The irreversibility of screening

Dr. C.Bour, September 26, 2022

A short history

Whether useful or not, introducing screening into the population is irreversible. This is demonstrated by history.

1° Prostate cancer screening

The American doctor who developed the test in 1970, Richard Albin, was himself alarmed by the "public health disaster" caused by his discovery. In an op-ed published in the New York Times in 2010, he wrote: "I could never have imagined, four decades earlier, that my discovery would cause such a public health disaster, driven by the pursuit of profit. The improper use of this dosage must be stopped. It would save billions of dollars and millions of men from unnecessary and mutilating treatments."

PSA testing has been controversial since 1989 in France. A "consensus conference" was organized by three urologists, Professors François Richard, Guy Vallancien, Yves Lanson, and the economist Laurent Alexandre. This expert consultation already concluded that "the organization of mass screening for prostate cancer is not recommended.”
A new consensus conference was held in 1998. The same year a clinical practice recommendation was issued that ruled even more clearly: "Since screening for prostate cancer (whether mass screening, directed at the entire population concerned or opportunistic screening, on a case-by-case approach) is not recommended in the current state of knowledge, so there is no indication for proposing a PSA test in this context.

But things are not that simple. The majority of learned societies and professional groups around the world are against screening. Still, three American associations (American Cancer Society, American Urological Society, and American College of Radiology) do not agree. Gradually, the French Association of Urology (AFU) (specialists in the male reproductive system) is gradually drifting away from this position, and a campaign is being launched to promote PSA testing.

The problem with this screening lies in the fact that there is no established effect on mortality, but that, on the other hand, it detects a large number of very slowly progressing cancers that would never have been manifested (overdiagnosis), but which, once detected, will be treated, with disastrous effects in terms of impotence and incontinence.
Another problem is that radiotherapy treatments can lead to the development of secondary cancers.

In 2011, the US Preventive Service Task Force (USPSTF) recommended that PSA screening for prostate cancer be discontinued, emphasizing its side effects. For every 1000 people treated, there are 5 premature deaths one month after surgery. Between 10 and 70 patients have serious complications but survive. Radiation therapy and surgery have long-term effects, and 200 to 300 patients will become impotent and/or incontinent.

And the French High Authority for Health (HAS) concluded, "No new scientific evidence is likely to justify re-evaluating the appropriateness of implementing a systematic screening program for prostate cancer by PSA testing." Opinion renewed in 2016: 2016 HAS opinion
"The French National Authority for Health thus recalls that current knowledge does not allow for the recommendation of systematic screening for prostate cancer by PSA testing in the general population or in populations of men considered to be at higher risk."
The National Cancer Institute's conclusion is along the same lines.

Unfortunately, the recommendations and day-to-day practice are making a big gap, and biopsies, as denounced in 2013, are increasing.

Prescription habits have a hard time, but credit insurers also impose this test in the "formalities" requested to take out a loan, exposing people to seriously harmful effects on their health.

2° breast cancer screening

From 1970 to 1980, in various countries (Norway, Denmark, Canada, New York, Sweden), women were included in experimental studies, called trials, which simply compared the outcome for screened women with unscreened women. At the time, this was possible because the women had never x-ray taken on their breasts. These studies showed a supposedly tremendous reduction in mortality due to screening, up to 30% less risk of dying of breast cancer.

However, as we now know, these first experiments were subject to numerous biases in the method, the distribution of women between the two groups, and the statistical analyses. The methodology did not meet the current qualification criteria. The best results were obtained with the worst mammograms.

From 1992 to 2000, the number of victorious and enthusiastic publications multiplied with a colossal media echo.

Finally, from 2000 to 2001, voices were raised to warn about the irregularities of the first trials and to raise the alarm about the risks of this screening.

Peter Gøtzsche and Ole Olsen, two independent Nordic researchers, performed a meta-analysis according to the methodology of the Cochrane collaboration to which they belong. And there is a shock because even by combining the best trials, there appears to be no statistically significant difference in mortality between screened and unscreened women: "there is no reliable evidence that screening decreases breast cancer mortality," concludes the study [1].
This conclusion was later confirmed by the independent journal Prescrire in 2006 [2].

Unfortunately, these researchers were not allowed to publish their results in the Cochrane reviews, except on the condition that they would include even the most biased trials to improve the results.

Lengthy negotiations followed, and in 2009, researchers Peter Gøtzsche and Margrethe Nielsen estimated that if all the trials, including the worst ones, were included in the meta-analysis, then screening could reduce breast cancer mortality by 15%, which is still a minimal and supposed benefit [3].
Above all, a surprise “guest” emerges, and that is overdiagnosis, i.e., the detection of indolent lesions, unnecessary to detect, which would never have had an impact on the life or health of the woman, but which will all be treated like any other cancer, with surgery, radiotherapy, or even chemotherapy, leading to deleterious overtreatment for the person. These over-treatments have physical, psychological, economic (loss of job), trans-generational (descendants labeled as 'at risk'), etc., consequences.

In 2005, Norwegian statistician Per-Henrik Zahl, a member of the Cochrane Collaboration, raised the problem of discrepancies between studies showing a decrease in mortality and data from the official Swedish cancer registry. There would be more reported deaths in the unscreened group and missing deaths in the screened group. The researcher proposed an article on these discrepancies to the medical journal The Lancet, which was rejected.

One year later, Per-Henrik Zahl managed to have it published online in the European Journal of Cancer [4]. This article was censored and was finally published in a Danish journal shortly afterward [5].

In The Lancet, Peter Gøtzsche, co-founder of the Cochrane Collaboration, denounced the unacceptable pressure he had been subjected to [6].

But the machine had been launched, and European countries had started campaigns with much media coverage, with slogans, celebrity endorsements, and popular events colored in pink. And the press, as well as the learned societies, the women largely influenced by the media, the doctors, the health authorities, preferred to stick to the enchanting story of a screening that saves...

In 2004, under the presidency of Jacques Chirac, breast cancer screening was generalized in France.

In 2015/2016, under the aegis of Health Minister Mrs. Marisol Touraine, a citizen and scientific consultation on breast cancer screening was organized. The steering committee proposed two scenarios in the final report, both calling for the cessation of breast cancer screening in its current form because of a very uncertain balance of benefits and risks, with a non-significant reduction in mortality and, in parallel important adverse effects, such as irradiation, false alarms (see video at the bottom of this link) leading to stressful complementary examinations, and overdiagnosis of course. The citizens request better information.

Nowadays, screening is still conducted in its usual form, and women receive information on the benefit-risk balance that is still unclear and obviously unbalanced[7][8].

The scientific controversy about this screening is qualified as fake news by the National Cancer Institute[9].

3-Bronchopulmonary cancer screening.

Two trials essentially (there were several studies) were supposed to provide evidence of a significant reduction in specific mortality from bronchopulmonary cancer due to low-dose radiation thoracic scanner (LDRT) screening. These were the US National Lung Screening Trial (NLST) and the NELSON trial conducted in Belgium and the Netherlands.

Already in 2014, in a scoping note, the HAS noted, ".... it is likely that the low specificity of low-dose CT screening will remain a major obstacle to the implementation of screening in clinical practice and a screening program."
"Disadvantages and risks associated with FD CT (low-dose CT) screening include radiation exposure ranging from 0.61 to 1.5 mSv, some degree of overdiagnosis that varies among studies, and a high rate of false-positive exams, usually explored with more imaging."

When we look at the study published in the NEJM on the NELSON trial, the last line of table n°4 reads: "All-cause mortality - deaths per 1000 person-yr 13.93 (screening group) 13.76 (control group) RR 1.01 (0.92-1.11)". Clearly, there is no impact on all-cause mortality by this scan screening. (Remember that the "overall mortality" figure includes everything, cancer, its treatment, and its non-treatment, and is, therefore, a better reflection of "real life" data)

But the Academy of Medicine has retained this criterion and expresses its concerns in a published report here and there. It notes several problems for not generalizing this screening:

  • The two major lung cancer screening trials with low-dose CT scans greatly underestimated the potential harms (false positives, overdiagnosis, false negatives, radiation, and overtreatment). The magnitude of the benefit and the magnitude of the risks are unknown, and even if the 25% cure rate is achieved among the subjects included in the study, the majority of patients will die early from other smoking-related diseases (other cancers, heart disease, emphysema, etc.) without increasing their life expectancy.
  • For screening to be effective, it is necessary to have cancers with a sufficiently long latency to "catch up" during a screening (thus the least possible number of interval cancers); however, the proportion of long latency cancers in the lung is low.
  • These cancers are mostly due to active smoking and, marginally, to passive smoking: more than 85% of cases can be attributed to smoking. The progressive decrease of smoking among men (60% of smokers in the 60s to 33% today) is reflected in the reduction of incidence and mortality due to these cancers", which is equivalent to saying that this cancer is simply accessible to good primary prevention campaigns, and to incentives to stop the main risk factor, tobacco.
    "The natural and progressive history of the disease must be known and the various forms defined." Between the ages of 50 and 74, lung cancers are mainly composed of adenocarcinomas, which seem to be the most easily detectable. For example, in the European NELSON trial, 61% of PBCs in the screened group were adenocarcinomas compared to 44% in the control group, which could explain a better effect of screening in women", explains the Academy.
  • Unknowns: on the target population, the desirable participation rate, the frequency of scans, the therapeutic indications for cancers discovered during the scan, the acceptability by patients, the motivation and the respect of smoking cessation, etc...
  • The people who participate in the trials are not representative of the entire population eligible for screening at a later date, which may lead to an overestimation of the effectiveness in the Nelson study.
  • An economic evaluation is also needed, as the Academy rightly points out that primary prevention is certainly more effective and less costly.

