Training Subjects On Key Concepts From Patient-Reported Outcomes (PROs) Improves Understanding And Data Accuracy

Abstract

Objectives: The majority of subjects do not understand how to accurately report PRO data due to conceptual misunderstandings. This study demonstrates how even a short 2-sentence instruction can improve subject understanding. Methods: For this study, 613 subjects completed an online survey, in which they were asked to provide responses to commonly seen PRO questions from various therapeutic areas. Demographic data were also collected. Results: Subjects were provided with scenarios relating to pain severity, the definition of a rescue laxative, reporting stool counts, reporting a bleeding event, and itch severity. After subjects provided an initial response to the question, they were provided with minimal training information consisting of 1–2 sentences and asked to provide a response again to the same question. A 16% increase in mean response accuracy was found amongst all 5 questions evaluated by subjects. Conclusion: Patient understanding of PRO items often seen as key endpoints in clinical trials was shown to increase with minimal training thus increasing the accuracy of data collected.