Berwanger Otavio, Ribeiro Rodrigo A, Finkelsztejn Alessandro, Watanabe Marcelo, Suzumura Erica A, Duncan Bruce B, Devereaux P J, Cook Deborah
Research Institute of Heart Hospital (IEP-HCor), São Paulo/SP, Brazil.
J Clin Epidemiol. 2009 Apr;62(4):387-92. doi: 10.1016/j.jclinepi.2008.05.013. Epub 2008 Nov 17.
To evaluate the quality of reporting of abstracts describing randomized controlled trials (RCTs) published in four major general medical journals.
Systematic survey of published RCT abstracts, with two reviewers independently extracting data. We searched MEDLINE and identified 227 RCT abstracts published in the New England Journal of Medicine (NEJM), Journal of the American Medical Association (JAMA), British Medical Journal (BMJ), and The Lancet in the year 2006.
Most abstracts identified the study as a randomized trial (98.7%), reported the objectives (92.5%), described the population (90.3%), detailed the intervention (81.5%), and defined the primary outcome (71.3%). Methodological quality was poorly reported: one (0.4%) described allocation concealment; 21 (9.3%) clearly specified blinding; 51 (22.5%) described intention-to-treat analysis; and 32 (14.1%) outlined losses to follow-up. Most of the abstracts reported the effect size and the confidence intervals (62.3%), but just half of them reported side effects or harms.
The quality of reporting of RCT abstracts published in main general medical journals is suboptimal. Space limitations notwithstanding, with the recent recommendations from the CONSORT for Abstracts, it is expected that the transparency of abstract reporting can and should improve.
评估发表于四种主要综合医学期刊上的描述随机对照试验(RCT)的摘要报告质量。
对已发表的RCT摘要进行系统调查,由两名评审员独立提取数据。我们检索了MEDLINE,并识别出2006年发表在《新英格兰医学杂志》(NEJM)、《美国医学会杂志》(JAMA)、《英国医学杂志》(BMJ)和《柳叶刀》上的227篇RCT摘要。
大多数摘要将该研究识别为随机试验(98.7%),报告了研究目的(92.5%),描述了研究人群(90.3%),详述了干预措施(81.5%),并定义了主要结局(71.3%)。方法学质量的报告较差:1篇(0.4%)描述了分配隐藏;21篇(9.3%)明确说明了设盲;51篇(22.5%)描述了意向性分析;32篇(14.1%)概述了失访情况。大多数摘要报告了效应量和置信区间(62.3%),但只有一半报告了副作用或危害。
主要综合医学期刊发表的RCT摘要报告质量欠佳。尽管存在篇幅限制,但鉴于近期CONSORT摘要声明的建议,预计摘要报告的透明度能够且应该得到提高。