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Synapse
May 2, 20260 citations

Signal Detection of Adverse Events in Medical Devices Using Natural Language Processing

Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh.

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Authors

TKThu‐Lan KellyTSTy StanfordCMCurtis Murray

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Overview

Randomized trial demonstrates signal detection for adverse events in pelvic mesh, suggesting implications for safety monitoring.

Key Points

  • The aim is to improve signal detection for adverse events using natural language processing on unstructured free-text data.
  • Implemented a proof-of-concept system integrating natural language processing with disproportionality analysis.
  • Classified free-text reports using topic modelling from an Australian adverse event report database (2012-2017).
  • Conducted signal detection quarterly using three disproportionality methods: Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, and maximized Sequential Probability Ratio Test.
  • A safety signal for pelvic mesh was detected compared to hernia and other mesh by all three methods in Q3 2014, three years prior to device withdrawal.
  • Bayesian Confidence Propagation Neural Network provided the most reliable assessment of uncertainty in classifying pain as an adverse event.

Cite This Study

Kelly et al. (2026) studied this question.

synapsesocial.com/papers/69f5947e71405d493afff56bhttps://doi.org/10.1038/s41598-026-50950-z
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