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What Every Reader Should Know About Studies Using Electronic Health Record Data but May Be Afraid to Ask.

Isaac S Kohane1, Bruce J Aronow2, Paul Avillach1

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Summary

Critically appraising studies using electronic health record (EHR) data requires understanding its unique strengths and limitations. This review outlines six key considerations for evaluating EHR-derived research, promoting rigor and reliability in this growing field.

Keywords:
COVID-19data qualityelectronic health recordsliteraturepublishingqualityreal-world datareporting checklistreporting standardsreviewstatistics

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Area of Science:

  • Health Informatics
  • Medical Data Science
  • Real-World Evidence Research

Background:

  • The COVID-19 pandemic spurred a rise in studies using electronic health record (EHR) data.
  • Several high-profile EHR studies faced retractions due to data quality and methodological concerns.
  • Many medical professionals and editors lack a framework for critically evaluating EHR-derived research.

Purpose of the Study:

  • To provide a framework for critically appraising studies that utilize electronic health record (EHR) data.
  • To highlight key considerations for researchers, clinicians, and stakeholders reviewing EHR-derived studies.
  • To promote best practices for ensuring the rigor and reliability of EHR-based research.

Main Methods:

  • Distillation of six crucial considerations from the broader informatics literature.
  • Focus on key aspects for evaluating EHR data and study methodologies.
  • Identification of best practices for manuscript and grant review.

Main Results:

  • Six key considerations for appraising EHR data studies were identified: data completeness, data collection/handling, data type (codified vs. textual), methodological robustness against EHR variability, transparency of data/code, and multidisciplinary approach.
  • These considerations address the inherent challenges and opportunities in EHR data analysis.
  • The framework aims to guide critical appraisal beyond conventional statistical methods.

Conclusions:

  • A structured approach is essential for evaluating the quality of EHR-derived studies.
  • Adherence to these six considerations will enhance the rigor and reliability of real-world evidence from EHRs.
  • Promoting critical appraisal fosters confidence and advances the field of health informatics.