title: TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for an international Delphi exercise to identify a core set of domains and domain items for national atopic eczema registries.
abstract: Patients with moderate-to-severe atopic eczema (AE) often require photo- or systemic immunomodulatory therapies to induce disease remission and maintain long-term control. The current evidence to guide clinical management is small, despite the frequent and often off-label use of these treatments. Registries of patients on photo- and systemic immunomodulatory therapies could fill this gap, and the collection of a core set concerning these therapies in AE will allow direct comparisons across registries as well as data sharing and pooling. Using an eDelphi approach, the international TREatment of ATopic eczema (TREAT) Registry Taskforce aims to seek consensus between key stakeholders internationally on a core set of domains and domain items for AE patient registries with a research focus that collect data of children and adults on photo- and systemic immunomodulatory therapies.
  
  
  
  Participants from six stakeholder groups will be invited: doctors, nurses, non-clinical researchers, patients, as well as industry and regulatory body representatives. The eDelphi will comprise three sequential online rounds, requesting participants to rate the importance of each proposed domain and domain items. Participants will be able to add domains and domain items to the proposed list in round 1. A final consensus meeting will be held with representatives of each stakeholder group.
  
  
  
  Identifying a uniform core set of domains and domain items to be captured by AE patient registries will increase the utility of individual registries, and provide greater insight into the effectiveness, safety and cost-effectiveness of photo- and systemic immunomodulatory therapies to guide clinical management across dermatology centres and country borders.
  
  
  
  Not applicable. This eDelphi study was registered in the Core Outcome Measures for Effectiveness Trials (COMET) database.
authors.affiliation: Department of Dermatology, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands. l.a.gerbens@amc.uva.nl.
authors.forename: Louise A A
authors.initials: LA
authors.lastname: Gerbens
authors.affiliation: Unit for Population-Based Dermatology Research, St. John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK.
authors.forename: Aaron E
authors.initials: AE
authors.lastname: Boyce
authors.affiliation: Department of Paediatric Dermatology, Our Lady's Children's Hospital, Crumlin, Dublin, Ireland.|Irish Skin Foundation, Dublin, Ireland.
authors.forename: Dmitri
authors.initials: D
authors.lastname: Wall
authors.affiliation: Department of Dermatology, Nantes University Hospital, Nantes, France.
authors.forename: Sebastien
authors.initials: S
authors.lastname: Barbarot
authors.affiliation: Department of Dermatology, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: de Booij
authors.affiliation: Department of Dermatology and Venereology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Mette
authors.initials: M
authors.lastname: Deleuran
authors.affiliation: Department of Dermatology, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.
authors.forename: Maritza A
authors.initials: MA
authors.lastname: Middelkamp-Hup
authors.affiliation: Nottingham Support Group for Carers of Children with Eczema, Nottingham, UK.
authors.forename: Amanda
authors.initials: A
authors.lastname: Roberts
authors.affiliation: Department of Dermatology and Venereology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Christian
authors.initials: C
authors.lastname: Vestergaard
authors.affiliation: Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Weidinger
authors.affiliation: Medical Sociology, Institute of Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany.
authors.forename: Christian J
authors.initials: CJ
authors.lastname: Apfelbacher
authors.affiliation: Department of Paediatric Dermatology, Our Lady's Children's Hospital, Crumlin, Dublin, Ireland.|Irish Skin Foundation, Dublin, Ireland.|Department of Clinical Medicine, Trinity College Dublin, Dublin, Ireland.|National Children's Research Centre, Dublin, Ireland.
authors.forename: Alan D
authors.initials: AD
authors.lastname: Irvine
authors.affiliation: Center for Evidence-based Healthcare, Medizinische Fakultät Carl Gustav Carus, TU Dresden, Dresden, Germany.|University Allergy Center, University Hospital Carl Gustav Carus Dresden, Dresden, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Schmitt
authors.affiliation: MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, UK.
authors.forename: Paula R
authors.initials: PR
authors.lastname: Williamson
authors.affiliation: Department of Dermatology, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.
authors.forename: Phyllis I
authors.initials: PI
authors.lastname: Spuls
authors.affiliation: Unit for Population-Based Dermatology Research, St. John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK.
authors.forename: Carsten
authors.initials: C
authors.lastname: Flohr
mesh_terms: D032921:Consensus; D003697:Delphi Technique; D003876:Dermatitis, Atopic / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects / Q000627:therapeutic use*; D033183:Interdisciplinary Communication; D010778:Photochemotherapy / Q000009:adverse effects; D012042:Registries / Q000592:standards*; D012107:Research Design; D012720:Severity of Illness Index; D000073597:Stakeholder Participation; D016896:Treatment Outcome
chemical_list: D007155:Immunologic Factors
keywords: Atopic dermatitis; Atopic eczema; Consensus methods; Core set; Daily practice data; Delphi; Disease registries; Immunomodulatory therapies; Interoperability; Patient registries