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 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).
  
  
  
  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.
authors.affiliation: University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: Rohit
authors.initials: R
authors.lastname: Aggarwal
authors.affiliation: NIH, Bethesda, Maryland.
authors.forename: Lisa G
authors.initials: LG
authors.lastname: Rider
authors.affiliation: Istituto Giannina Gaslini, Pediatria II - Reumatologia, PRINTO, Genoa, Italy.
authors.forename: Nicolino
authors.initials: N
authors.lastname: Ruperto
authors.affiliation: NIH, Bethesda, Maryland.
authors.forename: Nastaran
authors.initials: N
authors.lastname: Bayat
authors.affiliation: Social and Scientific Systems, Inc., Durham, North Carolina.
authors.forename: Brian
authors.initials: B
authors.lastname: Erman
authors.affiliation: The Hospital for Sick Children, Toronto, Ontario, Canada.
authors.forename: Brian M
authors.initials: BM
authors.lastname: Feldman
authors.affiliation: University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: Chester V
authors.initials: CV
authors.lastname: Oddis
authors.affiliation: Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
authors.forename: Anthony A
authors.initials: AA
authors.lastname: Amato
authors.affiliation: Central Manchester University Hospitals NHS Foundation Trust, University of Manchester, Manchester, UK.
authors.forename: Hector
authors.initials: H
authors.lastname: Chinoy
authors.affiliation: University of Liverpool, Liverpool, UK.
authors.forename: Robert G
authors.initials: RG
authors.lastname: Cooper
authors.affiliation: Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden.
authors.forename: Maryam
authors.initials: M
authors.lastname: Dastmalchi
authors.affiliation: Stanford University, Redwood City, California.
authors.forename: David
authors.initials: D
authors.lastname: Fiorentino
authors.affiliation: University College London, London, UK.
authors.forename: David
authors.initials: D
authors.lastname: Isenberg
authors.affiliation: NIH, Bethesda, Maryland.
authors.forename: James D
authors.initials: JD
authors.lastname: Katz
authors.affiliation: Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Andrew
authors.initials: A
authors.lastname: Mammen
authors.affiliation: Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Marianne
authors.initials: M
authors.lastname: de Visser
authors.affiliation: Mayo Clinic, Rochester, Minnesota.
authors.forename: Steven R
authors.initials: SR
authors.lastname: Ytterberg
authors.affiliation: Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden.
authors.forename: Ingrid E
authors.initials: IE
authors.lastname: Lundberg
authors.affiliation: Stanford University, Redwood City, California.
authors.forename: Lorinda
authors.initials: L
authors.lastname: Chung
authors.affiliation: University of Debrecen, Debrecen, Hungary.
authors.forename: Katalin
authors.initials: K
authors.lastname: Danko
authors.affiliation: Hospital General de Occidente de la Secretaría de Salud and University of Guadalajara, Guadalajara, México.
authors.forename: Ignacio
authors.initials: I
authors.lastname: García-De la Torre
authors.affiliation: Graduate School of Convergence Science and Technology and Seoul National University Hospital, Seoul, Korea.
authors.forename: Yeong Wook
authors.initials: YW
authors.lastname: Song
authors.affiliation: Istituto Giannina Gaslini, Pediatria II - Reumatologia, PRINTO, Genoa, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Villa
authors.affiliation: Istituto Giannina Gaslini, Pediatria II - Reumatologia, PRINTO, Genoa, Italy.
authors.forename: Mariangela
authors.initials: M
authors.lastname: Rinaldi
authors.affiliation: University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: Howard
authors.initials: H
authors.lastname: Rockette
authors.affiliation: NIH, Bethesda, Maryland.
authors.forename: Peter A
authors.initials: PA
authors.lastname: Lachenbruch
authors.affiliation: NIH, Bethesda, Maryland.
authors.forename: Frederick W
authors.initials: FW
authors.lastname: Miller
authors.affiliation: Charles University, Prague, Czech Republic.
authors.forename: Jiri
authors.initials: J
authors.lastname: Vencovsky
mesh_terms: D000410:Alanine Transaminase / Q000378:metabolism; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000378:metabolism; D003402:Creatine Kinase / Q000378:metabolism; D003882:Dermatomyositis / Q000188:drug therapy* / Q000378:metabolism / Q000503:physiopathology; D005060:Europe; D005634:Fructose-Bisphosphate Aldolase / Q000378:metabolism; D006801:Humans; D007770:L-Lactate Dehydrogenase / Q000378:metabolism; D016015:Logistic Models; D053580:Muscle Strength; D017063:Outcome Assessment, Health Care; D000071066:Patient Reported Outcome Measures; D017285:Polymyositis / Q000188:drug therapy / Q000378:metabolism / Q000503:physiopathology; D012219:Rheumatology; D012955:Societies, Medical; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014481:United States
chemical_list: D018501:Antirheumatic Agents; D007770:L-Lactate Dehydrogenase; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D003402:Creatine Kinase; D005634:Fructose-Bisphosphate Aldolase