Using electronic medical record data to report laboratory adverse events.

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.

journal_name

Br J Haematol

authors

Miller TP,Li Y,Getz KD,Dudley J,Burrows E,Pennington J,Ibrahimova A,Fisher BT,Bagatell R,Seif AE,Grundmeier R,Aplenc R

doi

10.1111/bjh.14538

subject

Has Abstract

pub_date

2017-04-01 00:00:00

pages

283-286

issue

2

eissn

0007-1048

issn

1365-2141

journal_volume

177

pub_type

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