
M3 - Article
C2 - 40228833
SN - 0959-8146
VL - 389
JO - BMJ
JF - BMJ
M1 - e081123
ER -