Abstract
Intention-to-treat (ITT) comparisons have a central place in reporting on randomized controlled trials, though there are typically additional analyses of interest such as those making adjustments for nonadherence. In our ITT reporting of results from the Women’s Health Initiative (WHI) randomized trials, we have relied primarily on highly flexible hazard ratio (Cox) regression methods. However, these methods, especially the proportional hazards special case, have been criticized for being difficult to interpret and frequently oversimplified, and for not being consistent with modern causality theories using potential outcomes. Here we address these topics and extend our use of hazard rate methods for ITT comparisons in the WHI trials.
Funding Statement
This work was partially supported by National Institutes of Health awards HHSN268201100046C and P30CA015704.
Citation
Ross L. Prentice. Aaron K. Aragaki. "Intention-to-Treat Comparisons in Randomized Trials." Statist. Sci. 37 (3) 380 - 393, August 2022. https://doi.org/10.1214/21-STS830
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