Patch test informed consent form: position statement by European Academy of Dermatology and Venereology Task Force on Contact Dermatitis

A Balato; E Scala; F Ayala; A Bauer; M-N Crépy; M Gonçalo; J Duus Johansen; S M John; T Rustemeyer; N Wagner; M Wilkinson; A Giménez-Arnau

doi:10.1111/jdv.17483

Patch test informed consent form: position statement by European Academy of Dermatology and Venereology Task Force on Contact Dermatitis

J Eur Acad Dermatol Venereol. 2021 Oct;35(10):1957-1962. doi: 10.1111/jdv.17483. Epub 2021 Jul 19.

Authors

A Balato¹, E Scala², F Ayala³, A Bauer⁴, M-N Crépy^{5

6}, M Gonçalo⁷, J Duus Johansen⁸, S M John⁹, T Rustemeyer¹⁰, N Wagner¹¹, M Wilkinson¹², A Giménez-Arnau¹³

Affiliations

¹ Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.
² Division of Dermatology and Venereology, Department of Medicine Solna, and Center for Molecular Medicine, Karolinska Institutet, Stockholm, Sweden.
³ Professor Emeritus of Dermatology, University of Naples Federico II, Naples, Italy.
⁴ Department of Dermatology, University Allergy Center, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany.
⁵ Department of Occupational and Environmental Diseases, Hôtel-Dieu Hospital, AP-HP, University Hospital of Centre of Paris, Paris, France.
⁶ Department of Dermatology, Cochin Hospital, AP-HP, University Hospital of Centre of Paris, Paris, France.
⁷ Department of Dermatology, University Hospital and Faculty of Medicine, University of Coimbra, Coimbra, Portugal.
⁸ National Allergy Research Centre, Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.
⁹ Department of Dermatology, Environmental Medicine, Health Theory, Institute for Interdisciplinary Dermatological Prevention and Rehabilitation (iDerm) at the University of Osnabrück, University of Osnabrück, Osnabrück, Germany.
¹⁰ Department of Dermatology-Allergology and Occupational Dermatology, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
¹¹ Department of Dermatology, Universitätsklinikum Erlangen-Nürnberg, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.
¹² Department of Dermatology, Chapel Allerton Hospital, Leeds, UK.
¹³ Department of Dermatology, Hospital del Mar, Universitat Autònoma de Barcelona, Barcelona, Spain.

PMID: 34286888
DOI: 10.1111/jdv.17483

Abstract

Background: To our knowledge, an international consensus is lacking regarding the development of an adequate informed consent form for a patch test (PT) and the information that should be included in such document.

Objectives: The aim of the study was to reach a consensus on the specific points that need to be addressed in a PT consent form.

Methods: A Delphi survey, comprising 2 rounds and 1 final discussion, was used to gather and analyse data, which was conducted over the Internet. Each statement that reached a consensus with the respondents (9 expert dermatologists from Europe) was defined as a median consensus score (MED) of ≥7 and agreement among panelists as an interquartile range (IQR) of ≤3. All study participants were members of the EADV task force on contact dermatitis.

Results: The expert panel addressed several topics that should be included in an informed consent form for a PT: introduction, preparation for PT, testing procedure, allowed activities, adverse events and additional authorizations.

Conclusions: Our results assess recommendations regarding points to be contained in an informed consent form for a PR. Future actions towards standardization and harmonization of this specific consent form are needed.

MeSH terms

Consent Forms
Dermatitis, Contact*
Dermatology*
Humans
Patch Tests
Venereology*