Search

PURPOSE: To evaluate the results from two software tools for measurement of mammographic breast density and compare them with observer-based scores in a large cohort of women. MATERIALS AND METHODS: Following written informed consent, a data set of 36 281 mammograms from 8867 women were collected from six United Kingdom centers in an ethically approved trial. Breast density was assessed by one of 26 readers on a visual analog scale and with two automated density tools. Mean differences were calculated as the mean of all the individual percentage differences between each measurement for each case (woman). Agreement in total breast volume, fibroglandular volume, and percentage density was assessed with the Bland-Altman method. Association with observer's scores was calculated by using the Pearson correlation coefficient (r). RESULTS: Correlation between the Quantra and Volpara outputs for total breast volume was r = 0.97 (P < .001), with a mean difference of 43.5 cm(3) for all cases representing 5.0% of the mean total breast volume. Correlation of the two measures was lower for fibroglandular volume (r = 0.86, P < .001). The mean difference was 30.3 cm(3) for all cases representing 21.2% of the mean fibroglandular tissue volume result. Quantra gave the larger value and the difference tended to increase with volume. For the two measures of percentage volume density, the mean difference was 1.61 percentage points (r = 0.78, P < .001). Comparison of observer's scores with the area-based density given by Quantra yielded a low correlation (r = 0.55, P < .001). Correlations of observer's scores with the volumetric density results gave r values of 0.60 (P < .001) and 0.63 (P < .001) for Quantra and Volpara, respectively. CONCLUSION: Automated techniques for measuring breast density show good correlation, but these are poorly correlated with observer's scores. However automated techniques do give different results that should be considered when informing patient personalized imaging. (©) RSNA, 2015 Clinical trial registration no. ISRCTN 73467396.

Background Mammographic density has been shown to be a strong independent predictor of breast cancer and a causative factor in reducing the sensitivity of mammography. There remain questions as to the use of mammographic density information in the context of screening and risk management, and of the association with cancer in populations known to be at increased risk of breast cancer. Aim To assess the association of breast density with presence of cancer by measuring mammographic density visually as a percentage, and with two automated volumetric methods, Quantra™ and VolparaDensity™. Methods The TOMosynthesis with digital MammographY (TOMMY) study of digital breast tomosynthesis in the Breast Screening Programme of the National Health Service (NHS) of the United Kingdom (UK) included 6020 breast screening assessment cases (of whom 1158 had breast cancer) and 1040 screened women with a family history of breast cancer (of whom two had breast cancer). We assessed the association of each measure with breast cancer risk in these populations at enhanced risk, using logistic regression adjusted for age and total breast volume as a surrogate for body mass index (BMI). Results All density measures showed a positive association with presence of cancer and all declined with age. The strongest effect was seen with Volpara absolute density, with a significant 3% (95% CI 1–5%) increase in risk per 10 cm3 of dense tissue. The effect of Volpara volumetric density on risk was stronger for large and grade 3 tumours. Conclusions Automated absolute breast density is a predictor of breast cancer risk in populations at enhanced risk due to either positive mammographic findings or family history. In the screening context, density could be a trigger for more intensive imaging., Highlights • Three different breast density measures compared: visual, Quantra and Volpara. • All density measures showed a positive association with presence of cancer. • The strongest effect was seen with Volpara absolute density measure. • A stronger effect of Volpara density on risk was observed for large and grade 3 cancers.

