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Clinical practice guidelines (CPGs) have a potentially important role regarding the assessment and communication of the risks of perioperative complications. This study aimed to (1) examine the content of German surgical CPGs in relation to surgical risks and (2) provide baseline results for future research in order to assess the development of surgical CPGs in Germany in relation to this issue.

Abstract Background Myalgic encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a challenging disease pattern and has gained increasing scientific and public interest in recent years due to the Corona pandemic and Long-Covid. The aim of this study was to investigate (1) medical students’ health-related control beliefs, (2) students’ awareness and views about ME/CFS at the beginning of their medical education, and (3) to examine whether there are correlations between students’ health-related control beliefs and their views about ME/CFS. Methods A cross-sectional online-survey was conducted in October 2020 with all new medical students at the Ludwig Maximilian University of Munich and the Technical University Munich. Results A total of 251 students completed the survey, representing a response rate of 27.0% (251/929). The examined health related locus of control of the students was predominantly internal oriented. Students’ awareness about ME/CFS at the beginning of their medical education were found to be low: 46,8% (117/250) of the students surveyed disagreed that they have heard or read about ME/CFS and 81,6% (204/250) disagreed that they feel sufficiently well informed about the disease. A possible correlation between students’ health-related locus of control and their views regarding ME/CFS-specific issues was found: The higher the students’ internal locus of control, the less they favored a strict separation of mental and physical suffering in medical practice, the less they believed that psychological causes for an illness should only be sought when no physically objective causes could be found, and the less they agreed that there is no indication for therapy if a disease is not objectively detectable. Conclusions As ME/CFS is a medical challenge and increasingly relevant in medical practice, the fact that 50% of medical students have never heard of this disease underscores the need for awareness and education. We found that the majority students in the sample largely have an internal health related locus of control. They rate their own influence on their health higher than those with an externally oriented control conviction.

Background: As clinical trials involving implantable neural devices (INDs) increase in frequency and attract greater public attention, it is paramount to ensure they are conducted in alignment with fundamental ethical guidelines. Particular focus must be placed on the often underexplored aspect of trial termination for INDs. Objective: To systematically review the ethical challenges encountered in clinical trials for INDs at the juncture of trial termination. Methods: We conducted a rapid review using PubMed with two specific search queries, including all publications addressing ethical issues in the context of IND clinical trials. Priority was given to publications focusing on the end of treatment or the discontinuation of clinical studies or trials. Results: We identified three primary groups of ethical challenges: patient-centric challenges, challenges faced by the research and physician team, and manufacturer-related issues. Further analysis highlights the importance of initiating early, transparent discussions regarding trial cessation protocols, ensuring that all stakeholders—patients, healthcare providers, researchers, and manufacturers—are equitably considered. Additionally, we found a discrepancy between current discontinuation strategies and international ethical guidelines. To address this, we emphasize the ethical obligation to establish comprehensive exit strategies that align with the principles in the Declaration of Helsinki and the CIOMS/WHO guidelines. Conclusion: Our findings highlight the need for increased attention to the ethical and practical aspects of exit strategies and encourage further empirical research to address gaps in current practices. This would ensure that the discontinuation of IND trials is handled with ethical rigor, prioritizing the interests and well-being of all stakeholders involved.

