Evidence-informed recommendations on managing breast screening atypia: perspectives from an expert panel consensus meeting reviewing results from the Sloane atypia project.

Evidence-based clinical guidelines are essential to maximize patient benefit and to reduce clinical uncertainty and inconsistency in clinical practice. Gaps in the evidence base can be addressed by data acquired in routine practice. At present, there is no international consensus on management of women diagnosed with atypical lesions in breast screening programmes. Here, we describe how routine NHS breast screening data collected by the Sloane atypia project was used to inform a management pathway that maximizes early detection of cancer and minimizes over-investigation of lesions with uncertain malignant potential. A half-day consensus meeting with 11 clinical experts, 1 representative from Independent Cancer Patients' Voice, 6 representatives from NHS England (NHSE) including from Commissioning, and 2 researchers was held to facilitate discussions of findings from an analysis of the Sloane atypia project. Key considerations of the expert group in terms of the management of women with screen detected atypia were: (1) frequency and purpose of follow-up; (2) communication to patients; (3) generalizability of study results; and (4) workforce challenges. The group concurred that the new evidence does not support annual surveillance mammography for women with atypia, irrespective of type of lesion, or woman's age. Continued data collection is paramount to monitor and audit the change in recommendations.

Performance of Radiologists and Radiographers in Double Reading Mammograms: The UK National Health Service Breast Screening Program.

Background Double reading can be used in screening mammography, but it is labor intensive. There is limited evidence on whether trained radiographers (ie, technologists) may be used to provide double reading. Purpose To compare the performance of radiologists and radiographers double reading screening mammograms, considering reader experience level. Materials and Methods In this retrospective study, performance and experience data were obtained for radiologists and radiographer readers of all screening mammograms in England from April 2015 to March 2016. Cancer detection rate (CDR), recall rate (RR), and positive predictive value (PPV) of recall based on biopsy-proven findings were calculated for first readers. Performance metrics were analyzed according to reader professional group and years of reading experience using the analysis of variance test. P values less than .05 were considered to indicate statistically significant difference. Results During the study period, 401 readers (224 radiologists and 177 radiographers) double read 1 404 395 screening digital mammograms. There was no difference in CDR between radiologist and radiographer readers (mean, 7.84 vs 7.53 per 1000 examinations, respectively; P = .08) and no difference for readers with more than 10 years of experience compared with 5 years or fewer years of experience, regardless of professional group (mean, 7.75 vs 7.71 per 1000 examinations respectively, P = .87). No difference in the mean RR was observed between radiologists and radiographer readers (5.0% vs 5.2%, respectively, P = .63). A lower RR was seen for readers with more than 10 years of experience compared with 5 years or fewer, regardless of professional group (mean, 4.8% vs 5.8%, respectively; P = .001). No variation in PPV was observed between them (P = .42), with PPV values of 17.1% for radiologists versus 16.1% for radiographers. A higher PPV was seen for readers with more than 10 years of experience compared with 5 years or less, regardless of professional group (mean, 17.5% and 14.9%, respectively; P = .02). Conclusion No difference in performance was observed between radiographers and radiologists reading screening mammograms in a program that used double reading. Published under a CC BY 4.0 license Online supplemental material is available for this article. See also the editorial by Hooley and Durand in this issue.

The relationship between missed breast cancers on mammography in a test-set based assessment scheme and real-life performance in a National Breast Screening Programme.

