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Abstract Objectives The randomized controlled trial comparing digital breast tomosynthesis and synthetic 2D mammograms (DBT + SM) versus digital mammography (DM) (the To-Be 1 trial), 2016–2017, did not result in higher cancer detection for DBT + SM. We aimed to determine if negative cases prior to interval and consecutive screen-detected cancers from DBT + SM were due to interpretive error. Methods Five external breast radiologists performed the individual blinded review of 239 screening examinations (90 true negative, 39 false positive, 19 prior to interval cancer, and 91 prior to consecutive screen-detected cancer) and the informed consensus review of examinations prior to interval and screen-detected cancers (n = 110). The reviewers marked suspicious findings with a score of 1–5 (probability of malignancy). A case was false negative if ≥ 2 radiologists assigned the cancer site with a score of ≥ 2 in the blinded review and if the case was assigned as false negative by a consensus in the informed review. Results In the informed review, 5.3% of examinations prior to interval cancer and 18.7% prior to consecutive round screen-detected cancer were considered false negative. In the blinded review, 10.6% of examinations prior to interval cancer and 42.9% prior to consecutive round screen-detected cancer were scored ≥ 2. A score of ≥ 2 was assigned to 47.8% of negative and 89.7% of false positive examinations. Conclusions The false negative rates were consistent with those of prior DM reviews, indicating that the lack of higher cancer detection for DBT + SM versus DM in the To-Be 1 trial is complex and not due to interpretive error alone. Critical relevance statement The randomized controlled trial on digital breast tomosynthesis and synthetic 2D mammograms (DBT) and digital mammography (DM), 2016–2017, showed no difference in cancer detection for the two techniques. The rates of false negative screening examinations prior to interval and consecutive screen-detected cancer for DBT were consistent with the rates in prior DM reviews, indicating that the non-superior DBT performance in the trial might not be due to interpretive error alone. Key points • Screening with digital breast tomosynthesis (DBT) did not result in a higher breast cancer detection rate compared to screening with digital mammography (DM) in the To-Be 1 trial. • The false negative rates for examinations prior to interval and consecutive screen-detected cancer for DBT were determined in the trial to test if the lack of differences was due to interpretive error. • The false negative rates were consistent with those of prior DM reviews, indicating that the lack of higher cancer detection for DBT versus DM was complex and not due to interpretive error alone. Graphical Abstract

Purpose: The European Society on Breast Imaging has recommended supplemental magnetic resonance imaging (MRI) every two to four years for women with mammographically dense breasts. This may not be feasible in many screening programs. Also, the European Commission Initiative on Breast Cancer suggests not implementing screening with MRI. By analyzing interval cancers and time from screening to diagnosis by density, we present alternative screening strategies for women with dense breasts. Methods: Our BreastScreen Norway cohort included 508 536 screening examinations, including 3125 screen-detected and 945 interval breast cancers. Time from screening to interval cancer was stratified by density measured by an automated software and classified into Volpara Density Grades (VDGs) 1–4. Examinations with volumetric density ≤3.4% were categorized as VDG1, 3.5%–7.4% as VDG2, 7.5%–15.4% as VDG3, and ≥15.5% as VDG4. Interval cancer rates were also determined by continuous density measures. Results: Median time from screening to interval cancer was 496 (IQR: 391–587) days for VDG1, 500 (IQR: 350–616) for VDG2, 482 (IQR: 309–595) for VDG3 and 427 (IQR: 266–577) for VDG4. A total of 35.9% of the interval cancers among VDG4 were detected within the first year of the biennial screening interval. For VDG2, 26.3% were detected within the first year. The highest annual interval cancer rate (2.7 per 1000 examinations) was observed for VDG4 in the second year of the biennial interval. Conclusions: Annual screening of women with extremely dense breasts may reduce the interval cancer rate and increase program-wide sensitivity, especially in settings where supplemental MRI screening is not feasible.

As more artificial intelligence (AI)-enhanced mammography screening tools enter the clinical market, greater focus will be placed on external validation in diverse patient populations. In this viewpoint, we outline lessons learned from prior efforts in this field, the need to validate algorithms on newer screening technologies and diverse patient populations, and conclude by discussing the need for a framework for continuous monitoring and recalibration of these AI tools. Sufficient validation and continuous monitoring of emerging AI tools for breast cancer screening will require greater stakeholder engagement and the creation of shared policies and guidelines.

Introduction: Medical imaging now accounts for most of the US population’s exposure to ionizingradiation. A substantial proportion of this medical imaging is ordered in the emergency setting. We aimto provide a general overview of radiation dose from medical imaging with a focus on computedtomography, as well as a literature review of recent efforts to decrease unnecessary radiation exposureto patients in the emergency department setting.Methods: We conducted a literature review through calendar year 2010 for all published articlespertaining to the emergency department and radiation exposure.Results: The benefits of imaging usually outweigh the risks of eventual radiation-induced cancer inmost clinical scenarios encountered by emergency physicians. However, our literature review identified3 specific clinical situations in the general adult population in which the lifetime risks of cancer mayoutweigh the benefits to the patient: rule out pulmonary embolism, flank pain, and recurrent abdominalpain in inflammatory bowel disease. For these specific clinical scenarios, a physician-patientdiscussion about such risks and benefits may be warranted.Conclusion: Emergency physicians, now at the front line of patients’ exposure to ionizing radiation,should have a general understanding of the magnitude of radiation dose from advanced medicalimaging procedures and their associated risks. Future areas of research should include thedevelopment of protocols and guidelines that limit unnecessary patient radiation exposure.