协和医学杂志

2018, v.9(01) 87-92

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临床研究结局指标选择与样本量估计
Outcome Measure Selection and Sample Size Estimation for Clinical Research

曾于珍;陈世耀;
TSENG Yu-jen;CHEN Shi-yao;Department of Gastroenterology,Zhongshan Hospital,Fudan University;Evidence-based Medicine,Fudan University;

摘要(Abstract):

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。
The selection of outcome measures should be based on the study design,anticipated results,and available resources. Biological parameters,analysis of economic benefits,and life-quality assessment are commonly employed outcome measures. Outcome measures,observation method,and evaluation method correlate with the study design and affect the sample size estimation. The sample size should be determined according to various factors,including power,significance level,expected effect sizes and standard deviation in the case of continuous variables. In clinical research,rationally selecting outcome measures and scientifically estimating sample sizes might markedly improve the reliability and feasibility of the study results.

关键词(KeyWords): 结局指标;样本量;临床研究
outcome measures;sample size;evidence-based medicine

Abstract:

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基金项目(Foundation): 上海市科学技术委员会科技创新项目(15411950500)

作者(Author): 曾于珍;陈世耀;
TSENG Yu-jen;CHEN Shi-yao;Department of Gastroenterology,Zhongshan Hospital,Fudan University;Evidence-based Medicine,Fudan University;

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