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La valutazione etica delle terapie digitali nei processi di Health Technology Assessment (HTA)

The AI-MIND EU funded project aims to develop an artificial intelligence (AI)-based digital tool, which will allow to estimate the risk of people with mild cognitive impairment to develop dementia. To facilitate its implementation in clinical practice, in the project attention is paid to the Health Technology Assessment (HTA) principles, criteria and model. HTA requires to assess clinical, safety, economical, organizational, ethical and legal implications of a given health technology (HT). In the AI-MIND project, first, a group explored the potential impact of the use of an AI on the doctor-patient relationship, then HTA experts identified potentially relevant issues for AI, and finally bioethical experts, trained in HTA, conducted an analysis on the role of explainability, a new ethical issue to take into consideration in an HTA process regarding AI-based HT. A Delphy panel conducted ended in April 2023 allowed to identify HTA issues potentially relevant for AI. 46 qualified experts from mainly provided their feedbacks. The highest level of consensus was reached on the importance of ethical issues, explainability included. Bioethical experts conducted an analysis on the role of explainability for AI-based digital tools for the risk assessment to develop dementia. Both global (information on the model as a whole) and local explainability (information on a specific prediction) were investigated and applied to the specific use case. Attention was dedicated to the designated role in the decision-making process (algorithm-based, -driven, or –determined) of the AI-MIND predicting tool. From the HTA perspective, explainability is increasingly considered crucial for ethical analysis and should be assessed in relation to other aspects such as the design of the technologies, the population target, or the market access. It should be one of the topic to address for building and implementing ethical AI-solutions for early diagnosis of dementia.

Intelligenza artificiale ed HTA: aspetti etici

"Evidence" is a key term in medicine and health services research, including Health Technology Assessment (HTA). Randomized clinical trials (RCTs) have undoubtedly dominated the scene of generating evidence for a long period of time, becoming the hallmark of evidence-based medicine (EBM). However, due to a number of misunderstandings, the lay audience and some researchers have sometimes placed too much trust in RCTs compared to other methods of investigation. One of the principal misunderstandings is to consider RCTs findings as isolated and self-apparent pieces of information. In other words, what has been essentially lacking was the awareness of the value-context of the evidence and, in particular, the value- and theory-ladenness (normativity) of scientific knowledge. This paper aims to emphasize the normativity that exists in the production of scientific knowledge, and in particular in the conduct of RCTs as well as in the performance of HTA. The work is based on some lessons learned from Philosophy of Science and the European project "VALIDATE" (VALues In Doing Assessments of healthcare TEchnologies"). VALIDATE was a three-year EU Erasmus+ strategic partnerships project (2018-2021), in which training in the field of HTA was further optimized by using insights from political science and ethics (in accordance with the recent definition of HTA). Our analysis may reveal useful insights for addressing some challenges that HTA is going to face in the future.

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Introduction: Ohtahara syndrome (OS) is a rare drug-resistant epileptic encephalopathy characterized by frequent tonic spasms or focal motor seizures associated with the specific electroencephalographic pattern of burst suppression. It begins in the first months of life and represents less than 4% of childhood epilepsy cases. The prognosis depends from the aetiology and is generally poor with death in most cases during early childhood. The management of severe encephalopathies associated with OS is controversial, especially regarding the strategies to ensure the well-being of young patients and their families, requiring a continuous modulation of medical interventions: from the intensity of care waiting for the diagnosis, to palliative care where a prognosis of incurability, up to the possible desist from intensive/invasive treatments when they are no longer proportionate to the current clinical situation. Objective: Through the case of M, a 38-week-old newborn, intubated and mechanically ventilated since birth due to the absence of spontaneous respiratory activity, for whom the clinical diagnosis of OS was reached at about 4 months of life, we intend to investigate the related ethical issues: a. the proportionality and ethical-clinical appropriateness of treatments in patients for whom a poor prognosis quoad vitam is reached; b. the decision-making process to be shared with the parents, those were unable to accept the irreversibility of their daughter's illness, despite the psychological support offered to them from the beginning. Discussion: In a situation of probably irreversible pathology, such as severe encephalopathy with cortico-subcortical dysfunction and electrical-clinical picture of OS, associated with the absence of respiratory trigger, in which elements capable of modifying the prognosis quoad vitam do not emerge, and it is difficult for the parents to elaborate awareness about the seriousness of the disease, it becomes difficult to identify the limits

