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

Journal of Rheumatology

Volumn 38, Issue 7, 2011, Pages 1487-1495

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

^a SWEDISH MEDICAL CENTER   (United States)

^b UNIVERSITY OF MICHIGAN   (United States)

^c Mental Health Services CPH   (Denmark)

^d UNIVERSITY OF KENTUCKY   (United States)

^e Cypress Bioscience Inc   (United States)

^f RTI HEALTH SOLUTIONS   (United States)

^g SDG LLC   (United States)

^h STANFORD UNIVERSITY   (United States)

ⁱ UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

^j University of Cincinnati College of Medicine ^*

more..

Author keywords

Disease activity score; Fibromyalgia; OMERACT; Outcome measures; Responder index

Indexed keywords

AMITRIPTYLINE; CYCLOBENZAPRINE; DISEASE MODIFYING ANTIRHEUMATIC DRUG; MILNACIPRAN; OXYBATE SODIUM; PLACEBO; TUMOR NECROSIS FACTOR INHIBITOR; ANTIRHEUMATIC AGENT; BIOLOGICAL MARKER; C REACTIVE PROTEIN; DULOXETINE; PREGABALIN; TUMOR NECROSIS FACTOR ANTIBODY;

ALGORITHM; ANKYLOSING SPONDYLITIS; CLINICAL FEATURE; CLINICAL RESEARCH; COGNITIVE DEFECT; CONFERENCE PAPER; CONSENSUS; DISEASE ACTIVITY; DISEASE COURSE; DISEASE MARKER; DISEASE SEVERITY; FATIGUE; FIBROMYALGIA; FIBROMYALGIA RESPONDER INDEX AND DISEASE ACTIVITY SCORE; FUNCTIONAL DISEASE; HUMAN; JOINT STIFFNESS; MOOD DISORDER; OUTCOME ASSESSMENT; PAIN; PRIORITY JOURNAL; PSYCHOMETRY; QUANTITATIVE DIAGNOSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RHEUMATOID ARTHRITIS; SCORING SYSTEM; SLEEP DISORDER; ANXIETY DISORDER; CLINICAL ASSESSMENT; CLINICAL EFFECTIVENESS; CLINICAL EVALUATION; DEPRESSION; ERYTHROCYTE SEDIMENTATION RATE; HEALTH ASSESSMENT QUESTIONNAIRE; MAGNETOTHERAPY; NEUROIMAGING; PAIN ASSESSMENT; QUANTITATIVE ANALYSIS; REVIEW; SHORT FORM 36; THERAPY EFFECT; VALIDATION PROCESS; VISUAL ANALOG SCALE; WORKING MEMORY;

ALGORITHMS; DISABILITY EVALUATION; FATIGUE; FIBROMYALGIA; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); PAIN; PSYCHOMETRICS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 79960023828     PISSN: 0315162X     EISSN: 14992752     Source Type: Journal    
DOI: 10.3899/jrheum.110277     Document Type: Conference Paper

References (48)

1. Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum 1990;33:160-72.
2. Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, et al. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res 2010;62:600-10.
3. Mease P. Fibromyalgia syndrome: Review of clinical presentation, pathogenesis, outcome measures, and treatment. J Rheumatol 2005;32:6-21. (Pubitemid 41113954)
4. Staud R. Abnormal pain modulation in patients with spatially distributed chronic pain: fibromyalgia. Rheum Dis Clin North Am 2009;35:263-74.
5. Williams DA, Clauw DJ. Understanding fibromyalgia: lessons from the broader pain research community. J Pain 2009;10:777-91.
6. Clauw DJ. Fibromyalgia: update on mechanisms and management. J Clin Rheumatol 2007;13:102-9. (Pubitemid 46597679)
7. Arnold LM, Russell IJ, Diri EW, Duan WR, Young JP, Sharma U, et al. A 14-week, randomized, double-blind, placebo-controlled, durability of effect study of pregabalin for pain associated with fibromyalgia. J Pain 2008;9:792-805.
8. Mease PJ, Russell IJ, Arnold LM, Florian H, Young JP Jr, Martin SA, et al. A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia. J Rheumatol 2008;35:502-14. (Pubitemid 351374429)
9. Crofford LJ, Mease PJ, Simpson SL, Young JP, Martin SA, Haig GM, et al. Fibromyalgia relapse evaluation and efficacy for durability of meaningful relief (FREEDOM): a 6-month, doubleblind, placebo-controlled trial with pregabalin. Pain 2008;136:419-31.
10. Arnold LM, Rosen A, Pritchett YL, D'Souza DN, Goldstein DJ, Iyengar S, et al. A randomized, double-blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder. Pain 2005;119:5-15. (Pubitemid 41752960)
11. Russell IJ, Mease PJ, Smith TR, Kajdasz DK, Wohlreich MM, Detke MJ, et al. Efficacy and safety of duloxetine for treatment of fibromyalgia in patients with or without major depressive disorder: Results from a 6-month, randomized, double-blind, placebo-controlled, fixed-dose trial. Pain 2008;136:432-44.
12. Mease PJ, Clauw DJ, Gendreau RM, Rao SG, Kranzler J, Chen W, et al. The efficacy and safety of milnacipran for treatment of fibromyalgia. a randomized, double-blind, placebo-controlled trial. J Rheumatol 2009;36:398-409.
13. Clauw DJ, Mease P, Palmer RH, Gendreau RM, Wang Y. Milnacipran for the treatment of fibromyalgia in adults: a 15-week, multicenter, randomized, double-blind, placebo-controlled, multiple-dose clinical trial. Clin Ther 2008;30:1988-2004.
14. Arnold LM, Gendreau RM, Palmer RH, Gendreau JF, Wang Y. Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2010;62:2745-56.
15. Mease PJ, Clauw DJ, Arnold LM, Goldenberg DL, Witter J, Williams DA, et al. Fibromyalgia syndrome. J Rheumatol 2005;32:2270-7. (Pubitemid 41587880)
16. Mease P, Arnold LM, Bennett R, Boonen A, Buskila D, Carville S, et al. Fibromyalgia syndrome. J Rheumatol 2007;34:1415-25. (Pubitemid 46898129)
17. Arnold LM, Crofford LJ, Mease PJ, Burgess SM, Palmer SC, Abetz L, et al. Patient perspectives on the impact of fibromyalgia. Patient Educ Couns 2008;73:114-20.
18. Mease PJ, Arnold LM, Crofford LJ, Williams DA, Russell IJ, Humphrey L, et al. Identifying the clinical domains of fibromyalgia: contributions from clinician and patient Delphi exercises. Arthritis Rheum 2008;59:952-60. (Pubitemid 351990991)
19. Choy EH, Arnold LM, Clauw DJ, Crofford LJ, Glass JM, Simon LS, et al. Content and criterion validity of the preliminary core dataset for clinical trials in fibromyalgia syndrome. J Rheumatol 2009;36:2330-4.
20. Mease P, Arnold LM, Choy EH, Clauw DJ, Crofford LJ, Glass JM, et al. Fibromyalgia syndrome module at OMERACT 9: domain construct. J Rheumatol 2009;36:2318-29.
21. Ware JEJ, Sherbourne CD. The MOS 36-Item Short Form Health Survey (SF-36): Conceptual framework and item selection. Med Care 1992;30:473-83.
22. Burckhardt CS, Clark SR, Bennett RM. The Fibromyalgia Impact Questionnaire: development and validation. J Rheumatol 1991;18:728-33.
23. Glass JM. Review of cognitive dysfunction in fibromyalgia: a convergence on working memory and attentional control impairments. Rheum Dis Clin North Am 2009;35:299-311.
24. Mease P, Arnold L, Wang F, Ahl J, Mohs R, Gaynor P, et al. The effect of duloxetine on cognition in patients with fibromyalgia. [abstract]. Arthritis Rheum 2010;62 Suppl:S46.
25. Witter J, Simon LS. Chronic pain and fibromyalgia: the regulatory perspective. Best Pract Res Clin Rheumatol 2003;17:541-6.
26. Simms RW, Felson DT, Goldenberg DL. Criteria for response to treatment in fibromyalgia [abstract]. Arthritis Rheum 2988;31:S100.
