Abstract #300026

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JSM 2003 Abstract #300026
Activity Number: 461
Type: Invited
Date/Time: Thursday, August 7, 2003 : 10:30 AM to 12:20 PM
Sponsor: ENAR
Abstract - #300026
Title: A Sensitivity Analysis for Subverting Randomization in Controlled Trials: Dealing with Unobserved Imbalances
Author(s): Sue M. Marcus*+
Companies: Mount Sinai School of Medicine
Address: 7200 McCallum St., Philadelphia, PA, 19119,
Keywords: treatment efficacy ; subverting randomization ; sensitivity analysis ; bias
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 noncompliance with the originally intended treatment assignment. Consequently, the estimate of treatment effect from these trials may be biased. This talk will clarify the determinants of the magnitude of bias and gives a sensitivity analysis that associates the amount that randomization has been subverted and the resulting unobserved bias in treatment effect estimation. The methods are illustrated with a randomized control trial that evaluates the efficacy of a culturally sensitive AIDS education video.


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Revised March 2003