Buderer N M
St. Vincent Medical Center, Research Department, Toledo, OH 43608, USA.
Acad Emerg Med. 1996 Sep;3(9):895-900. doi: 10.1111/j.1553-2712.1996.tb03538.x.
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.
在旨在评估诊断测试的研究中，仔细考虑与样本量选择相关的统计问题对于获得有意义的结果至关重要。在评估诊断测试筛查疾病的能力时，灵敏度、特异度和预测值等参数是值得关注的。研究样本量要求可根据临床上可接受的精确度、灵敏度和特异度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可指导研究人员在给定特定精确度和估计疾病患病率的情况下，决定在旨在估计诊断测试的灵敏度和特异度的研究中抽取多少受试者作为样本。
