Accuracy of Adverse Event Ascertainment in Clinical Trials for Pediatric Acute Myeloid Leukemia
| Autor: | Yimei Li, Alan S. Gamis, Tamara P. Miller, Andrea B. Troxel, Michael A. Pulsipher, Terzah M. Horton, Jessica A. Pollard, Selina M. Luger, Peter C. Adamson, Marko Kavcic, Richard Aplenc, Lillian Sung, Brian T. Fisher, Marla Daves, Rochelle Bagatell, Yuan Shun V Huang, Todd A. Alonzo, Matthew Hall, Alix E. Seif, Robert B. Gerbing |
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| Rok vydání: | 2016 |
| Předmět: |
Cancer Research
Pediatrics medicine.medical_specialty Myeloid business.industry ORIGINAL REPORTS Gold standard (test) medicine.disease Clinical trial 03 medical and health sciences Leukemia 0302 clinical medicine medicine.anatomical_structure Oncology Chart Abstraction Chart 030220 oncology & carcinogenesis medicine Electronic data Adverse effect business 030215 immunology |
| Zdroj: | Journal of Clinical Oncology. 34:1537-1543 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2015.65.5860 |
| Popis: | Purpose Reporting of adverse events (AEs) in clinical trials is critical to understanding treatment safety, but data on AE accuracy are limited. This study sought to determine the accuracy of AE reporting for pediatric acute myeloid leukemia clinical trials and to test whether an external electronic data source can improve reporting. Methods Reported AEs were evaluated on two trials, Children’s Oncology Group AAML03P1 and AAML0531 arm B, with identical chemotherapy regimens but with different toxicity reporting requirements. Chart review for 12 AEs for patients enrolled in AAML0531 at 14 hospitals was the gold standard. The sensitivity and positive predictive values (PPV) of the AAML0531 AE report and AEs detected by review of Pediatric Health Information System (PHIS) billing and microbiology data were compared with chart data. Results Select AE rates from AAML03P1 and AAML0531 arm B differed significantly and correlated with the targeted toxicities of each trial. Chart abstraction was performed on 204 patients (758 courses) on AAML0531. AE report sensitivity was < 50% for eight AEs, but PPV was > 75% for six AEs. AE reports for viridans group streptococcal bacteremia, a targeted toxicity on AAML0531, had a sensitivity of 78.3% and PPV of 98.1%. PHIS billing data had higher sensitivity (> 50% for nine AEs), but lower PPV (< 75% for 10 AEs). Viridans group streptococcal detection using PHIS microbiology data had high sensitivity (92.3%) and PPV (97.3%). Conclusion The current system of AE reporting for cooperative oncology group clinical trials in pediatric acute myeloid leukemia underestimates AE rates. The high sensitivity and PPV of PHIS microbiology data suggest that using external data sources may improve the accuracy of AE reporting. |
| Databáze: | OpenAIRE |
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