Domains and outcomes of the core outcome set of congenital melanocytic naevi for clinical practice and research, part 2 (the OCOMEN project).

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Congenital melanocytic naevi (CMN) can have a great impact on patients’ lives due to perceived stigmatization and the risk of melanoma development and neurological complications. Development of a core outcome set for care and research of CMN will allow standard reporting of outcomes. This will enable comparison of outcomes, allowing professionals to offer advice about best management options. In previous research, stakeholders (patients, parents, and professionals) reached consensus on the core domains of the core outcome set. To select the appropriate measurement instruments, the domains should be specified by outcomes.To reach consensus on the specific core outcomes describing the core domains pertaining to both CMN clinical care and research.A list of provisional outcomes, obtained earlier, was critically reviewed by the OCOMEN research team and by relevant stakeholders through an online questionnaire, to refine this list and provide clear definitions for every outcome. When needed, discussion with individual participants was undertaken over the telephone or by e-mail. During an online consensus meeting, stakeholders discussed the inclusion of potential outcomes. After the meeting, participants voted for inclusion of outcomes in two rounds.Forty-four stakeholders from nineteen countries participated in the study. Nine core outcomes were included in the core outcome set relative to clinical care and ten core outcomes for research.These core outcomes will enable standard reporting in future care and research of CMN. This study facilitates the next step of core outcome set development: selecting the appropriate measurement instruments for every outcome.

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Authors: A C Fledderus, S G M A Pasmans, A Wolkerstorfer, W Oei, H C Etchevers, M S van Kessel, C M A M van der Horst, P I Spuls