Training Subjects On Key Concepts From Patient-Reported Outcomes (PROs) Improves Understanding And Data Accuracy
Received 5 June 2019
Accepted for publication 27 August 2019
Published 21 October 2019 Volume 2019:10 Pages 315—319
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 2
Editor who approved publication: Professor Lynne Nemeth
Nadeeka R Dias,* Amanda R Howley,* Rinah Yamamoto, Susan M Dallabrida
Department of Clinical Science and Consulting, eResearch Technology (ERT), Boston, MA, USA
*These authors contributed equally to this work
Correspondence: Amanda R Howley
Department of Clinical Science and Consulting, ERT, 500 Rutherford Ave, Boston, MA 02129, USA
Tel +1 617 9731703
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.
Keywords: patient-reported outcomes PROs, subject training, data accuracy
Corrigendum for this paper has been published
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