摘要
目的了解近年来国内具有代表性的三本麻醉学专业期刊随机对照试验（RCT）文献的质量。方法本研究采用CONSORT清单对《中华麻醉学杂志》、《临床麻醉学杂志》和《国际麻醉学与复苏杂志》2011~2013年发表的所有RCT文献质量进行评价。结果本研究共纳入RCT文献1024篇,占发表文献总数的29.9%。纳入的文献中,科学背景、试验设计描述、受试者合格标准、干预措施的描述、统计学方法和不良反应等报告率达100%。而在重要方法的改变、设定主要和次要结局指标、主要指标的效应估计值等方面报告率为0。仅有13篇（1.3%）文献可以从文题中看出是否为RCT文献。仅有3篇（0.3%）文献有介绍如何计算样本量。有464（45.3%）文献报道了随机序列的产生方法。但仅有5篇（0.5%）有对随机方法类型的描述。只有9篇（0.9%）文献能在方法中看出使用了分配隐藏机制。盲法的使用要多一些,有69篇（6.7%）。介绍招募时间的文献只有148篇（14.5%）。基线表格的使用超过半数,有559篇（54.6%）。讨论中提及试验的局限性的文献有855篇（83.5%）。结论国内麻醉学期刊的RCT文献报告质量与CONSORT声明要求相比有较大差距,国内期刊应尽快采纳CONSORT,提高麻醉学文献的报告质量和科研水平。
Objective To assess the quality of randomized controlled trials（RCTs）in top 3anesthesiology journals in China from 2011 to 2013.Methods All RCTs published in the Chinese Journal of Anesthesiology,the Clinical Journal of Anesthesiology,and the International Journal of Anesthesiology and Resuscitation from 2011 to 2013,were searched through Wanfang database.CONSORT statement checklists were used to measure the quality of articles meeting the eligibility criteria.Results A total of 1 024（29.9%）RCTs were included.Items such as background and objectives,description of trial design,eligibility criteria for participants,statistical methods,and harms reached100% adherence.Other items such as changes to methods,prespecified primary and secondary outcomes and outcomes estimation were reported with 0%.Only 1.3%identification as a randomised trial in the title,0.3%reported how sample size was determined,0.5%reported type of randomization,0.9% had allocation concealment,6.7% had blinding.More than half of RCTs（54.6%）mentioned baseline data.The majority（83.5%）of the articles provided the information about trial limitations.Conclusion The quality of RCT reports in Chinese anesthesiology journals was poor.CONSORT statement should be promoted and used for improving the reporting quality.
出处
《临床麻醉学杂志》
CAS
CSCD
北大核心
2015年第10期1020-1024,共5页
Journal of Clinical Anesthesiology
