Title

Using electronic medical record data to report laboratory adverse events.

Year of Publication

2017

Date Published

2017 Feb 01

ISSN Number

1365-2141

Abstract

<p>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 &gt;98·2% for all AEs. These results demonstrate that EMR-based AE ascertainment and grading substantially improves laboratory AE reporting accuracy.</p>

DOI

10.1111/bjh.14538

Alternate Title

Br. J. Haematol.

PMID

28146330

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