From book to bedside? A critical perspective on the debate about "translational bioethics".

The concept of "translational bioethics" has received considerable attention in recent years. Most publications draw an analogy to translational medicine and describe bioethical research that aims at implementing and evaluating ethical interventions. However, current accounts of translational bioethics are often rather vague and seem to differ with regard to conceptual and methodological assumptions. It is not clear and scarcely analyzed what exactly "translation" in the field of bioethics means, in particular regarding goals and processes so that it is justified to appeal to translational medicine. In this article, we thus explore possible analogies and disanalogies between translational medicine and translational bioethics to establish whether the often occurring reference to concepts of translational medicine in the field of bioethics can be justified by substantial analogies. We will first provide an account of different models of translational medicine. In a second step, we will propose an analytic definition that explicitly articulates the essential characteristics of "translational research" irrespective of the research field (i.e., biomedicine, bioethics). Subsequently, we will explore whether and in how far general characteristics and phases of translational research in medicine can be applied to translational research in bioethics. Based on our analyses, we will come to the skeptical conclusion that at present there are considerable conceptual disanalogies and unsolved conceptual problems that disallow using "translational bioethics" in a meaningful analogy to respective accounts in biomedicine. Nevertheless, we will demonstrate that some insights gained by the conceptual accounts of translational medicine can contribute to advance current research activities in bioethics.

Expert-approved best practice recommendations on the use of sedative drugs and intentional sedation in specialist palliative care (SedPall).

BACKGROUND: The use of sedative drugs and intentional sedation in end-of-life care is associated with clinical, ethical and legal challenges. In view of these and of the issue's great importance to patients undergoing intolerable suffering, we conducted a project titled SedPall ("From anxiolysis to deep continuous sedation - Development of recommendations for sedation in palliative care") with the purpose of developing best practice recommendations on the use of sedative drugs and intentional sedation in specialist palliative care and obtaining feedback and approval from experts in this area. DESIGN: Our stepwise approach entailed drafting the recommendations, obtaining expert feedback, conducting a single-round Delphi study, and convening a consensus conference. As an interdisciplinary group, we created a set of best practice recommendations based on previously published guidance and empirical and normative analysis, and drawing on feedback from experts, including patient representatives and of public involvement participants. We set the required agreement rate for approval at the single-round Delphi and the consensus conference at ≥80%. RESULTS: Ten experts commented on the recommendations' first draft. The Delphi panel comprised 50 experts and patient and public involvement participants, while 46 participants attended the consensus conference. In total, the participants in these stages of the process approved 66 recommendations, covering the topics "indications", "intent/purpose [of sedation]", "decision-making", "information and consent", "medication and type of sedation", "monitoring", "management of fluids and nutrition", "continuing other measures", "support for relatives", and "team support". The recommendations include suggestions on terminology and comments on legal issues. CONCLUSION: Further research will be required for evaluating the feasibility of the recommendations' implementation and their effectiveness. The recommendations and the suggested terminology may serve as a resource for healthcare professionals in Germany on the use of sedative drugs and intentional sedation in specialist palliative care and may contribute to discussion on the topic at an international level. TRIAL REGISTRATION: DRKS00015047 (German Clinical Trials Register).

How to derive ethically appropriate recommendations for action? A methodology for applied ethics.

Researchers in applied ethics, and some areas of bioethics particularly, aim to develop concrete and appropriate recommendations for action in morally relevant real-world situations. When proceeding from more abstract levels of ethical reasoning to such concrete recommendations, however, even with regard to the very same normative principle or norm, it seems possible to develop divergent or even contradictory recommendations for action regarding a certain situation. This may give the impression that such recommendations would be arbitrary and, hence, not well justified. Against this background, we, first, aim at showing that ethical recommendations for action, although being contingent in some sense, are not arbitrary if developed appropriately. For this purpose, we examine two types of contingencies arising in applied ethics reasoning based on recent examples of recommendations for action in the context of the COVID-19 pandemic. In doing so, we refer to a three-step model of ethical reasoning towards recommendations for actions. This, however, leaves open the question of how applied ethics may cope with contingent recommendations for action. Therefore, in a second step, we analyze the role of bridge principles for developing ethically appropriate recommendations for action, i.e., principles which connect normative claims with relevant empirical information to justify certain recommendations for action in a given morally relevant situation. Finally, we discuss some implications for reasoning and reporting in empirically informed ethics.

What do you mean by "palliative sedation"? : Pre-explicative analyses as preliminary steps towards better definitions.

BACKGROUND: Sedation in palliative care is frequently but controversially discussed. Heterogeneous definitions and conceptual confusion have been cited as contributing to different problems 1) relevant to empirical research, for example, inconsistent data about practice, the 'data problem', and 2) relevant for an ethically legitimate characterisation of the practice, the 'problem of ethical pre-emption'. However, little is known about how exactly definitions differ, how they cause confusion and how this can be overcome. METHOD: Pre-explicative analyses: (A) systematic literature search for guidelines on sedation in palliative care and systematic decomposition of the definitions of the practice in these guidelines; (B) logical distinction of different ways through which the two problems reported might be caused by definitions; and (C) analysis of how content of the definitions contributes to the problems reported in these different ways. RESULTS: 29 guidelines from 14 countries were identified. Definitions differ significantly in both structure and content. We identified three ways in which definitions can cause the 'data problem' - 1) different definitions, 2) deviating implicit concepts, 3) disagreement about facts. We identified two ways to cause the problem of ethical pre-emption: 1) explicit or 2) implicit normativity. Decomposition of definitions linked to the distinguished ways of causing the conceptual problems shows how exactly single parts of definitions can cause the problems identified. CONCLUSION: Current challenges concerning empirical research on sedation in palliative care can be remediated partly by improved definitions in the future, if content and structure of the used definitions is chosen systematically. In addition, future research should bear in mind that there are distinct purposes of definitions. Regarding the 'data problem', improving definitions is possible in terms of supplementary information, checking for implicit understanding, systematic choice of definitional elements. 'Ethical pre-emption', in contrast, is a pseudo problem if definitions and the relationship of definitions and norms of good practice are understood correctly.

Terminological Confusion About Sedation in Palliative Care: Results of an International Online Vignette Survey.

Background: Terminological problems concerning sedation in palliative care and consequences for research and clinical decision making have been reported frequently. Objectives: To gather data on the application of definitions of sedation practices in palliative care to clinical cases and to analyze implications for high-quality definitions. Design: We conducted an online survey with a convenience sample of international experts involved in the development of guidelines on sedation in palliative care and members of the European Association for Palliative Care (EAPC). Participants were asked to apply four published definitions to four case vignettes. Data were analyzed using descriptive statistics. Results: A total of 32 experts and 271 EAPC members completed the survey. The definitions were applied correctly in n = 2200/4848 cases (45.4%). The mean number of correct applications of the definitions (4 points max.) was 2.2 ± 1.14 for the definition of the SedPall study group, 1.8 ± 1.03 for the EAPC definition, 1.7 ± 0.98 for the definition of the Norwegian Medical Association, and 1.6 ± 1.01 for the definition of the Japanese Society of Palliative Medicine. The rate of correct applications for the 16 vignette-definition pairs varied between 70/303 (23.1%) and 227/303 (74.9%). The content of definitions and vignettes together with free-text comments explains participants' decisions and misunderstandings. Conclusions: Definitions of sedation in palliative care are frequently incorrectly applied to clinical case scenarios under simplified conditions. This suggests that clinical communication and research might be negatively influenced by misunderstandings and inconsistent labeling or reporting of data. Clinical Trial Registration Number: DRKS00015047.

Documentation of Sedation in Palliative Care: A Scoping Review of Requirements, Recommendations, and Templates.

Objective: To identify and describe requirements, recommendations, and templates for the documentation of sedation in adult palliative care. Introduction: International literature shows inconsistency in clinical practice regarding sedation in palliative care accompanied by legal, ethical, and medical uncertainties. Documentation in general serves as proof for previous treatments. In the context of intentional sedation to relieve suffering at the end of life, documentation provides a clear demarcation against practices of euthanasia. Inclusion Criteria: Articles with full-text version published in English or German since 2000, covering documentation requirements, recommendations, monitoring parameters or templates for sedation in adult palliative care were included. Methods: Scoping review following the JBI methodology. Search in online databases, websites of professional associations in palliative care, reference lists of relevant publications, the archive of the German "Journal of Palliative Medicine" and databases for unpublished literature were used. Search terms included "palliative care,' "sedation," and "documentation." The search was conducted from January 2022 to April 2022 with an initial hand search in November 2021. Data were screened and charted by one reviewer after conducting a pilot test of the criteria. Results: From the initial 390 articles (database search), 22 articles were included. In addition, 15 articles were integrated from the hand search. The results can be clustered in two sets of items, regarding either the documentation before or during sedation. The documentation requirements referred both to inpatient and homecare settings but in many cases, a clear assignment was missing. Conclusions: The guidelines analyzed in this study rarely cover setting-specific differences in documentation and often treat documentation as minor topic. Further research is needed addressing legal and ethical concerns of health care teams and, therefore, help to improve treatment of patients suffering from otherwise intractable burden at the end of life.

Intentional Sedation as a Means to Ease Suffering: A Systematically Constructed Terminology for Sedation in Palliative Care.

Background: Terminology concerning sedation in palliative care is heterogeneous, vague, and difficult to apply with negative impact on the reliability of quantitative data, practice, and ethical discourse. Design: To clarify the concept, we systematically developed definitions of core terms in an interdisciplinary research group comprising palliative care, ethics, law, and philosophy, integrating feedback from external experts. Results: We define terms stepwise, separating matters of terminology (What is the practice?) from matters of good practice (How to use it?). We start with an operational definition of "reduced level of consciousness" (score < 0 on the Richmond Agitation-Sedation Scale modified for palliative care inpatients (RASS-PAL), followed by defining "sedating," "sedation," and "intentional sedation" as the result or process of sedating a patient as a means of achieving a previously defined treatment goal and the terms "light," "deep," "temporary," and "sedation until death." Conclusion: The terminology facilitates the precise phrasing of aims, indications, and rules for good practice. Empirical research on acceptance and feasibility is needed.