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Ciatto S.,U.O. Senologia Clinica e Screening Mammografico | Bernardi D.,U.O. Senologia Clinica e Screening Mammografico | Pellegrini M.,U.O. Senologia Clinica e Screening Mammografico | Borsato G.,U.O. Senologia Clinica e Screening Mammografico | And 5 more authors.
European Radiology

Objectives Surrogate measures of screening performance [e.g. interval cancer (IC) proportional incidence] allow timely monitoring of sensitivity and quality. This study explored measures using large (T2+) breast cancers as potential indicators of screening performance. Methods The proportional incidence of T2+ cancers (observed/ expected cases) in a population-based screening programme (Trento, 2001-2009) was estimated. A parallel review of 'negative' preceding mammograms for screendetected T2+ and for all ICs, using 'blinded' independent readings and case-mixes (54 T2+, 50 ICs, 170 controls) was also performed. Results T2+ cancers were observed in 168 screening participants: 48 at first screen, 67 at repeat screening and 53 ICs. The T2+ estimated proportional incidence was 68% (observed/ expected=168/247), corresponding to an estimated 32% reduction in the rate of T2+ cancers in screening participants relative to that expected without screening. Majority review classified 27.8% (15/54) of T2+ and 28% (14/50) of ICs as screening error (P=0.84), with variable recall rates amongst radiologists (8.8-15.2%). Conclusions T2+ review could be integrated as part of quality monitoring and potentially prove more feasible than IC review for some screening services. Key Points • Interval breast cancers, assumed as screening failures, are monitored to estimate screening performance • Large (T2+) cancers at screening may also represent failed prior screening detection • Analysis of T2+ lesions may be more feasible than assessing interval cancers • Analysis of T2+ cancers is a potential further measure of screening performance. © European Society of Radiology 2012. Source

Ciatto S.,Centro Prevenzione Screening | Bernardi D.,U.O. Senologia Clinica e Screening Mammografico | Caumo F.,Centro Of Prevenzione Senologica

Purpose. To summarize the existing evidence on the proportional incidence and review of interval cancers, as reported by Italian screening programs. Material and methods. Literature search of published reports on: a) proportional incidence, determined according to breast cancers expected in the absence of screening and estimated on the basis of patients/year at risk and age-specific incidence; and b) review of screening mammograms preceding interval cancers. Results were compared with European Commission recommended standards. Results. Evidence on proportional incidence or review of interval cancers was reported by 37 and 24 local health unit programs, respectively. Compared to European Commission standards, 94% and 87% of programs complied at first interval cancers survey with recommended standards for proportional incidence or screening error rate at review, respectively. Two programs initially below acceptable standards reached satisfactory results at repeat evaluation over time. Conclusions. Although they are a minority (20%) of all local health unit programs, which suggests a possible selection bias, Italian surveys reporting data on the proportional incidence or review of interval cancers show an overall good performance. Interval cancer survey appears feasible in any program and should become a routine procedure within the national quality control system. Source

Carbonaro L.A.,Unita di Radiologia | Azzarone A.,Servizio di Radiologia | Paskeh B.B.,Unita di Radiologia | Brunelli S.,Centro Of Prevenzione Senologica | And 11 more authors.
European Journal of Radiology

Purpose To evaluate the performance of the first years since the beginning of a mammographic population-based screening program. Materials and methods Women aged 49-69 were invited biennially for two-view film-screen mammography and double reading without arbitration was performed. Interval cancers (ICs) from 2001 to 2006 were identified using screening archives, local pathology archives, and hospital discharge records. The proportional incidence of IC was determined considering breast cancers expected without screening. Three offsite radiologists experienced in breast cancer screening blindly evaluated mammograms prior to diagnosis, randomly mixed with negative mammograms (1:2 ratio). Cases unrecalled at review were considered as true ICs, those recalled by only one reviewer as minimal signs, and those recalled by two or three reviewers as missed cancers. T and N stage of the reviewed ICs were evaluated and compared. Results A total of 86,276 first level mammograms were performed. Mean recall rate was 6.8% at first and 4.6% at repeat screening. We had 476 screen-detected cancers and 145 ICs (10 of them ductal carcinomas in situ). Absolute incidence was 17 per 10,000 screening examinations. Invasive proportional incidence was 19% (44/234) in the first year, 39% (91/234) in the second year, and 29% (135/468) in the two-year interval. Of 145 ICs, 130 (90%) were reviewed mixed with 287 negative controls: 55% (71/130) resulted to be true ICs, 24% (31/130) minimal signs, and 22% (28/130) missed cancers. The rate of ICs diagnosed in the first year interval was 21% (15/71) for true ICs, 46% (13/28) for missed cancers, and 39% (12/31) for minimal signs, with a significant difference of true ICs rate compared to missed cancers rate (p = 0.012). A higher rate of T3 and T4 stages was found for missed cancers (18%, 5/28) compared to minimal signs (6%, 2/31) or true ICs (8%, 6/71), while the rate of N2 and N3 stage for both minimal signs (19%, 6/31) or missed cancers (25%, 7/28) was higher than that for true ICs (10%, 7/71), although all these differences were not significant (p ≥ 0.480). Conclusion These results showed the possibility to comply with European Community standards in the first years of a screening program implementation. © 2013 Elsevier Ireland Ltd. Source

