Reporting of patient-reported outcomes in randomized trials: The CONSORT PRO extension

摘要

PRO extension was deemed unnecessary for many CONSORT checklist items. These recommendations are important for editors, reviewers, and readers of Value in Health (VIH). VIH may report PRO findings separate from the main results of the RCT, which are often found in journals targeted to clinicians. These recommendations also hold implications for ISPOR members in the documentation of study protocols, statistical analysis plans, and other elements of RCTs. Special attention can be given to these checklist items on PROs when developing sources of documentation for PRO outcomes used in the trial or analyses of PROs presented in trial data.