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covariate_adjustment.bib
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%%% OUR REFERENCES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
@article{VanLancker2022,
doi = {10.48550/ARXIV.2201.12921},
url = {https://arxiv.org/abs/2201.12921},
author = {Van Lancker, Kelly and Betz, Joshua and Rosenblum, Michael},
keywords = {Methodology (stat.ME), FOS: Computer and information sciences, FOS: Computer and information sciences},
title = {Combining Covariate Adjustment with Group Sequential, Information Adaptive Designs to Improve Randomized Trial Efficiency},
journal={arXiv preprint arXiv:1409.0473},
publisher = {arXiv},
year = {2022},
copyright = {Creative Commons Attribution 4.0 International}
}
%%% R PACKAGE REFERENCES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
@Manual{margins_package,
title = {margins: Marginal Effects for Model Objects},
author = {Thomas J. Leeper},
year = {2021},
note = {R package version 0.3.26},
}
@Manual{boot_package,
title = {boot: Bootstrap R (S-Plus) Functions},
author = {Angelo Canty and B. D. Ripley},
year = {2022},
note = {R package version 1.3-28.1},
}
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doi = {10.18637/jss.v016.i09},
url = {https://doi.org/10.18637/jss.v016.i09},
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publisher = {Foundation for Open Access Statistic},
volume = {16},
number = {9},
author = {Achim Zeileis},
title = {Object-Oriented Computation of Sandwich Estimators},
journal = {Journal of Statistical Software}
}
%%% STRATIFIED RANDOMIZATION REFERENCES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
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url = {https://doi.org/10.1002/sim.4431},
year = {2011},
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title = {Improper analysis of trials randomised using stratified blocks or minimisation},
journal = {Statistics in Medicine}
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journal = {Journal of Clinical Epidemiology}
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doi = {10.1016/j.cct.2015.07.011},
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volume = {45},
pages = {21--25},
author = {Yunzhi Lin and Ming Zhu and Zheng Su},
title = {The pursuit of balance: An overview of covariate-adaptive randomization techniques in clinical trials},
journal = {Contemporary Clinical Trials}
}
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doi = {10.1080/01621459.2021.1981338},
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title = {Model-Robust Inference for Clinical Trials that Improve Precision by Stratified Randomization and Covariate Adjustment},
journal = {Journal of the American Statistical Association}
}
%%% SURVEYS OF COVARIATE ADJUSTMENT IN PRACTICE %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
@article{Austin2010,
doi = {10.1016/j.jclinepi.2009.06.002},
url = {https://doi.org/10.1016/j.jclinepi.2009.06.002},
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volume = {63},
number = {2},
pages = {142--153},
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title = {A substantial and confusing variation exists in handling of baseline covariates in randomized controlled trials: a review of trials published in leading medical journals},
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}
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title = {Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems},
journal = {Statistics in Medicine}
}
%%% REVIEW ARTICLES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
@article{Benkeser2020,
doi = {10.1111/biom.13377},
url = {https://doi.org/10.1111/biom.13377},
year = {2020},
month = oct,
publisher = {Wiley},
volume = {77},
number = {4},
pages = {1467--1481},
author = {David Benkeser and Iv{\'{a}}n D{\'{\i}}az and Alex Luedtke and Jodi Segal and Daniel Scharfstein and Michael Rosenblum},
title = {Improving precision and power in randomized trials for {COVID}-19 treatments using covariate adjustment, for binary, ordinal, and time-to-event outcomes},
journal = {Biometrics}
}
%%% COMPARING ESTIMATORS %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
@article{Colantuoni2015,
doi = {10.1002/sim.6507},
url = {https://doi.org/10.1002/sim.6507},
year = {2015},
month = apr,
publisher = {Wiley},
volume = {34},
number = {18},
pages = {2602--2617},
author = {Elizabeth Colantuoni and Michael Rosenblum},
title = {Leveraging prognostic baseline variables to gain precision in randomized trials},
journal = {Statistics in Medicine}
}
%%% CONTINUOUS OUTCOMES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
@article{Tsiatis2008,
doi = {10.1002/sim.3113},
url = {https://doi.org/10.1002/sim.3113},
year = {2008},
month = oct,
publisher = {Wiley},
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number = {23},
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title = {Covariate adjustment for two-sample treatment comparisons in randomized clinical trials: A principled yet flexible approach},
journal = {Statistics in Medicine}
}
@article{Jiang2019,
doi = {10.1080/01621459.2018.1527226},