PURPOSE: This retrospective study determined whether a test-set based assessment scheme (PERFORMS) used in a national breast screening programme could be used to predict real-life performance by investigating if the number of cancers missed by mammography readers in real-life related to the number of cancers missed in the PERFORMS test-set and whether real-life reading volumes affected performance. METHOD: Data was obtained from consenting readers in the screening programme in England (NHSBSP) where double reading is standard. The rate of cancers missed by individual first readers but correctly identified by second readers was compared with the number of cancers missed in the PERFORMS test-set over a 3-year period. NHSBSP readers are required to interpret at least 1500 cases per year as a first reader, so results were compared between readers who exceeded this target and those that did not. Parametric and non-parametric correlations were calculated. RESULTS: Amongst the 536 readers, there was a highly significant positive correlation between the real-life and PERFORMS test-set missed cancer metrics (Pearson Correlation = 0.228, n = 536, p < .0001, Spearman's rho = 0.265, n = 536, p < .0001). There was no significant difference in rates of missed cancers between the 452 readers who exceeded the 1500 first read per year target and those who did not (t(94.2) = -1.87, p = .0643, r = 0.19). CONCLUSIONS: The use of a test-set based assessment scheme accurately reflects real-life mammography reading performance, indicating that it can be a useful tool in identifying poor reader performance.

The Relationship between Mammography Readers' Real-Life Performance and Performance in a Test Set-based Assessment Scheme in a National Breast Screening Program.

Purpose: To compare an individual's Personal Performance in Mammographic Screening (PERFORMS) score with their Breast Screening Information System (BSIS) real-life performance data and determine which parameters in the PERFORMS scheme offer the best reflection of BSIS real-life performance metrics. Materials and Methods: In this retrospective study, the BSIS real-life performance metrics of individual readers (n = 452) in the National Health Service Breast Screening Program (NHSBSP) in England were compared with performance in the test set-based assessment scheme over a 3-year period from 2013 to 2016. Cancer detection rate (CDR), recall rate, and positive predictive value (PPV) were calculated for each reader, for both real-life screening and the PERFORMS test. For each metric, real-life and test set versions were compared using a Pearson correlation. The real-life CDR, recall rate, and PPV of outliers were compared against other readers (nonoutliers) using analysis of variance. Results: BSIS real-life CDRs, recall rates, and PPVs showed positive correlations with the equivalent PERFORMS measures (P < .001, P = .002, and P < .001, respectively). The mean real-life CDR of PERFORMS outliers was 7.2 per 1000 women screened and was significantly lower than other readers (nonoutliers) where the real-life CDR was 7.9 (P = .002). The mean real-life screening PPV of PERFORMS outliers was 0.14% and was significantly lower than the nonoutlier group who had a mean PPV of 0.17% (P = .006). Conclusion: The use of test set-based assessment schemes in a breast screening program has the potential to predict and identify poor performance in real life.© RSNA, 2020Keywords: Breast, ScreeningSee also the commentary by Thigpen and Rapelyea in this issue.

Communicating biopsy results from breast screening assessment: current practice in English breast screening centres and staff perspectives of telephoning results.

OBJECTIVE: To record how breast screening centres in England deliver all biopsy results (cancer/non-cancer) from the breast assessment visit. DESIGN: Online survey of 63 of 79 breast screening centres in England from all regions (East Midlands, East of England, London, North East Yorkshire & Humber, North West, South East, South West, West Midlands). The survey contained quantitative measures of frequency for telephoning biopsy results (routinely, occasionally or never) and optional qualitative free-text responses. Surveys were completed by a staff member from each centre. RESULTS: There were no regional trends in the use of telephone results services, (X² (14, n=63)=11.55, p=0.64), Centres who telephoned results routinely did not deliver results sooner than centres who deliver results in-person (X² (16, n=63)=12.76, p=0.69).When delivering cancer results, 76.2% of centres never telephone results and 23.8% of centres occasionally telephone results. No centres reported delivering cancer results routinely by telephone. Qualitative content analysis suggests that cancer results are only telephoned at the patient request and under exceptional circumstances.When delivering non-cancer results, 12.7% of centres never telephoned results, 38.1% occasionally telephoned results and 49.2% routinely telephoned results. Qualitative content analysis revealed different processes for delivering telephone results, including patient choice and scheduling an in-person results appointment for all women attending breast assessment, then ringing non-cancer results unexpectedly ahead of this prebooked appointment. CONCLUSIONS: In the National Health Service Breast Screening Programme, breast assessment results that are cancer are routinely delivered in-person. However, non-cancer breast assessment results are often routinely delivered by telephone, despite breast screening policy recommendations. More research is needed to understand the impact of telephoning results on women attending breast assessment, particularly women who receive a non-cancer result. Future research should also consider how women themselves might prefer to receive their results.

