The normative basis of (health) technology assessment and the role of ethical expertise

The role of normative reflection and the possibilities of ethical inquiry in technology assessment have been under discussion in the TA community for several years. As an outcome of this discussion the necessity of explicitly dealing with normativity in TA has widely been acknowledged. However, it is still quite unclear in which way this should be done. This paper is dedicated to the role (and limitations) of ethical expertise in this field, especially in HTA. By methodological analysis an approach is developed to show how entry points for ethical expertise could be identified. The result is that ethical expertise can inform moral debates by uncovering underlying assumptions, by making the normative structure of argumentation transparent, and by weighing the strength of the arguments. In this way moral debates in HTA can become more transparent and opened to argumentative reasoning instead of consisting of bargaining processes determined by power distributions. Ethical reflection, however, does not replace decision-making.     

Health technology assessment: trying to bring empirical and ethical inquiry together

A comprehensive assessment of a health technology requires that a wide variety of questions are addressed. These range from whether the use of a technology results in achievement of its intended effects (e.g., better tumour control, pain relief, improved mobility, etc.) at acceptable costs and without incurring undue risks to the patient, to whether its use may challenge existing social arrangements and values (e.g., individual responsibility for preserving good health, the value of human life, etc.). Clearly, this is a major challenge, since it requires the use of quite different methods of inquiry. In the past decades, we have rarely witnessed assessments where both types of questions were addressed in a balanced way. Rather, a wide gap exists between inquiries with a strong empirical focus and an almost complete neglect of underlying normative issues, and inquiries which are largely discursive, but with a serious disregard of relevant empirical data. The complex interplay between normative frameworks and empirical data in the assessment of health technologies is illustrated in two case studies: the assessment of surgical management of children with glue ears, and the assessment of Extra Corporeal Membrane Oxygenation in neonates.

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Zusammenfassung Die unfassende Beurteilung einer Medizintechnologie erfordert das Angehen einer Vielfalt ganz verschiedener Fragen. Das Spektrum reicht von der Frage, ob der Einsatz einer Technologie die angestrebten Ergebnisse zeitigen wird (z. B. verbesserte Tumorkontrolle, Schmerzlinderung, bessere Beweglichkeit etc.), ob dies zu akzeptablen Kosten möglich ist, und ohne übermäßige Risiken für den Patienten, bis zu der Frage, ob ihr Einsatz bestehende gesellschaftliche Übereinkünfte und Werte bedroht (z. B. die Verantwortung des Individuums für die Erhaltung seiner Gesundheit, der Wert menschlichen Lebens etc.). Dies ist offenbar eine große Herausforderung, da die Beantwortung dieser Fragen den Einsatz verschiedenster Untersuchungsmethoden erfordert. In den vergangenen Jahrzehnten ist nur selten eine Beurteilung erschienen, in der beide Fragentypen auf ausgewogene Weise berücksichtigt waren. Das Bild ist eher das einer weiten Kluft zwischen in hohem Maße empirisch orientierten Studien, in denen die zugrunde liegenden normativen Fragen fast vollkommen vernachlässigt bleiben, und solchen, die weitgehend diskursiv gestaltet sind, dabei jedoch die relevanten Erfahrungsdaten sträflich missachten. Das komplexe Zusammenspiel zwischen dem normativen Rahmen und empirischen Daten in der Beurteilung von Medizintechnologien wird anhand zweier Fallstudien dargestellt: die Beurteilung des chirurgischen Managements von Kindern mit Mittelohrentzündung und die Beurteilung der extrakorporalen Membranoxygenation in Neugeborenen.

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Résumé Lévaluation complète dune technologie de la santé exige daborder un grand nombre de questions. Celles-ci vont de la question de savoir si la mise en oeuvre dune technologie aboutira aux résultats escomptés (p. ex. meilleure maîtrise des tumeurs, atténuation de la douleur, meilleure mobilité, etc.), à des coûts acceptables et sans risques excessifs pour le patient, à la question de savoir si son utilisation menace le consensus et les valeurs sociales (p. ex. responsabilité de lindividu pour la préservation de sa santé, valeur de la vie humaine, etc.). Ceci est certes un défi de taille, qui exige différentes méthodes détude. Au cours des décennies écoulées, nous avons rarement assisté à des évaluations dans lesquelles ces deux types de questions étaient pris en compte de façon équilibrée. Au contraire, il existe plutôt un profond fossé entre les études mettant fortement laccent sur les aspects empiriques et négligeant presque entièrement les questions normatives sous-jacentes, et les études largement discursives, mais qui ignorent superbement les données empiriques pertinentes. Linteraction complexe entre cadres normatifs et données empiriques dans lévaluation des technologies médicales est illustrée par deux études de cas : lévaluation de la gestion chirurgicale des enfants souffrant dotites, et lévaluation de loxygénation extracorporelle chez le nouveau-né (ECMO).