Purpose To assess whether individual reader performance with digital breast tomosynthesis (DBT) and two-dimensional (2D) mammography varies with number of years of experience or volume of 2D mammograms read. Materials and Methods After written informed consent was obtained, 8869 women (age range, 29–85 years; mean age, 56 years) were recruited into the TOMMY trial (A Comparison of Tomosynthesis with Digital Mammography in the UK National Health Service Breast Screening Program), an ethically approved, multicenter, multireader, retrospective reading study, between July 2011 and March 2013. Each case was read prospectively for clinical assessment and to establish ground truth. A retrospective reading data set of 7060 cases was created and randomly allocated for independent blinded review of (a) 2D mammograms, (b) DBT images and 2D mammograms, and (c) synthetic 2D mammograms and DBT images, without access to previous examinations. Readers (19 radiologists, three advanced practitioner radiographers, and two breast clinicians) who had 3–25 (median, 10) years of experience in the U.K. National Health Service Breast Screening Program and read 5000–13 000 (median, 8000) cases per annum were included in this study. Specificity was analyzed according to reader type and years and volume of experience, and then both specificity and sensitivity were analyzed by matched inference. The median duration of experience (10 years) was used as the cutoff point for comparison of reader performance. Results Specificity improved with the addition of DBT for all readers. This was significant for all staff groups (56% vs 68% and 49% vs 67% [P < .0001] for radiologists and advanced practitioner radiographers, respectively; 46% vs 55% [P = .02] for breast clinicians). Sensitivity was improved for 19 of 24 (79%) readers and was significantly higher for those with less than 10 years of experience (91% vs 86%; P = .03) and those with total mammographic experience of fewer than 80 000 cases (88% vs 86%; P = .03). Conclusion The addition of DBT to conventional 2D screening mammography improved specificity for all readers, but the gain in sensitivity was greater for readers with less than 10 years of experience.

Objective In a randomized controlled trial, the Promoting Early Presentation intervention increased older women’s breast cancer awareness after two years. We investigated whether this increase was sustained at three years, and the effect on breast screening self-referral. Methods We randomly allocated 867 women attending their final invited breast screening appointment to the Promoting Early Presentation intervention or usual care. We examined breast cancer awareness after three years and breast screening self-referrals after four years. Results Women in the Promoting Early Presentation intervention arm had higher breast cancer awareness at three years than the usual care arm (odds ratio: 10.4; 95% confidence interval: 3.1 to 34.8). There were no differences in proportions self-referring for breast screening between arms, but statistical power was limited. Conclusion The Promoting Early Presentation intervention has a sustained effect on breast cancer awareness in older women. The effect on self-referral for breast screening is unclear.

BACKGROUND: We have developed the Promoting Early Presentation (PEP) Intervention to equip older women with the knowledge, skills, confidence and motivation to present promptly with breast symptoms, and thereby improve survival from breast cancer. The PEP Intervention consists of a 10-min interaction between a radiographer and an older woman, supported by a booklet. Our previous report showed that at 1 year, the PEP intervention increased the proportion who were breast cancer aware compared with usual care. METHODS: We randomised 867 women aged 67-70 years attending for their final routine appointment on the National Health Service Breast Screening Programme to receive the PEP Intervention, a booklet alone or usual care. The primary outcome was breast cancer awareness measured using a validated questionnaire asking about knowledge of breast cancer symptoms, knowledge that the risk of breast cancer increases with age and breast checking behaviour. RESULTS: At 2 years, the PEP Intervention increased the proportion who were breast cancer aware compared with usual care (21 vs 6%; odds ratio 8.1, 95% confidence interval 2.7-25.0). CONCLUSIONS: The uniquely large and sustained effect of the PEP Intervention on breast cancer awareness increases the likelihood that a woman will present promptly should she develop breast cancer symptoms up to many years later.

