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Background The clinical ethics consultation (CEC) aims to help patients, relatives, caregivers and healthcare professionals to cope with ethical issues arising in patient care. CEC can be drafted in two different ways: 1. CEC provided by clinical ethics consultant requested by clinical wards; 2. CEC as “shared decision-making document” (SDM-D) among different “bedside” stakeholders (patient, relatives, healthcare professionals, health managers) aimed at an agreed advanced clinical planning, namely in dilemmatic/uncertain settings. In fact, SDM is “an approach where clinicians and patients share the best available evidence when faced with the task of making decisions, and where patients are supported to consider options, to achieve informed preferences” (Elwyn et al., 2010) Aim Assessing rising ethical/medico-legal issues in clinical cases requested for CEC and addressed through SDM-D. Methods We examined retrospectively SDM-Ds provided by IBioMedH-UCSC CEC Service and requested from different clinical Departments of “A. Gemelli” University Hospital Foundation (starting from January 2005 to December 2016), examining clinical indication, patient’s preferences, quality of life; context, in the light of personalist bioethical approach (Sgreccia, 1986).. Results 53 SDM-Ds out of 173 CECs were setup from 2005 to 2016. Clinical Departments that requested clinical ethics consultation were: Reproductive and maternal-Foetal Diseases (15, 28%); Internal Medicine & Infectious Diseases (12, 23%); Pediatrics and Neonatal care (11, 22%); Neurology (9, 15%); Hospice (3, 6%); Intensive Care Unit (2, 4%); Surgery (1, 2%). The following main ethical issues were recognized: cardiopulmonary resuscitation; tracheostomy, ectopic pregnancies; inducing childbirth; mechanical ventilation; palliative sedation. Possible ethical/medico-legal issues were identified: problems of communication and understanding between the parties; patients/family difficulties to identify benefits/burdens of treat

Background - Direct acting antivirals (DAAs) for hepatitis C virus (HCV) have quite changed the therapeutic routine in the last few years. Reported rates of sustained virological response (SVR), exceed 90% in all patients subgroups. Other, even more effective, DAAs combinations are being developed for use in the most difficult to treat and advanced patients, aiming for 100% of SVR in 100% of cases. The perspective is the eradication of HCV and reduction of main complications: liver cirrhosis and hepatocellular carcinoma. Aim and Methodology - Dealing with justice issues related to DAAs for HCV in Italy through the anlysis of available literature and documentation. Results - The ethical principle of beneficence/non maleficence is fulfilled for new DAAs. Otherwise, the principle of justice in a welfare context, like Italian National Health Service (NHS), generally requires “to give everyone his/her own" to feed citizens’ health needs. Anyway, in a setting of restricted access due to DAAs costs, availability and the wait for even better and universally applicable regimens is the crucial knot to deal with from justice perspective, also considering the need for a balance both of NHS expenditure and “inter nosological” fairness (e.g., oncology, neurology, etc.). So, the selection of patients for immediate treatment or deferral entails adherence to established and ethically accountable policies. In Italy, as well as in other countries, the early solution in 2015 was a stratification of patients for prioritization of treatment according a “needs-based” approach, which means allowing IFN-free DAAs treatment in patients with advanced fibrosis or cirrhosis, while keeping on hold persons with lesser stages of liver disease, through ‘informed deferral’ policies aimed at saving a really informed consent. Another justice issue is the conflict between the patient’s “right to care” and NHS economic charge due to the prevalence of HCV+ patients ≥ 70 yy (nearly half of overall infecte

The shoulder pain syndrome is the most frequent complication of lateral cervical neck dissection and may be caused by iatrogenic injury to the spinal accessory nerve, causing pain and functional limitation of the upper limb and of the cervical spine. Interdisciplinary collaboration and early rehabilitation can reduce the consequences of disability and the possible issues that can arise due to inadequate management of the problem

Sir William Osler is celebrated today not only for his contributions to the advancement of medical education, but also for the humanism he brought to the practice of medicine. He was a doctor whose bedside skills and manners were emulated, and can legitimately be called an infectious diseases specialist. Nonetheless, he was also a humanist in the broader sense of the term, a student of human affairs and human nature, who emphasised compassion for the individual. To what extent, if any, are today’s challenges influenced by departures from the paradigms created by Osler? In this paper we sought to ascertain whether such a tradition is still relevant to current practice and may foster a new perspective. We analysed two features of Osler’s legacy that may be useful to clinicians: the first is his vision of the patient-physician relationship; the second is his approach to humanities. William Osler saw medicine in its wider scope, with the right and duty to be concerned with the human condition as a whole. Indeed, his rounded concept of the medical profession as being engaged in helping and caring for the whole human being could help physicians build a more humanised medicine. Adopted in the age of evidence-based medicine, the Oslerian approach can enhance the relationship with patients and give physicians a role based on trust and authoritativeness rather than on authority.

