Patient-Reported Outcome Data

This chapter provides a brief introduction to patient-reported outcome measures (PROs), with an emphasis on measure characteristics and the implications for informatics of the use of PROs in clinical research. Because of increased appreciation on behalf of health-care funders and regulatory agencies for actual patient experience, PROs have become recognized as legitimate and attractive endpoints for clinical studies and for comparative effectiveness research. “Patient-reported outcomes” is an internationally recognized umbrella term that includes both single dimension and multidimension measures of symptoms, with the defining characteristic that all information is provided directly by the patient. PROs can be administered in a variety of formats and settings, ranging from face-to-face interaction in clinics to web interfaces to mobile devices (e.g., smart phones). PRO instruments measure one or more aspects of patients’ health status and are especially important when more objective measures of disease outcome are not available. PROs can be used to measure a broad array of health status indicators within the context of widely varying study designs exploring a multitude of diseases. As a result, they need to be well characterized so that they can be identified and used appropriately. The standardization, indexing, access, and implementation of PROs are issues that are particularly relevant to clinical research informatics. In this chapter, we discuss design characteristics of PROs, measurement issues relating to the use of PROs, modes of administration, item and scale development, scale repositories, and item banking.