Communicating benign biopsy results by telephone in the NHS Breast Screening Programme: a protocol for a cluster randomised crossover trial.

INTRODUCTION: One of the main harms from breast cancer screening is the anxiety caused by false positive results. Various factors may be associated with false-positive anxiety. One modifiable factor may be the method of communication used to deliver results. The aim of this study is to measure the effect on anxiety of receiving benign biopsy results in-person or by telephone. METHODS AND ANALYSIS: This is a multi-centre cluster randomised crossover trial in the English National Health Service Breast Screening Programme (NHSBSP) involving repeated survey measures at four time points. Participants will be women of screening age who have a biopsy following a suspicious mammography result, who ultimately receive a benign or normal (B1) result. Centres will trial both telephone and in-person results on a month-by-month basis, being randomised to which communication method will be trialled first. Women will be blinded to the method of communication they will receive. The analysis will compare women who have received telephone results and women who have received in-person results. The primary outcome measure will be anxiety (measured by the Psychological Consequences Questionnaire) after receiving results, while controlling for baseline anxiety. Secondary outcome measures will include anxiety at 3 and 6 months post-results, understanding of results and patient preferences for how results are communicated. Qualitative telephone interviews will also be conducted to further explore women's reasons for communication preferences. Qualitative and quantitative data will be integrated after initial separate analysis using the pillar integration process. ETHICS AND DISSEMINATION: This study has been approved by the Public Health England Breast Screening Programme Research Advisory Committee, (BSPRAC_0013, ODR1718_040) and the National Health Service Health Research Authority (HRA) West Midlands-Coventry & Warwickshire Research Ethics Committee (17/WM/0313). The findings from this study will be disseminated to key stakeholders within the NHSBSP and via academic publications. TRIAL REGISTRATION NUMBER: ISRCTN36997684 TRIAL SPONSOR: This research is part of a PhD award and is funded by the Economic and Social Research Council Doctoral Training Centre at the University of Warwick and Public Health England. The sponsor for this research is Jane Prewett (sponsorship@warwick.ac.uk).

Communication of cancer screening results by letter, telephone or in person: A mixed methods systematic review of the effect on attendee anxiety, understanding and preferences.

Attending and receiving a result from screening can be an anxious process. Using an appropriate method to deliver screening results could improve communication and reduce negative outcomes for screening attendees. Screening programmes are increasingly communicating results by letter or telephone rather than in-person. We investigated the impact of communication methods on attendees. We systematically reviewed the literature on the communication methods used to deliver results in cancer screening programmes for women, focusing on screening attendee anxiety, understanding of results and preferences for results communication. We included qualitative and quantitative research. We searched MEDLINE, PsycINFO, CINAHL, Cochrane Library and Embase. Results were analysed using framework synthesis. 10,558 papers were identified with seven studies meeting the inclusion criteria. Several key ideas emerged from the synthesis including speed, accuracy of results, visual support, ability to ask questions, privacy of results location and managing expectations. Verbal communication methods (telephone and in-person) were preferred and facilitated greater understanding than written methods, although there was considerable variability in attendee preferences. Findings for anxiety were mixed, with no clear consensus on which method of communication might minimise attendee anxiety. The low number of identified studies and generally low quality evidence suggest we do not know the most appropriate communication methods in the delivery of cancer screening results. More research is needed to directly compare methods of results communication, focusing on what impact each method may have on screening attendees.

Impact of Digital Mammography on Cancer Detection and Recall Rates: 11.3 Million Screening Episodes in the English National Health Service Breast Cancer Screening Program.