Aim To evaluate the feasibility of training sufficient radiographers to deliver an intervention to promote early presentation of breast cancer to all older women attending for their final routine mammogram within the NHS Breast Screening Programme. If the Promoting Early Presentation (PEP) intervention is demonstrated to be cost-effective, it may be implemented across the NHS requiring at least four radiographers per screening service to deliver the intervention. Methods A pilot study in a single breast screening service was conducted to assess the feasibility of training sufficient radiographers to meet this objective. Quantitative and qualitative methods were used to evaluate the impact of training on participating radiographers and the screening service. Competency to deliver the intervention was assessed at key points during training according to quality criteria based on delivery of the key messages and style of delivery. Confidence to deliver the intervention was assessed using a self-report measure before and after training. Radiographers' experiences of training were elicited in face-to-face qualitative interviews. Results Seven of eight radiographers who were released to undertake the training achieved the required level of competency to deliver the intervention within four months. All improved over time in their confidence to deliver the key messages of the intervention. The qualitative analysis revealed the benefits and challenges of training from the perspective of the radiographers. Conclusion It was feasible and acceptable to train sufficient radiographers to deliver the PEP Intervention. The training package will be streamlined to improve efficiency for large implementation trials and clinical practice across the NHS.

Aims To assess the feasibility of training radiographers to deliver a one-to-one intervention to raise breast cancer awareness among older women. The ultimate aim is to increase the likelihood of early presentation of breast cancer by older women and improve survival from the disease. Method Four radiographers were trained to deliver a 10-min scripted one-to-one intervention. Key elements of training included rehearsal of the intervention using role-play with actors and colleagues and practice interviews with women attending NHS breast screening clinics. All practice interventions were videotaped to facilitate positive, constructive feedback on performance. Competence to deliver the intervention was assessed on delivery of the key messages and the style of delivery. Radiographers' experiences of training and intervention delivery were collated from reflective diaries. Results Three radiographers were assessed as competent after training and all four increased in confidence to deliver the intervention. Reported benefits to radiographers included increased awareness of communication skills and enhanced interaction with women attending breast screening. Radiographers reported challenges relating to mastering the prescriptive nature of the intervention and to delivering complex health messages within time constraints. Discussion It was feasible but challenging for radiographers to be trained to deliver a one-to-one intervention designed to raise breast cancer awareness and thereby to promote early presentation of breast cancer. If the intervention is found to be cost-effective it may be implemented across the NHS Breast Screening Programme with diagnostic radiographers playing a key role in promoting early presentation of breast cancer.

Breast screening with full-field digital mammography (FFDM) fails to detect 15–30% of cancers. This figure is higher for women with dense breasts. A new tomographic technique in mammography has been developed — digital breast tomosynthesis (DBT) — which allows images to be viewed in sections through the breast and has the potential to improve cancer detection rates. Results from retrospective reading studies comparing DBT with FFDM have been largely favourable with improvement in sensitivity and specificity. Increases in diagnostic accuracy have been reported as being independent of breast density; however there are mixed reports regarding the detection of microcalcification. Prospective screening studies using DBT with FFDM have demonstrated increased rates in cancer detection compared with FFDM alone. A reduction in false-positive recall rates has also been shown. Screening with the addition of DBT would approximately double radiation dose; however a simulated FFDM image can be generated from a DBT scan. The combination of simulated FFDM images and DBT is being evaluated within several studies and some positive results have been published. Interval cancer rates for the UK National Health Service Breast Screening Programme (NHSBSP) demonstrate the limited sensitivity of FFDM in cancer detection. DBT has the potential to increase sensitivity and decrease false-positive recall rates. It has approval for screening and diagnostics in several countries; however, there are issues with DBT as a screening tool including additional reading time, IT storage and connectivity, over-diagnosis, and cost effectiveness. Feasibility and cost-effectiveness trials are needed before the implementation of DBT in NHSBSP can be considered.

