Single reading with computer-aided detection for screening mammography

BACKGROUND: 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. METHODS: 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. RESULTS: 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