BackgroundSocial media platforms are increasingly used to recruit patients for clinical studies. Yet, patients’ attitudes regarding social media recruitment are underexplored. ObjectiveThis mixed methods study aims to assess predictors of the acceptance of social media recruitment among patients with hepatitis B, a patient population that is considered particularly vulnerable in this context. MethodsUsing a mixed methods approach, the hypotheses for our survey were developed based on a qualitative interview study with 6 patients with hepatitis B and 30 multidisciplinary experts. Thematic analysis was applied to qualitative interview analysis. For the cross-sectional survey, we additionally recruited 195 patients with hepatitis B from 3 clinical centers in Germany. Adult patients capable of judgment with a hepatitis B diagnosis who understood German and visited 1 of the 3 study centers during the data collection period were eligible to participate. Data analysis was conducted using SPSS (version 28; IBM Corp), including descriptive statistics and regression analysis. ResultsOn the basis of the qualitative interview analysis, we hypothesized that 6 factors were associated with acceptance of social media recruitment: using social media in the context of hepatitis B (hypothesis 1), digital literacy (hypothesis 2), interest in clinical studies (hypothesis 3), trust in nonmedical (hypothesis 4a) and medical (hypothesis 4b) information sources, perceiving the hepatitis B diagnosis as a secret (hypothesis 5a), attitudes toward data privacy in the social media context (hypothesis 5b), and perceived stigma (hypothesis 6). Regression analysis revealed that the higher the social media use for hepatitis B (hypothesis 1), the higher the interest in clinical studies (hypothesis 3), the more trust in nonmedical information sources (hypothesis 4a), and the less secrecy around a hepatitis B diagnosis (hypothesis 5a), the higher the acceptance of social media as a recruitment tool for clinical hepatitis B studies. ConclusionsThis mixed methods study provides the first quantitative insights into social media acceptance for clinical study recruitment among patients with hepatitis B. The study was limited to patients with hepatitis B in Germany but sets out to be a reference point for future studies assessing the attitudes toward and acceptance of social media recruitment for clinical studies. Such empirical inquiries can facilitate the work of researchers designing clinical studies as well as ethics review boards in balancing the risks and benefits of social media recruitment in a context-specific manner.

This qualitative study examines the impact of scientific, ethical, and translational challenges of precision medicine for atopic dermatitis and psoriasis. The study explores how these challenges affect biomarker research for inflammatory skin diseases as identified by stakeholders, including patient board representatives, pharmaceutical industry partners, and postdoctoral and senior researchers from multiple disciplines in biomarker research. We recruited participating experts both within and associated with the international Biomarkers in Atopic Dermatitis and Psoriasis (BIOMAP) consortium to ensure representation of the different organizational units of the consortium. For the study, we followed the COREQ checklist. The interviews were conducted using GDPR-safe online platforms and the pseudonymized transcripts were analyzed using Atlas.ti. We analyzed the interviews from participants' personal experiences, topic-oriented, and group specific to identify the main themes presented in this article. The findings were presented to peers and to the wider BIOMAP audience, discussed, and a draft was circulated within the consortium for feedback. In this study, we identify and discuss the interrelation of challenges that are relevant to improving precision medicine with multimodal biomarkers. We show how scientific challenges can interrelate with ethical and translational issues, and explain these interdependencies and articulate epistemic and social factors of interdisciplinary collaboration. Based on our findings, we suggest that including patient representatives’ perspectives is crucial for highly interrelated and widely diverse research. The proposed integrative perspective is beneficial for all involved stakeholders. Effective communication of science requires reflection on the tension between scientific uncertainty and the goals of precision medicine. Furthermore, we show how changing the perception of the diseases, atopic dermatitis, and psoriasis can benefit patients beyond medical practice.

Abstract Background While solidarity practices were important in mitigating the Coronavirus Disease 2019 (COVID-19) pandemic, their limits became evident as the pandemic progressed. Taking a longitudinal approach, this study analyses German residents’ changing perceptions of solidarity practices during the COVID-19 pandemic and examines potential reasons for these changes. Methods Adults living in Germany were interviewed in April 2020 (n = 46), October 2020 (n = 43) and October 2021 (n = 40) as part of the SolPan Research Commons, a large-scale, international, qualitative, longitudinal study uniquely situated in a major global public health crisis. Interviews were analysed using qualitative content analysis. Results While solidarity practices were prominently discussed and positively evaluated in April 2020, this initial enthusiasm waned in October 2020 and October 2021. Yet, participants still perceived solidarity as important for managing the pandemic and called for institutionalized forms of solidarity in October 2020 and October 2021. Reasons for these changing perceptions of solidarity included (i) increasing personal and societal costs to act in solidarity, (ii) COVID-19 policies hindering solidarity practices, and (iii) a perceived lack of reciprocity as participants felt that solidarity practices from the state were not matching their individual efforts. Conclusions Maintaining solidarity contributes to maximizing public health during a pandemic. Institutionalized forms of solidarity to support those most in need contribute to perceived reciprocity among individuals, which might increase their motivation to act in solidarity. Thus, rather than calling for individual solidarity during times of crisis, authorities should consider implementing sustaining solidarity-based social support systems that go beyond immediate crisis management.

