"Introduction. The recent introduction of extremely effective drugs in treating diseases, but associated with exorbitant costs raised several issues in terms of distributive justice. However, in this ...debate justice is widely thought in intragenerational terms. The work will explore the concept of intergenerational health care justice, in particular the argument, often used to justify the introduction of this type of drugs, according to which the vast amount of money spent now will allow to have savings in the long run. The recent introduction of some drugs that are extremely effective in treating diseases but associated with exorbitant costs, raised several issues in terms of distributive justice. However, in this debate justice is widely thought in intragenerational terms. Methods: A review of key documents on intergenerational justice was conducted, followed by a nonsystematic review of peer-reviewed and gray literature. The existing material was analyzed and a draft manuscript was prepared and discussed. Some experts carried out the revision of the manuscript until consensus was reached. Results: The concept of intergenerational health care justice has never been well explored. From an intergenerational point of view, the argument – which is often supported by pharmaco-economic evaluations – according to which the vast amount of money spent now for this type of drugs will allow to have savings in the long run is not in itself coherent with the main theories of justice. Conclusions: Considerations that are extrinsic to the assumptions of the main theories of justice are needed in order to justify the argument above. "
Medical Anthropology is an interdisciplinary subfield of anthropology focused on the relationship between health, illness, and culture. It emerged as a formal area of study after World War II, when ...anthropologists began to formalize the process of applying ethnographic methods and theories to questions of health around the world. Medical anthropologists use anthropological theories and methods to generate unique insights into how different cultural groups around the world experience, interpret, and respond to questions, such as: How does a particular culture define health or illness? How might a diagnosis or condition be interpreted by different cultures? How are different conditions stigmatized or even celebrated in specific cultural contexts? We argue that the analysis and resolution of ethical dilemmas in clinical contexts as well as clinical ethics consultation itself might benefit from this young discipline. In particular, Medical Anthropology can help to better understand "human nature," and to identify "good solutions" for people with different cultural backgrounds.
A Perinatal Hospice is a place where different skills and specialties converge in order to guarantee optimal support to the family and the still unborn child, following a prenatal diagnosis with an ...unfortunate "quoad vitam" prognosis (i.e., end-life condition and/or life-limiting condition). However, a perinatal hospice is not just a place, but above all an approach to the patient characterized by interdisciplinarity, a shared medicine that speaks of a relational model of care and assistance, based on listening and accepting. This last characteristic makes hospices the place par excellence where the nascent life is respected in all its fragility and vulnerability. The accompaniment path are calibrated on the needs of the unborn child and the family, thus making perinatal hospices a place of hope rather than a place of death. The continuous search for the best assistance strategies opens up new care and assistance perspectives for diagnoses that were considered incompatible with extrauterine life until a few years ago. In this context of professionals coming from different specialties, a connecting figure may be useful: a figure who could stimulate, integrate and support the reflections of each specialist, placing them at the service of the good of the assisted families. Thus, the clinical ethics consultant gains a very specific value within the multidisciplinary team. Starting from a contextual analysis, and reaching an interdisciplinary evaluation, the consultant facilitates the Perina tal Hospice team and the family in the complex work of shared treatment planning: this will occur by examining the therapeutic perspectives and the ethical principles involved in each of the possible scenarios, in order to safeguard the good of the unborn children and their families. This paper will illustrate the specific experience of the clinical ethics consultant within the multidisciplinary perinatal hospice team "Mother Teresa of Calcutta" operating within the Fondazione Policlinico Universitario "A. Gemelli" IRCCS, in Rome.
Since Italian liver allocation policy was last revised (in 2012), relevant critical issues and conceptual advances have emerged, calling for significant improvements. We report the results of a ...national consensus conference process, promoted by the Italian College of Liver Transplant Surgeons (for the Italian Society for Organ Transplantation) and the Italian Association for the Study of the Liver, to review the best indicators for orienting organ allocation policies based on principles of urgency, utility, and transplant benefit in the light of current scientific evidence. MELD exceptions and hepatocellular carcinoma were analyzed to construct a transplantation priority algorithm, given the inequity of a purely MELD‐based system for governing organ allocation. Working groups of transplant surgeons and hepatologists prepared a list of statements for each topic, scoring their quality of evidence and strength of recommendation using the Centers for Disease Control grading system. A jury of Italian transplant surgeons, hepatologists, intensivists, infectious disease specialists, epidemiologists, representatives of patients’ associations and organ‐sharing organizations, transplant coordinators, and ethicists voted on and validated the proposed statements. After carefully reviewing the statements, a critical proposal for revising Italy's current liver allocation policy was prepared jointly by transplant surgeons and hepatologists.
