Bias correction optimizes the choice of screening test for early cancer detection

偏差校正优化了早期癌症检测筛查测试的选择

• 批准号: 7752747
• 负责人: TODD A ALONZO
• 金额: $ 9.24万
• 依托单位: UNIVERSITY OF COLORADO DENVER/HSC DENVER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7752747
• 关键词: Adopted; Area; Area Under Curve; Biopsy; Breast Cancer Early Detection; Cancer Detection; Cessation of life; Clinical Trials; Clinical Trials Design; Computer software; Confidence Intervals; Data; Detection; Diagnosis; Disease; Ensure; Epidemiologist; Film; Goals; Lead; Malignant Neoplasms; Mammography; Measures; Methodology; Methods; Metric; Modality; Morbidity - disease rate; Pain; Participant; Physicians; Publications; Receiver Operating Characteristics; Recommendation; Research; Research Design; Research Personnel; Screening for cancer; Screening procedure; Sensitivity and Specificity; Statistical Methods; Techniques; Test Result; Testing; Writing; base; comparative; design; diagnostic accuracy; digital; improved; malignant breast neoplasm; meetings; mortality; web site; Adopted; Area; Area Under Curve; Biopsy; Breast Cancer Early Detection; Cancer Detection; Cessation of life; Clinical Trials; Clinical Trials Design; Computer software; Confidence Intervals; Data; Detection; Diagnosis; Disease; Ensure; Epidemiologist; Film; Goals; Lead; Malignant Neoplasms; Mammography; Measures; Methodology; Methods; Metric; Modality; Morbidity - disease rate; Pain; Participant; Physicians; Publications; Receiver Operating Characteristics; Recommendation; Research; Research Design; Research Personnel; Screening for cancer; Screening procedure; Sensitivity and Specificity; Statistical Methods; Techniques; Test Result; Testing; Writing; base; comparative; design; diagnostic accuracy; digital; improved; malignant breast neoplasm; meetings; mortality; web site

DESCRIPTION (provided by applicant): Cancer screening is used for the early detection of cancer. The goal in screening is to detect more cancers and avoid the pain and suffering of incorrect diagnoses. As new cancer screening tests are developed, they are compared to existing modalities. The most common statistical approach for comparing screening tests in paired trials is to examine the difference between the areas under the receiver operating characteristic (ROC) curves, a summary measure of both sensitivity and specificity. However, this approach may cause bias severe enough to lead to the wrong decision as to which screening test is better. The bias arises because some cancer is clinically occult, and is not observed during the trial period. This inflates the observed sensitivity of the screening tests. The bias is worsened if the sensitivity is inflated differentially for the two screening tests being compared. This occurs when a different fraction of participants with disease are referred to biopsy by each screening test. Because increasing the rate of biopsy or making other changes in the design is ethically impossible, new statistical methods are needed to correct for this bias. We propose new techniques to test for the presence of bias in paired screening trials, to provide unbiased estimates of sensitivity, specificity, and area under the curve, and to allow correct decisions as to which screening test has the best diagnostic accuracy. The utility of the methods will be demonstrated using data from the Lewin et al., 2002 trial, a comparison of the diagnostic accuracy of digital and film mammography. Publications, presentations and interactive software will make our findings accessible to physicians, epidemiologists, statisticians and other study designers. Unbiased clinical trials will identify the screening tests with the best diagnostic accuracy. In turn, more accurate screening tests will improve cancer detection, reduce false negative diagnoses, and ultimately reduce cancer morbidity and mortality.

描述（由申请人提供）： 癌症筛查用于癌症的早期检测。筛查的目标是检测更多的癌症，并避免诊断不正确的痛苦和痛苦。随着新的癌症筛查测试，它们与现有方式进行了比较。在配对试验中比较筛选测试的最常见统计方法是检查接收器操作特征（ROC）曲线下的区域之间的差异，这是灵敏度和特异性的摘要度量。但是，这种方法可能会导致偏见严重，从而导致错误的决定，即哪种筛查测试更好。由于某些癌症在临床上是神秘的，因此之所以出现偏见，在试验期间未观察到。这夸大了观察到的筛选测试的灵敏度。如果对两个筛选测试的敏感性有差异化，则偏差会恶化。当每次筛查测试将不同部分的疾病参与者引用活检时，就会发生这种情况。由于在道德上增加了活检率或在设计上进行其他改变是不可能的，因此需要新的统计方法来纠正这种偏见。我们提出了新技术来测试配对筛选试验中存在偏差，以提供曲线下灵敏度，特异性和面积的无偏估计，并允许正确决定哪种筛查测试具有最佳的诊断精度。该方法的实用性将使用Lewin等人，2002年试验的数据进行证明，该试验比较了数字和电影X线摄影的诊断准确性。出版物，演示和交互式软件将使我们的发现可供医师，流行病学家，统计学家和其他研究设计师访问。公正的临床试验将以最佳的诊断准确性确定筛查测试。反过来，更准确的筛查测试将改善癌症的检测，减少假阴性诊断，并最终降低癌症的发病率和死亡率。