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1.
  • Larsen, Marthe, et al. (författare)
  • AI Risk Score on Screening Mammograms Preceding Breast Cancer Diagnosis
  • 2023
  • Ingår i: Radiology. - 1527-1315. ; 309:1, s. 1-8
  • Tidskriftsartikel (refereegranskat)abstract
    • Background Few studies have evaluated the role of artificial intelligence (AI) in prior screening mammography. Purpose To examine AI risk scores assigned to screening mammography in women who were later diagnosed with breast cancer. Materials and Methods Image data and screening information of examinations performed from January 2004 to December 2019 as part of BreastScreen Norway were used in this retrospective study. Prior screening examinations from women who were later diagnosed with cancer were assigned an AI risk score by a commercially available AI system (scores of 1-7, low risk of malignancy; 8-9, intermediate risk; and 10, high risk of malignancy). Mammographic features of the cancers based on the AI score were also assessed. The association between AI score and mammographic features was tested with a bivariate test. Results A total of 2787 prior screening examinations from 1602 women (mean age, 59 years ± 5.1 [SD]) with screen-detected (n = 1016) or interval (n = 586) cancers showed an AI risk score of 10 for 389 (38.3%) and 231 (39.4%) cancers, respectively, on the mammograms in the screening round prior to diagnosis. Among the screen-detected cancers with AI scores available two screening rounds (4 years) before diagnosis, 23.0% (122 of 531) had a score of 10. Mammographic features were associated with AI score for invasive screen-detected cancers (P < .001). Density with calcifications was registered for 13.6% (43 of 317) of screen-detected cases with a score of 10 and 4.6% (15 of 322) for those with a score of 1-7. Conclusion More than one in three cases of screen-detected and interval cancers had the highest AI risk score at prior screening, suggesting that the use of AI in mammography screening may lead to earlier detection of breast cancers.
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2.
  • Larsen, Marthe, et al. (författare)
  • Artificial Intelligence Evaluation of 122 969 Mammography Examinations from a Population-based Screening Program
  • 2022
  • Ingår i: Radiology. - : Radiological Society of North America (RSNA). - 1527-1315 .- 0033-8419. ; 303:3, s. 502-511
  • Tidskriftsartikel (refereegranskat)abstract
    • Background Artificial intelligence (AI) has shown promising results for cancer detection with mammographic screening. However, evidence related to the use of AI in real screening settings remain sparse. Purpose To compare the performance of a commercially available AI system with routine, independent double reading with consensus as performed in a population-based screening program. Furthermore, the histopathologic characteristics of tumors with different AI scores were explored. Materials and Methods In this retrospective study, 122 969 screening examinations from 47 877 women performed at four screening units in BreastScreen Norway from October 2009 to December 2018 were included. The data set included 752 screen-detected cancers (6.1 per 1000 examinations) and 205 interval cancers (1.7 per 1000 examinations). Each examination had an AI score between 1 and 10, where 1 indicated low risk of breast cancer and 10 indicated high risk. Threshold 1, threshold 2, and threshold 3 were used to assess the performance of the AI system as a binary decision tool (selected vs not selected). Threshold 1 was set at an AI score of 10, threshold 2 was set to yield a selection rate similar to the consensus rate (8.8%), and threshold 3 was set to yield a selection rate similar to an average individual radiologist (5.8%). Descriptive statistics were used to summarize screening outcomes. Results A total of 653 of 752 screen-detected cancers (86.8%) and 92 of 205 interval cancers (44.9%) were given a score of 10 by the AI system (threshold 1). Using threshold 3, 80.1% of the screen-detected cancers (602 of 752) and 30.7% of the interval cancers (63 of 205) were selected. Screen-detected cancer with AI scores not selected using the thresholds had favorable histopathologic characteristics compared to those selected; opposite results were observed for interval cancer. Conclusion The proportion of screen-detected cancers not selected by the artificial intelligence (AI) system at the three evaluated thresholds was less than 20%. The overall performance of the AI system was promising according to cancer detection.
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3.
