TY - JOUR
T1 - Development of a condition-specific patient-reported outcome measure for measuring symptoms and appearance in vascular malformations
T2 - the OVAMA questionnaire
AU - Lokhorst, M. M.
AU - Horbach, S. E. R.
AU - Young-Afat, D. A.
AU - Stor, M. L. E.
AU - Haverman, L.
AU - Spuls, P. I.
AU - van der Horst, C. M. A. M.
AU - the OVAMA Steering Group
AU - Blei, F.
AU - van der Vleuten, C. J. M.
AU - Frieden, I. J.
AU - Richter, G. T.
AU - Tan, S. T.
AU - Muir, T.
AU - Penington, A.
AU - Boon, L. M.
N1 - Funding Information: sources None.We would like to thank the collaborators from the OVAMA Steering Group for their participation in this project: F. Blei, MD; C.J.M. van der Vleuten, MD PhD; I.J. Frieden, MD; G.T. Richter, MD; S.T. Tan, MD PhD; T. Muir, MD; A. Penington, MD PhD; and L.M. Boon, MD PhD. Publisher Copyright: © 2021 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/10
Y1 - 2021/10
N2 - Background: The symptoms and appearance of vascular malformations can severely harm a patient’s quality of life. The aim of treatment of vascular malformations generally is to improve condition-specific symptoms and/or appearance. Therefore, it is highly important to start testing treatment effects in clinical studies from the patient’s perspective. Objectives: To develop a patient-reported outcome measure for measuring symptoms and appearance in patients with vascular malformations. Methods: A first draft of the patient-reported outcome measure was based on the previously internationally developed core outcome set. The qualitative part of this study involved interviews with 14 patients, which led to a second draft. The second draft was field tested cross-sectionally, after which groups of items were evaluated for adequate internal consistency (Cronbach’s alpha > 0·7) to form composite scores. Construct validity was evaluated by testing 13 predefined hypotheses on known-group differences. Results: The patient interviews ensured adequate content validity and resulted in a general symptom scale with six items, a head and neck symptom scale with eight items, and an appearance scale with nine items. Cronbach’s alpha was adequate for two composite scores: a general symptom score (0·88) and an appearance score (0·85). Ten out of 13 hypotheses on known-group differences were confirmed, confirming adequate construct validity. Conclusions: With the development of the OVAMA questionnaire, outcomes of patients with vascular malformations can now be evaluated from the patient’s perspective. This may help improve the development of evidence-based treatments and the overall care for patients with vascular malformations.
AB - Background: The symptoms and appearance of vascular malformations can severely harm a patient’s quality of life. The aim of treatment of vascular malformations generally is to improve condition-specific symptoms and/or appearance. Therefore, it is highly important to start testing treatment effects in clinical studies from the patient’s perspective. Objectives: To develop a patient-reported outcome measure for measuring symptoms and appearance in patients with vascular malformations. Methods: A first draft of the patient-reported outcome measure was based on the previously internationally developed core outcome set. The qualitative part of this study involved interviews with 14 patients, which led to a second draft. The second draft was field tested cross-sectionally, after which groups of items were evaluated for adequate internal consistency (Cronbach’s alpha > 0·7) to form composite scores. Construct validity was evaluated by testing 13 predefined hypotheses on known-group differences. Results: The patient interviews ensured adequate content validity and resulted in a general symptom scale with six items, a head and neck symptom scale with eight items, and an appearance scale with nine items. Cronbach’s alpha was adequate for two composite scores: a general symptom score (0·88) and an appearance score (0·85). Ten out of 13 hypotheses on known-group differences were confirmed, confirming adequate construct validity. Conclusions: With the development of the OVAMA questionnaire, outcomes of patients with vascular malformations can now be evaluated from the patient’s perspective. This may help improve the development of evidence-based treatments and the overall care for patients with vascular malformations.
KW - Humans
KW - Patient Reported Outcome Measures
KW - Psychometrics
KW - Quality of Life
KW - Reproducibility of Results
KW - Surveys and Questionnaires
KW - Vascular Malformations/diagnosis
UR - http://www.scopus.com/inward/record.url?scp=85108222210&partnerID=8YFLogxK
U2 - https://doi.org/10.1111/bjd.20429
DO - https://doi.org/10.1111/bjd.20429
M3 - Article
C2 - 33937977
SN - 0007-0963
VL - 185
SP - 797
EP - 803
JO - British Journal of Dermatology
JF - British Journal of Dermatology
IS - 4
ER -