Assessment of blinding in clinical trials
Assessment of blinding in clinical trials
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DOI：
10.1016/j.cct.2003.10.016
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发表时间：
2004-04-01
期刊：
影响因子：
--
通讯作者：
Davis, CE
中科院分区：
文献类型：
--
作者：
Bang, HJ;Ni, LY;Davis, CE
盲法的成功是许多临床试验中的一个基本问题。如果违背了这一重要假设，审判的有效性就可能受到质疑。尽管每年进行数千项表面上的双盲试验，研究人员也承认盲法的重要性，但很少讨论衡量盲法有效性的尝试。几篇已发表的论文提出了评价设盲成功的方法，但这些方法都不常用或被视为标准。本文探讨了一种新的方法来评估盲法在临床试验中的成功。拟定设盲指数的范围为-1至1，1表示完全不设盲，0表示完全设盲，-1表示可能与揭盲相关的相反猜测。它能够检测相对较低程度的盲法、反应偏倚和两组中的不同行为。所提出的方法是适用于一组老年人的降胆固醇药物的临床试验。(C)2004年爱思唯尔公司All rights reserved.
Success of blinding is a fundamental issue in many clinical trials. The validity of a trial may be questioned if this important assumption is violated. Although thousands of ostensibly double-blind trials are conducted annually and investigators acknowledge the importance of blinding, attempts to measure the effectiveness of blinding are rarely discussed. Several published papers proposed ways to evaluate the success of blinding, but none of the methods are commonly used or regarded as standard. This paper investigates a new approach to assess the success of blinding in clinical trials. The blinding index proposed is scaled to an interval of -1 to 1, 1 being complete lack of blinding, 0 being consistent with perfect blinding and -1 indicating opposite guessing which may be related to unblinding. It has the ability to detect a relatively low degree of blinding, response bias and different behaviors in two arms. The proposed method is applied to a clinical trial of cholesterol-lowering medication in a group of elderly people. (C) 2004 Elsevier Inc. All rights reserved.