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International consensus on preliminary definitions of improvement in adult and juvenile myositis.

Publication ,  Journal Article
Rider, LG; Giannini, EH; Brunner, HI; Ruperto, N; James-Newton, L; Reed, AM; Lachenbruch, PA; Miller, FW ...
Published in: Arthritis Rheum
July 2004

OBJECTIVE: To use a core set of outcome measures to develop preliminary definitions of improvement for adult and juvenile myositis as composite end points for therapeutic trials. METHODS: Twenty-nine experts in the assessment of myositis achieved consensus on 102 adult and 102 juvenile paper patient profiles as clinically improved or not improved. Two hundred twenty-seven candidate definitions of improvement were developed using the experts' consensus ratings as a gold standard and their judgment of clinically meaningful change in the core set of measures. Seventeen additional candidate definitions of improvement were developed from classification and regression tree analysis, a data-mining decision tree tool analysis. Six candidate definitions specifying percentage change or raw change in the core set of measures were developed using logistic regression analysis. Adult and pediatric working groups ranked the 13 top-performing candidate definitions for face validity, clinical sensibility, and ease of use, in which the sensitivity and specificity were >/=75% in adult, pediatric, and combined data sets. Nominal group technique was used to facilitate consensus formation. RESULTS: The definition of improvement (common to the adult and pediatric working groups) that ranked highest was 3 of any 6 of the core set measures improved by >/=20%, with no more than 2 worse by >/=25% (which could not include manual muscle testing to assess strength). Five and 4 additional preliminary definitions of improvement for adult and juvenile myositis, respectively, were also developed, with several definitions common to both groups. Participants also agreed to prospectively test 6 logistic regression definitions of improvement in clinical trials. CONCLUSION: Consensus preliminary definitions of improvement were developed for adult and juvenile myositis, and these incorporate clinically meaningful change in all myositis core set measures in a composite end point. These definitions require prospective validation, but they are now proposed for use as end points in all myositis trials.

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Published In

Arthritis Rheum

DOI

ISSN

0004-3591

Publication Date

July 2004

Volume

50

Issue

7

Start / End Page

2281 / 2290

Location

United States

Related Subject Headings

  • Terminology as Topic
  • Myositis
  • Humans
  • Child
  • Arthritis & Rheumatology
  • Adult
  • 1117 Public Health and Health Services
  • 1107 Immunology
  • 1103 Clinical Sciences
 

Citation

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Rider, L. G., Giannini, E. H., Brunner, H. I., Ruperto, N., James-Newton, L., Reed, A. M., … International Myositis Assessment and Clinical Studies Group. (2004). International consensus on preliminary definitions of improvement in adult and juvenile myositis. Arthritis Rheum, 50(7), 2281–2290. https://doi.org/10.1002/art.20349
Rider, Lisa G., Edward H. Giannini, Hermine I. Brunner, Nicola Ruperto, Laura James-Newton, Ann M. Reed, Peter A. Lachenbruch, Frederick W. Miller, and International Myositis Assessment and Clinical Studies Group. “International consensus on preliminary definitions of improvement in adult and juvenile myositis.Arthritis Rheum 50, no. 7 (July 2004): 2281–90. https://doi.org/10.1002/art.20349.
Rider LG, Giannini EH, Brunner HI, Ruperto N, James-Newton L, Reed AM, et al. International consensus on preliminary definitions of improvement in adult and juvenile myositis. Arthritis Rheum. 2004 Jul;50(7):2281–90.
Rider, Lisa G., et al. “International consensus on preliminary definitions of improvement in adult and juvenile myositis.Arthritis Rheum, vol. 50, no. 7, July 2004, pp. 2281–90. Pubmed, doi:10.1002/art.20349.
Rider LG, Giannini EH, Brunner HI, Ruperto N, James-Newton L, Reed AM, Lachenbruch PA, Miller FW, International Myositis Assessment and Clinical Studies Group. International consensus on preliminary definitions of improvement in adult and juvenile myositis. Arthritis Rheum. 2004 Jul;50(7):2281–2290.
Journal cover image

Published In

Arthritis Rheum

DOI

ISSN

0004-3591

Publication Date

July 2004

Volume

50

Issue

7

Start / End Page

2281 / 2290

Location

United States

Related Subject Headings

  • Terminology as Topic
  • Myositis
  • Humans
  • Child
  • Arthritis & Rheumatology
  • Adult
  • 1117 Public Health and Health Services
  • 1107 Immunology
  • 1103 Clinical Sciences