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加拿大支气管扩张症与非结核分枝杆菌登记处:一项研究方案。

The Canadian Bronchiectasis and Nontuberculous Mycobacteria Registry: a study protocol.

作者信息

Thornton Christina S, Boechler Nicole, Desai Vidhi, Somayaji Ranjani, Purighalla Swathi, Brode Sarah, Marras Theodore K, Cooper Ryan, Smith Maeve, Jarand Julie

机构信息

Department of Microbiology, Immunology and Infectious Diseases, Cumming School of Medicine University of Calgary, Calgary, AB, Canada.

Department of Medicine, Cumming School of Medicine, Alberta Health Services, University of Calgary, Calgary, AB, Canada.

出版信息

ERJ Open Res. 2024 Nov 25;10(6). doi: 10.1183/23120541.00412-2024. eCollection 2024 Nov.

Abstract

BACKGROUND

Bronchiectasis is a complex, chronic disease with geographic and ethnic diversity. While the most substantial cohort studies have been conducted in Europe and the USA, Canada also faces considerable challenges. The comprehensive Canadian Bronchiectasis and Nontuberculous Mycobacterial (NTM) Registry aims to 1) outline the clinical characteristics and natural history of bronchiectasis in Canada, 2) identify risk factors contributing to disease progression within Canadians, 3) integrate comprehensive clinical information to better understand the phenotypes of bronchiectasis and 4) support the development of large-scale, randomised controlled trials in Canada.

METHODS

The Canadian Bronchiectasis and NTM Registry is an ongoing prospective, longitudinal, multi-centre, observational cohort study. It aims to enrol at least 2000 participants to collect data such as medical history, aetiological assessments, lung function tests, microbiological profiles, radiographic evaluations, comorbidities and quality of life (QoL) metrics. Participants will undergo annual follow-ups to gather longitudinal information regarding outcomes, treatments and changes in QoL. The inclusion criteria are a diagnosis of bronchiectasis by clinical history and computed tomography and/or pulmonary NTM infection as defined by American Thoracic Society/Infectious Diseases Society of America guidelines. The study's protocol received ethical approval from the lead site, the University of Calgary, with future additional approval from local ethics committees at all participating centres.

DISCUSSION

The outcomes of the registry will be instrumental in uncovering the clinical traits and natural history of bronchiectasis. This longitudinal study will be used for analysis to form evidence-based clinical practices and serve as a resource in Canada to inform future studies in NTM and bronchiectasis.

摘要

背景

支气管扩张是一种复杂的慢性疾病,存在地域和种族差异。虽然欧洲和美国开展了规模最大的队列研究,但加拿大也面临着诸多挑战。加拿大支气管扩张和非结核分枝杆菌(NTM)综合登记处旨在:1)概述加拿大支气管扩张的临床特征和自然病史;2)确定加拿大人群中导致疾病进展的风险因素;3)整合全面的临床信息,以更好地了解支气管扩张的表型;4)支持加拿大开展大规模随机对照试验。

方法

加拿大支气管扩张和NTM登记处是一项正在进行的前瞻性、纵向、多中心观察性队列研究。其目标是招募至少2000名参与者,收集病史、病因评估、肺功能测试、微生物学特征、影像学评估、合并症和生活质量(QoL)指标等数据。参与者将接受年度随访,以收集有关结局、治疗和QoL变化的纵向信息。纳入标准为根据临床病史和计算机断层扫描诊断为支气管扩张,以及符合美国胸科学会/美国传染病学会指南定义的肺部NTM感染。该研究方案已获得牵头单位卡尔加里大学的伦理批准,未来还需各参与中心的当地伦理委员会进一步批准。

讨论

登记处的结果将有助于揭示支气管扩张的临床特征和自然病史。这项纵向研究将用于分析,以形成循证临床实践,并作为加拿大的一项资源,为未来NTM和支气管扩张的研究提供信息。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/55f0/11587054/ae0bbcab7fbc/00412-2024.01.jpg

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