[Xenotransplantation of solid organs]. / Xenotransplantation von Organen.

Transplantation of genetically modified porcine hearts and kidneys could become a solution to the persistent shortage of human organ donors. Progress has been made in genetic engineering of donor pigs, preservation techniques after organ harvesting and immunosuppression using co-stimulation blockade with anti-CD40/CD40L monoclonal antibodies. Progress has also been made in in the development of methods that detect pathogenic porcine viruses and prevent their transmission to the recipient. As normal land breed pig organs continue to grow in the recipient to their original size, different pig breeds (such as Auckland Island pigs) are now used which reach a final size suitable for humans. Alternatively, a knock-out of the growth hormone receptor gene has been established, e.g., in the 10GM genetically modified pigs from Revivicor/United Therapeutics, USA. The first clinical pilot studies including patients suffering from terminal heart failure are expected to start in Germany in about 2 years.

Assisted suicide in persons with mental disorders: a review of clinical-ethical arguments and recommendations.

Persons with mental disorders have the same right to self-determination as patients with somatic diseases, also regarding death and dying. However, there are several challenges that render persons with mental disorders especially vulnerable to inappropriate conduct of assisted suicide: their wish to die may be a symptom of their mental disease and not an autonomous choice, decision-making competence may be compromised by their illness and more difficult to assess, the severity of suffering may be more difficult to evaluate from an external perspective, the wish to die may be more variable over time and the prognostic uncertainty in mental illness makes it more difficult to determine whether the severe suffering is, in fact, treatment-resistant. After reviewing the clinical and ethical background of assisted suicide in persons with mental disorders, we assess each of these challenges to a medically and ethically justified practice of assisted suicide in mentally ill persons, based on relevant clinical and ethical literature. We conclude that the only ethically valid argument to exclude persons with mental disorders from suicide assistance is their potential inability to make a free, autonomous decision. However, the mentioned challenges should be taken into account in evaluating a person's request for assisted suicide and for promoting her well-informed and deliberated decision-making. In addition to assessing the person's decision-making capacity, the evaluation process should be guided by the goal to empower the person to make an autonomous choice between the available options. We conclude the paper with perspectives for a clinically and ethically justified practice of evaluating requests for assisted suicide in persons with mental disorders.

Prioritization and resource allocation in the context of the COVID-19 pandemic. Recommendations for colorectal and pancreatic cancer in Germany.

In the context of the COVID-19 pandemic, there has been a scarcity of resources with various effects on the care of cancer patients. This paper provides an English summary of a German guideline on prioritization and resource allocation for colorectal and pancreatic cancer in the context of the pandemic. Based on a selective literature review as well as empirical and ethical analyses, the research team of the CancerCOVID Consortium drafted recommendations for prioritizing diagnostic and treatment measures for both entities. The final version of the guideline received consent from the executive boards of nine societies of the Association of Scientific Medical Societies in Germany (AWMF), 20 further professional organizations and 22 other experts from various disciplines as well as patient representatives. The guiding principle for the prioritization of decisions is the minimization of harm. Prioritization decisions to fulfill this overall goal should be guided by 1. the urgency relevant to avoid or reduce harm; 2. the likelihood of success of the diagnostic or therapeutic measure advised; and 3. the availability of alternative treatment options. In the event of a relevant risk of harm as a result of prioritization, these decisions should be made by means of a team approach. Gender, age, disability, ethnicity, origin and other social characteristics, such as social or insurance status, as well as the vehemence of a patient's treatment request and SARS-CoV-2 vaccination status should not be used as prioritization criteria. The guideline provides concrete recommendations for 1. diagnostic procedures, 2. surgical procedures for cancer, and 3. systemic treatment and radiotherapy in patients with colorectal or pancreatic cancer within the context of the German healthcare system.

Transformative medical ethics: A framework for changing practice according to normative-ethical requirements.

We propose a step-by-step methodological framework of translational bioethics that aims at changing medical practice according to normative-ethical requirements, which we will thus call "transformative medical ethics." The framework becomes especially important when there is a gap between widely acknowledged, ethically justified normative claims and their realization in the practice of biomedicine and technology (ought-is gap). Building on prior work on translational bioethics, the framework maps a process with six different phases and 12 distinct translational steps. The steps involve various research activities including conceptual philosophical inquiry and (socio-)empirical research. On the one hand, the framework can be used as a heuristic tool to identify barriers to the transformation process. On the other hand, it can provide guidance for researchers and practitioners to develop appropriate (conceptual action and practice) models, which are then implemented and evaluated in specific practice contexts. We use the example of realizing the norm of respect for autonomy in the practice of medical decision-making to illustrate the framework. Further research is required, for example, to theoretically underpin the framework, to apply it to other ought-is gaps, and to evaluate its feasibility and effectiveness in various practice areas. Overall, the framework of transformative medical ethics suggests a strategic process to investigate and promote practice change that is ethically informed in all phases.

Current Status of Cardiac Xenotransplantation: Report of a Workshop of the German Heart Transplant Centers, Martinsried, March 3, 2023.

This report comprises the contents of the presentations and following discussions of a workshop of the German Heart Transplant Centers in Martinsried, Germany on cardiac xenotransplantation. The production and current availability of genetically modified donor pigs, preservation techniques during organ harvesting, and immunosuppressive regimens in the recipient are described. Selection criteria for suitable patients and possible solutions to the problem of overgrowth of the xenotransplant are discussed. Obviously microbiological safety for the recipient and close contacts is essential, and ethical considerations to gain public acceptance for clinical applications are addressed. The first clinical trial will be regulated and supervised by the Paul-Ehrlich-Institute as the National Competent Authority for Germany, and the German Heart Transplant Centers agreed to cooperatively select the first patients for cardiac xenotransplantation.

Simulation of the mortality after different ex ante (secondary) and ex post (tertiary) triage methods in people with disabilities and pre-existing diseases.

The significant increase in patients during the COVID-19 pandemic presented the healthcare system with a variety of challenges. The intensive care unit is one of the areas particularly affected in this context. Only through extensive infection control measures as well as an enormous logistical effort was it possible to treat all patients requiring intensive care in Germany even during peak phases of the pandemic, and to prevent triage even in regions with high patient pressure and simultaneously low capacities. Regarding pandemic preparedness, the German Parliament passed a law on triage that explicitly prohibits ex post (tertiary) triage. In ex post triage, patients who are already being treated are included in the triage decision and treatment capacities are allocated according to the individual likelihood of success. Legal, ethical, and social considerations for triage in pandemics can be found in the literature, but there is no quantitative assessment with respect to different patient groups in the intensive care unit. This study addressed this gap and applied a simulation-based evaluation of ex ante (primary) and ex post triage policies in consideration of survival probabilities, impairments, and pre-existing conditions. The results show that application of ex post triage based on survival probabilities leads to a reduction in mortality in the intensive care unit for all patient groups. In the scenario close to a real-world situation, considering different impaired and prediseased patient groups, a reduction in mortality of approximately 15% was already achieved by applying ex post triage on the first day. This mortality-reducing effect of ex post triage is further enhanced as the number of patients requiring intensive care increases.

Parental perspectives about information and deferred versus two-stage consent in studies of neonatal asphyxia.

OBJECTIVE: The ALBINO Trial (NCT03162653) investigates effects of very early postnatal allopurinol on neurocognitive outcome following perinatal asphyxia where prenatal informed consent (IC) is impossible. Ethically and legally, waiver of consent and/or deferred consent (DC) is acceptable in such an emergency. Short oral/two-step consent (SOC, brief information and oral consent followed by IC) has recently been investigated. METHODS: Mixed-methods analysis of parental opinions on DC versus SOC in the context of neonatal asphyxia in a survey at two German centres. Prospective parents (ProP), parents of healthy newborns (PNeo) and parents of asphyxiated infants (PAx) born between 2006 and 2016 were invited. RESULTS: 108 of 422 parents participated (ProP:43; PNeo:35; PAx:30). Most parents trusted physicians, wanted preinterventional information and agreed that in emergencies interventions should begin immediately. Intergroup and intragroup variability existed for questions about DC and SOC. In the ALBINO Trial situation, 55% preferred SOC, and 26% reported DC without information might adversely affect their trust. Only 3% reported to potentially take legal action after DC. PAx were significantly more likely to support DC. PAx more frequently expressed positive emotions and appreciation for neonatal research. In open-ended questions, parents gave many constructive recommendations. CONCLUSION: In this survey, parents expressed diverse opinions on consent, but the majority preferred SOC over DC. Parents who had experienced emergency admission of their asphyxiated neonates were more trusting. Obtaining parental perspectives is essential when designing studies, while being cognisant that these groups of parents may not represent the opinion of all parents.

Advance Care Planning in Germany.

Advance Care Planning (ACP) defined as a comprehensive concept requiring a cultural change following implementation at the individual, institutional and regional level in order to achieve care consistency with care preferences when individuals are incapable of participating in critical decisions was first implemented in two regional projects (LIMITS and beizeiten begleiten, North Rhine Westphalia) in Germany in the 2000s. Based on the positive evaluation of beizeiten begleiten, legislation of 2015 (§ 132g, Social Code Book V) allows nursing homes and care homes for persons with disabilities to offer qualified ACP facilitation covered by the statutory health insurance. However, trainers for ACP facilitators need no specific qualification, and the training program for ACP facilitators is only broadly defined, which resulted in great heterogeneity of ACP facilitator qualifications. Furthermore, neither the institutional nor the regional implementation are sufficiently considered in this legislation, i.e. essential components of a successful implementation of ACP are missing. Nevertheless, a growing number of initiatives, research projects and a professional national society for ACP, engage in approaches to advance institutional and regional implementation, and to offer ACP to other target groups beyond the legal framework.

[Simulation of mortality after different ex-ante and ex-post-triage methods in people with disabilities and comorbidities]. / Simulation der Letalität nach verschiedenen Ex-ante- und Ex-post-Triage-Verfahren bei Menschen mit Behinderungen und Vorerkrankungen.

The significant increase in patients during the COVID-19 pandemic presented the healthcare system with a variety of challenges. The intensive care unit is one of the areas particularly affected in this context. Only through extensive infection control measures as well as an enormous logistical effort was it possible to treat all patients requiring intensive care in Germany even during peak phases of the pandemic, and to prevent triage even in regions with high patient pressure and simultaneously low capacities. Regarding pandemic preparedness, the German Parliament passed a law on triage that explicitly prohibits ex post (tertiary) triage. In ex post triage, patients who are already being treated are included in the triage decision and treatment capacities are allocated according to the individual likelihood of success. Legal, ethical, and social considerations for triage in pandemics can be found in the literature, but there is no quantitative assessment with respect to different patient groups in the intensive care unit. This study addressed this gap and applied a simulation-based evaluation of ex ante (primary) and ex post triage policies in consideration of survival probabilities, impairments, and pre-existing conditions. The results show that application of ex post triage based on survival probabilities leads to a reduction in mortality in the intensive care unit for all patient groups. In the scenario close to a real-world situation, considering different impaired and prediseased patient groups, a reduction in mortality of approximately 15% was already achieved by applying ex post triage on the first day. This mortality-reducing effect of ex post triage is further enhanced as the number of patients requiring intensive care increases.

Secondary data for global health digitalisation.

Substantial opportunities for global health intelligence and research arise from the combined and optimised use of secondary data within data ecosystems. Secondary data are information being used for purposes other than those intended when they were collected. These data can be gathered from sources on the verge of widespread use such as the internet, wearables, mobile phone apps, electronic health records, or genome sequencing. To utilise their full potential, we offer guidance by outlining available sources and approaches for the processing of secondary data. Furthermore, in addition to indicators for the regulatory and ethical evaluation of strategies for the best use of secondary data, we also propose criteria for assessing reusability. This overview supports more precise and effective policy decision making leading to earlier detection and better prevention of emerging health threats than is currently the case.

[Testicular Cancer Screening in Men Aged 16 Years and Older: IQWiG ThemenCheck Health Technology Assessment Report on Medical, Economic, Social, Ethical, Legal and Organisational Aspects]. / Hodenkrebsscreening bei Männern ab 16 Jahren: IQWiG ThemenCheck Health Technology Assessment-Bericht zu medizinischen, ökonomischen, sozialen, ethischen, rechtlichen und organisatorischen Aspekten.

BACKGROUND: Testicular cancer occurs mainly in young men between 25 and 45 years and is the most common cancer at this age. Possible testicular cancer early detection measures, clinical palpation and scrotal ultrasound (CUS) or testicular self-examination (TSE) in asymptomatic men aged 16 years and older, could perhaps avoid deaths and aggressive late therapies. Therefore, we investigated whether these measures have an additional benefit compared to the current situation. Ethical, legal, social and organisational aspects were considered as well. METHODS: The methodology of this review follows IQWiG's "Allgemeine[n] Methoden Version 5.0". In addition, to estimate the theoretically possible benefits and potential harms of screening, a supplementary presentation was used for the benefit assessment based on published data from tumour registries and data on predictive values from diagnostic studies. RESULTS: No intervention studies were identified, therefore evidence-based statements on additional benefit or harm of the studied interventions could not be made. The epidemiological data showed that per 100,000 men participating in screening annually, a maximum of 1.2 advanced tumours and 0.4 deaths would have been preventable. Harm calculations suggest that with CUS of 100,000 men, 1 to 22 unnecessary testicular exposures or removals might be expected, with TSE it would be 2 cases. However, these data on the possible harm of screening are subject to great uncertainty. CONCLUSIONS: There are no intervention studies demonstrating that the benefit of testicular cancer screening in men aged 16 years and older outweighs the harm. The maximum possible additional benefit is low and chances of detection and cure are good even without screening. At present, testicular cancer screening cannot be recommended.

Effectiveness of a complex regional advance care planning intervention to improve care consistency with care preferences: study protocol for a multi-center, cluster-randomized controlled trial focusing on nursing home residents (BEVOR trial).

BACKGROUND: According to recent legislation, facilitated advance care planning (ACP) for nursing home (NH) residents is covered by German sickness funds. However, the effects of ACP on patient-relevant outcomes have not been studied in Germany yet. This study investigates whether implementing a complex regional ACP intervention improves care consistency with care preferences in NH residents. METHODS: This is a parallel-group cluster-randomized controlled trial (cRCT) with 48 NHs (≈ 3840 resident beds) between 09/2019 and 02/2023. The intervention group will receive a complex, regional ACP intervention aiming at sustainable systems redesign at all levels (individual, institutional, regional). The intervention comprises comprehensive training of ACP facilitators, implementation of reliable ACP processes, organizational development in the NH and other relevant institutions of the regional healthcare system, and education of health professionals caring for the residents. Control group NHs will deliver care as usual. Primary outcome is the hospitalization rate during the 12-months observation period. Secondary outcomes include the rate of residents whose preferences were known and honored in potentially life-threatening events, hospital days, index treatments like resuscitation and artificial ventilation, advance directives, quality of life, psychological burden on bereaved families, and costs of care. The NHs will provide anonymous, aggregated data of all their residents on the primary outcome and several secondary outcomes (data collection 1). For residents who have given informed consent, we will evaluate care consistency with care preferences and further secondary outcomes, based on chart reviews and short interviews with residents, surrogates, and carers (data collection 2). Process evaluation will aim to explain barriers and facilitators, economic evaluation the cost implications. DISCUSSION: This study has the potential for high-quality evidence on the effects of a complex regional ACP intervention on NH residents, their families and surrogates, NH staff, and health care utilization in Germany. It is the first cRCT investigating a comprehensive regional ACP intervention that aims at improving patient-relevant clinical outcomes, addressing and educating multiple institutions and health care providers, besides qualification of ACP facilitators. Thereby, it can generate evidence on the potential of ACP to effectively promote patient-centered care in the vulnerable population of frail and often chronically ill elderly. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT04333303 . Registered 30 March 2020.

[Effectiveness and Ethical Evaluation of Nudging to Promote the Self-Management in Diabetes Mellitus Type 2]. / Wirksamkeit und ethische Bewertung von Nudging-Interventionen zur Förderung des Selbstmanagements bei Diabetes Mellitus Typ 2.

BACKGROUND: Nudges offer a wide range of options for protecting health in everyday life that supplements traditional public health measures. Against this background, we conducted initial investigations on the effectiveness and ethical aspects of different nudges for promoting self-management of patients with diabetes mellitus type 2 in the context of Disease Management Programs (DMPs). METHODS: The ethical assessment of the nudges was done within the systematic framework of Marckmann et al. (2015) for public health ethics. The existing evidence on the effectiveness of nudges was summarised by means of a narrative literature review. RESULTS: Target agreements with implementation plans, reminder, feedback reports, shared appointments of patients with physicians, peer mentoring, and behavior contracts are nudging interventions with moderate interference with personal rights and relatively unproblematic ethical requirements, which have demonstrated effectiveness in different contexts. Default enrollment for patient training courses, involvement of partners, confrontation with social norms, and shocking pictures may be effective as well; however, they interfere more deeply with the freedom and privacy of patients and, therefore, are bound to stronger ethical requirements and restrictions. The evidence base is still insufficient, especially for social support measures by relatives and peers. CONCLUSIONS: Nudging offers a wide range of targeted interventions for supporting self-management of patients with chronic diseases, the potential of which has not yet been fully realized. Particularly promising interventions should be tested in pilot studies for their acceptance, effectiveness and cost-effectiveness in the context of DMPs.

[Quality and ethics in healthcare]. / Qualität und Ethik in der Gesundheitsversorgung.

The term "quality" in healthcare is frequently used but defined in different ways. On the one hand, quality describes the nature or characteristic of things and is descriptive in this respect. In quality management and quality assurance, however, the focus is on the normative dimension of quality, referring to the evaluation of structures, processes, or results of actions in the context of healthcare. There are several links between ethical considerations in healthcare and quality of healthcare. First, the provision and assurance of high quality is an ethical imperative, mandated by the principles of beneficence and nonmaleficence. However, for high ethical quality of care, the ethical principles of respect for patient autonomy and justice must also be considered. Last but not least, the determination and justification of what "good" or "high" quality in healthcare means must be reflected from an ethical perspective. This article analyses these ethical dimensions of quality management and quality assurance. To achieve this goal, it first explains which ethical requirements have to be considered as quality criteria in patient care. Subsequently, ethically relevant challenges in determining quality in healthcare are identified based on criteria of outcome quality, and the teaching of professional competencies in medical education is discussed as a possible contribution to quality and quality assurance in healthcare. The paper concludes with considerations on determining and assuring quality under conditions of limited healthcare resources.

Preparing n-of-1 Antisense Oligonucleotide Treatments for Rare Neurological Diseases in Europe: Genetic, Regulatory, and Ethical Perspectives.

Antisense oligonucleotide (ASO) therapies present a promising disease-modifying treatment approach for rare neurological diseases (RNDs). However, the current focus is on "more common" RNDs, leaving a large share of RND patients still without prospect of disease-modifying treatments. In response to this gap, n-of-1 ASO treatment approaches are targeting ultrarare or even private variants. While highly attractive, this emerging, academia-driven field of ultimately individualized precision medicine is in need of systematic guidance and standards, which will allow global scaling of this approach. We provide here genetic, regulatory, and ethical perspectives for preparing n-of-1 ASO treatments and research programs, with a specific focus on the European context. By example of splice modulating ASOs, we outline genetic criteria for variant prioritization, chart the regulatory field of n-of-1 ASO treatment development in Europe, and propose an ethically informed classification for n-of-1 ASO treatment strategies and level of outcome assessments. To accommodate the ethical requirements of both individual patient benefit and knowledge gain, we propose a stronger integration of patient care and clinical research when developing novel n-of-1 ASO treatments: each single trial of therapy should inherently be driven to generate generalizable knowledge, be registered in a ASO treatment registry, and include assessment of generic outcomes, which allow aggregated analysis across n-of-1 trials of therapy.

"We Absolutely Had the Impression That It Was Our Decision"-A Qualitative Study with Parents of Critically Ill Infants Who Participated in End-of-Life Decision Making.

BACKGROUND: Guidelines recommend shared decision making (SDM) between neonatologists and parents when a decision has to be made about the continuation of life-sustaining treatment (LST). In a previous study, we found that neonatologists and parents at a German Level-III Neonatal Intensive Care Unit performed SDM to a variable but overall small extent. However, we do not know whether parents in Germany prefer an extent of more or sharing. METHODS: We performed a qualitative interview study with parents who participated in our first study. We analyzed the semi-structured interviews with qualitative content analysis according to Kuckartz. RESULTS: The participation in medical decision making (MDM) varied across cases. Overall, neonatologists and parents conducted SDM in most cases only to a small extent. All parents appreciated their experience independent of how much they were involved in MDM. The parents who experienced a small extent of sharing were glad that they were protected by neonatologists from having to decide, shielding them from a conflict of interest. The parents who experienced a large extent of sharing especially valued that they were able to fulfil their parental duties even if that meant partaking in a decision to forgo LST. DISCUSSION: Other studies have also found a variety of possibilities for parents to partake in end-of-life decision making (EOL-DM). Our results suggest that parents do not have a uniform preference for one specific decision-making approach, but rather different parents appreciate their individual experience regardless of the model for DM. CONCLUSION: SDM is apparently not a one-size-fits-all approach. Instead, neonatologists and parents have to adapt the decision-making process to the parents' individual needs and preferences for autonomy and protection. Therefore, SDM should not be prescribed as a uniform standard in medico-ethical guidelines, but rather as a flexible guidance for DM for critically ill patients in neonatology.

