The authors of this article describe and review the use of data enclaves for sharing information derived from clinical and administrative data.
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The aims of this methods project are to develop and evaluate candidate global propensity scores for application with the propensity score cohort matched design and tree-based scan statistics. The examples used in this project are for methods development purposes and are not part of a regulatory evaluation of any medical product or safety issue.
The Inpatient Encounter Querying Tool focuses on evaluating what happens during inpatient encounters, and it is primarily designed to query electronic health record (EHR)-based Data Partners. This tool allows users to:
To examine the Sentinel System, a distributed data network of health plans, as a source for influenza surveillance, the authors compared trends in outpatient prescription dispensings of influenza antivirals in Sentinel to trends in the Centers for Disease Control and Prevention's ILINet and NREVSS systems over five seasons.
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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:
Building on the expert workshop, this public webinar featured key leaders of the Sentinel System who provided insight into the specific challenges surrounding ARIA insufficiency, and highlighted key approaches being explored in collaboration with the Sentinel Data Partners to improve outcome validation activities.
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) 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 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.