The authors present a critical proposal for the implementation of the current liver allocation policy in Italy developed following the results of a national Consensus Conference process aimed to revise, on the basis of scientific evidence, the best indicators for guiding organ allocation policies in the urgency, utility, and benefit models. See the editorial from Berg on page 2537.
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BFBNIB, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Health technology assessment (HTA) aims, through empirical analysis, to shed light on the value of health technologies (O’Rourke et al. 2020, International Journal of Technology Assessment in Health ...Care 36, 187–90). HTA is, then, where facts and values meet. But how, where, and when do facts and values meet in HTA? Currently, HTA is usually portrayed as a sequential process, starting with empirical analysis (assessment), followed by a deliberation on the implications of the findings for a judgment of a health technology’s value (appraisal). In this paper, we will argue that in HTA, empirical analysis and normative inquiry are much more closely entwined. In fact, as we hope to show, normative commitments act as an indispensable guide for the collection and interpretation of empirical evidence. Drawing on policy sciences, we will suggest a concrete methodology that can help HTA practitioners to integrate empirical analysis and normative inquiry in a transparent way. The proposed methodology can be conceived as a concrete means for conducting a scoping exercise in HTA. Moreover, it offers a distinct way of giving stakeholders a structural and constructive role in HTA. This paper outlines the approach developed by the values in doing assessments of health technologies project, a project funded by the Erasmus+ program (contract number 2018-1-NL01-KA203-038960), which is the European Union’s program to support education, training, youth, and sport in Europe. The project has resulted in an E-learning course, an accompanying handbook, and a consensus statement, all freely available from the project’s website www.validatehta.eu.
Clinical Ethics Consultation (CEC) provides an interdisciplinary comparison among several professionals who find themselves discussing complex and often very controversial issues. The different ...strictly clinical points of view (according to their training and background) and the different personal/moral approaches can make counseling a real challenge. The observation of the performance of some CECs by an external observer with skills in communication in the health field has allowed us to highlight different personal perspectives that make it difficult to understand each other on a technical level and to make shared decisions. We suggest integrating in CECs the Six Thinking Hats technique as a new approach. De Bono's Six Thinking Hats is a powerful technique for looking at decision making from different perspectives. The Six Thinking Hats technique allows professionals to look at a problem in six different ways, beyond any instinctive positions, and to explore a range of perspectives. It involves six distinct types of thinking, each represented by a different hat: (1) Blue Hat: organization and planning; (2) Green Hat: creative thinking; (3) Red Hat: feelings and instincts; (4) Yellow Hat: benefits and values; (5) Black Hat: risk assessment; (6) White Hat: information gathering. By "wearing" each of the Six Thinking Hats, everyone in the team can gain a rich understanding of the issues and the best ways forward. It also encourages everyone to be fully involved in the decision-making process. This new tool will be applied in a pilot study of 10 consultations in the pediatric-neonatological field at "A. Gemelli" Teaching Hospital Rome (Italy), to evaluate the degree of feasibility, reproducibility and effectiveness of this approach, before introducing it routinely in our consultations.
•Prioritization decisions are political decisions that are value-laden.•Italian pandemic vaccination program is characterized by limited presence of ethical considerations.•Pandemic vaccination ...programs should combine ethical considerations with technical-scientific data.•“VALIDATE” (https://validatehta.eu/) is profitable to address critical points of pandemic vaccination programs.
