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. 2020 Nov 2;9(11):e21811.
doi: 10.2196/21811.

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

Candace C Fuller  1 , Wei Hua  2 , Charles E Leonard  3 , Andrew Mosholder  2 , Ryan Carnahan  4 , Sarah Dutcher  2 , Katelyn King  1 , Andrew B Petrone  1 , Robert Rosofsky  5 , Laura A Shockro  1 , Jessica Young  1 , Jea Young Min  6 , Ingrid Binswanger  7 , Denise Boudreau  8 , Marie R Griffin  6 , Margaret A Adgent  6 , Jennifer Kuntz  9 , Cheryl McMahill-Walraven  10 , Pamala A Pawloski  11 , Robert Ball  2 , Sengwee Toh  1
Affiliations

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

Candace C Fuller et al. JMIR Res Protoc. .

Abstract

Background: Certain 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.

Objective: This 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.

Methods: We 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.

Results: We 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.

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 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.

Keywords: National Death Index; all-cause mortality; cause specific mortality; data linkage; distributed analysis; multisite research.

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Conflict of interest statement

Conflicts of Interest: CEL serves on the Executive Committee of the University of Pennsylvania's Center for Pharmacoepidemiology Research and Training. The Center receives funds for education from Pfizer and Sanofi. He recently received honoraria from the American College of Clinical Pharmacy Research Institute and the University of Florida College of Pharmacy. CEL's research is funded by the American Diabetes Association, Food and Drug Administration, and National Institutes of Health. CEL is a Special Government Employee of the Food and Drug Administration.

Figures

Figure 1
Figure 1
Overview of study questions and anticipated contributions. NDI: National Death Index; IRB: Institutional Review Board; PHI: Protected Health Information.
Figure 2
Figure 2
Overview of the distributed National Death Index data linkage process. NDI: National Death Index; PHI: Protected Health Information.
See this image and copyright information in PMC

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References

    1. Questions and Answers on FDA's Adverse Event Reporting System (FAERS) US Food and Drug Administration. 2018. [2018-03-28]. https://www.fda.gov/drugs/surveillance/questions-and-answers-fdas-advers....
    1. Colman E, Szarfman A, Wyeth J, Mosholder A, Jillapalli D, Levine J, Avigan M. An evaluation of a data mining signal for amyotrophic lateral sclerosis and statins detected in FDA's spontaneous adverse event reporting system. Pharmacoepidemiol Drug Saf. 2008 Nov;17(11):1068–76. doi: 10.1002/pds.1643. - DOI - PubMed
    1. Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: The importance of reporting suspected reactions. Arch Intern Med. 2005 Jun 27;165(12):1363–9. doi: 10.1001/archinte.165.12.1363. - DOI - PubMed
    1. Wong CK, Ho SS, Saini B, Hibbs DE, Fois RA. Standardisation of the FAERS database: a systematic approach to manually recoding drug name variants. Pharmacoepidemiol Drug Saf. 2015 Jul;24(7):731–7. doi: 10.1002/pds.3805. - DOI - PubMed
    1. Moore TJ, Cohen MR, Furberg CD. Serious adverse drug events reported to the food and drug administration, 1998-2005. Arch Intern Med. 2007 Sep 10;167(16):1752–9. doi: 10.1001/archinte.167.16.1752. - DOI - PubMed

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