Description
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Made available in DSpace on 2014-02-26T17:25:13Z (GMT). No. of bitstreams: 1 WOS000238172900004.pdf: 103404 bytes, checksum: 52ca85593f8181517f9ab1e237d2d561 (MD5) Previous issue date: 2006-06-15
Submitted by Vitor Silverio Rodrigues (vitorsrodrigues@reitoria.unesp.br) on 2014-05-20T15:20:26Z No. of bitstreams: 1 WOS000238172900004.pdf: 103404 bytes, checksum: 52ca85593f8181517f9ab1e237d2d561 (MD5)
Made available in DSpace on 2014-05-20T15:20:26Z (GMT). No. of bitstreams: 1 WOS000238172900004.pdf: 103404 bytes, checksum: 52ca85593f8181517f9ab1e237d2d561 (MD5) Previous issue date: 2006-06-15
Objective. To use the Pediatric Rheumatology International Trials Organization (PRINTO) core set of outcome measures to develop a validated definition of improvement for the evaluation of response to therapy in juvenile systemic lupus erythematosus (SLE).Methods. Thirty-seven experienced pediatric rheumatologists from 27 countries, each of whom had specific experience in the assessment of juvenile SLE patients, achieved consensus on 128 patient profiles as being clinically improved or not improved. Using the physicians' consensus ratings as the gold standard measure, the chi-square, sensitivity, specificity, false-positive and false-negative rates, area under the receiver operating characteristic curve, and kappa level of agreement for 597 candidate definitions of improvement were calculated. Only definitions with a kappa value greater than 0.7 were retained. The top definitions were selected based on the product of the content validity score multiplied by its kappa statistic.Results. The definition of improvement with the highest final score was at least 50% improvement from baseline in any 2 of the 5 core set measures, with no more than 1 of the remaining worsening by more than 30%.Conclusion. PRINTO proposes a valid and reproducible definition of improvement that reflects well the consensus rating of experienced clinicians and that incorporates clinically meaningful change in core set measures in a composite end point for the evaluation of global response to therapy in patients with juvenile SLE. The definition is now proposed for use in juvenile SLE clinical trials and may help physicians to decide whether a child with SLE responded adequately to therapy.
Univ Genoa, Pediat Rheumatol Int Trials Org, IRCCS G Gaslini, I-16147 Genoa, Italy
Inst Puericultura & Pediat Martagao Gesteira, Rio de Janeiro, Brazil
Univ Naples Federico II, Naples, Italy
Childrens Univ Hosp, Sofia, Bulgaria
Mother & Child Hlth Inst Serbia, Belgrade, Serbia Monteneg
Univ Catolica, Cordoba, Argentina
Hosp Gen Mexico City, Mexico City, DF, Mexico
Aristotle Univ Thessaloniki, Ippokrat Gen Hosp, Thessaloniki, Greece
Hosp Dr Exequiel Gonzalez Cortes, Santiago, Chile
Clin Pediat 2 de Marchi, Milan, Italy
Ist Gaetano Pini, Milan, Italy
Karolinska Univ Hosp, Stockholm, Sweden
Sanjay Gandhi Inst Med Sci, Lucknow, Uttar Pradesh, India
Fac Med 1, Prague, Czech Republic
Gen Fac Hosp, Prague, Czech Republic
Univ Estadual Paulista, Fac Med Botucatu, Botucatu, SP, Brazil
Hanyang Univ, Med Ctr, Hosp Rheumat Dis, Seoul 133791, South Korea
Univ Hosp, Kosice, Slovakia
Univ Med Ctr, Ljubljana, Slovenia
Royal Victoria Infirm, Newcastle Upon Tyne NE1 4LP, Tyne & Wear, England
Ctr Nacl Rehabil, Mexico City, DF, Mexico
Skejby Sygehus Univ Hosp, Aarhus, Denmark
Univ Klin & Poliklin Kinder & Jugendmed, Halle, Germany
Univ Trieste, Trieste, Italy
Emma Childrens Hosp, AMC, Amsterdam, Netherlands
IRCCS G Gaslini, Serv Epidemiol & Biostat, Genoa, Italy
Ryhovs Cty Hosp, Jonkoping, Sweden
Childrens Hosp, Med Ctr, Cincinnati, OH 45229 USA
Univ Estadual Paulista, Fac Med Botucatu, Botucatu, SP, Brazil
