Shared Meditation Involving Cancer Patients, Health Professionals and Third Persons: Perceptions of Participants Through a Focus Group Study.

People with cancer often experience psychological distress and in addition, the practice of oncology is one of the most stressful areas of medicine for health professionals. Mindfulness meditation has been used to alleviate stress-related symptoms. We therefore ran a pilot study to assess the feasibility of a mindfulness intervention involving cancer patients, health professionals, and third persons together, as part of a comprehensive project aiming to evaluate the added value of 'meditating together'. Following on from our quantitative analyses of the project, we investigated its qualitative aspects through focus groups to explore the perceptions of participants regarding their experience. Focus groups conducted in 7 patients, 7 health professionals, and 8 third persons after the intervention showed that 'meditating together' was generally appreciated, particularly by patients, who found it motivating and a way to relieve their feelings of loneliness in the face of illness. All participants reported better stress management. They also shared benefits and difficulties concerning the practice of meditation and the programme's modalities. In addition, they all stated that the programme should be lasting. The opinion of the patients (our target population) will be decisive in building an optimized programme that will suit them the best. In conclusion, the protocol and the qualitative findings of the present study validate the rationale for conducting a fully powered randomized trial to demonstrate the potential added value of shared meditation and how it improves well-being by promoting bridge-building between cancer patients, health professionals and others.Trial Registration: ClinicalTrials.gov. NCT04410185. Registered on June 1, 2020.

How do women comply with cancer screenings? A study in four regions of France.

BACKGROUND: This article looks at the behaviour of women facing different cancer screening options available to them from the age of 50 onward. The study was conducted in 2019 in four departments of the French territory with the objective of identifying the factors that influence acceptance of a population-based screening proposal. METHODS: A questionnaire was sent to women who had received three invitations to organised screenings (OS) for both breast and colorectal cancer. The categories of participants in both OS were designed from data from the regional cancer screening coordination centres in each department. Participation in opportunistic cervical cancer screening was evaluated as self-reported data. RESULTS: 4,634 questionnaires were returned out of the 17,194 sent, giving a global return rate of 27%. The highest rate of return (73.5%) was obtained from women who had participated at least once in both breast and colorectal cancer OS. An intermediate rate was obtained from women participating in breast cancer OS only (18.7%). Poor levels of return came from women who had participated in colorectal cancer OS only (3.6%) and from non-participants (4.1%). Our results suggest that women with lower educational levels tend to be the most regular attendants at OS (50.3%), compared to highly educated women (39.7%). 11.8% of women were overdue in their opportunistic cervical cancer screening. This percentage rose to 35.4% in the category of non-participants. In addition, women's comments provide a better understanding of the reasons for irregular attendance and non-participation. CONCLUSION: Overall, similar behaviours towards screening were observed in the four departments. Our analysis suggests that participation in one cancer OS increases the likelihood of participating in others. This adhesion could be an interesting lever for raising women's awareness of other cancer screenings.

Chapitre 5. COVID et privation du droit de visites en établissement sanitaire et médico-social : Maintenir la relation et penser l'usage des outils numériques.

The right to visit our next of kin and friends has been challenged since the beginning of COVID epidemic. In Health and social care services, the visits’ limitation has and continues to have consequences on the persons under care, their relatives and the care workers. This article aims to review the investigations of the Normandy Ethical Support Unit who has set up at the beginning of the COVID crisis, in response to the referrals from the fields in connection with the visits’ restrictions. This crisis served as a reminder of the importance of physical contact in maintaining social interactions. It also drew collective attention to the implementation of digital tools to counterbalance geographical distance, lack of time, and more broadly the evolution of society. The deployment of the digital tool raises many ethical questions and must be considered without neglecting physical contact.

Participation in breast cancer screening and its influence on other cancer screening invitations: study in women aged 56 years old in four French departments.

BACKGROUND: Today, women 50 years of age are offered three types of cancer screening in France. However, participation is not optimal. The aim was to describe (1) participation in organised breast cancer screening (OS) of women aged 56 years old, and the influence of this participation on colorectal and cervical cancer screening, (2) the reasons for non-participation in breast cancer OS, and (3) the reasons for screening before age 50. METHODS: A questionnaire was sent to 56-year-old women in four French departments to identify their participation behaviour in three breast cancer OS invitations and their reasons for non-participation. Three groups were determined according to the number of participations in breast cancer OS (3, 1-2 and 0). We described the quantitative responses and grouped the qualitative responses thematically. RESULTS: A total of 4634 women responded to the questionnaire. Seventy-six percent had undergone all three breast cancer OS, 16% irregular and 7% non-participant. Among women who irregularly perform breast cancer OS, 50.5% also irregularly perform colorectal cancer OS. Women who participated in all three invitations for the breast cancer OS performed more smear tests than women in the other groups. Many of the irregular participants or non-participants underwent opportunistic screening, often initiated before the age of 50. The reasons for non-participation in breast cancer OS were mainly medical or participation in opportunistic screening. CONCLUSION: There is no fundamental opposition to participation in breast cancer screening. However, it remains of the utmost importance that women should be better informed about OS and its benefits.

[Donation of the body to science: A new regulatory framework that answers some questions but raises many others!] / Don du corps à la science - Un nouveau cadre de régulation qui répond à certaines questions mais en soulève bien d'autres !

In France, between 2,500 and 3,000 people donate their bodies to science each year after their death; they contribute therefore to the teaching of anatomy, to research and to the learning and improvement of surgical practices. The decision to donate must be made during the donor's lifetime and consent must be expressed in writing to one of the 27 donation centers throughout the country. Following the scandal of the Parisian center of the Saints Pères, which revealed a lack of respect for bodies and fundamental ethical principles, the decree of April 27, 2022 concerning the donation of bodies for teaching and research purposes, which is part of the new bioethic laws, was eagerly awaited to clarify certain practices. However, this decree raises new questions because many of the rules it proposes do not appear to be relevant to the values of donation and the functioning of donation centers. The new modes of regulation proposed by the decree generate questions among donors and professionals in the field with a risk of poor regulation, detrimental to all with regard to major ethical issues. If the public authorities do not commit themselves to a regulation that is better adapted to the field, if the ethical stakes are not better clarified and if the universities do not have the means to implement these new organizations, the perpetuation of body donation and of donation centers could become challenging.

Title: Don du corps à la science - Un nouveau cadre de régulation qui répond à certaines questions mais en soulève bien d'autres ! Abstract: En France, entre 2 500 et 3 000 personnes donnent leur corps à la science chaque année après leur mort ; elles contribuent ainsi à l'enseignement de l'anatomie, à la recherche et à l'apprentissage et l'amélioration des pratiques chirurgicales. La décision doit être prise de son vivant et le consentement exprimé par écrit auprès d'un des vingt-sept centres de don du corps répartis sur le territoire national. Suite au scandale du centre parisien des Saints-Pères, le décret du 27 avril 2022 relatif au don de corps à des fins d'enseignement et de recherche, qui s'inscrit dans le cadre des nouvelles lois de bioéthique, était très attendu pour clarifier certaines pratiques. Mais ce décret soulève de nouvelles questions car nombreuses sont les règles qu'il propose qui ne nous apparaissent pas pertinentes au regard des valeurs du don et du fonctionnement des centres de don. Les nouveaux modes de régulation proposés génèrent des questions chez les donneurs et les professionnels de terrain avec un risque de mauvaise régulation. Nous pensons que si la puissance publique ne s'engage pas dans une régulation plus adaptée au terrain, si les enjeux éthiques ne sont pas mieux clarifiés et si les universités n'ont pas les moyens pour mettre en œuvre ces nouvelles organisations, la pérennisation du don du corps et des centres de don pourrait devenir difficile.

Information et consentement sur l'épisiotomie : Comment améliorer les pratiques ?

Intro Context and subject of the study: While women are increasingly demanding to be actors of their birth and to participate in the choices concerning their care, a study showed in 2013 that the information they received concerning episiotomy had improved, but that consent was very rarely sought. The interest of our study was therefore to explore the practices of midwives a few years later, and to highlight the factors that may encourage or hinder them in the delivery room to inform women and obtain their consent. METHOD: We conducted 12 semi-structured interviews with midwives working in the delivery room in several maternity hospitals in the Ile-de-France region. A manual content analysis was carried out independently by two researchers who then compared their results. A complementary analysis using NVivo software confirmed the validity of the manual analysis. RESULTS: Information on episiotomy and collection of consent in the delivery room were respectively limited by the anxiety-inducing nature of the information and its temporality (labour and delivery are not appropriate times for information according to the professionals), and by the fear of refusal. Information given beforehand during pregnancy and the drafting of a birth plan would facilitate the collection of consent in the delivery room. CONCLUSION: A time dedicated to information and the distribution of an information leaflet on episiotomy to patients could help improve the practices of health professionals.

Perceptions et connaissances concernant la décision de réaliser le dépistage du cancer de la prostate.

BACKGROUND: Because of the benefit-risk ratio, the French health authorities recommend that patients make an informed choice concerning prostate cancer screening. The aim of this study was to investigate men's decision process. The process was explored by assessing information-seeking behavior, knowledge on prostate cancer, and men's involvement in screening decisions. METHODS: Nineteen men aged 50 to 75 years old were included in the study in 2018. Semi structured face-to-face interviews were performed. Interviews were audio-recorded and then transcribed verbatim. A thematic analysis was performed. RESULTS: In some cases, men's knowledge about prostate anatomy, prostate physiology, and prostate cancer screening modalities (procedure and risks) was poor. Moreover, despite international recommendations about shared decision-making, several GPs (General Practitioner) prescribed prostate cancer screening without discussing the matter with their patients. CONCLUSION: French men should receive better information so that they can make an informed choice about prostate cancer screening and share the decision with their GP.

Methodological and ethical quality of surgical trials from 2016 to 2020.

PURPOSE: Randomized controlled trials (RCTs) are the gold standard tool used to evaluate therapeutic interventions. The published results showed that progress still needs to be made not only from a methodological point of view but also from an ethical point of view. The aim of this study was to evaluate the methodological and ethical qualities of randomized clinical trials in surgery over the last few years. METHODS: All of the articles chosen for review reported on randomized controlled surgical trials and were published in 10 international journals between 2016 and 2020. Eligible studies were identified, selected, and then evaluated based on a broad set of predetermined criteria. Methodological quality was evaluated using the Jadad scale, and ethical quality was evaluated using the Berdeu score. RESULTS: The methodological quality score (Jadad scale) ranged from 5 to 13, with a mean of 10.0 ± 1.54. The methodological quality was insufficient (score ≤ 9) for 162 trials (31.2%). The ethical quality score ranged from 0.25 to 1, with a mean of 0.8 ± 0.11. Fifty-two articles (10%) did not state that informed consent was requested from the participants, and 21 articles (4%) did not report either research ethics committee or institutional committee protocol approval. CONCLUSION: The randomized clinical surgical trials analyzed showed that they had satisfactory methods in only 70% of the cases and that they had respected the fundamental ethical principles in 90% of the cases. However, less than 8% of the studies reported planned interim analysis, prospectively defined stopping rules, and independent monitoring committee.

How do non-geneticist physicians deal with genetic tests? A qualitative analysis.

Genetic testing is accepted to be a common practice in many medical specialties. These genetic tests raise issues such as respect for basic rights, how to handle results and uncertainty and how to balance concerns for medical confidentiality with the rights of third parties. Physicians need help to deal with the rapid development of genomic medicine as most of them have received no specific training on the medical, ethical, and social issues involved. Analyzing how these professionals integrate genetic testing into the patient-provider relationship is essential to paving the way for a better use of genomics by all. We conducted a qualitative study comprising a series of focus groups with 21 neurologists and endocrinologists about their genetic testing practices in the western part of France. The interviews were transcribed and analyzed for major themes. We identified an automated care management procedure of genetic testing that affects patient autonomy. The simple fact of having a written consent cannot justify a genetic test given the stakes associated with the results. We also suggest orienting practices toward a systemic approach using a multidisciplinary team or network to provide resources for dealing with uncertainties in interpreting results or situations that require additional technical or clinical skills and, if necessary, to allow for joint consultations with both a geneticist and a non-geneticist medical specialist.

Multidisciplinary team meetings: are all patients presented and does it impact quality of care and survival - a registry-based study.

BACKGROUND: Multidisciplinary team meetings (MDTMs) are part of the standard cancer care process in many European countries. In France, they are a mandatory condition in the authorization system for cancer care administration, with the goal to ensure that all new patients diagnosed with cancer are presented in MDTMs. AIM: Identify the factors associated with non-presentation or unknown presentation in MDTMs, and study the impact of presentation in MDTMs on quality of care and survival in patients diagnosed with colorectal cancer (CRC). METHODS: 3999 CRC patients diagnosed between 2005 and 2014 in the area covered by the "Calvados Registry of Digestive Tumours" were included. Multivariate multinomial logistic regression was used to assess the factors associated with presentation in MDTMs. Univariate analyses were performed to study the impact of MDTMs on quality of care. Multivariate Cox model and the Log-Rank test were used to assess the impact of MDTMs on survival. RESULTS: Non-presentation or unknown presentation in MDTMs were associated with higher age at diagnosis, dying within 3 months after diagnosis, unknown metastatic status, non-metastatic cancer and colon cancer. Non-presentation was associated with a diagnosis after 2010. Unknown presentation was associated with a diagnosis before 2007 and a longer travel time to the reference care centres. Presentation in MDTMs was associated with more chemotherapy administration for patients with metastatic cancer and more adjuvant chemotherapy for patients with stage III colon cancer. After excluding poor prognosis patients, lower survival was significantly associated with higher age at diagnosis, unknown metastatic status or metastatic cancer, presence of comorbidities, rectal cancer and non-presentation in MDTMs (HR = 1.5 [1.1-2.0], p < 0.001). CONCLUSIONS: Elderly and poor prognosis patients were less presented in MDTMs. Geriatric assessments before presentation in MDTMs were shown to improve care plan establishment. The 100% objective is not coherent if MDTMs are only to discuss diagnosis and curative cares. They could also be a place to discuss therapeutic limitations. MDTMs were associated with better treatment and longer survival. We must ensure that there is no inequity in presentation in MDTMs that could lead to a loss of chance for patients.

Termination of pregnancy for foetal indication in the French context analysis of decision-making in a Multidisciplinary Centre For Prenatal Diagnosis.

OBJECTIVE: In France, termination of pregnancy (TOP) for medical reasons is legal, regardless of the term, after authorisation by a Multidisciplinary Centre for Prenatal Diagnosis (MCPD). This study analyses the elements supporting the TOP decision-making process faced with a foetal pathology. STUDY DESIGN: Medical records of one MCPD were analysed for the period 2013 and 2014 and semi-structured interviews with MCPD members were conducted. RESULTS: Out of 265 files concerning foetal indications, all but one resulted in a decision for TOP. The main indications in number for TOP were malformations and chromosomal abnormalities. For indications such as trisomy 21, authorisations are generally given without discussion. Our results underline the importance that professionals attach to the collegiality of decisions, particularly in situations of uncertainty. CONCLUSION: This study provides information about the activity of MCPDs within the field of prenatal diagnosis and shows the importance of these structures in supporting women and couples whilst respecting their autonomy. At present, the role of the MCPD is in the process of evolving and could become an information and advisory board for women, based on collegial expertise to guide their decision-making.

Implementation of a Medical Ethics Course in Undergraduate Dental Education and Assessment of Knowledge and Attitudes.

OBJECTIVES: A medical ethics course was launched in 2012 in a French University Dental School. We compared knowledge and attitudes, before and after implementation of that course. The aim of this study was to compare students who received an ethics course (third year) to those who did not have such training, however, most of them did have some clinical traineeship. MATERIALS AND METHODS: An anonymous questionnaire was sent to the second-, third-, and sixth-year students. It comprised questions with Likert item format answers and clinical vignettes with open responses. The results were analyzed by two approaches: a statistical analysis (chi-square or Fischer exact tests) and a content analysis using a predefined grid. RESULTS: A total of 299 respondents replied (75% students) the questionnaire. The analysis showed a statistically significant association between knowledge of the law and information procedures (P < 0.0001), access to medical files (P = 0.004), and recording consent (P = 0.049). It was also significant between knowledge of the law and the principles of biomedical ethics (P < 0.0001 for autonomy and beneficence). The third-year students could state the principles of medical ethics with their percentage always greater than the sixth-year students. After the third year, the students' attitudes switched from a social to a medical emphasis, and their point of view regarding patient's autonomy evolved. Patient's refusal of care raised potential conflicts between autonomy, professional judgment, information, and consent. CONCLUSION: Ethics teaching could offer a way to turn positive attitudes into real competencies and should be considered at an early stage.

[The refusal of care, complex situations]. / Le refus de soins, des situations complexes.

Over the last three decades, the evolution of medical care and the reorganization of our health care system have completely changed the relationship between health care professionals, patients and their families. The demand for patient participation in the healthcare process has been growing, raising the question of patients' freedom of choice and increasingly questioning the areas where this would be denied.

[Refusal of care, a discriminatory act?] / Le refus de soins, un acte discriminatoire ?

If a patient can refuse care, health professionals may refuse to treat a person, an act often considered discriminatory. Investigations have been carried out to shed light on this practice. This notion calls for a philosophical and ethical point of view.

Does a web-based decision aid improve informed choice for fertility preservation in women with breast cancer (DECISIF)? Study protocol for a randomised controlled trial.

INTRODUCTION: Chemotherapy may cause infertility in young survivors of breast cancer. Various fertility preservation techniques increase the likelihood of survivors becoming genetic mothers. Disclosure of cancer diagnosis may impact decision making about fertility preservation. This protocol will develop and test the effectiveness of a web-based decision aid for helping women with breast cancer to make well-informed choices about fertility preservation. METHODS AND ANALYSIS: This study will be conducted in three phases using mixed methods. In phase I, the aim is to develop a web-based patient decision aid (PDA) in French with a steering committee and using a focus group of five women already treated for breast cancer. In phase II, the face validity of the decision aid will be assessed using questionnaires. In phase III, the PDA will be assessed by a two-arm randomised controlled trial. This will involve a quantitative evaluation of the PDA in clinical practice comparing the quality of the decision-making process between usual care and the PDA. The primary outcome will be informed choice and its components. The secondary outcomes will be decisional conflict and anxiety. Data will be collected during and after an oncofertility consultation. Phase III is underway. Since September 2018, 52 participants have been enrolled in the study and have completed the survey. We expect to have results by February 2020 for a total of 186 patients. ETHICS AND DISSEMINATION: This study protocol was approved by the Ouest V Research Ethics Board. Results will be spread through peer-reviewed publications, and reported at suitable meetings. TRIAL REGISTRATION NUMBER: The ClinicalTrials.gov registry .(NCT03591848).

Éthique et dépistages organisés des cancers en France.

Cancer screening has been among the priorities of the French Cancer Plans since 2003. However, participation in screening programs remains below expectations. The predominance of the value of autonomy in today's society may compromise the legitimacy of a public health action if it does not gain the adhesion of individuals. The Group of Reflection on the Ethics of Screening (GRED) set up by the French National Cancer Institute has brought together experts from different disciplines around this issue. The aim of the present article is to summarize the work of the group, which successively focused on breast and colorectal cancer screening programs, followed by reflection on the implementation of organized cervical cancer screening. Information and health education appear to be key levers to enable individuals to understand the collective interest of public health policies and thus to be able to adhere to the proposed actions in an informed manner. This should be made possible by providing complete and high quality information, addressing the limits of each screening including benefits and risks. Valuing the collective dimension of public health, which calls for solidarity, must make it possible to raise awareness of the proper use of public services.

[Clinical management of intersex conditions in France]. / Prise en charge de l'intersexuation en France.

Clinical management of intersex conditions in france. Although a better understanding of the nuances of the spectrum linking the normal to the pathological seems to be acquired today, some situations such as intersexuality remain problematic and impose legitimate questions about intervention modalities by medical profession. It is characterized by variations in sexual development both in the genital organs and overall sexual characteristics. Since the 1950s, its clinical management has been based on heavy medical procedures in the first years of life and throughout childhood and adolescence. These procedures such as repeated surgical operations, hormonal treatments and vaginal dilations are often not agreed by the child. In the early 2000s, there was an emergence of associations promoting interests of intersex people and a dissemination of intersex testimonies. They aiming to alert the public opinion by showing consequences and limitations of early systematic sexual conformation. These procedures, practiced and defended today by some specialists, are a subject of debate. Therefore, we propose an analysis of ethical stakes of this situation, which is part of the current debate on patient care modalities. A reorganisation of care pathway based on a well-reasoned and supervised bio-psycho-social approach would therefore emerge. This approach avoids systematic interventionism and allows patients to make free choices.

Prise en charge de l'intersexuation en france. Si une meilleure appréhension des nuances du spectre reliant le normal au pathologique semble acquise aujourd'hui, certaines situations comme celles de l'intersexuation demeurent problématiques et imposent des interrogations légitimes sur les modalités d'intervention du corps médical. Elle se caractérise par des variations du développement sexuel tant au niveau des organes génitaux que des caractéristiques sexuelles globales. Depuis les années 1950, sa prise en charge repose sur des actes médicaux lourds dans les premières années de vie et tout au long de l'enfance et l'adolescence, souvent non consentis par l'enfant, tels que des opérations chirurgicales répétées, des traitements hormonaux et des dilatations vaginales. Au début des années 2000, la naissance d'associations portant les intérêts de personnes intersexes et la diffusion de témoignages visant à alerter l'opinion publique ont mis en lumière les conséquences et limites de ce paradigme de conformation sexuée précoce systématique. Ces actes, pratiqués et défendus par certains spécialistes aujourd'hui, font donc l'objet de débats. C'est pourquoi nous proposons une analyse des enjeux éthiques de la situation s'inscrivant dans le débat actuel sur les modalités de prise en charge. Se dessinerait donc une réorganisation du parcours de soin fondé sur une approche bio-psycho-sociale raisonnée et encadrée permettant d'éviter l'interventionnisme systématique et de permettre un réel libre choix des patients.

[Ethical considerations in the evolution of organised cancer screening programs]. / Apport de la réflexion éthique dans l'évolution des programmes de dépistage organisé des cancers.

Ethical considerations in the evolution of organised cancer screening programs Since 2009, the French National Cancer Institute has set up a working group on the ethics of screening programs for breast, colon and cervical cancer. Collective and individual interest, equity and respect for autonomy are the values addressed in the respective reports. Ethical analysis has highlighted issues that are specific to each programme: the importance of the information provided by health professionals in a context of uncertainty for breast cancer screening; health professionals as a relay of information, access to test and support in the colorectal cancer screening process and, for cervical cancer screening, the implementation of an organisation adapted to women populations concerned. A public health policy whose efficiency depends on the public's adhesion of screening proposals must respect a fundamental ethical principle, namely the assessment of the benefit/risk balance.

Apport de la réflexion éthique dans l'évolution des programmes de dépistage organisé des cancers Depuis 2009, l'Institut national du cancer a mis en place un groupe de réflexion sur l'éthique des programmes de dépistage des cancers du sein, du côlon et du col de l'utérus. L'intérêt collectif et individuel, l'équité et le respect de l'autonomie sont les valeurs abordées dans les rapports respectifs. L'analyse éthique a fait émerger des enjeux spécifiques à chaque programme : l'importance de l'information délivrée par les professionnels de santé dans un contexte d'incertitude, pour le dépistage du cancer du sein ; les professionnels de santé comme relais d'information, d'accès au test et d'accompagnement dans le parcours de dépistage du cancer colorectal et pour le dépistage du cancer du col de l'utérus, la mise en place d'une organisation adaptée aux populations de femmes concernées. Une politique de santé publique dont l'efficience dépend de l'adhésion de la population aux propositions de dépistage doit respecter un principe éthique fondamental qui est l'évaluation de la balance bénéfices-risques.