2016 ACR-EULAR adult dermatomyositis and polymyositis and juvenile dermatomyositis response criteria-methodological aspects.
Autor: | Rider LG; Environmental Autoimmunity Group, NIEHS, National Institutes of Health, Bethesda, MD, USA., Ruperto N; Istituto Giannina Gaslini, Pediatria II - Reumatologia, PRINTO., Pistorio A; Istituto Giannina Gaslini, Servizio di Epidemiologia e Biostatistica, Genoa, Italy., Erman B; Social and Scientific Systems, Inc., Durham, NC., Bayat N; Environmental Autoimmunity Group, NIEHS, National Institutes of Health, Bethesda, MD, USA., Lachenbruch PA; Environmental Autoimmunity Group, NIEHS, National Institutes of Health, Bethesda, MD, USA., Rockette H; Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA., Feldman BM; Division of Rheumatology, Hospital for Sick Children, Toronto, Ontario., Huber AM; Rheumatology Department, Izaak Walton Killam Health Centre, Halifax, Nova Scotia, Canada., Hansen P; Department of Economics, University of Otago, Dunedin, New Zealand., Oddis CV; Department of Medicine, Division of Rheumatology and Clinical Immunology, University of Pittsburgh, Pittsburgh, PA, USA., Lundberg IE; Rheumatology Unit, Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden., Amato AA; Department of Neurology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA., Chinoy H; National Institute of Health Research Manchester Musculoskeletal Biomedical Research Unit, Central Manchester University Hospitals NHS Foundation Trust.; Manchester Academic Health Science Centre, The University of Manchester, Manchester., Cooper RG; Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK., Chung L; Division of Rheumatology, Stanford University, Redwood City, CA, USA., Danko K; 3rd Department of Internal Medicine, Division of Immunology, University of Debrecen, Debrecen, Hungary., Fiorentino D; Department of Dermatology, Stanford University, Redwood City, CA, USA., García-De la Torre I; Hospital General de Occidente de la Secretaría de Salud, Guadalajara, Jalisco, Mexico., Reed AM; Department of Pediatrics, Duke University, Durham, NC, USA., Wook Song Y; Department of Molecular Medicine and Biopharmaceutical Sciences, Medical Research Center, Seoul National University, Seoul, Korea., Cimaz R; Pediatric Rheumatology, Azienda Ospedaliero Universitaria Meyer, University of Florence, Florence, Italy., Cuttica RJ; Department of Pediatric Rheumatology, Hospital de Niños Pedro de Elizalde, University of Buenos Aires, Buenos Aires, Argentina., Pilkington CA; Department of Paediatric Rheumatology, Great Ormond Street Hospital for Children NHS Trust, London, UK., Martini A; Istituto Giannina Gaslini, Pediatria II - Reumatologia, PRINTO.; Università degli Studi di Genova, Dipartimento di Pediatria, Genoa, Italy., van der Net J; Wilhelmina Children's Hospital, University Medical Center, Utrecht, The Netherlands., Maillard S; Department of Paediatric Rheumatology, Great Ormond Street Hospital for Children NHS Trust, London, UK., Miller FW; Environmental Autoimmunity Group, NIEHS, National Institutes of Health, Bethesda, MD, USA., Vencovsky J; Institute of Rheumatology and Department of Rheumatology, Charles University, Prague, Czech Republic., Aggarwal R; Department of Medicine, Division of Rheumatology and Clinical Immunology, University of Pittsburgh, Pittsburgh, PA, USA. |
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Jazyk: | angličtina |
Zdroj: | Rheumatology (Oxford, England) [Rheumatology (Oxford)] 2017 Nov 01; Vol. 56 (11), pp. 1884-1893. |
DOI: | 10.1093/rheumatology/kex226 |
Abstrakt: | Objective: The objective was to describe the methodology used to develop new response criteria for adult DM/PM and JDM. Methods: Patient profiles from prospective natural history data and clinical trials were rated by myositis specialists to develop consensus gold-standard ratings of minimal, moderate and major improvement. Experts completed a survey regarding clinically meaningful improvement in the core set measures (CSM) and a conjoint-analysis survey (using 1000Minds software) to derive relative weights of CSM and candidate definitions. Six types of candidate definitions for response criteria were derived using survey results, logistic regression, conjoint analysis, application of conjoint-analysis weights to CSM and published definitions. Sensitivity, specificity and area under the curve were defined for candidate criteria using consensus patient profile data, and selected definitions were validated using clinical trial data. Results: Myositis specialists defined the degree of clinically meaningful improvement in CSM for minimal, moderate and major improvement. The conjoint-analysis survey established the relative weights of CSM, with muscle strength and Physician Global Activity as most important. Many candidate definitions showed excellent sensitivity, specificity and area under the curve in the consensus profiles. Trial validation showed that a number of candidate criteria differentiated between treatment groups. Top candidate criteria definitions were presented at the consensus conference. Conclusion: Consensus methodology, with definitions tested on patient profiles and validated using clinical trials, led to 18 definitions for adult PM/DM and 14 for JDM as excellent candidates for consideration in the final consensus on new response criteria for myositis. (© The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com) |
Databáze: | MEDLINE |
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