- Vaccines, Blood & Biologics
- Devices and Radiologic Health
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 Operations Center posted this final draft protocol for public comment from June 19, 2020 through July 6, 2020. Any revisions done to this protocol following the public comment period will be noted in the change log document included in the amended protocol. Posting of the revised document will be listed on the Sentinel homepage, on the relevant assessments project details page, and in the Sentinel RSS feed.
This presentation, Hydrochlorothiazide Use and Risk of Non-Melanoma Skin Cancer, was delivered at the Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania.
The purpose of this project is to describe the natural history of coagulopathy among COVID-19 patients in the inpatient setting. Activities will include development of a study synopsis for a descriptive study of coagulopathy among hospitalized COVID-19 patients, as well as assessment of feasibility of study implementation within inpatient settings. SOC is partnering with leading infectious disease and hematology specialists on this activity.
A distributed data network approach combined with distributed regression analysis (DRA) can reduce the risk of disclosing sensitive individual and institutional information in multicenter studies. However, software that facilitates large-scale and efficient implementation of DRA is limited. This study aimed to assess the precision and operational performance of a DRA application comprising a SAS-based DRA package and a file transfer workflow developed within the open-source distributed networking software PopMedNet in a horizontally partitioned distributed data network.
The purpose of this project is to design and implement a system that enables rapid querying of electronic health record (EHR) data to support FDA's COVID-19 response. The project will partner with TriNetX to provide access to the TriNetX querying platform and TriNetX Live™ data network. On average 85% of the 60 U.S. healthcare organizations (HCOs) in the TriNetX Live™ data network refresh their data every two-to-four weeks.
The COVID-19 Natural History Master Protocol effort involves the development of a protocol designed to identify multiple COVID-19 cohorts to support a variety of on-demand queries and subsequent inferential studies. The protocol will be adaptable to various data sources with clinically rich data and will include specific populations of interest, such as the pediatric population, pregnant women, and other vulnerable populations identified by FDA.
The FDA is interested in identifying other International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes in the patient episode profile retrieval (PEPR) claims profiles from the Stillbirth Validation project and evaluate whether they can inform further refinement of the algorithm used in that project.
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 Alzheimer's disease, epilepsy in the emergency department care setting, and epilepsy in the inpatient care setting.
This activity supports investigators of COVID-19 related drug trials that need a digital platform for patient informed consent when face to face contact is not possible or practical. The COVID MyStudies application allows for secure and remote electronic consent. The end product is a signed consent form emailed to the patient or legally authorized representative and a copy which the investigator can access in a secure and compliant manner through the platform. The investigator can print the form or transfer an electronic copy into another electronic system. Under the FDA-Catalyst program, the Sentinel Operations Center will coordinate the branding and administration of this application.
The goal of this project is to conduct algorithm validation using diagnosis codes to identify potential hospitalized COVID-19 cases and validate the algorithm(s) using laboratory test results.
This presentation was delivered to the Reagan-Udall Foundation by representatives from the FDA, TriNetX, and Sentinel Operations Center.
FDA’s Sentinel System is engaged in numerous activities to protect and promote public health during the COVID-19 pandemic, ranging from monitoring the use of drugs, describing the course of illness among hospitalized patients, and evaluating the treatment impact of therapies actively being used under real-world conditions. Descriptions of efforts led by the Center for Drug Evaluation and Research are detailed in the link below.
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.
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.