Articles de revues : « Medical ethics – France »

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Dorozynski, A. « France adopts new code of medical ethics ». BMJ 311, n^o 7008 (23 septembre 1995) : 769–70. http://dx.doi.org/10.1136/bmj.311.7008.769a.

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Moulin, Anne Marie. « Medical ethics in France : The latest great political debate ». Theoretical Medicine 9, n^o 3 (octobre 1988) : 271–85. http://dx.doi.org/10.1007/bf00489702.

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Pires Marques, Tiago. « Global mental health, autonomy and medical paternalism : reconstructing the ‘French ethical tradition’ in psychiatry ». History of Psychiatry 28, n^o 3 (21 avril 2017) : 326–43. http://dx.doi.org/10.1177/0957154x17706475.

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In the last few decades, the definition of deontological ethics, a well-identified ethical territory in psychiatry, has been the object of increasing concerns. This has been the case in France, where claims of a specific ethical tradition in psychiatry have accompanied the institutionalization of psychiatric ethics and the perceived globalization of an Anglo-American model of mental health care. This study traces the history of the ‘French ethical tradition in psychiatry’ and its relationship with establishing institutional spaces for ethical decision-making. The ‘ethical tradition’ thus conceived proves to be functional in terms of preserving the threatened identity of French psychiatry. Nevertheless, this movement also pinpoints impasses that transcend the French context and may provide valuable resources for ethical reflections on mental health on a global scale.

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Mino, Jean-Christophe. « Hospital Ethics Committees in Paris ». Cambridge Quarterly of Healthcare Ethics 9, n^o 3 (juillet 2000) : 424–28. http://dx.doi.org/10.1017/s0963180100003170.

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Even if the term bioethics is used all over the world, its meanings are multiple and different, especially between American and European countries, depending on local cultural and medical contexts. These differences concern the issues discussed or the institutional form bioethics takes. In France, bioethics was used from the end of the 1970s and focused on research ethics and issues at the beginning of life. At the national level, a permanent commission, the “national consultative ethics committee on life sciences and health” (Comité Consultatif National d'Ethique, CCNE) was created by President François Mitterrand in 1983. Its recommendations dealt essentially with procreative medicine and biomedical research ethics.

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BARTOLI, C., D. GIOCANTI, D. PIERCECCHI-MARTI, A. L. PELISSIER-ALICOT, F. CIANFARANI et G. LEONETTI. « The Court Medical Expert in France : Changes in status ». Medicine, Science and the Law 46, n^o 4 (octobre 2006) : 328–34. http://dx.doi.org/10.1258/rsmmsl.46.4.328.

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Harsin, Jill. « Syphilis, Wives, and Physicians : Medical Ethics and the Family in Late Nineteenth-Century France ». French Historical Studies 16, n^o 1 (1989) : 72. http://dx.doi.org/10.2307/286434.

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Gromb, S., G. Manciet et A. Descamps. « Ethics and law in the field of medical care for the elderly in France. » Journal of Medical Ethics 23, n^o 4 (1 août 1997) : 233–38. http://dx.doi.org/10.1136/jme.23.4.233.

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Benhamou-Jantelet, Ghislaine. « Nurses’ Ethical Perceptions of Health Care and of Medical Clinical Research : an audit in a French university teaching hospital ». Nursing Ethics 8, n^o 2 (mars 2001) : 114–22. http://dx.doi.org/10.1177/096973300100800204.

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Very few data exist in France on: (1) nurses’ knowledge and behaviour concerning ethical decisions in clinical practice; and (2) their knowledge of ethical rules in clinical research. This questionnaire-based audit tried mainly to assess these questions in a large French university teaching hospital. Of the 257 questionnaires distributed to nurses in 23 clinical units of the hospital, 206 were returned (80% response rate). When responding to the vignette describing a clinical situation requiring an ethical decision to be made, most nurses acted as the patient’s advocate although they have had no formal training in ethics. Indeed, 66% of nurses responding considered that the patients themselves should be the primary decision makers in situations that relate to their health and medical care. For children or comatose patients, the decision should be left to the relatives according to 72% of the responses. The results indicated that the role of health care professionals in ethical decisions made for a given patient should be marginal. Nurses’ knowledge concerning research protocols, particularly their ethical requirements and consequences, is poor at present and information from and communication with doctors should be improved.

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Haddadi, A., et F. Ravaz. « Historical Approaches to Euthanasia : The Unfinished Story of a Concept ». Kutafin Law Review 8, n^o 1 (30 avril 2021) : 99–114. http://dx.doi.org/10.17803/2313-5395.2021.1.15.099-114.

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Various ethics committees in Belgium, Canada, Denmark, Luxembourg, Portugal, and France have made attempts to describe the notion of euthanasia. Opinion No 063 (January 27, 2000) of the National Advisory Committee on Ethics shows that there has been no concensus on the definition of this concept. It is therefore necessary to review historical background of euthanasia from ancient times to modern period to better understand its potential applications in divergent contexts.Studies devoted to euthanasia usually involve two modalities, namely active and passive. The active modality entails the act of deliberately killing a patient with or against their will in order to relieve persistent suffering, while the passive modality deals with the rational valid refusal of life-sustaining medical interventions necessary for the patient's life and health. The goal of this article is to present different historical approaches to euthanasia from two modalities and engage the bioethics community in a discussion on legal, social, and ethical issues of euthanasia all over the world.

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Gromb, Sophie, B. Chanseau et H. J. Lazarini. « Judicial Problems Related to Transsexualism in France ». Medicine, Science and the Law 37, n^o 1 (janvier 1997) : 27–31. http://dx.doi.org/10.1177/002580249703700107.

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The French courts have recently changed their juridical position about transsexualism. The new decisions have, among other things, asserted the necessity for preliminary judicial expertise, an ordinary medical report not being satisfactory as a legal basis. The authors present a summary of the juridical evolution, an expert analysis of transsexualism and the key concepts that the experts will have to debate.

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Quinlan, Sean. « Monstrous Births and Medical Networks : Debates over Forensic Evidence, Generation Theory, and Obstetrical Authority in France, ca. 1780-1815 ». Early Science and Medicine 14, n^o 5 (2009) : 599–629. http://dx.doi.org/10.1163/138374209x12465448337547.

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AbstractIn France between 1780 and 1815, doctors opened a broad correspondence with medical faculties and public officials about foetal anomalies ("monstrosities"). Institutional and legal reforms forced doctors to encounter monstrous births with greater frequency, and they responded by developing new ideas about heredity and embryology to explain malformations to public officials. Though doctors achieved consensus on pathogenesis, they struggled to apply these ideas in forensic cases, especially with doubtful sex. Medical networks simultaneously allowed doctors to explore obstetrical techniques, as licensing regulations forced practitioners into emotional encounters with child anomalies. Doctors thus developed a new ethics for treating monstrosities, viewing them as pathological specimens, forensic objects, and obstetrical tragedies.

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Gignon, M., S. Paupière, O. Jardé et C. Manaouil. « Victims of assault : a Europe-wide review of procedures for evaluating the seriousness of injuries ». Medicine, Science and the Law 50, n^o 3 (juillet 2010) : 145–48. http://dx.doi.org/10.1258/msl.2010.010020.

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In France, victims of assault receive a medical certificate describing their injuries. This certificate must fulfil certain criteria because it plays a major role in the subsequent judicial proceedings – notably the establishment of a period of ‘total incapacity for work’, which determines the court in which the case will be heard. Determination of the duration of this period of incapacity is complex. We decided to review medical examination procedures for victims of assault in a number of other European countries (England and Wales, Belgium, Germany, Switzerland and Spain). Our study revealed that only in France do physicians have to make a quantitative assessment of injuries, which is supposed to reflect the extent of the injuries and the intensity of the violence – despite the difficulties this may pose. We discuss the relevance of this quantitative assessment.

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Richards, Anna. « Localization of clinical research ». Journal of Internationalization and Localization 8, n^o 2 (31 décembre 2021) : 89–109. http://dx.doi.org/10.1075/jial.21002.ric.

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Abstract Clinical research using human participants to further medical knowledge has been at the forefront in 2021. Clinical research studying the efficacy of treatments can be categorised in two broad categories as ‘observational studies’ or ‘clinical trials’. Written from the perspective of a localization project manager at Vitaccess, which conducts global digital research for biopharmaceutical companies, this paper discusses five core challenges that impact the localization of such a study launched in France, Italy, Germany, Belgium, Spain, Japan, the UK, the US and Canada, conducted via a smartphone app. The localization project manager role provides a bridge between translators, revisers, ethics bodies, authors, legal, and medical reviewers, enabling oversight to keep the balance between launching the study globally and enabling each country to have the content and structure tailored to their cultural and linguistic expectations through localization. The main challenges in localizing a real-world evidence study is the complexity and volume of ethical, legal, and medical feedback required for the content of the study, which is further complicated by the need to target different countries and languages. Subjectivity and variance in the feedback per country also pose difficulties. International harmonisation of ethical, medical, and legal reviews of such global studies could streamline the process.

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McLennan, Matthew R. « Putting the Ghost into Language : Cartesian Echoes in Contemporary French Medical Humanism ». Journal of French and Francophone Philosophy 26, n^o 1 (4 juin 2018) : 38–63. http://dx.doi.org/10.5195/jffp.2018.809.

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This article offers a definition of medical humanism and identifies four key contemporary medical humanists in France. It then makes two claims about the historical provenance of their humanism. First, they define it in opposition to a process of iatric medicalization that they trace to certain conceptual errors made by Descartes. But second, they remain more Cartesian than they seem to realize because they accept Descartes's knotting together of humanity, ethics and language. By looking at Gori and Del Volgo, Roudinesco and Ricoeur, the author is able to show how French medical humanism repeats the Cartesian gesture of locating humanity in language - thus facing the problem of the moral standing of so-called "marginal" human persons and non-human animal persons. The author concludes with a call to radicalize French medical humanism in pursuit of a more inclusive medical "personism".

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Faisant, Maxime, Frédérique Papin-Lefebvre, Camille Rerolle, Pauline Saint-Martin et Clotilde Rougé-Maillart. « Twenty-five years of French jurisprudence in criminal medical liability ». Medicine, Science and the Law 58, n^o 1 (6 novembre 2017) : 39–46. http://dx.doi.org/10.1177/0025802417737402.

