IntroductionDevelopment of digital breast tomosynthesis (DBT) provides a technology that generates three-dimensional data sets, thus reducing the pitfalls of overlapping breast tissue. Observational studies suggest that the combination of two-dimensional (2D) digital mammography and DBT increases diagnostic accuracy. However, because of duplicate exposure, this comes at the cost of an augmented radiation dose. This undesired adverse impact can be avoided by using synthesised 2D images reconstructed from the DBT data (s2D).We designed a diagnostic superiority trial on a high level of evidence with the aim of providing a comparison of screening efficacy parameters resulting from DBT+s2D versus the current screening standard 2D full-field digital mammography (FFDM) in a multicentre and multivendor setting on the basis of the quality-controlled, population-based, biennial mammography screening programme in Germany.Methods and analysis80 000 women in the eligible age 50–69 years attending the routine mammography screening programme and willing to participate in the TOSYMA trial will be assigned by 1:1 randomisation to either the intervention arm (DBT+s2D) or the control arm (FFDM) during a 12-month recruitment period in screening units of North Rhine-Westphalia and Lower Saxony. State cancer registries will provide the follow-up of interval cancers.Primary endpoints are the detection rate of invasive breast cancers at screening examination and the cumulative incidence of interval cancers in the 2 years after a negative examination. Secondary endpoints are the detection rate of ductal carcinoma in situ and of tumour size T1, the recall rate for assessment, the positive predictive value of recall and the cumulative 12-month incidence of interval cancers. An adaptive statistical design with one interim analysis provides the option to modify the design.Ethics and disseminationThis protocol has been approved by the local medical ethical committee (2016-132-f-S). Results will be submitted to international peer-reviewed journals.Trial registrationNCT03377036; Pre-results.

No abstract

Introduction: Since 2008 the German Mammography Screening Programme has been available throughout Germany to all women aged between 50 and 69. The programme strictly follows the European Guidelines. There are controversial discussions in the media as well as in the specialised press. Materials and Methods: Overview of the available data with regard to an evaluation of randomised studies and with regard to quality-assured screening programmes in accordance with EU Guidelines (including data from 18 screening countries). Results: Positive effects of screening: reduction in mortality, less invasive treatment. Negative effects: False-positive diagnoses and biopsy recommendations, so-called overdiagnoses, radiation dose. Limits of screening: Interval carcinomas, incomplete reduction in mortality. A mathematical synopsis of the latest publications from the European screening programmes with the diagnosis rates in Germany determined from >?4.6 million screening examinations produces the following: a total of 10?000 mammograms are created for 1000 women (P) taking part in the Mammography Screening Programme (each of whom undergoes 10 mammograms in 20 years). Overall, the risk of triggering breast cancer through a mammogram is very clearly below the annual natural risk of suffering from breast cancer. In the German screening, of these 1000 women, an average of 288 women are called back once in 20 years as a result of changes that are ultimately benign (

No abstract

No abstract