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Characterizing permuted block randomization as a big stick procedure

机译:将置换块随机化表征为大棒过程

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摘要

There are numerous approaches to randomizing patients to treatment groups in clinical trials. The most popular is permuted block randomization, and a newer and better class, which is gaining in popularity, is the so-called class of MTI procedures, which use a big stick to force the allocation sequence back towards balance when it reaches the MTI (maximally tolerated imbalance). Three prominent members of this class are the aptly named big stick procedure, Chen's procedure, and the maximal procedure. As we shall establish in this article, blocked randomization, though not typically cast as an MTI procedure, does in fact use the big stick as well. We shall argue that its weaknesses, which are well known, arise precisely from its improper use, bordering on outright abuse, of this big stick. Just as rocket powered golf clubs add power to a golf swing, so too does the big stick used by blocked randomization hit with too much power. In addition, the big stick is invoked when it need not be, thereby resulting in the excessive prediction for which permuted blocks are legendary. We bridge the gap between the MTI procedures and block randomization by identifying a new randomization procedure intermediate between the two, namely based on an excessively powerful big stick, but one that is used only when needed. We shall then argue that the MTI procedures are all superior to this intermediate procedure by virtue of using a restrained big stick, and that this intermediate procedure is superior to block randomization by virtue of restraint in when the big stick is invoked. The transitivity property then completes our argument.
机译:在临床试验中,有许多方法可以将患者随机分为治疗组。最受欢迎的是置换块随机化,一种越来越流行的更新更好的类就是所谓的MTI程序类,它使用一根大棒将到达MTI的分配序列推回平衡(最大程度地容忍不平衡)。该类的三个突出成员是恰当命名的大棒程序,陈氏程序和最大程序。正如我们将在本文中确定的那样,尽管通常不将阻塞随机化作为MTI程序,但实际上也使用了大棒。我们将争辩说,众所周知,它的弱点恰恰是由于不当使用,直接滥用这一大棒导致的。就像由火箭驱动的高尔夫球杆为高尔夫挥杆动作增添力量一样,被阻塞的随机击球所使用的大棒也以太大的力量击中。另外,在不需要时调用大棒,从而导致过多的预测,其中置换块是传奇的。我们通过确定介于两者之间的新的随机程序来弥合MTI程序和块随机之间的差距,即基于一个功能强大的大棒,但仅在需要时才使用。然后我们将争辩说,由于使用了约束大棒,因此MTI程序都优于该中间程序,并且由于调用大棒时的约束,该中间程序优于块随机化。然后,传递性属性完善了我们的论点。

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