SynthesisPharmacoepidemiology and drug safety2016
Pharmacoepidemiological safety studies in children: a systematic review.
Synthesis in Pharmacoepidemiology and drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.
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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
10 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Pooled it
- Pharmacoepidemiological safety studies in children: a systematic review.Pharmacoepidemiology and drug safety · 2016Pooled it
- Stable Overall Volume, Shifting Structure: Nine Years of Paediatric Outpatient Prescribing and Dispensing in Finland, 2017-2025.Clinical epidemiology · 2026Article
- Using Natural Language Processing Techniques to Detect Adverse Events From Progress Notes Due to Chemotherapy.Cancer informatics · 2022Article
- Association of Selective Serotonin Reuptake Inhibitors With the Risk of Type 2 Diabetes in Children and Adolescents.JAMA psychiatry · 2021Article
- Real-World Evidence to Assess Medication Safety or Effectiveness in Children: Systematic Review.Drugs - real world outcomes · 2020Review
- Pharmaco-epidemiological research on herbal medicinal products in the paediatric population: data from the PhytoVIS study.European journal of pediatrics · 2020Article
- Severe Potential Drug-Drug Interactions and the Increased Length of Stay of Children in Intensive Care Unit.Frontiers in pharmacology · 2020Article
- Improving paediatric medications: A prescription for Canadian children and youth.Paediatrics & child health · 2019Review
- The Role of European Healthcare Databases for Post-Marketing Drug Effectiveness, Safety and Value Evaluation: Where Does Italy Stand?Drug safety · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeIn order to identify challenges in pediatric pharmacoepidemiological safety studies, we assessed the characteristics of such (published) studies.
methodsRelevant articles from inception to 2013 were retrieved from Embase and Medline. We sequentially screened titles, abstracts and full texts with independent validation. We systematically collected data regarding general information, study methods and results.
resultsOut of 4825 unique articles, 268 full texts (5.6%) were retained; 147 (54.9%) pertained to drugs rather than vaccines. Considering the 268 studies, 202 (75.4%) concerned children and adolescents (2 to 11 years) and 14 (5.3%) included preterm newborns. Most studies originated from North America (154 [57.5%]) or Europe (92 [34.3%]). Only 47 studies (17.5%) were privately funded. The majority (174 [64.9%]) were cohort studies. Out of 268 studies, 196 (73.1%) collected data retrospectively; paper medical charts were the most common data source for the exposures (85 [31.7%]) and outcomes (122 [45.5%]). Only 3 (2.0%) drug-only studies investigated rarely used drugs. Considering all 268 studies, only 27 (10.1%) reported sample size or power calculation. Most (75 [51.0%]) drug-only studies corrected confounding by multivariate modeling unlike stratification in 66 (55.9%) vaccine-only studies. Considering 75 child-only studies without any statistically significant result, 41 (54.7%) did not discuss lack of power.
conclusionsAlthough the field of pediatric pharmacoepidemiology is steadily developing evaluation seldom includes neonates, is mainly focused on few drug classes and safety outcomes and concerns mainly drug use in developed countries. Small study size is a specific challenge in pediatrics. Reporting should be improved. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.
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