Core Outcome Measures in Effectiveness Trials

The Outcome measures for COngenital MElanocytic Naevi (OCOMEN)

General Information

Congenital melanocytic naevi are melanocytic naevi present at birth. This type of birthmark occurs in an estimated 1% of infants worldwide. They have a small risk of developing melanoma or neurocutaneous melanosis. However, there is no need for prophylactic removing a benign looking CMN to prevent melanoma. An adequate follow up is enough to detect melanoma. Indication for treatment are: CMN suspect for melanoma, CMN who are difficult to follow up or for cosmetic reasons. Different techniques are known as a treatment for CMN such as: laser, curettage and excision. Since CMNs have a large impact on patients life, patients and health care professionals need good research to focus their treatment strategy on.

A.C. (Anne) Fledderus (BsC)
dr. S.J.H. (Saskia) Brinkmann
Prof.dr. C.M.A.M. (Chantal) van der Horst
dr. W. (Welling) Oei
Prof. dr. S.G.M.A. (Suzanne) Pasmans
Prof dr. P.I. (Phylllis) Spuls
dr. I.J. Korfage (Ida)
C. Eggen (Celine)
M. van Kessel (Marjolein)
Dr. A. Wolkerstorfer

Welling Oei will lead the e-delphi procedure and the consensus meeting and can be contacted for these studies

Further Study Information

Current Stage:
February 2018 - February 2019
Funding source(s):

Health Area

Disease Category

Disease Name
Congenital melanocytic naevi

Target Population

Age Range
0 - 100


Nature / type of Intervention


Consensus conference
Consensus meeting
Delphi process
Focus group(s)
Literature review
Systematic review

A systematic review will be done to make a list of outcomes reported in literature. Missing outcomes will be added to the list during a meeting with a focus group. The outcomes will be grouped in outcome domains. An e-Delphi study will be done where participants (patients and experts in the field) can rate the list of potentially relevant outcomes. Finally a consensus meeting will be held (with patients and experts in the field) where the outcomes are discussed where no consensus was reached in the e-Delphi study.

Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Journal editors
Patient/ support group representatives

Study Type

COS for clinical trials or clinical research
COS for practice

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