The OMERACT core set of outcome measures for use in clinical trials of ANCA-associated vasculitis

Journal of Rheumatology

Volumn 38, Issue 7, 2011, Pages 1480-1486

  Merkel, Peter A ^a   Aydin, Sibel Z ^b,c   Boers, Maarten ^d   Direskeneli, Haner ^c   Herlyn, Karen ^e   Seo, Philip ^g   Suppiah, Ravi ^f   Tomasson, Gunnar ^a   Luqmani, Raashid A ^f  

^a BOSTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF LEEDS   (United Kingdom)

^c MARMARA UNIVERSITY SCHOOL OF MEDICINE   (Turkey)

^d VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^e UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^f UNIVERSITY OF OXFORD   (United Kingdom)

^g JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

Activity; Damage; Outcomes; Quality of life; Vasculitis

Indexed keywords

ANCA ASSOCIATED VASCULITIS; CLINICAL ASSESSMENT TOOL; CLINICAL TRIAL (TOPIC); COHORT ANALYSIS; CONFERENCE PAPER; CONSENSUS; DISEASE ACTIVITY; EUROPE; HUMAN; IDIOPATHIC DISEASE; MICROANGIOPATHY; MORTALITY; MULTICENTER STUDY (TOPIC); OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROGNOSIS; QUALITY OF LIFE; SELF REPORT; SHORT FORM 36; SYSTEMIC DISEASE; UNITED STATES; VALIDATION STUDY; WEGENER GRANULOMATOSIS; CLINICAL ASSESSMENT; CLINICAL EVALUATION; CLINICAL PRACTICE; CONSENSUS DEVELOPMENT; DISEASE ASSOCIATION; FEASIBILITY STUDY; HEALTH STATUS; KIDNEY FAILURE; MULTIPLE ORGAN FAILURE; PHYSICIAN ATTITUDE; PLASMAPHERESIS; RELAPSE; REMISSION; REVIEW; SCORING SYSTEM; SENSITIVITY ANALYSIS; VALIDATION PROCESS;

ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY-ASSOCIATED VASCULITIS; CLINICAL TRIALS AS TOPIC; COHORT STUDIES; HUMANS; MULTICENTER STUDIES AS TOPIC; OUTCOME ASSESSMENT (HEALTH CARE); QUALITY OF LIFE; REPRODUCIBILITY OF RESULTS; TREATMENT OUTCOME;

BIOLOGICAL MARKER; C REACTIVE PROTEIN;

EID: 79959955445     PISSN: 0315162X     EISSN: 14992752     Source Type: Journal    
DOI: 10.3899/jrheum.110276     Document Type: Conference Paper

References (35)

