DECEMBER 14, 2022, BY CANCER ROSE
Recently, we relayed the EU Council's new screening guidelines, which we found to be rather prudent and thoughtful.
The text of the EU Council can be found here.
In broad terms, the Council emphasizes the need for additional information on the effectiveness, cost-effectiveness, and feasibility of certain screening strategies in the real life, especially for new screenings such as prostate, lung, and stomach cancer.
Member States are invited to evaluate the introduction of cancer screenings based on conclusive scientific evidence, taking into account the balance between the benefits and risks of the screenings, about which the public should be informed.
Publication in the Official Journal
The text has been published in the Official Journal. The following paragraphs seem to be of capital importance because they reflect the 2016 French citizens' consultation demands.
(8) “Screening is the process of testing for diseases in people in whom no symptoms have been detected. In addition to its beneficial effect on disease-specific mortality and on incidence of invasive cancers, the screening process also has inherent limitations, which can have negative effects for the screened population. These include false positive results, which can cause anxiety and may require additional testing that may pose potential risks, false negative results, which provide false reassurance leading to delays in diagnosis, overdiagnosis (i.e. detection of cancer not expected to cause symptoms during the patient’s lifetime) and subsequent overtreatment. Healthcare providers should be aware of all the potential benefits and risks of screening for a given type of cancer before embarking on new organised cancer screening programmes. Furthermore, these benefits and risks need to be presented in an understandable way that allows individual citizens to give informed consent to participate in the screening programmes.”
(24) It is an ethical, legal and social prerequisite that cancer screening should only be offered to fully informed people with no symptoms, if the benefits and risks of participating in the screening programme are well-known and the benefits outweigh the risks, and if the cost-effectiveness of the screening is acceptable. This assessment should be an inherent part of the implementation at national level.
The Council also recommends, in the same text, that Member States :
(4) “ensure that benefits and risks, including potential overdiagnosis and overtreatment, are presented to the people participating in the screening in an understandable way, potentially including on a health professional-to-participant basis, allowing individuals to express informed consent when deciding to participate in the screening programmes, and that the principles of health literacy and informed decision-making to increase participation and equity are taken into account;.”
Improving women's access to information: an absolute necessity
We emphasized the insufficient information in the INCa booklet sent to women, which, although some changes over the previous one, still lacks a visual pictogram allowing a simple understanding of the benefit/risk balance and does not mention screening risks but instead uses the term "limits" along with explanations to minimize them.
This publication is not in accordance with EU Council recommendations.
It is sent to the woman only once when she reaches the age of 50, after which she will only receive a leaflet at each subsequent screening, that fails to mention any of the risks of screening and refers to a website that is similarly susceptible to criticism. Over the course of a woman's lifetime, it is evident that the message that will remain in her memory will be the "embellished" leaflet, that omits the risks completely.
Leaflet - Breast Cancer Screening. Practical guide
This leaflet, whose content is largely based on that of the booklet, will be sent to women aged 50 and over when they renew their invitation to participate in the DOCS. It can also be distributed at information meetings.
In the EU Council's document, the different risks of screening, such as false alarms and overdiagnosis, are well defined (in part 8). In contrast, in the INCa leaflet, the definitions of these concepts are sometimes imprecise, often minimized, the definition of overdiagnosis is incomplete, and overtreatment is not explained (see our analysis).
In the booklet, there is no mention at all of overdiagnosis.
It is therefore urgent, based on the EU requirement regarding the presentation of screening risks to targeted populations, to improve the information provided to women invited to screening beyond the age of 50, from the age of 52 onwards, while also respecting the requirements for good literacy and without obscuring the concepts of false alarm and overdiagnosis, the two major risks of breast cancer screening.
In addition, 5-year survival is highlighted as a "benefit" in both the booklet and the leaflet, despite the fact that it is not a measure of screening effectiveness.
In the recommendation of the Council, it is stated:
(6) The main indicator of the effectiveness of screening is a reduction in disease-specific mortality or in incidence of invasive cancers.
In addition, the presentation of benefits and risks does not conform to EU Council recommendations for comprehension. The reduction in breast cancer mortality is given as a relative percentage reduction (15-21%), whereas the percentage of overdiagnosis is described as an absolute percentage (10-20%), making comparison impossible. This flaw already exists in the 2017 publication.
A 20% reduction in cancer mortality does not correspond to 20 fewer cancer deaths per 100 women screened.
This is an indication a relative risk only. 20% fewer deaths does not imply that 20 fewer women out of 100 will die of breast cancer if screened. The 20% reduction in mortality is simply a relative risk reduction between the two groups of women being studied.
In fact, according to a projection produced by the Cochrane Collective based on numerous studies, out of 2,000 women screened over a 10-year period, four die of breast cancer, whereas out of the same number of women who were not screened, five die of breast cancer. The shift from five to four represents a 20% reduction in mortality, but in absolute terms, just one woman's death will be prevented (absolute risk of 0.1% or 0.05%).
The range of 10-20% provided for the rate of overdiagnosis represents the lowest estimate. Other research indicate substantially higher overdiagnosis rates. Overdiagnosis is largely overlooked in the leaflet, and there is a striking omission of risk information that is easily understood.
What could be improved?
It is time for the health authorities to finally respond rigorously to the Council's recommendations published in the Official Journal and to respect the French population by complying with these recommendations.
These recommendations state that "the benefits and risks must be presented in an understandable way to allow citizens to give their informed consent to participate in screening programs."
To do this, a modern and validated strategy employs decision support tools, such as the one developed by the Harding Center for Literacy, which describes how harms might be presented visually.
The methodology is perfectly described here:
with the reference: https://www.hardingcenter.de/sites/default/files/2021-06/Methods_paper_Harding_Center_EN_20210616_final.pdf
8) Page 13, “Handling numbers and presentation of risks. The benefits and harms of medical intervention are balanced in fact boxes. By specifying the references and using the past tense, it is clear that these are study results, and thus no individual prediction is possible. The reference in numbers is always the same for the intervention and control groups. The event frequencies are communicated in absolute numbers. Relative risks are not reported. Which reference value is chosen (100, 1,000, or even 10,000) depends on the study data. It has to be ensured that the indication of integers is possible and that existing statistically significant differences become clear. The absolute change in risk is shown in the short summary of the fact box and the accompanying text. Mismatched framing (the presentation of advantages and disadvantages in different formats) is not used. ”
Another illustration is available in the WHO guide, on pages 37/38
“Both laypeople and clinicians tend to overestimate the benefits of screening and underestimate the harm of screening (36). Training personnel on communicating risk and tools such as infographics, videos and decision aids can be used to facilitate understanding and promote informed consent and evidence-informed practice (Fig. 15).”
See the infographic on page 38
We propose on our side a short illustrated tool, "Cancer Rose", based on French data, which you can consult here: https://cancer-rose.fr/en/breast-cancer-decision-aid/
The Council of the EU has issued recommendations, particularly on public information and the presentation of information that meets citizens' demands.
- The WHO calls for the respect of the Wilson and Junger principles (read here, middle of the article);
- the French citizen and scientific consultation asks for an improvement of the information with an honest and neutral presentation of the data,
- the EU Council strongly recommends an understandable presentation of the risks of screening, so what is the additional step that our French health authorities need to take in order to honestly and sincerely explain the benefits and risks to women allowing them to make a real informed choice?
We must stop hiding the risks of screening, to which women are shamefully subjected. Instead, we should inform them that screening might expose them to inconveniences and risks, including overdiagnosis, which can unnecessarily lead to a disease they would never have known without it.
Yes, it's really time....