CONSORT Statement & Trial Reporting

Introduction & rationale

• What CONSORT is — CONsolidated Standards Of Reporting Trials — an evidence-based minimum set of recommendations for reporting randomised controlled trials (RCTs). It is a reporting standard, not a design or quality-of-conduct standard: it tells authors what to write up about a trial that was done, not how to randomise, conceal or blind.
• Two core deliverables — a 25-item checklist (CONSORT 2010) of essential elements a trial report must contain, plus a participant flow diagram tracking subjects through four trial stages.
• Target design — the base statement applies to the commonest design — the individually randomised, two-group, parallel-group RCT (the standard MD-thesis interventional design); other designs are covered by official extensions.
• Why a reporting standard is needed — a well-conducted but poorly-reported trial is, to the reader, indistinguishable from a poorly-conducted one — the reader cannot judge validity (is the result believable?) or applicability (does it apply to my patient?). Incomplete reports are also unusable for systematic reviews/meta-analyses, the apex of the evidence pyramid.
• Reporting maps to bias (empirical rationale) — items were chosen because methodological studies link omitted/poorly-reported items to biased (usually exaggerated) effect estimates — trials with inadequate or unclear allocation concealment and lack of blinding report larger effect sizes. Transparent reporting is therefore a tool for bias detection by the reader.
• Reproducibility — sufficient detail (especially of the intervention, item 5, and outcomes, item 6) is what lets another team replicate the trial — and the regulatory standard of "adequate and well-controlled investigations" generally needs two replicate trials, which presupposes the first was reported in enough detail to be repeated.