201. Using electronic medical record data to report laboratory adverse events.
- Author
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Miller TP, Li Y, Getz KD, Dudley J, Burrows E, Pennington J, Ibrahimova A, Fisher BT, Bagatell R, Seif AE, Grundmeier R, and Aplenc R
- Subjects
- Humans, Laboratories, Retrospective Studies, Adverse Drug Reaction Reporting Systems, Drug-Related Side Effects and Adverse Reactions, Electronic Health Records
- Abstract
Despite the importance of adverse event (AE) reporting, AEs are under-reported on clinical trials. We hypothesized that electronic medical record (EMR) data can ascertain laboratory-based AEs more accurately than those ascertained manually. EMR data on 12 AEs for patients enrolled on two Children's Oncology Group (COG) trials at one institution were extracted, processed and graded. When compared to gold standard chart data, COG AE report sensitivity and positive predictive values (PPV) were 0-21·1% and 20-100%, respectively. EMR sensitivity and PPV were >98·2% for all AEs. These results demonstrate that EMR-based AE ascertainment and grading substantially improves laboratory AE reporting accuracy., (© 2017 John Wiley & Sons Ltd.)
- Published
- 2017
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