In line with how ethics has developed for the last three centuries, public health ethics has been widely dominated by a deontological as well as a utilitarian approach. The latter is a version of consequentialism, which states that maximizing utility is the primary goal of the majority of individuals or group action, while, on the other hand, virtue ethics, or at least the appeal to virtues, has been largely marginalized. The aim of this article is twofold. Firstly, we aim to highlight the political and ethical nature of public health interventions, often interpreted and presented as mere scientific enterprises. Secondly, we try to highlight the need to integrate or at least recognize the value of appeal to virtues in public health measures. The analysis will reference the Italian COVID-19 vaccination program as a case study. Initially, we will explore the political and ethical nature of any public health measure, using the implementation of the COVID-19 vaccination program in Italy as an example. Subsequently, we will illustrate the deontological approach to ethics, the utilitarian one, and the virtues one, focusing on the dynamic of the agent’s perspective. Lastly, we will briefly analyze both the Italian COVID-19 vaccination program and the communication campaign that promoted it.

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Health technology assessment (HTA) aims, through empirical analysis, to shed light on the value of health technologies (ORourke 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 technologys 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 Unions 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 projects website www.validatehta.eu., Funding Agencies|Erasmusthorn Program of the European Union [2018-1-NL01-KA203-038960]

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., Funding Agencies|Erasmus+ Programme of the European Union [2018-1-NL01-KA203-038960]

Objectives: To conduct a formative evaluation of applying the VALIDATE approach in practice by 1) assessing how students appreciated the e-learning course, 2) 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 3) 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 HTA practice, followed by semi-structured 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 re-defined 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.

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.

A critical transformation of the current era seems to be medicine’s conquest of old age, beginning with its acquired ability to prolong human life. Providing increasingly effective health care for the elderly has become the most extensive of medicine’s frontiers. This is also an ideal of a moral nature: it is a discrimination unworthy of medicine the idea that the age of the patient can be a variable to be taken into account, if there are the technical means to be able to bring him the benefits (the standards of treatment should not take into account the age). However, not everyone considers this orientation justified. More recently, following the current pandemic of COVID-19 has indicated age as a limit to entry into intensive care. Then the question of whether laparoscopic surgery should also be applied to the elderly patient also arose at first, and the conclusion was reached that despite underlying comorbidities, individuals older than 65 years tolerate laparoscopic procedures extremely well. Besides, sickness speaks to us of our limitations and human frailty. It can take the form of infirmity resulting from the simple passing of years or injury from the exuberance of youthful energy. It can be temporary or chronic, debilitating, and even terminal, but ethical principles that govern medical decisions in elderly and frail patients should be no different from those that guide all medical choices in all patients, although any decision cannot fail to take into account the condition of the elderly and frail patient as a contextual aspect and not as a decisional criterion. In surgery, it has been more difficult than in medicine to understand that when surgery is no longer possible, the surgeon’s task is not yet finished and he can offer palliative treatment to accompany patient. At this point, the ethical question arises as to whether what is technically possible is also ethically right.

L’articolo presenta il Documento Condiviso di Orientamento Etico Assistenziale, quale strumento di supporto decisionale – utilizzato dal Servizio di Consulenza di Etica Clinica (SCEC) della Fondazione Policlinico Universitario “A. Gemelli” IRCCS (FPG) di Roma – in grado di rispondere alle esigenze della relazione clinica medico-paziente/famiglia da un lato e all’appropriato rispetto dell’autonomia dei soggetti coinvolti dall’altro. Dopo aver richiamato i concetti ispiratori di advance care planning e shared decision-making, l’articolo prende in esame le caratteristiche peculiari del Documento Condiviso, in particolare l’analisi del contesto, la metodologia relazionale, la personalizzazione del caso, la valutazione interdisciplinare, l’impatto sul paziente e la famiglia, il tempo di elaborazione, i benefici ad esso connessi. In ultimo, l’articolo si sofferma a presentare la casistica relativa all’elaborazione di questa forma peculiare di consulenza di Etica clinica da parte del SCEC-FPG. A tal fine, attraverso un’indagine retrospettiva, sono stati presi in esame i Documenti Condivisi elaborati dall’inizio dell’attività del Servizio, dal 1992 ad oggi, mettendoli in relazione con il numero delle consulenze complessive richieste ed effettuate, oltre che individuando le aree cliniche per le quali sono stati elaborati.

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