Cross Cultural Adaptation and Validation of a Spanish Version of VascuQol-6 Questionnaire.

Background:Outcomes in peripheral arterial disease (PAD) are usually clinical alone, ignoring patient´s bio-psychological sphere. VascuQol-6 is a specific questionnaire aimed to asses quality of life of patients suffering PAD. Our objective was to carry out a cross-cultural adaptation and validation of VQ-6 questionnaire from original English version into Spanish, in order to have a rapid, sensitive and easy-to-apply clinical tool for evaluating HRQoL outcomes in PAD patients.MethodsA prospective study with 100 outpatients with PAD patients was carried out in two university hospitals. Patients completed the Spanish translated VasquQol-6 (VQ-6) questionnaire and the SF-12 questionnaire. Validation of the VQ-6 Spanish Version was assessed through statistical measurement of reliability, reproducibility and validity of the questionnaire. Reproducibility of the Spanish VQ-6 was assessed through Intraclass Correlation Coefficient, while Internal consistency was analyzed through Alpha Cronbach. Criterion Validity was assessed by comparing the SF-12 and with Pearson’s Correlation Coefficient. Construct Validity was assessed by comparing the results of the questionnaire with the stage of the PAD based on Rutherford-Becker Category.ResultsOn hundred patients were included in the study from July 2019 to January 2021. 82 % were male with a median age of 71.6 years. The reproducibility of the VQ-6 Spanish Version in each item was evaluated in a sample of 80 patients. Pain, Activity, Social and Emotional domains had ICC values ranging from 0.70 to 0.88, indicating a good agreement. The value obtained for Cronbach's Alpha was 0.89 using all the questions of the questionnaire, indicating a good internal consistency. VQ-6 and SF-12 showed positive correlations. The overall Pearson Correlation Coefficient was 0.77 for Physical SF-12, indicating an elevated Criterion Validity. Under´s curve area was 0.8, so discrimination capacity of VQ-6 Spanish Version to discriminate between IC and CLI was considered good.ConclusionVQ-6 Spanish Version is a reliable and valid instrument for evaluation of quality of life in patients suffering from PAD that can be used in clinical practice, adding a decision-base when evaluating different treatment options. This VQ-6 Spanish Version is intended to cover the spectrum of severity of PAD in Spanish-speaking patients.Trial registration: ClinicalTrials.gov NCT04741321. Retrospectively registered on February 05,2021)