A sensitivity analysis for subverting randomization in controlled trials.

Abstract:

:In some randomized controlled trials, subjects with a better prognosis may be diverted into the treatment group. This subverting of randomization results in an unobserved non-compliance with the originally intended treatment assignment. Consequently, the estimate of treatment effect from these trials may be biased. This paper clarifies the determinants of the magnitude of the bias and gives a sensitivity analysis that associates the amount that randomization is subverted and the resulting bias in treatment effect estimation. The methods are illustrated with a randomized controlled trial that evaluates the efficacy of a culturally sensitive AIDS education video.

journal_name

Stat Med

journal_title

Statistics in medicine

authors

Marcus SM

doi

10.1002/sim.715

subject

Has Abstract

pub_date

2001-02-28 00:00:00

pages

545-55

issue

4

eissn

0277-6715

issn

1097-0258

journal_volume

20

pub_type

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