Does accounting for seizure frequency variability increase clinical trial power?

ABSTRACT:

Objective

Seizure frequency variability is associated with placebo responses in randomized controlled trials (RCT). Increased variability can result in drug misclassification and, hence, decreased statistical power. We investigated a new method that directly incorporated variability into RCT analysis, Z_V.

Methods

Two models were assessed: the traditional 50%-responder rate (RR50), and the variability-corrected score, Z_V. Each predicted seizure frequency upper and lower limits using prior seizures. Accuracy was defined as percentage of time-intervals when the observed seizure frequencies were within the predicted limits. First, we tested the Z_V method on three datasets (SeizureTracker: n=3016, Human Epilepsy Project: n=107, and NeuroVista: n=1

SUBMITTER: Goldenholz DM 

PROVIDER: S-EPMC5650933 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature