Florian Steger’s research while affiliated with University Hospital Ulm and other places

The clinical autopsy of foetuses, stillborn babies, or neonates and the examination of the placenta help to inform the mother’s decision-making and her medical care for subsequent pregnancies. Indeed, these post-mortem examinations can identify unexpected congenital malformations or the cause of repeated miscarriage or stillbirth. However, the use of clinical pathology for diagnostic purposes in the context of family planning for bereaved parents with an unfulfilled desire to have a child, and IVF couples has received little attention to date. This article applies Beauchamp and Childress’ bioethical framework to identify, assess and systematically discuss ethical issues associated with the use of clinical foetal autopsy in reproductive healthcare within the German legal context. In the format of a clinical ethics consultation, the article examines the current policy on perinatal post-mortem examinations in Germany, and asks whether the clinical foetal autopsy for reproductive health purposes should be part of standard clinical examinations offered to bereaved parents. The conclusion of our research recommends clinical foetal autopsy as ethically acceptable, provided that the necessary resources are available. This recommendation is based on the ethical obligation towards the mother as the patient, which is grounded in the bioethical principles of autonomy and beneficence.

What people value today can differ from what they have valued. But what does this value variability mean in the context of healthcare? We ethically analyze the current state of research on the change of embedded values in healthcare systems and the driving processes behind it. Starting with a systematic literature review and a content analysis, we subject the selected articles to an ethical analysis through three ethical theories: principlism, value ethics, and utilitarianism. The included papers demonstrated how moral dissonance between individual values and behavior leads to moral distress. The occurrence of moral distress was related to current healthcare practices. Beneficence and non-maleficence played a central role where principlism was considered, virtue ethics was criticized for not addressing the structural problems in the healthcare system, and consequences of value change for healthcare professionals and the society were analyzed. Further, principlism cannot fully cover the value change in medical care with its top-down and bottom-up processes leading to consequences for the patients, healthcare professionals, and society as a whole. We found correlations between top-down value change processes in the healthcare system and the quality of care. Health professionals are forced to develop an attitude that does not adhere to traditional medical values any longer and eventually leads to low-value care. Accompanying phenomena like moral distress cause dropout of healthcare workers. These can be hardly slowed down from the bottom-up by the development of resilience and moral courage. More effectively, structural changes through value interventions have the potential to improve working conditions and the quality of care.

Background Geriatric comanagement has been shown to improve outcomes of older surgical inpatients. Furthermore, the choice of discharge location, that is, continuity of care, can have a fundamental impact on convalescence. These challenges and demands have led to the SURGE-Ahead project that aims to develop a clinical decision support system (CDSS) for geriatric comanagement in surgical clinics including a decision support for the best continuity of care option, supported by artificial intelligence (AI) algorithms. Objective This qualitative study aims to explore the current challenges and demands in surgical geriatric patient care. Based on these challenges, the study explores the attitude of interviewees toward the introduction of an AI-supported CDSS (AI-CDSS) in geriatric patient care in surgery, focusing on technical and general wishes about an AI-CDSS, as well as ethical considerations. Methods In this study, 15 personal interviews with physicians, nurses, physiotherapists, and social workers, employed in surgical departments at a university hospital in Southern Germany, were conducted in April 2022. Interviews were conducted in person, transcribed, and coded by 2 researchers (AU, LB) using content and thematic analysis. During the analysis, quotes were sorted into the main categories of geriatric patient care, use of an AI-CDSS, and ethical considerations by 2 authors (AU, LB). The main themes of the interviews were subsequently described in a narrative synthesis, citing key quotes. Results In total, 399 quotes were extracted and categorized from the interviews. Most quotes could be assigned to the primary code challenges in geriatric patient care (111 quotes), with the most frequent subcode being medical challenges (45 quotes). More quotes were assigned to the primary code chances of an AI-CDSS (37 quotes), with its most frequent subcode being holistic patient overview (16 quotes), then to the primary code limits of an AI-CDSS (26 quotes). Regarding the primary code technical wishes (37 quotes), most quotes could be assigned to the subcode intuitive usability (15 quotes), followed by mobile availability and easy access (11 quotes). Regarding the main category ethical aspects of an AI-CDSS , most quotes could be assigned to the subcode critical position toward trust in an AI-CDSS (9 quotes), followed by the subcodes respecting the patient’s will and individual situation (8 quotes) and responsibility remaining in the hands of humans (7 quotes). Conclusions Support regarding medical geriatric challenges and responsible handling of AI-based recommendations, as well as necessity for a holistic approach focused on usability, were the most important topics of health care professionals in surgery regarding development of an AI-CDSS for geriatric care. These findings, together with the wish to preserve the patient-caregiver relationship, will help set the focus for the ongoing development of AI-supported CDSS.

