The General Inspectorate for Social Affairs (IGAS) has been asked by letter from the Minister for Solidarity and Health to conduct a mission in relation to the organized screening programs for breast cancer (2004), colorectal cancer (2008) and cervical cancer (2018). The head of the IGAS appointed Stéphanie Dupays, Hervé Léost and Yannick Le Guen to undertake this mission. The work began on June 30, 2021.
The evaluation requested focused on the ability of the current system to meet the challenges of the ten-year cancer control strategy, which was launched by the French president on February 4, 2021, in terms of participation in screening (the objective is to perform one million additional screening tests by 2025), the quality of the programs, and the fight against access inequalities. There was a need for a strong emphasis on the assessment of the regionalization of control structures and therefore on the efficiency and effectiveness of the Regional Cancer Screening Coordination Centers (CRCDCs) created on January 1, 2019, while taking into account the multiple competent stakeholders in this field at national and territorial levels.
• Three organized screening programs have been set up in the last twenty years
In 2019, approximately 3.4 million people were treated for cancer in France compared to just over 3 million in 2015. In 2018, there were 12,148 deaths from breast cancer, 17,117 deaths from colorectal cancer, and 1,092 deaths in 2015 from cervical cancer.
The French screening strategy, which is supported by successive cancer plans, forms part of an international framework. The European Council Recommendation of December 2, 2003 on cancer screening sets target participation rates in organized colorectal cancer screening (DOCCR) at 45%, organized breast cancer screening (DOCS) at 70% and organized cervical cancer screening (DOCCU) at 80%. It also defines guidelines for quality assurance systems for these three screening programs. All three screening programs are “organized” in that they are based on a set of processes that start by identifying asymptomatic individuals who meet the screening criteria, aim to make a diagnosis, and end by initiating patient treatment where necessary.
Since 2004, the organized breast cancer screening (DOCS) program has targeted women aged 50 to 74 at average risk, i.e., with no apparent symptoms or specific risk factors. They are asked to attend appointments every two years by the CRCDCs to have a mammogram and a clinical breast examination by an approved radiologist. The organized screening program reads mammograms using double reading process. The quality of the program is also based on monitoring at regular intervals of mammography facilities and on training requirements for radiologists.
In widespread operation since 2008, the organized colorectal cancer screening (DOCCR) program is based on a fecal occult blood test offered every 2 years to all people aged 50 to 74 at average risk. A complete colonoscopy must be performed in case of a positive test.
Implemented in 2018, the organized cervical cancer screening (DOCCU) program covers all asymptomatic women between the ages of 25 and 65. It involves performing a cytological screening examination in asymptomatic women between 25 and 30 years of age and a test for high-risk human papillomavirus (HPV-HR test) in asymptomatic women from 30 to 65 years of age using a cervical swab. Unlike the other two organized screening programs, only women who have not been screened for cervical cancer within the recommended timeframes are invited to consult their gynecologist, primary care physician or midwife to undergo a screening test.
Each of the programs is regulated by a set of specifications annexed to a 2006 decree, which has been amended several times, and which also includes the specifications of the CRCDCs and the cancer control organizations that were in place before them.
• The programs involve a variety of stakeholders
Developments over the years have led to the current distribution of roles between the stakeholders. Until 2004, cancer screening and other areas of prevention, were the responsibility of the French départments, which often set up associative control structures in their areas. Screening responsibilities were transferred to the State by the law of August 13, 2004 relating to local freedoms and responsibilities, leading to the current situation in which programs are overseen by the State and the health insurance system while being implemented by the CRCDCs, which are almost all associations.
At national level, a simple listing of the respective responsibilities of the institutions involved shows the extreme complexity of the management :
○ The Directorate General for Health (DGS) provides strategic oversight of the programs. It chairs a strategic steering committee, makes regulatory changes to the specifications and prepares the instructions sent to the regional health agencies (ARS) ;
○ The French National Authority for Health (HAS) formulates recommendations for professional practices that serve as the basis for the specifications of each screening program ;
○ The French National Cancer Institute (INCa) provides operational oversight for programs, particularly in the area of promoting screening and invites, financing and monitoring trials, future planning for programs, etc.