Prioritization of COVID-19 vaccines is one of the most relevant topics in the current pandemic emergency. Prioritization decisions are political decisions that are value-laden, and as such of ethical nature. Despite the clear political and ethical nature of this topic, prioritization decisions are often interpreted and presented as scientific decisions. The aim of this article is twofold. First, we aim to show critical points that characterize certain pandemic vaccination plans from the ethical viewpoint using four dimensions (problem definitions, incorporation of different perspectives, context, and specification). The four dimensions were drawn from findings of the European project “VALIDATE” (VALues In Doing Assessments of healthcare TEchnologies”, https://validatehta.eu). Second, we aim to reframe the issue about prioritization itself in the light of the four dimensions mentioned. Our conclusion is that policy-problem definitions, incorporation of different perspectives, contextual considerations and specification of moral principles seem to be common critical points of some vaccination plan documents. The European project “VALIDATE” seems to be able to provide a useful and profitable approach to address many of these critical points.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background: Although value issues are increasingly addressed in health technology assessment (HTA) reports, HTA is still seen as a scientific endeavor and sometimes contrasted with value judgments, ...which are considered arbitrary and unscientific. This article aims at illustrating how numerous value judgments are at play in the HTA process, and why it is important to acknowledge and address value judgments.
Methods: A panel of experts involved in HTA, including ethicists, scrutinized the HTA process with regard to implicit value judgments. It was analyzed whether these value judgments undermine the accountability of HTA results. The final results were obtained after several rounds of deliberation.
Results: Value judgments are identified before the assessment when identifying and selecting health technologies to assess, and as part of assessment. They are at play in the processes of deciding on how to select, frame, present, summarize or synthesize information in systematic reviews. Also, in economic analysis, value judgments are ubiquitous. Addressing the ethical, legal, and social issues of a given health technology involves moral, legal, and social value judgments by definition. So do the appraisal and the decision-making process.
Conclusions: HTA by and large is a process of value judgments. However, the preponderance of value judgments does not render HTA biased or flawed. On the contrary they are basic elements of the HTA process. Acknowledging and explicitly addressing value judgments may improve the accountability of HTA.
Abstract
Objectives
To conduct a formative evaluation of applying the VALIDATE approach in practice by (i) assessing how students appreciated the e-learning course, (ii) exploring how, for what ...purposes and with what outcomes the acquired VALIDATE competences subsequently were used in internships in different institutional contexts, and how this was shaped by these contexts, and (iii) what this shows on real-world use of VALIDATE.
Methods
Comparative discussion of experiences of applying the VALIDATE approach via a semistructured survey and oral feedback from e-course students; final reports on internships in health technology assessment (HTA) practice, followed by semistructured interviews with interns and supervisors to complement and interpret results.
Results
All students considered the VALIDATE approach an enlightening and important addition to current HTA knowledge, especially regarding understanding the relation between empirical analysis and normative inquiry, identifying policy relevant questions and using the method of reconstructing interpretive frames for scoping. The latter appeared intellectually challenging and requiring some prior HTA knowledge. The use the VALIDATE approach in practice shows that interns productively redefined the HTA problem, based on appreciation of different stakeholders’ definition of the issue; they experienced constraints from retrieving all relevant perspectives from existing literature as well as from institutional rules and routines.
Conclusions
Some challenges in applying the VALIDATE approach deserve attention for its future use: currently used research approaches often assume a problem as “given”; and the data needed on different perspectives is often not reported in scientific literature. Finally, data gathering on and evaluation of value dimensions was experienced as challenging.
OBJECTIVE:The study proposes a possible roadmap for the ethical assessment of sham surgery clinical trials (CTs), focusing on methodological aspects, as a result of the lack of this type of practical ...tool in the literature/practice.
BACKGROUND:Surgical procedures are frequently conducted without closely controlled studies. For this reason, these procedures are less rigorous than those for drug/device clinical trials. The aim of a sham (placebo) surgery CT is to carry out a surgical CT with a legitimate control group. The use of sham surgery is controversial from an ethical point of view.
METHODS:This evaluation system is set up according to ICH/GCP, World Medical Association Declaration of Helsinki, CONSORT 2010 standards. The proposed roadmap is based on the following 4 steps/levelssafety/clinical indications; adequacy of trial methodology/design adopted for a sham surgery CT; specific informed consent, and economic issues.
RESULTS:A flowchart is proposed which can be used at two levelsas a basic guideline for the design of a surgical protocol representing a benchmark level of care; and a multiaxial assessment considering the first two sources of morality of human acts according to Aristotelian ethicsthe object of the act (step 1) and some of its circumstances (steps 2–4).
CONCLUSIONS:The use of a placebo and of double-blind control groups in surgery CTs would improves the quality of results, providing that an accurate ethical assessment procedure is in place, firstly to ensure patient safety and secondly to prevent abuses/procedural biases. Future testing of the proposed flowchart is outlined.
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