ARTICLE IN PRESS

Original Investigation

External Validation of a Deep

Learning Model for Predicting
Mammographic Breast Density in
Routine Clinical Practice
Brian N. Dontchos, MD, Adam Yala, MEng, Regina Barzilay, PhD, Justin Xiang, BS,
Constance D. Lehman, MD, PhD

Rationale and Objectives: Federal legislation requires patient notification of dense mammographic breast tissue because increased den-
sity is a marker of breast cancer risk and can limit the sensitivity of mammography. As previously described, we clinically implemented our
deep learning model at the academic breast imaging practice where the model was developed with high clinical acceptance. Our objective
was to externally validate our deep learning model on radiologist breast density assessments in a community breast imaging practice.
Materials and Methods: Our deep learning model was implemented at a dedicated breast imaging practice staffed by both academic and
community breast imaging radiologists in October 2018. Deep learning model assessment of mammographic breast density was pre-
sented to the radiologist during routine clinical practice at the time of mammogram interpretation. We identified 2174 consecutive screen-
ing mammograms after implementation of the deep learning model. Radiologist agreement with the model’s assessment was measured
and compared across radiologist groups.
Results: Both academic and community radiologists had high clinical acceptance of the deep learning model’s density prediction, with
94.9% (academic) and 90.7% (community) acceptance for dense versus nondense categories (p < 0.001). The proportion of mammo-
grams assessed as dense by all radiologists decreased from 47.0% before deep learning model implementation to 41.0% after deep
learning model implementation (p < 0.001).
Conclusion: Our deep learning model had a high clinical acceptance rate among both academic and community radiologists and reduced
the proportion of mammograms assessed as dense. This is an important step to validating our deep learning model prior to potential wide-
spread implementation.
Key Words: Breast Density; Mammography; Deep Learning.
© 2020 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

Abbreviations: DL deep learning, BI-RADS Breast Imaging Reporting and Data System, PACS Picture Archiving and Communication
System

INTRODUCTION vary, but most require direct notification of patients that their
increased mammographic breast density may mask breast can-

I
ncreased mammographic breast density can mask cancers
cer and that they may benefit from supplemental screening
on mammography and is an independent risk factor for
tests such as ultrasound or MRI. In February 2019, federal
breast cancer (1 3). As a result, more than 30 states
legislation was passed with similar requirements, expanding
passed legislation requiring direct patient notification of
the potential impact of dense mammogram assessments.
increased mammographic breast density. Individual state laws
Mammographic breast density assessment is subjective and
varies widely between and within radiologists (4 10). In one
Acad Radiol 2020; &:1–6 study of 83 radiologists, there was considerable variation of
From the Massachusetts General Hospital, 55 Fruit Street, WAC-240, Boston, qualitative Breast Imaging Reporting and Data System (BI-
MA 02114 (B.N.D., C.D.L.); Massachusetts Institute of Technology, Cambridge,
Massachusetts (A.Y., R.B., J.X.). Received November 11, 2019; revised Decem- RADS) density assessments with a range of 6% 85% of
ber 11, 2019; accepted December 12, 2019. Funding: There is no funding to dis- mammograms being assessed as heterogeneously or extremely
close. Address correspondence to: B.N.D. e-mail: bdontchos@mgh.harvard.edu
dense (4). In another study of 34 radiologists, the intraradiol-
© 2020 The Association of University Radiologists. Published by Elsevier Inc.
All rights reserved.
ogist density agreement among women with two exams
https://doi.org/10.1016/j.acra.2019.12.012 ranged from 62% to 87% (6). In addition, one study across

