Bjørn Hofmann

Broadening consent—and diluting ethics?

Biobank research is potentially fruitful. It is argued that broad consent is acceptable for future research on biological material because a) the benefit is high, b) it pays respect to people’s autonomy, c) it is consistent with current practices and d) because the risk is low. Furthermore, broad consent should be allowed if information is handled safely, people can withdraw and expanded research should be approved by an ethics review board. However, these arguments are flawed and the criteria for broad consent are either too restrictive to allow any research or fail to address important challenges with biobank research. Broad consent for biobank research can hide substantial ethical challenges and threaten trust in research. This does not mean that biobank research should be abandoned or that people cannot authorise future research on donated biological material.

Toward a procedure for integrating moral issues in health technology assessment

OBJECTIVES Although ethics has been on the agenda in health technology assessment (HTA) since its inception, the integration of moral issues is still not standard and is performed in a vast variety of ways. Therefore, there is a need for a procedure for integrating moral issues in HTA. METHODS Literature review of existing approaches together with application of various theories in moral philosophy and axiology. RESULTS The article develops a set of questions that addresses a wide range of moral issues related to the assessment and implementation of health technology. The issues include general moral issues and moral issues related to stakeholders, methodology, characteristics of technology, and to the HTA process itself. The questions form a kind of checklist for use in HTAs. CONCLUSIONS The presented approach for integrating moral issues in HTA has a broad theoretical foundation and has shown to be useful in practice. Integrating ethical issues in HTAs can be of great importance with respect to the dissemination of HTA results and in efficient health policy making.

The HTA Core Model: A novel method for producing and reporting health technology assessments

OBJECTIVES The aim of this study was to develop and test a generic framework to enable international collaboration for producing and sharing results of health technology assessments (HTAs). METHODS Ten international teams constructed the HTA Core Model, dividing information contained in a comprehensive HTA into standardized pieces, the assessment elements. Each element contains a generic issue that is translated into practical research questions while performing an assessment. Elements were described in detail in element cards. Two pilot assessments, designated as Core HTAs were also produced. The Model and Core HTAs were both validated. Guidance on the use of the HTA Core Model was compiled into a Handbook. RESULTS The HTA Core Model considers health technologies through nine domains. Two applications of the Model were developed, one for medical and surgical interventions and another for diagnostic technologies. Two Core HTAs were produced in parallel with developing the model, providing the first real-life testing of the Model and input for further development. The results of formal validation and public feedback were primarily positive. Development needs were also identified and considered. An online Handbook is available. CONCLUSIONS The HTA Core Model is a novel approach to HTA. It enables effective international production and sharing of HTA results in a structured format. The face validity of the Model was confirmed during the project, but further testing and refining are needed to ensure optimal usefulness and user-friendliness. Core HTAs are intended to serve as a basis for local HTA reports. Core HTAs do not contain recommendations on technology use.

The technological invention of disease

Technology has come to play a profound role in medicine since the middle of the 19th century, and many scholars have analysed the role of technology in medicine. Parallel to this development there has been a comprehensive debate on the concept of disease. This article combines these fields and investigates the influence of technology on the concept of disease. With reference to the literature it tries to elaborate an explicit account of the constitutive role of technology in relation to the concept of disease. It will be argued that technology constitutes the concept of disease in three profound ways. Firstly, technology provides the physiological, biochemical, and biomolecular entities that are applied in defining diseases. Secondly, it establishes the way we try to gain knowledge of disease and the way we recognise disease in practice. Technology constitutes the signs, markers and end points that define disease entities and it strongly influences the explanatory models of disease as well as medical taxonomy. Thirdly, technology establishes how we act towards disease: thorough diagnosis and treatment technology establishes the actions that constitute the concept of disease. Altogether, this constitutive technological influence on the concept of disease is considered as a technological invention of disease.

