Table 1.
Overview of the four strategies of dealing with treatment initation after baseline
| Strategy | Estimand | Example | Estimators | Key assumptions |
|---|---|---|---|---|
| Ignore treatment | Risk of the event, regardless of treatment | Risk of cardiovascular events where some patients will initiate statins according to routine-care prescriptions | Survival model for T, do not censor at V | Treatment assignment policy in application setting similar to development data |
| Composite | Risk of the event or treatment initiation | Risk of a composite of cardiovascular death, myocardial infarction and treatment with revascularisation (PCI or CABG) | Survival model for min(T, V) | Treatment assignment policy in application setting similar to development data |
| While untreated | Risk of the event occurring before treatment is started | Risk of dying while on the waiting list for a liver transplant | Competing risks methods | Treatment assignment policy in application setting similar to development data |
| Hypothetical | Risk of the event if treatment were never started | Risk of a natural pregnancy without IVF treatment | Survival model for T, censor at V or include treatment as time-dependent covariate in the model and set to 0 when predicting | Exchangeability, consistency and positivity |
T time to event of interest; V time to start of treatment; PCI percutaneous coronary intervention; CABG coronary artery bypass grafting; IVF in vitro fertilization