Defining laboratory medicine, or squaring the circle?

In the August 2020 issue of Clinical Chemistry and Laboratory Medicine, Giuseppe Lippi and Mario Plebani proposed a definition of laboratory medicine, which ends with this sentence: "The results of these measurements are translated into actionable information for improving the care and/or maintaining the wellness of both a single individual and an entire population". Nevertheless, the selfishness of individuals may, sometimes, jeopardize the interest of whole populations. The virtue of justice being within the reach of the entire human community more than of single individuals, the final sentence in the definition proposed by Giuseppe Lippi and Mario Plebani, should therefore, in our view, be rewritten, less selfishly, for example like this: "For a given investment, these measurements are preferably made when they bring as much beneficence, and non-maleficence, as possible to the whole population".

An International Review of Health Technology Assessment Approaches to Prescription Drugs and Their Ethical Principles.

In many countries, health technology assessment (HTA) organizations determine the economic value of new drugs and make recommendations regarding appropriate pricing and coverage in national health systems. In the US, recent policy proposals aimed at reducing drug costs would link drug prices to six countries: Australia, Canada, France, Germany, Japan, and the UK. We reviewed these countries' methods of HTA and guidance on price and coverage recommendations, analyzing methods and guidance documents for differences in (1) the methodologies HTA organizations use to conduct their evaluations and (2) considerations they use when making recommendations. We found important differences in the methods, interpretations of HTA findings, and condition-specific carve-outs that HTA organizations use to conduct evaluations and make recommendations. These variations have ethical implications because they influence the recommendations of HTA organizations, which affect access to the drug through national insurance and price negotiations with manufacturers. The differences in HTA approaches result from the distinct political, social, and cultural contexts of each organization and its value judgments. New cost-containment policies in the US should consider the ethical implications of the HTA reviews that they are considering relying on to negotiate drug prices and what values should be included in US pricing policy.

Alive inside.

This article provides an ethical analysis of the U.S. practice guideline update on disorders of consciousness. Our analysis focuses on the guideline's recommendations regarding the use of investigational neuroimaging methods to assess brain-injured patients. Complex and multifaceted ethical issues have emerged because these methods alter the clinical understanding of consciousness. We address issues of false hope, patient suffering, and cost. We argue that, in spite of these concerns, there is significant benefit to using neuroimaging to assess brain-injured patients in most cases.

LIMPRINT: A Sociological Perspective on "Chronic Edema".

Background: Chronic edema is a condition that is biologically complex, distressing for patients and sociopolitically weak. Like many other complex and chronic conditions, it has a low status within health care. The result is that it has a low priority in health policy and consequently is undervalued and undertreated. While evidence-based practice promotes a hierarchy of evidence, it is also the case that clinical practice is influenced by a hierarchy of social status. These are as much political as they are scientific. Methods and Results: This article will provide an explanation for why chronic edema is a low priority. It will do this through a critical review of the literature. We examine this through the theoretical lens of Pierre Bourdieu. The sociology of Bourdieu frames an understanding of power relations through habitus, field, and capital. We will employ these theoretical tools to understand the way that chronic edema is situated within the policy arena. We identify a number of social mechanisms that affect the status of chronic edema, including diagnostic uncertainty, social capital, scientific capital, cultural capital and economic capital. Conclusion: We argue that a whole system approach to care, based on human need rather than unequal power relations, is a prerequisite for the delivery of good health care. The specialty of chronic edema is not a powerless group and we identify some of the ways that the social mechanism that acts as barriers to change, can also be employed to challenge them.

Future unrelated medical costs need to be considered in cost effectiveness analysis.

New medical technologies that prolong life result in additional health care use in life years gained. Some of these costs in life years gained are considered to be related to the intervention while other costs are considered unrelated. Here, we argue that ignoring these so-called future medical costs in cost effectiveness analysis is contrary to common sense, results in lost health and fails to inform decision makers for whom cost effectiveness is supposed to serve.

Withholding and withdrawing treatment for cost-effectiveness reasons: Are they ethically on par?

In healthcare priority settings, early access to treatment before reimbursement decisions gives rise to problems of whether negative decisions for cost-effectiveness reasons should result in withdrawing treatment, already accessed by patients. Among professionals there seems to be a strong attitude to distinguish between withdrawing and withholding treatment, viewing the former as ethically worse. In this article the distinction between withdrawing and withholding treatment for reasons of cost effectiveness is explored by analysing the doing/allowing distinction, different theories of justice, consequentialist and virtue perspectives. The authors do not find any strong reasons for an intrinsic difference, but do find some reasons for a consequentialist difference, given present attitudes. However, overall, such a difference does not, all things considered, provide a convincing reason against withdrawal, given the greater consequentialist gain of using cost-effective treatment. As a result, patients should be properly informed when given early access to treatment, that such treatment can be later withdrawn following a negative reimbursement decision.

