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Estimating Clinical Trial Bleeding Events Using Electronic Health Record Data.

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Summary

Implementing complex clinical trial endpoints using electronic health record (EHR) data presents challenges. While EHR data can show associations with outcomes, consistent reliability and validity across sites remain uncertain for pragmatic clinical trials (PCT).

Keywords:
clinical trialelectronic health recordendpoint major bleed

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Area of Science:

  • Clinical Informatics
  • Health Services Research
  • Biostatistics

Background:

  • Clinical trials often collect data not routinely used in practice.
  • Pragmatic clinical trials (PCT) aim to use electronic health record (EHR) data for real-world effectiveness testing.
  • This creates challenges in aligning trial endpoints with available EHR data.

Purpose of the Study:

  • To explore the implementation of complex clinical trial endpoints using EHR data.
  • To illustrate this process using TIMI bleeding events as a case study.
  • To assess the reliability and validity of EHR-defined endpoints for PCT.

Main Methods:

  • Utilized EHR data to define and implement TIMI bleeding events.
  • Analyzed the association between EHR-defined bleeding events and patient clinical outcomes.
  • Evaluated the potential for consistent replication of these measurements across different settings.

Main Results:

  • Demonstrated that EHR-defined bleeding events were associated with differences in patient clinical outcomes.
  • Expressed uncertainty regarding the consistent reliability and validity of these EHR measurements in other locations.
  • Highlighted the need for standardized approaches to EHR data utilization in PCT.

Conclusions:

  • Implementing complex clinical trial endpoints in EHR data is feasible but faces challenges in standardization and validation.
  • Further development of PCT endpoint definitions is crucial.
  • Collaboration among professional societies, regulators, and industry is needed to address these issues.