ReviewEuropean journal of clinical pharmacology2011
Study designs in paediatric pharmacoepidemiology.
Review in European journal of clinical pharmacology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
8 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Pharmacoepidemiological safety studies in children: a systematic review.Pharmacoepidemiology and drug safety · 2016Pooled it
- Maternal use of antidepressant or anxiolytic medication during pregnancy and childhood neurodevelopmental outcomes: a systematic review.European child & adolescent psychiatry · 2014Pooled it
- Drug Utilization on Neonatal Wards: A Systematic Review of Observational Studies.Frontiers in pharmacology · 2017Article
- Article
- Comparison of two alternative study designs in assessment of medicines utilisation in neonates.BMC medical research methodology · 2014Article
- The intriguing future of pharmacoepidemiology.European journal of clinical pharmacology · 2013Article
- Methods in pharmacoepidemiology: a review of statistical analyses and data reporting in pediatric drug utilization studies.European journal of clinical pharmacology · 2013Review
- Treatment duration with selective serotonin reuptake inhibitors among children and adolescents in Finland: a nationwide register study.European journal of clinical pharmacology · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeFew data on the efficacy and safety of drugs in children are available as in the past, these children were not included in randomized controlled trials (RCTs). Data on the efficacy and safety of drugs in children are extrapolated from adults. The EMA recognizes the need for long-term safety studies on various drugs, a need that can best be answered by pharmacoepidemiological studies. In this article, we provide currently available information on study designs within the field of paediatric drug research.
methodsA PubMed search was conducted on all pharmacoepidemiological studies in children. In addition, data from handbooks on pharmacoepidemiology were consulted. Data were reviewed and the relevant literature on study designs in paediatric pharmacoepidemiology is described.
resultsThe various study designs in pharmacoepidemiology have their specific indications, all with their specific limitations. Case reports and case series are mainly used for signal detection of safety issues whereas case control and cohort studies are used for safety hypothesis testing. Observational studies can be conducted using data from automated databases that guarantee large sample size and long-term follow-up, which is ideal for safety studies, especially in case of rare events.
conclusionPharmacoepidemiological studies are crucial in research on the safety of drugs in children. Knowledge of the different pharmacoepidemiological methods is important to guarantee optimal use and correct interpretation of the data.
Indexed as
Identifiers
21107830What OpenQuestion holds
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.