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A graphical sensitivity analysis for clinical trials with non-ignorable missing binary outcome.

Hollis, Sally (2002) A graphical sensitivity analysis for clinical trials with non-ignorable missing binary outcome. Statistics in Medicine, 21 (24). pp. 3823-3834.

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Abstract

Many clinical trials are analysed using an intention-to-treat (ITT) approach. A full application of the ITT approach is only possible when complete outcome data are available for all randomized subjects. In a recent survey of clinical trial reports including an ITT analysis, complete case analysis (excluding all patients with a missing response) was common. This does not comply with the basic principles of ITT since not all randomized subjects are included in the analysis. Analyses of data with missing values are based on untestable assumptions, and so sensitivity analysis presenting a range of estimates under alternative assumptions about the missing-data mechanism is recommended. For binary outcome, extreme case analysis has been suggested as a simple form of sensitivity analysis, but this is rarely conclusive. A graphical sensitivity analysis is proposed which displays the results of all possible allocations of cases with missing binary outcome. Extension to allow binomial variation in outcome is also considered. The display is based on easily interpretable parameters and allows informal examination of the effects of varying prior beliefs.

Item Type: Article
Journal or Publication Title: Statistics in Medicine
Uncontrolled Keywords: randomized control trial • missing data • intention to treat • sensitivity analysis • binary data
Subjects: Q Science > QA Mathematics
Departments: Faculty of Science and Technology > Mathematics and Statistics
ID Code: 19273
Deposited By: ep_ss_importer
Deposited On: 19 Nov 2008 15:10
Refereed?: Yes
Published?: Published
Last Modified: 26 Jul 2012 15:27
Identification Number:
URI: http://eprints.lancs.ac.uk/id/eprint/19273

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