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Lack of available organs poses a significant challenge in meeting the needs of patients with life-threatening liver disease who could benefit from liver transplantation (LT). Psychosocial vulnerability markers have been linked to post-transplant outcomes, raising questions about their use in patient selection. However, their incorporation into selection criteria raises concerns about health equity and potential discrimination. As a result, there is a pressing need to refine fair allocation systems that consider both clinical and psychosocial factors to ensure equitable access and optimize post-transplant outcomes. The Equitable Benefit Approach (EBA) proposed in this paper by the multidisciplinary group of clinical experts in LT from the Italian Society for the Study of the Liver seeks to address these concerns. It presents four procedural principles, the two allocative principles usually applied in transplantation (urgency and utility) and introduces a new one, the principle of health equity. The EBA aims to prioritize patients with the highest transplant benefit while addressing health inequalities. It emphasizes evidence-based decision-making and standardized assessment tools to reliably evaluate psychosocial risk factors. Implementing the EBA involves a multi-step process, including stakeholder engagement, prospective studies to validate its efficacy, development of institutional policies and algorithms, and ongoing monitoring and revision. By following these steps, health care providers can ensure that LT allocation decisions are transparent and responsive to evolving clinical and social contexts. Ultimately, the EBA should offer a comprehensive framework for fair patient selection in LT, considering both biomedical and psychosocial aspects.

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Il contributo riguarda il ruolo della Bioetica clinica nella accoglienza della fragilità, particolarmente nella esperienza dell'"hospice perinatale" all'interno della Fondazione Policlinico Universitario "A. Gemelli" (FPG) IRCCS (Roma, Italia). Dopo avere definito cosa sia la consulenza di etica clinica (CEC), la riflessione sviluppa come il Servizio CEC-FPG contribuisca all'hospice perinatale, segnatamente attraverso lo strumento del documento condiviso di orientamento etico assistenziale.

This chapter aims to analyze the impact of the rise of Big Data, including ethical issues, particularly on the “beginning-of-life” topic. This was carried out in the light of updated available scientific literature. We have structured the chapter in three main parts: the first one is a general overview on Big Data as a whole, as it exceeds Biomedicine field; the second one reviews of main questions and applications of Big Data in healthcare; and the third one analyzes its potential usage and bioethical issues generated by it when detailing beginning-of-life issues. We have critically reviewed the main issues, including ethical, legal, and social implications (ELSI) appertaining to this topic and found that, even if Big Data era is in its infancy in this field, both from theoretical and operational points of view, it has a major development potential, and stakeholders should take it into account and use it at its full potential.

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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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.

Digital therapeutics (DTx) are a subset of digital health which are often coupled with artificial intelligence (A.I.) techniques and machine learning systems. DTx differ from common wellness apps or medication reminder tools in that they require "rigorous" clinical evidence. They are emerging as a new treatment option and are being applied in a variety of areas, including type II diabetes, hypertension, chronic respiratory problems, obesity, insomnia, Alzheimer's disease, various types of dementia or addiction (smoking, alcohol, drugs), anxiety, depression, autism, learning disabilities, and attention deficits. Today, there are roughly 35 to 40 products on the market, 8 of which approved by regulatory agencies. The value of the global DTx market was estimated at USD 1.8 billion in 2018, and it is expected to reach USD 8.9 billion by 2027. Implementing DTx across healthcare systems raises a number of ethical concerns. The present article aims to provide an overview of the main ethical issues pertaining the assessment, implementation, and use of this emerging technology. The final purpose is to support and facilitate an open and transparent deliberation with regard to DTx.

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.

