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Informed and shared decision making in breast cancer screening. Is it possible in France?

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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?

  1. 1. www.cancer-rose.fr Informed and Shared Decision Making in Breast Cancer Screening Is it possible in France ? An international review
  2. 2. www.cancer-rose.fr 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
  3. 3. www.cancer-rose.fr 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.
  4. 4. www.cancer-rose.fr Overdiagnosis
  5. 5. www.cancer-rose.fr Alert of Cochrane Collaboration The percentage variation between the initial value 0.0025 and the final value 0.002 is -20%.
  6. 6. www.cancer-rose.fr 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
  7. 7. www.cancer-rose.fr 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)
  8. 8. www.cancer-rose.fr 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 

  9. 9. www.cancer-rose.fr DECISION AIDS ALREADY EXISTING
  10. 10. www.cancer-rose.fr DECISION AIDS ALREADY EXISTING United Kingdom
  11. 11. www.cancer-rose.fr Australia DECISION AIDS ALREADY EXISTING
  12. 12. www.cancer-rose.fr DECISION AIDS ALREADY EXISTING Belgium Germany
  13. 13. www.cancer-rose.fr -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 ?
  14. 14. www.cancer-rose.fr 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.
  15. 15. www.cancer-rose.fr 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. »
  16. 16. www.cancer-rose.fr 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.)
  17. 17. www.cancer-rose.fr 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.)
  18. 18. www.cancer-rose.fr 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
  19. 19. www.cancer-rose.fr 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
  20. 20. www.cancer-rose.fr 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.)
  21. 21. www.cancer-rose.fr • 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
  22. 22. www.cancer-rose.fr
  23. 23. www.cancer-rose.fr 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.

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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