Outcome Measures Section
CONSORT 2025 requires randomized-trial reports to define primary and secondary outcomes sufficiently, including how and when they were assessed, so readers can interpret what the trial was designed to measure. Outcome terminology and required detail vary by design and discipline. Do not present randomized-trial reporting requirements as universal rules for every type of study.
An Outcome Measures section defines the study outcomes and explains how and when each important outcome was assessed.
Key details
Important caveats
Scope Boundary
Outcome terminology and required detail vary by design and discipline. Do not present randomized-trial reporting requirements as universal rules for every type of study.
Further guidance
Content
Keep the outcome definition distinct from the instrument description: an instrument is a tool used to collect data, while an outcome is the prespecified result or endpoint being evaluated.
Purpose
Name primary and secondary outcomes as applicable and specify the measurement variable, analysis metric or aggregation when needed, method of assessment, and time point.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- CONSORT 2025 statement: updated guideline for reporting randomised trials (opens in a new tab)BMJ / CONSORT Group · Primary 2025 CONSORT reporting guideline for randomized trials, including participant flow and trial-registration information.