Outcomes for congenital melanocytic naevi

Congenital Melanocytic Naevi (CMN) are birthmarks that can cover large areas of the body. They affect 1:100 new-borns, and large (>20 cm in adulthood) and giant CMN (>40 cm in adulthood) affect 1:20.000 and 1:500.000 new-borns, respectively. The clinical threat of CMN is the risk of developing malignant melanomas or neurocutaneous complications. In addition to these complications, the occurrence of CMN can lead to psychosocial problems due to their remarkable appearance or the extra care they may require.Adequate information and management for patients and their parents is crucial. Although different management strategies have been described, the quality of evidence is generally low which makes it difficult to set up best practice for CMN and to advise patients and their parents. One of the reasons for the low quality of the studies may be the limited patient numbers in studies owing to the rarity of the disease. Moreover, there is a lack of uniformity regarding the outcomes and measurement instruments used for CMN care and research. Heterogeneity impedes the comparison and pooling of outcomes of the small CMN studies. The aim of this thesis was to evaluate clinical considerations regarding CMN management and to achieve harmonization in the outcomes used in CMN care and research by developing a core outcome set. A core outcome set is a consensus-based (i.e. developed by patients and professionals) agreed minimum set of outcomes that are recommended to be measured in all care and research of a certain condition.