  • Moshina, Nataliia, et al. (författare)
  • Digital breast tomosynthesis in mammographic screening : false negative cancer cases in the To-Be 1 trial
  • 2024
  • Ingår i: Insights into Imaging. - 1869-4101. ; 15:1
  • Tidskriftsartikel (refereegranskat)abstract
    • Objectives: The randomized controlled trial comparing digital breast tomosynthesis and synthetic 2D mammograms (DBT + SM) versus digital mammography (DM) (the To-Be 1 trial), 2016–2017, did not result in higher cancer detection for DBT + SM. We aimed to determine if negative cases prior to interval and consecutive screen-detected cancers from DBT + SM were due to interpretive error. Methods: Five external breast radiologists performed the individual blinded review of 239 screening examinations (90 true negative, 39 false positive, 19 prior to interval cancer, and 91 prior to consecutive screen-detected cancer) and the informed consensus review of examinations prior to interval and screen-detected cancers (n = 110). The reviewers marked suspicious findings with a score of 1–5 (probability of malignancy). A case was false negative if ≥ 2 radiologists assigned the cancer site with a score of ≥ 2 in the blinded review and if the case was assigned as false negative by a consensus in the informed review. Results: In the informed review, 5.3% of examinations prior to interval cancer and 18.7% prior to consecutive round screen-detected cancer were considered false negative. In the blinded review, 10.6% of examinations prior to interval cancer and 42.9% prior to consecutive round screen-detected cancer were scored ≥ 2. A score of ≥ 2 was assigned to 47.8% of negative and 89.7% of false positive examinations. Conclusions: The false negative rates were consistent with those of prior DM reviews, indicating that the lack of higher cancer detection for DBT + SM versus DM in the To-Be 1 trial is complex and not due to interpretive error alone. Critical relevance statement: The randomized controlled trial on digital breast tomosynthesis and synthetic 2D mammograms (DBT) and digital mammography (DM), 2016–2017, showed no difference in cancer detection for the two techniques. The rates of false negative screening examinations prior to interval and consecutive screen-detected cancer for DBT were consistent with the rates in prior DM reviews, indicating that the non-superior DBT performance in the trial might not be due to interpretive error alone. Key points: • Screening with digital breast tomosynthesis (DBT) did not result in a higher breast cancer detection rate compared to screening with digital mammography (DM) in the To-Be 1 trial. • The false negative rates for examinations prior to interval and consecutive screen-detected cancer for DBT were determined in the trial to test if the lack of differences was due to interpretive error. • The false negative rates were consistent with those of prior DM reviews, indicating that the lack of higher cancer detection for DBT versus DM was complex and not due to interpretive error alone. Graphical Abstract: (Figure presented.)
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4.
  • Baldeh, Tejan, et al. (författare)
  • Development and use of health outcome descriptors : a guideline development case study
  • 2020
  • Ingår i: Health and Quality of Life Outcomes. - : BioMed Central. - 1477-7525 .- 1477-7525. ; 18:1
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: During healthcare guideline development, panel members often have implicit, different definitions of health outcomes that can lead to misunderstandings about how important these outcomes are and how to balance benefits and harms. McMaster GRADE Centre researchers developed ‘health outcome descriptors’ for standardizing descriptions of health outcomes and overcoming these problems to support the European Commission Initiative on Breast Cancer (ECIBC) Guideline Development Group (GDG). We aimed to determine which aspects of the development, content, and use of health outcome descriptors were valuable to guideline developers.Methods: We developed 24 health outcome descriptors related to breast cancer screening and diagnosis for the European Commission Breast Guideline Development Group (GDG). Eighteen GDG members provided feedback in written format or in interviews. We then evaluated the process and conducted two health utility rating surveys.Results: Feedback from GDG members revealed that health outcome descriptors are probably useful for developing recommendations and improving transparency of guideline methods. Time commitment, methodology training, and need for multidisciplinary expertise throughout development were considered important determinants of the process. Comparison of the two health utility surveys showed a decrease in standard deviation in the second survey across 21 (88%) of the outcomes.Conclusions: Health outcome descriptors are feasible and should be developed prior to the outcome prioritization step in the guideline development process. Guideline developers should involve a subgroup of multidisciplinary experts in all stages of development and ensure all guideline panel members are trained in guideline methodology that includes understanding the importance of defining and understanding the outcomes of interest.
