Rank-based principal stratum sensitivity analyses.

Abstract:

:We describe rank-based approaches to assess principal stratification treatment effects in studies where the outcome of interest is only well-defined in a subgroup selected after randomization. Our methods are sensitivity analyses, in that estimands are identified by fixing a parameter and then we investigate the sensitivity of results by varying this parameter over a range of plausible values. We present three rank-based test statistics and compare their performance through simulations, and provide recommendations. We also study three different bootstrap approaches for determining levels of significance. Finally, we apply our methods to two studies: an HIV vaccine trial and a prostate cancer prevention trial.

journal_name

Stat Med

journal_title

Statistics in medicine

authors

Lu X,Mehrotra DV,Shepherd BE

doi

10.1002/sim.5849

subject

Has Abstract

pub_date

2013-11-20 00:00:00

pages

4526-39

issue

26

eissn

0277-6715

issn

1097-0258

journal_volume

32

pub_type

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