Frequency of self-directed dying in the Netherlands: research protocol of a cross-sectional mixed-methods study.

INTRODUCTION: In the Netherlands, assisting in suicide is allowed for physicians and regulated by the Termination of Life on Request and Assisted Suicide (review procedures) Act. However, some people decide to end their lives outside the medical domain, without a physician's help. Two approaches for such self-directed dying are voluntary stopping eating and drinking (VSED) and independently taking lethal medication attended by a confidant (ILMC). The frequency of deaths by either of these methods in the Netherlands was examined in 2007. Since then, there have been societal, political and healthcare developments which may have had an influence on the frequency of self-directed dying. The primary objective of this study is to estimate how many people in the Netherlands currently die by VSED or ILMC. Secondary objectives include providing insight in the characteristics and quality of dying of people who choose for self-directed dying. METHODS AND ANALYSIS: This cross-sectional study consists of an online questionnaire study (January to February 2024) among a randomly drawn sample (n=37 500) from a representative panel of the Dutch adult population in which participants are asked about potential experiences of close relatives choosing for VSED or ILMC. A two-stage screening procedure will be used to determine whether the respondents' experiences represent a death by VSED or ILMC. Additional interviews (n=40) will be held with questionnaire respondents indicating their willingness to participate (May to September 2024). Quantitative data will be analysed using SPSS software, and qualitative data will be thematically analysed using NVivo software. ETHICS AND DISSEMINATION: The study obtained approval from the Medical Research Ethics Committee of the Erasmus Medical Center, under number MEC-2023-0689. Informed consent will be sought from study participants in line with General Data Protection Regulation legislation. Results of the study will be disseminated through publications in scientific journals and conference presentations. TRIAL REGISTRATION NUMBER: NCT06186791.

What if your research is suddenly affiliated with a tobacco manufacturing company?

The tobacco industry is accountable for an annual global death toll of approximately 8 million people and cigarette smoking is the foremost risk factor for several types of cancer. In addition, the tobacco industry has a long and controversial history of trying to influence scientific research and of engaging in other morally problematic practices. In September 2021, the respiratory community was alarmed by the takeover of Vectura Group (Vectura) by Philip Morris International. As a reaction to this acquisition, strict measures were imposed by the International Respiratory Societies to prohibit the involvement of Vectura in respiratory research and its participation in societies' activities. International Respiratory Societies argued that Vectura had become part of the tobacco industry due to this takeover and is, therefore, subject to the same rules and restrictions. From a healthcare and historical perspective, the reaction and imposed measures are very understandable. However, for researchers that were already affiliated with Vectura through long-standing agreements and for research that was funded by Vectura, the imposed measures have serious consequences. With this article, we provide an example of these consequences. By reflecting on this issue, we would like to start a conversation regarding the current measures and to encourage the respiratory community to begin thinking of a way to avoid these consequences in the future. In addition, we hope that with this conversation the Respiratory Societies can set an example for other medical societies on how to cope with possible morally tainted affiliations (eg, fast food companies, alcohol manufacturing companies) in the future.

The ethics of ethics conferences: Is Qatar a desirable location for a bioethics conference?

The next World Congress of Bioethics will be held in Doha, Qatar. Although this location provides opportunities to interact with a more culturally diverse audience, to advance dialogue between cultures and religions, offer opportunities for mutual learning, there are also huge moral concerns. Qatar is known for violations of human rights - including the treatment of migrant workers and the rights of women - corruption, criminalization of LGBTQI+ persons, and climate impact. Since these concerns are also key (bio)ethical concern we call for a broad debate within the bioethics community whether organizing and attending the World Congress in Qatar is ethically problematic and how ethical concerns should be dealt with.

Exploring doctors' reasons for not granting a request for euthanasia: a mixed-methods study.

