Evaluating whether Prostate Cancer UK’s risk checker is a help or hindrance to prostate-specific antigen testing policy: a mixed-methods study

Natalia Norori; Chiara de Biase; Yui Hang Wong; Sadie Robson Crabtree; Matt Cox; Esther Appleby; Andrew Seggie; Rachel Brown; Amy Rylance

doi:10.3399/BJGPO.2024.0040

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Response to authors’ reply about Prostate UK’s prostate risk checker
Margaret McCartney and Ash Paul

Published on: 13 November 2024
RE: help or hindrance? Author response
Chiara De Biase, Natalia Norori, Andrew Seggie and Amy Rylance

Published on: 03 October 2024
Help or hindrance?
Ash Paul and Margaret McCartney

Published on: 21 August 2024

Published on: (13 November 2024)
Page navigation anchor for Response to authors’ reply about Prostate UK’s prostate risk checker
Response to authors’ reply about Prostate UK’s prostate risk checker
Margaret McCartney, Senior Lecturer in General Practice, University of St Andrews
Other Contributors:
Ash Paul, Consultant in Public Health
We are disappointed to note the authors’ reply to our letter. The authors have tried to justify the risk checker, and have not answered the points raised in our reply.
Firstly, the authors have not responded to the ethical questions we raised around designing a risk checker where every black man over 45 and every man over fifty is designated as ‘high risk’ and is told to discuss their risk with their GP. This is not disinterested advice. By telling men they are high risk, this automatically frames knowledge and actions. This cannot be considered neutral advice especially as no absolute numbers are given to men completing the ‘risk checker’.
While the authors claim that their aim was to “assess whether Prostate Cancer UK’s risk checker could effectively support men in making an informed choice about the PSA test” their study design could not do this, given that did not measure how informed choice was improved or not. It asked men to organise a blood test without a GP appointment after an unsolicited text message saying the men were at ‘higher risk’ on basis of age and/or ethnicity. There was no measurement of whether men understood their risks any better after using the ‘risk checker’, or how they would be altered by having a PSA test. The ‘risk checker’ itself contains only limited information about the disbenefits of PSA testing (“But it could find a slow-growing cancer that’s unlikely to cause problems or shorten your life. Being diagnosed with cancer is a...
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We are disappointed to note the authors’ reply to our letter. The authors have tried to justify the risk checker, and have not answered the points raised in our reply.
Firstly, the authors have not responded to the ethical questions we raised around designing a risk checker where every black man over 45 and every man over fifty is designated as ‘high risk’ and is told to discuss their risk with their GP. This is not disinterested advice. By telling men they are high risk, this automatically frames knowledge and actions. This cannot be considered neutral advice especially as no absolute numbers are given to men completing the ‘risk checker’.
While the authors claim that their aim was to “assess whether Prostate Cancer UK’s risk checker could effectively support men in making an informed choice about the PSA test” their study design could not do this, given that did not measure how informed choice was improved or not. It asked men to organise a blood test without a GP appointment after an unsolicited text message saying the men were at ‘higher risk’ on basis of age and/or ethnicity. There was no measurement of whether men understood their risks any better after using the ‘risk checker’, or how they would be altered by having a PSA test. The ‘risk checker’ itself contains only limited information about the disbenefits of PSA testing (“But it could find a slow-growing cancer that’s unlikely to cause problems or shorten your life. Being diagnosed with cancer is a worrying experience that leads some men to choose unnecessary treatments. These cancers can be carefully and safely monitored instead”) which do not spell out the risks of overdiagnosis and overtreatment or the debated evidence on mortality. The conclusion that the ‘risk checker’ is useful because it “helps the UK PSA testing informed choice policy because it takes a difficult, time-consuming task (explaining the pros and cons of the PSA test) from primary care and delivers it at men’s convenience” is unsafe, because they have not measured the quality of decision making.
Secondly, the authors have avoided answering any questions around the design of the risk checker and the internal and external validity of the risk checker. These are extremely important issues which have been referred to innumerable times by internationally recognised academic experts in designing clinical risk algorithms (1–4). Again, given that Prostate Cancer UK is encouraging screening, which is against the independent UK National Screening Committee advice, we would appreciate information as to which ethics committee advised that approval was not required for this study.

References:
1. Clinical prediction models and the multiverse of madness https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-023-03212-y
2. Evaluation of clinical prediction models (part 1): from development to external validation https://www.bmj.com/content/384/bmj-2023-074819
3. Evaluation of clinical prediction models (part 2): how to undertake an external validation study https://www.bmj.com/content/384/bmj-2023-074820
4. Evaluation of clinical prediction models (part 3): calculating the sample size required for an external validation study https://www.bmj.com/content/384/bmj-2023-074821
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Competing Interests: None declared.

