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The impact of false positive breast cancer screening mammograms on screening retention: A retrospective population cohort study in Alberta, Canada


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p> OBJECTIVES: The impact of false positives on breast cancer screening retention is inconsistent across international studies. We investigate factors associated with screening retention, including false positive screening results, invasiveness of diagnostic procedures, and geographic variation in Alberta, Canada. METHODS: A total of 213 867 women aged 50–67 years who had an index screen mammogram between July 2006 and June 2008 were evaluated at 30 months post index screen to determine the screening retention rate. The association of screening retention with invasiveness of the diagnostic procedure, time to diagnostic resolution, and region of residence were investigated using multivariable log binomial regression, adjusting for women’s age. RESULTS: Women with false positive screening results were less likely to return for their next recommended screening than those with a true negative result (62.0% vs. 68.7%). Compared to women with normal screening results, the adjusted risk ratios of fail-to-rescreen for women with imaging-only follow-up, needle sampling, and open biopsy were 1.08 (95% CI: 1.05–1.12), 1.72 (95% CI: 1.44–2.07) and 2.29 (95% CI: 2.09–2.50) respectively. Screening retention rates were slightly higher for rural residents than urban residents. Time to diagnostic resolution was not associated with screening retention. Screening retention peaked at one year from the index date of the previous screening. CONCLUSION: Higher awareness of the strong negative impact that biopsies in the case of a false positive screening have on screening retention is needed. Such awareness can inform intervention strategies to mitigate the impact and improve screening retention rate.</p
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The impact of false positive breast cancer screening mammograms
on screening retention: A retrospective population cohort study in
Alberta, Canada
Ye Shen, MPH,
Marcy Winget, PhD,
Yan Yuan, PhD
OBJECTIVES: The impact of false positives on breast cancer screening retention is inconsistent across international studies. We investigate factors associated
with screening retention, including false positive screening results, invasiveness of diagnostic procedures, and geographic variation in Alberta, Canada.
METHODS: A total of 213 867 women aged 5067 years who had an index screen mammogram between July 2006 and June 2008 were evaluated at
30 months post index screen to determine the screening retention rate. The association of screening retention with invasiveness of the diagnostic procedure,
time to diagnostic resolution, and region of residence were investigated using multivariable log binomial regression, adjusting for womens age.
RESULTS: Women with false positive screening results were less likely to return for their next recommended screening than those with a true negative result
(62.0% vs. 68.7%). Compared to women with normal screening results, the adjusted risk ratios of fail-to-rescreen for women with imaging-only follow-up,
needle sampling, and open biopsy were 1.08 (95% CI: 1.051.12), 1.72 (95% CI: 1.442.07) and 2.29 (95% CI: 2.092.50) respectively. Screening
retention rates were slightly higher for rural residents than urban residents. Time to diagnostic resolution was not associated with screening retention.
Screening retention peaked at one year from the index date of the previous screening.
CONCLUSION: Higher awareness of the strong negative impact that biopsies in the case of a false positive screening have on screening retention is needed.
Such awareness can inform intervention strategies to mitigate the impact and improve screening retention rate.
KEY WORDS: Breast cancer; screening; retention; false positive
La traduction du résumé se trouve à la fin de larticle. Can J Public Health 2017;108(5-6):e539e545
doi: 10.17269/CJPH.108.6154
Biennial or triennial breast cancer screening mammography,
as an effective public health strategy to reduce breast
cancer mortality, has been recommended to women aged
5074 in the United States, Canada and most European
The survival benefits of breast cancer screening are
deemed to outweigh the harms from over-diagnosis, over-
treatment, false positive screening results, and benign biopsies.
The latter two have been shown to be associated with depression
and long-term anxiety in women and possibly reduce the
likelihood of future screening.
False positives account for about
9% of all screening mammograms and make up approximately
93% of abnormal calls in Canada and the US.
It is therefore
important to understand the magnitude of the impact of false
positives on screening retention in order to mitigate it.
The impact of false positives on screening retention rates,
however, is conflicting across studies. In a systematic review,
false positive screening mammograms were not associated with
retention rate in European countries, but were associated with an
increased retention rate in the US.
A recent study in the United
Kingdom showed that while the retention rate was not affected by
false positives, it was reduced in women who underwent biopsies.
Two studies in Canada, both published over a decade ago, found
that false positive screening results reduced the likelihood of
screening retention.
There are important differences in the
organization and delivery of screening programs and in the
characteristics of the populations screened across different
countries. Furthermore, practice has changed with respect to
follow-up procedures in the past decade; for instance, core biopsy
is now used broadly.
Efforts have also been made to improve
organized screening performance, which could affect retention
rates as well as the impact of false positives on them. It is therefore
unknown whether and which of the findings from previous studies
are applicable today.
The primary objective of this study was to investigate the impact
of false positives on breast cancer screening retention and to
determine whether invasiveness of the follow-up procedure and
time to diagnostic resolution have independent effects on
screening retention. A secondary objective was to investigate the
extent of geographical variation in retention rates. Implications of
these associations are discussed and recommendations are made to
improve screening programs and to benefit screen-eligible women.
Author Affiliations
1. School of Public Health, University of Alberta, Edmonton, AB
2. School of Medicine, Stanford University, Stanford, CA, USA
Correspondence: Yan Yuan, PhD, School of Public Health, University of Alberta,
3-299 Edmonton Clinic Health Academy, 11405 87 Avenue, Edmonton, AB T6G 1C9,
Tel: 780-248-5853, E-mail:
Conflict of Interest: None to declare.
© 2017 Canadian Public Health Association or its licensor. CANADIAN JOURNAL OF PUBLIC HEALTH VOL. 108, NO. 5-6, 2017 e539
Overview of breast cancer screening program in Alberta
The population-based Alberta Breast Cancer Screening Program
(ABCSP) was established in 2004 through the collaboration of two
organizations: Screen Test (ST), which utilizes radiologists
employed by Alberta Health Services, and the Alberta Society
of Radiologists (ASR), a non-profit professional organization
representing 92% of the fee-for-service radiologists and radiology
residents in Alberta.
The ABCSP ensures an organized approach
for screen-eligible women to access screening mammography. Prior
to the launch of the provincial-wide ABCSP, ST represented the
much smaller organized screening program available in the
province, while screening by ASR radiologists represented
opportunistic screening. Breast cancer screening and diagnostic
procedures performed in Alberta, including procedure type, date,
results and follow-up recommendations, were captured by
complementary ASR and ST databases. Breast cancer screening
and diagnostic procedures include imaging (screening and
diagnostic mammography, ultrasound, MRI) and biopsies
(aspiration, stereotactic core, closed, surgical/open). Breast
Imaging Reporting and Data System (BI-RADS) scores
captured for imaging procedures. BI-RADS classifies lesions into
seven categories: 0 for incomplete and further imaging is required,
1 for negative findings, 2 for benign findings, 3 for probably
benign, 4 for suspicious abnormality, 5 for a mammographic
appearance, and 6 for known malignancy.
ST provides mammography services in clinics in two
metropolitan cities (Edmonton and Calgary); mobile units
visit rural and remote communities throughout the province
once a year.
Additionally, ASR-member radiologists provide
mammography services in community radiology clinics
throughout the province.
Study design and data linkage
The Canadian province of Alberta has a single-payer publicly
funded health care system under which standard medical care,
including breast cancer screening services, are free. The Alberta
clinical guideline recommended breast cancer screening at least
every two years for women between 50 and 69 years of age during
the study period.
In order to satisfy the age eligibility at screening
retention, 67 years of age was chosen as the upper limit for
inclusion in this study.
All women aged 5067 years who had at least one screening
mammogram between July 1, 2006 and June 30, 2008 were
identified from the combined ASR and ST database. Women with
screen-detected breast cancer or who developed breast cancer prior
to their scheduled subsequent screening mammogram were
excluded. Breast cancers were identified from the Alberta Cancer
Registry (the third edition of International Classification of Disease
for Oncology (ICD-O-3) code C50 behaviors 2 and 3).
This study was approved by the ethics board at the University of
Alberta. Databases were linked using the unique provincial health
care identification number that was anonymized for data analysis.
Quality assurance and cross checks were performed to ensure
accuracy and completeness.
Index screening
Awomans first screening mammogram during the study period
was referred to as her index screen. The index screen test was
classified into either normal screening result group (BI-RADS
score 1 or 2) or abnormal group. At least two of the following three
criteria were required for the index screen to be classified into the
abnormal group: 1) from test result: a BI-RADS* score 0, 3, 4 or 5
for the index screen; 2) from radiologists recommendation: an
immediate, 3-month or 6-month follow-up recommendation; and
3) from follow-up test: at least one breast-related diagnostic
procedure within 30 days of index mammogram. Data for which
criterion 1) and criterion 2) were not consistent were assumed to
have a data entry error and the test was classified according to
criterion 3). For example, a screening mammogram record of a
BI-RADS* score 5 with a recommendation for a follow-up in two
years would not occur in practice and is evidence of a data error.
To determine whether the BI-RADS* score or the recommendation
was incorrect, we used criterion 3) which reflects what actually
occurred. If a follow-up breast-related diagnosis procedure was not
identified within 30 days of the screening mammogram, the
screening mammogram was deemed normal. Since women
diagnosed with breast cancer during the study period were
excluded from the study, the abnormal group only consists of
false positives.
Breast cancer diagnostic follow-up procedures conducted in
response to a false positive were categorized as follows (in order
of decreasing invasiveness): open biopsy, needle sampling
(fine needle aspiration, core needle biopsy, and closed biopsy),
imaging-only follow-up (typically diagnostic mammography
and/or ultrasound), and no follow-up procedure. There
were two possible explanations for the no follow-up
procedure: 1) The follow-up test data were missing: this could
occur if the breast-related diagnostic tests were performed by
radiologists who are outside ASR (approximately 8% of
radiologists in Alberta), resulting in test data not being captured
in the ASR database; and 2) those women did not comply with
the recommendation.
Diagnostic resolution
The most invasive procedure within six months of an abnormal
index screen was deemed the diagnostic resolution procedure,
based on an adaptation of a previously validated algorithm.
corresponding procedure date was used to calculate time to
diagnostic resolution and served as the index date for the
screening retention period for women with false positives. For
women with no follow-up procedures, the index date for the
screening retention period was six months after the initial screen,
to account for possible missing follow-up test dates. For women in
the normal screening group, the date of the index screen was used
as the index date of the screening retention period.
Screening retention
Screening retention was defined as the receipt of a subsequent
screening mammogram between 9 and 30 months from the index
date (see Figure 1), as 30-month is consistent with the definition
for calculating retention rate in Canada.
Statistical analysis
Screening retention rate was tabulated by the index screen result
and diagnostic follow-up procedure category, region of residence,
and time to diagnostic resolution. Region of residence was
categorized into the following three groups based on the
Regional Health Authorities (RHA) that existed at the beginning
of the study period: the RHAs that included Edmonton and Calgary
are classified as the metropolitan region; central and southern
Alberta are classified as small cities/rural region; northern Alberta is
classified as the remote region, where access to health care is most
limited (Figure 2). A histogram showing time from index screen to
rescreen in the study population is shown in Figure 3. A
multivariable log-binomial regression model was used to estimate
the risk ratios of fail-to-rescreen associated with invasiveness of
diagnostic procedure, region of residence, and time to diagnostic
resolution, adjusted for womens age. SAS
9.4 (SAS Institute, Cary,
NC) was used for data management and analyses.
A total of 213 867 women were eligible and included in the study.
The index screen results for 20 105 (9.4%) was a false positive: the
most invasive follow-up procedures performed were imaging
studies for 16 695 (83.0%), needle biopsy for 243 (1.2%) and
open biopsy for 1499 (7.5%) of those with a false positive. The
benign biopsy rate is 8.1 per 1000 screen.
Retention rate
Table 1 shows the retention rates for normal and abnormal index
screen and each follow-up procedure type, stratified by region, time
to diagnostic resolution, and age group. The retention rates were
62.2% and 68.7% for the false positive and normal index screen
groups respectively. The unadjusted risk ratio was 0.9 (95% CI:
0.900.92). As the invasiveness of procedure increased, the
retention rate decreased. The retention rates were 64.0%, 57.6%,
and 39.8% for imaging-only follow-up, needle sampling and open
biopsy respectively. For women with no follow-up procedure after
an abnormal result, the retention rate was 65.0%.
The retention rate varied considerably across regions by
invasiveness of procedure. For women who resided in
metropolitan regions, the retention rate for those with an index
false positive result decreased with increasing invasiveness of
procedure (63.9% for imaging only follow-up, 53.1% for needle
sample and 37.2% for open biopsy). This trend did not exist for
residents outside the metropolitan areas, however, retention rate
was lowest for residents of the small cities/rural region who
received an open biopsy. Women with false positives had lower
retention rate than those with normal results across all regions. The
retention rate increased with increasing rurality (67.9% for
metropolitan region, 68.7% for small cities/rural region and
70.5% for remote region). A longer time to diagnostic resolution
was also associated with a lower retention rate for those who
received open biopsy: 48% same day, 41% within 1 month, and
36% within 6 months, but not for those who received imaging
only (63%, 65% and 65% respectively).
Women aged 5059 and 6067 have similar rescreen rates by
invasiveness of procedure (Table 1).
Time from index to rescreen
The provincial screening guideline recommended women aged
5069 receive screening for breast cancer at least every two years
during the study period. The screening retention peaked close to
one year (12 months) from the index date (Figure 3). A second peak
of screening retention occurred close to two years from the index
date, but the number of women at the second peak was much
lower than the number at the first peak. Among women who
rescreened within 30 months, approximately 50% had their
rescreening mammograms within 15 months of their index screen.
Log-binomial regression analysis of fail-to-rescreen
Figure 4 illustrates the adjusted risk ratio estimates of factors
associated with fail-to-rescreen. Age is adjusted in the model using
a cubic spline. Compared with women who had a normal index
screen result, the adjusted risk ratios of fail-to-rescreen were
1.08 (95% CI: 1.051.12) in women who had imaging-only
Figure 1. Diagram of outcome definition
follow-up, 1.72 (95% CI: 1.442.07) in women who had needle
sampling and 2.29 (95% CI: 2.092.50) among women who had
open biopsy.
Screening retention rates varied to a smaller extent across regions
after adjusting for other factors. In small cities/rural and remote
regions, the risk ratios are 0.99 (95% CI: 0.981.00; p=0.193) and
0.96 (95% CI: 0.941.00; p=0.026) respectively, compared to
the metropolitan region. Time to diagnostic resolution was not
significantly associated with the fail-to-rescreen in the
multivariable regression analysis.
The factor most strongly related to screening retention after a false
positive screening result was the procedure used for diagnostic
resolution: screening retention decreased with increasing
invasiveness of the diagnostic resolution procedure. Women who
had an open biopsy were 2.3 times less likely to be rescreened
within 30 months after their diagnostic resolution compared to
those who had a normal index screen. The negative effect of false
positives on screening retention is consistent with the findings
from two-decade-old Canadian studies
and a more recent study
conducted in Spain, where breast cancer screening is also free and
is recommended biennially.
Retention rates were higher in the
Spanish study than in ours: retention rates for women with false
positive vs. normal results were 78.3% vs. 81.9%, compared to ours
which were 68.1% vs. 68.7% respectively. Both studies found
significantly lower retention rates, 66.5% (Spain) and 45.8%
(Alberta) for those who underwent invasive procedures, including
aspiration, closed biopsy and/or open biopsy.
Invasive follow-up
tests have been shown to create psychological distress in the
context of false positive breast cancer screens,
which can last for
up to three years;
it is likely that psychological distress plays an
important role in screening retention.
We did not find a statistical association between time to
diagnostic resolution and retention rate in our study. This is
consistent with a study conducted in The Netherlands.
residing in remote regions were more likely to rescreen compared
to the women residing in metropolitan regions. This may reflect
that the availability of care is valued and acted upon in remote
regions where the health care resources are limited.
Fifty percent of the women in our study were rescreened within
15 months in spite of provincial guidelines at the time for biennial
screening. This is of concern as more frequent screening results in
higher cumulative false positive findings,
which in turn increases
the risk of invasive procedures and, based on our study and others,
lowers screening retention. In addition, modeling studies show
that biennial screening does not lead to higher prevalence of late-
stage breast cancer than annual screening.
More frequent
screening mammography also increases womens exposure to
X-ray and cost to the publicly funded health system. Combined,
these facts suggest that annual breast cancer screening is
unnecessary, and may even be harmful, for average-risk women.
Currently, the Canadian guidelines recommend breast cancer
screening for women aged 5074 every 23 years, although these
guidelines have not been embraced in all provinces.
Although invasive procedures appear to reduce breast cancer
screening retention rates, sometimes invasive tests are necessary to
Figure 2. Region division. Metropolitan region: Regions of
Edmonton and Calgary, i.e., R6 and R3. Small cities/
rural region: R1, R2, R4, R5 and R7. Remote region:
R8 and R9
Figure 3. Proportion of rescreening mammograms performed
each month of the total conducted between 9 and
30 months of the index screen
determine whether a tumour is present. Identifying and
implementing factors that positively contribute to screening
behaviours is therefore important as they may overcome the
negative impact of invasive follow-up procedures. Tailored
invitation letters as well as motivational telephone calls have
been shown to positively impact breast cancer screening
The combination of a tailored letter and
motivational phone calls may improve screening retention
among those with false positive screening mammograms,
particularly those who have invasive follow-up tests.
Our study is the first population-based study to assess breast
cancer screening retention and factors related to it in Alberta, and
the most recent one in more than a decade in Canada. It provides
an updated and detailed picture of the screening retention in
Alberta, which is useful to screening programs in Canada and
elsewhere. A strength of the study was our use of population-based
data from the screening program, however, there are a few notable
limitations to our analyses, largely based on the data available for
the dataset. First, we were not able to determine and adjust for
whether the index screen in our study was the initial screen for a
particular woman. One study reported that initial screening had
higher false positive results (12% vs. 6%) and lower retention rate
(70% vs. 81%).
