Development of an international core domain set for medium, large and giant congenital melanocytic naevi as a first step towards a core outcome set for clinical practice and research*

W. Oei, A. C. Fledderus, P. I. Spuls, C. A.M. Eggen, J. Kottner, C. M.A.M. van der Horst, A. Wolkerstorfer, M. S. van Kessel, S. Krengel, H. C. Etchevers, I. J. Korfage, S. G.M. Pasmans*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

8 Citations (Scopus)

Abstract

Background: Medium, large and giant congenital melanocytic naevi (CMN) can impose a psychosocial burden on patients and families, and are associated with increased risk of developing melanoma or neurological symptoms. Lack of consensus on what outcomes to measure makes it difficult to advise patients and families about treatment and to set up best practice for CMN. Objectives: Fostering consensus among patient representatives and professionals, we aim to develop a core outcome set, defined as the minimum set of outcomes to measure and report in care and all clinical trials of a specific health condition. We focused on the ‘what to measure’ aspect, the so-called core domain set (CDS), following the COMET and CS-COUSIN guidelines. Methods: We conducted a systematic review to identify outcomes reported in the literature. Focus groups with patient representatives identified patient-reported outcomes. All these outcomes were classified into domains. Through e-Delphi surveys, 144 stakeholders from 27 countries iteratively rated the importance of domains and outcomes. An online consensus meeting attended by seven patient representatives and seven professionals finalized the CDS. Results: We reached consensus on six domains, four of which were applied to both care and research: ‘quality of life’, ‘neoplasms’, ‘nervous system’ and ‘anatomy of skin’. ‘Adverse events’ was specific to care and ‘pathology’ to research. Conclusions: We have developed a CDS for medium-to-giant CMN. Its application in reporting care and research of CMN will facilitate treatment comparisons. The next step will be to reach consensus on the specific outcomes for each of the domains and what instruments should be used to measure these domains and outcomes.

Original languageEnglish
Pages (from-to)371-379
Number of pages9
JournalBritish Journal of Dermatology
Volume185
Issue number2
DOIs
Publication statusPublished - 1 Aug 2021

Bibliographical note

Funding Information:
This project is funded by the European Academy of Dermatology and Venereology (EADV PPRC‐2014‐033). H.C.E. was supported by funding from the Association du Naevus Géant Congénital, Naevus 2000 France‐Europe and the Asociación Española de Nevus Gigante Congénito. Funding sources

Funding Information:
sources This project is funded by the European Academy of Dermatology and Venereology (EADV PPRC-2014-033). H.C.E. was supported by funding from the Association du Naevus G?ant Cong?nital, Naevus 2000 France-Europe and the Asociaci?n Espa?ola de Nevus Gigante Cong?nito.This project is part of the European Reference Network-SKIN thematic group Cutaneous Mosaic Disorders ? Nevi & Naevoid skin disorders ? Complex vascular malformations and vascular tumors (https://ern-skin.eu).

Publisher Copyright:
© 2020 British Association of Dermatologists.

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