NHS Breast Screening Programme Research Articles

Optimising the diagnostic accuracy of First post-contrAst SubtracTed breast MRI (FAST MRI) through interpretation-training: a multicentre e-learning study, mapping the learning curve of NHS Breast Screening Programme (NHSBSP) mammogram readers using an enriched dataset

BackgroundAbbreviated breast MRI (FAST MRI) is being introduced into clinical practice to screen women with mammographically dense breasts or with a personal history of breast cancer. This study aimed to optimise diagnostic accuracy through the adaptation of interpretation-training.MethodsA FAST MRI interpretation-training programme (short presentations and guided hands-on workstation teaching) was adapted to provide additional training during the assessment task (interpretation of an enriched dataset of 125 FAST MRI scans) by giving readers feedback about the true outcome of each scan immediately after each scan was interpreted (formative assessment). Reader interaction with the FAST MRI scans used developed software (RiViewer) that recorded reader opinions and reading times for each scan. The training programme was additionally adapted for remote e-learning delivery.Study designProspective, blinded interpretation of an enriched dataset by multiple readers.Results43 mammogram readers completed the training, 22 who interpreted breast MRI in their clinical role (Group 1) and 21 who did not (Group 2).Overall sensitivity was 83% (95%CI 81–84%; 1994/2408), specificity 94% (95%CI 93–94%; 7806/8338), readers’ agreement with the true outcome kappa = 0.75 (95%CI 0.74–0.77) and diagnostic odds ratio = 70.67 (95%CI 61.59–81.09). Group 1 readers showed similar sensitivity (84%) to Group 2 (82% p = 0.14), but slightly higher specificity (94% v. 93%, p = 0.001). Concordance with the ground truth increased significantly with the number of FAST MRI scans read through the formative assessment task (p = 0.002) but by differing amounts depending on whether or not a reader had previously attended FAST MRI training (interaction p = 0.02). Concordance with the ground truth was significantly associated with reading batch size (p = 0.02), tending to worsen when more than 50 scans were read per batch. Group 1 took a median of 56 seconds (range 8–47,466) to interpret each FAST MRI scan compared with 78 (14–22,830, p < 0.0001) for Group 2.ConclusionsProvision of immediate feedback to mammogram readers during the assessment test set reading task increased specificity for FAST MRI interpretation and achieved high diagnostic accuracy. Optimal reading-batch size for FAST MRI was 50 reads per batch.Trial registration (25/09/2019): ISRCTN16624917.

Abstract PO2-17-11: Management guidelines for epithelial atypia diagnosed in breast screening, based on an analysis of a large prospective cohort study (Sloane Project)

Abstract Background: Epithelial atypia in the breast is most frequently detected through breast screening. Internationally, guidelines differ between advising diagnostic surgical excision of screen-detected atypia versus vacuum-assisted excision (VAE), often with annual follow up surveillance mammography. Prospective data with detailed follow-up and outcomes for subsequent cancer events is lacking. We evaluated a large prospective cohort of screen-detected atypia (Sloane Project) and an expert consensus meeting to develop management recommendations. Methods: We undertook an observational analysis of women with screen-detected epithelial atypia (Atypical Ductal Hyperplasia (ADH), Flat Epithelial Atypia (FEA), Lobular In Situ Neoplasia (LISN), or mixed atypia) reported to the National Health Service (NHS) Breast Screening Programme (BSP) between 01/04/03 and 20/06/18. We estimated cumulative incidence of invasive cancers per 1000 women within 1 and 2 subsequent screening rounds using cumulative incidence functions and repeated these by women’s age, type of atypia and year of diagnosis. Flexible parametric modelling produced hazard ratios (HR). The results were presented at a consensus meeting with clinical experts, patient representation, national decision-makers and commissioners from the NHS in England. A consensus on management recommendations was reached. Results: Among 3238 women (19088 person-years of follow up) with screen-detected atypia, diagnoses increased from 2010 (n=119) to 2015 (n=502). This coincided with the introduction of digital mammography into English screening centres from 2010 and changes in biopsy technique. A total of 141 invasive breast cancers were detected up to December 2018. Cumulative incidence of invasive breast cancer per 1000 women with atypia (ADH, FEA, LISN or mixed) was 14.2 (95% CI 10.3, 19.1) and 45.0 (36.3, 55.1) at 3- and 6-years post atypia based on 40 and 94 cancers, respectively. Women diagnosed with atypia during 2013-2018 had an invasive cancer detected less frequently within 3 years than women with an atypia diagnosis between 2003-2007 or 2008-2012 (6.0 invasive cancers (3.1, 10.9) per 1000 women in 2013-2018 Vs 24.3 (13.7, 40.1) and 24.6 (14.9, 38.3) in 2003-2007 and 2008-2012), suggesting that atypia diagnosis may increasingly contribute to ‘overdiagnosis’. Cancers detected were similar to the general screening population regarding grade, size and nodal involvement. Ipsilateral and contralateral cancers were detected in equal numbers, supporting the concept that atypia represents a risk factor rather than precursor of invasive cancer in the short term. Results by age and type of atypia did not suggest a need for risk-stratified management. Considering subsequent invasive cancer, VAE appeared to be as safe as diagnostic surgical excision of atypia (HR 0.75 (0.45, 1.25)). The expert consensus considered that increased screening of women with screen-detected atypia over and above routine 3-yearly screening was not beneficial, given the overall low numbers of cancers at three years. This applied to all types of atypia and all women who received digital mammography and diagnosis of atypia on core or vacuum-assisted biopsy followed by VAE within a quality assured NHS BSP. Conclusions: Breast atypia represents a risk factor for invasive cancer and does not necessitate surgical excision. Changes to mammography (digital vs plain film) and biopsy techniques (gauge of needle and use of vacuum-assistance) may lead to detection of atypia which is then ‘over-managed’. Current recommendations for annual mammography for 5 years after a diagnosis of epithelial atypia may be overly cautious. We suggest that women with screen detected atypia should be followed up with routine screening appointments. Citation Format: Karoline Freeman, David Jenkinson, Karen Clements, Matthew Wallis, Sarah E Pinder, Elena Provenzano, Hilary Stobart, Nigel Stallard, Olive Kearins, Nisha Sharma, Abeer Shaaban, Cliona Kirwan, Bridget Hilton, Alastair Thompson, Sian Taylor-Phillips. Management guidelines for epithelial atypia diagnosed in breast screening, based on an analysis of a large prospective cohort study (Sloane Project) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-17-11.

