Background: Observational studies are increasingly being used in medicine to estimate the effects of treatments or exposures on outcomes. To minimize the potential for confounding when estimating treatment effects, propensity score methods are frequently implemented. Often outcomes are the time to occurrence of an event. While it is common to report the treatment effect in terms of a relative effect, such as the hazard ratio, reporting the effect using an absolute measure of effect is also important. One commonly used absolute measure of effect is the risk difference or difference in probability of the occurrence of an event within a specified duration of follow-up between a treatment and comparison group.
Objectives: Evaluate methods for point and variance estimation of the risk difference when using weighting or matching based on the propensity score when outcomes are time-to-event in nature.
Methods: We conducted Monte Carlo simulations to compare the relative performance of these methods with respect to bias of the point estimate, accuracy of variance estimates, and coverage of estimated confidence intervals.
Results: The results of the simulation generally support the use of weighting methods (untrimmed ATT weights and IPTW) or caliper matching when the prevalence of treatment is low for point estimation. For standard error estimation the simulation results support the use of weighted robust standard errors, bootstrap methods, or matching with a naïve standard error (i.e., Greenwood method).
Conclusions: The methods that performed best in the simulations are recommended for use in pharmacoepidemiology studies.