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We report on a comprehensive 25-year study on criminal medical liability in France, undertaken to establish trends in the number of cases being brought before the criminal courts. We did this by interrogating the database on the Légifrance website using a Boolean equation (‘ pénal’ (criminal) AND ‘ médecin’ (physician) OR ‘ docteur’ (doctor)). In total 539 cases were selected, in which the status of the physician either influenced the punishment imposed, or was a prerequisite for the commission of the offence. The results of the search produced two outcomes: offences and the dates of the most recent criminal judgements (which had been left blank). Further data were also collected: references to court cases, hearing dates, offence dates, procedural time limits, numbers of accused parties, types of punishments and physician characteristics. The number of court hearings increased from the 1980s until the late 1990s. Since then, it has remained stable at around 25 cases per year. Of the defendants appearing before the courts, 39.2% have been found guilty. On average, 10 to 13 physicians every year – that is, one per month – are punished. Those most often punished are obstetrician-gynaecologists (13%), followed by intensive care anaesthetists (11%) and then by general practitioners (6.7%). The offences most frequently occurring are manslaughter (36.5%), illegal profits (12%), unintentional injuries (11.5%) and sexual offences (10.1%). The results are most reassuring in terms of the risks posed by the practice of medicine in France. Such a risk does indeed exist; however, it is at a low level and stable.

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Kumar, Sameer. « Do prestige and trust sustain knowledge-based communities ? Evidence from Medical Ethics co-authorship networks in France ». Aslib Journal of Information Management 71, n^o 2 (18 mars 2019) : 281–302. http://dx.doi.org/10.1108/ajim-06-2018-0155.

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Purpose The purpose of this paper is to identify embedded communities among Medical Ethics scholars in France based on their position and strength of association in the social networks they form. Design/methodology/approach The author constructed a co-authorship network by linking two authors if they co-authored a paper. Once the co-authorship network was constructed, the author investigated the entire network quantitatively using standard research methods known as social network analysis. The author’s mechanism of community detection was via identification, i.e. communities were user-defined based on topological analysis. Findings The study identified that communities formed by trust (bonding or repeat connections) or by prestige (connection of well-connected scholars with those that are already well-connected) overlap each other, suggesting that trust and prestige may go hand in hand in sustaining communities. Structural holes within trust networks indicated that some actors played more of a broker role than did other actors. Research limitations/implications The study uses Web of Science field based category to extract data. Although thorough cleaning of data has been performed, author disambiguation over a three decade period remains a limitation. Originality/value Although there have been numerous studies on mapping co-authorship networks, there has been limited work investigating the underlying communities formed by author associations. The results of this study should be of immense benefit to those studying the science of science and S&T policy.

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Carey, Lindsay B. « The Generosity of the Dead : A Sociology of Organ Procurement in France [Medical Law and Ethics Series] ». Australian Journal of Primary Health 17, n^o 1 (2011) : 122. http://dx.doi.org/10.1071/pyv17n1_br.

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Inquimbert, Camille, Yoann Maitre, Estelle Moulis, Vincent Gremillet, Paul Tramini, Jean Valcarcel et Delphine Carayon. « Recreational Nitrous Oxide Use and Associated Factors among Health Profession Students in France ». International Journal of Environmental Research and Public Health 19, n^o 9 (26 avril 2022) : 5237. http://dx.doi.org/10.3390/ijerph19095237.

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The first aim of this study was to investigate the recreational use of nitrous oxide (N2O) among health profession students at Montpellier University (France). The second aim was to identify the factors associated with N2O use. All students in medicine, dentistry, pharmacy and midwifery of the Montpellier University were contacted by email to participate in the survey. The students answered directly online by filling out anonymously a questionnaire including demographic information and questions about N2O, illicit drugs and alcohol use. Ethical approval was granted by the ethics committee of the Montpellier University. The sample comprised 593 students (mean age = 22.3 ± 2.6 yr), with 68.6% of females. Lifetime N2O use was reported by 76.6% and frequent alcohol use by 30.5% of the respondents. The lifetime use of cannabis, ‘poppers’, cocaine, ecstasy and LSD was 26.8%, 54.6%, 9.6%, 10.1% and 2.0% respectively. In multivariate analysis, the substances significantly associated with lifetime N2O were alcohol drinking and ‘poppers’ use. With respect to this self-nominated sample, our results indicate that respondents who were alcohol drinkers, were poppers users, follow longer studies, divert medical products for recreational use or were members of a students’ corporation had higher odds of lifetime N2O use.

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Inquimbert, Camille, Yoann Maitre, Estelle Moulis, Vincent Gremillet, Paul Tramini, Jean Valcarcel et Delphine Carayon. « Recreational Nitrous Oxide Use and Associated Factors among Health Profession Students in France ». International Journal of Environmental Research and Public Health 19, n^o 9 (26 avril 2022) : 5237. http://dx.doi.org/10.3390/ijerph19095237.

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The first aim of this study was to investigate the recreational use of nitrous oxide (N2O) among health profession students at Montpellier University (France). The second aim was to identify the factors associated with N2O use. All students in medicine, dentistry, pharmacy and midwifery of the Montpellier University were contacted by email to participate in the survey. The students answered directly online by filling out anonymously a questionnaire including demographic information and questions about N2O, illicit drugs and alcohol use. Ethical approval was granted by the ethics committee of the Montpellier University. The sample comprised 593 students (mean age = 22.3 ± 2.6 yr), with 68.6% of females. Lifetime N2O use was reported by 76.6% and frequent alcohol use by 30.5% of the respondents. The lifetime use of cannabis, ‘poppers’, cocaine, ecstasy and LSD was 26.8%, 54.6%, 9.6%, 10.1% and 2.0% respectively. In multivariate analysis, the substances significantly associated with lifetime N2O were alcohol drinking and ‘poppers’ use. With respect to this self-nominated sample, our results indicate that respondents who were alcohol drinkers, were poppers users, follow longer studies, divert medical products for recreational use or were members of a students’ corporation had higher odds of lifetime N2O use.

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Masson, Claire, Gabriel Birgand, Enrique Castro-Sánchez, Vanessa Maria Eichel, Alexa Comte, Hugo Terrisse, Brice Rubens-Duval et al. « Is virtual reality effective to teach prevention of surgical site infections in the operating room ? study protocol for a randomised controlled multicentre trial entitled VIP Room study ». BMJ Open 10, n^o 6 (juin 2020) : e037299. http://dx.doi.org/10.1136/bmjopen-2020-037299.

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IntroductionSome surgical site infections (SSI) could be prevented by following adequate infection prevention and control (IPC) measures. Poor compliance with IPC measures often occurs due to knowledge gaps and insufficient education of healthcare professionals. The education and training of SSI preventive measures does not usually take place in the operating room (OR), due to safety, and organisational and logistic issues. The proposed study aims to compare virtual reality (VR) as a tool for medical students to learn the SSI prevention measures and adequate behaviours (eg, limit movements…) in the OR, to conventional teaching.Methods and analysisThis protocol describes a randomised controlled multicentre trial comparing an educational intervention based on VR simulation to routine education. This multicentre study will be performed in three universities: Grenoble Alpes University (France), Imperial College London (UK) and University of Heidelberg (Germany). Third-year medical students of each university will be randomised in two groups. The students randomised in the intervention group will follow VR teaching. The students randomised in the control group will follow a conventional education programme. Primary outcome will be the difference between scores obtained at the IPC exam at the end of the year between the two groups. The written exam will be the same in the three countries. Secondary outcomes will be satisfaction and students’ progression for the VR group. The data will be analysed with intention-to-treat and per protocol.Ethics and disseminationThis study has been approved by the Medical Education Ethics Committee of the London Imperial College (MEEC1920-172), by the Ethical Committee for the Research of Grenoble Alpes University (CER Grenoble Alpes-Avis-2019-099-24-2) and by the Ethics Committee of the Medical Faculty of Heidelberg University (S-765/2019). Results will be published in peer-reviewed medical journals, communicated to participants, general public and all relevant stakeholders.

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Michaut, Carine, Antoine Baumann, Hélène Gregoire, Corinne Laviale, Gérard Audibert et Xavier Ducrocq. « An assessment of advance relatives approach for brain death organ donation ». Nursing Ethics 26, n^o 2 (23 juin 2017) : 553–63. http://dx.doi.org/10.1177/0969733017708331.

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Background: Advance announcement of forthcoming brain death has developed to enable intensivists and organ procurement organisation coordinators to more appropriately, and separately from each other, explain to relatives brain death and the subsequent post-mortem organ donation opportunity. Research aim: The aim was to assess how potentially involved healthcare professionals perceived ethical issues surrounding the strategy of advance approach. Research design: A multi-centre opinion survey using an anonymous self-administered questionnaire was conducted in the six-member hospitals of the publicly funded East of France regional organ and tissue procurement network called ‘Prélor’. Participants: The study population comprised 460 physicians and nurses in the Neurosurgical, Surgical and Medical Intensive Care Units, the Stroke Units and the Emergency Departments. Ethical considerations: The project was approved by the board of the Lorraine University Diploma in Medical Ethics and the Prélor Network administrators. Main findings: A slight majority of 53.5% of respondents had previously participated in an advance relatives approach: 83% of the physicians and 42% of the nurses. A majority of healthcare professionals (68%) think that the main justification for advance relatives approach is the comprehensive care of the dying patient and the research of his or her most likely opinion (74%). The misunderstanding of the related issues by relatives is an obstacle for 47% of healthcare professionals and 51% think that the answer given by the relatives regarding the most likely opinion of the person regarding post-mortem organ donation really corresponds to the person opinion in only 50% of the cases or less. Conclusion: Time given by advance approach should be employed to help and enable relatives to authentically bear the values and interests of the potential donor in the post-mortem organ donation discussion. Nurses’ attendance of advance relatives approach seems necessary to enable them to optimally support the families facing death and post-mortem organ donation issues.

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Sass, Hans-Martin, et Hanna Hubenko. « Interview with professor of philosophy Hans-Martin Sass. November 15-18, 2020 ». Filosofiya osvity. Philosophy of Education 26, n^o 2 (25 juin 2021) : 188–93. http://dx.doi.org/10.31874/2309-1606-2020-26-2-13.

