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2016 American College of Rheumatology/European League Against Rheumatism Criteria for Minimal, Moderate, and Major Clinical Response in Juvenile Dermatomyositis: An International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation Collaborative Initiative
LG. Rider, R. Aggarwal, A. Pistorio, N. Bayat, B. Erman, BM. Feldman, AM. Huber, R. Cimaz, RJ. Cuttica, SK. de Oliveira, CB. Lindsley, CA. Pilkington, M. Punaro, A. Ravelli, AM. Reed, K. Rouster-Stevens, A. van Royen-Kerkhof, F. Dressler, CS....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu konsensus - konference, časopisecké články
Odkazy
PubMed
28382778
DOI
10.1002/art.40060
Knihovny.cz E-zdroje
- MeSH
- alanintransaminasa metabolismus MeSH
- aldolasa metabolismus MeSH
- antirevmatika terapeutické užití MeSH
- aspartátaminotransferasy metabolismus MeSH
- cyklosporin terapeutické užití MeSH
- dermatomyozitida farmakoterapie metabolismus patofyziologie MeSH
- dítě MeSH
- glukokortikoidy terapeutické užití MeSH
- hodnocení výsledků péče pacientem MeSH
- hodnocení výsledků zdravotní péče MeSH
- kreatinkinasa metabolismus MeSH
- L-laktátdehydrogenasa metabolismus MeSH
- lidé MeSH
- logistické modely MeSH
- methotrexát terapeutické užití MeSH
- mladiství MeSH
- prednison terapeutické užití MeSH
- průzkumy a dotazníky MeSH
- reprodukovatelnost výsledků MeSH
- revmatologie MeSH
- rituximab terapeutické užití MeSH
- společnosti lékařské MeSH
- svalová síla MeSH
- výsledek terapie MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- mladiství MeSH
- Publikační typ
- časopisecké články MeSH
- konsensus - konference MeSH
- Geografické názvy
- Evropa MeSH
- Spojené státy americké MeSH
OBJECTIVE: To develop response criteria for juvenile dermatomyositis (DM). METHODS: We analyzed the performance of 312 definitions that used core set measures from either the International Myositis Assessment and Clinical Studies Group (IMACS) or the Paediatric Rheumatology International Trials Organisation (PRINTO) and were derived from natural history data and a conjoint analysis survey. They were further validated using data from the PRINTO trial of prednisone alone compared to prednisone with methotrexate or cyclosporine and the Rituximab in Myositis (RIM) trial. At a consensus conference, experts considered 14 top candidate criteria based on their performance characteristics and clinical face validity, using nominal group technique. RESULTS: Consensus was reached for a conjoint analysis-based continuous model with a total improvement score of 0-100, using absolute percent change in core set measures of minimal (≥30), moderate (≥45), and major (≥70) improvement. The same criteria were chosen for adult DM/polymyositis, with differing thresholds for improvement. The sensitivity and specificity were 89% and 91-98% for minimal improvement, 92-94% and 94-99% for moderate improvement, and 91-98% and 85-86% for major improvement, respectively, in juvenile DM patient cohorts using the IMACS and PRINTO core set measures. These criteria were validated in the PRINTO trial for differentiating between treatment arms for minimal and moderate improvement (P = 0.009-0.057) and in the RIM trial for significantly differentiating the physician's rating for improvement (P < 0.006). CONCLUSION: The response criteria for juvenile DM consisted of a conjoint analysis-based model using a continuous improvement score based on absolute percent change in core set measures, with thresholds for minimal, moderate, and major improvement.
Charles University Prague Czech Republic
Duke University Durham North Carolina
Emory University School of Medicine Atlanta Georgia
Great Ormond Street Hospital for Children NHS Trust London UK
Hannover Medical School Hannover Germany
Hospital de Niños Pedro de Elizalde University of Buenos Aires Buenos Aires Argentina
Hospital de Pediatría Garrahan Buenos Aires Argentina
Istituto Giannina Gaslini Pediatria 2 Reumatologia and Università degli Studi di Genova Genoa Italy
Istituto Giannina Gaslini Pediatria 2 Reumatologia PRINTO Genoa Italy
Istituto Giannina Gaslini Servizio di Epidemiologia e Biostatistica Genoa Italy
IWK Health Centre Halifax Nova Scotia Canada
Karolinska University Hospital Stockholm Sweden
Royal Hospital for Sick Children Glasgow UK and Royal Hospital for Sick Children Edinburgh UK
Semmelweis University Budapest Hungary
Social and Scientific Systems Inc Durham North Carolina
The Hospital for Sick Children Toronto Ontario Canada
Universidade Estadual Paulista Júlio de Mesquita Filho Botucatu Saõ Paulo Brazil
Universidade Federal do Rio de Janeiro Rio de Janeiro Brazil
University Medical Centre Utrecht Wilhelmina Children's Hospital Utrecht The Netherlands
University of Firenze Florence Italy
University of Kansas City Medical Center Kansas City Kansas
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- $a OBJECTIVE: To develop response criteria for juvenile dermatomyositis (DM). METHODS: We analyzed the performance of 312 definitions that used core set measures from either the International Myositis Assessment and Clinical Studies Group (IMACS) or the Paediatric Rheumatology International Trials Organisation (PRINTO) and were derived from natural history data and a conjoint analysis survey. They were further validated using data from the PRINTO trial of prednisone alone compared to prednisone with methotrexate or cyclosporine and the Rituximab in Myositis (RIM) trial. At a consensus conference, experts considered 14 top candidate criteria based on their performance characteristics and clinical face validity, using nominal group technique. RESULTS: Consensus was reached for a conjoint analysis-based continuous model with a total improvement score of 0-100, using absolute percent change in core set measures of minimal (≥30), moderate (≥45), and major (≥70) improvement. The same criteria were chosen for adult DM/polymyositis, with differing thresholds for improvement. The sensitivity and specificity were 89% and 91-98% for minimal improvement, 92-94% and 94-99% for moderate improvement, and 91-98% and 85-86% for major improvement, respectively, in juvenile DM patient cohorts using the IMACS and PRINTO core set measures. These criteria were validated in the PRINTO trial for differentiating between treatment arms for minimal and moderate improvement (P = 0.009-0.057) and in the RIM trial for significantly differentiating the physician's rating for improvement (P < 0.006). CONCLUSION: The response criteria for juvenile DM consisted of a conjoint analysis-based model using a continuous improvement score based on absolute percent change in core set measures, with thresholds for minimal, moderate, and major improvement.
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