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A score test for binary data with patient non-compliance

Branson, M. and Whitehead, J. (2003) A score test for binary data with patient non-compliance. Statistics in Medicine, 22 (20). pp. 3115-3132. ISSN 0277-6715

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To link to this item DOI: 10.1002/sim.1542


A score test is developed for binary clinical trial data, which incorporates patient non-compliance while respecting randomization. It is assumed in this paper that compliance is all-or-nothing, in the sense that a patient either accepts all of the treatment assigned as specified in the protocol, or none of it. Direct analytic comparisons of the adjusted test statistic for both the score test and the likelihood ratio test are made with the corresponding test statistics that adhere to the intention-to-treat principle. It is shown that no gain in power is possible over the intention-to-treat analysis, by adjusting for patient non-compliance. Sample size formulae are derived and simulation studies are used to demonstrate that the sample size approximation holds. Copyright © 2003 John Wiley & Sons, Ltd.

Item Type:Article
Divisions:Science > School of Mathematical, Physical and Computational Sciences > Department of Mathematics and Statistics > Applied Statistics
ID Code:9480
Uncontrolled Keywords:non-compliance , binary data , score test , likelihood ratio test , Wald's test , sample size

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