Compensating patients in trials: Perspectives from an ethical committee versus sponsor.

BACKGROUND: According to European clinical research legislation, no undue influence, including financial incentives, should be used to encourage participation in clinical trials. Financial compensation should be based on the inconvenience experienced by patients and is determined by the sponsor. OBJECTIVES: The objective of this study was to assess the adequacy of patients' financial compensation by obtaining an external ethical opinion compared to the actual compensation provided. METHODS: We randomly selected and reviewed 50 clinical drug trials, including 25 academic and 25 industry-sponsored studies. An external ethics group consisting of three members from French ethics committees, blinded to the actual compensation and the sponsor, retrospectively reviewed the study characteristics and assessed whether financial compensation was appropriate. Cohen's Kappa test measured agreement between actual compensation and the ethics group's opinion, and the McNemar test measured discrepancies. RESULTS: There was no agreement between the actual financial compensation and the ethics group's opinion (K = -.07; 95% CI = [-.16-.02]). More discrepancies were found in favour of financial compensation according to the ethics group than provided by sponsors (12 vs. 2, p = .016). The ethics group recommended financial compensation in 12 out of 50 studies (24%), which were studies with a higher number of additional visits (p = .004) and were more frequently sponsored by industry (p = .008). Sponsors only provided financial compensation in 2 out of 50 studies (4%). CONCLUSION: Patients are rarely compensated despite the perceived inconvenience. Both sponsors and ethics members struggle to determine the need for financial compensation, indicating a need for more precise recommendations for both parties.

Social inequalities in cervical cancer screening: a discrete choice experiment among French general practitioners and gynaecologists.

BACKGROUND: Cervical cancer screening is effective in reducing mortality due to uterine cervical cancer (UCC). However, inequalities in participation in UCC screening exist, especially according to age and social status. Considering the current situation in France regarding the ongoing organized UCC screening campaign, we aimed to assess general practitioners' (GPs) and gynaecologists' preferences for actions designed to reduce screening inequalities. METHODS: French physicians' preferences to UCC screening modalities was assessed using a discrete choice experiment. A national cross-sectional questionnaire was sent between September and October 2014 to 500 randomly selected physicians, and numerically to all targeted physicians working in the French region Midi-Pyrénées. Practitioners were offered 11 binary choices of organized screening scenarios in order to reduce inequalities in UCC screening participation. Each scenario was based on five attributes corresponding to five ways to enhance participation in UCC screening while reducing screening inequalities. RESULTS: Among the 123 respondents included, practitioners voted for additional interventions targeting non-screened women overall (p <  0.05), including centralized invitations sent from a central authority and involving the mentioned attending physician, or providing attending physicians with the lists of unscreened women among their patients. However, they rejected the specific targeting of women over 50 years old (p <  0.01) or living in deprived areas (p <  0.05). Only GPs were in favour of allowing nurses to perform Pap smears, but both GPs and gynaecologists rejected self-collected oncogenic papillomavirus testing. CONCLUSIONS: French practitioners tended to value the traditional principle of universalism. As well as rejecting self-collected oncogenic papillomavirus testing, their reluctance to support the principle of proportionate universalism relying on additional interventions addressing differences in socioeconomic status needs further evaluation. As these two concepts have already been recommended as secondary development leads for the French national organized screening campaign currently being implemented, the adherence of practitioners and the adaptation of these concepts are necessary conditions for reducing inequalities in health care.

[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.

French Therapeutic Education Programme Aimed at Improving the Quality of Life of Laryngectomised Patients and their Close Relations: the Three Stages (Observational and Interventional Randomised) of the Study "PETAL".

The therapeutic education of patients and their close relations is, as yet, poorly developed in France in the field of oncology. Total laryngectomy is a mutilating surgical procedure having a major impact on the patient's life, due to its physical and functional sequelae. Its psychosocial consequences are also important and alter the quality of life of patients and their close relations. Currently, care for laryngectomised patients consists essentially in informing and educating them on some technical procedures during hospital admission. The intervention of a speech therapist, often serves as the link between the patient and the hospital care team. These healthcare modalities often insufficiently account for the social, environmental and personal factors that interact in health-related problems. This report presents the therapeutic education programme protocol "PETAL" for laryngectomised patients and their close relations to improve their quality of life. The trial will be conducted over three phases: (1) the "pilot" phase aims at developing knowledge on the consequences of laryngectomy on the quality of life of patients and their close relations and developed a pluridisciplinary therapeutic education program, (2) the prospective intervention "replication" phase aims at evaluating the programme's transferability in three centres and (3) the cluster-randomised multicentric comparative intervention phase, will assess the benefits of the developed programme. Phase I identified nine themes of workshops related to therapeutic education, training and coordination of care. The developed programme should reinforce town-hospital links to improve help, follow-up and support for patients and their close relations.