     

Integrating critical realist and feminist methodologies: ethical and analytical dilemmas

This paper reflects on research carried out with a group of women receiving intensive family support aimed at addressing the cause of their family’s ‘anti-social behaviour’. The methodological approach to the research was underpinned by the philosophical principles of critical realism. It was also informed by the ethical and political concerns of feminist scholarship. The paper reports on the potential points of tension that arise between feminism and critical realism in empirical research. In particular, attention is centred on the process of trying to marry approaches which stress the central role of participants’ knowledge, particularly those who are ‘labelled’ and whose voices are not readily heard, with the principle that some accounts of ‘reality’ are better than others.     

On value-judgements and ethics in health technology assessment

The widespread application of technology in health care has imposed a broad range of challenges. The field of health technology assessment (HTA) is developed in order to face some of these challenges. However, this strategy has not been as successful as one could hope. One of the reasons for this is that social and ethical considerations have not been integrated in the HTA process. Nowadays however, such considerations have been included in many HTAs. Still, the conclusions and recommendations of the HTAs are not followed. The reason for this may be that the methods for integrating ethics for HTA are not sufficiently developed, or that they are not adequate. This article presents a supplementary approach to the ethical inquiry in HTA. It is argued that a value analysis is crucial in order to address the ethical issues of health care technology in a fruitful way and to make viable decisions about such technology.

Health technology assessment between our health care system and our health

In this contribution, I wish to explore the potential of health technology assessment and ethics for increasing our capacity to pre-empt the shortcomings and undesired consequences of modern health care while maintaining its benefits. Central is the presumption that in case of some health problems this cannot be done unless we explicitly reconsider some features of the modern health care system, especially those related to its strong reliance on scientific rationality and the strong role played by medical professionals. So as to both maintain the benefits of advanced health care and ensure that it produces less reason for concern, we need to reconsider our approach to rationality—and maybe even the way in which we build our health care system around that rationality. That is, we need to introduce an element of reflexivity. Two types of circumstances are being explored in which such reflexivity may prove worthwhile: controversies on side effects, and persistent problems encountered in optimising health care. Drawing on brief discussions of typical cases, we explore the potential of reflexive HTA and its methodical prerequisites. We conclude that ethicists may contribute to reflexive HTA, if they combine a hermeneutic—and often also participative—methodology with a solid understanding of the relation between the health problem under scrutiny and more general critique of the health care system. Insights from the areas of science and technology studies, as well as from social philosophy may be critical items in their tool kit.     

Analyzing mental health evaluation: moral and ethical dimensions

Now that evaluators have been sensitized to the importance of moral and ethical issues in their work, it is time to move beyond generalities and examine the moral and ethical implications of specific evaluation models in specific settings. This paper proposes a framework that can be used to examine moral and ethical dimensions of evaluation and illustrates it by analyzing a selected model of mental health evaluation. Such a systematic identification of moral issues can improve evaluation practice both proactively, by shaping the training of evaluators, and retrospectively, by contributing to meta-evaluation.     

Navigating stormy waters: Challenges and opportunities for social work in mental health

The reforms driven by the National Mental Health Strategy have created both opportunities and challenges for social work as a profession. This paper examines the rapidly changing context for practice in mental health, including policy change, and developments in the education and training of the mental health workforce. Key practice issues identified for social work include: (i) the need to establish a viable paradigm for practice; (ii) a more positive response to the challenge of evidence-based practice models; (iii) a national agenda for education and training; and (iv) the importance of working collaboratively with consumers and families in a way that values their human rights and the lived experience of mental illness.     

Learning opportunities through camping for mental health nursing

1. To equip nurses with the skills necessary for working with disturbed people, nurse educators need to be mindful of not watering down the essential skills necessary for nurses to deal with difficult behaviour in all branches of nursing. 2. These components of a mental health clinical experience should equip the graduate to deal with the pressures of dealing with disturbed people in any environment, as the skills learned generalize to any branch of nursing. 3. Universities can combine with traditional hospital services and community mental health services to provide services to clients with mental illness. An additional benefit is in providing students with an intensive clinical learning experience that reinforces the theory taught in the classroom.     

Towards a prospective technology assessment: challenges and requirements for technology assessment in the age of technoscience

The objective of this paper is to contribute to the expanding discourse on conceptual elements of TA. As a point of departure, it takes the recent transformation of the science, technology and innovation system (“technoscience”). We will show that the age of technoscience can be regarded as presenting not only a challenge, but also a chance and opportunity for TA. Embracing this opportunity, however, implies imposing several requirements on TA. In order to specify these requirements and to foster the ongoing discourse on the foundations of TA, this paper suggests a programmatic term: prospective technology assessment (ProTA). This term is intended mainly as a reflection framework, aimed at providing an extension and complement—and not a replacement—of well-established TA concepts. Three requirements for ProTA are sketched: (1) early stage orientation—the temporal dimension, (2) intention and potential orientation—the knowledge dimension, (3) shaping orientation—the power/actor dimension. Examples from fusion and nano research will illustrate the need for ProTA, as well as its specific focus. The paper concedes that ProTA is in its infancy and that there is a clear need for further clarification.     

