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统计估计与临床试验。

Statistical estimates and clinical trials.

作者信息

Braitman L E

机构信息

Office for Research Development, Albert Einstein Medical Center, Philadelphia, Pennsylvania 19141.

出版信息

J Biopharm Stat. 1993 Sep;3(2):249-56. doi: 10.1080/10543409308835063.

DOI:10.1080/10543409308835063
PMID:8220407
Abstract

Statistical estimates and significance tests address distinct (but related) questions using the same data. Point estimates and confidence intervals of differences are statistical estimates that address: "How LARGE is the difference in the population of interest?" A significance test addresses the question: "How LIKELY was the difference to have occurred by chance?" Because p-values deal with the existence of a real nonzero difference between treatments but not the size of that treatment difference, they cannot be used to assess clinical (practical) significance. A confidence interval is a range of values used to infer both the size of a difference and the uncertainty of the estimate. Examples illustrate how confidence intervals help us assess both the clinical significance and the statistical significance of an observed difference. The point estimate is the outcome difference actually observed in the study sample; it is also the best single-number estimate of the unknown difference in the sampled population. Point estimates, confidence intervals, and p-values extract complementary information from study data and should all be reported for major results.

摘要

统计估计和显著性检验使用相同的数据来解决不同(但相关)的问题。差异的点估计和置信区间是解决以下问题的统计估计:“在感兴趣的总体中差异有多大?” 显著性检验解决的问题是:“该差异偶然发生的可能性有多大?” 由于p值处理的是治疗之间存在实际非零差异的情况,而不是该治疗差异的大小,因此它们不能用于评估临床(实际)意义。置信区间是用于推断差异大小和估计不确定性的一系列值。示例说明了置信区间如何帮助我们评估观察到的差异的临床意义和统计意义。点估计是在研究样本中实际观察到的结果差异;它也是抽样总体中未知差异的最佳单数值估计。点估计、置信区间和p值从研究数据中提取互补信息,对于主要结果都应予以报告。

相似文献

1
Statistical estimates and clinical trials.统计估计与临床试验。
J Biopharm Stat. 1993 Sep;3(2):249-56. doi: 10.1080/10543409308835063.
2
Confidence interval construction for a difference between two dependent intraclass correlation coefficients.两个相关组内相关系数之差的置信区间构建。
Stat Med. 2009 Mar 30;28(7):1041-53. doi: 10.1002/sim.3523.
3
[Clinical interpretation of statistical significance].[统计学显著性的临床解读]
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4
Confidence interval construction for proportion difference in small-sample paired studies.小样本配对研究中比例差异的置信区间构建
Stat Med. 2005 Dec 15;24(23):3565-79. doi: 10.1002/sim.2216.
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Confidence intervals and controlled clinical trials: incompatible tools for medical research.置信区间与对照临床试验:医学研究中不相容的工具。
J Biopharm Stat. 1993 Sep;3(2):257-63. doi: 10.1080/10543409308835064.
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Estimation of a parameter and its exact confidence interval following sequential sample size reestimation trials.序贯样本量重新估计试验后参数估计及其精确置信区间
Biometrics. 2004 Dec;60(4):910-8. doi: 10.1111/j.0006-341X.2004.00246.x.
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Statistical and clinical significance, and how to use confidence intervals to help interpret both.统计学和临床意义,以及如何使用置信区间来帮助解释这两者。
Aust Crit Care. 2010 May;23(2):93-7. doi: 10.1016/j.aucc.2010.03.001. Epub 2010 Mar 29.
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Exact statistical inference for group sequential trials.序贯试验的精确统计推断。
Biometrics. 1991 Dec;47(4):1399-408.
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Clinical versus statistical significance: interpreting P values and confidence intervals related to measures of association to guide decision making.临床意义与统计学意义:解读与关联度量相关的P值和置信区间以指导决策。
J Pharm Pract. 2010 Aug;23(4):344-51. doi: 10.1177/0897190009358774. Epub 2010 Apr 13.
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