- Vaccines, Blood & Biologics
- Devices and Radiologic Health
In collaboration with the Office of Medical Policy (OMP) at U.S. Food and Drug Administration (FDA), the Sentinel Operations Center (SOC) will work with the Department of Population Health Sciences (DPHS) at the Duke University School of Medicine to link patients enrolled in the (Patient-Centered Outcomes Research Institute) PCORI RELIANCE trial to traditional fee-for-service Medicare data.
An individually randomized trial of a patient and provider level educational intervention to increase anticoagulant use among untreated members with atrial fibrillation and increased risk of stroke (i.e. CHA2DS2-VASc score ≥2). This project is a proof of concept effort, the first trial conducted using Sentinel Infrastructure, and will inform future interventional studies that are designed to utilize existing healthcare data as part of their design.
This project seeks to add a new table to the Sentinel Common Data Model (SCDM) to capture results from chart validation studies and add data elements to allow for the preservation of medical records that were digitally translated using optical character recognition (OCR) technology.
A general methodological framework for developing improved health outcome of interest identification algorithms in the Sentinel Distributed Databases (SDD) using machine learning and natural language processing (NLP) techniques is being developed for the ongoing Sentinel project, “Validation of Anaphylaxis Using Machine Learning.”
In a plasmode‐based simulation study, the authors compared performance of the standard parametric approach, which ignores uncertainty in propensity score estimation and matching, with two bootstrapping methods.
The purpose of these reports was 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) codes. These health outcomes include endometrial cancer, esophageal cancer, kidney and pelvis cancer, leukemia, lung cancer, and lymphoma.
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 5.0.0 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.