Scientific article
Open access

Development of a core outcome domain set for clinical research on capillary malformations (the COSCAM project)

Published inJournal of the European Academy of Dermatology and Venereology, vol. 35, no. 9, p. 1888-1895
Publication date2021-09
First online date2021-05-20

Background: Due to a large variety in treatment outcomes reported in therapeutic trials and lacking patient-relevant outcomes, it is hard to adequately compare and improve current therapies for patients with capillary malformations (CMs). The Core Outcome Set for Capillary Malformations (COSCAM) project aims to develop a core outcome set (COS) for use in future CM trials, in which we will first develop a core outcome (sub)domain set (CDS). Here, we describe the methods for the development of a CDS and present the results of the first development stage.

Methods: The COSCAM project is carried out according to the recommendations of the Cochrane Skin Core OUtcomes Set INitiative (CS-COUSIN) and the Core Outcome Measures in Effectiveness Trials (COMET) initiative. During the first stage, we identified all potentially relevant outcome subdomains based on a systematic review, two focus group sessions and input from patient representatives of Dutch patient organizations and the COSCAM-founding group. In stage two, we will present the subdomains in a three-round e-Delphi study and online consensus meeting, in which CM patients, parents/caregivers and CM experts worldwide rate the importance of the proposed subdomains, hereby finalizing the core outcome (sub)domains of the CDS.

Results: A total of 67 potential outcome subdomains were included; sixteen were previously used in the literature, 20 were proposed by Dutch patients and their parents/caregivers (n = 13) in focus group sessions and 38 were suggested by the experts of the COSCAM-founding group. Seven were excluded because of overlap.

Conclusion: The final CDS may serve as a minimum standard in future CM trials, thereby facilitating adequate comparison of treatment outcomes. After this CDS development, we will select appropriate outcome measurement instruments to measure the core outcome subdomains.

  • Capillaries / abnormalities
  • Delphi Technique
  • Endpoint Determination
  • Humans
  • Outcome Assessment, Health Care
  • Research Design
  • Systematic Reviews as Topic
  • Treatment Outcome
  • Vascular Malformations
Citation (ISO format)
LANGBROEK, G B et al. Development of a core outcome domain set for clinical research on capillary malformations (the COSCAM project). In: Journal of the European Academy of Dermatology and Venereology, 2021, vol. 35, n° 9, p. 1888–1895. doi: 10.1111/jdv.17376
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Article (Published version)
ISSN of the journal0926-9959

Technical informations

Creation03/18/2022 7:48:00 AM
First validation03/18/2022 7:48:00 AM
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