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随机试验中的样本大小偏差:排除和丢失和失控
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 13, 2002
概括
适当的临床试验分析需要包括所有随机参与者. 错误的排除,即使是善意的排除,也会破坏研究的有效性和概括性.
科学领域:
- 临床试验 临床试验
- 生物统计学 生物统计学
- 研究方法研究方法研究方法学
背景情况:
- 随机化对于在临床试验中进行公正的治疗比较至关重要.
- 参与者坚持和保留是影响试验完整性的重大挑战.
- 随机化后的排除可能会损害结果的有效性.
研究的目的:
- 强调包括所有随机参与者在初级分析中的重要性.
- 突出随机化后排除参与者引入的潜在偏见.
- 引导研究人员了解参与者保留和数据分析的最佳实践.
主要方法:
- 讨论了初级结果的治疗意图 (ITT) 分析的原则.
- 解释了资格标准和随机化后排除的影响.
- 建议策略,以最大限度地保持参与者和透明的报告.
主要成果:
- 在随机化后排除参与者,无论原因如何,都可能引入偏见.
- 治疗意图分析是初级分析的黄金标准,以保持随机化的好处.
- 二次分析 (按协议,按处理) 应该清楚地标识为非随机比较.
结论:
- 严格遵守包括所有随机参与者在初级分析中的规定对于有效的临床试验结果至关重要.
- 积极采取措施,最大限度地保持参与者和透明的报告至关重要.
- 错误处理排除提出了严重的方法挑战,这可能会破坏试验有效性.
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