Randomization and allocation concealment: a practical guide for researchers
Randomization and allocation concealment: a practical guide for researchers
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DOI：
10.1016/j.jcrc.2005.04.005
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发表时间：
2005-06-01
影响因子：
3.7
通讯作者：
Simpson, F
中科院分区：
文献类型：
--
作者：
Doig, GS;Simpson, F
尽管随机对照试验是目前客观评估新疗法影响的最重要工具，但随机化本身往往执行不力且报告不完整。将患者随机分为治疗组的主要目的是防止研究人员、临床医生和患者预测并从而影响哪些患者将接受哪些治疗。通过向研究人员和参与者隐瞒即将到来的分配序列，可以消除这种重要的偏差来源。尽管已知有许多随机化方法可以有效隐藏随机化序列，但使用顺序编号的不透明密封信封 (SNOSE) 既便宜又有效。本教程的目的是描述准备 SNOSE 的分步过程。我们将概述如何准备 SNOSE 以在一项试验中保持分配隐藏，该试验 (a) 使用无限制（简单）随机化，(b) 根据一个因素对随机化进行分层，(e) 使用排列区组，以及 (d) 在多个研究地点进行。 (c) 2005 Elsevier Inc. 保留所有权利。
Although the randomized controlled trial is the most important tool currently available to objectively assess the impact of new treatments, the act of randomization itself is often poorly conducted and incompletely reported. The primary purpose of randomizing patients into treatment arms is to prevent researchers, clinicians, and patients from predicting, and thus influencing, which patients will receive which treatments. This important source of bias can be eliminated by concealing the upcoming allocation sequence from researchers and participants. Although there are many approaches to randomization that are known to effectively conceal the randomization sequence, the use of sequentially numbered, opaque sealed envelopes (SNOSE) is both cheap and effective. The purpose of this tutorial is to describe a step-by-step process for the preparation of SNOSE. We will outline how to prepare SNOSE to preserve allocation concealment in a trial that (a) uses unrestricted (simple) randomization, (b) stratifies randomization on one factor, (e) uses permuted blocks and, and (d) is conducted at more than I study site. (c) 2005 Elsevier Inc. All rights reserved.