Recommendations from the European Breast Cancer Guidelines

Should screening using tomosynthesis (including synthesised 2D images) in addition to digital mammography vs. digital mammography be used for early detection of breast cancer in asymptomatic women?

Recommendation

The ECIBC's Guidelines Development Group suggests that women who are not at high risk of breast cancer and do not have symptoms, have either a mammogram or have a mammogram plus tomosynthesis when being screened for breast cancer.

Recommendation strength

  •   Strong recommendation against the intervention
  •   Conditional recommendation against the intervention
  • Conditional recommendation for either the intervention or the comparison
  •   Conditional recommendation for the intervention
  •   Strong recommendation for the intervention

A recommendation can be strong or conditional.

When a recommendation is strong, most women will want to follow it. When a recommendation is conditional, the majority of women want to follow it but may need more discussion with their healthcare professional first.

What would following this recommendation mean for you?

It might be important to speak with your healthcare professional to determine if you are at high, average or low risk of breast cancer and whether you have or do not have any symptoms of breast cancer.

To decide whether it is better to have only a digital mammogram or a digital mammogram plus digital breast tomosynthesis, you may wish to speak with your healthcare professional about these tests and how you feel about

  • the radiation exposure of the tests
  • the chances of finding breast cancer
  • the chance of being called back for further tests which find that you do not have cancer
  • what could happen in the long term, and
  • your comfort during the tests.

Who is this recommendation for?

  • You are between 45 and 74
  • You do not have a high risk of breast cancer
  • You do not have symptoms of breast cancer

Justification

This recommendation suggests having either a digital mammogram or a digital mammogram plus digital breast tomosynthesis (3D x-rays) when being screened for breast cancer because the overall benefits and harms of each may be similar. Having both tests may find more breast cancers (about 2 to 3 more per 1000 women). However, it is uncertain whether finding more breast cancers leads to finding more advanced breast cancers or fewer deaths. When having both tests, compared to having only a digital mammogram, more women may have to come back for more tests (15 to 60 more per 1000 women) and have unnecessary tests (such as a biopsy of the tissue in the breast). Having both tests may also mean more visits to the screening service and would also increase a woman’s exposure to radiation.

The ECIBC’s Guideline Development Group thought that women may feel differently about the benefits and harms and might need to discuss them with their healthcare professional before deciding on whether to have two tests or one.

More research is being done now that will provide more information in the future about whether screening with the two tests is better than with one.

The ECIBC’s Guidelines Development Group also noted that the costs to a country would likely be higher when both tests are provided.

Considerations

Subgroup

Women with high mammographic breast density are likely to benefit most from the increased detection capability of DBT plus DM. However, this group was not specifically considered in this question.

Implementation

- Evidence will be emerging from ongoing and newly starting screening trials on tomosynthesis that may influence the current recommendations. - Inappropriate worry about radiation dose should be dealt with in case programmes that are using the DBT plus DM combination. In general, the GDG believes it is important to educate women and health professionals on the risk of radiation in the context of possible benefits of screening. - GDG indicates that it will be very unlikely to implement DBT plus DM in practice because it means two examinations instead of one, with additional radiation and discomfort for women. However, other GDG members indicate that this is currently already done in certain setttings.
 
- There will be significantly increased data storage needs for screening programmes using DBT plus DM as compared to only DM.
 
- The GDG noted that health equity in access to screening should be considered for countries choosing DBT-based screening programmes, due to different resource settings and the capacity for different countries to be able to pay for DBT plus DM over DM which may lead to increased health inequities.

Monitoring and Evaluation

Quality control procedures and quality standards should be further developed. Standards should be developed in particular for the image quality of synthesised 2D images from the tomosynthesis technology.

Research Priorities

- Evidence will be emerging from ongoing and newly starting screening trials on tomosynthesis that may influence the current recommendations.

- Collecting evidence relevant to implementation challenges of screening programmes using DBT in addition to DM.

- Further research information on harms of DBT used together with DM, including rates of overdiagnosis of breast cancer, are warranted.

