Quantifying and controlling the impact of regression to the mean on randomized controlled trials in epilepsy.
Daniel M GoldenholzEliana B GoldenholzTed J KaptchukPublished in: Epilepsia (2023)
The manipulation of eligibility criteria for RCTs has a predictable and important impact on RTM, and therefore on placebo response; the difference between drug and placebo was more easily detected. This in turn impacts trial efficacy and therefore cost. This study found dramatic improvements in efficacy and cost when baseline was not included in eligibility.