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

Rohit Aggarwal, Lisa G. Rider, Nicolino Ruperto, Nastaran Bayat, Brian Erman, Brian M. Feldman, Chester V. Oddis, Anthony A. Amato, Hector Chinoy, Robert G. Cooper, Maryam Dastmalchi, David Fiorentino, David Isenberg, James D. Katz, Andrew Mammen, Marianne de Visser, Steven R. Ytterberg, Ingrid E. Lundberg, Lorinda Chung, Katalin Danko & 31 others Ignacio García-De la Torre, Yeong Wook Song, Luca Villa, Mariangela Rinaldi, Howard Rockette, Peter A. Lachenbruch, Frederick W. Miller, Jiri Vencovsky, Lisa G. Rider, Nicolino Ruperto, Rohit Aggarwal, Frederick W. Miller, Jiri Vencovsky, Rohit Aggarwal, Brian Erman, Nastaran Bayat, Angela Pistorio, Adam M. Huber, Brian M. Feldman, Paul Hansen, Howard Rockette, Peter A. Lachenbruch, Nicolino Ruperto, Lisa G. Rider, Anthony A. Amato, Hector Chinoy, Lisa Christopher-Stine, Lorinda Chung, Robert G. Cooper, Maryam Dastmalchi, for the International Myositis Assessment and Clinical Studies Group and the Paediatric Rheumatology International Trials Organisation

Research output: Contribution to journalArticle

Abstract

Objective: To develop response criteria for adult dermatomyositis (DM) and polymyositis (PM). Methods: 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. Results: Consensus was reached for a conjoint analysis–based continuous model using absolute percent 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). Conclusion: The response criteria for adult DM/PM consisted of the conjoint analysis model based on absolute percent change in 6 core set measures, with thresholds for minimal, moderate, and major improvement.

LanguageEnglish (US)
Pages898-910
Number of pages13
JournalArthritis and Rheumatology
Volume69
Issue number5
DOIs
StatePublished - May 1 2017
Externally publishedYes

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

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology

Cite this

Aggarwal, R., Rider, L. G., Ruperto, N., Bayat, N., Erman, B., Feldman, B. M., ... for the International Myositis Assessment and Clinical Studies Group and the Paediatric Rheumatology International Trials Organisation (2017). 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. Arthritis and Rheumatology, 69(5), 898-910. DOI: 10.1002/art.40064

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. / Aggarwal, Rohit; Rider, Lisa G.; Ruperto, Nicolino; Bayat, Nastaran; Erman, Brian; Feldman, Brian M.; Oddis, Chester V.; Amato, Anthony A.; Chinoy, Hector; Cooper, Robert G.; Dastmalchi, Maryam; Fiorentino, David; Isenberg, David; Katz, James D.; Mammen, Andrew; de Visser, Marianne; Ytterberg, Steven R.; Lundberg, Ingrid E.; Chung, Lorinda; Danko, Katalin; García-De la Torre, Ignacio; Song, Yeong Wook; Villa, Luca; Rinaldi, Mariangela; Rockette, Howard; Lachenbruch, Peter A.; Miller, Frederick W.; Vencovsky, Jiri; Rider, Lisa G.; Ruperto, Nicolino; Aggarwal, Rohit; Miller, Frederick W.; Vencovsky, Jiri; Aggarwal, Rohit; Erman, Brian; Bayat, Nastaran; Pistorio, Angela; Huber, Adam M.; Feldman, Brian M.; Hansen, Paul; Rockette, Howard; Lachenbruch, Peter A.; Ruperto, Nicolino; Rider, Lisa G.; Amato, Anthony A.; Chinoy, Hector; Christopher-Stine, Lisa; Chung, Lorinda; Cooper, Robert G.; Dastmalchi, Maryam; for the International Myositis Assessment and Clinical Studies Group and the Paediatric Rheumatology International Trials Organisation.

In: Arthritis and Rheumatology, Vol. 69, No. 5, 01.05.2017, p. 898-910.

