Statistical methodology .1. Incorporating the prevalence of disease into the sample size calculation for sensitivity and specificity
Statistical methodology .1. Incorporating the prevalence of disease into the sample size calculation for sensitivity and specificity
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DOI：
10.1111/j.1553-2712.1996.tb03538.x
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发表时间：
1996-09-01
影响因子：
4.4
通讯作者：
Buderer, NMF
中科院分区：
文献类型：
--
作者：
Buderer, NMF
仔细考虑与样本量选择相关的统计问题对于在旨在评估诊断测试的研究中获得有意义的结果至关重要。当评估诊断测试筛查疾病的能力时，参数灵敏度、特异性和预测值是感兴趣的。研究样本量要求可以根据临床可接受的精确度、敏感性和特异性的假设值以及目标人群中疾病的估计患病率来计算，本文中的简单方法和表格指导研究人员在决定在设计用于估计诊断测试的敏感性和特异性的研究中抽取多少受试者时，给定特定的精度和估计的疾病流行率。
Careful consideration of statistical issues related to the choice of a sample size is critical for achieving meaningful results in research studies designed to evaluate diagnostic tests. When assessing the ability of a diagnostic test to screen for disease, the parameters sensitivity, specificity, and predictive values are of interest. Study sample size requirements can be calculated based on a clinically acceptable degree of precision, the hypothesized values of sensitivity and specificity, and the estimated prevalence of disease in the target population, The simple methods and tables in this paper guide the researcher when deciding how many subjects to sample in a study designed to estimate both the sensitivity and the specificity of a diagnostic test, given a specified precision and estimated disease prevalence.