To rebound on the arguments of the Academy of Medicine, one must keep in mind the economic stakes of this screening, not only of the initial examination but also of the importance of the expenses caused by the iterative examinations in case of intermediate nodules (which must be followed during the years to control their evolution). Screening for bronchial cancer by CT would be 4 times more expensive than screening for breast cancer and 10 times more costly than screening for colorectal cancer.

For academics, what is essential is the fight against the main risk factor: smoking, the acceptance of its reduction is the very condition for the candidates selected for a possible regular screening.

The reactions were not long in coming. An APM news release of February 24, 2021, tells us three learned societies have taken a position.
"The three learned societies are the Francophone Intergroup of Thoracic Oncology, the Society of Pneumology in the French Language, and the Society of Thoracic Imaging. In this text, which updates previous recommendations, the learned societies reaffirm their position in favor of individual screening, by low-dose thoracic CT scan without injection of contrast medium, for which they specify the modalities." ......
"Contrary to the French Academy of Medicine, which proposes a low-dose CT scan once during a smoker's health check-up, the learned societies envisage a recurrent examination. They believe 2 CT scans should be performed one year apart and then one every 2 years, except for risk factors or previous examinations with an intermediate result, which should continue every year. And this screening should be continued "for a minimum period of at least 5.5 to 10 years."

Three radiologists contest the opinion of the Academy of Medicine, which persists and signs: https://lequotidiendumedecin.fr/specialites/cancerologie/controverse-sur-le-depistage-du-cancer-du-poumon-lacademie-de-medecine-repond-aux-prs-revel-lederlin... with an argument that should prevail in any screening: namely that of the GLOBAL mortality.
"The authors mention that PBC (bronchopulmonary cancer) mortality is reduced in the Nelson and NLST trials, but without taking into account the general mortality of the smoking population, the only important parameter to consider organized screening and which does not change in the various trials."
This parameter, let's remember, includes PBC mortality but also mortality due to treatments and mortality due to other causes, smokers being exposed to other pathologies (emphysema, other cancers, cardiovascular diseases).
The Academy still says it does not want to return to the "irradiation controversy" the authors write: "... our report is factual on this point, and we encourage you to reread this paragraph. However, it is regrettable that in none of the trials was precise dosimetry performed."

The High Authority of Health, initially reluctant in 2016, completely changed its attitude and gave in 2022 its green light to an experiment on lung cancer screening, despite the ineffectiveness of this scannographic screening to reduce all-cause mortality.

"The HAS considers that the state of knowledge is still incomplete and insufficiently robust for implementing a systematic and organized screening of PBC (bronchopulmonary cancer) in France. However, the data shows a decrease in specific mortality and authorize the initiation of a pilot program to document: the modalities of screening, the performance/efficacy and efficiency, the organizational constraints, and the ethical and social dimensions by testing several possible scenarios and on several screening ranks.

Thus, the HAS recommends that experimentation be carried out in real life concerning the French healthcare system to answer the outstanding questions."

In its report on page 70, the HAS considers that "The meta-analyses do not show a significant reduction in all-cause mortality, whatever the procedures compared: this criterion of judgment is not very relevant because of the interference of age and chronic smoking on mortality, and the need for very long-term follow-up on a large cohort.

This means that the HAS does not recognize overall mortality as the primary efficacy criterion, puts specific lung cancer mortality ahead, ignoring other causes of smoking-related mortality and morbidity, and considers randomized studies with 10-year follow-up insufficient. This means that any unproven screening can be defended and maintained, as is the case with breast cancer screening, which is currently unable to prove its effectiveness.

A new study is published in 2022. This population-based ecological cohort study found that low-dose CT screening of low-risk, mostly nonsmoking Asian women was associated with significant overdiagnosis of lung cancer. Five-year survival is biased by the increased detection of indolent, early-stage lung cancers that would never have killed.
She concluded that unless randomized trials can show some value for low-risk groups, low-dose CT screening should remain targeted only at heavy smokers.

A HAS opinion on the relevance of screening

Dr. Catherine Rumeau-Pichon, Assistant to the Director of Medical, Economic and Public Health Evaluation, HAS, explained in this video from 5 years ago, that screening must meet the following six criteria:

1- A disease that can be detected early before the onset of symptoms

2- A reliable test

3- Effective treatments against the disease must exist

4- People at risk must be identifiable

5- Screening must be known to decrease cancer mortality.

6- The benefit/risk balance must favor a preponderant benefit over the risks.

Let's examine screening (breast, prostate) in the light of these criteria

1- Early detection of disease before symptoms.

For breast and prostate, not always...

Cancers with a long residence time in the breast, therefore not very progressive, are easily detected by screening before their symptoms because they are slowly progressive. They contribute to the overdiagnosis of many cancers.

On the other hand, cancers with a poor prognosis, with a high potential for progression and rapid growth, are 'missed' by screening because they are too fast to be 'caught' (these are the false negatives).

Their natural history is, therefore, not linear and predictable and is still not known at present. For prostate cancer, aggressive cancers often release their metastases from the start.

2- Reliability of the test

No

Mammography is a poor screening tool; it has good sensitivity for atypical lesions and in situ cancers, the least aggressive ones; it has poor sensitivity for high-stage cancers, triple negatives, and infiltrating forms.

The PSA level may be high in cases of simple benign prostate hypertrophy. A high level is not specific to cancer.

3-Effective treatments

Yes

For breast cancer, the effectiveness of treatments has improved significantly since the 1990s, and it is said that 9 out of 10 cancers are cured, even for those not detected.
For this reason, moreover, the usefulness of screening is diminishing.

Whether treated or not, prostate cancer rarely metastasizes (about 1 in 10 cases). When it does metastasize 90% of the time, it results in bone metastases.
While bone metastases usually have a poor prognosis for other cancers, this is not necessarily the case for prostate cancer. Whether it has metastasized or not, prostate cancer is often a slow-moving disease.
For this cancer, patient survival is improving year after year thanks to the appearance of new treatments and therapeutic combinations.

4-Identifiable persons at risk.

No

For breast cancer, risk factors predisposing to cancer can be identified, such as exposure to toxic substances, night work, and family history...
But not all women who smoke or work at night will automatically develop breast cancer, and there is no reliable link between a specific risk factor and breast cancer, not as clear-cut as smoking and developing bronchopulmonary cancer (and yet, here again, systematic screening of smokers is not recommended).

Only 5% of cancers are hereditary. This is too rare a phenomenon to impose screening on an entire healthy population with no family risk.

Women without risk, neither exposure nor intrinsic, can develop breast cancer without apparent 'reason.'

For prostate cancer, too, no risk factor has been identified and linked to this cancer.

5-Decrease in mortality

No

Impact studies have shown that mortality decline for several solid cancers has been effective since the 1990s and was not attributable to screening. This pattern of decline was also found for cancers not included in screening programs.

Breast: Norway study; impact study
Prostate: Ref: http://onlinelibrary.wiley.com/doi/10.1002/pros.20017/abstract; Labrie, Quebec, 2004

6-The benefit/risk balance in favor of the benefit

No

For the breast, this is no longer the case. Even in the most favorable hypotheses, such as the Marmot report, there is still more overdiagnosis than "lives saved."
M.G. Marmot, D. Altman, D. Cameron, J. Dewar, S. Thompson, M. WilcoxThe benefits and harms of breast cancer screening: an independent review Lancet, 380 (2012),. Marmot
Other independent reviews are even more severe; see our summary here: https://cancer-rose.fr/en/2020/12/15/the-over-diagnosis-in-a-graph-and-a-table/

When the three main disadvantages of systematic breast cancer screening are added: overdiagnosis, false alarms, radiation-induced cancers, and deaths attributable to overtreatment, the benefit/risk balance is always unfavorable.

