Health Agency and Perfectionism: The Case of Perinatal Health Inequalities.

Poor pregnancy outcomes and inequalities in these outcomes remain a major challenge, even in prosperous societies that have high-quality health care and public health policy in place. In this article, we propose that justice demands the improvement of what we call the 'health agency' of parents-to-be as part of a response to these poor outcomes. We take health agency to have three aspects: (i) the capacity to form health-goals one has reason to value, (ii) the control one perceives to have over achieving those health-goals and (iii) the freedom(s) one has to achieve those health-goals. We will moreover argue that this demand of justice can be best based on a perfectionist rather than neutralist method of justification. Subsequently, we will argue that perfectionist policy may be paternalistic but not wrongfully paternalistic. This leads us to conclude that perfectionism should be adopted to inform and justify public health policy that is aimed at improving health agency in general and counteracting poor pregnancy outcomes and inequalities in perinatal health outcomes in particular.

Non-invasive prenatal testing (NIPT): societal pressure or freedom of choice? A vignette study of Dutch citizens' attitudes.

The introduction of the accurate and procedurally easy non-invasive prenatal test (NIPT) raises ethical concerns that public attitudes towards prenatal screening may change, leading to societal pressure to participate in aneuploidy screening. This study examined Dutch citizens' attitudes towards a pregnant woman's decision to (1) decline NIPT in the context of two different funding policies and (2) to terminate or continue a pregnancy affected by different disorders. The attitudes of 1096 respondents were assessed with the contrastive vignette method, using two pairs of vignettes about declining NIPT and termination of pregnancy. Most respondents either agreed with a woman's decision to decline NIPT or were neutral about it, stating that this decision should be made independently by women, and does not warrant judgement by others. Interestingly, funding policies did influence respondents' attitudes: significantly more respondents disagreed with declining NIPT when it was fully reimbursed. Respondents had similar attitudes to the vignettes on termination and continuation of pregnancy in case of Down's syndrome. In case of Edwards' or Patau's syndrome, however, significantly more respondents disagreed with continuation, citing the severity of the disorder and the child's best interests. This study demonstrates broad acknowledgement of women's freedom of choice in Dutch society; a finding that may help to rebut existing concerns about societal pressure for pregnant women to participate in prenatal screening. As the reimbursement policy and the scope of NIPT may influence people's attitudes and elicit moral judgements, however, maintaining freedom of choice warrants sustained efforts by health professionals and policy makers.

Prevention in the age of personal responsibility: epigenetic risk-predictive screening for female cancers as a case study.

Epigenetic markers could potentially be used for risk assessment in risk-stratified population-based cancer screening programmes. Whereas current screening programmes generally aim to detect existing cancer, epigenetic markers could be used to provide risk estimates for not-yet-existing cancers. Epigenetic risk-predictive tests may thus allow for new opportunities for risk assessment for developing cancer in the future. Since epigenetic changes are presumed to be modifiable, preventive measures, such as lifestyle modification, could be used to reduce the risk of cancer. Moreover, epigenetic markers might be used to monitor the response to risk-reducing interventions. In this article, we address ethical concerns related to personal responsibility raised by epigenetic risk-predictive tests in cancer population screening. Will individuals increasingly be held responsible for their health, that is, will they be held accountable for bad health outcomes? Will they be blamed or subject to moral sanctions? We will illustrate these ethical concerns by means of a Europe-wide research programme that develops an epigenetic risk-predictive test for female cancers. Subsequently, we investigate when we can hold someone responsible for her actions. We argue that the standard conception of personal responsibility does not provide an appropriate framework to address these concerns. A different, prospective account of responsibility meets part of our concerns, that is, concerns about inequality of opportunities, but does not meet all our concerns about personal responsibility. We argue that even if someone is responsible on grounds of a negative and/or prospective account of responsibility, there may be moral and practical reasons to abstain from moral sanctions.

The Impact of Incidental Findings Detected During Brain Imaging on Research Participants of the Rotterdam Study: An Interview Study.

