In the year 2009, Public Health England found anomalies in the analyzed data from the age X trial, where it was seen that around 450,000 women of old age around 68-70 were not invited in a NHS mammography screenings.[i] The reason behind this cause was not particular as there was no particular information on the issue, though there were two possible reasons – failure in the IT system and there could have been a cut-off at age 70, and not 71, thereby excluding women who had not yet reached their 71st birthday and should have been included. According to Jeremy Hunt the health secretary, among 135 and 270 women might have reduced their life duration as a consequence. The primary purpose of the case study is to identify the main issues for which the error has occurred and to mention recommendations for the following problems to prevent them from reoccurring in the future.

Description

According to Public Health England (PHE), the screening programme detects around 18,400 cancers each year and saves 1300 lives. Annually around 350,000 women receive invitations for screening, but since last nine years, there has been a short of 50 000 women per year. According to PHE, of the 450,000 women who were not invited for screening, 309,000 are still alive. The reason behind this issue was not properly determined as there was no particular information on the issue, though there were two possible reasons identified – failure in the IT system and there could have been a cut-off at age 70, and not 71, thereby excluding women who had not yet reached their 71st birthday and should have been included. Public Health England has determined to help the 309,000 women who are still alive. According to the PHE all women of age 72, who are registered with a GP, can expect to get an appointment by the end of May month.[ii]

Discussion

Breast cancer is a kind of cancer that occurs in the breast cells, where these cells undergo abnormal rapid multiplications compared to the healthy cells. These cancerous cells as a result accumulate forming a mass or lump in the breast tissues, especially in the milking ducts or glandular breast tissues. The cancer cells cover the lobules or the ducts of the breasts. The lump or tumor is considered malignant, when the cells invade surrounding tissues and healthy cells.[iii] According to some researches around 9 out of 10 women get breast cancer surviving for five years or more. In the year 1985, Professor Sir Patrick Forrest was ordered by the then Minister of State for Health, the Rt Hon Kenneth Clarke MP, to make an evaluation of the efficacy of mammographic screening in decreasing death rate from breast cancer in women, and to recommend about the costs and benefits of the screening programme to the government.[iv] The screening program initiated in the year 1988, and it continued to go on, and in 1993 all eligible women were invited for screening.

Errors in Breast Screening

Breast screening and diagnostic methods include mammography and biopsy, which helps detect the presence of cancer cells in the breast. The errors in breast screening can be due to many associated factors including inaccuracies during the conduction of the screening processes like mammography, diagnostic procedures like biopsy, as well as sample collection processes, which have been found to often provide false negatives and positives sometimes.[v] Results of these screening tests are mostly very accurate in determining the invasive cancer cells however; it often fails to provide with the right diagnosis if the symptoms are less indicative. The false negative mammograms can often facilitate the false sense of security in women, preventing the early detection of breast cancer.[vi] The incident in England which was highlighted in an independent review was due to a computer error, can be considered as one of the most significant examples of breast screening errors. After the investigation of the breast screening error, many possible reasons were found for which the error might have arose.[vii]

Breast screening program policy

From the time of introduction of the breast screening programme there was an ambiguity regarding the age at which women should be stopped being invited for screening.[viii] As per the screening error of the breast cancer report it appeared that there was a lack of understanding in what was being delivered in breast screening units.[ix] As per the Public Health England official’s investigations, some women might not have been invited to the final screenings because there was a confusion regarding the entitlement.[x] The resolution to base the response of the event on the policy as set out in the November 2013 Service Specification was taken on internal legal advice, but without the understanding of the specification which did not align with the procedures and practice in breast screening units.[xi]

The ambiguity should have been made clear during the early phase of the programme, and assessments should have been done regarding the consistency across the country. In 2013 when programme was split among the Department of Health, Public Health England and NHS England, service specifications were recorded in an attempt to address the uncertainty[xii]. However, an attempt to clarify the uncertainty was late and incorrect as, those accountable for ensuring the specification and the governance structures put in place to assure the specification did not notice and identify the mistake. (Asri, Mousannif, Al Moatassime, Noel, 2016). This created a lack of security in women, mainly due to the false negatives and false positives. [xiii]

IT Department

Breast cancer screening consists of specialized imaging tools, utilized by trained specialists mammographers and radiographers.[xiv] During the breast screening procedures, women from the surrounding area who have registered with a GP and are of specific age range are called in batches, for to be screened. To create the batches used to invite women, breast screening units use two IT systems: the National Breast Screening Services (NBSS); and Breast Screening Select (BS-Select). According to the Independent Breast Screening Review 2018, around 5,000 women were not called to their breast cancer screening procedures.[xv] As per the review this did not happen because of any systemic IT error but it occurred because of the usage of two different and complex systems and blunders in the screenings done by the unit staffs. These led women have incremental enlargement of their screening intervals until they left the age range for core screening.

