Continuing with the theme of exploring small issues that come up in trial design, I recently used simulation to assess the impact of stratifying (or not) in the context of a multi-site Covid-19 trial with a binary outcome. The investigators are concerned that baseline health status will affect the probability of an outcome event, and are interested in randomizing by health status. The goal is to ensure balance across the two treatment arms with respect to this important variable. This randomization would be paired with an estimation model that adjusts for health status.
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