Modificazioni controllate nel genoma sono possibili, tramite svariate tecniche, sin dagli anni ’70. Nucleasi a dito di zinco, nucleasi TALE, ma soprattutto CRISPR-Cas9 sono tecniche di editing genetico che hanno reso più semplice effettuarle. Il sistema CRISPR-Cas9, in particolare, si sta dimostrando estremamente vantaggioso in termini di accessibilità, efficienza e versatilità. Gli obiettivi del presente contributo consistono nel: 1. ricostruire i “fatti” salienti che hanno determinato l’emergere del topic dell’“editing genetico”; 2. provare a dar risposta a un primo fondamentale interrogativo circa l’originalità dei dilemmi etici da esso sollevato con particolare riferimento al CRISPR-Cas9. La conclusione è che, allo stato attuale, l’impiego di queste nuove tecniche non solleva questioni etiche nuove. L’unica eccezione sembrerebbe essere data dal particolare tipo di mutazioni indotte da queste tecniche, indistinguibili a lungo termine da quelle prodotte dalla natura, fatto che sta già determinando qualche difficoltà nella classificazione degli OGM ottenuti tramite queste tecniche.

OBJECTIVES: The clinical practice guidelines published by the Renal Physicians Association (USA) recommend instituting advance care planning (ACP) for patients with end-stage renal disease. Studies on this issue are lacking in Italy. Our aim was to determine the attitudes of patients on ACP in our dialysis centre. METHODS: We performed a cross-sectional survey. We recruited patients on maintenance haemodialysis (HD) at Hemodialysis Center of Università Cattolica del Sacro Cuore, from 1 March 2014 to 31 March 2015. The only exclusion criterion was inability to give an informed consent. Patients completed a questionnaire concerning their treatment preferences in three hypothetical disease scenarios: persistent vegetative state, advanced dementia, severe terminal illness; for each patients, we also collected clinical, functional and socioeconomic data. RESULTS: Thirty-four HD outpatients completed the study questionnaire. The majority of respondents (85%) considered information about prognosis, health conditions and treatment options, including withdrawing dialysis, as very important and 94% of respondents considered treatment of uraemic/dialytic symptoms the most important issue. In the health scenarios provided, dialysis was the treatment least withheld. Dependence on instrumental activities of daily living (0.048) and higher Charlson Comorbidity Index scores (p=0.035) were associated with continuing dialysis in at least one scenario. CONCLUSIONS: ACP should be tailored to patients' value, culture and preferences. A significant proportion of patients, however, do not want to be involved in end of life decisions. Frail elderly patients, in particular, are not inclined to interrupt dialysis, despite poor quality of life or a poor prognosis.

The aim of the present study is to propose legal reform limiting surgeons' criminal liability in high-accuracy and high-risk surgery such as endoscopic sinus surgery (ESS). The study includes a review of the medical literature, focusing on identifying and examining reasons why ESS carries a very high risk of serious complications related to inaccurate surgical manoeuvers and reviewing British and Italian legal theory and case-law on medical negligence, especially with regard to Italian Law 189/2012 (so called "Balduzzi" Law). It was found that serious complications due to inaccurate surgical manoeuvers may occur in ESS regardless of the skill, experience and prudence/diligence of the surgeon. Subjectivity should be essential to medical negligence, especially regarding high-accuracy surgery. Italian Law 189/2012 represents a good basis for the limitation of criminal liability resulting from inaccurate manoeuvres in high-accuracy surgery such as ESS. It is concluded that ESS surgeons should be relieved of criminal liability in cases of simple/ordinary negligence where guidelines have been observed.

Il contributo fornisce una visione di insieme delle attività dell’Istituto di Bioetica e Medical Humanities dell’Università Cattolica del Sacro Cuore di Roma a difesa della vita nascente. In particolare, si approfondisce il tema della didattica, della formazione e partecipazione al dibattito socio-culturale, della ricerca e documentazione, delle attività di consulenza e della dimensione internazionale.

Negli ultimi trent’anni anche nell’ambito della Storia della medicina si è accentuato un approccio narrativo, soprattutto nei Paesi anglosassoni. L’attenzione viene centrata sull’essere umano, sulle relazioni interpersonali, sulla storia individuale piuttosto che su quella collettiva. Tale prospettiva si avvale del contributo privilegiato della scrittura (il romanzo, la poesia, il teatro, le favole, i diari, gli epistolari) e di quello evocativo dell’arte. In primo piano l’esperienza di vita di medici e malati, ma anche di familiari, colta attraverso il processo empatico che l’opera suscita nel lettore/osservatore. La malattia è quindi vista come condizione esistenziale. Lo storico Roy Porter definisce questa prospettiva “the history from below” e ritiene possa essere utile nel ricostruire gli aspetti antropologici della malattia “from the patients’ point of view”. Lo studente di medicina “immergendosi” nelle storie di medici e malati del passato acquisisce la capacità di capire non solo la malattia ma di sentire l’esperienza del malato (empatia). Le storie aiutano a focalizzare ciò che manca o è andato perduto nella pratica medica, stimolano l’introspezione personale perché spingono a riflettere non sulle abilità pratiche (competenza tecnica) ma su se stessi, sulle proprie emozioni. Il linguaggio denotativo non esaurisce tutta la realtà umana perché «la medicina è contemporaneamente scienza naturale e scienza umanistica. Il chiarire e il comprendere sono necessari allo stesso modo» (D. Von Engelhardt).