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5.
  • Giordano, Livia, et al. (författare)
  • Mammographic screening programmes in Europe : organization, coverage and participation
  • 2012
  • Ingår i: Journal of Medical Screening. - : SAGE Publications. - 0969-1413 .- 1475-5793. ; 19, s. 72-82
  • Tidskriftsartikel (refereegranskat)abstract
    • Objectives To summarize participation and coverage rates in population mammographic screening programmes for breast cancer in Europe. Methods We used the European Network for Information on Cancer (EUNICE), a web-based data warehouse (EUNICE Breast Cancer Screening Monitoring, EBCSM) for breast cancer screening, to obtain information on programme characteristics, coverage and participation from its initial application in 10 national and 16 regional programmes in 18 European countries. Results The total population targeted by the screening programme services covered in the report comprised 26.9 million women predominantly aged 50-69. Most of the collected data relates to 2005, 2006 and/or 2007. The average participation rate across all programmes was 53.4% (range 19.4-88.9% of personally invited); or 66.4% excluding Poland, a large programme that initiated personal invitations in 2007. Thirteen of the 26 programmes achieved the European Union benchmark of acceptable participation (>70%), nine achieved the desirable level (>75%). Despite considerable invitation coverage across all programmes (79.3%, range 50.9-115.2%) only 48.2% (range 28.4-92.1%) of the target population were actually screened. The overall invitation and examination coverage excluding Poland was 70.9% and 50.3%, respectively. Conclusions The results demonstrate the feasibility of European-wide screening monitoring using the EBCSM data warehouse, although further efforts to refine the system and to harmonize standards and data collection practices will be required, to fully integrate all European countries. The more than threefold difference in the examination coverage should be taken into account in the evaluation of service screening programmes.
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6.
  • Giorgi Rossi, Paolo, et al. (författare)
  • Recommendations from the European Commission Initiative on Breast Cancer for multigene testing to guide the use of adjuvant chemotherapy in patients with early breast cancer, hormone receptor positive, HER-2 negative
  • 2021
  • Ingår i: British Journal of Cancer. - : Springer. - 0007-0920 .- 1532-1827. ; 124:9, s. 1503-1512
  • Forskningsöversikt (refereegranskat)abstract
    • Background: Predicting the risk of recurrence and response to chemotherapy in women with early breast cancer is crucial to optimise adjuvant treatment. Despite the common practice of using multigene tests to predict recurrence, existing recommendations are inconsistent. Our aim was to formulate healthcare recommendations for the question “Should multigene tests be used in women who have early invasive breast cancer, hormone receptor-positive, HER2-negative, to guide the use of adjuvant chemotherapy?”Methods: The European Commission Initiative on Breast Cancer (ECIBC) Guidelines Development Group (GDG), a multidisciplinary guideline panel including experts and three patients, developed recommendations informed by systematic reviews of the evidence. Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision frameworks were used. Four multigene tests were evaluated: the 21-gene recurrence score (21-RS), the 70-gene signature (70-GS), the PAM50 risk of recurrence score (PAM50-RORS), and the 12-gene molecular score (12-MS).Results: Five studies (2 marker-based design RCTs, two treatment interaction design RCTs and 1 pooled individual data analysis from observational studies) were included; no eligible studies on PAM50-RORS or 12-MS were identified and the GDG did not formulate recommendations for these tests.Conclusions: The ECIBC GDG suggests the use of the 21-RS for lymph node-negative women (conditional recommendation, very low certainty of evidence), recognising that benefits are probably larger in women at high risk of recurrence based on clinical characteristics. The ECIBC GDG suggests the use of the 70-GS for women at high clinical risk (conditional recommendation, low certainty of evidence), and recommends not using 70-GS in women at low clinical risk (strong recommendation, low certainty of evidence).
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7.
