Using electronic medical record data to report laboratory adverse events.
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.
Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.|Center for Pediatric Clinical Effectiveness, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.|Department of Biomedical and Health Informatics, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Tamara P
TP
Miller
Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.|Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.
Yimei
Y
Li
Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.|Center for Pediatric Clinical Effectiveness, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Kelly D
KD
Getz
Department of Biomedical and Health Informatics, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Jesse
J
Dudley
Department of Biomedical and Health Informatics, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Evanette
E
Burrows
Department of Biomedical and Health Informatics, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Jeffrey
J
Pennington
Albert Einstein Medical Center, Philadelphia, PA, USA.
Azada
A
Ibrahimova
Center for Pediatric Clinical Effectiveness, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.|Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.|Division of Infectious Diseases, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.|Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.
Brian T
BT
Fisher
Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.|Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.
Rochelle
R
Bagatell
Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.|Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.
Alix E
AE
Seif
Department of Biomedical and Health Informatics, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.|Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.
Robert
R
Grundmeier
Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.|Center for Pediatric Clinical Effectiveness, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.|Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.|Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.
Richard
R
Aplenc
D016907:Adverse Drug Reaction Reporting Systems; D064420:Drug-Related Side Effects and Adverse Reactions; D057286:Electronic Health Records; D006801:Humans; D007753:Laboratories; D012189:Retrospective Studies
accuracy; adverse events; electronic medical record; epidemiology; paediatrics