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. Issue 5 (6th April 2017)

• Record Type: Journal Article
• Authors: 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
• Other Names: author non-byline.; Pistorio Angela author non-byline.; Huber Adam M author non-byline.; Hansen Paul author non-byline.; Christopher-Stine Lisa author non-byline.; Criscione-Schreiber Lisa author non-byline.; Crofford Leslie author non-byline.; Cronin Mary E author non-byline.; Dankó Katalin author non-byline.; Gordon Patrick author non-byline.; Hengstman Gerald author non-byline.; Marder Galina author non-byline.; McHugh Neil author non-byline.; Schiopu Elena author non-byline.; Selva-O'Callaghan Albert author non-byline.; Wolfe Gil author non-byline.; Wortmann Robert author non-byline.; Gourley Mark author non-byline.; Plotz Paul author non-byline.; Ascherman Dana author non-byline.; Barohn Richard author non-byline.; Benveniste Olivier author non-byline.; De Bleecker Jan author non-byline.; Callen Jeffrey author non-byline.; Charles-Schoeman Christina author non-byline.; Danoff Sonye author non-byline.; Dimachkie Mazen author non-byline.; DiMartino Steve author non-byline.; Dourmishev Lyubomir author non-byline.; Ernste Floranne author non-byline.; Gono Takahisa author non-byline.; Katsumata Yasuhiro author non-byline.; Kissel John author non-byline.; Leff Richard L author non-byline.; Levine Todd author non-byline.; Mann Herman author non-byline.; Marie Isabelle author non-byline.; Merola Joseph author non-byline.; Olesinska Marzena author non-byline.; Olsen Nancy author non-byline.; Pipitone Nicolo author non-byline.; Ramchandren Sindhu author non-byline.; Rutkove Seward author non-byline.; Ann Saketkoo Lesley author non-byline.; Schiffenbauer Adam author non-byline.; Shinjo Samuel Katsuyuki author non-byline.; Shupak Rachel author non-byline.; Swierkocka Katarzyna author non-byline.; Wanschitz Julia author non-byline.; Werth Victoria author non-byline.; Whitt Irene author non-byline.; Cimaz Rolando author non-byline.; Cuttica Rubén author non-byline.; de Oliveira Sheila Knupp Feitosa author non-byline.; Lindsley Carol B author non-byline.; Pilkington Clarissa author non-byline.; Punaro Marilynn author non-byline.; Ravelli Angelo author non-byline.; Reed Ann author non-byline.; Rouster-Stevens Kelly author non-byline.; van Royen-Kerkhof Annet author non-byline.;
• Is Part Of: Annals of the rheumatic diseases. Volume 76:Issue 5(2017)
• Page Start: 792
• Page End: 801
• Publication Date: 2017-04-06
• Subjects: Dermatomyositis -- Polymyositis -- Treatment; Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2017-211400
• Languages: English
• ISSNs: 0003-4967

Abstract

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.