Sophie’s testimony

June 6, 2021

By Sophie, testimony and point of view

Ethics of screening, information for women, training of professionals on breast cancer screening: what is the strategy of the new Cancer Plan?

A testimonial

...Before age of 50, I had a breast cancer screening test prescribed by my doctor as part of a health check-up, for no particular reason, just to be reassured. I showed up at the radiology center with a simple prescription, without the least information on the radiation, nor on the additional examinations, or the consequences of the test in case of abnormality, just as I would have a blood test for a general check-up. I was not given any information about what they were really looking for in the absence of symptoms, nor about the fact that they will be using a super-powerful tomosynthesis technology that detects the smallest anomaly of a few millimeters, for which no one can tell the outcome, nor on the doses of radiation delivered by the ten x-ray images with enlargements, with a total dose (16.5 mGy) of radiation four times higher than the dose delivered by a classic mammographic examination (3-4 mGy), and that I will have to repeat in 6 months, then 12 months and then 24 months. If all goes well, if not something else will happen?

If I were to draw a parallel with a drug, I would have had an information leaflet listing potential side effects.  But a mammogram is considered a harmless, banal examination.  I don't have any doubt about my doctor's good intentions, but unfortunately the tests and the anxious waiting were  overwhelming, then came the regret of having  this exam which should better not have been done.
I should have been able to decide, with the right information, but I didn't have it.

I may be told that this is a test done to save my life, although studies by independent researchers from the Cochrane organization have shown that for every 2000 women invited for screening throughout 10 years, one will avoid dying of breast cancer and 10 healthy women, who would not have been diagnosed if there had not been screening, will be treated unnecessarily. 
Would I be that lucky one, although I did not feel in any imminent danger, I had no particular concern for breast cancer, nor any family history of it, I was not even 50 years old, which is the starting age for screening mammography in France? Or on the other side, could I be one of the other 10 women unnecessarily treated ? In any case, it was up to me to weigh the benefits and risks and choose. And it's not fair that I didn't get all this information in advance.

... Among close contacts of mine, a woman had a screening mammogram at her age of 72, without any information except invitation letters. She gave in to the reminder letters and decided to undergo the exam so that, she would be left in peace. Similarly, after the mammography followed additional tests and anxious waiting of results for the whole family, with regrets for having done this exam without being properly informed.

Once again, lack of honesty and transparency…

......Another woman I know, in her forties, with no particular risk factors, had pressure from her gynecologist to have a mammogram, with no particular reason, and  without receiving any information. She tries to hold on and hope to not upset her gynecologist, because it is difficult to find another one.

Where is the information?

And there are many such cases... Here, we are talking about healthy women with no symptoms suggestive of breast cancer. It’s not about women who have a symptom and who should consult, because in this case the mammography is necessary.

These cases show the lack of information and training of professionals, whether it is the GP, the radiologist or the gynaecologist, who focus on mammographic screening examinations to find existing, hypothetical or future breast cancers in healthy women, forgetting to inform them correctly and without taking into account their autonomy of decision.

And yet it could be done better. Information on the benefits and risks of breast cancer screening, in the case of a healthy woman with no particular symptoms, is a due to women: it is up to them to choose according to their own values and preferences if they wish to undergo it or not, especially since the benefits are not clear; the controversy between the benefits and the real damage has been going on for 40 years now.

This was also one of the first recommendations of the steering committee following the 2016 citizen and scientific consultation on breast cancer screening in France :  "The consideration of controversy in the information provided to women and in the information and training (initial and continuous) of professionals in this area, so that women concerned by breast cancer screening are provided with balanced and complete information, and that professionals involved in breast cancer screening are trained to acquire the relevant knowledge to accompany women, offering them adequate support to make their decision" (1).

Why women are not told the truth, why doctors do not humbly acknowledge their doubts about the appropriateness of this exam in the absence of any symptoms? They prefer to put forward benefits that they are not sure of, forgetting everything else, including informed consent and patient autonomy.

A new cancer plan, situation in France

The ten-year strategy of the new cancer plan has been adopted by decree (2).

We expected measures to improve information for women while respecting the autonomy of patients, as is done in Great Britain, Australia, Canada and Germany. Elsewhere, the objective is to inform and not to persuade, the emphasis is on the women's decision without making them feel guilty, by providing decision support tools, which correctly communicate risks in absolute numbers and not in percentages by minimizing them.

