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Patch test informed consent form: position statement by European Academy of Dermatology and Venereology Task Force on
1Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.
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.
