Developing a Valid Patient-Reported Outcome Measure

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. Clinical Pharmacology & Therapeutics (2011); 90 5, 737–742. doi:10.1038/clpt.2011.195