ArticleDrug safety2016
Drug Safety Monitoring in Children: Performance of Signal Detection Algorithms and Impact of Age Stratification.
Article in Drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.
- Pooled it
- Sirolimus Therapy and Dyslipidemia in Neonates and Infants: A Retrospective Cohort and Pharmacovigilance Analysis.Paediatric drugs · 2026Article
- Caveats of Covariate Adjustment in Disproportionality Analysis for Best Practices.Drug safety · 2025Article
- The State of Use and Utility of Negative Controls in Pharmacoepidemiologic Studies.American journal of epidemiology · 2024Review
- Important Considerations for Signal Detection and Evaluation.Therapeutic innovation & regulatory science · 2023Review
- Efficacy and Safety of NSAIDs in Infants: A Comprehensive Review of the Literature of the Past 20 Years.Paediatric drugs · 2022Review
- A database of pediatric drug effects to evaluate ontogenic mechanisms from child growth and development.Med (New York, N.Y.) · 2022Article
- No population left behind: Improving paediatric drug safety using informatics and systems biology.British journal of clinical pharmacology · 2022Review
- Evaluating risk detection methods to uncover ontogenic-mediated adverse drug effect mechanisms in children.BioData mining · 2021Article
- Detection of Drug-Induced Thrombocytopenia Signals in Children Using Routine Electronic Medical Records.Frontiers in pharmacology · 2021Article
- Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports.Drug safety · 2020Article
- Serious Adverse Drug Reactions and Safety Signals in Children: A Nationwide Database Study.Frontiers in pharmacology · 2020Article
- Useful pharmacodynamic endpoints in children: selection, measurement, and next steps.Pediatric research · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionSpontaneous 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.
methodsWe 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.
resultsA 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.
conclusionThe 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.