Ghislaine J.M.W. van Thiel

Opinions of health care professionals and the public after eight years of euthanasia legislation in the Netherlands: A mixed methods approach

Background: The practice of euthanasia and physician-assisted suicide (PAS) in the Netherlands has been regulated since 2002 by the Euthanasia Act. In the ongoing debate about the interpretation of this Act, comparative information about the opinions of the different stakeholders is needed. Aim: To evaluate the opinions of Dutch physicians, nurses and the general public on the legal requirements for euthanasia and PAS. Design: A cross-sectional survey among Dutch physicians and nurses in primary and secondary care and members of the Dutch general public, followed by qualitative interviews among selected respondents. The participants were: 793 physicians, 1243 nurses and 1960 members of the general public who completed the questionnaire; 83 were interviewed. Results: Most respondents agreed with the requirement of a patient request (64–88%) and the absence of a requirement concerning life expectancy (48–71%). PAS was thought acceptable by 24–39% of respondents for patients requesting it because of mental suffering due to loss of control, chronic depression or early dementia. In the case of severe dementia, one third of physicians, 58% of nurses and 77% of the general public agreed with performing euthanasia based on an advance directive. Interviewees illustrated these findings and supported the Act. Conclusions: Health care professionals and the general public mostly support the legal requirements for euthanasia and PAS. The law permits euthanasia or PAS for mental suffering but this possibility is not widely endorsed. The general public is more liberal towards euthanasia for advanced dementia than health care professionals. We conclude that there is ample support for the law after eight years of legal euthanasia.

End-of-life decisions in patients with severe acute brain injury

Most in-hospital deaths of patients with stroke, traumatic brain injury, or postanoxic encephalopathy after cardiac arrest occur after a decision to withhold or withdraw life-sustaining treatments. Decisions on treatment restrictions in these patients are generally complex and are based only in part on evidence from published work. Prognostic models to be used in this decision-making process should have a strong discriminative power. However, for most causes of acute brain injury, prognostic models are not sufficiently accurate to serve as the sole basis of decisions to limit treatment. These decisions are also complicated because patients often do not have the capacity to communicate their preferences. Additionally, surrogate decision makers might not accurately represent the patients preferences. Finally, in the acute stage, prediction of how a patient would adapt to a life with major disability is difficult.

The Principle of Respect for Autonomy in the Care of Nursing Home Residents

Respect for autonomy is well known as a core element of normative views on good care. Most often it is interpreted in a liberal way, with a focus on independence and self-determination. In this article we argue that this interpretation is too narrow in the context of care in nursing homes. With the aim of developing an alternative view on respect for autonomy in this setting we described four interpretations and investigated the moral intuitions (i.e. moral judgements) of caregivers regarding these approaches. We found that these caregivers seemed to value different notions relating to respect for autonomy under different circumstances. There was no significant difference in moral judgements between men and women or between doctors and nurses. We conclude that a multidimensional understanding of this principle would best fit this context. We end this article with a description of a modest theory of respect for autonomy in nursing homes.In this study of attitudes to autonomy held by Dutch nursing home managers and physicians, vignettes were used to ascertain their views. As the concept of autonomy itself is much debated by ethicists, the authors constructed the vignettes so that they epitomised four approaches to this principle.

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. Design: A ‘Review of Reasons’ based on the systematic Preferred Reporting Items for Systematic Reviews and Meta-Analyses approach and a thematic synthesis. Data source: PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature and PsycINFO from 2000 to May 20 2015 were searched. Studies in children (aged <18 years) and patients with dementia were excluded. Results: Thirty papers on gatekeeping in palliative care research were included. Five groups of potential gatekeepers were identified: healthcare professionals, research ethics committees, management, relatives and researchers. The fear of burdening vulnerable patients was the most reported reason for gatekeeping. Other reasons included ‘difficulty with disclosure of health status’, ‘fear of burdening the patient’s relatives’, ‘doubts about the importance or quality of the study’, ‘reticent attitude towards research and (research) expertise’ and ‘logistics’. In hospice and homecare settings, the pursuit of comfort care may trigger a protective attitude. Gatekeeping is also rooted in a (perceived) lack of skills to recruit patients with advanced illness. Conclusion: Gatekeeping is motivated by the general assumption of vulnerability of patients, coupled with an emphasis on the duty to protect patients. Research is easily perceived as a threat to patient well-being, and the benefits appear to be overlooked. The patients’ perspective concerning study participation is needed to gain a full understanding and to address gatekeeping in palliative care research.

Reflective Equilibrium as a Normative-Empirical Model in Bioethics

You cannot do ethics until you know the facts. Therefore, the need for empirical research in ethics is very clear. Its task is to describe the morally relevant facts. Thus, facts provide the ethicist with the information she needs. In order to develop an ethically sound protocol about Do-Not-Resuscitate decisions, for instance, one has to know what the chances of success are of cardiopulmonary resuscitation and in what condition the survivor will spend the rest of her life. Likewise, one will want to know what the chances are of getting a certain disease, and what therapeutic possibilities medicine can offer before answering the question whether it is morally acceptable to perform a certain predictive genetic test. We take it that this contribution of empirical research to (bio)ethics is undisputed, so we will not go into this any further. Moreover, this kind of research will mostly be performed by doctors, geneticists, etc., not by ethicists.