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Hans-Martin Sass, Honorary Professor of Philosophy (Ruhr University, Bochum, Germany). Founder and board member of the Centre for Medical Ethics (CME), Bochum, Germany. Honorary Senior Research Fellow at Kennedy Institute of Ethics at Georgetown University, Washington, DC. Honorary Professor of the Bioethics Research Centre, Beijing. He has written more than 60 books and pamphlets, more than 250 articles in professional journals. Editor of the Ethik in der Praxis/ Practical ethics, Muenster: Lit. Founder and co-editor of the brochures “Medizinethische Materialien”, Bochum: ZME. He has lectured in Argentina, Austria, Belgium, Bulgaria, Brazil, Canada, Croatia, the Chech Republic, India, Iran, Israel, Italy, Japan, France, the Netherlands, the Philippines, Poland, Portugal, Russia, Spain, Switzerland and Taiwan. The interview devoted to exposition of the concept of bioethics in America and Germany, as well as the professor`s attitude to the idea of the integrative concept of bioethics. The concept of integrative bioethics has been developed in different countries, a component of this concept is the idea of the need for discussion on bioethics in various sectors of society (not only medical). Equally important in this concept are the definitions of bioethics and the bioethical imperative proposed by Fritz Jahr in 1926. The scientist`s article, which was discovered in 1997, contains a new format of bioethical ideas, as well as a valuable opportunity to enhance understanding the term of bioethics as an integrative science. Interview has been conducted by Hanna Hubenko as a part of the joint international course «Integrative Bioethics». At the meeting it was discussed the experience of cooperation and plans for the future. Cooperation and feedback between scientists remains an unconditional prerogative, also in a pandemic situation (to be continued).

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Saint-Martin, Pauline, Marie Bouyssy et Patrick O'Byrne. « Analysis of 756 cases of sexual assault in Tours (France) : medico-legal findings and judicial outcomes ». Medicine, Science and the Law 47, n^o 4 (octobre 2007) : 315–24. http://dx.doi.org/10.1258/rsmmsl.47.4.315.

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We describe the medico-legal findings in a population of sexual assault cases assessed in an urban French referral centre, analyse the subsequent legal dispositions in each case and determine whether the characteristics of the assault and the medico-legal findings were associated with conviction of the assailant. We performed a retrospective study of medico-legal reports in all the sexual assault cases reported in Tours (France) during a seven-year period. We defined two groups of victims: children under 15 years old and victims aged 15 years or more. Legal outcomes were obtained from courtroom proceedings. The relationship between the outcomes and the circumstances of the case was analyzed by logistic regression. We enrolled a total of 756 cases during the study period. The mean age of the study population was 16.5 years and 68.3% of the cases involved children under 15 years old. In 57% of these cases, the assailant was a family member. 31.7% of all the victims were aged 15 years or more. The assailant was an acquaintance of the victim in 62.2% of the cases. Drug-facilitated assault was suspected in 2.9% of the cases. In 46.2% of the cases, formal criminal charges were not filed due to insufficient evidence; 36.3% of the assailants were convicted. Examination at the request of the police authorities and previous acquaintance of the assailant by the victim were significantly associated with conviction. Allegations of penetration, the presence of general body trauma and the presence of genital trauma were not necessarily associated with conviction. Medical examiners need to be circumspect when they record non-medical variables. Physical evidence of trauma was neither predictive nor essential for conviction. Successful prosecution depends on the quality of the testimony provided by the victim.

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Derbez, Benjamin, Antoine de Pauw, Dominique Stoppa-Lyonnet, Frédéric Galactéros et Sandrine de Montgolfier. « Familial disclosure by genetic healthcare professionals : a useful but sparingly used legal provision in France ». Journal of Medical Ethics 45, n^o 12 (28 août 2019) : 811–16. http://dx.doi.org/10.1136/medethics-2018-105212.

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Familial disclosure of genetic information is an important, long-standing ethical issue that still gives rise to much debate. In France, recent legislation has created an innovative and unprecedented procedure that allows healthcare professionals (HCPs), under certain conditions, to disclose relevant information to relatives of a person carrying a deleterious genetic mutation. This article will analyse how HCPs in two medical genetics clinics have reacted to these new legal provisions and show how their reticence to inform the patients’ relatives on their behalf leads them to use this option sparingly.

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Decullier, Evelyne, et Hervé Maisonneuve. « Have ignorance and abuse of authorship criteria decreased over the past 15 years ? » Journal of Medical Ethics 46, n^o 4 (8 novembre 2019) : 255–58. http://dx.doi.org/10.1136/medethics-2019-105737.

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ObjectiveA high prevalence of authorship problems can have a severe impact on the integrity of the research process. We evaluated the authorship practices of clinicians from the same university hospital in 2019 to compare them with our 2003 data and to find out if the practices had changed.MethodsPractitioners were randomly selected from the hospital database (Hospices Civils de Lyon, France). The telephone interviews were conducted by a single researcher (HM) using a simplified interview guide compared with the one used in 2003. The doctors were informed that their answers would be aggregated without the possibility of identifying the respondents. During the interviews, the researcher ticked the boxes with the answers on a paper file.ResultsWe interviewed 26 clinicians (mean age 49±8 years) from various medical specialties. They were unfamiliar with the ICMJE (International Committee of Medical Journal Editors) criteria for writing medical articles and felt that these criteria were not well met in general. With regard to ways of reducing the practice of honorary authors, the participants clearly felt that asking for a signature was hypocritical and of little use. The ghost authors were well known; this practice was considered as rather rare. The ‘publish or perish’ has always been cited as being responsible for bad practices (26/26: 100%). We compared these results with those observed in 2003 and no improvement has been observed in the past 15 years.ConclusionFor the second time in France, within a 15-year interval, we have shown that the ICMJE criteria were ignored and that honorary authorship was frequent.

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Medina, Eva. « The Impact of Information Sessions on Women’s Anxiety When Facing a Voluntary Termination of Pregnancy (VTP)—A Case Study about Geneva University Hospitals (Switzerland) ». Societies 12, n^o 5 (9 septembre 2022) : 126. http://dx.doi.org/10.3390/soc12050126.

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Women going through a termination of their pregnancy (VTP) face a stressful situation that should be managed by hospitals in a multidisciplinary way: law, public health, and communication. This paper aims to analyze how the information sessions organized by hospitals influence women’s decisions when facing a VTP. To achieve that, we resorted to four main methodologies: (a) literature review about law, public health, and communication; (b) a 4-week participant observation at Port Royal Hospital (France) and in a social restaurant in Katowice (Poland), as well as three focus groups in the first institution (2012); (c) an online survey addressed to 500 women in Poland, France, and Switzerland (2012–2014); and (d) two focus groups and one deep interview with doctors and nurses from Geneva University Hospitals and Lausanne University Hospital in Switzerland (2017–2018). Based on our quantitative results, we developed a medical protocol to help doctors interact with patients going through a VTP. This protocol was approved by the Geneva University Hospitals’ Ethics Committee (BASEC 2018-01983). We concluded that women’s informed consent is an intimate, reciprocal decision; doctors should help them to make independent decisions; and hospitals need to establish a harmonized discourse based on a code of internal communication, train their doctors in communication skills, and help them adopt a more flexible approach when taking care of these patients.

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Rashidpouraie, Roya, Mohammad Nader Sharifi et Mina Rashidpouraei. « Abortion Laws and Regulations in Iran and European Countries During the COVID-19 Pandemic ». Journal of Arak University Medical Sciences 23, n^o 5 (1 décembre 2020) : 686–97. http://dx.doi.org/10.32598/jams.23.cov.6394.1.

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Background and Aim: Abortion has always posed challenges in the areas of ethics, law, religion, philosophy, and reproductive health. Some countries have had different approaches to abortion at different times. Today, abortion is a major challenge in Iran. Social developments and increasing level of health literacy, awareness and participation of women in social and economic fields have led to incompatibility of theoretical and practical aspects in these areas. Women sometimes have abortions without attention to the national law. In Iran, the reasons for legal abortion are the life-threatening conditions of the mother and the fetus. During the Coronavirus Disease 2019 (COVID-19) pandemic, some countries have revised their abortion laws and regulations. In some countries, such as France and Finland, these revisions are permanent; in countries such Portugal and Norway, the changes are temporary; and in other countries such as Germany and Belgium, it is unclear whether the changes are permanent or temporary. In this study, we aim to review the abortion laws and regulations in Europe and Iran. Then, by discussing the new guidelines for the COVID-19 pandemic, we evaluate the effects and consequences of this pandemic on abortion. Methods & Materials: The search was conducted in PubMed/MEDLINE, ScienceDirect, Scopus and Google Scholar as well as national databases such as SID, MagIran, and IranMedex on studies published from 2002 to 2020 using the following keywords:Abortion, illegal abortion, induced abortion, and COVID-19. Due to the onset of SARS-COV1 epidemic in 2002, all articles published between these two outbreaks were searched. Ethical Considerations: All ethical principles were observed in this article. Results: During the COVID-19 pandemic, some European countries revised the abortion laws and regulations, mostly due to realize the reproductive health right. It seems that, this revision has not yet been taken place in Iran. Conclusion: With the emergence of COVID-19, some countries had revised their abortion laws and regulations to reduce unsafe abortions. It seems that during the Covid19 pandemic, due to changes in lifestyle such as social distancing and economic and social lockdowns, it needs to revise medical laws and regulations in health-oriented and time-dependent areas (such as abortion) so that the principles of medical ethics such as beneficence and maleficent, can be applied. Having COVID-19 and consequently abortion during the pandemic is one of the most challenging issues that should be addressed in terms of ethical, jurisprudential and legal aspects. Development of regulations based on ethical principles during the COVID-19 pandemic is necessary to prevent illegal and unsafe abortions.

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Rodríguez-Arias, D., G. Moutel, M. P. Aulisio, A. Salfati, J. C. Coffin, J. L. Rodríguez-Arias, L. Calvo et C. Hervé. « Advance directives and the family : French and American perspectives ». Clinical Ethics 2, n^o 3 (1 septembre 2007) : 139–45. http://dx.doi.org/10.1258/147775007781870038.

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Several studies have explored differences between North American and European doctor patient relationships. They have focused primarily on differences in philosophical traditions and historic and socioeconomic factors between these two regions that might lead to differences in behaviour, as well as divergent concepts in and justifications of medical practice. However, few empirical intercultural studies have been carried out to identify in practice these cultural differences. This lack of standard comparative empirical studies led us to compare differences between France and the USA regarding end-of-life decision-making. We tested certain assertions put forward by bioethicists concerning the impact of culture on the acceptance of advance directives in such decisions. In particular, we compared North American and French intensive care professional's attitudes toward: (1) advance directives, and (2) the role of the family in decisions to withhold or withdraw life-support.

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Suehs, Carey Meredith, Isabelle Vachier, David Galeazzi, François Vaast, Fanny Cardon, Nicolas Molinari et Arnaud Bourdin. « Standard patient training versus Vik-Asthme chatbot-guided training : ‘AsthmaTrain’ – a protocol for a randomised controlled trial for patients with asthma ». BMJ Open 13, n^o 2 (février 2023) : e067039. http://dx.doi.org/10.1136/bmjopen-2022-067039.

