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. OBJECTIVE: The purpose of this study was to provide insight into the content and aims of the questionnaire to understand its potential and usability. METHODS: We conducted a qualitative, retrospective content analysis of patients' answers using NVivo Pro (QSR International). The questionnaire was used in the outpatient neuro-oncology department of a Dutch academic hospital. RESULTS: Of 374 invited patients, 78 (20.9%) completed the questionnaire. We selected a sample of 42 (54%) of the 78 patients. Patients used a median of 16 (IQR 7-27) words per question, and most answers were easily interpretable. When asked about important activities, social activities, sports, or maintaining a normal life were most frequently mentioned. Patients wrote about fear of the disease, its possible influence on life, or fear of the future in general. Patients wanted HCPs to know about their care and communication preferences or shared personal information. They formulated expectations about effective treatment, communication, and the care process. CONCLUSIONS: The questionnaire seems usable because patients provide interpretable answers that take little time to read, which HCPs can use to personalize care. Our study shows the potential of the questionnaire to help deliver PCC.

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. The aim of this study is to explore potential causes of the rise in the use of CDS in the Netherlands according to health care providers who have been participating in this practice. METHODS: Semi-structured interviews were conducted and thematically analysed. Participants were Dutch health care providers (HCPs), working at patients' homes, hospices, elderly care facilities and in hospitals and experienced in providing CDS, who were recruited via purposeful sampling. RESULTS: 41 Health care providers participated in an interview. For these HCPs the reason to start CDS is often a combination of symptoms resulting in a refractory state. HCPs indicated that symptoms of non-physical origin are increasingly important in the decision to start CDS. Most HCPs felt that suffering at the end of life is less tolerated by patients, their relatives, and sometimes by HCPs; they report more requests to relieve suffering by using CDS. Some HCPs in our study have experienced increasing pressure to perform CDS. Some HCPs stated that they more often used intermittent sedation, sometimes resulting in CDS. CONCLUSIONS: This study provides insight into how participating HCPs perceive that their practice of CDS changed over time. The combination of a broader interpretation of refractory suffering by HCPs and a decreased tolerance of suffering at the end of life by patients, their relatives and HCPs, may have led to a lower threshold to start CDS. TRIAL REGISTRATION: The Research Ethics Committee of University Medical Center Utrecht assessed that the study was exempt from ethical review according to Dutch law (Protocol number 19-435/C).

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. Data were analysed using descriptive and nonparametric inferential statistics. Respondents favoured the potential to manage changing consent preferences over time. There was much agreement between people favouring closer and more specific control over data reuse approval and those in favour of broader approval, facilitated by an opt-out system or an independent data reuse committee. People want to receive more information about reuse, outcomes and return of results. Respondents supported an interactive model of research participation, welcoming regular, diverse and interactive forms of communication, like a digital communication platform. Approval for reuse and providing meaningful information, including meaningful return of results, are intricately related to facilitating better communication. Respondents favoured return of actionable research results. These findings emphasize the potential of dynamic consent for enabling participants to maintain control over how their data are being used for which purposes by whom. Allowing different options to shape a dynamic consent interface in health data reuse in a personalized manner is pivotal to accommodate plurality in a flexible though robust manner. Interaction via dynamic consent enables participants to tailor the elements of participation they deem relevant to their own preferences, engaging diverse perspectives, interests and preferences.

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. This paper explores whether and how the enactment of solidarity among pregnant people can be stimulated to help address the poor evidence base on medications used during pregnancy. METHOD: We use the concept of solidarity formulated by Prainsack and Buyx and enrich their concept by providing an account for stimulating the enactment of solidarity. Then we apply this account to the case of pregnant people who use medication. RESULTS: Solidarity means enacted commitment on the part of an individual to assisting others with whom the person recognizes a similarity in a relevant respect. Although solidarity cannot be imposed, we argue that the empowerment of people is a crucial concept in understanding how solidarity can be stimulated. Empowerment in the context of pregnant people means creating awareness about their status quo, explaining how scientific research can help close the knowledge gap, and how pregnant people can themselves contribute. In particular, how pregnant people can contribute to the collection of health data to strengthen the evidence base for medications used during pregnancy. CONCLUSIONS: We conclude that acting in solidarity can help change the status quo for pregnant people. Furthermore, we argue that the empowerment of pregnant people and other relevant stakeholders is a way to stimulate the enactment of solidarity. The process of empowerment starts by raising awareness about the lack of evidence on medications used during prengnacy and by explaining to pregnant people how they can contribute to changing the way knowledge is being generated by, for example, sharing data on the health effects of medications.

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. Furthermore, it is unclear whether input from the public or patients has been included. In 2017, the leadership at a web-based patient research network began to envision a new kind of community compact that laid out what the company believed, how the company should behave, and what it promised both to the individuals who engaged with them and to the community at large. While having already earned a social license from patient members as a trusted data steward with strong privacy, transparency, and openness policies, the company sought to protect and strengthen that social license by creating a socially and ethically responsible data contract. Going beyond regulatory and legislative requirements, this contract considered the ethical use of multiomics and phenotypic data in addition to patient-reported and generated data. OBJECTIVE: A multistakeholder working group sought to develop easy-to-understand commitments that established expectations for data stewardship, governance, and accountability from those who seek to collect, use, and share personal data. The working group cocreated a framework that was radically patient-first in its thinking and collaborative in the process of its codevelopment; it reflected the values, ideas, opinions, and perspectives of the cocreators, inclusive of patients and the public. METHODS: Leveraging the conceptual frameworks of cocreation and participatory action research, a mixed methods approach was used that included a landscape analysis, listening sessions, and a 12-question survey. The methodological approaches used by the working group were guided by the combined principles of biomedical ethics and social license and shaped through a collaborative and reflective process with similarities to reflective equilibrium, a method well known in ethics. RESULTS: Commitments for the Digital Age are the output of this work. The six commitments in order of priority are (1) continuous and shared learning; (2) respect and empower individual choice; (3) informed and understood consent; (4) people-first governance; (5) open communication and accountable conduct; and (6) inclusivity, diversity, and equity. CONCLUSIONS: These 6 commitments-and the development process itself-have broad applicability as models for (1) other organizations that rely on digitized data sources from individuals and (2) patients who seek to strengthen operational policies for the ethical and responsible collection, use, and reuse of that data.

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. DESIGN: Cluster-randomised trial, registered as ISRCTN63110516, of advance care planning conversations supported by certified facilitators. SETTING/PARTICIPANTS: Patients with advanced lung or colorectal cancer from 23 hospitals in Belgium, Denmark, Italy, the Netherlands, Slovenia and the UK. Data on healthcare use were collected from hospital medical files during 12 months after inclusion. RESULTS: Patients with a good performance status were underrepresented in the intervention group (p< 0.001). Intervention and control patients spent on average 9 versus 8 days in hospital (p = 0.07) and the average number of X-rays was 1.9 in both groups. Fewer intervention than control patients received systemic cancer treatment; 79% versus 89%, respectively (p< 0.001). Total average costs of hospital care during 12 months follow-up were €32,700 for intervention versus €40,700 for control patients (p = 0.04 with bootstrap analyses). Multivariable multilevel models showed that lower average costs of care in the intervention group related to differences between study groups in country, religion and WHO-status. No effect of the intervention on differences in costs between study groups was observed (p = 0.3). CONCLUSIONS: Lower care costs as observed in the intervention group were mainly related to patients' characteristics. A definite impact of the intervention itself could not be established.

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. We looked at the first 4 hours episode after the start of the Care Programme and the last 4 hours episode prior to death. RESULTS: We analysed records of 2786 patients. In the first 4 hours episode, at least one symptom-related care goal was not achieved for 28.5%-42.8% of patients, depending on the care setting. In the last 4 hours episode, these percentages were 17.5%-26.9%. Care goals concerning pain and restlessness were most often not achieved: percentages varied from 7.3% to 20.9% for pain and from 9.3% to 21.9% for restlessness. CONCLUSIONS: Symptom control at the end of life is not optimal in a substantial minority of patients. Systematic assessment and attention as well as further research on symptom management are of the essence.

