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A modified Delphi exercise to determine the extent of consensus with OMERACT outcome domains for studies of acute and chronic gout
  1. W J Taylor1,
  2. H R Schumacher Jr2,
  3. H S B Baraf3,
  4. P Chapman4,
  5. L Stamp5,
  6. M Doherty6,
  7. F McQueen7,
  8. N Dalbeth7,
  9. N Schlesinger8,
  10. D E Furst9,
  11. J Vazquez Mellado10,
  12. M A Becker11,
  13. A Kavanaugh12,
  14. W Louthrenoo13,
  15. T Bardin14,
  16. D Khanna9,
  17. L S Simon15,
  18. H Yamanaka16,
  19. H K Choi17,
  20. X Zeng18,
  21. V Strand19,
  22. R Grainger1,
  23. D Clegg20,
  24. J A Singh21,
  25. C Diaz-Torne22,
  26. M Boers23,
  27. P Gow24,
  28. V G Barskova25
  1. 1
    University of Otago, Wellington, New Zealand
  2. 2
    University of Pennsylvania and VA Medical Center, Philadelphia, PA, USA
  3. 3
    George Washington University, Washington, DC, USA
  4. 4
    Canterbury District Health Board, Christchurch, New Zealand
  5. 5
    University of Otago, Christchurch, New Zealand
  6. 6
    University of Nottingham, Nottingham, UK
  7. 7
    University of Auckland, Auckland, New Zealand
  8. 8
    Robert Wood Johnson Medical School, University of Medicine and Dentistry of New Jersey, New Brunswick, NJ, USA
  9. 9
    University of California at Los Angeles, Los Angeles, CA, USA
  10. 10
    Hospital General de Mexico, Mexico City, Mexico
  11. 11
    University of Chicago, Chicago, IL, USA
  12. 12
    University of California at San Diego, San Diego, CA, USA
  13. 13
    Chiang Mai University, Chiang Mai, Thailand
  14. 14
    Assistance Publique des Hôpitaux de Paris & University Paris VII, Paris, France
  15. 15
    Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA
  16. 16
    Tokyo Women’s Medical University, Japan
  17. 17
    The University of British Columbia, Vancouver, Canada
  18. 18
    Peking Union Medical College Hospital, China
  19. 19
    Division of Immunology/Rheumatology, Stanford University, CA, USA
  20. 20
    University of Utah, Salt Lake City, UT, USA
  21. 21
    Minneapolis Veterans Affairs Medical Center and University of Minnesota, Minneapolis, MN, USA
  22. 22
    Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
  23. 23
    VU University Medical Center, Amsterdam, the Netherlands
  24. 24
    Counties-Manukau District Health Board, Auckland, New Zealand
  25. 25
    State Institute of Rheumatology, Russian Academy of Medical Sciences, Moscow, Russia
  1. Dr William Taylor, Department of Medicine, University of Otago Wellington, PO Box 7343, Wellington 6242, New Zealand; will.taylor{at}otago.ac.nz

Abstract

Objectives: To reach consensus with recommendations made by an OMERACT Special Interest Group (SIG).

Methods: Rheumatologists and industry representatives interested in gout rated and clarified, in three iterations, the importance of domains proposed by the OMERACT SIG for use in acute and chronic gout intervention studies. Consensus was defined as a value of less than 1 of the UCLA/RAND disagreement index.

Results: There were 33 respondents (61% response rate); all agreed the initial items were necessary, except “total body urate pool”. Additional domains were suggested and clarification sought for defining “joint inflammation” and “musculoskeletal function”. Items that demonstrated no clear decision were re-rated in the final iteration. There were six highly rated items (rating 1–2) with four slightly lower rating items (rating 3) for acute gout; and 11 highly rated items with eight slightly lower ratings for chronic gout.

Conclusions: Consensus is that the following domains be considered mandatory for acute gout studies: pain, joint swelling, joint tenderness, patient global, physician global, functional disability; and for chronic gout studies: serum urate, gout flares, tophus regression, health-related quality of life, functional disability, pain, patient global, physician global, work disability and joint inflammation. Several additional domains were considered discretionary.

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Footnotes

  • For numbered affiliations see end of article

  • Competing interests: None.

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    BMJ Publishing Group Ltd and European League Against Rheumatism