Patient and Public Involvement Section
CONSORT 2025 added an item asking reports to describe how patients and/or the public were involved in the design, conduct, and/or reporting of the trial. Use the terminology and reporting expectations appropriate to the study, jurisdiction, funder, journal, and community; involvement is not the same as enrollment as a participant.
A Patient and Public Involvement section explains whether and how patients or members of the public contributed to trial design, conduct, or reporting.
Key details
Important caveats
Scope Boundary
Use the terminology and reporting expectations appropriate to the study, jurisdiction, funder, journal, and community; involvement is not the same as enrollment as a participant.
Further guidance
Content
Describe who was involved, the stages or decisions they influenced, and the nature of their contribution; state clearly when there was no such involvement if the reporting context requires it.
Purpose
Make substantive patient/public involvement visible and distinguish it from participation as research subjects.
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.