Abstract PS01-10: Surgical margins in breast conserving surgery (BCS) for ductal carcinoma in-situ (DCIS) and clinical outcomes: significant associations with increased recurrence and overall survival

Abstract Background: Optimal surgical margin in breast conserving surgery (BCS) for DCIS are not established, largely due to an absence of accurate margin data. A margin width of 2mm was adopted by the American College of Surgeons (ACS). The UK Association of Breast Surgery (ABS) recommended a 1mm margin. Conducting a randomized controlled trial to answer this question is unfeasible; therefore we used retrospective histological margin data from available datasets to assess whether there is an association between margin width and time to recurrence (TTR). Methods: Patients were included if aged &amp;gt;18 years with a new diagnosis of DCIS alone, between 2003-2014, within UK NHS Breast Screening Programme (BSP). Primary treatment included BCS and a minimum histological excision margin width recorded. Exclusion criteria included: i) prior history of DCIS; ii) prior history of invasive cancer or its diagnosis within 3 months of initial surgical treatment for DCIS. Data was extracted from English Cancer Registries (CR), ABS and Sloane audits. TTR was defined as time from diagnosis to local or distant recurrence. Cox regression was used to compare TTR by surgical margin width utilising a range of thresholds, with focus on &amp;lt; 1mm vs ≥1mm; &amp;lt; 2mm vs ≥2mm and ≥1- &amp;lt; 2mm vs ≥2mm. Patients with 0mm margin or where categorized as “clear/not stated” were excluded from these analyses. Models were adjusted for age group, DCIS grade and size, ER status, number of BCSs, radiotherapy (RT) received, diagnosis year and CR centre. Overall survival (OS) was a secondary endpoint. Results: 17,260 patients diagnosed with DCIS having BCS as definitive surgery were identified between 2003-2014; 679 (5%), 2105 (15%), 1339 (10%) and 9744 (70%) with recorded margins of &amp;gt;0- &amp;lt; 1mm, ≥1- &amp;lt; 2mm, ≥2- &amp;lt; 3mm and ≥3mm, respectively. 10,253 (59%) patients received RT and in 7,007 (41%) RT receipt was unknown. Overall, 14,004 (81%), 3,052 (18%) and 201 (1%) patients had one, two and ≥3 BCSs respectively; there was no significant change in these percentages over time (p=0.2 Cuzick test). Median follow-up time for the cohort was 8.2 years (IQR: 6.1-11.2). 2221 (13%) patients had a subsequent event: 1741/2221 (78%) invasive recurrence and 480/2221 (22%) DCIS alone. The annual event rate over 15 years of follow-up was relatively consistent at 1.2% per annum (pa) for margins ≥2mm versus 1.8% pa for margins &amp;lt; 2mm. A shorter TTR was observed for patients with surgical margins &amp;lt; 1mm vs ≥1mm (adjusted HR=1.30; 95%CI: 1.05-1.62; p=0.02); &amp;lt; 2mm vs ≥2mm (adjusted HR=1.20; 95%CI: 1.06-1.36; p=0.004) and ≥1- &amp;lt; 2mm vs ≥2mm (adjusted HR=1.20; 95%CI: 1.04-1.40; p=0.02). Margins &amp;gt;2mm did not appear to significantly improve TTR (adjusted HR=0.96; 95%CI: 0.85-1.08; p=0.50 for ≥5mm vs ≥2- &amp;lt; 5mm). Models also showed that risk of recurrence increased as the number of BCSs increased (adjusted HR=1.25; 95%CI: 1.10-1.43: p&amp;lt; 0.001 for 2 vs 1 and adjusted HR=2.03; 95%CI: 1.36-3.03: p&amp;lt; 0.001 for 3+ vs 1). In total, 1552 (9%) patients had died. OS appeared reduced for patients with surgical margins &amp;lt; 2mm vs ≥2mm (adjusted HR=1.25 (1.07-1.45); p=0.005) and for ≥1- &amp;lt; 2mm vs ≥2mm (adjusted HR=1.28 (1.07-1.54); p=0.008). Margins &amp;lt;2mm did not appear to significantly improve OS further (adjusted HR=1.06; 95%CI: 0.92-1.21; p=0.43 for ≥5mm vs ≥2- &amp;lt; 5mm). Conclusion: Patients with DCIS with histological margins of &amp;lt; 2mm, adjusted for other clinical factors, have significantly worse TTR and OS rates compared to margins ≥2mm; the increased annual event rate is consistent out to 15 years. More than 1 BCS is also associated with an increased risk of recurrence. These findings are important for the treatment of patients with DCIS. Citation Format: John Robertson, D Mark Sibbering, Sikhuphukile Ndebele-Mahati, Olive Kearins, Sarah Pinder, Ashu Gandhi, Judith Bliss, Lucy Kilburn. Surgical margins in breast conserving surgery (BCS) for ductal carcinoma in-situ (DCIS) and clinical outcomes: significant associations with increased recurrence and overall survival [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PS01-10.