Summary: Background: With the ever-increasing amount of medical imaging data, the demand for algorithms to assist clinicians has amplified. Unsupervised anomaly detection (UAD) models promise to aid in the crucial first step of disease detection. While previous studies have thoroughly explored fairness in supervised models in healthcare, for UAD, this has so far been unexplored. Methods: In this study, we evaluated how dataset composition regarding subgroups manifests in disparate performance of UAD models along multiple protected variables on three large-scale publicly available chest X-ray datasets. Our experiments were validated using two state-of-the-art UAD models for medical images. Finally, we introduced subgroup-AUROC (sAUROC), which aids in quantifying fairness in machine learning. Findings: Our experiments revealed empirical “fairness laws” (similar to “scaling laws” for Transformers) for training-dataset composition: Linear relationships between anomaly detection performance within a subpopulation and its representation in the training data. Our study further revealed performance disparities, even in the case of balanced training data, and compound effects that exacerbate the drop in performance for subjects associated with multiple adversely affected groups. Interpretation: Our study quantified the disparate performance of UAD models against certain demographic subgroups. Importantly, we showed that this unfairness cannot be mitigated by balanced representation alone. Instead, the representation of some subgroups seems harder to learn by UAD models than that of others. The empirical “fairness laws” discovered in our study make disparate performance in UAD models easier to estimate and aid in determining the most desirable dataset composition. Funding: European Research Council Deep4MI.

Background: Patients with cancer often have to make complex decisions about treatment, with the options varying in risk profiles and effects on survival and quality of life. Moreover, inefficient care paths make it hard for patients to participate in shared decision-making. Data-driven decision-support tools have the potential to empower patients, support personalized care, improve health outcomes and promote health equity. However, decision-support tools currently seldom consider quality of life or individual preferences, and their use in clinical practice remains limited, partly because they are not well integrated in patients’ care paths. Aim and objectives: The central aim of the 4D PICTURE project is to redesign patients’ care paths and develop and integrate evidence-based decision-support tools to improve decision-making processes in cancer care delivery. This article presents an overview of this international, interdisciplinary project. Design, methods and analysis: In co-creation with patients and other stakeholders, we will develop data-driven decision-support tools for patients with breast cancer, prostate cancer and melanoma. We will support treatment decisions by using large, high-quality datasets with state-of-the-art prognostic algorithms. We will further develop a conversation tool, the Metaphor Menu, using text mining combined with citizen science techniques and linguistics, incorporating large datasets of patient experiences, values and preferences. We will further develop a promising methodology, MetroMapping, to redesign care paths. We will evaluate MetroMapping and these integrated decision-support tools, and ensure their sustainability using the Nonadoption, Abandonment, Scale-Up, Spread, and Sustainability (NASSS) framework. We will explore the generalizability of MetroMapping and the decision-support tools for other types of cancer and across other EU member states. Ethics: Through an embedded ethics approach, we will address social and ethical issues. Discussion: Improved care paths integrating comprehensive decision-support tools have the potential to empower patients, their significant others and healthcare providers in decision-making and improve outcomes. This project will strengthen health care at the system level by improving its resilience and efficiency.

Abstract The emergence of ethical concerns surrounding artificial intelligence (AI) has led to an explosion of high-level ethical principles being published by a wide range of public and private organizations. However, there is a need to consider how AI developers can be practically assisted to anticipate, identify and address ethical issues regarding AI technologies. This is particularly important in the development of AI intended for healthcare settings, where applications will often interact directly with patients in various states of vulnerability. In this paper, we propose that an ‘embedded ethics’ approach, in which ethicists and developers together address ethical issues via an iterative and continuous process from the outset of development, could be an effective means of integrating robust ethical considerations into the practical development of medical AI.

