真实世界研究与随机对照试验在临床实践及卫生决策中应用的比较

Comparison of real world study and randomized controlled trial applications in clinical practice and healthcare decision making

在临床指南和卫生政策制定的过程中,随机对照试验虽然一直被认为是"金标准",但也存在外部效度较低的局限性,因此真实世界研究得到了迅速的发展。本文通过对国内外现有的相关研究和文献进行综述,对比真实世界研究与随机对照试验在临床实践和卫生决策应用中的差异,发现国内外现有关于真实世界研究与随机对照试验的研究仍然存在着很多问题,开展不同研究设计但针对同一临床问题相同干预措施的基于患者个体水平的临床研究,从方法学、结果、证据应用等多个层面对真实世界研究与随机对照试验进行系统比较,是十分必要与迫切的。

As a gold standard of obtaining clinical evidence,well-designed randomized controlled trials(RCT)provide essential evidence for making healthcare decisions and guiding clinical practice,but RCTs have been proved to be limited to inferiorexternal validity.So real world studies(RWS)have been developed rapidly.By comparison between all available studies,thispaper is aimed to find out the difference between RWS and RCT in clinical practice and healthcare decision making.There aremany problems in all available studies,so it is urgently needed to carry out a reach that studies the same disease by using thesame interventions through different study designs to systematically compare the difference of RCT and RWS in methodology,results,evidence using and so on.