For prostate cancer, really aggressive cancers release their metastases at the beginning of the disease. In this case, treatment will not protect against death. The treatments for this cancer have adverse effects that can be important (urinary incontinence, impotence). The patient's life will be altered more than "saved."
The elderly patient is more likely to die before from something other than his cancer.
Between 50 and 75, there is no proof that screening for this cancer would save people (HAS). The WHO does not recommend this screening either.

In the Canadian study, there is more mortality in the screened group because the risks of screening and the collateral effects of biopsies and treatments in screened men outweigh the benefit, which is minimal.

Overall all-cause mortality was almost the same in men who had surgery as in men who did not have surgery.

==> in total:

Of 6 requirements, breast and prostate cancer screening fail to meet 5 of them.

And nevertheless...

...the European Commission proposes at the end of 2022 an extension and/or a resumption of certain screenings and the implementation of new ones.
The objective is that by 2025, 90% of the EU population will be screened for breast, prostate, cervical, and colorectal cancer.
In addition, lung and stomach cancer screening will be included, although no conclusive studies exist for the latter.

Many media have copiously relayed this information without any further critical analysis...

The European commissioner Mrs. Stella Kyriakides issued in September the following speech
"Today, we know that it is estimated that one in two EU citizens will develop cancer during their lifetime."

However, the European Commissioner fails to mention that life expectancy in Europe continues to increase.
This is pure fear-mongering, creating a feeling of urgency, threatening the population, and must be addressed with great diligence.
This is a well-known technique to push for a change to be immediate and experienced as necessary, as is advocated in the business world.

John P. Kotter, Professor at Harvard Business School, outlines the elements for management of change:
"To succeed in a project or a change, it is important to demonstrate the need for it. The most effective way is to trigger a need that your project will meet by creating a sense of emergency among all your employees. Expose the risks the company is taking by not changing the way it operates."

Conclusion

Cancer takes a particular place, unlike other pathologies, even the most serious or deadly. It has replaced the scourges of the Middle Ages, tuberculosis, and syphilis of our elders. It symbolizes insidious evil and is always associated with the silent killer.

Despite all the knowledge accumulated over the last decades on the flaws and failures of screening, the fear of cancer is so deeply rooted in us, perpetually conveyed by societal, medical, and media messages, that any call for caution about the myth of saving early detection is vain.

Advances have been made, thanks to the failure of screening, our knowledge has progressed on the mechanics of cancer evolution, and we have learned about the complexity of the natural history of the disease.

But often, during the media communication of the pink October campaigns, it is enough for one or several "cancer-survivor" stars, television hosts, or politicians to claim to have survived thanks to a "saving" screening, feeling missioned to carry his experience as exemplary and emblematic, presumptuously setting himself up as a spearhead of a "noble cause," for everything to be reconsidered.
Or a blind decision by the European Commission...

There is nothing more powerful than the infusion of terror to suppress all reasoned, prudent, and scientific argumentation and to sweep away all efforts of neutral and objective information of the population.

We have not learned from past medical errors, the history outlined at the beginning of this article shows to what extent decisions taken too hastily and prematurely in the implementation of screenings lead to health disasters, carefully concealed from the public to whom only "benefits" are dangled.
These disasters and endangerment of people continue, and the media only communicate very sparingly on this subject.
Many screenings, especially for breast cancer, should never have been done and have resulted in resounding fiascos (like thyroid, neuroblastoma in children, and melanoma).
The European Commission even plans to implement a stomach cancer screening for which there is NO scientific evaluation...

The future seems quite dark because, at this frantic pace of repeated screenings, the only healthy individuals will be the ones who escape these macabre rituals, renewed during their life like a morbid litany, and which will propel healthy people into diseases they should never have known.

Read also the last post of Luc Perino-(in French)

References


[1] Olsen, O., & Gøtzsche, P. C. Screening for breast cancer with mammography. The Cochrane Database of Systematic Reviews. 2001; (4): CD001877.

[2] Mammographies et dépistage des cancers du sein : Pour un choix éclairé des femmes désirant participer au dépistage. In : Prescrire. [En ligne : https://www.prescrire.org/aLaUne/ dossierKcSeinDepSyn.php]. Consulté le 12 mai 2021.

[3] Gøtzsche P. C., Nielsen M. Screening for breast cancer with mammography. The Cochrane Database of Systematic Reviews. 2009 Oct 7; (4): CD001877.

[4] Zahl PH., et al. WITHDRAWN: Results of the Two-County trial of mammography screening are not compatible with contemporaneous o icial Swedish breast cancer statistics. European Journal of Cancer. 2006 Mar 9.

[5] Zahl PH, et al. Results of the Two-County trial of mammography screening are not compatible with contemporaneous o icial Swedish breast cancer statistics. Danish Medical Bulletin. 2006 Nov; 53(4): 438-40.

[6] Gøtzsche P. C. What is publication? The Lancet. Nov 2006; 368(9550): 1854-56

[7] https://cancer-rose.fr/en/2021/01/01/critical-analysis-of-the-new-inca-information-booklet/

[8] https://cancer-rose.fr/2018/02/11/10552/

[9] https://cancer-rose.fr/en/2021/06/24/press-release-cancer-rose/

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Too much, too mild, too early: the excessive expansion of diagnoses

A summary of three articles

DOI https://doi.org/10.2147/IJGM.S368541

By Bjørn Hofmann 1, 2
1 Institute of Health Sciences, Norwegian University of Science and Technology, Gjøvik, Norway; 2 The Center of Medical Ethics, Faculty of Medicine, the University of Oslo, Oslo, Norway

Considerable scientific and technological progress has dramatically improved diagnosis. At the same time, false alarms, overdiagnosis, overmedicalization, and overdetection have emerged as corollaries compromising health care quality and sustainable clinical practice.

The article summarized here identifies three generic types of overdiagnosis: too much, too little, and too soon.

Due to significant scientific and technological advances, diagnoses have increased dramatically. More people are being diagnosed with more diseases than ever before, with an unwarranted expansion of diagnoses.

An increase in the number of diagnoses in the International Classification of Disease (ICD).

A-too many diagnoses:

This consists of labeling previously undiagnosed phenomena and including new phenomena in a pathology framework.
These may be a) ordinary life experiences, such as loneliness or grief, b) social phenomena, such as academic behavior in children (ADHD), or c) biomedical phenomena, such as high blood pressure, obesity, or risk factors that are measurable.
But this trend does not benefit individuals and can be harmful.

B-Diagnoses issued too lightly: setting thresholds too low and making it too easy to include in pathology

This is a lowering of the threshold for detection of pathology beyond what benefits the person, i.e., accepting threshold values that are too low.
By including less severe cases in the definition of disease or its diagnostic criteria, people may be diagnosed with diseases that may not bother them.
Examples include gestational diabetes and chronic kidney disease.

C- Diagnoses made too early:

Diagnosing conditions too early that will never impact individuals, detection of precursor or low-grade lesions, is consistent with overdiagnosis which leads to overtreatment.

Why is this harmful?

First, the author explains that our diagnostic capabilities far exceed our helping capabilities. Not only do we lack curative measures for all established diagnoses, but the many diagnostic technologies also come with errors, and we come to diagnose when it does not help people.
Although we can detect more phenomena than ever, we do not know if they are relevant in what they represent or predict.

A- over-diagnosing...

.... of biomedical phenomena when they are not experienced in pain, dysfunction or suffering leads to doing the wrong thing by applying inappropriate labels and treatments, diverting us from more effective measures and causing harm through treatment.
Mild hypertension or hyperglycemia, or various risk factors, such as obesity, are most often not experienced as painful or dysfunctional, but their treatment can introduce potential diagnostic and treatment-related harm.
For example, the increased use of statins inappropriately in people with no complaints leads to headaches, dizziness, constipation, diarrhea, muscle pain, fatigue, sleep problems, and decreased blood platelet counts. Here, getting an over-diagnosis can reduce the quality of life, cause anxiety and stigma.

B-In the case of a diagnosis made too lightly,

we inflate the diagnosis by including phenomena that are too mild to cause a symptom, pain, dysfunction, or suffering, and the treatment causes more harm than good.
In such cases, we provide unnecessary treatment and introduce potential harm through diagnosis and treatment.

