Breast screening atypia and subsequent development of cancer: protocol for an observational analysis of the Sloane database in England (Sloane atypia cohort study)

IntroductionThe National Health Service (NHS) Breast Screening Programme aims to detect cancer earlier when treatment is more effective but can harm women by over diagnosing and overtreating cancers which would never have become symptomatic. As well as breast cancer, a spectrum of atypical epithelial proliferations (atypia) can also be detected as part of screening. This spectrum of changes, while not cancer, may mean that a woman is more likely to develop breast cancer in the future. Follow-up of atypia is not evidence based. We currently do not know which atypia should be detected to avoid future cancer. This study will explore how atypia develops into breast cancer in terms of number of women, time of cancer development, cancer type and severity, and whether this varies for different types of atypia.Methods and analysisThe Sloane cohort study began in April 2003 with ongoing data collection including atypia diagnosed through screening at screening units in the UK. The database for England has 3645 cases (24 September 2020) of epithelial atypia, with follow-up from 1 to 15 years. The outcomes include subsequent invasive breast cancer and the nature of subsequent cancer. Descriptive statistics will be produced. The observed rates of breast cancer at 1, 3 and 6 years for types of atypia will be reported with CIs, to enable comparison to women in the general population. Time to event methods will be used to describe the time to breast cancer diagnosis for the types of atypia, including flexible parametric modelling if appropriate. Patient representatives from Independent Cancer Patients’ Voice are included at every stage of the research.Ethics and disseminationThe study has received research ethics approval from the University of Warwick Biomedical and Scientific Research Ethics Committee (BSREC 10/20–21, 8 October 2020), Public Health England office for data release approvals (ODR1718_313) and approval from the English Breast Research Advisory Committee (BSPRAC_031). The findings will be disseminated to breast screening clinicians (via journal publication and conference presentation), to the NHS Breast Screening Programme to update their guidelines on how women with atypia should be followed up, and to the general public.

Testing a breast cancer prevention and a multiple disease prevention weight loss programme amongst women within the UK NHS breast screening programme—a randomised feasibility study

Background Excess weight and unhealthy behaviours (e.g. sedentariness, high alcohol) are common amongst women including those attending breast screening. These factors increase the risk of breast cancer and other diseases. We tested the feasibility and acceptability of a weight loss/behaviour change programme framed to reduce breast cancer risk (breast cancer prevention programme, BCPP) compared to one framed to reduce risk of breast cancer, cardiovascular disease (CVD) and diabetes (T2D) (multiple disease prevention programme, MDPP). Methods Women aged 47-73 years with overweight or obesity (n = 1356) in the NHS Breast Screening Programme (NHSBSP) were randomised (1:2) to be invited to join a BCPP or a MDPP. The BCPP included personalised information on breast cancer risk and a web and phone weight loss/behaviour change intervention. The MDPP also included an NHS Health Check (lipids, blood pressure, HbA1c and personalised feedback for risk of CVD [QRISK2] and T2D [QDiabetes and HbA1c]). Primary outcomes were uptake and retention and other feasibility outcomes which include intervention fidelity and prevalence of high CVD and T2D risk. Secondary outcomes included change in weight. Results The BCPP and MDPP had comparable rates of uptake: 45/508 (9%) vs. 81/848 (10%) and 12-month retention; 33/45 (73%) vs. 53/81 (65%). Both programmes had a high fidelity of delivery with receipt of mean (95% CI) 90 (88-98% of scheduled calls, 91 (86-95%) of scheduled e-mails and 89 (76-102) website entries per woman over the 12-month period. The MDPP identified 15% of women with a previously unknown 10-year CVD QRISK2 of ≥ 10% and 56% with 10-year Qdiabetes risk of ≥ 10%. Both groups experienced good comparable weight loss: BCPP 26/45 (58%) and MDPP 46/81 (57%) with greater than 5% weight loss at 12 months using baseline observation carried forward imputation. Conclusions Both programmes appeared feasible. The MDPP identified previously unknown CVD and T2D risk factors but does not appear to increase engagement with behaviour change beyond a standard BCPP amongst women attending breast screening. A future definitive effectiveness trial of BCPP is supported by acceptable uptake and retention, and good weight loss. Trial registration ISRCTN91372184, registered 28 September 2014.

