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Reporting

CONSORT

Also called: Consolidated Standards of Reporting Trials

CONSORT is the standard reporting guideline for randomized controlled trials, comprising a 25-item checklist and a participant flow diagram. It specifies what a trial report must disclose, including randomization, blinding, primary outcomes, and participant flow, so readers can judge validity and reproduce the design.

The checklist walks through a trial from title to interpretation, demanding details that are easy to omit and easy to manipulate: how the allocation sequence was generated and concealed, who was blinded, what the prespecified primary outcome was, how the sample size was justified, and how many participants were lost at each step. The flow diagram makes attrition and analysis populations visible at a glance.

Endorsed by hundreds of journals and extended for specific designs such as cluster and non-inferiority trials, CONSORT exists because poorly reported trials cannot be evaluated or trusted. Selective outcome reporting and switched endpoints, in particular, become detectable when a trial report is held against the checklist and its registration.

Reviewers of a randomized trial can use CONSORT as a direct audit tool, checking that the primary outcome matches the registry, that the flow diagram accounts for every randomized participant, and that the analysis follows intention-to-treat.

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