Governance

Like many other wellness programs, the breast screening program is operated by a community of organizations with mutual responsibility and accountability. However, in the case of breast screening program, it is seen that there is a governance structure, but there is no individual to guarantee that the system is functioning properly. All the responsibilities are shared between the Department of Health and Social Care, the National Health Agency of England and the Public Health Agency of England, without a shared sense of how they fit together to create a coherent and effective whole. [xvi]According to the article the primary deed which is the 7A agreement consisted of the November 2013 Service Specification and its succeeding iterations, signifying that it was approved as a proposal by the Department and NHS England. It is evident that a transition in policy has not been deliberate. It is also evident that the governance framework designed to guarantee that there was shared accountability for the establishment and implementation of the strategy did not function correctly. The National Health Service of England failed t NHS o keep breast screening facilities to consideration for delivery against agreements depending on the Service Specifications.

Management of the scenario

Public Health England was reluctant to create a definite knowledge of the event and the triggers of breast screening mistakes. As the analysis of the incident response advanced and disclosed more data contributing to the realization that some females had missed the testing and why, the survey considered that the coordinating team did not properly adapt their reaction to the event. This resulted to a national unveiling that exceeded the magnitude of the event, and many females grew nervous until they got the outcomes of their catch-up testing sessions.

Impact on Women

According to an article most of the women responded to the breast screening survey. According to the statement of the women their trust in the breast screening program was still the same and it did not reduced as a result of the incident. Those who were identified with breast cancer were concerned and wondering if their individual condition might have been different, had they obtained a screening proposal at the correct moment. [xvii]

Age X Trial

At the moment of the unveiling by the then Secretary of State, it was thought that the method used to randomize females to the AgeX test may have been the source of women’s inability to be asked during their last screening. In the early stages of the investigation, the review team found that the method was working as intended and, furthermore, that the Oxford University study-leading scholars had no involvement in the randomization process.

Recommendation

The Health and Social Care organizations should approve and issue the service specification for breast screening which would describe the age range for women after which screenings should be stopped [xviii]. The service specification for breast screening should also consist of the advice of the UK National Screening Committee and Public Health England. It should also consist of the advice of NHS England regarding the execution procedure of this specification.
The new breast screening specification formed should be shared with all the people who are involved in breast cancer screening procedures and should be utilized as the main source for the understanding, executing and guaranteeing the programme.[xix]
Significantly, the information regarding health of public should be restructured so as to make it clear for women regarding what they should anticipate from the breast screening programme, and also when they will receive their final screening invitation and from what age they are entitled to self-refer.
Public health England should conduct a review in collaboration with the NHS England to designate the users of the system and NHS digital as system experts. It will help in reducing the manual input and duplication in NBSS and BS-select and will help in simplifying the user interface.[xx]
Once a policy has been made regarding the women’s age during which they should be stopped for breast screening, the IT systems should also be reviewed to ensure that function.
Whenever any new system is formed to support the screening programmes, it should follow the principles of the Future of Healthcare: Our Vision for Digital Data and Technology in Health and Care.
The performance predictor in Section 7A of the Agreement is not sufficiently particular for the population qualified for screening. This needs to be made clear.
Quality assurance taken out by the Screening Quality Assurance Service should represent the strategy of the breast screening programme. This is probable to imply that guidelines and instruction should be revised to ensure that everyone conducting checks is conscious of what needs to be assessed against it.
NHS England should enhance its program governance procedures to guarantee that suppliers deliver the service as outlined in the Service Specifications.
The Health and Social Care Department and its arm-length bodies should check their occurrence response guidelines and guarantee that they are suitable for adapting to all events concerning screening programs in their various types. The protocols should guarantee that all associates, including those accountable for promoting IT or execution schemes, are included in the survey and response.
Existing protocols should be revised to guarantee that those providing the operating service are notified as soon as possible to schedule and execute their response. Such as in this case the operating services are breast screening centers and devolved administrations.
Women who have been approached through the Patient Notification Exercise and have been identified with breast cancer will be evaluated to attempt to assess whether the breast screening program has induced damage. Public Health England should collaborate with these females, their relatives and their healthcare practitioners rapidly and sensitively to attempt to clarify this and to guarantee that females have the assistance they need.
The AgeX Trial should proceed to allow the widest feasible assessment of the effects of expanding the breast screening program in both younger and elderly age types until its scheduled closure period, presently 2026.

