Developing a valid patient-reported outcome measure

Clin Pharmacol Ther. 2011 Nov;90(5):737-42. doi: 10.1038/clpt.2011.195. Epub 2011 Oct 5.

Abstract

Many aspects of patients’ experiences with illness, medication, and health care are best captured from patient-reported outcomes (PROs). In this article, we describe the process for constructing quality PRO instruments, from conceptual model development through instrument validation. We also discuss PROs as clinical trial end points and the potential of PRO data for aiding clinicians and patients in choosing from among multiple therapeutic options. Finally, we provide an overview of some existing PRO instruments.

MeSH terms

  • Clinical Trials as Topic / methods*
  • Data Collection / methods*
  • Humans
  • Outcome Assessment, Health Care / methods
  • Reproducibility of Results
  • Self Report*
  • Validation Studies as Topic