- Vaccines, Blood & Biologics
- Devices and Radiologic Health
The Sentinel Operations Center and the Center for Pharmacoepidemiology Research and Training at the University of Pennsylvania’s Perelman School of Medicine are hosting a free one-day training on Sentinel’s Cohort Identification and Descriptive Analysis (CIDA) tool, which will take place the day after the 35th International Conference on Pharmacoepidemiology & Therapeutic Risk Management.
This project informed appropriate use of the PSM tool within the ARIA system for a one-time (non-sequential) data analysis via rigorous demonstration of relative performance under numerous simulated circumstances similar to real-world safety analyses. The project also assesses other related PS methods that could expand the functionality of the existing PSM tool by adding PS stratification, regression, and inverse-probability weighting methods. The goal of this project is to describe the statistical and epidemiological performance of these PS-based methods under conditions likely to be encountered by the ARIA system so that end-users will be able to optimize the tools’ use.
This article evaluated the positive predictive value (PPV) of ICD-9 codes for post-vaccination febrile seizures to identify optimal algorithms for use in post-market safety surveillance.
This paper reviews sequential methods designed for observational safety monitoring that use the whole exposed and unexposed cohort by implementing regression or weighting to control confounding.
This analysis investigates the risk of non-melanoma skin cancer for patients treated with hydrochlorothiazide-containing products compared to non-hydroclorothiazide angiotensin-converting-enzyme inhibitor (ACEI)-containing products, including captopril, enalapril maleate, and lisinopril monotherapies and combination therapies in the Sentinel Distributed Database. The Level 2 analytic package for this analysis is now publicly available in the Sentinel Git repository.
This analysis estimates the rates of valsartan (contaminated and uncontaminated with N-nitrosodimethylamine (NDMA) or N-nitrosodiethylamine (NDEA)), angiotensin II receptor blocker (ARB), and angiotensin-converting enzyme (ACE) inhibitor use in the Sentinel Distributed Database (SDD).
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.
The documentation, appendices, and SAS programs associated with version 5.0.1 of the Sentinel Data Quality Review and Characterization Programs can be found externally in Sentinel's Git Repository.
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.
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.