Breast cancer detection rate: Designing imaging trials to demonstrate improvements
Breast cancer detection rate: Designing imaging trials to demonstrate improvements
复制标题
DOI：
10.1148/radiol.2432060253
复制
发表时间：
2007-05-01
期刊：
影响因子：
19.7
通讯作者：
Schmidt, Robert A.
中科院分区：
文献类型：
--
作者：
Jiang, Yulei;Miglioretti, Diana L.;Schmidt, Robert A.
目的：估计筛查乳房x光检查癌症检出率的变异性程度及其对一项用于测量癌症检出率变化的新筛查方式的假设临床试验的影响。材料和方法：每个注册中心和统计协调中心都获得了机构审查委员会的批准，并批准了同意程序或放弃同意，以登记参与者、链接数据和进行分析研究。本研究符合HIPAA标准。作者估计了参加乳腺癌监测联盟的510名美国放射科医生从1996年到2002年阅读的289132张筛查乳房x光片（9030种癌症）的个体放射科医生的乳腺癌检出率分布。然后，他们计算了筛查乳房x光检查和多名放射科医生试验预期的乳腺癌检出率的分布，以及假设的新模式的类似分布，即每1000次筛查检查中每个读者增加一个癌症。计算统计功率。结果：个体放射科医生的平均乳房x线筛查癌症检出率为每1000次检查3.91例（标准差1.93，范围0.25-13.75）。为了达到80%的检测能力，即假设每1000次筛查检查中每名扫描者能额外检测出一种癌症，一项将新模式与标准乳房x光检查进行比较的试验将需要至少25名放射科医生每人阅读至少8000次筛查检查的图像，或者91名放射科医生每人阅读1000-2000次检查的图像。结论：在平均风险筛查人群中，乳腺癌患病率较低，而观察到的癌症检出率在放射科医生之间存在较大差异，这表明新技术要在临床试验中显示出癌症检出率的显著提高，就需要非常大的放射科医生和患者样本。(c) RSNA， 2007年。
Purpose: To estimate the extent of variability in screening mammography cancer detection rates and its effect on a hypothetical clinical trial of a new screening modality used to measure changes in cancer detection rate.Materials and Methods: Each registry and the statistical coordinating center received institutional review board approval along with approval for consenting processes or a waiver of consent to enroll participants, link data, and perform analytic studies. This study was HIPAA compliant. The authors estimated the distribution of individual radiologists' breast cancer detection rates for 2 289 132 screening mammograms ( 9030 cancers) read by 510 radiologists in the United States who participated in the Breast Cancer Surveillance Consortium from 1996 through 2002. They then computed the distributions of breast cancer detection rates expected from a trial of screening mammography and multiple radiologists, as well as similar distributions for a hypothetical new modality that depicts one additional cancer per reader per 1000 screening examinations. Statistical power was calculated.Results: The mean screening mammography cancer detection rate for individual radiologists was 3.91 cancers ( standard deviation, 1.93; range, 0.25-13.75) per 1000 examinations. To achieve 80% power to detect a hypothetical increase of one additional cancer detected per reader per 1000 screening examinations, a trial in which a new modality was compared with standard mammography would require at least 25 radiologists each reading the images of at least 8000 screening examinations or 91 radiologists each reading the images of 1000-2000 examinations.Conclusion: The low breast cancer prevalence in an average-risk screening population and the large interradiologist variability in the observed cancer detection rate suggest that for new technologies to demonstrate significant improvement in cancer detection rate in a clinical trial, very large samples of both radiologists and patients will be required. (c) RSNA, 2007.