Systematic evaluation of the patient-reported outcome (PRO) content of clinical trial protocols.

ABSTRACT:

Background

Qualitative evidence suggests patient-reported outcome (PRO) information is frequently absent from clinical trial protocols, potentially leading to inconsistent PRO data collection and risking bias. Direct evidence regarding PRO trial protocol content is lacking. The aim of this study was to systematically evaluate the PRO-specific content of UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme trial protocols.

Methods and findings

We conducted an electronic search of the NIHR HTA programme database (inception to August 2013) for protocols describing a randomised controlled trial including a primary/secondary PRO. Two investigators independently reviewed the content of each protocol, using a specially constructed PRO-specif

SUBMITTER: Kyte D 

PROVIDER: S-EPMC4198237 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature