Toward development of a fibromyalgia responder index and disease activity score: OMERACT module update

Philip J. Mease, Daniel J. Clauw, Robin Christensen, Leslie J. Crofford, R. Michael Gendreau, Susan A. Martin, Lee S. Simon, Vibeke Strand, David A. Williams, Lesley M. Arnold, Alarcos Cieza, Anne Cazorla, Annelies Boonen, Brian Cuffel, Brian Walitt, Chinglin Lai, Dan Buskila, Dan J. Clauw, David Williams, Dennis AngDiane Guinta, Don Goldenberg, Ernest Choy, Geoff O. Littlejohn, Gergana Zlateva, Harvey Moldofsky, Jamal Mikdashi, Jaime De Cunha Branco, James Perhach, Jennifer Glass, I. Jon Russell, Kathy Longley, Kim Jones, Larry Bradley, Louise Humphrey, Lynne Matallana, Micheal Spaeth, Olivier Vitton, Piercarlo Sarzi-Puttini, Raj Tummala, Richard Gracely, Robert Allen, Robert Bennett, Robert Palmer, Sabine Bongardt, Steve Plotnick, Stuart Silverman, Serge Perrot, Susan Martin, Tanja Stamm, Tatiana Kharkevitch, Yves Mainguy

    Research output: Contribution to journalArticlepeer-review

    55 Scopus citations


    Following development of the core domain set for fibromyalgia (FM) in Outcome Measures in Rheumatology Clinical Trials (OMERACT) meetings 7 to 9, the FM working group has progressed toward the development of an FM responder index and a disease activity score based on these domains, utilizing outcome indices of these domains from archived randomized clinical trials in FM. Possible clinical domains that could be included in a responder index and disease activity score include pain, fatigue, sleep disturbance, cognitive dysfunction, mood disturbance, tenderness, stiffness, and functional impairment. Outcome measures for these domains demonstrate good to adequate psychometric properties, although measures of cognitive dysfunction need to be further developed. The approach used in the development of responder indices and disease activity scores for rheumatoid arthritis and ankylosing spondylitis represents heuristic models for our work, but FM is challenging in that there is no clear algorithm of treatment that defines disease activity based on treatment decisions, nor are there objective markers that define thresholds of severity or response to treatment. The process of developing candidate dichotomous responder definitions and continuous quantitative disease activity measures is described, along with participant discussions from OMERACT 10. Final results of this work will be published in a separate report pending completion of analyses. The Journal of Rheumatology

    Original languageEnglish
    Pages (from-to)1487-1495
    Number of pages9
    JournalJournal of Rheumatology
    Issue number7
    StatePublished - 1 Jul 2011


    • Disease activity score
    • Fibromyalgia
    • Outcome measures
    • Responder index

    ASJC Scopus subject areas

    • Rheumatology
    • Immunology and Allergy
    • Immunology


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