C-Too early diagnosis,

(as in many screenings) leads to overdiagnosis and overtreatment and potential harm from both. The cases we detect and treat would never have caused the person problems if undiscovered.

Therefore, we violate the ethical principles of non-maleficence and beneficence.

In addition, we drain resources from health services (justice of care issue), and patients are unaware that they are overdiagnosed and overtreated (patient autonomy issue).

Other examples cited in the article:

Changing the definition of osteoporosis by modifying the T-score threshold that reflects bone density in the 2008 National Osteoporosis Foundation guideline increased the prevalence (present+new cases) from 21% to 72% in US women older than 65.
Changing the definition of prediabetes by fasting blood glucose in the 2010 American Diabetes Association criteria increased the prevalence from 26% to 50% in Chinese adults older than 18.

Conclusion

As a result, the author of the article suggests three ways to reduce excesses and advance higher-value care for the population: a)we must stop diagnosing new phenomena, b)we must stop diagnosing benign conditions, including lowering diagnostic thresholds, c) and we must stop looking for early signs and markers that do not cause pain, dysfunction, and suffering, and will not harm if undetected..

A more precise definition of overdiagnosis, the "too early" of the previous article

According to Jeffrey K Aronson, the concept of "Overdiagnosis" (the "too soon" of the previous article) includes 2 categories:
1° labeling people with a disease that, undiscovered, would not have harmed them ;
2° broadening the definition of a disorder to as many individuals as possible by changing the threshold of a diagnostic test (which is the same as "too light")

The author, a British clinical pharmacologist at the Centre for Evidence-Based Medicine (Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK), explains in his article published in the BMJ the genesis of this term, now included in the Mesh, (Medical Subject Headings) which is the reference thesaurus in the biomedical field.
Read here: https://www.bmj.com/content/375/bmj.n2854

In recent years says the author, "definitions (of overdiagnosis) that have been suggested include:
- "...people ...diagnosed with conditions that will never cause symptoms or death."
- "Diagnoses of a condition that, if not known, would not cause symptoms or harm to the patient in their lifetime."
- "(The act of) making people 'patients' unnecessarily, by identifying problems that would never have caused harm or medicalizing ordinary life experiences through expanded definitions of disease."

The last of these definitions include the two main factors that constitute overdiagnosis, although they are not synonymous with it: overdetection and over definition. "

The author further reminds us that overdiagnosis is not synonymous with a false alarm, although this confusion is often made. (Overdiagnosis: true lesion but whose discovery does not bring anything; false alarm: suspicion of cancer but which is not confirmed).

As a final thought, J. Aronson summarizes three different ways of turning people into "patients" or "sick":

1.         Labeling them with some condition that would not have harmed them if it had not been discovered; this is related to the heterogeneity of many conditions, resulting in a range of conditions within the category, not all of which require attention; this is called blurring within the disease category;
2.         Expanding the definition of a disorder to encompass more individuals; this has been attributed to what has been called the blurring of the outer boundary of a disease definition ;
3.         By labeling them with a category of illness that medicalizes ordinary experience, such as pregnancy, this phenomenon is known as "mongering."

A call from Canadian scientists

We conclude this article by quoting a call for action by Canadian scientists to improve health care education.

The authors write:
▸ Over the past decade, decisions about screening have become more complex owing to a better understanding of potential benefits and harms. Strongly held beliefs and screening advocacy from individuals and groups point to the need to understand and consider individual patient preferences and values in screening decisions.
▸ Many physicians, other health care providers, and learners find conflicting and misleading information on screening to be challenging.
▸ Most screening decisions include a trade-off between potential harms and benefits.
▸ Physicians should understand the evidence and communicate it using shared decision-making skills to arrive at an appropriate screening decision based on their patient's values and preferences.”

Many physicians, health professionals, and learners lack the necessary knowledge and skills related to screening challenges. Many lack critical thinking skills, statistical understanding, or communication skills.

The authors suggest a need to improve the training of physicians, health care professionals, and learners in screening, risk understanding, and risk communication.

Conclusion of the call:

There are two challenges:

The first challenge is the development of educational content related to key concepts related to screening.
The second challenge is the development of educational strategies to place the teaching and adoption of these concepts at the core of medical education among medical students, residents, and clinicians.

“Clinician teachers, learners, professional societies that develop guidelines, screening agencies, and academic institutions should reconsider the optimal approach to the uptake and implementation of guidelines. This change in focus should encompass the breadth of learners from undergraduate medicine to continuing professional development and the breadth of stakeholders from patients to agencies. Now is the time to swim against the tide and reconsider our approaches to teaching and communicating prevention and screening information, ensuring they encompass an understanding of complexity, core concepts, and best practices.”

References

  1. Hofmann B.
    Too Much, Too Mild, Too Early: Diagnosing the Excessive Expansion of Diagnoses. Int J Gen Med. 2022;15:6441-6450 https://doi.org/10.2147/IJGM.S368541

2. Viola Antao, Roland Grad, Guylène Thériault, James A. Dickinson, Olga Szafran, Harminder Singh, Raphael Rezkallah, Earle Waugh, Neil R. Bell 
À l’encontre du statu quo en matière de dépistage Canadian Family Physician May 2022, 68 (5) e140-e145; DOI: 10.46747/cfp.6805e140

3. Aronson J K. When I use a word . . . . Too much healthcare—overdiagnosis  BMJ  2022;  378 :o2062 doi:10.1136/BMJ.o2062

Cancer Rose est un collectif de professionnels de la santé, rassemblés en association. Cancer Rose fonctionne sans publicité, sans conflit d’intérêt, sans subvention. Merci de soutenir notre action sur HelloAsso.


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.

Cancer screening for older adults; a bad idea

Patient-Reported Factors Associated With Older Adults' Cancer Screening Decision-making: A Systematic Review
https://pubmed.ncbi.nlm.nih.gov/34748004/

Jenna Smith 1 2Rachael H Dodd 1 2Karen M Gainey 2Vasi Naganathan 3Erin Cvejic 2Jesse Jansen 1 2 4Kirsten J McCaffery 1 2

  • Wiser Healthcare, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
  • 2Sydney Health Literacy Lab, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.

Objective of the study: 

To summarize the patient-reported factors associated with older adults' decisions regarding screening for breast, prostate, colorectal, and cervical cancer.

Method:

21 studies were included.

Factors associated with decision-making were synthesized into 5 categories: demographic, health and clinical, psychological, physician, and social system.

The most commonly identified factors included personal or family history of cancer, positive screening attitudes, routine or habit, gaining knowledge, friends, and a physician’s recommendation.

Results:

Although guidelines suggest incorporating life expectancy and health status to inform older adults’ cancer screening decisions, older adults’ ingrained beliefs about screening may run counter to these concepts.

Consequently, communication strategies are needed that support older adults to make informed cancer screening decisions by addressing underlying screening beliefs in context with their perceived and actual risk of developing cancer.

Cancer Rose commentary

We analyzed the CNGOF (CNGOF-French national college of obstetricians and gynecologists) campaign of 2019, a stunning "cry of alarm" for breast cancer screening in older women, with spectacular media coverage in a clear sky, while no country practicing screening recommends screening beyond the age of 74, nor even the WHO...

Why is this campaign, still relayed on this learned society's homepage, a danger to the elderly?

A study from the University of Leyden provides an answer.

Read here: https://cancer-rose.fr/2019/04/07/la-campagne-pour-le-depistage-de-la-femme-agee-par-le-college-national-des-gynecologues-et-obstetriciens-de-france-cngof/

Few trials have focused on screening women in old age. The study by researchers from the University of Leyden on data from the Netherlands, published in 2014 in the BMJ, makes up for this lack.

According to the authors, after the age of 70, organized breast cancer screening would be useless. Indeed, at this age, screening does not significantly improve the detection of advanced cancers but instead increases the number of overdiagnosis and, therefore, overtreatment.

In the Netherlands, breast cancer screening has been offered to women up to 75 since the late 1990s. "Yet there is no evidence that screening older women is effective," the study authors explain, citing that few trials have been conducted specifically on these age groups.

For the Dutch researchers, systematic screening after 70 years of age would mainly lead to the detection and treatment of lesions that would not have developed into disease during the life of the patients.

These unnecessary treatments have a considerable impact on health, and the co-morbidity of these older adults is too high, as they are less able to tolerate the side effects of treatments, such as surgery, radiotherapy, and chemotherapy.

For this reason, they recommend that generalized screening not be extended to those over 70 years of age and recommend an individualized decision based on life expectancy, breast cancer risk, general condition, and preference of the women concerned.