BACKGROUND: In a growing number of jurisdictions, physician-assisted death (PAD) is now an established part of medical care. Although PAD is allowed under certain criteria in The Netherlands, physicians can always refuse a request. The Euthanasia Expertise Centre (EEC) offers PAD to patients whose request was declined in circumstances where their own physician could have satisfied the legal criteria. The number of requests reaching EEC has increased, suggesting the threshold for treating physicians to refer patients to EEC has become lower. AIM: To explore the reasons of physicians for not granting a request for PAD and/or referring a patient to EEC, and any needs physicians may have in handling requests for PAD. DESIGN & SETTING: Survey and interviews among Dutch physicians in The Netherlands. METHOD: A questionnaire was sent to 500 physicians who declined a request for PAD and whose patient subsequently requested PAD at EEC. This was followed by a qualitative study, in which in-depth interviews were held with 21 of the physicians who responded to the survey. RESULTS: Doctors were identified as those who had objections on principle, or with other reasons for refusing a request for PAD and/or to refer the patient to EEC. These reasons were mostly related to concerns about complying with the due care criteria for PAD, or to difficulties with PAD in specific patient groups. In these cases they often valued support from another healthcare professional. CONCLUSION: For patients of physicians with objections on principle against PAD, EEC offered a good solution. Doctors who struggle with whether they can comply with the legal criteria might benefit from peer support.

Feeling Seen, Being Heard: Perspectives of Patients Suffering from Mental Illness on the Possibility of Physician-Assisted Death in the Netherlands.

Physician-assisted death (PAD) for patients suffering from a mental illness is allowed in the Netherlands under certain conditions but is a very controversial topic, mainly discussed by ethicists and physicians. The voice of the patient is rarely included in the debate, so we know little about what their views on the topic are. We aim to understand the views of patients with mental illness and wish to die with regard to the possibility of PAD in the Netherlands. The data for this qualitative study were collected through 21 in-depth interviews with Dutch patients who have a wish for PAD as a result of suffering from a mental illness. We identified four themes in relation to the meaning of PAD for the patients suffering from mental illness and wish to die. These themes are (1) Autonomy and self-determination, (2) ending the suffering, (3) recognition, and (4) a dignified end-of-life. The option of PAD for patients suffering from mental illnesses was considered of great importance to the patients who have a wish to die. We highlight the importance of 'recognition' for the situation of the patient, as this could lead to new perspective. We argue that psychiatrists need to reflect on providing this recognition in earlier phases of treatment, taking seriously and discussing a wish for PAD in treatment is beneficial to patients. It provides space for the patient to discuss their wishes and could cause them not wanting to die anymore.

Reflections on Including Patients in a Randomized Placebo-Controlled Multicentre Trial in the Dying Phase - the SILENCE Study.

A need exists for studies investigating symptom relief at the end of life. Randomised controlled trials (RCTs) are the gold standard for demonstrating efficacy of medication, but they are difficult to perform at the end of life due to barriers such as the vulnerability of patients, and gatekeeping by healthcare professionals. We analyzed and reflected on recruitment, participation, and strategies used in an RCT at the end of life. The SILENCE study, performed in six inpatient hospice facilities, was a placebo-controlled trial to study the effect of ScopolamIne butyLbromidE giveN prophylactiCally for dEath rattle in dying patients. We addressed patients' vulnerability by using an advance consent procedure, and potential gatekeeping by extensive training of health care professionals and the appointment of hospice doctors as daily responsible researchers. In almost three years, 1097 patients were admitted of whom 626 were eligible at first assessment. Of these, 119 (19%) dropped out because of physical deterioration before they could be informed about the study (44) or sign informed consent (75). Twenty-five (4%) patients were not asked to participate. In 24 cases (4%), relatives advised against the patient participating. Overall, 229 patients (37%) gave informed consent to participate. The vulnerability of patients was the most important barrier in this medication study at the end of life. Gatekeeping by HCPs and relatives occurred in a small number of patients. The robust design and applied strategies to facilitate patient recruitment in this study resulted in a successful study with sufficient participants.

Wish for euthanasia persists for at least one year after the request was declined by Euthanasia Expertise Center.

