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Abstract |
Background Many clinical and epidemiological studies include a composite outcome. Conventional analysis of a composite outcome uses the time to the occurrence of first event, ignoring the clinical importance of each component event. As a result, the result of a composite outcome could be dominated by clinical less important events. To address this limitation, win ratio has been proposed and applied in design and analysis of some high-profile clinical trials. However, win ratio has not been applied in the observational studies since it is a univariate approach that is unable to control for confounders. Methods This project will propose an adjusted win ratio to address the confounding issue in the observational studies. Below are the specific objectives of this project.
We will perform the statistical computing using the R package, WINS, available on the Comprehensive R Archive Network. Expected Results The following results are expected:
Conclusion Adjusted win ratio can provide alternative measurements of exposure effect for a composite outcome in observational studies. In addition, the IPCW-adjusted win ratio is effective at controlling for baseline characteristics imbalances in clinical trials and confounding factors in the observational studies. |
Where does the project lie on the Translational Pathway? |
T2 Human / Clinical Research T3 Evidence into Practice T4 Practice to Policy / Population |
Expected Outputs |
1. Adjusted win ratio using inverse-probability-of-weighting (IPW) via propensity score. 2. Application of adjusted win ratio in the analysis of composite outcome in clinical trials. 3. Application of adjusted win ratio in the analysis of composite outcome in observational studies. |
Training Opportunities |
1. Design and analysis of clinical research 2. Advanced statistical methods and their applications in clinical research 3. Advanced SAS programming for data analysis |
Skills Required |
The ideal candidate should have: (1) MSc in Medical statistics or related subject; (2) Some experience in design and analysis of clinical trials and complex datasets; (3) Good command of at least one statistical packages such as STATA/R/SAS; (4) Some experience of writing academic reports; (5) Excellent communication skills; and (6) Knowledge of clinical trials methodology, medical statistics and epidemiology. |
Key Publications associated with this project |
Pocock SJ, Ariti CA, Collier TJ, Wang D. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J. 2012 Jan;33(2):176-82. |
Wang D, Pocock S. A win ratio approach to comparing continuous non-normal outcomes in clinical trials. Pharm Stat. 2016 May;15(3):238-45. |
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Dong G, Qiu J, Wang D, Vandemeulebroecke M. The stratified win ratio. J Biopharm Stat. 2018;28(4):778-796. |
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Dong G, Huang B, Wang D, Verbeeck J, Wang J, Hoaglin DC. Adjusting win statistics for dependent censoring. Pharm Stat. 2021 May;20(3):440-450. |
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Dong G, Huang B, Verbeeck J, Cui Y, Song J, Gamalo-Siebers M, Wang D, Hoaglin DC, Seifu Y, Mütze T, Kolassa J. Win statistics (win ratio, win odds, and net benefit) can complement one another to show the strength of the treatment effect on time-to-event outcomes. Pharm Stat. 2022 Jun 27. |