Professor Ann O'Doherty:

By way of background, I am a practising clinician and the lead clinical director for BreastCheck. I am very pleased to have this opportunity to reassure the elected Members of the quality and safety of our breast screening programme in order that they in turn can reassure women of the quality of our programme. The past four weeks have been very difficult for Irish women, and it is incumbent on those of us who deliver the breast screening service to provide the reassurance necessary. I have devoted my professional life to the diagnosis of breast cancer both in the screening and the symptomatic setting. I established the first breast screening programme in Belfast in 1988. I was appointed clinical director of the Merrion BreastCheck unit in 1998.

BreastCheck is the national breast cancer screening programme. The screening programme aims to diagnose cancers at the earliest possible stage, when there is a better outcome and the cancer, it is to be hoped, may be treated less aggressively and with less morbidity. The programme was established following the publication of seminal randomised controlled trials in Sweden and other countries that demonstrated a reduction in breast cancer mortality of up to 30% by mammographic screening. BreastCheck offers mammograms to women every two years. Initially, they were offered to those between the ages of 50 and 64, but over the past two years we have been extending the age to 69 on a phased basis.

It is important to note that since the establishment of the programme in 2000, we have performed more than 1.5 million mammograms, and in that time more than 11,500 women have been diagnosed with breast cancer. BreastCheck is fortunate to be well funded and to have state-of-the-art equipment. Every mammogram is read independently in the static unit by two consultant breast radiologists. The Irish programme mirrors the UK programme in almost every aspect but with two important differences. Our programme screens at two yearly intervals as opposed to three yearly intervals. Recognising that diagnosing breast cancer does not save a single life, we have included treatment and, in particular, the surgical management of screen-detected breast cancer in our programme. We have been fortunate to have the opportunity to train our radiographers and radiological staff to the highest international standard. I must mention at this stage that we have had wonderful co-operation from our host hospitals. Even with the pressures on beds and theatre time, we have been greatly facilitated in the treatment of screen-detected cancer in this country.

BreastCheck has four static units, two of which are in Dublin. One of these two units is on the St. Vincent's University Hospital campus and the other is on the Mater Hospital campus. The other two units are on the Cork University Hospital and University Hospital Galway campuses, respectively. In spite of this, most screening happens on mobiles. Our aim is to deliver the service as near as possible to the patient's home. All patients recalled to assessment who have a mammographic abnormality on their initial mammogram are recalled to the static unit. Patients recalled to assessment have all further tests, tomomammography, ultrasound, biopsy and clinical examination carried out in the static unit. Patients who require biopsy are discussed at a multidisciplinary meeting and then return for results. There is a dedicated team of specialist breast care nurses to support patients through diagnosis and surgical treatment.

The programme was established with stringent quality assurance parameters and key performance indicators. These key performance indicators pertain to every aspect of the programme and are supported by extensive standard operating procedures. We publish an annual report and we have a multidisciplinary quality assurance committee comprising, inter alia, radiologists, radiographers, pathologists, surgeons, epidemiologists, medical physicists, nursing and administration overseeing the quality of our programme.

Approximately 2,600 breast cancers are diagnosed every year in Ireland and, unfortunately, 680 women die from the disease. It was noted in the 2016 annual report that BreastCheck screened more than 145,000 women in the previous year. Of these, 986 women were diagnosed with screen-detected breast cancer. The aim of our programme is to reduce mortality by 20%. To achieve this goal, we need 70% of women to accept their invitation to screening. This is why it is important for us to enlist the support of our public representatives to maintain acceptance rates. If we do not maintain our acceptance rates, we will not reduce mortality, which is the ultimate goal.

On a happier note, over the past five years, survival from breast cancer in this country has improved from 75% to 83%. I have no doubt that breast cancer screening has contributed to this improvement in survival together with improved treatment in the symptomatic centres and improved drug management in women with breast cancer. The programme detects approximately seven cancers in every 1,000 women screened. It is important for us to keep the recall rate as low as possible, preferably lower than 7%. The reason for this is that every woman recalled to assessment will experience a diagnosis of breast cancer, and we know from evidence in the literature that it takes women two years to get back to baseline anxiety levels about breast cancer following a recall to assessment. There is a constant balance to be struck between keeping recall rates low and cancer detection rates high, and this is a challenge to every cancer screening programme.

A women's charter is in place to ensure that the service is delivered in a timely manner and in line with promises made to women when the programme was established. Since the outset of our programme, we have understood the need to produce and publish our data. We have also understood the necessity of external accreditation. Since the outset of the programme, we have had three external reviews carried out. The most recent inspection was by the European Reference Organisation for Quality Assured Breast Screening and Diagnostic Services, EUREF. Following a very detailed inspection, including protocols, procedures and interval cancer documentation, we were awarded reference status last year, indicating that our policy and practices are an example for other national programmes to follow. EUREF has only awarded six screening programmes accreditation since 2009, only two of which have been awarded the highest quality of accreditation, which is category 4 reference centre accreditation, and BreastCheck is one of those two.

