Reducing inequalities by supporting individuals to make informed decisions about accepting their breast screening invitations.

OBJECTIVES: Individuals from deprived areas are less likely to attend breast screening. Inequalities in the coverage of breast screening are associated with poorer cancer outcomes. Individuals who have a positive first experience are more likely to attend subsequent mammograms. This work evaluates the provision of an additional telephone call to individuals who have never attended breast screening, to establish whether this increases attendance. SETTING AND METHODS: 1423 patients from four general practitioner practices within socially deprived areas of National Health Service Tayside (UK) comprised the study population. In addition to their standard appointment letter, individuals were to receive a call at least 24 h prior to their appointment. The call identified barriers to screening, and offered a supportive, problem-solving approach to overcoming these barriers. Data collected included: age, Scottish Index of Multiple Deprivation, first-time invite or previous non-attender, if contactable, duration of call, number of days prior to appointment, and confirmation appointment letter was received. The primary outcome was attendance at the screening. RESULTS: Contact by phone was made with 678 (47.6%) of the study population. Of those, 483 (71.2%) attended their appointment, 122 (18%) cancelled and 73 (10.8%) did not attend (DNA), versus 344 (46.2%) attending, 34 (4.6%) cancelling and 367 (49.3%) not attending among those who were not able to be contacted. Those who received a call were more likely to attend their appointment and less likely to DNA compared to individuals not receiving the call. CONCLUSION: The intervention is simple and low cost; results indicate that the additional call may increase attendance and reduce DNA appointments at breast screening.

Contrast-enhanced digital breast tomosythesis and breast MRI to monitor response to neoadjuvant chemotherapy: patient tolerance and preference.

OBJECTIVE: Contrast-enhanced digital breast tomosynthesis (CE-DBT) is a novel imaging technique, combining contrast-enhanced spectral mammography and tomosynthesis. This may offer an alternative imaging technique to breast MRI for monitoring of response to neoadjuvant chemotherapy. This paper addresses patient experience and preference regarding the two techniques. METHODS: Conducted as part of a prospective pilot study; patients were asked to complete questionnaires pertaining to their experience of CE-DBT and MRI following pre-treatment and end-of-treatment imaging. Questionnaires consisted of eight questions answered on a categorical scale, two using a visual analogue scale (VAS), and a question to indicate preference of imaging technique. Statistical analysis was performed with Wilcoxon signed rank test and McNemar test for related samples using SPSS v. 25. RESULTS: 18 patients were enrolled in the pilot study. Matched CE-DBT and MRI questionnaires were completed after 22 patient episodes. Patient preference was indicated after 31 patient episodes. Overall, on 77% of occasions patients preferred CE-DBT with no difference between pre-treatment and end-of-treatment imaging. Overall experience (p = 0.008), non-breast pain (p = 0.046), anxiety measured using VAS (p = 0.003), and feeling of being put at ease by staff (p = 0.023) was better for CE-DBT. However, more breast pain was experienced during CE-DBT when measured on both VAS (p = 0.011) and categorical scale (p = 0.021). CONCLUSION: Our paper suggests that patients prefer CE-DBT to MRI, adding further evidence in favour of contrast-enhanced mammographic techniques. ADVANCES IN KNOWLEDGE: Contrast mammographic techniques offer an alternative, more accessible imaging technique to breast MRI. Whilst other studies have addressed patient experience of contrast-enhanced spectral mammography, this is the first study to directly explore patient preference for CE-DBT over MRI in the setting of neoadjuvant chemotherapy, finding that overall, patients preferred CE-DBT despite the relatively long breast compression.

Application of the Rasch measurement framework to mammography positioning data.

The purpose of this article is to provide raw data and measure-validation data pertaining to a co-submission published in European Journal of Radiology and entitled: Development and validation of a novel measure of adverse patient positioning in mammography. This Data in Brief article serves not only to provide greater detail than its companion article but also as an educational worked example of the Rasch measurement framework. Rasch measurement is a form of modern psychometric technique and our articles provide the first known example of its use in the evaluation of clinical radiological image quality. The data consist of observations of mammographic images, plus limited participant parameters relevant to the measure validation process. Also provided are validation indices produced by subjecting the primary data to Rasch analysis. An expert observer generated the primary data by reviewing mammographic images to judge the presence or absence of a set of features developed through theory and consultation with other experts. The validation data were generated through Rasch analysis, performed using Winsteps® software, which mathematically models the probability of having a correct response (or a present feature in this dataset) to an item in a given measurement instrument (e.g. questionnaire), as a function of the participant's ability/position on the underlying construct under study. The data can be reused by anyone wishing to learn and practice psychometric validation techniques. They can also form a basis for researchers wishing to build on our preliminary measure for the assessment of mammographic clinical image quality.

