Drug Safety Monitoring in Children: Performance of Signal Detection Algorithms and Impact of Age Stratification
Osemeke U. Osokogu,
Caitlin Dodd (),
Alexandra Pacurariu,
Florentia Kaguelidou,
Daniel Weibel and
Miriam C. J. M. Sturkenboom
Additional contact information
Osemeke U. Osokogu: Erasmus University Medical Center
Caitlin Dodd: Erasmus University Medical Center
Alexandra Pacurariu: Erasmus University Medical Center
Florentia Kaguelidou: Erasmus University Medical Center
Daniel Weibel: Erasmus University Medical Center
Miriam C. J. M. Sturkenboom: Erasmus University Medical Center
Drug Safety, 2016, vol. 39, issue 9, No 8, 873-881
Abstract:
Abstract Introduction Spontaneous reports of suspected adverse drug reactions (ADRs) can be analyzed to yield additional drug safety evidence for the pediatric population. Signal detection algorithms (SDAs) are required for these analyses; however, the performance of SDAs in the pediatric population specifically is unknown. We tested the performance of two SDAs on pediatric data from the US FDA Adverse Event Reporting System (FAERS) and investigated the impact of age stratification and age adjustment on the performance of SDAs. Methods We tested the performance of two established SDAs: the proportional reporting ratio (PRR) and the empirical Bayes geometric mean (EBGM) on a pediatric dataset from FAERS (2004–2012). We compared the performance of the SDAs with a published pediatric-specific reference set by calculating diagnostic test-related statistics, including the area under the curve (AUC) of receiver operating characteristics. Impact of age stratification and age-adjustment on the performance of the SDAs was assessed. Age adjustment was performed by pooling (Mantel-Hanszel) stratum-specific estimates. Results A total of 115,674 pediatric reports (patients aged 0–18 years) comprising 893,587 drug–event combinations (DECs) were analysed. Crude values of the AUC were similar for both SDAs: 0.731 (PRR) and 0.745 (EBGM). Stratification unmasked four DECs, e.g., ‘ibuprofen and thrombocytopenia’. Age adjustment did not improve performance. Conclusion The performance of the two tested SDAs was similar in the pediatric population. Age adjustment does not improve performance and is therefore not recommended to be performed routinely. Stratification can reveal new associations, and therefore is recommended when either drug use is age-specific or when an age-specific risk is suspected.
Date: 2016
References: View complete reference list from CitEc
Citations:
Downloads: (external link)
http://link.springer.com/10.1007/s40264-016-0433-x Abstract (text/html)
Access to the full text of the articles in this series is restricted.
Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.
Export reference: BibTeX
RIS (EndNote, ProCite, RefMan)
HTML/Text
Persistent link: https://EconPapers.repec.org/RePEc:spr:drugsa:v:39:y:2016:i:9:d:10.1007_s40264-016-0433-x
Ordering information: This journal article can be ordered from
http://www.springer.com/adis/journal/40264
DOI: 10.1007/s40264-016-0433-x
Access Statistics for this article
Drug Safety is currently edited by Nitin Joshi
More articles in Drug Safety from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().