随机试验中的失明:隐藏谁得到了什么
Kenneth F Schulz1, David A Grimes
1Family Health International, PO Box 13950, Research Triangle Park, NC 27709, USA. KSchulz@fhi.org
Lancet (London, England)
|March 7, 2002
概括
临床试验中的失明通常被误解,单盲和双盲等术语具有不同的含义. 适当报告谁是盲目的,以及如何对评估研究中的偏见减少至关重要.
科学领域:
- 临床试验方法论 临床试验方法论
- 研究诚信研究诚信
- 减少偏见的策略
背景情况:
- 研究中的失明有着悠久的历史,但术语经常被许多研究人员误解.
- 在遮蔽和分配隐藏之间存在常见的混,表明这两个概念缺乏清晰度.
- 在全球范围内,对单盲,双盲和三盲等术语的不同解释仍然存在.
研究的目的:
- 澄清随机对照试验中盲目的定义和重要性.
- 解决关于盲目化术语及其应用的常见误解.
- 强调需要在研究出版物中明确报告盲目化方法.
主要方法:
- 该研究回顾了临床研究中盲目的历史背景和常见解释.
- 它分析了对减少信息偏见,改善合规性和最大限度地减少共同干预的盲目的影响.
- 文本讨论了盲目化和分配隐之间的区别.
主要成果:
- 盲目的目的是防止参与者,调查人员和评估人员知道分配的干预,以减少偏见.
- 虽然双盲 (参与者,调查人员,评估人员) 表示强有力的设计,但这并不是试验质量的唯一决定因素.
- 明确报告谁被蒙蔽以及如何被蒙蔽,比仅仅依赖术语更有价值.
结论:
- 研究人员应该清楚地报告失明程序,包括谁被失明以及使用的方法.
- 除了死亡等客观结果之外,结果评估者盲目化尤为重要.
- 对于声称盲目的研究,如果没有明确,详细的报告来确保减少偏见,那么怀疑是有必要的.
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