Abstract PO4-18-09: SMALL: Open Surgery versus Minimally invasive vacuum-Assisted excision for smaLL screen-detected breast cancer – a UK phase III randomised multi-centre trial

Abstract Background: Mammographic screening programmes reduce breast cancer mortality but detect many small good-prognosis tumours which may not progress. Screen-detected cancers are currently treated with standard surgery and adjuvant therapies, with associated morbidities. There is a need to reduce overtreatment of good prognosis tumours and numerous studies are evaluating omission of radiotherapy in low-risk disease. However, there is little evidence to support surgical de-escalation, although percutaneous minimally invasive treatment approaches have been described. Vacuum-assisted excision (VAE) is in widespread use for management of lesions of uncertain malignant potential and benign lesions. SMALL (ISRCTN 12240119) is designed to determine the feasibility of using this approach to treat small invasive tumours detected within the UK NHS Breast Screening Programme. Methods: SMALL is a phase III multicentre randomised trial comparing standard surgery with VAE for screen-detected cancers. Main eligibility criteria are age ≥47 years, unifocal grade 1 tumours with maximum diameter 15mm, strongly ER/PR+ve and HER2-ve, with negative axillary staging. Patients are randomised 2:1 to VAE or surgery, with no axillary surgery in the VAE arm. Completeness of excision is assessed radiologically, and if excision is incomplete, patients undergo surgery. Adjuvant radiotherapy and endocrine therapy are mandated in the VAE arm but may be omitted following surgery. Co-primary end-points are: 1. Non-inferiority comparison of the requirement for a second procedure following excision 2. Single arm analysis of local recurrence (LR) at 5 years following VAE Recruitment of 800 patients will permit demonstration of 10% non-inferiority of VAE for requirement of a second procedure. This ensures sufficient patients for single arm analysis of LR rates, where expected LR free survival is 99% at 5 years, with an undesirable survival probability after VAE of 97%. To ensure that the trial as a whole only has 5% alpha, the significance level for each co-primary outcome is set at 2.5% with 90% power. The Data Monitoring Committee will monitor LR events to ensure these do not exceed 3% per year. Secondary outcome measures include time to ipsilateral recurrence, overall survival, complications, quality of life and health economic analysis. A novel feature of SMALL is the integration of a QuinteT Recruitment Intervention (QRI), which aims to optimise recruitment to the study. Recruitment challenges are identified by analysing recruiter/patient interviews and audio-recordings of trial discussions, and by review of trial screening logs, eligibility and recruitment data and study documentation. Solutions to address these are developed collaboratively, including individual/group recruiter feedback and recruitment tips documents. Results: SMALL opened in December 2019, but recruitment halted in 2020 for 5 months due to COVID-19. At 6th July 2023, 39 centres are open, with 300 patients randomised from 32 of these, with a randomisation rate of approximately 45%, and a per site recruitment rate of 0.4-0.5 patients/month. Despite the pandemic, SMALL achieved the internal pilot feasibility targets and continues to recruit to the main study, with estimated completion of recruitment in June 2025. Drawing from preliminary QRI findings and insights from patient representatives, a recruitment tips document has been circulated (on providing balanced information about treatments, encouraging recruiters to engage with patient preferences, and explaining randomisation). Individual recruiter feedback has commenced and wider feedback is being delivered across sites via recruitment training workshops. Conclusion: Despite pandemic-related challenges, SMALL has excellent recruitment to date and is expected to have a global impact on treatment of breast cancer within mammographic screening programmes. SMALL is funded by the UK NIHR HTA programme award 17/42/32 Citation Format: Stuart McIntosh, Charlotte Coles, David Dodwell, Kenneth Elder, Jessica Foster, Claire Gaunt, Amanda Kirkham, Iain Lyburn, Sangeetha Paramasivan, Jenna Morgan, Sarah Pinder, Shelley Potter, Tracy Roberts, Nisha Sharma, Hilary Stobart, Elizabeth Southgate, Sian Taylor-Phillips, Matthew Wallis, Daniel Rea. SMALL: Open Surgery versus Minimally invasive vacuum-Assisted excision for smaLL screen-detected breast cancer – a UK phase III randomised multi-centre trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-18-09.