It should also be remembered that the immune system weakens with age. This means that we contract more cancers and infectious diseases.  All the organs become exhausted and function less well, and the healing and tissue regeneration faculties are lessened, all of which must be considered when administering heavy treatments.

Conclusion

A point of view published in the JAMA in 2019 raised the question of the relevance of screening for older adults. While all recommendations stop this screening at 74 years of age, it is unfortunately not uncommon to see people beyond that age being sent for screening and "check-ups."

The authors argue that the evidence of benefits for older adults is unclear, and the chance of harm becomes greater (e.g., overdiagnosis, burdens of additional testing, false-positive results, and psychological impacts).

Although aging-related concepts are challenging to communicate, older people must be counseled about the reduced benefit and increased chance of harm from screening associated with limited life expectancy and worsening health to make better quality screening decisions. Communication strategies are needed that support older adults in making informed cancer screening decisions.

The principle of non-maleficence implies not harming people, a principle that even a learned society like the CNGOF must adopt.

Glasgow-communication

The Australian author reported at this week's ICCH2022 INTERNATIONAL CONFERENCE ON

COMMUNICATION IN HEALTHCARE (September 5-9, 2022, Glasgow), the results of an interview-based study involving general practitioners regarding cancer screening in older adults.

General Practitioners' Approaches to Cancer Screening in Older People, A Qualitative Interview Study
https://each.international/eachevents/conferences/icch-2022/programme/

Session Description:

Background: Older adults continue to be screened for cancer with limited knowledge of the potential hams. In Australia, general practitioners (GPs) may play an important role in communication and decision-making around cancer screening for older people. This study aimed to investigate GP’s attitudes and behaviours regarding cancer screening (breast, cervical, prostate and bowel) in patients aged ≥70 years (as screening programs recently began targeting ages 70-74). Methods: Semi-structured interviews were conducted with GPs practising in Australia (n=28), recruited through multiple avenues to ensure diverse perspectives (e.g., practice-based research networks, primary health networks, social media, cold emailing). Transcribed audio-recordings were analysed thematically. Findings: Some GPs initiated screening discussions only with patients younger than the upper targeted age of screening programs (i.e., some thought 69 or 74 years). Others initiated discussions beyond recommended ages. When providing information, some GPs were uncomfortable discussing why screening reminders stop, some believed patients would need to pay to access breast screening, and detailed benefit and harms discussions were more likely for prostate screening. When navigating patient preferences, GPs described patients who were open to recommendation, insistent on continuing/stopping, or offended they were not invited anymore, and tailored their responses accordingly. Ultimately the patient had the final say. Finally, GPs considered the patient’s overall health/function, risk, and previous screening experience as factors in whether screening was worthwhile in older age. 

Discussion: There is no uniform approach to cancer screening communication and decision-making for older adults in general practice and limited understanding among both older people and GPs around why screening has an upper targeted age. Tools to support effective communication of the reduced benefit and increased chance of harm from cancer screening in older age are needed to support both older people and GPs to make more informed cancer screening choices.

Cancer Rose est un collectif de professionnels de la santé, rassemblés en association. Cancer Rose fonctionne sans publicité, sans conflit d’intérêt, sans subvention. Merci de soutenir notre action sur HelloAsso.


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.

Overdiagnosis, the silent pandemic of the West?

May, 25th

http://www.publichealthtoxicology.com/Overdiagnosis-The-silent-pandemic-of-the-West-,145733,0,2.html

The use of so-called "preventive" medicine to maintain good health is an intense and widespread phenomenon in modern Western societies. Although this appears logical and may have a solid scientific basis because it reflects medical community recommendations, several questions that require further investigation arise.

The authors believe that the most serious issue with this behavior in relation to modern medicine is overdiagnosis.

"What is good health?" and "What is a medical problem?" "What exactly are we looking for in medical examinations?" and "What is the relationship between medicine, society, and its practices?"

Cancer Rose est un collectif de professionnels de la santé, rassemblés en association. Cancer Rose fonctionne sans publicité, sans conflit d’intérêt, sans subvention. Merci de soutenir notre action sur HelloAsso.


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.

Why don’t we change our vocabulary?

May, 31th

https://philarchive.org/archive/LARCDS

This article argues that the phenomenon of overdiagnosis is linked to both our increasing knowledge of cancer and the fact that this new knowledge causes bias in cancer screening, but also to our approach to cancer and the associated medical vocabulary.

The authors selected two types of cancer as particularly exemplary: papillary thyroid cancer and carcinoma in situ of the breast.

The often militaristic semantics and abusive designations of "cancers" for lesions that are not life-threatening contribute to both an increase in societal anxiety and overdiagnosis, a real scourge of post-modern medicine.

Cancer Rose est un collectif de professionnels de la santé, rassemblés en association. Cancer Rose fonctionne sans publicité, sans conflit d’intérêt, sans subvention. Merci de soutenir notre action sur HelloAsso.


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.

Awareness of breast cancer overdiagnosis among women with breast cancer

June, 22

Effects of awareness of breast cancer overdiagnosis among women with screen-detected or incidentally found breast cancer: a qualitative interview study

This is a study conducted by an Australian team from the University of Sydney (Prof. Alexandra Barratt's team) that consists of qualitative research conducted through international interviews with women diagnosed with breast cancer who are aware of the concept of overdiagnosis.

The majority of the women who were followed became aware of overdiagnosis after their own diagnosis and felt impacted.

The discovery of overdiagnosis or overtreatment has had a negative psychosocial impact on the women's self-image and the quality of their interactions with health care professionals. For some, it has triggered deep remorse about their past decisions and actions.

The experiences of this small group of women provide unprecedented insight into the serious consequences of overdiagnosis after a breast cancer diagnosis.




Cancer Rose est un collectif de professionnels de la santé, rassemblés en association. Cancer Rose fonctionne sans publicité, sans conflit d’intérêt, sans subvention. Merci de soutenir notre action sur HelloAsso.


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.

The effect of breast cancer screening is declining

JULY 1, 2022 BY CANCER ROSE

https://academic.oup.com/eurpub/advance-article/doi/10.1093/eurpub/ckac047/6609838?login=false

By Søren R Christiansen, Philippe Autier, Henrik Støvring

The effect of breast cancer screening is declining

A new study raises the debate about the progressive decrease in the benefits of breast cancer screening which would be at a too low level compared to their consequences in terms of overdiagnosis and overtreatment.
Researchers from the University of Aarhus, Department of Public Health, Denmark, and the International Prevention Research Institute (IPRI), Lyon, France, are the authors of the study.
They state that breast cancer mortality has decreased over the past three decades due to improvements in patient management and better therapies, while the number of women needed to be invited to mammography screening in Denmark to prevent one cancer death in 10 years has doubled.

"As the beneficial effects of mammography screening declines ever more, we should consider abandoning the current mammography screening program with biennial mammograms for everyone aged 50-70. Perhaps a more targeted, high-risk screening strategy could be an alternative, if studies showed the strategy's beneficial effects," Støvring, associate professor in the department of public health at Aarhus University declared in an interview.

"I think we are approaching a point where just continuing might become untenable from an ethical point of view, as fewer and fewer women will experience gains due to screening (they would not die from breast cancer anyway due to improved treatment), but the number of women harmed due to overdiagnosis and overtreatment remains constant," he noted.

H.Støvring believes that for breast cancer the evidence for mammography screening is not convincing. He declared: "I think it is critical that we reassess screening programs as new evidence becomes available”. 

In conclusion, improvements in cancer therapy over the past 30 years have reduced mortality, which may erode the benefit-harm balance of mammography screening.

In addition, future improvements in the management of patients with breast cancer will increasingly reduce the benefit-risk ratio of screening.

The benefit of mammography in terms of reduced mortality declines while the harms such as overdiagnosis are unaffected. Screening leads to both overdiagnosis and overtreatment, which has a cost both on a human level and in terms of the economy.

Interview with the main author, June 24, 2022 by Helle Horskjær Hansen

https://health.au.dk/en/display/artikel/effekten-af-brystkraeftscreening-bliver-mindre-og-mindre-1

Screening for breast cancer has a cost. This is shown by a Danish/Norwegian study that analysed 10,580 breast cancer deaths among Norwegian women aged 50 to 75 years. 
"The beneficial effect of screening is currently declining because the treatment of cancer is improving. Over the last 25 years, the mortality rate for breast cancer has been virtually halved," says Henrik Støvring, who is behind the study.
According to the researcher, the problem is that screenings lead to both overdiagnosis and overtreatment, which has a cost both on a human level and in terms of the economy. 

