A randomized controlled trial of digital breast tomosynthesis versus digital mammography in population-based screening in Bergen: interim analysis of performance indicators from the To-Be trial

European Radiology
Hildegunn S AaseSolveig Hofvind

Abstract

To describe a randomized controlled trial (RCT) of digital breast tomosynthesis including synthesized two-dimensional mammograms (DBT) versus digital mammography (DM) in a population-based screening program for breast cancer and to compare selected secondary screening outcomes for the two techniques. This RCT, performed in Bergen as part of BreastScreen Norway, was approved by the Regional Committees for Medical Health Research Ethics. All screening attendees in Bergen were invited to participate, of which 89% (14,274/15,976) concented during the first year, and were randomized to DBT (n = 7155) or DM (n = 7119). Secondary screening outcomes were stratified by mammographic density and compared using two-sample t-tests, chi-square tests, ANOVA, negative binomial regression and tests of proportions (z tests). Mean reading time was 1 min 11 s for DBT and 41 s for DM (p < 0.01). Mean time spent at consensus was 3 min 12 s for DBT and 2 min 12 s for DM (p < 0.01), while the rate of cases discussed at consensus was 6.4% and 7.4%, respectively for DBT and DM (p = 0.03). The recall rate was 3.0% for DBT and 3.6% for DM (p = 0.03). For women with non-dense breasts, recall rate was 2.2% for DBT versus 3.4% for DM (p = 0.04). The rate did...Continue Reading

Associated Clinical Trials

References

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May 23, 2007·Radiology·Michael J SchellRebecca Smith-Bindman
Feb 10, 2010·Cancer Epidemiology, Biomarkers & Prevention : a Publication of the American Association for Cancer Research, Cosponsored by the American Society of Preventive Oncology·Zoe AitkenIsabel dos Santos Silva
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Citations

Aug 6, 2019·Annals of Saudi Medicine·Khawaja Bilal WaheedZechriah Jebakumar Arulanatham
Aug 16, 2019·Radiology·Michael H Fuchsjäger, Gabriel Adelsmayr
Aug 11, 2019·The European Journal of Health Economics : HEPAC : Health Economics in Prevention and Care·Tron Anders MogerSolveig Hofvind
Mar 12, 2021·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Nehmat HoussamiSolveig Hofvind
Jul 31, 2021·The Breast : Official Journal of the European Society of Mastology·Baoqi ZengQingxin Zhou

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Methods Mentioned

BETA
biopsy
imaging technique

Clinical Trials Mentioned

NCT02835625

Software Mentioned

STATA
Volpara
BreastScreen

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