- The currently included studies only present data from first round DBT plus DM screening studies, thus the effects for several patient important outcomes, which need a longer follow-up period, could not be taken into account. Thus, research on several screening rounds of DBT plus DM are warranted.

- Further research is needed to build the evidence on benefits and harms of DBT in addition to DM vs DM through comparison of direct outcomes, including impacts of interval cancer detection, stage of breast cancer at detection and mortality reduction.

- Research investigating the cost-effectiveness of a breast cancer screening programme using DBT in addition to DM is needed to inform decision-making on breast cancer screening.

- Research is needed to define the quality parameters that need to be fulfilled for breast cancer screening programmes using DBT in addition to DM to be implemented.

Evidence

Download the evidence profile

Assessment

Background

Breast cancer is the second most common cancer in the world and, by far, the most frequent cancer among women, with an estimated 1.67 million new cancer cases diagnosed in 2012 (25% of all cancers) (Ferlay 2012). Breast cancer ranks as the fifth cause of death from cancer overall (522 000 deaths), the most frequent cause of cancer death in women in less developed regions (324 000 deaths, 14.3% of total), and it is now the second cause of cancer death in more developed regions (198 000 deaths, 15.4%) after lung cancer (Ferlay 2012). Screening programmes play a crucial role in early breast cancer detection; it can increase the chance of survival as well as have an impact on the rate of death from breast cancer. Mammography remains the best method to detect breast cancer in an early stage. Mammography is a technique of imaging which produces a 2D image of the 3D organ. Inevitably, this implies that lesions can be obscured by superposition of dense tissue. Indeed, the superposition of tissue can lead to false positives as well as false negatives. Digital breast tomosynthesis is a pseudo-3D imaging technique based on a series of low dose images of the breast from different angles and therefore has the potential to overcome the tissue superposition issue thus improving detection of breast lesions (Rafferty 2013; Gur 2009). The series of projections is then processed by a reconstruction algorithm to estimate the 3D radiographic appearance of the breast which can be viewed in successive slices. Additional software can also allow the construction of synthesised 2D images.

Management of Conflicts of Interest (CoI): CoIs for all Guidelines Development Group (GDG) members were assessed and managed by the Joint Research Centre (JRC) following an established procedure in line with European Commission rules. GDG member participation in the development of the recommendations was restricted, according to CoI disclosure. Consequently, for this particular question, the following GDG members were recused from voting: Edoardo Colzani, Roberto d'Amico, Jan Danes, Solveig Hofvind, Elsa Pérez, and Kenneth Young. Miranda Langendam was not allowed to vote due to the established rules for external experts.
For more information please visit http://ecibc.jrc.ec.europa.eu/gdg-documents

Is the problem a priority?
Yes *
* Possible answers: ( No , Probably no , Probably yes , Yes , Varies , Don't know )
Research Evidence
Breast cancer ranks as the fifth cause of death from cancer overall (522 000 deaths), the most frequent cause of cancer death in women in less developed regions (324 000 deaths, 14.3% of total), and it is now the second cause of cancer death in more developed regions (198 000 deaths, 15.4%) after lung cancer (Ferlay 2012). Breast cancer is the fourth cancer with the highest disease burden (Tsilidis 2016).

Digital mammography (DM) is widely used in screening and diagnosis of breast cancer. However, some aspects such as superposition of breast tissue reduce the sensitivity of mammography and increase false-positives and false negatives. Digital Breast Tomosynthesis (DBT) might provide better imaging and discriminative capacity in these cases.

