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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.

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., (© 2021. The Author(s).)

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., Competing Interests: Declaration of Competing Interest The authors have no conflict of interest to declare., (Copyright © 2021 Elsevier Masson SAS. All rights reserved.)

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., Competing Interests: A. Boisgontier, M. Charvin, G. Grandazzi et L. Thibault déclarent n’avoir aucun lien d’intérêts. G. Moutel déclare être expert judiciaire près la cours d’appel de Caen.

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., Competing Interests: There are no conflicts of interest., (Copyright: © 2020 Journal of International Society of Preventive and Community Dentistry.)

Competing Interests: Les auteurs déclarent n’avoir aucun lien d’intérêts.

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)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

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., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

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.

The evaluation of the risk-benefit balance in public health is an ethical commitment, based on the imperative of not harming people. Screening is a probabilistic approach, which, in order to serve the needs of a few, involves the largest number to share the potential harmful effects. Improvement of scientific knowledge and opening of the societal debate modified the relation between collective and individual stakes over time. This article traces the evolution of the discourse surrounding cancer screening, particularly following the controversy surrounding breast cancer screening. Within the framework of a health policy, screening leads in the first place to a collective benefit and second, to an individual benefit. It describes how, within the French context, the debate has induced a complete re-examination of the modalities of information and consent leading to a shift from the promotion of screening to more balanced information on benefits and risks, so that people can decide whether to participate in a more informed way., (Copyright © 2018 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.)

International studies have shown a significant reduction in colorectal cancer (CRC) mortality following the implementation of organized screening programs, given a sufficient participation rate and adequate follow-up. The French national CRC screening program has been generalized since 2008 and targets 18 million men and women aged 50-74 years. Despite broad recommendations, the participation rate remains low (29.8%), questioning the efficiency of the program. A panel of experts was appointed by the French National Cancer Institute to critically examine the place of autonomy and efficiency in CRC screening and propose recommendations. In this paper, we explore the ethical significance of a public health intervention that falls short of its objectives owing to low take-up by the population targeted. First, we analyze the reasons for the low CRC screening participation. Second, we examine the models that can be proposed for public health actions, reconciling respect for the individual and the collective good. Our expert panel explored possible ways to enhance take-up of CRC screening within the bounds of individual autonomy, adapting awareness campaigns, and new educational approaches that take into account knowledge and analysis of sociocultural hurdles. Although public health actions must be universal, target actions should nonetheless be developed for nonparticipating population subgroups.

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.

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., Competing Interests: Les auteurs déclarent n’avoir aucun lien d’intérêts.

Background: The French national cancer institute (INCa) conducted a series of studies to assist decision-making in view of the implementation of organised cervical cancer screening that will be launched in 2018. The programme will concern all women aged 25-65 and targeted interventions will be developed for underscreened populations. This is an evolution from an equality-based approach to a step-by-step strategy of equity aiming to tackle health cancer inequalities that are avoidable and represents unfair differences. Here we present the work of the expert-group in ethics drafted by INCa to review the ethical issues prior to the programme implementation., Discussion: We discuss the value of such a strategy and presents reflections with regard to issues of stigmatization, respect for individual freedom and autonomy. Indeed, the balance has to be found between the search for beneficence and the potential occurrence of perverse effects, which should be considered with particular attention., Conclusion: Moving toward an equity-oriented policy under a strategy of proportionate universalism faces a number of challenges, thus an overview of ethics and social sciences must be an integral part of the process.

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., (© 2018 médecine/sciences – Inserm.)

Many people think that the intensive care unit is reserved for patients with extreme and life-threatening disease, and as such, it remains hypothetical in the collective conscience, and not something that can be predicted or anticipated. Yet, intensive care can be required in a number of situations, and raises many questions depending on whether the illness is chronic, or of sudden onset. It is essential, in this context, to ask whether, and how potential patients are informed, and prepared for the eventuality of intensive care unit (ICU) care. In this view, anticipating ICU admission is a key, yet new issue, and it raises questions about the place of the ICU physician and ICU teams in the healthcare pathway, and in life trajectories overall., Competing Interests: Conflicts of Interest: The author has no conflicts of interest to declare.