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IntroductionTherapeutic education for patients with asthma has been shown to reduce asthma morbidity. The high availability of smart phones provides the opportunity to furnish patient training via specifically designed chatbot applications. The goal of this protocol is to perform a first pilot comparison of traditional face to face versus chatbot-guided patient therapeutic education programmes for patients with asthma.Methods and analysisEighty adult patients with a physician-confirmed diagnosis of asthma will be enrolled in a two-parallel-arm, randomised (1:1) controlled pilot trial. A single-Zelen consent procedure is deployed to first enrol all participants in the comparator arm, that is, the standard patient therapeutic education programme at the University Hospitals of Montpellier, France. This means of patient therapeutic education is based on reoccurring interviews and discussion with qualified nursing staff as per usual care. Following baseline data acquisition, randomisation will be performed. Those patients randomised to the comparator arm will not be informed of the second arm. Those patients randomised to the experimental arm will be proposed access to a specifically designed chatbot (Vik-Asthme) as the second tested means of patient training (refusals continue with standard training, though analysed as intention to treat). The primary outcome is change in the total Asthma Quality of Life Questionnaire score at the end of follow-up (6 months). Secondary outcomes cover asthma control, spirometry, general health status, programme adherence and burden for medical staff, exacerbations and medical resource use (medications, consults, emergency visits, hospitalisation and intensive care).Ethics and disseminationThis study (‘AsthmaTrain’ protocol version 4–20220330) has been approved by the Committee for the Protection of Persons Ile-de-France VII on 28 March 2022 (reference number 21.03617.000059). Enrolment began on 24 May 2022. Results will be published in international peer-reviewed journals.Trial registration numberNCT05248126.

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Camut, Stéphanie, Antoine Baumann, Véronique Dubois, Xavier Ducrocq et Gérard Audibert. « Non-therapeutic intensive care for organ donation ». Nursing Ethics 23, n^o 2 (8 décembre 2014) : 191–202. http://dx.doi.org/10.1177/0969733014558969.

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Background and Purpose: Providing non-therapeutic intensive care for some patients in hopeless condition after cerebrovascular stroke in order to protect their organs for possible post-mortem organ donation after brain death is an effective but ethically tricky strategy to increase organ grafting. Finding out the feelings and opinion of the involved healthcare professionals and assessing the training needs before implementing such a strategy is critical to avoid backlash even in a presumed consent system. Participants and methods: A single-centre opinion survey of healthcare professionals was conducted in 2013 in the potentially involved wards of a French University Hospital: the Neurosurgical, Surgical and Medical Intensive Care Units, the Stroke Unit and the Emergency Department. A questionnaire with multiple-choice questions and one open-ended question was made available in the different wards between February and May 2013. Ethical considerations: The project was approved by the board of the Lorraine University Diploma in Medical Ethics. Results: Of a total of 340 healthcare professionals, 51% filled the form. Only 21.8% received a specific education on brain death, and only 18% on potential donor’s family approach and support. Most healthcare professionals (93%) think that non-therapeutic intensive care is the continuity of patient’s care. But more than 75% of respondents think that the advance patient’s consent and the consent of the family must be obtained despite the presumed consent rule regarding post-mortem organ donation in France. Conclusion: The acceptance by healthcare professionals of non-therapeutic intensive care for brain death organ donation seems fairly good, despite a suboptimal education regarding brain death, non-therapeutic intensive care and families’ support. But they ask to require previously expressed patient’s consent and family’s approval. So, it seems that non-therapeutic intensive care should only remain an ethically sound mean of empowerment of organ donors and their families to make post-mortem donation happen as a full respect of individual autonomy.

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Costa, Marie, Fabienne Marcellin, Marion Coste, Tangui Barré, Sandra Nordmann, Marion Mora, Gwenaëlle Maradan et al. « Access to care for people with alcohol use disorder in France : a mixed-method cross-sectional study protocol (ASIA) ». BMJ Open 8, n^o 9 (septembre 2018) : e024669. http://dx.doi.org/10.1136/bmjopen-2018-024669.

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IntroductionAlcohol use disorder (AUD) is a major public health concern worldwide. In France, only 10% of people with AUD (PWAUD) receive medical care. General practitioners (GP) are one of the main entry points for AUD care. The present ongoing study, entitled ASIA (Access to Care and Indifference toward Alcohol,Accès aux Soins et Indifference à l’Alcoolin French), aims to improve knowledge about factors associated with access to care for AUD by exploring related GP and PWAUD practices, experiences and perceptions.Methods and analysisThe ASIA project is an ongoing cross-sectional multisite study based on a complementary mixed-method approach (quantitative and qualitative) using a convergent parallel design. The double-perspective design of the study will enable us to collect and compare data regarding both PWAUD and GP points of view. For the PWAUD quantitative study, 260 PWAUD will be interviewed using a telephone-based questionnaire. For the qualitative study, 36 PWAUD have already been interviewed. The GP quantitative study will include 100 GP in a 15 min survey. Fifteen GP have already participated in semistructured interviews for the qualitative study. Logistic regression will be used to identify predictors for access to care. With respect to data analyses, qualitative interviews will be analysed using semantic analysis while quantitative logistic regression will be used for quantitative interviews.Ethics and disseminationThis study was approved by the CNIL (French National Commission on Informatics and Liberties) (approval reference number: C16-10, date of approval: 17 July 2017), the CCTIRS (Advisory Committee on Information Processing in Material Research in the Field of Health) and the CEEI (Evaluation and Ethics Committee) (approval reference number: 16–312, date of approval: 8 July 2016) of INSERM (French National Institute of Health and Medical Research). Results from ASIA will be disseminated in peer-reviewed publications, conference presentations, reports and in a PhD thesis.

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Panchaud, Catherine. « Enhancing Ethical Thinking : the Role of a National Nurses' Association ». Nursing Ethics 2, n^o 3 (septembre 1995) : 243–46. http://dx.doi.org/10.1177/096973309500200307.

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In democratic Switzerland, each of its 26 cantons (states) has its own government and its own laws. Thus there are 26 ministries of health and as many different laws regulating medical and health care practice. The Swiss Nurses' Association likewise has 13 regional chapters and a central organization that works on the national level. Medicine is private and practically all of the Swiss population is privately insured. High technology has led to high specialization with, among other results, a reduced number of premature deaths, longer life span but also rising costs of health. Health professionals are also becoming much more aware of ethical issues such as cost versus quality, high technology versus compassionate care, etc. A multilingual (four national languages) and multicultural country, Switzerland's health care system relies heavily on foreign nurses, many of whom come from neighbouring France and Germany but also from England, Yugoslavia, Canada and other countries. Regulation of nursing practice is still poor. Nursing or nurses are hardly mentioned in the state laws and, when mentioned, are often put in a dependent relation to the physician. Basic nurse training is regulated nationally by cantonal delegations to the Swiss Red Cross. Although there is a good postbasic training scheme, nurses are still striving for access to the university. Meanwhile, they go abroad to acquire degrees. Research in nursing is being developed mainly by the efforts of individuals and the Swiss Nurses' Association.

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Cazes, Cécile, Kevin Phelan, Victoire Hubert, Rodrigue Alitanou, Harouna Boubacar, Liévin Izie Bozama, Gilbert Tshibangu Sakubu et al. « Simplifying and optimising management of acute malnutrition in children aged 6 to 59 months : study protocol for a community-based individually randomised controlled trial in Kasaï, Democratic Republic of Congo ». BMJ Open 10, n^o 12 (décembre 2020) : e041213. http://dx.doi.org/10.1136/bmjopen-2020-041213.

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IntroductionAcute malnutrition (AM) is a continuum condition, arbitrarily divided into moderate and severe AM (SAM) categories, funded and managed in separate programmes under different protocols. Optimising acute MAlnutrition (OptiMA) treatment aims to simplify and optimise AM management by treating children with mid-upper arm circumference (MUAC) <125 mm or oedema with one product—ready-to-use therapeutic food—at a gradually tapered dose. Our main objective was to compare the OptiMA strategy with the standard nutritional protocol in children 6–59 months presenting with MUAC <125 mm or oedema without additional complications, as well as in children classified as uncomplicated SAM (ie, MUAC <115 mm or weight-for-height Z-score (WHZ) <−3 or with oedema).Methods and analysisThis study was a non-inferiority, individually randomised controlled clinical trial conducted at community level in the Democratic Republic of Congo. Children 6–59 months presenting with MUAC <125 mm or WHZ <−3 or with bipedal oedema and without medical complication were included after signed informed consent in outpatient health facilities. All participants were followed for 6 months. Success in both arms was defined at 6 months post inclusion as being alive, not acutely malnourished per the definition applied at inclusion and without an additional episode of AM throughout the 6-month observation period. Recovery among children with uncomplicated SAM was the main secondary outcome. For the primary objective, 890 participants were needed, and 480 children with SAM were needed for the main secondary objective. We will perform non-inferiority analyses in per-protocol and intention-to-treat basis for both outcomes.Ethics and disseminationEthics approvals were obtained from the National Health Ethics Committee of the Democratic Republic of Congo and from the Ethics Evaluation Committee of Inserm, the French National Institute for Health and Medical Research (Paris, France). We will submit results for publication to a peer-reviewed journal and disseminate findings in international and national conferences and meetings.Trial registration numberNCT03751475. Registered 19 September 2018, https://clinicaltrials.gov/ct2/show/NCT03751475.

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Price, David P. T. « Contemporary Transplantation Initiatives : Where's the Harm in Them ? » Journal of Law, Medicine & ; Ethics 24, n^o 2 (1996) : 139–49. http://dx.doi.org/10.1111/j.1748-720x.1996.tb01846.x.

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Two contemporary strategies in cadaver organ transplantation, both with the potential to affect significantly expanding organ transplant waiting list sizes, have evolved: elective ventilation (EV) and use of nonheart-beating donors (NHBDs). Both are undergoing a period of critical review. It is not clear how widely EV is practiced around the world. In Great Britain, the Royal Devon and Exeter Hospital was the first hospital to develop an EV protocol (the Exeter Protocol), in 1988, after which other British hospitals followed suit. In the 1980s, new NHBD protocols of two distinct types were implemented worldwide, although both rely on death confirmed by traditional cardiopulmonary criteria. The first type involves the removal of organs immediately after death, the preeminent example being the University of Pittsburgh Medical Center Protocol (the Pittsburgh Protocol). The second involves the perfusion and cooling of kidneys immediately following death and subsequent organ removal. Protocols of this type have sprung up in Holland, Great Britain (for example, at Leicester General Hospital), Italy, France, Spain, Japan, and the United States (for example, the Regional Organ Bank of Illinois).

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Roche, Mélanie, Christine Ravot, Amélie Malapert, Sophie Paget-Bailly, Charlène Garandeau, Virginie Pitiot, Mélanie Tomatis et al. « Feasibility of a prehabilitation programme dedicated to older patients with cancer before complex medical–surgical procedures : the PROADAPT pilot study protocol ». BMJ Open 11, n^o 4 (avril 2021) : e042960. http://dx.doi.org/10.1136/bmjopen-2020-042960.

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BackgroundAgeing is associated with an increased prevalence of comorbidities and sarcopenia as well as a decline of functional reserve of multiple organ systems, which may lead, in the context of the disease-related and/or treatment-related stress, to functional deconditioning. The multicomponent ‘Prehabilitation & Rehabilitation in Oncogeriatrics: Adaptation to Deconditioning risk and Accompaniment of Patients’ Trajectories (PROADAPT)’ intervention was developed multiprofessionally to implement prehabilitation in older patients with cancer.MethodsThe PROADAPT pilot study is an interventional, non-comparative, prospective, multicentre study. It will include 122 patients oriented to complex medical–surgical curative procedures (major surgery or radiation therapy with or without chemotherapy). After informed consent, patients will undergo a comprehensive geriatric assessment and will be offered a prehabilitation kit that includes an advice booklet with personalised objectives and respiratory rehabilitation devices. Patients will then be called weekly and monitored for physical and respiratory rehabilitation, preoperative renutrition, motivational counselling and iatrogenic prevention. Six outpatient visits will be planned: at inclusion, a few days before the procedure and at 1, 3, 6 and 12 months after the end of the procedure. The main outcome of the study is the feasibility of the intervention, defined as the ability to perform at least one of the components of the programme. Clinical data collected will include patient-specific and cancer-specific characteristics.Ethics and disseminationThe study protocol was approved by the Ile de France 8 ethics committee on 5 June 2018. The results of the primary and secondary objectives will be published in peer-reviewed journals.Trial registration numberNCT03659123. Pre-results of the trial.

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Pouget, Alix Marie, Elodie Civade, Philippe Cestac et Charlotte Rouzaud-Laborde. « From hospitalisation to primary care : integrative model of clinical pharmacy with patients implanted with a PICC line—research protocol for a prospective before–after study ». BMJ Open 11, n^o 4 (avril 2021) : e039490. http://dx.doi.org/10.1136/bmjopen-2020-039490.

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IntroductionClinical pharmacy improves patient safety and secures drug management using information, education and good clinical practices. However, medical device management is still unexplored, and proof of effectiveness is needed. A PICC line (peripherally inserted central catheter) is a medical device for infusion. It accesses the central venous system after being implanted in a peripheral vein. However, complications after implantation often interfere with smooth execution of the treatment. We hypothesise that clinical pharmacy for medical devices could be as effective as clinical pharmacy for medications. The main objective is to assess the effectiveness of clinical pharmacy activities on the complication rate after PICC line implantation.Methods and analysisThis is a before–after prospective study. The study will begin with an observational period without clinical pharmacy activities, followed by an interventional period where pharmacists will intervene on drug and medical device management and provide personalised follow-up and advice. Sixty-nine adult patients will be recruited in each 6-month period from all traditional care units. The main inclusion criteria will be the implantation of a PICC line. The primary outcome is the decrease in the number of complications per patient and per month. Secondary outcomes are the consultation and hospital readmission rates, the acceptance rate of pharmaceutical interventions, the patients’ quality of life, the direct hospital induced or avoided costs and the participants’ satisfaction. Data will be collected using case report forms during hospitalisation and telephone follow-up after discharge. The analysis will compare these criteria during the two periods.Ethics and disseminationThe study has received the approval of our Ethics Committee (Clermont-Ferrand Southeast VI, France, number AU1586). Results will be made available to the patients or their caregivers, the sponsor and other researchers when asked, as described in the consent form.Trial registration numberNCT04359056.

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Briko, Nikolay I., P. I. Melnichenko, V. R. Kuchma, N. I. Prokhorov et Yu V. Pavlova. « DEONTOLOGY IN PREVENTIVE MEDICINE : SCIENTIFIC AND HISTORICAL BASES, CHALLENGES OF THE PRESENT AND SOLUTIONS ». Hygiene and sanitation 97, n^o 5 (15 mai 2018) : 389–95. http://dx.doi.org/10.18821/0016-9900-2018-97-5-389-395.

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The article presents the peculiarities of medical deontology in preventive medicine. The differences between deontological problems in the activity of a Clinician and a Physician in the specialty of medical and preventive medicine are considered. The historical stages of the formation and development of ideas of deontology and medical ethics in Russia are shown. The comparative plan presents an analysis of the main legislative acts in the field of bioethics and deontology of medical and preventive medicine. The world community was noted to show a great interest in topical problems of bioethics: several World Congresses and European Conferences were held, in most countries of Europe and America national bioethics committees were established (in the USA and France they were organized under the Presidents of these States). The main goal of the doctor’s professional activity is to preserve human life, prevent diseases and restore health, as well as reduce suffering from incurable diseases. Much attention is paid to this problem in the Federal law of November 21, 2011. (N 323-FZ) about bases of the protection of the health of citizens in the Russian Federation “which is fundamental in the field of healthcare”. It establishes the obligation of medical and pharmaceutical workers to carry out their activities in accordance with the legislation of the Russian Federation, guided by the principles. The aim of this study was to develop and substantiate the main differences between deontological problems in the activities of clinicians and physicians in the specialty medical and preventive care in the historical aspect. An invaluable role in the development of the principles of deontology was played by outstanding doctors of the past: Hippocrates, Abu-l-Faraj, as well as Russian and Soviet scientists and doctors M.Ya. Mudrov, 8N.I. Pirogov, V.A. Manassein, V.I. Davydovsky, N.Kh. Petrov, B.V. Petrovsky. Separately, it is noted that the role of medicine can be radically changed, if not exclude the importance of the preventive direction, but, on the contrary, through it to strengthen the ideological and controlling.

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Katib, Atif Abdulhamid. « Research ethics challenges during the COVID-19 pandemic : what should and what should not be done ». Journal of Ideas in Health 3, Special1 (19 septembre 2020) : 185–87. http://dx.doi.org/10.47108/jidhealth.vol3.issspecial1.49.

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This article is directed primarily at how clinical trials can be ethically conducted in the midst of the current global COVID-19 pandemic. We explain why ethical issues are more complicated than they once were. Furthermore, we discuss the relevant parties` roles in protecting participants` rights and in keeping basic research ethics of justice, respect, equity, and beneficence strongly implemented on the ground. References Moorthy V, Restrepo H, Preziosi MP, Swaminathan S. Data sharing for novel coronavirus (COVID-19). Bull World Health Organ. 2020; 98: 150. http://dx.doi.org/10.2471/BLT.20.251561 Angus DC. Optimizing the trade-off between learning and doing in a pandemic. Epub ahead of print, 2020. https://doi.org/10.1001/jama.2020.4984)JAMA Park YR, Koo H, Yoon YK, Park S, Lim Y-S, Baek S, et al. Expedited Safety Reporting to Sponsors Through the Implementation of an Alert System for Clinical Trial Management at an Academic Medical Center: Retrospective Design Study. JMIR Med Inform. 2020;8(2): e14379. https://doi.org/2196/14379. Bae J, Lee J, Jang Y, Lee Y. Development of simulation education debriefing protocol with faculty guide for enhancement clinical reasoning. BMC Med Educ. 2019;19(1):197. https://doi.org/10.1186/s12909-019-1633-8. Cox EM, Edmund AV, Kratz E, Lockwood SH, Shankar A. Regulatory Affairs 101: Introduction to Expedited Regulatory Pathways. Clin Transl Sci. 2020;13(3):451‐ https://doi.org/10.1111/cts.12745. Epub 2020 Feb 6. Rivenbark JG, Ichou M. Discrimination in healthcare as a barrier to care: experiences of socially disadvantaged populations in France from a nationally representative survey. BMC Public Health. 2020;20(1):31. https://doi.org/1186/s12889-019-8124-z Arsenijevic J, Tummers L, Bosma N. Adherence to Electronic Health Tools Among Vulnerable Groups: Systematic Literature Review and Meta-Analysis. J Med Internet Res. 2020;22(2): e11613. https://doi.org/2196/11613 Plotkin S, Robinson JM, Cunningham G, Iqbal R, Larsen S. The complexity and cost of vaccine manufacturing: An overview. Vaccine. 2017;35(33):4064–71. https://doi.org/1016/j.vaccine.2017.06.003. Deming D. Do extraordinary claims require extraordinary evidence? Philosophia (Ramat Gan). 2016;44(4):1319‐ https://doi.org/10.3389/fpsyg.2011.00117

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Paget, Louis-Marie, Cécile Forgeot, Fleur Lorton, Nozar Aghakhani, Maurice Raphael, Anne Gallay et Nathalie Beltzer. « Validity of algorithms for identifying mild traumatic brain injury in the French national emergency department database OSCOUR : a retrospective multicentre validation study protocol ». BMJ Open 12, n^o 12 (décembre 2022) : e059961. http://dx.doi.org/10.1136/bmjopen-2021-059961.

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IntroductionThe French emergency department (ED) surveillance network OSCOUR transmits data on ED visits to Santé publique France (the national public health agency). As these data are collected daily and are almost exhaustive at a national level, it would seem relevant to use them for national epidemiological surveillance of mild traumatic brain injury (mTBI). This article presents the protocol of a planned study to validate algorithms for identifying mTBI in the OSCOUR database. Algorithms to be tested will be based on International Classification of Diseases (ICD)-10 codes.Methods and analysisWe will perform a multicentre validation study of algorithms for identifying mTBI in OSCOUR. Different combinations of ICD-10 codes will be used to identify cases of mTBI in the OSCOUR database. A random sample of mTBI cases and non-cases will be selected from four EDs. Medical charts will serve as the reference standard to validate the algorithms. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the different algorithms, as well as their 95% CIs, will be calculated and compared.Ethics and disseminationThe ethics committee of the French National Data Protection Authority (CNIL) approved this study (n° 921152, 1 August 2021). Results will be submitted to national and international peer-reviewed journals and presented at conferences dedicated to trauma and to methodologies for the construction and validation of algorithms.

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Sauvaget, Anne, Lydie Lagalice, Solène Schirr-Bonnans, Christelle Volteau, Morgane Péré, Cécile Dert, Annabelle Rivalland et al. « Cost-utility analysis of transcranial direct current stimulation (tDCS) in non-treatment-resistant depression : the DISCO randomised controlled study protocol ». BMJ Open 10, n^o 1 (janvier 2020) : e033376. http://dx.doi.org/10.1136/bmjopen-2019-033376.

