Background Having large congenital melanocytic naevi (CMN) is associated with a psychosocial burden on patients and their parents because of its remarkable appearance and the extra care it may require. Large CMN also pose an increased risk of malignant melanoma or neurocutaneous melanosis. There is a lack of international consensus on what important outcome domains to measure in relation to treatment. This makes it difficult to compare options, to properly inform patients and their parents, and to set up treatment policy for CMN. Therefore, we aim to develop a core outcome set (COS), i.e. the minimum set of outcomes that are recommended to be measured and reported in all clinical trials of a specific health condition. This COS can be used in the follow‐up of CMN patients with or without treatment, in clinical research and practice. Methods In the Outcomes for Congenital Melanocytic Nevi (OCOMEN) projects, we follow the recommendations from the Core Outcome Measures in Effectiveness Trials (COMET) initiative and the Cochrane Skin Core Outcomes Set Initiative (CS‐COUSIN). This project entails the following: (i) a systematic review to identify the previous reported outcomes in literature; (ii) focus groups with national and international patients and parents to identify patient‐important outcomes; (iii) classification of outcomes into outcome domains; (iv) e‐Delphi surveys in which stakeholders (patients/parents and professionals) can rate the importance of domains and outcomes; and (v) an online consensus meeting to finalize the core outcome domains of the COS. Results The results will be disseminated by means of publication in a leading journal and presentations in international meetings or conferences. We engage international experts in CMN, both patients and professionals, to ensure the international utility and applicability of the COS.

Recent studies on congenital melanocytic naevi (CMN) indicate a lower risk of melanoma than has been previously assumed. As a result, the treatment paradigm in CMN has shifted from complete removal to cosmetically acceptable, less invasive treatment options, such as laser treatment. Our objective was to review systematically the efficacy and safety of laser therapy for CMN. We searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials and PubMed. We rated the quality of evidence with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Twenty-four eligible studies (three nonrandomized controlled studies; 21 case series) with 434 patients were included; the majority were of poor quality). Twenty different laser modalities or combinations were evaluated. Overall, the Q-switched laser was used most frequently, although large or giant CMN were generally treated with an ablative laser. Owing to heterogeneity between studies, comparison between laser modalities was hampered and statistical analysis was precluded. Lasers in CMN showed rather good results (albeit with very low-quality evidence) for clearing of hyperpigmentation in the short term. Outcome measures varied widely, patient satisfaction was rarely measured and high incidences of scarring, repigmentation and complications were reported. No malignant change was seen. While most studies report short-term improvement of CMN after laser therapy, there is no high-quality evidence for the efficacy and safety of laser modalities in CMN in the long term. Future research should focus on well-conducted and well-reported prospective studies on different laser modalities for CMN, with the use of recognized and validated outcome measures.

Melanoma is very rare under the age of 12 with stable incidence rates. In comparison with childhood melanoma, melanomas in adolescents are more common with a decreasing trend in the past decade. Male sex and increasing Breslow thickness are associated with worse survival in paediatric melanoma patients.

No abstract

No abstract

Summary 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.

No abstract

No abstract