How substantial are the desirable anticipated effects?
Don't know *
* Possible answers: ( Trivial , Small , Moderate , Large , Varies , Don't know )
Research Evidence

Outcomes№ of participants
(studies)
Follow up
Quality of the evidence
(GRADE)
Relative effect
(95% CI)
Anticipated absolute effects* (95% CI)
Risk with digital mammography Risk difference with UPDATE screening using tomosynthesis (including synthesised 2D images) in addition to digital mammography
Breast cancer detection rate (double reading)59180
(3 observational studies)
a

LOW
b
OR 1.36
(1.26 to 1.46)
c,d
Study population
598 per 100.000a214 more per 100.000
(154 more to 273 more)
Recall rate19914
(2 observational studies)
e

LOW
b,f
OR 1.26
(1.22 to 1.30)
Low
2.200 per 100.000e556 more per 100.000
(471 more to 641 more)
High
15.600 per 100.000e3.290 more per 100.000
(2.800 more to 3.773 more)
False positive recall73646
(4 observational studies)

LOW
b
OR 1.22
(1.16 to 1.27)
Low
10.700 per 100.000g2.054 more per 100.000
(1.503 more to 2.507 more)
High
41.500 per 100.000g4.894 more per 100.000
(3.643 more to 5.894 more)
Invasive stage cancer 39826
(2 observational studies)
a

VERY LOW
b,h
OR 1.46
(1.30 to 1.64)
Study population
457 per 100.000a209 more per 100.000
(136 more to 290 more)
Radiation exposure0
(3 observational studies)

VERY LOW
i,j
-Radiation doses for digital mammography plus tomosynthesis were approximately twice that reported for digital mammography alone.









k
  1. Median or mean of the control group of the included studies as appropriate unless otherwise specified.
  2. Although only women with suggestive findings of malignancy were followed–up, it was agreed that there was not an important risk of information bias, as the same strategy was implemented in both arms of the included studies, and the effects were consistent across them.
  3. Relative effect was adjusted for paired design.
  4. Incremental cancer detection was 215 cancers per 100 000 (from 162 more to 267 more).
  5. Baseline risk calculated from Roman 2014 (PMID 24972452) and Hofvind (PMID 22972811)
  6. Although the STORM study (2013/2014) and OTST study (2013) evaluated women recalled in a different way (radiologist vs. radiologist plus meeting arbitration) the results were consistent.
  7. Baseline risk calculated from Roman 2014 (PMID 24972452).
  8. Invasive cancer stage is a surrogate outcome of cumulative incidence of advance breast cancer.
  9. Radiation exposure is a surrogate outcome of "other cancer related to radiation".
  10. Results were consistent independently of the technology used (Hologic Selenia Dimension or Senographe Dimension).
  11. Doses levels are known to vary (diagnostic reference levels are typically country/region and system specific).


* with screening using tomosynthesis (including synthesised 2D images) in addition to digital mammography .
Additional Considerations

The currently included studies only present data from first round DBT plus DM screening.

The included studies did not assess the outcomes of breast cancer mortality, quality of life, and other causes of mortality.
The anticipated desirable effects were examined individually by the GDG:

Cancer detection rate: large, based on the results of the 3 studies included.

Mortality: don’t know as no studies were available that examined mortality.

Cancer stage: don’t know, in that there were no studies reporting the effect on incidence of cancer by stage. However, given the relative increase of 46% in invasive cancer's detected, the technology is likely to confer a substantial reduction in late stage disease.

Interval cancer rate: don’t know based on included studies reporting only data from a first DBT plus DM screening round. However, the GDG took the view that a decrease in interval cancer rates can be expected as the sensitivity of the intervention proved to be higher.


How substantial are the undesirable anticipated effects?
Varies *
* Possible answers: ( Large , Moderate , Small , Trivial , Varies , Don't know )
Research Evidence

Outcomes№ of participants
(studies)
Follow up
Quality of the evidence
(GRADE)
Relative effect
(95% CI)
Anticipated absolute effects* (95% CI)
Risk with digital mammography Risk difference with UPDATE screening using tomosynthesis (including synthesised 2D images) in addition to digital mammography
Breast cancer detection rate (double reading)59180
(3 observational studies)
a

LOW
b
OR 1.36
(1.26 to 1.46)
c,d
Study population
598 per 100.000a214 more per 100.000
(154 more to 273 more)
Recall rate19914
(2 observational studies)
e

LOW
b,f
OR 1.26
(1.22 to 1.30)
Low
2.200 per 100.000e556 more per 100.000
(471 more to 641 more)
High
15.600 per 100.000e3.290 more per 100.000
(2.800 more to 3.773 more)
False positive recall73646
(4 observational studies)

