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Patient Reported Outcomes in Rheumatoid Arthritis Clinical Trials

  • Rheumatoid Arthritis (L Moreland, Section Editor)
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Abstract

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.

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Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

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Conflict of Interest

Ana-Maria Orbai declares the receipt of grant money in the form of a Scientist Development Award from the Rheumatology Research Foundation (RRF). Clifton O. Bingham declares the receipt of grant money via a Patient-Centered Outcomes Research Institute (PCORI) Pilot Project Program Award (1IP2-PI000737-01). All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors, or Methodology Committee. Dr. Bingham is a member of the Executive Committee of OMERACT (Outcome Measures in Rheumatology), an international group that develops and evaluates health outcomes; OMERACT receives hands-off funding from more than 23 pharmaceutical and research companies.

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This article does not contain any studies with human or animal subjects performed by the authors.

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  1. Divisions of Rheumatology, Johns Hopkins University, Baltimore, MD, USA

    Ana-Maria Orbai & Clifton O. Bingham III

  2. Allergy and Immunology, Department of Medicine, Johns Hopkins University, Baltimore, MD, USA

    Clifton O. Bingham III

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  1. Ana-Maria Orbai
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Correspondence to Ana-Maria Orbai.

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This article is part of the Topical Collection on Rheumatoid Arthritis

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Orbai, AM., Bingham, C.O. Patient Reported Outcomes in Rheumatoid Arthritis Clinical Trials. Curr Rheumatol Rep 17, 28 (2015). https://doi.org/10.1007/s11926-015-0501-8

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