CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials

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

doi:10.1136/bmj-2024-081124

CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials

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

^*Corresponding author for this work

Research output: Contribution to journal › Article › Research › peer-review

17 Citations (Scopus)

Abstract

Critical appraisal of the quality of randomised trials is possible only if their design, conduct, analysis, and results are completely and accurately reported. Without transparent reporting of the methods and results, readers will not be able to fully evaluate the reliability and validity of trial findings. The CONSORT (Consolidated Standards of Reporting Trials) statement aims 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 and was updated in 2001 and 2010. CONSORT comprises a checklist of essential items that should be included in reports of randomised trials and a diagram for documenting the flow of participants through a trial. The CONSORT statement has been updated (CONSORT 2025) to reflect recent methodological advancements and feedback from end users, ensuring that it remains fit for purpose. Here, we present the updated CONSORT explanation and elaboration document, which has been extensively revised and describes the rationale and scientific background for each CONSORT 2025 checklist item and provides published examples of good reporting. The objective is to enhance the use, understanding, and dissemination of CONSORT 2025 and provide guidance to authors about how to improve the reporting of their trials and ensure trial reports are complete, and transparent.

Original language	English
Article number	081124
Pages (from-to)	1-61
Number of pages	61
Journal	BMJ
Volume	389
DOIs	https://doi.org/10.1136/bmj-2024-081124
Publication status	Published - 14 Apr 2025

Access to Document

10.1136/bmj-2024-081124Licence: CC BY

Cite this

Hopewell, S., Chan, A. W., Collins, G. S., Hróbjartsson, A., Moher, D., Schulz, K. F., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., Bhandari, N., Butcher, N. J., Campbell, M. K., Chidebe, R. C. W., Elbourne, D., Farmer, A., Fergusson, D. A., Golub, R. M., Goodman, S. N., ... Boutron, I. (2025). CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials. BMJ, 389, 1-61. Article 081124. https://doi.org/10.1136/bmj-2024-081124

@article{96f5c931d8ec417cb9243378b2f80160,

title = "CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials",

abstract = "Critical appraisal of the quality of randomised trials is possible only if their design, conduct, analysis, and results are completely and accurately reported. Without transparent reporting of the methods and results, readers will not be able to fully evaluate the reliability and validity of trial findings. The CONSORT (Consolidated Standards of Reporting Trials) statement aims 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 and was updated in 2001 and 2010. CONSORT comprises a checklist of essential items that should be included in reports of randomised trials and a diagram for documenting the flow of participants through a trial. The CONSORT statement has been updated (CONSORT 2025) to reflect recent methodological advancements and feedback from end users, ensuring that it remains fit for purpose. Here, we present the updated CONSORT explanation and elaboration document, which has been extensively revised and describes the rationale and scientific background for each CONSORT 2025 checklist item and provides published examples of good reporting. The objective is to enhance the use, understanding, and dissemination of CONSORT 2025 and provide guidance to authors about how to improve the reporting of their trials and ensure trial reports are complete, and transparent.",

author = "Sally Hopewell and Chan, {An Wen} and Collins, {Gary S.} and Asbjorn Hr{\'o}bjartsson and David Moher and Schulz, {Kenneth F.} and Ruth Tunn and Rakesh Aggarwal and Michael Berkwits and Berlin, {Jesse A.} and Nita Bhandari and Butcher, {Nancy J.} and Campbell, {Marion K.} and Chidebe, {Runcie C.W.} and Diana Elbourne and Andrew Farmer and Fergusson, {Dean A.} and Golub, {Robert M.} and Goodman, {Steven N.} and Hoffmann, {Tammy C.} and Ioannidis, {John P.A.} and Kahan, {Brennan C.} and Knowles, {Rachel L.} and Lamb, {Sarah E.} and Steff Lewis and Elizabeth Loder and Martin Offringa and Philippe Ravaud and Richards, {Dawn P.} and Rockhold, {Frank W.} and Schriger, {David L.} and Siegfried, {Nandi L.} and Sophie Staniszewska and Taylor, {Rod S.} and Lehana Thabane and David Torgerson and Sunita Vohra and White, {Ian R.} and Isabelle Boutron",