○ The assurance maladie health insurance system (French National Health Insurance Fund (CNAM), France’s Agricultural Social Mutual Organization (MSA) and their networks) is involved in several ways : co-financing and therefore regional co-steering of the CRCDCs, management by the CNAM of the national requirements for colorectal cancer tests and their interpretation, distribution of files enabling the CRCDCs to invite the target population, actions by the territorial networks to promote screening, and contractual negotiations with the professionals concerned.
○ The French National Agency for Public Health (SPF) evaluates programs in conjunction with the European Commission.
○ The French National Agency for Medicines and Health Products Safety (ANSM) is the competent authority for medical devices and issues quality control standards for all screening facilities and tests, including mammography facilities for DOCS.
○ The French National Data Protection Authority (CNIL) acts as the regulator of personal data and issues guiding rules for the exchange of information between stakeholders and the protection of personal data.
At the regional level, the screening programs are overseen by the ARS in conjunction with the Regional Health Insurance Risk Management Coordinator (DCGDR) and the director of the Regional Association of Agricultural Social Mutual Funds (ARCMSA). Each of these regional coordinators are assigned specific objectives related to participation in screening programs. The regional coordinators sign an agreement with the CRCDCs and allocate their funding through an annual management discussion. Many other stakeholders (associations, local authorities, etc.) are involved in promoting screening, either at the initiative of the CRCDCs or the ARSs.
The activity of the CRCDCs is in fact mainly regulated by national specifications that assign them eight tasks : implementation of the plan and contribution to national and regional oversight ; relations with the population ; monitoring of the population ; relations with healthcare professionals ; management of the information system ; evaluation of the plan ; quality assurance of the plan ; research and trials.
Lastly, successfully implementing screening relies on healthcare professionals, mainly those working in community care, attending physicians, radiologists, gastroenterologists, midwives, occupational health physicians, etc., which creates challenges in terms of informing these professionals, involving them and providing them with training to ensure and standardize the quality of practices.
• The results of the programs are disappointing in relation to the resources allocated and the objectives assigned
The mission estimated the total spending allocated to screening, whether organized or individual programs, at approximately €600M by consolidating the operating expenses of the various institutions, the health insurance reimbursements and the remaining expenses of insured persons. In view of this figure and the public health issues involved, the results of the programs fall far short of the objectives set.
For DOCS and DOCCR, participation rates in organized screening stalled in the 2010s and have even been declining since 2018-2019. The national DOCS participation rate is 42.8%, which is well below the European target of 70% and the European average, even though the comparability of rates is perhaps questionable due to the specificities of national systems and measurement differences. For DOCCR, the annual mean participation rate is 28.9% for 2019-2020, which is also well below the national objectives and the European target, regardless of any reservations about comparability. The programs are also characterized by significant territorial differences, although analysis is made difficult by the influence of individual screening, which is difficult to estimate due to a lack of specific coding. Lots of analysis has been performed on the factors explaining the low rates and the territorial differences that highlights the difficulties of access to healthcare or the influence of social factors.
In addition to participation, there are other program quality indicators in the specifications, such as the time taken to access screening tests, the rate of positive results, etc., which are not regularly published. These indicators should be analyzed more regularly to avoid monitoring participation alone.
• Regionalization has been unable to overcome several structural limitations of the programs
The assessment of regionalization, while it is a provisional assessment three years after its implementation in the context of the pandemic, suggests mixed results in terms of both the expected improvement in the quality of programs and their efficiency. The complexity of the merger operations linked to regionalization was underestimated, whether it was in terms of legal aspects, human resources support or databases. As a result, during their first years of existence, the CRCDCs were occupied with internal reorganizations, which put achieving the primary objectives of regionalization on the back burner.
The ambition to improve the quality and promotion of screening is obstructed by the staffing levels of the 17 CRCDCs (which are distributed over many departmental sites) and the skills present in the teams : 43 FTEs on average in 2019, with five centers having fewer than 10 employees and five centers having more than 60 employees. Almost 60% of these staff are secretaries and assistants. The efficiency objective linked to regionalization has only been partially achieved due to the additional cost factors represented mainly by adherence to a collective agreement or the implementation of DOCCU. Only the support functions and purchasing policies have yielded collective gains.
