The study aims at developing a Bayesian alternative procedure to improve the performance of vaccine safety surveillance. Empirical evaluations based on large-scale observational healthcare databases are conducted to compare the proposed procedure against the state-of-art approach, MaxSPRT, with testing-oriented and estimation-oriented metrics.
These results are being shared as part of OHDSI's open science community efforts. Until final publication, all results are to be considered preliminary and subject to change, and may only be used under the terms of use of the respective data partner contributors.
Manuscript preprint is available at [LINK PENDING]
To view results:
Testing metrics
for results on Type 1 error rates, statistical power, and time-to-signal.Estimation metrics
for comparisons on estimation accuracy and quality, with mean squared errors (MSEs) and coverage rates of 95% CIs.Database information
and Vaccine information
for details on databases and vaccine exposures.Resources:
Disclosures:
This study is performed under the collaborative contract between OHDSI and FDA CBER BEST.
Authors of this work received funding from the US National Institutes of Health and the US Food & Drug Administration and contracts from the US Department of Veterans Affairs and Janssen Research and Development.