A 10-Year Analysis of the Effects of Media Coverage of Regulatory Warnings on Antidepressant Use in The Netherlands and UK

Background In 2003–2004 and 2007–2008, the regulatory banning of SSRI use in pediatrics and young adults due to concerns regarding suicidality risk coincided with negative media coverage. SSRI use trends were analyzed from 2000–2010 in the Netherlands (NL) and the UK, and whether trend changes might be associated with media coverage of regulatory warnings. Methods Monthly SSRIs sales were presented as DDDs/1000 inhabitants/day. SSRI-use trends were studied using time-series segmented regression analyses. Timing of trend changes was compared with two periods of media coverage of warnings. Annual Dutch SSRI prescription data were analyzed by age group. Results Trend changes in SSRI use largely corroborated with the periods of media coverage of warnings. British SSRI use declined from 3.9 to 0.7 DDDs/month (95%CI 3.3;4.5 & 0.5;0.9, respectively) before the first warning period (2003–2004). A small decrease of −0.6 DDDs/month (−1.2; −0.05) was observed in Dutch SSRI use shortly after 2003–2004. From 2007–2008, British SSRI use stabilized, whilst Dutch SSRI use diminished to −0.04 DDDs/month (−0.4;0.3). Stratified analyses showed a rapid decrease of −1.2 DDDs/month (−2.1; −1.7) in UK paroxetine use before 2003–2004, but only a minimal change in Dutch paroxetine use (−0.3 DDDs/month −0.8;0.2). Other SSRI use, especially (es)citalopram, increased during 2003–2004 in both countries. Significant reductions in Dutch paroxetine use were observed in pediatrics, adolescents, and young adults after 2003–2004. Conclusion Changes in SSRI use (NL & UK) were associated with the timing of the combined effect of media coverage and regulatory warnings. Our long-term assessment illustrates that changes in SSRI use were temporal, drug-specific and more pronounced in pediatrics and young adults. The twofold increase in SSRI use over one decade indicates that regulatory warnings and media coverage may come and go, but they do not have a significant impact on the overall upward trend of SSRI use as a class in both countries.

Series: Pragmatic trials and real world evidence: Paper 1. Introduction

This is the introductory paper in a series of eight papers. In this series, we integrate the theoretical design options with the practice of conducting pragmatic trials. For most new market-approved treatments, the clinical evidence is insufficient to fully guide physicians and policy makers in choosing the optimal treatment for their patients. Pragmatic trials can fill this gap, by providing evidence on the relative effectiveness of a treatment strategy in routine clinical practice, already in an early phase of development, while maintaining the strength of randomized controlled trials. Selecting the setting, study population, mode of intervention, comparator, and outcome are crucial in designing pragmatic trials. In combination with monitoring and data collection that does not change routine care, this will enable appropriate generalization to the target patient group in clinical practice. To benefit from the full potential of pragmatic trials, there is a need for guidance and tools in designing these studies while ensuring operational feasibility. This paper introduces the concept of pragmatic trial design. The complex interplay between pragmatic design options, feasibility, stakeholder acceptability, validity, precision, and generalizability will be clarified. In this way, balanced design choices can be made in pragmatic trials with an optimal chance of success in practice.

Pragmatic randomized trials in drug development pose new ethical questions : A systematic review

Implementation of pragmatic design elements in drug development could bridge the evidence gap that currently exists between the knowledge we have regarding the efficacy of a drug versus its true, comparative effectiveness in real life. We performed a review of the literature to identify the ethical challenges thus far related to pragmatic trials. The three central ethical questions identified for pragmatic trials are: (i) what level of oversight should pragmatic trials require; (ii) do randomized patients face additional risks; and (iii) is a waiver of informed consent ethically defensible? Despite the fact all reviewed publications dealt with post-launch pragmatic trials, these results could serve as an important starting point for conceptualizing which challenges could potentially arise in the pre-launch setting.

Assistance in dying for older people without a serious medical condition who have a wish to die: a national cross-sectional survey

Background The Dutch euthanasia law regulates physician assistance in dying for patients who are suffering unbearably from a medical condition. We studied the attitudes of the Dutch population to assistance in dying for older persons who have a wish to die without the presence of a serious medical condition. Methods A cross-sectional survey was conducted among a random sample of the Dutch public (response rate 78%, n=1960), using statements and vignettes about attitudes to assistance in dying for older persons who are tired of living. Results A minority of 26% agreed with a vignette in which a physician warrants the request for physician-assisted suicide of an older person who is tired of living without having a serious medical condition. Furthermore, 21% agreed with the statement ‘In my opinion euthanasia should be allowed for persons who are tired of living without having a serious disease’. People supporting euthanasia for older persons who are tired of living were more likely than opponents to be highly educated (OR 1.6; 95% CI 1.1 to 2.3), to be non-religious (OR 1.7; 95% CI 1.3 to 2.3), to have little trust in physicians (OR 1.6; 95% CI 1.2 to 2.2), and to prefer to make their own healthcare decisions (OR 1.7; 95% CI 1.3 to 2.3). Conclusions Although it is lower than the level of support for assistance in dying for patients whose suffering is rooted in a serious medical condition, our finding that a substantial minority of the general public supports physician assistance in dying for older people who are tired of living implies that this topic may need to be taken seriously in the debate about end-of-life decision-making.

The risk-benefit task of research ethics committees: an evaluation of current approaches and the need to incorporate decision studies methods.

BackgroundResearch ethics committees (RECs) are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis.DiscussionBy looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs’ risk-benefit task confusing, if not impossible. We further realize that RECs are not meant to do all the risk-benefit tasks; instead, RECs are meant to evaluate risks and benefits, appraise risk treatment suggestions, and make the final decision.ConclusionAs such, research ethics would benefit from looking beyond the procedure-level approaches and allowing disciplines like decision studies to be involved in the discourse on RECs’ risk-benefit task.