Are baseline mammographic and ultrasound features associated with metastasis free survival in women receiving neoadjuvant chemotherapy for invasive breast cancer?

OBJECTIVES: To identify associations between baseline ultrasound (US) and mammographic features and metastasis free survival (MFS) in women receiving neo-adjuvant chemotherapy (NACT) for breast cancer. METHODS: The data were collected as part of an ethically approved prospective study. Women with invasive breast cancer receiving NACT who were metastasis free at diagnosis were included. Baseline US and mammography were performed. Imaging was assessed by an experienced breast radiologist who was blinded to outcomes. US imaging features documented included posterior effect, skin thickening, size and stiffness using shear wave elastography (SWE). The mammographic features documented were spiculation and microcalcification. The development of metastatic disease was ascertained from computer records. Statistical analysis was performed using Kaplan Meier survival curves and Receiver Operator Characteristic (ROC) analysis. RESULTS: 171 women with 172 cancers were included in the study and 55 developed metastatic disease. Mean follow-up was 6.0 years. Women with mammographic calcification had significantly poorer metastasis free survival (MFS) compared to women without calcification (p = 0.043, 6 yr MFS 50 % vs 69 %). Women bearing cancer with distal shadowing had poorer MFS than women without shadowing (p = 0.025, 6 yr MFS 47 % vs. 73 %). Women with US skin thickening had poorer MFS compared to women without skin thickening (p = 0.032, 6 yr MFS 52 % vs. 68 %). Mammographic spiculation, US size and stiffness at SWE had no significant association with MFS. CONCLUSION: We have identified mammographic and US features associated with MFS in women receiving NACT. Such information may be useful when counselling patients about the benefits and risks of NACT.

Development and validation of a novel measure of adverse patient positioning in mammography.

PURPOSE: The primary aim was to develop and validate a novel mammography positioning measure, specifically incorporating parameters which might relate to mammography pain. We then explored relationships between the new adverse positioning score and (1) pain; (2) patient and technique factors. METHODS: A 15-item instrument incorporating positioning features with potential to relate to mammography pain was developed. Participants' mammograms (n = 310) were reviewed for presence of these features. Validity was investigated using the Rasch model. Scores produced by the resultant measure were investigated for associations with patients' pain scores and relevant patient and technique factors, using Pearson correlation, analysis of variance, and multiple linear regression. RESULTS: Statistical indices within the Rasch measurement framework provided good evidence that the measure reflected a coherent construct of adverse positioning. Thus, the scores produced with the measurement instrument were valid for use in further statistical analysis. There is, however, scope for improvement of the measure's discriminatory properties. Adverse positioning scores were higher for greater breast volumes (r = 0.12, p=.0391) and body mass index (BMI) (r = 0.13, p=.0349), and varied by mammographer (F(11,298) 2.38, p = .0078). The relationships with BMI and mammographer persisted in regression modelling. No relationship was found between adverse positioning and pain. CONCLUSIONS: Evidence from Rasch analysis suggests that this novel measure is valid for quantifying a coherent "adverse positioning" construct in mammography. Adverse positioning scores varied by mammographer and were related to higher patient BMI but not to mammography pain. The measure warrants expansion, further refinement, and testing in larger studies.

Digital breast tomosynthesis: sensitivity for cancer in younger symptomatic women.

