An ethics framework for the transition to an operational learning healthcare system.

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.

Cardiac organoids do not warrant additional moral scrutiny.

Certain organoid subtypes are particularly sensitive. We explore whether moral intuitions about the heartbeat warrant unique moral consideration for newly advanced contracting cardiac organoids. Despite the heartbeat's moral significance in organ procurement and abortion discussions, we argue that this significance should not translate into moral implications for cardiac organoids.

Getting to Know Your Patient: Content Analysis of Patients' Answers to a Questionnaire for Promoting Person-Centered Care.

Background: Person-centered care (PCC) encourages patients to actively participate in health care, thus facilitating care that fits the life of the patient. Therefore, health care professionals (HCPs) need to know the patient. As part of a broad policy for improving PCC, a digital questionnaire ("We would like to know you") consisting of 5 questions has previously been developed to help HCPs to get to know the patient with the help of patient and staff involvement.

Continuous deep sedation at the end of life: a qualitative interview-study among health care providers on an evolving practice.

Background: Continuous deep sedation (CDS) can be used for patients at the end of life who suffer intolerably from severe symptoms that cannot be relieved otherwise. In the Netherlands, the use of CDS is guided by an national guideline since 2005. The percentage of patients for whom CDS is used increased from 8% of all patients who died in 2005 to 18% in 2015.

Dynamic consent, communication and return of results in large-scale health data reuse: Survey of public preferences.

Dynamic consent forms a comprehensive, tailored approach for interacting with research participants. We conducted a survey study to inquire how research participants evaluate the elements of consent, information provision, communication and return of results within dynamic consent in a hypothetical health data reuse scenario. We distributed a digital questionnaire among a purposive sample of patient panel members.

Stimulating solidarity to improve knowledge on medications used during pregnancy : A contribution from the ConcePTION project.

Background: Pregnant people have been overlooked or excluded from clinical research, resulting in a lack of scientific knowledge on medication safety and efficacy during pregnancy. Thus far, both the opportunities to generate evidence-based knowledge beyond clinical trials and the role of pregnant people in changing their status quo have not been discussed. Some scholars have argued that for rare disease patients, for whom, just like pregnant people, a poor evidence base exists regarding treatments, solidarity has played an important role in addressing the evidence gap.

Commitments for Ethically Responsible Sourcing, Use, and Reuse of Patient Data in the Digital Age: Cocreation Process.

Background: Personal information, including health-related data, may be used in ways we did not intend when it was originally shared. However, the organizations that collect these data do not always have the necessary social license to use and share it. Although some technology companies have published principles on the ethical use of artificial intelligence, the foundational issue of what is and is not acceptable to do with data, not just the analytical tools to manage it, has not been fully considered.

Healthcare use and healthcare costs for patients with advanced cancer; the international ACTION cluster-randomised trial on advance care planning.

Background: Advance care planning supports patients to reflect on and discuss preferences for future treatment and care. Studies of the impact of advance care planning on healthcare use and healthcare costs are scarce.

Aim: To determine the impact on healthcare use and costs of an advance care planning intervention across six European countries.

Symptom evolution in the dying.

Objective: Provide insight in the prevalence of symptoms in patients who are in the last days of life.

Methods: A retrospective descriptive analysis of data on patients who died between 2012 and 2019 at the age of 18 or older in 1 of 20 Dutch healthcare facilities, including hospitals, inpatient hospices and long-term care facilities. We analysed data from 4 hourly registrations in the Care Programme for the Dying Person, to assess for how many patients symptom-related goals of care were not achieved.

The utility of the surprise question: A useful tool for identifying patients nearing the last phase of life? A systematic review and meta-analysis.

Background: The surprise question is widely used to identify patients nearing the last phase of life. Potential differences in accuracy between timeframe, patient subgroups and type of healthcare professionals answering the surprise question have been suggested. Recent studies might give new insights.

Ethical and research governance approval across Europe: Experiences from three European palliative care studies.

Background: Research requires high-quality ethical and governance scrutiny and approval. However, when research is conducted across different countries, this can cause challenges due to the differing ethico-legal framework requirements of ethical boards. There is no specific guidance for research which does not involve non-medicinal products.

Real-Time Access to Electronic Health Record via a Patient Portal: Is it Harmful? A Retrospective Observational Study.

Background: The rapid implementation of patient portals, through which patients can view their electronic health record, creates possibilities for information exchange and communication between patients and health care professionals. However, real-time disclosure of test results and clinical reports poses a source of concern.

Objective: This study aimed to examine negative experiences resulting from real-time disclosure of medical information through a patient portal.

Use and the Users of a Patient Portal: Cross-Sectional Study.

Background: Patient portals offer patients access to their medical information and tools to communicate with health care providers. It has been shown that patient portals have the potential to positively impact health outcomes and efficiency of health care. It is therefore important that health care organizations identify the patients who use or do not use the patient portal and explore the reasons in either case.

Parental experiences with a paediatric palliative care team: A qualitative study.

Background: Parents of children with a life-limiting disease have to rely on themselves at home while adequate paediatric palliative care is lacking. In several countries, paediatric palliative care teams are introduced to ensure continuity and quality of care and to support the child and the family. Yet, little is known about how parents experience such multidisciplinary teams.

Organoid biobanking: identifying the ethics: Organoids revive old and raise new ethical challenges for basic research and therapeutic use.

Organoid technology is at the margin of basic research, precision medicine, and regenerative medicine where various research and clinical ethical issues converge. Resolving these interrelated ethical challenges requires an integrated approach rather than assessing each issue individually. [Image: see text]

A systematic review of reasons for gatekeeping in palliative care research.

Background: When healthcare professionals or other involved parties prevent eligible patients from entering a trial as a research subject, they are gatekeeping. This phenomenon is a persistent problem in palliative care research and thought to be responsible for the failure of many studies.

Aim: To identify potential gatekeepers and explore their reasons for gatekeeping in palliative care research.

Consent procedures in pediatric biobanks.

The inclusion of children's samples in biobanks brings forward specific ethical issues. Guidelines indicate that children should be involved in the consent procedure. It is, however, unclear how to allocate an appropriate role for children.

Regenerative medicine interventions for orthopedic disorders: ethical issues in the translation into patients.

Regenerative medicine (RM) technologies, such as cell therapy, gene transfer and tissue engineering, are expected to move the field of orthopedics into a new era. Now that more and more attempts are underway to translate preclinical research into clinical studies, it is time to proactively discuss the ethical issues associated with first-in-human applications of RM interventions for musculoskeletal disorders. The design and launch of early clinical trials will be ethically challenging due to the specific features of RM in general, and the application for musculoskeletal disorders specifically.