CONSORT 2025 statement: Updated guideline for reporting randomised trials

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 (e.g., 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. CONCLUSIONS: 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.

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UNC Libraries
Published
2025-05-02
DOI
https://doi.org/10.17615/y62g-ks55
Primary Topic
Meta-analysis and systematic reviews
Type
article
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article

CONSORT 2025 statement: Updated guideline for reporting randomised trials

R. Tunn, Rakesh Aggarwal, Martin Offringa, Lehana Thabane et al.
UNC Libraries
Meta-analysis and systematic reviews
article

CONSORT 2025 statement: Updated guideline for reporting randomised trials

R. Tunn, Rakesh Aggarwal, Martin Offringa, Lehana Thabane, Robert Golub, Brennan C Kahan, Dawn P. Richards, R. S. Taylor, Nita Bhandari, Sophie H. Staniszewska, Sally Hopewell, Philippe Ravaud, An‐Wen Chan, Elizabeth Loder, Runcie C.W. Chidebe, Kenneth F. Schulz, Diana Elbourne, Ian R. White, Steven N. Goodman, Professor Gary S. Collins, Andrew A. Farmer, Isabelle Boutron, Dean Fergusson, Steff Lewis, David Moher, Sarah E Lamb, Sunita Vohra, Nancy J. Butcher, David L. Schriger, Nandi Siegfried, Marion Campbell, Frank W. Rockhold, Tammy Hoffmann, Rachel L Knowles, David Torgerson, Michael Berkwits, Jesse A. Berlin, Asbjørn Hróbjartsson, John P. A. Ioannidis
article en

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 (e.g., 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. CONCLUSIONS: 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.

UNC Libraries
University of North Carolina at Chapel Hill (US)
Openalex Percentile: Top 66%
Meta-analysis and systematic reviews
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