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 CTis 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/levels: safety/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 levels: as 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 ethics: the 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.

Within surgical disciplines, obstetrics and anesthesia carry a greater risk of medicolegal liability although with improved monitoring and practice standards issued by national scientific societies such as the American College of Obstetricians and Gynecologists (ACOG) and the American Society of Anesthesiologists (ASA). Pain relief is becoming an area of concern. Analgesia refers to the relief of pain without the loss of consciousness. Modalities of analgesia during childbirth include regional analgesia, systemic opioid analgesia, continuous labor support, pudendal blocks, immersion in water during the first stage of labor, sterile water injections in the lumbosacral spine, hypnosis, and acupuncture. Even though there are multiple options for labor pain management, women often experience pain during childbirth in accordance with their expectations. The ASA Closed Claims database has shown that since the 1990s the proportion of claims associated with general anesthesia has progressively declined while the proportion associated with regional analgesia has steadily increased although the majority of maternal injuries are minor (e.g., headache, back pain, pain during analgesia, neuropsychological consequences). In addition, it reported that postnatal depression may be more common when analgesia is not used and pain during labor has been correlated with the development of posttraumatic stress disorder. Furthermore, men are also affected by severe labor pain. A survey of first-time fathers showed that the men whose partners received an epidural felt three times as helpful and involved during labor and delivery and had less anxiety and stress, as compared with men whose partners did not receive an epidural. All these situations may reflect unrealistic expectations and dissatisfaction with parturient care, and litigation serves the purpose not only of reparation of injury and deterrence of standard of care but also of emotional vindication. This is especially true in Italy

Il tema del corpo non conosce limiti spazio-temporali e investe tutto lo scibile umano dalla medicina alla psicologia, dall’arte e dalla letteratura alla musica. In particolare, nella storia della medicina, legata alle origini al mito di Chirone e alla sua ferita inguaribile, acquista rilevanza l’immagine del corpo ferito dalla malattia che molti artisti hanno indagato nelle loro opere. Lo sguardo dell’artista, nella formazione dello studente di medicina, è indispensabile affinchè la dimensione scientifica non riduca l’uomo alla sua malattia. La verità della scienza medica necessita di un’altra verità, quella che attraversa tutta la persona, la sua psiche, la sua fisicità. Alla luce di questo, tale contributo intende dare una lettura etico-antropologica del corpo ferito dalla malattia, dalla prospettiva dell’autoritratto ferito, genere scelto da alcuni artisti che, tra Ottocento e Novecento, hanno raffigurato il proprio disagio fisico o psichico (Van Gogh, Kahlo, Munch, Bacon, Klee). Siamo convinti che il linguaggio artistico, soprattutto quando trae origine dal vissuto personale, abbia una finalità etico-formativa per lo studente di medicina che può guardare oltre il tracciato medico-scientifico delle malattie per cogliere quella che lo storico Roy Porter definiva “the history from below”, ossia “from the patient point of view”.

Il tema del corpo non conosce limiti spazio-temporali e investe tutto lo scibile umano dalla medicina alla psicologia, dall’arte e dalla letteratura alla musica. In particolare, nella storia della medicina, legata alle origini al mito di Chirone e alla sua ferita inguaribile, acquista rilevanza l’immagine del corpo ferito dalla malattia che molti artisti hanno indagato nelle loro opere. Lo sguardo dell’artista, nella formazione dello studente di medicina, è indispensabile affinchè la dimensione scientifica non riduca l’uomo alla sua malattia. La verità della scienza medica necessita di un’altra verità, quella che attraversa tutta la persona, la sua psiche, la sua fisicità. Alla luce di questo, tale contributo intende dare una lettura etico-antropologica del corpo ferito dalla malattia, dalla prospettiva dell’autoritratto ferito, genere scelto da alcuni artisti che, tra Ottocento e Novecento, hanno raffigurato il proprio disagio fisico o psichico (Van Gogh, Kahlo, Munch, Bacon, Klee). Siamo convinti che il linguaggio artistico, soprattutto quando trae origine dal vissuto personale, abbia una finalità etico-formativa per lo studente di medicina che può guardare oltre il tracciato medico-scientifico delle malattie per cogliere quella che lo storico Roy Porter definiva “the history from below”, ossia “from the patient point of view”.

The implementation of the new pharmaceuticals for the treatment of chronic hepatitis C is currently facing cost and access issues. Less patients than needed are currently treated and many patients are forced to defer effective treatments. Irrespective from real effectiveness of these new drugs, health systems in many countries are facing a huge problem of distributive justice. While these should guarantee individual rights, among which the right to health - in its broader sense that is not limited to healing, but extended to quality of life - they also have to grant equal access new therapies Surmounting it will require collaboration among healthcare providers, drug manufacturers, local and national governments, and other stakeholders. Most urgently there is a need to consider ethical issues linked to access to new therapies and to eligibility criteria. In a setting of restricted access, the selection of patients for immediate treatment or deferral entails strict adherence to established, validated and ethically accountable policies.