Stuck in the Middle: The Many Moral Challenges With Bariatric Surgery

Bariatric surgery is effective on short- and medium-term weight loss, reduction of comorbidities, and overall mortality. A large and increasing portion of the population is eligible for bariatric surgery, which increases instant health care costs. A review of the literature identifies a series of ethical challenges: unjust distribution of bariatric surgery, autonomy and informed consent, classification of obesity and selecting assessment endpoints, prejudice among health professionals, intervention in peoples life-world, and medicalization of appearance. Bariatric surgery is particularly interesting because it uses surgical methods to modify healthy organs, is not curative, but offers symptoms relief for a condition that it is considered to result from lack of self-control and is subject to significant prejudice. Taking the reviewed ethical issues into account is important when meeting persons eligible for bariatric surgery, as well as in the assessment of and decision making on surgery for obesity.

Ethics of palliative surgery in patients with cancer.

Surgery is an important palliative method for patients with advanced malignant disease. In addition to concerns related to clinical decision making, various moral challenges are encountered in palliative surgery. Some of these relate to the patients and their illness, others to the surgeons, their attitudes, skills and knowledge base.

The new holism: P4 systems medicine and the medicalization of health and life itself.

The emerging concept of systems medicine (or ‘P4 medicine’—predictive, preventive, personalized and participatory) is at the vanguard of the post-genomic movement towards ‘precision medicine’. It is the medical application of systems biology, the biological study of wholes. Of particular interest, P4 systems medicine is currently promised as a revolutionary new biomedical approach that is holistic rather than reductionist. This article analyzes its concept of holism, both with regard to methods and conceptualization of health and disease. Rather than representing a medical holism associated with basic humanistic ideas, we find a technoscientific holism resulting from altered technological and theoretical circumstances in biology. We argue that this holism, which is aimed at disease prevention and health optimization, points towards an expanded form of medicalization, which we call ‘holistic medicalization’: Each person’s whole life process is defined in biomedical, technoscientific terms as quantifiable and controllable and underlain a regime of medical control that is holistic in that it is all-encompassing. It is directed at all levels of functioning, from the molecular to the social, continual throughout life and aimed at managing the whole continuum from cure of disease to optimization of health. We argue that this medicalization is a very concrete materialization of a broader trend in medicine and society, which we call ‘the medicalization of health and life itself’. We explicate this holistic medicalization, discuss potential harms and conclude by calling for preventive measures aimed at avoiding eventual harmful effects of overmedicalization in systems medicine (quaternary prevention).

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.ZusammenfassungDie weit verbreitete Anwendung technischer Verfahren im Gesundheitswesen hat eine Vielfalt von Herausforderungen in den Vordergrund gerückt. Um einigen dieser Herausforderungen gegenübertreten zu können, ist das Gebiet des Health Technology Assessment (HTA, Beurteilung medizintechnischer Verfahren) entwickelt worden. Diese Strategie ist bisher jedoch nicht so erfolgreich wie man sich erhoffen könnte. Als einer der Gründe für diesen Umstand wurde früher angenommen, soziale und ethische Überlegungen seien aus dem HTA-Prozess ausgeklammert geblieben. Heute gehören jedoch gerade solche sozialen und ethischen Erwägungen zu vielen HTAs. Dennoch werden die Schlussfolgerungen und Empfehlungen der HTAs nicht befolgt. Der Grund hierfür könnte sein, dass die Ethik für HTA nicht ausreichend entwickelt ist, oder dass sie den Anforderungen von HTA nicht gerecht wird. In diesem Artikel wird ein ergänzender Ansatz zur ethischen Untersuchung im Rahmen von HTA präsentiert. Demnach ist eine Wertanalyse zwingend notwendig, um die ethischen Fragen bearbeiten zu können und zu angemessenen Entscheidungen über solche Technologien zu gelangen.RèsuméL’application largement répandue de procédés technologiques dans le domaine de la santé a mis en lumiére un grand nombre de défis. Le domaine de l’évaluation des technologies de la santé (ETS) a été développé pour maîtriser quelques uns de ces défis. Cette stratégie n’a cependant pas rencontré le succés escompté. On en vit tout d’abord la raison dans le fait que les aspects sociaux et éthiques n’avaient pas été pris en compte dans le processus d’ETS. Aujourd’hui pourtant, des considérations sociales et éthiques ont été intégrées dans de nombreuses ETS. Mais les conclusions et les recommandations des ETS ne sont toujours pas suivies. Cela s’explique peut-être par un développement insuffisant des aspects éthiques appliqués à l’ETS, ou par leur caractére inadéquat. Cet article présente une approche complémentaire des réflexions éthiques dans l’ETS. Il montre qu’une analyse des valeurs est essentielle pour aborder de maniére fructueuse les questions éthiques liées aux technologies médicales et pour déboucher sur des décisions viables sur ces technologies.