Organ transplants of the future: planning for innovations including xenotransplantation.

The future clinical application of animal-to-human transplantation (xenotransplantation) is of importance to society as a whole. Favourable preclinical data relevant to cell, tissue and solid organ xenotransplants have been obtained from many animal models utilizing genetic engineering and protocols of pathogen-free husbandry. Findings have reached a tipping point, and xenotransplantation of solid organs is approaching clinical evaluation, the process of which now requires close deliberation. Such discussions include considering when there is sufficient evidence from preclinical animal studies to start first-in-human xenotransplantation trials. The present article is based on evidence and opinions formulated by members of the European Society for Organ Transplantation who are involved in the Transplantation Learning Journey project. The article includes a brief overview of preclinical concepts and biology of solid organ xenotransplantation, discusses the selection of candidates for first-in-human studies and considers requirements for study design and conduct. In addition, the paper emphasizes the need for a regulatory framework for xenotransplantation of solid organs and the essential requirement for input from public and patient stakeholders.

Advance care planning by proxy in German nursing homes: Descriptive analysis and policy implications.

BACKGROUND: Legally recognized advance directives (ADs) have to be signed by the person to whom the decisions apply. In practice, however, there are also ADs written and signed by legal proxies (surrogates) on behalf of patients who lack decision-making capacity. Given their practical relevance and substantial ethical and legal implications, ADs by proxy (AD-Ps) have received surprisingly little scientific attention so far. OBJECTIVES: To study the form, content, validity, and applicability of AD-Ps among German nursing home residents and develop policy implications. METHODS: Secondary analysis of two independent cross-sectional studies in three German cities, comprising 21 nursing homes and 1528 residents. The identified AD-Ps were analyzed in parallel by three independent raters. Inter-rater agreement was measured using free-marginal multi-rater kappa statistics. RESULTS: Altogether, 46 AD-Ps were identified and pooled for analysis. On average (range), AD-Ps were 1 (1-7) year(s) old, 0.5 (0.25-4) pages long, signed by 1 (0-5) person, with evidence of legal proxy involvement in 35%, and signed by a physician in 20% of cases. Almost all the AD-Ps reviewed aimed to limit life-sustaining treatment (LST), but had widely varying content and ethical justifications, including references to earlier statements (30%) or actual behavior (11%). The most frequent explicit directives were: do-not-hospitalize (67%), do-not-tube-feed (37%), do-not-attempt-resuscitation (20%), and the general exclusion of any LST (28%). Inter-rater agreement was mostly moderate (kappa ≥0.6) or strong (kappa ≥0.8). CONCLUSIONS: Although AD-Ps are an empirical reality in German nursing homes, formal standards for such directives are lacking and their ethical justification based on substituted judgment or best interest standard often remains unclear. A qualified advance care planning process and corresponding documentation are required in order to safeguard the appropriate use of this important instrument and ensure adherence to ethico-legal standards.

What does it take to consent to islet cell xenotransplantation?: Insights from an interview study with type 1 diabetes patients and review of the literature.

BACKGROUND: The transplantation of porcine islet cells provides a new potential therapy to treat patients with type 1 diabetes mellitus (T1DM). Compared to other biomedical technologies, xenotransplantation stands out in terms of its involvement of animals as graft sources, as well as the possible transmission of infectious diseases. As these aspects are especially relevant for potential xenotransplantation recipients, it is important to assess their opinion regarding this technology, in particular in terms of the requirements that should be met in the informed consent process for xenotransplantation. METHODS: We conducted qualitative interviews with seven T1DM patients to assess their information needs prior to xenotransplantation. Before the interview, the participants received a model informed consent form for a clinical trial with porcine islet cells transplantation. The interviews were transcribed and analysed using qualitative content analysis. RESULTS: In the interviews, we identified several requirements that are crucial for patients with T1DM in order to consider xenotransplantation as a potential treatment option: therapy-related requirements, professional care and supervision, successful behaviour and attitude management, improving quality of life, and managing control/self-determination challenges. Regarding the informed consent form, several of the participants' questions remained open and should be addressed in more detail. The interviewees stressed the importance of personal consultations. CONCLUSIONS: To become a sustainable therapeutic option, patients especially expected an improved diabetes control and a reduction of diabetes-related burdens. Health-related aspects prove to be pivotal for diabetic patients when considering porcine islet cell transplantation. The use of pigs as source for organ retrievals was not considered as problematic.