Overdiagnosis and overtreatment

When the screening was introduced, the assessment was that around twenty per cent of the deaths from breast cancer among those screened could be averted. While this corresponded to approximately 220 deaths a year in Denmark 25 years ago, today the number has been halved. 

The study shows that in 1996 it was necessary to invite 731 women to avoid a single breast cancer death in Norway, you would have to invite at least 1364 and probably closer to 3500 to achieve the same result in 2016. 
On the other hand, the adverse effects of screening are unchanged.

"One in five women aged 50-70, who is told they have breast cancer, has received a 'superfluous' diagnosis because of screening – without screening, they would never have noticed or felt that they had breast cancer during their lifetime," says the researcher. 

One in five corresponds to 900 women annually in Denmark. In addition, every year more than 5000 women are told that the screening has given rise to suspicion of breast cancer – a suspicion that later turns out to be incorrect.

Peaceful, small nodes – but in who?

Henrik Støvring notes that the result is not beneficial for the screening programmes.

According to the researcher, the challenge is that we are not currently able to tell the difference between the small cancer tumours that will kill you and those that will not.

Some of these small nodes are so peaceful or slow-growing that the woman would die a natural death with undetected breast cancer, if she had not been screened. But once a cancer node has been discovered, it must of course be treated, even though this was not necessary for some of the women – we just do not know who.

"The women who are invited to screening live longer because all breast cancer patients live longer, and because we have got better drugs, more effective chemotherapy, and because we now have cancer care pathways, which mean the healthcare system reacts faster than it did a decade ago,” says Henrik Støvring.

Abstract of the study

Source:

Søren R Christiansen, Philippe Autier, Henrik Støvring, Change in effectiveness of mammography screening with decreasing breast cancer mortality: a population-based study, European Journal of Public Health, 2022;, ckac047, https://doi.org/10.1093/eurpub/ckac047

Background

Reductions in breast cancer mortality observed over the last three decades are partly due to improved patient management, which may erode the benefit-harm balance of mammography screening.

Methods

We estimated the numbers of women needed to invite (NNI) to prevent one breast cancer death within 10 years. Four scenarios of screening effectiveness (5–20% mortality reduction) were applied on 10,580 breast cancer deaths among Norwegian women aged 50–75 years from 1986 to 2016. We used three scenarios of overdiagnosis (10–40% excess breast cancers during screening period) for estimating ratios of numbers of overdiagnosed breast cancers for each breast cancer death prevented.

Results

Under the base case scenario of 20% breast cancer mortality reduction and 20% overdiagnosis, the NNI rose from 731 (95% CI: 644–830) women in 1996 to 1364 (95% CI: 1181–1577) women in 2016, while the number of women with overdiagnosed cancer for each breast cancer death prevented rose from 3.2 in 1996 to 5.4 in 2016. For a mortality reduction of 8.7%, the ratio of overdiagnosed breast cancers per breast cancer death prevented rose from 7.4 in 1996 to 14.0 in 2016. For a mortality reduction of 5%, the ratio rose from 12.8 in 1996 to 25.2 in 2016.

Conclusions

Due to increasingly potent therapeutic modalities, the benefit in terms of reduced breast cancer mortality declines while the harms, including overdiagnosis, are unaffected. Future improvements in breast cancer patient management will further deteriorate the benefit–harm ratio of screening.

Key points

Assuming a relative effect of mammography screening at 20% on breast cancer mortality, the number of women who needs to be invited to save one life has increased by 87% from 1996 to 2016. (Editor's note: this means that it is currently necessary to screen an ever increasing number of women in order to have a breast cancer death that would be prevented by screening, so it is more difficult to find a woman who has benefited from screening, while the adverse effects do not decrease (overdiagnosis)).

The number of women overdiagnosed with breast cancer per woman saved from dying of breast cancer has increased substantially from 1996 to 2016.

The deterioration in benefit-to-harm ratio of breast screening will continue due to steady improvement in therapies.

This study supports the need for re-evaluation of national screening programmes in high-income countries.

Tables

Download / Télécharger

“A cost both on a human level and in terms of the economy... “

...According to the lead author.

Another recent study raises the issue of additional costs associated with declining screening effectiveness: https://www.sciencedirect.com/science/article/pii/S0277953622003793

In this paper, the authors exploit a natural experiment resulting from the phased geographic rollout of a national mammography screening programme in Ireland to examine the impact of screening on breast cancer outcomes from both a patient cohort and a population perspective. 

Ireland is one of the few countries where, for operational reasons, the rollout of screening has resulted in a cohort of unscreened women that has existed long enough to serve as an appropriate comparison group.

Using data from 33,722 breast cancer cases diagnosed between 1994 and 2011, the authors employ a difference-in-differences research design using ten-year follow-up data for cases diagnosed before and after the introduction of the programme in screened and unscreened regions. 

They conclude that, although the programme produced the intended intermediate effects on breast cancer presentation and incidence, these failed to translate into significant decreases in overall population-level mortality, though screening may have helped to reduce socioeconomic disparities in late stage breast cancer incidence.

Highlights of the study

  • Screening increased detection of asymptomatic and early stage cancers.
  • There was no significant effect on population breast cancer or all-cause mortality.
  • Screening may have reduced socioeconomic disparities in late stage incidence.
  • Results call in to question the overall effectiveness of this common intervention.

Cancer Rose est un collectif de professionnels de la santé, rassemblés en association. Cancer Rose fonctionne sans publicité, sans conflit d’intérêt, sans subvention. Merci de soutenir notre action sur HelloAsso.


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.

Evaluation of information on screening, the situation in Italy, French parallel, and hope…

Synthesis Dr. C.Bour, May 11, 2022

https://bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-022-01718-w

According to the authors of this Italian study published in BioMed Central (BMC, a scientific journal) on April 22, 2022, information about overdiagnosis showed a notable increase in 2021 compared with 2014. However, the frequency of this information in the documents aimed at women was still low, probably because it is both the most recent and harmful risk for women. Therefore, not all health operators are aware of overdiagnosis. If they are aware of it, they might avoid reporting the information in public documents for fear of dissuading women from undergoing screening. Moreover, many reports of overdiagnosis are unclear.

It is difficult not to find a parallel with the situation regarding information in France.

This situation of insufficient information for women persists for many reasons.

One of the most frequently reported justifications is that providing information on potential harms could reduce adherence to screening.

Method and results

As information provided to women on the benefit-risk balance is still highly biased, F. Atténa (Department of Experimental Medicine, University of Campania "Luigi Vanvitelli") and her collaborators have decided to evaluate documents addressed to the general female public and published on the Internet by the Italian national and regional public health services.

Information on false positives and false negatives, biopsy-proven false positives, interval cancer, overdiagnosis, radiation exposure, and mortality risk reduction was analyzed. In addition, quantitative data were investigated.

The 2021 situation was compared with the 2014 situation.

Overdiagnosis and biopsy-proven false-positive results were the least reported risks of screening (20.1% and 10.4%).
Compared to the 2014 information, the 2021 information showed some improvements. The most marked improvements concern overdiagnosis. The declarations of this adverse effect increased from 8.0 to 20.1%.
Concerning the number of false positives proven by biopsy, there is also an increase in the information from 1.4 to 10.4%.
But quantitative data remained scarce in 2021.

The authors conclude with the evidence of moderate improvements in information observed from 2014 to 2021.

However, information about breast cancer screening in materials for women published on Italian websites remains too sparse.

A previous shocking Italian study from 2020

A study published in September 2020 by Italian authors moved us: this economic study explained how to effectively manipulate women to make them participate ever more in organized breast cancer screening by mammography. The authors then congratulated themselves with confusing cynicism on the effectiveness of manipulation techniques: by withholding information from women in the invitation letters, insisting on a negative effect and a potential danger of not participating in screening, by "limiting the cognitive overload of women" (sic), it would be possible to increase participation in screening significantly.

This kind of unethical study can explain, among other things, the persistence of misinformation of women and biases in the information, which are constantly renewed, as seen in this BMC study mentioned above.

A problem common to many countries, including France

Danish authors analyzed how health authorities can subtly influence citizens to participate in cancer screening programs: https://cancer-rose.fr/en/2021/04/20/methods-of-influencing-the-public-to-attend-screenings/

The researchers identified and analyzed several "categories of influence," i.e., several methods that can be used to push the public to undergo screening.