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.

[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.

[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.

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).

[The digital pill, between beneficence and vigilance: ethical stakes]. / Le médicament connecté, entre bienveillance et surveillance - Analyse des enjeux éthiques.

Since November 2017, the digital pill, which makes it possible to know whether a patient has achieved compliance or not with the treatment has become a reality. This drug can benefit the patients by helping them to better follow their treatment and avoid misuse. However, even though the use of this device requests patient consent, major questions arise regarding the respect for privacy and freedom of action. Evidently, the correct use of drugs is both a public health and economic issue, but through this digital tool, the temptation could be to implement measures to control citizens, in particular regarding the use of treatments that affect health expenditure. A too prescriptive conception of monitoring algorithms could alter the care relationship, denying the part of adaptation that a patient can legitimately claim in taking his treatment. The digital pill could be a helpful tool but it is necessary to evaluate its fair place in terms of respect for the person and adequacy with its liberties.

Health professionals prepared for the future. Why Social Sciences and Humanities teaching in Medical Faculties matter.

This article was migrated. The article was marked as recommended. A public debate took place place in France in 2018 concerning ethical and social issues of biomedicine and life science and technologies. As faculty members of French medical schools and scholars in Social Sciences and Humanities, we contributed to introduce the central theme of health professionals education. What roles and what place should we assign to the social sciences and Humanities in preparing health professionals who will work in a transforming and largely unpredictable context? In this paper, we list 4 crucial issues for the present and the future of healthcare profession, concerning changes of medical roles; new biomedical concepts and innovations; long term consequences on health social contract; ethical issues in health care daily life settings. Then, we list 4 kinds of resources that are brought to students by Social Sciences and Humanities courses. They concern the connection to patients's experiences the social and cultural construction of these experiences; the social responsibility of medical doctors; and the independence of their professional judgments. This is a plea for the development of reflexivity and critical thought backed up by well identified, well integrated and sufficiently developed Social Sciences and Humanities courses in French medical schools.

Cooperation between medicine and sociology in head and neck oncology.

Twenty-first-century medicine is facing many challenges--knowledge and command of technical advances, research development, team management, knowledge transmission, and adaptation to economic constraints--without neglecting "human" aspects, via transformed carer-patient relationships, social change, and so on. The "modern" physicians know that simply treating disease is no longer enough. One of their essential missions lies in offering the individual patient overall care, which implies acknowledging the latter as an individual within a family, social, and professional environment. Indeed, medical practice requires pluridimensional knowledge of the patients' experience of their disease. Yet the contribution sociology can offer to health care remains largely unknown to many physicians, and medical training includes only limited instruction in the human sciences. On the basis of a few observations taken from sociological research, we would like to demonstrate how, in head and neck oncology, interdisciplinary collaboration between medicine and sociology can prove propitious to improving patient care and attention to their close relations.

[Quality of life and supportive care in head and neck cancers]. / Qualité de vie des patients et soins de support en cancérologie des VADS.

The quality of life of patients treated for head and neck cancers and their carers is part of the current concerns of health care teams. Assessment tools were created and helped to highlight the severe physical effects (pain, mucositis…) and chronic (mutilation, post-radiation complications…) related to the disease or to different treatments but also to consider the psychosocial impact of this disease. Improving the quality of life through a thoughtful and comprehensive support that must be associated with somatic care, mental health care, rehabilitation and inclusion of social difficulties and suffering relatives. Supportive care shall ensure a good quality of life for patients treated and their families but also reduce the physical effects associated with the disease and treatment. They rely on coordination of care including the cancer networks established in the cancer plan to ensure comprehensive and continuous care for these patients.