LOW
b
OR 1.22
(1.16 to 1.27)
Low
10.700 per 100.000g2.054 more per 100.000
(1.503 more to 2.507 more)
High
41.500 per 100.000g4.894 more per 100.000
(3.643 more to 5.894 more)
Invasive stage cancer 39826
(2 observational studies)
a

VERY LOW
b,h
OR 1.46
(1.30 to 1.64)
Study population
457 per 100.000a209 more per 100.000
(136 more to 290 more)
Radiation exposure0
(3 observational studies)

VERY LOW
i,j
-Radiation doses for digital mammography plus tomosynthesis were approximately twice that reported for digital mammography alone.









k
  1. Median or mean of the control group of the included studies as appropriate unless otherwise specified.
  2. Although only women with suggestive findings of malignancy were followed–up, it was agreed that there was not an important risk of information bias, as the same strategy was implemented in both arms of the included studies, and the effects were consistent across them.
  3. Relative effect was adjusted for paired design.
  4. Incremental cancer detection was 215 cancers per 100 000 (from 162 more to 267 more).
  5. Baseline risk calculated from Roman 2014 (PMID 24972452) and Hofvind (PMID 22972811)
  6. Although the STORM study (2013/2014) and OTST study (2013) evaluated women recalled in a different way (radiologist vs. radiologist plus meeting arbitration) the results were consistent.
  7. Baseline risk calculated from Roman 2014 (PMID 24972452).
  8. Invasive cancer stage is a surrogate outcome of cumulative incidence of advance breast cancer.
  9. Radiation exposure is a surrogate outcome of "other cancer related to radiation".
  10. Results were consistent independently of the technology used (Hologic Selenia Dimension or Senographe Dimension).
  11. Doses levels are known to vary (diagnostic reference levels are typically country/region and system specific).


* with screening using tomosynthesis (including synthesised 2D images) in addition to digital mammography .
Additional Considerations

The anticipated undesirable effects were examined individually by the GDG:

Recall rate: the GDG notes that the recall rate may vary based on the baseline recall rate in the screening population (Hofvind 2012, Roman 2014).

False positive rate: varies. The GDG agreed the effect would vary depending, once again, on the baseline rate (Bernardi 2016).

Increase in other cancers due to radiation dose: small. Although the dose would be increased by using DBT plus DM, the absolute increase in radiation induced cancers is likely to be small.

Overall the GDG felt that the undesirable anticipated effects vary.

What is the overall certainty of the evidence of effects?
Very low *
* Possible answers: ( Very low , Low , Moderate , High , No included studies )
Additional Considerations

Due to varied undesirable effects and uncertain effects of DBT plus DM on breast cancer mortality the GDG agreed that there is very low certainty of the evidence of effects. However, the GDG agreed that DBT in addition to DM has substantially greater detection capability than DM alone.

Is there important uncertainty about or variability in how much people value the main outcomes?
Important uncertainty or variability *
* Possible answers: ( Important uncertainty or variability , Possibly important uncertainty or variability , Probably no important uncertainty or variability , No important uncertainty or variability , No known undesirable outcomes )
Research Evidence
No specific studies focusing in tomosynthesis were identified. The findings, all from mammography studies (JRC Technical Report PICO 10-11, contract FWC443094012015; available upon request), however, are likely to be generalisable to tomosynthesis, as both screening tests are associated with similar desirable and undesirable effects.

A systematic review shows that participants in mammography screening programmes place a low value on the psychosocial and physical effects of false positive results and overdiagnosis (JRC Technical Report PICO 10-11, contract FWC443094012015). Women generally consider these undesirable effects acceptable (low confidence). However, these findings are of limited value, mainly given the significant concerns regarding the adequacy of the information provided to women, in order to make an informed decision about participation. Also, acceptability of false positive results is based on studies of participants who had already received a false positive result. Their preference may differ from the general population. Another finding is that breast cancer screening represents a significant burden for some women due to the associated psychological distress and inconvenience.

