Lehman Constance D, Wellman Robert D, Buist Diana S M, Kerlikowske Karla, Tosteson Anna N A, Miglioretti Diana L
Department of Radiology, Massachusetts General Hospital, Boston.
Group Health Research Institute, Seattle, Washington.
JAMA Intern Med. 2015 Nov;175(11):1828-37. doi: 10.1001/jamainternmed.2015.5231.
After the US Food and Drug Administration (FDA) approved computer-aided detection (CAD) for mammography in 1998, and the Centers for Medicare and Medicaid Services (CMS) provided increased payment in 2002, CAD technology disseminated rapidly. Despite sparse evidence that CAD improves accuracy of mammographic interpretations and costs over $400 million a year, CAD is currently used for most screening mammograms in the United States.
To measure performance of digital screening mammography with and without CAD in US community practice.
DESIGN, SETTING, AND PARTICIPANTS: We compared the accuracy of digital screening mammography interpreted with (n = 495 818) vs without (n = 129 807) CAD from 2003 through 2009 in 323 973 women. Mammograms were interpreted by 271 radiologists from 66 facilities in the Breast Cancer Surveillance Consortium. Linkage with tumor registries identified 3159 breast cancers in 323 973 women within 1 year of the screening.
Mammography performance (sensitivity, specificity, and screen-detected and interval cancers per 1000 women) was modeled using logistic regression with radiologist-specific random effects to account for correlation among examinations interpreted by the same radiologist, adjusting for patient age, race/ethnicity, time since prior mammogram, examination year, and registry. Conditional logistic regression was used to compare performance among 107 radiologists who interpreted mammograms both with and without CAD.
Screening performance was not improved with CAD on any metric assessed. Mammography sensitivity was 85.3% (95% CI, 83.6%-86.9%) with and 87.3% (95% CI, 84.5%-89.7%) without CAD. Specificity was 91.6% (95% CI, 91.0%-92.2%) with and 91.4% (95% CI, 90.6%-92.0%) without CAD. There was no difference in cancer detection rate (4.1 in 1000 women screened with and without CAD). Computer-aided detection did not improve intraradiologist performance. Sensitivity was significantly decreased for mammograms interpreted with vs without CAD in the subset of radiologists who interpreted both with and without CAD (odds ratio, 0.53; 95% CI, 0.29-0.97).
Computer-aided detection does not improve diagnostic accuracy of mammography. These results suggest that insurers pay more for CAD with no established benefit to women.
1998年美国食品药品监督管理局（FDA）批准了用于乳腺X线摄影的计算机辅助检测（CAD）技术，2002年美国医疗保险和医疗补助服务中心（CMS）提高了对其的报销额度，此后CAD技术迅速普及。尽管几乎没有证据表明CAD能提高乳腺X线摄影解读的准确性，且每年成本超过4亿美元，但目前美国大多数乳腺筛查X线摄影都使用了CAD。
评估在美国社区实践中，使用和不使用CAD的数字乳腺筛查X线摄影的性能。
设计、地点和参与者：我们比较了2003年至2009年期间，323973名女性中使用CAD（n = 495818）和不使用CAD（n = 129807）的数字乳腺筛查X线摄影的准确性。乳腺X线摄影由乳腺癌监测联盟中66个机构的271名放射科医生进行解读。与肿瘤登记处的数据关联显示，在筛查后的1年内，323973名女性中有3159例乳腺癌。
使用逻辑回归模型，并纳入放射科医生特定的随机效应以考虑同一位放射科医生解读的检查之间的相关性，同时对患者年龄、种族/族裔、上次乳腺X线摄影后的时间、检查年份和登记处等因素进行调整，来模拟乳腺X线摄影的性能（敏感性、特异性以及每1000名女性中的筛查发现癌和间期癌）。使用条件逻辑回归比较了107名既解读过使用CAD的乳腺X线摄影也解读过不使用CAD的乳腺X线摄影的放射科医生之间的数据。
在评估的任何指标上，CAD都未提高筛查性能。使用CAD时乳腺X线摄影的敏感性为85.3%（95%CI，83.6% - 86.9%），不使用CAD时为87.3%（95%CI，84.5% - 89.7%）。特异性使用CAD时为91.6%（95%CI，91.0% - 92.2%），不使用CAD时为91.4%（95%CI，9生 0.6% - 92.0%）。癌症检出率在使用和不使用CAD的筛查女性中无差异（每1000名女性中均为4.1例）。计算机辅助检测并未提高放射科医生内部的性能。在既解读过使用CAD也解读过不使用CAD的放射科医生子集中，使用CAD解读的乳腺X线摄影的敏感性显著低于不使用CAD的情况（优势比，0.53；95%CI，0.29 - 0.97）。
计算机辅助检测并未提高乳腺X线摄影的诊断准确性。这些结果表明，保险公司为CAD支付了更多费用，但对女性并没有既定的益处。