PURPOSE: To compare the diagnostic performance of two-dimensional (2D) mammography, 2D mammography plus digital breast tomosynthesis (DBT), and synthetic 2D mammography plus DBT in depicting malignant radiographic features. MATERIALS AND METHODS: In this multicenter, multireader, retrospective reading study (the TOMMY trial), after written informed consent was obtained, 8869 women (age range, 29-85 years; mean, 56 years) were recruited from July 2011 to March 2013 in an ethically approved study. From these women, a reading dataset of 7060 cases was randomly allocated for independent blinded review of (a) 2D mammography images, (b) 2D mammography plus DBT images, and (c) synthetic 2D mammography plus DBT images. Reviewers had no access to results of previous examinations. Overall sensitivities and specificities were calculated for younger women and those with dense breasts. RESULTS: Overall sensitivity was 87% for 2D mammography, 89% for 2D mammography plus DBT, and 88% for synthetic 2D mammography plus DBT. The addition of DBT was associated with a 34% increase in the odds of depicting cancer (odds ratio [OR] = 1.34, P = .06); however, this level did not achieve significance. For patients aged 50-59 years old, sensitivity was significantly higher (P = .01) for 2D mammography plus DBT than it was for 2D mammography. For those with breast density of 50% or more, sensitivity was 86% for 2D mammography compared with 93% for 2D mammography plus DBT (P = .03). Specificity was 57% for 2D mammography, 70% for 2D mammography plus DBT, and 72% for synthetic 2D mammography plusmDBT. Specificity was significantly higher than 2D mammography (P < .001in both cases) and was observed for all subgroups (P < .001 for all cases). CONCLUSION: The addition of DBT increased the sensitivity of 2D mammography in patients with dense breasts and the specificity of 2D mammography for all subgroups. The use of synthetic 2D DBT demonstrated performance similar to that of standard 2D mammography with DBT. DBT is of potential benefit to screening programs, particularly in younger women with dense breasts. (©) RSNA, 2015.

BackgroundDigital breast tomosynthesis (DBT) is a three-dimensional mammography technique with the potential to improve accuracy by improving differentiation between malignant and non-malignant lesions.ObjectivesThe objectives of the study were to compare the diagnostic accuracy of DBT in conjunction with two-dimensional (2D) mammography or synthetic 2D mammography, against standard 2D mammography and to determine if DBT improves the accuracy of detection of different types of lesions.Study populationWomen (aged 47–73 years) recalled for further assessment after routine breast screening and women (aged 40–49 years) with moderate/high of risk of developing breast cancer attending annual mammography screening were recruited after giving written informed consent.InterventionAll participants underwent a two-view 2D mammography of both breasts and two-view DBT imaging. Image-processing software generated a synthetic 2D mammogram from the DBT data sets.Retrospective reading studyIn an independent blinded retrospective study, readers reviewed (1) 2D or (2) 2D + DBT or (3) synthetic 2D + DBT images for each case without access to original screening mammograms or prior examinations. Sensitivities and specificities were calculated for each reading arm and by subgroup analyses.ResultsData were available for 7060 subjects comprising 6020 (1158 cancers) assessment cases and 1040 (two cancers) family history screening cases. Overall sensitivity was 87% [95% confidence interval (CI) 85% to 89%] for 2D only, 89% (95% CI 87% to 91%) for 2D + DBT and 88% (95% CI 86% to 90%) for synthetic 2D + DBT. The difference in sensitivity between 2D and 2D + DBT was of borderline significance (p = 0.07) and for synthetic 2D + DBT there was no significant difference (p = 0.6). Specificity was 58% (95% CI 56% to 60%) for 2D, 69% (95% CI 67% to 71%) for 2D + DBT and 71% (95% CI 69% to 73%) for synthetic 2D + DBT. Specificity was significantly higher in both DBT reading arms for all subgroups of age, density and dominant radiological feature (p p p = 0.03); for grade 2 invasive tumours, sensitivities were 91% versus 87% (p = 0.01); where the dominant radiological feature was a mass, sensitivities were 92% and 89% (p = 0.04) For synthetic 2D + DBT, there was significantly (p = 0.006) higher sensitivity than 2D alone in invasive cancers of size 11–20 mm, with a sensitivity of 91%.ConclusionsThe specificity of DBT and 2D was better than 2D alone but there was only marginal improvement in sensitivity. The performance of synthetic 2D appeared to be comparable to standard 2D. If these results were observed with screening cases, DBT and 2D mammography could benefit to the screening programme by reducing the number of women recalled unnecessarily, especially if a synthetic 2D mammogram were used to minimise radiation exposure. Further research is required into the feasibility of implementing DBT in a screening setting, prognostic modelling on outcomes and mortality, and comparison of 2D and synthetic 2D for different lesion types.Study registrationCurrent Controlled Trials ISRCTN73467396.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 4. See the HTA programme website for further project information.

