Perceived Burden of Completion of Patient-Reported Outcome Measures in Clinical Trials:: Results of a Preliminary Study.

Abstract

Understanding the perceived burden of clinical trial participation is an important element of patient-centric trial design and conduct. We report the results of a study to gain preliminary insights into the perceived burden associated with patient-reported outcome (PRO) data collection among a sample (n = 61) of volunteers from the general population including people with various health conditions resulting in chronic pain. Participants identified morning completion as more burdensome than completion of PRO measures in the evening. Weekly completion was perceived as less burdensome than daily, and twice-a-day more burdensome than once-a-day. Our results, while not generalizable in isolation, provide a valuable starting point to understand the complex construct of subject burden. This preliminary work is intended to be a catalyst for more in-depth research to better understand and predict burden and acceptable burden thresholds in clinical trials. Understanding subject burden is a vital component of human subject research that will be valuable in helping to inform future clinical trial designs.