This comprehensive executive summary reports on a case study designed to demonstrate the application of a number of the key concepts and methods developed in the INTEGRATE-HTA project to the assessment of complex technologies. The case study focuses on models of home based palliative care with and without an additional element of caregiver support, known as reinforced and non-reinforced home based palliative care respectively.

El artículo presenta un caso clínico, dirigido en el año 2011 por el equipo de servicio de consulta ética clínica del Instituto de Bioética y Humanidades Médicas de la Facultad “Agostino Gemelli” de Medicina de la Universidad Católica del Sacro Cuore en Roma (Italia). El caso clínico se refiere a los dilemas éticos sobre las perspectivas del paciente para recibir un trasplante hepático ortotópico porque no era residente del país y carecía de un cuidador para asistirlo durante el periodo de seguimiento, así como de un lugar para quedarse después de la cirugía.

The authors raise the question of what should be done when legally recognized human rights come into conflict. This serious problem is further complicated by a lack of consensus concerning prioritization among human rights. Nevertheless, the authors believe that a solid legal and ethical case can be made that the right to life should trump other human rights claims, particularly in its negative version. It is in fact, logically and chronologically the most basic human right. The authors believe that there is a strong logic to prioritizing the three generations of human rights as generally more important to less so. Viewing the problem of conscience rights in healthcare settings through the prism of conflicting rights and attempting to determine which rights should prevail is also a helpful exercise. The authors concur with the generally high position that the human right of conscience of healthcare professionals has been granted in most legislation and court decisions on the issue.

Trigger point "dry needling" is a technique used to treat myofascial pain. It involves using filiform needles which are inserted into muscles to give local pain relief. Few cases of serious adverse events following this treatment have been reported in the literature. In this paper we describe the case of a professional swimmer who developed pneumothorax after dry needling treatment and discuss the medicolegal and ethical aspects related to competencies and responsibilities of medical doctors and physiotherapists performing the procedure.

A Second level Master in “Clinical Bioethics Consultation” has been organized in Italy to offer an opportunity to offer an adequate training to carry out an ethics consultation in different health fields. The master has been promoted and realized by different institutions: Catholic University of Sacred Hearth in Rome, Insubria University in Varese, “Federico II” University in Naples, Lanza Foundation in Padua and the Local Health and Social Care Unit n.7 (ULSS) in Veneto Region. The aim of the master is train ethics consultants to offer help regarding a correct decision, which will take by others. The choice must be as much as possible shared between patient, family and health care team. Ethics consultation can be primarily request by the physicians, nurses and health care staff such as support about a choice that wants to be the most appropriate and to clarify a dilemma between different options. Secondly an ethics consultation can be demand by the patient and the family members to find a clarification about their dilemmas and future choices. Also the administrative staff could ask the consultation, when it need to better explain ad example about a specific clinical case or a question concerned the health policy.

Health Technology Assessment (HTA) is a multidisciplinary process that collect information about the medical, economic, organizational, social, legal and ethical issues related to the use of a certain health technology in a systematic, transparent, unbiased, manner. Its main purpose is to support health care decision-makers. From the conception of HTA in the 1970s, it has been argued that the ethical domain is a constitutive part of HTA and that value judgments are inherent in the whole process of HTA. Specifically, ethical domain aims at analyzing both the ethical questions that a given technology raises when it is put into use/disinvestment and the ethical issues that the HTA process itself raises. Despite almost 40 years with similar considerations, ethics has not so frequently been part of HTA reports. The paper provides an overview of the ethical domain within the HTA processes and the experience of the Institute of Bioethics and Medical Humanities of the Universita`Cattolica del Sacro Cuore.

Although existing clinical evidence shows that the transfusion of blood components is becoming increasingly safe, the risk of transmission of known and unknown pathogens, new pathogens or re-emerging pathogens still persists. Pathogen reduction technologies may offer a new approach to increase blood safety. The study is the output of collaboration between the Italian National Blood Centre and the Post-Graduate School of Health Economics and Management, Catholic University of the Sacred Heart, Rome, Italy. A large, multidisciplinary team was created and divided into six groups, each of which addressed one or more HTA domains.Plasma treated with amotosalen + UV light, riboflavin + UV light, methylene blue or a solvent/detergent process was compared to fresh-frozen plasma with regards to current use, technical features, effectiveness, safety, economic and organisational impact, and ethical, social and legal implications. The available evidence is not sufficient to state which of the techniques compared is superior in terms of efficacy, safety and cost-effectiveness. Evidence on efficacy is only available for the solvent/detergent method, which proved to be non-inferior to untreated fresh-frozen plasma in the treatment of a wide range of congenital and acquired bleeding disorders. With regards to safety, the solvent/detergent technique apparently has the most favourable risk-benefit profile. Further research is needed to provide a comprehensive overview of the cost-effectiveness profile of the different pathogen-reduction techniques. The wide heterogeneity of results and the lack of comparative evidence are reasons why more comparative studies need to be performed.

