Department of Radiology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan, ROC.
J Chin Med Assoc. 2012 Sep;75(9):464-7. doi: 10.1016/j.jcma.2012.06.018. Epub 2012 Aug 11.
This study was conducted to investigate whether detectable missed breast cancers could be distinguished from truly false negative images in a mammographic screening by a regular peer auditing.
Between 2004 and 2007, a total of 311,193 free nationwide biennial mammographic screenings were performed for 50- to 69-year-old women in Taiwan. Retrospectively comparing the records in Taiwan's Cancer registry, 1283 cancers were detected (4.1 per 1000). Of the total, 176 (0.6 per 1000) initial mammographic negative assessments were reported to have cancers (128 traditional films and 48 laser-printed digital images). We selected 186 true negative films (138 traditional films and 48 laser-printed ones) as control group. These were seeded into 4815 films of 2008 images to be audited in 2009. Thirty-four auditors interpreted all the films in a single-blind, randomized, pair-control study. The performance of 34 auditors was analyzed by chi-square test. A p value of < 0.05 was considered significant.
Eight (6 traditional and 2 digital films) of the 176 false negative films were not reported by the auditors (missing rate of 4.5%). Of this total, 87 false negatives were reassessed as positive, while 29 of the 186 true negatives were reassessed as positive, making the overall performance of the 34 auditors in interpreting the false negatives and true negatives a specificity of 84.4% and sensitivity of 51.8%. The specificity and sensitivity in traditional films and laser-printed films were 98.6% versus 43.8% and 41.8% versus 78.3%, respectively. Almost 42% of the traditional false negative films had positive reassessment by the auditors, showing a significant difference from the initial screeners (p < 0.001). The specificity of their reinterpretation of laser-printed films was obviously low.
Almost 42% of the false negative traditional films were judged as missed cancers in this study. A peer auditing should reduce the probability of missed cancers.
本研究旨在通过常规同行审核来探讨在乳腺筛查中，是否可以区分可检测到的漏诊乳腺癌与真正的假阴性图像。
2004 年至 2007 年，台湾对 50 至 69 岁女性进行了总计 311193 例免费全国性两年一次的乳腺筛查。通过与台湾癌症登记处的记录进行回顾性比较，共发现 1283 例癌症（每 1000 例中有 4.1 例）。在这 1283 例癌症中，有 176 例（每 1000 例中有 0.6 例）初始乳腺 X 线摄影评估为阴性，报告有癌症（128 例传统胶片和 48 例激光打印数字图像）。我们选择了 186 例真正的阴性胶片（138 例传统胶片和 48 例激光打印胶片）作为对照组。这些胶片被随机混入 2008 年的 4815 例图像中，以便在 2009 年进行审核。34 名审核员以单盲、随机、成对对照的方式对所有胶片进行了评估。采用卡方检验分析 34 名审核员的表现。p 值<0.05 被认为具有统计学意义。
176 例假阴性胶片中有 8 例（6 例传统胶片和 2 例数字胶片）未被审核员报告（漏诊率为 4.5%）。在这 8 例中，87 例假阴性被重新评估为阳性，而在 186 例真正的阴性中，有 29 例被重新评估为阳性，这使得 34 名审核员对假阴性和真正阴性的总体表现特异性为 84.4%，敏感性为 51.8%。传统胶片和激光打印胶片的特异性和敏感性分别为 98.6%对 43.8%和 41.8%对 78.3%。近 42%的传统假阴性胶片被审核员判定为阳性，与初始筛查者相比差异有统计学意义（p<0.001）。他们对激光打印胶片的重新解读特异性明显较低。
本研究中，近 42%的传统假阴性胶片被判定为漏诊癌症。同行审核应降低漏诊癌症的概率。