Purpose To report the impact of changing from screen-film mammography to digital mammography (DM) in a large organized national screening program. Materials and Methods A retrospective analysis of prospectively collected annual screening data from 2009-2010 to 2015-2016 for the 80 facilities of the English National Health Service Breast Cancer Screening Program, together with estimates of DM usage for three time periods, enabled the effect of DM to be measured in a study of 11.3 million screening episodes in women aged 45-70 years (mean age, 59 years). Regression models were used to estimate percentage and absolute change in detection rates due to DM. Results The overall cancer detection rate was 14% greater with DM (P < .001). There were higher rates of detection of grade 1 and 2 invasive cancers (both ductal and lobular), but no change in the detection of grade 3 invasive cancers. The recall rate was almost unchanged by the introduction of DM. At prevalent (first) screening episodes for women aged 45-52 years, DM increased the overall detection rate by 19% (P < .001) and for incident screening episodes in women aged 53-70 years by 13% (P < .001). Conclusion The overall cancer detection rate was 14% greater with digital mammography with no change in recall rates and without confounding by changes in other factors. There was a substantially higher detection of grade 1 and grade 2 invasive cancers, including both ductal and lobular cancers, but no change in the detection of grade 3 invasive cancers. © RSNA, 2018 Online supplemental material is available for this article. See also the editorial by C.I. Lee and J.M. Lee in this issue.

Screen detection of ductal carcinoma in situ and subsequent incidence of invasive interval breast cancers: a retrospective population-based study.

BACKGROUND: The value of screen detection and treatment of ductal carcinoma in situ (DCIS) is a matter of controversy. At present, the extent to which the diagnosis and treatment of DCIS could prevent the occurrence of invasive breast cancer in the future is not clear. We sought to estimate the association between detection of DCIS at screening and invasive interval cancers subsequent to the relevant screen. METHODS: We obtained aggregate data for screen-detected cancers from 84 local screening units within 11 regional Quality Assurance Reference Centres in England, Wales, and Northern Ireland from the National Health Service Breast Screening Programme. Data for DCIS diagnoses were obtained for women aged 50-64 years who were invited to and attended mammographic breast screening from April 1, 2003, to March 31, 2007 (4 screening years). Patient-level data for interval cancer arising in the 36 months after each of these were analysed by Poisson regression with invasive interval cancer screen detection rate as the outcome variable; DCIS detection frequencies were fitted first as a continuous and then as a categorical variable. We repeated this analysis after adjustment with both small size and high-grade invasive screen-detected cancers. FINDINGS: We analysed data for 5,243,658 women and on interval cancers occurring in the 36 months after the relevant screen. The average frequency of DCIS detected at screening was 1·60 per 1000 women screened (median 1·50 [unit range 0·54-3·56] [corrected to] per 1000 women). There was a significant negative association of screen-detected DCIS cases with the rate of invasive interval cancers (Poisson regression coefficient -0·084 [95% CI -0·13 to -0·03]; p=0·002). 90% of units had a DCIS detection frequency within the range of 1·00 to 2·22 per 1000 women; in these units, for every three screen-detected cases of DCIS, there was one fewer invasive interval cancer in the next 3 years. This association remained after adjustment for numbers of small screen-detected invasive cancers and for numbers of grade 3 invasive screen-detected cancers. INTERPRETATION: The association between screen-detected DCIS and subsequent invasive interval cancers suggests that detection and treatment of DCIS is worthwhile in prevention of future invasive disease. FUNDING: UK Department of Health Policy Research Programme and NHS Cancer Screening Programmes.

National survey of B1 and B2 reporting of breast needle core biopsies.

AIM: This survey investigated the variation in the use of the breast core biopsy categories B1 normal and B2 benign. METHOD: A survey with case scenarios was circulated to 701 breast pathologists in the UK. RESULTS: The response rate was 40%. If there was concordance between the radiological and histological findings, then there was a clear consensus on the appropriate B category. However, if there was discordance between the radiological and histological findings, then frequently there was poor agreement on the appropriate category. Analysis of these cases and supplementary questions on the criteria used to make a pathological categorisation showed that some pathologists are influenced by the radiological features or by the multidisciplinary discussion, rather than just using the histological features. CONCLUSIONS: This survey shows that pathologists frequently do not follow the National Health Service breast screening guideline that B categories should be based solely on the histological changes.

