随机对照试验质量评价标准的比较分析

Analysis of Quality Standards Assessing Randomized Controlled Trials

目的系统收集并分析随机对照试验质量评价的相关标准并初步探究其演进规律,为标准的使用者提供参考与指导。方法计算机检索Cochrane Library、PubMed、EMBASE、中国生物医学文献数据库等数据库,并用Google等搜索引擎在互联网上查找相关资料。由两位评价员独立筛选文献,提取资料。遴选出具有代表性的标准进行对比分析。结果初检出3282篇文献,筛选相关随机对照试验质量评价标准31个,对遴选出的具有代表性的21个标准进行对比分析。其中,10个标准适用于所有类型的随机对照试验,11个标准针对药物、针灸等特定领域。标准主要从方法学质量和报告质量两个方面对随机对照试验进行评价。本研究对随机对照试验质量评价标准的发展历程进行了初步探究。结论目前随机对照试验的质量评价标准较多,评价内容、条目不一致。建议使用者根据研究内容和目的针对性地选用随机对照试验的质量评价标准。

Objective Systematically analyzing the quality assessment standards of RCT was conducted,meanwhile,the evolution of the standards was also investigated in order to provide reference or guidance for standards users.Methods An electronic search of the Cochrane Library,PubMed,EMBASE and CBM was progressed.What＇s more,Google and some other search engines were applied to find relevant studies.Two people screened the articles selecting those typical standards and extracted the data independently.Result 31 assessment standards were identified from 3 282 articles,and 21 of which were introduced in detail in our study.Among the 21 standards,10 were designed for all kinds of RCTs and others could only be applied to special fields,such as acupuncture.Besides,the regularity of these standards＇ evolution was explored.Conclusion The existing RCT quality assessment standards are numerous and various from each other,so users are advised to choose standards objectively.