An absence of pediatric randomized controlled trials in general medical journals, 1985-2004.
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.


METHODS
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).


CONCLUSIONS
There may be significant barriers to the publication of high-quality pediatric RCTs in GMJs.
Cohen
Eyal
E
Division 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
Uleryk
Elizabeth
E
Jasuja
Mona
M
Parkin
Patricia C
PC
D002648:Child; D015510:Clinical Medicine; D016206:Databases, Bibliographic; D006801:Humans; D016247:Information Storage and Retrieval; D010372:Pediatrics; D010506:Periodicals as Topic; D016032:Randomized Controlled Trials as Topic