  • Hofvind, Solveig, et al. (författare)
  • Effect of invitation letter in language of origin on screening attendance : Randomised controlled trial in BreastScreen Norway
  • 2023
  • Ingår i: BMJ. - 0959-8146.
  • Tidskriftsartikel (refereegranskat)abstract
    • Objective: To explore attendance at organised mammographic screening among immigrant groups that received an invitation letter and information leaflet (invitation) in their language of origin and Norwegian compared with Norwegian only. Design: Randomised controlled trial. Setting: Population based screening programme for breast cancer in Norway (BreastScreen Norway), which invites women aged 50-69 to two-view mammographic screening biennially. Participants: All women invited to BreastScreen Norway in the study period April 2021 to June 2022 whose language of origin was Arabic (women born in Algeria, Egypt, Lebanon, Iraq, Palestine, Sudan, Syria, Tunisia, or Morocco), English (women born in the Philippines), Polish (women born in Poland), Somali (women born in Somalia), or Urdu (women born in Pakistan) (n=11 347). Intervention: The study group received an invitation to screening in their language of origin and in Norwegian, whereas the control group received an invitation in Norwegian only during the study period. Main outcome measure: Attendance at BreastScreen Norway during the study period. Results: Overall attendance was 46.5% (2642/5683) in the study group and 47.4% (2682/5664) in the control group. No statistical differences in attendance were observed after stratification by language of invitation, age at invitation, or years since immigration. Conclusions: No difference in attendance was observed between immigrant women invited to BreastScreen Norway in their language of origin and in Norwegian compared with Norwegian only. Several barriers to cancer screening may exist among immigrants, and translating the invitation is probably only a part of a complex explanation. Trial registration: NCT04672265.ClinicalTrials.gov NCT04672265.
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8.
  • Holen, Åsne Sørlien, et al. (författare)
  • Early screening outcomes before, during, and after a randomized controlled trial with digital breast tomosynthesis
  • 2023
  • Ingår i: European Journal of Radiology. - 0720-048X. ; 167
  • Tidskriftsartikel (refereegranskat)abstract
    • Purpose: To describe and compare early screening outcomes before, during and after a randomized controlled trial with digital breast tomosynthesis (DBT) including synthetic 2D mammography versus standard digital mammography (DM) (To-Be 1) and a follow-up cohort study using DBT (To-Be 2). Methods: Retrospective results of 125,020 screening examinations from four consecutive screening rounds performed in 2014–2021 were described and compared for pre-To-Be 1 (DM), To-Be 1 (DM or DBT), To-Be 2 (DBT), and post-To-Be 2 (DM) cohorts. Descriptive analyses of rates of recall, biopsy, screen-detected and interval cancer, distribution of histopathologic tumor characteristics and time spent on image interpretation and consensus were presented for the four rounds including five cohorts, one cohort in each screening round except for the To-Be 1 trail, which included a DBT and a DM cohort. Odds ratios (OR) with 95% CIs was calculated for recall and cancer detection rates. Results: Rate of screen-detected cancer was 0.90% for women screened with DBT in To-Be 2 and 0.64% for DM in pre-To-Be 1. The rates did not differ for the To-Be 1 DM (0.61%), To-Be 1 DBT (0.66%) and post-To-Be 2 DM (0.67%) cohorts. The interval cancer rates ranged between 0.13% and 0.20%. The distribution of histopathologic tumor characteristics did not differ between the cohorts. Conclusions: Screening all women with DBT following a randomized controlled trial in an organized, population-based screening program showed a temporary increase in the rate of screen-detected cancer.
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9.
