Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)
Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)
The purpose of this study is to develop a standardized assessment for patients treated for
 venous malformations (VM).

 Venous malformations result from the abnormal development of veins which may result in pain,
 swelling, bleeding, functional impairment, disfigurement, and psychological distress. The
 impact of VM on patient quality of life varies based on the location and size of the
 malformation.

 A patient reported outcome (PRO) is a patient's own account of patient's health condition.
 PRO measures are valued to clinicians, as many treatment effects are known only to the
 patient. No studies to date have analyzed the validity of existing PRO measures for VM
 patients.

 Current assessment does not include all symptoms or take in to account the relevance of VM
 location. Past studies show a discrepancy between treatment outcomes reported by patients and
 physicians. Therefore, there is a need to develop VM-specific PROs to better understand the
 effectiveness and benefits of treatment for VM.
Inclusion Criteria:

 -  Male and Female pediatric patients, aged between 0-17 with diagnosis of vascular
 malformations.

 -  Male and Female adult patients aged 18-100 with diagnosis of vascular malformations.

 -  Vascular malformation symptoms significant enough to seek treatment.

 Exclusion Criteria:

 -  Patients with extensive VM not suitable for sclerotherapy.

 -  Prior therapy for treatment of a VM within 3 months.

 -  Condition or impairment that may render the patient unable to take part in the study
 (e.g. cognitive, sight, hearing, etc.).