Published on: (3 October 2024)

Page navigation anchor for RE: help or hindrance? Author response

RE: help or hindrance? Author response

Chiara De Biase, Director of Health Services, Equity & Improvement, Prostate Cancer UK, London, UK
Other Contributors:
- Natalia Norori, Senior Data & Evidence Manager
- Andrew Seggie, Health Influencing Senior Officer - Earlier Diagnosis Lead
- Amy Rylance, Assistant Director of Health Improvement

As stated in our article, the risk checker was created to help men understand their prostate cancer risk and support them in making an informed choice about the PSA test. Contrary to the claim that it contradicts current UK National Screening Committee (NSC) recommendations, the risk checker closely mirrors the language and structure of the official Prostate Cancer Risk Management Programme (PCRMP) information sheet. Both tools inform men about their risk and the pros and cons of the PSA test. This aligns with the current UK PSA testing policy for asymptomatic men. Table 1 provides a comparison of the risk checker language and current NHS language.

The letter from Paul and McCartney raises concerns about the impact of the risk checker on primary care workload. While evaluating the impact of the risk checker on the broader healthcare system was beyond the scope of our study, data from the general practice case studies suggests the tool can help primary care reach higher-risk patients. Practices which sent the risk checker link to their patients reported minimal workload increase and patient perceptions were positive.

In our original article, we acknowledge and state explicitly that the UK NSC advises against routine prostate cancer screening. The primary aim of our study was to assess whether Prostate Cancer UK’s risk checker could effectively support men in making an informed choice about the PSA test; at no point did we advocate for prostate cancer screening. We agree that level 1 evidence is necessary for making definitive screening decisions and Prostate Cancer UK is committed to adding to the evidence base about the harms and benefits of screening. Indeed, in collaboration with the National Screening Committee we have recently funded TRANSFORM: a £42m trial to close the evidence gaps that remain or will prevent future practice change. In the meantime, online tools like the risk checker can help men access the information they need to make a choice as to whether to have a PSA test or not.

Table 1. Comparison of the risk checker language and current NHS language

Topic	NHS language	Risk checker language
About risk	“You are at higher risk of developing prostate cancer if you: are aged 50 or older have a close relative, for example brother or father, who has had prostate cancer are of black ethnic origin (double the risk)”	In the risk checker men are asked questions about their age, family history and ethnicity and those that are: aged 50 or older have a close relative (father or brother)... are Black are told.... “You are at higher risk of getting prostate cancer.”
About speaking to a GP	“Before making a decision, you may want to talk to your GP” “Talk to your GP about the possible advantages and disadvantages of the test and your own risk of prostate cancer.”	“You may want to speak to your GP about your risk. Many GPs offer phone and video appointments, so you may not need to go in.” “We recommend that if you are at higher risk, you talk to your GP about the pros and cons of the PSA blood test.”
About symptoms	“Most early stage prostate cancers do not have any symptoms.”	“Prostate cancer often has no symptoms, so don’t wait for symptoms if you want to talk to your GP about your risk of prostate cancer.”
About pros and cons of the PSA blood test	“Possible advantages A PSA test can help pick up prostate cancer before you have any symptoms. A PSA test can help pick up a fast-growing cancer at an early stage, when treatment could stop it spreading and causing problems or shortening your life. Possible disadvantages You might have a raised PSA level, without cancer. Many individuals with a raised PSA level do not have prostate cancer. The PSA test can miss prostate cancer. A small proportion of men who have a low PSA level will later be found to have prostate cancer. If your PSA level is raised, you may need a biopsy. This can cause side effects, such as pain, infection and bleeding. Not all men will need to have a biopsy. You might be diagnosed with a slow-growing cancer that would never have caused any problems or shortened your life. Being diagnosed with cancer could make you worry, and you might decide to have treatment you do not need. Treatments can cause side effects which can affect you daily for the rest of your life, such as urinary, bowel and erection problems.”	“...about the pros and cons of the PSA blood test. To help you decide if it’s right for you, here are some facts about the PSA blood test. A high PSA could mean you have cancer, but PSA can also be raised by having an enlarged prostate, an infection, exercise, or ejaculation. To know for sure, you would need to have more tests including an MRI scan. The PSA blood test sometimes misses prostate cancer. 1 in 7 men with a normal PSA level may have prostate cancer, and 1 in 50 men with a normal PSA level may have a fast-growing cancer. One normal PSA result can’t rule out a future diagnosis of prostate cancer. Regular tests can spot trends in PSA blood levels, which could be a sign of prostate cancer developing, particularly if you have an increased risk So should I have a PSA blood test or not? It can help find aggressive prostate cancers early – when treatments are more likely to cure the cancer. But it could find a slow-growing cancer that’s unlikely to cause problems or shorten your life. Being diagnosed with cancer is a worrying experience that leads some men to choose unnecessary treatments. These cancers can be carefully and safely monitored instead.”

