Randomised controlled trial.
The study is being carried out in up to 10 screening centres in England. The study aims to recruit 100,000 women aged 49-71 years who are attending for routine screening. 50,000 will undergo standard mammography and 50,000 will undergo standard mammography plus tomosynthesis. We will then compare the results between the two groups in order to assess the effect of tomosynthesis on the accuracy of mammography in both cancer detection and ‘false alarm’ recalls. The cost of implementation of tomosynthesis in routine screening will also be assessed. The results of the trial will be used to decide whether to implement tomosynthesis for routine screening. If it is decided to introduce tomosynthesis for routine screening, this would be phased in over a period of time.