Martinez-Castaldi Carolina, Silverstein Michael, Bauchner Howard
Division of General Pediatrics, Boston University School of Medicine, Boston Medical Center, 88 E Newton St, Vose 3, Boston, MA 02118, USA.
Pediatrics. 2008 Jul;122(1):52-7. doi: 10.1542/peds.2007-2849.
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.
本研究的目的是确定已发表的以儿童和成人为主的临床研究在研究设计和目的上是否存在差异。
我们回顾了2005年第一季度发表在《新英格兰医学杂志》《美国医学会杂志》《内科学年鉴》《儿科学》《内科学文献》以及《青少年与儿科学文献》上的所有文章，并评估了每项研究的设计和目的。我们将关注成人的文章与关注儿童的文章进行了比较。
我们在分析中纳入了370篇原创研究报告（《新英格兰医学杂志》，46篇；《美国医学会杂志》，60篇；《内科学年鉴》，27篇；《儿科学》，130篇；《内科学文献》，73篇；《青少年与儿科学文献》，34篇），其中189篇仅将成人作为研究对象，181篇仅将儿童作为研究对象。在成人研究中，与儿童研究相比，有更多的随机对照试验（23.8%对8.8%）和系统评价（10.6%对1.7%），横断面研究较少（16.9%对40.9%）。研究目的也有所不同，治疗研究占成人研究的38.1%，而占儿童研究的17.7%。相比之下，流行病学研究（定义为描述疾病患病率或发病率、风险因素或显示风险因素与疾病之间关联的研究）占成人研究的6.4%，而占儿童研究的26.5%。
在6种主要的综合及专科期刊中，涉及成人的研究比儿童研究更有可能是随机对照试验、系统评价或治疗研究。如果将此类研究视为最高质量的证据，那么这种差异对儿童医疗质量以及涉及儿童的临床研究的资金投入和未来方向都有影响。