Hepatitis C virus (HCV) infection is a major health problem worldwide. Chronic HCV infection may in the long run cause cirrhosis, hepatic decompensation and hepatocellular carcinoma, with an ultimate disease burden of at least 350,000 deaths per year worldwide. The new generation of highly effective direct acting antivirals (DAA) to treat HCV infection brings major promises to infected patients in terms of exceedingly high rates of sustained virological response (SVR) but also of tolerability, allowing even the sickest patients to be treated. Even in the face of the excellent safety and efficacy and wide theoretical applicability of these regimens, their introduction is currently facing cost and access issues denying their use to many patients in need. Health systems in all countries are facing a huge problem of distributive justice, since while they should guarantee individual rights, among which the right to health in its broader sense, therefore not limited to healing, but extended to quality of life, they must also grant equal access to the healthcare resources and keep the distribution system sustainable. In the face of a disease with a relatively unpredictable course, where many but not of all chronically infected will eventually die of liver disease, selective allocation of this costly resource is debatable. In most countries the favorite solution has been a stratification of patients for prioritization of treatment, which means allowing Interferon-free DAA treatment only in patients with advanced fibrosis or cirrhosis, while keeping on hold persons with lesser stages of liver disease. In this report, we will perform an ethical assessment addressing the issues linked to access to new therapies, prioritization and eligibility criteria, analyzing the meaning of the term "distributive justice" and the different approaches that can guide us (individualistic libertarianism, social utilitarianism and egalitarianism) on this specific matter. Even if over time the pr

Il contributo affronta il tema della liceità da un punto di vista etico dell'uso degli analgesici, dei narcotici e della sedazione palliativa profonda

Ethics has been identified as a key element in Health Technology Assessment (HTA) since its conception. However, ethical issues are still not frequently addressed explicitly in HTA. Several valuable reasons have been identified. The basis of the article is the claim that ethics is often not part of HTA for “epistemological reasons”. Hence, the main aim of the contribution is to explore in more details and emphasize them by using the fact/value dichotomy. Our conclusion is that current HTA configuration is dominantly based on the comparison among objective and empirically testable “facts”, whilst ethics is not empirically testable. In this sense, there is a sort of “epistemological gap”, which can explain why it is so difficult to integrate ethics in HTA. We suggest that the epistemological differences among the various domains of HTA are addressed more explicitly.

l volume, dopo aver descritto l’origine, la natura e gli scopi della consulenza etica clinica, analizza le diverse modalità in cui si è sviluppata e realizzata negli Stati Uniti, in Europa e in Italia. In seguito vengono presentati i due testi "Documento di Trento – La consulenza etica in ambito sanitario" del Gruppo nazionale di Etica Clinica e Consulenza Etica in ambito sanitario e "Le competenze essenziali per la consulenza etica in ambito sanitario" dell’American Society for Bioethics and Humanities.

Il contributo affronta la questione delle deliberazioni in campo bioetico

Il contributo affronta il tema delle questioni etiche sollevate dall'uso del test prenatale non invasivo (NIPT) basato sul DNA

Il contribuo approfondisce i cambiamenti relativi a "Medicina e Morale. Rivista internazionale di Bioetica"

Il contributo realizza alcuni commenti relativi alla celebrazione della prima Giornata Mondiale di Bioetica (19 ottobre 2016), istituita dalla Cattedra UNESCO di Bioetica, in occasione del decimo anniversario della “Dichiarazione Universale su Bioetica e Diritti umani” emanata dall’UNESCO il 19 ottobre 2005.

Background: Palliative care services are growing, but vary across Europe. Palliative care is being used as a case study to test the methodology developed within the INTEGRATE-HTA project. The project aims to develop methods to enable an integrated assessment of complex technologies such as palliative care. The engagement of stakeholders in Health Technology Assessment (HTA) is widely recommended as it ensures that a large number of perspectives have a voice and due consideration. Aims: To identify stakeholder views of the key issues impacting on palliative care to facilitate the HTA project scope development. The present work focuses on the findings from participants in Italy. Design: “Patient” (n=7) and professional (n=8) stakeholders were enrolled as participants in qualitative research. Semi-structured interviews, lasting approximately 45 minutes, were either conducted face-to-face or over the telephone. An adapted version of the EUnetHTA core model, which guides HTA development, supported the interviews. Responses were audio recorded and transcribed into a synopsis presentation. Thematic analysis identified key issues. Results: Respondents identified similar issues including: access to palliative care services above all for non-cancer populations; availability of palliative care throughout the country; availability of home palliative care services; communication with patients and family members; improvement of quality of life in patients; staff education; training; implementation of legislation regulating palliative care. Conclusions: Interviewing persons with experience of palliative care allowed us to identify important topics and to assist the INTEGRATE-HTA project scope development. This engagement will ensure that perspectives of patients, families, carers, professionals will have due consideration within the HTA process. [The projects is co-funded by the European Commission under the Seventh Framework Programme (Grant Agreement No. 306141)]

HTA of alternative methods of pathogen inactivation of fresh frozen plasma

Il personalismo permette di prospettare un tipo di biopolitica positivo perché umanizzante. Il volume propone alcuni lavori che possono essere intesi come tentativi di risposta in questa direzione.

