Brigham & Women's Hospital, Boston, Massachusetts.
University of Utah, Salt Lake City, Utah.
J Am Coll Radiol. 2018 Oct;15(10):1430-1436. doi: 10.1016/j.jacr.2018.05.004. Epub 2018 Jun 12.
To evaluate perceptual difference in breast density classification using synthesized mammography (SM) compared with standard or full-field digital mammography (FFDM) for screening.
This institutional review board-approved, retrospective, multireader study evaluated breast density on 200 patients who underwent baseline screening mammogram during which both SM and FFDM were obtained contemporaneously from June 1, 2016, through November 30, 2016. Qualitative breast density was independently assigned by seven readers initially evaluating FFDM alone. Then, in a separate session, these same readers assigned breast density using synthetic views alone on the same 200 patients. The readers were again blinded to each other's assignment. Qualitative density assessment was based on BI-RADS fifth edition. Interreader agreement was evaluated with κ statistic using 95% confidence intervals. Testing for homogeneity in paired proportions was performed using McNemar's test with a level of significance of .05.
For patients across the SM and standard 2-D data set, diagnostic testing with McNemar's test with P = 0.32 demonstrates that the minimal density transitions across FFDM and SM are not statistically significant density shifts. Taking clinical significance into account, only 8 of 200 (4%) patients had clinically significant transition (dense versus not dense). There was substantial interreader agreement with overall κ in FFDM of 0.71 (minimum 0.53, maximum 0.81) and overall SM κ average of 0.63 (minimum 0.56, maximum 0.87).
Overall subjective breast density assignment by radiologists on SM is similar to density assignment on standard 2-D mammogram.
评估合成乳腺摄影术（SM）与标准或全视野数字乳腺摄影术（FFDM）在筛查中的乳腺密度分类的感知差异。
本机构审查委员会批准的回顾性多读者研究评估了 200 名患者的乳腺密度，这些患者于 2016 年 6 月 1 日至 2016 年 11 月 30 日期间进行了基线筛查乳房 X 光检查，同时获得了 SM 和 FFDM。最初，七位读者独立评估 FFDM 时，对乳腺密度进行了定性评估。然后，在一个单独的会议上，这些相同的读者仅使用合成视图对同一 200 名患者进行了乳腺密度评估。读者彼此之间再次被蒙住双眼。定性密度评估基于 BI-RADS 第五版。使用 95%置信区间的κ统计量评估读者间的一致性。使用 McNemar 检验测试配对比例的同质性，显著性水平为.05。
对于 SM 和标准 2-D 数据集的患者，McNemar 检验的诊断测试 P=0.32 表明 FFDM 和 SM 之间的最小密度转换没有统计学显著的密度转移。考虑到临床意义，只有 200 名患者中的 8 名（4%）有临床显著的过渡（致密与不致密）。FFDM 的整体κ值为 0.71（最小为 0.53，最大为 0.81），SM 的整体κ平均值为 0.63（最小为 0.56，最大为 0.87），读者间的一致性很高。
放射科医生对 SM 的总体主观乳腺密度评估与标准 2-D 乳房 X 光检查的密度评估相似。
