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The potential role of EHR data in optimizing eligibility criteria definition for cardiovascular outcome trials

Jae Hyun Kim1, Alex M Butler1, Casey N Ta1

  • 1Department of Biomedical Informatics, Columbia University, New York, NY 10032, USA.

International Journal of Medical Informatics
|October 8, 2021
PubMed

Insights

Optimizing inclusion criteria for cardiovascular outcome trials (CVOTs) is key. Specific criteria, like age ≥ 60 with multiple risk factors, maximize cardiovascular event incidence in diabetes patients.

Area of Science:

  • Cardiology
  • Clinical Trials
  • Epidemiology

Background:

  • Cardiovascular outcome trials (CVOTs) enroll high-risk patients.
  • The effect of specific inclusion criteria on patient accrual and event rates in CVOTs is not well understood.

Purpose of the Study:

  • To evaluate the impact of inclusion criteria on patient accrual and cardiovascular event incidence.
  • To identify optimal criteria for CVOTs in diabetes patients.

Main Methods:

  • Retrospective cohort study of 1544 diabetes patients.
  • Utilized electronic health records from New York Presbyterian Hospital / Columbia University Irving Medical Center.
  • Analyzed the relationship between various inclusion criteria and the incidence of composite cardiovascular events.

Main Results:

  • The highest incidence of composite events (cardiovascular mortality, stroke, myocardial infarction) occurred with criteria including pre-existing cardiovascular diseases or age ≥ 60 plus at least two risk factors (diabetes duration, hypertension, dyslipidemia, smoking, albuminuria).

Conclusions:

  • Electronic health records can optimize CVOT inclusion criteria.
  • Balancing study inclusiveness and event numbers is achievable through data-driven criteria selection.
Abstract

Keywords:
Cardiovascular outcome trialsClinical trialElectronic health recordsEligibility criteriaMajor adverse cardiovascular events

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