Making sense of complexity in context and implementation: the Context and Implementation of Complex Interventions (CICI) framework

BackgroundThe effectiveness of complex interventions, as well as their success in reaching relevant populations, is critically influenced by their implementation in a given context. Current conceptual frameworks often fail to address context and implementation in an integrated way and, where addressed, they tend to focus on organisational context and are mostly concerned with specific health fields. Our objective was to develop a framework to facilitate the structured and comprehensive conceptualisation and assessment of context and implementation of complex interventions.MethodsThe Context and Implementation of Complex Interventions (CICI) framework was developed in an iterative manner and underwent extensive application. An initial framework based on a scoping review was tested in rapid assessments, revealing inconsistencies with respect to the underlying concepts. Thus, pragmatic utility concept analysis was undertaken to advance the concepts of context and implementation. Based on these findings, the framework was revised and applied in several systematic reviews, one health technology assessment (HTA) and one applicability assessment of very different complex interventions. Lessons learnt from these applications and from peer review were incorporated, resulting in the CICI framework.ResultsThe CICI framework comprises three dimensions—context, implementation and setting—which interact with one another and with the intervention dimension. Context comprises seven domains (i.e., geographical, epidemiological, socio-cultural, socio-economic, ethical, legal, political); implementation consists of five domains (i.e., implementation theory, process, strategies, agents and outcomes); setting refers to the specific physical location, in which the intervention is put into practise. The intervention and the way it is implemented in a given setting and context can occur on a micro, meso and macro level. Tools to operationalise the framework comprise a checklist, data extraction tools for qualitative and quantitative reviews and a consultation guide for applicability assessments.ConclusionsThe CICI framework addresses and graphically presents context, implementation and setting in an integrated way. It aims at simplifying and structuring complexity in order to advance our understanding of whether and how interventions work. The framework can be applied in systematic reviews and HTA as well as primary research and facilitate communication among teams of researchers and with various stakeholders.

Ethical Challenges with Welfare Technology: A Review of the Literature

Demographical changes in high income counties will increase the need of health care services but reduce the number of people to provide them. Welfare technology is launched as an important measure to meet this challenge. As with all types of technologies we must explore its ethical challenges. A literature review reveals that welfare technology is a generic term for a heterogeneous group of technologies and there are few studies documenting their efficacy, effectiveness and efficiency. Many kinds of welfare technology break with the traditional organization of health care. It introduces technology in new areas, such as in private homes, and it provides new functions, e.g. offering social stimuli and entertainment. At the same time welfare technology is developed for groups that traditionally have not been extensive technology users. This raises a series of ethical questions with regard to the development and use of welfare technologies, which are presented in this review. The main challenges identified are: (1) Alienation when advanced technology is used at home, (2) conflicting goals, as welfare technologies have many stakeholders with several ends, (3) respecting confidentiality and privacy when third-party actors are involved, (4) guaranteeing equal access and just distribution, and (5) handling conflicts between instrumental rationality and care in terms of respecting dignity and vulnerability. Addressing these issues is important for developing and implementing welfare technologies in a morally acceptable manner.