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A sensitivity analysis for subverting randomization in controlled trials
Author(s) -
Marcus Sue M.
Publication year - 2001
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.715
Subject(s) - randomization , randomized controlled trial , sensitivity (control systems) , restricted randomization , clinical trial , statistics , treatment effect , econometrics , medicine , computer science , mathematics , surgery , electronic engineering , engineering , traditional medicine
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. Copyright © 2001 John Wiley & Sons, Ltd.