Applying results from clinical trials: tranexamic acid in trauma patientsReport as inadecuate

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Journal of Intensive Care

, 2:56

First Online: 05 October 2014Received: 19 August 2014Accepted: 16 September 2014


This paper considers how results from clinical trials should be applied in the care of patients, using the results of the Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage CRASH-2 trial of tranexamic acid in bleeding trauma patients as a case study. We explain why an understanding of the mechanisms of action of the trial treatment, and insight into the factors that might be relevant to this mechanism, is critical in order to properly apply generalise trial results and why it is not necessary that the trial population is representative of the population in which the medicine will be used. We explain why cause mechanism-specific mortality is more generalizable than all-cause mortality and why the risk ratio is the generalizable measure of the effect of the treatment. Overall, we argue that a biological insight into how the treatment works is more relevant when applying research results to patient care than the application of statistical reasoning.

KeywordsEvidence-based medicine Generalizability Clinical trials Tranexamic acid Trauma Electronic supplementary materialThe online version of this article doi:10.1186-s40560-014-0056-1 contains supplementary material, which is available to authorized users.

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Author: Ian Roberts - David Prieto-Merino


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