S Ziehfreund1, L Tizek1, N Hangel2, M-C Fritzsche2, S Weidinger3, C Smith4, P J Bryce5, D Greco6,7, E H van den Bogaard8, C Flohr9, J Rastrick Ucb10, S Eyerich11, A Buyx2, C Conrad12, K Eyerich1,13,14, A Zink1,13. 1. Department of Dermatology and Allergy, Technical University of Munich, School of Medicine, Munich, Germany. 2. Institute for History and Ethics of Medicine, Technical University of Munich, Munich, Germany. 3. Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Kiel, Germany. 4. St John's Institute of Dermatology, Kings College London and Guys and St Thomas' NHS Foundation Trust, Guy's Hospital, London, UK. 5. Type 2 Inflammation & Fibrosis Cluster, Immunology & Inflammation Therapeutic Area, Sanofi US, Cambridge, Massachusetts, USA. 6. Faculty of Medicine and Health Technology, BioMediTech Institute, Tampere University, Tampere, Finland. 7. Institute of Biotechnology, Helsinki Institute for Life Science (HiLife), University of Helsinki, Helsinki, Finland. 8. Department of Dermatology, Radboud University Medical Center, Radboud Institute for Molecular Life Sciences, Nijmegen, The Netherlands. 9. Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, School of Basic and Medical Biosciences, King's College London, London, UK. 10. Immunology Research, New Medicines UCB Pharma, Slough, UK. 11. Center of Allergy and Environment (ZAUM), Technical University and Helmholtz Center Munich, Munich, Germany. 12. Department of Dermatology, Lausanne University Hospital CHUV, Lausanne, Switzerland. 13. Division of Dermatology and Venerology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden. 14. Department of Dermatology and Venereology, Medical Center, University of Freiburg, Freiburg, Germany.
Abstract
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.
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.