Presentation « Informed and shared decision making in breast cancer screening. Is it possible in France? » by Dr. Cécile Bour, Radiologist and President of non-profit organization Cancer Rose (www. cancer-rose.fr) during «  International days on the partnership of care with the patient » event organized by University of Côte d'Azur, Faculty of Medicine, Center for Patient and Public Partnership Innovation (CI3P), France, September 28-29, 2020. Cancer Rose is a French non-profit organization of health professionals.  Independent French medical doctors and a doctor in toxicology, have created the site www.cancer-rose.fr to inform you of the most recent and relevant data on breast cancer mass screening. By decoding and popularizing the most recent research findings published in the most important international medical journals, analyzing the controversy and providing a social and feminine analysis, our objective is to inform women concerned by breast cancer mass screening in order to help them making their choice and to provide independent information resources to interested physicians. Cancer Rose has no sponsorships, honoraria, monetary support or conflict of interest from any commercial sources.

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Informed and Shared Decision Making in Breast Cancer Screening
Is it possible in France ?
An international review

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Alert of Cochrane Collaboration
2000 - Cochrane's "Screening for Breast Cancer
with mammography".
• A surprise guest: over-diagnosis, the concepts of
needless diagnosis and the perverse effects of
mammography screening are identified
• False alarms
• No significant decrease in mortality
-Between 1980 and 2000 : breast cancer
incidence x 2
-Overall mortality unchanged

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Overdiagnosis
Definition : histological diagnosis of a "disease"
which, if it had remained unknown, would never
have caused any harm to the patient's health or life
during her lifetime.
• Irrefutable; demonstrated by :
• epidemiological studies with a high level of
evidence,
• autopsy studies.
• At least 20%, between 30 and 50%: one out of
three cancers detected, or even one out of two,
would be an unnecessary diagnosis.

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Overdiagnosis

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Alert of Cochrane Collaboration
The percentage variation between the initial value 0.0025
and the final value 0.002 is -20%.

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Whistleblowing en France
2003 : Bernard Junod, researcher in epidemiology and public
health, concepts of over-diagnosis
Prescrire French medical journal :
2006: publication of a series of articles
No evidence of benefits
Underestimation of adverse effects
Unfair information for women
Que choisir French magazine : Consumer Association Files
Formindep /Cancer Rose, two French non-profit health
professionals organizations : work on promoters conflicts of
interest - launching information campaigns

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French Civil and Scientific consultation on breast cancer
screening , September 2015
• Panel of scientists
• Panel of citizens
• Steering committee (without
interest links with
mammography screening).
Third independent European evaluation
of screening after Switzerland and Great
Britain
All three request :
• A complete and balanced information
• Recognition of overdiagnosis
Two of them request :
• Termination of screening
( Swiss and French inquiries )
INCa (National Institute of Cancer in France), yet highly criticized for its
shortcomings, is entrusted to design "aids", a leaflet and a site.
• Overdiagnosis minimized, overtreatment not mentioned.
• No visual support with concrete data.
• Effect on mastectomies not addressed.
• Breast cancers screening remains a target of ROSP (remuneration on public health
objectives for doctors)

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WHY MAKE DECISION AIDS TOOLS?
Evolution of practices
EBM or evidence based medicine
1) External experience : scientific studies
2) Internal experience : what we learn form medical practice
3) Preferences and values of patients

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DECISION AIDS ALREADY EXISTING

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DECISION AIDS ALREADY EXISTING
United Kingdom

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Australia
DECISION AIDS ALREADY EXISTING

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DECISION AIDS ALREADY EXISTING
Belgium Germany

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-Checklist of items requested to comply with requirements of a
decision aid tool of quality
-Quantified data necessary to comply with checklist items
Decision aids tools of quality for informing patients :
• Positive and negative characteristics of the choices available to him,
patient understanding for shared decision, taking into account his
values
• Option to do nothing
• Quantification of the risks and harms resulting from his choice
• Provide the scientific sources on which it is based
• Use of visual diagrams
A decision aid tool complying with IPADD criteria,
would be feasible in France ?

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PROBLEM !!!
NO RELIABLE DATA IN FRANCE
FRANCIM NETWORK: 14 cancer registers for 19 French
departments, i.e. 24% of the population, from which national
estimates are made and generalized to the entire French
population.
BUT
• Non homogeneous populations
• Demographic, social and age disparities according to regions, not
entirely comparable.
• National figures = projections
• INCa (National Institute of Cancer) and Santé Publique France
(Public Health France) sites : cancer incidence rates are not
exactly superposable, depending on each institute's estimates.

