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中华重症医学电子杂志 ›› 2020, Vol. 06 ›› Issue (04) : 365 -369. doi: 10.3877/cma.j.issn.2096-1537.2020.04.003

所属专题: 重症医学 文献

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现今临床研究方法学对随机对照试验结果的影响
朱熠冰1, 席修明2,()   
  1. 1. 100037 北京,中国医学科学院阜外医院医学统计部
    2. 100038 北京,首都医科大学附属复兴医院重症医学科
  • 收稿日期:2020-10-10 出版日期:2020-11-28
  • 通信作者: 席修明

The impact of current clinical research methodology on randomized controlled studies

Yibing Zhu1, Xiuming Xi2,()   

  1. 1. Medical Research and Biometrics Center, National Center for Cardiovascular Disease, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China
    2. Capital Medical University, Fuxing Hospital, Beijing 100038, China
  • Received:2020-10-10 Published:2020-11-28
  • Corresponding author: Xiuming Xi
  • About author:
    Corresponding author: Xi Xiuming, Email:
引用本文:

朱熠冰, 席修明. 现今临床研究方法学对随机对照试验结果的影响[J/OL]. 中华重症医学电子杂志, 2020, 06(04): 365-369.

Yibing Zhu, Xiuming Xi. The impact of current clinical research methodology on randomized controlled studies[J/OL]. Chinese Journal of Critical Care & Intensive Care Medicine(Electronic Edition), 2020, 06(04): 365-369.

随机对照试验是用于确证干预措施能否改善临床结局的金标准。但是诸多研究方法学因素,都会对试验结果产生影响。本文将介绍荟萃流行病学,一种系统性探索研究方法对结果影响的研究,并综述样本量,分配隐藏和盲法,研究基金来源,和研究注册对试验结果影响的荟萃流行病学研究。并介绍适应性试验设计,一种更高效并有助于识别优效性干预措施的方法学。

Randomized controlled trials are the gold standard that used to confirm whether interventions can improve clinical outcomes. However, many methodology factors can affect the results. We introduce a meta-epidemiology that systematically explores the impact of research methodology on results and review the meta-epidemiological studies exploring the effects of sample size, allocation concealment and blinding, sources of research funding, and registration on trial results in this paper. We also introduce the adaptive trial design, a methodology that makes the trial more efficient and more likely to identify effective interventions.

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