An absence of pediatric randomized controlled trials in general medical journals, 1985-2004
ABSTRACT 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.
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).
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).
There may be significant barriers to the publication of high-quality pediatric RCTs in GMJs.
- Rheumatology (Oxford, England) 06/2008; 47(5):563-6. DOI:10.1093/rheumatology/ken055 · 4.44 Impact Factor
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ABSTRACT: The objective of this study was to determine whether there were differences in study design and purpose between published child- and adult-focused clinical research. We reviewed all articles published in the New England Journal of Medicine, Journal of the American Medical Association, Annals of Internal Medicine, Pediatrics, Archives of Internal Medicine, and Archives of Adolescent and Pediatric Medicine during the first 3 months of 2005 and assessed each study's design and purpose. We compared articles focused on adults with those focused on children. We included 370 original research reports in our analysis (New England Journal of Medicine, n = 46; Journal of the American Medical Association, n = 60; Annals of Internal Medicine, n = 27; Pediatrics, n = 130; Archives of Internal Medicine, n = 73; Archives of Adolescent and Pediatric Medicine, n = 34), of which 189 included only adults as subjects and 181 only children. Among adult studies, compared with child studies, there were more randomized, controlled trials (23.8% vs 8.8%) and systematic reviews (10.6% vs 1.7%) and fewer cross sectional studies (16.9% vs 40.9%). Study purposes also varied, with studies of therapies constituting 38.1% of adult studies, compared with 17.7% of child studies. In contrast, epidemiological studies, defined as studies describing the prevalence or incidence of diseases or risk factors or showing associations between risk factors and diseases, constituted 6.4% of adult studies, compared with 26.5% of child studies. In 6 leading generalist and specialist journals, studies involving adults were significantly more likely than child studies to be randomized, controlled trials, systematic reviews, or studies of therapies. If such studies are to be viewed as the highest possible quality of evidence, then this difference has implications for quality of care for children and for funding and future directions in clinical research involving children.PEDIATRICS 08/2008; 122(1):52-7. DOI:10.1542/peds.2007-2849 · 5.30 Impact Factor
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ABSTRACT: Terry Klassen and colleagues discuss a new study examining whether children and adults with drug-resistant partial epilepsy respond differently to antiepileptic drugs.PLoS Medicine 09/2008; 5(8):e172. DOI:10.1371/journal.pmed.0050172 · 14.00 Impact Factor