Gilbert Fiona J, Astley Susan M, Gillan Maureen G C, Agbaje Olorunsola F, Wallis Matthew G, James Jonathan, Boggis Caroline R M, Duffy Stephen W
Aberdeen Biomedical Imaging Centre, University of Aberdeen, Aberdeen, Scotland, United Kingdom.
N Engl J Med. 2008 Oct 16;359(16):1675-84. doi: 10.1056/NEJMoa0803545. Epub 2008 Oct 1.
The sensitivity of screening mammography for the detection of small breast cancers is higher when the mammogram is read by two readers rather than by a single reader. We conducted a trial to determine whether the performance of a single reader using a computer-aided detection system would match the performance achieved by two readers.
The trial was designed as an equivalence trial, with matched-pair comparisons between the cancer-detection rates achieved by single reading with computer-aided detection and those achieved by double reading. We randomly assigned 31,057 women undergoing routine screening by film mammography at three centers in England to double reading, single reading with computer-aided detection, or both double reading and single reading with computer-aided detection, at a ratio of 1:1:28. The primary outcome measures were the proportion of cancers detected according to regimen and the recall rates within the group receiving both reading regimens.
The proportion of cancers detected was 199 of 227 (87.7%) for double reading and 198 of 227 (87.2%) for single reading with computer-aided detection (P=0.89). The overall recall rates were 3.4% for double reading and 3.9% for single reading with computer-aided detection; the difference between the rates was small but significant (P<0.001). The estimated sensitivity, specificity, and positive predictive value for single reading with computer-aided detection were 87.2%, 96.9%, and 18.0%, respectively. The corresponding values for double reading were 87.7%, 97.4%, and 21.1%. There were no significant differences between the pathological attributes of tumors detected by single reading with computer-aided detection alone and those of tumors detected by double reading alone.
Single reading with computer-aided detection could be an alternative to double reading and could improve the rate of detection of cancer from screening mammograms read by a single reader. (ClinicalTrials.gov number, NCT00450359.)
当由两位阅片者而非一位阅片者阅读乳腺钼靶片时，乳腺钼靶筛查对小乳腺癌的检测敏感性更高。我们进行了一项试验，以确定使用计算机辅助检测系统的单一阅片者的表现是否能与两位阅片者的表现相匹配。
该试验设计为等效性试验，对计算机辅助检测单阅片与双阅片的癌症检出率进行配对比较。我们将在英格兰三个中心接受常规乳腺钼靶筛查的31057名女性，按照1:1:28的比例随机分配至双阅片组、计算机辅助检测单阅片组或双阅片与计算机辅助检测单阅片均进行组。主要结局指标为根据方案检测出的癌症比例以及接受两种阅片方案组内的召回率。
双阅片组227例癌症中检测出199例（87.7%），计算机辅助检测单阅片组227例癌症中检测出198例（87.2%）（P = 0.89）。双阅片的总体召回率为3.4%，计算机辅助检测单阅片的总体召回率为3.9%；两者差异虽小但具有统计学意义（P<0.001）。计算机辅助检测单阅片的估计敏感性、特异性和阳性预测值分别为87.2%、96.9%和18.0%。双阅片的相应值分别为87.7%、97.4%和21.1%。仅计算机辅助检测单阅片检测出的肿瘤与仅双阅片检测出的肿瘤的病理特征之间无显著差异。
计算机辅助检测单阅片可作为双阅片的替代方法，且可提高单一阅片者阅读乳腺钼靶筛查片时的癌症检出率。（临床试验注册号，NCT***0359。）