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 ARTICLE IN PRESS
DONTCHOS ET AL
multiple states demonstrated a change in radiologists’ density
assessments after notification laws were enacted (5). These
studies not only show that mammographic density assess-
ments are subjective and variable but can also be influenced.
Commercially available methods of automated breast den-
sity assessment have produced mixed results in agreement with
expert density assessments, with both over and under reporting
of density compared to radiologists’ qualitative assessments
(11,12). A recent study found significant differences in density
assessments of the same 4170 women by two software pro-
grams (Volpara—Volpara Solutions, Wellington, New Zea-
land and Quantra—Hologic, Bedford, MA), with one
program assessing 37% of the women as having dense breast
tissue and the other program assessing 51% of the same women
as having dense breast tissue. Radiologists assessed 43% of the
same set of mammograms as having dense breast tissue (12).
Deep learning (DL) has been gaining traction in radiology
(13 16). Specifically, some early studies have evaluated algo-
rithms that automatically assess mammographic breast density
(17,18). In the first clinical implementation of a DL algo-
rithm, we developed and implemented a DL model to assess
mammographic breast density into routine clinical practice at
an academic breast imaging center. After clinical implementa-
tion, the interpreting radiologist accepted the DL model
assessment in 94% of exams (19). While this study was an
important initial step, the model was not externally validated
on patients or radiologists outside the institution that pro-
vided the reference images and density assessments to train
the model.
The primary aim of this study is to measure the clinical accep-
tance of the DL model’s density assessment in routine clinical
practice among both academic and community breast imaging
radiologists. The secondary aim is to measure the influence the
DL model had on radiologist’s density assessments.
METHODS
Our retrospective study was approved by our institutional
review board (with a waiver for the need to obtain informed
consent) and was compliant with the Health Insurance Porta-
bility and Accountability Act.
Development of the Deep Learning Model
We developed and tested our DL model using 58,894 ran-
domly selected digital mammograms (Hologic, Bedford,
MA) without exclusion criteria from 39,272 women screened
between January 2009 and May 2011 by using a deep convo-
lutional neural network, ResNet-18 (21), with PyTorch
(2018, version 0.31; pytorch.org) as previously described (19).
In brief, women were randomly assigned to training, devel-
opment, and test sets, resulting in 41,479; 8738; and 8677
mammograms for each set, respectively. Breast density was
recorded by one of 12 academic radiologists subspecialized in
breast imaging, with between 5 and 33 years of experience,
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Academic Radiology, Vol &, No &&, && 2020
following the American College of Radiology BI-RADS
lexicon of category a (almost entirely fatty), b (scattered areas
of fibroglandular density), c (heterogeneously dense), and d
(extremely dense).
Clinical Implementation and Influence of the Deep
Learning Model
After 6 months of evaluation at our primary academic breast
imaging practice (19), the DL model was implemented in an
identical fashion at our partner community breast imaging
practice on June 1, 2018. Our partner community breast imag-
ing site is a dedicated breast imaging center located in a subur-
ban ambulatory care center. The radiologist staffing is shared
equally between our academic practice radiologists and our
partner community practice radiologists. Screening mammo-
grams performed at the community practice site are divided
randomly and equally between the two groups of breast imag-
ing radiologists, then assessed and reported independently.
Identical to our academic breast imaging practice, mam-
mograms from the community breast imaging practice were
automatically retrieved after image acquisition and processed
by the DL algorithm; the DL density assessment (BI-RADS
category a, b, c, or d) was sent to a commercially available
mammography reporting software program (Magview, 2018,
Version 8.0.143. Burtonsville, MD). We allowed a several
month training period for our community practice radiolog-
ists from June 1, 2018 to September 30, 2018 to familiarize
themselves with the DL model workflow integration.
Eight academic radiologists (range of 2 24 years of experi-
ence; mean of 8.3 years; median of 4 years) and five commu-
nity radiologists (range of 4 20 years of experience; mean of
11.6 years; median of 10 years) interpreted screening mam-
mograms during the clinical implementation phase. All eight
of the academic radiologists and four of the five community
radiologists completed a dedicated fellowship training pro-
gram in breast imaging (the one community radiologist who
did not complete a dedicated breast imaging fellowship has
practiced clinical breast imaging for 17 years). None of these
13 radiologists contributed prospective density assessments to
the training, development, or test sets for the DL algorithm.
During the screening mammogram review, all radiologists
were provided with the DL model’s density assessment in the
electronic imaging report provided by the reporting software.
The final density assessment of the mammogram was at the dis-
cretion of the radiologist, that is, to agree or disagree with the
DL model. All mammograms were analyzed on our review
workstations (Hologic, Bedford, MA) following our routine
clinical workflow for mammogram assessment and reporting.
We identified consecutive digital screening mammograms
performed at the community breast imaging site during two
time periods as follows: 5696 mammograms before DL model
implementation from June 1, 2017 to May 31, 2018 (preim-
plementation); and 2174 mammograms from October 1,
2018 to February 28, 2019 (postimplementation). No
 ARTICLE IN PRESS
Academic Radiology, Vol &, No &&, && 2020 EXTERNAL VALIDATION OF A DEEP LEARNING MODEL