A recent report from the Canadian Partnership
Against Cancer (CPAC) also found that women with initial
screening had lower retention rates compared to those with
subsequent screening. Screening participation rates in Alberta
have been relatively stable, however between 55% and 60% in
the last 10 years
so we expect that our adjustment for age
in the multivariable regression analysis mitigates the confounding
effect of the index screen status.
The second limitation is that we did not have access to detailed
demographic data; some factors have been found to be associated
with screening rates.
The third limitation is that about 8% of
the biopsy data are estimated to be missing from the ASR database.
This could lead to a slight underestimation of the odds of fail-to-
rescreen for women who had benign biopsies, which means the
reported effect size is likely to be conservative. In contrast, the fourth
limitation limiting the definition of rescreen to 30 months
may overestimate the effect size. It is possible that a higher
proportion of women who had false positive results at their index
screen were rescreened more than 30 months after their index
screen than those with a true negative. Thirty months, however,
has been used consistently in studies
to define rescreen rates, so
our analysis is comparable to previous reported rates. Furthermore,
it is unlikely that even if the rescreen definition were extended to
include screens within 36 months, the more than 10% difference
in retention rates for those women who had needle sampling or
open biopsy would be eliminated. Last, the follow-up time for
105 women who had an abnormal index screen was slightly less
than 30 months (the median follow-up time was 28 months) and
they were categorized as fail-to-rescreen; as this group only
accounted for 0.5% of all women with an abnormal index screen,
the expected bias introduced is negligible.
In order to maximize the benefits of breast cancer screening in
populations and individuals, greater efforts are needed to
minimize both the risk of false positives as well as their burden
on women, which affect likelihood of rescreening. Suggested
tactics include screening average-risk women no more than
Table 1. Frequency of procedure and retention rate (% screened within 30 months of index date) by invasiveness of procedure, stratified by region and time to diagnostic resolution
Normal index
screen False positive index screening Total
follow-up Needle
sampling Open biopsy No follow-up procedure
within 6 months Total n(retention rate)
n(retention rate) n(retention
Overall 193 762 (68.7) 16 695 (64.0) 243 (57.6) 1499 (39.8) 1668 (65.0) 20 105 (62.2) 213 867 (68.1)
Metropolitan 145 860 (68.5) 13 838 (63.9) 162 (53.1) 1201 (37.2) 1247 (65.0) 16 448 (61.9) 162 308 (67.9)
Small city/rural 42 119 (69.1) 2584 (65.1) 62 (66.1) 254 (46.9) 202 (57.4) 3102 (63.1) 45221 (68.7)
Remote 5783 (70.9) 273 (61.5) 19 (68.4) 44 (68.2) 219 (71.7) 555 (66.3) 6338 (70.5)
Time to diagnostic resolution
Same day 193 762 (68.7) 8959 (63.2) 47 (63.8) 110 (48.2) NA 9116 (63.0) 202 878 (68.4)
Within 1 month 0 6825 (65.0) 40 (35.0) 778 (41.4) NA 7643 (62.4) 7643 (51.9)
Within 6 months 0 911 (65.2) 156 (61.5) 611 (36.2) NA 1678 (54.3) 1678 (46.6)
No follow-up procedure within 6 months 0 NA NA NA 1668 (65.0) 1668 (65.0) 1668 (65.0)
Age (years)
5059 131 006 (68.6) 11 444 (63.6) 176 (59.1) 980 (40.4) 1114 (64.9) 13714 (62.0) 144 720 (68.0)
6067 62 756 (69.0) 5251 (64.9) 67 (53.7) 519 (38.5) 554 (65.2) 6391 (62.7) 69147 (68.4)
Note: Women with breast cancer during study period were excluded.
* Region: region division can be found in Figure 2.
NA =not applicable.
biennially, minimizing invasive testing and providing targeted
communication with those with a previous false positive screen.
Further improvements in technology are also needed to decrease
false positive rates and reduce the need for invasive follow-up
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Figure 4. Adjusted risk ratios of fail-to-rescreen. Log binomial regression model includes test procedure, region, time to diagnostic
resolution, and age (adjusted as a cubic spline)
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Received: March 9, 2017
Accepted: May 28, 2017
OBJECTIFS : Lincidence des faux positifs sur la fidélisation au dépistage du
cancer du sein varie dans les études internationales. Nous étudions les
facteurs associés à la fidélisation au dépistage en Alberta, au Canada, dont
les résultats faux positifs au dépistage, le caractère invasif de la méthode
diagnostique et la variation spatiale.
MÉTHODE : En tout, 213 867 femmes de 50 à 67 ans ayant subi une
mammographie de dépistage indicielle entre juillet 2006 et juin 2008 ont
été évaluées 30 mois après pour déterminer le taux de fidélisation au
dépistage. Les associations entre la fidélisation au dépistage et le caractère
invasif de la méthode diagnostique, le délai de résolution du diagnostic et la
région de résidence ont été étudiées par régression log-binomiale
multivariée avec ajustement en fonction de lâge des femmes.
RÉSULTATS : Les femmes ayant obtenu des résultats faux positifs au
dépistage étaient moins susceptibles de retourner subir leur prochain
dépistage recommandé que celles ayant obtenu des résultats vrais négatifs
(62,0 % c. 68,7 %). Comparativement aux femmes ayant obtenu des
résultats normaux au dépistage, les risques relatifs ajustés des femmes
nayant pas subi un dépistage ultérieur étaient de 1,08 (IC de 95 % :
1,051,12) pour le suivi avec imagerie seulement, de 1,72 (IC de 95 % :
1,442,07) pour le prélèvement à laide dune aiguille et de 2,29
(IC de 95 % : 2,092,50) pour la biopsie ouverte. Les taux de fidélisation au
dépistage étaient légèrement plus élevés chez les résidentes des zones
rurales que chez celles des zones urbaines. Le délai de résolution du
diagnostic nétait pas associé à la fidélisation au dépistage. La fidélisation
au dépistage a culminé un an après la date indicielle du dépistage
CONCLUSION : Il est nécessaire dêtre plus sensibilisé à leffet très
nuisible des biopsies sur la fidélisation au dépistage en cas de résultats
faux positifs. Une telle sensibilisation peut éclairer les stratégies
dintervention pour atténuer cet effet et améliorer les taux de fidélisation
au dépistage.
