The
CONSORT statement comprises a 25-item checklist and a flow diagram. The checklist covers various aspects of trial design, analysis, and interpretation, including:
Title and Abstract
Introduction (background and objectives)
Methods (trial design, participants, interventions, outcomes, sample size, randomization, blinding, statistical methods)
Results (participant flow, recruitment, baseline data, numbers analyzed, outcomes and estimation, ancillary analyses, harms)
Discussion (limitations, generalizability, interpretation)
Other Information (registration, protocol, funding)
The flow diagram visually depicts the progress of participants through the phases of the trial, including enrollment, intervention allocation, follow-up, and analysis.
