CONSORT: Reporting Randomized Trials
Understand the 25-item CONSORT checklist and the mandatory flow diagram for transparent reporting of randomized controlled trials.
You'll learn
The 25-item CONSORT checklist for transparent reporting of randomized controlled trials.
Use this when
You are writing up a randomized controlled trial.
What CONSORT Is
CONSORT — Consolidated Standards of Reporting Trials — is a 25-item checklist and mandatory participant flow diagram for randomized controlled trials. Updated in 2010 (CONSORT 2010), it is endorsed by over 600 journals and required by all major medical publishers.
💡 The CONSORT flow diagram is mandatory
The flow diagram shows how many participants were assessed for eligibility, randomized, allocated to each arm, received the intervention, completed follow-up, and were analyzed. It must be included in any RCT submission to a CONSORT-endorsing journal.
Critical CONSORT Items
- ●Item 3 — Trial design: state allocation ratio, any changes after trial start
- ●Item 7 — Outcomes: pre-specified primary and secondary outcomes with assessment timepoints
- ●Item 8–10 — Randomization: sequence generation, allocation concealment, and implementation — three separate items
- ●Item 11 — Blinding: who was blinded and how, and if not blinded, why not
- ●Item 13 — Baseline data: Table 1 for both groups (no p-values)
- ●Item 17 — Outcomes: for each outcome: number analyzed, effect estimate, precision (CI)
- ●Item 23 — Registration: trial registry and registration number
CONSORT Extensions
CONSORT has been extended for specific trial types. Always check whether an extension applies to your trial before submission.
- ●CONSORT-PRO: patient-reported outcomes
- ●CONSORT-harms: adverse events
- ●CONSORT for pilot and feasibility trials
- ●CONSORT for cluster randomized trials
- ●CONSORT for non-inferiority and equivalence trials
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Further reading
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