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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
Author(s) -
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,
GarcíaDe la Torre Ignacio,
Song Yeong Wook,
Villa Luca,
Rinaldi Mariangela,
Rockette Howard,
Lachenbruch Peter A.,
Miller Frederick W.,
Vencovsky Jiri
Publication year - 2017
Publication title -
arthritis and rheumatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 4.106
H-Index - 314
eISSN - 2326-5205
pISSN - 2326-5191
DOI - 10.1002/art.40064
Subject(s) - polymyositis , medicine , rheumatology , dermatomyositis , rheumatism , physical therapy , myositis , conjoint analysis , pairwise comparison , core (optical fiber) , statistics , mathematics , preference , computer science , telecommunications
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.