CONSORT Statement
CONSORT (Consolidated Standards of Reporting Trials) is a guideline that provides a minimum set of recommendations for reporting randomized controlled trials.
1Detailed Explanation
The CONSORT statement was first published in 1996 and has been updated multiple times, with the most recent version in 2010 (CONSORT 2010). It includes a 25-item checklist and a flow diagram. Key elements include: trial design, participants, interventions, outcomes, sample size, randomization, blinding, statistical methods, recruitment, numbers analyzed, outcomes and estimation, harms, and discussion limitations. Extensions exist for specific trial types: cluster RCTs, non-inferiority/equivalence trials, pragmatic trials, and pilot trials. Most major medical journals require CONSORT compliance, and many require submission of the flow diagram.
2Examples
- A.CONSORT flow diagram showing 500 patients assessed for eligibility, 200 randomized, 100 per arm, with complete follow-up at 12 months
- B.A non-inferiority trial reported following the CONSORT extension for non-inferiority trials
3Why It Matters in Research
CONSORT is mandatory for RCT publication in most major medical journals. Incomplete reporting is a common reason for desk rejection. Familiarity with CONSORT is essential for both writing and reviewing RCTs.
Related Journal Format Guides
Journals that commonly use CONSORT Statement in their manuscripts
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