Validation of VascuQol-6 Spanish Version

Peripheral Artery Disease Clinical Trial

Official title:

Cross-cultural Adaptation and Validation of the VascuQol-6 Spanish Version

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04741321
• Other study ID #: VALVAS
• Status: Recruiting
• Start date: September 15, 2019
• Est. completion date: February 15, 2021

Study information

• Verified date: January 2021
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: Barbara Soria-Juan, MD
• Phone: +34 661295031
• Email: barbara.soria[@]quironsalud.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

VascuQol (VQ) is a specific questionnaire to assess the quality of life of patients with critical limb ischemia which is also used as an index in vascular registries. The original version has 25 items (VQ-25), divided into 5 subscales or domains: pain, symptoms, activity, social and emotional. The shortened version, VascuQol-6 (VQ-6) is made up of 6 questions and 4 possible answers, which score from 1 (worst quality of life perceived by the patient) to 4 (best quality of life perceived by the patient). The total score is between 6 and 24, and a higher value is related to better health.

While the VQ-25 questionnaire has been translated and validated in 21 languages, the shortened version VQ-6 has been translated and validated in some languages, not including Spanish. As it is a fast and easy-to-use tool iwhich has demonstrated statistical validation to measure PAD in other versions of the same questionnaire (other languages), a cross-cultural adaptation and statistical validation of the questionnaire from English to Spanish will be carried out.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: February 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 years of age

• With a diagnosis of Peripheral Arterial Disease (intermittent claudication and critical lower limb ischemia)

• Whose first language is Spanish

• Who sign the informed consent.

Exclusion Criteria:

• Patients with cognitive impairment that difficults understanding of the questionnaire

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Other:
• VascuQol-6 questionnaire Spanish version
VascuQol-6 questionnaire was translated by two professional translators into Spanish.

Locations

Country	Name	City	State
Spain	Jimenez Diaz Foundation University Hospital	Madrid
Spain	La Paz University Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Country where clinical trial is conducted

Spain, 

References & Publications (20)

Aday LA, Cornelius LJ, Steven F, Cohen B, Aday LA, Cornelius LJ, et al. Published by Jossey-Bass.

Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. Review. — View Citation

Carvajal A, Centeno C, Watson R, Martínez M, Rubiales AS. [How is an instrument for measuring health to be validated?]. An Sist Sanit Navar. 2011 Jan-Apr;34(1):63-72. Review. Spanish. — View Citation

de Almeida Correia M, Andrade-Lima A, Mesquita de Oliveira PL, Domiciano RM, Ribeiro Domingues WJ, Wolosker N, Puench-Leão P, Ritti-Dias RM, Cucato GG. Translation and Validation of the Brazilian-Portuguese Short Version of Vascular Quality of Life Questionnaire in Peripheral Artery Disease Patients with Intermittent Claudication Symptoms. Ann Vasc Surg. 2018 Aug;51:48-54.e1. doi: 10.1016/j.avsg.2018.02.026. Epub 2018 May 15. — View Citation

Frans FA, van Wijngaarden SE, Met R, Koelemay MJ. Validation of the Dutch version of the VascuQol questionnaire and the Amsterdam Linear Disability Score in patients with intermittent claudication. Qual Life Res. 2012 Oct;21(8):1487-93. doi: 10.1007/s11136-011-0060-z. Epub 2011 Nov 15. — View Citation

Guía de Consenso Multidisciplinar en Enfermedad Arterial Periférica de extremidades inferiores - Acta Sanitaria.

Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med. 1993 Apr 15;118(8):622-9. Review. — View Citation

Larsen ASF, Reiersen AT, Jacobsen MB, Kløw NE, Nordanstig J, Morgan M, Wesche J. Validation of the Vascular quality of life questionnaire - 6 for clinical use in patients with lower limb peripheral arterial disease. Health Qual Life Outcomes. 2017 Sep 22;15(1):184. doi: 10.1186/s12955-017-0760-3. — View Citation

Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, Bouter LM, de Vet HC. The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. J Clin Epidemiol. 2010 Jul;63(7):737-45. doi: 10.1016/j.jclinepi.2010.02.006. — View Citation

