Adjustment for treatment changes in epilepsy trials: A comparison of causal methods for time-to-event outcomes.

ABSTRACT:

Background

When trials are subject to departures from randomised treatment, simple statistical methods that aim to estimate treatment efficacy, such as per protocol or as treated analyses, typically introduce selection bias. More appropriate methods to adjust for departure from randomised treatment are rarely employed, primarily due to their complexity and unfamiliarity. We demonstrate the use of causal methodologies for the production of estimands with valid causal interpretation for time-to-event outcomes in the analysis of a complex epilepsy trial, as an example to guide non-specialist analysts undertaking similar analyses.

Methods

Two causal methods, the structural failure time model and inverse probability of censoring weighting, are adapted to allow for skewed time-var

SUBMITTER: Dodd S 

PROVIDER: S-EPMC6419234 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature