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数字乳腺筛查中,盲法双读比非盲法双读具有更高的方案敏感性:荷兰南部一项基于人群的前瞻性研究。

Blinded double reading yields a higher programme sensitivity than non-blinded double reading at digital screening mammography: a prospected population based study in the south of The Netherlands.

机构信息

Department of Radiology, Catharina Hospital, PO Box 1350, 5602 ZA Eindhoven, The Netherlands.

Comprehensive Cancer Centre South (IKZ)/Eindhoven Cancer Registry, PO Box 231, 5600 AE Eindhoven, The Netherlands; Department of Epidemiology, Maastricht University, PO Box 616, 6200 MD Maastricht, The Netherlands.

出版信息

Eur J Cancer. 2015 Feb;51(3):391-9. doi: 10.1016/j.ejca.2014.12.008. Epub 2015 Jan 5.

Abstract

PURPOSE

To prospectively determine the screening mammography outcome at blinded and non-blinded double reading in a biennial population based screening programme in the south of the Netherlands.

METHODS

We included a consecutive series of 87,487 digital screening mammograms, obtained between July 2009 and July 2011. Screening mammograms were double read in either a blinded (2nd reader was not informed about the 1st reader's decision) or non-blinded fashion (2nd reader was informed about the 1st reader's decision). This reading strategy was alternated on a monthly basis. Women with discrepant readings between the two radiologists were always referred for further analysis. During 2 years follow-up, we collected the radiology reports, surgical correspondence and pathology reports of all referred women and interval breast cancers.

RESULTS

Respectively 44,491 and 42,996 screens had been read either in a blinded or non-blinded fashion. Referral rate (3.3% versus 2.8%, p<0.001) and false positive rate (2.6% versus 2.2%, p=0.002) were significantly higher at blinded double reading whereas the cancer detection rate per 1000 screens (7.4 versus 6.5, p=0.14) and positive predictive value of referral (22% versus 23%, p=0.51) were comparable. Blinded double reading resulted in a significantly higher programme sensitivity (83% versus 76%, p=0.01). Per 1000 screened women, blinded double reading would yield 0.9 more screen detected cancers and 0.6 less interval cancers than non-blinded double reading, at the expense of 4.4 more recalls.

CONCLUSION

We advocate the use of blinded double reading in order to achieve a better programme sensitivity, at the expense of an increased referral rate and false positive referral rate.

摘要

目的

前瞻性地确定荷兰南部基于人群的两年一次筛查计划中盲法和非盲法双读筛查的乳房 X 线摄影结果。

方法

我们纳入了 2009 年 7 月至 2011 年 7 月期间连续获得的 87487 例数字筛查乳房 X 线摄影结果。筛查乳房 X 线摄影结果以盲法(第二位阅读者不知道第一位阅读者的决定)或非盲法(第二位阅读者知道第一位阅读者的决定)进行双读。这种阅读策略每月交替进行。当两位放射科医生的阅读结果不一致时,总是对女性进行进一步分析。在 2 年的随访期间,我们收集了所有转诊女性的放射学报告、外科信件和病理学报告以及间隔期乳腺癌。

结果

分别有 44491 例和 42996 例筛查结果以盲法或非盲法进行了阅读。盲法双读的转诊率(3.3%对 2.8%,p<0.001)和假阳性率(2.6%对 2.2%,p=0.002)显著更高,而每 1000 例筛查的癌症检出率(7.4 对 6.5,p=0.14)和转诊的阳性预测值(22%对 23%,p=0.51)相似。盲法双读显著提高了方案的敏感性(83%对 76%,p=0.01)。每 1000 名筛查女性中,盲法双读会导致 0.9 例更多的筛查检出癌症和 0.6 例更少的间隔期癌症,代价是增加 4.4 次召回。

结论

我们主张使用盲法双读以提高方案的敏感性,但其代价是转诊率和假阳性转诊率增加。

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