Regarding breast cancer diagnosis, there is very limited data available on people’s views. One of the main themes identified in the literature is that people disvalue highly the anxiety caused by delays in the receipt of results of diagnostic procedures, or by a lack of understanding of the tests due to suboptimal communication with physicians (moderate confidence). Also, people have a higher overall preference towards more comfortable, brief diagnostic procedures (moderate confidence).
Additional Considerations

From the studies reviewed there was not much confidence in the findings and there is, therefore, uncertainty in how much people value the main outcomes.

The GDG agreed that the increase in breast cancer detection rate (although there is uncertainty about how this affects breast cancer mortality), as well as the variation in recall rate, and the increase in radiation exposure are likely to be valued very differently by women.

Does the balance between desirable and undesirable effects favor the intervention or the comparison?
Probably favors the intervention *
* Possible answers: ( Favors the comparison , Probably favors the comparison , Does not favor either the intervention or the comparison , Probably favors the intervention , Favors the intervention , Varies , Don't know )
Additional Considerations

Given the lack of research and the uncertainty of the effects of DBT plus DM screening on mortality, the GDG could not reach consensus on whether the balance of desirable and undesirable effects favours the intervention or the comparison.

As agreement was not reached, voting was conducted among GDG members: One member voted that the balance "does not favour either the intervention or the comparison"; 11 members voted that it "probably favours the intervention"; one member voted that it "varies"; six members voted they "don't know"; two members abstained.

How large are the resource requirements (costs)?
Moderate costs *
* Possible answers: ( Large costs , Moderate costs , Negligible costs and savings , Moderate savings , Large savings , Varies , Don't know )
Research Evidence
No relevant economic evaluations were identified.
Additional Considerations

The GDG agreed that resources required for moving from digital mammography alone to tomosynthesis combined with digital mammography could be moderate. These resources may include, amongst other factors: costs of the technology, capital costs of the machines and the lifetime of the machine, data transport and capacity for data storage, and additional time for radiologists to read tomosynthesis images, and increased time for the DBT plus DM examination compared to 2D mammography only examination.

Based on the information from three observational studies identified from the systematic review of Gilbert et al. (Gilbert 2016) radiologists’ reading time would have an increase of between 100% and 200% for the combination of tomosynthesis with digital mammography compared with digital mammography alone (Skaane 2013, Bernardi 2012a, Wallis 2012). This corresponds to absolute times of 33-67 seconds for digital mammography alone and 77-191 seconds for tomosynthesis plus digital mammography.

Staff cost may vary depending on the country context and they are not transferable from one country to another.

As there is a variation in recall rates expected and reported, a variation in savings or additional expenses should be expected. Nevertheless, the GDG members took the view that even if these variations were in favour of screening with DBT plus DM, they would probably not outweigh the extra costs mentioned above (equipment, reading time, etc.).

As agreement was not reached, voting was conducted among GDG members: two members voted "large costs"; 12 voted "moderate costs"; one member voted "varies"; two members voted "don't know"; two members abstained.

What is the certainty of the evidence of resource requirements (costs)?
No included studies *
* Possible answers: ( Very low , Low , Moderate , High , No included studies )
Research Evidence
No relevant economic evaluations were identified.
Does the cost-effectiveness of the intervention favor the intervention or the comparison?
No included studies *
* Possible answers: ( Favors the comparison , Probably favors the comparison , Does not favor either the intervention or the comparison , Probably favors the intervention , Favors the intervention , Varies , No included studies )
Research Evidence
No relevant economic evaluations were identified.
What would be the impact on health equity?
Varies *
* Possible answers: ( Reduced , Probably reduced , Probably no impact , Probably increased , Increased , Varies , Don't know )
Additional Considerations

The GDG felt that within screening programmes there may be policy decisions to restrict the programme if there are increased costs and the screening programme is unable to fund universal participation. This could have influences on equity in either direction.