While mammography is the best screening test available for the early detection of breast cancer, it is neither 100% sensitive nor 100% specific and is not an ideal screening test from that point of view. Not all cancers are detected by screening mammography, and we need to understand that a screening test is not the same as a diagnostic test and has an inherent false negative rate, as publicised in the international literature. Women attending for screening are informed of this in all our documentation. In fact, women who attend for screening sign a consent form that includes a statement to the effect that breast cancer screening does not detect all breast cancers. In addition, when a woman gets a letter advising her that her screening mammogram is normal, it is stated in the result letter that if she develops any symptoms at any time, she must present to her general practitioner and, if deemed necessary, she should be referred to one of the eight symptomatic breast cancer centres in our country.

Breast cancer detected in the interval between screenings is deemed an interval cancer. There is an international standard for interval cancer rates in screening programmes. The expected rate of interval cancers is two per 1,000 women screened. It is a very important determinant of the quality of a screening programme. BreastCheck interval cancer rates are in accordance with the international published literature. In fact, we ourselves published our interval cancer rates in the Journal of Medical Screeningin April 2015. Interval cancers rates are an important parameter of the quality of a programme because, unlike background cancer detection rates, they are independent of the background incidence rate in a country. We find our interval cancer rate in the following way. BreastCheck is informed of all cancers by the National Cancer Registry. BreastCheck then determines if a woman has attended for screening and validates if it was within the past two years and if at the time of diagnosis the cancer was invasive. If these criteria are fulfilled, it is deemed to be an interval cancer and included in the rates published in our literature.

The formal review has been ongoing since the establishment of our programme 20 years ago and in the UK programme for the past 30 years. It is by necessity a retrospective and complex process. The current validated data are available up to 2011. In association with this, and while the review is ongoing, there is a practice performed in exactly the same way as in other European and UK countries. In conjunction with this, however, any woman diagnosed with an interval breast cancer can request a review of her screening mammogram, or her clinician can do so on her behalf.

That review happens in real time at the earliest possible convenience. It is performed by two consultant radiologists who were not involved in reporting the screening mammogram. The information is then communicated to the patient. While screening aims to reduce the mortality from breast cancers by 20%, there are definite downsides to screening of which we must be aware. The most important one is interval cancers. Anxiety associated with recall is a downside of screening.

Another downside is over-diagnosis, which has been prominent in the literature over the past five years. This is when we commit women to open surgical biopsies for benign disease. In other words, they have surgery that they would never have needed if they had not come for a screening mammogram because it is for benign disease. Our aim is to make sure we do not perform any unnecessary surgery. We may, through breast screening, detect breast cancer that may not affect a woman during her lifetime. We may diagnose and treat a woman for breast cancer that she may have died with, rather than from. Unfortunately, we cannot tell when we diagnose breast cancer which cancers will progress. We do not have that ability at the moment. With increased and more complex genetic marker testing in breast cancers that may be in our gift in the next decade but at the moment we do not know which cancers will kill women and which will not. Therefore, we have to treat all breast cancers. Giving a woman a diagnosis of breast cancer when she may not have died from it is termed lead-time bias and it is an inherent problem associated with breast cancer screening.

It is appropriate and necessary that we outline our plans for open disclosure. Open disclosure has been a policy for the HSE since 2013 but it is planned to introduce it for breast cancer screening. However, open disclosure is not a facet of, and does not happen in, other UK screening programmes. It has, however, happened only in the past year in England. On foot of the duty of candour legislation published in England in 2014, a detailed process was put in place to introduce open disclosure. Even while there was a requirement and a wish to introduce it as quickly as possible, it was introduced only in 2017. Scotland and Northern Ireland have not yet commenced open disclosure. We are very fortunate in that we have had a lot of discussion with the English programme and it has shared its methodology and training videos which were released in May of this year, following the UK local elections. It has released all its information on how it did this to us. We look forward to implementing open disclosure in early 2019 but I emphasise that open disclosure in screening is very complex. It is not the same as the symptomatic service or other diagnostic areas. This complex process will involve many stakeholders, particularly women, counselling agencies, the symptomatic breast cancer service, the State agency, the HSE and the Department of Health. We may need the help of this committee as legislators in navigating the complex issues surrounding the legal aspects of open disclosure.

I hope that the committee realises that the Irish breast cancer screening programme operates to the highest international standard. There are, however, challenges, the main ones for the future being: recruitment and retention of staff which is a real issue, maintenance of acceptance rates in excess of 70% if we wish to reduce mortality, open disclosure and litigation. I hope I have given the committee reassurance on the quality and safety of our screening programme.