CONSORT 2025 Statement: updated guideline for reporting randomised trials

Reporting guidelines are recommendations to help write up research clearly.

Your research will be used by people from different disciplines and backgrounds for decades to come. Reporting guidelines are community-created recommendations for describing what you did and what you found so that everyone can understand, repeat, apply, and synthesise your work. Although they recommend information to include in your manuscript, they don’t dictate how to order that information.

Most reporting guidelines consist of the full guidance (sometimes called an Explanation and Elaboration document) and a checklist. The full guidance provides detailed explanations and examples for each item, and the checklist allows you to demonstrate adherence to editors.

You can use reporting guidelines throughout your research process. However you use reporting guidelines, please cite them.

Writing manuscripts

Write confidently using a reporting guideline to quickly turn a blank page into a thorough and impactful manuscript.

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Checking

Use a reporting checklist to demonstrate to an editor or peer reviewer that you have included everything. Many journals require completed checklists at submission.

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Writing applications

Reporting guidelines can help you write funding applications, ethics applications, and protocols, but they won’t make design decisions for you!

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Reporting guidelines are neither design nor quality appraisal tools.

Although reporting guidelines recommend information to include when writing up research, they do not mandate how to design research. Similarly, when reviewing literature, although you can use reporting guidelines to assess whether a manuscript is well reported, you cannot use them to appraise whether that study is well designed.

Key information

Reporting guideline acronym

CONSORT

Provided for

Reporting of randomised trials.

Relevant URLs (full-text if available)

https://www.consort-spirit.org/

PubMed ID

Downloads

CONSORT 2025 Checklist (Download from CONSORT-SPIRIT website)

Bibliographic reference

Commonly used reporting guidelines

STROBE Observational Studies
PRISMA Systematic reviews of trials
PRISMA-P Systematic review protocols
CONSORT Randomised trials
SPIRIT Randomised trial protocols
SRQR Qualitative Research
CARE Case Reports
STARD Diagnostic studies
TRIPOD+AI Prediction Models
ARRIVE Animal Research
SQUIRE Quality Improvement
CHEERS Economic Evaluations
Search all

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, Siegried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 statement: updated guideline for reporting randomised trials.

This guideline was published simultaneously in 5 journals. You can read the guideline in any of these journals using the links below.

BMJ. 2025; 388:e081123. PMID: 40228833
JAMA. 2025; 333:1998-2005 PMID: 40228499
Lancet. 2025. PMID: 40245901
Nat Med. 2025; 31:1776-1783 PMID: 40229553
PLoS Med. 2025; 22(4): e1004587. PMID: 40228477

Additional information

Language

English

Availability in additional languages

CONSORT 2010 has been translated into the following languages: Chinese; French; German; Greek; Italian; Japanese; Persian; Polish; Portuguese; Russian; Spanish; Turkish. \

Study design

  • Clinical trials
  • Experimental studies

Clinical area

  • No clinical specialty specified

Applies to the whole report or to individual sections of the report?

  • Whole report

Reporting guideline website URL

https://www.consort-spirit.org/

Previous versions of this guideline / Guideline history

CONSORT 2001
CONSORT 2010

Other

Contextualisation guidance for using the CONSORT guideline to report deprescribing trials has been developed:

Blom JW, Muth C, Glasziou P, McCormack JP, Perera R, Poortvliet RKE, Numans ME, Thürmann P, Thiem U, Thio SL, Van Driel M, Beyer M, Van den Akker M, Knottnerus JA. Describing deprescribing trials better: an elaboration of the CONSORT statement. J Clin Epidemiol. 2020;127:87-95.  PMID: 32707072

Additional Information

Guidance for developing protocols for clinical trials is provided in the SPIRIT 2013 Statement. For further details please visit: SPIRIT Statement