Research output: Contribution to journalArticle

Aggarwal, R, Rider, LG, Ruperto, N, Bayat, N, Erman, B, Feldman, BM, Oddis, CV, Amato, AA, Chinoy, H, Cooper, RG, Dastmalchi, M, Fiorentino, D, Isenberg, D, Katz, JD, Mammen, A, de Visser, M, Ytterberg, SR, Lundberg, IE, Chung, L, Danko, K, García-De la Torre, I, Song, YW, Villa, L, Rinaldi, M, Rockette, H, Lachenbruch, PA, Miller, FW, Vencovsky, J, Rider, LG, Ruperto, N, Aggarwal, R, Miller, FW, Vencovsky, J, Aggarwal, R, Erman, B, Bayat, N, Pistorio, A, Huber, AM, Feldman, BM, Hansen, P, Rockette, H, Lachenbruch, PA, Ruperto, N, Rider, LG, Amato, AA, Chinoy, H, Christopher-Stine, L, Chung, L, Cooper, RG, Dastmalchi, M & for the International Myositis Assessment and Clinical Studies Group and the Paediatric Rheumatology International Trials Organisation 2017, '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' Arthritis and Rheumatology, vol 69, no. 5, pp. 898-910. DOI: 10.1002/art.40064
Aggarwal, Rohit ; Rider, Lisa G. ; Ruperto, Nicolino ; Bayat, Nastaran ; Erman, Brian ; Feldman, Brian M. ; Oddis, Chester V. ; Amato, Anthony A. ; Chinoy, Hector ; Cooper, Robert G. ; Dastmalchi, Maryam ; Fiorentino, David ; Isenberg, David ; Katz, James D. ; Mammen, Andrew ; de Visser, Marianne ; Ytterberg, Steven R. ; Lundberg, Ingrid E. ; Chung, Lorinda ; Danko, Katalin ; García-De la Torre, Ignacio ; Song, Yeong Wook ; Villa, Luca ; Rinaldi, Mariangela ; Rockette, Howard ; Lachenbruch, Peter A. ; Miller, Frederick W. ; Vencovsky, Jiri ; Rider, Lisa G. ; Ruperto, Nicolino ; Aggarwal, Rohit ; Miller, Frederick W. ; Vencovsky, Jiri ; Aggarwal, Rohit ; Erman, Brian ; Bayat, Nastaran ; Pistorio, Angela ; Huber, Adam M. ; Feldman, Brian M. ; Hansen, Paul ; Rockette, Howard ; Lachenbruch, Peter A. ; Ruperto, Nicolino ; Rider, Lisa G. ; Amato, Anthony A. ; Chinoy, Hector ; Christopher-Stine, Lisa ; Chung, Lorinda ; Cooper, Robert G. ; Dastmalchi, Maryam ; for the International Myositis Assessment and Clinical Studies Group and the Paediatric Rheumatology International Trials Organisation. / 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. In: Arthritis and Rheumatology. 2017 ; Vol. 69, No. 5. pp. 898-910
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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 = "Objective: To develop response criteria for adult dermatomyositis (DM) and polymyositis (PM). Methods: 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. Results: Consensus was reached for a conjoint analysis–based continuous model using absolute percent 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). Conclusion: The response criteria for adult DM/PM consisted of the conjoint analysis model based on absolute percent change in 6 core set measures, with thresholds for minimal, moderate, and major improvement.",
author = "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 and Rider, {Lisa G.} and Nicolino Ruperto and Rohit Aggarwal and Miller, {Frederick W.} and Jiri Vencovsky and Rohit Aggarwal and Brian Erman and Nastaran Bayat and Angela Pistorio and Huber, {Adam M.} and Feldman, {Brian M.} and Paul Hansen and Howard Rockette and Lachenbruch, {Peter A.} and Nicolino Ruperto and Rider, {Lisa G.} and Amato, {Anthony A.} and Hector Chinoy and Lisa Christopher-Stine and Lorinda Chung and Cooper, {Robert G.} and Maryam Dastmalchi and {for the International Myositis Assessment and Clinical Studies Group and the Paediatric Rheumatology International Trials Organisation}",
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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 - Arthritis and Rheumatology

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

AU - Rider,Lisa G.

AU - Ruperto,Nicolino

AU - Aggarwal,Rohit

AU - Miller,Frederick W.

AU - Vencovsky,Jiri

AU - Aggarwal,Rohit

AU - Erman,Brian

AU - Bayat,Nastaran

AU - Pistorio,Angela

AU - Huber,Adam M.

AU - Feldman,Brian M.

AU - Hansen,Paul

AU - Rockette,Howard

AU - Lachenbruch,Peter A.

AU - Ruperto,Nicolino

AU - Rider,Lisa G.

AU - Amato,Anthony A.

AU - Chinoy,Hector

AU - Christopher-Stine,Lisa

AU - Chung,Lorinda

AU - Cooper,Robert G.

AU - Dastmalchi,Maryam

AU - for the International Myositis Assessment and Clinical Studies Group and the Paediatric Rheumatology International Trials Organisation

PY - 2017/5/1

Y1 - 2017/5/1

N2 - Objective: To develop response criteria for adult dermatomyositis (DM) and polymyositis (PM). Methods: 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. Results: Consensus was reached for a conjoint analysis–based continuous model using absolute percent 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). Conclusion: The response criteria for adult DM/PM consisted of the conjoint analysis model based on absolute percent change in 6 core set measures, with thresholds for minimal, moderate, and major improvement.

AB - Objective: To develop response criteria for adult dermatomyositis (DM) and polymyositis (PM). Methods: 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. Results: Consensus was reached for a conjoint analysis–based continuous model using absolute percent 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). Conclusion: The response criteria for adult DM/PM consisted of the conjoint analysis model based on absolute percent change in 6 core set measures, with thresholds for minimal, moderate, and major improvement.

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