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Introduction: While Learning Healthcare Systems (LHSs) have received increasing attention in health care and research, the amount of operational LHSs remains limited. Given the investment of resources in these projects, a moral responsibility to pursue the transition toward an LHS falls on projects and their participating stakeholders. This paper provides an ethics framework for projects that have taken steps toward building an LHS and are in the position to transition to an operational LHS. Method: To articulate relevant ethical requirements, we analyze established ethics frameworks in the fields of LHSs, data‐intensive health research, and transitioning or innovating health systems. The overlapping content and shared values are used to articulate overarching ethical requirements. To provide necessary context, we apply the insights from the analysis to the Innovative Medicines Initiative ConcePTION project. This project is specifically designed to generate knowledge on the safety of medications used during pregnancy and lactation through the establishment of an LHS. Results: Upon analyzing the consulted frameworks, we identified four overlapping ethical requirements that are also of significant relevance within the scope of our ethics framework. These requirements are: (1) public benefit and favorable harm–benefit ratio; (2) equity and justice; (3) stakeholder engagement; and (4) sustainability. Additionally, we apply these ethical requirements to the context of an LHS for pregnant and lactating people. Conclusion: Although tailored to the context of pregnancy and lactation, our ethics framework can provide guidance for the transition to an operational LHS across diverse healthcare domains. [ABSTRACT FROM AUTHOR]

Advance care planning (ACP) is increasingly implemented in oncology and beyond, but a definition of ACP and recommendations concerning its use are lacking. We used a formal Delphi consensus process to help develop a definition of ACP and provide recommendations for its application. Of the 109 experts (82 from Europe, 16 from North America, and 11 from Australia) who rated the ACP definitions and its 41 recommendations, agreement for each definition or recommendation was between 68-100%. ACP was defined as the ability to enable individuals to define goals and preferences for future medical treatment and care, to discuss these goals and preferences with family and health-care providers, and to record and review these preferences if appropriate. Recommendations included the adaptation of ACP based on the readiness of the individual; targeting ACP content as the individual's health condition worsens; and, using trained non-physician facilitators to support the ACP process. We present a list of outcome measures to enable the pooling and comparison of results of ACP studies. We believe that our recommendations can provide guidance for clinical practice, ACP policy, and research.

Background: The incidence of continuous deep sedation (CDS) has more than doubled over the last decade in The Netherlands, while reasons for this increase are not fully understood. Patients and relatives have an essential role in deciding on CDS. We hypothesize that the increase in CDS practice is related to the changing role of patients and relatives in deciding on CDS. Objective: To describe perceptions and experiences of patients and relatives with regard to CDS. This insight may help professionals and policymakers to better understand and respond to the evolving practice of CDS. Methods: Qualitative interviews were held with patients and relatives who had either personal experience with CDS as a relative or had contemplated CDS for themselves. Results: The vast majority of respondents appreciated CDS as a palliative care option, and none of the respondents reported (moral) objections to CDS. The majority of respondents prioritized avoiding suffering at the end of life. The patients and families generally considered CDS a palliative care option for which they can choose. Likewise, according to our respondents, the decision to start CDS was made by them, instead of the physician. Negative experiences with CDS care were mostly related to loss of sense of agency, due to insufficient communication or information provision by healthcare professionals. Lack of continuity of care was also a source of distress. We observed a variety in the respondents' understanding of the distinction between CDS and other end‐of‐life care decisions, including euthanasia. Some perceived CDS as hastening death. Conclusion: The traditional view of CDS as a last resort option for a physician to relieve a patient's suffering at the end of life is not explicit among patients and relatives. Instead, our results show that they perceive CDS as a regular palliative care option. Along with this normalization of CDS, patients and relatives claim a substantial say in the decision‐making and are mainly motivated by a wish to avoid suffering and exercise control at the end of life. These distinct views on CDS of patients, their relatives and healthcare providers should be reconciled in guidelines and protocols for CDS. Patient or Public Contribution: One of the authors in our team (G. H.) has experience with CDS as a relative and ensured that the patient/relative viewpoint was adequately reflected in the design and conduct of our study. In the preliminary phase of our study, G. H. adjusted the topic list so it was better adapted to the current practice of CDS. During the data analysis, G. H. read several interviews and took part in the open and critical discussion on central themes and core concepts as an important member of the author team, thereby guaranteeing the central position of the patient/relative perspective in our final research outcome. [ABSTRACT FROM AUTHOR]

Purpose Survivors of critical illness often suffer from reduced health-related quality of life (HRQoL) due to long-term physical, cognitive, and mental health problems, also known as post-intensive care syndrome (PICS). Some intensive care unit (ICU) survivors even consider their state of health unacceptable. The aim of this study was to investigate the determinants of self-reported unacceptable outcome of ICU treatment. Methods Patients who were admitted to the ICU for at least 48 h and survived the first year after discharge completed validated questionnaires on overall HRQoL and the components of PICS and stated whether they considered their current state of health an acceptable outcome of ICU treatment. The effects of overall HRQoL and components of PICS on unacceptable outcome were studied using multiple logistic regression analysis. Results Of 1453 patients, 67 (5%) reported their health state an unacceptable outcome of ICU treatment. These patients had a lower score on overall HRQoL (EQ-5D-index value of 0.57 vs. 0.81; p < 0.001), but we could not determine a cutoff value of the EQ-5D-index value that reliably identified unacceptable outcome. In the multivariate analysis, only the hospital anxiety and depression scale was significantly associated with an unacceptable outcome (OR 2.06, 99% CI 1.18-3.61). Conclusions Although there is a strong association between low overall HRQoL and self-reported unacceptable outcome of ICU treatment, patients with low overall HRQoL may still consider their outcome acceptable. The mental component of PICS, but not the physical and cognitive component, is strongly associated with self-reported unacceptable outcome., Author(s): Monika C. Kerckhoffs [sup.1], Felicia F. L. Kosasi [sup.1], Ivo W. Soliman [sup.1], Johannes J. M. van Delden [sup.2], Olaf L. Cremer [sup.1], Dylan W. de Lange [sup.1], Arjen [...]