BACKGROUND: Euthanasia Expertise Center (EEC) in the Netherlands provides euthanasia or physician-assisted suicide for patients who meet all requirements of the Dutch Euthanasia Law, but whose treating physician declined their request. Little is known about how life continues for a patient after a request for physician-assisted death (PAD) is also declined by EEC. OBJECTIVE: To follow-up patients whose request for PAD was declined at EEC. METHODS: Between December 2016 and January 2020, 66 patients were prospectively followed for one year after their request was declined. Their general well-being and health, persistence of the wish for PAD, and mortality was measured by means of a questionnaire administered after three, six and 12 months. Furthermore, information was extracted from the patient's medical record. FINDINGS: More than half (58%) of the included patients suffered from an accumulation of old-age complaints. In the year after the request was declined, 15 patients (23%) died, three of whom committed suicide. Almost all patients who were alive after one year, persisted in their wish for PAD. Moreover, they were often not doing well. CONCLUSIONS: Considering that EEC is a last resort for those who were not granted PAD elsewhere, and that the wish for PAD persists, aftercare services should be provided to people whose request has been declined.

Do Doctors Differentiate Between Suicide and Physician-Assisted Death? A Qualitative Study into the Views of Psychiatrists and General Practitioners.

Physician-assisted death for patients suffering from psychiatric disorders is allowed in the Netherlands under certain circumstances. One of the central problems that arise with regard to this practice is the question of whether it is possible to distinguish between suicidality and a request for physician-assisted death. We set up this study to gain insight into how psychiatrists and general practitioners distinguish between suicidality and physician-assisted death. The data for this study were collected through qualitative interviews with 20 general practitioners and 17 psychiatrists in the Netherlands. From the interviews, we conclude that physicians distinguish three types of death wishes among patients suffering from psychiatric disorders: 'impulsive suicidality,' 'chronic suicidality,' and 'rational death wishes.' To discern between them they evaluate whether the death wish is seen as part of the psychopathology, whether it is consistent over time, and whether they consider it treatable. Some considered physician-assisted death an alternative to a 'rational suicide,' as this was perceived to be a more humane manner of death for the patient and their relatives. We argue that physician-assisted death can be justified also in some cases in which the death wish is part of the psychopathology, as the patient's suffering can be unbearable and irremediable. Physician-assisted death in these cases may remain the only option left to relieve the suffering.

Ethical Advice for an Intensive Care Triage Protocol in the COVID-19 Pandemic: Lessons Learned from The Netherlands.

At the height of the COVID-19 crisis in the Netherlands a shortness of intensive care beds was looming. Dutch professional medical organizations asked a group of ethicists for assistance in drafting guidelines and criteria for selection of patients for intensive care (IC) treatment in case of absolute scarcity, when medical selection criteria would no longer suffice. This article describes the Dutch context, the process of drafting the advice and reflects on the role of ethicists and lessons learned. We argue that timely interaction between clinical and ethical expertise is necessary since the distinction between medical and non-medical considerations is not as clearcut as sometimes assumed. Furthermore, pragmatic considerations related to the specifics of an epidemic are of importance, for example, in relation to prioritizing health care workers. As a consequence, any protocol already present before the pandemic would need alterations to fit the current situation. The 'fair innings' criterion we proposed, rephrased as an argument of intergenerational solidarity, was considered reasonable by professionals as well as patient organizations. While it is desirable to draft ethical guidelines in 'peacetime' as a matter of pandemic preparedness, the pressure of an actual crisis facilitates decision-making, although it will also complicate a more democratic approach.

[Ethical principles compromised during the COVID-19 pandemic?] / Ethische principes in het gedrang door COVID-19?

