加拿大支气管扩张和非结核分枝杆菌登记:研究方案。

IF 4.3 3区 医学 Q1 RESPIRATORY SYSTEM
ERJ Open Research Pub Date : 2024-11-25 eCollection Date: 2024-11-01 DOI:10.1183/23120541.00412-2024
Christina S Thornton, Nicole Boechler, Vidhi Desai, Ranjani Somayaji, Swathi Purighalla, Sarah Brode, Theodore K Marras, Ryan Cooper, Maeve Smith, Julie Jarand
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引用次数: 0

摘要

背景:支气管扩张症是一种复杂的慢性疾病,具有地域和种族多样性。欧洲和美国开展了最大规模的队列研究,而加拿大也面临着相当大的挑战。加拿大支气管扩张症和非结核分枝杆菌(NTM)综合登记处旨在:1)概述加拿大支气管扩张症的临床特征和自然病史;2)确定导致加拿大人疾病进展的风险因素;3)整合综合临床信息以更好地了解支气管扩张症的表型;4)支持在加拿大开展大规模随机对照试验:加拿大支气管扩张症和非淋菌性支气管炎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。该研究旨在招募至少 2000 名参与者,收集病史、病因评估、肺功能测试、微生物学特征、放射学评估、合并症和生活质量(QoL)指标等数据。参与者将接受年度随访,以收集有关结果、治疗和 QoL 变化的纵向信息。纳入标准是通过临床病史和计算机断层扫描确诊支气管扩张症,以及/或美国胸科学会/美国传染病学会指南定义的肺非淋菌性鼻炎感染。研究方案已获得牵头机构卡尔加里大学的伦理批准,未来还将获得所有参与中心当地伦理委员会的批准:讨论:登记的结果将有助于揭示支气管扩张症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,为今后的非淋菌性肺病和支气管扩张症研究提供信息。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The Canadian Bronchiectasis and Nontuberculous Mycobacteria Registry: a study protocol.

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.

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来源期刊
ERJ Open Research
ERJ Open Research Medicine-Pulmonary and Respiratory Medicine
CiteScore
6.20
自引率
4.30%
发文量
273
审稿时长
8 weeks
期刊介绍: ERJ Open Research is a fully open access original research journal, published online by the European Respiratory Society. The journal aims to publish high-quality work in all fields of respiratory science and medicine, covering basic science, clinical translational science and clinical medicine. The journal was created to help fulfil the ERS objective to disseminate scientific and educational material to its members and to the medical community, but also to provide researchers with an affordable open access specialty journal in which to publish their work.
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