Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío, Sevilla, España.
Arch Bronconeumol. 2012 Dec;48(12):453-9. doi: 10.1016/j.arbres.2012.05.006. Epub 2012 Jul 4.
This present paper describes the method and the organization of the study known as the COPD History Assessment In SpaiN (CHAIN), whose main objective is to evaluate the long-term natural history of a chronic obstructive pulmonary disease (COPD) patient cohort from a multidimensional standpoint and to identify clinical phenotypes, in comparison with another non-COPD control cohort.
CHAIN is a multicenter, observational study of prospective cohorts carried out at 36 Spanish hospitals. Both cohorts will be followed-up during a 5-year study period with complete office visits every 12 months and telephone interviews every 6 months in order to evaluate exacerbations and the vital state of the subjects. The recruitment period for cases was between 15 January 2010 and 31 March 2012. At each annual visit, information will be collected on: (i) clinical aspects (socio-economic situation, anthropometric data, comorbidities, smoking, respiratory symptoms, exacerbations, quality of life, anxiety-depression scale, daily life activities, treatments); (ii) respiratory function (spirometry, blood gases, hyperinflation, diffusion, respiratory pressures); (iii) BODE index (main study variable); (iv) peripheral muscle function, and (v) blood work-up (including IgE and cardiovascular risk factors). In addition, a serum bank will be created for the future determination of biomarkers. The data of the patients are anonymized in a database with a hierarchical access control in order to guarantee secure information access. The CHAIN study will provide information about the progression of COPD and it will establish a network of researchers for future projects related with COPD.
本研究描述了 COPD 西班牙研究（CHAIN）的方法和组织，其主要目的是从多维角度评估慢性阻塞性肺疾病（COPD）患者队列的长期自然史，并与另一个非 COPD 对照组进行比较，确定临床表型。
CHAIN 是一项在 36 家西班牙医院进行的多中心、前瞻性队列观察研究。两个队列将在为期 5 年的研究期间进行随访，每 12 个月进行一次完整的门诊随访，每 6 个月进行一次电话随访，以评估加重情况和受试者的生命状态。病例的招募期为 2010 年 1 月 15 日至 2012 年 3 月 31 日。在每年的就诊时，将收集以下信息：（i）临床方面（社会经济状况、人体测量数据、合并症、吸烟、呼吸症状、加重情况、生活质量、焦虑抑郁量表、日常生活活动、治疗）；（ii）呼吸功能（肺量计、血气、过度充气、扩散、呼吸压力）；（iii）BODE 指数（主要研究变量）；（iv）外周肌肉功能；以及（v）血液检查（包括 IgE 和心血管危险因素）。此外，还将建立一个血清库，用于未来确定生物标志物。患者的数据在一个具有分层访问控制的数据库中进行匿名化，以确保安全的信息访问。CHAIN 研究将提供 COPD 进展的信息，并将建立一个与 COPD 相关的未来项目的研究人员网络。
