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OMERACT 7 Workshop

Fibromyalgia Syndrome

PHILIP J. MEASE, DANIEL J. CLAUW, LESLEY M. ARNOLD, DON L. GOLDENBERG, JAMES WITTER, DAVID A. WILLIAMS, LEE S. SIMON, C. VIBEKE STRAND, CANDACE BRAMSON, SUSAN MARTIN, TIMOTHY M. WRIGHT, BRUCE LITTMAN, J.F. WERNICKE, R. MICHAEL GENDREAU, and LESLIE J. CROFFORD

ABSTRACT.

The objectives of the first OMERACT Fibromyalgia Syndrome (FM) Workshop were to identify and prioritize symptom domains that should be consistently evaluated in FM clinical trials, and to identify aspects of domains and outcome measures that should be part of a concerted research agenda of FM researchers. Such an effort will help standardize and improve the quality of outcomes research in FM. A principal assumption in this workshop has been that there exists a clinical syndrome, generally known as FM, characterized by chronic widespread pain typically associated with fatigue, sleep disturbance, mood disturbance, and other symptoms and signs, and considered to be related to central neuromodulatory dysregulation. FM can be diagnosed using 1990 American College of Rheumatology criteria. In preparation for the workshop a Delphi exercise involving 23 FM researchers was conducted to establish a preliminary prioritization of domains of inquiry. At the OMERACT meeting, the workshop included presentation of the Delphi results; a review of placebo-controlled trials of FM treatment, with a focus on the outcome measures used and their performance; a panel discussion of the key issues in FM trials, from both an investigator and regulatory agency perspective; and a voting process by the workshop attendees. The results of the workshop were presented in the plenary session on the final day of the meeting. A prioritized list of domains of FM to be investigated was thus developed, key issues and controversies in the field were debated, and consensus on a research agenda on outcome measure development was reached. (J Rheumatol 2005;32:2270-7)

Key Indexing Terms:

FIBROMYALGIA
CHRONIC PAIN
OMERACT
OUTCOME MEASURES


From Swedish Medical Center and the University of Washington School of Medicine, Seattle, WA; Division of Rheumatology, Chronic Pain and Fatigue Research Center, Center for the Advancement of Clinical Research, University of Michigan, Ann Arbor, MI; Women's Health Research Program, University of Cincinnati College of Medicine, Cincinnati, OH; Tufts University School of Medicine, Boston, MA; US Food and Drug Administration, Rockville, MD; Center for the Advancement of Clinical Research, Chronic Pain and Fatigue Research Program, University of Michigan, Ann Arbor, MI; Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA; Division of Immunology, Stanford University, Portola Valley, CA; Pfizer Global Research and Development, Ann Arbor, MI, and Groton, CT; Novartis Institutes for Biomedical Research, Cambridge, MA; Global Product Safety, Eli Lilly and Company, Indianapolis, IN; Cypress Bioscience, Inc., San Diego, CA; and Rheumatology Division, University of Kentucky, Lexington, KY, USA.

P.J. Mease, MD, Head, Seattle Rheumatology Associates, Chief, Rheumatology Clinical Research, Swedish Hospital Medical Center, Clinical Professor, University of Washington School of Medicine; D.J. Clauw, MD, Professor of Medicine, Division of Rheumatology, Director, Chronic Pain and Fatigue Research Center, Director, Center for the Advancement of Clinical Research, University of Michigan; L.M. Arnold, MD, Associate Professor of Psychiatry, Director, Women's Health Research Program, University of Cincinnati College of Medicine; D.L. Goldenberg, MD, Chief of Rheumatology, Newton-Wellesley Hospital, Professor of Medicine, Tufts University School of Medicine; J. Witter, MD, PhD, Lead Medical Officer, FDA; D.A. Williams, PhD, Associate Professor, Medicine/Rheumatology, Director, Research Development, Center for the Advancement of Clinical Research, Director, Chronic Pain and Fatigue Research Program, University of Michigan; L.S. Simon, MD, Associate Clinical Professor of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center; C.V. Strand, MD, Biopharmaceutical Consultant, Adjunct Clinical Professor, Division of Immunology, Stanford University; C. Bramson, MD, Associate Director; S. Martin, MSPH, Associate Director, Pfizer Global Research and Development; T.M. Wright, MD, Deputy Head, Exploratory Clinical Development, Novartis Institutes for Biomedical Research; B. Littman, MD, Head, Experimental Medicine, Pfizer Global Research and Development; J.F. Wernicke, PhD, MD, Associate Director – Neuroscience, Global Product Safety, Eli Lilly and Company; R.M. Gendreau, MD, PhD, Vice President, Chief Medical Officer, Cypress Bioscience, Inc.; L.J. Crofford, MD, Professor of Internal Medicine, Chief, Rheumatology Division, University of Kentucky.

Address reprint requests to Dr. P.J. Mease, Seattle Rheumatology Associates, 1101 Madison Street, 10th Floor, Seattle, WA 98104. E-mail: pmease@nwlink.com




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