Due to a large variety in treatment outcomes reported, a lack of outcomes relevant to patients, and a large heterogeneity in outcome measures used, it is hard to adequately compare and improve current treatment regimens for patients with capillary malformations (CMs, a.k.a port wine stains).
The Core Outcome Set for CApillary Malformations (COSCAM) project aims to reach international consensus on a core outcome set (COS) for clinical research on capillary malformations. We aim to determine what outcome domains and items should be included in the COS.
- Arne Meesters, Dermatologist, Amsterdam University Medical Center (UMC) - location AMC, Amsterdam, The Netherlands
- Ginger Beau Langbroek, PhD candidate, Amsterdam University Medical Center (UMC) - location AMC, Amsterdam, The Netherlands
- Chantal MAM van der Horst, Plastic surgeon, Amsterdam University Medical Center (UMC) - location AMC, Amsterdam, The Netherlands
- Albert Wolkerstorfer, Dermatologist, Amsterdam University Medical Center (UMC) - location AMC, Amsterdam, The Netherlands
- Dirk T Ubbink, Epidemiologist, Amsterdam University Medical Center (UMC) - location AMC, Amsterdam, The Netherlands
- Sophie ER Horbach, Plastic surgeon in training, Amsterdam University Medical Center (UMC) - location AMC, Amsterdam, The Netherlands
as part of the The COSCAM founding and steering group
- Hans-Joachim Laubach, Dermatologist, Geneva University Hospitals, Geneva, Switzerland
- Ashraf Badawi, Dermatologist, Szeged University, Hungary.
- Kristen Kelly, Dermatologist, UC Irvine/ Beckman Laser Institute, California, USA
- Agneta Troilius, Dermatologist, Skåne University Hospital, Malmö, Sweden
- Merete Haedersdal, Dermatologist, University of Copenhagen/ Bispebjerg Hospital, Copenhagen, Denmark
as part of the COSCAM steering group
Disease Category: Skin
Disease Name: Vascular malformations, Capillary malformation, Port-wine stain, Naevus flammeus
Age Range: 0 - 100
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Systematic review
In a recently published systematic review, members of our research group found that there is a lot of heterogeneity in outcomes and outcome measure used in clinical research on capillary malformations (van Raath, M. I., Chohan, S., Wolkerstorfer, A., van der Horst, C. M., Limpens, J., Huang, X., ... & Heger, M. (2020). Clinical outcome measures and scoring systems used in prospective studies of port wine stains: A systematic review. PLOS ONE, 15(7), e0235657).
In order to reach an international consensus on a core outcome set, we will perform an international three-round e-Delphi consensus study in which all stakeholders will be involved (patients, parents, medical specialists and researchers). The final list of proposed outcome measures will be discussed in a consensus meeting of the COSCAM group. Once there is an international consensus on the COS (of outcome domains/items), we will perform a literature review on the measurement instruments for these domains. If necessary, a new disease specific outcome measurement instrument will be developed.