Requests for euthanasia or assisted suicide of people without (severe) illness.

BACKGROUND: Some people request euthanasia or assisted suicide (EAS) even though they are not (severely) ill. In the Netherlands the presence of sufficient medical ground for the suffering is a strict prerequisite for EAS. The desirability of this 'medical ground'-boundary is currently questioned. Legislation has been proposed to facilitate EAS for older persons with "completed life" or "tiredness of life" in the absence of (severe) illness. OBJECTIVES: To describe the characteristics and motivations of persons whose requests for EAS in the absence of (severe) illness did not result in EAS and the decision-making process of medical professionals in these types of requests. METHODS: Analysis of 237 applicant records of the Dutch Euthanasia Expertise Center. We studied both the perspectives of applicants and medical professionals. FINDINGS: The majority of the applicants were women (73%) aged 75 years and older (79%). Applicants most often indicated physical suffering as element of suffering and reason for the request. Medical professionals indicated in 40% of the cases no or insufficient medical ground for the suffering. CONCLUSIONS: Physical suffering plays an important role in requests for EAS even for persons who are not (severely) ill. From the presence of physical suffering it does not necessarily follow that for medical professionals there is sufficient medical ground to comply with the 'medical ground'-boundary.

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. AIM: To determine the accuracy of the surprise question in predicting death, differentiating by timeframe, patient subgroup and by type of healthcare professional. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Electronic databases PubMed, Embase, Cochrane Library, Scopus, Web of Science and CINAHL were searched from inception till 22nd January 2021. Studies were eligible if they used the surprise question prospectively and assessed mortality. Sensitivity, specificity, negative predictive value, positive predictive value and c-statistic were calculated. RESULTS: Fifty-nine studies met the inclusion criteria, including 88.268 assessments. The meta-analysis resulted in an estimated sensitivity of 71.4% (95% CI [66.3-76.4]) and specificity of 74.0% (95% CI [69.3-78.6]). The negative predictive value varied from 98.0% (95% CI [97.7-98.3]) to 88.6% (95% CI [87.1-90.0]) with a mortality rate of 5% and 25% respectively. The positive predictive value varied from 12.6% (95% CI [11.0-14.2]) with a mortality rate of 5% to 47.8% (95% CI [44.2-51.3]) with a mortality rate of 25%. Seven studies provided detailed information on different healthcare professionals answering the surprise question. CONCLUSION: We found overall reasonable test characteristics for the surprise question. Additionally, this study showed notable differences in performance within patient subgroups. However, we did not find an indication of notable differences between timeframe and healthcare professionals.

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. AIM: To describe and address differences in ethical and research governance procedures applied by research ethics committees for non-pharmaceutical palliative care studies including adult participants in collaborative European studies. DESIGN: An online survey analysed using descriptive statistics. SETTING/PARTICIPANTS: Eighteen principal investigators in 11 countries conducting one of three European-funded studies. RESULTS: There was variation in practice including whether ethical approval was required. The time to gain full approvals differed with the United Kingdom having governance procedures that took the longest time. Written consent was not required in all countries nor were data safety monitoring committees for trials. There were additional differences in relation to other data management issues. CONCLUSION: Researchers need to take the differences in research approval procedures into account when planning studies. Future research is needed to establish European-wide recommendations for policy and practice that dovetail ethical procedures and enhance transnational research collaborations.

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. METHODS: Data were collected over a 2-year period in 4 datasets consisting of incidents reported by health care professionals, complaints of patients, patient issues at a portal helpdesk, and a survey among health care professionals. Incidents, complaints, issues, and answers on the survey were counted and analyzed through an iterative process of coding. RESULTS: Within the chosen time frame of 2 years, on average, 7978 patients per month logged into the portal at least once. The amount of negative incidents and complaints was limited. A total of 6 incidents, 4 complaints, and 2506 issues at the helpdesk concerning the patient portal were reported, of which only 2, 1, and 3 cases of these respective databases concerned real-time disclosure of medical information through the patient portal. Moreover, 32 out of 216 health care professionals reported patients that had negative experiences with real-time disclosure. Most negative consequences concerned confused and anxious patients when confronted with unexpected or incomprehensible results. CONCLUSIONS: Real-time access through a patient portal did not substantially result in negative consequences. The negative consequences that did occur can be mitigated by adequate preparation and instruction of patients concerning the various functionalities of the patient portal, real-time disclosure of test results in particular, and can also be managed through educating health care professionals about the patient portal and making adjustments in the daily practice of health care professionals.

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. The Unified Theory of Acceptance and Use of Technology (UTAUT) is a frequently used theory for explaining the use of information technology. It consists of the following constructs: performance expectancy, effort expectancy, social influence, facilitating conditions, and behavioral intention to use. OBJECTIVE: This study aimed to explore the prevalence of patient portal use and the characteristics of patients who use or do not use a patient portal. The main constructs of UTAUT, together with demographics and disease- and care-related characteristics, have been measured to explore the predictive factors of portal use. METHODS: A cross-sectional study was conducted in the outpatient departments for adult patients of a university hospital in the Netherlands. Following outcomes were included: self-reported portal use, characteristics of users such as demographics, disease- and care-related data, eHealth literacy (modified score), and scores of UTAUT constructs. Descriptive analyses and univariate and multivariate logistic regression were also conducted. RESULTS: In the analysis, 439 adult patients were included. Furthermore, 32.1% (141/439) identified as being a user of the patient portal; 31.2% (137/439) indicated as nonusers, but being aware of the existence of the portal; and 36.6% (161/439) as being nonusers not aware of the existence of the portal. In the entire study population, the factors of being chronically ill (odds ratio, OR 1.62, 95% CI 1.04-2.52) and eHealth literacy (modified score; OR 1.12, 95% CI 1.07-1.18) best predicted portal use. In users and nonusers who were aware of the portal, UTAUT constructs were added to the multivariate logistic regression, with chronically ill and modified eHealth literacy sum score. Effort expectancy (OR 13.02, 95% CI 5.68-29.87) and performance expectancy (OR 2.84, 95% CI 1.65-4.90) are shown to significantly influence portal use in this group. CONCLUSIONS: Approximately one-third of the patients of a university hospital self-reported using the patient portal; most expressed satisfaction. At first sight, being chronically ill and higher scores on the modified eHealth literacy scale explained portal use. Adding UTAUT constructs to the model revealed that effort expectancy (ease of use and knowledge and skills related to portal use) and performance expectancy (perceived usefulness) influenced portal use. Interventions to improve awareness of the portal and eHealth literacy skills of patients and further integration of the patient portal in usual face-to-face care are needed to increase use and potential subsequent patient benefits.

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. AIM: To obtain insight into the support provided by a new paediatric palliative care team from the parents' perspective. DESIGN: An interpretative qualitative interview study using thematic analysis was performed. SETTING/PARTICIPANTS: A total of 47 single or repeated interviews were undertaken with 42 parents of 24 children supported by a multidisciplinary paediatric palliative care team located at a university children's hospital. The children suffered from malignant or non-malignant diseases. RESULTS: In advance, parents had limited expectations of the paediatric palliative care team. Some had difficulty accepting the need for palliative care for their child. Once parents experienced what the team achieved for their child and family, they valued the team's involvement. Valuable elements were as follows: (1) process-related aspects such as continuity, coordination of care, and providing one reliable point of contact; (2) practical support; and (3) the team members' sensitive and reliable attitude. As a point of improvement, parents suggested more concrete clarification upfront of the content of the team's support. CONCLUSION: Parents feel supported by the paediatric palliative care team. The three elements valued by parents probably form the structure that underlies quality of paediatric palliative care. New teams should cover these three valuable elements.