SynthesisPediatrics2014
Safety of medical interventions in children versus adults.
Synthesis in Pediatrics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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
12 citing papers in PubMed.
- In silico & in vitro approaches suggest osteoclastogenesis induction underlying fractures in Entrectinib-treated children.Archives of toxicology · 2025Article
- LEVERAGING UNSTRUCTURED DATA IN ELECTRONIC HEALTH RECORDS TO DETECT ADVERSE EVENTS FROM PEDIATRIC DRUG USE - A SCOPING REVIEW.medRxiv : the preprint server for health sciences · 2025Article
- Value of preclinical systematic reviews and meta-analyses in pediatric research.Pediatric research · 2024Article
- PICC tip dislodgement causing massive pleural effusion and atelectasis with acute respiratory failure: a case report.BMC pediatrics · 2024Article
- Off-label prescription: developing a guideline and validating an instrument to measure physicians' and clinical pharmacists' knowledge and attitudes toward off-label medication use.Journal of diabetes and metabolic disorders · 2023Article
- Off-Label and Unlicenced Medicine Use among Hospitalised Children in South Africa: Practice and Policy Implications.Pharmacy (Basel, Switzerland) · 2023Article
- High prevalence of off-label and unlicensed paediatric prescribing in a hospital in Indonesia during the period Aug.-Oct. 2014.PloS one · 2020Article
- Comparison of nuisance parameters in pediatric versus adult randomized trials: a meta-epidemiologic empirical evaluation.BMC medical research methodology · 2018Article
- Do systematic reviews on pediatric topics need special methodological considerations?BMC pediatrics · 2017Article
- Are child-centric aspects in newborn and child health systematic review and meta-analysis protocols and reports adequately reported?-two systematic reviews.Systematic reviews · 2017Article
- Design and conduct of early phase drug studies in children: challenges and opportunities.British journal of clinical pharmacology · 2016Review
- Effect of bivalent human papillomavirus vaccination on pregnancy outcomes: long term observational follow-up in the Costa Rica HPV Vaccine Trial.BMJ (Clinical research ed.) · 2015Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
objectiveCompare the risk of harm from pharmacologic interventions in pediatric versus adult randomized controlled trials (RCTs).
methodsWe used systematic reviews from the Cochrane Database of Systematic Reviews. We considered separately 7 categories of harms/harm-related end points: severe harms, withdrawals due to harms, any harm, organ system-level harms, specific harms, withdrawals for any reason, and mortality. Systematic reviews with quantitative synthesis from at least 1 adult and 1 pediatric RCT for any of those end points were eligible. We calculated the summary odds ratio (experimental versus control intervention) in adult and pediatric trials/meta-analysis; the relative odds ratio (ROR) in adults versus children per meta-analysis; and the summary ROR (sROR) across all meta-analyses for each end point. ROR <1 means that the experimental intervention fared worse in children than adults.
resultsWe identified 176 meta-analyses for 52 types of harms/harm-related end points with 669 adult and 184 pediatric RCTs. Of those, 165 had sufficient data for ROR estimation. sRORs showed statistically significant discrepancy between adults and children only for headache (sROR 0.82; 95% confidence interval 0.70-0.96). Nominally significant discrepancies for specific harms were identified in 12 of 165 meta-analyses (RORs <1 in 7, ROR >1 in 5). In 36% of meta-analyses, the ROR estimates suggested twofold or greater differences between children and adults, and the 95% confidence intervals could exclude twofold differences only in 18% of meta-analyses.
conclusionsAvailable evidence on harms/harm-related end points from pharmacologic interventions has large uncertainty. Extrapolation of evidence from adults to children may be tenuous. Some clinically important discrepancies were identified.
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What 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.