mammograms were excluded (e.g., due to prior surgery,
implants, etc.). Note that density legislation in our state went
into effect on January 1, 2015, well before the study. Both
academic and community radiologists interpreted screening
mammograms at the community breast imaging site during
both time periods. The group of academic and community
radiologists assessing the mammograms was nearly identical in
each time period, save for one academic radiologist that left
the practice before the DL model was implemented. We
measured the proportion of mammograms categorized by the
radiologist as dense or nondense and across the four
BI-RADS categories for the final read during the pre- and
postimplementation time periods, compared across academic
and community radiologists. Finally, we recorded the pro-
portion of mammograms categorized by the DL model as
dense or nondense and across the four BI-RADS categories
during the postimplementation time period.
Statistical Analysis
We quantified the types of disagreements and computed
agreement between final assessment and DL assessment across
the four BI-RADS categories, estimating with weighted
Kappa using linear weighting. Kappa statistics were compared
across 5000 bootstrap samples to assess significance. To com-
pare density distributions, we compared Academic radiolog-
ists, Community radiologists and all radiologists across time
Periods 1 and 2 using Pearson’s chi-squared test to calculate
significance. We computed all statistics using scikit-learn
(scikit-learn.org, v0.19.1).
RESULTS
After clinical implementation of the DL model, 2174 screening
mammograms were interpreted by prospectively assessed by
academic (1079 exams) and community radiologists (1095
exams). Mean age, age distribution, and race were similar
between academic and community radiologist assessed exams.
Academic radiologists assessed 39.3% exams as dense and com-
munity radiologists assessed 42.8% exams as dense (p = 0.09).
The DL model assessed a similar proportion of exams as dense
in the academic (34.9%) and community radiologist assessed
exams (34.1%) (p = 0.67). Availability of a comparison exam
was similar across academic (94.1%) and community (92.8%)
radiologist assessed exams (p = 0.23) (Table 1).
The academic radiologists had high clinical acceptance of
the DL model’s density prediction, with 94.9% acceptance
for dense versus nondense categories, and 92.1% acceptance

TABLE 1. Patient demographics and mammographic breast density assessment distribution, after implementation of the DL
model

Academic Radiologist Community Radiologist p

Screening mammograms N = 1079 N = 1095

Age, mean (range) 60.7 (38-90) 60.4 (30-91) 0.551
<40 3 (0.3%) 6 (0.5%) 0.532
40 49 211 (19.6%) 221 (20.2%)
50 59 317 (29.4%) 303 (27.7%)
60 69 270 (25.0%) 299 (27.3%)
70 278 (25.8%) 266 (24.3%)
Race 0.272
White 979 (90.7%) 992 (90.6%)
Non-White 43 (4.0%) 56 (5.1%)
Unknown/no response 57 (5.3%) 47 (4.3%)
Radiologist assessed breast density number (percentage) N = 1079 N = 1095
Almost entirely fatty 39 (3.6 %) 60 (5.5%) <0.0012
Scattered areas of fibroglandular tissue 616 (57.1%) 566 (51.7%)
Heterogeneously dense 397 (36.8%) 406 (37.1%)
Extremely dense 27 (2.5%) 63 (5.8%)
Nondense 655 (60.7%) 626 (57.2%) 0.092
Dense 424 (39.3%) 469 (42.8%)
DL assessed breast density number (percentage) N = 1079 N = 1095
Almost entirely fatty 54 (5.0%) 57 (5.2%) 0.972
Scattered areas of fibroglandular tissue 648 (60.1%) 665 (60.7%)
Heterogeneously dense 363 (33.6%) 360 (32.9%)
Extremely dense 14 (1.3%) 13 (1.2%)
Nondense 702 (65.1%) 722 (65.9%) 0.672
Dense 377 (34.9%) 373 (34.1%)
Screening mammograms with comparison available (%) 1015 (94.1%) 1016 (92.8%) 0.232

Significance comparisons made between academic and community radiologists: Tests used: 1two-tailed t test; 2Pearson’s chi-square test.

