Abstract
Patient reported outcomes (PROs) are questionnaire measures of patients’ symptoms, functioning, and health-related quality of life. They are designed to provide important clinical information that generally cannot be captured with objective medical testing. Recent legislative developments in the United States support greater efforts to include patients’ reports of health experience to evaluate treatment outcomes, engage in shared decision-making, and prioritize the focus of treatment. PROs have garnered increased attention by the Food and Drug Administration (FDA) for evaluating drugs and medical devices. Recent calls for comparative effectiveness research favor inclusion of PROs. In 2004, the National Institutes of Health launched a research initiative to improve the clinical research enterprise by developing state-of-the-art PROs. The NIH Patient Reported Outcomes Measurement System (PROMIS) and Assessment Center are the products of that initiative. Adult, pediatric, and parent-proxy item banks have been developed using contemporary psychometric methods, yielding rapid, accurate measurement. PROMIS currently provides tools for assessing physical, mental, and social health using short-form and computer adaptive testing methods. The PROMIS tools are being adopted for use in clinical trials and translational research. They are also being introduced in clinical medicine to assess a broad range of disease outcomes. There is potential for use of PROs to improve quality of care and disease outcomes, to provide patient-centered assessment for comparative effectiveness research, and to enable a common metric for tracking outcomes across providers and medical systems.