  • Houssami, Nehmat, et al. (författare)
  • Effectiveness of digital breast tomosynthesis (3D-mammography) in population breast cancer screening : A protocol for a collaborative individual participant data (IPD) meta-analysis
  • 2017
  • Ingår i: Translational Cancer Research. - : AME Publishing Company. - 2218-676X .- 2219-6803. ; 6:4, s. 869-877
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: There is accumulating evidence that digital breast tomosynthesis, referred to as 3D-mammography in this protocol, improves screen-detection measures compared to standard 2D-mammography in the context of population screening for breast cancer. However, the effect of 3D-mammography at follow-up of screened women is not yet known: it is unknown whether additional cancer detection from 3D-mammography leads to incremental screening benefit through a reduction of interval cancers, or whether it is mostly over-detecting indolent cancers. Methods: The aim of this study is to examine whether 3D-mammography population screening improves breast cancer screening effectiveness by reducing interval cancer rates compared to standard digital (2D) mammography screening, using individual participant data (IPD) meta-analysis. In this protocol, we outline the research plan which includes systematic identification of studies eligible to contribute data into the IPD meta-analysis, and sourcing and assembling IPD for participants screened with 3D-mammography (3D alone or integrated 2D/3D or integrated 2Dsynthetic/3D) and comparison participants screened with 2D-mammography (standard of care in breast screening). The primary end-point of this work is the interval breast cancer rate per 10,000 screens for 3D-mammography versus 2D-mammography screening. The IPD meta-analysis will also assess secondary outcomes including: screening sensitivity, cancer detection rates, cancer (prognostic) characteristics, and recall rates, for 3D-mammography versus 2D-mammography screening. The use of IPD meta-analysis will allow stratification of results by age and breast density, and will also facilitate analysis of cancer histological (prognostic) characteristics. Discussion: Finalization of data collection procedures and analysis plans will be complete by the end of 2017. Data collection will occur from late 2017 to late 2018 (screen-detection measures: cancer detection and recall data) and from mid-2018 to mid-2019 (interval cancer data). Results of detection measures should be available by 2019, and interval cancer results in 2020. By addressing the critical evidence gap on whether 3D-mammography screening reduces interval cancer rates (compared to 2D-mammography), we expect that our findings will inform timely translation of 3D-mammography technology into breast screening practice in population-based health programs.
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10.
  • Houssami, Nehmat, et al. (författare)
  • Interval breast cancer rates for digital breast tomosynthesis versus digital mammography population screening : An individual participant data meta-analysis
  • 2021
  • Ingår i: EClinicalMedicine. - : Elsevier BV. - 2589-5370. ; 34
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Digital breast tomosynthesis (DBT) improves breast cancer (BC) detection compared to mammography, however, it is unknown whether this reduces interval cancer rate (ICR) at follow-up. Methods: Using individual participant data (IPD) from DBT screening studies (identified via periodic literature searches July 2016 to November 2019) we performed an IPD meta-analysis. We estimated ICR for DBT-screened participants and the difference in pooled ICR for DBT and mammography-only screening, and compared interval BC characteristics. Two-stage meta-analysis (study-specific estimation, pooled synthesis) of ICR included random-effects, adjusting for study and age, and was estimated in age and density subgroups. Comparative screening sensitivity was calculated using screen-detected and interval BC data. Findings: Four prospective DBT studies, from European population-based programs, contributed IPD for 66,451 DBT-screened participants: age-adjusted pooled ICR was 13.17/10,000 (95%CI: 8.25–21.02). Pooled ICR was higher in the high-density (21.08/10,000; 95%CI: 6.71–66.27) than the low-density (8.63/10,000; 95%CI: 5.25–14.192) groups (P = 0.03) however estimates did not differ across age-groups (P = 0.32). Based on two studies that also provided data for 153,800 mammography screens (age-adjusted ICR 17.69/10,000; 95%CI: 13.22–23.66), DBT's pooled ICR was 16.83/10,000 (95%CI: 11.89–23.82). Comparative meta-analysis showed a non-significant difference in ICR (-0.44/10,000; 95%CI: -11.00–10.11) and non-significant difference in screening sensitivity (6.79%; 95%CI: -0.73–14.87%) between DBT and DM but a significant pooled difference in cancer detection rate of 33.49/10,000 (95%CI: 23.88–43.10). Distribution of interval BC prognostic characteristics did not differ between screening modalities except that those occurring in DBT-screened participants were significantly more likely to be negative for axillary-node metastases (P = 0.005). Interpretation: Although heterogeneity in ICR estimates and few datasets limit recommendations, there was no difference between DBT and mammography in pooled ICR despite DBT increasing cancer detection.
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