随机分配方案的隐藏

Allocation Concealment:Why and How?

随机分配是保证组间基线可比和避免选择性偏倚的最好方法。随机分配的成功实施取决于相互关联的两个过程。一是采用随机的方法产生不可预测的随机分配序列 ,二是必须采用分配方案隐藏的方法严格执行随机分配序列 ,以防止选择和分配受试对象入组的研究人员预先知道随后的分配情况。

Random allocation to intervention groups remains the best method of ensuring that the groups being compared are similar at the onset of study and of avoiding removing selection bias between groups of patients. The success of randomization depends on two interrelated processes. First, an unpredictable allocation sequence must be generated based on a random procedure. Second, strict implementation of that sequence must be secured through an assignment mechanism called allocation concealment to prevent those involved in a trial from knowing upcoming assignments. Inadequate allocation concealment can lead to clinicians scheduling patient's assignment and compromising the unpredictable allocation sequence.