The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies.

ABSTRACT:

Background

Adjustment for prognostic covariates can lead to increased power in the analysis of randomized trials. However, adjusted analyses are not often performed in practice.

Methods

We used simulation to examine the impact of covariate adjustment on 12 outcomes from 8 studies across a range of therapeutic areas. We assessed (1) how large an increase in power can be expected in practice; and (2) the impact of adjustment for covariates that are not prognostic.

Results

Adjustment for known prognostic covariates led to large increases in power for most outcomes. When power was set to 80% based on an unadjusted analysis, covariate adjustment led to a median increase in power to 92.6% across the 12 outcomes (range 80.6 to 99.4%). Power was increased to over 85% for 8 of

SUBMITTER: Kahan BC 

PROVIDER: S-EPMC4022337 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature