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2016 ACR-EULAR adult dermatomyositis and polymyositis and juvenile dermatomyositis response criteria-methodological aspects.

Publication ,  Journal Article
Rider, LG; Ruperto, N; Pistorio, A; Erman, B; Bayat, N; Lachenbruch, PA; Rockette, H; Feldman, BM; Huber, AM; Hansen, P; Oddis, CV; Amato, AA ...
Published in: Rheumatology (Oxford)
November 1, 2017

OBJECTIVE: The objective was to describe the methodology used to develop new response criteria for adult DM/PM and JDM. METHODS: Patient profiles from prospective natural history data and clinical trials were rated by myositis specialists to develop consensus gold-standard ratings of minimal, moderate and major improvement. Experts completed a survey regarding clinically meaningful improvement in the core set measures (CSM) and a conjoint-analysis survey (using 1000Minds software) to derive relative weights of CSM and candidate definitions. Six types of candidate definitions for response criteria were derived using survey results, logistic regression, conjoint analysis, application of conjoint-analysis weights to CSM and published definitions. Sensitivity, specificity and area under the curve were defined for candidate criteria using consensus patient profile data, and selected definitions were validated using clinical trial data. RESULTS: Myositis specialists defined the degree of clinically meaningful improvement in CSM for minimal, moderate and major improvement. The conjoint-analysis survey established the relative weights of CSM, with muscle strength and Physician Global Activity as most important. Many candidate definitions showed excellent sensitivity, specificity and area under the curve in the consensus profiles. Trial validation showed that a number of candidate criteria differentiated between treatment groups. Top candidate criteria definitions were presented at the consensus conference. CONCLUSION: Consensus methodology, with definitions tested on patient profiles and validated using clinical trials, led to 18 definitions for adult PM/DM and 14 for JDM as excellent candidates for consideration in the final consensus on new response criteria for myositis.

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Published In

Rheumatology (Oxford)

DOI

EISSN

1462-0332

Publication Date

November 1, 2017

Volume

56

Issue

11

Start / End Page

1884 / 1893

Location

England

Related Subject Headings

  • Treatment Outcome
  • Polymyositis
  • Minimal Clinically Important Difference
  • Logistic Models
  • Humans
  • Dermatomyositis
  • Arthritis & Rheumatology
  • Area Under Curve
  • 3204 Immunology
  • 3202 Clinical sciences
 

Citation

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Rider, L. G., Ruperto, N., Pistorio, A., Erman, B., Bayat, N., Lachenbruch, P. A., … International Myositis Assessment and Clinical Studies Group and                    the Paediatric Rheumatology International Trials Organisation, . (2017). 2016 ACR-EULAR adult dermatomyositis and polymyositis and juvenile dermatomyositis response criteria-methodological aspects. Rheumatology (Oxford), 56(11), 1884–1893. https://doi.org/10.1093/rheumatology/kex226
Rider, Lisa G., Nicolino Ruperto, Angela Pistorio, Brian Erman, Nastaran Bayat, Peter A. Lachenbruch, Howard Rockette, et al. “2016 ACR-EULAR adult dermatomyositis and polymyositis and juvenile dermatomyositis response criteria-methodological aspects.Rheumatology (Oxford) 56, no. 11 (November 1, 2017): 1884–93. https://doi.org/10.1093/rheumatology/kex226.
Rider LG, Ruperto N, Pistorio A, Erman B, Bayat N, Lachenbruch PA, et al. 2016 ACR-EULAR adult dermatomyositis and polymyositis and juvenile dermatomyositis response criteria-methodological aspects. Rheumatology (Oxford). 2017 Nov 1;56(11):1884–93.
Rider, Lisa G., et al. “2016 ACR-EULAR adult dermatomyositis and polymyositis and juvenile dermatomyositis response criteria-methodological aspects.Rheumatology (Oxford), vol. 56, no. 11, Nov. 2017, pp. 1884–93. Pubmed, doi:10.1093/rheumatology/kex226.
Rider LG, Ruperto N, Pistorio A, Erman B, Bayat N, Lachenbruch PA, Rockette H, Feldman BM, Huber AM, Hansen P, Oddis CV, Lundberg IE, Amato AA, Chinoy H, Cooper RG, Chung L, Danko K, Fiorentino D, García-De la Torre I, Reed AM, Wook Song Y, Cimaz R, Cuttica RJ, Pilkington CA, Martini A, van der Net J, Maillard S, Miller FW, Vencovsky J, Aggarwal R, International Myositis Assessment and Clinical Studies Group and                    the Paediatric Rheumatology International Trials Organisation. 2016 ACR-EULAR adult dermatomyositis and polymyositis and juvenile dermatomyositis response criteria-methodological aspects. Rheumatology (Oxford). 2017 Nov 1;56(11):1884–1893.
Journal cover image

Published In

Rheumatology (Oxford)

DOI

EISSN

1462-0332

Publication Date

November 1, 2017

Volume

56

Issue

11

Start / End Page

1884 / 1893

Location

England

Related Subject Headings

  • Treatment Outcome
  • Polymyositis
  • Minimal Clinically Important Difference
  • Logistic Models
  • Humans
  • Dermatomyositis
  • Arthritis & Rheumatology
  • Area Under Curve
  • 3204 Immunology
  • 3202 Clinical sciences