Systematic Evaluation of Patient-Reported Outcome Protocol Content and Reporting in Cancer Trials.

ABSTRACT:

Background

Patient-reported outcomes (PROs) are captured within cancer trials to help future patients and their clinicians make more informed treatment decisions. However, variability in standards of PRO trial design and reporting threaten the validity of these endpoints for application in clinical practice.

Methods

We systematically investigated a cohort of randomized controlled cancer trials that included a primary or secondary PRO. For each trial, an evaluation of protocol and reporting quality was undertaken using standard checklists. General patterns of reporting where also explored.

Results

Protocols (101 sourced, 44.3%) included a mean (SD) of 10 (4) of 33 (range = 2-19) PRO protocol checklist items. Recommended items frequently omitted included the rationale a

SUBMITTER: Kyte D 

PROVIDER: S-EPMC6855977 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature