Ethical framework of informed consent and decision-making in dementia research

Impaired decision-making capacity is a symptomatic feature in a number of neurodegenerative diseases, but the nature of these decision-making deficits depends on the particular disease. The level of impairment that renders a patient unable to make valid decisions should ideally reflect a societal judgment about the appropriate balance between respecting the patient’s autonomy and protecting the patient from the potentially negative consequences of such a decision. Although many types of decision-making exist, studies of decision-making in patients with neurodegenerative diseases generally use two decision-making paradigms; decision-making under ambiguity and decision-making under risk. The main objective of this study is to determine the issues that should be taken into account during the informed consent process. This study encompasses two intertwined phases. The results will be integrated into an in-depth normative analysis of the conceptual and ethical issues raised by the informed consent process in clinical dementia research.info:eu-repo/semantics/publishedVersio

Integration of palliative care and psychiatry: ethico-clinical and organisational challenges based on professionals’ views

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How to enhance the informed consent process in persons unable to consent? Experiences from different contexts and settings

Background: Informed consent is the most scrutinized and controversial aspect of clinical research ethics. In palliative and end-of-life care, assessing decision-making capacity may be challenging. Patients, particularly those with cognitive impairment, deserve special attention when developing, implementing, and evaluating the informed consent process. Respecting patients’ autonomy in research includes obtaining informed consent; facilitating and supporting patients’ choices about research options; allowing patients to refuse participating in research; disclosing comprehensive and truthful information; and maintaining privacy and confidentiality. An autonomous decision requires that participants/patients have the capacity to provide informed consent. Aim: To explore how to enhance the informed consent process in persons unable to consent (e.g., persons with cognitive impairment, dementia, severe and persistent mental illness, and/or at the end-of-life) to increase equity and fair participant selection. Methods: This presentation is based on a series of systematic reviews and international research projects. It combines theoretical frameworks and ethical principles with empirical research conducted in different contexts and settings. Results: The informed consent process involves both consent and assent, which should be monitored throughout the research process. Informed consent must be an ongoing process of communication, understanding and decision-making that involves a wide range of key stakeholders (the patient and potential participant, possible surrogates, clinicians, and researchers) throughout the course of the study. Cognitive impairment, and other disorders affecting cognition, may have a negative impact on patients’ capacity to provide consent to research participation. Also, stereotypes among researchers can contribute to failures in the informed consent process. This might prevent patients with limited decision-making capacity from participating in relevant research. Conclusions: This presentation provides an overview of ethical frameworks and principles linked to the informed consent process and decision-making capacity in palliative care research, particularly in patients with cognitive impairment and/or limited decision-making capacity. A core set of ethical questions and recommendations is drawn to aid researchers, institutional review boards and potential research participants in the process of obtaining informed consent for palliative and end-of-life care research.info:eu-repo/semantics/acceptedVersio

Anticipatory medication in home palliative care: a systematic review of existing practices, challenges and safeguards

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Anticipatory medication in home palliative care: a systematic review of existing practices, challenges and safeguards

info:eu-repo/semantics/publishedVersio

What does “assisted dying” mean for professionals providing end-of-life care? Results from a nationwide qualitative study

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How to improve ethical decision-making in clinical practice? Practical models and guidelines

Background: Clinical practice in palliative care is characterized by the need of making ethico-clinical decisions, particularly at the end-of-life. End-of-life situations are situations in which a severe deterioration in health, due to the evolution of a disease or another cause, threatens the life of a person irreversibly in the near future, posing the need to make ethico-clinical decisions. Often, these decisions are difficult and challenging; the so-called “ethical challenges” emerge. Despite its ubiquity, there is no consensualized definition of this expression. Various terms are used interchangeably, e.g., “ethical challenges”, “ethical problems”, “ethical issues”, “ethical dilemmas”. Moreover, even though there is a wide range of ethical decisions that need to be made in palliative and end-of-life care, there is no unique model or guideline to help professionals and teams in making difficult and complex decisions. Aim: To explore practical models and guidelines that can be used in clinical contexts to improve ethical decision-making in palliative and end-of-life situations. Methods: This presentation is based on the work developed within project DELiCare: Decisions, Decision-making, and End-of-Life Care: Ethical Framework and Reasoning. The overall project, its objectives, methods, results, and implications will be presented in an integrated fashion, including the application of ethical decision-making models and guidelines to specific clinical cases. Results: End-of-life decisions are rooted in clinical, sociocultural, political, legal, economic, and ethical concerns. Several models and guidelines for ethical decision-making at the end-of-life coexist but are rarely used in clinical practice. These models and guidelines can be a relevant aid for healthcare professionals and teams. They can stimulate the debate around disputed and controversial issues, helping professionals to follow a well-informed and shared decision-making model in order to meet patients’ values, wishes and preferences. Conclusions: Decision-making processes underlying end-of-life decisions are influenced by and foster clinical, ethical, sociocultural, religious, political, legal, and economic concerns and debates. Healthcare professionals working in palliative and end-of-life care often perceive these decision-making processes as complex and challenging. The use of practical models and guidelines can enhance professionals and teams’ competencies and effectiveness in making ethico-clinical decisions at the end-of-life.info:eu-repo/semantics/acceptedVersio

Contact with death, ethical decisions, and communication of bad news in intensive care and palliative units: results from a mixed-methods study

Introduction: Professionals working in intensive care and palliative units (ICUs/PCUs) care for patients with life-threatening diseases, make ethical decisions, and provide end-of-life care. However, while palliative care aims to reduce suffering, intensive care has a major focus on saving lives. Objectives: To identify and compare the experiences of ICU and PCU healthcare professionals related to: contact with dying and death, making of ethical decisions and communication and delivery of bad news. Methods: Mixed approach, combining quantitative (questionnaire on experiences in the work context) and qualitative ones (interviews with doctors and nurses). 10 ICU and 9 PCU participated in this study. 392 professionals completed the survey; 28 were interviewed. A descriptive quantitative analysis was performed; the chi-square test was used to analyse the association between variables (significance level of p < .05). Interviews were subject to content analysis. Results: In the week prior to survey completion, more professionals working in ICUs reported a patient's death; this was not statistically significant. The experience most mentioned by the professionals of both types of units during interviews was caring for patients nearing death. In the week before completing the questionnaire, the most common ethical decision was palliative/terminal sedation; this was more, often in ICUs (27 % vs. 12 %; p = .004). In the day of questionnaire completion, the most frequent ethical decision was also palliative sedation. Though this decision was more frequent in ICU, statistical significance was not reached (p = .440). The communication of the diagnosis/prognosis to the patient, either in the week before or in the day of questionnaire completion was more frequent in PCUs (45 % vs. 29 %, p = .005; 22 % vs. 12 %, p = .026, respectively). Communication about the diagnosis/prognosis with the family in the week before survey completion was held with equal frequency by professionals from both contexts (58 % of professionals). Although not reaching statistical significance (p = .303), more professionals from PCU proceeded to communication with family about the diagnosis and prognosis (32 % vs. 26 %) in the survey day. From the analysis of the interviews, it was denoted that it were mainly professionals of PCU who referred to the communication on the diagnosis/ prognosis, both with the patient as with the family. Conclusions: The workplace experiences in ICU and PCU are, despite some differences, guided by similarities. Caring for patients with lifethreatening situations and imminent death and the need to make ethical decisions occur frequently in both contexts. The communication about the diagnosis/prognosis occurs more often in PCU. This highlights the need for integrating communication strategies of palliative care, in intensive care.info:eu-repo/semantics/publishedVersio

Ethical challenges and decisions at the end-of-life in burn intensive care units. Results from a qualitative interview study

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Experiencing total pain in burn intensive care units: a meta-ethnographic review

Background: Critically burned patients and their families experience unbearable pain and suffering. Working in burn intensive care units (Burn ICUs) is also a major cause of emotional distress for healthcare professionals. Although burn-related pain is part of the acute care provided to burned patients, little is known on how to optimally provide suffering relief. Aim: To understand patients, families, and healthcare professionals’ experiences with total pain and its relief in Burn ICUs. Methods: Meta-ethnography of qualitative evidence following PRISMA. Studies were retrieved from 3 databases (PubMed, ISI and EBSCO host searching CINAHL Complete, MEDLINE Complete, and MedicLatina), combining 3 sets of terms (suffering AND burns AND qualitative). Original qualitative studies exploring experiences of critically burned patients, their families and healthcare teams in BurnICUs were included from inception to October 2022. Results: 305 articles retrieved; 10 selected for analysis and synthesis, with 263 participants. 11 themes emerged from the analysis: Patients’ suffering (changed self, mental anguish, physical pain and its management from onset until discharge when it happened, and divergent opinions about sedation); Families’ suffering (navigating through the experience, managing uncertainty about survival, vicarious suffering, and isolation in their “bubble of trauma”); and Nurses’ suffering (stress, compassion fatigue, and burnout). Discussion/Conclusions: This meta-ethnographic review shows that critically burned patients and their families experience total pain. Nurses caring for these patients and their families express signs of physical and emotional suffering. Timely and targeted palliative care could have a positive impact on these patients, families, and professionals, improving care outcomes. Further research is needed to determine how healthcare systems can best optimise palliative care provision to critically burned patients and their families to address their experience of total pain.info:eu-repo/semantics/acceptedVersio