Background Si afferma spesso che l’HTA debba molto del suo successo al legame con l’Evidence-based Medicine (EBM), un approccio alla medicina che pone enfasi su un particolare tipo di “evidenza”, ossia quella proveniente dagli studi randomizzati (RCTs) e le revisioni sistematiche. In tempi recenti, tuttavia, i processi di HTA sembrano sempre di più incorporare nelle valutazioni dati provenienti da studi non randomizzati e di Real World Evidence. È un fenomeno preoccupante? L’HTA sta forse abbassando la qualità delle sue indagini? I report di HTA hanno bisogno necessariamente di dati provenienti da RCTs e revisioni sistematiche per essere realizzati? Obiettivi del lavoro L’obiettivo del lavoro è quello di provare a fornire una risposta a tali quesiti. In particolare, l’obiettivo è quello di esplicitare, da un punto di vista epistemologico, il ruolo che gli studi non randomizzati e i RWD possono svolgere nei processi di HTA. Metodologia del lavoro L’analisi verrà condotta attraverso un processo di rivisitazione delle principali conclusioni a cui è pervenuta l’odierna epistemologia della scienza sul tema dell’evidenza e della loro applicazione al campo dell’HTA nell’ambito del progetto VALIDATE (VAlues in Doing Assessments of healthcare Technologies). Quest’ultima è una ricerca finanziata dall’Unione Europea nell’ambito del programma Erasmus+ per la formazione della prossima generazione di esperti nell’HTA. Per l’analisi autori di riferimento saranno coloro i quali hanno contribuito, a vario titolo, al superamento in ambito filosofico della c.d. dicotomia “fatti-valori” come Popper, Khun, Duhem, Quine, Gadamer, Habermas e Putman. Conclusioni Gli studi randomizzati e RWD non rappresentano una minaccia per l’HTA. Le questioni che accompagnano il loro uso non sono questioni di legittimità ma di rilevanza.

Digital therapeutics (DTx) are innovative evidence-based medical interventions, driven by high- quality software programs to prevent, manage, or treat diseases of patients. DTx are also defined as “drugs” where algorithms are the active ingredient instead of a chemical or biological substance. DTX can be used alone or in combination with other devices or medications. DTxs are finding application in a variety of areas, including chronic diseases (type II diabetes, hypertension, obesity, insomnia, Alzheimer’s), and above all addictions (alcohol, smoking, and drugs). Today there are roughly 35 to 40 products on the market, 8 of which approved by regulatory agencies. The value of the global DTx market has been estimated at USD 1.8 billion in 2018, and it is expected to reach USD 8.9 billion by 2027. DTx differ from common wellness apps or medication reminder tools in that they require “rigorous” clinical evidence. However, their use raises a number of ethical concerns. Aim of the present work is to provide an overview of the main ethical issues pertaining the assessment of this emerging technology. The final purpose is to support and facilitate an open and transparent ethical debate with regard to DTx.

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.

This chapter is focused on the so-called “fact/value dichotomy”. In the current practice of HTA, value judgments are often considered external to HTA or separate from it and are addressed by experts (in ethics) and decision makers after the “real” HTA is finished. In other words, facts and values seem to be two completely different “substances” that come from two completely different sources. Is this dichotomy attainable? 2) is it desirable? This chapter will argue that a strict fact-value distinction is not so easy to maintain, based on insights from Philosophy and HTA practice. Key messages of this chapter: HTA cannot be considered a matter of collecting the facts about a certain health technology, but rather “a matter of collecting facts that are considered plausibly associated with the use of the technology, relevant, and amenable to accepted methods of scientific inquiry”.

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.

This chapter is focused on the so-called “fact/value dichotomy”. In the current practice of HTA, value judgments are often considered external to HTA or separate from it and are addressed by experts (in ethics) and decision makers after the “real” HTA is finished. In other words, facts and values seem to be two completely different “substances” that come from two completely different sources. Is this dichotomy attainable? 2) is it desirable? This chapter will argue that a strict fact-value distinction is not so easy to maintain, based on insights from Philosophy and HTA practice. Key messages of this chapter: HTA cannot be considered a matter of collecting the facts about a certain health technology, but rather “a matter of collecting facts that are considered plausibly associated with the use of the technology, relevant, and amenable to accepted methods of scientific inquiry”.