[The ethical problems in limiting the role for cost-effectiveness]. / Etiskt problematiskt att begränsa rollen för kostnadseffektivitet - Begränsad roll kan leda till godtycke och strida mot andra principer för prioriteringar i vården.

In relation to the Swedish ethical platform for priority setting in health-care it is debated what role cost-effectiveness should play. In the article an ethical analysis is presented showing that a limited role risks leading to unequal priorities between similar needs in conflict with the human dignity and need-solidarity principles of the platform. It is also argued that resulting problems with effect comparability over different conditions and resulting equality problems with the current praxis can be mitigated through strategies like explicitly considering outcome measure and by adjusting the cost-effectiveness threshold under specific conditions.

Controlling Healthcare Costs: Just Cost Effectiveness or "Just" Cost Effectiveness?

Meeting healthcare needs is a matter of social justice. Healthcare needs are virtually limitless; however, resources, such as money, for meeting those needs, are limited. How then should we (just and caring citizens and policymakers in such a society) decide which needs must be met as a matter of justice with those limited resources? One reasonable response would be that we should use cost effectiveness as our primary criterion for making those choices. This article argues instead that cost-effectiveness considerations must be constrained by considerations of healthcare justice. The goal of this article will be to provide a preliminary account of how we might distinguish just from unjust or insufficiently just applications of cost-effectiveness analysis to some healthcare rationing problems; specifically, problems related to extraordinarily expensive targeted cancer therapies. Unconstrained compassionate appeals for resources for the medically least well-off cancer patients will be neither just nor cost effective.

Benefit-Cost Analysis and Emerging Technologies.

Emerging technologies are, by definition, full of surprises: developments that we cannot fully anticipate and that might have some bad outcomes as well as good ones. This presents a challenge for anyone trying to make forward-looking policy decisions, including those who apply benefit-cost analysis. BCA is now widely known and used, but it is also widely misunderstood-by many of its advocates as well as its detractors. In this essay, I will begin by examining some of the strengths and weaknesses of BCA as a normative science. Yes, "normative science" is an oxymoron, and the incongruity it speaks to is a source of much of the controversy; BCA is an imperfect answer, but often the best available answer, to the question of how a society should go about making collective but not unanimous choices. I also want to take a hard look at the question of what we are evaluating. BCA is designed to weigh government actions, to see whether they are in the public interest; it is not designed to evaluate private actions. But if the government action is to approve a private action that otherwise would be prohibited, then the BCA inevitably must evaluate the latter. From the perspective of a government regulator, it is very tempting to shift the burden of proof onto private innovators-to obligate them to seek permission to proceed, and to demonstrate that their proposed actions have acceptable risks and will produce a net social benefit. But such burden-shifting is not merely an administrative convenience; it has serious economic consequences that need to be examined.

Valuing Our Communities: Ethical Considerations for Economic Evaluation of Community-Based Prevention.

Restricted public budgets and increasing efforts to link the impact of community interventions to public savings have increased the use of economic evaluation. While this type of evaluation can be important for program planning, it also raises important ethical issues about how we value the time of local stakeholders who support community interventions. In particular, researchers navigate issues of scientific accuracy, institutional inequality, and research utility in their pursuit of even basic cost estimates. We provide an example of how we confronted these issues when estimating the costs of a large-scale community-based intervention. Principles for valuing community members' time and conducting economic evaluations of community programs are discussed.

Values in Time Discounting.

Controversies about time discounting loom large in decisions about climate change. Prominently, a particularly controversial debate about time discounting in climate change decision-making has been conducted within climate economics, between the authors of Stern et al. (Stern review on the economics of climate change, 2006) and their critics (most prominently Dasgupta in Comments on the Stern review's economics of climate change, 2006; Tol in Energy Environ 17(6):977-981, 2006; Weitzman in J Econ Lit XLV:703-724, 2007; Nordhaus in J Econ Lit XLV:686-702, 2007). The article examines the role of values in this debate. Firstly, it is shown that time discounting is a case in which values are key because it is at heart an ethical problem. Secondly, it is argued that time discounting in climate economics is a case of economists making frequent and routine references to ethical values and indeed conduct ethical debates with each other. Thirdly, it is argued that there is evidence for deep and pervasive entanglement between facts and values in the prevalent methodologies for time discounting. Finally, it is argued that this means that economists have given up the 'value-free ideal' concerning time discounting, and discussed how the current methodology of time discounting in economics can be improved.

Money in Tension with Ethics: A Commentary.

Monetary incentives are frequently in tension with evidence-based and cost-effective clinical care, thus posing an ethical concern in the practice of dentistry. The purpose of this commentary was to examine the issue of treating children in the context of caries risk assessment and with specific reference to the periodic oral examination, radiographic surveillance, topical fluorides, and the pumice rubber prophylaxis.