Strategy-proof and anonymous rule in queueing problems: a relationship between equity and efficiency

We consider a relationship between equity and efficiency in queueing problems. We show that under strategy-proofness, anonymity in welfare implies queue-efficiency. Furthermore, by combining the result of Kayı and Ramaekers (Games Econ Behav 68:220–232, 2010) with ours, we also give a characterization of the class of rules that satisfy strategy-proofness, anonymity in welfare, and budget-balance.     

Information technology, unions, and the new organization: Challenges and opportunities for union survival

The rapid transformation of the U.S. business environment has radically changed the character of organizations where unions seek to represent workers. Many of the structural elements that have provided critical support to union representation in collective bargaining have been significantly altered, or lost altogether. We have argued that information technologies have been a pivotal force of change in business organizations and have identified a set of key structural elements of these transformed organizations. It is our belief that while the new organization creates significant challenges for private sector unions, it also creates an opportunity for unions to develop new roles and new opportunities to prosper in the next millennium.     

Racial/ethnic segregation and health disparities: Future directions and opportunities

Health researchers have investigated the association between racial segregation and racial health disparities with multilevel approaches. This study systematically reviews these multilevel studies and identifies broad trends and potential directions for future research on racial segregation and health disparities in the US. After searching databases including CINAHL and MEDLINE, we systematically reviewed 66 articles published between 2003 and 2019 and found four major gaps in racial/ethnic segregation and health disparities: (a) the concept of segregation was rarely operationalized at the neighborhood level, (b) except for the evenness and exposure dimension, other dimensions of segregation are overlooked, (c) little attention was paid to the segregation between whites and non‐black minorities, particularly Hispanics and Asians, and (d) mental health outcomes were largely absent. Future directions and opportunities include: First, other segregation dimensions should be explored. Second, the spatial scales for segregation measures should be clarified. Third, the theoretical frameworks for black and non‐black minorities should be tested. Fourth, mental health, substance use, and the use of mental health care should be examined. Fifth, the long‐term health effect of segregation has to be investigated, and finally, other competing explanations for why segregation matters at the neighborhood level should be answered.     

Trade-off between equity and efficiency in a general economy with indivisible goods

In most of the recent literature on fair allocation in economies with indivisible goods and a single infinitely divisible good, it is assumed that each agent can consume at most one indivisible good. In this paper, we show that if this assumption is dropped, there do not necessarily exist envy-free and Pareto efficient allocations. However, envy-free allocations still exist and so do Pareto efficient allocations. Hence, a trade-off between equity and efficiency arises.     

效率与公平视角下的城市公共物品供给

改革开放二十多年来,我国城市化进程日益加快,城市公共物品的供给总量虽然达到了前所未有的规模,但就城市化进程中的实际需求而言,这一供给还明显不足,还存在着巨大的缺口.众所周知,在一定时期内可用于生产与配置的资源总是具有稀缺性.同时,由于我国正处于全面建设小康社会和改革开放的攻坚阶段,社会主义现代化建设事业的各个方面都亟须政府的财政支出,财政压力明显过大,银根严重吃紧.因此,在既能保证效率又能兼顾公平的前提下,探讨如何提高城市公共物品的有效供给以满足日益增长的城市公共需求,缓解城市公共物品供需矛盾,就显得尤为必要.     

Polymorphism-screening: genetic testing for predisposition—guidance for technology assessment

Health policy is increasingly confronted with the demand for financing genetic testing on inherited susceptibility to disease. Tests on polymorphism/SNP associated with multicausal and chronic conditions are already offered in private commercial institutions or in academic hospitals. The increasing pressure on public health services to offer SNP testing leads to first methodological approaches for a generally valid regulatory framework applicable for inclusion or refusal of genetic tests into the public health services. Systematic search in Medline, Embase and the Web for methodological papers or guidelines for the assessment of polymorphism-screening. Since genetic testing has not only clinical and economic effects on health care, but also primarily ethical consequences by profiling our understanding of “health” and “disease”, this paper gives an overview of relevant aspects and background information to consider in the assessment of genetic tests. Although 2–3 million SNPs are identified and the journals are full of reported “significant” associations between disease and mutation, only a few can be replicated unequivocally. The ACCE (Analytic and Clinical Validity, Clinical utility; Ethical, legal and social implications)-framework was developed by the Center of Disease Control for the assessment of genetic testing. This standardised appraisal approach proposes collecting and evaluating: (a) Prevalence, genotype-/phenotype-relation. (b) Clinical presentation: natural history; the different expressions of disease. (c) Performance of the genetic test. (d) Implications for therapy and prevention. (e) Conclusion for clinical applications of risk-profiling of health on their susceptibility to disease and/or for clarification of disease for therapy planning. Since genetic testing is urging its way into the health care system, the actual danger is, that population screening starts before valid evidence from big prospective studies have been carried out and delivered proofs of direct causal associations. Before diffusing into the health care system we are suggesting to take a cautious and standardised approach.