Bias, Precision and Timeliness of Historical (Background) Rate Comparison Methods for Vaccine Safety Monitoring: An Empirical Multi-Database Analysis

• Main Authors: Xintong Li (Author), Lana YH Lai (Author), Anna Ostropolets (Author), Faaizah Arshad (Author), Eng Hooi Tan (Author), Paula Casajust (Author), Thamir M. Alshammari (Author), Talita Duarte-Salles (Author), Evan P. Minty (Author), Carlos Areia (Author), Nicole Pratt (Author), Patrick B. Ryan (Author), George Hripcsak (Author), Marc A. Suchard (Author), Martijn J. Schuemie (Author), Daniel Prieto-Alhambra (Author)
• Format: Book
• Published: Frontiers Media S.A., 2021-11-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Using real-world data and past vaccination data, we conducted a large-scale experiment to quantify bias, precision and timeliness of different study designs to estimate historical background (expected) compared to post-vaccination (observed) rates of safety events for several vaccines. We used negat...