严重慢性阻塞性肺病的自然史:SPOCCAT 研究方案

Jessica González , Dan Sánchez , Daniel Ross-Monserrate , Elena Miguel , Marc Miravitlles , Roser Costa , on behalf of the SPOCCAT study
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引用次数: 0

摘要

导言严重慢性阻塞性肺疾病(COPD)患者在队列中的比例往往偏低,导致该亚群的自然病史和预后因素存在不确定性。我们的目标是描述 SPOCCAT(严重慢性阻塞性肺病:加泰罗尼亚慢性阻塞性肺病前瞻性观察研究)研究方案。材料和方法SPOCCAT 是一项针对严重慢性阻塞性肺病患者(FEV1 预测值为 50%)的非干预性、多中心、前瞻性队列研究。该研究旨在:(1) 建立一个为期五年的前瞻性队列;(2) 识别人口统计学和临床特征;(3) 描述治疗模式;(4) 更好地了解重度慢性阻塞性肺病的自然病史,包括肺功能下降、恶化率和死亡率;(5) 识别不良结局的预后因素。基线数据包括人口统计学、实验室分析、合并症、肺功能、呼吸道症状、呼吸道疾病恶化和病因、生活质量、体力活动、胸部计算机断层扫描和治疗。每年的随访将评估治疗的变化、病情恶化的频率和严重程度、微生物学结果、辅助检查和死亡率。结果SPOCCAT的研究结果将提供有关严重慢性阻塞性肺疾病的特征、治疗和预后因素的相关信息。结论SPOCCAT有可能加深对严重慢性阻塞性肺疾病的了解,探索创新方面,并为未来的慢性阻塞性肺疾病相关项目建立一个强大的研究框架。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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The Natural History of Severe Chronic Obstructive Pulmonary Disease: The SPOCCAT Study Protocol

Introduction

Patients with severe chronic obstructive pulmonary disease (COPD) are often underrepresented in cohorts, creating uncertainty about the natural history and prognostic factors of this subgroup. Our goal was to describe the SPOCCAT (Severe COPD: Prospective Observational study of COPD in Catalonia) study protocol.

Material and methods

SPOCCAT is a non-interventional, multicenter, prospective cohort study of patients with severe COPD (FEV1% predicted < 50%). The study aims to: (1) establish a five-year prospective cohort; (2) identify demographic and clinical characteristics; (3) describe treatment patterns; (4) better understand the natural history of severe COPD, including lung function decline, exacerbation rates, and mortality; and (5) identify prognostic factors for poor outcomes.

Recruitment began in January 2024, and the cohort will be followed for a minimum of five years (or until death or lung transplant) with follow-up visits every 12 months. Baseline data include demographics, laboratory analyses, comorbidities, lung function, respiratory symptoms, respiratory disease exacerbations and etiology, quality of life, physical activity, chest computed tomography, and treatment. Annual follow-up visits will assess changes in treatment, exacerbation frequency and severity, microbiological outcomes, complementary tests, and mortality. Participation requires written informed consent from all patients, with data collected in an anonymized electronic Case Report Form.

Results

The results of the SPOCCAT study will provide relevant information about the characteristics, treatment, and prognostic factors of severe COPD.

Conclusions

SPOCCAT has the potential to enhance understanding of severe COPD, exploring innovative aspects and establishing a robust research framework for future COPD-related projects.

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来源期刊
Open Respiratory Archives
Open Respiratory Archives Medicine-Pulmonary and Respiratory Medicine
CiteScore
1.10
自引率
0.00%
发文量
58
审稿时长
51 days
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