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. 2025 Apr 14;22(4):e1004587.
doi: 10.1371/journal.pmed.1004587. eCollection 2025 Apr.

CONSORT 2025 statement: Updated guideline for reporting randomised trials

Sally Hopewell  1 , An-Wen Chan  2 , Gary S Collins  3 , Asbjørn Hróbjartsson  4   5 , David Moher  6 , Kenneth F Schulz  7 , Ruth Tunn  1 , Rakesh Aggarwal  8 , Michael Berkwits  9 , Jesse A Berlin  10   11 , Nita Bhandari  12 , Nancy J Butcher  13   14 , Marion K Campbell  15 , Runcie C W Chidebe  16   17 , Diana Elbourne  18 , Andrew Farmer  19 , Dean A Fergusson  20 , Robert M Golub  21 , Steven N Goodman  22 , Tammy C Hoffmann  23 , John P A Ioannidis  24 , Brennan C Kahan  25 , Rachel L Knowles  26 , Sarah E Lamb  27 , Steff Lewis  28 , Elizabeth Loder  29   30 , Martin Offringa  13 , Philippe Ravaud  31 , Dawn P Richards  32 , Frank W Rockhold  33 , David L Schriger  34 , Nandi L Siegried  35 , Sophie Staniszewska  36 , Rod S Taylor  37 , Lehana Thabane  38   39 , David Torgerson  40 , Sunita Vohra  41 , Ian R White  25 , Isabelle Boutron  42   43
Affiliations

CONSORT 2025 statement: Updated guideline for reporting randomised trials

Sally Hopewell et al. PLoS Med. .

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.

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Conflict of interest statement

I have read the journal’s policy and the authors of this manuscript have the following competing interests: support from MRC-NIHR for the submitted work. SH, IB, A-WC, AH, KFS, and DM are members of the SPIRIT-CONSORT executive group. SH, IB, A-WC, AH, KFS, GSC, DM, MKC, NJB, MO, RST, and SV are involved in the development, update, implementation, and dissemination of several reporting guidelines. GSC is the director of the UK EQUATOR Centre, a statistical editor for The BMJ and NIHR Senior Investigator, DM is the director of the Canadian EQUATOR Centre, and member of The BMJ’s regional advisory board for North America, IB is deputy director and PR is director of the French EQUATOR Centre, TCH is director of the Australasian EQUATOR Centre, JPAI is director of the US EQUATOR Centre. RA is president of the World Association of Medical Editors. MKC is chair of the MRC-NIHR: Better Methods Better Research funding panel. RCWC is executive director of Project PINK-BLUE, which receives funding from Roche-Product. AF is director of the UK National Institute for Health and Care Research Health Technology Assessment Programme. DPR is a full time employee of Five02 Laboratories, which under contract to Clinical Trials Ontario provides services related to patient and public engagement; and is the volunteer vice president of the Canadian Arthritis Patient Alliance, which receives funding through independent grants from pharmaceutical companies. IRW was supported by the MRC Programmes MCUU00004/07 and MCUU00004/09. DLS is JAMA associate editor and receives editing stipends from JAMA and Annals of Emergency Medicine.Provenance and peer review: Not commissioned; externally peer reviewed.

Figures

Fig 1
Fig 1. CONSORT 2025 flow diagram.
Flow diagram of the progress through the phases of a randomised trial of two groups (i.e., enrolment, intervention allocation, follow-up, and data analysis). CONSORT = Consolidated Standards of Reporting Trials.
See this image and copyright information in PMC

Comment in

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