Tests for Equivalence Based on Odds Ratio for Matched-Pair Design
- 1 November 2005
- journal article
- research article
- Published by Taylor & Francis in Journal of Biopharmaceutical Statistics
- Vol. 15 (6) , 889-901
- https://doi.org/10.1080/10543400500265561
Abstract
Currently, methods for evaluation of equivalence under a matched-pair design use either difference in proportions or relative risk as measures of risk association. However, these measures of association are only for cross-sectional studies or prospective investigations, such as clinical trials and they cannot be applied to retrospective research such as case-control studies. As a result, under a matched-pair design, we propose the use of the conditional odds ratio for assessment of equivalence in both prospective and retrospective research. We suggest the use of the asymptotic confidence interval of the conditional odds ratio for evaluation of equivalence. In addition, a score test based on the restricted maximum likelihood estimator (RMLE) is derived to test the hypothesis of equivalence under a matched-pair design. On the other hand, a sample size formula is also provided. A simulation study was conducted to empirically investigate the size and power of the proposed procedures. Simulation results show that the score test not only adequately controls the Type I error but it can also provide sufficient power. A numerical example illustrates the proposed methods.Keywords
This publication has 6 references indexed in Scilit:
- On tests of equivalence via non‐unity relative risk for matched‐pair designStatistics in Medicine, 2003
- Tests for equivalence or non‐inferiority for paired binary dataStatistics in Medicine, 2001
- Unconditional Exact Tests for Equivalence or Noninferiority for Paired Binary EndpointsBiometrics, 2001
- Biostatistical MethodsWiley Series in Probability and Statistics, 2000
- Approximation Theorems of Mathematical StatisticsPublished by Wiley ,1980
- Estrogens and Endometrial Cancer in a Retirement CommunityNew England Journal of Medicine, 1976