Toward a valid definition of gout flare: Results of consensus exercises using delphi methodology and cognitive mapping

Authors

  • W. J. Taylor,

    Corresponding author
    1. University of Otago and Wellington Regional Rheumatology Unit, Hutt Valley District Health Board, Wellington, New Zealand
    • Department of Medicine, Wellington School of Medicine and Health Sciences, University of Otago, PO Box 7343, Wellington 6242, New Zealand
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    • Dr. Taylor has received consulting fees (less than $10,000) from Xoma.

  • R. Shewchuk,

    1. University of Alabama at Birmingham
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  • K. G. Saag,

    1. University of Alabama at Birmingham
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    • Dr. Saag has received consulting fees (less than $10,000 each) from TAP, Takeda, Savient, and Novartis.

  • H. R. Schumacher Jr.,

    1. University of Pennsylvania School of Medicine and Veterans Affairs Medical Center, Philadelphia
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    • Dr. Schumacher has received consulting fees (less than $10,000 each) from TAP, Takeda, Savient, Pfizer, Merck, Regeneron, Xoma, and Ipsen.

  • J. A. Singh,

    1. Minneapolis VA Medical Center and University of Minnesota, Minneapolis
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    • Dr. Singh is recipient of investigator-initiated research grants from TAP and Savient for a different project.

  • R. Grainger,

    1. Malaghan Institute of Medical Research and Wellington Regional Rheumatology Unit, Hutt Valley District Health Board, Wellington, New Zealand
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    • Dr. Grainger has received honoraria (less than $10,000) from Merck Sharp & Dohme.

  • N. L. Edwards,

    1. University of Florida, Gainesville
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    • Dr. Edwards has received consultancies, speaking fees, and/or honoraria (less than $10,000) from Regeneron and (more than $10,000 each) from Savient and Takeda.

  • T. Bardin,

    1. Hôpital Lariboisiére, Paris, France
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  • R. W. Waltrip,

    1. Savient Pharmaceuticals, East Brunswick, NJ
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    • Dr. Waltrip is a stockholder (less than $10,000) in Savient.

  • L. S. Simon,

    1. Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts
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    • Dr. Simon is a member of the Board of Directors of Savient, is a paid regulatory consultant for Leerink Swann Investment Bank, and has received consulting fees (less than $10,000 each) from AAI, Affinergy, AstraZeneca, Abraxis, Alpha Rx, Nuvo/Dimethaid, Roche, Pfizer, Novartis, PLx, Hisamitsu, LAB, Dr.Reddys, Biosense, Avanir, Cerimon, Alimera, Nomura, Luxor, Parexel, Nitec, Bayer, CombinatoRx, Rigel, Chelsea, Regeneron, Genelabs, Cypress, SNBL, SkyePharma, Proctor and Gamble, Savient, EyeGate, NicOx, Fidelity, BioCryst, Extera, Wyeth, Anesiva, Solace, Puretech Ventures, Puretech Development, White Mountain, TAP, Abbott, Cell Therapeutics, Ometor, Jazz, Schwarz, ProEthic, Takeda, Teva, Zydus, Proprius, Savient, Alder, Cure, Cellegy, ChemoCentryx, McKesson, DiObex, Sepracor, Purdue, Serono, Coley, MedImmune, Altea, Neuromed, Polymerix, Talagen, Tigenix, Millenium, IDM, Antigenics, GPC Biotech, Forest, Genzyme, Acusphere, and CaloSyn.

  • R. Burgos-Vargas

    1. Hospital General de México, Universidad Nacional Autónoma de México, México City México
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    • Dr. Burgos-Vargas has received consultancies, speaking fees, and/or honoraria (less than $10,000 each) from Abbott, Roche, Schering Plough, and Wyeth.


Abstract

Objective

To identify, in people known to have gout, the testable, key components of a standard definition of gout flare for use in clinical research.

Methods

Consensus methodology was used to identify key elements of a gout flare. Two Delphi exercises were conducted among different groups of rheumatologists. A cognitive mapping technique among 9 gout experts with hierarchical cluster analysis provided a framework to guide the panel discussion, which identified the final set of items that should be tested empirically.

Results

From the Delphi exercises, 21 items were presented to the expert panel. Cluster analysis and multidimensional scaling showed that these items clustered into 5 concepts (joint inflammation, severity of symptoms, stereotypical nature, pain, and gout archetype) distributed along 2 dimensions (objective to subjective features and general features to specific features of gout). Using this analysis, expert panel discussion generated a short list of potential features: joint swelling, joint tenderness, joint warmth, severity of pain, patient global assessment, time to maximum pain, time to complete resolution of pain, an acute-phase marker, and functional impact of the episode.

Conclusion

A short list of features has been identified and now requires validation against a patient- and physician-defined gout flare in order to determine the best combination of features.

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