Background: The reasons for participation in fecal immunological testing (FIT) of subjects who were previously non-respondents to guaiac fecal occult blood testing (g-FOBT) have not been assessed., Population and Methods: We aimed to determine the reasons for current compliance with FIT among non-responders to g-FOBT, termed "converts‿, in a French district. A questionnaire was returned by 170 converts aged from 55 to 75 years (response rate 75.2% after exclusions)., Results: The major barriers to participation in screening with g-FOBT were test-related: the test was perceived as complicated (24%) and it required three consecutive stools (28%). Among the test-related major determinants of FIT compliance was the perception that the test was less complicated than previous test (30%) and that a unique stool sample was required (29%). Among the non-test related major determinants of FIT compliance were the perception that the general practitioner was more convincing (31%) and the feeling to be more concerned because of age (21%). The reasons for compliance among converts did not differ according to age, sex, and rural or urban residence., Conclusions: Our study demonstrated that the simplicity of FIT and the endorsement of practitioners were both major motivations for FIT compliance among non-respondents in at least two previous consecutive campaigns., (Copyright © 2017 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Objective: French health authorities put general practitioners at the heart of the colorectal cancer screening. This position raises organisational issues and poses medico-legal problems for the professionals and institutions involved in these campaigns, related to the key concepts of medical decisions and suitability of standards. The objective of our study is to reveal the preferences of general practitioners related to colorectal cancer screening organisation with regard to the medico-legal risk METHODS: A discrete choice questionnaire presenting hypothetical screening scenarios was mailed to 2114 physicians from 20 French different areas. The preferences of 358 general practitioners were analysed using logistic regression models., Results: The factors that have significant impact on the preferences of general practitioners are the capacity of the primary care professional in the procedure, the manner in which pre-screening information is given to patients, the manner in which screening results are given to patients, the number of reminders sent to patients who test positive and who do not undergo a colonoscopy and the remuneration of the attending physician., Conclusions: Our results reveals that current colorectal cancer screening organisation is not adapted to general practitioners preferences. This work offers the public authorities avenues for reflection on possible developments in order to optimize the involvement of general practitioners in the promotion of cancer screening programme., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Competing Interests: G. Moutel déclare avoir des liens durables ou permanents avec Le Comité de déontologie des entreprises du médicament au sein du syndicat représentatif de ce secteur en France (rémunération au titre de Président de ce comité). Il déclare par ailleurs être membre du comité d’éthique de l’Inserm, chef du service de médecine légale et droit de la santé du CHU de Caen et directeur de l’espace régional de réflexion éthique.

Background: Little is known about case managers' ethical issues and professional values., Objectives: This article presents an overview of ethical issues in case managers' current practice. Findings are examined in the light of nursing ethics, social work ethics and principle-based biomedical ethics., Research Design: A systematic literature review was performed to identify and analyse empirical studies concerning ethical issues in case management programmes. It was completed by systematic content analysis of case managers' national codes of ethics., Findings: Only nine empirical studies were identified, eight of them from North America. The main dilemmas were how to balance system goals against the client's interest and client protection against autonomy. Professional codes of ethics shared important similarities, but offered different responses to these two dilemmas., Discussion: We discuss the respective roles of professional and organizational ethics. Further lines of research are suggested., (© The Author(s) 2015.)

