Analysis of responder-based endpoints: improving power through utilising continuous components.

ABSTRACT:

Background

Clinical trials and other studies commonly assess the effectiveness of an intervention through the use of responder-based endpoints. These classify patients based on whether they meet a number of criteria which often involve continuous variables categorised as being above or below a threshold. The proportion of patients who are responders is estimated and, where relevant, compared between groups. An alternative method called the augmented binary method keeps the definition of the endpoint the same but utilises information contained within the continuous component to increase the power considerably (equivalent to increasing the sample size by > 30%). In this article we summarise the method and investigate the variety of clinical conditions that use endpoints to which it c

SUBMITTER: Wason J 

PROVIDER: S-EPMC7249409 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature