Impact of mammographic screening and advanced cancer definition on the percentage of advanced-stage cancers in a steady-state breast screening programme in the Netherlands.

BACKGROUND: To estimate the percentages of advanced-stage breast cancers (BCs) detected during the course of a steady-state screening programme when using different definitions of advanced BC. METHODS: Data of women aged 49-74 years, diagnosed with BC in 2006-2015, were selected from the Netherlands Cancer Registry and linked to the screening registry. BCs were classified as screen-detected, interval or non-screened. Three definitions of advanced BC were used for comparison: TNM stage (III-IV), NM stage (N+ and/or M+) and T size (invasive tumour ≥15 mm). Analyses were performed assuming a 10% overdiagnosis rate. In sensitivity analyses, this assumption varied from 0 to 30%. RESULTS: We included 46,734 screen-detected, 17,362 interval and 24,189 non-screened BCs. By TNM stage, 4.9% of screen-detected BCs were advanced, compared with 19.4% and 22.8% of interval and non-screened BCs, respectively (p < 0.001). Applying the other definitions led to higher percentages of advanced BC being detected. Depending on the definition interval, non-screened BCs had a 2-5-times risk of being advanced. CONCLUSION: Irrespective of the definition, screen-detected BCs were less frequently in the advanced stage. These findings provide evidence of a stage shift to early detection and support the potential of mammographic screening to reduce treatment-related burdens and the mortality associated with BC.

Pressure-based Compression Guidance of the Breast in Digital Breast Tomosynthesis Using Flexible Paddles Compared to Conventional Compression.

OBJECTIVE: We investigated the effect of introducing a pressure-based flexible paddle on compression parameters and user and patient experience of digital breast tomosynthesis (DBT) combined with patient-assisted compression or technologist compression. METHODS: After institutional review board approval, women with a DBT appointment who gave informed consent received pressure-based flexible paddle breast compression. Eight lights on the paddle were illuminated (1.9 kPa per light) as pressure was applied, aiming for an 8-13.9 kPa target range. The compression level was applied by the technologist or the participant utilizing a remote control device. The participant's and technologist's experiences were assessed by a questionnaire. Compression parameters were compared to previous examinations. Comparative statistics were performed using t-tests. RESULTS: Pressure-based compression (PBC) was judged to be similar or more comfortable compared with previous traditional exams (80%, 83/103), and 87% (90/103) of participants would recommend PBC to friends. Pressure variability decreased for craniocaudal (CC) views (-55%, P < 0.001) and mediolateral oblique (MLO) views (-34%, P < 0.0001). Subgroup analysis showed a similar glandular dose for CC views, while breast thickness was reduced (-3.74 mm, P < 0.0001). For MLO views, both glandular dose (-0.13 mGy, P < 0.0001) and breast thickness were reduced (-6.70 mm, P < 0.0001). Mean compression parameters were similar for technologist compression and patient-assisted examinations. CONCLUSION: Use of the pressure-based flexible paddle in DBT, with or without patient-assisted compression, improved participant and technologist experience and reduced compression pressure variability, mean breast thickness, and glandular dose.

Is the incidence of advanced-stage breast cancer affected by whether women attend a steady-state screening program?

In this cross-sectional population-based study, we assessed the incidence of advanced breast cancer based on screening attendance. Women from the Netherlands Cancer Registry were included if aged ≥49 years and diagnosed with breast cancer between 2006 and 2011, and data were linked with the screening program. Cancers were defined as screen-related (diagnosed <24 months after screening) or nonscreened (all other breast cancers). Two cut-offs were used to define advanced breast cancer: TNM-stage (III-IV vs 0-I-II) and T-stage alone (≥15 mm vs <15 mm or DCIS). The incidence rates were adjusted for age and logistic regression was used to compare groups. Of the 72,612 included women diagnosed with breast cancer, 44,246 (61%) had screen-related breast cancer. By TNM stage, advanced cancer was almost three times as likely to be at an advanced TNM stage in the nonscreened group compared with the screen-related group (38 and 94 per 100,000, respectively; OR: 2.86, 95%CI: 2.72-3.00). By T-stage, the incidence of advanced cancer was higher overall, and in nonscreened women was significantly higher than in screened women (210 and 169 per 100,000; OR: 1.85, 95%CI: 1.78-1.93). Data on actual screening attendance showed that the incidence of advanced breast cancer was significantly higher in nonscreened women than in screened women, supporting the expectation that screening would cause a stage shift to early detection. Despite critical evaluations of breast cancer screening programs, our data show that breast cancer screening is a valuable tool that can reduce the disease burden in women.

Growth rate of invasive ductal carcinomas from a screened 50-74-year-old population.

Objective As breast cancer growth rate is associated with menopause, most screening programmes target mainly women aged 50-74. We studied the association between age at diagnosis and growth rate in this screening-specific age range. Methods We used data from breast cancer patients diagnosed in the screening programme in Nijmegen, the Netherlands. The data were restricted to the screening rounds when analogue mammography was used in both the screening and clinical setting. Growth rate expressed as tumour volume doubling time was based on increasing tumour size in longitudinal series of mammograms. Estimates were based on (a) tumours showing at least two measurable shadows, (b) tumours showing a shadow at detection only (left censored), and (c) tumours showing no growth (right-censored observation). All 293 tumours were consecutively diagnosed invasive ductal breast cancers in participants of the Nijmegen screening programme in the period 2000-2007. Results Depending on the assumptions made on tumour margins and mammographic density, the relation of volume doubling time with age non-significantly varies from a decrease of 3.3% to an increase of 1.4% for each year increase in age at diagnosis (all P-values ≥ 0.18). Applying left censoring on indistinct tumours, the geometric mean volume doubling time was 191 days (95% confidence interval 158-230). Conclusion We found no significant change in growth rate with age in women diagnosed with invasive ductal breast cancer in the screening age range 50-74. This outcome does not support differential screening intervals by age based solely on breast cancer growth rate for this particular group.

Influence of breast compression pressure on the performance of population-based mammography screening.

BACKGROUND: In mammography, breast compression is applied to reduce the thickness of the breast. While it is widely accepted that firm breast compression is needed to ensure acceptable image quality, guidelines remain vague about how much compression should be applied during mammogram acquisition. A quantitative parameter indicating the desirable amount of compression is not available. Consequently, little is known about the relationship between the amount of breast compression and breast cancer detectability. The purpose of this study is to determine the effect of breast compression pressure in mammography on breast cancer screening outcomes. METHODS: We used digital image analysis methods to determine breast volume, percent dense volume, and pressure from 132,776 examinations of 57,179 women participating in the Dutch population-based biennial breast cancer screening program. Pressure was estimated by dividing the compression force by the area of the contact surface between breast and compression paddle. The data was subdivided into quintiles of pressure and the number of screen-detected cancers, interval cancers, false positives, and true negatives were determined for each group. Generalized estimating equations were used to account for correlation between examinations of the same woman and for the effect of breast density and volume when estimating sensitivity, specificity, and other performance measures. Sensitivity was computed using interval cancers occurring between two screening rounds and using interval cancers within 12 months after screening. Pair-wise testing for significant differences was performed. RESULTS: Percent dense volume increased with increasing pressure, while breast volume decreased. Sensitivity in quintiles with increasing pressure was 82.0%, 77.1%, 79.8%, 71.1%, and 70.8%. Sensitivity based on interval cancers within 12 months was significantly lower in the highest pressure quintile compared to the third (84.3% vs 93.9%, p = 0.034). Specificity was lower in the lowest pressure quintile (98.0%) compared to the second, third, and fourth group (98.5%, p < 0.005). Specificity of the fifth quintile was 98.4%. CONCLUSION: Results suggest that if too much pressure is applied during mammography this may reduce sensitivity. In contrast, if pressure is low this may decrease specificity.

Toward image quality assessment in mammography using model observers: Detection of a calcification-like object.

PURPOSE: Model observers (MOs) are of interest in the field of medical imaging to assess image quality. However, before procedures using MOs can be proposed in quality control guidelines for mammography systems, we need to know whether MOs are sensitive to changes in image quality and correlations in background structure. Therefore, as a proof of principle, in this study human and model observer (MO) performance are compared for the detection of calcification-like objects using different background structures and image quality levels of unprocessed mammography images. METHOD: Three different phantoms, homogeneous polymethyl methacrylate, BR3D slabs with swirled patterns (CIRS, Norfolk, VA, USA), and a prototype anthropomorphic breast phantom (Institute of Medical Physics and Radiation Protection, Technische Hochschule Mittelhessen, Germany) were imaged on an Amulet Innovality (FujiFilm, Tokyo, Japan) mammographic X-ray unit. Because the complexities of the structures of these three phantoms were different and not optimized to match the characteristics of real mammographic images, image processing was not applied in this study. In addition, real mammograms were acquired on the same system. Regions of interest (ROIs) were extracted from each image. In half of the ROIs, a 0.25-mm diameter disk was inserted at four different contrast levels to represent a calcification-like object. Each ROI was then modified, so four image qualities relevant for mammography were simulated. The signal-present and signal-absent ROIs were evaluated by a non-pre-whitening model observer with eye filter (NPWE) and a channelized Hotelling observer (CHO) using dense difference of Gaussian channels. The ROIs were also evaluated by human observers in a two alternative forced choice experiment. Detectability results for the human and model observer experiments were correlated using a mixed-effect regression model. Threshold disk contrasts for human and predicted human observer performance based on the NPWE MO and CHO were estimated. RESULTS: Global trends in threshold contrast were similar for the different background structures, but absolute contrast threshold levels differed. Contrast thresholds tended to be lower in ROIs from simple phantoms compared with ROIs from real mammographic images. The correlation between human and model observer performance was not affected by the range of image quality levels studied. CONCLUSIONS: The correlation between human and model observer performance does not depend on image quality. This is a promising outcome for the use of model observers in image quality analysis and allows for subsequent research toward the development of MO-based quality control procedures and guidelines.

Technical Note: Validation of two methods to determine contact area between breast and compression paddle in mammography.

PURPOSE: To assess the accuracy of two methods of determining the contact area between the compression paddle and the breast in mammography. An accurate method to determine the contact area is essential to accurately calculate the average compression pressure applied by the paddle. METHODS: For a set of 300 breast compressions, we measured the contact areas between breast and paddle, both capacitively using a transparent foil with indium-tin-oxide (ITO) coating attached to the paddle, and retrospectively from the obtained mammograms using image processing software (Volpara Enterprise, algorithm version 1.5.2). A gold standard was obtained from video images of the compressed breast. During each compression, the breast was illuminated from the sides in order to create a dark shadow on the video image where the breast was in contact with the compression paddle. We manually segmented the shadows captured at the time of x-ray exposure and measured their areas. RESULTS: We found a strong correlation between the manual segmentations and the capacitive measurements [r = 0.989, 95% CI (0.987, 0.992)] and between the manual segmentations and the image processing software [r = 0.978, 95% CI (0.972, 0.982)]. Bland-Altman analysis showed a bias of -0.0038 dm2 for the capacitive measurement (SD 0.0658, 95% limits of agreement [-0.1329, 0.1252]) and -0.0035 dm2 for the image processing software [SD 0.0962, 95% limits of agreement (-0.1921, 0.1850)]. CONCLUSIONS: The size of the contact area between the paddle and the breast can be determined accurately and precisely, both in real-time using the capacitive method, and retrospectively using image processing software. This result is beneficial for scientific research, data analysis and quality control systems that depend on one of these two methods for determining the average pressure on the breast during mammographic compression.

The effect of population-based mammography screening in Dutch municipalities on breast cancer mortality: 20 years of follow-up.

Long-term follow-up data on the effects of screening are scarce, and debate exists on the relative contribution of screening versus treatment to breast cancer mortality reduction. Our aim was therefore to assess the long-term effect of screening by age and time of implementation. We obtained data on 69,630 breast cancer deaths between 1980 and 2010 by municipality (N = 431) and age of death (40-79) in the Netherlands. Breast cancer mortality trends were analyzed by defining the municipality-specific calendar year of introduction of screening as Year 0. Additionally, log-linear Poisson regression was used to estimate the turning point in the trend after Year 0, per municipality, and the annual percentage change (APC) before and after this point. Twenty years after introduction of screening breast cancer mortality was reduced by 30% in women aged 55-74 and by 34% in women aged 75-79, compared to Year 0. A similar and significant decrease was present in municipalities that started early (1987-1992) and late (1995-1997) with screening, despite the difference in availability of effective adjuvant treatment. In the age groups 55-74 and 75-79, the turning point in the trend in breast cancer mortality was estimated in Years 2 and 6 after the introduction of screening, respectively, after which mortality decreased significantly by 1.9% and 2.6% annually. These findings show that the implementation of mammography screening in Dutch municipalities is associated with a significant decline in breast cancer mortality in women aged 55-79, irrespective of time of implementation.

Consistency of breast density categories in serial screening mammograms: A comparison between automated and human assessment.

Reliable breast density measurement is needed to personalize screening by using density as a risk factor and offering supplemental screening to women with dense breasts. We investigated the categorization of pairs of subsequent screening mammograms into density classes by human readers and by an automated system. With software (VDG) and by four readers, including three specialized breast radiologists, 1000 mammograms belonging to 500 pairs of subsequent screening exams were categorized into either two or four density classes. We calculated percent agreement and the percentage of women that changed from dense to non-dense and vice versa. Inter-exam agreement (IEA) was calculated with kappa statistics. Results were computed for each reader individually and for the case that each mammogram was classified by one of the four readers by random assignment (group reading). Higher percent agreement was found with VDG (90.4%, CI 87.9-92.9%) than with readers (86.2-89.2%), while less plausible changes from non-dense to dense occur less often with VDG (2.8%, CI 1.4-4.2%) than with group reading (4.2%, CI 2.4-6.0%). We found an IEA of 0.68-0.77 for the readers using two classes and an IEA of 0.76-0.82 using four classes. IEA is significantly higher with VDG compared to group reading. The categorization of serial mammograms in density classes is more consistent with automated software than with a mixed group of human readers. When using breast density to personalize screening protocols, assessment with software may be preferred over assessment by radiologists.

Towards personalized screening: Cumulative risk of breast cancer screening outcomes in women with and without a first-degree relative with a history of breast cancer.

Several reviews have estimated the balance of benefits and harms of mammographic screening in the general population. The balance may, however, differ between individuals with and without family history. Therefore, our aim is to assess the cumulative risk of screening outcomes; screen-detected breast cancer, interval cancer, and false-positive results, in women screenees aged 50-75 and 40-75, with and without a first-degree relative with a history of breast cancer at the start of screening. Data on screening attendance, recall and breast cancer detection were collected for each woman living in Nijmegen (The Netherlands) since 1975. We used a discrete time survival model to calculate the cumulative probability of each major screening outcome over 19 screening rounds. Women with a family history of breast cancer had a higher risk of all screening outcomes. For women screened from age 50-75, the cumulative risk of screen-detected breast cancer, interval cancer and false-positive results were 9.0, 4.4 and 11.1% for women with a family history and 6.3, 2.7 and 7.3% for women without a family history, respectively. The results for women 40-75 followed the same pattern for women screened 50-75 for cancer outcomes, but were almost doubled for false-positive results. To conclude, women with a first-degree relative with a history of breast cancer are more likely to experience benefits and harms of screening than women without a family history. To complete the balance and provide risk-based screening recommendations, the breast cancer mortality reduction and overdiagnosis should be estimated for family history subgroups.

[The correct mammographic positioning in breast cancer screening]. / De juiste instelling in borstkankerscreening. Positionering van de mamma door nieuwe en ervaren mammografielaboranten.

OBJECTIVE: To compare the positioning quality of mammograms produced by new (NRs) versus experienced (ERs) screening radiographers in the Dutch breast cancer screening programme. DESIGN: Retrospective study. METHOD: NRs must successfully complete an education programme before being allowed to start work in Dutch screening practice. This education programme consists of a theoretical component, a practical component and a final practical examination, including a portfolio review. Furthermore, each unit undergoes an audit once every three years. During the audit, mammograms produced by ERs in the unit are assessed on the basis of criteria relating to the positioning of the breast. In this retrospective study, we analysed 13,520 images from portfolios (NRs) and 14,896 images from audits (ERs) on the basis of pre-specified quality criteria, e.g. depiction of the pectoral muscle. RESULTS: Positioning quality was significantly better by NRs than ERs (CC views: 97% versus 86% adequate, p<0.01; MLO views: 92% versus 84% adequate, p<0.01). NRs scored better for most of the CC criteria but had more difficulty with for example the inframammary angle in MLO views than ERs. Overall, the mammograms from NRs were more often considered adequate, because their errors were less serious. CONCLUSION: NRs perform better than ERs in terms of quality of positioning technique. These results stress the need for continuous monitoring of and feedback into the Dutch breast cancer screening programme to maintain high-quality screening mammography.

Comparing Visually Assessed BI-RADS Breast Density and Automated Volumetric Breast Density Software: A Cross-Sectional Study in a Breast Cancer Screening Setting.

INTRODUCTION: The objective of this study is to compare different methods for measuring breast density, both visual assessments and automated volumetric density, in a breast cancer screening setting. These measures could potentially be implemented in future screening programmes, in the context of personalised screening or screening evaluation. MATERIALS AND METHODS: Digital mammographic exams (N = 992) of women participating in the Dutch breast cancer screening programme (age 50-75y) in 2013 were included. Breast density was measured in three different ways: BI-RADS density (5th edition) and with two commercially available automated software programs (Quantra and Volpara volumetric density). BI-RADS density (ordinal scale) was assessed by three radiologists. Quantra (v1.3) and Volpara (v1.5.0) provide continuous estimates. Different comparison methods were used, including Bland-Altman plots and correlation coefficients (e.g., intraclass correlation coefficient [ICC]). RESULTS: Based on the BI-RADS classification, 40.8% of the women had 'heterogeneously or extremely dense' breasts. The median volumetric percent density was 12.1% (IQR: 9.6-16.5) for Quantra, which was higher than the Volpara estimate (median 6.6%, IQR: 4.4-10.9). The mean difference between Quantra and Volpara was 5.19% (95% CI: 5.04-5.34) (ICC: 0.64). There was a clear increase in volumetric percent dense volume as BI-RADS density increased. The highest accuracy for predicting the presence of BI-RADS c+d (heterogeneously or extremely dense) was observed with a cut-off value of 8.0% for Volpara and 13.8% for Quantra. CONCLUSION: Although there was no perfect agreement, there appeared to be a strong association between all three measures. Both volumetric density measures seem to be usable in breast cancer screening programmes, provided that the required data flow can be realized.

Geographic variation in volumetric breast density between screening regions in the Netherlands.

OBJECTIVES: Differences in breast density between populations may explain part of the variation in regional breast cancer screening performance. This study aimed to determine whether regional differences in breast density distribution are present in the Dutch screening population. METHODS: As part of the DENSE trial, mammographic density was measured using a fully-automated volumetric method. The regions in our study were based on the geographic coverage of 14 reading units representing a large part of the Netherlands. General linear models were used. RESULTS: Four hundred eighty-five thousand and twenty-one screening participants with a median age of 60 years were included (2013-2014). The proportion of women with heterogeneously or extremely dense breasts ranged from 32.5% to 45.7% between regions. Mean percent dense volume varied between 6.51% (95% confidence interval [CI]: 6.46-6.55) and 7.68% (95% CI: 7.66-7.71). Age differences could not explain the variation. Socio-economic status (SES) was positively associated with volumetric density in all analyses (low SES: 6.95% vs. high SES: 7.63%; p trend < 0.0001), whereas a potential association between urbanisation and breast density only became apparent after SES adjustment. CONCLUSION: There appears to be geographic variation in mammographic density in the Netherlands, emphasizing the importance of including breast density as parameter in the evaluation of screening performance. KEY POINTS: • Mammographic density may affect regional breast cancer screening performance. • Volumetric breast density varies across screening areas. • SES is positively associated with breast density. • Implications of volumetric breast density differences need to be studied further.

Mammographic positioning quality of newly trained versus experienced radiographers in the Dutch breast cancer screening programme.

PURPOSE: Our purpose was to compare mammographic positioning quality of new (NR) versus experienced screening radiographers (ER) in the Netherlands. METHODS AND MATERIALS: Before starting to work in breast screening, NR must complete an education programme including a theoretical course (four days), practical training (six weeks), and a portfolio-review of 50 mammographic screening examinations performed by the radiographer. Furthermore, Dutch screening has an extensive system of quality assurance, including an audit-review of positioning quality of mammograms by ER. We analysed 13,520 portfolio views (NR) and 14,896 audit views (ER) based on pre-specified criteria, e.g., depiction of inframammary angle. RESULTS: Overall positioning was more adequate for NR than ER (CC views: 97% versus 86%, p = 0.00; MLO views: 92% versus 84%, p = 0.00). NR scored better for most of the CC-criteria and showed, for instance, less folds (inadequate: 10% versus 16%, p = 0.00). In contrast, NR encountered more difficulties for MLO views in, for example, depiction of infra-mammary angle (inadequate: 38% versus 34%, p = 0.00). Overall, mammograms from NR were more often considered adequate, because of less severe errors. CONCLUSION: NR perform better than ER in overall positioning technique. These results stress the need for continuous monitoring and training in breast screening programmes to keep positioning skills up to date. KEY POINTS: • We evaluated positioning quality of new and experienced Dutch screening radiographers. • New radiographers outperform their experienced colleagues in mammographic positioning quality. • New radiographers make less severe errors compared to experienced colleagues. • There is a need for a continuous individual monitoring and feedback system.

Value of audits in breast cancer screening quality assurance programmes.

OBJECTIVES: Our aim was to retrospectively evaluate the results of all audits performed in the past and to assess their value in the quality assurance of the Dutch breast cancer screening programme. METHODS: The audit team of the Dutch Reference Centre for Screening (LRCB) conducts triennial audits of all 17 reading units. During audits, screening outcomes like recall rates and detection rates are assessed and a radiological review is performed. This study investigates and compares the results of four audit series: 1996-2000, 2001-2005, 2003-2007 and 2010-2013. RESULTS: The analysis shows increased recall rates (from 0.66%, 1.07%, 1.22% to 1.58%), increased detection rates (from 3.3, 4.5, 4.8 to 5.4 per 1000) and increased sensitivity (from 64.5%, 68.7%, 70.5% to 71.6%), over the four audit series. The percentage of 'missed cancers' among interval cancers and advanced screen-detected cancers did not change (p = 0.4). CONCLUSIONS: Our audits not only provide an opportunity for assessing screening outcomes, but also provide moments of self-reflection with peers. For radiologists, an accurate understanding of their performance is essential to identify points of improvement. We therefore recommend a radiological review of screening examinations and immediate feedback as part of an audit. KEY POINTS: • Radiological review and immediate feedback are recommended as part of an audit. • For breast screening radiologists, audits provide moments of self-reflection with peers. • Radiological review of screening examinations provides insights in recall behaviour. • Accurate understanding of radiologists' performance is essential to identify points of improvement.

Discrepant screening mammography assessments at blinded and non-blinded double reading: impact of arbitration by a third reader on screening outcome.

OBJECTIVES: To determine the value of adding a third reader for arbitration of discrepant screening mammography assessments. METHODS: We included a consecutive series of 84,927 digital screening mammograms, double read in a blinded or non-blinded fashion. Arbitration was retrospectively performed by a third screening radiologist. Two years' follow-up was performed. RESULTS: Discrepant readings comprised 57.2% (830/1452) and 29.1% (346/1188) of recalls at blinded and non-blinded double readings, respectively. At blinded double reading, arbitration would have decreased recall rate (3.4 to 2.2%, p < 0.001) and programme sensitivity (83.2 to 76.0%, p = 0.013), would not have influenced the cancer detection rate (CDR; 7.5 to 6.8 per 1,000 screens, p = 0.258) and would have increased the positive predictive value of recall (PPV; 22.3 to 31.2%, p < 0.001). At non-blinded double reading, arbitration would have decreased recall rate (2.8 to 2.3%, p < 0.001) and increased PPV (23.2 to 27.5%, p = 0.021), but would not have affected CDR (6.6 to 6.3 per 1,000 screens, p = 0.604) and programme sensitivity (76.0 to 72.7%, p = 0.308). CONCLUSION: Arbitration of discrepant screening mammography assessments is a good tool to improve recall rate and PPV, but is not desirable as it reduces the programme sensitivity at blinded double reading. KEY POINTS: • Blinded double reading results in higher programme sensitivity than non-blinded reading. • Discrepant readings occur more often at blinded compared to non-blinded reading. • Arbitration of discrepant readings reduces the recall rate and PPV. • Arbitration would reduce the programme sensitivity at blinded double reading.

Pain-preventing strategies in mammography: an observational study of simultaneously recorded pain and breast mechanics throughout the entire breast compression cycle.

BACKGROUND: Many women consider mammography painful. Existing studies on pain-preventing strategies only mention pain scores reported before and after breast compression. Studying the pain dynamics during the entire compression cycle may provide new insights for effective pain-preventing strategies. METHODS: This observational study included 117 women who consented to use a custom turning knob to indicate their pain experience during standard mammographic breast compressions in the Academic Medical Center in Amsterdam, The Netherlands. The breast thickness, compression force, contact area, contact pressure and pain experience were recorded continuously. Breast volume was calculated retrospectively from the mammograms. We visualized the progression of pain in relation to breast mechanics for five groups of breast volumes and we performed multivariable regressions to identify factors that significantly predict pain experience. RESULTS: Breast compressions consisted of a deformation phase for flattening, and a clamping phase for immobilization. The clamping phase lasted 12.8 ± 3.6 seconds (average ± standard deviation), 1.7 times longer than the 7.5 ± 2.6 seconds deformation phase. During the clamping phase, the average pain score increased from 4.75 to 5.88 (+24 %) on a 0 - 10 Numerical Rating Scale (NRS), and the proportion of women who reached severe pain (NRS ≥ 7) increased from 23 % to 50 % (more than doubled). Moderate pain (NRS ≥ 4) was reported up to four days after the mammogram. Multivariable analysis showed that pain recollection of the previous mammogram and breast pain before the compression, are significant predictors for pain. Women with smallest breasts experienced most pain: They received highest contact pressures (force divided by contact area) and the pressure increased at the highest rate. CONCLUSION: We suggest further research on two pain-preventing strategies: 1) using a personalized compression protocol by applying to all breasts the same target pressure at the same, slow rate, and 2) shortening the phase during which the breast is clamped.

Towards personalized compression in mammography: a comparison study between pressure- and force-standardization.

OBJECTIVE: To compare a conventional 14 decanewton (daN) force-standardized compression protocol with a personalized 10kilopascal (kPa) pressure-standardized protocol. METHODS: A new add-on contact area detector, which enables pressure-standardized compression, is validated in a double-blinded intra-individual comparison study. Breast screening participants (433) received one craniocaudal (CC) and one mediolateral oblique (MLO) compression for both breasts. Three of these compressions were force-standardized, and one, blinded and randomly assigned, was pressure-standardized. Participants scored their pain experience on an 11-point numerical rating scale (NRS). Three experienced breast-screening radiologists, blinded for compression protocol, indicated which images required retakes. RESULTS: An unanticipated under-compression issue that occurred at forces below 5daN was effectively solved with minimal extra radiographer training during the study. For pressure-standardized compressions obtained at 5daN or more, the compressed breasts thickness increased on average 4.2% (MLO)-6.3% (CC), average pain scores were reduced by 10% (MLO)-17% (CC) and the proportion of women experiencing severe pain (NRS≥7) was reduced by 27% (MLO)-32% (CC), compared with force-standardized compressions (all p-values <0.05). Average glandular dose (AGD) and proportions of retakes were similar for both protocols. CONCLUSION: Pressure-standardized compressions resulted in AGD values and a retake proportion similar to force-standardized compressions, while pain was significantly reduced.

Blinded double reading yields a higher programme sensitivity than non-blinded double reading at digital screening mammography: a prospected population based study in the south of The Netherlands.

PURPOSE: To prospectively determine the screening mammography outcome at blinded and non-blinded double reading in a biennial population based screening programme in the south of the Netherlands. METHODS: We included a consecutive series of 87,487 digital screening mammograms, obtained between July 2009 and July 2011. Screening mammograms were double read in either a blinded (2nd reader was not informed about the 1st reader's decision) or non-blinded fashion (2nd reader was informed about the 1st reader's decision). This reading strategy was alternated on a monthly basis. Women with discrepant readings between the two radiologists were always referred for further analysis. During 2 years follow-up, we collected the radiology reports, surgical correspondence and pathology reports of all referred women and interval breast cancers. RESULTS: Respectively 44,491 and 42,996 screens had been read either in a blinded or non-blinded fashion. Referral rate (3.3% versus 2.8%, p<0.001) and false positive rate (2.6% versus 2.2%, p=0.002) were significantly higher at blinded double reading whereas the cancer detection rate per 1000 screens (7.4 versus 6.5, p=0.14) and positive predictive value of referral (22% versus 23%, p=0.51) were comparable. Blinded double reading resulted in a significantly higher programme sensitivity (83% versus 76%, p=0.01). Per 1000 screened women, blinded double reading would yield 0.9 more screen detected cancers and 0.6 less interval cancers than non-blinded double reading, at the expense of 4.4 more recalls. CONCLUSION: We advocate the use of blinded double reading in order to achieve a better programme sensitivity, at the expense of an increased referral rate and false positive referral rate.

Mammographic compression--a need for mechanical standardization.

BACKGROUND: A lack of consistent guidelines regarding mammographic compression has led to wide variation in its technical execution. Breast compression is accomplished by means of a compression paddle, resulting in a certain contact area between the paddle and the breast. This procedure is associated with varying levels of discomfort or pain. On current mammography systems, the only mechanical parameter available in estimating the degree of compression is the physical entity of force (daN). Recently, researchers have suggested that pressure (kPa), resulting from a specific force divided by contact area on a breast, might be a more appropriate parameter for standardization. Software has now become available which enables device-independent cross-comparisons of key mammographic metrics, such as applied compression pressure (force divided by contact area), breast density and radiation dose, between patient populations. PURPOSE: To compare the current compression practice in mammography between different imaging sites in the Netherlands and the United States from a mechanical point of view, and to investigate whether the compression protocols in these countries can be improved by standardization of pressure (kPa) as an objective mechanical parameter. MATERIALS AND METHODS: We retrospectively studied the available parameters of a set of 37,518 mammographic compressions (9188 women) from the Dutch national breast cancer screening programme (NL data set) and of another set of 7171 compressions (1851 women) from a breast imaging centre in Pittsburgh, PA (US data set). Both sets were processed using VolparaAnalytics and VolparaDensity to obtain the applied average force, pressure, breast thickness, breast volume, breast density and average glandular dose (AGD) as a function of the size of the contact area between the breast and the paddle. RESULTS: On average, the forces and pressures applied in the NL data set were significantly higher than in the US data set. The relative standard deviation was larger in the US data set than in the NL data set. Breasts were compressed with a force in the high range of >15 daN for 31.1% and >20 kPa for 12.3% of the NL data set versus, respectively, 1.5% and 1.7% of the US data set. In the low range we encountered compressions with a pressure of <5 daN for 21.1% and <5 kPa for 21.7% of the US data set versus, respectively, 0.05% and 0.6% in the NL data set. Both the average and the standard deviation of the AGD were higher in the US data set. CONCLUSION: (1) Current mammographic breast compression policies lead to a wide range of applied forces and pressures, with large variations both within and between clinical sites. (2) Pressure standardization could decrease variation, improve reproducibility, and reduce the risk of unnecessary pain, unnecessary high radiation doses and inadequate image quality.