Politicians, policymakers, and mass media alike have emphasized the importance of solidarity during the COVID-19 pandemic, calling for the need of social cohesion in society to protect risk groups and national healthcare systems. In this study, which is part of an international Consortium, we analyzed 77 qualitative interviews with members of the general public in Germany and German-speaking areas of Switzerland on solidaristic behavior and its limits during the first COVID-19 related lockdown in April 2020. We found interdependencies between the interpersonal, group, and state tiers of solidarity that offer insights into what promotes solidaristic practice and what does not. We argue that because solidarity does not have a necessary and sufficient normative value in itself, those wanting to promote solidarity need to consider these interdependencies to effectively implement policy measures. Our study shows that inter-societal solidarity was based on individual voluntary agency and promoted through recognizing a shared goal, shared values, or other communalities including group effort. It also shows that individuals held state authorities accountable for the same values and expect inter-societal reciprocity from the contractual level. Tensions between those complying or willing to follow recommendations voluntarily and those perceived as not promoting the shared goal, posed challenges for solidarity. Another challenge for solidaristic behavior was when acting in solidarity with others was in direct conflict with the needs of close ones. Our study provides a clearer picture of promoting and limiting factors concerning solidarity which is relevant when communicating health policy measures to individuals and groups.

The sudden and dramatic advent of the COVID-19 pandemic led to urgent demands for timely, relevant, yet rigorous research. This paper discusses the origin, design, and execution of the SolPan research commons, a large-scale, international, comparative, qualitative research project that sought to respond to the need for knowledge among researchers and policymakers in times of crisis. The form of organization as a research commons is characterized by an underlying solidaristic attitude of its members and its intrinsic organizational features in which research data and knowledge in the study is shared and jointly owned. As such, the project is peer-governed, rooted in (idealist) social values of academia, and aims at providing tools and benefits for its members. In this paper, we discuss challenges and solutions for qualitative studies that seek to operate as research commons.

Abstract Background In the COVID-19 pandemic, Switzerland introduced broad nationwide face mask mandates only by October 2020, later than other Western European countries. This study aims to assess the underlying values and considerations of individuals to wear face masks in the absence of face mask mandates in the COVID-19 pandemic in German-speaking Switzerland. Methods As part of the “Solidarity in times of a pandemic” (SolPan) research commons, we interviewed 31 participants living in the German-speaking part of Switzerland in April 2020 and 25 of them again in October 2020. Qualitative inductive thematic analysis was applied for data analysis and interpretation. Public health ethics principles guided the interpretation and organization of findings. Results Five themes were identified: Trust and governmental policy; perceived benefits of mask-wearing; perceived risks of mask-wearing; social exclusion and prejudice; and decision-making in the absence of mandates. In light of increasing infection rates in October 2020, many participants started to consider the benefits higher than the risks and were willing to accept face mask mandates in that context, despite earlier reservations. Conclusions The absence of face mask mandates underline individual autonomy but may also suppress personal responsibility due to social influence. Face masks are only temporarily acceptable in liberal Western societies and face mask mandates should be enforced only when epidemiologically necessary.