Background. Women over 70 with breast cancer have poorer one-year survival and present at a more advanced stage than younger women. Promoting early symptomatic presentation in older women may reduce stage cost effectively and is unlikely to lead to overdiagnosis. After examining efficacy in a randomised controlled trial, we piloted a brief health professional-delivered intervention to equip women to present promptly with breast symptoms, as an integral part of the final invited mammogram at age~70, in the English National Health Service Breast Screening Programme.Methods. We trained mammographers, who then offered the intervention to older women in four breast screening services. We examined breast cancer awareness at baseline and one month in women receiving the intervention, and also in a service where the intervention was not offered.Results. We trained 27 mammographers to deliver the intervention confidently to a high standard. Breast cancer awareness increased 7-fold at one month in women receiving the intervention compared with 2-fold in the comparison service (odds ratio 15.2, 95% confidence interval 10.0 to 23.2).Conclusions. The PEP Intervention can be implemented in routine clinical practice with a potency similar to that achieved in a randomised controlled trial. It has the potential to reduce delay in diagnosis for breast cancer in older women.

Background: There is virtually no evidence for the effectiveness of interventions to promote early presentation in breast cancer. We aimed to test the efficacy of an intervention to equip older women with the knowledge, skills, confidence and motivation to detect symptoms and seek help promptly, with the aim of promoting early presentation with breast cancer symptoms. Methods: We randomised 867 women aged 67–70 years attending for their final routine appointment on the UK NHS Breast Screening Programme to receive: a scripted 10-min interaction with a radiographer plus a booklet, a booklet alone or usual care. The primary outcome was whether or not a woman was breast cancer aware based on knowledge of breast cancer symptoms and age-related risk, and reported breast checking. Results: At 1 month, the intervention increased the proportion who were breast cancer aware compared with usual care (interaction arm: 32.8% vs 4.1%; odds ratio (OR): 24.0, 95% confidence interval (CI): 7.7–73.7; booklet arm: 12.7% vs 4.1%; OR: 4.4, 95% CI: 1.6–12.0). At 1 year, the effects of the interaction plus booklet, and the booklet, on breast cancer awareness were largely sustained, although the interaction plus booklet remained much more effective. Conclusions: An intervention to equip older women with the knowledge, skills, confidence and motivation to detect breast cancer symptoms and seek help promptly increases breast cancer awareness at 1 year. Future research will evaluate whether the intervention promotes early presentation and reduces breast cancer mortality.

The London Psychosocial Group has been funded by Cancer Research UK to implement and evaluate a psychoeducational intervention to promote early presentation amongst older women with breast cancer. The intervention is designed to be radiographer-delivered to women receiving their final invited mammogram with the National Health Service Breast Screening Programme.

The purpose of this study was to assess the diagnostic performance/utility of digital breast tomosynthesis (DBT) in symptomatic patients in a multidisciplinary clinical setting.

Introduction and aims Older women are more likely to delay presentation in breast cancer,1 which in turn contributes to poorer survival.2 We have developed a health professional-delivered intervention to promote early presentation in older women with breast symptoms (Promoting Early Presentation (PEP) Intervention) to be delivered when they attend for their final routine mammogram. We aimed to evaluate its efficacy in an randomized controlled trial (RCT) and adapt it for use in routine clinical practice. Methods We randomised 867 women attending for their final round of screening on the NHS Breast Screening Programme to receive either the PEP Intervention delivered by a radiographer or usual care. We measured breast cancer awareness at baseline and 2 years post-randomisation. We are adapting and piloting the PEP Intervention to be suitable for adoption in routine practice across the NHS Breast Screening Programme. Results In the RCT, the PEP Intervention increased the proportion breast cancer aware at 2 years compared with usual care (21% vs 6%, OR: 8.1, 95% CI: 2.7 to 25.0). We have adapted the intervention so that it can be delivered feasibly while maintaining consistent quality. Conclusions We have demonstrated the efficacy of the PEP Intervention in an RCT. We plan to evaluate its effectiveness in routine practice by implementing it in three breast screening services, and measuring feasibility, costs and health outcomes (comparing these with health outcomes in control services). Our findings will provide the data needed to inform possible implementation across the entire NHS Breast Screening Programme.

