Abstract

ZULUAGA GOMEZ, Mateo; VANEGAS ISAZA, Daniel  and  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.

Keywords : clinical trial; sample size; outcome; incidence.

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