随机试验中的多重性I:终点和治疗方法
Kenneth F Schulz1, David A Grimes
1Family Health International, PO Box 13950, Research Triangle Park, NC 27709 USA.
Lancet (London, England)
|May 4, 2005
概括
调查性试验可以产生大量的比较,冒着重大发现的偏见报告的风险. 研究人员必须报告所有分析,虽然存在多重性的统计调整,但在关键的临床决策中应谨慎使用它们.
科学领域:
- 生物统计学 生物统计学
- 临床试验方法论 临床试验方法论
- 科学完整性 科学完整性
背景情况:
- 临床试验通常涉及多个终点和治疗组比较,导致潜在的多重性问题.
- 调查人员可以选择性地报告重大发现,如果不故意报告,那么它是非科学的,如果故意报告,那么它是欺诈性的.
研究的目的:
- 突出临床试验中的多重性问题.
- 讨论统计分析的选择性报告的影响.
- 评估多重性的统计调整的作用和局限性.
主要方法:
- 讨论与多重性相关的统计原则.
- 分析临床研究中选择性报告的实践.
- 在假设测试中对多重性的统计调整的评估.
主要成果:
- 数以千计的潜在比较可以从单个试验中产生.
- 对重要结果的选择性报告可能会扭曲科学结论.
- 对多重性的统计调整通常是原始的,但当临床决策取决于初级终点显著性时,它可能是有用的.
结论:
- 研究人员必须报告所有分析的终点和比较的治疗方法,以确保透明度.
- 对于读者来说,意识到潜在的分析报告不足对于读者来说至关重要.
- 应谨慎地应用多重性的统计调整,特别是当临床决策取决于特定的初级终点结果时.
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