MOTS CLÉS : cancer du sein; dépistage; fidélisation; faux positifs
... We used 20 breast cancer tissue samples (case) and 20 noncancerous tissues (control) from the OICR Tumor Bank. We previously reported this sample set and tested mature miRNA expression [14,16,17,25,26]. The demography of these samples is presented in Supplementary Table S1. ...
... In Canada and other countries around the globe, breast cancer incidence in younger women continues to rise. Mammographic screening starts at the age of 50, and this procedure contributes to 9% of all false-positive results [25]. However, if cancer is detected early, a patient's survival is enhanced up to 98% [26]. ...
... Mature miR526b and miR655 expressions are regulated by COX2 and EP4, and inhibition of COX2 and EP4 with a specific COX-2 inhibitor and EP4-antagonist (EP4A) significantly inhibited miRNA-induced functions in breast cancer [23][24][25]. Moreover, EP4A has already been approved by the FDA for arthritis treatment [34]. ...
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We reported that two microRNAs, miR526b and miR655, are oncogenic in breast cancer (BC). Overexpression of these two miRNAs in poorly metastatic BC cells promotes aggressive BC phenotypes in vitro and in vivo. High expression of each miRNA was associated with poor patient survival. In this pilot biomarker study, we report for the first time that miRNA precursor RNAs (pri-miRNAs) are robust and sensitive biomarkers for BC, detectable in both human blood plasma and biopsy tissues. Pri-miRNA detection and quantification do not require a special enrichment procedure, thus reducing specimen quantity. Blood plasma samples from 90 malignant tumor-bearing patients and 20 benign lesion-bearing participants (control) were analyzed for pri-miRNA expression with a quantitative real-time polymerase chain reaction. Results revealed that normalized expressions of plasma pri-miR526b and pri-miR655 are significantly upregulated in malignancy compared to benign plasmas (p = 0.002 and p = 0.03, respectively). Both pri-miRNAs showed more prominent results to distinguish stage I plasmas from benign plasmas (p = 0.001 for pri-miR526b and p = 0.0001 for pri-miR655). We have also validated pri-miRNA expression in independent tumor bank tissues, showing significant upregulation of both pri-miRNAs in BC; thus, pri-miRNAs are robust markers. The diagnostic relevance of pri-miRNAs was computed with the area under the curve (AUC). Pri-miR526b is a sensitive biomarker to distinguish cancer from control plasmas (sensitivity of 86%; AUC = 71.47%, p = 0.0027) with a positive predictive value of 88.89%; however, pri-miR655 did not show significant sensitivity. Furthermore, pri-miR526b could also significantly distinguish tumors as early as stage I from control (sensitivity of 75%; AUC = 72.71%, p = 0.0037). Therefore, pri-miR526b can be used as an early diagnostic biomarker. The expression of both pri-miRNAs was significantly high in ER-positive and HER2-negative subgroups of BC; hence, these biomarkers might play a role in the management of endocrine therapy designs. Additionally, with a case–control cohort study, we identified that high expression of pri-miR526b in the blood is also a risk factor associated with breast cancer (OR = 4.3, CI = 1.39–13.34, p = 0.01). Pri-miRNAs could be considered novel breast cancer blood biomarkers.
... Additionally, diagnostic tests after a false positive have been shown to reduce the likelihood of future screening participation: benign biopsies have the largest negative impact. 23 The operations and quality assurance practices of Screen Test and community clinics were distinct in a several ways during 2006 to 2010. In Screen Test, staff radiologists read batches of 70 to 90 screening mammograms in a 2 to 4 hour screening session. ...
... Our previous analysis showed that more than 55% of the follow-up imaging procedures were performed the same day. 23 Although this practice minimises time to diagnosis/resolution, it encourages a diagnostic rather than a screening mindset. Second, screening mammograms are not read separately from diagnostic mammograms thus images from symptomatic and asymptomatic patients are read without clear distinction. ...
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Objectives Regular breast cancer screening is a widely used cancer prevention strategy. Important quality indicators of screening include cancer detection rate, false positive rate, benign biopsy rate and post-screen invasive cancer rate. We compared quality indicators of community radiology clinics to those of ‘Screen Test’, which feature centralised batch reading and quality control processes. Both types of providers operated under a single provincial Breast Cancer Screening Programme. Setting Community radiology clinics are operated by independent fee-for-service radiologists serving large and small communities throughout the Canadian province of Alberta. Launched by the provincial cancer agency, the Screen Test operates two physical clinics serving metropolises and mobile units serving remote regions. Eligible women may self-refer to any provider for screening mammography. Participants Women aged 50 to 69 years who had at least one screening mammogram between July 2006 and June 2010 in Alberta were included. Women with missing health region information or prior breast cancer diagnosis were excluded. Results A total of 389 788 screening mammograms were analysed, of which 12.7% were performed by Screen Test. Compared with Screen Test during 2006 to 2008, community radiology clinics had a lower cancer detection rate (3.6 vs 4.6 per 1000 screens, risk ratio (RR): 0.81, 95% CI: 0.67 to 0.98) and a much higher false positive rate (9.4% vs 3.4%, RR: 2.72, 95% CI: 2.55 to 2.90). Most other performance indicators were also better in Screen Test overall and across all health regions. These performance indicators were similar during 2008 to 2010, showing no improvement with time. Conclusions Screen Test has a quality assurance process in place and performed significantly better. This provides empirical evidence of the effectiveness of a quality assurance process and may explain some of the large differences in breast cancer screening indicators between provinces and countries with formal programmes and those without.
... Despite the success of NBS, the approach has some limitations. Although its false positive rates are low compared to other population-based screenings [2][3][4][5], several disorders in NBS, such as classic galactosemia [6], tyrosinemia type 1 [7] and isovaleric acidemia [8], still have a relatively high false positive rate. This results in unnecessary referrals and parental concern. ...
