Improving efficiency of inferences in randomized clinical trials using auxiliary covariates

Biometrics

Volumn 64, Issue 3, 2008, Pages 707-715

  Zhang, Min ^a   Tsiatis, Anastasios A ^a   Davidian, Marie ^a  

^a NORTH CAROLINA STATE UNIVERSITY   (United States)

Author keywords

Covariate adjustment; Hypothesis test; k arm trial; Kruskal Wallis test; Log odds ratio; Longitudinal data; Semiparametric theory

Indexed keywords

MEDICAL APPLICATIONS; STATISTICAL TESTS;

COVARIATE ADJUSTMENT; COVARIATES; HYPOTHESIS TESTS; K-ARM TRIAL; KRUSKAL-WALLIS TESTS; LOG ODD RATIO; LONGITUDINAL DATA; ODD RATIOS; SEMIPARAMETRIC; SEMIPARAMETRIC THEORY;

EFFICIENCY;

COMPARATIVE STUDY; COVARIANCE ANALYSIS; DISEASE TREATMENT; ESTIMATION METHOD; HYPOTHESIS TESTING; PERFORMANCE ASSESSMENT;

ANALYSIS OF COVARIANCE; ARTICLE; INFORMATION PROCESSING; PARAMETRIC TEST; RANDOMIZED CONTROLLED TRIAL; STATISTICAL ANALYSIS; STATISTICAL MODEL; TREATMENT OUTCOME;

EID: 49749151360     PISSN: 0006341X     EISSN: 15410420     Source Type: Journal    
DOI: 10.1111/j.1541-0420.2007.00976.x     Document Type: Article

References (21)

1. Carroll, R. J., Ruppert, D., Stefanski, L. A., and Crainiceanu, C. M. (2006). Measurement Error in Nonlinear Models: A Modern Perspective, 2nd edition. Boca Raton, Florida : Chapman and Hall/CRC.
2. Grouin, J. M., Day, S., and Lewis, J. (2004). Adjustment for baseline covariates: An introductory note. Statistics in Medicine 23, 697 699.
3. Hammer, S. M., Katzenstein, D. A., Hughes, M. D., Gundaker, H., Schooley, R. T., Haubrich, R. H., Henry, W. K., Lederman, M. M., Phair, J. P., Niu, M., Hirsch, M. S., and Merigan, T. C., for the AIDS Clinical Trials Group Study 175 Study Team 1996). A trial comparing nucleoside monotherapy with combination therapy in HIV-infected adults with CD4 cell counts from 200 to 500 per cubic millimeter. New England Journal of Medicine 335, 1081 1089.
4. Harrington, R. A., for the PURSUIT Investigators 1998). Inhibition of platelet glycoprotein IIb/IIIa with eptifibatide in patients with acute coronary syndromes without persistent ST-segment elevation. New England Journal of Medicine 339, 436 443.
5. Hauck, W. W., Anderson, S., and Marcus, S. M. (1998). Should we adjust for covariates in nonlinear regression analyses of randomized trials? Controlled Clinical Trials 19, 249 256.
6. Hjort, N. L. and Claeskens, G. (2003). Frequentist model average estimators. Journal of the American Statistical Association 98, 879 899.
7. Koch, G. G., Tangen, C. M., Jung, J. W., and Amara, I. A. (1998). Issues for covariance analysis of dichotomous and ordered categorical data from randomized clinical trials and non-parametric strategies for addressing them. Statistics in Medicine 17, 1863 1892.
8. Leon, S., Tsiatis, A. A., and Davidian, M. (2003). Semiparametric efficient estimation of treatment effect in a pretest-posttest study. Biometrics 59, 1046 1055.
9. Lesaffre, E. and Senn, S. (2003). A note on non-parametric ANCOVA for covariate adjustment in randomized clinical trials. Statistics in Medicine 22, 3586 3596.
10. Pocock, S. J., Assmann, S. E., Enos, L. E., and Kasten, L. E. (2002). Subgroup analysis, covariate adjustment, and baseline comparisons in clinical trial reporting: Current practice and problems. Statistics in Medicine 21, 2917 2930.
11. Robinson, L. D., Dorroh, J. R., Lein, D., and Tiku, M. L. (1998). The effects of covariate adjustment in generalized linear models. Communications in Statistics, Theory and Methods 27, 1653 1675.
12. SAS Institute, Inc. (2006). SAS Online Doc 9.1.3. Cary, North Carolina : SAS Institute, Inc.
13. Senn, S. (1989). Covariate imbalance and random allocation in clinical trials. Statistics in Medicine 8, 467 475.
14. Shen, X., Huang, H. C., and Ye, J. (2004). Inference after model selection. Journal of the American Statistical Association 99, 751 762.
15. Stefanski, L. A. and Boos, D. D. (2002). The calculus of M-estimation. The American Statistician 56, 29 38.
16. Tangen, C. M. and Koch, G. G. (1999). Nonparametric analysis of covariance for hypothesis testing with logrank and Wilcoxon scores and survival-rate estimation in a randomized clinical trial. Journal of Biopharmaceutical Statistics 9, 307 338.
17. Tsiatis, A. A. (2006). Semiparametric Theory and Missing Data. New York : Springer.
18. Tsiatis, A. A., Davidian, M., Zhang, M., and Lu, X. (2007). Covariate adjustment for two-sample treatment comparisons in randomized clinical trials: A principled yet flexible approach. Statistics in Medicine, DOI :.
19. van der Laan, M. J. and Robins, J. M. (2003). Unified Methods for Censored Longitudinal Data and Causality. New York : Springer.
20. van der Vaart, A. W. (1998). Asymptotic Statistics. Cambridge, U.K. : Cambridge University Press.
21. Yang, L. and Tsiatis, A. A. (2001). Efficiency study for a treatment effect in a pretest-posttest trial. The American Statistician 56, 29 38.