Regionalization has not been supported by the necessary revision of programs on several formative points that were already the subject of longstanding discussions :
○ The transfer of invitations to the CNAM, although included in the two most recent total operating costs of this organization, has not been implemented. However, the screening invitation and reminder activity requires the CRCDCs to process numerous files from the various health insurance schemes, which must be supplemented with information from various sources to determine program exclusions. The additional costs associated with having to oversee, operate and maintain 17 regional information systems and regional or even departmental databases are substantial ;
○ The second reading of mammograms has not yet become digital, despite the territorial trials initiated ten years ago ; the maintenance of the images involves a large proportion of the centers’ staff, generating an annual additional cost estimated to be at least €10M. This way of working is not sustainable in the short term because negatoscopes are no longer manufactured and their maintenance is becoming increasingly difficult and expensive ;
○ Regarding data processing, the principle of a national information system was included in the specifications but has not been implemented.
The new roles provided for in the specifications have hardly been developed, whether they be quality specialists, data managers or public health officers. Similarly, the objective of standardizing and improving promotion and outreach activities has not been achieved. The resources allocated to outreach are still too limited, even though they are absolutely critical given the insufficient population participation rates in the three screening tests.
The effectiveness of the follow-up of individuals varies in accordance with the type of cancer, depending on the region, and even the départment, and is still non-existent for DOCCU because the CRCDCs do not receive the results of the tests.
Lastly, the national oversight procedures are too complex. The respective roles of the DGS, INCa and CNAM are not very clear. In addition, there are not enough discussions at national level on changes in programs, which is a source of regret for the ARSs, DCGDR and CRCDCs.
Tensions are very high with the governance of the CRCDCs, whose presidents feel that they are not involved in national decisions, while also having to contend with excessive reporting requirements and overly intrusive management that discourages any initiative. At the regional level, the levers for action of the coordinators are limited by the shortcomings of the current legal system governing the associative status of the centers, particularly by the lack of an accreditation procedure.
• The need to invest in digital technology to realign CRCDCs to the responsibilities for which they offer the most added value
The mission has several recommendations related to digital technology that should help refocus the CRCDCs on missions that are best suited to their skills.
Firstly, the CRCDCs offer very limited added value in relation to screening invitations and reminders, which is based on data mainly from the health insurance system. The mission recommends, in accordance with the commitments made in the context of the two previous total operating costs of the CNAM, that preparations start being made to transfer this task, in between campaigns, to the CNAM. It will be crucial to plan ahead for the full organizational, financial and human resource impact of this transfer for the CNAM and for the CRCDCs.
This transfer must also be used as an opportunity to redefine how consent is obtained for the processing of personal data, the current implementation of which may be an obstacle to the monitoring of results in DOCCU and varies depending on the screening program.
The second reading system using hard copies is obsolete, unattractive to radiologists, and costly in terms of human and financial resources : the second reading of mammograms must go digital, which will improve both the quality and the efficiency of the program. This complex digitization project must be overseen at the national level, in conjunction with the digital health department, and cannot be left solely to the CRCDCs as regional project managers.
In addition to these two formative proposals, the mission has also made complementary recommendations aimed at harnessing the full potential of digital technology : setting up a national screening database and a national information system for the CRCDCs, digitizing the various stages of the patient journey, for example at the time of invitations, and providing information related to target population risks according to their healthcare use characteristics.
Refocusing the CRCDCs’ responsibilities will require a plan to support the staff, allowing for changes in skills, training or staff transfers in the event of a transfer of responsibilities.
• Rethinking CRCDC measures for outreach, follow-up and even prevention
Even if transferring responsibility for invitations to health insurance and digitization of the second reading will take away a significant part of the CRCDCs’ activity, the mission does not recommend getting rid of them. In fact, the CRCDCs should play a key role that is difficult to replace in several areas.
This is the case for the promotion of screening among professionals or for outreach, in which the CRCDCs’ initiatives are often interesting but too fragmented, inconsistent and poorly evaluated :
○ The mission first recommends to improve understanding of the state of screening in the territories to ensure better-coordinated measures for the population. This requires better knowledge of exclusion rates and the role of individual screening, as well as analysis of territorial social data, which would be made possible by a routine agreement with regional organizations competent in this area, such as the regional health monitoring bodies.
○ It is also necessary to better understand and evaluate outreach measures in order to build a repertoire of evidence-based measures for all partners, which must be established and overseen at the national level to avoid each one adapting the measures.