Conclusion

The issue went to the context in January 2018 when a PHE assessment discovered that between their 68th and 71st birthdays many invites for a complete mammogram had not been sent to females. This was because an IT mistake implied that a cut-off level of 70 was used, which indicated that when they were 70 years old, thousands of females were not permitted to screen each year. To resolve this issue Jeremy Hunt, the secretary of state for health and social care pledged that all females under the age of 72 who are impacted and enrolled with a GP might hope to obtain a notice notifying them of their request moment and deadline before the beginning of May. Women aged 72 and elder could telephone a specific helpline to address whether a mammogram would benefit their particular condition. It is because there is a considerable danger for elderly females that screening will catch up non-threatening cancers that may result in useless and dangerous testing and therapy. Thus it would be beneficial for all the members associated with the program to follow and implement the suggested recommendations.

REFERENCES

[i] England NH. 16 national health visiting core service specification. NHS England, London. 2015.

[ii] Gov.UK. Women offered NHS breast screening after missed invitations [Internet]. GOV.UK. 2019 [cited 3 October 2019]. Available from: https://www.gov.uk/government/news/women-offered-nhs-breast-screening-after-missed-invitations

[iii] Welch HG, Prorok PC, O’Malley AJ, Kramer BS. Breast-cancer tumor size, overdiagnosis, and mammography screening effectiveness. New England Journal of Medicine. 2016 Oct 13;375(15):1438-47.

[iv] Iacobucci G. NHS in 2017: the long arm of government. BMJ. 2017 Jan 13;356:j41.

[v] Palazzetti V, Guidi F, Ottaviani L, Valeri G, Baldassarre S, Giuseppetti GM. Analysis of mammographic diagnostic errors in breast clinic. La radiologiamedica. 2016 Nov 1;121(11):828-33.

[vi] Chaurasia V, Pal S. A novel approach for breast cancer detection using data mining techniques. International Journal of Innovative Research in Computer and Communication Engineering (An ISO 3297: 2007 Certified Organization) Vol. 2017 Jun 29;2.

[vii] McCartney M. Margaret McCartney: Can we now talk openly about the risks of screening?. Bmj. 2018 May 14;361:k2055.

[viii] Ghanouni A, von Wagner C, Waller J. Public awareness of and responses to media coverage of invitation errors in the Breast Screening Programme in England: a cross-sectional population survey. BMJ open. 2019 Sep 1;9(9):e028040.

[ix] Hawkes N. Breast cancer screening error: fatal mistake or lucky escape?.

[x] Sheikh S, Sasieni P. When should the errors in the UK’s breast screening programme have been spotted?. The Lancet. 2018 Jun 9;391(10137):2319-20.

[xi]The Independent Breast Screening Review. The Independent Breast Screening Review 2018 [Internet]. Pub-csrd.escribemeetings.com. 2018 [cited 3 October 2019]. Available from: https://pub-csrd.escribemeetings.com/Meeting?Id=185bd19d-7184-4bd5-99fc-fdf5727e5972&Agenda=Merged&lang=English

[xii] Bewley S, Blennerhassett M, Payne M. Cost of extending the NHS breast screening age range in England. Bmj. 2019 Apr 10;365:l1293.

[xiii] Quaile A. More rigorous investigating needed to improve maternity safety. British Journal of Midwifery. 2018 Feb 1;26(2):75-.

[xiv] Lutz CM, Poulsen PR, Fledelius W, Offersen BV, Thomsen MS. Setup error and motion during deep inspiration breath-hold breast radiotherapy measured with continuous portal imaging. Acta Oncologica. 2016 Feb 1;55(2):193-200.

[xv] Keating NL, Pace LE. Breast cancer screening in 2018: time for shared decision making. Jama. 2018 May 1;319(17):1814-5.

[xvi] Bewley S. The NHS breast screening programme needs independent review. Bmj. 2011 Oct 25;343:d6894.

[xvii] Fielden HG, Brown SL, Saini P, Beesley H, Salmon P. How do women at increased breast cancer risk perceive and decide between risks of cancer and risk‐reducing treatments? A synthesis of qualitative research. Psycho‐oncology. 2017 Sep;26(9):1254-62.

[xviii] Al-Zalabani AH, Alharbi KD, Fallatah NI, Alqabshawi RI, Al-Zalabani AA, Alghamdi SM. Breast cancer knowledge and screening practice and barriers among women in Madinah, Saudi Arabia. Journal of Cancer Education. 2018 Feb 1;33(1):201-7.

[xix] Gøtzsche PC, Jørgensen KJ. The breast screening programme and misinforming the public. Journal of the Royal Society of Medicine. 2011 Sep;104(9):361-9.

[xx] Evans DG, Astley S, Stavrinos P, Harkness E, Donnelly LS, Dawe S, Jacob I, Harvie M, Cuzick J, Brentnall A, Wilson M. Improvement in risk prediction, early detection and prevention of breast cancer in the NHS Breast Screening Programme and family history clinics: a dual cohort study.

Report – 1091450

Introduction