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临床研究结局指标选择与样本量估计

曾于珍 陈世耀

曾于珍, 陈世耀. 临床研究结局指标选择与样本量估计[J]. 协和医学杂志, 2018, 9(1): 87-92. doi: 10.3969/j.issn.1674-9081.2018.01.016
引用本文: 曾于珍, 陈世耀. 临床研究结局指标选择与样本量估计[J]. 协和医学杂志, 2018, 9(1): 87-92. doi: 10.3969/j.issn.1674-9081.2018.01.016
Yu-jen TSENG, Shi-yao CHEN. Outcome Measure Selection and Sample Size Estimation for Clinical Research[J]. Medical Journal of Peking Union Medical College Hospital, 2018, 9(1): 87-92. doi: 10.3969/j.issn.1674-9081.2018.01.016
Citation: Yu-jen TSENG, Shi-yao CHEN. Outcome Measure Selection and Sample Size Estimation for Clinical Research[J]. Medical Journal of Peking Union Medical College Hospital, 2018, 9(1): 87-92. doi: 10.3969/j.issn.1674-9081.2018.01.016

临床研究结局指标选择与样本量估计

doi: 10.3969/j.issn.1674-9081.2018.01.016
基金项目: 

上海市科学技术委员会科技创新项目 15411950500

详细信息
    通讯作者:

    陈世耀 电话:021-64041990, E-mail:chen.shiyao@zs-hospital.sh.cn

  • 中图分类号: R-1

Outcome Measure Selection and Sample Size Estimation for Clinical Research

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  • 摘要: 结局指标的选择应考虑研究设计、预期结果及可用资源。目前常用的结局指标包括生物学指标、卫生经济学评价及生活质量评价。结局指标、观察方法、评价方法与研究设计相关并影响样本量估计。样本量估计需同时考虑检验效力、差异显著水平、效应量及连续变量中的标准差值。临床研究中, 合理的结局指标选择与样本量估计可显著提高临床研究结果的可靠性及可行性。
  • 图  1  药物治疗肝硬化门脉高压可选择的结局指标及其临床重要性

    HVPG:肝静脉楔压

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出版历程
  • 收稿日期:  2017-12-05
  • 刊出日期:  2018-01-30

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