ePRO Overview
A patient reported outcome (PRO) is a measurement taken from a patient's point of view without interpretation from a researcher, physician or anyone else. Typical PRO measurements include questionnaires to assess symptoms and other consequences of treatment such as quality of life. Frequently PRO measurements take the form of daily patient diaries or medication logs.
PRO instruments are included in clinical trials for new medical products because (1) some treatment effects are known only to the patient; (2) there is a desire to know the patient's perspective about the effectiveness of a treatment; or (3) systematic assessment of the patient's perspective may provide valuable information that can be lost when that perspective is filtered through a clinician's evaluation of the patient's response to clinical interview questions.1
Patient reported outcomes are rapidly gaining favor among researchers, clinicians and regulatory agencies as an essential decision-making tool for evaluating the use of medical products, with the number of randomized clinical trials using these instruments growing from 886 in 1996 to 5,177 in 2006.2
An electronic patient reported outcome (ePRO) refers to capturing these reports via electronic mode such as smartphone, tablet computer, web or interactive voice recognition. The considerable benefits of electronic systems over paper systems have been well documented and are resulting in the relentless expansion of the ePRO market, with some industry experts calling for an outright ban on paper-based PRO systems.
1. U.S. Department of Health and Human Services Food and Drug Administration. (February 2006). Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Draft Guidance. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071975.pdf
2. Patrick, Donald L. (25 October 2007). Assessing and reporting outcomes important to patients in clinical trials and Cochrane reviews> XV Cochrane Collaboration.