27. Carette S, Bell MJ, Reynolds WJ, Haraoui B, McCain GA, Bykerk VP, et al. Comparison of amitriptyline, cyclobenzaprine, and placebo in the treatment of fibromyalgia. A randomized, double-blind clinical trial. Arthritis Rheum 1994;37:32-40.
28. Simms RW, Felson DT, Goldenberg DL. Development of preliminary criteria for response to treatment in fibromyalgia syndrome. J Rheumatol 1991;18:1558-63.
29. Dunkl PR, Taylor AG, McConnell GG, Alfano AP, Conaway MR. Responsiveness of fibromyalgia clinical trial outcome measures. J Rheumatol 2000;27:2683-91.
30. Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001;94:149-58.
31. Russell IJ, Perkins AT, Michalek JE. Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: a randomized, double-blind, placebo-controlled, multicenter clinical trial. Arthritis Rheum 2009;60:299-309.
32. van der Heijde DM, van 't Hof MA, van Riel PL, Theunisse LA, Lubberts EW, van Leeuwen MA, et al. Judging disease activity in clinical practice in rheumatoid arthritis: first step in the development of a disease activity score. Ann Rheum Dis 1990;49:916-20.
33. van Gestel AM, Prevoo ML, van 't Hof MA, van Rijswijk MH, van de Putte LB, van Riel PL. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis. Comparison with the preliminary American College of Rheumatology and the World Health Organization/International League Against Rheumatism Criteria. Arthritis Rheum 1996;39:34-40.
34. Prevoo ML, van 't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum 1995;38:44-8.
35. Aletaha D, Smolen JS. The definition and measurement of disease modification in inflammatory rheumatic diseases. Rheum Dis Clin North Am 2006;32:9-44, vii.
36. Felson DT, Anderson JJ, Boers M, Bombardier C, Chernoff M, Fried B, et al. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. The Committee on Outcome Measures in Rheumatoid Arthritis Clinical Trials. Arthritis Rheum 1993;36:729-40. (Pubitemid 23175613)
37. Felson D, American College of Rheumatology Committee to Reevaluate Improvement Criteria. A proposed revision to the ACR20: the hybrid measure of American College of Rheumatology response. Arthritis Rheum 2007;57:193-202. (Pubitemid 47164079)
38. Anderson JJ, Baron G, van der Heijde D, Felson DT, Dougados M. Ankylosing Spondylitis Assessment Group preliminary definition of short-term improvement in ankylosing spondylitis. Arthritis Rheum 2001;44:1876-86. (Pubitemid 32758236)
39. Lukas C, Landewé R, Sieper J, Dougados M, Davis J, Braun J, et al. Development of an ASAS-endorsed disease activity score (ASDAS) in patients with ankylosing spondylitis. Ann Rheum Dis 2009;68:18-24.
40. Pedersen SJ, Sorensen IJ, Hermann KG, Madsen OR, Tvede N, Hansen MS, et al. Responsiveness of the Ankylosing Spondylitis Disease Activity Score (ASDAS) and clinical and MRI measures of disease activity in a 1-year follow-up study of patients with axial spondyloarthritis treated with tumour necrosis factor alpha inhibitors. Ann Rheum Dis 2009;69:1065-71.
41. van der Heijde D, Lie E, Kvien TK, Sieper J, Van den Bosch F, Listing J, et al. ASDAS, a highly discriminatory ASAS-endorsed disease activity score in patients with ankylosing spondylitis. Ann Rheum Dis 2009;68:1811-8.
42. Mease PJ, Choy EH. Pharmacotherapy of fibromyalgia. Rheum Dis Clin North Am 2009;35:359-72.
43. Arnold LM, Goldenberg D, Stanford SB, Lalonde JK, Sandhu HS, Keck PE Jr, et al. Gabapentin in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled, multicenter trial. Arthritis Rheum 2007;56:1336-44. (Pubitemid 46608659)
44. Geisser ME, Clauw DJ, Strand V, Gendreau RM, Palmer R, Williams DA. Contributions of change in clinical status parameters to Patient Global Impression of Change (PGIC) scores among persons with fibromyalgia treated with milnacipran. Pain 2010;149:373-8.
45. Hudson JI, Arnold LM, Bradley LA, Choy EH, Mease PJ, Wang F, et al. What makes patients with fibromyalgia feel better? Correlations between Patient Global Impression of Improvement and changes in clinical symptoms and function: a pooled analysis of 4 randomized placebo-controlled trials of duloxetine. J Rheumatol 2009;36:2517-22.
46. Arnold LM, Zlateva G, Sadosky A, Emir B, Whalen E. Correlations between fibromyalgia symptom and function domains and patient global impression of change: A pooled analysis of three randomized, placebo-controlled trials of pregabalin. Pain Med 2011;12:260-7.
47. Hays R, Stewart A. Measuring functioning and well-being. In: Stewart A, Ware J, editors. Sleep measures. Durham, NC: Duke University Press; 1992:232-59.
48. Seidenberg M, Haltiner A, Taylor MA, Hermann BB, Wyler A. Development and validation of a Multiple Ability Self-Report Questionnaire. J Clin Exp Neuropsychol 1994;16:93-104. (Pubitemid 24051080)