Sentinel System Quarterly Newsletter

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In This Issue:

Multi-Source Observational Safety study for Advanced Information

Classification using Natural Language Processing (MOSAIC-NLP

Learn about Sentinel's

Race and COVID-19

Outcomes Work

Engage With Sentinel:

Sentinel Innovation

and Methods

Seminar Series

Multi-Source Observational Safety study for Advanced Information

Classification using Natural Language Processing (MOSAIC-NLP)

As highlighted in a recent press release, Sentinel ‘s MOSAIC-NLP project is now underway. This project is led by a team at Cerner Enviza (an Oracle company) in collaboration with Harvard Pilgrim Health Care Institute, Mass General Brigham, and John Snow Labs. By developing artificial intelligence (AI) tools that extract critical information from clinical notes within electronic health records (EHR), this project aims to aid the FDA in better understanding the effects of medicines on large populations. This two-year project will use longitudinal data from the Cerner Enviza Electronic Health Records linked to health care claims. One of the main goals is to demonstrate how the use of machine learning and NLP technology with unstructured data may help fill gaps in knowledge by enabling outcome and covariate identification.

The project is also supported by the participation of Children’s Hospital of Orange County, National Jewish Health, and Kaiser Permanente Washington Health Research Institute who will provide clinical expertise and consulting.

Learn about Sentinel's Race and COVID-19 Outcomes Work

In 2022, Sentinel investigators conducted a large study looking at race and COVID-19 outcomes in the first year of the pandemic. The Sentinel System is routinely used to evaluate post-market utilization and safety of regulated medical products as well as post-market benefits of regulated medical products. This study demonstrated that the Sentinel System can be a resource for supporting broader surveillance on health outcomes in the United States.

The study included around 850,000 individuals with COVID-19 and around 130,000 individuals hospitalized with COVID-19 from across the country from April 2020 to March 2021, making it among the largest studies known to date. After controlling for demographic, clinical, and socioeconomic differences at baseline, the results showed that minoritized groups had increased odds for hospitalization and 30-day mortality following COVID-19 relative to their White counterparts in the United States. American Indian or Alaska Native (AIAN) (Odds Ratio (OR): 1.52 [1.20-1.91]), Asians (OR: 1.30 [1.13-1.49]), and Native Hawaiian or Other Pacific Islander (NHOPI) (OR: 1.24 [1.06-1.45]) had significantly higher odds of 30-day inpatient mortality compared to Whites. Read more about the results here.

Engage with the Sentinel Community

The 2023 Sentinel Innovation and Methods Seminar Series

The Sentinel Innovation and Methods Seminar Series features presentations by leading experts and innovators on topics related to the work of the Innovation Center and the Sentinel Operations Center. The Seminar Series describes emerging approaches in real world data utilization such as feature extraction, Natural Language Processing (NLP), machine learning, and techniques to advance causal inference improving Sentinel's capabilities.

2023 Sentinel Public Training and Innovation Day:

The 2023 Sentinel Public Training and Innovation Day was successfully held on April 11th and April 12th. You can now access the presentations and recordings for the Public Training here and Innovation Day here.

2023 Sentinel Public Webinars:

Leveraging Missing Data and Measurement Error Approaches in Propensity Score-Based Analyses of Real-World Data Webinar: On August 21, 2023, Epidemiologist, Dr. Rebecca Hubbard will present an evaluation of measurement error and missing data approaches to this problem motivated by a real-world study of the comparative effectiveness of treatments for advanced urothelial cancer and conclude with reflections on how to embrace modern advances in data sources and methodology while preserving time-tested principles that support research rigor and reproducibility. Click here to view: the full description of this event and register for this webinar.

PDUFA Pregnancy Workshop: The organizers of this workshop will post the event details and registration link on the Sentinel website soon. Click here to view: the full description of this event and registration link when this information is available.

PDUFA Negative Controls Workshop: On March 8, 2023, the Duke-Margolis Center for Health Policy, under cooperative agreement with the FDA, convened a Public Workshop on how negative controls could support new methodological approaches for causal inference in the Sentinel System. Discussion informed the methods development projects aimed at: 1) establishing empirical methods to automate the negative controls identification in Sentinel and integrated it into the Sentinel Initiative tools, and 2) developed approaches to use a double-negative control adjustment to reduce unmeasured confounding in studying effectiveness of vaccines. Click here to view: Understanding the Use of Negative Controls to Assess the Validity of Non-Interventional Studies of Treatment Using Real-World Evidence.

Visit the Sentinel Meetings, Workshops, & Trainings page to view past seminars,

webinars, and workshops and to register for upcoming events in 2023.

Sentinel Community Building and Outreach Center (CBOC) Training Series

CBOC WEBINAR SERIES

The Community Building and Outreach Center has developed a webinar series to increase stakeholder awareness and engagement with the Sentinel System.

An Overview of Sentinel's Publicly Available Tools: On September 14, 2022, CBOC hosted a webinar to provide an understanding of Sentinel’s publicly available analytic tools, the Sentinel Common Data Model, and how to access those resources from the Sentinel website. Click here to view a recording of the recently released webinar.

CBOC INFORMATIONAL VIDEOS

The Community Building and Outreach Center has created informational videos to provide on-demand resources to become more familiar with Sentinel. Click below to learn more about two recently released videos.

MAJOR MOMENTS details the evolution of Sentinel as a national resource, starting from the Mini-Sentinel pilot in 2009 to Sentinel today. Click here to view the video.

THE SENTINEL USERBASE highlights various groups of stakeholders that can use Sentinel as a resource to inform their work. Click here to view the video.

CBOC VIRTUAL TRAINING SESSIONS

SENTINEL VIEWS is a data visualization application designed to increase comprehension of the Sentinel System study results. It has been integrated into the existing Sentinel querying and reporting infrastructure, to support the work of the Sentinel System. The Sentinel Views web graphics are interactive and help to visualize results. The tool also includes a public facing dashboard accessible to the general public. Click here to view the virtual training.