Health insurance claims data currently form the backbone of the Sentinel Distributed Database (SDD), owing to their complete capture of outpatient pharmacy dispensing records, medical encounters, and hospitalizations during well-defined periods of health plan enrollment. However, due to limitations inherent to claims data, Sentinel’s Active Risk Identification and Analysis (ARIA) system is, at times, deemed insufficient to address a regulatory question of interest, e.g., due to the lack of granular clinical information available.
In an effort to minimize this occurrence and enhance the SDD, the Sentinel Innovation Center (IC) has undertaken efforts to establish a query-ready, quality-checked distributed data network linking longitudinal electronic health records (EHRs) with claims data for 21 million patients from two large commercial data assets, HealthVerity and TriNetX.
This project aims to build on these previous efforts via the following aims:
- Aim 1: For a selection of health outcomes of interest for which typical ARIA analyses were previously determined to be insufficient due to poor outcome identification, conduct fitness-for-purpose (FFP) analyses and make recommendations regarding the likelihood of successful development of computable phenotype algorithms by incorporating rich EHR data and data-driven modeling methods (using data from the EHR-claims linked system).
- Aim 2: Identify at least one relevant use case to conduct protocol-based pharmacoepidemiologic analyses to evaluate the complexities encountered and propose solutions for typical ARIA analyses that will be handled by this EHR-claims linked system.
This Sentinel Innovation Center (IC) project is led by Kaiser Permanente Washington Health Research Institute and Mass General Brigham, in collaboration with the Harvard Pilgrim Health Care Institute and Harvard Medical School. This project will utilize data sets prepared by two commercial Data Partners, HealthVerity and TriNetX.
Rishi Desai, MS, PhD; Janick Weberpals, PhD; Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA
Sascha Dublin, MD, PhD; Kaiser Permanente Washington Health Research Institute, Seattle, WA
Jose J. Hernandez, RPh, MPH, MSc, PhD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD
Mukund Desibhatla, MPH; Christine Draper; Rebecca Hawrusik, MS; Daniel Kiernan; Jennifer Lyons, PhD, MPH; Meighan Rogers Driscoll, MPH; Ryan Schoeplein, MPH; Darren Toh, ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Adebola Ajao, PhD, MPH; Robert Ball, MD, MPH; Patricia Bright, PhD, MSPH; Rhoda Eniafe, MHA, MT(ASCP); Monique Falconer, MD, MS; Chanelle Jones, MHA, CPhT; Jamal T. Jones, PhD, MPH; Terrence Lee, PhD, MPH; Jie (Jenni) Li, PhD; Fatma Shebl, MD, PhD, MS; Mingfeng Zhang, MD, PhD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD
Haritha Pillai, MPH; Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA
David S. Carrell, PhD; David Cronkite; Nicole M. Gatto, PhD, MPH; Linda Kiel, MA; Jennifer C. Nelson, PhD; Paige D. Wartko, PhD, MPH; Kaiser Permanente Washington Health Research Institute, Seattle, WA
James S. Floyd, MD, MS; Departments of Medicine and Epidemiology, University of Washington, Seattle, WA
Jeffrey Brown, PhD; John Doole, PharmD, MFA; Jeffrey Graham, BS; Sapna Rajupet; Mike Swartzsbaugh; TriNetX, Cambridge, MA
Rick Edwards; Daniel Glazier; Tracy Hammonds; Jason Meyer; HealthVerity, Philadelphia, PA
Mark Khayter, MS; Don Torok, MS; Ephir, Boston, MA