JMIR Publications

ABSTRACT

Background:

Certain medications may increase the risk of death or death from specific causes (e.g., sudden cardiac death [SCD]), but these risks may not be identified in pre-market randomized trials. Having the capacity to examine death in post-market safety surveillance activities is important to the United States Food and Drug Administration (FDA)’s mission to protect public health. Distributed networks of electronic health plan databases used by the FDA to conduct multi-center research or medical product safety surveillance studies often do not systematically include death or cause of death information.

Objective:

This study will 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.

Methods:

We will develop efficient administrative workflows to facilitate multi-center Institutional Review Board (IRB) review and approval within a distributed network of six 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 non-users of antiarrhythmic medications.

Results:

We will use the linked health plan and NDI+ datasets to estimate the incidences and incidence rates of mortality and specific causes of death within the study use case and compare the results to 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 was approved by the Institutional Review Board at Harvard Pilgrim Health Care in Boston, Massachusetts. Results will be presented to the FDA, at academic conferences, and published in peer-reviewed journals.

Conclusions:

This 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 FDA’s ability to assess mortality-related safety questions in the post-market, real-world setting.