Background: Palliative care services are growing, but vary across Europe. Palliative care is being used as a case study to test the methodology developed within the INTEGRATE-HTA project. The project aims to develop methods to enable an integrated assessment of complex technologies such as palliative care. The engagement of stakeholders in Health Technology Assessment (HTA) is widely recommended as it ensures that a large number of perspectives have a voice and due consideration. Aims: To identify stakeholder views of the key issues impacting on palliative care to facilitate the HTA project scope development. The present work focuses on the findings from participants in Italy. Design: “Patient” (n=7) and professional (n=8) stakeholders were enrolled as participants in qualitative research. Semi-structured interviews, lasting approximately 45 minutes, were either conducted face-to-face or over the telephone. An adapted version of the EUnetHTA core model, which guides HTA development, supported the interviews. Responses were audio recorded and transcribed into a synopsis presentation. Thematic analysis identified key issues. Results: Respondents identified similar issues including: access to palliative care services above all for non-cancer populations; availability of palliative care throughout the country; availability of home palliative care services; communication with patients and family members; improvement of quality of life in patients; staff education; training; implementation of legislation regulating palliative care. Conclusions: Interviewing persons with experience of palliative care allowed us to identify important topics and to assist the INTEGRATE-HTA project scope development. This engagement will ensure that perspectives of patients, families, carers, professionals will have due consideration within the HTA process. [The projects is co-funded by the European Commission under the Seventh Framework Programme (Grant Agreement No. 306141)]

Costs of new anti Hepatitis C regimens and access to care: the case for prioritization or universal cure

It is estimated that by 2025 more than 20% of Europeans will be 65 or over, with a particularly rapid increase in the number of over 80s. Chronic diseases, malnutrition, weakened immune system and other health factors increase risk of foodborne illness and hazardous nutritional habits in elderly. Food safety and nutrition security are essential to promote active ageing. In order to evaluate elderly’s perceptions, practices and attitudes with respect to food safety, an articulate questionnaire was elaborated to investigate knowledge and critical aspects about unsafe food-handling practices and nutrition habits, including ethical aspects. This study was conducted in Gemelli Teaching Hospital, in Rome, Italy, between April 2014 and March 2015. Were interviewed 201 elderly 65 years old attending the Geriatrics Ward, the Outpatient Unit and the Gym of the Centre of Aging Medicine. Data were analyzed by means of frequencies and mean and standard deviations. The mean age of the sample was 74 years (SD = 7.7). The subjective perception of safe nutrition is high, in fact 64.2% of the elderly respondents think to have a balanced diet. Interviewed people get information about proper nutrition mainly from TV, papers and Internet (30%) and from health workers (34.8%) such as dietitian and nutritionist whereas only 15.4% from general practitioners. Regarding food safety and hygiene, 33.8% refers to consume expired food, even more than once a month. Between 80% and 90% of all the participants affirm to follow all the food safety practices during preparation and cooking, even though 49.3% defrost food at room temperature before preparation. These results underline the need for empowerment of elderly with respect to nutritional health and food safety. In fact, specific and targeted educational interventions for the elderly and their care-givers could be promoted in order to improve adoption of recommended food safety practices and safe nutritional habits among older adults. Key mess

Il contributo affronta i temi del giudizio morale degli interventi sanitari e dell'etica delle politiche sanitarie e della prevenzione

no abstract

Since chronic hepatitis C has become mostly curable, issues concerning choice and allocation of treatment are of major concern. We assessed the foremost ethical issues in hepatitis C virus therapy with 1st generation protease inhibitors, using the personalist ethical framework within the health technology assessment methodology. Our aim was to identify values at stake/in conflict and to support both the physicians’ choices in hepatitis C therapy and social (macro-)allocation decision-making. The ethical assessment indicates that: 1. safety/effectiveness profile of treatment is guaranteed if its use is restricted to the patients subgroups who may benefit; 2. patients should be carefully informed, particularly in treatment deferral, and widespread information on these therapies should be implemented; 3. since treatment was proven to be cost-effective, its use is acceptable in respect of the resource macro-allocation. Concerning individual (micro-)allocation criteria: a. criteria for eligibility to treatment should be clearly identified and updated periodically; b. information on criteria for eligibility/deferral to treatment for specific patients subgroups should be made widely known. Interferon-based regimens will disappear from use within the next year, with the arrival of highly effective/ tolerable combination regimens of direct-acting antiviral, profoundly changing the social choices. Our model could nonetheless support future ethical assessment, since the evaluation pertaining ethical domain remains applicable overall.

Patients undergoing major surgery are at risk for postoperative cognitive dysfunction (POCD). The consciousness of the POCD arises new ethical and medico-legal issues that should be identified, managed and, if possible, prevented. Elderly patients still represent a real challenge for physicians and medical science. This challenge can be surmounted not only through technical progress but also by safeguarding the correct ethical behavior at the base of each relationship between a patient and his physician. Effective communication with the elderly patient is a prerequisite for clear and complete information, involving family members and caregivers when necessary. In every case, the identification of patients with pre-existing risk factors of POCD, shortening the period of time preceding the surgery and a proper technique of the procedure as well as physical and intellectual exercises, nutrition and medication play an important role in decreasing the incidence of neurocognitive deficits in the elderly.

