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Pain ; 139(3): 485-493, 2008 Oct 31.
Artículo en Inglés | MEDLINE | ID: mdl-18706763

RESUMEN

The increasing complexity of randomized clinical trials and the practice of obtaining a wide variety of measurements from study participants have made the consideration of multiple endpoints a critically important issue in the design, analysis, and interpretation of clinical trials. Failure to consider important outcomes can limit the validity and utility of clinical trials; specifying multiple endpoints for the evaluation of treatment efficacy, however, can increase the rate of false positive conclusions about the efficacy of a treatment. We describe the use of multiple endpoints in the design, analysis, and interpretation of pain clinical trials, and review available strategies and methods for addressing multiplicity. To decrease the probability of a Type I error (i.e., the likelihood of obtaining statistically significant results by chance) in pain clinical trials, the use of gatekeeping procedures and other methods that correct for multiple analyses is recommended when a single primary endpoint does not adequately reflect the overall benefits of treatment. We emphasize the importance of specifying in advance the outcomes and clinical decision rule that will serve as the basis for determining that a treatment is efficacious and the methods that will be used to control the overall Type I error rate.


Asunto(s)
Ensayos Clínicos como Asunto/estadística & datos numéricos , Determinación de Punto Final/estadística & datos numéricos , Manejo del Dolor , Factores de Confusión Epidemiológicos , Humanos , Análisis de los Mínimos Cuadrados , Análisis Multivariante , Teoría de la Probabilidad , Proyectos de Investigación/estadística & datos numéricos
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