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50岁以下乳腺癌筛查试验的样本量确定:基于人群与病例死亡率的方法。

Sample size determination for a trial of breast cancer screening under age 50: population versus case mortality approach.

作者信息

Peer P G, Verbeek A L, Straatman H

机构信息

Department of Medical Informatics, Epidemiology and Statistics, University of Nijmegen, The Netherlands.

出版信息

J Med Screen. 1995;2(2):90-3. doi: 10.1177/096914139500200207.

Abstract

OBJECTIVE

To determine the efficacy of screening for breast cancer in women aged 40 to 49.

METHODS

A large number of women will have to be enrolled to ensure adequate statistical power. Attention will be restricted to the deaths from breast cancer that occur among comparable groups of patients with breast cancer rather than to an analysis in which all women entering into the trial are considered at risk of dying from breast cancer (population mortality analysis). As the new trial is likely to be conducted in regions where screening has been established for all women from age 50 onward, comparability may be reached by including the breast cancers detected at the routine screening examination at age 50.

CONCLUSIONS

When comparability of cases can be reached, such a case mortality analysis requires 15-30% fewer women to be enrolled than a population approach.

摘要

目的

确定对40至49岁女性进行乳腺癌筛查的效果。

方法

必须招募大量女性以确保有足够的统计效力。关注将局限于乳腺癌患者可比组中发生的乳腺癌死亡情况,而非对所有进入试验的女性都视为有死于乳腺癌风险的分析(总体死亡率分析)。由于新试验可能在已为50岁及以上所有女性建立筛查的地区进行,通过纳入50岁常规筛查检查中发现的乳腺癌,可实现可比性。

结论

当能够实现病例可比性时,这种病例死亡率分析比总体方法所需招募的女性少15%至30%。

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