Pilot Test of Vital Signs and Laboratory Results Table Descriptive Modules in the Sentinel Distributed Database

The proposed goal of this project was to pilot, via two use cases, the ability to more routinely and broadly understand how FDA might conduct “on-demand quality assurance” for selected vital signs and laboratory results in a within cohort fashion. The first use case evaluated a cohort of pediatric patients with hypertension. The second use case evaluated a cohort of new adult users of sodium-glucose co-transporter-2 (SGLT-2) inhibitors.

Vital signs and laboratory measures were evaluated for each use case. Measures included blood pressure as well as smoking use/status, height, and weight. Laboratory tests included Hemoglobin A1c and creatinine.

A comparison of the identification using a claims-only phenotype versus a clinical data (e.g., electronic health record based) phenotype was conducted. Two reports are posted from the first use case that evaluated a cohort of pediatric patients with hypertension. In the first report, the hypertension algorithm is simplified. The second report utilized a more complex hypertension algorithm to define events of interest. Two reports are posted from the second use case that evaluated counts of individuals with SGLT-2 inhibitor and sitagliptin dispensings in the Sentinel Distributed Database (SDD) along with baseline conditions and other medication use. The first report did not include integrated delivery systems data in the analysis; the second report only included integrated delivery systems data in the analysis.