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DONTCHOS ET AL Academic Radiology, Vol &, No &&, && 2020

TABLE 2. Percent acceptance of community and academic radiologists with the DL model density assessment after clinical
implementation with 95% confidence interval in parenthesis

Accuracy/Acceptance (95% Confidence Interval) p

Density comparison Academic radiologist Community radiologist

(N = 1079) (N = 1095)
Dense or nondense 1024/1079 993/1095 <0.001
94.9% (93.4%, 96.0%) 90.7% (88.8%, 92.3%)
Four BI-RADS 994/1079 908/1095 <0.001
Categories 92.1% (90.4%, 93.6%) 82.3% (80.6%, 85.0%)

for the four BI-RADS categories. The community radiolog- DISCUSSION

ists also had high clinical acceptance of the DL model’s den-
Subjectivity and variability of mammographic breast density
sity prediction, with 90.7% acceptance for dense versus
assessments is established and directly impacts patients and
nondense categories, and 82.3% acceptance for the four
healthcare costs with the passage of state and federal legisla-
BI-RADS categories (Table 2) (Figure 1).
tion mandating patient notification of their increased density
When the radiologist did not accept the DL model predic-
(4 10). As such, we sought to alleviate this by clinically
tion of scattered areas of fibroglandular densities, they
implementing and externally validating a DL model that pre-
increased the density category to heterogeneously dense in
dicts mammographic breast density based on expert breast
83.9% (community radiologist) and 98.1% (academic radiolo-
imaging radiologist’s assessments (19). Secondarily, we sought
gist) of cases. When the radiologist did not accept the DL
to measure the DL model’s influence on breast imaging. We
model prediction of heterogeneously dense, they increased
demonstrated a high clinical acceptance of the DL model
the density category to extremely dense in 94.3% (commu-
assessments by both academic and community radiologists
nity radiologist) and 76.5% (academic radiologist) of cases.
and detected a significant reduction of dense mammogram
Prior to clinical implementation of the DL model, 5696
assessments from 47% to 41%. The high clinical acceptance of
screening mammograms were prospectively assessed by aca-
the DL model among both groups of radiologists with shift in
demic (2829 exams) and community radiologists (2867 exams).
density assessments toward the DL model’s density distribu-
The proportion of exams categorized as dense significantly
tion may support more widespread clinical use.
decreased from 46.2% to 39.3% (academic), 47.6% 42.9%
Our study was performed on prospectively collected conse-
(community), and 47.0% 41.0% (combined) comparing pre-
cutive mammograms without exclusion criteria at a breast
and post-DL model implementation (p < 0.001) (Table 3).
imaging practice separate from where the DL model was
Since one radiologist left the academic group before the DL
developed, while still achieving a high clinical acceptance rate.
model was implemented, a separate analysis was performed
External validation of DL models is necessary in order to verify
after excluding 455 exams interpreted by this radiologist in the
that the algorithm is generalizable across a variety of patient
pre-DL implementation time period in order to have identical
populations and healthcare systems. Most recently published
radiologists interpreting exams during each time period. There
performance studies on artificial intelligence algorithms in
was still a significant decrease in the proportion of exams cate-
medical imaging lack external validation, with one review
gorized as dense among the academic (47.1% 39.3%) and
showing that only 6% of studies over an 8-month period in
combined groups (47.4% 41.0%) comparing pre- and post-
2018 had external validation (20). External validation was the
DL model implementation time periods (p < 0.001).

TABLE 3. Distribution of prospectively reported density assessments during before implementation of the DL model (6/1/2017 to
5/31/2018), and after implementation of the DL model (10/1/2018 to 2/28/2019)

Pre-DL Implementation Post-DL Implementation p

Academic breast imagers N = 2829 N = 1079 p < 0.001

Nondense 53.8% 60.7%
Dense 46.2% 39.3%
Community breast imagers N = 2867 N = 1095 p = 0.006
Nondense 52.4% 57.2%
Dense 47.6% 42.9%
All breast imagers N = 5696 N = 2174 p < 0.001
Nondense 53.0% 59.0%
Dense 47.0% 41.0%

Significance by Pearson’s chi-square test.

