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Br J Haematol. 2017 Apr;177(2):283-286. doi: 10.1111/bjh.14538. Epub 2017 Feb 1.

Using electronic medical record data to report laboratory adverse events.

Author information

1
Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
2
Center for Pediatric Clinical Effectiveness, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
3
Department of Biomedical and Health Informatics, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
4
Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.
5
Albert Einstein Medical Center, Philadelphia, PA, USA.
6
Division of Infectious Diseases, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
7
Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.

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.

KEYWORDS:

accuracy; adverse events; electronic medical record; epidemiology; paediatrics

PMID:
28146330
PMCID:
PMC5384859
[Available on 2018-04-01]
DOI:
10.1111/bjh.14538
[Indexed for MEDLINE]
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