Temporal changes in breast cancer incidence in South Asian women.

BACKGROUND: Breast cancer in the UK resident population of South Asian ethnicity has been lower than that in indigenous women. Leicester has a large South Asian population and a breast cancer unit with comprehensive data on diagnosed cancers. This study analysed the annual incidence of new breast cancer diagnoses in females from 1998 to 2009 to determine any changes in recent years. METHODS: Ethnicity was known in over 98% of cases. Population denominators were based on published figures for 2001 and 2011, projected back to 1998. Age-adjusted directly standardised incidence rates were determined by ethnicity and broken down by invasive status and screening classification. Incidence rates were analysed using logistic regression in order to identify statistically significant effects of age, ethnicity, deprivation and year of diagnosis. Interactions with invasive status and screening classification were also investigated. RESULTS: At the start of the study period South Asian incidence was estimated to be 45% of that of the white population (p<0.001); by the end of the period the difference was still significant (p=0.022) but smaller, at 17%. CONCLUSION: South Asians should no longer be considered at low risk of breast cancer.

Outcome of pure mucocele-like lesions diagnosed on breast core biopsy.

AIM: Current guidelines recommend that mucocele-like lesions (MLL) of the breast diagnosed on needle core biopsy (NCB) should be categorized as a lesion of uncertain malignant potential (B3). However, data on the outcome of MLL diagnosed on NCB remains limited due to the rarity of this lesion. The aim of this study was to assess the outcome of pure MLL without atypia diagnosed on NCB using a large series of cases and a review of the literature to provide evidence that can guide management. METHODS AND RESULTS: Patients who underwent diagnostic excision biopsy after a core biopsy diagnosis of MLL without atypia were identified from several centres. Two of 54 patients (4%) with MLL without atypia on core biopsy had ductal carcinoma in situ in the subsequent excision specimen. This is similar to the rate in previous studies of 4% (four of 106). If there is atypia in the core biopsy, previous studies found that the frequency of malignancy is much higher at 21% (seven of 33). CONCLUSIONS: Our results provide evidence that pure MLL without atypia diagnosed on NCB is usually associated with a benign outcome.

Characterization and outcome of breast needle core biopsy diagnoses of lesions of uncertain malignant potential (B3) in abnormalities detected by mammographic screening.

In the setting of breast cancer screening, 5-9% of needle core biopsies are diagnosed as lesions of uncertain malignant potential (B3). The management of these lesions is potentially problematic as the data on their outcome remains limited. In our study, we aim to assess the outcome of screen-detected lesions diagnosed as B3 in a large series to validate previous studies and to characterize the malignant lesions detected after a B3 diagnosis. Therefore, the results of 1,025 needle core biopsies of women screened over a 7-year period (1999-2006) in two different regions in the UK with B3 diagnoses who underwent surgical excision were reviewed and compared to the final excision histology. Final histology showed that 25% of cases were malignant (17% ductal carcinoma in situ and 8% invasive). Predictors of malignancy included calcification on imaging and epithelial atypia on needle core biopsy particularly atypical ductal hyperplasia [positive predictive value 50%]. Pure flat epithelial atypia showed the lowest positive predictive value amongst all epithelial atypia groups (21%). The positive predictive value was low for complex sclerosing lesions (9%) and papillary lesions (13%) without epithelial atypia. Malignant tumors detected after B3 diagnosis showed favorable histological features, the majority were in situ, and most belonged to the low grade breast neoplasia family that is associated with indolent behavior. The underlying radiological abnormality was calcification in 44% of cases and the imaging classification was malignant/suspicious in 38%. In conclusion, our results further emphasize the heterogeneity of B3 lesions and that the likelihood of malignancy varies substantially between different histological subtypes. Malignancy is particularly associated with epithelial atypia suggesting the use of two categories of with and without epithelial atypia. Radiological findings provided useful information regarding the nature and outcome of B3 lesions.