| Title |
Drug Safety Monitoring in Children: Performance of Signal Detection Algorithms and Impact of Age Stratification
|
|---|---|
| Published in |
Drug Safety, June 2016
|
| DOI | 10.1007/s40264-016-0433-x |
| Pubmed ID | |
| Authors |
Osemeke U. Osokogu, Caitlin Dodd, Alexandra Pacurariu, Florentia Kaguelidou, Daniel Weibel, Miriam C. J. M. Sturkenboom |
| Abstract |
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. 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. 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. 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. |
X Demographics
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Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Spain | 1 | 50% |
| Unknown | 1 | 50% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 2 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 35 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 35 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 7 | 20% |
| Student > Doctoral Student | 4 | 11% |
| Student > Bachelor | 4 | 11% |
| Student > Postgraduate | 4 | 11% |
| Student > Ph. D. Student | 4 | 11% |
| Other | 5 | 14% |
| Unknown | 7 | 20% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 10 | 29% |
| Pharmacology, Toxicology and Pharmaceutical Science | 7 | 20% |
| Agricultural and Biological Sciences | 3 | 9% |
| Nursing and Health Professions | 2 | 6% |
| Chemistry | 2 | 6% |
| Other | 4 | 11% |
| Unknown | 7 | 20% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 03 June 2016.
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#17,550,880
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#1,548
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#227,018
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Outputs of similar age from Drug Safety
#12
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