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

By P.J. Mease, D.J. Clauw, R. Christensen, L.J. Crofford, R.M. Gendreau, S.A. Martin, L.S. Simon, V. Strand, D.A. Williams, L.M. Arnold, A. Cieza, A. Cazorla, A. Boonen, B. Cuffel, B. Walitt, C. Lai, D. Buskila, D.J. Clauw, D. Williams, D. Ang, D. Guinta, D. Goldenberg, E. Choy, G.O. Littlejohn, G. Zlateva, H. Moldofsky, J. Mikdashi, J. De Cunha Branco, J. Perhach, J. Glass, I.J. Russell, K. Longley, K. Jones, L. Bradley, L. Humphrey, L. Matallana, M. Spaeth, O. Vitton, P. Sarzi-Puttini, R. Tummala, R. Gracely, D.R. Allen, R. Bennett, R. Palmer, S. Bongardt, S. Plotnick, S. Silverman, S. Perrot, S. Martin, T. Stamm, T. Kharkevitch and Y. Mainguy

Abstract

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

Topics: Disease activity score, Fibromyalgia, OMERACT, Outcome measures, Responder index, Algorithms, Fatigue, Fibromyalgia, Humans, Outcome Assessment (Health Care), Pain, Psychometrics, Randomized Controlled Trials as Topic, Treatment Outcome, Disability Evaluation, Severity of Illness Index, Settore MED/16 - Reumatologia
Publisher: 'The Journal of Rheumatology'
Year: 2011
DOI identifier: 10.3899/jrheum.110277
OAI identifier: oai:air.unimi.it:2434/667478
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