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The US Food and Drug Administration (FDA) created the Sentinel System in response to a requirement in the FDA Amendments Act of 2007 that the agency establish a system for monitoring risks associated with drug and biologic products using data from disparate sources. The Sentinel System has completed hundreds of analyses, including many that have directly informed regulatory decisions. The Sentinel System also was designed to support a national infrastructure [...]

The lack of diversity, equity, and inclusion continues to hamper the artificial intelligence (AI) field and is especially problematic for healthcare applications. In this article, we expand on the need for diversity, equity, and inclusion, specifically focusing on the composition of AI teams. We call to action leaders at all levels to make team inclusivity and diversity the centerpieces of AI development, not the afterthought. These recommendations take into consideration [...]

Monkeypox virus was historically rare outside of West and Central Africa until the current 2022 global outbreak, which has required clinicians to be alert to identify individuals with possible monkeypox, institute isolation, and take appropriate next steps in evaluation and management. Clinical decision support systems (CDSS), which have been shown to improve adherence to clinical guidelines, can support frontline clinicians in applying the most current evaluation and management guidance in [...]

Visual timelines of patient-reported outcomes (PRO) can help prostate cancer survivors manage longitudinal data, compare with population averages, and consider future trajectories. PRO visualizations are most effective when designed with deliberate consideration of users. Yet, graph literacy is often overlooked as a design constraint, particularly when users with limited graph literacy are not engaged in their development. We conducted user testing to assess comprehension, utility, and preference of longitudinal PRO [...]

Prediction models can be useful tools for monitoring patient status and personalizing treatment in health care. The goal of this study was to compare the relative strengths and weaknesses of 2 different approaches for predicting functional recovery after knee arthroplasty: a neighbors-based "people-like-me" (PLM) approach and a linear mixed model (LMM) approach.

As the informatics community grows in its ability to address health disparities, there is an opportunity to expand our impact by focusing on the disability community as a health disparity population. Although informaticians have primarily catered design efforts to one disability at a time, digital health technologies can be enhanced by approaching disability from a more holistic framework, simultaneously accounting for multiple forms of disability and the ways disability intersects [...]

Occupational injuries (OIs) cause an immense burden on the US population. Prediction models help focus resources on those at greatest risk of a delayed return to work (RTW). RTW depends on factors that develop over time; however, existing methods only utilize information collected at the time of injury. We investigate the performance benefits of dynamically estimating RTW, using longitudinal observations of diagnoses and treatments collected beyond the time of initial [...]

This study aimed is to: (1) extend the Integrating the Biology and the Bedside (i2b2) data and application models to include medical imaging appropriate use criteria, enabling it to serve as a platform to monitor local impact of the Protecting Access to Medicare Act's (PAMA) imaging clinical decision support (CDS) requirements, and (2) validate the i2b2 extension using data from the Medicare Imaging Demonstration (MID) CDS implementation.

Plain language in medicine has long been advocated as a way to improve patient understanding and engagement. As the field of Natural Language Processing has progressed, increasingly sophisticated methods have been explored for the automatic simplification of existing biomedical text for consumers. We survey the literature in this area with the goals of characterizing approaches and applications, summarizing existing resources, and identifying remaining challenges.