In the late 1970s, the American bioethicists Tom Beauchamp and James Childress described the four ethical principles that should guide a physician's actions in individual patient care. These principles are: (a) respect for autonomy; (b) doing well (beneficence); (c) not harming (non-maleficence); and (d) justice. In many countries, the global outbreak of SARS-CoV-2 has led to overloaded healthcare systems due to large numbers of COVID-19 patients. In order to provide care to this high volume of patients, far-reaching measures are taken that affect everyone. These measures are not taken from an individual patient's perspective but in the interest of public health; nonetheless, they can directly affect the individual patient's interests. This article examines the extent to which Beauchamp and Childress' ethical principles may be compromised during the COVID-19 pandemic.

First prosecution of a Dutch doctor since the Euthanasia Act of 2002: what does the verdict mean?

On 11 September 2019, the verdict was read in the first prosecution of a doctor for euthanasia since the Termination of Life on Request and Assisted Suicide (Review Procedures) Act of 2002 was installed in the Netherlands. The case concerned euthanasia on the basis of an advance euthanasia directive (AED) for a patient with severe dementia. In this paper we describe the review process for euthanasia cases in the Netherlands. Then we describe the case in detail, the judgement of the Regional Review Committees for Termination of Life on Request and Euthanasia (RTE) and the judgement of the medical disciplinary court. Both the review committees and the disciplinary court came to the conclusion there were concerns with this case, which mainly hinged on the wording of the AED. They also addressed the lack of communication with the patient, the absence of oral confirmation of the wish to die and the fact that the euthanasia was performed without the patient being aware of this. However, the doctor was acquitted by the criminal court as the court found she had in fact met all due care criteria laid down in the act. We then describe what this judgement means for euthanasia in the Netherlands. It clarifies the power and reach of AEDs, it allows taking conversations with physicians and the testimony of the family into account when interpreting the AED. However, as a practical consequence the prosecution of this physician has led to fear among doctors about prosecution after euthanasia.

Physicians' experiences with euthanasia: a cross-sectional survey amongst a random sample of Dutch physicians to explore their concerns, feelings and pressure.

BACKGROUND: Physicians who receive a request for euthanasia or assisted suicide may experience a conflict of duties: the duty to preserve life on the one hand and the duty to relieve suffering on the other hand. Little is known about experiences of physicians with receiving and granting a request for euthanasia or assisted suicide. This study, therefore, aimed to explore the concerns, feelings and pressure experienced by physicians who receive requests for euthanasia or assisted suicide. METHODS: In 2016, a cross-sectional study was conducted. Questionnaires were sent to a random sample of 3000 Dutch physicians. Physicians who had been working in adult patient care in the Netherlands for the last year were included in the sample (n = 2657). Half of the physicians were asked about the most recent case in which they refused a request for euthanasia or assisted suicide, and half about the most recent case in which they granted a request for euthanasia or assisted suicide. RESULTS: Of the 2657 eligible physicians, 1374 (52%) responded. The most reported reason not to participate was lack of time. Of the respondents, 248 answered questions about a refused euthanasia or assisted suicide request and 245 about a granted EAS request. Concerns about specific aspects of the euthanasia and assisted suicide process, such as the emotional burden of preparing and performing euthanasia or assisted suicide were commonly reported by physicians who refused and who granted a request. Pressure to grant a request was mostly experienced by physicians who refused a request, especially if the patient was ≥80 years, had a life-expectancy of ≥6 months and did not have cancer. The large majority of physicians reported contradictory emotions after having performed euthanasia or assisted suicide. CONCLUSIONS: Society should be aware of the impact of euthanasia and assisted suicide requests on physicians. The tension physicians experience may decrease their willingness to perform euthanasia and assisted suicide. On the other hand, physicians should not be forced to cross their own moral boundaries or be tempted to perform euthanasia and assisted suicide in cases that may not meet the due care criteria.

Considerations by Dutch Psychiatrists Regarding Euthanasia and Physician-Assisted Suicide in Psychiatry: A Qualitative Study.