More severe atopic dermatitis and psoriasis are associated with a higher cumulative impact on quality of life, multimorbidity and healthcare costs. Proactive, early intervention in those most at risk of severe disease may reduce this cumulative burden and modify the disease trajectory to limit progression. The lack of reliable biomarkers for this at-risk group represents a barrier to such a paradigm shift in practice. To expedite discovery and validation, the BIOMarkers in Atopic Dermatitis and Psoriasis (BIOMAP) consortium (a large-scale European, interdisciplinary research initiative) has curated clinical and molecular data across diverse study designs and sources including cross-sectional and cohort studies (small-scale studies through to large multicentre registries), clinical trials, electronic health records and large-scale population-based biobanks. We map all dataset disease severity instruments and measures to three key domains (symptoms, inflammatory activity and disease course), and describe important codependencies and relationships across variables and domains. We prioritize definitions for more severe disease with reference to international consensus, reference standards and/or expert opinion. Key factors to consider when analysing datasets across these diverse study types include explicit early consideration of biomarker purpose and clinical context, candidate biomarkers associated with disease severity at a particular point in time and over time and how they are related, taking the stage of biomarker development into account when selecting disease severity measures for analyses, and validating biomarker associations with disease severity outcomes using both physician- and patient-reported measures and across domains. The outputs from this exercise will ensure coherence and focus across the BIOMAP consortium so that mechanistic insights and biomarkers are clinically relevant, patient-centric and more generalizable to current and future research efforts. [ABSTRACT FROM AUTHOR]

The Federal Ministry of Education and Research (BMBF) issued a call for a new nationwide research network on mental disorders, the German Center of Mental Health (DZPG). The Munich/Augsburg consortium was selected to participate as one of six partner sites with its concept “Precision in Mental Health (PriMe): Understanding, predicting, and preventing chronicity.” PriMe bundles interdisciplinary research from the Ludwig-Maximilians-University (LMU), Technical University of Munich (TUM), University of Augsburg (UniA), Helmholtz Center Munich (HMGU), and Max Planck Institute of Psychiatry (MPIP) and has a focus on schizophrenia (SZ), bipolar disorder (BPD), and major depressive disorder (MDD). PriMe takes a longitudinal perspective on these three disorders from the at-risk stage to the first-episode, relapsing, and chronic stages. These disorders pose a major health burden because in up to 50% of patients they cause untreatable residual symptoms, which lead to early social and vocational disability, comorbidities, and excess mortality. PriMe aims at reducing mortality on different levels, e.g., reducing death by psychiatric and somatic comorbidities, and will approach this goal by addressing interdisciplinary and cross-sector approaches across the lifespan. PriMe aims to add a precision medicine framework to the DZPG that will propel deeper understanding, more accurate prediction, and personalized prevention to prevent disease chronicity and mortality across mental illnesses. This framework is structured along the translational chain and will be used by PriMe to innovate the preventive and therapeutic management of SZ, BPD, and MDD from rural to urban areas and from patients in early disease stages to patients with long-term disease courses. Research will build on platforms that include one on model systems, one on the identification and validation of predictive markers, one on the development of novel multimodal treatments, one on the regulation and strengthening of the uptake and dissemination of personalized treatments, and finally one on testing of the clinical effectiveness, utility, and scalability of such personalized treatments. In accordance with the translational chain, PriMe’s expertise includes the ability to integrate understanding of bio-behavioral processes based on innovative models, to translate this knowledge into clinical practice and to promote user participation in mental health research and care.

Public perceptions of COVID-19 vaccines are critical in reaching protective levels of herd immunity. Vaccine skepticism has always been relatively high in Germany, and surveys suggest that over the course of the pandemic, enthusiasm for the COVID-19 vaccine has dropped. Looking at the period just prior to the approval of the Pfizer/BioNTech and Moderna vaccines in Germany in the latter half of 2020, this paper aims to assess the reasons for and against COVID-19 vaccine uptake among residents of Germany, and to provide in-depth qualitative data to better understand and address concerns surrounding the safety and efficacy of a COVID-19 vaccine. Our findings indicate that there is widespread trust in German institutions and health experts to provide a safe vaccine for those who need it most. However, interviewees also point to the need for more information and the centrality of support from trusted medical authorities in making individual vaccination decisions. We also present the complexity of individual positions on vaccination, and suggest that vaccine hesitancy in relation to COVID-19 needs to be understood as a nuanced, and socially malleable, territory. This indicates that the goal of a vaccination campaign is not only achieving 'herd immunity,' but also a social endorsement of the collaborative effort that is required for a vaccine to be successful.