This interview study investigates the short- and long-term implications of incidental findings detected through brain imaging on research participants' lives and their surroundings. For this study, nine participants of the Rotterdam Scan Study with an incidental finding were approached and interviewed. When examining research participants' narratives on the impact of the disclosure of incidental findings, the authors identified five sets of tensions with regard to motivations for and expectations of research participation, preferences regarding disclosure, short- and long-term impacts and impacts on self and others. The paper shows: (1) that the impact of incidental findings may be greater than participants at first let on; (2) incidental findings can have significant effects on participants' social environment; and (3) participants may not feel prepared for disclosure even if incidental findings have been discussed during the informed consent process. The authors call for investigators to be aware of research participants' experiences and these short- and long-term impacts when designing suitable courses of action for the detection and management of incidental findings in research settings.

Ethical frameworks for complex medical decision making in older patients: A narrative review.

BACKGROUND: With an ageing population physicians are more and more faced with complex medical and moral situations. Medical professional guidelines are often of limited use in these cases. To assist the decision making process, several ethical frameworks have been proposed. Ethical frameworks are analytical tools that are designed to assist physicians and other involved healthcare workers in complex moral decision-making situations. Most frameworks are step-by-step plans that can be followed chronologically during moral case deliberations. Some of these step-by-step plans provide specific moral guidance as to what would constitute a morally acceptable conclusion, while others do not. OBJECTIVE: In this narrative review we will present and discuss the ethical frameworks used for medically complex situations in older people that have been proposed in literature. METHODS: Three electronic databases (embase.com. Medline Ovid and PsychINFO Ovid) were searched from inception to January 24, 2020, with the help of expert librarians. RESULTS: Twenty-three studies were included in the review, containing seventeen different frameworks. Twenty studies described step-by-step-frameworks, with the number of steps varying from three to twelve. In four studies suggestions were made as how to balance conflicting moral values. CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS: Ethical frameworks are meant to assist healthcare professionals who are faced with morally complex decisions in older patients. In our view, these frameworks should contain a step-by-step plan, moral values and an approach to balancing moral values.

Rethinking counselling in prenatal screening: An ethical analysis of informed consent in the context of non-invasive prenatal testing (NIPT).

Informed consent is a key condition for prenatal screening programmes to reach their aim of promoting reproductive autonomy. Reaching this aim is currently being challenged with the introduction of non-invasive prenatal testing (NIPT) in first-trimester prenatal screening programmes: amongst others its procedural ease-it only requires a blood draw and reaches high levels of reliability-might hinder women's understanding that they should make a personal, informed decision about screening. We offer arguments for a renewed recognition and use of informed consent compared to informed choice, and for a focus on value-consistent choices and personalized informational preferences. We argue for a three-step counselling model in which three decision moments are distinguished and differently addressed: (1) professionals explore women's values concerning whether and why they wish to know whether their baby has a genetic disorder; (2) women receive layered medical-technical information and are asked to make a decision about screening; (3) during post-test counselling, women are supported in decision-making about the continuation or termination of their pregnancy. This model might also be applicable in other fields of genetic (pre-test) counselling, where techniques for expanding genome analysis and burdensome test-outcomes challenge counselling of patients.

Requests for futile treatments: what mechanisms play a role? Results of a qualitative study among Dutch physicians.