BACKGROUND: Euthanasia and physician-assisted suicide (EAS) in psychiatry are permitted in the Netherlands under certain legal conditions. Doctors may help patients who suffer unbearably and who have no prospect of improvement from psychiatric illnesses. Although this practice is permitted, it remains controversial, and the acceptability of EAS and the conditions under which it should be allowed are still debated. As the number of psychiatric patients requesting EAS is increasing, Dutch psychiatrists are becoming more reluctant to consider EAS. OBJECTIVE: This study aims for a better understanding of Dutch psychiatrists' considerations for supporting or rejecting EAS for psychiatric patients. METHODS: The data for this qualitative study were collected through 17 in-depth interviews with Dutch psychiatrists. These interviews were held from January until June 2016 as a part of the Third Evaluation of the Dutch Termination of Life on Request and Assisted Suicide Act. RESULTS: Irrespective of their own position in the debate, most Dutch psychiatrists consider reasons for and against EAS, including moral (justice and equality, professional responsibility, compassion), epistemologic (how can one ever know the suffering is without prospect), practical, and contextual (mental health care provisions) reasons. CONCLUSIONS: The variation in views on EAS in psychiatry seems to be related to a difference in views on the nature of psychiatric diseases. Some psychiatrists stress the similarity between psychiatric and somatic diseases, whereas others stress the fundamental difference. These opposing views could be bridged by a pragmatic view, such as a 2-track approach to EAS.

Parents' Perspectives on Decisions to Participate in Pediatric Clinical Research: Results From a Focus Group Study With Laypeople.

Knowing why parents decide to consent or dissent to participation of their child in pediatric clinical research is essential to further the ethical debate concerning pediatric research. We performed this qualitative focus group study with 16 parents from the Dutch general public to explore their perspectives on decisions to participate in pediatric clinical research. Group discussion revealed the following: Parents conflate clinical research and clinical care, they do not grasp the trajectory of pediatric drug development, their protectiveness matches current research guidelines, and benefit for their child is the most important factor in their decision. Research professionals should be aware of the knowledge gap of parents, the pitfalls of jargon, and unintended false expectations.

Little to lose and no other options: Ethical issues in efforts to facilitate expanded access to investigational drugs.

BACKGROUND: Today, public and private bodies around the world are trying to facilitate and increase expanded access to unapproved, investigational drugs for patients with unmet medical needs. METHODS: This paper discusses three major shifts in the field of expanded access and presents an argumentative account of ethical issues connected with those shifts, based on a literature study and unstructured interviews with 35 stakeholders in the Netherlands. RESULTS AND DISCUSSION: Traditionally, expanded access has been based on three key principles: 1) it is exceptional, 2) it is done 'out of compassion', and 3) it has a therapeutic aim. Current efforts to facilitate expanded access affect these key principles, rendering expanded access a default option, allowing companies to charge for investigational drugs and gather data on its outcomes. These shifts may generate new ethical issues, including false hope, safety concerns and funding issues, which must be anticipated by physicians, pharmaceutical companies, payers and policymakers. CONCLUSION: Healthcare systems allow for the use of promising unapproved drugs in exceptional circumstances, but do not always assist patients with unmet medical needs in getting access. It is time to replace the current patchwork of practices with systems for expanded access in which criteria are clearly described, responsibilities are assigned and arrangements are made, so that patients will know what (not) to expect from expanded access.

Are Concerns About Irremediableness, Vulnerability, or Competence Sufficient to Justify Excluding All Psychiatric Patients from Medical Aid in Dying?

Some jurisdictions that have decriminalized assisted dying (like Canada) exclude psychiatric patients on the grounds that their condition cannot be determined to be irremediable, that they are vulnerable and in need of protection, or that they cannot be determined to be competent. We review each of these claims and find that none have been sufficiently well-supported to justify the differential treatment psychiatric patients experience with respect to assisted dying. We find bans on psychiatric patients' access to this service amount to arbitrary discrimination. Proponents of banning the practice ignore or overlook alternatives to their proposal, like an assisted dying regime with additional safeguards. Some authors have further criticized assisted dying for psychiatric patients by highlighting allegedly problematic practices in those countries which allow it. We address recent evidence from the Netherlands, showing that these problems are either misrepresented or have straightforward solutions. Even if one finds such evidence troubling despite our analysis, other jurisdictions need not adopt every feature of the Dutch system.