1344 Assessment of Appropriateness of Red Flag Referrals to One Stop Breast Clinic in Antrim Area Hospital

Aim To assess the appropriateness of red flag referrals to breast clinic. Method Retrospective study of patients attending breast clinic as red flag referrals within a few months period. 149 patients were identified. Their referrals and clinic notes were accessed through electronic care records. Out of the 149 patients used, 2 were routine referrals and the others were red flag. Various sources of referrals were seen such as from GP, Screening programme, SDA programme, and other departments. Results From the referrals, 95% are female (N = 142) and the remaining N = 7 (5%) were males. The youngest patient referred was 14 years old and the oldest 92. The average age for the referrals were 50 years old. From all the 125 referrals from GPs, 81.6% are in accordance with NI guideline and 78.4% are in accordance to NICE guidance. Of the 10 referrals made by other specialties, only 80% are in accordance with NICE and NI guidelines. The remaining 12 of the patients were from the SDA programme/ Breast screening programme. Interestingly of all the red flag referrals, only (9%, N = 13) are cancer. Conclusions Currently there is no triage system for red flag referrals in Antrim Area Hospital for breast clinic. We are currently seeing all the patients that are referred as red flag although some of them are inappropriate. A triage system needs to be placed.

Women’s attitudes to the use of AI image readers: a case study from a national breast screening programme

BackgroundResearchers and developers are evaluating the use of mammogram readers that use artificial intelligence (AI) in clinical settings.ObjectivesThis study examines the attitudes of women, both current and future users of breast screening, towards the use of AI in mammogram reading.MethodsWe used a cross-sectional, mixed methods study design with data from the survey responses and focus groups. We researched in four National Health Service hospitals in England. There we approached female workers over the age of 18 years and their immediate friends and family. We collected 4096 responses.ResultsThrough descriptive statistical analysis, we learnt that women of screening age (≥50 years) were less likely than women under screening age to use technology apps for healthcare advice (likelihood ratio=0.85, 95% CI 0.82 to 0.89, p<0.001). They were also less likely than women under screening age to agree that AI can have a positive effect on society (likelihood ratio=0.89, 95% CI 0.84 to 0.95, p<0.001). However, they were more likely to feel positive about AI used to read mammograms (likelihood ratio=1.09, 95% CI 1.02 to 1.17, p=0.009).Discussion and ConclusionsWomen of screening age are ready to accept the use of AI in breast screening but are less likely to use other AI-based health applications. A large number of women are undecided, or had mixed views, about the use of AI generally and they remain to be convinced that it can be trusted.

Organisational readiness for the adoption of AI diagnostic tools in clinical workflows – a case study from the National Breast Screening Programme in the East Midlands of England. (Preprint)

BACKGROUND Application of artificial intelligence (AI) in healthcare is accelerating but relatively little is yet known about the real-world implementation of AI in clinical workflows. OBJECTIVE In this paper, we have focused on one application of AI as a second reader of breast mammograms in the context of a national breast screening programme. We look at the development and testing of an AI image reading tool for mammograms and the effect of organisational readiness for AI tool adoption. We focus on two aspects of organisational readiness as conceptualised by Weiner (2009) for AI technology specifically and answer the questions (1) what are the views of the technology adopters in a healthcare organisation to the use of AI technology in the case of breast screening? (2) What are some of the emerging organisation factors that are likely to effect adoption and spread and are any unique to AI technology? METHODS A prospective mixed methods study of the real-world development of AI tools for use in the National Breast Screening Programme in England. We recruited 67 radiologists and reporting radiographers in four breast screening services and 18 organisational leaders who were the AI project decision-makers. Data was collected using an online survey of breast screening staff (adopters), semi-structured interviews with organisational leaders, participant observation of project meetings and document review. Data regarding organisational and adopter readiness for technology adoption was analysed over the duration of the project. RESULTS Sixty-seven clinicians and eighteen organisational leaders participated the study. Commitment to adoption is positive but adopters want to see clinical evidence of AI safety and accuracy. Decision-makers and other organisational adopters do not yet have shared views on their resources, capacity and capability to adopt and spread the technology and significant challenges related to task demands and situational factors emerged during the project causing substantial delays to adoption. The nature of AI and ML technology surfaced novel complexities not encountered by traditional health technology related to explainability and meaningful decision-support. CONCLUSIONS The case study shows that adopter commitment in this case and AI technology in breast screening is growing but gaps remain in the collective capability of organisations to adopt these novel technologies. CLINICALTRIAL Not applicable