Background Experiences of discrimination in healthcare lead to poorer mental and physical health for transgender individuals. There is evidence that trans-specialists, i.e. health professionals specializing in transgender care, are an important source of discrimination experienced by transgender individuals in healthcare. In this qualitative interview study, we explored the reasons for this possibly surprising finding by analyzing subjective views of trans-specialists on various issues related to discrimination of transgender individuals. Methods We conducted 20 semi-structured, qualitative, exploratory interviews with healthcare professionals specializing in transgender care. Interview questions were developed based on an extensive literature analysis and results of previous research on the topic. The interviews were conducted online, were digitally recorded and transcribed. Data analysis was conducted using the methods of content analysis and thematic analysis. Results The interviewees had great difficulty giving a consistent definition of the concept of gender identity. Most of them saw it as a self-determination of a transgender individual. Although herewith emphasizing the autonomy of transgender individuals, most trans-specialists felt that they had to be convinced of their patient’s transsexuality to carry out treatment. Most trans-specialists reported having had doubts about whether some transgender individuals were suffering from gender incongruence or not. There was also ambiguity among interviewees about whether transsexuality is a mental illness. Conclusions We were able to identify specific topics that can cause discrimination experiences on the part of transgender individuals in their contact with trans-specialists. These include the vagueness of the construct of gender identity and the ambivalence between respect for the autonomy of transgender individuals and the validation of the diagnosis “transsexuality”. Also, uncertainties regarding the classification of transsexuality as a mental illness can lead to experiences of discrimination. Furthermore, our results imply that trans-specialists might remember own discriminatory behavior less than it actually took place. Our results can contribute to the development of specific measures to avoid discrimination experiences of transgender individuals in contact with trans-specialists. These should include a reflection on one’s own gender identity and training on mechanisms of discrimination.

Background Research for personalised therapies concerning the Systemic Inflammatory Response Syndrome (SIRS) in children involves the utilisation of OMICS technologies and Artificial Intelligence (AI). Methods To identify specific ethical challenges through the perspective of healthcare professionals, we conducted 10 semi-structured interviews. The development of interview questions for the interviews was preceded by a systematic review of the scientific literature. To address the complexities of paediatric emergency research, informed consent, and data processing, experts with expertise in paediatric intensive care, computer science, and medical law were sought. After the transcription and anonymisation, the analysis followed established guidelines for qualitative content and thematic analysis. Results Interviewees highlighted the intricacies of managing consent in personalised SIRS research due to the large amount and complexity of information necessary for autonomous decision-making. Thus, instruments aimed at enhancing the understanding of legal guardians and to empowering the child were appreciated and the need for specific guidelines and establishing standards was expressed. Medical risks were estimated to be low, but the challenges of securing anonymisation and data protection were expected. It was emphasised that risks and benefits cannot be anticipated at this stage. Social justice issues were identified because of possible biases within the research population. Our findings were analysed using current ethical and legal frameworks for research with a focus on the particularities of the patient group and the emergency background. In this particular context, experts advocated for an enabling approach pertaining to AI in combination with OMICS technologies. Conclusion As with every new technological development, ethical and legal challenges cannot be foreseen for SIRS-personalised treatment. Given this circumstance, experts emphasised the importance of extending the ethics-legal discourse beyond mere restrictions. The organisation of supervision should be reconsidered and not limited only to the precautionary principle, which per se was seen as impeding both the medical progress and clinical flexibility. It was noted that the establishment and monitoring of guidelines were emergent and should evolve through an interdisciplinary discourse. Therefore, it was recommended to enhance the qualifications of physicians in the field of computer science, impart ethics training to AI developers, and involve experts with expertise in medical law and data protection.

