CONSORT (Consolidated Standards of Reporting Trials) provides a minimum set of recommendations for reporting randomized controlled trials.

Improve transparency and completeness of randomized trial reports so readers can assess validity and bias.

Who should use it

Clinical trialists, biostatisticians, and authors of interventional clinical studies.

Required or strongly recommended when reporting randomized controlled trials.

• Title identifies randomized trial design
• Abstract structured with trial registration
• Background with rationale and objectives
• Methods: eligibility, interventions, outcomes, sample size
• Results with participant flow diagram
• Discussion with limitations and generalizability

• Trial registration number
• CONSORT flow diagram
• Primary and secondary outcomes predefined
• Intervention details sufficient for replication

• Missing participant flow diagram
• Unregistered or late-registered trials
• Switching primary outcomes post hoc