Improving analysis practice of continuous adverse event outcomes in randomised controlled trials - a distributional approach.

ABSTRACT:

Background

Randomised controlled trials (RCTs) provide valuable information for developing harm profiles but current analysis practices to detect between-group differences are suboptimal. Drug trials routinely screen continuous clinical and biological data to monitor participant harm. These outcomes are regularly dichotomised into abnormal/normal values for analysis. Despite the simplicity gained for clinical interpretation, it is well established that dichotomising outcomes results in a considerable reduction in information and thus statistical power. We propose an automated procedure for the routine implementation of the distributional method for the dichotomisation of continuous outcomes proposed by Peacock and Sauzet, which retains the precision of the comparison of means.

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SUBMITTER: Chis Ster A 

PROVIDER: S-EPMC8243742 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature