2016 ACR-EULAR adult dermatomyositis and polymyositis and juvenile dermatomyositis response criteria-methodological aspects

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Arquivos
art_RIDER_2016_ACREULAR_adult_dermatomyositis_and_polymyositis_and_juvenile_2017.PDF (285.57 KB)
Citações na Scopus
28
Tipo de produção
article
Data de publicação
2017
DOI
Scopus
Web of Science
PubMed
Título da Revista
ISSN da Revista
Título do Volume
Editora
OXFORD UNIV PRESS
Autores
RIDER, Lisa G.
RUPERTO, Nicolino
PISTORIO, Angela
ERMAN, Brian
BAYAT, Nastaran
LACHENBRUCH, Peter A.
ROCKETTE, Howard
FELDMAN, Brian M.
HUBER, Adam M.
HANSEN, Paul
Citação
RHEUMATOLOGY, v.56, n.11, p.1884-1893, 2017
Projetos de Pesquisa
Unidades Organizacionais
Fascículo
Resumo
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.
Palavras-chave
dermatomyositis, polymyositis, juvenile dermatomyositis, response criteria, 1000Minds software, conjoint analysis, hybrid measure, outcome assessment
URI
https://observatorio.fm.usp.br/handle/OPI/39086
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Coleções
Artigos e Materiais de Revistas Científicas - FM/MCM
Artigos e Materiais de Revistas Científicas - LIM/17