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

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A graphical sensitivity analysis for clinical trials with non-ignorable missing binary outcome. / Hollis, Sally.
In: Statistics in Medicine, Vol. 21, No. 24, 30.12.2002, p. 3823-3834.

Research output: Contribution to Journal/Magazine › Journal article › peer-review

Harvard

Hollis, S 2002, 'A graphical sensitivity analysis for clinical trials with non-ignorable missing binary outcome.', Statistics in Medicine, vol. 21, no. 24, pp. 3823-3834. https://doi.org/10.1002/sim.1276

APA

Hollis, S. (2002). A graphical sensitivity analysis for clinical trials with non-ignorable missing binary outcome. Statistics in Medicine, 21(24), 3823-3834. https://doi.org/10.1002/sim.1276

Vancouver

Hollis S. A graphical sensitivity analysis for clinical trials with non-ignorable missing binary outcome. Statistics in Medicine. 2002 Dec 30;21(24):3823-3834. doi: 10.1002/sim.1276

Author

Hollis, Sally. / A graphical sensitivity analysis for clinical trials with non-ignorable missing binary outcome. In: Statistics in Medicine. 2002 ; Vol. 21, No. 24. pp. 3823-3834.

Bibtex

@article{074df2d603cc4facb67156cf32976616,
title = "A graphical sensitivity analysis for clinical trials with non-ignorable missing binary outcome.",
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.",
keywords = "randomized control trial • missing data • intention to treat • sensitivity analysis • binary data",
author = "Sally Hollis",
year = "2002",
month = dec,
day = "30",
doi = "10.1002/sim.1276",
language = "English",
volume = "21",
pages = "3823--3834",
journal = "Statistics in Medicine",
issn = "1097-0258",
publisher = "John Wiley and Sons Ltd",
number = "24",

}

RIS

TY - JOUR

T1 - A graphical sensitivity analysis for clinical trials with non-ignorable missing binary outcome.

AU - Hollis, Sally

PY - 2002/12/30

Y1 - 2002/12/30

N2 - 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.

AB - 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.

KW - randomized control trial • missing data • intention to treat • sensitivity analysis • binary data

U2 - 10.1002/sim.1276

DO - 10.1002/sim.1276

M3 - Journal article

VL - 21

SP - 3823

EP - 3834

JO - Statistics in Medicine

JF - Statistics in Medicine

SN - 1097-0258

IS - 24

ER -