Table 14False Positives in Studies Comparing Digital Breast Tomosynthesis and Digital Mammography

OutcomeStudy Design

Author, Year

Study/Trial Name

Comparison (IG vs. CG)AgeFollowupIG n/N (rate per 1,000 screened)CG n/N (rate per 1,000 screened)Effect (95% CI)
False-positive recallRCT

Armaroli, 2022129

Proteus Donna

DBT/DM vs. DM (round 1), DM vs. DM (round 2)46 to 68First Round1,699/30,844 (55.1)1,943/43,022 (45.2)RR: 1.22 (95% CI, 1.14 to 1.30)*
Second Round900/23,760 (37.9)1,286/33,534 (38.3)RR: 0.99 (95% CI, 0.91 to 1.08)*

Pattacini, 2022160

RETomo§

DBT/DM (round 1), DM (round 2) vs. DM45 to 69First Round410/13,356 (30.7)461/13,521 (34.1)RR: 0.90 (95% CI, 0.79 to 1.00)*
Second Round403/12,733 (31.7)430/12,911 (33.3)RR: 0.95 (95% CI, 0.83 to 1.09)*

Hofvind, 2021143

To-Be§

DBT/sDM vs. DM (round 1), DBT/sDM (round 2)50 to 69First Round349/14,380 (24.3)484/14,369 (33.7)RR: 0.72 (95% CI, 0.63 to 0.83)*
Second Round349/11,201 (31.2)340/11,105 (30.6)RR: 1.02 (95% CI, 0.88 to 1.18)*
NRSI

Sprague, in press

BCSC-in press

DBT vs. DM40 to 79First RoundNR (66)NR (101)Proportion difference: −34 (95% CI, −47 to −22)§
Second RoundNR (60)NR (78)Proportion difference: −18 (95% CI, −30 to −7)§
≥Third roundNR (55)NR (66)Proportion difference: −11 (95% CI, −23 to 2)§

Hovda, 2020144

OVVV||

DBT/sDM vs. DM (round 1), DM vs. DM (round 2)50 to 69First Round905/37,185 (24.3)1,658/61,742 (26.9)RR: 0.91 (95% CI, 0.84 to 0.98)*
Second Round518/26,474 (19.6)1,154/45,543 (25.3)RR: 0.77 (95% CI, 0.70 to 0.86)*
False-positive biopsyRCT

Hofvind, 2021143

To-Be

DBT/sDM vs. DM (round 1), DBT/sDM (round 2)50 to 69First Round157/14,380 (10.9)184/14,369 (12.8)RR: 0.85 (95% CI, 0.69 to 1.05)*
Second Round157/11,201 (14.0)157/11,105 (14.1)RR: 0.99 (95% CI, 0.80 to 1.24)*
NRSI

Sprague, 2023

BCSC

DBT vs. DM40 to 79First RoundNR (10)NR (13)Proportion difference: −3 (95% CI, −5 to −2)
Second RoundNR (8)NR (10)Proportion difference: −2 (95% CI, −4 to 0)
≥Third roundNR (8)NR (8)Proportion difference: −1 (95% CI, −3 to 1)
*

Relative risk calculated from Ns.

Recalled for assessment without a finding of invasive cancer or DCIS.

Recalled for an assessment after double reading based on positive or suspicious screening result by either radiologist (without consensus or arbitration).

§

Adjusted for age, breast density, race and ethnicity, time since last mammogram, Breast Cancer Screening Consortium 5-year invasive breast cancer risk, benign biopsy history, family history of breast cancer, and examination year.

||

Recalled for an assessment (after double reading and arbitration) based on positive or suspicious screening results.

Underwent biopsy without a finding of invasive cancer or DCIS.

Abbreviations: CG=control group; CI=confidence interval; DBT=digital breast tomosynthesis; DM=digital mammography; IG=intervention group; NRSI=nonrandomized study of intervention; RCT=randomized controlled trial; RETomo=Reggio Emilia Tomosynthesis Trial; RR=relative risk; sDM=synthetic 2-view mammography; To-Be=Tomosynthesis Trial in Bergen; OVVV=Oslo-Vestfold-Vestre Viken

From: Chapter 3, Results

Cover of Screening for Breast Cancer: A Comparative Effectiveness Review for the U.S. Preventive Services Task Force
Screening for Breast Cancer: A Comparative Effectiveness Review for the U.S. Preventive Services Task Force [Internet].
Evidence Synthesis, No. 231.
Henderson JT, Webber EM, Weyrich M, et al.

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