Bernardi D.,U.O. Senologia Clinica e Screening Mammografico | Caumo F.,Centro Of Prevenzione Senologica | Macaskill P.,University of Sydney | Ciatto S.,U.O. Senologia Clinica e Screening Mammografico | And 9 more authors.
European Journal of Cancer

Objective We investigated the effect of integrating three-dimensional (3D)-mammography with 2D-mammography on radiologists' detection measures in the 'screening with tomosynthesis or standard mammography' (STORM) trial. Methods STORM, a prospective population-based trial (Trento and Verona breast screening services) compared sequential screen-reading: 2D-mammography alone and integrated 2D/3D-mammography. Radiologist-specific detection measures were calculated for each screen-reading phase for eight radiologists: number of detected cancers, proportion of true-positive (TP) detection, and number and rate of false-positive (FP) recalls (FPR). We estimated the incremental cancer detection rate (CDR). Results There were 59 cancers and 395 false recalls amongst 7292 screening participants. At 2D-mammography screening, radiologist-specific TP detection ranged between 38% and 83% (median 63%; mean 60% and sd 15.4%); at integrated 2D/3D-mammography, TP detection ranged between 78% and 93% (median 87%; mean 87% and sd 5.2%). For all but one radiologist, 2D/3D-mammography improved breast cancer detection (relative to 2D-mammography) ranging between 0% and 54% (median 29%; mean 27% and sd 16.2%) increase in the proportion of detected cancers. Incremental CDR attributable to integrating 3D-mammography in screening varied between 0/1000 and 5.3/1000 screens (median 1.8/1000; mean 2.3/1000 and sd 1.6/1000). Radiologist-specific FPR for 2D-mammography ranged between 1.5% and 4.2% (median 3.1%; mean 2.9% and sd 0.87%), and FPR based on the integrated 2D/3D-mammography read ranged between 1.0% and 3.3% (median 2.4%; mean 2.2% and sd 0.72%). Integrated 2D/3D-mammography screening, relative to 2D-mammography, had the effect of reducing FP and increasing TP detection for most radiologists. Conclusion There was broad variability in radiologist-specific TP detection at 2D-mammography and hence in the additional TP detection and incremental CDR attributable to integrated 2D/3D-mammography; more consistent (less variable) TP-detection estimates were observed for the integrated screen-read. Integrating 3D-mammography with 2D-mammography improves radiologists' screen-reading through improved cancer detection and/or reduced FPR, with most readers achieving both using integrated 2D/3D mammography. © 2014 Elsevier Ltd. All rights reserved. Source

Houssami N.,University of Sydney | Macaskill P.,University of Sydney | Bernardi D.,U.O. Senologia Clinica e Screening Mammografico | Caumo F.,Centro Of Prevenzione Senologica | And 8 more authors.
European Journal of Cancer

Purpose We compared detection measures for breast screening strategies comprising single-reading or double-reading using standard 2D-mammography or 2D/3D-mammography, based on the 'screening with tomosynthesis or standard mammography' (STORM) trial. Methods STORM prospectively examined screen-reading in two sequential phases, 2D-mammography alone and integrated 2D/3D-mammography, in asymptomatic women participating in Trento and Verona (Northern Italy) population-based screening services. Outcomes were ascertained from assessment and/or excision histology or follow-up. For each screen-reading strategy we calculated the number of detected and non-detected (including interval) cancers, cancer detection rates (CDRs), false positive recall (FPR) measures and incremental CDR relative to a comparator strategy. We estimated the false:true positive (FP:TP) ratio and sensitivity of each mammography screening strategy. Paired binary data were compared using McNemar's test. Results Amongst 7292 screening participants, there were 65 (including six interval) breast cancers; estimated first-year interval cancer rate was 0.82/1000 screens (95% confidence interval (CI): 0.30-1.79/1000). For single-reading, 35 cancers were detected at both 2D and 2D/3D-mammography, 20 cancers were detected only with 2D/3D-mammography compared with none at 2D-mammography alone (p < 0.001) and 10 cancers were not detected. For double-reading, 39 cancers were detected at 2D-mammography and 2D/3D-mammography, 20 were detected only with 2D/3D-mammography compared with none detected at 2D-mammography alone (p < 0.001) and six cancers were not detected. The incremental CDR attributable to 2D/3D-mammography (versus 2D-mammography) of 2.7/1000 screens (95% CI: 1.6-4.2) was evident for single and for double-reading. Incremental CDR attributable to double-reading (versus single-reading) of 0.55/1000 screens (95% CI: -0.02-1.4) was evident for 2D-mammography and for 2D/3D-mammography. Estimated FP:TP ratios showed that 2D/3D-mammography screening strategies had more favourable FP to TP trade-off and higher sensitivity, applying single-reading or double-reading, relative to 2D-mammography screening. Conclusion The evidence we report warrants rethinking of breast screening strategies and should be used to inform future evaluations of 2D/3D-mammography that assess whether or not the estimated incremental detection translates into improved screening outcomes such as a reduction in interval cancer rates. © 2014 The Authors. Published by Elsevier Ltd. Source

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