The influence of breast screening on breast cancer incidence in England: observational study based on cancer registries and bulletins of the NHS Breast Screening Programme.

To assess the amount of breast cancer overdiagnosis associated with the National Health Service Breast Screening Programme (NHSBSP) that started in 1988 in England. First, numbers of breast cancers in women eligible for breast screening not attending screening were estimated for the period 1995-2019, which were extrapolated to all women. A second method was based on ratios of incidence rates of breast cancers in women aged 50-69 to women aged 70 years or more in 1971-1985. The ratio was used for estimating expected numbers of cancers in 1988-2019, and 1995-2019. From 1995 to 2019, 506,607 non-invasive and invasive breast cancers were diagnosed among women aged 50-64 years (1995-2001) and 50-70 years (2002-2019). A first method estimated that 95,297 cancers were in excess to the number of cancers that would be expected had the NHSBSP not existed. 42,567 screen-detected non-invasive and micro-invasive cancers represented 45.8% of the total excess cancer. 18.8% of all cancers diagnosed among women invited to screening, 25.1% of cancers found in women attending screening, and 35.1% of cancers detected by screening would represent overdiagnosis. A second method estimated that, 18.0% of all cancers diagnosed in 1988-2019, and 18.2% of all cancers diagnosed in 1995-2019 among women invited to screening would represent overdiagnosis. The two independent methods obtained similar estimates of overdiagnosis. The NHS Breast Screening Programme in England is associated with substantial amount of overdiagnosis.

Healthcare professionals' experiences of caring for women with false-positive screening test results in the National Health Service Breast Screening Programme.

Understanding healthcare professionals' (HCPs) experiences of caring for women with false-positive screening test results in the National Health Service Breast Screening Programme (NHSBSP) is important for reducing the impact of such results. Interviews were undertaken with 12 HCPs from a single NHSBSP unit, including advanced radiographer practitioners, breast radiographers, breast radiologists, clinical nurse specialists (CNSs), and a radiology healthcare assistant. Data were analysed thematically using Template Analysis. Two themes were produced: (1) Gauging and navigating women's anxiety during screening assessment was an inevitable and necessary task for all participants. CNSs were perceived as particularly adept at this, while breast radiographers reported a lack of adequate formal training. (2) Controlling the delivery of information to women (including amount, type and timing of information). HCPs reported various communication strategies to facilitate women's information processing and retention during a distressing time. Women's anxiety could be reduced through dedicated CNS support, but this should not replace support from other HCPs. Breast radiographers may benefit from more training to emotionally support recalled women. While HCPs emphasised taking a patient-centred communication approach, the use of other strategies (e.g., standardised scripts) and the constraints of the 'one-stop shop' model pose challenges to such an approach. During the study design, two Patient and Public Involvement members (women with false-positive-breast screening test results) were consulted to gain an understanding of patient perspectives and experiences of being recalled specifically in the NHSBSP. Their feedback informed the formulations of the research aim, objectives and the direction of the interview guide.

Invasive breast cancer and breast cancer death after non-screen detected ductal carcinoma in situ from 1990 to 2018 in England: population based cohort study

ObjectivesTo evaluate the long term risks of invasive breast cancer and death related to breast cancer after non-screen detected ductal carcinoma in situ. Risks for women in the general population...

SMALL: Open surgery versus minimally invasive vacuum-assisted excision for small screen-detected breast cancer—A UK phase III randomised multi-centre trial.

