Quantifying and controlling the impact of regression to the mean on randomized controlled trials in epilepsy.

ABSTRACT:

Objective

Randomized controlled trials (RCTs) in epilepsy for drug treatments are plagued by high costs. One potential remedy is to reduce placebo response via better control over regression to the mean (RTM). Here, RTM represents an initial observed seizure rate higher than the long-term average, which gradually settles closer to the average, resulting in apparent response to treatment. This study used simulation to clarify the relationship between eligibility criteria and RTM.

Methods

Using a statistically realistic seizure diary simulator, the impact of RTM on placebo response and trial efficacy was explored by varying eligibility criteria for a traditional treatment phase II/III RCT for drug-resistant epilepsy.

Results

When the baseline period was included in the

SUBMITTER: Goldenholz DM 

PROVIDER: S-EPMC10592227 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature