Fibromyalgia Syndrome

PHILIP MEASE, LESLEY M. ARNOLD, ROBERT BENNETT, ANNELIES BOONEN, DAN BUSKILA, SERENA CARVILLE, AMY CHAPPELL, ERNEST CHOY, DANIEL CLAUW, DINA DADABHOY, MICHAEL GENDREAU, DON GOLDENBERG, GEOFFREY LITTLEJOHN, SUSAN MARTIN, PHILIP PERERA, I. JON RUSSELL, LEE SIMON, MICHAEL SPAETH, DAVID WILLIAMS, and LESLIE CROFFORD

ABSTRACT.

The fibromyalgia syndrome (FM) workshop at OMERACT 8 continued the work initiated in the first FM workshop at OMERACT 7 in 2004. The principal objectives were to work toward consensus on core domains for assessment in FM studies, evaluate the performance quality of outcome measures used in a review of recent trials in FM, and discuss the research agenda of the FM working group. An initiative to include the patient perspective on identification and prioritization of domains, consisting of focus groups and a patient Delphi exercise, was completed prior to OMERACT 8. Patient-identified domains were, for the most part, similar to those identified by clinician-investigators in terms of symptoms and relative importance. However, patients identified certain domains, such as stiffness, that were not included by physicians, and emphasized the importance of domains such as dyscognition and impaired motivation. Many of the principal domains agreed upon by the clinician-investigators, patients, and OMERACT participants, including pain, fatigue, sleep, mood, and global measures, have been used in clinical trials and performed well when viewed through the OMERACT filter. The research agenda items reviewed and approved for continued study included development of objective "biomarkers" in FM, development of a responder index for FM, and coordination with the WHO's International Classification of Functioning Disability and Health (ICF) Research Branch and the US National Institutes of Health's Patient Reported Outcome Measures Information System network (PROMIS) to develop improved measures of function, quality of life, and participation. The OMERACT process has provided a framework for identification of key domains to be assessed and a path toward validation and standardization of outcome measures for clinical trials in FM. (J Rheumatol 2007;34:1415-25)

Key Indexing Terms:

FIBROMYALGIA
OMERACT
OUTCOME MEASURES
PAIN

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Supported by a grant from Pfizer Global Research and Development, Ann Arbor, Michigan, USA, for the patient focus groups and Delphi exercise.

P.J. Mease, MD, Seattle Rheumatology Associates, Chief, Division of Rheumatology Research, Swedish Medical Center, Clinical Professor of Medicine, University of Washington, Seattle, WA; L.M. Arnold, Associate Professor, Director, Women's Health Research Program, Department of Psychiatry, University of Cincinnati College of Medicine, Cincinnati, OH; R. Bennett, Professor of Medicine and Nursing Research, Oregon Health & Science University, Portland, OR, USA; A. Boonen, PhD, Department of Internal Medicine, Division of Rheumatology, University Hospital Maastricht and Caphri Research Institute, University of Maastricht, Maastricht, The Netherlands; D. Buskila, Department of Medicine H, Soroka Medical Center, Beer Sheva, Israel; S. Carville, Sir Alfred Baring Garrod Clinical Trials Unit, Department of Academic Rheumatology, King's College London, London, UK; A. Chappell, Medical Fellow, Eli Lilly and Company, Indianapolis, IN, USA; E. Choy, Sir Alfred Baring Garrod Clinical Trials Unit, Department of Academic Rheumatology, King's College London, London, UK; D. Clauw, Professor of Medicine and Psychiatry, University of Michigan, Ann Arbor, MI; D. Dadabhoy, Clinical Lecturer, Division of Rheumatology, University of Michigan, Ann Arbor, MI; R.M. Gendreau, Chief Medical Officer, Cypress Bioscience, Inc., San Diego, CA; D. Goldenberg, Chief, Rheumatology, Newton-Wellesley Hospital, Professor of Medicine, Tufts University School of Medicine, Newton, MA, USA; G. Littlejohn, Director of Rheumatology, Monash Medical Centre, Associate Professor, Monash University, Melbourne, Australia; S. Martin, Director, Outcomes Research, Pfizer, Ann Arbor, MI; P. Perera, Chief Medical Officer, Vice-President of Clinical Research, Jazz Pharmaceuticals, Palo Alto, CA; I.J. Russell, Associate Professor of Medicine, Director, University Clinical Research Center, The University of Texas Health Science Center at San Antonio, San Antonio, TX; L. Simon, Associate Clinical Professor of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA; M. Spaeth, Friedrich-Baur-Institut, University of Munich, Munich, Germany; D.A. Williams, Associate Professor, Rheumatology/Internal Medicine, University of Michigan, Ann Arbor, MI; L. Crofford, Gloria W. Singletary Professor of Internal Medicine, Chief, Division of Rheumatology and Women's Health, University of Kentucky, Lexington, KY, USA.

Address reprint requests to Dr. P.J. Mease, Seattle Rheumatology Associates, 1101 Madison, Suite 1000, Seattle, WA 98104. E-mail: pmease@nwlink.com

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