IntroductionHigh healthcare costs make illness precarious for both patients and their families’ economic situation. Despite the recent focus on the interconnection between health and financial risk at the systemic level, the ethical conflict between concerns for potential health benefits and financial risk protection at the household level in a low-income setting is less understood.MethodsUsing a seven-step ethical analysis, we examine a real-life dilemma faced by families and health workers at the micro level in Ethiopia and analyse the acceptability of limiting (...) treatment for an ill newborn to protect against financial risk. We assess available evidence and ethical issues at stake and discuss the dilemma with respect to three priority setting criteria: health maximisation, priority to the worse-off and financial risk protection.ResultsGiving priority to health maximisation and extra priority to the worse-off suggests, in this particular case, that limiting treatment is not acceptable even if the total well-being gain from reduced financial risk is taken into account. Our conclusion depends on the facts of the case and the relative weight assigned to these criteria. However, there are problematic aspects with the premise of this dilemma. The most affected parties—the newborn, family members and health worker—cannot make free choices about whether to limit treatment or not, and we thereby accept deprivations of people’s substantive freedoms.ConclusionIn settings where healthcare is financed largely out-of-pocket, families and health workers face tragic trade-offs. As countries move towards universal health coverage, financial risk protection for high-priority services is necessary to promote fairness, improve health and reduce poverty. (shrink)

Objective The objective of this article is to provide an ethical analysis of a high-risk, advanced treatment case where the patient received transcatheter aortic valve insertion, for aortic valve stenosis. Particular emphasis will be placed upon the significance of evidence and the implications for priority setting. Method One paradigmatic case involving a TAVI patient from a large university hospital in Norway is described and analysed. The method used was ethical case analysis modified after Kymlicka by Miljeteig et al. Perioperative mortality (...) risk was estimated using the Euroscore risk-logarithm and the Society of Thoracic Surgeons’ risk model, STS. These predict the risk of operative mortality and morbidity associated with adult cardiac surgery. GRADE, the Grading of Recommendations Assessment, Development and Evaluation, was used to evaluate the evidence. Results In the case analysis, we found that it would be ethically justifiable not to recommend TAVI treatment for this patient. Although the patient had a severe condition in need of treatment, the expected improvement was marginal, the quality of evidence was low and the opportunity costs for other patients and society were higher than usually deemed appropriate. Conclusions Decision-making in the absence of high quality evidence from randomized trials is a complex process involving difficult ethical judgments. Novel high-risk devices often enter the European market with limited clinical evidence. Transparency and improved clinical evaluation are required so patient safety is not jeopardized. We argue that implementation of high risk, high cost interventions should be better regulated at a national level. Background All clinical decisions imply priority setting and therefore indirectly affect other patients and other patient groups. The use of expensive, innovative health technologies has an affect on individual patients as well as on other patient groups competing for the same resources. (shrink)

BackgroundDeciding whether to resuscitate extremely preterm infants (EPIs) is clinically and ethically problematic. The aim of the study was to understand neonatologists’ clinical–ethical decision-making for resuscitation of EPIs.MethodsWe conducted a qualitative study in Belgium, following a constructivist account of the Grounded Theory. We conducted 20 in-depth, face-to-face, semi-structured interviews with neonatologists. Data analysis followed the qualitative analysis guide of Leuven.ResultsThe main principles guiding participants’ decision-making were EPIs’ best interest and respect for parents’ autonomy. Participants agreed that justice as resource allocation (...) should not be considered in resuscitation decision-making. The main ethical challenge for participants was dealing with the conflict between EPIs’ best interest and respect for parents’ autonomy. This conflict was most prominent when parents and clinicians disagreed about births within the gray zone (24–25 weeks). Participants’ coping strategies included setting limits on extent of EPI care provided and rigidly following established guidelines. However, these strategies were not always feasible or successful. Although rare, these situations often led to long-lasting moral distress.ConclusionsParticipants’ clinical–ethical reasoning for resuscitation of EPIs can be mainly characterized as an attempt to balance EPIs’ best interest and respect for parents’ autonomy. This approach could explain why neonatologists considered conflicts between these principles as their main ethical challenge and why lack of resolution increases the risk of moral distress. Therefore, more research is needed to better understand moral distress in EPI resuscitation decisions.Clinical Trial Registration: The study received ethical approval from the ethics committee of UZ/ku Leuven (S62867). Confidentiality of personal information and anonymity was guaranteed in accordance with the General Data Protection Regulation of 25 May 2018. (shrink)

ObjectiveTo present (1) the ethical concepts related to the debate on resuscitation of extremely premature infants (EPIs) as they are described in the ethical literature; and (2) the ethical arguments based on these concepts.DesignWe conducted a systematic review of the ethical literature. We selected articles based on the following predefined inclusion/exclusion criteria: (1) English language articles (2) presenting fully elaborated ethical arguments (3) on resuscitation (4) of EPIs, that is, infants born before 28 weeks of gestation.AnalysisAfter repeated reading of articles, (...) we developed individual summaries, conceptual schemes and an overall conceptual scheme. Ethical arguments and concepts were identified and analysed.ResultsForty articles were included out of 4709 screened. Personhood, best interest, autonomy and justice were concepts grounding the various arguments. Regarding these concepts, included authors agreed that the best interest principle should guide resuscitation decisions, whereas justice seemed the least important concept. The arguments addressed two questions: Should we resuscitate EPIs? Who should decide? Included authors agreed that not all EPIs should be resuscitated but disagreed on what criteria should ground this decision. Overall, included authors agreed that both parents and physicians should contribute to the decision.ConclusionsThe included publications suggest that while the best interest is the main concept guiding resuscitation decisions, justice is the least important. The included authors also agree that both parents and physicians should be actively involved in resuscitation decisions for EPIs. However, our results suggest that parents’ decision should be over-ridden when in contrast with the EPI’s best interest. (shrink)