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Background  This study aimed to systematically review and to meta-analyse the accuracy of digital breast tomosynthesis (DBT) versus digital mammography (DM) in women with mammographically dense breasts in screening and diagnosis.    Methods  Two independent reviewers identified screening or diagnostic studies reporting at least one of four outcomes (cancer detection rate-CDR, recall rate, sensitivity and specificity) for DBT and DM in women with mammographically dense breasts. Study quality was assessed using QUADAS-2. Meta-analysis of CDR and recall rate used a random effects model. Summary ROC curve summarized sensitivity and specificity.    Results  Sixteen studies were included (five diagnostic; eleven screening). In diagnosis, DBT increased sensitivity (84%–90%) versus DM alone (69%–86%) but not specificity. DBT improved CDR versus DM alone (RR: 1.16, 95% CI 1.02–1.31). In screening, DBT + DM increased CDR versus DM alone (RR: 1.33, 95% CI 1.20–1.47 for retrospective studies; RR: 1.52, 95% CI 1.08–2.11 for prospective studies). Recall rate was significantly reduced by DBT + DM in retrospective studies (RR: 0.72, 95% CI 0.64–0.80) but not in two prospective studies (RR: 1.12, 95% CI 0.76–1.63).    Conclusion  In women with mammographically dense breasts, DBT+/−DM increased CDR significantly (versus DM) in screening and diagnosis. In diagnosis, DBT+/−DM increased sensitivity but not specificity. The effect of DBT + DM on recall rate in screening dense breasts varied between studies.    Electronic supplementary material  The online version of this article (10.1186/s12885-018-4263-3) contains supplementary material, which is available to authorized users.

Digital breast tomosynthesis for breast cancer screening and diagnosis in women with dense breasts – a systematic review and meta-analysis