url = {https://doi.org/10.1080/01621459.2018.1527226},
year = {2019},
month = mar,
publisher = {Informa {UK} Limited},
volume = {114},
number = {528},
pages = {1854--1864},
author = {Fei Jiang and Lu Tian and Haoda Fu and Takahiro Hasegawa and L. J. Wei},
title = {Robust Alternatives to {ANCOVA} for Estimating the Treatment Effect via a Randomized Comparative Study},
journal = {Journal of the American Statistical Association}
}
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doi = {10.1111/j.1541-0420.2007.00976.x},
url = {https://doi.org/10.1111/j.1541-0420.2007.00976.x},
year = {2008},
month = jan,
publisher = {Wiley},
volume = {64},
number = {3},
pages = {707--715},
author = {Min Zhang and Anastasios A. Tsiatis and Marie Davidian},
title = {Improving Efficiency of Inferences in Randomized Clinical Trials Using Auxiliary Covariates},
journal = {Biometrics}
}
%%% BINARY OUTCOMES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
@article{Ge2011,
doi = {10.1177/009286151104500409},
url = {https://doi.org/10.1177/009286151104500409},
year = {2011},
month = jul,
publisher = {Springer Science and Business Media {LLC}},
volume = {45},
number = {4},
pages = {481--493},
author = {Miaomiao Ge and L. Kathryn Durham and R. Daniel Meyer and Wangang Xie and Neal Thomas},
title = {Covariate-Adjusted Difference in Proportions from Clinical Trials Using Logistic Regression and Weighted Risk Differences},
journal = {Drug Information Journal}
}
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doi = {10.1002/sim.3445},
url = {https://doi.org/10.1002/sim.3445},
year = {2009},
month = jan,
publisher = {Wiley},
volume = {28},
number = {1},
pages = {39--64},
author = {K. L. Moore and M. J. van der Laan},
title = {Covariate adjustment in randomized trials with binary outcomes: Targeted maximum likelihood estimation},
journal = {Statistics in Medicine}
}
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doi = {10.1016/j.cct.2016.12.026},
url = {https://doi.org/10.1016/j.cct.2016.12.026},
year = {2017},
month = mar,
publisher = {Elsevier {BV}},
volume = {54},
pages = {18--24},
author = {Jon Arni Steingrimsson and Daniel F. Hanley and Michael Rosenblum},
title = {Improving precision by adjusting for prognostic baseline variables in randomized trials with binary outcomes, without regression model assumptions},
journal = {Contemporary Clinical Trials}
}
%%% ORDINAL OUTCOMES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
@article{Diaz2015,
doi = {10.1111/biom.12450},
url = {https://doi.org/10.1111/biom.12450},
year = {2015},
month = nov,
publisher = {Wiley},
volume = {72},
number = {2},
pages = {422--431},
author = {Iv{\'{a}}n D{\'{\i}}az and Elizabeth Colantuoni and Michael Rosenblum},
title = {Enhanced precision in the analysis of randomized trials with ordinal outcomes},
journal = {Biometrics}
}
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doi = {10.1002/sim.6386},
url = {https://doi.org/10.1002/sim.6386},
year = {2014},
month = dec,
publisher = {Wiley},
volume = {34},
number = {6},
pages = {1012--1030},
author = {Karel Vermeulen and Olivier Thas and Stijn Vansteelandt},
title = {Increasing the power of the Mann-Whitney test in randomized experiments through flexible covariate adjustment},
journal = {Statistics in Medicine}
}
%%% TIME TO EVENT %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
@article{Brooks2013,
doi = {10.1515/jci-2013-0001},
url = {https://doi.org/10.1515/jci-2013-0001},
year = {2013},
month = nov,
publisher = {Walter de Gruyter {GmbH}},
volume = {1},
number = {2},
pages = {235--254},
author = {Jordan C. Brooks and Mark J. van der Laan and Daniel E. Singer and Alan S. Go},
title = {Targeted Minimum Loss-Based Estimation of Causal Effects in Right-Censored Survival Data with Time-Dependent Covariates: Warfarin, Stroke, and Death in Atrial Fibrillation},
journal = {Journal of Causal Inference}
}
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doi = {10.1016/j.conctc.2017.09.004},
url = {https://doi.org/10.1016/j.conctc.2017.09.004},
year = {2017},
month = dec,
publisher = {Elsevier {BV}},
volume = {8},
pages = {147--155},
author = {Ray S. Lin and Larry F. Le{\'{o}}n},
title = {Estimation of treatment effects in weighted log-rank tests},
journal = {Contemporary Clinical Trials Communications}
}
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doi = {10.1080/10543400903243017},
url = {https://doi.org/10.1080/10543400903243017},
year = {2009},
month = oct,
publisher = {Informa {UK} Limited},
volume = {19},
number = {6},
pages = {1099--1131},
author = {K. L. Moore and M. J. van der Laan},
title = {Increasing Power in Randomized Trials with Right Censored Outcomes Through Covariate Adjustment},
journal = {Journal of Biopharmaceutical Statistics}
}
@article{Parast2014,
doi = {10.1080/01621459.2013.842488},
url = {https://doi.org/10.1080/01621459.2013.842488},
year = {2014},
month = jan,
publisher = {Informa {UK} Limited},
volume = {109},
number = {505},
pages = {384--394},
author = {Layla Parast and Lu Tian and Tianxi Cai},
title = {Landmark Estimation of Survival and Treatment Effect in a Randomized Clinical Trial},
journal = {Journal of the American Statistical Association}
}
@article{Stitelman2012,
doi = {10.1515/1557-4679.1334},
url = {https://doi.org/10.1515/1557-4679.1334},
year = {2012},
month = jan,
publisher = {Walter de Gruyter {GmbH}},
volume = {8},
number = {1},
author = {Ori M. Stitelman and Victor De Gruttola and Mark J. van der Laan},
title = {A General Implementation of {TMLE} for Longitudinal Data Applied to Causal Inference in Survival Analysis},
journal = {The International Journal of Biostatistics}
}
%%% RESTRICTED MEAN SURVIVAL TIME %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
@article{Chen2001,
doi = {10.1111/j.0006-341x.2001.01030.x},
url = {https://doi.org/10.1111/j.0006-341x.2001.01030.x},
year = {2001},
month = dec,
publisher = {Wiley},
volume = {57},
number = {4},
pages = {1030--1038},
author = {Pei-Yun Chen and Anastasios A. Tsiatis},
title = {Causal Inference on the Difference of the Restricted Mean Lifetime Between Two Groups},
journal = {Biometrics}
}
@article{Diaz2018,
doi = {10.1007/s10985-018-9428-5},
url = {https://doi.org/10.1007/s10985-018-9428-5},
year = {2018},
month = feb,
publisher = {Springer Science and Business Media {LLC}},
volume = {25},
number = {3},
pages = {439--468},
author = {Iv{\'{a}}n D{\'{\i}}az and Elizabeth Colantuoni and Daniel F. Hanley and Michael Rosenblum},
title = {Improved precision in the analysis of randomized trials with survival outcomes, without assuming proportional hazards},
journal = {Lifetime Data Analysis}
}
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doi = {10.1111/1467-9868.00310},
url = {https://doi.org/10.1111/1467-9868.00310},
year = {2001},
month = nov,
publisher = {Oxford University Press ({OUP})},
volume = {63},
number = {4},
pages = {745--757},
author = {A. G. DiRienzo and S. W. Lagakos},
title = {Effects of model misspecification on tests of no randomized treatment effect arising from Cox{\textquotesingle}s proportional hazards model},
journal = {Journal of the Royal Statistical Society: Series B (Statistical Methodology)}
}
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doi = {10.1002/sim.4274},
url = {https://doi.org/10.1002/sim.4274},
year = {2011},
month = may,
publisher = {Wiley},
volume = {30},
number = {19},
pages = {2409--2421},
author = {Patrick Royston and Mahesh K. B. Parmar},
title = {The use of restricted mean survival time to estimate the treatment effect in randomized clinical trials when the proportional hazards assumption is in doubt},
journal = {Statistics in Medicine}
}
@article{Royston2013,
doi = {10.1186/1471-2288-13-152},
url = {https://doi.org/10.1186/1471-2288-13-152},
year = {2013},
month = dec,
publisher = {Springer Science and Business Media {LLC}},
volume = {13},
number = {1},
author = {Patrick Royston and Mahesh KB Parmar},
title = {Restricted mean survival time: an alternative to the hazard ratio for the design and analysis of randomized trials with a time-to-event outcome},
journal = {{BMC} Medical Research Methodology}
}
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doi = {10.1002/sim.4505},
url = {https://doi.org/10.1002/sim.4505},
year = {2012},
month = feb,
publisher = {Wiley},
volume = {31},
number = {16},
pages = {1722--1737},
author = {Kyle D. Rudser and Michael L. LeBlanc and Scott S. Emerson},
title = {Distribution-free inference on contrasts of arbitrary summary measures of survival},
journal = {Statistics in Medicine}
}
@article{VanLancker2021,
doi = {10.1002/sim.9017},
url = {https://doi.org/10.1002/sim.9017},
year = {2021},
month = may,
publisher = {Wiley},
volume = {40},
number = {18},
pages = {4108--4121},
author = {Kelly Van Lancker and Oliver Dukes and Stijn Vansteelandt},
title = {Principled selection of baseline covariates to account for censoring in randomized trials with a survival endpoint},
journal = {Statistics in Medicine}
}
%%% DOUBLY ROBUST ESTIMATORS %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
@article{Tan2010,
doi = {10.1093/biomet/asq035},
url = {https://doi.org/10.1093/biomet/asq035},
year = {2010},
month = jul,
publisher = {Oxford University Press ({OUP})},
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%%% SANDWICH REFERENCES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
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%%% BOOTSTRAP REFERENCES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
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%%% CLINICAL TRIALS REFERENCES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
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%%% GROUP SEQUENTIAL DESIGNS REFERENCES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
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%%% MISTIE III EXAMPLE %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
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%%% CTN-0003 EXAMPLE REFERENCES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
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%%% CTN-030 EXAMPLE REFERENCES %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
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