Abstract

In recent years, there has been increasing interest, as indicated by a growing number of citations in the medical literature, on the assessment of outcomes in patients with rheumatoid arthritis (RA) focusing on the patient's perspective. This article describes the domains of patient-reported outcomes (PROs), instruments for measuring responses, as well as the use of PRO in clinical trials with newer agents, including biologic agents. At the 10th Outcome Measure in Rheumatology Clinical Trials (OMERACT) conference, several methodological issues about the choice of PRO domains, the development of instruments measuring these domains, and the methods for assessing response criteria were addressed. Composite domains like the RA impact of disease (RAID) score and core outcomes for the RA patient priorities for pharmacologic interventions (RAPP-PI) were introduced. Minimally clinically important differences in various PROs have been used to measure responsiveness to change in clinical trials. Many randomized clinical trials show significant improvements in PRO, such as the health assessment questionnaire disability index, and the medical outcomes study short form with effective treatment. PRO has become an essential part when assessing patients with RA. This trend will likely continue into the future, in both clinical trials as well as clinical practice.

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