Is the intervention acceptable to key stakeholders?
Varies *
* Possible answers: ( No , Probably no , Probably yes , Yes , Varies , Don't know )
Research Evidence
No specific studies focusing on tomosynthesis (including synthesised 2D images) in addition to digital mammography were identified. The findings, all from mammography studies, however, are likely to be generalisable to tomosynthesis (including synthesised 2D images) in addition to digital mammography, as both (DBT and DM) are associated with similar desirable and undesirable effects.

However, a systematic review (JRC Technical Report PICO 16-17, contract FWC443094032016; available upon request) found the following barriers associated with breast cancer screening with mammography: (a) lack of knowledge and misperceptions regarding preventive medicine and breast health (high confidence in evidence), (b) poor communication skills of healthcare providers (high confidence in evidence), (c) poor accessibility to breast screening, especially among women with disabilities (high confidence in evidence), (d) fear and stress related to the procedure and the possibility of cancer diagnosis (high confidence in evidence), (e) pain and discomfort during the procedure (moderate confidence in evidence), (f) embarrassment and shyness during the procedure (moderate confidence in evidence), (g) lack of support and encouragement from family members, caregivers and social network (moderate confidence in evidence), (h) lack of information regarding the available resources (low confidence in evidence) and (i) low prioritisation of breast cancer screening (low confidence in evidence). Women and relevant stakeholders expressed similar opinions.
Additional Considerations

Participants:
There is likely variability in acceptability for women. If there is a higher radiation dose, women may be more concerned. Additional compression time for the test and/or additional compressions might be necessary depending on the manufacturer of the device. Women who come for screening may be concerned that if they only have 2-D-mammography, and are not offered DBT, they are not getting the screening technology with the highest detection rate. Women may appreciate the increased confidence in the screening result if there is higher detection of cancers when screening with DBT in addition to DM vs DM alone. Participation rates in the trials reviewed are high which may indicate their general acceptability of DBT plus DM vs DM alone.

Radiologists:
DBT may be preferred by radiologists reading screening tests because their certainty in the diagnosis may be higher when using DBT plus DM compared to using DM alone.

Policy makers:
In settings with universal healthcare coverage, for directors of hospitals and screening programmes, carrying out DBT as well as DM may not be acceptable because there will likely be increased costs.

Is the intervention feasible to implement?
Varies *
* Possible answers: ( No , Probably no , Probably yes , Yes , Varies , Don't know )
Additional Considerations

The GDG felt that in contexts where there are the resources to support this and where there is access to new technologies that are capable of DBT, it is feasible. For other countries without the technology and resources to support this it may not be feasible. In addition, although DBT requires some extra training for radiologists, this was not seen by GDG as a major barrier to implementation.

The need to establish quality standards for synthesised 2D imaging for implementation was mentioned by the GDG.

