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An absence of pediatric randomized controlled trials in general medical journals, 1985-2004
Eyal Cohen1, Elizabeth Uleryk, Mona Jasuja
1Division of Paediatric Medicine and the Paediatric Outcomes Research Team, Department of Paediatrics, The Hospital for Sick Children, University of Toronto, Faculty of Medicine, Toronto, ON, Canada. eyal.cohen@sickkids.ca
Insights
Pediatric randomized controlled trials (RCTs) are published less frequently than adult RCTs in general medical journals, suggesting potential barriers to pediatric research publication.
Area of Science:
- Clinical Trials
- Pediatric Research
- Medical Journal Publishing
Background:
- Randomized controlled trials (RCTs) are crucial for evidence-based medicine.
- Conducting RCTs in pediatric populations presents unique challenges.
- The publication trends and quality of pediatric RCTs in general medical journals (GMJs) are not well understood.
Purpose of the Study:
- To compare the quantity, trends, characteristics, and quality of pediatric RCTs versus adult RCTs published in GMJs.
- To identify potential barriers to publishing pediatric RCTs.
Main Methods:
- A comprehensive search of adult and pediatric RCTs published between 1985-2004 was conducted.
- A manual search of RCTs published in five high-impact GMJs in the year 2000 was performed.
- Publication characteristics and quality scores (Jadad score, intention-to-treat analysis, citation frequency) were analyzed.
Main Results:
- Adult RCTs increased significantly more per year than pediatric RCTs (4.71 vs. 0.4 RCTs/year).
- Adult RCTs were more likely to be hospital-based and involve more centers.
- While quality scores were similar, adult RCTs received more citations.
Conclusions:
- There are likely significant barriers hindering the publication of high-quality pediatric RCTs in major general medical journals.
- Further research is needed to understand and overcome these barriers to improve pediatric clinical trial dissemination.
Objective:
There are numerous potential barriers to conducting randomized controlled trials (RCTs) in children. The purpose of this study was to compare the quantity, trends over time, characteristics, and quality of pediatric RCTs published in general medical journals (GMJs) with adult RCTs.
Study Design And Setting:
We conducted an electronic search of adult and pediatric RCTs from 1985-2004 and a manual search of published RCTs in the year 2000 in five high-impact GMJs (New England Journal of Medicine, Journal of the American Medical Association [JAMA], the Lancet, British Medical Journal [BMJ], Canadian Medical Association Journal [CMAJ]). Linear trends were identified and the 1-year sample was analyzed for publication characteristics (location of recruitment, sample size, number of centers, funding sources, and results) and quality scoring (Jadad score, intention-to-treat analysis, and citation frequency since publication).
Results:
Adult RCTs increased by 4.71 RCTs/year (95% confidence interval (CI) 3.62-5.80; P<0.001), which was significantly higher (P<0.0001) than pediatric RCTs, which increased by 0.4 RCTs/year (95% CI -0.02 to 0.9; P=0.06). Adult RCTs were more likely to be hospital-based (P=.001) and to involve more centers in multicenter studies (P=0.02). Quality scores were similar, although adult RCTs were cited more frequently (P=0.003).
Conclusion:
There may be significant barriers to the publication of high-quality pediatric RCTs in GMJs.
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