To investigate the ability of various definitions of improvement to distinguish between patients with juvenile rheumatoid arthritis (JRA) treated with active drug from those given placebo in randomized trials.
A core set of 6 response (outcome) variables for use in JRA has been reported.
These core variables were combined into a number of « definitions of improvement » for the purpose of classifying individual patients as either « clinically significantly improved » or « not improved. » We used a large dataset from randomized controlled trials to test the discriminant ability (sensitivity to change) of the definitions.
We calculated the proportion of patients classified as « improved » by each definition in each of the treatment and control groups.
Effect sizes were weak in 4 of the treatment regimens used (D-penicillamine, hydroxychloroquine, auranofin, and very low dose methotrexate) and no definition discriminated well between drug and placebo treated groups.
Definitions that required 20 to 30% improvement in 3 to 4 of the 6 core set variables showed statistically significant differences in the proportions of patients who were classified as improved in the group treated with low dose methotrexate (10 mg/m2 body surface area/wk) compared to placebo. (...)
Mots-clés Pascal : Arthrite chronique juvénile, Chimiothérapie, Antimétabolite, Méthotrexate, Auranofine, Pénicillamine, Evaluation, Evolution, Amélioration, Définition, Evaluation performance, Enfant, Homme, Chronique, Système ostéoarticulaire pathologie, Rhumatisme inflammatoire
Mots-clés Pascal anglais : Juvenile rheumatoid arthritis, Chemotherapy, Antimetabolic, Methotrexate, Auranofin, Penicillamine, Evaluation, Evolution, Improvement, Definition, Performance evaluation, Child, Human, Chronic, Diseases of the osteoarticular system, Inflammatory joint disease
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 98-0260867
Code Inist : 002B15D. Création : 11/09/1998.