Sensitivity analyses comparing time-to-event outcomes existing only in a subset selected postrandomization

Journal of the American Statistical Association

Volumn 102, Issue 478, 2007, Pages 573-582

  Shepherd, Bryan E ^a   Gilbert, Peter B ^b   Lumley, Thomas ^c  

^a VANDERBILT UNIVERSITY   (United States)

^b Fred Hutchinson Cancer Research Center   (United States)

^c UNIVERSITY OF WASHINGTON   (United States)

Author keywords

Acquired immune deficiency syndrome; Causal inference; Kaplan Meier; Principal stratification

Indexed keywords

EID: 34250711244     PISSN: 01621459     EISSN: None     Source Type: Journal    
DOI: 10.1198/016214507000000130     Document Type: Article

References (25)

1. Andersen, P. K., Borgan, O., Gill, R. D., and Keiding, N. (1992), Statistical Models Based on Counting Processes, Berlin: Springer.
2. Chen, P. Y., and Tsiatis, A. A. (2001), "Causal Inference on the Difference of the Restricted Mean Lifetime Between Two Groups," Biometrics, 57, 1030-1038.
3. Flynn, N. M., Forthal, D. N., Harro, C. D., Judson, F. N., Mayer, K. H., Para, M. F., and the rgp120 HIV Vaccine Study Group (2005), "Placebo- Controlled Phase 3 Trial of a Recombinant Glycoprotein 120 Vaccine to Prevent HIV-1 Infection," Journal of Infectious Diseases, 191, 647-649.
4. Frangakis, C. E., and Rubin, D. B. (2002), "Principal Stratification in Causal Inference," Biometrics, 58, 21-29.
5. Gilbert, P. B., Ackers, M. L., Berman, P. W., Francis, D. P., Popovic, V., Hu, D. J., Heyward, W. L., Sinangil, F., Shepherd, B. E., and Gurwith, M. (2005), "HIV-1 Virologic and Immunologic Progression and Antiretroviral Therapy Initiation Among HIV-1-Infected Participants in an Efficacy Trial of Recombinant Glycoprotein 120 Vaccine," Journal of Infectious Diseases, 192, 974-983.
6. Gilbert, P. B., Bosch, R. J., and Hudgens, M. G. (2003), "Sensitivity Analysis for the Assessment of Causal Vaccine Effects on Viral Load in HIV Vaccine Trials," Biometrics, 59, 531-541.
7. Graham, B. S. (2002), "Clinical Trials of HIV Vaccines," Annual Review of Medicine, 53, 207-221.
8. Halloran, M. E., and Struchiner, C. J. (1995), "Causal Inference for Infectious Diseases," Epidemiology, 6, 142-151.
9. Hudgens, M. G., and Halloran, M. E. (2006), "Causal Vaccine Effects on Binary Postinfection Outcomes," Journal of the American Statistical Association, 101, 51-64.
10. Hudgens, M. G., Hoering, A., and Self, S. G. (2003), "On the Analysis of Viral Load Endpoints in HIV Vaccine Trials," Statistics in Medicine, 22, 2281-2298.
11. Jemiai, Y., and Rotnitzky, A. (2005), "Asymptotic Properties of an Estimator of Treatment Effects on an Outcome Only Existing if a Post-Randomization Event Has Occured," Yannis Jemiai doctoral dissertation, Harvard School of Public Health, Department of Biostatistics.
12. Kalbfleish, J. D., and Prentice, R. L. (1980), The Statistical Analysis of Failure Time Data, New York: Wiley.
13. Nabel, G. J. (2001), "Challenges and Opportunities for Development of an AIDS Vaccine," Nature, 410, 1002-1007.
14. Neyman, J. (1923), "On the Application of Probability Theory to Agricultural Experiments: Essay on Principles," Translated in Statistical Science, 5, 465-480.
15. Robins, J. M. (1986), "A New Approach to Causal Inference in Mortality Studies With Sustained Exposure Periods, With Application to Control of the Healthy Worker Survivor Effect," Mathematical Modeling, 1, 1393-1512.
16. _ (1995), "An Analytic Method for Randomized Trials With Informative Censoring: Part I," Lifetime Data Analysis, 1, 241-254.
17. Robins, J. M., and Greenland, S. (2000), Comment on "Causal Inference Without Counterfactuals," by A. P. Dawid, Journal of the American Statistical Association, 95, 431-435.
18. Rosenbaum, P. R. (1984), "The Consequences of Adjustment for a Concomitant Variable That Has Been Affected by the Treatment," Journal of the Royal Statistical Society, Ser. A, 147, 656-666.
19. Rubin, D. B. (1978), "Bayesian Inference for Causal Effects: The Role of Randomization," The Annals of Statistics, 6, 34-58.
20. _ (2000), Comment on "Causal Inference Without Counterfactuals, " by A. P. Dawid, Journal of the American Statistical Association, 95, 435-437.
21. Scharfstein, D. O., Rotnitzky, A., and Robins, J. M. (1999), "Adjusting for Nonignorable Dropout Using Semiparametric Nonresponse Models," Journal of the American Statistical Association, 94, 1096-1146.
22. Shepherd, B. E., Gilbert, P. B., Jemiai, Y., and Rotnitzky, A. (2006), "Sensitivity Analyses Comparing Outcomes Only Existing in a Subset Selected PostRandomization, Conditional on Covariates, With Application to HIV Vaccine Trials," Biometrics, 62, 332-342.
23. Shepherd, B. E., Gilbert, P. B., and Mehrotra, D. V. (2007), "Eliciting a Counterfactual Sensitivity Parameter," The American Statistician, 61, 56-63.
24. Stute, W. (1995), "The Central Limit Theorem Under Random Censorship," The Annals of Statistics, 23, 422-439.
25. van der Vaart, A. W. (1998), Asymptotic Statistics, Cambridge, U.K.: Cambridge University Press.