Statistical issues arising in the Women's Health Initiative
Statistical issues arising in the Women's Health Initiative
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DOI：
10.1111/j.0006-341x.2005.454_1.x
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发表时间：
2005-12-01
期刊：
影响因子：
1.9
通讯作者：
Anderson, GL
中科院分区：
文献类型：
--
作者：
Prentice, RL;Pettinger, M;Anderson, GL
简要概述了妇女健康倡议（WHI）临床试验和观察性研究的设计，并总结了绝经后激素治疗临床试验的结果。自1992年成立以来，世卫组织遇到了一些统计问题，需要进一步发展方法。其中包括用于饮食和身体活动评估的测量误差建模和分析程序；当治疗可能对多种临床结果产生有利或不利影响时，采用临床试验监测方法；高维基因组学和蛋白质组学数据的研究设计和分析程序；而失效时间数据分析程序中，治疗组的风险比与时间有关。在解决WHI临床试验和观察性研究结果在绝经后激素治疗和心血管疾病方面的差异方面，最后一个主题似乎很重要。
A brief overview of the design of the Women's Health Initiative (WHI) clinical trial and observational study is provided along with a summary of results from the postmenopausal hormone therapy clinical trial components. Since its inception in 1992, the WHI has encountered a number of statistical issues where further methodology developments are needed. These include measurement error modeling and analysis procedures for dietary and physical activity assessment; clinical trial monitoring methods when treatments may affect multiple clinical outcomes, either beneficially or adversely; study design and analysis procedures for high-dimensional genomic and proteomic data; and failure time data analysis procedures when treatment group hazard ratios are time dependent. This final topic seems important in resolving the discrepancy between WHI clinical trial and observational study results on postmenopausal hormone therapy and cardiovascular disease.