Gastromalacia is the acute autolytic erosion of the gastric wall. It generally occurs postmortem, and it appears as a slimy brownish black region of the wall which occurs principally in the gastric fundus. A 59-year-old woman died in the Emergency Department following a 2-day period of mild abdominal pain, vomiting, and diarrhea. A forensic autopsy was performed which revealed a rupture of the gastric fundus that had caused leakage of gastric content into the abdominal cavity. There was no macroscopic evidence of peritonitis, and the stomach wall adjacent to the rupture site showed marked thinning. The gross appearance was typical of gastromalacia. In contrast, histological observations revealed the presence of an ulcer at the site of perforation and a severe acute inflammatory reaction indicating a robust reaction with an antemortem rupture. © 2014 American Academy of Forensic Sciences.

Obiettivi del lavoro: 1. tracciare lo stato dell’arte dell’attività di valutazione etica nei processi di HTA svolta presso l’Istituto di Bioetica della Facoltà di Medicina e chirurgia “A. Gemelli” dell’Università Cattolica del Sacro Cuore di Roma; 2. enucleare, per mezzo di un’analisi comparativa dei report realizzati, le principali questioni/problematicità più frequentemente riscontrate. Metodologia del lavoro: La ricerca è stata condotta fondamentalmente su Banche dati primarie (Medline-PubMed). Alcuni dati sono stati desunti da attività di valutazione in processi di HTA condotte dall’Istituto di Bioetica della Facoltà di Medicina e chirurgia “A. Gemelli” dell’Università Cattolica del Sacro Cuore di Cuore di Roma. Principali contenuti del lavoro: L’etica è stata da sempre considerata parte integrante dei processi di HTA, nel senso che la valutazione delle conseguenze di tipo etico relative all’impiego di tecnologie sanitarie rappresenta uno degli obiettivi fondamentali di questo settore di ricerca, alla stregua delle valutazioni sulla sicurezza, l’efficacia, l’impatto economico, quello organizzativo, socio-culturale e legale. Nella pratica però raramente le analisi etiche hanno trovato posto nei report. In questo panorama, le valutazioni etiche in processi di HTA condotte dall’Istituto di Bioetica della Facoltà di Medicina e chirurgia “A. Gemelli” dell’Università Cattolica del Sacro Cuore di Roma rappresentano, almeno per il panorama nazionale, una indubbia novità sul piano della ricerca. L’intervento intende tracciare lo stato dell’arte di questa attività. In particolare, si tenterà, attraverso un’analisi comparativa di tutti i report finora realizzati, di enucleare le principali questioni/problematicità più frequentemente riscontrate.

Obiettivi del lavoro: L’intervento intende argomentare sull’ipotesi secondo cui, alla base dell’insuccesso dell’integrazione dell’etica nell’HTA, vi sia anche e soprattutto un problema di natura epistemologica Metodologia del lavoro: La ricerca è stata condotta su Banche dati primarie (Medline-PubMed). Principali contenuti del lavoro: Come modalità di ricerca multidisciplinare, l’HTA ha accolto, sin dalle sue origini, l’idea della legittimità/opportunità di una valutazione anche delle conseguenze di tipo etico relative all’impiego di tecnologie sanitarie – alla stregua di quelle cliniche, economiche, organizzative, legali, ecc. A riprova, basti far notare come in quasi tutte le definizioni prodotte nel tempo dalle varie agenzie, l’HTA venga descritta come una modalità di ricerca che debba incorporare anche l’expertise etico. Tuttavia, al di là di questo riconoscimento, per così dire “formale”, le valutazioni etiche hanno ricevuto nella pratica scarsa considerazione: l’etica non ha infatti avuto grande spazio nell’HTA e solo raramente le analisi etiche hanno trovato posto nei report. L’intervento intende argomentare sull’ipotesi secondo cui, alla base dell’insuccesso dell’integrazione dell’etica nell’HTA, vi sia anche e soprattutto un problema di natura epistemologica.

For the evaluation of the ethics of a study, the members of the ethics committee should consider all parts of the research protocol and various ethical issues could be raised. The ethical codes of conduct (Nuremberg Code, Helsinki Declaration, Belmont Report, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Good Clinical Practice, etc.) are the sources of international ethics of clinical trials but also of national and European laws but not always, on specific issues, these guidelines are accepted and shared, and none of these documents provides an ethical framework for the evaluation of the studies. Referring to these sources and relevant literature on the ethics of clinical research, we consider critical to the ethics of an research protocol, the following aspects: the value and scientific validity, the selection of subjects, the balance of risks and benefits for individuals, the informed consent, the confidentiality of data, the information on new data and the final results overall, the assistance in case of adverse events, the post-study arrangements, the insurance coverage. These requirements should all be considered and satisfied to judge a clinical trial ethically justified and acceptable, even if these may not always have unanimous interpretation. In this regard it is essential that the legislation provides clear and updated provisions on specific issues, and that the primacy of the dignity and fundamental rights of persons involved in trials than any other interest is accepted and shared among the members of the ethics committee

The importance of human microbiota in preserving human organism healthy is nowadays well acknowledged. The alteration of the microbiota can be the consequence of a persistent use of antibiotics or immunosuppressive medications or abdominal irradiation or surgery, wrong diet, or can be caused by surgery or anatomical condition. These alterations can cause many infections and diseases that today can be treated with Fecal Microbiota Transplantation (FMT), also called Bacteriotherapy, that is the administration of a fecal solution from a donor into the intestinal tract of a recipient. Although to date, FMT appears to be safe and without serious adverse effects, there are some ethical issues that are worthy to be investigated. The aim of this article is to highlight these issues in order to give some notes for a better implementation of this particular clinical practice.