TPS625 Background: Mammographic screening programmes reduce breast cancer mortality but detect many small tumours with favourable biology which may not progress. These are treated with surgery and adjuvant therapies, but associated morbidities mean there is a need to reduce overtreatment. Minimally invasive treatments such as vacuum-assisted excision (VAE) have been described but there is no prospective randomised evidence to support their routine use. SMALL (ISRCTN 12240119) is designed to establish the feasibility of using VAE to treat small tumours detected within the UK NHS Breast Screening Programme (BSP). Methods: Phase III multicentre randomised trial comparing surgery with VAE for screen-detected good prognosis cancers. Eligibility criteria are age ≥47 years, unifocal grade 1 tumours (maximum diameter 15mm), strongly ER/PR+ve and HER2-ve, with negative axillary staging. Patients are randomised 2:1 to VAE or surgery, with no axillary surgery in the VAE arm. Excision is assessed radiologically, and if incomplete, patients undergo surgery. Adjuvant radiotherapy and endocrine therapy are mandated in the VAE arm. Co-primary end-points are 1) Non-inferiority comparison of the requirement for a second procedure. 2) Single arm analysis of local recurrence (LR) at 5 years after VAE. Recruitment of 800 patients will permit demonstration of 10% non-inferiority of VAE for requirement of a second procedure, ensuring sufficient patients for single arm analysis of LR rates, where expected LR free survival is 99% at 5 years, with an undesirable survival probability after VAE of 97%. Secondary outcome measures include time to ipsilateral recurrence, overall survival, complications, quality of life and health economic analysis. A QuinteT Recruitment Intervention (QRI) is integrated throughout SMALL to optimise recruitment and informed consent. Recruitment challenges are identified by analysing recruiter/patient interviews, audio-recordings of trial discussions, and by review of screening, eligibility and recruitment data and study documentation. Solutions are developed collaboratively, including recruiter feedback and recruitment tips documents. Results: At 10th February 2023, 231 patients had been recruited from 32 centres, (~45% of eligible patients), with per site recruitment of 0.4-0.5 patients/month. Based on preliminary QRI findings, a recruitment tips document has been circulated (on discussing SMALL, providing balanced information on treatment options and explaining randomisation), with individual recruiter feedback underway and wider feedback planned shortly. Conclusion: SMALL has excellent recruitment to date, confirming feasibility and acceptability, and is expected to have a global impact on treatment of screen-detected breast cancer. Clinical trial information: ISRCTN12240119 .

What do women think about having received their breast cancer risk as part of a risk-stratified NHS Breast Screening Programme? A qualitative study

BackgroundRisk-stratified screening is being considered for national breast screening programmes. It is unclear how women experience risk-stratified screening and receipt of breast cancer risk information in real time. This study aimed to explore the psychological impact of undergoing risk-stratified screening within England’s NHS Breast Screening Programme.MethodsIndividual telephone interviews were conducted with 40 women who participated in the BC-Predict study and received a letter indicating their estimated breast cancer risk as one of four risk categories: low (<2% 10-year risk), average (2–4.99%), above average (moderate; 5–7.99%) or high (≥8%). Audio-recorded interview transcriptions were analysed using reflexive thematic analysis.ResultsTwo themes were produced: ‘From risk expectations to what’s my future health story?’ highlights that women overall valued the opportunity to receive risk estimates; however, when these were discordant with perceived risk, this causes temporary distress or rejection of the information. ‘Being a good (woman) citizen’ where women felt positive contributing to society but may feel judged if they then cannot exert agency over the management of their risk or access follow-up supportConclusionsRisk-stratified breast screening was generally accepted without causing long-lasting distress; however, issues related to risk communication and access to care pathways need to be considered for implementation.

Quantifying the effects of risk-stratified breast cancer screening when delivered in real time as routine practice versus usual screening: the BC-Predict non-randomised controlled study (NCT04359420)

BackgroundRisk stratification as a routine part of the NHS Breast Screening Programme (NHSBSP) could provide a better balance of benefits and harms. We developed BC-Predict, to offer women when invited to the NHSBSP, which collects standard risk factor information; mammographic density; and in a sub-sample, a Polygenic Risk Score (PRS).MethodsRisk prediction was estimated primarily from self-reported questionnaires and mammographic density using the Tyrer–Cuzick risk model. Women eligible for NHSBSP were recruited. BC-Predict produced risk feedback letters, inviting women at high risk (≥8% 10-year) or moderate risk (≥5–<8% 10-year) to have appointments to discuss prevention and additional screening.ResultsOverall uptake of BC-Predict in screening attendees was 16.9% with 2472 consenting to the study; 76.8% of those received risk feedback within the 8-week timeframe. Recruitment was 63.2% with an onsite recruiter and paper questionnaire compared to <10% with BC-Predict only (P < 0.0001). Risk appointment attendance was highest for those at high risk (40.6%); 77.5% of those opted for preventive medication.DiscussionWe have shown that a real-time offer of breast cancer risk information (including both mammographic density and PRS) is feasible and can be delivered in reasonable time, although uptake requires personal contact. Preventive medication uptake in women newly identified at high risk is high and could improve the cost-effectiveness of risk stratification.Trial registrationRetrospectively registered with clinicaltrials.gov (NCT04359420).

Abstract PD14-01: PD14-01 A model to assess the utility of risk-based screening algorithms

Abstract PD14-01: PD14-01 A model to assess the utility of risk-based screening algorithms

Abstract OT3-20-02: SMALL: Open Surgery versus Minimally invasive vacuum-Assisted excision for smaLL screen-detected breast cancer – a UK phase III randomised multi-centre trial