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Newborn screening (NBS) aims to identify neonates with severe conditions for whom immediate treatment is required. Currently, a biochemistry-first approach is used to identify these disorders, which are predominantly inherited meta1bolic disorders (IMD). Next-generation sequencing (NGS) is expected to have some advantages over the current approach, for example the ability to detect IMDs that meet all screening criteria but lack an identifiable biochemical footprint. We have now designed a technical study to explore the use of NGS techniques as a first-tier approach in NBS. Here, we describe the aim and set-up of the NGS-first for the NBS (NGSf4NBS) project, which will proceed in three steps. In Step 1, we will identify IMDs eligible for NGS-first testing, based on treatability. In Step 2, we will investigate the feasibility, limitations and comparability of different technical NGS approaches and analysis workflows for NBS, eventually aiming to develop a rapid NGS-based workflow. Finally, in Step 3, we will prepare for the incorporation of this workflow into the existing Dutch NBS program and propose a protocol for referral of a child after a positive NGS test result. The results of this study will be the basis for an additional analytical route within NBS that will be further studied for its applicability within the NBS program, e.g., regarding the ethical, legal, financial and social implications.
... More attention should be paid to women aged 50 or older, especially those who are socially disadvantaged. In [4], between July 2006 and June 2008, the authors screened 213,867 women between the ages of 50 and 67 for mammograms and evaluated them to determine the sieve. The authors used a multivariate logarithmic binomial regression analysis to study the invasiveness of screening retention rates and diagnostic procedures, and to diagnose the relationship between time and residential area. ...
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In recent years, with the change of lifestyle in Europe and America, the incidence of breast cancer in Chinese women is increasing. In order to find the model of breast cancer image screening and diagnosis with higher accuracy and better classification performance, this paper mainly constructs the breast cancer CT image detection model and the breast cancer screening model based on the convolution and deconvolution neural network (CDNN) through the convolution neural network (CNN). In this paper, the fuzzy C-means clustering algorithm (FCM) is used to improve and optimize the image of breast cancer, and the experimental results are analyzed. The optimized kernel fuzzy C-means clustering algorithm was tested on a common dataset to segment the region of interest more accurately. Our experiments show that the new deep learning model of this paper improves the automatic classification performance of breast cancer. In this paper, the research results of deep learning are applied to the medical field, and a new method based on CNN model for breast cancer screening and diagnosis is proposed, which provides a new idea for improving the artificial intelligence assisted medical diagnosis method.
Surveillance began with counting the numbers of people in the population. At various times in history, numbers have been used to assess the overall strength of the population, to identify the march of dangerous contagion, or to determine needs for food or labor. But even simple counting of population numbers, vital statistics, or reports of disease has been controversial. Information is power and the most rudimentary surveillance can be used both for good and for harm. This chapter sets ethical questions about these basic surveillance methods in historical and epistemological context. It gives examples of uses of data about population numbers, vital statistics, or outbreaks that have been clearly beneficial, as well as examples that have bordered on the genocidal. Counting numbers, as a rudimentary epidemiological method, also presents the opportunity to explore ethical problems raised by epidemiology as a science, such as incomplete data, biased data, or false negatives or positives. Today, with increasing understanding of disease and availability of prevention or treatment, the advantages of outbreak detection may be shared far more widely and more equally. Nonetheless, outbreak detection can generate fear and hostility if patterns of disease track otherwise disfavored groups. COVID-19 has revealed the importance of demographic data about the distribution of disease burdens—data that may either generate mistrust as people see their disadvantage starkly, or that may foster trust if the result is increased attention to disparities in treatment and in health.
Résumé Objectif Évaluer l’impact d’une relecture radiologique systématique par un radiologue spécialisé en sénologie dans la prise en charge thérapeutique des patientes présentant une lésion maligne mammaire. Matériels et méthodes Les patientes adressées pour une lésion maligne histologiquement prouvée ou une lésion mammaire suspecte décrite hors centre ont été incluses. Les patients bénéficiaient d’une échographie mammaire et axillaire systématique, d’une relecture de l’imagerie et si nécessaire de clichés mammographiques complémentaires. Nous avons analysé le nombre de biopsies mammaires et cytoponctions axillaires additionnelles avec leurs résultats histologiques. Nous avons étudié leur impact en comparant le traitement chirurgical final à celui prévu avant relecture. Résultats Deux cent dix-sept patientes ont été incluses avec un total de 230 lésions mammaires BIRADS 0, 4, 5 ou 6. Soixante-seize biopsies mammaires additionnelles ont été réalisées permettant le diagnostic de 43 lésions BIRADS 6 supplémentaires (24 carcinomes infiltrants, neuf CCIS et dix lésions atypiques) chez 30 patientes (13,82 %). Trente-cinq cytoponctions ganglionnaires additionnelles ont été réalisées avec 12 métastases additionnelles et trois faux négatifs. La relecture radiologique a modifié la prise en charge chirurgicale pour 59 patientes (27,19 %, p < 0,001), avec une modification mammaire chez 37 patientes, axillaire chez huit patientes et des deux sites chez 12 patientes. Conclusion Cette étude montre un impact significatif de la relecture systématique de l’imagerie par un radiologue spécialisé en sénologie dans la prise en charge thérapeutique des lésions mammaires malignes.
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Background Breast cancer is one of the leading cause of mortality and morbidity in Canada. Screening is the most promising approach in identification and treatment of the disease at early stage of its development. Research shows higher rate of breast cancer mortality among ethno-racial immigrant women despite their lower incidence which suggests disparities in mammography screening. This study aimed to compare the prevalence of appropriate mammography screening among immigrant and native borne women and determine predicators of low mammography screening. Methods We conducted secondary data analyses on Ontario linked social and health databases to determine the proportion of women who were screened during the two- year period of 2010–2012 among 1.4 million screening-eligible women living in urban centres in Ontario. We used multivariate Poisson regression to adjust for various socio-demographic, health care-related and migration related variables. Results 64 % of eligible women were appropriately screened. Screening rates were lowest among new and recent immigrants compared to referent group (Canadian-born women and immigrant who arrived before 1985) (Adjusted Rate Ratio (ARR) (0.87, 95 % CI 0.85 –0.88 for new immigrants and 0.90, 95 % CI 0.89–0.91 for recent immigrants. Factors that were associated with lower rates of screening included living in low- income neighborhoods, having a male physician, having internationally- trained physician and not being enrolled in primary care patient enrolment models. Those not enrolled were 22 % less likely to be screened compared to those who were (ARR 0.78, 95 % CI 0.77–0.79). Conclusion To enhance immigrant women screening rates efforts should made to increase their access to primary care patient enrolment models and preferably female health professionals. Support should be provided to interventions that address screening barriers like language, acculturation limitations and knowledge deficit. Health professionals need to be educated and take an active role in offering screening guidelines during health encounters.
