Clinical performance of digital mammography systems in a breast screening programme – An update

Abstract

The purpose of this research was to compare the clinical performance of three individual digital mammography (DM) systems utilised within a population based screening program. The results presented here expand on previously published data from a 3 to a 9 year period. 28 DM systems from three different vendors were involved in the study. The retrospective analysis included 971612 screening examinations of females aged between 50 and 64 years. All images were double read and assigned a result according to a 5 point rating scale to indicate the probability of cancer. Women with a positive result were recalled for further assessment imaging and biopsy if necessary. Clinical performance in terms of cancer detection rate was analysed and the results presented A total of 5262 cancers were diagnosed. No statistically significant difference was found between the three individual mammography systems in terms of overall cancer detection rate or in the detection of invasive cancer and ductal carcinoma in situ. This was shown in both prevalent and subsequent screening examination categories. The results demonstrate comparable cancer detection performance for the three imaging system types. The study expansion from a 3 to a 9 year period provided sufficient numbers of cancers, 5262 (n = 971612) compared to 1632 (n = 238182) in the original study, to prove statistical significance. Overall the results provide a reassuring audit measure, suggesting that technical differences evident from routine quality assurance measurements do not appear to be reflected clinically in terms of overall cancer detection.