Using electronic medical record data to report laboratory adverse events

Tamara P Miller; Yimei Li; Kelly D Getz; Jesse Dudley; Evanette Burrows; Jeffrey Pennington; Azada Ibrahimova; Brian T Fisher; Rochelle Bagatell; Alix E Seif; Robert Grundmeier; Richard Aplenc

doi:10.1111/bjh.14538

Using electronic medical record data to report laboratory adverse events

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

Authors

Tamara P Miller^{1

2

3}, Yimei Li^{1

4}, Kelly D Getz^{1

2}, Jesse Dudley³, Evanette Burrows³, Jeffrey Pennington³, Azada Ibrahimova⁵, Brian T Fisher^{2

4

6

7}, Rochelle Bagatell^{1

7}, Alix E Seif^{1

7}, Robert Grundmeier^{3

7}, Richard Aplenc^{1

2

4

7}

Affiliations

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.

Publication types

Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Adverse Drug Reaction Reporting Systems*
Drug-Related Side Effects and Adverse Reactions*
Electronic Health Records*
Humans
Laboratories
Retrospective Studies

Abstract

Publication types

MeSH terms

Grants and funding