- Vaccines, Blood & Biologics
- Devices and Radiologic Health
This report presents counts of individuals with medical and drug coverage and number of days covered in the Sentinel Distributed Database (SDD). Results were generated using the Sentinel Distributed Query Tool from 2012-2018. The query was distributed on January 2, 2019 and includes data from 17 Data Partners.
The CHA2DS2‐VaSc and HAS‐BLED risk scores are commonly used in the studies of oral anticoagulants (OACs). The best ways to map these scores to the International Classification of Diseases, 10th Revision, Clinical Modification (ICD‐10‐CM) codes is unclear, as is how they perform in various types of OAC users. We aimed to assess the distributions of CHA2DS2‐VaSc and HAS‐BLED scores and C‐statistics for outcome prediction in the ICD‐10‐CM era using different mapping strategies.
Evidence on the risk of febrile seizures after inactivated influenza vaccine (IIV) and 13-valent pneumococcal conjugate vaccine (PCV13) is mixed. In the FDA-sponsored Sentinel Initiative, we examined risk of febrile seizures after IIV and PCV13 in children 6-23 months of age during the 2013-14 and 2014-15 influenza seasons.
The Sentinel Initiative, an active medical product surveillance system, was established in response to the Food and Drug Administration (FDA) Amendments Act of 2007 and has become one of the Agency’s premier evidence generation platforms. The 12th Annual Sentinel Initiative Public Workshop is being convened on April 20-21, 2020 by the Robert J. Margolis, MD, Center for Health Policy under a cooperative agreement with the FDA. The two-day workshop will be held at the Washington Plaza Hotel in Washington, DC and provides an opportunity to discuss recent achievements and engage with the broader community of patients, consumers, and scientific stakeholders.
In this report we estimated the prevalence of penicillin allergy testing in the Sentinel Distributed Database (SDD).
The purpose of these reports were to compare the frequency of diagnoses for several selected health outcomes using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) versus International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis codes. These health outcomes include acute myocardial infarction, angioedema, and diabetes.
We conducted this exploratory analysis to examine stillbirths and the proportion of those stillbirths that had a select 12 prenatal tests recommended during pregnancy. This report contains estimates of utilization of the 12 selected prenatal tests among a population of women with stillbirths in the Sentinel Distributed Database (SDD).
In this report we evaluated concurrent use of ticagrelor (all strength, 60mg, and 90mg) with atorvastatin or rosuvastatin in the Sentinel Distributed Database (SDD).
In this request, we examined the number of checkpoint inhibitor users with a diagnosis of Guillain-Barré syndrome (GBS) or Bell's palsy after drug initiation in the Sentinel Distributed Database (SDD). We also examined the time to GBS or Bell's palsy diagnosis after checkpoint inhibitor initiation among users in the SDD.
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.
The documentation, appendices, and SAS programs associated with version 6.1.0 of the Sentinel Data Quality Review and Characterization Programs can be found externally in Sentinel's Git Repository.
The goals of this methods project are to evaluate the performance of TreeScan to assess maternal and infant outcomes, test signal identification methods in a pregnancy setting, and evaluate methods performance using older drugs with relatively well-characterized safety profiles. A Propensity Score-Based TreeScan approach will be the primary analysis for this project.
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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) module 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 Query Builder is a web application which allows users to visualize, draft, and create medical product utilization queries with a user-friendly interface from a set of pre-defined parameters and convert them into Sentinel query request packages. The Sentinel Query Builder application can now be downloaded onto users' computers.
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 Operations Center and IBM Watson Health have partnered to make SAS® code available for transforming the IBM MarketScan® Commercial and Medicare Supplemental Databases into the Sentinel Common Data Model.
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.