Abstract Background: Mammographic screening programmes reduce breast cancer mortality, but detect many small tumours with favourable biological features which may not progress during a woman’s lifetime. Screen-detected cancers are treated with standard surgery and adjuvant therapies, with associated morbidities. There is a need to reduce overtreatment of good prognosis tumours and numerous studies have evaluated the omission of radiotherapy in this context. However, there is little evidence to support surgical de-escalation, although percutaneous minimally invasive treatment approaches have been described. Vacuum-assisted excision (VAE) is in widespread use for management of benign lesions and lesions of uncertain malignant potential. SMALL (ISRCTN 12240119) is designed to determine the feasibility of using this approach for treatment of small invasive tumours detected within the UK NHS Breast Screening Programme (BSP). Methods: SMALL is a phase III multicentre randomised trial comparing standard surgery with VAE for screen-detected good prognosis cancers. The main eligibility criteria are age ≥47 years, unifocal grade 1 tumours with maximum diameter 15mm, which are strongly ER/PR+ve and HER2-ve, with negative clinical/radiological axillary staging. Patients are randomised 2:1 in favour of VAE or surgery; with no axillary surgery in the VAE arm. Completeness of excision is assessed radiologically, and if excision is incomplete, patients undergo open surgery. Adjuvant radiotherapy and endocrine therapy are mandated in the VAE arm but may be omitted following surgery. Co-primary end-points are: 1. Non-inferiority comparison of the requirement for a second procedure following excision 2. Single arm analysis of local recurrence (LR) at 5 years following VAE Recruitment of 800 patients will permit demonstration of 10% non-inferiority of VAE for requirement of a second procedure. This ensures sufficient patients for single arm analysis of LR rates, where expected LR free survival is 99% at 5 years, with an undesirable survival probability after VAE of 97%. To ensure that the trial as a whole only has 5% alpha, the significance level for each co-primary outcome is set at 2.5% with 90% power. The Data Monitoring Committee will monitor LR events to ensure these do not exceed 3% per year. Secondary outcome measures include time to ipsilateral recurrence, overall survival, complications, quality of life and health economic analysis. A novel feature of SMALL is the integration of a QuinteT Recruitment Intervention (QRI), which aims to optimise recruitment to the study. Recruitment challenges are identified by analysing recruiter/patient interviews and audio-recordings of trial discussions, and by review of trial screening logs, eligibility and recruitment data and study documentation. Solutions to address these are developed collaboratively, including individual/group recruiter feedback and recruitment tips documents. Results: SMALL opened in December 2019, but recruitment halted in 2020 for 5 months due to COVID-19. At 7st July 2022, 142 patients had been randomised from 26 centres, with a randomisation rate of approximately 45%, and a per site recruitment rate of 0.4-0.5 patients/month, approaching the feasibility recruitment target of 144 patients. Drawing from preliminary QRI findings and insights from patient representatives, a recruitment tips document has been circulated (on providing balanced information about treatments, encouraging recruiters to engage with patient preferences, and explaining randomisation). Individual recruiter feedback has commenced, with wider feedback delivered across sites via recruitment training workshops. Conclusion: Despite pandemic-related challenges, SMALL has an excellent recruitment rate to date and is expected to have a global impact on treatment of breast cancer within mammographic screening programmes. SMALL is funded by the UK NIHR HTA programme, award 17/42/32 Citation Format: Stuart A. McIntosh, Charlotte E. Coles, David Dodwell, Kenneth Elder, Jessica Foster, Claire Gaunt, Amanda Kirkham, Iain Lyburn, Jenna Morgan, Sangeetha Paramasivan, Sarah E. Pinder, Sarah Pirrie, Shelley Potter, Tracy Roberts, Nisha Sharma, Hilary Stobart, Elizabeth Southgate, Sian Taylor-Phillips, Matthew Wallis, Daniel Rea. SMALL: Open Surgery versus Minimally invasive vacuum-Assisted excision for smaLL screen-detected breast cancer – a UK phase III randomised multi-centre trial [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT3-20-02.

Psychological impact of risk-stratified screening as part of the NHS Breast Screening Programme: multi-site non-randomised comparison of BC-Predict versus usual screening (NCT04359420)

BackgroundAdding risk stratification to standard screening via the NHS Breast Screening Programme (NHSBSP) allows women at higher risk to be offered additional prevention and screening options. It may, however, introduce new harms such as increasing cancer worry. The present study aimed to assess whether there were differences in self-reported harms and benefits between women offered risk stratification (BC-Predict) compared to women offered standard NHSBSP, controlling for baseline values.MethodsAs part of the larger PROCAS2 study (NCT04359420), 5901 women were offered standard NHSBSP or BC-Predict at the invitation to NHSBSP. Women who took up BC-Predict received 10-year risk estimates: “high” (≥8%), “above average (moderate)” (5–7.99%), “average” (2–4.99%) or “below average (low)” (<2%) risk. A subset of 662 women completed questionnaires at baseline and at 3 months (n = 511) and 6 months (n = 473).ResultsState anxiety and cancer worry scores were low with no differences between women offered BC-Predict or NHSBSP. Women offered BC-Predict and informed of being at higher risk reported higher risk perceptions and cancer worry than other women, but without reaching clinical levels.ConclusionsConcerns that risk-stratified screening will produce harm due to increases in general anxiety or cancer worry are unfounded, even for women informed that they are at high risk.

Lessons learned from independent external validation of an AI tool to detect breast cancer using a representative UK data set.

