L A A Gerbens1, C J Apfelbacher2, A D Irvine3,4,5, S Barbarot6, R J de Booij7, A E Boyce8, M Deleuran9, L F Eichenfield10, M H Hof11, M A Middelkamp-Hup1, A Roberts7,12, J Schmitt13,14, C Vestergaard9, D Wall3,15, S Weidinger16, P R Williamson17, C Flohr8, P I Spuls1. 1. Department of Dermatology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands. 2. Medical Sociology, Institute of Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany. 3. Department of Paediatric Dermatology, Our Lady's Children's Hospital, Crumlin, Dublin, Ireland. 4. Department of Clinical Medicine, Trinity College Dublin, Dublin, Ireland. 5. National Children's Research Centre, Dublin, Ireland. 6. Department of Dermatology, Nantes University Hospital, Nantes, France. 7. Contributing patient. 8. Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, Guy's & St Thomas' NHS Foundation Trust and King's College London, London, U.K. 9. Department of Dermatology and Venereology, Aarhus University Hospital, Aarhus, Denmark. 10. Departments of Dermatology and Pediatrics, University of California, San Diego, CA, U.S.A. 11. Department of Clinical Epidemiology, Biostatistics, and Bioinformatics, Academic Medical Centre, Amsterdam, the Netherlands. 12. Nottingham Support Group for Carers of Children with Eczema, Nottingham, U.K. 13. Center for Evidence-based Healthcare, Medizinische Fakultät Carl Gustav Carus, TU Dresden, Dresden, Germany. 14. University Allergy Center, University Hospital Carl Gustav Carus, Dresden, Germany. 15. Irish Skin Foundation, Dublin, Ireland. 16. Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany. 17. MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, U.K.
Abstract
BACKGROUND: Evidence of immunomodulatory therapies to guide clinical management of atopic eczema (AE) is scarce, despite frequent and often off-label use. Patient registries provide valuable evidence for the effects of treatments under real-world conditions that can inform treatment guidelines, give the opportunity for health economic evaluation and the evaluation of quality of care, as well as pharmacogenetic and dynamic research, which cannot be adequately addressed in clinical trials. OBJECTIVES: The TREatment of ATopic eczema (TREAT) Registry Taskforce aims to seek international consensus on a core set of domains and items ('what to measure') for AE research registries, using a Delphi approach. METHODS: Participants from six stakeholder groups were included: doctors, nurses, nonclinical researchers, patients, industry and regulatory body representatives. The eDelphi comprised three sequential online rounds, requesting participants to rate the importance of each proposed domain item. Participants could add domain items to the proposed list in round 1. A final consensus meeting was held to ratify the core set. RESULTS: Participants (n = 479) from 36 countries accessed the eDelphi platform, of whom 86%, 79% and 74% completed rounds 1, 2 and 3, respectively. At the face-to-face consensus meeting attended by 42 participants the final core set was established containing 19 domains with 69 domain items (49 baseline and 20 follow-up items). CONCLUSIONS: This core set of domains and items to be captured by national AE systemic therapy registries will standardize data collection and thereby allow direct comparability across registries and facilitate data pooling between countries. Ultimately, it will provide greater insight into the effectiveness, safety and cost-effectiveness of photo- and systemic immunomodulatory therapies.
BACKGROUND: Evidence of immunomodulatory therapies to guide clinical management of atopic eczema (AE) is scarce, despite frequent and often off-label use. Patient registries provide valuable evidence for the effects of treatments under real-world conditions that can inform treatment guidelines, give the opportunity for health economic evaluation and the evaluation of quality of care, as well as pharmacogenetic and dynamic research, which cannot be adequately addressed in clinical trials. OBJECTIVES: The TREatment of ATopic eczema (TREAT) Registry Taskforce aims to seek international consensus on a core set of domains and items ('what to measure') for AE research registries, using a Delphi approach. METHODS:Participants from six stakeholder groups were included: doctors, nurses, nonclinical researchers, patients, industry and regulatory body representatives. The eDelphi comprised three sequential online rounds, requesting participants to rate the importance of each proposed domain item. Participants could add domain items to the proposed list in round 1. A final consensus meeting was held to ratify the core set. RESULTS:Participants (n = 479) from 36 countries accessed the eDelphi platform, of whom 86%, 79% and 74% completed rounds 1, 2 and 3, respectively. At the face-to-face consensus meeting attended by 42 participants the final core set was established containing 19 domains with 69 domain items (49 baseline and 20 follow-up items). CONCLUSIONS: This core set of domains and items to be captured by national AE systemic therapy registries will standardize data collection and thereby allow direct comparability across registries and facilitate data pooling between countries. Ultimately, it will provide greater insight into the effectiveness, safety and cost-effectiveness of photo- and systemic immunomodulatory therapies.
Authors: Marjolein De Bruin-Weller; Tilo Biedermann; Robert Bissonnette; Mette Deleuran; Peter Foley; Giampiero Girolomoni; Jana Hercogová; Chih-Ho Hong; Norito Katoh; Andrew E Pink; Marie-Aleth Richard; Stephen Shumack; Juan F Silvestre; Stephan Weidinger Journal: Acta Derm Venereol Date: 2021-02-17 Impact factor: 3.875
Authors: F M Vermeulen; L A A Gerbens; A L Bosma; C J Apfelbacher; A D Irvine; B W M Arents; S Barbarot; M Deleuran; L F Eichenfield; A Manca; J Schmitt; C Vestergaard; D Wall; S Weidinger; M A Middelkamp-Hup; P I Spuls; C Flohr Journal: Br J Dermatol Date: 2019-06-23 Impact factor: 9.302
Authors: Dmitri Wall; Raed Alhusayen; Bernd Arents; Christian Apfelbacher; Esther A Balogh; Laita Bokhari; Manja Bloem; Angela L Bosma; Tim Burton; Leslie Castelo-Soccio; Nicole Fagan; Steven R Feldman; Godfrey Fletcher; Carsten Flohr; Esther Freeman; Lars E French; Christopher E M Griffiths; George J Hruza; John R Ingram; Michael D Kappelman; Irene Lara-Corrales; Henry W Lim; Nekma Meah; Devon E McMahon; Satveer K Mahil; Ian McNicoll; Annelie Musters; Haley B Naik; Rodney Sinclair; Catherine H Smith; Phyllis Spuls; Desmond J Tobin; Katherine York; Alan D Irvine Journal: Clin Dermatol Date: 2021-04-06 Impact factor: 3.541
Authors: Fiona Curran; Kieran P Dowd; Casey L Peiris; Hidde P van der Ploeg; Mark S Tremblay; Grainne O'Donoghue Journal: Int J Environ Res Public Health Date: 2022-08-05 Impact factor: 4.614
Authors: F M Vermeulen; L A A Gerbens; J Schmitt; M Deleuran; A D Irvine; K Logan; W Ouwerkerk; C Vestergaard; C Flohr; P I Spuls Journal: Br J Dermatol Date: 2020-03-18 Impact factor: 9.302