OBJECTIVES: Overtreatment is increasingly seen as a challenge in clinical practice and can lead to unnecessary interventions, poor healthcare outcomes and increasing costs. However, little is known as to what exactly causes overtreatment. In 2015, the Royal Dutch Medical Association (RDMA) attempted to address this problem and distinguished several mechanisms that were thought to drive overtreatment. In 14 qualitative interviews among Dutch physicians, we investigated which mechanisms played a role in decision-making and whether all mechanisms were considered equally important. DESIGN: We asked physicians to present a case from personal experience, in which the patient or family requested continuing treatment against the advice of the physician. PARTICIPANTS: Fourteen physicians from five different medical areas agreed to participate. SETTING: Interviews were held face-to-face at the workplace of the physician. RESULTS: Three closely related mechanisms were mentioned most frequently as drivers of overtreatment, as perceived by the physician: 'death is not a common topic of conversation', ''never give up' is the default attitude in our society' and 'patients' culture and outlook on life influences their perception of death'. The mechanism 'medical view taking priority' was mentioned to be an inhibitor of overtreatment. CONCLUSIONS: Of the 15 mechanisms described by the report of the Steering Committee of the RDMA, not all mechanisms were mentioned as driving overtreatment. Three mechanisms were mentioned most as being a driver of overtreatment ('death is not a common topic of conversation'; ''never give up' is the default attitude in our society'' and 'patients' culture and outlook on life influences their perception of death'), some played no role at all, and others were considered to be inhibitors of overtreatment, especially the mechanism 'medical view taking priority'.

What to do when patients and physicians disagree? Qualitative research among physicians with different working experiences.

PURPOSE: Impasses between patients, relatives and physicians occur frequently. With the growing attention for shared decision making, it is valuable to know how impasses arise. To understand the challenges experienced by physicians when their opinion on medical decisions differ from those of patients or relatives. METHODS: Fifteen physicians with different working experiences, from five medical specialties were interviewed using a narrative approach. Interviews were based on two patient stories provided by the physician. First of a patient (or relative) who did not want to adhere to a treatment the physician deemed necessary, and the second of a patient (or relative) who requested a treatment the physician felt was unnecessary. Data were analyzed using a bottom-up approach, with identification of five themes (autonomy of the patient, communication, emotions, circumstances and metaphors). Twenty subthemes were formed. RESULTS: 693 references were made. Six major nodes were identified: frustration experienced by the physician, role of the relatives, agreement, cultural/religious aspects, comprehension by the patient of the situation and the existence of an established relationship between patient and physician. CONCLUSIONS: Physicians felt uncomfortable when there was disagreement between themselves and patients or relatives. Frustration was felt when relatives spoke on behalf of the patient, while there was no evidence the desired decision was ever expressed by the patient. A disagreement with a patient was described as being less frustrating, when the patient was able to explain the reasons for making a decision. Differences in background, especially religious, were often mentioned as complicating communication.

Why NIPT should be publicly funded.

Asking pregnant women to (co)pay for non-invasive prenatal testing (NIPT) out of pocket leads to unequal access across socioeconomic strata. To avoid these social justice issues, first-trimester prenatal screening should be publicly funded in countries such as the Netherlands, with universal coverage healthcare systems that offer all other antenatal care services and screening programmes free of charge. In this reply, we offer three additional reasons for public funding of NIPT. First, NIPT may not primarily have medical utility for women and children, but rather offers relevant information and reproductive options, and thus serves important autonomy interests of women. Second, public funding of NIPT can be justified because it results in a reduction of collectively borne costs associated with care and support for children with chromosomal abnormalities. It is important to note that this is not an argument for individual women to take part in screening or to terminate an affected pregnancy. However, it is a legitimate argument in policy making regarding funding arrangements for screening programmes. Finally, public funding would help to amend current misunderstandings among pregnant women (eg, that they are not at risk), and thus to support informed consent for first-trimester prenatal screening.

Should pregnant women be charged for non-invasive prenatal screening? Implications for reproductive autonomy and equal access.

The introduction of non-invasive prenatal testing (NIPT) in healthcare systems around the world offers an opportunity to reconsider funding policies for prenatal screening. In some countries with universal access healthcare systems, pregnant women and their partners are asked to (co)pay for NIPT. In this paper, we discuss two important rationales for charging women for NIPT: (1) to prevent increased uptake of NIPT and (2) to promote informed choice. First, given the aim of prenatal screening (reproductive autonomy), high or low uptake rates are not intrinsically desirable or undesirable. Using funding policies to negatively affect uptake, however, is at odds with the aim of screening. Furthermore, copayment disproportionally affects those of lower socioeconomic status, which conflicts with justice requirements and impedes equal access to prenatal screening. Second, we argue that although payment models may influence pregnant women's choice behaviours and perceptions of the relevance of NIPT, the copayment requirement does not necessarily lead to better-informed choices. On the contrary, external (ie, financial) influences on women's personal choices for or against prenatal screening should ideally be avoided. To improve informed decision-making, healthcare systems should instead invest in adequate non-directive, value-focused pretest counselling. This paper concludes that requiring (substantial) copayments for NIPT in universal access healthcare systems fails to promote reproductive autonomy and is unfair.