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IntroductionDepression is among the most widespread psychiatric disorders in France. Psychiatric disorders are associated with considerable social costs, amounting to €22.6 billion for treatment and psychotropic medication in 2011. Treatment as usual (TAU), mainly consisting of pharmacotherapy and psychotherapy, is effective for only a third of patients and in most cases fails to prevent treatment resistance and chronicity. Transcranial direct current stimulation (tDCS) consists in a non-invasive and painless application of low-intensity electric current to the cerebral cortex through the scalp. Having proved effective in depressed patients, it could be used in combination with TAU to great advantage. The objective is to compare, for the first time ever, the cost-utility of tDCS-TAU and of TAU alone for the treatment of a depressive episode that has been refractory to one or two drug treatments.Methods and analysisThis paper, based on the DISCO study protocol, focuses on the design of a prospective, randomised, controlled, open-label multicentre economic study to be conducted in France. It will include 214 patients with unipolar or bipolar depression, assigning them to two parallel arms: group A (tDCS-TAU) and group B (TAU alone). The primary outcome is the incremental cost-effectiveness ratio, that is, the ratio of the difference in cost between each strategy to the difference in their effects. Their effects will be expressed as numbers of quality-adjusted life-years, determined through administration of the EuroQol Five-Dimension questionnaire over a 12-month period to patients (EQ-5D-5L). Expected benefits are the reduction of treatment resistance and suicidal ideation as well as social and professional costs of depression. Should depression-related costs fall significantly, tDCS might be considered an efficient treatment for depression.Ethics and disseminationThis protocol has been approved by a French ethics committee, the CPP-–Est IV (Comité de Protection des Personnes–Strasbourg). Data are to be published in peer-reviewed medical journals.Trial registration numberRCB 2018-A00474-51;NCT03758105

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Lasjaunias, P., et Paul Legmann. « Recommendations of the Assistance Publique des Hopitaux de Paris, AP-HP (Paris Public Hospitals Group) France : The Role of Medical and Non-Medical Staff in Providing Information to Patients ». Interventional Neuroradiology 6, n^o 4 (décembre 2000) : 269–76. http://dx.doi.org/10.1177/159101990000600401.

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The 20 key points of the AP-HP document (Assistance Publique des Hopitaux de Paris) 1) Hospital doctors must provide health care recipients with information in compliance with standards laid down by the medical code of ethics. 2) Radiographers and nursing staff must contribute to the provision of information within the framework of their assigned responsibilities and in compliance with their professional rules. 3) Doctors must draft prescriptions clearly, ensure that the patient and immediate family circle understand them and encourage compliance. 4) Doctors have a duty when examining, treating or advising to provide clear, appropriate and fair information regarding the patient's condition and the investigations and treatment proposed. During the course of the illness, physicians must take into account their patients' individual personalities when providing explanation and ensure these are understood. 5) Unless the condition places others at risk, a particularly grave diagnosis or prognosis may be withheld from a patient if the doctor, in good faith and for legitimate reasons, believes this to be in the best interests of the patient. 6) A patient should be informed of a fatal illness only after due consideration by the physician. Close relatives must always be informed, however, unless the patient has previously forbidden this or designated third parties to impart the information. 7) When several doctors collaborate on a diagnostic or treatment procedure, they must keep each other updated on the case. Each practitioner shall assume personal responsibility and inform the patient within the realm of his/her competence. 8) Oral information is priority and must be clear, fair, understandable and ordered. 9) The duty to inform is continuous. Consistent and constant information must be provided at all stages and, where possible, by the same physician. 10) Information must be provided on the benefits expected from a procedure and possible serious attendant risks, however exceptional. 11) Where possible, the practitioner should always verify that the information imparted has been properly understood. 12) It is recommended that: – hospital doctors accompany oral information with printed leaflets where these aid understanding; – departments set down a list of those invasive procedures requiring information leaflets. This practice will also help to standardise presentation of the risks and benefits. 13) Patients should not be requested to sign information sheets. 14) It is recommended that for each patient, one member of the medical team be designated, with responsibility for informing the patient and close relatives. 15) On patient admission, details of the family members to be informed must be systematically collected. Similarly, parents or guardians must be systematically contacted on the admission of children. 16) What information is to be given the patient and close family must be discussed by the medical group and the decisions taken recorded in the patient's file. 17) Each department shall define rules on giving information over the telephone to the family or immediate circle. These rules must be set down in writing and understood by all staff concerned. 18) Any information given to the patient must be noted in the medical file. It is to be presumed that only the details noted have been communicated. In this way, the patients' medical record serves as a communication tool for the various members of the medical team regarding the information given to the patient. 19) Obtaining written patient consent (permission to operate and similar documents) is neither compulsory nor recommended, except where required by law. The law demands that written consent be obtained for the following: biomedical research, fertility treatment, termination of pregnancy, genetic research, harvesting of organs from a living donor, certain organ harvesting from a deceased person, surgical procedures on a child. 20) In the event of litigation centring around failure to inform, no evidence, not even written evidence, is a watertight guarantee that the doctor has fulfilled his obligation. Whether information has been correctly imparted or not will be assessed on the basis of a range of elements such as: the period allowed the patient to take an informed decision, the number of visits, practitioners consulted before proceeding, the systematic provision of information leaflets and the notes made on the patient record.

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Grimaud, Olivier, Sahar Bayat, Anne Renault, Eric Maury, Julien Pottecher, Manuel Dolz, François Braun et al. « TRANSCOV cohort protocol : an epidemiological study assessing the impact of critically ill COVID-19 patients long distance transfers between intensive care units ». BMJ Open 11, n^o 10 (octobre 2021) : e054774. http://dx.doi.org/10.1136/bmjopen-2021-054774.

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IntroductionDuring spring 2020, four regions of France faced a surge of severe COVID-19 patients which threatened to overflow local intensive care units (ICU) capacities. As an emergency response, between 13 March 2020 and 10 April 2020, an estimated 661 patients were transferred from overcrowded ICUs to eight other French regions and four neighbouring countries. The intensity, geographical spread and the diversity of vectors used are unprecedented. The study aims at assessing the impact of these inter-ICU transfers on the short-term and medium-term physical and psychological outcomes in this population of severe COVID-19 patients.Methods and analysisThe TRANSCOV cohort is a multicentre observational retrospective study. All transferred patients between ICUs outside the origin region will be invited to take part. For each transfer, up to four control patients will be selected among those admitted in the same ICU during the same period (±4 days of transfer date). Clinical data will be extracted from medical records and will include haemodynamic and respiratory parameters, as well as clinical severity scores before, during and after transfer. Data linkage with medicoadministrative data will enrich the clinical database and allow follow-up up to 1 year after initial admission.Ethics and disseminationThe study has been approved by the French Ethics and Scientific Committee on the 16 July 2020 (file no. 2046524). The results will be disseminated via publication of scientific articles and communications in national and international conferences.Trial registration number20 CO 015 CZ.

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Resseguier, Noémie, Natacha Rosso-Delsemme, Any Beltran Anzola, Karine Baumstarck, Vanessa Milien, Laurent Ardillon, Sophie Bayart et al. « Determinants of adherence and consequences of the transition from adolescence to adulthood among young people with severe haemophilia (TRANSHEMO) : study protocol for a multicentric French national observational cross-sectional study ». BMJ Open 8, n^o 7 (juillet 2018) : e022409. http://dx.doi.org/10.1136/bmjopen-2018-022409.

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IntroductionSevere haemophilia is a rare disease characterised by spontaneous bleeding from early childhood, which may lead to various complications, especially in joints. It is nowadays possible to avoid these complications thanks to substitutive therapies for which the issue of adherence is major. The transition from adolescence to adulthood in young people with severe haemophilia is a critical period as it is associated with a high risk of lack of adherence to healthcare, which might have serious consequences on daily activities and on quality of life.Methods and analysisWe present the protocol for a cross-sectional, observational, multicentric study to assess the differences between adolescents and young adults with severe haemophilia in France through the transition process, especially on adherence to healthcare. This study is based on a mixed methods design, with two complementary and consecutive phases, comparing data from a group of adolescents (aged 14–17 years) with those from a group of young adults (aged 20–29 years). The quantitative phase focuses on the determinants (medical, organisational, sociodemographic and social and psychosocial and behavioural factors) of adherence to healthcare (considered as a marker of the success of transition). The qualitative phase explores participants’ views in more depth to explain and refine the results from the quantitative phase. Eligible patients are contacted by the various Haemophilia Treatment Centres participating in the French national registry FranceCoag.Ethics and disseminationThe study was approved by the French Ethics Committee and by the French National Agency for Medicines and Health Products Safety (number: 2016-A01034-47). Study findings will be disseminated to the scientific and medical community in peer-reviewed journals and presented at scientific meetings. Results will be popularised to be communicated via the French association for people with haemophilia to participants and to the general public.Trial registration numberNCT02866526; Pre-results.

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Petit-Monéger, Aurélie, Frantz Thiessard, Vianney Jouhet, Pernelle Noize, Driss Berdaï, Marion Kret, Rémi Sitta, Louis-Rachid Salmi et Florence Saillour-Glénisson. « Development and validation of hospital information system-generated indicators of the appropriateness of oral anticoagulant prescriptions in hospitalised adults : the PACHA study protocol ». BMJ Open 7, n^o 8 (août 2017) : e016488. http://dx.doi.org/10.1136/bmjopen-2017-016488.

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IntroductionThe appropriateness of oral anticoagulant prescriptions is a major challenge to improve quality and safety of care. As indicators of the appropriateness of oral anticoagulant prescriptions are lacking, the aim of the study is to develop and validate a panel of such indicators, in hospitalised adults, from the hospital information system of two university hospitals in France.Methods and analysisThe study will be carried out in four steps: (1) a literature review to identify indicators of the appropriateness of oral anticoagulant prescriptions and their conditions of appropriateness; (2) a Delphi consensus method to assess the potential utility and operational implementation of the selected indicators; (3) techniques of medical data search to implement indicators from the hospital information system and; (4) a cross-sectional study to assess the ability of indicators to detect inappropriate oral anticoagulant prescriptions, performance of medical data search techniques for tracking or retrieving information and the ability of tools to be transferred into other institutions. The fourth step will include up to 80 patient hospital stays for each indicator, depending on the prevalence of inappropriate prescriptions estimated in interim analyses.Ethics and disseminationThis work addresses the current lack of quality indicators of the appropriateness of oral anticoagulant prescriptions. We aim to develop and validate such indicators for integrating them into hospital clinical practice, as part of a structured approach to improve quality and safety of care. As each hospital information system is different, we will propose tools transferable to other healthcare institutions to allow an automated construction of these indicators. The PACHA study protocol was approved by institutional review boards and ethics committees (CPP Sud-Ouest et Outre Mer III—DC 2016/119; CPP Ile-de-France II—CDW_2016_0014).Registration detailsClinical Trial.gov registration:NCT02898090.

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Evstratov, D. A., L. H. Anderzhanova, A. V. Pshonkin, Yu G. Abugova, N. V. Myakova, P. A. Zharkov, V. V. Fominykh, N. M. Ershov, Yu Yu Dyakonova et L. A. Vavilova. « Incidence of venous thromboembolism in children with primary lymphomas ». Pediatric Hematology/Oncology and Immunopathology 20, n^o 3 (8 octobre 2021) : 46–50. http://dx.doi.org/10.24287/1726-1708-2021-20-3-46-50.

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Cancer increases the risk of venous thromboembolism (VTE) in adults and children. The aim of our study was to evaluate the incidence of VTE in children and adolescents with lymphomas. The study was approved by the Independent Ethics Committee of the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology. A retrospective analysis based on medical data of 262 children and adolescents (0–18 years) with primary lymphomas (n = 262) who were treated in Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology since 01.01.2013 to 31.12.2019 had been performed. Such parameters as age and sex distribution of patients, the frequency, as well as the cumulative incidence of detection (CI) and differences in localization, the median time of detection of symptomatic (sVTE) and asymptomatic episodes of VT (aVTE), their relationship with central venous catheters (CVC) were analyzed. Statistical processing of the obtained data was carried out using the XLSTAT 2020 program (Addinsoft, France). The median age was 11,1 years (interquartile range (IQR) 6.5–15 years), the ratio of males to females was 2.2:1. There were 71 episodes of VTE in 65 patients (24.8%, 95% confidence interval (CI): 19.6–30). Among all episodes of VTE 31% were defined as sVTE at 400 day CI for sVTE was found to be 8.1% (95% CI: 5.4–12.2) and CI for aVTE – 18.7% (95% CI: 14.4–24.2). The median time to VTE episode was 38 days (IQR 16.5–91.5 days). There was a trend towards an earlier diagnosis of sVTE (median 23.5 days, IQR – 17–42 days) than aVTE (median 62 days, IQR 14–80 days), p = 0.075. VTE was CVC-related in 67.7 of all VTE cases. In one case, asymptomatic thrombosis of right atrium led to pulmonary embolism (PE). VTE is a frequent complication in children and adolescents with lymphomas. Most episodes of VTE were asymptomatic, one of which was the most likely cause of PE in the child. Further research is needed to find risk factors for VTE.

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Grignani, Giovanni, Piotr Rutkowski, Celeste Lebbe, Natalie Prinzi, Jean-jaques Grob, Enrica Teresa Tanda, Michele Guida et al. « 545 A phase 2 study of retifanlimab in patients with advanced or metastatic merkel cell carcinoma (MCC) (POD1UM-201) ». Journal for ImmunoTherapy of Cancer 9, Suppl 2 (novembre 2021) : A574—A575. http://dx.doi.org/10.1136/jitc-2021-sitc2021.545.

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BackgroundRetifanlimab (INCMGA00012) is a humanized, hinge-stabilized immunoglobulin G4 kappa (IgG4κ), anti-programmed cell death protein (PD)-1 monoclonal antibody with safety and clinical pharmacology that are characteristic for the class. Evaluation of retifanlimab in solid tumors is under investigation in phase 2 and 3 studies. POD1UM-201 is an open-label, single-arm, multicenter, phase 2 study evaluating the efficacy and safety of retifanlimab in patients with chemotherapy-naïve or chemotherapy-refractory advanced/metastatic Merkel cell carcinoma (MCC). Updated results from the chemotherapy-naïve cohort are reported here.MethodsEligible patients were ≥18 years of age, had metastatic or recurrent unresectable loco-regional MCC, Eastern Cooperative Oncology Group performance status ≤1, measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and had not received prior systemic treatment for MCC. Retifanlimab 500 mg IV every 4 weeks (Q4W) was administered for up to 2 years. The primary endpoint was overall response rate (ORR) assessed by independent central review per RECIST v1.1. Secondary endpoints included duration of response, disease control rate (DCR; defined as proportion of patients with either an objective response or stable disease lasting at least 6 months), progression-free survival, overall survival, safety, and pharmacokinetics.ResultsAs of April 16, 2021, 87 patients with chemotherapy-naïve advanced/metastatic MCC had received retifanlimab. Per protocol, the primary efficacy analyses are based on the first 65 patients assessed. At the data cutoff, 34 of these 65 patients (52.3%) were on treatment; 4 (6.2%) had completed treatment; and 27 (41.5%) had discontinued treatment for reasons including disease progression (18 [27.7%]), adverse event (AE; 7 [10.8%]), death (1 [1.5%]), and physician decision (1 [1.5%]). The ORR in these patients was 46.2% (n=30: complete response, 8 [12.3%]; partial response, 22 [33.8%]). The DCR was 53.8% (n=35). Other secondary efficacy results are not yet mature. Among all treated patients (n=87), 66 (75.9%) had a treatment-emergent AE (TEAE), 25 (28.7%) had a grade ≥3 TEAE, and 12 (13.8%) had a grade ≥3 treatment-related AE. Twenty-three patients (26.4%) had an immune-related AE (irAE), and 8 (9.2%) had a grade ≥3 irAE. Four patients (4.6%) discontinued treatment due to irAEs (peripheral sensorimotor neuropathy, pancreatitis, eosinophilic fasciitis, and polyarthritis [each n=1]). One patient (1.1%) had a grade 3 infusion reaction.ConclusionsThese data from the POD1UM-201 trial show that retifanlimab monotherapy at 500 mg Q4W continues to demonstrate promising clinical activity and safety in patients with advanced/metastatic chemotherapy-naïve MCC. Updated results will be presented at the meeting.AcknowledgementsThe study is sponsored by Incyte Corporation (Wilmington, DE). Statistical support was provided by Xiaohan Xu of Incyte Corporation. Editorial assistance was provided by Matthew Bidgood of Envision Pharma Group (Philadelphia, PA, USA).Trial RegistrationClinicaltrials.gov NCT03599713; EudraCT 2018-001627-39Ethics ApprovalThe study was approved by institutional review boards or independent ethics committees in Canada (McGill University Health Center-Research Ethics Board [MP-37-2019-5103, MEO-37-2019-1616]; Ontario Cancer Research Ethics Board [1728]; Health Research Ethics Board of Alberta – Cancer Committee [HREBA.CC-19-0004, HREBA.CC-19-0020]); Czech Republic (Eticka komise Fakultni nemocnice Kralovske Vinohrady, Eticka komise IKEM a FTNsP, Eticka komise Nemocnice Na Bulovce, Statni ustav pro kontrolu leciv, Eticka komise FN a LF UP Olomouc [169/18MEK24, LEK/04/07/2018, (L-18-85) 8522/23.3.2021, 22.3.2021/9965/EK-Z]); France (Comité de Protection des Personnes Ile de France X [CNRIPH : 18.11.19.49212/Id. 2043]; Agence Nationale de Sécurité du Médicament et des Produits de Santé); Germany (Ethik-Kommission der Medizinischen Fakultaet der Universitaet Duisburg-Essen [18-8371-AF]; Bundesamt fuer Strahlenschutz; Paul-Ehrlich Institute); Hungary (Egeszsegugyi Tudomanyos Tanacs Klinikai Farmakologiai Etikai Bizottsaga [IV/2407-0/2021-EKL, OGYÉI/11697-2/2021]; Orszagos Gyogyszereszeti es Elelmezes-egeszsegugyi Intezet); Italy (Comitato Etico IRCCS Pascale Napoli [116/21 E - 87/18]; Comitato Etico IRCCS di Candiolo [232/2021]; Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari [736/CE]; Comitato Etico Locale per la Sperim. Clin. dei Medicinali dell’Az. Osp.ra Univ.ria Senese di Siena [14107]; Comitato Etico dell’IRCCS Istituto Nazionale per la Ricerca sul Cancro di Genova [389/2018 - 24/05/2021]; Comitato etico degli IRCCS Istituto Europeo di Oncologia e Centro Cardiologico Monzino [IEO 948 - RE3065/IB Edition 7 dated 10Nov2020 (SA7)]; Comitato Etico, Fondazione IRCCS Istituto Nazionale dei Tumori, .c. Medicina Oncologica 1 – Fondazio [INT 01/19]; Comitato Etico IRCCS Istituto Oncologico Veneto di Padova [EM 109/2021]; Comitato Etico dell’IRCCS Istituto Dermopatico dell’Immacolata Ospedale Generale S. Carlo di Roma [550/7]; AIFA – Agenzia Italiana del Farmaco [0040152-01/04/2021-AIFA-AIFA_USC-P]; Comitatao Etico Policlinico di Modena [1017/2018/FARM/AOUMO - EMENDAMENTO SOSTANZIALE IB EDIZIONE 7 DEL 10/11/20 (201800162739-010) (p. 9869/21)]); Poland (Komisja Bioetyczna przy Centrum Onkologii [no. 55/2019]; Office for Registration of Medicinal Products, Medical Devices and Biocidal Products [UR/DBL/D/328/2019]); Spain (CEIC Hospital General Universitario Gregorio Marañon [280/18]; Agencia Española del Medicamento y Productos Sanitarios); Switzerland (Kantonale Ethikkommission Zürich (KEK-Zürich) [2019-00200]; Swissmedic [2019DR2035]); United Kingdom (North East – York Research Ethics Committee [248465]; Medicines and Healthcare products Regulatory Agency; Health Research Authority); United States (Copernicus Group IRB; Western Institutional Review Board [20181738, Work order number -– IQV1-18-309]; Roswell Park Cancer Institute IRB [STUDY00000802/P 75918]; Inova Institutional Review Board, Human Research Protection Program; Stanford IRB Research Compliance Office [48198]; Rush University Medical Center [18072304-IRB01]; University of Miami IRB; Mayo Clinic IRB – Rochester).

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Khamisy-Farah, Rola, Peter Gilbey, Leonardo B. Furstenau, Michele Kremer Sott, Raymond Farah, Maurizio Viviani, Maurizio Bisogni, Jude Dzevela Kong, Rosagemma Ciliberti et Nicola Luigi Bragazzi. « Big Data for Biomedical Education with a Focus on the COVID-19 Era : An Integrative Review of the Literature ». International Journal of Environmental Research and Public Health 18, n^o 17 (26 août 2021) : 8989. http://dx.doi.org/10.3390/ijerph18178989.

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Medical education refers to education and training delivered to medical students in order to become a practitioner. In recent decades, medicine has been radically transformed by scientific and computational/digital advances—including the introduction of new information and communication technologies, the discovery of DNA, and the birth of genomics and post-genomics super-specialties (transcriptomics, proteomics, interactomics, and metabolomics/metabonomics, among others)—which contribute to the generation of an unprecedented amount of data, so-called ‘big data’. While these are well-studied in fields such as medical research and methodology, translational medicine, and clinical practice, they remain overlooked and understudied in the field of medical education. For this purpose, we carried out an integrative review of the literature. Twenty-nine studies were retrieved and synthesized in the present review. Included studies were published between 2012 and 2021. Eleven studies were performed in North America: specifically, nine were conducted in the USA and two studies in Canada. Six studies were carried out in Europe: two in France, two in Germany, one in Italy, and one in several European countries. One additional study was conducted in China. Eight papers were commentaries/theoretical or perspective articles, while five were designed as a case study. Five investigations exploited large databases and datasets, while five additional studies were surveys. Two papers employed visual data analytical/data mining techniques. Finally, other two papers were technical papers, describing the development of software, computational tools and/or learning environments/platforms, while two additional studies were literature reviews (one of which being systematic and bibliometric).The following nine sub-topics could be identified: (I) knowledge and awareness of big data among medical students; (II) difficulties and challenges in integrating and implementing big data teaching into the medical syllabus; (III) exploiting big data to review, improve and enhance medical school curriculum; (IV) exploiting big data to monitor the effectiveness of web-based learning environments among medical students; (V) exploiting big data to capture the determinants and signatures of successful academic performance and counteract/prevent drop-out; (VI) exploiting big data to promote equity, inclusion, and diversity; (VII) exploiting big data to enhance integrity and ethics, avoiding plagiarism and duplication rate; (VIII) empowering medical students, improving and enhancing medical practice; and, (IX) exploiting big data in continuous medical education and learning. These sub-themes were subsequently grouped in the following four major themes/topics: namely, (I) big data and medical curricula; (II) big data and medical academic performance; (III) big data and societal/bioethical issues in biomedical education; and (IV) big data and medical career. Despite the increasing importance of big data in biomedicine, current medical curricula and syllabuses appear inadequate to prepare future medical professionals and practitioners that can leverage on big data in their daily clinical practice. Challenges in integrating, incorporating, and implementing big data teaching into medical school need to be overcome to facilitate the training of the next generation of medical professionals. Finally, in the present integrative review, state-of-art and future potential uses of big data in the field of biomedical discussion are envisaged, with a focus on the still ongoing “Coronavirus Disease 2019” (COVID-19) pandemic, which has been acting as a catalyst for innovation and digitalization.

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Auriacombe, Marc, Perrine Roux, Laélia Briand Madrid, Sébastien Kirchherr, Charlotte Kervran, Carole Chauvin, Marie Gutowski et al. « Impact of drug consumption rooms on risk practices and access to care in people who inject drugs in France : the COSINUS prospective cohort study protocol ». BMJ Open 9, n^o 2 (février 2019) : e023683. http://dx.doi.org/10.1136/bmjopen-2018-023683.

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IntroductionThe high prevalence of hepatitis C and the persistence of HIV and hepatitis C virus (HCV) risk practices in people who inject drugs (PWID) in France underlines the need for innovative prevention interventions. The main objective of this article is to describe the design of the COSINUS cohort study and outline the issues it will explore to evaluate the impact of drug consumption rooms (DCR) on PWID outcomes. Secondary objectives are to assess how DCR (a) influence other drug-related practices, such as the transition from intravenous to less risky modes of use, (b) reduce drug use frequency/quantity, (c) increase access to treatment for addiction and comorbidities (infectious, psychiatric and other), (d) improve social conditions and (e) reduce levels of violence experienced and drug-related offences. COSINUS will also give us the opportunity to investigate the impact of other harm reduction tools in France and their combined effect with DCR on reducing HIV-HCV risk practices. Furthermore, we will be better able to identify PWID needs.Methods and analysisEnrollment in this prospective multi-site cohort study started in June 2016. Overall, 680 PWID in four different cities (Bordeaux, Marseilles, Paris and Strasbourg) will be enrolled and followed up for 12 months through face-to-face structured interviews administered by trained staff to all eligible participants at baseline (M0), 3 month (M3), 6 month (M6) and 12 month (M12) follow-up visits. These interviews gather data on socio-demographic characteristics, past and current drug and alcohol consumption, drug-use related practices, access to care and social services, experience of violence (as victims), offences, other psychosocial issues and perception and needs about harm reduction interventions and services. Longitudinal data analysis will use a mixed logistic model to assess the impact of individual and structural factors, including DCR attendance and exposure to other harm reduction services, on the main outcome (HIV-HCV risk practices).Ethics and disseminationThis study was reviewed and approved by the institutional review board of the French Institute of Medical Research and Health (opinion number: 14–166). The findings of this cohort study will help to assess the impact of DCR on HIV-HCV risk practices and other psycho-social outcomes and trajectories. Moreover, they will enable health authorities to shape health and harm reduction policies according to PWID needs. Finally, they will also help to improve current harm reduction and therapeutic interventions and to create novel ones.

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Heidet, Matthieu, Roland Amathieu, Etienne Audureau, Oriane Augusto, Violaine Nicolazo de Barmon, Amandine Rialland, David Schmitz et al. « Efficacy and tolerance of early administration of tranexamic acid in patients with cirrhosis presenting with acute upper gastrointestinal bleeding : a study protocol for a multicentre, randomised, double-blind, placebo-controlled trial (the EXARHOSE study) ». BMJ Open 8, n^o 8 (août 2018) : e021943. http://dx.doi.org/10.1136/bmjopen-2018-021943.

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IntroductionThe management of acute upper gastrointestinal bleeding (UGIB) is challenging in patients with cirrhosis, as it is responsible for severe complications and high mortality rates. Tranexamic acid (TXA) may help control the bleeding by counterbalancing cirrhosis-related hyperfibrinolysis. Still, there is a lack of unbiased data to conclude on its efficacy. The aim of this study is to evaluate the efficacy of TXA in the early treatment of acute UGIB in patients with cirrhosis.Methods and analysisThis study is a multicentre, randomised, double-blind, placebo-controlled trial, for adult patients with cirrhosis presenting with an acute UGIB and allocated to one of two arms: TXA or placebo (saline). Physicians from emergency mobile services, emergency departments (EDs) or intensive care units (ICUs) can include patients. Besides study intervention, standard care for UGIB will be performed as recommended. Intervention will consist an intravenous infusion of 10 mL of TXA (1 g) or saline, immediately followed by three identical intravenous infusions over 8 hours each (total dose of 4 g of TXA or 40 mL of placebo over 24 hours). Main analyses will be conducted in intention to treat on every patient included, then in modified intention to treat on patients with underlying lesion of portal hypertension visualised by endoscopy. The main objective is to show efficacy of TXA until day 5 on a composite criterion (bleeding control, rebleeding episodes and mortality). Secondary objectives aim at showing the efficacy of TXA on each individual component of the main outcome measure and others at 6 weeks and later (transjugular intrahepatic portosystemic shunt procedure, cirrhosis-specific complications, length of stay in ICU and in hospital, safety and tolerance of TXA, liver transplantation). Included patients will be followed up to 1 year after inclusion.500 patients will be necessary to show a reduction in the prevalence of the primary outcome from 30% to 18% with a bilateral alpha risk of 5% and a power of 80%.Ethics and disseminationEthical approval has been obtained from the Comité de Protection des Personnes Ile-de-France 1 (CPP-IDF1). Results will be disseminated via publications in peer-review medical journals and scientific forums.Protocol versionThis protocol is based on the latest version, as established on 11 October 2017 and validated by the IRB CPP Ile-de-France 1.Trial registration numberNCT03023189.

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Truchot, Michael, Baptiste Balança, Pierre François Wey, Karim Tazarourte, François Lecomte, Arnaud Le Goff, Simon Leigh-Smith, Jean Jacques Lehot, Thomas Rimmele et Jean Christophe Cejka. « Use of a Digital Cognitive Aid in the Early Management of Simulated War Wounds in a Combat Environment, a Randomized Trial ». Military Medicine 185, n^o 7-8 (24 février 2020) : e1077-e1082. http://dx.doi.org/10.1093/milmed/usz482.

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Abstract Introduction The French army has implemented an algorithm based on the acronym “MARCHE RYAN,” each letter standing for a key action to complete in order to help first care providers during emergency casualty care. On the battlefield, the risk of error is increased, and the use of cognitive aids (CAs) might be helpful to avoid distraction. We investigated the effect of using a digital CA (MAX, for Medical Assistance eXpert) by combat casualty care providers on their technical and nontechnical performances during the early management of simulated war wounds, compared to their memory and training alone. Materials and Methods We conducted a randomized, controlled, unblinded study between July 2016 and February 2017. This study was approved by the Ethics Committee of the Ethical Board of Desgenettes Army Training Hospital (14.06.2017 n°385) and was registered on clinicaltrials.gov (NCT03483727). It took place during medicalization training in hostile environment (“MEDICHOS”) in Chamonix Mont-Blanc and in the first aid training center in La Valbonne military base (France). Each participant had to deal with two different scenarios, one with MAX (MAX+) and the other without (MAX−). Scenarios were held using either high-fidelity patient simulators or actors as wounded patients. The primary outcome was participants’ technical performance rated as their adherence to the MARCHE RYAN procedure (maximum 100%). The secondary outcome was the nontechnical performance according to the Ottawa crisis resource management Global Rating Scale (maximum 42). Results Technical performance was significantly higher in the MAX+ scenarios (70.60 IQR [63.70–73.56] than in the MAX− scenarios (56.25 IQR [52.88–62.09], p = 0.002). The Ottawa scores were significantly higher in the MAX+ scenarios (31.50 IQR [29.50–33.75]) than in the MAX− scenarios (29.50 IQR [24.50–32.00], p = 0.031). Conclusions The use of a digital CA by combat casualty care providers improved technical and nontechnical performances during field training of simulated crises. Following recommendations on the design and use of CA, regular team training would improve fluidity in the use and acceptance of an aid, by a highly drilled professional corporation with a strong culture of leadership. Digital CA should be tested at a larger scale in order to validate their contribution to real combat casualty care.

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