Discrepancias entre las frecuencias de los desenlaces primarios propuestos y obtenidos en ensayos clínicos aleatorizados

Mateo Zuluaga Gómez, Daniel Vanegas Isaza, Jorge Hernando Donado Gómez

    Resultado de la investigación: Contribución a una revistaArtículorevisión exhaustiva

    Resumen

    Objective: To determine the differences between the frequencies of the outcomes proposed in the initial protocol of randomized clinical trials for the outcomes obtained at endpoint. Methods: An observational, cross-sectional that included cardiology clinical trials published in The New England Journal of Medicine from 2002-2013. Results: We identified 28 trials. In 60.7 % of the estimated outcome studies incidence was higher than that found, showing discrepancy (difference greater than 10 %) in 13 (46.4%) studies. 10.7 % of the studies showed a discrepancy between the size estimated by the authors and the sample calculated by us. Conclusion: We found that although the authors of clinical trials have a good estimate of the sample size, its assumptions are not good, because the expected incidence in the control group is often overestimated in 60 % of cases.

    Título traducido de la contribuciónDifferences between the proposed frequencies of the research protocols of randomized clinical trials with outcomes obtained at the end of the primary study outcomes
    Idioma originalEspañol
    Páginas (desde-hasta)201-207
    Número de páginas7
    PublicaciónSalud Uninorte
    Volumen32
    N.º2
    DOI
    EstadoPublicada - 1 may. 2016

    Nota bibliográfica

    Publisher Copyright:
    © 2016, Universidad del Norte. All rights reserved.

    Palabras clave

    • Clinical trial
    • Incidence
    • Outcome
    • Sample size

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