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Breast cancer, a major cause of female morbidity and mortality, is a global health problem; 2008 data show an incidence of ~450,000 new cases and 140,000 deaths (mean incidence rate 70.7 and mortality rate 16.7, world age-standardized rate per 100,000 women) in European Union Member States. Incidence rates in Western Europe are among the highest in the world. We review the situation of BC screening programmes in European Union. Up to date information on active BC screening programmes was obtained by reviewing the literature and searching national health ministries and cancer service websites. Although BC screening programmes are in place in nearly all European Union countries there are still considerable differences in target population coverage and age and in the techniques deployed. Screening is a mainstay of early BC detection whose main weakness is the rate of participation of the target population. National policies and healthcare planning should aim at maximizing participation in controlled organized screening programmes by identifying and lowering any barriers to adhesion, also with a view to reducing healthcare costs.
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To investigate the effect of false positive breast screening examination results on subsequent attendance in the UK National Health Service Breast Screening Programme. 253,017 previously screened women who were invited for rescreening were studied. Attendance rates of women who had received a normal result at the last (index) screen were compared with those of women who had received a false positive result. The effects of age, type of index screening examination (prevalent or incident) and tissue sampling at assessment were investigated. Women who had a false positive prevalent index screening examination were significantly more likely to reattend than those who had a normal prevalent index screening examination (87.7 vs. 86.0). There was no significant difference in reattendance rates between women who had a false positive incident index screening examination and those with a normal incident index screening examination. However, women who underwent needle sampling or open biopsy following false positive incident index screening examinations were 12 and 60 less likely to reattend, respectively, than women whose index screening examinations were normal (p < 0.001), although there was variation between centres. Increasing age significantly reduced the likelihood of reattendance. The overall reattendance of women who had been screened only once was six percentage points lower than that of women who had been screened more than once. The findings suggest that most women who undergo the breast screening assessment process retain confidence in breast screening. Needle sampling and open biopsy should be used judiciously in the assessment of screen-detected abnormalities in view of the reduced reattendance that results from their use after incident screening examinations.
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In the UK, women aged 50-73 years are invited for screening by mammography every 3 years. In 2009-10, more than 2.24 million women in this age group in England were invited to take part in the programme, of whom 73% attended a screening clinic. Of these, 64,104 women were recalled for assessment. Of those recalled, 81% did not have breast cancer; these women are described as having a false-positive mammogram. The aim of this systematic review was to identify the psychological impact on women of false-positive screening mammograms and any evidence for the effectiveness of interventions designed to reduce this impact. We were also looking for evidence of effects in subgroups of women. MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, Health Management Information Consortium, Cochrane Central Register for Controlled Trials, Cochrane Database of Systematic Reviews, Centre for Reviews and Dissemination (CRD) Database of Abstracts of Reviews of Effects, CRD Health Technology Assessment (HTA), Cochrane Methodology, Web of Science, Science Citation Index, Social Sciences Citation Index, Conference Proceedings Citation Index-Science, Conference Proceeding Citation Index-Social Science and Humanities, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Sociological Abstracts, the International Bibliography of the Social Sciences, the British Library's Electronic Table of Contents and others. Initial searches were carried out between 8 October 2010 and 25 January 2011. Update searches were carried out on 26 October 2011 and 23 March 2012. Based on the inclusion criteria, titles and abstracts were screened independently by two reviewers. Retrieved papers were reviewed and selected using the same independent process. Data were extracted by one reviewer and checked by another. Each included study was assessed for risk of bias. Eleven studies were found from 4423 titles and abstracts. Studies that used disease-specific measures found a negative psychological impact lasting up to 3 years. Distress increased with the level of invasiveness of the assessment procedure. Studies using instruments designed to detect clinical levels of morbidity did not find this effect. Women with false-positive mammograms were less likely to return for the next round of screening [relative risk (RR) 0.97; 95% confidence interval (CI) 0.96 to 0.98] than those with normal mammograms, were more likely to have interval cancer [odds ratio (OR) 3.19 (95% CI 2.34 to 4.35)] and were more likely to have cancer detected at the next screening round [OR 2.15 (95% CI 1.55 to 2.98)]. This study was limited to UK research and by the robustness of the included studies, which frequently failed to report quality indicators, for example failure to consider the risk of bias or confounding, or failure to report participants' demographic characteristics. We conclude that the experience of having a false-positive screening mammogram can cause breast cancer-specific psychological distress that may endure for up to 3 years, and reduce the likelihood that women will return for their next round of mammography screening. These results should be treated cautiously owing to inherent weakness of observational designs and weaknesses in reporting. Future research should include a qualitative interview study and observational studies that compare generic and disease-specific measures, collect demographic data and include women from different social and ethnic groups. PROSPERO: CRD42011001345. The National Institute for Health Research Health Technology Assessment programme.
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Objectives: To identify the psychological effects of false-positive screening mammograms in the UK. Methods: Systematic review of all controlled studies and qualitative studies of women with a false-positive screening mammogram. The control group participants had normal mammograms. All psychological outcomes including returning for routine screening were permitted. All studies had a narrative synthesis. Results: The searches returned seven includable studies (7/4423). Heterogeneity was such that meta-analysis was not possible. Studies using disease-specific measures found that, compared to normal results, there could be enduring psychological distress that lasted up to 3 years; the level of distress was related to the degree of invasiveness of the assessment. At 3 years the relative risks were, further mammography, 1.28 (95% CI 0.82 to 2.00), fine needle aspiration 1.80 (95% CI 1.17 to 2.77), biopsy 2.07 (95% CI 1.22 to 3.52) and early recall 1.82 (95% CI 1.22 to 2.72). Studies that used generic measures of anxiety and depression found no such impact up to 3 months after screening. Evidence suggests that women with false-positive mammograms have an increased likelihood of failing to reattend for routine screening, relative risk 0.97 (95% CI 0.96 to 0.98) compared with women with normal mammograms. Conclusions: Having a false-positive screening mammogram can cause breast cancer-specific distress for up to 3 years. The degree of distress is related to the invasiveness of the assessment. Women with false-positive mammograms are less likely to return for routine assessment than those with normal ones.
