Journal
BRITISH JOURNAL OF HAEMATOLOGY
Volume 177, Issue 2, Pages 283-286Publisher
WILEY
DOI: 10.1111/bjh.14538
Keywords
paediatrics; adverse events; electronic medical record; epidemiology; accuracy
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Funding
- National Institutes of Health [R01 CA165277, K12 CA076931]
- Statistics and Data Center Grant [U10CA098413]
- National Clinical Trials Network (NCTN) Operations Center Grant [U10CA180886]
- NCTN Statistics Data Center [U10CA180899]
- St. Baldrick's Foundation
- [U10CA098543]
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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 0-211% and 20-100%, respectively. EMR sensitivity and PPV were >982% for all AEs. These results demonstrate that EMR-based AE ascertainment and grading substantially improves laboratory AE reporting accuracy.
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