Shen Y, Wu D, Zelen M
Department of Biostatistics, M. D. Anderson Cancer Center, The University of Texas, Houston 77030, USA.
Biometrics. 2001 Dec;57(4):1009-17. doi: 10.1111/j.0006-341x.2001.01009.x.
Consider two diagnostic procedures having binary outcomes. If one of the tests results in a positive finding, a more definitive diagnostic procedure will be administered to establish the presence or absence of a disease. The use of both tests will improve the overall screening sensitivity when the two tests are independent, compared with employing two tests that are positively correlated. We estimate the correlation coefficient of the two tests and derive statistical methods for testing the independence of the two diagnostic procedures conditional on disease status. The statistical tests are used to investigate the independence of mammography and clinical breast exams aimed at establishing the benefit of early detection of breast cancer. The data used in the analysis are obtained from periodic screening examinations of three randomized clinical trials of breast cancer screening. Analysis of each of these trials confirms the independence of the clinical breast and mammography examinations. Based on these three large clinical trials, we conclude that a clinical breast exam considerably increases the overall sensitivity relative to screening with mammography alone and should be routinely included in early breast cancer detection programs.
考虑两种具有二元结果的诊断程序。如果其中一项检测结果呈阳性，将采用更具确定性的诊断程序来确定疾病的存在与否。当两项检测相互独立时，与使用正相关的两项检测相比，同时使用这两项检测将提高总体筛查敏感性。我们估计两项检测的相关系数，并推导在疾病状态条件下检验两种诊断程序独立性的统计方法。这些统计检验用于研究乳房X线摄影和临床乳腺检查的独立性，目的是确定早期发现乳腺癌的益处。分析中使用的数据来自三项乳腺癌筛查随机临床试验的定期筛查检查。对这些试验中的每一项进行分析均证实了临床乳腺检查和乳房X线摄影检查的独立性。基于这三项大型临床试验，我们得出结论，相对于单独使用乳房X线摄影进行筛查，临床乳腺检查可显著提高总体敏感性，应常规纳入早期乳腺癌检测项目。
