随机化技术概述：临床研究中对结果的无偏评估。
An overview of randomization techniques: An unbiased assessment of outcome in clinical research.
作者信息
Suresh Kp
机构信息
Department of Biostatics, National Institute of Animal Nutrition & Physiology (NIANP), Adugodi, Bangalore, India.
出版信息
J Hum Reprod Sci. 2011 Jan;4(1):8-11. doi: 10.4103/0974-1208.82352.
Abstract
Randomization as a method of experimental control has been extensively used in human clinical trials and other biological experiments. It prevents the selection bias and insures against the accidental bias. It produces the comparable groups and eliminates the source of bias in treatment assignments. Finally, it permits the use of probability theory to express the likelihood of chance as a source for the difference of end outcome. This paper discusses the different methods of randomization and use of online statistical computing web programming (www.graphpad.com/quickcalcs or www.randomization.com) to generate the randomization schedule. Issues related to randomization are also discussed in this paper.
摘要
随机化作为一种实验控制方法，已在人类临床试验和其他生物学实验中广泛使用。它可防止选择偏倚，并确保避免偶然偏倚。它产生可比的组，并消除治疗分配中的偏倚来源。最后，它允许使用概率论来表达机会作为最终结果差异来源的可能性。本文讨论了不同的随机化方法以及使用在线统计计算网络编程（www.graphpad.com/quickcalcs或www.randomization.com）生成随机化方案。本文还讨论了与随机化相关的问题。
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本文引用的文献
1
Comparison of stratification and adaptive methods for treatment allocation in an acute stroke clinical trial.
Stat Med. 2003 Mar 15;22(5):705-26. doi: 10.1002/sim.1366.
2
Allocation concealment in randomised trials: defending against deciphering.
Lancet. 2002 Feb 16;359(9306):614-8. doi: 10.1016/S0140-6736(02)07750-4.
3
How to randomise.
BMJ. 1999 Sep 11;319(7211):703-4. doi: 10.1136/bmj.319.7211.703.
4
Statistics notes. Treatment allocation in controlled trials: why randomise?
BMJ. 1999 May 1;318(7192):1209. doi: 10.1136/bmj.318.7192.1209.
5
Treatment allocation methods in clinical trials: a review.
Stat Med. 1985 Apr-Jun;4(2):129-44. doi: 10.1002/sim.4780040204.
6
Randomization in clinical trials: conclusions and recommendations.
Control Clin Trials. 1988 Dec;9(4):365-74. doi: 10.1016/0197-2456(88)90049-9.
7
Randomized consent designs for clinical trials: an update.
Stat Med. 1990 Jun;9(6):645-56. doi: 10.1002/sim.4780090611.
8
Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial.
Biometrics. 1975 Mar;31(1):103-15.
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