Details
This project was aim 1 of the overall UC2 project “Empirical Application of the Sentinel EHR and Claims Data Partner Network to Enhance ARIA Sufficient Inferential requests and Atypical Descriptive Requests.”
A key limitation of claims-based analyses is the potential for unmeasured confounding. Common unmeasured factors include information available in other data sources, such as laboratory test results recorded in structured fields of electronic health records (EHRs), or cognitive decline recorded in unstructured physician notes. In this specific aim, granular data from EHRs available through the Sentinel Development Network were used to construct cohorts identical to those used in a prototypical claims-based Active Risk Identification and Analysis (ARIA) inferential query. Extensive characterization of factors unmeasured in claims was provided to summarize the threat to internal validity due to confounding by these factors. The use case selected for this project was comparing initiators of sacubitril-valsartan versus initiators of angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers on the labeled risk of angioedema.
Additional Information
Contributors
Shirley V. Wang, PhD; Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA
Sushama Kattinakere Sreedhara, MBBS, MSPH; Rishi J. Desai, PhD; Haritha Pillai, MPH; Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA
Darren Toh, ScD; Meighan Rogers Driscoll, MPH; MSc; John Connolly, PhD; Anne Vasquez, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Sarah Dutcher, PhD, MS; Youjin Wang, PhD; Jummai Apata, MBBS, DrPH; Fang Tian, PhD; Ikponmwosa Osaghae, MD, PhD, MPH, MHPM; Jiwei He, PhD; Tiffany Austin, MPH; US Food and Drug Administration, Silver Spring, MD