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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<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.
Conclusions 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
[ClinicalTrials.gov]
.)
Source Information
From the Aberdeen Biomedical Imaging Centre, University of Aberdeen, Aberdeen (F.J.G., M.G.C.G.); the Department of Imaging Science and Biomedical Engineering, University of Manchester, Manchester (S.M.A.); the Department of Epidemiology, Mathematics, and Statistics, Wolfson Institute of Preventive Medicine, London (O.F.A., S.W.D.); the Cambridge Breast Unit, Addenbrookes Hospital, Cambridge (M.G.W.); the Nottingham Breast Institute, Nottingham City Hospital, Nottingham (J.J.); and the Nightingale Breast Screening Unit, Wythenshawe Hospital, Manchester (C.R.M.B.) — all in the United Kingdom.
This article (10.1056/NEJMoa0803545) was published at www.nejm.org on October 1, 2008.
Address reprint requests to Dr. Gilbert at the Aberdeen Biomedical Imaging Centre, University of Aberdeen, Lilian Sutton Bldg., Foresterhill, Aberdeen AB25 2ZD, Scotland, United Kingdom, or at f.j.gilbert{at}abdn.ac.uk.
Related Letters:
Computer-Aided Mammography Screening
Hall F. M.
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N Engl J Med 2009;
360:836, Feb 19, 2009.
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