2016 American College of Rheumatology/European League Against Rheumatism criteria for minimal, moderate, and major clinical response in adult dermatomyositis and polymyositis: An International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation Collaborative Initiative

International Myositis Assessment and Clinical Studies Group, Paediatric Rheumatology International Trials Organisation

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Abstract

To develop response criteria for adult dermatomyositis (DM) and polymyositis (PM). Expert surveys, logistic regression, and conjoint analysis were used to develop 287 definitions using core set measures. Myositis experts rated greater improvement among multiple pairwise scenarios in conjoint analysis surveys, where different levels of improvement in 2 core set measures were presented. The PAPRIKA (Potentially All Pairwise Rankings of All Possible Alternatives) method determined the relative weights of core set measures and conjoint analysis definitions. The performance characteristics of the definitions were evaluated on patient profiles using expert consensus (gold standard) and were validated using data from a clinical trial. The nominal group technique was used to reach consensus. Consensus was reached for a conjoint analysis-based continuous model using absolute per cent change in core set measures (physician, patient, and extramuscular global activity, muscle strength, Health Assessment Questionnaire, and muscle enzyme levels). A total improvement score (range 0-100), determined by summing scores for each core set measure, was based on improvement in and relative weight of each core set measure. Thresholds for minimal, moderate, and major improvement were ≥20, ≥40, and ≥60 points in the total improvement score. The same criteria were chosen for juvenile DM, with different improvement thresholds. Sensitivity and specificity in DM/PM patient cohorts were 85% and 92%, 90% and 96%, and 92% and 98% for minimal, moderate, and major improvement, respectively. Definitions were validated in the clinical trial analysis for differentiating the physician rating of improvement (p<0.001). The response criteria for adult DM/PM consisted of the conjoint analysis model based on absolute per cent change in 6 core set measures, with thresholds for minimal, moderate, and major improvement.

Original languageEnglish (US)
Pages (from-to)792-801
Number of pages10
JournalAnnals of the Rheumatic Diseases
Volume76
Issue number5
DOIs
StatePublished - May 1 2017

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Pediatrics
Myositis
Dermatomyositis
Rheumatology
Muscle
Clinical Trials
Physicians
Logistics
Weights and Measures
Health
Muscle Strength
Enzymes
Logistic Models
Regression Analysis
Sensitivity and Specificity
Muscles
Surveys and Questionnaires
Clinical Studies

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology
  • Biochemistry, Genetics and Molecular Biology(all)

Cite this

@article{25f6f98fbd704e4e840d8ff048c9e969,
title = "2016 American College of Rheumatology/European League Against Rheumatism criteria for minimal, moderate, and major clinical response in adult dermatomyositis and polymyositis: An International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation Collaborative Initiative",
abstract = "To develop response criteria for adult dermatomyositis (DM) and polymyositis (PM). Expert surveys, logistic regression, and conjoint analysis were used to develop 287 definitions using core set measures. Myositis experts rated greater improvement among multiple pairwise scenarios in conjoint analysis surveys, where different levels of improvement in 2 core set measures were presented. The PAPRIKA (Potentially All Pairwise Rankings of All Possible Alternatives) method determined the relative weights of core set measures and conjoint analysis definitions. The performance characteristics of the definitions were evaluated on patient profiles using expert consensus (gold standard) and were validated using data from a clinical trial. The nominal group technique was used to reach consensus. Consensus was reached for a conjoint analysis-based continuous model using absolute per cent change in core set measures (physician, patient, and extramuscular global activity, muscle strength, Health Assessment Questionnaire, and muscle enzyme levels). A total improvement score (range 0-100), determined by summing scores for each core set measure, was based on improvement in and relative weight of each core set measure. Thresholds for minimal, moderate, and major improvement were ≥20, ≥40, and ≥60 points in the total improvement score. The same criteria were chosen for juvenile DM, with different improvement thresholds. Sensitivity and specificity in DM/PM patient cohorts were 85{\%} and 92{\%}, 90{\%} and 96{\%}, and 92{\%} and 98{\%} for minimal, moderate, and major improvement, respectively. Definitions were validated in the clinical trial analysis for differentiating the physician rating of improvement (p<0.001). The response criteria for adult DM/PM consisted of the conjoint analysis model based on absolute per cent change in 6 core set measures, with thresholds for minimal, moderate, and major improvement.",
author = "{International Myositis Assessment and Clinical Studies Group} and {Paediatric Rheumatology International Trials Organisation} and Rohit Aggarwal and Rider, {Lisa G.} and Nicolino Ruperto and Nastaran Bayat and Brian Erman and Feldman, {Brian M.} and Oddis, {Chester V.} and Amato, {Anthony A.} and Hector Chinoy and Cooper, {Robert G.} and Maryam Dastmalchi and David Fiorentino and David Isenberg and Katz, {James D.} and Andrew Mammen and {De Visser}, Marianne and Ytterberg, {Steven R} and Lundberg, {Ingrid E.} and Lorinda Chung and Katalin Danko and {Garc{\'i}a-De La Torre}, Ignacio and Song, {Yeong Wook} and Luca Villa and Mariangela Rinaldi and Howard Rockette and Lachenbruch, {Peter A.} and Miller, {Frederick W.} and Jiri Vencovsky",
year = "2017",
month = "5",
day = "1",
doi = "10.1136/annrheumdis-2017-211400",
language = "English (US)",
volume = "76",
pages = "792--801",
journal = "Annals of the Rheumatic Diseases",
issn = "0003-4967",
publisher = "BMJ Publishing Group",
number = "5",

}

TY - JOUR

T1 - 2016 American College of Rheumatology/European League Against Rheumatism criteria for minimal, moderate, and major clinical response in adult dermatomyositis and polymyositis

T2 - An International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation Collaborative Initiative

AU - International Myositis Assessment and Clinical Studies Group

AU - Paediatric Rheumatology International Trials Organisation

AU - Aggarwal, Rohit

AU - Rider, Lisa G.

