M-12: Completing Patient-Reported Outcome Measures Electronically: A Review of the Literature on Subject Burden in Clinical Trials

Poster Presenter

Shannon Vaffis

Graduate Research Assistant/PhD Student
University of Arizona
United States

Objectives

In order to characterize important aspects of the clinical trial subject’s experience, this review sought to identify published reports of the subject-perceived burden when completing patient-reported outcome (PRO) measures electronically as part of a clinical trial protocol.

ORAL PRESENTATION: 1:55PM

Method

The literature search was conducted in PubMed/MEDLINE, Embase, CINAHL, and PsycINFO databases. A secondary search was conducted on supplementary sources including reference lists of key articles and conference abstracts. Abstract and full-text reviews were completed and study data collated.

Results

A total of 1,622 articles were identified; 822 were included in the abstract review, full-text review included 25 articles, and 15 articles were included in the analysis. Study publication dates ranged from 2004 to 2016 with five articles published between 2013 and 2016. The majority of studies were conducted in the United States (n=8). The most common therapeutic area (n=6) and study setting (n=5) were related to cancer care. The mode of data collection was varied with three studies including more than one mode of administration. The most popular type of data collection tool was questionnaires (n=9) used to collect data at a single point in time (n=8). Measures of subject burden were varied; two studies included measures for device use, length of measure, and time required for participation; five studies included measures for device use and time availability; four studies measured device use alone, and two studies measured time availability alone.

Conclusion

This review demonstrated an existing gap in the literature on how to describe and measure the subject’s burden of completing PRO measures electronically within clinical trials. To date, few studies have attempted to directly measure this concept. Some studies sought to understand subject preference for ePRO mode of data collection or commented on researchers’ perceptions of what the burden to the subject might have been. However, to date there is no universally accepted measure of subject burden when completing PRO measures electronically. Further research can aid in identifying methods to measure the degree of burden placed on subjects when PRO data is captured using electronic data collection devices or systems in clinical trials.