Vaccine Safety Surveillance Using Routinely Collected Healthcare Data-An Empirical Evaluation of Epidemiological Designs.

ABSTRACT: Background: Routinely collected healthcare data such as administrative claims and electronic health records (EHR) can complement clinical trials and spontaneous reports to detect previously unknown risks of vaccines, but uncertainty remains about the behavior of alternative epidemiologic designs to detect and declare a true risk early. Methods: Using three claims and one EHR database, we evaluate several variants of the case-control, comparative cohort, historical comparator, and self-controlled designs against historical vaccinations using real negative control outcomes (outcomes with no evidence to suggest that they could be caused by the vaccines) and simulated positive control outcomes. Results: Most methods show large type 1 error, often identifying false positive

SUBMITTER: Schuemie MJ 

PROVIDER: S-EPMC9299244 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature