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Active-control trials with binary data: a comparison of methods for testing superiority or non-inferiority using the odds ratio.

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Active-control trials with binary data: a comparison of methods for testing superiority or non-inferiority using the odds ratio. / Siqueira, Arminda; Whitehead, Anne; Todd, Susan.
In: Statistics in Medicine, Vol. 27, No. 3, 10.02.2008, p. 353-370.

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

Harvard

Siqueira, A, Whitehead, A & Todd, S 2008, 'Active-control trials with binary data: a comparison of methods for testing superiority or non-inferiority using the odds ratio.', Statistics in Medicine, vol. 27, no. 3, pp. 353-370. https://doi.org/10.1002/sim.2975

APA

Siqueira, A., Whitehead, A., & Todd, S. (2008). Active-control trials with binary data: a comparison of methods for testing superiority or non-inferiority using the odds ratio. Statistics in Medicine, 27(3), 353-370. https://doi.org/10.1002/sim.2975

Vancouver

Siqueira A, Whitehead A, Todd S. Active-control trials with binary data: a comparison of methods for testing superiority or non-inferiority using the odds ratio. Statistics in Medicine. 2008 Feb 10;27(3):353-370. doi: 10.1002/sim.2975

Author

Siqueira, Arminda ; Whitehead, Anne ; Todd, Susan. / Active-control trials with binary data : a comparison of methods for testing superiority or non-inferiority using the odds ratio. In: Statistics in Medicine. 2008 ; Vol. 27, No. 3. pp. 353-370.

Bibtex

@article{7e735511a2b146cdb9d31010d139ad4c,
title = "Active-control trials with binary data: a comparison of methods for testing superiority or non-inferiority using the odds ratio.",
abstract = "This paper considers methods for testing for superiority or non-inferiority in active-control trials with binary data, when the relative treatment effect is expressed as an odds ratio. Three asymptotic tests for the log-odds ratio based on the unconditional binary likelihood are presented, namely the likelihood ratio, Wald and score tests. All three tests can be implemented straightforwardly in standard statistical software packages, as can the corresponding confidence intervals. Simulations indicate that the three alternatives are similar in terms of the Type I error, with values close to the nominal level. However, when the non-inferiority margin becomes large, the score test slightly exceeds the nominal level. In general, the highest power is obtained from the score test, although all three tests are similar and the observed differences in power are not of practical importance. ",
keywords = "binary data, likelihood ratio test , non-inferiority, odds ratio , score test , Wald test",
author = "Arminda Siqueira and Anne Whitehead and Susan Todd",
year = "2008",
month = feb,
day = "10",
doi = "10.1002/sim.2975",
language = "English",
volume = "27",
pages = "353--370",
journal = "Statistics in Medicine",
issn = "1097-0258",
publisher = "John Wiley and Sons Ltd",
number = "3",

}

RIS

TY - JOUR

T1 - Active-control trials with binary data

T2 - a comparison of methods for testing superiority or non-inferiority using the odds ratio.

AU - Siqueira, Arminda

AU - Whitehead, Anne

AU - Todd, Susan

PY - 2008/2/10

Y1 - 2008/2/10

N2 - This paper considers methods for testing for superiority or non-inferiority in active-control trials with binary data, when the relative treatment effect is expressed as an odds ratio. Three asymptotic tests for the log-odds ratio based on the unconditional binary likelihood are presented, namely the likelihood ratio, Wald and score tests. All three tests can be implemented straightforwardly in standard statistical software packages, as can the corresponding confidence intervals. Simulations indicate that the three alternatives are similar in terms of the Type I error, with values close to the nominal level. However, when the non-inferiority margin becomes large, the score test slightly exceeds the nominal level. In general, the highest power is obtained from the score test, although all three tests are similar and the observed differences in power are not of practical importance.

AB - This paper considers methods for testing for superiority or non-inferiority in active-control trials with binary data, when the relative treatment effect is expressed as an odds ratio. Three asymptotic tests for the log-odds ratio based on the unconditional binary likelihood are presented, namely the likelihood ratio, Wald and score tests. All three tests can be implemented straightforwardly in standard statistical software packages, as can the corresponding confidence intervals. Simulations indicate that the three alternatives are similar in terms of the Type I error, with values close to the nominal level. However, when the non-inferiority margin becomes large, the score test slightly exceeds the nominal level. In general, the highest power is obtained from the score test, although all three tests are similar and the observed differences in power are not of practical importance.

KW - binary data

KW - likelihood ratio test

KW - non-inferiority

KW - odds ratio

KW - score test

KW - Wald test

U2 - 10.1002/sim.2975

DO - 10.1002/sim.2975

M3 - Journal article

VL - 27

SP - 353

EP - 370

JO - Statistics in Medicine

JF - Statistics in Medicine

SN - 1097-0258

IS - 3

ER -