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Using electronic medical record data to report laboratory adverse events
Open accessAbstract
Summary: 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.
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Miller et al used NLP to automatically monitor laboratory-based adverse effects.
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From Artificial intelligence in healthcare: past, present and future (2017) · cites this paper as [44]
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Accuracy of Adverse Event Ascertainment in Clinical Trials for Pediatric Acute Myeloid Leukemia
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Artificial intelligence in healthcare: past, present and future
Jiang, F., Jiang, Y., Zhi, H., Dong, Y., Li, H., Ma, S., Wang, Y., Dong, Q., Shen, H., & Wang, Y. (2017) · Stroke and Vascular Neurology · doi:10.1136/svn-2017-000101 · Cited by 4,837
Metadata
- Authors
- Miller, T. P., Li, Y., Getz, K. D., Dudley, J., Burrows, E., Pennington, J., Ibrahimova, A., Fisher, B. T., Bagatell, R., Seif, A. E., Grundmeier, R., & Aplenc, R.
- Affiliations
- Children's Hospital of Philadelphia (US)
- Jefferson Einstein Philadelphia Hospital (US)
- Corresponding author
- Miller, Tamara P.
- ORCID
- Venue
- British Journal of Haematology
- Publisher
- Wiley
- Published
- 2017-02
- Volume
- 177
- Issue
- 2
- Pages
- 283-286
- ISSN
- 0007-1048 (ISSN-L)
- 1365-2141
- PMC
- PMC5384859
- OpenAlex
- W2584243050
- Cited by
- 47
- References
- 14
- Citations by year
- 2026: 3 · 2025: 2 · 2024: 5 · 2023: 9 · 2022: 9 · 2021: 3 · 2020: 8 · 2019: 5 · 2018: 2 · 2017: 1
- FWCI
- 3.26
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- British Journal of Haematology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (R01 CA165277, K12 CA076931)
- St. Baldrick's Foundation
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Health Professions › Health Information Management › Electronic Health Records Systems
- Health Sciences › Health Professions › Health Information Management › Medical Coding and Health Information
- Keywords
- adverse event reporting, electronic health records, adverse event grading, Children's Oncology Group trials, sensitivity and positive predictive value, underreporting
- MeSH terms
- Humans, Laboratories, Retrospective Studies, Adverse Drug Reaction Reporting Systems, Electronic Health Records, Drug-Related Side Effects and Adverse Reactions
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