隐蔽分组(分配隐藏)和盲法的概念、实施与报告

The Concepts,Design,Practice and Reports of Allocation Concealment and Blinding

“分配隐藏”很容易被误解而被广大临床试验实施者和论文作者所忽略,尤其是常将“分配隐藏”与盲法混淆。分配隐藏实质是产生随机序列者和决定分配序别者不能参与纳入受试者,也不宜参与以后的试验过程,尤其不能参与结果的测量。本文通过实例介绍了正确的分配隐藏和盲法实施过程。最后,还举例介绍了论文写作中方法学的描述。

The original meaning of ＂allocation concealment＂ is that the statistician and the trial designer who generated the random sequence and allocation sequence should not recruit and allocate the participants for the purpose of avoiding selection bias. In the process of generating allocation sequence, combined blinding measures are so called ＂settingblinding＂ , for instance, by using ＂double simulation＂ . We use a example to describe how to perform an adequate allocation and conceal the sequence, and setting blinding. Another example is used to describe how to report the methods of randomization, allocation concealment and the effect of blinding, etc.