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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ackground and Aim: Digital health technologies (DHTs) are one of the most promising perspectives in healthcare. On the other hand, the investment in of DHTs has an impact on the (ethical, economic, organizational, environmental) sustainability of National Healthcare Systems (NHSs). A relevant tool for supporting healthcare decision-makers is Health Technology Assessment (HTA), ‘a multidisciplinary process that summarizes information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner’ (EUnetHTA 2007). The aim of our contribution is to deal with HTA around DHTs, particularly ethical, legal and social implications (ELSI). Materials and Methods: The literature/documentation review on HTA and DHTs was carried out on PubMed database through a query, merging the following MESH terms: “digital technolog*”; healthcare; health technology assessment; HTA (last access. August 17, 2021). Results: 90 items were found: 4 were considered relevant for our analysis. The literature on our focus is at the very beginning. Early contributions underline as follows: 1. current HTA frameworks are not well equipped for assessing DHTs. The development of DHT-specific content for HTA frameworks is hampered by DHTs having varied benefit and risk profiles (von Huben et al., 2021); 2. existing HTA process should be adapted for assessing DHTs, including to make provisions for an assessment of app cybersecurity, the impact on DHT clinical utility of software updates, and compatibility issues (Moshi et al., 2020) as well as the need for standardization of reporting characteristics of eHealth services, and specifying assessment outcomes and methods following a stepped-approach tailored to the functional characteristics of eHealth services (Vis et al., 2020); 3. attention should also be paid to ethical issues, such as data privacy, and technology specific characteristics (Moshi et al., 2018).

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.

Una delle questioni più spinose che accompagna il dibattito sulla campagna vaccinale anti-SARS-CoV-2/COVID- 19 è quella che riguarda l’accesso ai vaccini, ossia l’ordine di priorità da seguire, soprattutto nella fase iniziale di somministrazione, caratterizzata da un forte squilibrio tra domanda e offerta. In Italia, l’accesso è regolato dal Piano strategico dell’Italia per la vaccinazione anti-SARS-CoV-2/COVID-19 del dicembre 2020, a cui ha fatto seguito un documento di aggiornamento del febbraio 2021. L’obiettivo del presente contributo è di analizzare sotto un profilo etico i due documenti, approfondendo in particolare il tema delle giustificazioni che sono alla base delle scelte prese e del loro inquadramento rispetto alla prospettiva egualitarista del Servizio Sanitario Nazionale (SSN) italiano

This workshop will deepen understanding the role of Hospital Based HTA on the decision making; participants will learn the steps for developing an assessment in hospital-based context and tools to perform a rapid assessment; it will be presented the implementation process of its recommendations. For each section there is an analysis of the impact of the pandemic. The coronavirus pandemic has changed the global scenario regarding healthcare and the use of tools such as HB-HTA. Operational processes have become much faster and there has been a greater need for information on technologies for diagnosing and treating COVID. Which of these had a rationale, some potential evidence, which impact on the organization and which costs. All questions to which the Hospital Based HTA was asked to give answers that required its reorganization both of a methodological and operational type. The workshop aims to illustrate these changes resulting from real experiences lived in different parts of the globe. 1. Main role of HB-HTA – functions 2. Has HB-HTA role changed as a consequence of the pandemic? 3. Steps for a HB-HTA, relying on AdHopHtA 4. Rapid Assessment? Criteria 4.a. Assessment of clinical outcomes, evidence level and safety 4.b. Assessment with real world HTA 4.c. Assessment of patient perception 4.d. Assessment of economic consequences 4.e. Assessment of organizational consequences 4.f. Assessment of other potential aspects: Strategical, legal, ethical etc. 4.g. How to ensure the quality of HB HTA? 5. Implementation process of the HB-HTA recommendations into the hospital decision making. Impact of pandemic 6. Discussion and closing • To give the participants: - an understanding of how HB HTA can be organized, produced and implemented at hospitals as the basis for decisions on investment in new health technologies - skills to produce high quality HB HTAs on their hospitals on the basis of the evidence from the AdHopHTA project. • To show potentials of HB-HTA to push for va

