Roberta Minacori

Health Technology Assessment of pathogen reduction technologies applied to plasma for clinical use.

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.

Ethical and deontological issues in Transfusion Medicine

Recent developments in Transfusion Medicine Since the second half of the 1980s, Transfusion Medicine has gradually taken on an increasing autonomous place in the world of medical specialties, continuing its evolution from its initial, mainly immunohaematological role, towards new diagnostic, clinical-therapeutic and research activities. Currently, in addition to direct care activities for patients and support of specific highly specialised care processes, Transfusion Medicine ranges from the collection and banking of haematopoietic stem cells to the banking of tissues and cell therapy. In parallel to the growth of the activities mentioned above, there has been constant progress in research activities, as evidenced by the exponential increase in randomised controlled trials and meta-analyses1. Despite this gradual transformation, blood collection and the production of sufficient amounts of blood components to reach and/or maintain local and national self-sufficiency continue to be priority aims and the object of planning the activities of the whole national transfusion network2. Blood donation and Transfusion Medicine now constitute an essential component of the integrated care processes that are typical of the current, modern vision of health, oriented in a logic of disease management. Operational coordination and management, including administrative area, of the many activities that are part of the transfusion process have a fundamental role in the clinical governance of all the procedures pertaining to the field of transfusion3. Blood and blood components are in fact “the final result of various processes (clinical, laboratory, social), which are linked together and intertwine, involving different professional skills and responsibilities”4. The transfusion process can be defined as a “supply chain” because, ultimately, the patients’ demands condition the supply, that is, the need for blood donations. A lack of blood occurs when the supply is not sufficient to meet the demand and the transfusion needs of the patients cannot be met quantitatively and/or qualitatively, or waiting times are imposed, particularly for elective surgery. The supply chain in the transfusion field begins with the donor and the donor procedures and continues through the processing, qualification and biological validation, reception of transfusion requests, evaluation of the appropriateness of the requests, determination of the immunological compatibility, allocation of blood components to individual patients, delivery to the requesting clinical unit, transfusion to the recipient patient and recording and reporting of any side effects and adverse events possibly associated with the transfusion5. The correct management of the processes that make up the transfusion supply chain affects the safety of the whole process, the monitoring of which is a specific aim of haemovigilance systems. A good haemovigilance system includes appropriate management of patients’ transfusion requirements as well as safe fulfilment of these needs. Transfusion safety goes beyond the intrinsic safety of the transfused therapeutic products, depending on a series of closely interconnected processes which start with the donor and finish with the recipient. The systematic recording of transfusion outcomes and adverse events associated with transfusion therapy constitutes the afferent branch of every haemovigilance system and plays a fundamental role in the search for and the identification of possible strategies for improvement. In contrast, the purpose of the efferent branch of these systems is to achieve a constant, global improvement in the transfusion process through an analysis of the data collected and their possible changes over time, to identify possible corrective or preventive strategies based on objective evidence. Therefore, it seems clear that the multifaceted and complex transfusion process, with its unique global organisational and management framework, is not possible without a systematic approach aimed at raising quality and, therefore, at continuous improvement4. Since 2002, and in particular in the 3-year period from 2005 to 2007, national and European community law-making in the field of blood transfusion, and related activities, has been more intense and important than ever before6–18. The regulatory scenario that has developed is, therefore, very complex in terms of relations between European and national legislations, in particular because of the need to harmonise the acts implementing the European Directives with existing national laws. The European regulatory provisions concerning transfusions and associated activities are strongly inspired by the social and ethical concepts of solidarity, voluntariness and periodic repetition of donations, as well as the fundamental principle of protecting public health, in terms of fairness, transparency and right of access to safe and systematically controlled services19. Great emphasis is also given to the principles of management and control of the specific care processes, in order that these are aimed at ensuring high organisational and professional standards as well as safeguarding the appropriateness of the clinical use of blood products. Finally, specific regulations concerning the cord blood banking have been introduced20. The aim of this review is to focus on the ethical and deontological issues of the macro-processes of the transfusion chain, extending the considerations to the most recent, innovate area of development of Transfusion Medicine, biobanking, and outlining possible additional areas of practical ethical reflection related to it, such as health technology assessment and the organisational ethics of services. The reason for this is the paucity of specific contributions on the subject. The ethical issues related to the donation of cord blood will not be dealt with here: the reader is referred to the recent, but still limited literature21–22.

Survey on advance care planning of Italian outpatients on chronic haemodialysis

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.

CENTRALIZAR-SE NA PRÁTICA: ETICA CLÍNICA DE CONSULTA NUM CASO DE TRANSPLANTE HEPÁTICO ORTOTÓPICO

espanolEl articulo presenta un caso clinico, dirigido en el ano 2011 por el equipo de servicio de consulta etica clinica del Instituto de Bioetica y Humanidades Medicas de la Facultad “Agostino Gemelli” de Medicina de la Universidad Catolica del Sacro Cuore en Roma (Italia). El caso clinico se refiere a los dilemas eticos sobre las perspectivas del paciente para recibir un trasplante hepatico ortotopico porque no era residente del pais y carecia de un cuidador para asistirlo durante el periodo de seguimiento, asi como de un lugar para quedarse despues de la cirugia.DOI: 10.5294/pebi.2016.20.1.7 EnglishThe contribution describes a case report addressed in 2011 by the clinical ethics consultation service team of the Institute of Bioethics and Medical Humanities at the “Agostino Gemelli” School of Medicine of the Universita Cattolica del Sacro Cuore, Rome (Italy). The clinical case regards ethical dilemmas about the patient’s prospects for receiving an orthotopic liver transplant, because she was a non-resident and lacked a caregiver to assist her during the follow-up period, as well as a place to stay after liver transplant surgery.DOI: 10.5294/pebi.2016.20.1.7 portuguesEste artigo apresenta um caso clinico dirigido em 2011 pela equipe de servico de consulta etica clinica do Instituto de Bioetica e Humanidades Medicas da Faculdade de Medicina Agostino Gemelli, da Universita Cattolica del Sacro Cuore (Roma, Italia). O caso clinico se refere aos dilemas eticos sobre as perspectivas da paciente para receber um transplante hepatico ortotopico porque nao era residente do pais, carecia de um cuidador para assisti-la durante o periodo de observacao e de um lugar para ficar depois da respectiva cirurgia.DOI: 10.5294/pebi.2016.20.1.7The contribution describes a case report addressed in 2011 by the clinical ethics consultation service team of the Institute of Bioethics and Medical Humanities at the “Agostino Gemelli” School of Medicine of the Universita Cattolica del Sacro Cuore, Rome (Italy). The clinical case regards ethical dilemmas about the patient’s prospects for receiving an orthotopic liver transplant, because she was a non-resident and lacked a caregiver to assist her during the follow-up period, as well as a place to stay after liver transplant surgery. DOI: 10.5294/pebi.2016.20.1.7

Focus on practice- Clinical ethics consultation on an orthotopic liver transplant case

espanolEl articulo presenta un caso clinico, dirigido en el ano 2011 por el equipo de servicio de consulta etica clinica del Instituto de Bioetica y Humanidades Medicas de la Facultad “Agostino Gemelli” de Medicina de la Universidad Catolica del Sacro Cuore en Roma (Italia). El caso clinico se refiere a los dilemas eticos sobre las perspectivas del paciente para recibir un trasplante hepatico ortotopico porque no era residente del pais y carecia de un cuidador para asistirlo durante el periodo de seguimiento, asi como de un lugar para quedarse despues de la cirugia.DOI: 10.5294/pebi.2016.20.1.7 EnglishThe contribution describes a case report addressed in 2011 by the clinical ethics consultation service team of the Institute of Bioethics and Medical Humanities at the “Agostino Gemelli” School of Medicine of the Universita Cattolica del Sacro Cuore, Rome (Italy). The clinical case regards ethical dilemmas about the patient’s prospects for receiving an orthotopic liver transplant, because she was a non-resident and lacked a caregiver to assist her during the follow-up period, as well as a place to stay after liver transplant surgery.DOI: 10.5294/pebi.2016.20.1.7 portuguesEste artigo apresenta um caso clinico dirigido em 2011 pela equipe de servico de consulta etica clinica do Instituto de Bioetica e Humanidades Medicas da Faculdade de Medicina Agostino Gemelli, da Universita Cattolica del Sacro Cuore (Roma, Italia). O caso clinico se refere aos dilemas eticos sobre as perspectivas da paciente para receber um transplante hepatico ortotopico porque nao era residente do pais, carecia de um cuidador para assisti-la durante o periodo de observacao e de um lugar para ficar depois da respectiva cirurgia.DOI: 10.5294/pebi.2016.20.1.7The contribution describes a case report addressed in 2011 by the clinical ethics consultation service team of the Institute of Bioethics and Medical Humanities at the “Agostino Gemelli” School of Medicine of the Universita Cattolica del Sacro Cuore, Rome (Italy). The clinical case regards ethical dilemmas about the patient’s prospects for receiving an orthotopic liver transplant, because she was a non-resident and lacked a caregiver to assist her during the follow-up period, as well as a place to stay after liver transplant surgery. DOI: 10.5294/pebi.2016.20.1.7

Centrarse en la práctica”: ética clínica de consulta en un caso de trasplante hepático ortotópico

espanolEl articulo presenta un caso clinico, dirigido en el ano 2011 por el equipo de servicio de consulta etica clinica del Instituto de Bioetica y Humanidades Medicas de la Facultad “Agostino Gemelli” de Medicina de la Universidad Catolica del Sacro Cuore en Roma (Italia). El caso clinico se refiere a los dilemas eticos sobre las perspectivas del paciente para recibir un trasplante hepatico ortotopico porque no era residente del pais y carecia de un cuidador para asistirlo durante el periodo de seguimiento, asi como de un lugar para quedarse despues de la cirugia.DOI: 10.5294/pebi.2016.20.1.7 EnglishThe contribution describes a case report addressed in 2011 by the clinical ethics consultation service team of the Institute of Bioethics and Medical Humanities at the “Agostino Gemelli” School of Medicine of the Universita Cattolica del Sacro Cuore, Rome (Italy). The clinical case regards ethical dilemmas about the patient’s prospects for receiving an orthotopic liver transplant, because she was a non-resident and lacked a caregiver to assist her during the follow-up period, as well as a place to stay after liver transplant surgery.DOI: 10.5294/pebi.2016.20.1.7 portuguesEste artigo apresenta um caso clinico dirigido em 2011 pela equipe de servico de consulta etica clinica do Instituto de Bioetica e Humanidades Medicas da Faculdade de Medicina Agostino Gemelli, da Universita Cattolica del Sacro Cuore (Roma, Italia). O caso clinico se refere aos dilemas eticos sobre as perspectivas da paciente para receber um transplante hepatico ortotopico porque nao era residente do pais, carecia de um cuidador para assisti-la durante o periodo de observacao e de um lugar para ficar depois da respectiva cirurgia.DOI: 10.5294/pebi.2016.20.1.7The contribution describes a case report addressed in 2011 by the clinical ethics consultation service team of the Institute of Bioethics and Medical Humanities at the “Agostino Gemelli” School of Medicine of the Universita Cattolica del Sacro Cuore, Rome (Italy). The clinical case regards ethical dilemmas about the patient’s prospects for receiving an orthotopic liver transplant, because she was a non-resident and lacked a caregiver to assist her during the follow-up period, as well as a place to stay after liver transplant surgery. DOI: 10.5294/pebi.2016.20.1.7

L’uso di Internet nei trial clinici

Recruiting patients is a critical point of todays clinical research and, along the years, several solutions have been proposed, even if their efficacy seems to be doubtful. On the other hand, nowadays, Internet represents a great opportunity for improving clinical trial recruitments. Nevertheless, on-line recruitment services (e-recruitment) could ensure some advantages (such as facilitating interaction between supply and demand of clinical research, time and money savings/optimizations, data entry errors reduction), but also raise some issues (such as those related to sampling, information, consent, real identity of participants and risks for data breaches). The article debates on the difficulties to recruit patients for clinical research, in general, and e-recruitment particularly, discussing some ethical issues raised by internet enrolment.

Il consenso informato nella cura del paziente con frattura del femore

Informed consent is fundamental in the process of care, except in case of urgent, lifesaving treatments. In Italy, the legal sources are the Italian Constitution, the numerous judgments of the courts and the current “Codice di Deontologia medica”. In clinical practice, as in the case of the elderly patient with hip fracture, the physician may encounter problems if the patient is incompetent and without legal representation.

Clinical Bioethics: Guideline on Initiation of and Withdrawal from Dialysis

The clinical issue of initiation of and withdrawal from dialysis for patients with chronic renal failure (CRF) is addressed evaluating for which patients the treatment is not indicated. Therefore, the initial question on the provision of dialytic procedure for all the patients who might obtain a benefit was alternated by an opposite problem: to understand, among the many candidates for dialysis, those who wouldn’t have a benefit. In fact, if the treatment is not able to offer the expected effectiveness, so configuring a medical futility or where the burdensomeness of the treatment (side effects, complications, etc.) exceed the benefits, it is ethically more appropriate not to start (or possibly withdraw) the treatment itself. Some scientific societies have edited specific guidelines. The article focuses on the last version of the Shared Decision Making in the Appropriate Initiation of and Withdrawal from Dialysis, Clinical Practice Guideline of the U.S. Renal Physician Association (RPA), that takes into account changes in epidemiology and clinical management of patients eligible for renal replacement treatment: mainly, increasingly advanced age, cardiovascular and metabolic disorders and comorbidity. The most compelling clinical issue is the identification of patients whose dialysis treatment is not beneficial in terms of survival and quality of health. Moreover, the RPA guidelines highlight the relevance of shared decision making as elective way for the physician-patient relationship. From the bioethics perspective, some lexical changes could reflect cultural changes: e.g., the term informed consent/refusal has been replaced by “information to the patient”, as well as “advance directive” by advance care planning. Some commentaries to RPA guidelines argue in favor of the reverse of some paradigms of North American bioethics: for example the overcoming of principle of autonomy towards a presumed restore of the principle of beneficence/ non-maleficence. In the appendix, a “Proposal for ethical guidelines for an appropriate indication for dialysis treatment” is offered to the debate. The document born from a common reflection and interaction between Hemodialysis Unit personnel of “Agostino Gemelli” Teaching Hospital (Rome, Italy) and clinical ethics consultations provided by ethicists of the Institute of Bioethics of the Universita Cattolica del Sacro Cuore (Rome, Italy) along the SINTEA Project (Integrated Service for Applied Bioethics) presented for the first time during a scientific meeting in 2010.

L’etica della sperimentazione sull’uomo dal processo di Norimberga ai comitati di etica

The article deals with how the journal “Medicina e Morale” has faced ethics in clinical trials, which represents a very large and complex bioethical issue, but also deontological one. This area comprises many questions and the literature is huge. It has risen after unethical clinical trials that have shocked the public and have produced a big rethinking about it. In general, from the ’60s to the ’80s of the XXth century, an intense commitment and interest have prevailed on the elaboration of the reference principles and on theoretical reflection on various issues, such as informed consent, the ethical significance of clinical research, the protection of vulnerable people, the risk acceptability). Since the ’90s onwards the development of codes, regulations, guidelines – that have guided the development of the discipline in a procedural and also deontological sense – has increased, probably due to the large diffusion of ethics committees. Particularly, the journal “Medicine and Morale” has always been present on these issues, since the beginning of its history, creating an original voice in the debate, as well as a dissemination tool (especially in the pre-internet era) of national and especially international documentation. The journal has been, especially in the last thirty years, a real national, and sometimes international, benchmark, offering original suggestions which are then accepted in guidelines and regulations.