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A core outcome domain set for clinical research on capillary malformations (the COSCAM project): an e-Delphi process
Ginger Beau Langbroek1,2, Albert Wolkerstorfer3, Sophie E R Horbach2
1Department of Surgery, Amsterdam University Medical Centers, location AMC, University of Amsterdam, Amsterdam, the Netherlands.
The British Journal of Dermatology
|June 28, 2022
Summary
A core outcome domain set (CDS) was developed for capillary malformations (CMs) research. This standardized set will improve treatment comparisons and patient information on best therapeutic options.
Area of Science:
- Medical research methodology
- Dermatology
- Clinical trial design
Background:
- Limited evidence exists for optimal capillary malformation (CM) treatments due to inconsistent outcome measures in clinical trials.
- A core outcome set (COS) is crucial for standardizing trial reporting and facilitating treatment comparisons.
Purpose of the Study:
- To develop a core outcome domain set (CDS) for clinical research on capillary malformations (CMs).
- This CDS is a foundational component for establishing a comprehensive COS in CM research.
Main Methods:
- An international online Delphi study involving CM experts and patients/parents was conducted over three rounds.
- Consensus on outcome subdomains was defined as agreement among ≥80% of both stakeholder groups.
- The CDS was finalized through an online consensus meeting.
Main Results:
- 269 participants from 45 countries engaged in the study.
- Consensus was achieved on 11 critical outcome subdomains for CM research.
- These include physical aspects (color, thickness, noticeability, anatomical distortion), associated conditions (glaucoma), quality of life (overall, emotional, social), and treatment-related factors (tolerability, satisfaction, recurrence).
Conclusions:
- The developed CDS should be adopted as a minimum reporting standard in all future CM therapy trials.
- The next step involves selecting validated instruments to measure these core outcome subdomains.
- Standardized reporting via the CDS will enable robust comparison of treatment results, informing patients about the most effective therapies.
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