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

Authors Dias NR, Howley AR, Yamamoto R, Dallabrida SM

Received 5 June 2019

Accepted for publication 27 August 2019

Published 21 October 2019 Volume 2019:10 Pages 315—319

DOI https://doi.org/10.2147/PROM.S218376

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
Email Amanda.Howley@ert.com

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

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