Characterization of Confounding Covariate Data Capture in the U.S. Food and Drug Administration’s Sentinel Distributed Database

The Sentinel Distributed Database (SDD) comprises mainly United States (U.S.) administrative claims data provided by Data Partners (health insurance providers, healthcare systems, academic medical centers). However, a known limitation of claims data is its inadequate capture of key common confounding covariates, which could lead to biased study estimates potentially negatively impacting the validity of study findings.

This poster describes a study that evaluates the capture of selected confounding covariates, including vitals data, in the SDD over time, by assessing their incidence and prevalence. It was presented at the 2025 ISPE Annual Meeting.