Incentives for Smoking Cessation During Pregnancy: An Ethical Framework.

INTRODUCTION: Smoking during pregnancy increases the risk of morbidity and mortality of the mother and child. The inability of the unborn child to protect itself, raises the social and academic responsibility to protect the child from the harmful effects of smoking. Interventions including rewards (incentives) for lifestyle changes are an upcoming trend and can encourage women to quit smoking. However, these incentives can, as we will argue, also have negative consequences, for example the restriction of personal autonomy and encouragement of smoking to become eligible for participation. To prevent these negative consequences, we developed an ethical framework that enables to assess and address unwanted consequences of incentive-based interventions whereby moral permissibility can be evaluated. AIMS AND METHODS: The possible adverse consequences of incentives were identified through an extensive literature search. Subsequently, we developed ethical criteria to identify these consequences based on the biomedical ethical principles of Beauchamp and Childress. RESULTS: Our framework consists of 12 criteria. These criteria concern (1) effectiveness, (2) support of a healthy lifestyle, (3) motivational for the target population, (4) stimulating unhealthy behavior, (5) negative attitudes, (6) personal autonomy, (7) intrinsic motivation, (8) privacy, (9) fairness, (10) allocation of incentives, (11) cost-effectiveness, and (12) health inequity. Based on these criteria, the moral permissibility of potential interventions can be evaluated. CONCLUSIONS: Incentives for smoking cessation are a response to the responsibility to protect the unborn child. But these interventions might have possible adverse effects. This ethical framework aims to identify and address ethical pitfalls in order to avoid these adverse effects. IMPLICATIONS: Although various interventions to promote smoking cessation during pregnancy exist, many women still smoke during pregnancy. Interventions using incentives for smoking cessation during pregnancy are a promising and upcoming trend but can have unwanted consequences. This ethical framework helps to identify and address ethical pitfalls in order to avoid these adverse effects.It can be a practical tool in the development and evaluation of these interventions and in evaluating the moral permissibility of interventions using incentives for smoking cessation during pregnancy.

Implementing non-invasive prenatal testing (NIPT) in the Netherlands: An interview study exploring opinions about and experiences with societal pressure, reimbursement, and an expanding scope.

The noninvasive prenatal test (NIPT) as the first trimester prenatal screening (FTS) for trisomies 21, 18, and 13 is offered to all pregnant women in the Netherlands. NIPT using genome sequencing allows for an expansion of the scope of FTS and the introduction of NIPT gives rise to ethical and societal concerns about deliberated decision-making, pressure to engage in screening, and possible lack of equal access due to the financial contribution (€175) to NIPT. We explored the opinions and experiences of pregnant women, who were offered FTS, about these concerns, and the possibility of a broadened scope. Nineteen pregnant women representing a diversity of backgrounds were interviewed using a semi-structured interview guide. Eight women did not opt for prenatal screening while 11 did (NIPT = 4, combined test = 7). Women experienced a free choice to accept or decline prenatal screening, despite sometimes receiving advice from others. Prior to pretest counseling, some women had already deliberated about what an abnormal test result would mean to them. Others accepted or declined FTS without deliberation. The current Dutch policy of requiring a co-payment was acceptable to some, who believed that it functioned as a threshold to think carefully about FTS. Others were concerned that a financial threshold would lead to unequal access to screening. Finally, pregnant women found it difficult to formulate opinions on the scope of FTS, because of lack of knowledge. Life expectancy, severity, and treatability were considered important criteria for the inclusion of a condition in NIPT.

Percutaneous endoscopic gastrostomy in older patients with and without dementia: Survival and ethical considerations.