Purpose: To consider, on a patient specific basis according to volumetric breast density (VBD) the mean glandular dose (MGD) imparted by mammography and tomosynthesis so as to determine which women might benefit from tomosynthesis in consideration with the clinical benefits. Methods: For a set of 23 Hologic combo-mode images, MGD was calculated for the tomosynthesis and mammogram acquisitions, with glandularity derived from a personalised measure of VBD. The doses for each acquisition type were compared as a function of VBD, and correlated with breast thickness. Results: For dense breasts - precisely, those with a Volpara Density Grade (VDG) (analogous to BI-RADS) of 3 and 4 - the MGDs were approximately equal for both tomosynthesis and mammography. However, for low density breasts - those with a VDG of 1 and 2 - the MGD was significantly greater in the tomosynthesis examination than for the mammogram. The compressed breast thickness was generally greater for the lower density (VDG 1 and 2) breasts, than for higher density (VDG 3 and 4) breasts. Conclusion: In breasts of low VBD, examination by mammography offers a lower patient specific MGD than tomosynthesis, sometimes substantially. In breasts of high VBD, the MGD values are approximately equal. The lower MGD is likely due to the increased compressed breast thickness observed in the low density cases. This causes such images to be acquired at a higher MGD in tomosynthesis in order to obtain a satisfactory contrast-to-noise ratio. This results from fundamental differences in the characteristics of the function relating contrast-to-noise ratio to dose between the techniques. Since the possibility of lesion masking arising from tissue superposition is limited in low density breasts, clinicians need to consider the diagnostic benefits versus the apparent increased dose in fatty breasts, which will remain even if the 2D component is stopped. Volpara Solutions Ltd market software for measuring volumetric breast density (Volpara Density), and measuring personalised mean glandular dose (Volpara Dose).

Women over 70 have poorer breast cancer survival than younger women, and this may be due to late stage at presentation [1]. Promoting early presentation with symptoms in older women attending for their final round of breast screening may reduce stage at diagnosis cost-effectively, and is unlikely to lead to overdiagnosis. We tested the efficacy of the 10-minute radiographer-delivered Promoting Early Presentation (PEP) Intervention to promote early presentation by increasing breast cancer awareness in the NHS Breast Screening Programme.

Objective To develop and pilot a training programme for radiographers to deliver a psycho-educational intervention to women receiving their final invited mammogram with the National Health Service Breast Screening Programme (NHSBSP). Background A 10-minute structured interview has been developed and tested, which aims to improve older women's knowledge about breast symptoms and personal risk, and to increase confidence to detect a breast change. The intervention is quality assured against competency ratings on the content and style of the interview. Training model Includes didactic teaching, communication skills training, experiential learning using role-play with actors and feedback on videotaped interviews. Skills are rehearsed in a clinic setting with mentoring from trained radiographers. Evaluation Feasibility of training in the NHSBSP was tested with four radiographers working in the South East and South West London breast screening services. Competence and confidence to deliver the interview were assessed before and after training. Results All four radiographers completed the training programme. Three of the four radiographers were assessed as competent and all increased their confidence to deliver the intervention. Conclusion It is feasible to train diagnostic radiographers to reliably deliver an intervention to promote early presentation of breast cancer, and thereby potentially save lives.