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Development of an international core outcome set for peripheral vascular malformations: the OVAMA project.

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Horbach, Sophie E R van der Horst, Chantal M A M Blei, Francine van der Vleuten, Catharina J M Frieden, Ilona J Boon, Laurence M. [UCL] OVAMA Consensus Group

BACKGROUND: An important limitation in vascular malformation research is the heterogeneity in outcome measures used for the evaluation of treatment outcome. OBJECTIVES: To reach international consensus on a core outcome set (COS) for clinical research on peripheral vascular malformations: lymphatic (LM), venous (VM) and arteriovenous malformations (AVM). In this consensus study, we determined what domains should constitute the COS. METHODS: Thirty-six possibly relevant outcome domains were proposed to an international group of physicians, patients and the parents of patients. In a three-round e-Delphi process using online surveys, participants repeatedly rated the importance of these domains on a five-point Likert scale. Participants could also propose other relevant domains. This process was performed for LM, VM and AVM separately. Consensus was predefined as 80% agreement on the importance of a domain among both the physician group and the patient/parent group. Outcomes were then re-evaluated in an online consensus meeting. RESULTS: 167 physicians and 134 patients and parents of patients with LM (n = 50), VM (n = 71) and AVM (n = 29) participated in the study. After three rounds and a consensus meeting, consensus was reached for all three types of vascular malformations on the core domains of radiological assessment, physician-reported location-specific signs, patient-reported severity of symptoms, pain, quality of life, satisfaction and adverse events. Vascular malformation type-specific signs and symptoms were included for LM, VM and AVM, separately. CONCLUSIONS: Our recommendation is that therapeutic-efficacy studies on peripheral vascular malformations should measure at least these core outcome domains.

Document type Article de périodique (Journal article) – Article de recherche
Access type Accès mixte
Publication date 2018
Language Anglais
Journal information "The British journal of dermatology" - Vol. 178, no.2, p. 473-481 (2018)
Peer reviewed yes
Publisher Blackwell Scientific Publications ((United Kingdom) Oxford)
issn 0007-0963
e-issn 1365-2133
Publication status Publié
Affiliations UCL - SSS/DDUV - Institut de Duve
UCL - SSS/DDUV/GEHU - Génétique
UCL - (SLuc) Service de chirurgie plastique
MESH Subject Arteriovenous Malformations ; Consensus ; Delphi Technique ; Humans ; Lymphatic System ; Treatment Outcome ; Vascular Malformations
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Bibliographic reference Horbach, Sophie E R ; van der Horst, Chantal M A M ; Blei, Francine ; van der Vleuten, Catharina J M ; Frieden, Ilona J ; et. al. Development of an international core outcome set for peripheral vascular malformations: the OVAMA project.. In: The British journal of dermatology, Vol. 178, no.2, p. 473-481 (2018)
Permanent URL http://hdl.handle.net/2078.1/219045