BACKGROUND AND AIM: Notwithstanding multiple recommendations in guidelines, percutaneous endoscopic gastrostomy (PEG)-tube placement is still performed in patients with dementia. In this study, we aim to investigate survival in patients with and without dementia after PEG-tube placement. METHODS: We conducted a retrospective multicenter study in four different hospitals in the Netherlands. Furthermore, we explored the ethical considerations that may play a role in the decision whether or not to insert a PEG tube in a patient with dementia. RESULTS: Three-hundred-and-three patients were included, mean age of 77.4 years. Forty-two (13.9%) patients had dementia. Short-term complications did not differ between patients with and without cognitive disorders (P 0.224). However, patients with dementia survived significantly shorter after PEG placement than did patients without dementia. Adjusted for age and sex, patients with dementia had a 49% increased risk of mortality (hazard ratio 1.49, 95% confidence interval 1.01-2.19). In our exploratory literature search, we found that several ethical concerns and considerations play a role in the decision process of PEG placement. These considerations are both medical and nonmedical and include beliefs regarding the benefits of a PEG tube, a lack of knowledge about the natural course of dementia in both professionals and family of patients, and a fear of letting a patient die hungry. CONCLUSIONS: Patients with dementia had higher mortality rates after PEG placement than patients without dementia. Although multiple ethical concerns and considerations play a role, insertion of a PEG tube in patients with dementia is not appropriate.

Brain death and postmortem organ donation: report of a questionnaire from the CENTER-TBI study.

BACKGROUND: We aimed to investigate the extent of the agreement on practices around brain death and postmortem organ donation. METHODS: Investigators from 67 Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) study centers completed several questionnaires (response rate: 99%). RESULTS: Regarding practices around brain death, we found agreement on the clinical evaluation (prerequisites and neurological assessment) for brain death determination (BDD) in 100% of the centers. However, ancillary tests were required for BDD in 64% of the centers. BDD for nondonor patients was deemed mandatory in 18% of the centers before withdrawing life-sustaining measures (LSM). Also, practices around postmortem organ donation varied. Organ donation after circulatory arrest was forbidden in 45% of the centers. When withdrawal of LSM was contemplated, in 67% of centers the patients with a ventricular drain in situ had this removed, either sometimes or all of the time. CONCLUSIONS: This study showed both agreement and some regional differences regarding practices around brain death and postmortem organ donation. We hope our results help quantify and understand potential differences, and provide impetus for current dialogs toward further harmonization of practices around brain death and postmortem organ donation.

Ethical, Legal, and Regulatory Issues for the Implementation of Omics-Based Risk Prediction of Women's Cancer: Points to Consider.

BACKGROUND AND OBJECTIVE: Advances in omics open new opportunities for cancer risk prediction and risk-based screening interventions. However, implementation of risk prediction in clinical practice may impact the ethical, legal, and regulatory aspects of current cancer screening programs. In order to support decision-making, we analyzed the ethical, legal, and regulatory issues and developed a set of Points to Consider to support management of these issues. METHODS: We analyzed the legal and policy frameworks applicable to breast and cervical cancer screening programs in 7 European countries. We identified the most relevant issues to be considered, and we developed considerations for their management, based on the literature, the legal and policy frameworks, and our experience with similar issues. RESULTS: The considerations focus on five topics: (A) health services planning, (B) information and invitation, (C) consent and data/sample collection, (D) risk calculation and communication of results, and (E) storage of data and residual samples. CONCLUSION: Current frameworks might not be adequate to implement a risk prediction approach using omics factors due to the different characteristics of such approaches.

Forced caesareans: applying ordinary standards to an extraordinary case.