As for this decision aid in Canada (3) which states:

« Why is shared decision making important? 
Screening is a personal decision. It is important to understand and weigh the benefits and harms for women in your age group (as shown below) with your health care provider. This will help you get a better understanding of the issues so that you can decide what is best for you. Some women may wish to not be screened if they are concerned about potential harms. »

Click to enlarge

Instead of developing such tools, in France the focus is on the number of screenings and the participation rate, without the slightest concern for informed consent, the objective of the Cancer Plan being "to achieve one million more screenings by 2025 for the three screening programs, including organized breast cancer screening and to exceed the coverage targets recommended at the European level in terms of screening and join the leading group in terms of adherence with a participation rate of 70% for organized breast cancer screening, while today the participation rate announced for 2018-2019 is : 49.3% + 10-15% (organized + individual). "((2), action sheet I.12, p.20)

And yet the rate of participation in screenings should not be a goal of these programs. The real goal should be related to informed patient decision. As danish researchers (Rahbek et al, 2021) point out, instead of evaluating cancer screening programs on the basis of participation rates, the measure of engagement could be the rate of informed decisions, regardless of participation or non-participation (4). The authors note that authorities assume that for most citizens, participation is the right choice. This view is not necessarily shared by informed citizens. Indeed, current evidence suggests that the more informed citizens are, the less likely they are to participate in cancer screening (4). (see also : https://cancer-rose.fr/en/2021/01/24/objective-information-and-less-acceptance-of-screening-by-women/ )

Yet the 2020 WHO guide (5) on screening provides very clear information on the principles to be followed. The guide points out that the risk of these measures to increase participation rates is that people's autonomy to make an informed decision is threatened.

To avoid this, the guide recommends taking care to enable informed consent and to protect individual autonomy.

However, none of the actions in the roadmap of the Cancer Plan address the improvement of information to the population on the benefits and risks of screening, as recommended by the WHO 2020 guide. Similarly, there is no measure on the training of professionals in risk communication as recommended by the WHO. Yet the WHO guide gives as examples tools such as infographics, videos and decision aids can facilitate understanding and promote informed consent as well as evidence-based practices. And it points out that both lay people and clinical physicians tend to overestimate the benefits of screening and underestimate its harms. (see also https://cancer-rose.fr/en/2020/12/18/perception-and-reality-2/)

The WHO guide also indicates the principles that must be respected in a screening policy: 

« 1. Respect for dignity and autonomy. Autonomy is the capacity to make an informed and uncoerced decision. »

2.Non-maleficence and beneficence. Non-maleficence means doing no harm to people; beneficence aims to do good for people.

3.Justice and equity. In health care, justice concerns fair allocation of resources and that resources are allocated proportionate to the need.

4.Prudence and precaution. The precautionary principle requires foresight, planning for the potential outcomes of screening and making wise judgements based on these future concerns.

5.Honesty and transparency. This requires clear and transparent communica- tion, thus promoting accountability. » One may wonder whether these fundamental ethical principles will be respected in the new roadmap of the Cancer Plan, which focuses as much on the participation rate, with the ambition of exceeding the European objectives, but without worrying about information to the population and the training of professionals

How to make an informed decision when information is not provided or is incomplete and biased (see :

https://cancer-rose.fr/en/2021/01/01/critical-analysis-of-the-new-inca-information-booklet/ )?

The INCA booklet should be reviewed, particularly with regard to the targets for participation rates. It should be produced by an independent committee without conflict of interest and with the involvement of a panel of women as was done by the National Health Service in the UK and described by Forbes et al, 2014 (6). The 25 women on the panel, aged 47 to 73 years and recruited from the streets of London, came from a variety of professional and ethnic backgrounds. The NHS brochure does not seek to encourage screening or ask citizens to make decisions without guidance. And the committee that wrote UK brochure states that :  « policy of judging the performance of cancer screening only on measures of uptake is, arguably, inconsistent with the policy of supporting informed choice. » (6)

How can the principle of non-maleficence be respected when some women suffer the effects of overdiagnosis, without being properly informed of these risks beforehand?

Concerning the principle of honesty and transparency, danish researchers in screening (Rahbek et al, 2021 (4)) have cited the official INCA brochure as an example of presenting statistics in a misleading way, such as relative % reduction in mortality. And according to these scientists, this misrepresentation is an influence technique to increase participation in screening. The bias introduced by these relative mortality reduction values is also explained and criticized in the GIJN guide developed by RecheckHealth for investigative journalists reporting on health affairs and issues (7).

According to Rahbek et al, 2021 (4) insofar as patient autonomy and informed choice are important, the use of these types of influence remains ethically dubious in cancer screening programs where the benefit/harm ratio is complex and scientifically contested.

In addition, this INCA brochure, even if biased and incomplete, is not transmitted to all women, since it is sent only one time at age of 50, so women who were over the age of 50 in 2017, when the brochure started to be sent, have not received it.

Conclusion

Elsewhere than in France, efforts are being made to provide better information. Increasingly, the scientific literature emphasizes the need to inform citizens in order to make an informed decision about the benefits and harmful effects of screening for healthy people.

Especially this is the case in screening programs where the benefit/harm ratio is complex and scientifically contested and where the consequences of screening are complex and require personal choice, as in the case of breast cancer screening.

The ten-year strategy could have taken this into account in France as well, but it missed this opportunity, at the cost of a lack of information for women and training for professionals. 

References

  • (1) Citizen and scientific consultation, 2016

Report Key points Translated in English https://cancer-rose.fr/en/2021/03/16/citizen-and-scientific-inquiry-report/

https://www.re-check.ch/wordpress/en/projects/gijn-guide/

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Cancer Rose is a French non-profit organization of health care professionals. Cancer Rose performs its activity without advertising, conflict of interest, subsidies. Thank you to support our activity on HelloAsso.