Resumo

ZULUAGA GOMEZ, Mateo; VANEGAS ISAZA, Daniel  e  DONADO GOMEZ, Jorge Hernando. Differences between the proposed frequencies of the research protocols of randomized clinical trials with outcomes obtained at the end of the primary study outcomes. Salud, Barranquilla [online]. 2016, vol.32, n.2, pp.201-207. ISSN 0120-5552.

Abstract 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 trialspublished 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 (differencegreater 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. Conclusión: 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.

Palavras-chave : clinical trial; sample size; outcome; incidence.

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