Health Services Evaluation and Clinical Epidemiology Department, IMIM-Hospital del Mar, CIBER Epidemiología y Salud Pública, Passeig Marítim 25-29, 08008 Barcelona, Spain.
Radiology. 2011 Feb;258(2):388-95. doi: 10.1148/radiol.10100874.
To evaluate the effect of the introduction of digital mammography on the recall rate, detection rate, false-positive rate, and rates of invasive procedures in a cohort of women from four population-based breast cancer screening programs in Spain.
The study was approved by the ethics committee; informed consent was not required. A total of 242,838 mammograms (171,191 screen film [screen-film mammography group] and 71,647 digital [digital mammography group]) obtained in 103,613 women aged 45-69 years were included. False-positive results for any additional procedure and for invasive procedures, the breast cancer rate, and the positive predictive value in each group were compared by using Pearson χ(2) test. The effect of the mammographic technology used (screen-film or digital) on the false-positive results and cancer detection risk was evaluated with multivariate logistic regression models, adjusted according to women's and the screening program's characteristics and time trends.
The false-positive rate was higher for screen-film than for digital mammography (7.6% and 5.7%, respectively; P < .001). False-positive results after an invasive procedure were significantly higher for screen-film than for digital mammography (1.9% and 0.7%, respectively; P < .001). No significant differences were observed in the overall cancer detection rate between the two groups (0.45% and 0.43% in the screen-film and digital mammography groups, respectively; P = .59). The adjusted risk of a false-positive result was higher for screen-film than for digital mammography (odds ratio = 1.32). The adjusted risk was also lower for the digital mammography group when time trends were taken into account.
The lower false-positive risk with use of digital mammography should be taken into account when balancing the risks and benefits of breast cancer screening.
评估西班牙四个基于人群的乳腺癌筛查项目中引入数字乳腺摄影对召回率、检出率、假阳性率和侵袭性操作率的影响。
该研究获得伦理委员会批准；无需获得知情同意。共纳入 103613 名年龄在 45-69 岁的妇女的 242838 张乳房 X 线照片（171191 张屏片[屏片乳腺摄影组]和 71647 张数字[数字乳腺摄影组]）。使用 Pearson χ²检验比较两组的任何额外检查和侵袭性操作的假阳性结果、乳腺癌发生率和阳性预测值。使用多变量逻辑回归模型评估所使用的乳腺摄影技术（屏片或数字）对假阳性结果和癌症检出风险的影响，根据妇女和筛查计划的特征和时间趋势进行调整。
屏片乳腺摄影的假阳性率高于数字乳腺摄影（分别为 7.6%和 5.7%；P<.001）。屏片乳腺摄影的假阳性后行侵袭性操作的比例显著高于数字乳腺摄影（分别为 1.9%和 0.7%；P<.001）。两组的总体癌症检出率无显著差异（屏片乳腺摄影组和数字乳腺摄影组分别为 0.45%和 0.43%；P=0.59）。调整后屏片乳腺摄影的假阳性结果风险高于数字乳腺摄影（比值比=1.32）。当考虑时间趋势时，数字乳腺摄影组的调整风险也较低。
在权衡乳腺癌筛查的风险和益处时，应考虑使用数字乳腺摄影的假阳性风险较低。
