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

被引:59
作者
Aggarwal, Rohit [1 ]
Rider, Lisa G. [2 ]
Ruperto, Nicolino [3 ]
Bayat, Nastaran [2 ]
Erman, Brian [4 ]
Feldman, Brian M. [5 ]
Oddis, Chester V. [1 ]
Amato, Anthony A. [6 ,7 ]
Chinoy, Hector [8 ]
Cooper, Robert G. [9 ]
Dastmalchi, Maryam [10 ]
Fiorentino, David [11 ]
Isenberg, David [12 ]
Katz, James D. [2 ]
Mammen, Andrew [13 ]
de Visser, Marianne [14 ]
Ytterberg, Steven R. [15 ]
Lundberg, Ingrid E. [10 ]
Chung, Lorinda [11 ]
Danko, Katalin [16 ]
Garcia-De la Torre, Ignacio [17 ,18 ]
Song, Yeong Wook [19 ,20 ]
Villa, Luca [3 ]
Rinaldi, Mariangela [3 ]
Rockette, Howard [1 ]
Lachenbruch, Peter A. [2 ]
Miller, Frederick W. [2 ]
Vencovsky, Jiri [21 ]
机构
[1] Univ Pittsburgh, Pittsburgh, PA USA
[2] NIEHS, NIH, Bethesda, MD USA
[3] PRINTO, Pediat Reumatol 2, Ist Giannina Gaslini, Genoa, Italy
[4] Social & Sci Syst Inc, Durham, NC USA
[5] Hosp Sick Children, Toronto, ON, Canada
[6] Brigham & Womens Hosp, 75 Francis St, Boston, MA 02115 USA
[7] Harvard Med Sch, Boston, MA USA
[8] Univ Manchester, Cent Manchester Univ Hosp NHS Fdn Trust, Manchester, Lancs, England
[9] Univ Liverpool, Liverpool, Merseyside, England
[10] Karolinska Univ Hosp, Karolinska Inst, Stockholm, Sweden
[11] Stanford Univ, Redwood City, CA USA
[12] UCL, London, England
[13] Johns Hopkins Univ, Sch Med, Baltimore, MD USA
[14] Acad Med Ctr, Amsterdam, Netherlands
[15] Mayo Clin, Rochester, MN USA
[16] Univ Debrecen, Debrecen, Hungary
[17] Hosp Gen Occidente Secretaria Salud, Guadalajara, Jalisco, Mexico
[18] Univ Guadalajara, Guadalajara, Jalisco, Mexico
[19] Grad Sch Convergence Sci & Technol, Seoul, South Korea
[20] Seoul Natl Univ Hosp, Seoul, South Korea
[21] Charles Univ Prague, Prague, Czech Republic
关键词
IDIOPATHIC INFLAMMATORY MYOPATHIES; HEALTH QUESTIONNAIRE CHQ; JUVENILE DERMATOMYOSITIS; CLASSIFICATION CRITERIA; CORE SET; PATIENT PREFERENCES; SYSTEMIC-SCLEROSIS; OUTCOME ASSESSMENT; CONJOINT-ANALYSIS; CHRONIC GOUT;
D O I
10.1002/art.40064
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:898 / 910
页数:13
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