The CONSORT statement includes a 25-item checklist and a flow diagram. Some key components include:
Title and Abstract: Ensures that the trial is identified as a randomized trial in the title and that the abstract provides a structured summary of trial design, methods, results, and conclusions.
Introduction: Describes the trial's background and objectives.
Methods: Detailed information on trial design, participants, interventions, outcomes, sample size, randomization, and blinding.
Results: Provides information on participant flow, recruitment, baseline data, numbers analyzed, outcomes, and estimation.
Discussion: Includes interpretation of results, limitations, generalizability, and overall evidence.
