METHODS: Ethics committees approved this multicenter study. Patients gave informed consent. Women recalled from population-based screening reading were included. Reference standard was histology and/or ≥ 1 year follow up. Negative multiple assessment was considered for patients lost at follow up. Two blinded readers (R1, R2) evaluated first DM and subsequently DM+DBT. RR, sensitivity, specificity, accuracy, positive and negative predictive values (PPV, NPV), were calculated for R1, R2, and DR. Cohen κ and χ(2) were used for R1-R2 agreement and RR related to breast density.
RESULTS: We included 280 cases (41 malignancies, 66 benign lesions, and 173 negative examinations). The RR reduction was 43% (R1), 58% (R2), 43% (DR). Sensitivity, specificity, accuracy, PPV and NPV were: 93%, 67%, 71%, 33%, 98% for R1; 88%, 73%, 75%, 36%, 97% for R2; 98%, 55%, 61%, 27%, 99% for DR. The agreement was higher for DM+DBT (κ=0.459 versus κ=0.234). Reduction in RR was independent from breast density (p=0.992).
CONCLUSIONS: DBT was confirmed to reduce RR, as shown by 13 of 15 previous studies (reported reduction 6-82%, median 31%). This reduction is confirmed when using DR. DBT allows an increased inter-reader agreement.
方法:伦理委员会批准了这项多中心研究。患者给予知情同意。包括从基于人群的筛查阅读中召回的妇女。参考标准为组织学和/或≥1年随访。对于在随访中丢失的患者,多重评估被认为是阴性的。两个盲读器(R1,R2)首先评估DM,随后评估DM+DBT。RR,灵敏度,特异性,准确度,阳性和阴性预测值(PPV,净现值),计算R1、R2和DR。Cohenκ和χ(2)用于与乳腺密度相关的R1-R2一致性和RR。
结果:我们包括280例(41例恶性肿瘤,66个良性病变,和173次阴性检查)。RR降低了43%(R1),58%(R2),43%(DR)。灵敏度,特异性,准确度,PPV和NPV分别为:93%,67%,71%,33%,R1为98%;88%,73%,75%,36%,R2为97%;98%,55%,61%,27%,99%为DR。DM+DBT的一致性更高(κ=0.459对κ=0.234)。RR的降低与乳腺密度无关(p=0.992)。
结论:DBT被证实可以降低RR,如先前15项研究中的13项所示(报告减少了6-82%,中位数31%)。这种减少在使用DR时得到证实。DBT允许增加读者之间的协议。