Mapping ethical and social aspects of biomarker research and its application in atopic dermatitis and psoriasis: a systematic review of reason.

Biomarker research is associated with high hopes for atopic dermatitis and psoriasis research. Although various effective treatments have been developed, many challenges remain concerning diagnostics and the development of targeted treatments, but also regarding a number of ethical and social issues. In this paper, building on a systematic literature review and review of reason, we examine the ethical and social debate on biomarker research for atopic dermatitis and psoriasis. We discuss topics such as risks and benefits of stratification of patient groups, ethical aspects of big data and advanced analytics for biomarker use in atopic dermatitis and psoriasis. Our systematic literature review of reason, based on established methodological standards, includes argument-based ethics publications and scientific literature with implicitly ethically relevant aspects. The first search of biomarker research in dermatology and adjacent fields (e.g., oncology) resulted in a large amount of literature concerning general normative aspects of biomarker research, but suggested a lack of explicit argument-based ethical literature in atopic dermatitis and psoriasis research. We, therefore, conducted a second systematic search, focusing specifically on atopic dermatitis and psoriasis biomarker research. The 43 relevant articles identified through both systematic searches were clustered into three topic groups: (i) ethical aspects of stratification and precision medicine, (ii) digital ethics and (iii) research ethics with a focus on complexity and validation. We found that compared to other fields, such as cancer research, the ethical aspects of atopic dermatitis and psoriasis are rarely explained and addressed in detail. In particular, more work is required on scientific standards, digital ethics and responsible clinical application of biomarkers for atopic dermatitis and psoriasis, patient participation and ethical implications of biomarker use for children or young people with atopic dermatitis and psoriasis. We close with suggestions on how to address the ethical and social dimension of atopic dermatitis and psoriasis research and practice more directly in future.

Risks and benefits of dermatological machine learning health care applications-an overview and ethical analysis.

BACKGROUND: Visual data are particularly amenable for machine learning techniques. With clinical photography established for skin surveillance and documentation purposes as well as progress checks, dermatology is an ideal field for the development and application of emerging machine learning health care applications (ML-HCAs). To date, several ML-HCAs have detected malignant skin lesions on par with experts or found overlooked visual patterns that correlate with certain dermatological diseases. However, it is well established that ML-HCAs come with ethical and social implications. OBJECTIVES: Currently, there is a lack of research that establishes model design, training, usage and regulation of such technologies sufficient to ensure ethically and socially responsible development and clinical translation, specifically within the field of dermatology. With this paper, we aim to give an overview of currently discussed ethical issues relating to dermatological ML-HCAs. METHODS: On the basis of a thematic, keyword-based literature search, we performed an ethical analysis against established frameworks of biomedical ethics. We combined our results with current, relevant normative machine learning ethics literature to identify the status quo of the ethics of ML-HCAs in dermatology. We describe the benefits and risks of dermatological ML-HCAs that are currently being developed for clinical purposes. RESULTS: The potential benefits range from better patient outcomes to better knowledge accessibility to decreasing health care disparities, that is, standards of care between different population groups. The risks associated with ML-HCAs range from confidentiality issues to individual patient outcomes as well as the exacerbation of prevalent health care disparities. We discuss the practical implications for all stages of dermatological ML-HCA development. CONCLUSION: We found that ML-HCAs present stakeholder-specific risks for patients, health care professionals and society, which need to be considered separately. The discipline lacks sufficient biomedical ethics research that could standardize the approach to ML-HCA model design, training, use and regulation of such technologies.

Requirements and expectations of high-quality biomarkers for atopic dermatitis and psoriasis in 2021-a two-round Delphi survey among international experts.

BACKGROUND: Chronic inflammatory skin diseases such as atopic dermatitis (AD) and psoriasis (PSO) present major challenges in health care. Thus, biomarkers to identify disease trajectories and response to treatments to improve the lives of affected individuals warrant great research consideration. The requirements that these biomarkers must fulfil for use as practical clinical tools have not yet been adequately investigated. AIM: To identify the core elements of high-quality AD and PSO biomarkers to prepare recommendations for current biomarker research. METHOD: A cross-sectional two-round Delphi survey was conducted from August to October 2019 and October to November 2020. All participants were members of the BIOMAP project, an EU-funded consortium of clinicians, researchers, patient organizations and pharmaceutical industry partners. The first round consisted of three open-ended questions. Responses were qualitatively analysed, and 26 closed statements were developed. For the second round, 'agreement' was assumed when the responses of ≥70% of the participants were ≥5 points on a 7-point Likert scale for each statement. Priority classification was based on mean scores (<20th percentile = low, 20th to 60th percentile = medium, >60th percentile = high). RESULTS: Twenty-one and twenty-six individuals participated in rounds one and two, respectively. From 26 statements that were included in round 2, 18 achieved agreement (8 concerning the performance, 8 for the purpose and 2 on current obstacles). Seven statements were classified as high priority, e.g. those concerning reliability, clinical validity, a high positive predictive value, prediction of the therapeutic response and disease progression. Another seven statements were assigned medium priority, e.g. those about analytical validity, prediction of comorbidities and therapeutic algorithm. Low priority included four statements, like those concerning cost effectiveness and prediction of disease flares. CONCLUSION: The core requirements that experts agreed on being essential for high-quality AD and PSO biomarkers require rapid validation. Biomarkers can therefore be assessed based on these prioritized requirements.

[Equity in health? Health inequalities, ethics, and theories of distributive justice]. / Wie gleich kann Gesundheit sein? Ethische und gerechtigkeitstheoretische Aspekte gesundheitlicher Ungleichheiten.

It is well-documented that the socio-economic status has an important influence on health. In all developed countries, health is closely correlated with income, education, and type of employment, as well as with several other social determinants. While data on this socio-economic health gradient have been available for decades, the moral questions surrounding social health inequalities have only recently been addressed within the field of public health ethics. The present article offers a brief overview of relevant data on social health inequalities and on some explanatory models from epidemiology, social medicine and related disciplines. The main part explores three influential normative accounts addressing the issue of health inequalities. Finally, an agenda for future work in the field of public health ethics and health inequalities is sketched, with particular attention to the German context.

Advancing Biomarker Development Through Convergent Engagement: Summary Report of the 2nd International Danube Symposium on Biomarker Development, Molecular Imaging and Applied Diagnostics; March 14-16, 2018; Vienna, Austria.

Here, we report on the outcome of the 2nd International Danube Symposium on advanced biomarker development that was held in Vienna, Austria, in early 2018. During the meeting, cross-speciality participants assessed critical aspects of non-invasive, quantitative biomarker development in view of the need to expand our understanding of disease mechanisms and the definition of appropriate strategies both for molecular diagnostics and personalised therapies. More specifically, panelists addressed the main topics, including the current status of disease characterisation by means of non-invasive imaging, histopathology and liquid biopsies as well as strategies of gaining new understanding of disease formation, modulation and plasticity to large-scale molecular imaging as well as integrative multi-platform approaches. Highlights of the 2018 meeting included dedicated sessions on non-invasive disease characterisation, development of disease and therapeutic tailored biomarkers, standardisation and quality measures in biospecimens, new therapeutic approaches and socio-economic challenges of biomarker developments. The scientific programme was accompanied by a roundtable discussion on identification and implementation of sustainable strategies to address the educational needs in the rapidly evolving field of molecular diagnostics. The central theme that emanated from the 2nd Donau Symposium was the importance of the conceptualisation and implementation of a convergent approach towards a disease characterisation beyond lesion-counting "lumpology" for a cost-effective and patient-centric diagnosis, therapy planning, guidance and monitoring. This involves a judicious choice of diagnostic means, the adoption of clinical decision support systems and, above all, a new way of communication involving all stakeholders across modalities and specialities. Moreover, complex diseases require a comprehensive diagnosis by converging parameters from different disciplines, which will finally yield to a precise therapeutic guidance and outcome prediction. While it is attractive to focus on technical advances alone, it is important to develop a patient-centric approach, thus asking "What can we do with our expertise to help patients?"

Personal responsibility for health as a rationing criterion: why we don't like it and why maybe we should.

Whether it is fair to use personal responsibility of patients for their own health as a rationing criterion in healthcare is a controversial matter. A host of difficulties are associated with the concept of personal responsibility in the field of medicine. These include, in particular, theoretical considerations of justice and such practical issues as multiple causal factors in medicine and freedom of health behaviour. In the article, personal responsibility is evaluated from the perspective of several theories of justice. It is argued that in a healthcare system based on both equality of opportunity and solidarity, responsible health behaviour can -- in principle -- be justifiably expected. While the practical problems associated with personal responsibility are important, they do not warrant the common knee-jerk refusal to think more deeply about responsibility for health as a means of allocating healthcare resources. In conclusion, the possibility of introducing personal responsibility as a fair rationing criterion is briefly sketched.

Hemispheric lateralization of spatial attention in right- and left-hemispheric language dominance.

Hemispheric lateralization of the neural systems supporting language and spatial attention most commonly dissociate in healthy individuals. However, the reverse pattern with association of language and attention within the right hemispheres has also been observed. We investigated in 75 healthy volunteers (37 right-handed, 38 left-handed) if language and spatial attention may associate not only in individuals with an atypical pattern of language lateralization, but also in subjects showing the standard, i.e. left-hemispheric dominance for language. Hemispheric lateralization of cerebral perfusion was determined with functional transcranial Doppler ultrasonography during a visuospatial attention, and a word generation task. We found that language and visuospatial attention associated within the left hemisphere in five subjects and within the right hemisphere in eight subjects. We conclude that all combinations of cerebral lateralization for language and attention may exist in the healthy brain.

Quality of life, coping, and mental health status after living kidney donation.

The main aim of the study was to explore well-being after donation. This retrospective, cross-sectional study of 161 living kidney donors (104 women; response rate 81.4%) who were aged between 32 and 80 years (x = 56.3; standard deviation = 10.9) included responses to standardized questionnaires concerning quality of life (QOL), coping, and mental health status. Most donors recovered fully from donation within 6 months (90.8%). Donor willingness to donate again (96.1%) was high. Their relationship to the recipient did not change (67.9%) or even improved (27.5%) in most cases. Donor QOL (as assessed by the Short-Form [SF]-36) did not differ from healthy norms. In 25% of donors, screening with the Hospital Anxiety and Depression Scale revealed anxious and/or depressive symptoms above the clinical cutoff score. Donor predominant coping style with their recipient's renal disease was "active problem-focused coping." The component scores of the SF-36 correlated positively with sociodemographic and self-reported medical parameters, coping, and mental health status. Although living kidney donation again proved to be a treatment without negative impact on donor QOL, the results underlined the importance of screening for donor mental health status and coping both in the evaluation process and after the procedure.

[Moderate financial incentives for organ donation]. / Moderate finanzielle Anreize für postmortale Organspenden.

Despite many efforts to increase the number of organs for transplantations, there is still a worrying shortage of transplantable organs - in Germany as well as in almost every developed country. One possibility to increase the amount of organs is the introduction of financial incentives for cadaveric organ donation. In this article, several forms of moderate financial incentives for organ donation are described. Ethical arguments for and against an implementation of financial incentives are weighed against each other. Finally, an argument is developed in favour of moderate financial incentives which supports careful research into possible modes of implementation.

[Personal responsibility -- a criterion for allocation in health care?]. / Eigenverantwortung -- Verteilungskriterium im Gesundheitswesen?

Personal responsibility of patients for their own health is often cited as a means of allocating health care resources. It is however unclear whether applying responsibility as a distributive criterion is just. Several difficulties are associated with the concept of personal responsibility in the medical field. These include in particular 1) theoretical considerations of justice 2) causal factors in medicine, and 3) freedom of health behaviour. The article investigates these problems and tries to determine conditions for a fair use of self-responsibility as a criterion for allocation of resources in health care.