Alternative analytic and matching approaches for the prevalent new-user design: A simulation study.

PURPOSE: To describe the creation of prevalent new user (PNU) cohorts and compare the relative bias and computational efficiency of several alternative analytic and matching approaches in PNU studies. METHODS: In a simulated cohort, we estimated the effect of a treatment of interest vs a comparator among those who switched to the treatment of interest using the originally proposed time-conditional propensity score (TCPS) matching, standardized morbidity ratio weighting (SMRW), disease risk scores (DRS), and several alternative propensity score matching approaches. For each analytic method, we compared the average RR (across 2000 replicates) to the known risk ratio (RR) of 1.00. RESULTS: SMRW and DRS yielded unbiased results (RR = 0.998 and 0.997, respectively). TCPS matching with replacement was also unbiased (RR = 0.999). TCPS matching without replacement was unbiased when matches were identified starting with patients with the shortest treatment history as initially proposed (RR = 0.999), but it resulted in very slight bias (RR = 0.983) when starting with patients with the longest treatment history. Similarly, creating a match pool without replacement starting with patients with the shortest treatment history yielded an unbiased estimate (RR = 0.997), but matching with the longest treatment history first resulted in substantial bias (RR = 0.903). The most biased strategy was matching after selecting one random comparator observation per individual that continued on the comparator (RR = 0.802). CONCLUSIONS: Multiple analytic methods can estimate treatment effects without bias in a PNU cohort. Still, researchers should be wary of introducing bias when selecting controls for complex matching strategies beyond the initially proposed TCPS.