Work

Validation of Acute Myocardial Infarction (AMI) in the FDA’s Mini-Sentinel Distributed Database

Year: 2020

Type: article

Abstract: The Food and Drug Administration’s (FDA) Mini-Sentinel is a pilot program that aims to conduct active surveillance to detect and refine safety signals that emerge for marketed medical products. The purpose of this Mini-Sentinel AMI Validation project was to: (a) develop and design an abstraction and adjudication process to use when full text medical record review is required to confirm a coded diagnosis; and (b) to test this approach by validating a code algorithm for acute myocardial infarction (AMI).

Source: eScholarship@UMassChan

DOI: 10.13028/p3ce-8e74

Authors: Cutrona, Sarah L., Toh, Darren, Iyer, Aarthi, Foy, Sarah, Cavagnaro, Elizabeth, Forrow, Susan, Goldberg, Robert J., Gurwitz, Jerry H.

Language: English

Topic: Pharmacovigilance and Adverse Drug Reactions

Subfield: Toxicology

Field: Pharmacology, Toxicology and Pharmaceutics

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: green

OpenAlex ID: W1521919917

FWCI:

Cites:

Cited by: 1

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