Harms Section
CONSORT 2025 includes reporting of harms and unintended effects so readers can assess adverse outcomes alongside potential benefits of an intervention. Harms terminology and reporting requirements vary by intervention, field, regulator, and journal. Do not imply that every study uses the same adverse-event taxonomy.
A Harms section reports important adverse or unintended effects and explains how harms were defined, collected, and summarized when the study evaluates them.
Key details
Important caveats
Scope Boundary
Harms terminology and reporting requirements vary by intervention, field, regulator, and journal. Do not imply that every study uses the same adverse-event taxonomy.
Further guidance
Content
Define or categorize harms consistently with the protocol and analysis plan, report important events transparently, and distinguish prespecified monitoring from post hoc observations.
Purpose
Report the harms relevant to the design, including collection methods and group-specific results when applicable, rather than discussing benefits alone.
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.