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 (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.Peer reviewe

Advanced MR techniques for preoperative glioma characterization: Part 1

Preoperative clinical magnetic resonance imaging (MRI) protocols for gliomas, brain tumors with dismal outcomes due to their infiltrative properties, still rely on conventional structural MRI, which does not deliver information on tumor genotype and is limited in the delineation of diffuse gliomas. The GliMR COST action wants to raise awareness about the state of the art of advanced MRI techniques in gliomas and their possible clinical translation or lack thereof. This review describes current methods, limits, and applications of advanced MRI for the preoperative assessment of glioma, summarizing the level of clinical validation of different techniques. In this first part, we discuss dynamic susceptibility contrast and dynamic contrast-enhanced MRI, arterial spin labeling, diffusion-weighted MRI, vessel imaging, and magnetic resonance fingerprinting. The second part of this review addresses magnetic resonance spectroscopy, chemical exchange saturation transfer, susceptibility-weighted imaging, MRI-PET, MR elastography, and MR-based radiomics applications. Evidence Level: 3 Technical Efficacy: Stage 2

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

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

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 (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.Peer reviewe