Factors Influencing Background Incidence Rate Calculation: Systematic Empirical Evaluation Across an International Network of Observational Databases.

ABSTRACT: Objective: Background incidence rates are routinely used in safety studies to evaluate an association of an exposure and outcome. Systematic research on sensitivity of rates to the choice of the study parameters is lacking. Materials and Methods: We used 12 data sources to systematically examine the influence of age, race, sex, database, time-at-risk, season and year, prior observation and clean window on incidence rates using 15 adverse events of special interest for COVID-19 vaccines as an example. For binary comparisons we calculated incidence rate ratios and performed random-effect meta-analysis. Results: We observed a wide variation of background rates that goes well beyond age and database effects previously observed. While rates vary up to a factor of 1,000 acro

SUBMITTER: Ostropolets A 

PROVIDER: S-EPMC9087898 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature