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.

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.

Ethical Reasoning During a Pandemic: Results of a Five Country European Study.

Introduction: There has been no work that identifies the hidden or implicit normative assumptions on which participants base their views during the COVID-19 pandemic, and their reasoning and how they reach moral or ethical judgements. Our analysis focused on participants' moral values, ethical reasoning and normative positions around the transmission of SARS-CoV-2.Methods: We analyzed data from 177 semi-structured interviews across five European countries (Germany, Ireland, Italy, Switzerland and the United Kingdom) conducted in April 2020.Results: Findings are structured in four themes: ethical contention in the context of normative uncertainty; patterns of ethical deliberation when contemplating restrictions and measures to reduce viral transmission; moral judgements regarding "good" and "bad" people; using existing structures of meaning for moral reasoning and ethical judgement.Discussion: Moral tools are an integral part of people's reaction to and experience of a pandemic. 'Moral preparedness' for the next phases of this pandemic and for future pandemics will require an understanding of the moral values and normative concepts citizens use in their own decision-making. Three important elements of this preparedness are: conceptual clarity over what responsibility or respect mean in practice; better understanding of collective mindsets and how to encourage them; and a situated, rather than universalist, approach to the development of normative standards.