[Electronic health record: strongbox, PDF bin, or collective public health project ?] / Dossier électronique du patient: coffre-fort, poubelle à PDF, ou projet collectif de santé publique ?

The advent of the electronic health record (EHR) raises many questions regarding its adoption and its added value for patients, clinicians and the entire healthcare system. Based on the results of a participatory project that brought together citizens and experts, we show that the EHR should be understood as a collective and evolving project serving public health objectives, and that both patients and healthcare professionals should contribute to its development. Therefore, this common project represents a significant opportunity to strengthen the patient-professionals partnership.

L'arrivée du dossier électronique du patient (DEP) soulève de nombreuses questions concernant son adoption et ses plus-values pour les patients, les cliniciens et l'ensemble du système de santé. Sur la base des résultats d'un projet participatif réunissant des citoyens et des experts, nous montrons dans cet article que le DEP devrait être compris comme un projet collectif et évolutif au service des objectifs de santé publique, dont le développement devrait bénéficier d'apports conjoints des patients et des professionnels de santé. Ce dossier commun représente ainsi une opportunité majeure pour renforcer le partenariat patients-professionnels.

Patients' decision to contribute to a biobank in the light of the patient-recruiter relationship-a qualitative study of broad consent in a hospital setting.

Findings from recent studies show that the relationship developed with the particular researcher asking for broad consent plays an important role in the participant's willingness to give consent. Interviews and focus groups were conducted in order to present a description and analysis of meetings in which broad consent took place and to examine the role of recruiters in the patients' decision-making and in building trust in the Lausanne University Hospital Institutional Biobank (BIL). Our findings suggest that patient broad consent to biobanking is strongly related to its setting. BIL recruiters' were aware of their role as ambassadors of the BIL and their responsibility towards patients. Patient interviewees were sensitive to the quality of the information delivered, the timing of the consent request and the recruiters' attitudes and behaviours, including the presence of the white coat. Participating in the BIL also seemed to reinforce the patient's self-esteem and perceived efficacy, particularly since they are themselves ill and inactive when requested to participate. Recruiters and participants report that participation may be motivated by fundamental (existential) goals. Organisational factors also affected recruiters' activity and the broad consent procedure raising several ethical issues. This qualitative study suggests that biobanking based on information-based models of decision-making might need to be re-evaluated in order to improve broad consent. Our findings have implications for the practice of broad consent and patient autonomy, as well as for the recruiters' role and training.

Citizen Responses to Government Restrictions in Switzerland During the COVID-19 Pandemic: Cross-Sectional Survey.

BACKGROUND: The success of government-recommended mitigation measures during the COVID-19 pandemic depends largely on information uptake and implementation by individual citizens. OBJECTIVE: Our aim was to assess citizens' knowledge and perceptions about COVID-19 recommendations in the Canton of Vaud, Switzerland. METHODS: A cross-sectional electronic survey with open and closed questions was disseminated by community-based partners prior to the relaxation of government restrictions. Outcomes included citizen knowledge (9-question measure) and worry about the virus, perception of government measures, and recommendations for improvements. Comparisons used linear regression, controlling for age, sex, education, and health literacy. Free-text answers were analyzed thematically. RESULTS: Of 807 people who accessed the survey, 684 (85%) completed all questions and 479 (60%) gave free-text recommendations. Overall, 75% were female, the mean age was 48 years, and 93% had high health literacy. Knowledge scores were high, with a median score of 8 out of 9. Mean levels of worry about the COVID-19 pandemic were higher in women than men (55/100 versus 44/100, P<.001), and in respondents with lower health literacy (57/100 versus 52/100, P=.03). Self-reported adherence to recommendations was high (85%) and increased with age and worry (both P<.001). Respondents rated their own adherence higher than others (85% versus 61%, P<.001). Moreover, 34% of respondents reported having self-quarantined; this rose to 52% for those aged ≥75 years. Those who had self-quarantined reported higher levels of fear. Nearly half (49%) of respondents felt the government response had been adequate, though younger age and higher levels of worry were associated with considering the response to be insufficient (both P<.001). Analysis of open-text answers revealed 4 major themes: access to and use of masks, gloves, and hand sanitizer; government messaging; lockdown and lockdown exit plan communication; and testing for COVID-19. CONCLUSIONS: Knowledge, adherence, and satisfaction regarding government recommendations and response were high in this sample, but many desired greater access to personal protective equipment. Those with lower health literacy and those who have been in self-isolation reported greater concerns about the pandemic.

Broad consent in practice: lessons learned from a hospital-based biobank for prospective research on genomic and medical data.

Broad consent is increasingly recommended as an acceptable consent model for biobanking human samples and health data with a view to their future use in research. Empirical evidence on the practice of broad consent and its implementation in the hospital setting, however, is still very limited. We analyse and discuss results from a qualitative study of perceptions of a sample of patients and biobank recruiters regarding broad consent to participate in a hospital-based biobank for prospective research on genomic and health data. Our findings suggest that contextual and relational factors play an important role in the practice of broad consent, and illustrate that broad consent relies as much on intuition as on reasoning. Moreover, we show that seeking broad consent in the hospital affects patient-recruiter interaction and that "conditional" trust plays a significant role in broad-consent decision-making. In conclusion, we provide recommendations to improve patient autonomy in the context of hospital-based broad consent.

"Still Rather Hazy at Present": Citizens' and Physicians' Views on Returning Results from Biobank Research Using Broad Consent.

AIMS: Informed consent and return of research results are among the most debated topics in the biobank literature. We discuss ethical, social, and policy issues associated with returning results in the context of biobanks using a broad consent approach, in the light of data from a qualitative survey of citizens' and physicians' views. MATERIALS AND METHODS: Data were collected through interviews and focus groups to investigate stakeholders' perspectives about a large-scale hospital-based biobank designed to foster biomedical research, including prospective genomics research, and "personalized" medicine. RESULTS: Both physicians and citizens considered psychosocial impacts as crucial in the assessment of benefits expected from a return of results to biobank participants. In particular, physicians highlighted the possible consequences on the patient-doctor relationship and discussed implications for the concept of "personalized" medicine. Citizens held ambivalent attitudes toward returning individual research results: they defended the "right not to know," while they also considered a sort of "responsibility to know" because of potential implications of results for family members. Moreover, physicians and citizens raised questions about the broad consent model used for inhospital biobank recruitment and expressed their needs for more training in genomics and more information on the biobank initiative. CONCLUSIONS: Stakeholders such as citizens and physicians, who may be concerned as potential biobank participants or as healthcare professionals involved in the management of clinically relevant research results, provide useful insights into several aspects of broad consent and return of results, related in particular to the interface between research and the clinic.

Adapting Preclinical Benchmarks for First-in-Human Trials of Human Embryonic Stem Cell-Based Therapies.

UNLABELLED: : As research on human embryonic stem cell (hESC)-based therapies is moving from the laboratory to the clinic, there is an urgent need to assess when it can be ethically justified to make the step from preclinical studies to the first protocols involving human subjects. We examined existing regulatory frameworks stating preclinical requirements relevant to the move to first-in-human (FIH) trials and assessed how they may be applied in the context of hESC-based interventions to best protect research participants. Our findings show that some preclinical benchmarks require rethinking (i.e., identity, purity), while others need to be specified (i.e., potency, viability), owing to the distinctive dynamic heterogeneity of hESC-based products, which increases uncertainty and persistence of safety risks and allows for limited predictions of effects in vivo. Rethinking or adaptation of how to apply preclinical benchmarks in specific cases will be required repeatedly for different hESC-based products. This process would benefit from mutual learning if researchers included these components in the description of their methods in publications. SIGNIFICANCE: To design translational research with an eye to protecting human participants in early trials, researchers and regulators need to start their efforts at the preclinical stage. Existing regulatory frameworks for preclinical research, however, are not really adapted to this in the case of stem cell translational medicine. This article reviews existing regulatory frameworks for preclinical requirements and assesses how their underlying principles may best be applied in the context of human embryonic stem cell-based interventions for the therapy of Parkinson's disease. This research will help to address the question of when it is ethically justified to start first-in-human trials in stem cell translational medicine.

[Ethical and social issues associated with genomic medicine]. / Enjeux éthiques et sociaux de la médecine génomique.

Genomic medicine is often presented as a new paradigm for personalized healthcare. Encompassing both a translational approach in research and a vision of future medical practice, genomic medicine may have important impact on the way healthcare professionals diagnostics, treat and prevent diseases. We discuss some ethical and social issues raised by the prospect of genome-based medical practice, namely: changing definitions of disease and identity, assessment of clinical validity and utility of genome screening, mastery of genomic information by healthcare professionals and its communication to patients, and questions related to the costs of genomic medicine for future healthcare.

La médecine génomique est souvent présentée comme un nouveau paradigme permettant une prise en charge personnalisée du patient. Englobant à la fois une démarche de recherche et une vision de la médecine du futur, elle pourrait avoir des conséquences importantes sur la manière de diagnostiquer, traiter et prévenir la maladie. Cet article présente quelques grands enjeux éthiques et sociaux soulevés par le développement de la médecine génomique: les implications sur nos conceptions de la maladie et de l'identité, la question de la validité et de l'utilité clinique des analyses du génome, les enjeux liés à la maîtrise de l'information génétique par les soignants et à sa communication aux patients, et la question des coûts pour le système de santé.

Life-extension: a biomedical goal? Scientific prospects, ethical concerns.

The potential for development of biomedical technologies capable of extending the human lifespan raises at least two kinds of question that it is important both to distinguish and to connect with one another: scientific, factual questions regarding the feasibility of life extension interventions; and questions concerning the ethical issues related to the extension of life- and healthspans. This paper provides an account of some life extension interventions considered to be amongst the most promising, and presents the ethical questions raised by the prospect of their pursuit. It is suggested that problems concerning the effects of these technologies on health care resources and on intergenerational relationships will be the most difficult to tackle.

What "best practice" could be in Palliative Care: an analysis of statements on practice and ethics expressed by the main Health Organizations.

BACKGROUND: In palliative care it would be necessary to refer to a model. Nevertheless it seems that there are no official statements which state and describe that model. We carried out an analysis of the statements on practice and ethics of palliative care expressed by the main health organizations to show which dimensions of end-of-life care are taken into consideration. METHODS: The official documents by the most representative health organisations committed to the definition of policies and guidelines for palliative and end-of-life care had been considered. The documents were analysed through a framework of the components of end-of-life care derived from literature, which was composed of 4 main "areas" and of 12 "sub-areas". RESULTS: Overall, 34 organizations were identified, 7 international organisations, and 27 organisations operating on the national level in four different countries (Australia, Canada, UK and United States). Up to 56 documents were selected and analysed. Most of them (38) are position statements. Relevant quotations from the documents were presented by "areas" and "sub-areas". In general, the "sub-areas" of symptoms control as well as those referring to relational and social issues are more widely covered by the documents than the "sub-areas" related to "preparation" and to "existential condition". Indeed, the consistency of end-of-life choices with the patient's wishes, as well as completion and meaningfulness at the end of life is given only a minor relevance. CONCLUSIONS: An integrated model of the best palliative care practice is generally lacking in the documents. It might be argued that the lack of a fixed and coherent model is due to the relevance of unavoidable context issues in palliative care, such as specific cultural settings, patient-centred variables, and family specificity. The implication is that palliative care staff have continuously to adapt their model of caring to the specific needs and values of each patient, more than applying a fixed, although maybe comprehensive, care model.

A challenged choice: donating spare embryos to stem cell research in Switzerland.