Background: Many critically ill patients are incapable of receiving information or expressing their own opinion on treatment decisions due to the severity of their disease, or because they are under sedation. French legislation requires that when a physician proposes further tests or treatment for a patient, this proposal should be accompanied by clear and honest information that is appropriate in view of the circumstances and the patient's state of health, and the physician must obtain the patient's consent before proceeding. However, this is often impossible in critical care. We evaluated whether provisions for surrogates are adequate in meeting information needs of patients and families in critical care., Methods: Survey of intensive care physicians by electronic questionnaire in December 2010 and January 2011 to evaluate actual practices. The questionnaire comprised 6 domains covering various aspects relating to the information of patients' relatives as regards diagnostic testing in critical care, when the patient was unable to be appropriately informed. We recorded responders' socio-demographic data (age, how long in practice, where they practised)., Results: Among 1279 physicians contacted, 139 (10.8%) from 98 critical care departments (France, Belgium, Switzerland) responded. A total of 66.2% said they believed it is possible to perform diagnostic tests without informing the patient's relatives. Invasive or high-risk tests, time available to provide information, and quality of prior relations with the patient's family were factors likely to prompt the physician to inform the family, while potentially serious implications for the relatives, and degree of relation of the family member to the patient were reported to make the physician more reluctant to inform relatives. Less than 6% considered routine procedures to require provision of information to relatives., Conclusion: Our results suggest that modalities for providing information to families and relatives, as defined by current French legislation, are not suitable to the context of critical care., (Copyright © 2016 Société française d'anesthésie et de réanimation (Sfar). Published by Elsevier Masson SAS. All rights reserved.)

The purpose of this study was to explore patient and family views on the sharing of their medical data in the context of compiling a European leukodystrophies database. A survey questionnaire was delivered with help from referral centers and the European Leukodystrophies Association, and the questionnaires returned were both quantitatively and qualitatively analyzed. This study found that patients/families were strongly in favor of participating. Patients/families hold great hope and trust in the development of this type of research. They have a strong need for information and transparency on database governance, the conditions framing access to data, all research conducted, partnerships with the pharmaceutical industry, and they also need access to results. Our findings bring ethics-driven arguments for a process combining initial broad consent with ongoing information. On both, we propose key item-deliverables to database participants.

The evolution of science and our society raises ethical questions in medical and nursing practice. These give rise to the requirement for individual and collective reflection in order to consider the consequences of decisions and to judge on sometimes complex choices. This reflection concerns both nursing practices and the organisation of the health system., (Copyright © 2015 Elsevier Masson SAS. All rights reserved.)

The evolution of the care relationship, which gives a growing place to the wishes of the patient, poses two sorts of questions to the teams on the clinical wards. How far should they go in order to respect these wishes when the patient's autonomy is diminished? Can the user's free choice be conceived as absolute, or must it be framed by collective rules governing medical practice and the functioning of the institution. Consequently, how can the rights and obligations of the players and users of the healthcare system be articulated?, (Copyright © 2015 Elsevier Masson SAS. All rights reserved.)

Objective: The purpose of this study was to analyze modalities of the transition from pediatric to adult epilepsy care and patients' acquisition of autonomy., Method: This study was conducted using semidirected interviews composed of three major parts: the patient's criteria of transition toward adult healthcare (factors taken into account, anticipation, the patient's opinion, etc.), conditions (teamwork with the neurologists, transmission of the medical record, continuity of health care, etc.), and the role played by social workers and psychologists. We interviewed 10 doctors belonging to six major Parisian hospital units involved in the monitoring of children and adolescents with epilepsy and working in Pediatric Neurology Departments of the Île-de-France region., Results: For most of the doctors, reaching 18 years of age was the major argument taken into account to consider transition to adult care. According to the doctors interviewed, parents are generally worried when their child has to find another doctor (7/10). According to eight out of 10 doctors, the neurologist is selected to take over. The doctors recognize the importance of psychologists and social workers even if they are not always included. The process by which the patient gains autonomy depends a great deal on the role played by the pediatricians and parents, although some parents are very protective. This behavior weakens the patient's capacity for autonomy and it varies according to the degree of his or her physical and/or neurological disabilities. Furthermore, developing autonomy requires interdisciplinary work that is not yet fully in place., Conclusion: The lack of structures well-adapted to the uniqueness of each patient and the lack of coordination between the various institutions do not favor the acquisition of autonomy. A network that could efficiently respond to the needs of epileptic patients as well as medical care tailored to adolescents would be the answer to this dilemma., (Copyright © 2015 Elsevier Masson SAS. All rights reserved.)

Background: Disclosure of obtaining informed consent from patients (ICP) and research ethics committee (REC) approval in published reports is sometimes omitted. To date, no disclosure data are available on surgical research., Objective: Our aim was to assess whether REC approval and ICP were documented in surgical trials., Study Design: Overall, 657 randomised trials, published between 2005 and 2010 in 10 international journals, were included. We collected the report rate of REC approval and ICP and contacted the corresponding author when ethical information was lacking., Results: Among the 657 randomised controlled trials (RCT), 576 (87.7%) stated that an REC had approved the research, and 606 (92.2%) stated that ICP had been requested. Furthermore, 28 RCTs (4.3%) reported neither REC nor ICP., Conclusions: The phase III randomised surgical trials that were analysed were shown to have respected fundamental ethical principles in approximately 90% of the cases examines., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background: Discussions regarding disclosure of funding sources and conflicts of interest (COI) in published peer-reviewed journal articles are becoming increasingly more common and intense. The aim of the present study was to examine whether randomized controlled trials (RCTs) published in leading surgery journals report funding sources and COI., Methods: All articles reporting randomized controlled phase III trials published January 2005 through December 2010 were chosen for review from ten international journals. We evaluated the number of disclosed funding sources and COI, and the factors associated with such disclosures., Results: From a review of 657 RCT from the ten journals, we discovered that presence or absence of a funding source and COI was disclosed by 47 % (309) and 25.1 % (165), respectively. Most articles in "International Committee of Medical Journal Editors (ICMJE)-affiliated journals" did not disclose COI. Disclosure of funding was associated with a journal impact factor >3 (51.7 vs 41.6 %; p < 0.01), statistician/epidemiologist involvement (64.2 vs 43.7 %; p < 0.001), publication after 2008 (52.9 vs 41.1 %; p < 0.01), and the journal being ICMJE-affiliated (49.3 vs 40 %; p < 0.05). Conflict of interest disclosure was associated with publication after 2008 (38.7 vs 11.3 %; p < 0.001), and with the journal not being affiliated with ICMJE (36.9 vs 21.3 %; p < 0.001)., Conclusions: Of the published studies we investigated, over half did not disclose funding sources (i.e., whether or not there was a funding source), and almost three quarters did not disclose whether COI existed. Our findings suggest the need to adopt best current practices regarding disclosure of competing interests to fulfill responsibilities to readers and, ultimately, to patients.

Background: The EU LeukoTreat program aims to connect, enlarge and improve existing national databases for leukodystrophies (LDs) and other genetic diseases affecting the white matter of the brain. Ethical issues have been placed high on the agenda by pairing the participating LD expert research teams with experts in medical ethics and LD patient families and associations. The overarching goal is to apply core ethics principles to specific project needs and ensure patient rights and protection in research addressing the context of these rare diseases., Aim: This paper looks at how ethical issues were identified and handled at project management level when setting up an ethics committee., Methods: Through a work performed as a co-construction between health professionals, ethics experts, and patient representatives, we expose the major ethical issues identified., Results: The committee acts as the forum for tackling specific issues tied to data sharing and patient participation: the thin line between care and research, the need for a charter establishing the commitments binding health professionals and the information items to be delivered. Ongoing feedback on the database, including delivering global results in a broad-audience format, emerged as a key recommendation. Information should be available to all patients in the partner countries developing the database and should be scaled to different patient profiles., Conclusion: This work led to a number of recommendations for ensuring transparency and optimizing the partnership between scientists and patients., (Copyright © 2014 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.)

Background: Breast cancer is a major public health challenge. Organized mammography screening (OS) is considered one way to reduce breast cancer mortality. EU recommendations prone mass deployment of OS, and back in 2004, France introduced a national OS programme for women aged 50-74 years. However, in 2012, participation rate was still just 52.7%, well short of the targeted 70% objective. In an effort to re-address the (in) efficiency of the programme, the French National Cancer Institute has drafted an expert-group review of the ethical issues surrounding breast cancer mammography screening., Discussion: Prompted by emerging debate over the efficiency of the screening scheme and its allied public information provision, we keynote the experts' report based on analysis of epidemiological data and participation rate from the public health authorities. The low coverage of the OS scheme may be partly explained by the fact that a significant number of women undergo mammography outside OS and thus outside OS criteria. These findings call for further thinking on (i) the ethical principles of beneficence and non-malfeasance underpinning this public health initiative, (ii) the reasons behind women's and professionals' behavior, and (iii) the need to analyze how information provision to women and the doctor-patient relationship need to evolve in response to scientific controversy over the risks and benefits of conducting mammographic screening., Summary: This work calls for a reappraisal of the provision of screening programme information. We advocate a move to integrate the points sparking debate over the efficiency of the screening scheme to guarantee full transparency. The perspective is to strengthen the respect for autonomy allowing women to make an informed choice in their decision on whether or not to participate.

Background: Based on international and national recommendations, organized breast cancer screening in France raises questions of medical ethics built around the key concepts of individual autonomy and public health policy. Because of the evolving knowledge, professionals and institutions involved in the program must review the ethical values associated with this medical practice., Methods: The ethical aspects of organized breast cancer screening were studied. In response to newly acquired knowledge highlighted by a review of texts governing this practice in France, proposals for changes resulting from reflections of a working group coordinated by the National Cancer Institute are presented., Results: Ethical issues raised by screening must find expression in the general principles of the program's organization: acceptability of screening, efficiency, adverse effects, equity of access, free care…, but also at different stages of the procedure: information delivery, first and second invitations, refusal of further diagnostic investigation…, Conclusion: A better match between breast cancer screening and recently developed knowledge requires optimal information delivery to women targeted by the program as well as a stronger role for the referring healthcare professional., (Copyright © 2014 Elsevier Masson SAS. All rights reserved.)

Purpose: Case management is a new professional field in France. It is addressed to elderly persons living in community whose situation is regarded as particularly complex. Case managers have to assess needs and coordinate necessary services. One common criteria of complexity is refusal of care. The objective of this study is to compare the words of users with those of case managers about refusal of care, in order to understand its meaning, professionals' attitudes and ethical challenges., Methods: Two researchers have cooperated on this qualitative research: the first one, anthropologist, interviewed 19 individuals, and 11 of their caregivers. The second one, geriatrician and researcher in medical ethics, lead four focus groups gathering a total of 18 case managers., Results: Refusal of care often is the result of the will of preserving one's identity, compromised by illness. Individuals seek control on their life. Facing this behaviour, case managers try to secure the individual, by establishing a personal relationship that respects their choices, even if care has to be delayed. Refusal of care may sometimes disclose a desire to vanish, in front of which professionals meet their own limits., Conclusion: To recognise an elderly person that refuses care as a unique individual who can make choices secure his identity, and allow him to change., (Copyright © 2013 Société nationale française de médecine interne (SNFMI). Published by Elsevier SAS. All rights reserved.)

During the acute phase of a severe burn, surgery is an emergency. In this situation, human skin allografts constitute an effective temporary skin substitute. However, information about the use of human tissue can not be given to the patients because most of the allografted patients are unconscious due to their injury. This study explored the restitution of information on skin donation to patients who have been skin allografted and who have survived their injury. A qualitative study was conducted due to the limited number of patients in ability to be interviewed according to our medical and psychological criteria. 12 patients who had been treated between 2002 and 2008 were interviewed. Our results show that 10 of them ignored that they had received skin allografts. One of the two patients who knew that they had received allografts knew that skin had been harvested from deceased donor. All patients expressed that there is no information that should not be delivered. They also expressed their relief to have had the opportunity to discuss their case and at being informed during their interview. Their own experience impacted their view in favor of organ and tissue donation.

Although selective termination of pregnancy and fetal reduction in multiple pregnancy both involve the termination in utero of the development of live fetuses, these two procedures are different in several aspects. Nevertheless, several authors tend to amalgamate and confuse their psychosocial consequences and the ethical issues they raise. Therefore, this narrative review, derived from a comparative analysis of 91 articles, shines a light on these amalgamations and confusions, as well as on the medical, contextual, experiential and ethical differences specific to selective termination and fetal reduction., (Copyright © 2013 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.)

In 2001, a French expert panel recommended that presymptomatic tests should not be carried out on minors in families affected by Li-Fraumeni syndrome (LFS), flying in the face of possible parental demands for such testing. We decided to investigate the legitimacy of such a recommendation. We conducted a national multicenter survey using self-administered questionnaires mailed to French oncogeneticists in 33 regional centers in France. We aimed to (1) determine the extent to which these doctors were confronted with parental requests for TP53 testing, (2) study how they responded to these requests and the arguments used and (3) assess the attitude of oncogeneticists concerning the normative framework regulating the prescription of tests for minors. Twenty oncogeneticists stated that they had managed at least one LFS family. Eleven of these doctors had been confronted with parental requests for testing and three had prescribed such tests on at least one occasion. The oncogeneticists gave balanced medical, psychological and ethical arguments, highlighting the dilemma they face in the decision-making process. This dilemma is due to the lack of a consensus concerning this recommendation, which aims to protect the minor by limiting presymptomatic tests to cases in which a clear medical benefit can be demonstrated but which prevents the unique situation of particular families from being taken into account. In conclusion, the recommendation has a normative status but first, from a clinical stance, it is difficult to dissociate it from the evaluation of individual family situations, and second, the benefit of a specific medical follow-up for TP53 mutation carriers is currently being investigated.

All recommendations and laws concerning biomedical research, including the most recent in France in 2012, emphasize the quality of patient information to justify its participation. To optimize practices, it is important to take into account the central issues: what limits of information? What role for the relatives and family in the decision in case of disability or vulnerability of a patient? What need for specific information for long protocol and follow-up cohort? What information about research results?, (© 2013 médecine/sciences – Inserm / SRMS.)

As case management is under development in France for elderly people, this study sets out to identify and analyse key situations responsible for ethical dilemmas for French case managers. We based our study on the analyses of individual interviews made with case managers and focus-group discussions, bringing together all case managers working in local organisations running for at least a year. We identified three situations giving rise to ethical dilemmas: in the order of importance, the refusals of care, the practicalities of collecting and sharing personal data and the allocation of resources. These three situations can lead to conflict between the principle of beneficence and those of respect for autonomy, non-maleficence and justice. We describe here how French case managers practically deal with these situations.

Observation of medical practices still show that, in some institutions, obtaining consent could be in the mode of a trivialization, or even some administrative automaticity. To ensure a truly informed choice, this article explains why the information in the sensitive field of reproductive medicine and perinatology should remain an act of care and relationship. It outlines why medical information issued to couples must take into account not only validated data, but also the doubts and uncertainties. This is especially true when risk management because the meaning we give to the acceptance of risk is not simply the result of a calcul of probability but also the result of a social construction. All signed consent and collected outside of such an approach to quality and completeness of the information would be considered questionable., (Copyright © 2012 Elsevier Masson SAS. All rights reserved.)

Background: The randomized controlled trial (RCT) is the gold standard tool used to evaluate therapeutic interventions. Methodological and ethical aspects should be adequately reported to enable readers to make informed and justified judgments regarding the validity of a trial and the treatment effectiveness., Objective: The aim of this study was to evaluate the methodological and ethical qualities of randomized clinical trials in gastrointestinal surgery and to assess the relationship between these two qualities., Study Design: All of the articles chosen for review reported on phase III randomized controlled gastrointestinal surgical trials were published in 12 international journals during 2006 and 2007. The eligible studies were identified, selected, and then evaluated based on a broad set of predetermined criteria. The methodological quality was evaluated using the Jadad scale, and the ethical quality was evaluated using the Berdeu score., Results: The mean Jadad score was 9.7 ± 1.78. The methodological quality was insufficient in 64 RCTs (37.4 %; Jadad score <9). The mean Berdeu score was 0.36 ± 0.08. The journal impact factor, number of randomized patients, and number of centers correlated with the outcome of the Jadad score, and the journal impact factor, industry funding, and year in which the trial began correlated with the outcome of the Berdeu score. Informed consent from patients was not obtained in 7 % (n = 12) of the RCTs, and research ethics committee approval was not mentioned in 14.6 % (n = 25) of the RCTs., Conclusions: The reporting of gastrointestinal surgery RCTs is less than optimal. In our study, the trials of higher methodological quality were more likely to provide information about their ethical aspects. These results suggest the need for more attention to be paid to the conduct of clinical research and the reporting of ethical aspects. The appropriation of the ethical rules by surgeons involved in human clinical trials could improve the methodology and reporting of RCTs in gastrointestinal surgery.

Objectives: To describe the condition of the decision-making of admission and non-admission in intensive care unit., Study Design: Non-interventional observational cohort., Patients and Methods: Retrospective analysis of declarative terms of decision-making of patients admitted or denied in a surgical intensive care unit. The decision-making in the two admitted or not admitted troops was compared., Results: That it is during a non-admission (149 decisions) or of an admission (149 decisions), the decision-making process was not very different. The instruction of the files was regarded as collegial in nearly 80% of the cases by the intensivist in load. The dialogue precedent the decision utilized generally several speakers but who could be residents. The participation of the patient and/or his close relations, as that of the ancillary medical personnel was rare. No person of confidence or anticipated directive was quoted. More than 50% of the decisions were taken within a time lower than 30 minutes. The decisions of non-admission were considered to be more difficult than the decisions of admission. Traceability was not automatically given., Conclusion: Thus, this study shows that in its current form the intensivists of the service estimate that in the majority of the cases the instruction of the files was collegial. However, the conditions of seniorisation of the decision, the collection of opinion of the patient and/or his close relations and the traceability are tracks of improvement to be implemented in certain circumstances of admission or non-admission., (Copyright © 2011 Société française d’anesthésie et de réanimation (Sfar). Published by Elsevier SAS. All rights reserved.)

Context: The setting of multidisciplinary meeting (MDM) by the French Cancer Plan has introduced new decisional elements in the patient-physician relationship in oncology., Methods: To assess the potential impact of MDM on this relationship, a study was conducted at the Tours Hospital: 145 questionnaires were collected from patients whose files have been discussed in MDM, 40 questionnaires were collected from physicians attending these meetings and an analysis of 324 files was performed., Results: Patients recognize the decisional process of MDM as reassuring for 80% of them. However, a majority (73%) expressed that the most important for them is the relationship with the referring physician, almost all (96%) having a total or great confidence in him. The results emphasize that trust appears to be related to the quality of communication, open dialogue and the competence of the doctor in particular in the choice of treatment. A review of files shows that in 91% of cases, the opinion of the RCP is applied and that, in 69% of cases, the referring doctor delivers the information to the patient after MDM. From the physicians' perspective, 33/40 report that the MDM do not alter their relationship with the patient. We note that 35/40 express that the consultation after MDM facilitates the presentation of the decision and 37/40 that the decision is always or often applied in accordance with the opinion of the MDM., Conclusion: MDM appears in most cases in this study not to modify the patient-physician relationship. Due to the patient confidence into the referring physician, the role of this one is essential in integrating the decisional multidisciplinary opinion of MDM and it is important to ensure from his/her disengagement in the decisional process., (Copyright © 2011 Elsevier Masson SAS. All rights reserved.)

Objective: To review outcomes following reductions in trichorionic triplet pregnancies at our institution., Method: Retrospective analysis of the outcome of trichorionic triamniotic triplets reduced to singletons (group I, n = 44) or twins (group II, n = 136) at 10 and 12 weeks of gestation., Results: Reduction to one or two was based on parent's preference, hence unrelated to any specific obstetrical or maternal issue. Early fetal loss rate (e.g. <24 weeks) was 9.1% in group I versus 5.1% in group II (p = 0.83). In group I, the take-home baby rate was 86.4% versus 91.9% in group II (p = 0.8). In group I, 17.5% of the women gave birth between 33 and 36(+6) weeks of gestation versus 40.6% in group II (p = 0.026). Delivery beyond 37 weeks was 72.5% in group I and 46.9% in group II (p = 0.01). Intrauterine growth restriction rate was 27.0% in group I versus 45.0% in group II (p = 0.049)., Conclusion: Reduction to one rather than two fetuses led to significantly higher term delivery rate without significant differences in fetal loss rate or take-home baby rate., (© 2012 John Wiley & Sons, Ltd.)

Purpose: Burnout syndrome (BOS) has frequently been reported in healthcare workers, and precipitating factors include communication problems in the workplace and stress related to end-of-life situations. We evaluated the effect of an intensive communication strategy on BOS among caregivers working in intensive care (ICU)., Methods: Longitudinal, monocentric, before-and-after, interventional study. BOS was evaluated using the Maslach Burnout Inventory (MBI) and depression using the Centre for Epidemiologic Studies Depression Scale (CES-D) in 2007 (period 1) and 2009 (period 2). Between periods, an intensive communication strategy on end-of-life practices was implemented, based on improved organisation, better communication, and regular staff meetings., Results: Among 62 caregivers in the ICU, 53 (85%) responded to both questionnaires in period 1 and 49 (79%) in period 2. We observed a significant difference between periods in all three components of the MBI (emotional exhaustion, p = 0.04; depersonalization p = 0.04; personal accomplishment, p = 0.01). MBI classified burnout as severe in 15 (28%) caregivers in period 1 versus 7 (14%) in period 2, p < 0.01, corresponding to a 50% risk reduction. Symptoms of depression as evaluated by the CES-D were present in 9 (17%) caregivers in period 1 versus 3 (6%) in period 2, p < 0.05, corresponding to a risk reduction of almost 60%., Conclusion: The implementation of an active, intensive communication strategy regarding end-of-life care in the ICU was associated with a significant reduction in the rate of burnout syndrome and depression in a stable population of caregiving staff.

Purpose: Since the 2005 French law on end of life and patients' rights, it is unclear whether practices have evolved. We investigated whether an intensive communication strategy based on this law would influence practices in terms of withholding and withdrawing treatment (WWT), and outcome of patients hospitalised in intensive care (ICU)., Methods: This was a single-centre, two-period study performed before and after the 2005 law. Between these periods, an intensive strategy for communication was developed and implemented, comprising regular meetings and modalities for WWT. We examined medical records of all patients who died in the ICU or in hospital during both periods., Results: In total, out of 2,478 patients admitted in period 1, 678 (27%) died in the ICU and 823/2,940 (28%) in period 2. In period 1, among patients who died in the ICU, 45% died subsequent to a decision to WWT versus 85% in period 2 (p < 0.01). Among these, median time delay between ICU admission and initiation of decision-making process was significantly different (6-7 days in period 1 vs. 3-5 days in period 2, p < 0.05). Similarly, median time from admission to actual WWT decision was significantly shorter in period 2 (11-13 days in period 1 vs. 4-6 days in period 2, p < 0.05). Finally, median time from admission to death in the ICU subsequent to a decision to WWT was 13-15 days in period 1 versus 7-8 days in period 2, p < 0.05. Reasons for WWT were not significantly different between periods., Conclusion: Intensive communication brings about quicker end-of-life decision-making in the ICU. The new law has the advantage of providing a legal framework.

While investigators have a duty to provide research participants with summary findings at the end of a study, providing general information during the course of research is rarely considered. However, this raises an important ethical issue in the context of long-term studies such as cohorts or biobanks. We investigated this issue in the context of two ANRS cohorts of HIV-infected patients, AQUITAINE and COPILOTE. Face-to-face interviews were conducted with HIV patient representatives and research professionals concerning the delivery of information in the course of the research. Respondents stated that participants wish to be informed of research results (both aggregate and individual) but also expect general information about the cohort itself, research progression, and what their participation may provide. It was concluded that information provided during the course of the research may help participants to distinguish between care and research. The essential role of clinicians-investigators in providing information was emphasized.