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

Abstract

Background Congenital melanocytic naevi (CMN) can have a great impact on patients’ lives owing to perceived stigmatization, and the risk of melanoma development and neurological complications. Development of a core outcome set (COS) for care and research in CMN will allow standard reporting of outcomes. This will enable comparison of outcomes, allowing professionals to offer advice about the best management options. In previous research, stakeholders (patients, parents and professionals) reached consensus on the core domains of the COS. To select the appropriate measurement instruments, the domains should be specified by outcomes. Objectives To reach consensus on the specific core outcomes describing the core domains pertaining to clinical care and research in CMN. Methods A list of provisional outcomes (obtained earlier) was critically reviewed by the Outcomes for COngenital MElanocytic Naevi (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 email. During an online consensus meeting, stakeholders discussed the inclusion of potential outcomes. After the meeting, participants voted in two rounds for the inclusion of outcomes. Results Forty‐four stakeholders from 19 countries participated. Nine core outcomes were included in the COS relative to clinical care and 10 core outcomes for research. Conclusions These core outcomes will enable standard reporting in future care and research of CMN. This study facilitates the next step of COS development: selecting the appropriate measurement instruments for every outcome.

Neurological signs, symptoms and MRI abnormalities in patients with congenital melanocytic naevi and evaluation of routine MRI-screening: systematic review and meta-analysis

“…To gain high-level evidence regarding CMN, uniformity and standard reporting is needed. We recommend the use of the Krengel classification and the 6B classification [50,51] for homogenous baseline characteristics and the CMN core outcome set for homogenous outcomes, i.e., a consensus-based agreed minimum set of outcomes that should be measured and reported in all clinical research and care of CMN [14,[52][53][54]. Neurological signs and symptoms are selected as core outcomes and the next step will be to find a measurement instrument to standardize reporting on neurological signs and symptoms in patients with CMN.…”

Another step on the road towards standardized outcome reporting for congenital melanocytic naevi: one more to go!

“…This endeavour is not entirely novel as several classification schemes have been proposed for CMN in the past. 4 Within the OCOMEN initiative, Fledderus et al 3 agreed on size of the lesion, number of satellite naevi, colour and texture as outcomes for the domain 'skin appearance'. These parameters were also part of a consensus-based scheme for the categorization of CMN published previously by an interdisciplinary panel of experts.…”

“…This endeavour is not entirely novel as several classification schemes have been proposed for CMN in the past 4 . Within the OCOMEN initiative, Fledderus et al 3 . agreed on size of the lesion, number of satellite naevi, colour and texture as outcomes for the domain ‘skin appearance’.…”

“…In this issue of the BJD , Fledderus et al . take this initiative one step further and define for the first time a set of outcomes for both research and patient care 3 …”

“…2 In this issue of the BJD, Fledderus et al take this initiative one step further and define for the first time a set of outcomes for both research and patient care. 3 Adhering to a rigorous methodology and including all relevant stakeholders on an international level, a list of provisional outcomes for CMN was critically reviewed through an online questionnaire and further modified to provide clear definitions for every outcome. Thereafter, various stakeholders discussed the inclusion of potential outcomes in an online consensus conference.…”