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Objectives. There is no consensus on who might be qualified to conduct ethical analysis in the field of health technology assessment (HTA). Is there a specific expertise or skill set for doing this work? The aim of this article is to (i) clarify the concept of ethics expertise and, based on this, (ii) describe and specify the characteristics of ethics expertise in HTA. Methods. Based on the current literature and experiences in conducting ethical analysis in HTA, a group of members of the Health Technology Assessment International (HTAi) Interest Group on Ethical Issues in HTA critically analyzed the collected information during two face-to-face workshops. On the basis of the analysis, working definitions of “ethics expertise” and “core competencies” of ethics experts in HTA were developed. This paper reports the output of the workshop and subsequent revisions and discussions online among the authors. Results. Expertise in a domain consists of both explicit and tacit knowledge and is acquired by formal training and social learning. There is a ubiquitous ethical expertise shared by most people in society; nevertheless, some people acquire specialist ethical expertise. To become an ethics expert in the field of HTA, one needs to acquire general knowledge about ethical issues as well as specific knowledge of the ethical domain in HTA. The core competencies of ethics experts in HTA consist of three fundamental elements: knowledge, skills, and attitudes. Conclusions. The competencies described here can be used by HTA agencies and others involved in HTA to call attention to and strengthen ethical analysis in HTA.

Tra i temi più discussi durante l’emergenza pandemica da Sars-CoV-2 c’è quello che riguarda l’accesso (o l’eventuale sospensione) a trattamenti intensivi (specificatamente i supporti ventilatori), nel caso di forte squilibrio tra necessità cliniche e risorse disponibili. Particolare clamore ha suscitato in Italia la pubblicazione il 6 marzo 2020, dunque in una delle fasi più gravi dell’emergenza, del documento Raccomandazioni di etica clinica per l’ammissione a trattamenti intensivi e per la loro sospensione, in condizioni eccezionali di squilibrio tra necessità e risorse disponibili ad opera della Società Italiana di Anestesia Analgesia Rianimazione e Terapia Intensiva (SIAARTI), per aver prospettato la possibilità di utilizzare l’età come criterio di accesso ai supporti ventilatori. Obiettivo del presente contributo è discutere l’impostazione teorica di fondo che SIAARTI ha adottato, e il criterio specifico che ha proposto per stabilire la priorità di trattamento dei pazienti intensivi nel contesto dell’emergenza. A ciò farà seguito un breve approfondimento della questione in chiave egualitarista.

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This work will aim at critically illustring the six-year experience of the master in “Clinical Bioethics Consultation” (2013-2018). This advanced second-level master was promoted by the Catholic University of the Sacred Heart of Rome, and co-worked by other Italian clinical as well as academic institutions (University Campus Bio-medico of Rome, Insubria University of Varese, “Federico II” University of Naples, Lanza Foundation of Padua, Local Health and Social Care Unit n. 7 (ULSS) of Veneto Region, Treviso; Ospedale San Giovanni Calibita Fatebenefratelli - Isola Tiberina, Rome, and Italian Group for clinical ethics consultation (GIBCE)). To this aim, it first will discuss two points: firstly, an epistemological one, i.e. the defence of the activity of ethicist consultant in clinical settings supported by the authors; and a pedagogical one, i.e. the identification of the learning needs clinical bioethics gives birth to. The second part of the work will focus on the experience of the Master, explaining its basic features (objectives, methods, contents, evaluation tools, etc), offering a critical review, and identifying the challenges this initiative has to face in the next future.

Gli odierni processi di HTA prevedono la valutazione di sicurezza, efficacia clinica e costo-efficacia relativi all’impiego di tecnologie sanitarie, e talvolta ad essi si aggiunge la valutazione degli aspetti organizzativi, etici, sociali e legali. Tali elementi di valutazione vengono, di norma, considerati singolarmente. Il principale inconveniente di questo approccio è che esso non tiene in debito conto il fatto che la selezione degli aspetti che devono essere valutati nel processo di HTA dipende, fondamentalmente, dal framework valoriale, a parte dal quale la valutazione viene condotta. I differenti stakeholders ragionano e agiscono essi stessi a partire da framework valoriali differenti, cosa che ha un evidente impatto sul processo di HTA. Pertanto, piuttosto che considerare gli aspetti etici, sociali e legali come separati, occorrerebbe riconoscere che essi costituiscono il framework a partire dal quale è possibile determinare quali evidenze empiriche sono necessarie, al fine di valutare il valore di una determinata tecnologia sanitaria. VALIDATE” (VAlues in Doing Assessments of healthcare Technologies) è un progetto finanziato dall’Unione Europea nell’ambito del programma Erasmus+. Il suo obiettivo consiste nel formare la prossima generazione di esperti nell’HTA ad utilizzare un approccio, dove la valutazione di sicurezza, efficacia e impatto economico risulti integrata a quella degli aspetti organizzativi, etici, sociali e legali. Obiettivo dell’intervento sarà quello di illustrare contesto, obiettivi, contenuti e output del progetto VALIDATE.