Testing a Breast Cancer Prevention and a Multiple Disease Prevention Weight Loss Programme Among Women Within The UK NHS Breast Screening Programme - A Randomised Feasibility Study

Excess weight and unhealthy behaviours (sedentariness, high alcohol and suboptimal diet) are common among women attending breast screening. These factors increase the risk of breast cancer and other diseases. We tested the feasibility and acceptability of a weight loss/ behaviour change programme framed to reduce breast cancer risk (breast cancer prevention programme, BCPP) compared to one framed to reduce risk of breast cancer, cardiovascular disease (CVD) and diabetes (T2D) (multiple disease prevention programme, MDPP). Methods Women aged 47-73 years with overweight or obesity (n=1356) in the NHS Breast Screening Programme (NHSBSP) were randomized (1:2) to be invited to join a BCPP or a MDPP. The BCPP included personalised information on individual level of breast cancer risk and a web and phone weight loss/behaviour change intervention. The MDPP also included an NHS Health Check (lipids, blood pressure, HbA1c and personalised feedback for risk of CVD [QRISK2] and T2D [QDiabetes and HbA1c]). Uptake, retention, change in weight, and potential harms (anxiety and self-rated health) were assessed, along with the numbers in the MDPP with previously unknown CVD and T2D risk.ResultsThe BCPP and MDPP had comparable rates of uptake; 45/508 (9%) vs. 81/848 (10%) 12-month retention; 33/45 (73%) vs. 53/81 (65%) and numbers (%) losing ≥5% body weight at 12 months; 26/45 (58%) vs. 46/81 (57%) with baseline observation carried forward imputation. Both groups experienced reductions in state anxiety score; BCPP (n=37) -0.7 (-4.6 to 3.2), MDPP (n=60) -3.5 (-6.7 to -0.4) and an increase in the EQ-5D-5L score; BCPP (n=40) 4.1 (0.6 to 7.6), MDPP (n=60) 7.3 (3.6 to 11.1). The MDPP identified 15% of women with a previously unknown 10 year CVD QRISK2 of ≥10% and 56% with 10-year Qdiabetes risk of ≥10%.ConclusionsThe MDPP identified previously unknown CVD and T2D risk factors but does not appear to increase engagement with behaviour change beyond a standard BCPP amongst women attending breast screening. The results suggest a definitive effectiveness trial of the BCPP intervention is warranted, with acceptable uptake and retention, and a clear weight loss signal.Trial Registration ISRCTN91372184, https://doi.org/10.1186/ISRCTN91372184, registered 28 September 2014.

A case-control study to evaluate the impact of the breast screening programme on mortality in England

Background Over the past 30 years since the implementation of the National Health Service Breast Screening Programme, improvements in diagnostic techniques and treatments have led to the need for an up-to-date evaluation of its benefit on risk of death from breast cancer. An initial pilot case-control study in London indicated that attending mammography screening led to a mortality reduction of 39%. Methods Based on the same study protocol, an England-wide study was set up. Women aged 47–89 years who died of primary breast cancer in 2010 or 2011 were selected as cases (8288 cases). When possible, two controls were selected per case (15,202 controls) and were matched by date of birth and screening area. Results Conditional logistic regressions showed a 38% reduction in breast cancer mortality after correcting for self-selection bias (OR 0.62, 95% CI 0.56–0.69) for women being screened at least once. Secondary analyses by age group, and time between last screen and breast cancer diagnosis were also performed. Conclusions According to this England-wide case-control study, mammography screening still plays an important role in lowering the risk of dying from breast cancer. Women aged 65 or over see a stronger and longer lasting benefit of screening compared to younger women.