year = "2025",

month = apr,

day = "14",

doi = "10.1136/bmj-2024-081124",

language = "English",

volume = "389",

pages = "1--61",

journal = "BMJ",

issn = "0959-8146",

publisher = "BMJ Publishing Group",

}

Hopewell, S, Chan, AW, Collins, GS, Hróbjartsson, A, Moher, D, Schulz, KF, Tunn, R, Aggarwal, R, Berkwits, M, Berlin, JA, Bhandari, N, Butcher, NJ, Campbell, MK, Chidebe, RCW, Elbourne, D, Farmer, A, Fergusson, DA, Golub, RM, Goodman, SN, Hoffmann, TC, Ioannidis, JPA, Kahan, BC, Knowles, RL, Lamb, SE, Lewis, S, Loder, E, Offringa, M, Ravaud, P, Richards, DP, Rockhold, FW, Schriger, DL, Siegfried, NL, Staniszewska, S, Taylor, RS, Thabane, L, Torgerson, D, Vohra, S, White, IR & Boutron, I 2025, 'CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials', BMJ, vol. 389, 081124, pp. 1-61. https://doi.org/10.1136/bmj-2024-081124

TY - JOUR

T1 - CONSORT 2025 explanation and elaboration: 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

PY - 2025/4/14

Y1 - 2025/4/14

N2 - Critical appraisal of the quality of randomised trials is possible only if their design, conduct, analysis, and results are completely and accurately reported. Without transparent reporting of the methods and results, readers will not be able to fully evaluate the reliability and validity of trial findings. The CONSORT (Consolidated Standards of Reporting Trials) statement aims 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 and was updated in 2001 and 2010. CONSORT comprises a checklist of essential items that should be included in reports of randomised trials and a diagram for documenting the flow of participants through a trial. The CONSORT statement has been updated (CONSORT 2025) to reflect recent methodological advancements and feedback from end users, ensuring that it remains fit for purpose. Here, we present the updated CONSORT explanation and elaboration document, which has been extensively revised and describes the rationale and scientific background for each CONSORT 2025 checklist item and provides published examples of good reporting. The objective is to enhance the use, understanding, and dissemination of CONSORT 2025 and provide guidance to authors about how to improve the reporting of their trials and ensure trial reports are complete, and transparent.

AB - Critical appraisal of the quality of randomised trials is possible only if their design, conduct, analysis, and results are completely and accurately reported. Without transparent reporting of the methods and results, readers will not be able to fully evaluate the reliability and validity of trial findings. The CONSORT (Consolidated Standards of Reporting Trials) statement aims 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 and was updated in 2001 and 2010. CONSORT comprises a checklist of essential items that should be included in reports of randomised trials and a diagram for documenting the flow of participants through a trial. The CONSORT statement has been updated (CONSORT 2025) to reflect recent methodological advancements and feedback from end users, ensuring that it remains fit for purpose. Here, we present the updated CONSORT explanation and elaboration document, which has been extensively revised and describes the rationale and scientific background for each CONSORT 2025 checklist item and provides published examples of good reporting. The objective is to enhance the use, understanding, and dissemination of CONSORT 2025 and provide guidance to authors about how to improve the reporting of their trials and ensure trial reports are complete, and transparent.

UR - http://www.scopus.com/inward/record.url?scp=105002766720&partnerID=8YFLogxK

U2 - 10.1136/bmj-2024-081124

DO - 10.1136/bmj-2024-081124

M3 - Article

C2 - 40228832

AN - SCOPUS:105002766720

SN - 0959-8146

VL - 389

SP - 1

EP - 61

JO - BMJ

JF - BMJ

M1 - 081124

ER -

CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials

Abstract

Access to Document

Other files and links

CONSORT 2025 statement: updated guideline for reporting randomised trials

Cite this

CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials

Abstract

Access to Document

Other files and links

Related Research Outputs

CONSORT 2025 statement: updated guideline for reporting randomised trials

Cite this