Creating a Medication Therapy Observational Research Database from an Electronic Medical Record: Challenges and Data...

Area of Science:

• Medical Informatics
• Pharmacovigilance
• Pediatric Research

Background:

• Observational research leverages secondary use of hospital treatment data to complement experimental studies and clinical trials.
• Understanding pediatric drug utilization is crucial for establishing safer drug therapies.
• Clinical documentation in pediatric electronic medical records often suffers from data quality issues requiring extensive curation.

Purpose of the Study:

• To transform and curate departmental electronic medical record data into an observational research database.
• To identify data quality problems and their causes within electronic medical records.
• To describe a systematic data curation process for generating high-quality research data.

Main Methods:

• Data extraction from an electronic medical record system at a German university children's hospital (April 2012 - June 2020).
• Implementation of a four-step data preparation, mapping, and curation process.
• Data quality assessment using a 3x3 guideline and comparison with a gold standard.

Main Results:

• A dataset comprising 770,158 medication dispensations and 89,955 drug exposures from 21,285 clinical encounters was generated.
• Narrative drug therapy descriptions were mapped to standardized terms, improving data consistency.
• The database demonstrated high agreement with the gold standard for the correctness quality criterion.

Conclusions:

• A semi-automated data curation process successfully addressed data quality issues in electronic medical records.
• The resulting high-quality observational research database supports pediatric drug utilization studies.
• Limitations include the absence of detailed dosage information due to inconsistencies in original documentation.