This project includes implementing several enhancements to the FDA-Catalyst MyStudies app to improve its usability and facilitate collection of detailed information. The work will also include implementation of the app to facilitate collection of patient-reported data for up to two Patient-Centered Outcomes Research Institute (PCORI) pragmatic trials and one PCORI registry selected by the FDA.
The goal of this query was to estimate phosphodiesterase type 5 (PDE5) inhibitor utilization among women in the Sentinel Distributed Database (SDD).
The Eleventh Annual Sentinel Initiative Public Workshop will be held on Wednesday, April 3, 2019. Convened by the Duke-Margolis Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this annual workshop serves as a forum to bring together leading experts and interested stakeholders to discuss the ongoing development of the Sentinel Initiative.
The goal of this pilot project is to develop a draft framework to use machine learning and natural language processing (NLP) techniques to improve health outcome of interest (HOI) detection algorithms that may later be used in the larger Sentinel Distributed Database.
This publication sought to determine whether the risk for VTE is higher with use of continuous/extended combined oral contraceptives than with cyclic combined oral contraceptives among women who initiated a combined oral contraceptives containing ethinyl estradiol and levonorgestrel.
The 34th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE) was held August 22-26, 2017, in Prague, Czech Republic. A variety of Sentinel-related work was featured, including presentations, posters, and more. These materials are now available in the Publications and Presentations section of the website.
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).
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:
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.