Description: Update of the 2002 U. S. Preventive Services Task Force (USPSTF) recommendation statement on screening for breast cancer in the general population. Methods: The USPSTF examined the evidence on the efficacy of 5 screening modalities in reducing mortality from breast cancer: film mammography, clinical breast examination, breast self-examination, digital mammography, and magnetic resonance imaging in order to update the 2002 recommendation. To accomplish this update, the USPSTF commissioned 2 studies: 1) a targeted systematic evidence review of 6 selected questions relating to benefits and harms of screening, and 2) a decision analysis that used population modeling techniques to compare the expected health outcomes and resource requirements of starting and ending mammography screening at different ages and using annual versus biennial screening intervals. Recommendations: The USPSTF recommends against routine screening mammography in women aged 40 to 49 years. The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take into account patient context, including the patient's values regarding specific benefits and harms. (Grade C recommendation) The USPSTF recommends biennial screening mammography for women between the ages of 50 and 74 years. (Grade B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of screening mammography in women 75 years or older. (I statement) The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of clinical breast examination beyond screening mammography in women 40 years or older. (I statement) The USPSTF recommends against clinicians teaching women how to perform breast self-examination. (Grade D recommendation) The USPSTF concludes that the current evidence is insufficient to assess additional benefits and harms of either digital mammography or magnetic resonance imaging instead of film mammography as screening modalities for breast cancer. (I statement)
Background: Women screened with digital mammography may receive false-positive and false-negative results and subsequent imaging and biopsies. How these outcomes vary by age, time since the last screening, and individual risk factors is unclear. Objective: To determine factors associated with false-positive and false-negative digital mammography results, additional imaging, and biopsies among a general population of women screened for breast cancer. Design: Analysis of registry data. Setting: Participating facilities at 5 U.S. Breast Cancer Surveillance Consortium breast imaging registries with linkages to pathology databases and tumor registries. Patients: 405 191 women aged 40 to 89 years screened with digital mammography between 2003 and 2011. A total of 2963 were diagnosed with invasive cancer or ductal carcinoma in situ within 12 months of screening. Measurements: Rates of false-positive and false-negative results and recommendations for additional imaging and biopsies from a single screening round; comparisons by age, time since the last screening, and risk factors. Results: Rates of false-positive results (121.2 per 1000 women [95% CI, 105.6 to 138.7]) and recommendations for additional imaging (124.9 per 1000 women [CI, 109.3 to 142.3]) were highest among women aged 40 to 49 years and decreased with increasing age. Rates of false-negative results (1.0 to 1.5 per 1000 women) and recommendations for biopsy (15.6 to 17.5 per 1000 women) did not differ greatly by age. Results did not differ by time since the last screening. False-positive rates were higher for women with risk factors, particularly family history of breast cancer; previous benign breast biopsy result; high breast density; and, for younger women, low body mass index. Limitations: Confounding by variation in patient-level characteristics and outcomes across registries and regions may have been present. Some factors, such as numbers of first- and second-degree relatives with breast cancer and diagnoses associated with previous benign biopsy results, were not examined. Conclusion: False-positive mammography results and additional imaging are common, particularly for younger women and those with risk factors, whereas biopsies occur less often. Rates of false-negative results are low. Primary funding source: Agency for Healthcare Research and Quality and National Cancer Institute.
Appropriate use of administrative data enables the assessment of care quality at the population level. Our objective was to develop/validate methods for assessing quality of breast cancer diagnostic care using administrative data, specifically by identifying relevant medical tests to estimate the percentage screen/symptom-detected cancers and time to diagnosis. Two databases were created for all women diagnosed with a first-ever breast cancer in years 2007–2010 in Alberta, Canada, with dates of medical tests received in years 2006–2010. One purchased database had test results and was used to determine the ‘true’ first relevant test of a cancer diagnosis. The other free administrative database had test types but no test results. Receiver operating characteristic curves and concordance rates were used to assess estimates of percent screen/symptom-detected breast cancers; Log-rank test was used to assess time to diagnosis obtained from the two databases. Using a look-back period of 4–6 months from cancer diagnosis to identify relevant tests resulted in over 94% concordance, sensitivity and specificity for classifying patients into screen/symptom-detected group; good agreement between the distributions of time to diagnosis was also achieved. Our findings support the use of administrative data to accurately identify relevant tests for assessing the quality of breast cancer diagnostic care.
Purpose: Cancer screening programs have the potential of intended beneficial effects, but they also inevitably have unintended harmful effects. In the case of screening mammography, the most frequent harm is a false-positive result. Prior efforts to measure their psychosocial consequences have been limited by short-term follow-up, the use of generic survey instruments, and the lack of a relevant benchmark-women with breast cancer. Methods: In this cohort study with a 3-year follow-up, we recruited 454 women with abnormal findings in screening mammography over a 1-year period. For each woman with an abnormal finding on a screening mammogram (false and true positives), we recruited another 2 women with normal screening results who were screened the same day at the same clinic. These participants were asked to complete the Consequences of Screening in Breast Cancer-a validated questionnaire encompassing 12 psychosocial outcomes-at baseline, 1, 6, 18, and 36 months. Results: Six months after final diagnosis, women with false-positive findings reported changes in existential values and inner calmness as great as those reported by women with a diagnosis of breast cancer (Δ = 1.15; P = .015; and Δ = 0.13; P = .423, respectively). Three years after being declared free of cancer, women with false-positive results consistently reported greater negative psychosocial consequences compared with women who had normal findings in all 12 psychosocial outcomes (Δ >0 for 12 of 12 outcomes; P <.01 for 4 of 12 outcomes). Conclusion: False-positive findings on screening mammography causes long-term psychosocial harm: 3 years after a false-positive finding, women experience psychosocial consequences that range between those experienced by women with a normal mammogram and those with a diagnosis of breast cancer.