RESEARCH QUESTIONS: Couples undergoing IVF in Switzerland may have embryos in excess of their clinical need that they can donate to human embryonic stem cell research. Thus a new practice has emerged in Switzerland when IVF treatment and embryonic stem cell research come into contact. This interface needs to be investigated from an ethical-legal point of view to facilitate a fair informed choice process for the couples involved. METHODS: Ethical analysis, patient perspectives elaboration. Interdisciplinary approach that draws on the research project JESP-ELSI (joint embryonic stem cell research project--ethical legal and societal implications). RESULTS AND CONCLUSIONS: To facilitate the donation of surplus embryos to human embryonic stem cell research, we propose a procedure of informed choice that fits to the current Swiss legal situation. In addition we identify problems within the current legal setting and suggest methods to improve communication at the interface between IVF and embryonic stem cell research from an ethical perspective.

Autonomy, responsibility and the Italian Code of Deontology for Nurses.

This article is a first assessment of the Italian Code of deontology for nurses (revised in 1999) on the basis of data collected from focus groups with nurses taking part in the Ethical Codes in Nursing (ECN) project. We illustrate the professional context in which the Code was introduced and explain why the 1999 revision was necessary in the light of changes affecting the Italian nursing profession. The most remarkable findings concern professional autonomy and responsibility, and how the Code is thought of as a set of guidelines for nursing practice. We discuss these issues, underlining that the 1999 Code represents a valuable instrument for ethical reflection and examination, a stimulus for putting the moral sense of the nursing profession into action, and that it represents a new era for professional nursing practice in Italy. The results of the analysis also deserve further qualitative study and future consideration.

Ethical codes in nursing practice: the viewpoint of Finnish, Greek and Italian nurses.

AIM: This paper is a report of a study exploring the use of ethical codes and obstacles to their use in nursing practice as perceived by Finnish, Greek and Italian nurses. BACKGROUND: In all European countries nurses are responsible for the well-being of patients, for their own technical and ethical competence and, for their own part, for the high standard of health care in society. These points illustrate the central content areas of nursing codes of ethics. Recent advances in medical technology have added to the complexity of nursing. Nurses today are increasingly confronted with ethical dilemmas, underlining the role and meaning of ethical codes in their decision-making. However, there is only very limited research literature on codes of ethics, their use in nursing practice and obstacles to their use. METHODS: Twenty-three focus group interviews were conducted in 2003 with a total of 138 Registered Nurses: 35 in Finland, 54 in Greece and 49 in Italy. The data were content analysed. FINDINGS: Two main categories emerged from our analysis of the use of ethical codes: (1) conscious and (2) unconscious use. Seven main categories described the obstacles to the use of ethical codes: (1) the codes themselves, (2) nurses themselves, (3) multiprofessional teamwork, (4) patients' family members, (5) the organization, (6) the nursing profession and (7) society/healthcare policy. Participants in all three countries were firmly committed to the values expressed in ethical nursing codes. Nonetheless, continued efforts are needed in all these countries to remove the remaining obstacles so that nursing care can be provided in keeping with the requirements of ethical codes. CONCLUSION: The use of codes is connected with the changes in nursing profession and in society at large. The core of nursing, however, has remained stable. Future studies should be conducted in order to generalize the findings to a broader population.

The value of nurses' codes: European nurses' views.

Nurses are responsible for the well-being and quality of life of many people, and therefore must meet high standards of technical and ethical competence. The most common form of ethical guidance is a code of ethics/professional practice; however, little research on how codes are viewed or used in practice has been undertaken. This study, carried out in six European countries, explored nurses' opinions of the content and function of codes and their use in nursing practice. A total of 49 focus groups involving 311 nurses were held. Purposive sampling ensured a mix of participants from a range of specialisms. Qualitative analysis enabled emerging themes to be identified on both national and comparative bases. Most participants had a poor understanding of their codes. They were unfamiliar with the content and believed they have little practical value because of extensive barriers to their effective use. In many countries nursing codes appear to be 'paper tigers' with little or no impact; changes are needed in the way they are developed and written, introduced in nurse education, and reinforced/implemented in clinical practice.