OBJECTIVE: Full-field digital mammography (FFDM) has limited sensitivity for cancer in younger women with denser breasts. Digital breast tomosynthesis (DBT) can reduce the risk of cancer being obscured by overlying tissue. The primary study aim was to compare the sensitivity of FFDM, DBT and FFDM-plus-DBT in women under 60 years old with clinical suspicion of breast cancer. METHODS: This multicentre study recruited 446 patients from UK breast clinics. Participants underwent both standard FFDM and DBT. A blinded retrospective multireader study involving 12 readers and 300 mammograms (152 malignant and 148 benign cases) was conducted. RESULTS: Sensitivity for cancer was 86.6% with FFDM [95% CI (85.2-88.0%)], 89.1% with DBT [95% CI (88.2-90%)], and 91.7% with FFDM+DBT [95% CI (90.7-92.6%)]. In the densest breasts, the maximum sensitivity increment with FFDM +DBT over FFDM alone was 10.3%, varying by density measurement method. Overall specificity was 81.4% with FFDM [95% CI (80.5-82.3%)], 84.6% with DBT [95% CI (83.9-85.3%)], and 79.6% with FFDM +DBT [95% CI (79.0-80.2%)]. No differences were detected in accuracy of tumour measurement in unifocal cases. CONCLUSIONS: Where available, DBT merits first-line use in the under 60 age group in symptomatic breast clinics, particularly in women known to have very dense breasts. ADVANCES IN KNOWLEDGE: This study is one of very few to address the accuracy of DBT in symptomatic rather than screening patients. It quantifies the diagnostic gains of DBT in direct comparison with standard digital mammography, supporting informed decisions on appropriate use of DBT in this population.

Prediction of Pathological Complete Response to Neoadjuvant Chemotherapy for Primary Breast Cancer Comparing Interim Ultrasound, Shear Wave Elastography and MRI.

BACKGROUND: Prediction of pathological complete response (pCR) of primary breast cancer to neoadjuvant chemotherapy (NACT) may influence planned surgical approaches in the breast and axilla. The aim of this project is to assess the value of interim shear wave elastography (SWE), ultrasound (US) and magnetic resonance imaging (MRI) after 3 cycles in predicting pCR. METHODS: 64 patients receiving NACT had baseline and interim US, SWE and MRI examinations. The mean lesion stiffness at SWE, US and MRI diameter was measured at both time points. We compared four parameters with pCR status: a) Interim mean stiffness ≤ or > 50 kPa; b) Percentage stiffness reduction; c) Percentage US diameter reduction and d) Interim MRI response using RECIST criteria. The Chi square test was used to assess significance. RESULTS: Interim stiffness of ≤ or > 50 kPa gave the best prediction of pCR with pCR seen in 10 of 14 (71 %) cancers with an interim stiffness of ≤ 50 kPa, compared to 7 of 50 (14 %) of cancers with an interim stiffness of > 50 kPa, (p < 0.0001) (sensitivity 59 %, specificity 91 %, PPV 71 %, NPV 86 % and diagnostic accuracy 83 %). Percentage reduction in stiffness was the next best parameter (sensitivity 59 %, specificity 85 %, p < 0.0004) followed by reduction in MRI diameter of > 30 % (sensitivity 50 % and specificity 79 %, p = 0.03) and % reduction in US diameter (sensitivity 47 %, specificity 81 %, p = 0.03). Similar results were obtained from ROC analysis. CONCLUSION: SWE stiffness of breast cancers after 3 cycles of NACT and changes in stiffness from baseline are strongly associated with pCR after 6 cycles.

A mammography image set for research purposes using BI-RADS density classification.

PURPOSE: Breast density categorization consistency is important when performing research, and minimization of interoperator and intraoperator variability is essential. This research aimed to validate a set of mammography images for visual breast density estimation to achieve consistency in future research projects and to determine observer performance. METHODS: Using the Breast Imaging Reporting and Data System (BI-RADS) as the visual grading scale, 50 mammography images were scored for density grade by 8 observers. RESULTS: Six of 8 observers achieved near-complete intraobserver agreement (kappa > 0.81). Strong agreement among observers (kappa = 0.61-0.8) was found in 10 of 28 paired observation episodes on the first iteration and 12 of 28 on the second. No observers demonstrated a delta variance above 1. Fleiss' kappa was used to evaluate concordance among all observers on the first and second iterations (first iteration, 0.64; second iteration, 0.56). DISCUSSION: This research illustrates the difficulties of comparing observer visual performance scores because differences can exist when studies are repeated by and among individuals. CONCLUSION: We confirmed that the 50 images were suitable for research purposes. Some variability existed among observers; however, overall density classification agreement was strong. Future research should include repeating this study with digitally acquired images.

