Related Experiment Video
Updated: Mar 8, 2026

Reduced Procedure Time and Variability with Active Esophageal Cooling During Radiofrequency Ablation for Atrial Fibrillation
Published on: August 25, 2022
Using electronic medical record data to report laboratory adverse events
Tamara P Miller1,2,3, Yimei Li1,4, Kelly D Getz1,2
1Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Electronic medical record (EMR) data significantly improves adverse event (AE) reporting accuracy in clinical trials. This method enhances the ascertainment and grading of laboratory-based AEs, addressing under-reporting issues.
Area of Science:
- Clinical research methodology
- Health informatics
- Oncology drug development
Background:
- Adverse event (AE) reporting is crucial for clinical trial safety but is often under-reported.
- Current manual methods for AE ascertainment have limitations in accuracy and completeness.
Purpose of the Study:
- To evaluate the accuracy of electronic medical record (EMR) data for ascertaining laboratory-based adverse events (AEs) in pediatric oncology clinical trials.
- To compare the performance of EMR-based AE ascertainment with traditional manual methods.
Main Methods:
- Retrospective extraction and processing of EMR data for 12 specific AEs in patients on two Children's Oncology Group (COG) trials.
- Grading of AEs using EMR data and comparison against a gold standard of manual chart review.
- Calculation of sensitivity and positive predictive values (PPV) for both EMR-based and manual AE reporting.
Main Results:
- Manual AE reporting (COG) demonstrated low sensitivity (0-21.1%) and variable PPV (20-100%).
- EMR-based AE ascertainment achieved high sensitivity and PPV (>98.2%) for all evaluated laboratory-based AEs.
- EMR data processing significantly improved the accuracy of AE reporting compared to manual methods.
Conclusions:
- Electronic medical record (EMR) data offers a highly accurate and sensitive method for ascertaining and grading laboratory-based adverse events in clinical trials.
- Implementing EMR-based systems can substantially enhance the reliability of AE reporting, improving patient safety monitoring in oncology research.
More Related Videos
07:50A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts
Published on: September 20, 2018
07:31Implementation of a Real-Time Psychosis Risk Detection and Alerting System Based on Electronic Health Records using CogStack
Published on: May 15, 2020
Related Concept Videos
Methods of Documentation VII: EMR
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Types of Reports II: Incident or Occurrence Report
Purposes:
In the healthcare industry, reports play a crucial role in documenting incidents within an agency. The primary objective of these reports is to ensure patient safety, uphold the...
Data Reporting and Recording
Pharmaceutical Poisoning: Potential Scenarios
Guidelines and Strategies for Safe Computer Charting
Maintain Confidentiality and Security: