Emanuela Midolo

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.

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

I diritti umani alla vita e alla coscienza e la risoluzione dei conflitti dei diritti umani / The human rights to life and conscience and resolving conflicts of human rights

Gli autori affrontano la questione del criterio da seguire per risolvere le situazioni in cui i diritti umani legalmente riconosciuti entrano in conflitto tra loro. La questione e aggravata dalla mancanza di consenso per quanto riguarda le priorita tra i diritti umani. Tuttavia, gli autori ritengono che quando e in gioco il diritto alla vita, questo – sia dal punto di vista etico che giuridico – dovrebbe prevalere sulle rivendicazioni di altri diritti, quanto meno nella sua formulazione negativa (non cagionare la morte). Si tratta infatti, logicamente e cronologicamente del piu fondamentale dei diritti. Gli autori ritengono che vi sia una forte logica a stabilire una priorita tra le tre generazioni di diritti umani andando dal piu al meno importante. E comunque un utile esercizio quello di esaminare – nella dimensione del conflitto tra diritti – la questione del diritto al rispetto della coscienza nell’ambito sanitario, cercando di stabilire l’ordine delle priorita. Gli autori approvano la posizione assunta da legislazioni e decisioni giudiziarie che generalmente assicurano il riconoscimento del diritto al rispetto della coscienza per gli operatori sanitari. ---------- 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.