This paper describes the design and implementation of a fully functional prototype open‐source tool, the Cross‐Network Directory Service (CNDS), which addresses much of what keeps distributed networks disconnected from each other.
This analysis investigates the risk of stroke, gastrointestinal bleeding, and intracranial hemorrhage for patients with non-valvular atrial fibrillation treated with apixaban compared to warfarin in the Sentinel Distributed Database. The Level 2 analytic package for this analysis is now publicly available in the Sentinel Git repository.
The purpose of this manuscript was to develop a flexible analytic tool for the Food and Drug Administration's (FDA's) Sentinel System to assess adherence to safe use recommendations with two capabilities: characterize adherence to patient monitoring recommendations for a drug, and characterize concomitant medication use before, during, and/or after drug therapy.
Neurological complications including seizures have been reported with ranolazine. The authors sought to quantify the risk of seizure-related hospitalizations or emergency department events following ranolazine exposure in the Sentinel System (2006–2015).
Sentinel Initiative Public Workshop
The Eleventh Annual Sentinel Initiative Public Workshop will be held on Wednesday, April 3, 2019. Convened by the Duke-Margolis Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this annual workshop serves as a forum to bring together leading experts and interested stakeholders to discuss the ongoing development of the Sentinel Initiative.
Public Sentinel Training at FDA
The 2019 Sentinel Public Training, Day 2 of the Eleventh Annual Sentinel Initiative Public Workshop will be held on April 4, 2019. The Training will focus on enabling expanded use of Sentinel tools among the public and will consist of a series of presentations and exercises on the Cohort Identification and Descriptive Analysis (CIDA) tool.
International Regulator’s Forum
The U.S. Food and Drug Administration (FDA) will be hosting a forum on April 5, 2019 on the Sentinel System for other regulatory agencies immediately following the two-day Sentinel Annual Meeting. This is a forum designed for staff from regulatory agencies worldwide: it is a meeting by regulators, for fellow regulators.
The FDA Sentinel Initiative and the Kaiser Permanente Center for Health Research are hosting a free one-day training on Sentinel’s Cohort Identification and Descriptive Analysis (CIDA) tool.
To lay out the major goals associated with the future of the Sentinel System and FDA Catalyst, the FDA has released the Sentinel System Five-Year Strategy: 2019-2023. This plan is intended to serve as a roadmap to guide the development of the Sentinel System between 2019 and 2023.
In this article, FDA Commissioner Scott Gottlieb and Office of Surveillance and Epidemiology Director Gerald Dal Pan describe how Sentinel has become an integral part of FDA's safety monitoring efforts and announce new steps that the Agency is taking to make Sentinel more robust.
Sentinel routine querying tools are SAS programs designed to run against the Sentinel Common Data Model (SCDM). They allow rapid implementation of standard queries across the Sentinel Distributed Database (SDD). The programs can be customized using various input parameters that define medical product exposures, outcomes, covariates, diagnoses, date ranges, age ranges, and other implementation details. Tools can perform simple cohort characterization and descriptive analyses, but may also be used to perform more complex adjustment for confounding and support prospective surveillance activities.
The Cohort Identification and Descriptive Analysis (CIDA) program is the foundation of the routine querying system. CIDA is responsible for identifying, extracting, and characterizing cohorts of interest from the SDD based on the specification of a number of requester-defined options (e.g., continuous enrollment requirements, incidence criteria, inclusion/exclusion criteria).
The Sentinel Operations Center (SOC) coordinates the network of Sentinel Data Partners and leads development of the Sentinel Common Data Model (SCDM), a standard data structure that allows Data Partners to quickly execute distributed programs against local data.
Changes in this release from v6.0.2 to v7.0.0 include a new Mother-Infant Linkage table and are listed in the “History of Modifications” tab of the SCDM v7.0.0 document.
The Sentinel Operations Center (SOC) has transformed the Medicare Claims Synthetic Public Use Files (SynPUFs) into the Sentinel Common Data Model (SCDM) format as part of an ongoing effort to make Sentinel resources available to external investigators, with the goal of creating a community of investigators who can understand, utilize, and contribute to the Sentinel enterprise.