Patient-reported outcome (PRO) assessment in clinical trials: a systematic review of guidance for trial protocol writers.

ABSTRACT:

Background

Evidence suggests there are inconsistencies in patient-reported outcome (PRO) assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers.

Methods and findings

We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013) for PRO-specific guidance regarding trial protocol development. Further guidance documents were

SUBMITTER: Calvert M 

PROVIDER: S-EPMC4198295 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature