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. 2022 Apr 6;119:106758. doi: 10.1016/j.cct.2022.106758

Table 3.

Summary of high-level results and conclusions comparing the 9 methods.

Methods Summary
Standard Survival Analysis Censor death at the time of death 1a: Cox PH Model Low death Rate
(≤ 5%)
No substantial impact on the statistical inference.
Moderate to severe death rate
(15%–25%)
In general, lower chance to detect the treatment efficacy in the scenario that treatment reduces the death rate.
2a: Log Rank Test
3a: RMST
Censor death at Day 28 1b: Cox PH Model Analogous to competing risk analysis methods for the respective simulation settings.
2b: Log Rank Test
3b: RMST
Competing Risk Analysis 4: Subdistribution Hazard Model Well established survival analysis methods to handle competing risk data.

Incorporating the death effect into consideration for the claim of treatment efficacy on recovery.
5: CIF Chi-square
6: CIF AUC

Method 1a: Cox PH model, censor death at the time of death;

Method 1b: Log rank test, censor death at the time of death;

Method 1c: Test the Restricted Mean Survival Time (RMST) difference, censor death at the time of death;

Method 2a: Cox PH model, censor death at Day 28;

Method 2b: Log rank test, censor death at Day 28;

Method 2c: Test the Restricted Mean Survival Time (RMST) difference, censor death at Day 28;

Method 4: Subdistribution hazard model;

Method 5: Test cumulative incidence function (CIF) difference using a modified log-rank Chi-square test;

Method 6: Test the difference of the area under the cumulative incidence function (CIF) curve.