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 Ang; Diane 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

doi:10.3899/jrheum.110277

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 journal › Article › peer-review

56 Scopus citations

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. The Journal of Rheumatology

Original language	English (US)
Pages (from-to)	1487-1495
Number of pages	9
Journal	Journal of Rheumatology
Volume	38
Issue number	7
DOIs	https://doi.org/10.3899/jrheum.110277
State	Published - Jul 2011
Externally published	Yes

Keywords

Disease activity score
Fibromyalgia
OMERACT
Outcome measures
Responder index

ASJC Scopus subject areas

Rheumatology
Immunology and Allergy
Immunology

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10.3899/jrheum.110277

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Mease, P. J., Clauw, D. J., Christensen, R., Crofford, L. J., Gendreau, R. M., Martin, S. A., Simon, L. S., Strand, V., Williams, D. A., Arnold, L. M., Cieza, A., Cazorla, A., Boonen, A., Cuffel, B., Walitt, B., Lai, C., Buskila, D., Clauw, D. J., Williams, D., ... Mainguy, Y. (2011). Toward development of a fibromyalgia responder index and disease activity score: OMERACT module update. Journal of Rheumatology, 38(7), 1487-1495. https://doi.org/10.3899/jrheum.110277

Mease, PJ, Clauw, DJ, Christensen, R, Crofford, LJ, Gendreau, RM, Martin, SA, Simon, LS, Strand, V, Williams, DA, Arnold, LM, Cieza, A, Cazorla, A, Boonen, A, Cuffel, B, Walitt, B, Lai, C, Buskila, D, Clauw, DJ, Williams, D, Ang, D, Guinta, D, Goldenberg, D, Choy, E, Littlejohn, GO, Zlateva, G, Moldofsky, H, Mikdashi, J, De Cunha Branco, J, Perhach, J, Glass, J, Russell, IJ, Longley, K, Jones, K, Bradley, L, Humphrey, L, Matallana, L, Spaeth, M, Vitton, O, Sarzi-Puttini, P, Tummala, R, Gracely, R, Allen, R, Bennett, R, Palmer, R, Bongardt, S, Plotnick, S, Silverman, S, Perrot, S, Martin, S, Stamm, T, Kharkevitch, T & Mainguy, Y 2011, 'Toward development of a fibromyalgia responder index and disease activity score: OMERACT module update', Journal of Rheumatology, vol. 38, no. 7, pp. 1487-1495. https://doi.org/10.3899/jrheum.110277

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title = "Toward development of a fibromyalgia responder index and disease activity score: OMERACT module update",

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. The Journal of Rheumatology",

keywords = "Disease activity score, Fibromyalgia, OMERACT, Outcome measures, Responder index",

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

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AU - Gendreau, R. Michael

AU - Martin, Susan A.

AU - Simon, Lee S.

AU - Strand, Vibeke

AU - Williams, David A.

AU - Arnold, Lesley M.

AU - Cieza, Alarcos

AU - Cazorla, Anne

AU - Boonen, Annelies

AU - Cuffel, Brian

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AU - Lai, Chinglin

AU - Buskila, Dan

AU - Clauw, Dan J.

AU - Williams, David

AU - Ang, Dennis

AU - Guinta, Diane

AU - Goldenberg, Don

AU - Choy, Ernest

AU - Littlejohn, Geoff O.

AU - Zlateva, Gergana

AU - Moldofsky, Harvey

AU - Mikdashi, Jamal

AU - De Cunha Branco, Jaime

AU - Perhach, James

AU - Glass, Jennifer

AU - Russell, I. Jon

AU - Longley, Kathy

AU - Jones, Kim

AU - Bradley, Larry

AU - Humphrey, Louise

AU - Matallana, Lynne

AU - Spaeth, Micheal

AU - Vitton, Olivier

AU - Sarzi-Puttini, Piercarlo

AU - Tummala, Raj

AU - Gracely, Richard

AU - Allen, Robert

AU - Bennett, Robert

AU - Palmer, Robert

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AU - Plotnick, Steve

AU - Silverman, Stuart

AU - Perrot, Serge

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AU - Kharkevitch, Tatiana

AU - Mainguy, Yves

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

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