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Area of Science:

  • Health Informatics
  • Observational Research Methods
  • Real-World Data Analysis

Background:

  • Electronic health records (EHRs) are a significant source of real-world health data.
  • Analyzing EHR data for research requires careful attention to data quality and established research principles.

Purpose of the Study:

  • To provide specific recommendations for conducting observational research using electronic health records.
  • To address unique challenges and considerations inherent in EHR-based studies.

Main Methods:

  • Review and synthesis of existing guidelines for observational research.
  • Identification and discussion of considerations unique to EHR data.
  • Recommendations for assessing computer-executable cohort definitions and managing data challenges.

Main Results:

  • Core principles of observational research apply to EHR data.
  • Unique challenges include accuracy of cohort definitions using unstructured data and data irregularities (sampling, missingness, variation).

Conclusions:

  • Applying existing guidelines with additional EHR-specific considerations improves study quality.
  • Enhanced quality of EHR-based observational studies is achievable through principled application of recommendations.