In a systematic table, we find that information bias is used in many countries, among which we find European countries like Italy, corroborating the finding of this BMC study, Spain, and also France, where biased information from the National Cancer Institute (INCa) is present in two of the systematic categories. See the table: https://cancer-rose.fr/wp-content/uploads/2021/04/Supplementary-Tables-Rahbak-et-al-210421.pdf

The INCa's disregard for information to women culminates with the qualification of the scientific controversy of screening as "fake news ." (Cf https://cancer-rose.fr/en/2021/06/24/press-release-cancer-rose/)

Hope for improvement and consideration of overdiagnosis

A position of French sociologists on the "health projects" of the next government can be read in the article "The main topics for the next Minister of Health" published in the media 20Minutes; they are alarmed by the overdiagnosis of organized screening (in the section "Prevention").

We can read:

 "We must be wary of organized screenings; it can generate overdiagnosis, criticizes Frédéric Pierru (doctor in political science, a sociologist at the CNRS, research fellow (CR-CNRS), works at the Center for Political and Social Administrative Studies and Research (CERAPS), attached to the University of Lille). This is an individualistic, medicalized, and poor vision of prevention". He believes that it would be more effective to put resources back into maternal and child protection centers (PMI), school medicine, occupational medicine...

"Effective prevention would mean addressing diet, stress, alcohol..." says Daniel Benamouzig (sociologist, Director of Research at the CNRS, holder of the Health Chair at Sciences Po, and researcher at the Centre Sociologie des Organisations (CNRS and Sciences Po)). We know that this President is not very inclined to oppose the alcohol or pesticide lobbies. Health, particularly public health and the ecological transition, is a long-term task. It is not easy to prove oneself in five years..."

Let's hope that these far-sighted scientists are heard...


Cancer Rose est un collectif de professionnels de la santé, rassemblés en association. Cancer Rose fonctionne sans publicité, sans conflit d’intérêt, sans subvention. Merci de soutenir notre action sur HelloAsso.


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.

False-positive results in screening: tomosynthesis not effective enough

Summary Dr. C.Bour, March 28, 2022

Tomosynthesis and annual screening: half of the women experience a false alarm

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2790521?utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_term=032522

A study conducted by UC Davis Health* found that half of all women screened annually with tomosynthesis** experience at least one false-positive mammogram over a decade of screening.

Reminder: A false positive occurs when a mammogram is indicated as abnormal, but there is no cancer in the breast; this is after verification by other examinations (ultrasound, MRI, sometimes breast biopsy) and after a waiting period for the results between a few days and a few weeks.

Also, to be reminded, false positives in this screening are common. While approximately 12% of 2D screening mammograms are recalled for further investigation because of a false alarm, only 4.4% of these recalls, or 0.5% overall, result in a cancer diagnosis. Thus, women are most commonly alerted and recalled for nothing, resulting in significant moral harm.

* UC Davis Medical Center is part of a major academic health center located in Sacramento, California.

** Tomosynthesis (TDS): Tomosynthesis (or 3-D mammography) is an X-ray imaging technique that decreases the effect of breast tissue overlay by reconstructing a three-dimensional image of the breast from multiple low-dose X-rays acquired at different projection angles.

The objective of the study

This study aims to answer the following question: Is there a difference between screening with digital breast tomosynthesis (3D) vs. digital mammography (2D) in the probability of false-positive results after 10 years of screening?

Method

This is a comparative effectiveness study of 903 495 individuals undergoing 2 969 055 screening examinations.

Results:

The study found that repeated breast cancer screening with 3D mammography only modestly decreased the risk of having a false-positive result compared with standard 2D digital mammography.

The 10-year cumulative probability of at least 1 false-positive result was 6.7% lower for tomosynthesis vs. digital mammography with annual screening and 2.4% lower for tomosynthesis vs. digital mammography with biennial screening.
Therefore, the risk of false positives is lower when screening is performed every two years instead of every year, but also in the case of non-dense breasts and for older women.
However, as can be seen, the difference is modest, and the reduction in false positives with 3D mammography is only 2.4% compared to standard mammography.

Conclusion.

"Screening technology did not have a very large impact on reducing false positives," said Michael Bissell, an epidemiologist in the UC Davis Department of Public Health Sciences and co-leader of the study, on interview.

The first author notes, "We were surprised that the new 3D technology in breast cancer screening did not significantly reduce the risk of having a false-positive result after 10 years of screening; however, the risks of false-positive results are much lower with biennial screening compared with annual screening."

Contribution of this study

An earlier study was published in JAMA Oncol in 2018 and suggested that screening with the 3D technique was associated with better specificity (i.e., fewer false positives) and an increased proportion of breast cancers with a better prognosis (smaller and node-free) across all age and breast density groups. As the false positive rate was lowered, this resulted in a decrease in the number of repeat examinations.

We had analyzed this study here (only in French) and highlighted several limitations of this study, starting with the too-small size of the sample.
The over-detection problem remained unresolved since the claimed improvement in recalling rates was made at the cost of a significant over-diagnosis.

An article in the BMJ in July 2019 by Jeanne Lenzer, a science journalist, questioned the value of adding tomosynthesis to digital mammography, which she said was unproven. According to this author, the information given to women undergoing this technique, which is on the rise in the United States, is more of a marketing argument than neutral and scientific information.

3D technology has not been integrated into the French screening program due to the uncertainties highlighted by the French High Authority for Health.

Cancer Rose est un collectif de professionnels de la santé, rassemblés en association. Cancer Rose fonctionne sans publicité, sans conflit d’intérêt, sans subvention. Merci de soutenir notre action sur HelloAsso.


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.

Respect patient preferences

Summary by Sophie, patient et C.Bour, MD

March 28, 2022

Patient Preferences for Outcomes Following DCIS Management Strategies: A Discrete Choice Experiment*

Chapman BM, Yang JC, Gonzalez JM, Havrilesky L, Reed SD, Hwang ES.

JCO Oncol Pract. 2021 Nov;17(11):e1639-e1648. doi: 10.1200/OP.20.00614. Epub 2021 Mar 12. PMID: 33710917.
https://ascopubs.org/doi/10.1200/OP.20.00614

*The Discrete Choice Method (DCM) analyzes consumer choices. Under specific behavioral hypotheses, it makes it possible to explain the trade-offs individuals make between the various attributes of a good or service.

Summary:

Ductal carcinoma in situ (DCIS) is more frequent as it is routinely screened; estimates indicate that 80% of DCIS are of good prognosis and do not threaten women's health. They thus contribute significantly to the overdiagnosis of breast cancer, i.e., needless diagnoses of lesions that, if they had not been found, would not have impacted either the health or the life of women.
But almost all DCIS are treated aggressively by surgery, often combined with radiotherapy and/or hormonal therapy, depending on the management guidelines in each country. In some countries, active surveillance is proposed; in others, like France, DCIS are treated with the same aggressiveness as "true" invasive cancers.

However, there are few studies on patients' preferences for treatment options.

Here the question asked is: What trade-offs are women willing to make between side effects of treatment for ductal carcinoma in situ (DCIS) and future risk of invasive cancer?

Main result: A majority of women (71%) were willing to accept a small increase in future risk of invasive cancer for treatment scenarios that offered a reduction in treatment-related side effects.

The results of this study underscore the importance of shared decision making, weighing risks and benefits, between the patient and the caregiver managing a low-risk condition.

Background

The term "overtreatment" has been used to characterize treatment for conditions that look like early cancer but are not destined to cause symptoms during a patient's lifetime or to be a cause of death. It has been estimated that as many as one in four patients with breast cancer detected by screening may be subject to overdiagnosis and overtreatment.
Much of this burden relates to treating ductal carcinoma in situ (DCIS or preinvasive breast cancer).
In fact, almost all CCIS are treated aggressively with surgery, radiotherapy, and/or endocrine therapy, especially in France.

The 10-year breast cancer–specific survival among women treated for DCIS is 98%-99%, implying that either current therapy is almost completely effective in eradicating breast cancer mortality or many women with DCIS would not have progressed to invasive breast cancer and thus were overtreated.

The exceptionally high breast cancer–specific survival across alternative treatment options has raised concern that in patients who have an indolent form of DCIS, treatment imposes harm without offering significant benefit.

An alternative to standard guidelines that has been proposed is the active surveillance (AS) approach, as is currently offered for many men with early prostate cancer and for women with other conditions considered high risk for breast cancer, such as atypical ductal hyperplasia, lobular carcinoma in situ, or a hereditary deleterious mutation. An AS strategy would entail close monitoring, with the aim of intervening only upon evidence of disease progression.

At the international level, four active prospective clinical trials are testing the safety and benefits of this approach: the LORD trial, which still includes patients.