Bibliography

Evidence of effects and background
  • Bernardi D, Macaskill P, Pellegrini M, Valentini M, Fantò C, Ostillio L, et al. Breast cancer screening with tomosynthesis (3D mammography) with acquired or synthetic 2D mammography compared with 2D mammography alone (STORM- 2): a population-based prospective study. Lancet Oncol. 2016 Aug;17(8):1105-13.
  • Ciatto S, Houssami N, Bernardi D, Caumo F, Pellegrini M, Brunelli S, et al. Integration of 3D digital mammography with tomosynthesis for population breast-cancer screening (STORM): a prospective comparison study. The Lancet Oncology. 2013; 14(7):583-9.
  • Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray, F. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available from: http://globocan.iarc.fr, accessed on day/month/year.
  • Gur D, Abrams GS, Chough DM, Ganott MA, Hakim CM, Perrin RL, et al. Digital breast tomosynthesis: observer performance study. AJR American Journal of Roentgenology. 2009;193(2):586-91.
  • Hofvind S, Ponti A, Patnick J, Ascunce N, Njor S, Broeders M, et al. False-positive results in mammographic screening for breast cancer in Europe: a literature review and survey of service screening programmes. J Med Screen. 2012;19 Suppl 1:57-66.
  • Houssami N, Macaskill P, Bernardi D, Caumo F, Pellegrini M, Brunelli S, et al. Breast screening using 2D-mammography or integrating digital breast tomosynthesis (3D-mammography) for single-reading or double-reading--evidence to guide future screening strategies. Eur J Cancer. 2014; 50(10):1799-807.
  • Lang K, Andersson I, Rosso A, Tingberg A, Timberg P, Zackrisson S. Performance of one-view breast tomosynthesis as a stand-alone breast cancer screening modality: results from the Malmo Breast Tomosynthesis Screening Trial, a population-based study. Eur Radiol. 2015.
  • Lång K, Nergården M, Andersson I, Rosso A, Zackrisson S. False positives in breast cancer screening with one-view breast tomosynthesis: An analysis of findings leading to recall, work-up and biopsy rates in the Malmö Breast Tomosynthesis Screening Trial.Eur Radiol. 2016 Mar 4.
  • Paulis LE, Lobbes MB, Lalji UC, Gelissen N, Bouwman RW, Wildberger JE, Jeukens CR.Radiation exposure of digital breast tomosynthesis using an antiscatter grid compared with full-field digital mammography. Invest Radiol. 2015 Oct;50(10):679-85.
  • Rafferty EA, Park JM, Philpotts LE, Poplack SP, Sumkin JH, Halpern EF, et al. Assessing radiologist performance using combined digital mammography and breast tomosynthesis compared with digital mammography alone: Results of a multicenter, multireader trial. Radiology. 2013;266(1):104-13.
  • Roman M, Skaane P, Hofvind S. The cumulative risk of false-positive screening results across screening centres in the Norwegian Breast Cancer Screening Program.Eur J Radiol. 2014 Sep;83(9):1639-44.
  • Skaane (a) P, Bandos AI, Gullien R, Eben EB, Ekseth U, Haakenaasen U, et al. Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Radiology. 2013;267(1):47-56.
  • Skaane (b) P, Bandos AI, Gullien R, et al. Prospective trial comparing full-field digital mammography (FFDM) versus combined FFDM and tomosynthesis in a population-based screening programme using independent double reading with arbitration. Eur Radiol 2013;23:2061e71.
  • Skaane P, Bandos AI, Eben EB, et al. Two-view digital breast tomosynthesis screening with synthetically reconstructed projection images: comparison with digital breast tomosynthesis with full-field digital mammographic images Radiology 2014;271:655e63.
  • Tsilidis KK, Papadimitriou N, Capothanassi D et al. Burden of Cancer in a Large Consortium of Prospective Cohorts in Europe. J Natl Cancer Inst. 2016 May 6;108(10).
  • Wallis MG, Moa E, Zanca F, Leifland K, Danielsson M. Two-view and single-view tomosynthesis versus full-field digital mammography: high-resolution X-ray imaging observer study. Radiology 2012; 262: 788–96.
Economic Evidence
  • Bernardi D, Macaskill P, Pellegrini M, Valentini M, Fantò C, Ostillio L, et al. Breast cancer screening with tomosynthesis (3D mammography) with acquired or synthetic 2D mammography compared with 2D mammography alone (STORM- 2): a population-based prospective study. Lancet Oncol. 2016 Aug;17(8):1105-13.
  • Gilbert FJ, Tucker L, Young KC. Digital breast tomosynthesis (DBT): a review of the evidence for use as a screening tool. Clin Radiol. 2016 Feb; 71(2): 141-50.
  • Skaane (a) P, Bandos AI, Gullien R, Eben EB, Ekseth U, Haakenaasen U, et al. Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Radiology. 2013;267(1):47-56.
  • Skaane (b) P, Bandos AI, Gullien R, et al. Prospective trial comparing full-field digital mammography (FFDM) versus combined FFDM and tomosynthesis in a population-based screening programme using independent double reading with arbitration. Eur Radiol 2013;23:2061e71.
  • Wallis MG, Moa E, Zanca F, Leifland K, Danielsson M. Two-view and single-view tomosynthesis versus full-field digital mammography: high-resolution X-ray imaging observer study. Radiology 2012; 262: 788–96.