The course has been specifically developed for international participants and is based on more recent international achievements in the field. It will emphasize adapting approaches in ethics for all types of health technologies and across international settings. Participants who attend this course will strengthen their understanding and facilitate their participation in ethical assessment in HTA, as well their ability to participate in broader discussions. Most importantly it provides a number of approaches for ‘how to’ incorporate ethics into an HTA. After the preconference workshop participants will be able to: • explain and acknowledge the role of ethical issues in HTA; • recognize potential ethical issues in HTA and formulate appropriate research questions, • know about and use methods for analysing ethical issues; • know how to find and critically approach literature used when identifying ethical implications of health care technologies; • describe different ways of synthesizing and communicating the results of an ethics analysis.

La consulenza di etica clinica (CEC) si colloca quale peculiare expertise – un parere motivato a carattere consultivo – volto ad aiutare pazienti, familiari, operatori e manager sanitari, o quanti altri coinvolti direttamente o indirettamente nell’assistenza, in ordine a dubbi o conflitti morali che emergono nella pratica clinica caratterizzata oggi da una inedita complessità, e per la quale l’esperienza e la sensibilità del singolo medico possono non bastare per risolvere i problemi etici incontrati nell’esercizio della professione. Tra gli aspetti tecnici che vanno attenzionati, un peculiare ambito è rappresentato dalle modalità attraverso cui la CEC viene effettuata, vale a dire le procedure operative. Infatti, l’ordinata sequenza delle fasi, tramite cui un consulto etico si dipana, rappresenta un requisito necessario affinché l’obiettivo finale della CEC possa essere meglio raggiunto. L’obiettivo del presente contributo è dunque quello di contribuire al dibattito su questo argomento attraverso l’illustrazione delle procedure operative standard (SOPs) utilizzate dal Servizio di Bioetica clinica (SBC) svolto dall’Istituto di Bioetica e Medical Humanities (IBioMedH) dell’Università Cattolica del Sacro Cuore (UCSC) per la Fondazione Policlinico Universitario “A. Gemelli” IRCCS (FPUG) in Roma (Italia).

Objective:To investigate, through a questionnaire, older adults' demographic and socio-economic characteristics, knowledge, attitudes and practices in terms of food safety and healthy diet; and to develop dietary and hygiene indices able to represent participants' nutritional and food safety behaviour, exploring their association with demographic and socio-economic factors.Design:One-year cross-sectional study.Setting:Gemelli Teaching Hospital (Rome, Italy).Participants:People aged ≥65 years, Italian speaking, accessing the Centre of Ageing Medicine.Results:Mean age of the sample was 74 (sd 7·7) years. Subjective perception of a safe diet was high: 64·2 % of respondents believed they have a balanced diet. Interviewees got informed about proper nutrition mainly from television, magazines, newspapers, Internet (29·9 %) and from health professionals (34·8 %) such as dietitians, whereas 15·4 % from general practitioners. Regarding food safety, 33·8 % of participants reported to consume expired food, even more than once per month; between 80 and 90 % of participants reported to follow food safety practices during preparation and cooking, even though 49·3 % defrosted food at room temperature. Calculated dietary and hygiene indices showed that the elderly participants were far from having optimal nutritional and food safety behaviours.Conclusions:These results suggest it is necessary to increase the awareness of older adults in the matter of healthy diet and food safety. Specific and targeted educational interventions for the elderly and their caregivers could improve the adoption of recommended food safety practices and safe nutritional behaviours among older adults.