González Jessica, Sánchez Dan, Ross-Monserrate Daniel, Miguel Elena, Miravitlles Marc, Costa Roser
Translational Research in Respiratory Medicine, University Hospital Arnau de Vilanova and Santa Maria, IRBLleida, Lleida, Spain.
CIBER of Respiratory Diseases (CIBERES), Institute of Health Carlos III, Madrid, Spain.
Open Respir Arch. 2024 Apr 4;6(2):100321. doi: 10.1016/j.opresp.2024.100321. eCollection 2024 Apr-Jun.
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.
SPOCCAT is a non-interventional, multicenter, prospective cohort study of patients with severe COPD (FEV% 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.
The results of the SPOCCAT study will provide relevant information about the characteristics, treatment, and prognostic factors of severe COPD.
SPOCCAT has the potential to enhance understanding of severe COPD, exploring innovative aspects and establishing a robust research framework for future COPD-related projects.
重度慢性阻塞性肺疾病（COPD）患者在队列研究中往往代表性不足，这使得该亚组疾病的自然史和预后因素存在不确定性。我们的目标是描述SPOCCAT（重度慢性阻塞性肺疾病：加泰罗尼亚慢性阻塞性肺疾病前瞻性观察研究）研究方案。
SPOCCAT是一项针对重度慢性阻塞性肺疾病患者（预测FEV%<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）确定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疾病的自然史，包括肺功能下降、急性加重率和死亡率；（5）确定不良预后的预测因素。招募工作于2024年1月开始，该队列将至少随访五年（或直至死亡或进行肺移植），每12个月进行一次随访。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、呼吸道疾病急性加重及其病因、生活质量、体力活动、胸部计算机断层扫描和治疗情况。年度随访将评估治疗变化、急性加重频率和严重程度、微生物学结果、补充检查和死亡率。参与研究需要所有患者签署书面知情同意书，数据通过匿名电子病例报告表收集。
SPOCCAT研究结果将提供有关重度慢性阻塞性肺疾病的特征、治疗和预后因素的相关信息。
SPOCCAT有潜力增强对重度慢性阻塞性肺疾病的理解，探索创新方面，并为未来与慢性阻塞性肺疾病相关的项目建立一个强大的研究框架。
