Life beyond life: Perceptions of post-mortem organ donation and consent to donate-A focus group study in Italy.

OBJECTIVES: Many factors such as personal and cultural beliefs, misinformation, fear of death and inadequate will registering procedures can influence post-mortem organ donation. The present study aimed to explore the perceptions, beliefs and information around post-mortem donation and will expression in different groups of the Italian population, to orient future interventions and raise awareness. DESIGN: Qualitative research with focus groups. METHODS: A total of 38 focus groups involving 353 participants including the general population (young adults: 18-39, mature adults: 40-70), local and hospital health professionals, critical area health professionals (emergency room and intensive care), registry office employees and opinion leaders, were conducted in six regions from different parts of Italy between June and November 2021. Thematic analysis was conducted with the use of Atlas.ti9. RESULTS: Five overarching themes were identified: dilemmas regarding donation, resistance to donation, facilitators of donation, difficulties in terms of will expression and proposals to encourage will expression. Possible facilitators were having personal and professional experiences with organ donation, feeling useful for society, having reliable information and trust in the health care system. Potential barriers to donation were doubts and fears about brain death, bodily integrity concerns, religious beliefs, misinformation and distrust in the health care system. CONCLUSIONS: These results highlighted the significance of a bottom-up perspective with regard to identifying the personal perceptions and beliefs with regard to donation, underlining the urgency of creating tailored interventions to sensitize different groups of the population in terms of promoting an informed choice and a culture of donation.

Kidney transplantation and withdrawal rates among wait-listed first-generation immigrants in Italy.

BACKGROUND: Multiple barriers diminish access to kidney transplantation (KT) in immigrant compared to non-immigrant populations. It is unknown whether immigration status reduces the likelihood of KT after wait-listing despite universal healthcare coverage with uniform access to transplantation. METHODS: We retrospectively collected data of all adult waiting list (WL) registrants in Italy (2010-20) followed for 5 years until death, KT in a foreign center, deceased-donor kidney transplant (DDKT), living-donor kidney transplant (LDKT) or permanent withdrawal from the WL. We calculated adjusted relative probability of DDKT, LDKT and permanent WL withdrawal in different immigrant categories using competing-risks multiple regression models. RESULTS: Patients were European Union (EU)-born (n = 21 624), Eastern European-born (n = 606) and non-European-born (n = 1944). After controlling for age, sex, blood type, dialysis vintage, case-mix and sensitization status, non-European-born patients had lower LDKT rates compared to other immigrant categories: LDKT adjusted relative probability of non-European-born vs. Eastern European-born 0.51 (95% CI: 0.33-0.79; P = 0.002); of non-European-born vs. EU-Born: 0.65 (95% CI: 0.47-0.82; P = 0.001). Immigration status did not affect the rate of DDKT or permanent WL withdrawal. CONCLUSIONS: Among EU WL registrants, non-European immigration background is associated with reduced likelihood of LDKT but similar likelihood of DDKT and permanent WL withdrawal. Wherever not available, new national policies should enable coverage of travel and medical fees for living-donor surgery and follow-up for non-resident donors to improve uptake of LDKT in immigrant patients, and provide KT education that is culturally competent, individually tailored and easily understandable for patients and their potential living donors.

Access of non-residents to transplantation of deceased donor organs: practices and strategies in the European setting.

The access of non-resident patients to the deceased donor waiting list (DDWL) poses different challenges. The European Committee on Organ Transplantation of the Council of Europe (CD-P-TO) has studied this phenomenon in the European setting. A questionnaire was circulated among the Council of Europe member states to inquire about the criteria applied for non-residents to access their DDWL. Information was compiled from 28 countries. Less than 1% of recipients of deceased donor organs were non-residents. Two countries never allow non-residents to access the DDWL, four allow access without restrictions and 22 only under specific conditions. Of those, most give access to non-resident patients already in their jurisdictions who are in a situation of vulnerability (urgent life-threatening conditions). In addition, patients may be given access: (i) after assessment by a specific committee (four countries); (ii) within the framework of official cooperation agreements (15 countries); and (iii) after patients have officially lived in the country for a minimum length of time (eight countries). The ethical and legal implications of these policies are discussed. Countries should collect accurate information about residency status of waitlisted patients. Transparent criteria for the access of non-residents to DDWL should be clearly defined at national level.

Building Kidney Exchange Programmes in Europe-An Overview of Exchange Practice and Activities.

BACKGROUND: Considerable differences exist among the living donor Kidney Exchange Programmes (KEPs) that are in use and being built in Europe, contributing to a variation in the number of living donor transplants (Newsletter Transplant; International figures on donation and transplantation 2016). Efforts of European KEPs to exchange (best) practices and share approaches to address challenges have, however, been limited. METHODS: Experts from 23 European countries, collaborating on the European Network for Collaboration on Kidney Exchange Programmes Cooperation on Science and Technology Action, developed a questionnaire to collect detailed information on the functioning of all existing KEPs in Europe, as well as their opportunities and challenges. Following a comparative analysis, results were synthesized and interpreted by the same experts. RESULTS: The practices, opportunities and challenges reported by 17 European countries reveal that some of the 10 operating programs are mature, whereas others are in earlier stages of development. Over 1300 transplants were performed through existing KEPs up to the end of 2016, providing approximately 8% of their countries' living kidney donations in 2015. All countries report challenges to either initiating KEPs or increasing volumes. Some challenges are shared, whereas others differ because of differences in context (eg, country size, effectiveness of deceased donor program) and ethical and legal considerations (eg, regarding living donation as such, nonrelated donors, and altruistic donation). Transnational initiatives have started in Central Europe, Scandinavia, and Southern Europe. CONCLUSIONS: Exchange of best practices and shared advancement of national programs to address existing challenges, aided by transnational exchanges, may substantially improve access to the most (cost) effective treatment for the increasing number of patients suffering from kidney disease.

The effect of differing kidney disease treatment modalities and organ donation and transplantation practices on health expenditure and patient outcomes.

The Effect of Differing Kidney Disease Treatment Modalities and Organ Donation and Transplantation Practices on Health Expenditure and Patient Outcomes (EDITH) aims to obtain information on long-term kidney transplant outcomes, long-term health outcomes of living kidney donors and detailed outcomes and costs related to the different treatment modalities of end-stage kidney disease. Nine partners from seven European Union countries will participate in this project.

From the EU Legislation to the Application of the Single European Code: Support to the Implementation.

The Italian National Transplant Centre (CNT) is coordinating with the Italian National Blood Centre (CNS) the Joint Action '!' (www.eurocet128.eu), already built the European Tissue Establishment and Tissue and Cell Product Compendia between 2011 and 2014 in order to provide European Member States with a tool which would grant traceability of tissues and cells at human transplant purpose across the European Union. The two compendia are available on an online platform hosted and managed by the European Commission.

The joint action MODE (Mutual Organ Donation and Transplantation Exchanges): a sound contribution to implementation of health policies in organ donation and transplantation.

BACKGROUND: The main objective of the joint action MODE is the transfer of best-practices in the field of organ donation and transplantation and the creation of positive synergies among participating European (EU) Member States (MS) apt to support authorities in possible decision-making and policy contexts. METHODS: The consortium has chosen to foster the exchange of best-practice through a series of exchange visits followed by the provision of a set of specialized trainings.Each participating MS has presented its strengths and weaknesses through a questionnaire based on the Organ Action Plan. Once the situation was clearer, countries with the strongest program organized and hosted the on-site visits and each country had the opportunity to perform five exchange visits on five selected topics.Specific courses for healthcare staff of organ coordinating and transplantation centres were organized. Based on evaluation of the results of the on-site visits and training needs indicated by the partners, the chosen topics were:• reporting on adverse events and reactions• quality assurance programme of the donation process in Spain• quality assurance of the transplantation process RESULTS AND CONCLUSIONS: The outcome is that within the EU, even among MS with well-developed services, the organ donation and transplantation activity has substantial differences so that all participating countries would benefit from investigating foreign donation and transplant systems. Collaboration at EU level can be beneficial for all systems and the joint action MODE indicated that in some countries the sharing of expertise across the EU Member States has already proved to be useful in starting a virtuous circle in organization and training that would allow to increase organ donor rates and improve overall performance.

The EUROCET Network: Support for Coding, Vigilance and Surveillance.

BACKGROUND: In the last years, there have been increasing concerns about the safety and traceability of human tissues and cells in Europe. In order to regulate this part of medical practice, the European Commission issued 3 directives between 2004 and 2006 and endorsed EUROCET to support member states in fulfilling some of their obligations. MATHODS: EUROCET created a connection with the European Union (EU) Competent Authorities (CAs) and set up a website where lists of the CAs, the authorized Tissue Establishments (TEs) and the activity data are published and updated. Moreover, EUROCET is involved within the Vigilance and Surveillance of Substances of Human Origin (SOHO V&S) project, aiming to support the EU member states in the establishment of vigilance and surveillance systems for tissues and cells. EUROCET is also working with EU stakeholders to develop a common coding system concerning donation and products. RESULTS: There are 33 countries in EUROCET and 57 CAs. 3,974 TEs are recorded: 1,108 for tissues, 1,480 for haematopoietic progenitor cells and 1,386 for assisted reproduction. On the website, it is possible to find the 2010 activity data report. CONCLUSION: Based on its cooperation with the CAs, EUROCET represents them in the European network. Nowadays, the EU member states can rely on a web portal and database in order to put the tissue and cell directives into practice.