Morgan MB, Crayford T, Murrin B, Fraser SC. Developing the Vascular Quality of Life Questionnaire: a new disease-specific quality of life measure for use in lower limb ischemia. J Vasc Surg. 2001 Apr;33(4):679-87. — View Citation

Nordanstig J, Wann-Hansson C, Karlsson J, Lundström M, Pettersson M, Morgan MB. Vascular Quality of Life Questionnaire-6 facilitates health-related quality of life assessment in peripheral arterial disease. J Vasc Surg. 2014 Mar;59(3):700-7. doi: 10.1016/j.jvs.2013.08.099. Epub 2013 Dec 15. — View Citation

Olmedo JMD, Mendoza JAP, Reina-Bueno M. Revisión sistemática sobre el impacto de las complicaciones podológicas de la diabetes mellitus sobre la calidad de vida. Rev Esp Podol. 2017;28(1):30-6.

Perneger TV, Courvoisier DS, Hudelson PM, Gayet-Ageron A. Sample size for pre-tests of questionnaires. Qual Life Res. 2015 Jan;24(1):147-51. doi: 10.1007/s11136-014-0752-2. Epub 2014 Jul 10. — View Citation

Piault E, Doshi S, Brandt BA, Angün Ç, Evans CJ, Bergqvist A, Trocio J. Linguistic validation of translation of the Self-Assessment Goal Achievement (SAGA) questionnaire from English. Health Qual Life Outcomes. 2012 Apr 23;10:40. doi: 10.1186/1477-7525-10-40. — View Citation

Poku E, Duncan R, Keetharuth A, Essat M, Phillips P, Woods HB, Palfreyman S, Jones G, Kaltenthaler E, Michaels J. Patient-reported outcome measures in patients with peripheral arterial disease: a systematic review of psychometric properties. Health Qual Life Outcomes. 2016 Nov 24;14(1):161. Review. — View Citation

Ramada-Rodilla JM, Serra-Pujadas C, Delclós-Clanchet GL. [Cross-cultural adaptation and health questionnaires validation: revision and methodological recommendations]. Salud Publica Mex. 2013 Jan-Feb;55(1):57-66. Review. Spanish. — View Citation

Schwartzmann L. CALIDAD DE VIDA RELACIONADA CON LA SALUD: ASPECTOS CONCEPTUALES. Cienc Enferm. diciembre de 2003;9(2):09- 21.

Serrano Hernando FJ, Martín Conejero A. [Peripheral artery disease: pathophysiology, diagnosis and treatment]. Rev Esp Cardiol. 2007 Sep;60(9):969-82. Review. Spanish. — View Citation

Soria-Juan B, Escacena N, Capilla-González V, Aguilera Y, Llanos L, Tejedo JR, Bedoya FJ, Juan V, De la Cuesta A, Ruiz-Salmerón R, Andreu E, Grochowicz L, Prósper F, Sánchez-Guijo F, Lozano FS, Miralles M, Del Río-Solá L, Castellanos G, Moraleda JM, Sackstein R, García-Arranz M, García-Olmo D, Martín F, Hmadcha A, Soria B; Collaborative Working Group "Noma Project Team". Cost-Effective, Safe, and Personalized Cell Therapy for Critical Limb Ischemia in Type 2 Diabetes Mellitus. Front Immunol. 2019 Jun 4;10:1151. doi: 10.3389/fimmu.2019.01151. eCollection 2019. Erratum in: Front Immunol. 2020 Sep 02;11:2029. — View Citation

Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. Epub 2006 Aug 24. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability	Reliability refers to the degree to which an instrument is capable of measuring without errors. It measures the proportion or variation in the measurements that is due to the diversity of values adopted by the variable and not to the possible systematic or random error. Reliability will be assessed trough Cronbach's alpha coefficient measured for every item of the questionnaire.	3 -4 weeks from basal
Primary	Reproducibility	Reproducibility of intra-observer reliabilty refers to the repeatibility of the instrument, when it is administered with the same method to the same population at two times. Kappa Index will be measured	3-4 weeks from basal
Primary	Validity	Validity is the ability of the questionnaire to measure the construct for which it has been designed. Pearson correlation between the domains of the questionnaire and ABI from each patient will be measured	3-4 weeks from basal