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Detection of Antithrombotic-Related Bleeding in Older Inpatients: Multicenter Retrospective Study Using Structured

Claire Coumau1,2,3, Frederic Gaspar1,2,3, Mehdi Zayene4

  • 1Center for Research and Innovation in Clinical Pharmaceutical Sciences, Lausanne University Hospital and University of Lausanne, Rue du Bugnon 19, Lausanne, Switzerland, 1 021 314 42 63.

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|January 29, 2026
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Summary

Automated algorithms combining structured data and NLP effectively detect bleeding events in older patients on antithrombotics. This approach improves drug safety surveillance and clinical risk management for major bleeding (MB) and clinically relevant nonmajor bleeding (CRNMB).

Keywords:
adverse drug eventsadverse drug reactionsantithromboticartificial intelligenceelectronic medical recordshemorrhagemachine learningmulticenter studynatural language processingolder inpatientspharmacovigilancestructured data mining

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Area of Science:

  • Medical Informatics
  • Pharmacovigilance
  • Clinical Data Science

Background:

  • Bleeding complications are a significant risk for older inpatients using antithrombotic agents.
  • Accurate detection of bleeding events is crucial for drug safety and patient risk management.

Purpose of the Study:

  • To develop and validate automated algorithms for detecting major bleeding (MB) and clinically relevant nonmajor bleeding (CRNMB).
  • To combine structured data-based rule models and natural language processing (NLP) for enhanced bleeding event detection.
  • To evaluate algorithm performance and generalizability using a gold standard and external dataset.

Main Methods:

  • Retrospective multicenter study using electronic medical records (EMRs) from Swiss university hospitals.
  • Development of rule-based algorithms using structured data (ICD-10-GM codes, labs, transfusions, prescriptions).
  • Application of a supervised NLP model to discharge summaries and combination with structured data algorithms (SDA+NLP) for validation.

Main Results:

  • The combined SDA+NLP model achieved the best performance (sensitivity 0.84, PPV 0.51, F1-score 0.64) in detecting MB and CRNMB.
  • Laboratory data was the most significant contributor to event detection within the structured data algorithms.
  • External validation confirmed algorithm reproducibility, with evolving prevalence reflecting clinical practice changes.

Conclusions:

  • An integrated approach combining structured data algorithms (SDA) and NLP enhances bleeding event detection in older inpatients on antithrombotics.
  • This method shows potential utility for improving drug safety monitoring and clinical risk management.
  • The findings highlight the importance of advanced data analysis for pharmacovigilance.