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Despite a high false-positive rate, screening mammography fails to detect one in five breast cancers and even fewer in women with dense breasts. New technologies have been developed to address these limitations, including digital mammography, breast tomosynthesis, MRI and computer-aided detection (CAD). Conceivably, a new technology—either alone or alongside mammography—could yield net benefits to women, ushering in a new era of breast cancer screening. But what sort of data will be needed to infer that a new screening method is better than mammography alone?
New breast cancer screening modalities would ideally be evaluated in head-to-head randomised trials comparing breast cancer mortality in patients screened with the new modality versus patients screened with conventional mammography. In light of variable interpretation across radiologists and the relatively small incremental benefits of new screening modalities, head-to-head trials would likely require huge sample sizes of patients and radiologists to achieve sufficient statistical power.1 In addition, for mortality outcomes, many years of follow-up are …
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