1. de Groot K, Harper L, Jayne DR, Flores Suarez LF, Gregorini G, Gross WL, et al. Pulse versus daily oral cyclophosphamide for induction of remission in antineutrophil cytoplasmic antibody-associated vasculitis: a randomized trial. Ann Intern Med 2009;150:670-80.
2. De Groot K, Rasmussen N, Bacon PA, Tervaert JW, Feighery C, Gregorini G, et al. Randomized trial of cyclophosphamide versus methotrexate for induction of remission in early systemic antineutrophil cytoplasmic antibody-associated vasculitis. Arthritis Rheum 2005;52:2461-9. (Pubitemid 41117433)
3. Jayne D, Rasmussen N, Andrassy K, Bacon P, Tervaert JW, Dadoniene J, et al. A randomized trial of maintenance therapy for vasculitis associated with antineutrophil cytoplasmic autoantibodies. N Engl J Med 2003;349:36-44. (Pubitemid 36765101)
4. WGET Research Group. Etanercept plus standard therapy for Wegener's granulomatosis. N Engl J Med 2005;352:351-61.
5. Jayne DR, Gaskin G, Rasmussen N, Abramowicz D, Ferrario F, Guillevin L, et al. Randomized trial of plasma exchange or high-dosage methylprednisolone as adjunctive therapy for severe renal vasculitis. J Am Soc Nephrol 2007;18:2180-8. (Pubitemid 47041083)
6. Jones RB, Tervaert JW, Hauser T, Luqmani R, Morgan MD, Peh CA, et al. Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis. N Engl J Med 2010;363:211-20.
7. Stone JH, Merkel PA, Spiera R, Seo P, Langford CA, Hoffman GS, et al. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med 2010;363:221-32.
8. Merkel PA, Seo P, Aries P, Neogi T, Villa-Forte A, Boers M, et al. Current status of outcome measures in vasculitis: focus on Wegener's granulomatosis and microscopic polyangiitis. Report from OMERACT 7. J Rheumatol 2005;32:2488-95. (Pubitemid 41780676)
9. Seo P, Luqmani RA, Flossmann O, Hellmich B, Herlyn K, Hoffman GS, et al. The future of damage assessment in vasculitis. J Rheumatol 2007;34:1357-71. (Pubitemid 46898123)
10. Merkel PA, Herlyn K, Mahr AD, Neogi T, Seo P, Walsh M, et al. Progress towards a core set of outcome measures in small-vessel vasculitis. Report from OMERACT 9. J Rheumatol 2009;36:2362-8.
11. Tugwell P, Boers M, Brooks P, Simon L, Strand V, Idzerda L. OMERACT: an international initiative to improve outcome measurement in rheumatology. Trials 2007;8:38.
12. Boers M, Brooks P, Strand CV, Tugwell P. The OMERACT filter for outcome measures in rheumatology. J Rheumatol 1998;25:198-9.
13. de Groot K, Gross WL, Herlyn K, Reinhold-Keller E. Development and validation of a disease extent index for Wegener's granulomatosis. Clin Nephrol 2001;55:31-8. (Pubitemid 32041780)
14. Guillevin L, Lhote F, Gayraud M, Cohen P, Jarrousse B, Lortholary O, et al. Prognostic factors in polyarteritis nodosa and Churg-Strauss syndrome. A prospective study in 342 patients. Medicine (Baltimore) 1996;75:17-28.
15. Whiting-O'Keefe QE, Stone JH, Hellmann DB. Validity of a vasculitis activity index for systemic necrotizing vasculitis. Arthritis Rheum 1999;42:2365-71. (Pubitemid 30333417)
16. Luqmani RA, Bacon PA, Moots RJ, Janssen BA, Pall A, Emery P, et al. Birmingham Vasculitis Activity Score (BVAS) in systemic necrotizing vasculitis. QJM 1994;87:671-8. (Pubitemid 24334817)
17. Stone JH, Hoffman GS, Merkel PA, Min YI, Uhlfelder ML, Hellmann DB, et al. A disease-specific activity index for Wegener's granulomatosis: modification of the Birmingham Vasculitis Activity Score. International Network for the Study of the Systemic Vasculitides (INSSYS). Arthritis Rheum 2001;44:912-20. (Pubitemid 32319784)
18. Mukhtyar C, Lee R, Brown D, Carruthers D, Dasgupta B, Dubey S, et al. Modification and validation of the Birmingham Vasculitis Activity Score (version 3). Ann Rheum Dis 2009;68:1827-32.
19. Luqmani RA, Exley AR, Kitas GD, Bacon PA. Disease assessment and management of the vasculitides. Baillieres Clin Rheumatol 1997;11:423-46. (Pubitemid 27296604)
20. Exley AR, Bacon PA, Luqmani RA, Kitas GD, Gordon C, Savage CO, et al. Development and initial validation of the Vasculitis Damage Index for the standardized clinical assessment of damage in the systemic vasculitides. Arthritis Rheum 1997;40:371-80. (Pubitemid 27114101)
21. Suppiah R, Flossmann O, Mukhtyar C, Alberici F, Baslund B, Brown D, et al. Measurement of damage in systemic vasculitis: a comparison of the Vasculitis Damage Index with the Combined Damage Assessment Index. Ann Rheum Dis 2011;70:80-5.
22. Seo P, Merkel PA, Specks U, Hoffman GS, Langford CA Spiera R, et al. Damage in ANCA-associated vasculitis: Preliminary evidence for the ANCA-associated Vasculitis Index of Damage [abstract]. Arthritis Rheum 2006;54 Suppl:S487.
23. Seo P, Silva F, Hoffman GS, Spiera R, Davis JC, McCune WJ, et al. Morbidity and mortality of Wegener's granulomatosis: Data from a current multicenter longitudinal cohort [abstract]. Arthritis Rheum 2008;58 Suppl:S852-3.
24. Luqmani R, Suppiah R, Edwards CJ, Phillip R, Maskell J, Culliford D, et al. Mortality in Wegener's granulomatosis: a bimodal pattern. Rheumatology 2011;50:697-702.
25. Flossmann O, Berden A, De Groot K, Hagen C, Harper L, Heijl C, et al. Long-term patient survival in ANCA-associated vasculitis. Ann Rheum Dis 2011;70:488-94.
26. Herlyn K, Hellmich B, Seo P, Merkel PA. Patient-reported outcome assessment in vasculitis provides important data and a unique perspective. Arthritis Care Res (Hoboken) 2010;62:1639-45.
27. Seo P, Jayne D, Luqmani R, Merkel PA. Assessment of damage in vasculitis: expert ratings of damage. Rheumatology 2009;48:823-7.
28. Neogi T, Xie H, Felson DT. Relative responsiveness of physician/assessor-derived and patient-derived core set measures in rheumatoid arthritis trials. J Rheumatol 2008;35:757-62. (Pubitemid 351747113)
29. McHorney CA, Ware JE Jr, Lu JF, Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care 1994;32:40-66.
30. McHorney CA, Ware JE Jr, Rogers W, Raczek AE, Lu JF. The validity and relative precision of MOS short- and long-form health status scales and Dartmouth COOP charts. Results from the Medical Outcomes Study. Med Care 1992;30 Suppl:MS253-65.
31. Koutantji M, Harrold E, Lane SE, Pearce S, Watts RA, Scott DG. Investigation of quality of life, mood, pain, disability, and disease status in primary systemic vasculitis. Arthritis Rheum 2003;49:826-37. (Pubitemid 37523636)
32. Newall C, Schinke S, Savage CO, Hill S, Harper L. Impairment of lung function, health status and functional capacity in patients with ANCA-associated vasculitis. Rheumatology 2005;44:623-8. (Pubitemid 41487231)
33. Srouji IA, Andrews P, Edwards C, Lund VJ. General and rhinosinusitis-related quality of life in patients with Wegener's granulomatosis. Laryngoscope 2006;116:1621-5. (Pubitemid 44368083)
34. Walsh M, Mukhtyar C, Mahr A, Herlyn K, Luqmani R, Merkel PA, et al. Health-related quality of life in patients with newly diagnosed antineutrophil cytoplasmic antibody-associated vasculitis. Arthritis Care Res 2011 Mar 30 [Epub ahead of print].
35. Tomasson G, Boers M, Walsh M, Cuthbertson D, Carette S, Davis JC, et al. Measurement of health-related quality of life among patients with ANCA-associated vasculitis using the SF-36. (submitted).