Background: Congenital melanocytic naevi (CMN) can impact on patients' lives due to their appearance and the risk they carry of neurological complications or melanoma development. The development of a core outcome set (COS) will allow standardised reporting and enable comparison of outcomes. This will help to improve guidelines. In previous research, relevant stakeholders reached a consensus over which core outcomes should be measured in any future care or research. The next step of the COS development is to select the appropriate measurement instruments.
Aim: Step 1: to update a systematic review identifying all core outcomes and measurement instruments available for CMN. Step 2: to evaluate the measurement properties of the instruments for the core outcomes.
Methods: This study was registered in PROSPERO and performed according to the PRISMA checklist. Step 1 includes a literature search in EMBASE (Ovid), PubMed and the Cochrane Library to identify core outcomes and instruments previously used in research of CMN. Step 2 yields a systematic search for studies on the measurement properties of instruments that were either developed or validated for CMN, including a methodological quality assessment following the COSMIN methodology.
Results: Step 1 included twenty-nine studies. Step 2 yielded two studies, investigating two quality of life measurement instruments.
Conclusion: Step 1 provided an overview of outcomes and instruments used for CMN. Step 2 showed that additional research on measurement properties is needed to evaluate which instruments can be used for the COS of CMN. This study informs the instrument selection and/or development of new instruments.
A.C. Fledderus, T. Booma, C.M. Legematea, C.M.A.M. van der Horst, P.I. Spuls
Disease Category: Skin
Disease Name: Congenital melanocytic naevi
Age Range: 0 - 100
Sex: Either
Nature of Intervention: Observation, Surgery
- Systematic review of outcome measures/measurement instruments
- Systematic review
Step 1: A systematic review to identify and describe the outcomes and instruments used in previously published studies for CMN, as an update from a previously performed systematic review. The previously systematic review included all outcomes and instruments used; the update only focusses on the outcomes of the COS and their instruments.
Step 2: A systematic review to evaluate the quality of the measurement instruments developed or validated for domains and outcomes of the COS of CMN.