OBJECTIVE. To analyse some ethical issues involved in umbilical cord blood (UCB) collection, storage and use. MATERIALS AND METHODS. Ethical issues were addressed in the light of the wellknown fundamental ethical principles for biomedicine: beneficence/non maleficence, respect for autonomy and justice. Specific issues that have been debated concerning the clinical utility of autologous use compared with allogeneic use for transplantation, the validity of informed consent, especially in private UCB banking, and finally the controversial question of private UCB banking for-profit compared to public UCB banking non-profit. RESULTS. Our ethical analysis has highlighted that the allogeneic UCB use for transplantation, compared to autologous UCB use, seems to fulfil the principle of beneficence/non maleficence as it provides “logistic” and clinical benefits and it decreases risks; the acquisition of informed consent requires some counselling, particularly for autologous collection; finally, public UCB banking seems to fulfil the criteria for justice more than private ones. CONCLUSION. Present and future therapeutic UCB possibilities for treating a wide variety of diseases need to increase the number of UCB units available. For this purpose, a “gift” culture and a “solidarity chain” between donors and recipients are requested. Moreover, in recent years, a further and emerging model of bank seems usable, i.e. “hybrid” banking.

Cerebral venous sinus thrombosis (CVST) is a rare cerebrovascular condition that affects approximately 5 per 1 million people annually, and develops in 0.5% of all stroke patients. Herein we report a case involving a 31-year-old woman with CVST. She initially presented with a 2-month history of intermittent headaches at the nape of her neck with cervical pain. Other than these symptoms, she was in apparently good health and was a nonsmoker. She had no children and did not take contraceptives. She became comatose with unequal pupil size and CVST was diagnosed. An autopsy revealed CVST that extended from the confluence of the sinuses to the transverse sinuses and tip of the superior sagittal sinus, as well as a thrombus that obstructed the right internal jugular vein. A correct and early diagnosis of CVST combined with heparin-based therapy and/or interventional endovascular strategies may be of benefit by preventing intracerebral extension of jugular venous thrombosis and subsequent serious or even fatal neurological sequelae.

The differential diagnosis between self-inflicted and nonself-inflicted, suicidal and homicidal, injuries is difficult or impossible in many cases and, above all, cannot be made on the basis of information obtained solely from the autopsy or the medicolegal clinical examination. The purpose of this study is to analyze the literature on suicidal and homicidal sharp force injuries and identify the relevant parameters that may help differentiate between suicidal and homicidal deaths. To achieve this goal, a review of 595 potentially relevant articles was performed. After excluding the nonrelevant papers by screening the titles, all abstracts were reviewed, and articles meeting the inclusion criteria underwent a full-text review. The following parameters were compiled into a table: number of cases, localization of the injuries, and number of injuries. The data were statistically analyzed and compared with those available in the forensic literature. On the basis of the heterogeneity of data revealed by the present review, a simple and short checklist of the parameters that should be included when reporting suicides and homicides by sharp force has been proposed.

A new system for evaluating production of research has been introduced in Italy by the Law of 30 December 2010 no. 240 (also called Gelmini’s Reform). This system is based on a strict distinction between the evaluation of “academic production” concerning “hard sciences” and evaluation of “academic production” concerning “humanities and social sciences”. The first evaluation uses bibliometric criteria, while the second one uses non-bibliometric criteria. The article deals with the impact of this new system on Italian academic bioethics, Un nuevo sistema para evaluar los resultados de la investigación ha sido introducido en Italia, bajo la Ley no 240 del 30 de Diciembre de 2010, la así llamada “Reforma Gelmini”. Este sistema tiene su fundamento en la separación entre la evaluación de resultados de investigacion con referencia a las ciencias experimentales y la evaluación de resultados de investigación con referencia a las humanidades y ciencias sociales. La primera se basa en criterios bibliometricos, la segunda utiliza criterios no-bibliometricos. El artículo trata del impacto de este nuevo sistema en la bioetica academica italiana

Patient recruitment is a critical point of today’s clinical research. Several proposals have been made for improving it, but the effectiveness of these measures is actually uncertain. The use of Internet (e-recruitment) could represent a great chance to improve patient enrolment, even though the effectiveness of this implementation is not so evident. E-recruitment could bring some advantages, such as better interaction between clinical research demand and clinical research supply, time and resources optimization, and reduction of data entry errors. It raises some issues too, such as sampling errors, validity of informed consent, and protection of privacy. Research Ethics Committees/Institutional Review Boards should consider these critical points. The paper deals with Internet recruitment for clinical research. It also attempts to provide Research Ethics Committees/Institutional Review Boards with notes for assessing e-recruitment based clinical protocols.