随机试验中的分配隐藏:防范破译
Kenneth F Schulz1, David A Grimes
1Family Health International, PO Box 13950, 27709, Research Triangle Park, NC, USA. KSchulz@fhi.org
Lancet (London, England)
|February 28, 2002
概括
适当的分配隐藏对于公正的随机对照试验至关重要. 没有它,试验结果可能会扭曲,强调需要聪明的试验设计来防止操纵.
科学领域:
- 临床试验方法论 临床试验方法论
- 生物统计学 生物统计学
- 研究诚信研究诚信
背景情况:
- 随机对照试验 (RCT) 是基于证据的医学的基础.
- 适当的分配隐藏对于保持RCT的完整性至关重要.
- 随机分配序列的颠覆可能发生,如果隐藏是不充分的.
研究的目的:
- 突出在RCT中强有力的分配隐藏的重要性.
- 讨论分配隐藏不足所带来的挑战和影响.
- 强调需要聪明的试验设计,以防止偏见.
主要方法:
- 摘要讨论了临床试验设计中分配隐藏的原则.
- 它检查了随机分配序列的颠覆潜力.
- 它回顾了不充分隐对治疗效果估计的影响.
主要成果:
- 不充分的分配隐导致对治疗效果的偏见估计,通常是夸大.
- 对分配的改破坏了试验结果的有效性和可靠性.
- 需要聪明的设计策略来防止调查人员破译分配序列.
结论:
- 有效的分配隐蔽对于免疫试验对选择和混偏见至关重要.
- 试验设计人员必须保持警,并采用复杂的方法来确保隐藏.
- 报告基线比较很重要,但不建议对这些进行假设测试.
相关概念视频
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Simple randomization
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Simple randomization
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