PROTEUS — TRIALS
Reporting Data [Consort Pro]
Improved reporting of PRO data should facilitate robust interpretation of the results from clinical trials and strengthen patient care. The 2013 CONSORT PRO guidance addresses the specific elements related to PRO endpoints that should be included in clinical trial publications.
CONSORT PRO is an extension of the original 2010 CONSORT guidance (Consolidated Standards of Reporting Trials), which provides general recommendations for publications reporting clinical trial results.
This guidance ensuring that PRO methods and results are clearly described is detailed in the paper Reporting of Patient-Reported Outcomes in Randomized Trials: The CONSORT PRO Extension.