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Competing Interests: Natalia Norori, Chiara de Biase, Andrew Seggie, and Amy Rylance are employees of Prostate Cancer UK.

Published on: (21 August 2024)
Page navigation anchor for Help or hindrance?
Help or hindrance?
Ash Paul, Consultant in Public Health, n/a
Other Contributors:
Margaret McCartney, Senior Lecturer
There are several concerns with this research paper, whose authors are mostly employees of Prostate Cancer UK (PCUK) (1). They describe various activities in terms of surveys, focus groups, and interviews, and say that their online "risk checker" tool can help "reach men at high risk of prostate cancer and support them in making an informed choice about the PSA test".

Their study rests on the assumption that testing is an overall benefit: and that the on-request system for PSA screening, as currently operating in the UK, is unfair, as not all men know about it. They cite a paper in support of their claim that the current UK system leads to health inequalities, but it is test volume that is referred to, not outcomes related to morbidity and mortality: authors say "the effects of disparate rates of PSA testing on health outcomes are still unclear" (2). It is not good enough to claim that screening is successful based on the volume of tests.

The study assumed that the online prostate cancer risk tool, designed and hosted by PCUK, was valid and effective. This advises all black men over 45, and all men over 50, to speak to their GP about their risk. This is not in keeping with UK National Screening Committee recommendations which clearly states that "Screening is not recommended for this condition" (3). This may change in the future, but if it does, it should be part of an organised, audited, and resourced programme which...
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There are several concerns with this research paper, whose authors are mostly employees of Prostate Cancer UK (PCUK) (1). They describe various activities in terms of surveys, focus groups, and interviews, and say that their online "risk checker" tool can help "reach men at high risk of prostate cancer and support them in making an informed choice about the PSA test".

Their study rests on the assumption that testing is an overall benefit: and that the on-request system for PSA screening, as currently operating in the UK, is unfair, as not all men know about it. They cite a paper in support of their claim that the current UK system leads to health inequalities, but it is test volume that is referred to, not outcomes related to morbidity and mortality: authors say "the effects of disparate rates of PSA testing on health outcomes are still unclear" (2). It is not good enough to claim that screening is successful based on the volume of tests.

The study assumed that the online prostate cancer risk tool, designed and hosted by PCUK, was valid and effective. This advises all black men over 45, and all men over 50, to speak to their GP about their risk. This is not in keeping with UK National Screening Committee recommendations which clearly states that "Screening is not recommended for this condition" (3). This may change in the future, but if it does, it should be part of an organised, audited, and resourced programme which gives independent information to men about the risk of harm and potential impact on mortality and morbidity. PCUK do not refer men to independent NHS information (4). Nor has PCUK accounted for the workload on primary care as a result of their advice — not recommended by the NHS — in launching their campaign. It would be helpful if PCUK were to recommend what work GPs should stop doing to fit this in, and what patients PCUK recommend should be deprioritised on the basis of the increased workload resulting from their advice. While their title asks whether their "risk checker" is a "help or hindrance", an examination of systemic harms was not completed. Given that PCUK was using a non independently validated 'risk checker' at odds with the UK NSC advice, and write that ethics approval was "not required", it would be helpful to know which ethics committee gave this opinion.

1) Evaluating whether Prostate Cancer UK’s risk checker is a help or hindrance to prostate-specific antigen testing policy: a mixed-methods study
Natalia Norori, Chiara de Biase, Yui Hang Wong, Sadie Robson Crabtree, Matt Cox, Esther Appleby, Andrew Seggie, Rachel Brown, Amy Rylance
BJGP Open 26 June 2024; BJGPO.2024.0040. DOI: 10.3399/BJGPO.2024.0040
2) Vickers A, O' Brien F, Montorsi F, Galvin D, Bratt O, Carlsson S et al. Current policies on early detection of prostate cancer create overdiagnosis and inequity with minimal benefit BMJ 2023; 381 :e071082 doi:10.1136/bmj-2022-071082
3) UK National Screening Committee. Adult screening programme. Prostate cancer. https://view-health-screening-recommendations.service.gov.uk/prostate-ca...
4) PSA testing and prostate cancer: advice for men without symptoms of prostate disease aged 50 and over. https://www.gov.uk/government/publications/prostate-specific-antigen-tes...
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Competing Interests: MM has written about overdiagnosis, some of which has been paid journalism.