- Vaccines, Blood & Biologics
- Devices and Radiologic Health
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 6.2.0 of the Sentinel Data Quality Review and Characterization Programs can be found externally in Sentinel's Git Repository.
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 U.S. Food and Drug Administration (FDA) is strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair and generics), which is a prescription medicine for asthma and allergy.
This presentation, Hydrochlorothiazide Use and Risk of Non-Melanoma Skin Cancer, was delivered at the Department of Pharmaceutical Outcomes & Policy, College of Pharmacy, University of Florida.
In this report we examined the association between exposure to hydrochlorothiazide (HCTZ)-containing products and incidence of non-melanoma skin cancer (NMSC) in the Sentinel Distributed Database (SDD). We distributed this request to 17 Sentinel Data Partners. The study period included data from January 1, 2000 to August 31, 2018.
The project team, comprised of members from Kaiser Permanente Washington Health Research Institute (KPWHRI), Kaiser Permanente Northern California, Division of Research (KPNC), Kaiser Permanente Southern California (KPSC), Henry Ford Health System (HFHS), and Harvard Pilgrim Health Care Institute (HPHC), proposes a comprehensive program of infrastructure development, methods development, and innovative research to generate real-world evidence of suicide and suicidal ideation in the United States. The goal of this project is to enable a robust future program of research to evaluate the effects of medical products on suicidal ideation and behavior. Specific aims include:
This presentation was delivered at the Use of Real World Data / Evidence to Inform Regulatory Decision Making Workshop hosted by the Canadian Society for Pharmaceutical Sciences. It was delivered during a session on Data Sources and Data Quality – Meeting the Bar for “Fit for Purpose” in Regulatory Decision Making.
This presentation was delivered at the Canadian Mother-Child Cohort (CAMCCO) Active Surveillance 1st Team and Stakeholders Symposium. Topics covered include an overview of the Sentinel system and routine querying tools, an introduction to Cohort Identification and Analysis (CIDA), and the steps involved in conducting pregnancy analyses.
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 Twelfth Annual Sentinel Initiative Public Workshop was originally scheduled for April 20-21, 2020, but has been postponed until further notice.
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.