○ In parallel, a partnership framework must be established by the CRCDCs for their territory. Agreements must routinely be signed with the main partners, whether they are territorial professional healthcare communities and multidisciplinary primary health care centers, the main health institutions, complementary organizations or occupational health services.
○ We must be in a position to supplement national information with local messages for specific populations subject to validation by the ARS.
In terms of patient follow-up, the mission proposes to better manage this activity and to examine the scenario of following up patients not included through screening criteria, which the CRCDCs are currently unable to do.
Lastly, reflection on the evolution of the CRCDCs’ responsibilities could also lead to exploring the opportunity to position the promotion of screening within a more comprehensive approach to cancer prevention, similar to the model implemented in Nouvelle-Aquitaine, where the ARS has entrusted the CRCDC with a comprehensive role of coordinating cancer prevention. This sort of initiative is worth considering in light of the work in progress under the aegis of Professor Franck Chauvin to outline the institutional aspects of the organization of public health in the future, particularly at the regional level.
• Reforming program management under the new framework of the 10-year strategy.
Under the new governance of the 10-year strategy, keeping a strategic committee dedicated to screening, which has not met for several years, can no longer be justified.
The role of the new annual strategic steering committee for the 10-year cancer control strategy will be to decide on major directions for screening, such as the launch of a new organized screening program. The operational steering committee will make decisions on other changes, which will be prepared by an ad hoc committee specifically for screening, chaired by the DGS. The mission proposes that, from the beginning of 2022, all the stakeholders meet in this format in order to establish a multi-year roadmap based on the recommendations in this report.
National steering must be able to make use of a limited number of strategic indicators, which go beyond the participation rate in screening, and which allow the national and regional coordinators to evaluate in real time the improvement or deterioration of the situation in the territory. Tracking participation rate indicators must still play a key role in achieving the objective of one million additional screenings by 2025, and should be used in the same way in the steering documents of the ARSs and the health insurance network.
Achieving the objectives of the ten-year strategy requires that local stakeholders have more freedom to operate, by allowing exemptions from the national framework validated by the ARS. This principle could also be applied to the status of the CRCDCs : the ARS could recommend an alternative way of organizing screening, for example, in territories where the CRCDC does not have the critical mass.
Lastly, program management must be based on the latest recommendations. The mission emphasizes the urgency of completing the work by the HAS on tomosynthesis and by the INCa on self-collected sampling standards. Similarly, the ANSM’s decision on mammography facilities must be revised by 2022 to ensure it aligns with the best European quality standards, thus bringing to an end the use of computer radiology (CR) equipment in favor of digital radiology (DR) equipment only.
Lastly, a new referral to the HAS must be drafted urgently in order to take into account the changes that have occurred over the last ten years in organized breast and colorectal cancer screening. Subjects to be addressed, which will have to be reflected in future changes to the specifications, include the age limits for screening (lower and upper), and the role of artificial intelligence.
ABBREVIATIONS & ACRONYMS
|ANSM||Agence Nationale de Sécurité du Médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products)|
|ARCMSA||Association régionale des caisses de mutualité sociale agricole (Regional Association of Agricultural Social Mutual Funds)|
|ARS||Agence régionale de santé (Regional Health Agency)|
|CNAM||Caisse nationale d’assurance maladie (French National Health Insurance Fund)|
|CNIL||Commission Nationale de l’Informatique et des Libertés (French National Data Protection Authority)|
|CRDC||Centre region de coordination des detection des cancer (Regional Cancer Screening Coordination Center)|
|DCGDR||Directeur coordonnateur régional de la gestion du risque de l’assurance maladie (Regional Health Insurance Risk Management Coordinator)|
|DGS||Direction générale de la santé (Directorate General for Health)|
|DOCCR||Dépistage organisé du cancer colorectal (Organized colorectal cancer screening)|
|DOCCU||Dépistage organisé du cancer du col de l’utérus (Organized cervical cancer screening)|
|DOCS||Dépistage organisé du cancer du sein (Organized breast cancer screening)|
|HAS||Haute autorité de santé (French National Authority for Health)|
|HPV||Human papilloma virus|
|INCa||Institut national du cancer (French National Cancer Institute)|
|MSA||Mutualité sociale agricole (French National Agricultural Social Mutual Fund)|