“多伦多主动脉瓣狭窄生活质量（TASQ）问卷”在接受外科主动脉瓣置换术（SAVR）或经股动脉（TF）经导管主动脉瓣植入术（TAVI）患者中的验证试验方案：TASQ注册研究
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.
作者信息
Frank Derk, Kennon Simon, Bonaros Nikolaos, Romano Mauro, Lefèvre Thierry, Di Mario Carlo, Stefàno Pierluigi, Ribichini Flavio Luciano, Himbert Dominique, Urena-Alcazar Marina, Salgado-Fernandez Jorge, Cuenca Castillo Jose Joaquin, Garcia Bruno, Kurucova Jana, Thoenes Martin, Lüske Claudia, Bramlage Peter, Styra Rima
机构信息
Departmentof Internal Medicine III (Cardiology, Angiology and Intensive Care Medicine), UKSH University Clinical Center Schleswig-Holstein, Kiel, Germany and DZHK (German Centre for Cardiovascular Research), partner site Hamburg/Kiel/Lübeck, Kiel, Germany.
Department of Cardiology, Barts Heart Centre, St. Bartholomew's Hospital London, London, UK.
出版信息
Open Heart. 2019 May 21;6(1):e001008. doi: 10.1136/openhrt-2019-001008. eCollection 2019.
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.
背景
重度主动脉瓣狭窄（AS）患者由于年龄较大且存在多种合并症，预期寿命和生活质量（QoL）降低。目前，尚无针对AS的生活质量测量工具，这使得无法准确评估这种慢性疾病及其治疗对患者的影响。为解决这一缺陷，开发了多伦多主动脉瓣狭窄生活质量问卷（TASQ）。
方法
本试验方案旨在对TASQ进行验证，该问卷已制作成五种语言（英语、法语、德语、意大利语和西班牙语）以提高其可用性。将要求接受外科主动脉瓣置换术（SAVR）或经导管主动脉瓣植入术（TAVI）的重度AS患者完成TASQ，为作比较，还要完成堪萨斯城心肌病问卷和一般健康相关生活质量简表12问卷。这些问卷将在干预前、出院时以及随访30天和3个月时完成。将在加拿大的一个中心和欧洲的九个中心共招募290名患者。总体而言，方案验证旨在纳入120例接受经股动脉TAVI（TF-TAVI）的患者、120例接受SAVR的患者以及最多50例接受药物治疗的患者。该登记研究的主要目的是在五种不同语言中验证TASQ。次要目的是评估TASQ在评估接受TF-TAVI、SAVR或药物治疗AS的患者之间生活质量结果差异方面的效用。
讨论
TASQ的验证和推广将使临床医生能够准确评估AS及其管理如何影响患者的生活质量，并将帮助他们为个体患者确定最合适的治疗策略。
试验注册号
NCT03186339。
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