Intention-to-treat concept: A review.
Intention-to-treat concept: A review.
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DOI：
10.4103/2229-3485.83221
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发表时间：
2011-07
影响因子：
--
通讯作者：
Gupta SK
中科院分区：
文献类型：
--
作者：
Gupta SK
随机对照试验通常有两个主要的并发症，即，不遵守和缺失的结果。这个问题的一个潜在的解决方案是一个被称为意向治疗（ITT）分析的统计概念。ITT分析包括根据随机化治疗分配进行随机化的每例受试者。它忽略了不依从、方案偏离、退出和随机化后发生的任何事情。ITT分析维持了原始随机治疗分配产生的预后平衡。在ITT分析中，治疗效果的估计通常是保守的。如果可以获得所有随机化受试者的完整结局数据，则可以更好地应用ITT方法。符合方案人群定义为完成研究且无任何重大方案违背的ITT人群的子集。
Randomized controlled trials often suffer from two major complications, i.e., noncompliance and missing outcomes. One potential solution to this problem is a statistical concept called intention-to-treat (ITT) analysis. ITT analysis includes every subject who is randomized according to randomized treatment assignment. It ignores noncompliance, protocol deviations, withdrawal, and anything that happens after randomization. ITT analysis maintains prognostic balance generated from the original random treatment allocation. In ITT analysis, estimate of treatment effect is generally conservative. A better application of the ITT approach is possible if complete outcome data are available for all randomized subjects. Per-protocol population is defined as a subset of the ITT population who completed the study without any major protocol violations.