AU - Ruperto, Nicolino

AU - Bayat, Nastaran

AU - Erman, Brian

AU - Feldman, Brian M.

AU - Oddis, Chester V.

AU - Amato, Anthony A.

AU - Chinoy, Hector

AU - Cooper, Robert G.

AU - Dastmalchi, Maryam

AU - Fiorentino, David

AU - Isenberg, David

AU - Katz, James D.

AU - Mammen, Andrew

AU - De Visser, Marianne

AU - Ytterberg, Steven R

AU - Lundberg, Ingrid E.

AU - Chung, Lorinda

AU - Danko, Katalin

AU - García-De La Torre, Ignacio

AU - Song, Yeong Wook

AU - Villa, Luca

AU - Rinaldi, Mariangela

AU - Rockette, Howard

AU - Lachenbruch, Peter A.

AU - Miller, Frederick W.

AU - Vencovsky, Jiri

PY - 2017/5/1

Y1 - 2017/5/1

N2 - To develop response criteria for adult dermatomyositis (DM) and polymyositis (PM). Expert surveys, logistic regression, and conjoint analysis were used to develop 287 definitions using core set measures. Myositis experts rated greater improvement among multiple pairwise scenarios in conjoint analysis surveys, where different levels of improvement in 2 core set measures were presented. The PAPRIKA (Potentially All Pairwise Rankings of All Possible Alternatives) method determined the relative weights of core set measures and conjoint analysis definitions. The performance characteristics of the definitions were evaluated on patient profiles using expert consensus (gold standard) and were validated using data from a clinical trial. The nominal group technique was used to reach consensus. Consensus was reached for a conjoint analysis-based continuous model using absolute per cent change in core set measures (physician, patient, and extramuscular global activity, muscle strength, Health Assessment Questionnaire, and muscle enzyme levels). A total improvement score (range 0-100), determined by summing scores for each core set measure, was based on improvement in and relative weight of each core set measure. Thresholds for minimal, moderate, and major improvement were ≥20, ≥40, and ≥60 points in the total improvement score. The same criteria were chosen for juvenile DM, with different improvement thresholds. Sensitivity and specificity in DM/PM patient cohorts were 85% and 92%, 90% and 96%, and 92% and 98% for minimal, moderate, and major improvement, respectively. Definitions were validated in the clinical trial analysis for differentiating the physician rating of improvement (p<0.001). The response criteria for adult DM/PM consisted of the conjoint analysis model based on absolute per cent change in 6 core set measures, with thresholds for minimal, moderate, and major improvement.

AB - To develop response criteria for adult dermatomyositis (DM) and polymyositis (PM). Expert surveys, logistic regression, and conjoint analysis were used to develop 287 definitions using core set measures. Myositis experts rated greater improvement among multiple pairwise scenarios in conjoint analysis surveys, where different levels of improvement in 2 core set measures were presented. The PAPRIKA (Potentially All Pairwise Rankings of All Possible Alternatives) method determined the relative weights of core set measures and conjoint analysis definitions. The performance characteristics of the definitions were evaluated on patient profiles using expert consensus (gold standard) and were validated using data from a clinical trial. The nominal group technique was used to reach consensus. Consensus was reached for a conjoint analysis-based continuous model using absolute per cent change in core set measures (physician, patient, and extramuscular global activity, muscle strength, Health Assessment Questionnaire, and muscle enzyme levels). A total improvement score (range 0-100), determined by summing scores for each core set measure, was based on improvement in and relative weight of each core set measure. Thresholds for minimal, moderate, and major improvement were ≥20, ≥40, and ≥60 points in the total improvement score. The same criteria were chosen for juvenile DM, with different improvement thresholds. Sensitivity and specificity in DM/PM patient cohorts were 85% and 92%, 90% and 96%, and 92% and 98% for minimal, moderate, and major improvement, respectively. Definitions were validated in the clinical trial analysis for differentiating the physician rating of improvement (p<0.001). The response criteria for adult DM/PM consisted of the conjoint analysis model based on absolute per cent change in 6 core set measures, with thresholds for minimal, moderate, and major improvement.

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U2 - 10.1136/annrheumdis-2017-211400

DO - 10.1136/annrheumdis-2017-211400

M3 - Article

C2 - 28385805

AN - SCOPUS:85019025865

VL - 76

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EP - 801

JO - Annals of the Rheumatic Diseases

JF - Annals of the Rheumatic Diseases

SN - 0003-4967

IS - 5

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