Developing a Standardized and Reusable Method to Link Distributed Health Plan Databases to the National Death Index: Methods Development Study Protocol.

Robert Ball,Wei Hua,Jea Young Min,Jessica Young,Katelyn King,Sengwee Toh,Candace C Fuller ,Cheryl N Mcmahill‐Walraven ,Andrew B Petrone ,Ingrid A Binswanger ,Margaret A Adgent ,Pamala A Pawloski ,Laura Shockro ,Ryan M Carnahan ,Charles E Leonard ,Denise M Boudreau ,Sarah K Dutcher ,Andrew D Mosholder ,Marie R Griffin ,Jennifer L Kuntz ,Robert Rosofsky

doi:10.2196/21811

Abstract

BackgroundCertain medications may increase the risk of death or death from specific causes (eg, sudden cardiac death), but these risks may not be identified in premarket randomized trials. Having the capacity to examine death in postmarket safety surveillance activities is important to the US Food and Drug Administration’s (FDA) mission to protect public health. Distributed networks of electronic health plan databases used by the FDA to conduct multicenter research or medical product safety surveillance studies often do not systematically include death or cause-of-death information.ObjectiveThis study aims to develop reusable, generalizable methods for linking multiple health plan databases with the Centers for Disease Control and Prevention’s National Death Index Plus (NDI+) data.MethodsWe will develop efficient administrative workflows to facilitate multicenter institutional review board (IRB) review and approval within a distributed network of 6 health plans. The study will create a distributed NDI+ linkage process that avoids sharing of identifiable patient information between health plans or with a central coordinating center. We will develop standardized criteria for selecting and retaining NDI+ matches and methods for harmonizing linked information across multiple health plans. We will test our processes within a use case comprising users and nonusers of antiarrhythmic medications.ResultsWe will use the linked health plan and NDI+ data sets to estimate the incidences and incidence rates of mortality and specific causes of death within the study use case and compare the results with reported estimates. These comparisons provide an opportunity to assess the performance of the developed NDI+ linkage approach and lessons for future studies requiring NDI+ linkage in distributed database settings. This study is approved by the IRB at Harvard Pilgrim Health Care in Boston, MA. Results will be presented to the FDA at academic conferences and published in peer-reviewed journals.ConclusionsThis study will develop and test a reusable distributed NDI+ linkage approach with the goal of providing tested NDI+ linkage methods for use in future studies within distributed data networks. Having standardized and reusable methods for systematically obtaining death and cause-of-death information from NDI+ would enhance the FDA’s ability to assess mortality-related safety questions in the postmarket, real-world setting.International Registered Report Identifier (IRRID)DERR1-10.2196/21811

Highlights

Public Health Significance and Study MotivationCertain medications may increase the risk of death and specific causes of death, but these risks may not be identified in premarket randomized controlled trials owing to the relatively small sample sizes and the highly selected patient populations in these trials
We will use the linked health plan and National Death Index (NDI)+ data sets to estimate the incidences and incidence rates of mortality and specific causes of death within the study use case and compare the results with reported estimates. These comparisons provide an opportunity to assess the performance of the developed NDI+ linkage approach and lessons for future studies requiring NDI+ linkage in distributed database settings
This study is approved by the institutional review board (IRB) at Harvard Pilgrim Health Care in Boston, MA

Summary

Introduction

Public Health Significance and Study MotivationCertain medications may increase the risk of death and specific causes of death (eg, sudden cardiac death [SCD]), but these risks may not be identified in premarket randomized controlled trials owing to the relatively small sample sizes and the highly selected patient populations in these trials. The capacity to examine the risk of death in postmarket safety surveillance activities is an important part of the US Food and Drug Administration’s (FDA) mission to protect public health. The FDA’s Sentinel System [7,8] includes a distributed network of electronic health plan databases. The health plans that participate in the Sentinel System or other multicenter research networks routinely capture data on in-hospital deaths and medically attended deaths but often do not have complete capture of out-of-hospital deaths or cause-of-death information. Having the capacity to examine death in postmarket safety surveillance activities is important to the US Food and Drug Administration’s (FDA) mission to protect public health. Distributed networks of electronic health plan databases used by the FDA to conduct multicenter research or medical product safety surveillance studies often do not systematically include death or cause-of-death information

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