Does shear wave ultrasound independently predict axillary lymph node metastasis in women with invasive breast cancer?

Shear wave elastography (SWE) shows promise as an adjunct to greyscale ultrasound examination in assessing breast masses. In breast cancer, higher lesion stiffness on SWE has been shown to be associated with features of poor prognosis. The purpose of this study was to assess whether lesion stiffness at SWE is an independent predictor of lymph node involvement. Patients with invasive breast cancer treated by primary surgery, who had undergone SWE examination were eligible. Data were retrospectively analysed from 396 consecutive patients. The mean stiffness values were obtained using the Aixplorer® ultrasound machine from SuperSonic Imagine Ltd. Measurements were taken from a region of interest positioned over the stiffest part of the abnormality. The average of the mean stiffness value obtained from each of two orthogonal image planes was used for analysis. Associations between lymph node involvement and mean lesion stiffness, invasive cancer size, histologic grade, tumour type, ER expression, HER-2 status and vascular invasion were assessed using univariate and multivariate logistic regression. At univariate analysis, invasive size, histologic grade, HER-2 status, vascular invasion, tumour type and mean stiffness were significantly associated with nodal involvement. Nodal involvement rates ranged from 7 % for tumours with mean stiffness <50 kPa to 41 % for tumours with a mean stiffness of >150 kPa. At multivariate analysis, invasive size, tumour type, vascular invasion, and mean stiffness maintained independent significance. Mean stiffness at SWE is an independent predictor of lymph node metastasis and thus can confer prognostic information additional to that provided by conventional preoperative tumour assessment and staging.

The effect of mammography pain on repeat participation in breast cancer screening: a systematic review.

Uptake is crucial to reducing breast cancer mortality through screening. This review synthesised all available evidence on mammography pain as a deterrent to subsequent breast screening. Ten databases were searched. Studies containing empirical data relating mammography pain to breast screening re-attendance were included (n = 20). In the most robust studies asking women why they had not re-attended, 25%-46% cited pain, equivalent to approximately 47,000-87,000 women per year in England. The most robust evidence for an association between pain experienced at a previous mammogram and subsequent rates of re-attendance suggests that women who previously experienced pain are more likely than those who did not to fail to re-attend: RR 1.34 (95% CI: 0.94-1.91). The complexity of the pain phenomenon and of screening behaviours must be recognised. However, there is sufficient evidence to conclude that painful mammography contributes to non-re-attendance. Given the importance of cumulative participation, effective pain-reducing interventions in mammography are needed.

Invasive breast cancer: relationship between shear-wave elastographic findings and histologic prognostic factors.

PURPOSE: To compare the histologic prognostic feature of invasive breast cancer with mean stiffness as measured with shear-wave elastography. MATERIALS AND METHODS: This retrospective study was exempted from ethical committee review. Patient consent for use of images for research was obtained. The study group comprised 101 consecutive women (age range, 38-91 years) with solid lesions identified during routine breast ultrasonography (US) performed between April 2010 and March 2011 and subsequently confirmed at histologic examination to be invasive cancers. Four elastographic images in two orthogonal planes were obtained of each lesion, and mean stiffness values were obtained from each image. Histologic findings following surgery were used for comparison, namely histologic grade, tumor type, invasive size, vascular invasion status, and lymph node status. Relationship between mean stiffness and histologic parameters was investigated by using a general linear model and multiple regression analysis. RESULTS: High histologic grade (P < .0001), large invasive size (P < .0001), lymph node involvement (P < .0001), tumor type (P < .0001), and vascular invasion (P = .0077) all showed statistically significant positive association with high mean stiffness values. Multiple linear regression indicated that invasive size is the strongest pathologic determinant of mean stiffness (P < .0001), with histologic grade also having significant influence (P = .022). CONCLUSION: In this study, breast cancers with higher mean stiffness values at shear-wave elastography had poorer prognostic features.

The number of women who would need to be screened regularly by mammography to prevent one death from breast cancer.