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ASSUMED MANIPULATION OF WOMEN
AS A RESEARCH STUDY TOPIC !
ITALIAN STUDY 2020https://www.journals.uchicago.edu/doi/10.1086/708930
Early July 2020 -Scientific article - how to effectively
manipulate women to participate in mammography
screening under the title :
"A field experiment on the formatting of breast cancer
screening invitation letters".
"Our basic invitation letter does not contain any information
on the consequences of screening. »

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ITALIAN STUDY 2020https://www.journals.uchicago.edu/doi/10.1086/708930
"We show that a negatively-framed message, which adds “cheap”
information in the form of brief and general statements about the
consequences of screening to the original invitation letter, is able to
enhance take-ups »
Authors justify this manipulation as necessary for « limiting women’s
cognitive overload »
"this manipulation helps to decrease inequalities in screening”, as it
allows for a greater manipulative impact for subjects that, according to
them, are “with low average education, with no recent screening
experience, and for whom the available observable characteristics
would lead us to predict a low likelihood of screening in the absence of
any manipulation”
ASSUMED MANIPULATION OF WOMEN
AS A RESEARCH STUDY TOPIC ! (Cont.)

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FRENCH STUDY 2016 https://www.oncotarget.com/article/7332/text/:
"Decision Support for Breast Cancer Screening Reduces Attendance:
Results of a Large-Scale, Randomized, Controlled Study by the
DECIDEO Group".
".... Recent data on over-diagnosis and over-treatment have not
been implemented in decision support"
"In this large randomized clinical trial, we observed that the
DECIDEO decision aid led to a decrease in participation in breast
cancer screening "
ASSUMED MANIPULATION OF WOMEN
AS A RESEARCH STUDY TOPIC ! (Cont.)

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New Australian studies on over-diagnosis and mortality
trends: screening is no longer reaching its goal at all
to demonstrate real benefits.We are beyond controversy.
30,000 over-diagnosed cancers per year in Australia
https://www.mja.com.au/journal/2020/212/4/estimating-magnitude-
cancer-overdiagnosis-australia
-22% of breast cancers (including 13% invasive cancers)
-73% of thyroid cancers
The decrease in breast cancer mortality since the 1990s,
emerging in all countries and long before the introduction
of screening campaigns, is not attributable to screening
• Results UK Age Trial: after 23 years
• No significant decrease in breast cancer mortality for
women aged between 40 and 49 years.
• No impact on overall mortality

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MYPEBS STUDY in progress
'My Personal Breast Screening’
• Evaluate personalized risk-based screening strategy
• 80,000 female volunteers aged 40 to 70 years old
• 5 countries: Belgium, France, Israel, Italy and the United
Kingdom.
Verify that individualized risk-based screening is not worse than current
screening, tolerating an arbitrary 25% loss of effectiveness.
• Standard group, 480 tumors of stage 2 or higher expected / 100,000
women / 4 years of trial.
• If up to 600 advanced cancers in the individual screening group /
100,000 women (instead of 480), i.e. +25% : new screening
considered "not inferior" or "equivalent" to standard screening.
BEWARE OF POORLY DESIGNED CLINICAL STUDIES

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MYPEBS STUDY in progress
'My Personal Breast Screening’
MyPeBS is not a scientific study : it is a Marketing study !
Insufficient
information
for
participants
Software for the
individual risk
calculation without
scientific validation
Overdiagnosis and
overtreatment
minimized
Irradiation of
recruited young
women starting at
40 years old
BEWARE OF POORLY DESIGNED CLINICAL STUDIES (cont.)

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• MASS Screening benefit VERY UNCERTAIN
• Proven risks, immediately detectable in the population
(overdiagnosis, overtreatment, false alarms, irradiation, stress,
anxiety...)
-Accepting uncertainty and the option to do nothing
-Have the honesty to make a SHARED DECISION AID TOOL without
manipulation of information
-You can't tell a woman that screening will save her life, but you
can tell her that she is at risk of entering a disease trajectory that
she would not have known without it
-Instead of holding on to rigid positions, we must be honest,
informed and take into account the values and personal
experiences of patients (EBM)
CONCLUSION: NEED TO MOVE TOWARDS A SHARED DECISION

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Cancer Rose is a French non-profit organization of health care professionals.
Cancer Rose has no sponsorships, honoraria, monetary support or conflict of interest from any
commercial sources.