Patient reported outcomes in rheumatoid arthritis clinical trials.

Patient reported outcomes (PRO) are at the core of assessing RA treatment response with patient assessments of global health or disease activity, pain, and physical function included in the calculation of American College of Rheumatology (ACR) responses. Progress has been made in assessing PROs that include additional patient-valued aspects of disease in recent RA randomized clinical trials (RCTs), particularly fatigue. Importantly, the National Institute of Health (NIH)--Patient Reported Outcomes Measurement Information System (PROMIS) development of psychometrically advanced generic health measures that span the range of symptoms potentially affected in RA, with high precision across the entire range of a symptom are undergoing additional study in RA and other rheumatologic diseases to establish their construct validity, responsiveness, and clinically meaningful cutoffs. PRO measures that are currently used and widely available can provide important perspectives not captured in composite clinical response criteria with the potential of better informing treatment decisions in clinical practice.