敏感性和特异性分析的最小样本量要求。
Requirements for Minimum Sample Size for Sensitivity and Specificity Analysis.
作者信息
Bujang Mohamad Adam, Adnan Tassha Hilda
机构信息
Biostatistics Unit, National Clinical Research Centre , Ministry of Health, Malaysia .
出版信息
J Clin Diagn Res. 2016 Oct;10(10):YE01-YE06. doi: 10.7860/JCDR/2016/18129.8744. Epub 2016 Oct 1.
Abstract
Sensitivity and specificity analysis is commonly used for screening and diagnostic tests. The main issue researchers face is to determine the sufficient sample sizes that are related with screening and diagnostic studies. Although the formula for sample size calculation is available but concerning majority of the researchers are not mathematicians or statisticians, hence, sample size calculation might not be easy for them. This review paper provides sample size tables with regards to sensitivity and specificity analysis. These tables were derived from formulation of sensitivity and specificity test using Power Analysis and Sample Size (PASS) software based on desired type I error, power and effect size. The approaches on how to use the tables were also discussed.
摘要
敏感性和特异性分析常用于筛查和诊断测试。研究人员面临的主要问题是确定与筛查和诊断研究相关的足够样本量。尽管有样本量计算的公式，但由于大多数研究人员不是数学家或统计学家，因此，样本量计算对他们来说可能并不容易。这篇综述文章提供了关于敏感性和特异性分析的样本量表。这些表格是基于所需的I型错误、检验效能和效应量，使用功效分析和样本量（PASS）软件制定敏感性和特异性检验而得出的。还讨论了如何使用这些表格的方法。
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本文引用的文献
1
Risk Factors and Prediction Models for Retinopathy of Prematurity.
Malays J Med Sci. 2015 Sep;22(5):57-63.
2
Validation of the Malay version of Berlin questionaire to identify Malaysian patients for obstructive sleep apnea.
Malays Fam Physician. 2013 Apr 30;8(1):5-11. eCollection 2013.
3
Sensitivity and specificity of reflectance-mode confocal microscopy for in vivo diagnosis of basal cell carcinoma: a multicenter study.
J Am Acad Dermatol. 2004 Dec;51(6):923-30. doi: 10.1016/j.jaad.2004.06.028.
4
Glioma grading: sensitivity, specificity, and predictive values of perfusion MR imaging and proton MR spectroscopic imaging compared with conventional MR imaging.
AJNR Am J Neuroradiol. 2003 Nov-Dec;24(10):1989-98.
5
Screening for depression in primary care with two verbally asked questions: cross sectional study.
BMJ. 2003 Nov 15;327(7424):1144-6. doi: 10.1136/bmj.327.7424.1144.
6
Establishment of standardised SLA/LP immunoassays: specificity for autoimmune hepatitis, worldwide occurrence, and clinical characteristics.
Gut. 2002 Aug;51(2):259-64. doi: 10.1136/gut.51.2.259.
7
The sensitivity and specificity of scanning laser polarimetry in the detection of glaucoma in a clinical setting.
Ophthalmology. 2001 May;108(5):899-904. doi: 10.1016/s0161-6420(00)00652-7.
8
Estimation of sensitivity and specificity of diagnostic tests and disease prevalence when the true disease state is unknown.
Prev Vet Med. 2000 May 30;45(1-2):61-81. doi: 10.1016/s0167-5877(00)00117-3.
9
Using the Berlin Questionnaire to identify patients at risk for the sleep apnea syndrome.
Ann Intern Med. 1999 Oct 5;131(7):485-91. doi: 10.7326/0003-4819-131-7-199910050-00002.
10
Statistical methodology: I. Incorporating the prevalence of disease into the sample size calculation for sensitivity and specificity.
Acad Emerg Med. 1996 Sep;3(9):895-900. doi: 10.1111/j.1553-2712.1996.tb03538.x.
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