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001-es BibID:BIBFORM073197
Első szerző:Rider, Lisa G.
Cím:2016 ACR-EULAR adult dermatomyositis and polymyositis and juvenile dermatomyositis response criteria-methodological aspects / Lisa G. Rider, Nicolino Ruperto, Angela Pistorio, Brian Erman, Nastaran Bayat, Peter A. Lachenbruch, Howard Rockette, Brian M. Feldman, Adam M. Huber, Paul Hansen, Chester V. Oddis, Ingrid E. Lundberg, Anthony A. Amato, Hector Chinoy, Robert G. Cooper, Lorinda Chung, Katalin Danko, David Fiorentino, Ignacio García-De la Torre, Ann M. Reed, Yeong Wook Song, Rolando Cimaz, Rubén J. Cuttica, Clarissa A. Pilkington, Alberto Martini, Janjaap van der Net, Susan Maillard, Frederick W. Miller, Jiri Vencovsky, Rohit Aggarwal, International Myositis Assessment and Clinical Studies Group, Paediatric Rheumatology International Trials Organisation
Dátum:2017
ISSN:1462-0324
Megjegyzések: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.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
1000Minds software
conjoint analysis
dermatomyositis
hybrid measure
juvenile dermatomyositis
outcome assessment
polymyositis
response criteria
Megjelenés:Rheumatology 56 : 11 (2017), p. 1884-1893. -
További szerzők:Ruperto, Nicolino Pistorio, Angela Erman, Brian Bayat, Nastaran Lachenbruch, Peter A. Rockette, Howard Feldman, Brian M. Huber, Adam M. Hansen, Paul Oddis, Chester V. Lundberg, Ingrid Amato, Anthony A. Chinoy, Hector Cooper, Robert G. Chung, Lorinda Dankó Katalin (1952-2021) (belgyógyász, allergológus és klinikai immunológus) Fiorentino, David Torre, Ignacio García-De la Reed, Ann M. Song, Yeong Wook Cimaz, Rolando Cuttica, Ruben Pilkington, Clarissa Martini, Alberto Net, Janjaap van der Maillard, Susan Miller, Frederick W. Vencovsky, Jiri Aggarwal, Rohit International Myositis Assessment and Clinical Studies Group Paediatric Rheumatology International Trials Organisation (PRINTO)
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