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Academic Radiology, Vol &, No &&, && 2020
logical next step to support our model’s expanded use in a vari-
ety of practice types and patient populations.
The American College of Radiology has highlighted the
variability of breast density assessments in a statement discus-
sing potential outcomes and harms of mandatory density
notification (22). We showed a 6% absolute reduction in
dense mammogram assessments after DL model implementa-
tion, and more expanded use of our DL model could have
direct beneficial implications on limited imaging resources,
patients and payers, with substantial cost reduction by reduc-
ing the number of women potentially referred for supple-
mental screening tests and/or high-risk clinic evaluations.
Interestingly, when the radiologists did not accept the DL
model assessment, most cases were categorized into a higher
density category (i.e., when the DL model’s assessment was
scattered areas of fibroglandular density, the disagreeing radi-
ologist much more often assessed density as heterogeneously
dense as opposed to almost entirely fatty), demonstrating the
radiologist’s tendency to increase the density category.
There is also potential for improved consistency of density
assessments given the known wide variation in radiologist
density assessments, as Sprague et al. have shown with
between 6% and 85% exams categorized as dense in their
large study (4). After clinical implementation of our model,
the academic radiologists categorized 39.3% exams as dense,
and the community radiologists categorized 42.8% as dense,
while our model categorized 34.9% and 34.1% of exams as
dense in both groups of patients, highlighting potential for
the model to improve radiologist consistency. This is increas-
ingly important because risk models such as the Tyrer-Cuzick
v8 and Breast Cancer Surveillance Consortium 5-year risk
models incorporate mammographic breast density into their
prediction criteria (23,24).
Figure 1. Comparison of the original interpreting radiologist assessment with the deep learning (DL) model assessment for four-way mam-
mographic breast density classification for all radiologists (a). Corresponding examples of mammograms with concordant and discordant
assessments by the radiologist with the DL model (b).
EXTERNAL VALIDATION OF A DEEP LEARNING MODEL
There were limitations to our study. Our DL model was
developed and trained with the reference standard being the
original interpreting radiologist’s assessment, which is known
to be prone to inter- and intrareader variation. We acknowl-
edge that the acceptance of the DL density assessment was
measured in an unblinded manner, and that “acceptance” is
not equivalent to “truth” or “accuracy”. Note however, that
the early studies showing association of incremental breast
density and increased breast cancer risk were based on subjec-
tive radiologist assessments, implying that the radiologist’s
subjective assessment carries validity as a marker for risk pre-
diction (1,3). It is important to note that a reduction in the
proportion of mammograms assessed as dense—as influenced
by the DL model—is only meaningful if the assessments are
accurate. The model would not be beneficial if women with
dense breasts were inaccurately categorized as nondense (or
conversely, if women with nondense breasts were inaccu-
rately categorized as dense). Nevertheless, the high rate of
clinical acceptance among both academic and community
practice fellowship trained breast imagers is evidence that the
DL model provides reasonable guidance. While a secondary
aim of this study, measuring the model’s influence on radiol-
ogists warrants further study on a much larger volume of
screening mammograms. Prior studies have used CT or MRI
breast density as the reference standard to compare to auto-
mated breast density assessments, yet this approach is limited
given the small sample sizes (100 200 patients) and sample
bias toward high-risk patients (25,26). CT and MRI have the
potential benefit of a more objective volumetric assessment of
fibroglandular tissue volume compared to a subjective radiol-
ogist assessment of mammographic breast density, however
development of our model utilized mammograms in over
30,000 women at average risk and using CT or MRI for this
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 ARTICLE IN PRESS
DONTCHOS ET AL
purpose would not be feasible. It is important to point out
that density assessment guidance has changed over time with
the publication of the fifth edition of the BI-RADS manual
in 2013, however this was several years before our study took
place and likely had little impact on our results (27). Finally,
we did not directly measure influence of the DL model on
intra reader agreement as clinical cases are not double read.
In conclusion, this external validation demonstrated high
clinical acceptance of our DL model in routine clinical practice
among both academic and community radiologists, suggesting
our model may have widespread applicability. The DL model
also influenced radiologists by significantly reducing the pro-
portion of screening mammograms categorized as dense after
DL model implementation. In the era of federally mandated
breast density notification, consideration of a more widespread
DL model to predict mammographic breast density should be
given as this tool could supply more accurate information to
patients and help healthcare systems more appropriately utilize
limited supplemental screening resources.
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