To pilot a process for the independent external validation of an artificial intelligence (AI) tool to detect breast cancer using data from the NHS breast screening programme (NHSBSP). A representative data set of mammography images from 26,000 women attending 2 NHS screening centres, and an enriched data set of 2054 positive cases were used from the OPTIMAM image database. The use case of the AI tool was the replacement of the first or second human reader. The performance of the AI tool was compared to that of human readers in the NHSBSP. Recommendations for future external validations of AI tools to detect breast cancer are provided. The tool recalled different breast cancers to the human readers. This study showed the importance of testing AI tools on all types of cases (including non-standard) and the clarity of any warning messages. The acceptable difference in sensitivity and specificity between the AI tool and human readers should be determined. Any information vital for the clinical application should be a required output for the AI tool. It is recommended that the interaction of radiologists with the AI tool, and the effect of the AI tool on arbitration be investigated prior to clinical use. This pilot demonstrated several lessons for future independent external validation of AI tools for breast cancer detection. Knowledge has been gained towards best practice procedures for performing independent external validations of AI tools for the detection of breast cancer using data from the NHS Breast Screening Programme.

Supporting a patient with learning disabilities through screening and treatment for primary breast cancer

This article presents a case study evaluation of supporting a patient with learning disabilities through the NHS Breast Screening Programme diagnostic pathway and subsequent treatments for breast cancer. The process encompassed best interests meetings and treatment planning, surgeries, chemotherapy and anti-Her2 treatments, radiotherapy and endocrine therapy. Problems that occurred during this period included issues around completing surgery, managing chemotherapy treatment during the COVID-19 pandemic and the feasibility and tolerance of radiotherapy. The role of a breast care nurse in this patient's pathway was to facilitate treatment, support the patient and her family, and to liaise with the wider nursing and medical teams to coordinate care.

Cohort profile of the Sloane Project: methodology for a prospective UK cohort study of >15 000 women with screen-detected non-invasive breast neoplasia

PurposeThe introduction of breast screening in the UK led to an increase in the detection of non-invasive breast neoplasia, predominantly ductal carcinoma in situ (DCIS), a non-obligatory precursor of invasive...

Healthcare professionals’ views following implementation of risk stratification into a national breast cancer screening programme

BackgroundIt is crucial to determine feasibility of risk-stratified screening to facilitate successful implementation. We introduced risk-stratification (BC-Predict) into the NHS Breast Screening Programme (NHSBSP) at three screening sites in north-west England from 2019 to 2021. The present study investigated the views of healthcare professionals (HCPs) on acceptability, barriers, and facilitators of the BC-Predict intervention and on the wider implementation of risk-based screening after BC-Predict was implemented in their screening site.MethodsFourteen semi-structured interviews were conducted with HCPs working across the breast screening pathway at three NHSBSP sites that implemented BC-Predict. Thematic analysis interpreted the data.ResultsThree pre-decided themes were produced. (1) Acceptability of risk-based screening: risk-stratification was perceived as a beneficial step for both services and women. HCPs across the pathway reported low burden of running the BC-Predict trial on routine tasks, but with some residual concerns; (2) Barriers to implementation: comprised capacity constraints of services including the inadequacy of current IT systems to manage women with different risk profiles and, (3) Facilitators to implementation: included the continuation of stakeholder consultation across the pathway to inform implementation and need for dedicated risk screening admin staff, a push for mammography staff recruitment and guidance for screening services. Telephone helplines, integrating primary care, and supporting access for all language needs was emphasised.ConclusionRisk-stratified breast screening was viewed as a progressive step providing it does not worsen inequalities for women. Implementation of risk-stratified breast screening requires staff to be reassured that there will be systems in place to support implementation and that it will not further burden their workload. Next steps require a comprehensive assessment of the resource needed for risk-stratification versus current resource availability, upgrades to screening IT and building screening infrastructure. The role of primary care needs to be determined. Simplification and clarification of risk-based screening pathways is needed to support HCPs agency and facilitate implementation. Forthcoming evidence from ongoing randomised controlled trials assessing effectiveness of breast cancer risk-stratification will also determine implementation.

Implementing Risk-Stratified Breast Screening in England: An Agenda Setting Meeting.

Simple SummaryA risk-stratified approach to breast cancer screening has gained international interest as a mechanism to better balance the benefits, harms and costs of screening programmes. The aim of our agenda setting meeting was to identify key uncertainties to resolve in order to implement a risk-stratified breast screening programme within England. Findings from a 5-year programme of research assessing the feasibility of such an approach in England were presented before individual discussion groups and an open plenary session regarding what preparation needs to take place. Key findings highlight the need to further develop risk modelling to ensure equity of access to breast cancer risk assessment and ensure a risk-stratified programme is cost-effective. Other issues highlighted related to capacity and capability of the health services to offer an integrated risk assessment pathway that is accessible. Attendees identified ways in which risk-stratification could be implemented to minimise inequity of access to screening.It is now possible to accurately assess breast cancer risk at routine NHS Breast Screening Programme (NHSBSP) appointments, provide risk feedback and offer risk management strategies to women at higher risk. These strategies include National Institute for Health and Care Excellence (NICE) approved additional breast screening and risk-reducing medication. However, the NHSBSP invites nearly all women three-yearly, regardless of risk. In March 2022, a one-day agenda setting meeting took place in Manchester to discuss the feasibility and desirability of implementation of risk-stratified screening in the NHSBSP. Fifty-eight individuals participated (38 face-to-face, 20 virtual) with relevant expertise from academic, clinical and/or policy-making perspectives. Key findings were presented from the PROCAS2 NIHR programme grant regarding feasibility of risk-stratified screening in the NHSBSP. Participants discussed key uncertainties in seven groups, followed by a plenary session. Discussions were audio-recorded and thematically analysed to produce descriptive themes. Five themes were developed: (i) risk and health economic modelling; (ii) health inequalities and communication with women; (iii); extending screening intervals for low-risk women; (iv) integration with existing NHSBSP; and (v) potential new service models. Most attendees expected some form of risk-stratified breast screening to be implemented in England and collectively identified key issues to be resolved to facilitate this.

