TY - JOUR
T1 - Development and Preliminary Validation of the Patient-Reported Outcome Measure for Vascular Malformation Questionnaire
T2 - A Prospective Cohort Study
AU - England, Ryan W.
AU - Motaghi, Mina
AU - Kohler, Beatriz
AU - Hemmingson, Thomas E.
AU - Wu, Albert W.
AU - Weiss, Clifford R.
N1 - Funding Information:
C.R.W. is funded by Boston Scientific , Siemens Healthcare , and Medtronic and is a consultant for BTG and Medtronic (all unrelated to this study).None of the remaining authors have identified a conflict of interest.
Publisher Copyright:
© 2021 SIR
PY - 2021/5
Y1 - 2021/5
N2 - Purpose: To develop and validate the Patient-Reported Outcome Measure for Vascular Malformation (PROVAM) questionnaire to assess the health-related quality of life in patients with vascular malformations. Materials and Methods: We developed and validated PROVAM using a mixed methods design during a prospective clinical trial at a vascular anomalies clinic. From July 2019 to February 2020, 108 consecutive patients completed 130 questionnaires. The 30-item instrument assessed the domains of pain, emotional/social well-being, functional impact, and treatment satisfaction. Two additional items assessed ease of understanding and relevance. The primary outcomes of instrument reliability and validity were evaluated across several indices. The secondary outcome of responsiveness evaluated total score changes for patients who completed questionnaires both before and after treatment. Results: Instrument reliability, as measured by Cronbach alpha, was ≥0.79 for pain, emotional/social well-being, and functional impact domains. Primary domain structure was confirmed by factor analysis (P < .001) and convergent construct validity for all but 1 Likert scale item. In the subgroup analysis of 13 participants who completed PROVAM before and after treatment, instrument responsiveness, as measured by the total score, showed a significant decrease (median, −10 points; interquartile range [IQR], −3 to −16; P = .04). Participants found the questions easy to understand (median, 5 points; IQR, 4–5 on a 5-point scale) and relevant (median score, 4; IQR, 3–5). Conclusions: Preliminary data support the reliability and validity of PROVAM in measuring the health-related quality of life in patients with vascular malformations.
AB - Purpose: To develop and validate the Patient-Reported Outcome Measure for Vascular Malformation (PROVAM) questionnaire to assess the health-related quality of life in patients with vascular malformations. Materials and Methods: We developed and validated PROVAM using a mixed methods design during a prospective clinical trial at a vascular anomalies clinic. From July 2019 to February 2020, 108 consecutive patients completed 130 questionnaires. The 30-item instrument assessed the domains of pain, emotional/social well-being, functional impact, and treatment satisfaction. Two additional items assessed ease of understanding and relevance. The primary outcomes of instrument reliability and validity were evaluated across several indices. The secondary outcome of responsiveness evaluated total score changes for patients who completed questionnaires both before and after treatment. Results: Instrument reliability, as measured by Cronbach alpha, was ≥0.79 for pain, emotional/social well-being, and functional impact domains. Primary domain structure was confirmed by factor analysis (P < .001) and convergent construct validity for all but 1 Likert scale item. In the subgroup analysis of 13 participants who completed PROVAM before and after treatment, instrument responsiveness, as measured by the total score, showed a significant decrease (median, −10 points; interquartile range [IQR], −3 to −16; P = .04). Participants found the questions easy to understand (median, 5 points; IQR, 4–5 on a 5-point scale) and relevant (median score, 4; IQR, 3–5). Conclusions: Preliminary data support the reliability and validity of PROVAM in measuring the health-related quality of life in patients with vascular malformations.
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U2 - 10.1016/j.jvir.2021.01.263
DO - 10.1016/j.jvir.2021.01.263
M3 - Article
C2 - 33678569
AN - SCOPUS:85101995274
SN - 1051-0443
VL - 32
SP - 683-690.e4
JO - Journal of Vascular and Interventional Radiology
JF - Journal of Vascular and Interventional Radiology
IS - 5
ER -