Hidden costs: The ethics of cost-effectiveness analyses for health interventions in resource-limited settings.

Cost-effectiveness analysis (CEA) is an increasingly appealing tool for evaluating and comparing health-related interventions in resource-limited settings. The goal is to inform decision-makers regarding the health benefits and associated costs of alternative interventions, helping guide allocation of limited resources by prioritising interventions that offer the most health for the least money. Although only one component of a more complex decision-making process, CEAs influence the distribution of health-care resources, directly influencing morbidity and mortality for the world's most vulnerable populations. However, CEA-associated measures are frequently setting-specific valuations, and CEA outcomes may violate ethical principles of equity and distributive justice. We examine the assumptions and analytical tools used in CEAs that may conflict with societal values. We then evaluate contextual features unique to resource-limited settings, including the source of health-state utilities and disability weights, implications of CEA thresholds in light of economic uncertainty, and the role of external donors. Finally, we explore opportunities to help align interpretation of CEA outcomes with values and budgetary constraints in resource-limited settings. The ethical implications of CEAs in resource-limited settings are vast. It is imperative that CEA outcome summary measures and implementation thresholds adequately reflect societal values and ethical priorities in resource-limited settings.

[Biosimilars in Gastroenterology - how much uncertainly is ethically acceptable?] / Biosimilars in der Gastroenterologie ­ Wie viel Unsicherheit ist ethisch akzeptabel?

Biosimilars use raises uncertainties with regards to efficacy despite potentially significant cost reductions. This requires a classical harm-benefit analysis. Important stakeholders include physicians and patients, companies producing biologica (drugs containing biotechnology-derived proteins as active substance), and companies producing biosimilars, as well as health insurance companies and politicians. They all have their distinct interests. In a rule-setting process, transparency is needed to protect the trust between patients and physicians. In an ideal world, the price of biologica without patent protection would be negotiated in a way that makes biosimilars unnecessary.

Individualised and personalised QALYs in exceptional treatment decisions.

Quality-adjusted life years (QALYs) are used to determine how to allocate resources to health programmes or to treatments within those programmes in order to gain maximum utility from those limited, shared healthcare resources. However, if we use those same population- based QALYs when faced with individual treatment decisions we may act unjustly in relation to that individual or in relation to the wider population. A treatment with a population-based incremental cost-effectiveness ratio beyond our willingness to pay threshold may be denied to a patient even if, for that particular patient, the QALYs gained for the cost would fall within that threshold. When considering individual cases, it is proposed that we should take an individualised approach to the cost of treatment and response to treatment ('individualised QALYs') and a personalised approach to the valuation of health states ('personalised QALYs'). Only if we do this, can we maximise utility and give the patient a fair opportunity to benefit. Individualised and personalised QALYs also allow us to express patient choice and religious treatment preferences in terms of utility. Individualised and personalised QALYs are explored in the context of individual funding requests in the National Health Service. In preference to the concept of 'clinical exceptionality', individualised and personalised QALYs provide the potential for better and more consistent decisions and improved utility. Rather than treating unequal patients as if they were equal, individualised and personalised QALYs promote fair and unequal access to resources for some of our most unequal patients. Potential challenges are also considered.

¿Es posible medir la calidad de vida en el ámbito asistencial? Historia, límites y posibilidades / Can quality of life be measured in a health care setting? History, constraints and possibilities

Los conceptos y escalas de calidad de vida relacionada con salud (CVRS) comienzan a ser habituales en la práctica clínica, y juegan hoy un importante papel en discusiones bioéticas, especialmente en el manejo de pacientes terminales. En este artículo estudiamos la evolución que ha sufrido dicho concepto y la relación que guarda con el binomio salud-enfermedad. En este sentido, mostramos algunos importantes inconvenientes que arrastra la noción de calidad de vida (CV) desde sus orígenes y que se traducen en una difícil aplicabilidad en las ciencias de la salud y, sobre todo, que conllevan enormes sesgos. En nuestras conclusiones defendemos que es necesario mejorar el concepto de CV a partir de la inclusión de dimensiones y factores relacionados con el bienestar que, a pesar de no ser enteramente cuantificables, dotan de coherencia y sentido a los datos que, sobre el paciente, el profesional de la salud maneja habitualmente

Quality of life concepts and scales related to health (QLRH) are beginning to be customary in clinical practice and now play an important role in bioethical discussions, particularly concerning the management of terminal patients. This paper looks at how that concept has evolved and how it relates to the health-illness binomial. We illustrate some important complexities the notion of quality of life (QL) has borne since its inception and that make applicability in the health sciences difficult and, most of all, lead to tremendous biases. In our conclusions, we argue it is necessary to improve the concept of QL by including aspects and factors related to well-being. Although not entirely quantifiable, they give coherence and meaning to the patient data health professionals normally work with