Electronic patient-reported outcome assessments: evaluating patient preference for the number of items per screen

Abstract

Abstract Background: In clinical trials, the single-item-per-screen format is commonly used for electronic patient-reported outcomes (ePROs). However, participant preferences for this format over multiple items per screen have not been investigated. This study evaluated participant preferences for single-item-per-screen vs. multiple-items-per-screen ePRO formats, the effect on completion times, and the comparability of scores between formats. Methods: Participation in this randomized, crossover, observational study involved ePRO completion in both single-item-per-screen and multiple-items-per-screen formats on an electronic tablet device during two study visits. A paper-based preference questionnaire was completed at each visit. Results: Thirty-seven adults (mean [SD] age=49.6 [15.4] years; 51.4% female; 54.1% White) enrolled and 36 participants completed both visits. Twelve participants (33.3%) preferred the multiple-item format, 12 (33.3%) preferred the single-item format, 10 (27.8%) had no preference, and 2 (5.6%) did not notice a difference. Seventeen participants (47.2%) preferred the single-item format when participating in a clinical trial, and most (n=20; 55.6%) believed that others would prefer this format in a clinical trial. The ePRO completion time (minutes: seconds) was longer for the single-item format than the multiple-item format (mean [SD], 6:42 [2:24] vs. 6:21 [2:22]; p = 0.1540). The ePRO scores were similar across both formats. Conclusion: This study provided evidence that both single-item and multiple-items-per-screen presented on an electronic tablet device are acceptable to users and that format preference may be specific to each individual. Thus, clinical programs need to consider the targeted study population, the purpose of use, and the overall the trial design when designing ePRO solutions.