The number of women who would need to be screened regularly by mammography to prevent one death from breast cancer depends strongly on several factors, including the age at which regular screening starts, the period over which it continues, and the duration of follow-up after screening. Furthermore, more women would need to be INVITED for screening than would need to be SCREENED to prevent one death, since not all women invited attend for screening or are screened regularly. Failure to consider these important factors accounts for many of the major discrepancies between different published estimates. The randomised evidence indicates that, in high income countries, around one breast cancer death would be prevented in the long term for every 400 women aged 50-70 years regularly screened over a ten-year period.

Quantitative shear wave ultrasound elastography: initial experience in solid breast masses.

INTRODUCTION: Shear wave elastography is a new method of obtaining quantitative tissue elasticity data during breast ultrasound examinations. The aims of this study were (1) to determine the reproducibility of shear wave elastography (2) to correlate the elasticity values of a series of solid breast masses with histological findings and (3) to compare shear wave elastography with greyscale ultrasound for benign/malignant classification. METHODS: Using the Aixplorer® ultrasound system (SuperSonic Imagine, Aix en Provence, France), 53 solid breast lesions were identified in 52 consecutive patients. Two orthogonal elastography images were obtained of each lesion. Observers noted the mean elasticity values in regions of interest (ROI) placed over the stiffest areas on the two elastography images and a mean value was calculated for each lesion. A sub-set of 15 patients had two elastography images obtained by an additional operator. Reproducibility of observations was assessed between (1) two observers analysing the same pair of images and (2) findings from two pairs of images of the same lesion taken by two different operators. All lesions were subjected to percutaneous biopsy. Elastography measurements were correlated with histology results. After preliminary experience with 10 patients a mean elasticity cut off value of 50 kilopascals (kPa) was selected for benign/malignant differentiation. Greyscale images were classified according to the American College of Radiology (ACR) Breast Imaging Reporting and Data System (BI-RADS). BI-RADS categories 1-3 were taken as benign while BI-RADS categories 4 and 5 were classified as malignant. RESULTS: Twenty-three benign lesions and 30 cancers were diagnosed on histology. Measurement of mean elasticity yielded an intraclass correlation coefficient of 0.99 for two observers assessing the same pairs of elastography images. Analysis of images taken by two independent operators gave an intraclass correlation coefficient of 0.80. Shear wave elastography versus greyscale BI-RADS performance figures were sensitivity: 97% vs 87%, specificity: 83% vs 78%, positive predictive value (PPV): 88% vs 84%, negative predictive value (NPV): 95% vs 82% and accuracy: 91% vs 83% respectively. These differences were not statistically significant. CONCLUSIONS: Shear wave elastography gives quantitative and reproducible information on solid breast lesions with diagnostic accuracy at least as good as greyscale ultrasound with BI-RADS classification.

Promoting early presentation of breast cancer by older women: a preliminary evaluation of a one-to-one health professional-delivered intervention.

OBJECTIVE: To test the early effects of a novel one-to-one health professional-delivered intervention designed to increase awareness and thereby promote early presentation of breast cancer among older women. METHODS: Women attending their final routine appointment in the English NHS Breast Screening Programme received a booklet or a booklet supplemented by a brief interview, in addition to usual care. This was a within-group before-and-after evaluation of the two versions of the intervention. The primary outcome was change in the knowledge of breast cancer symptoms from baseline to 1 month postintervention. Secondary outcomes were knowledge of risk of developing breast cancer, confidence to detect a breast change, and likelihood of disclosure to someone close. Levels of cancer worry and any adverse effects caused by the intervention were also monitored. RESULTS: One hundred seventy-six women received the booklet and 116 received the booklet-plus-interview. At 1-month postintervention, the mean number of breast cancer symptoms identified (out of 11) increased from 5.3 by 1 symptom (P<.001) in the booklet group and by 1.9 (P<.001) in the booklet-plus-interview group. Improvements were sustained at 6 months. Positive improvements were made in the knowledge of risk of developing breast cancer and the confidence to detect a breast change in both groups; however, neither version of the intervention had an impact on encouraging women to disclose to someone close immediately on discovery of a breast symptom. No adverse effects were reported, and there was no significant increase in the level of cancer worry. DISCUSSION: Both versions of the intervention are worthy of testing in randomized trials to assess the impact on breast cancer awareness and ultimately on delayed presentation of breast cancer and mortality.