Evaluating the effectiveness of abbreviated breast MRI (abMRI) interpretation training for mammogram readers: a multi-centre study assessing diagnostic performance, using an enriched dataset

BackgroundAbbreviated breast MRI (abMRI) is being introduced in breast screening trials and clinical practice, particularly for women with dense breasts. Upscaling abMRI provision requires the workforce of mammogram readers to learn to effectively interpret abMRI.The purpose of this study was to examine the diagnostic accuracy of mammogram readers to interpret abMRI after a single day of standardised small-group training and to compare diagnostic performance of mammogram readers experienced in full-protocol breast MRI (fpMRI) interpretation (Group 1) with that of those without fpMRI interpretation experience (Group 2).MethodsMammogram readers were recruited from six NHS Breast Screening Programme sites. Small-group hands-on workstation training was provided, with subsequent prospective, independent, blinded interpretation of an enriched dataset with known outcome. A simplified form of abMRI (first post-contrast subtracted images (FAST MRI), displayed as maximum-intensity projection (MIP) and subtracted slice stack) was used. Per-breast and per-lesion diagnostic accuracy analysis was undertaken, with comparison across groups, and double-reading simulation of a consecutive screening subset.Results37 readers (Group 1: 17, Group 2: 20) completed the reading task of 125 scans (250 breasts) (total = 9250 reads). Overall sensitivity was 86% (95% confidence interval (CI) 84–87%; 1776/2072) and specificity 86% (95%CI 85–86%; 6140/7178). Group 1 showed significantly higher sensitivity (843/952; 89%; 95%CI 86–91%) and higher specificity (2957/3298; 90%; 95%CI 89–91%) than Group 2 (sensitivity = 83%; 95%CI 81–85% (933/1120) p < 0.0001; specificity = 82%; 95%CI 81–83% (3183/3880) p < 0.0001). Inter-reader agreement was higher for Group 1 (kappa = 0.73; 95%CI 0.68–0.79) than for Group 2 (kappa = 0.51; 95%CI 0.45–0.56). Specificity improved for Group 2, from the first 55 cases (81%) to the remaining 70 (83%) (p = 0.02) but not for Group 1 (90–89% p = 0.44), whereas sensitivity remained consistent for both Group 1 (88–89%) and Group 2 (83–84%).ConclusionsSingle-day abMRI interpretation training for mammogram readers achieved an overall diagnostic performance within benchmarks published for fpMRI but was insufficient for diagnostic accuracy of mammogram readers new to breast MRI to match that of experienced fpMRI readers. Novice MRI reader performance improved during the reading task, suggesting that additional training could further narrow this performance gap.

Extending the scope of practice for experienced assistant practitioners in breast screening and the impact on service resilience

IntroductionHistorically, the NHS Breast Screening Programme (NHSBSP) required Assistant Practitioners (APs), who are non-registered practitioners, to be supervised by and work alongside a registered radiographer (RPs). Following a national pilot looking at the implementation of two APs working remotely without direct supervision by a radiographer, this study seeks to evaluate a local trial of this new model of working. MethodsPairs of APs were deployed to work together on a mobile breast screening unit over a four-month period. Assessments were carried out to review technical performance using established NHSBSP technical repeat and recall rates in the United Kingdom. Notes on any queries from those involved during the dual AP sessions were prospectively collected and reviewed. Feedback from APs and other multi-disciplinary team members were collected and content analysis was applied. ResultsA total of 828 women were screened across the 26 AP clinics that were delivered. Technical repeat and recall rates of participating APs remained stable throughout the pilot period and marginally improved across all participating staff. No women attended the AP clinic who could not be screened and no support from a RP was required during the sessions. Seven normal clinics were converted to AP clinics due to lack of staff on the day, avoiding the cancellation of screening clinics. Feedback from across the screening team was positive. ConclusionsIncreasing the autonomy of experienced APs can significantly contribute to the delivery of a resilient radiographic workforce that maintains service performance. Suitable experience and wider team involvement appear to be keys to success in this case. Implication for practiceIncreasing the autonomy and voice of the APs has a positive effect on the resilience of the wider radiographic workforce and the service as a whole. It also can provide a mechanism for raising their profile with a possible raise in job satisfaction, staff engagement and retention.