Sustainable deployment of clinical prediction tools-a 360° approach to model maintenance.

BACKGROUND: As the enthusiasm for integrating artificial intelligence (AI) into clinical care grows, so has our understanding of the challenges associated with deploying impactful and sustainable clinical AI models. Complex dataset shifts resulting from evolving clinical environments strain the longevity of AI models as predictive accuracy and associated utility deteriorate over time. OBJECTIVE: Responsible practice thus necessitates the lifecycle of AI models be extended to include ongoing monitoring and maintenance strategies within health system algorithmovigilance programs. We describe a framework encompassing a 360° continuum of preventive, preemptive, responsive, and reactive approaches to address model monitoring and maintenance from critically different angles. DISCUSSION: We describe the complementary advantages and limitations of these four approaches and highlight the importance of such a coordinated strategy to help ensure the promise of clinical AI is not short-lived.

Enhancing Postmarketing Surveillance of Medical Products With Large Language Models.

Importance: The Sentinel System is a key component of the US Food and Drug Administration (FDA) postmarketing safety surveillance commitment and uses clinical health care data to conduct analyses to inform drug labeling and safety communications, FDA advisory committee meetings, and other regulatory decisions. However, observational data are frequently deemed insufficient for reliable evaluation of safety concerns owing to limitations in underlying data or methodology. Advances in large language models (LLMs) provide new opportunities to address some of these limitations. However, careful consideration is necessary for how and where LLMs can be effectively deployed for these purposes. Observations: LLMs may provide new avenues to support signal-identification activities to identify novel adverse event signals from narrative text of electronic health records. These algorithms may be used to support epidemiologic investigations examining the causal relationship between exposure to a medical product and an adverse event through development of probabilistic phenotyping of health outcomes of interest and extraction of information related to important confounding factors. LLMs may perform like traditional natural language processing tools by annotating text with controlled vocabularies with additional tailored training activities. LLMs offer opportunities for enhancing information extraction from adverse event reports, medical literature, and other biomedical knowledge sources. There are several challenges that must be considered when leveraging LLMs for postmarket surveillance. Prompt engineering is needed to ensure that LLM-extracted associations are accurate and specific. LLMs require extensive infrastructure to use, which many health care systems lack, and this can impact diversity, equity, and inclusion, and result in obscuring significant adverse event patterns in some populations. LLMs are known to generate nonfactual statements, which could lead to false positive signals and downstream evaluation activities by the FDA and other entities, incurring substantial cost. Conclusions and Relevance: LLMs represent a novel paradigm that may facilitate generation of information to support medical product postmarket surveillance activities that have not been possible. However, additional work is required to ensure LLMs can be used in a fair and equitable manner, minimize false positive findings, and support the necessary rigor of signal detection needed for regulatory activities.

Integrating Clinical and Air Quality Data to Improve Prediction of COPD Exacerbations.

Several studies have found associations between air pollution and respiratory disease outcomes. However, there is minimal prognostic research exploring whether integrating air quality into clinical prediction models can improve accuracy and utility. In this study, we built models using both logistic regression and random forests to determine the benefits of including air quality data with meteorological and clinical data in prediction of COPD exacerbations requiring medical care. Logistic models were not improved by inclusion of air quality. However, the net benefit curves of random forest models showed greater clinical utility with the addition of air quality data. These models demonstrate a practical and relatively low-cost way to include environmental information into clinical prediction tools to improve the clinical utility of COPD prediction. Findings could be used to provide population level health warnings as well as individual-patient risk assessments.