Is it morally justifiable to force non-consenting pregnant women to submit to caesarean surgery to save their fetus in distress? Even though proponents and opponents largely agree on the interests at stake, such as the health and life of the fetus and the respect for bodily integrity and autonomy of pregnant women, they disagree on which moral weight to attach to these interests. This is why disagreements about the justifiability of forced caesareans tend to be pervasive and intractable. To sidestep this deadlock, we will focus on conditions that give rise to the 'caesarean dilemma' in the first place, namely the conflict between inherent norms and values medical professionals are committed to by virtue of being a medical professional. Using the reflective equilibrium, we will test the opponents' and proponents' considered judgments about forced caesareans against the norms and values they-as medical professionals-are committed to and determine whether they are coherent. Subsequently we will identify the proponents' incoherencies between the considered judgments and norms and values they are committed to and conclude that as long as these incoherencies are in place, forced caesareans are morally impermissible.

Organ donation after euthanasia, morally acceptable under strict procedural safeguards.

In this paper, we will present a case of organ donation after active euthanasia (ODE) in the Netherlands from a patient who had his life ended at his explicit and voluntary request. The form of ODE we describe here concerns patients who are not unconscious and on life support, but who are conscious and want to have their life ended because of their hopeless and unbearable suffering, for instance due to a terminal illness such as Amyotrophic Lateral Sclerosis (ALS) or Multiple Sclerosis (MS). This form of ODE is of course only possible in jurisdictions where euthanasia is allowed. In these jurisdictions, organ donation after euthanasia is an option that may be considered. We believe ODE is worthwhile to pursue, as it can strengthen patient autonomy, can give meaning to the inevitable death of the patient, and be an extra source of much needed donor organs. To ensure voluntariness of both euthanasia and organ donation and avoid conflict of interest by physicians, ODE does need strict procedural safeguards however. The most important safeguard is a strict separation between the 2 procedures. The paper discusses several ethical issues such as who should broach the subject of organ donation and who should perform the euthanasia, and how a conflict of interest can be avoided.

Ethics of routine: a critical analysis of the concept of 'routinisation' in prenatal screening.

In the debate surrounding the introduction of non-invasive prenatal testing (NIPT) in prenatal screening programmes, the concept of routinisation is often used to refer to concerns and potential negative consequences of the test. A literature analysis shows that routinisation has many different meanings, which can be distinguished in three major versions of the concept. Each of these versions comprises several inter-related fears and concerns regarding prenatal screening and particularly regarding NIPT in three areas: (1) informed choice, (2) freedom to choose and (3) consequences for people with a disability. Three of the strongest arguments raised under the flag of routinisation are assessed for their validity: the threat that NIPT poses to informed choice, the potential increase in uptake of first-trimester prenatal screening and its consequences for social pressure to participate in screening or terminate affected pregnancies, and the negative consequences for disabled people. These routinisation arguments lack empirical or normative ground. However, the results of this analysis do not imply that no attention should be paid to possible problems surrounding the introduction of NIPT. At least two problems remain and should be addressed: there should be an ongoing debate about the requirements of informed choice, particularly related to an expanded scope of prenatal screening. Also, reproductive autonomy can only be achieved when expecting parents' options are variegated, real and valuable, so that they can continue to choose whether or not to screen or to terminate a pregnancy.

Epigenome-based cancer risk prediction: rationale, opportunities and challenges.

The incidence of cancer is continuing to rise and risk-tailored early diagnostic and/or primary prevention strategies are urgently required. The ideal risk-predictive test should: integrate the effects of both genetic and nongenetic factors and aim to capture these effects using an approach that is both biologically stable and technically reproducible; derive a score from easily accessible biological samples that acts as a surrogate for the organ in question; and enable the effectiveness of risk-reducing measures to be monitored. Substantial evidence has accumulated suggesting that the epigenome and, in particular, DNA methylation-based tests meet all of these requirements. However, the development and implementation of DNA methylation-based risk-prediction tests poses considerable challenges. In particular, the cell type specificity of DNA methylation and the extensive cellular heterogeneity of the easily accessible surrogate cells that might contain information relevant to less accessible tissues necessitates the use of novel methods in order to account for these confounding issues. Furthermore, the engagement of the scientific community with health-care professionals, policymakers and the public is required in order to identify and address the organizational, ethical, legal, social and economic challenges associated with the routine use of epigenetic testing.