Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension

The original CONSORT-Outcomes 2022 was explicitly developed as an extension to CONSORT 2010. It adds 17 outcome-specific reporting items that elaborate on several CONSORT checklist items, particularly those concerning:

• definition and justification of outcomes,
• sample size target differences,
• statistical analyses for outcomes,
• reporting of prespecified versus non-prespecified analyses,
• interpretation of outcome results.

When CONSORT 2025 was published, it became the new core reporting guideline for randomized trials. The EQUATOR Network now lists CONSORT-Outcomes 2022 as a generic extension associated with the CONSORT 2025 Statement, indicating that it should be used alongside the updated core checklist