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Title: The Provisional Paediatric Rheumatology International Trials Organisation/American College of Rheumatology/European League Against Rheumatism disease activity core set for the evaluation of response to therapy in juvenile dermatomyositis: A prospective validation study
Authors: Ruperto, Nicolino
Ravelli, Angelo
Pistorio, Angela
Ferriani, Virginia
Calvo, Immaculada
Ganser, Gerd
Brunner, Jurgen
Dannecker, Guenther
Silva, Clovis Arthur
Stanevicha, Valda
Ten Cate, Rebecca
van Suijlekom-Smit, Lisette W. A.
Voygioyka, Olga
Fischbach, Michel
Foeldvari, Ivan
Hilário, Maria Odete Esteves [UNIFESP]
Modesto, Consuelo
Saurenmann, Rotraud K.
Sauvain, Marie-Josephe
Scheibel, Iloite
Sommelet, Daniele
Tambic-Bukovac, Lana
Barcellona, Roberto
Brik, Riva
Ehl, Stephan
Jovanovic, Mirjana
Rovensky, Jozef
Bagnasco, Francesca
Lovell, Daniel J.
Martini, Alberto
Univ Genoa
Universidade de São Paulo (USP)
Hos Univ La Fe
Rheumaabt Kinder St Josef Stift
Univ Klin Fuer Kinder & Jugendheilkunde
Olga Hosp
Riga Stradins Univ
Acad Hosp Leiden
Erasmus MC Sophia Childrens Hosp
Kyriakou Childrens Hosp Athens Univ
Hop Univ Hautepierre
Kinder & Jugendrheumatol Sprechstunde
Universidade Federal de São Paulo (UNIFESP)
Hosp Valle de Hebron
Univ Kinder Klin
Policlin Pediat Hop Univ
Hosp Clin Porto Alegre
Univ Brabois
Med Sch Zagreb
Osped Bambini G Cristina
Rambam Med Ctr
Univ Kinder Klin Freiburg
Inst Child Hlth & Youth Hlth Care
Inst Rheumatol Dis
Cincinnati Childrens Hosp Med Ctr
IRCCS G Gaslini
Univ Milan
Issue Date: 15-Jan-2008
Publisher: Wiley-Blackwell
Citation: Arthritis & Rheumatism-arthritis Care & Research. Hoboken: Wiley-liss, v. 59, n. 1, p. 4-13, 2008.
Abstract: Objective. To validate a core set of outcome measures for the evaluation of response to treatment in patients with juvenile dermatomyositis (DM).Methods. in 2001, a preliminary consensus-derived core set for evaluating response to therapy in juvenile DM was established. in the present study, the core set was validated through an evidence-based, large-scale data collection that led to the enrollment of 294 patients from 36 countries. Consecutive patients with active disease were assessed at baseline and after 6 months. the validation procedures included assessment of feasibility, responsiveness, discriminant and construct ability, concordce in the evaluation of response to therapy between physicians and parents, redundancy, internal consistency, and ability to predict a therapeutic response.Results. the following clinical measures were found to be feasible, and to have good construct validity, discriminative ability, and internal consistency; furthermore, they were not redundant, proved responsive to clinically important changes in disease activity, and were associated strongly with treatment outcome and thus were included in the final core set: 1) physician's global assessment of disease activity, 2) muscle strength, 3) global disease activity measure, 4) parent's global assessment of patient's well-being, 5) functional ability, and 6) health-related quality of life.Conclusion. the members of the Paediatric Rheumatology International Trials Organisation, with the endorsement of the American College of Rheumatology and the European Leauge Against Rheumatism, propose a core set of criteria for the evaluation of response of therapy that is scientifically and clinically relevant and statistically validated. the core set will help standardize the conduct and reporting of clinical trials and assist practitioners in deciding whether a child with juvenile DM has responded adequately to therapy.
ISSN: 0004-3591
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