(Read here: https://clinicaltrials.gov/ct2/show/NCT02492607
-Since February 2019, are also accepted CIS grade II, in addition to grade I
-Since July 2020, the randomized trial has been transformed into a patient preference trial: women have the choice of the trial arm (either surveillance or conventional treatment)
-Estrogen receptor and HER2 testing has been added before patients are enrolled in the trial to rule out high-grade lesions, to make the trials even safer
-There are now 28 sites open in the Netherlands, 6 in Belgium, including a francophone site opened in Brussels : https://www.chu-brugmann.be/fr/research/trials/trial.asp?num=82
15 sites will open in other countries, including France, to come!)

As awaiting the results of these trials, it is important to discern whether AS might be an acceptable option to some women if they were offered the opportunity to evaluate the benefits and harms of alternative management options.

In other words, would women accept other options such as AS instead of standard treatments if the benefit/risk balance was well explained to them?
To test this hypothesis, this study elicited patient preferences to quantify how women are willing to accept trade-offs among the possible management options for CCIS, including AS.

Discrete choice experiments, as in this case, are survey-based instruments used to obtain information about preferences for different aspects of goods and services of interest.
In a discrete choice experiment, participants are asked to choose between two or more experimentally designed scenarios that require trade-offs across the features (termed "attributes") of a good or a service; here, the management of DCIS; by analyzing participants' choices across questions, it is possible to estimate the relative importance of features on choices and how this orients the choices that persons then make.
In oncology scenarios, this may include trade-offs among the additional survival afforded by a proposed cancer treatment and the side effects, inconveniences, or costs associated with that treatment.

Methods

To better understand patient preferences, using a "discrete choice experiment," Hwang and coauthors recruited 194 healthy women in a screening mammography clinic.

Participants were provided with informational videos about the diagnosis and clinical significance of CCIS.
Then the women were asked to imagine that they had been diagnosed with CCIS and then choose between several management scenarios that included the option of aggressive treatments, less aggressive treatments, which also included the estimated risk of cancer and the side effects of treatments.
Different criteria were defined, such as breast appearance, severity of infection in the first year, chronic pain, hot flashes, and risk of developing or dying from breast cancer within 10 years, to create clinical pictures or "health profiles" for the different scenarios, for a more concrete representation for women depending on the choice they would make.

Results:

Not surprisingly, future risk of breast cancer and its attendant risk of mortality were the most important factors when women evaluated hypothetical management options.
However, the study found that over two-thirds of participants were willing to accept some increase in future breast cancer risk to reduce the extent of surgery or the severity and/or duration of treatment-related side effects.

In other words, a majority of women were willing to accept a small increase in a possible future risk of invasive cancer for treatment scenarios that offered reduced treatment side effects.

Conclusion and implication in real life :

This indicates that there is likely a subset of women who, when diagnosed with DCIS, would prioritize a reduction in side effect burden or extent of surgery over future breast cancer risk in certain contexts,  researchers concluded.

Most women were willing to make trade-offs between treatment-related effects and risk of invasive cancer, underscoring the need for shared decision making between patients and providers regarding treatment strategies for carcinoma in situ.

Although many discussions of management options for CCIS focus almost exclusively on future breast cancer risk and risk reduction, the results of this study confirm that women benefit if they are presented with detailed information about risks and treatment outcomes, allowing them to make a fully informed, personalized health decision.

The study confirms that treatment choice decisions for CCIS are highly sensitive to personal preferences, and that no a priori assumptions can be made about the trade-offs patients would be willing to consider when weighing the risks and side effects of treatment.

These complex considerations are fundamental to efforts to de-escalate treatments for low-risk conditions such as CCIS.

Advice for Oncologists, interview with principal author:

https://www.medpagetoday.com/reading-room/asco/breast-cancer/97547
By Jeff Minerd, MedPage Editor March 8, 2022

In an interview, the principal author provides advice to oncologists on how to discuss CCIS treatment options with patients in a thorough and balanced manner.
Shelley Hwang, MD, on Helping Patients Make DCIS Management Decisions/Excerpts

Ductal carcinoma in situ (DCIS) is common in the United States, but there are few studies of patient preferences for treatment options. Authors :
"Estimates indicate that only 30% of DCIS may progress to invasive cancer. Nevertheless, almost all DCIS is aggressively treated with surgery, often combined with radiation and/or endocrine therapy, according to guideline-concordant care."

To better understand patient preferences, using a "discrete choice experiment, "Hwang and co-authors recruited 194 women without breast cancer from a screening mammography clinic. The women were asked to imagine they had been diagnosed with DCIS and then asked to choose among several scenarios that included aggressive and less-aggressive forms of treatment, estimation of cancer risk, and side effects.
Not surprisingly, future risk of breast cancer and mortality were the most important factors when the women evaluated hypothetical management options. However, the study found that more than two-thirds of the participants were willing to accept some increase in future breast cancer risk to reduce the extent of surgery or the severity and/or duration of treatment-related side effects.

This indicates that there is likely a subset of women who, when diagnosed with DCIS, would prioritize a reduction in side effect burden or extent of surgery over future breast cancer risk in certain contexts," the researchers concluded.

In the following interview, Hwang elaborates on the details of the study and how to discuss treatment options with patients.

Do you have any advice for how oncologists can discuss treatment options for DCIS with patients in a thorough and balanced way?

Hwang: One key step is eliciting how much knowledge a patient has about her diagnosis and its implications. I think a surgical oncologist would tend to jump right in and say, it's a cancer, we need to remove it, these are the surgical options. That's always the easiest thing for us to do, but we sometimes neglect to spend time with the patient upfront talking about the diagnosis itself and what the clinical implications are.
And when you're dealing with a disease that has no immediate clinical or life-threatening implications, and specifically for DCIS when we don't even know if it will turn into cancer even if we don't intervene surgically, I think framing the diagnosis first and making sure the patient understands the implications of the diagnosis is important.

Your study used discrete choice experiments, which were first developed for market research. Can you briefly describe how these work?

Hwang: Discrete choice experiments have been used a lot in areas such as health economics to see how people make decisions and weigh pros and cons of all the different aspects of making that decision. So say you're about to buy a house, not only do you have to consider cost but also location, how many bedrooms it has --there are many different components that go into that decision.
It's never just one driver that makes an individual decide which house to buy. There are some very emotional aspects to that too. So a discrete choice experiment tries to come up with a set of attributes that are important for making a certain kind of decision.

In this case it was a diagnosis of DCIS and the decision about how to manage it. We tried to include attributes we thought would be meaningful for patients. So postoperative pain, for instance -- that's something people wonder about and are concerned about. We included different levels of pain in the experiment. Cosmesis and side effects of treatment are also important considerations. We created different scenarios where we mixed and matched these different attributes. We presented them to patients and asked them to choose which scenario most matched their preferences. That gave us an idea of what values patients considered most important when trying to make a decision about DCIS.

I think this is something that's becoming more and more relevant. Cancer screening detects precancers such as DCIS that have no immediate clinical implications. There are no symptoms, there are no mortality implications, there's just this concern, that we're trying to prevent cancers from occurring. And I think the better we are at screening, the more we're going to find ourselves in this position, not only with cancer but also with cardiac disease and metabolic diseases, where we diagnose a condition before the patient has any symptoms.

So I think balancing the pros and cons is a lot more relevant when you're not dealing with immediate life-threatening illnesses, and learning how to talk to patients about these scenarios will be an increasingly important skill.

Your study included women without an actual diagnosis of DCIS. Do you think this limits the generalizability of your results to the general DCIS population?

Hwang:That's a really good point. We didn't feel we could do this study with women who were diagnosed with DCIS, because we didn't know what information they would come in with already. If someone somewhere along the way said to them you have cancer and it needs to come out, that could certainly affect how they viewed their choices.
To do this discrete choice experiment, we needed a group of patients that didn't have a lot of other sources of information about the disease already.
...........

On the other hand, women in the study were coming in and presenting with an abnormality, or they were coming for a breast cancer screening, so they were  already thinking about what would happen if they did have a diagnosis. So we felt like it wasn't a stretch to use this population.

We as surgeons are taught to focus on cancer outcomes and mortality, and we should focus on those things. However, sometimes our training hasn't incorporated how to balance other things that patients care about and helping them apply these values to a treatment decision that's comfortable or preferable to them.

I've found that sometimes surgical oncologists, and oncologists in general, treat the cancer, but what we really need to do is holistically treat the patient along with the cancer. That's the take-home message of this study, underscoring how important it is to treat each person as a unique individual and someone who may not necessarily share the treating provider's belief system.

There is room in medicine to accommodate many differing views of risk and health.

For more information:

Surtraitement du CCIS du cancer du sein de stade 0

Perspective : Les risques de surdiagnostic - Nature

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