Applying patient-reported outcome methodology to capture patient-reported health data: Report from an NIH...

Patient-reported health data provide information for pragmatic clinical trials that may not be readily available from electronic health records or administrative claims data. In this report, we present key considerations for collecting patient-reported health information in pragmatic clinical trials, which are informed by best practices from patient-reported outcome research. We focus on question design and administration via electronic data collection platforms with respect to 3 types of patient-reported health data: medication use, utilization of health care services, and comorbid conditions. We summarize key scientific literature on the accuracy of these patient-reported data compared with electronic health record data. We discuss question design in detail, specifically defining the concept to be measured, patient understanding of the concept, recall periods of the question, and patient willingness to report. In addition, we discuss approaches for question administration and data collection platforms, which are key aspects of successful patient-reported data collection.