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.
Study Type
OBSERVATIONAL
Enrollment
200
Johns Hopkins Hospital
Baltimore, Maryland, United States
RECRUITINGChange in patient reported VM pain
Patients are asked to rate pain associated with VM during the past seven days on a 0-10 scale.
Time frame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
Change in patient reported VM impact on daily life
Patients are asked to rate the impact that their VM has on daily life with the options "Not at all", "A little bit", "Somewhat", "Quite a bit" or "Very Much".
Time frame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
Change in patient reported efficacy of treatment
Patients are asked to rate the efficacy of their treatment with the options "Not at all", "A little bit", "Somewhat", "Quite a bit" or "Very Much".
Time frame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
Change in patient reported relevancy of the PROVEN Questionnaire
Patients are asked to rate the personal relevancy and clarity of the survey questions with the options "Not at all", "A little bit", "Somewhat", "Quite a bit" or "Very Much".
Time frame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year
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