Trial protocol for the validation of the 'Toronto Aortic Stenosis Quality of Life (TASQ) Questionnaire' in patients undergoing surgical aortic valve replacement (SAVR) or transfemoral (TF) transcatheter aortic valve implantation (TAVI): the TASQ registry.
aortic stenosis
aortic valve replacement
quality of life
questionnaire
transcatheter
Journal
Open heart
ISSN: 2053-3624
Titre abrégé: Open Heart
Pays: England
ID NLM: 101631219
Informations de publication
Date de publication:
Historique:
received:
09
01
2019
revised:
05
03
2019
accepted:
14
04
2019
entrez:
21
6
2019
pubmed:
21
6
2019
medline:
21
6
2019
Statut:
epublish
Résumé
Patients with severe aortic stenosis (AS) have a reduced life expectancy and quality of life (QoL), owing to advanced age and the presence of multiple comorbidities. Currently, there is no AS-specific QoL measurement tool, which prevents an accurate assessment of how this chronic condition and its treatment affect patients. The Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) was developed in order to address this deficiency. The present trial protocol was designed to enable validation of the TASQ, which has been produced in five languages (English, French, German, Italian and Spanish) to increase usability. Patients with severe AS who are undergoing surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) will be asked to complete the TASQ and, for comparative purposes, the Kansas City Cardiomyopathy Questionnaire and the general health-related QoL Short Form-12 questionnaire. The questionnaires will be completed prior to the intervention, at discharge, as well as at 30 days and 3 months follow-up. A total of 290 patients will be recruited across one Canadian and nine European centres. Overall, the protocol validation aims to include 120 patients undergoing transfemoral TAVI (TF-TAVI), 120 undergoing SAVR and up to 50 being treated medically. The primary objective of the registry is to validate the TASQ in five different languages. The secondary objective is to assess the utility of the TASQ for assessing differences in QoL outcome between patients undergoing TF-TAVI, SAVR or medical management for their AS. Validation and roll-out of the TASQ will enable clinicians to capture an accurate assessment of how AS and its management affects the QoL of patients and will help them to determine the most appropriate treatment strategy for individual patients. NCT03186339.
Sections du résumé
Background
Patients with severe aortic stenosis (AS) have a reduced life expectancy and quality of life (QoL), owing to advanced age and the presence of multiple comorbidities. Currently, there is no AS-specific QoL measurement tool, which prevents an accurate assessment of how this chronic condition and its treatment affect patients. The Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) was developed in order to address this deficiency.
Methods
The present trial protocol was designed to enable validation of the TASQ, which has been produced in five languages (English, French, German, Italian and Spanish) to increase usability. Patients with severe AS who are undergoing surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) will be asked to complete the TASQ and, for comparative purposes, the Kansas City Cardiomyopathy Questionnaire and the general health-related QoL Short Form-12 questionnaire. The questionnaires will be completed prior to the intervention, at discharge, as well as at 30 days and 3 months follow-up. A total of 290 patients will be recruited across one Canadian and nine European centres. Overall, the protocol validation aims to include 120 patients undergoing transfemoral TAVI (TF-TAVI), 120 undergoing SAVR and up to 50 being treated medically. The primary objective of the registry is to validate the TASQ in five different languages. The secondary objective is to assess the utility of the TASQ for assessing differences in QoL outcome between patients undergoing TF-TAVI, SAVR or medical management for their AS.
Discussion
Validation and roll-out of the TASQ will enable clinicians to capture an accurate assessment of how AS and its management affects the QoL of patients and will help them to determine the most appropriate treatment strategy for individual patients.
Trial registration number
NCT03186339.
Identifiants
pubmed: 31218003
doi: 10.1136/openhrt-2019-001008
pii: openhrt-2019-001008
pmc: PMC6546188
doi:
Banques de données
ClinicalTrials.gov
['NCT03186339']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Pagination
e001008Déclaration de conflit d'intérêts
Competing interests: PB is the representative of the Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany. All centres were paid by IPPMed for the enrolment and documentation of patients.
Références
Health Policy. 1990 Dec;16(3):199-208
pubmed: 10109801
J Am Coll Cardiol. 2000 Apr;35(5):1245-55
pubmed: 10758967
Qual Life Res. 2002 Mar;11(2):173-83
pubmed: 12018740
Am Heart J. 1992 Oct;124(4):1017-25
pubmed: 1529875
J Psychosom Res. 2010 Jun;68(6):591-602
pubmed: 20488277
Interact Cardiovasc Thorac Surg. 2010 Dec;11(6):750-3
pubmed: 20847067
N Engl J Med. 2010 Oct 21;363(17):1597-607
pubmed: 20961243
Circulation. 2011 Nov 1;124(18):1964-72
pubmed: 21969017
J Card Surg. 2012 Jan;27(1):20-3
pubmed: 22211277
J Am Coll Cardiol. 2012 May 8;59(19):1672-80
pubmed: 22554597
J Am Coll Cardiol. 2012 Aug 7;60(6):548-58
pubmed: 22818074
Circ Heart Fail. 2013 Jan;6(1):61-7
pubmed: 23230306
Circ Cardiovasc Qual Outcomes. 2013 Sep 1;6(5):591-7
pubmed: 24021691
EuroIntervention. 2015 Jun;11(2):221-9
pubmed: 24769484
Clin Res Cardiol. 2015 Oct;104(10):877-86
pubmed: 25896479
JACC Cardiovasc Interv. 2015 Aug 17;8(9):1207-1217
pubmed: 26292584
JAMA Cardiol. 2017 Apr 1;2(4):409-416
pubmed: 28146260
Eur J Cardiothorac Surg. 2017 May 1;51(5):919-926
pubmed: 28369303
Eur Heart J. 2017 Sep 21;38(36):2739-2791
pubmed: 28886619
J Geriatr Cardiol. 2017 Jun;14(6):379-382
pubmed: 29056944
J Gerontol A Biol Sci Med Sci. 2018 Aug 25;:null
pubmed: 30165422
JAMA Cardiol. 2018 Nov 1;3(11):1060-1068
pubmed: 30285058
JACC Cardiovasc Interv. 2018 Nov 12;11(21):2148-2156
pubmed: 30343022
J Am Coll Cardiol. 1995 Feb;25(2):333-41
pubmed: 7829785
Med Care. 1996 Mar;34(3):220-33
pubmed: 8628042