首页> 外文期刊>The Journal of the American Association of Gynecologic Laparoscopists >Randomization in controlled clinical trials: why the flip of a coin is so important.
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Randomization in controlled clinical trials: why the flip of a coin is so important.

机译:对照临床试验中的随机性:为什么掷硬币如此重要。

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摘要

The randomized controlled trial (RCT) is considered the highest level of medical evidence. In this brief overview, we discuss several key principles of the RCT. First, balance is paramount. Comparison groups must have similar proportions of participants with "important" prognostic and confounding factors. Randomization may or may not achieve this balance; if it does not, statistical adjustments should be used. Second, a statistical analysis should emphasize comparability and not mask dissimilarity. If the trial was indeed randomized, certain analysis techniques, such as an intention to treat analysis, should always be presented. Third, additional bias-reducing techniques, such as concealing treatment assignments from treating physicians and participants (i.e., masking) and using clearly defined exclusion and inclusion criteria, should be used wherever possible.
机译:随机对照试验(RCT)被认为是医学证据的最高水平。在此简短概述中,我们讨论了RCT的几个关键原则。首先,平衡至上。比较组必须具有相似比例的参与者,这些参与者具有“重要的”预后和混杂因素。随机化可能会或可能不会达到这种平衡;如果不是,则应使用统计调整。其次,统计分析应强调可比性,而不应掩盖不相似之处。如果试验确实是随机的,则应始终提供某些分析技术,例如治疗分析的意图。第三,应尽可能使用其他减少偏见的技术,例如对主治医生和参与者隐瞒治疗任务(即掩蔽)并使用明确定义的排除和纳入标准。

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