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Recent Developments for Optimal End-Points in Rheumatoid Arthritis Clinical Studies

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Author Info

  • Esmeralda T.H. Molenaar

    (Rheumatology Department, University Hospital Vrije Universiteit, Amsterdam, The Netherlands)

  • Maarten Boers

    (Clinical Epidemiology Department, University Hospital Vrije Universiteit, Amsterdam, The Netherlands)

  • Peter M. Brooks

    (Health Sciences Department, University of Queensland, Herston, Brisbane, Queensland, Australia)

  • Lee Simon

    (Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School,Boston, Massachusetts, USA)

  • Vibeke Strand

    (Immunology Department, Stanford University, San Francisco, California, USA)

  • Peter Tugwell

    (Department of Internal Medicine, University of Ottawa, Ontario, Canada)

Registered author(s):

    Abstract

    Clinical studies in patients with rheumatoid arthritis (RA) provide valuable information on the course and outcome of the disease whereas clinical trials provide information on optimal treatment for patients. This paper discusses measurement concepts and most frequently used measures in RA. To optimise the information that can be obtained from clinical studies, uniform measures are essential. Therefore, the international rheumatology community has made an effort to propose uniform end-points for clinical studies in RA. Measurement in RA is traditionally divided into the measurement of `the process' and measurement of `outcome'. Current measures in use include: 1. disease activity measures - global assessments, symptoms (e.g. morning stiffness), health status/ physical function, physical signs (e.g. joint counts) and laboratory assessments; and 2. measures of damage - radiography of affected joints and physical function. Several Outcome Measures in Rheumatology (OMERACT) conferences have resulted in a core set of end-points to be used in RA clinical trials, which are supported by the World Health Organization and International League of Associations for Rheumatology (WHO/ILAR). In addition, the OMERACT conferences focused on minimum important differences for patients and in trials, resulting in recommendations for improvement criteria. Improvement criteria were further developed and validated by both the American College of Rheumatology (ACR) and European League Against Rheumatology (EULAR). The ACR criteria use the WHO/ILAR core set of end-points to define minimum improvement in each of the measures. The EULAR criteria define improvement using the Disease Activity Score.

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    Bibliographic Info

    Article provided by Wolters Kluwer Health | Adis in its journal Disease Management & Health Outcomes.

    Volume (Year): 8 (2000)
    Issue (Month): 2 ()
    Pages: 87-97
    Download reference. The following formats are available: HTML (with abstract), plain text (with abstract), BibTeX, RIS (EndNote, RefMan, ProCite), ReDIF
    Handle: RePEc:wkh:dmhout:v:8:y:2000:i:2:p:87-97

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    Web page: http://diseasemanagement.adisonline.com/

    For corrections or technical questions regarding this item, or to correct its listing, contact: (Dave Dustin).

    Related research

    Keywords: Outcomes research; Pharmacoeconomics; Rheumatoid arthritis; Rheumatoid arthritis;

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