Sensitivity analyses comparing time-to-event outcomes only existing in a subset selected postrandomization and relaxing monotonicity.

ABSTRACT: In randomized studies researchers may be interested in the effect of treatment assignment on a time-to-event outcome that only exists in a subset selected after randomization. For example, in preventative HIV vaccine trials, it is of interest to determine whether randomization to vaccine affects the time from infection diagnosis until initiation of antiretroviral therapy. Earlier work assessed the effect of treatment on outcome among the principal stratum of individuals who would have been selected regardless of treatment assignment. These studies assumed monotonicity, that one of the principal strata was empty (e.g., every person infected in the vaccine arm would have been infected if randomized to placebo). Here, we present a sensitivity analysis approach for relaxing monotonicity with a

SUBMITTER: Shepherd BE 

PROVIDER: S-EPMC3116075 | biostudies-literature | 2011 Sep

REPOSITORIES: biostudies-literature