Statistical Methods for Electronic Medical Records: A New Frontier in Health Care Research

• Activity Number: 631
• Type: Topic Contributed
• Date/Time: Thursday, August 13, 2015 : 8:30 AM to 10:20 AM
• Sponsor: Section on Statistics in Epidemiology
• Author(s): Jennifer Clark Nelson*
• Companies: Group Health Research Institute
• Keywords: data analytics ; health care data ; health policy ; safety surveillance ; sequential testing

Abstract

Gaps in post-licensure drug and vaccine safety evidence have spurred the development of new national systems that prospectively monitor large observational cohorts of health plan enrollees. These multi-site systems, which include CDC's Vaccine Safety Datalink (VSD) and FDA's Sentinel Initiative, attempt to leverage the vast amount of administrative and clinical information that is captured during the course of routine medical care in health plan databases. One method that has been used in this context to rapidly detect increases in adverse event risk after the introduction of a new vaccine or drug is sequential testing. However, many challenges arise when adapting sequential methods to this setting. We will give an overview of the VSD and Sentinel Initiative and the role of statisticians in these efforts. We will illustrate some of the design and analysis complications that arise in this setting using example data from a VSD safety study. These include confounding, rare adverse event outcomes, and an inability to pool individual level data across the multiple health plan sites. Last, we will introduce a new group sequential approach designed to address these challenges.