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https://github.com/chartgerink/2015poldermans


https://github.com/chartgerink/2015poldermans

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# Analyzing DECREASE trials to estimate evidence of data manipulation

By [Chris H. J. Hartgerink](https://orcid.org/0000-0003-1050-6809), E. M. Kemper, [Markus W. Hollman](https://orcid.org/0000-0001-8248-0244), [Gerben ter Riet](https://orcid.org/0000-0002-2231-7637)"

The effect of beta-blockers on perioperative mortality in non-cardiac surgery has been controversial due to concerns regarding the scientific integrity of the DECREASE-I and DECREASE-IV trials. In this report, we investigate these DECREASE trials and model their veracity (i.e., the probability that these effects or more extreme occurred naturally) and estimate how many data points might have been manipulated in the DECREASE trials. Our research indicates that the DECREASE trials are nearly impossible if we assume they investigate the same effect as the non-DECREASE trials and under that assumption, our results provide evidence that at least some data points were manipulated. However, these differences might also be due to different conceptual approaches as to how beta-blockade might prevent mortality in non-cardiac surgery. Considering this, we recommend new and more extensively controlled, confirmatory trials to determine whether there is any use in administering beta-blockers in order to decrease perioperative mortality.