Examples
Worked examples
- Is an instance
An RCT publication including a CONSORT flow diagram of randomised, lost-to-follow-up, and analysed participants.
- Is an instance
A journal's submission portal validating presence of CONSORT items at upload.
Counter-examples
Looks similar, but isn't
- Not an instance
A meta-analysis (covered by PRISMA, not CONSORT).
- Not an instance
An observational cohort study (STROBE).
Editorial commentary
CONSORT 2010 (Schulz, Altman and Moher, BMJ 2010) is the 2010 edition of the Consolidated Standards of Reporting Trials: a 25-item checklist and a participant-flow diagram specifying what should be reported in the publication of any randomised controlled trial, covering trial design, randomisation and allocation concealment, blinding, outcome definitions, statistical methods, and the flow of participants through enrolment, allocation, follow-up, and analysis. Numbered extensions built on the same base checklist cover cluster-randomised trials, non-inferiority and equivalence designs, pragmatic trials, and harms reporting.
CONSORT 2010 has since been superseded. CONSORT 2025 was published simultaneously on 14 April 2025 in The BMJ, JAMA, The Lancet, Nature Medicine, and PLOS Medicine, expanding the checklist from 25 to 30 items — seven new items, three revised, one deleted — and folding in material that previously sat in separate extensions covering harms, outcomes, and non-pharmacological treatments. The updated checklist is organised into six sections (title and abstract; a new open-science section; introduction; methods; results; discussion), and consort-statement.org now redirects to consort-spirit.org, which fronts the CONSORT and SPIRIT guideline families jointly. The core flow diagram concept — tracking participants through enrolment, allocation, follow-up, and analysis — is unchanged between the two versions.
This page describes the 2010 edition specifically, which remains relevant for understanding trials published under it and for tracing how reporting requirements have evolved. For the current 30-item CONSORT 2025 checklist, a 2010-to-2025 comparison, and the flow diagram in its current form, see CASRAI’s CONSORT checklist guide for RCT reporting. CONSORT covers randomised controlled trials specifically; observational studies use STROBE, systematic reviews use PRISMA 2020, and animal studies use ARRIVE 2.0.
References
- Schulz, Altman, Moher, ‘CONSORT 2010 Statement’ (BMJ, 2010)
- CONSORT 2025 Statement (The BMJ, JAMA, The Lancet, Nature Medicine, PLOS Medicine, 14 April 2025)
- EQUATOR Network CONSORT resources; consort-spirit.org
Also known as
CONSORT · CONSORT statement
Machine-readable encodings
Use in your systems
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