The child's perspective on discomfort during medical research procedures: a descriptive study.

OBJECTIVE: The evaluation of discomfort in paediatric research is scarcely evidence-based. In this study, we make a start in describing children's self-reported discomfort during common medical research procedures and compare this with discomfort during dental check-ups which can be considered as a reference level of a 'minimal discomfort' medical procedure. We exploratory study whether there are associations between age, anxiety-proneness, gender, medical condition, previous experiences and discomfort. We also describe children's suggestions for reducing discomfort. DESIGN: Cross-sectional descriptive study. SETTING: Paediatric research at three academic hospitals. PATIENTS: 357 children with and without illnesses (8-18 years, mean=10.6 years) were enrolled: 307 from paediatric research studies and 50 from dental care. MAIN OUTCOME MEASURES: We measured various generic forms of discomfort (nervousness, annoyance, pain, fright, boredom, tiredness) due to six common research procedures: buccal swabs, MRI scans, pulmonary function tests, skin prick tests, ultrasound imaging and venepunctures. RESULTS: Most children reported limited discomfort during the research procedures (means: 1-2.6 on a scale from 1 to 5). Compared with dental check-ups, buccal swab tests, skin prick tests and ultrasound imaging were less discomforting, while MRI scans, venepunctures and pulmonary function tests caused a similar degree of discomfort. 60.3% of the children suggested providing distraction by showing movies to reduce discomfort. The exploratory analyses suggested a positive association between anxiety-proneness and discomfort. CONCLUSIONS: The findings of this study support the acceptability of participation of children in the studied research procedures, which stimulates evidence-based research practice. Furthermore, the present study can be considered as a first step in providing benchmarks for discomfort of procedures in paediatric research.

Considerations on requests for euthanasia or assisted suicide; a qualitative study with Dutch general practitioners.

Background: In the Netherlands, euthanasia or assisted suicide (EAS) is neither a right of the patient nor a duty of the physician. Beside the legal requirements, physicians can weigh their own considerations when they decide on a request for EAS. Objective: We aim at a better understanding of the considerations that play a role when physicians decide on a request for EAS. Methods: This was a qualitative study. We analysed 33 interviews held with general practitioners (GPs) from various regions in the Netherlands. Results: The considerations found can be divided in three main types. (i) Perceived legal criteria, (ii) individual interpretations of the legal criteria and (iii) considerations unrelated to the legal criteria. Considerations of this 3rd type have not been mentioned so far in the literature and the debate on EAS. Examples are: the family should agree to EAS, the patient's attitude must reflect resignation, or conflicts must be resolved. Conclusions: Our study feeds the ethical discussion on the tension that can arise between a physician's own views on death and dying, and the views and preferences of his patients. When considerations like 'no unresolved conflicts' or 'enough resignation' influence the decision to grant a request for EAS this poses questions from an ethical and professional point of view. We hypothesise that these considerations reflect GPs' views on what 'good dying' entails and we advocate further research on this topic.

The changing landscape of expanded access to investigational drugs for patients with unmet medical needs: ethical implications.

When patients are told that standard medical treatment options have been exhausted, their treating physicians may start looking for promising new drugs that are not yet approved, and still under investigation. Some patients can be included in clinical trials, but others cannot. It is not widely known that these patients might still be eligible for trying investigational drugs, in a therapeutic context. Worldwide, public and private parties are seeking to change this by informing patients and physicians about opportunities for expanded access and/or by facilitating its processes. When expanded access becomes available to larger groups of patients, ethical issues gain prominence, including informed consent, funding issues, disparities in access, and potential adverse effects on clinical drug development. Physicians, patients and policy-makers should not shift the responsibility to address these issues to pharmaceutical companies, but work together to resolve them.