This webinar hosted by the International Society for Pharmacoepidemiology will describe new methods and tools developed in FDA’s multisite Sentinel System that allow for the evaluation of medication safety in pregnancy.
Date: Friday, November 30, 2018
Time: 10:00 - 11:00am EDT
Mortality data within the Sentinel Death Tables remain generally uncharacterized. Assessment of mortality data within Sentinel will help inform its utility for medical product safety studies.
The purpose of this pilot project was to develop a generalizable mobile device application that can be used to collect data from patients in real-time and link it to existing electronic health data.
The Mother-Infant Linkage (MIL) Table was added to the Sentinel Common Data Model (SCDM) in October 2018.
This enhancement was added to enable routine evaluation of medical product exposures during pregnancy on outcomes in infants. To facilitate linkage, Sentinel Operations Center has developed a reusable program package to identify mothers and infants in the Sentinel Distributed Database. The Quality Assurance program evaluates whether the data in the table conforms to SCDM specifications, and it identifies anomalies that require further investigation or explanation (e.g., relatively high multiple-birth rate compared to national average).
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 2019 Sentinel Public Training, Day 2 of the Eleventh Annual Sentinel Initiative Public Workshop, will focus on enabling expanded use of Sentinel tools among the public. The training will consist of a series of presentations and exercises on the Cohort Identification and Descriptive Analysis (CIDA) tool.
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.
This public workshop will explore opportunities to implement signal detection capabilities in the Sentinel System. Stakeholder input received at this workshop will further inform the FDA’s thinking around these priority issues and support strategic planning in the Sentinel System.
Workshop will be held:
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.
The Sentinel Data Quality Review and Characterization Programs are used by the Sentinel Operations Center (SOC) for data quality review and characterization of the Sentinel Distributed Database (SDD). To create the SDD, each Data Partner transformed local source data into the Sentinel Common Data Model (SCDM) format. The SOC created a set of data quality review and characterization programs to ensure that the SDD meets reasonable standards for data transformation consistency and quality and that the SDD data meets expectations needed for a distributed health data network.