Background Systemic Inflammatory Response Syndrome (SIRS) is an often-emergent condition, which lacks specific diagnostic tools. Personalised therapy could fill this gap but as every new technology, it raises issues of social justice. Our report aims at identification and analysis of social justice implications within the bigger ERA PerMed funded project of development of tailored immunotherapy for paediatric SIRS patients (TIPS) coordinated by Prof. Catharina Schütz from Technic University Dresden. Methods Qualitative research methodology thought 10 semi-structured interviews. Systematic literature review grounded the interview questionnaire. Transcripts were subjected to thematic analysis by two independent researchers. Results Social justice was seen as equal chances of inclusion of different population groups in research. Socioeconomic differences were perceived as a challenge to ensure justice across various populations (N = 7). Two interviewees saw discrimination as inherent to precision medicine, which is focused on personalised treatment. Two experts viewed the exclusion of specific patients’ groups as an unsolvable problem, that only advocates for the inclusion of as many patients as possible. On the opinion of six experts individual and ethnocultural factors may influence outcomes in personalised treatment, especially considering the small sample size and the diverse populations. One medical expert, on the contrary, perceived no significant challenges associated with the heterogeneity of patients. Whether socioeconomic injustices should be addressed by guidelines and how these correspond to the rights of the patient were further discussed. Conclusions The issues of social justice accompany research in personalised medicine, including SIRS. In general, there is sensitivity to this issue, but current guidelines are too vague. As with other ethical problems, so with social justice we seem to have a rethinking of the concept, that needs further study. Key messages • In the context of SIRS personalised therapy research, there is a sensitivity to the issue of social justice, but no consensus how to ensure it. • Issues of social justice are often boiled down to equal chances of inclusion in research and equal access to treatment. In the case of personalised therapy, there seems to be more to it.

Background Pediatric Systemic Inflammatory Response Syndrome (SIRS) presents diagnostic and therapeutic challenge that can be addressed through personalised therapy. Related ethical challenges are understudied. Our report aims at identification and analysis of research ethics implications within the bigger ERA PerMed funded project of development of tailored immunotherapy for paediatric SIRS patients (TIPS) coordinated by Prof. Catharina Schütz from Technic University Dresden. Methods A sample of 10 experts with different backgrounds was studied through semi-structured interviews. Systematic literature review grounded the interview questionnaire. The transcripts were subjected to thematic analysis by two independent researchers. Results Five classical research ethics issues were identified: respect for autonomy; informed consent; risk-benefits ratio; data protection; social justice. All experts favoured the empowerment of children (N = 10) and obtainment of informed consent rather than assent was seen as a common goal (N = 5). The emergency context of SIRS research impeded the informed consent. Despite favourable risk-benefits ratio, no direct benefits resulted to study participants. Data anonymisation though necessary (N = 10), hinders proper dealing with incidental findings. Social justice issues apparently accompanied research design in personalised medicine (N = 2) but should not extend to access to personalised therapy. Conclusions The classical framework of research ethics is challenged by the new fields of medical research. Traditional concepts, such as informed consent in minors, are subject to rethinking. Current ethical and legal guidelines fall short of proper practical instructions in the specific case of SIRS pediatric patients. Thus, ethical aspects of new technology development should always be studied in parallel to the biometrics within personalised medicine projects so as to the development of guidelines is more evidence-based than precautionary driven. Key messages • Current ethical and legal guidelines fall short of proper practical instructions in the specific case of SIRS pediatric patients. • Ethical aspects of new technology development should always be studied within personalised medicine projects so as to the development of guidelines is more evidence-based than precautionary driven.

Background Systemic Inflammatory Response Syndrome (SIRS) is a rare disease often presenting emergency. While the aetiology varies, current diagnostic criteria do not allow differentiation. Hopes are placed on OMICs research and development of Artificial intelligence (AI) algorithms for personalised disease management. Our report aims at identification and analysis of AI-driven ethical issues within the bigger ERA PerMed funded project of development of tailored immunotherapy for paediatric SIRS patients (TIPS) coordinated by Prof. Catharina Schütz from Technic University Dresden. Methods Systematic literature review followed by qualitative research methodology. Ten experts with different backgrounds were interviewed. Subsequent thematic analysis was performed by two independent researchers. Results Experts were on the opinion that AI can lead to a depart from individual approach in the medicine, as the physician may be induced to only act based on algorithms that are more or less representative (N = 2). Interviewees were aware that AI can lead to changes in the assessment of reality, as it is dependent on data quality (N = 4). AI-aided decision-making might be useful for special therapeutic situations, although it may not always capture the subtleties of individual situations (N = 2). Positive implications of AI were significantly more emphasised, though current frameworks were perceived as more limiting than enabling. Conclusions Personalised therapy is making its first steps while the ethical apprehensions has already been there with a strong emphasis on precautionary principle and resulting limitations on the application of AI-algorithms. The multifaceted nature of the AI-driven ethical issues in personalised medicine research requires an interdisciplinary discourse, strengthened ethics training of all professionals involved in the technology development and more active involvement of physicians in the shaping of AI. Key messages • AI algorithms promise therapeutic benefits, not achievable by other means, for specific categories of vulnerable pediatrics patients. • The multifaceted nature of the AI-driven ethical issues in personalised medicine research requires an interdisciplinary discourse and further ethics training of all stakeholders.