| Title | Using electronic medical record data to report laboratory adverse events. |
| Publication Type | Journal Article |
| Year of Publication | 2017 |
| 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 |
| Journal | Br J Haematol |
| Date Published | 2017 Feb 01 |
| ISSN | 1365-2141 |
| 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. |
| DOI | 10.1111/bjh.14538 |
| Alternate Journal | Br. J. Haematol. |
| PubMed ID | 28146330 |