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REALizing and improving management of stable COPD in China: a multi-center, prospective, observational study to realize the current situation of COPD patients in China (REAL) - rationale, study design, and protocol

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单位: [1]Department of Pulmonary and Critical Care Medicine, National ClinicalResearch Center for Respiratory Diseases, Institute of RespiratoryMedicine, Chinese Academy of Medical Science, China-JapanFriendship Hospital, No 2, East Yinghua Road, Chaoyang District,Beijing 100029, China [2]Department of Respiratory Medicine, PekingUnion Medical College Hospital, Beijing, China [3]Department ofRespiratory Medicine, The First Hospital of China Medical University,Shenyang, China [4]Department of Respiratory Medicine, West ChinaHospital, Sichuan University, Chengdu, China [5]Department ofRespiratory Medicine, Peking University Third Hospital, Beijing, China [6]Department of Respiratory Medicine, Guangzhou Institute ofRespiratory Disease, 1st Affiliated Hospital of Guangzhou MedicalCollege, Guangzhou, China [7]Department of Medical Affairs,AstraZeneca China, Shanghai, China
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关键词: China Chronic obstructive pulmonary disease GOLD Observational trial Prospective trial Real-world

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Background Chronic obstructive pulmonary disease (COPD) is the fifth leading cause of death in China with a reported prevalence of 8.2% people aged >= 40 years. It is recommended that Chinese physicians follow Global Initiative for Chronic Obstructive Lung Disease (GOLD) and national guidelines, yet many patients with COPD in China remain undiagnosed. Furthermore, missed diagnoses and a lack of standardized diagnosis and treatment remain significant problems. The situation is further complicated by a lack of large-scale, long-term, prospective studies of real-world outcomes, including exacerbation rates, disease severity, efficacy of treatment, and compliance of COPD patients in China. Methods/design The REALizing and improving management of stable COPD in China (REAL) study is a 52-week multi-center, prospective, observational trial. REAL aims to recruit approximately 5000 outpatients aged >= 40 years with a clinical diagnosis of COPD per GOLD 2016. Outpatients will be consecutively recruited from approximately 50 tertiary and secondary hospitals randomly selected across six geographic regions to provide a representative population. Patients will receive conventional medical care as determined by their treating physicians. The primary objective is to evaluate COPD patient outcomes including lung function, health status, exacerbations, hospitalization rate, and dyspnea following 1 year of current clinical practice. Secondary objectives are to assess disease severity, treatment patterns, adherence to medication, and associated risk factors. Data will be collected at two study visits, at patients' usual care visits, and by telephone interview every 3 months. Discussion Knowledge of COPD among physicians in China is poor. The REAL study will provide reliable information on COPD management, outcomes, and risk factors that may help improve the standard of care in China. Patient recruitment began on 30 June 2017 and the estimated primary completion date is 30 July 2019.

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出版当年[2019]版:
大类 | 3 区 医学
小类 | 4 区 呼吸系统
最新[2025]版:
大类 | 3 区 医学
小类 | 3 区 呼吸系统
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Q3 RESPIRATORY SYSTEM
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Q2 RESPIRATORY SYSTEM

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第一作者单位: [1]Department of Pulmonary and Critical Care Medicine, National ClinicalResearch Center for Respiratory Diseases, Institute of RespiratoryMedicine, Chinese Academy of Medical Science, China-JapanFriendship Hospital, No 2, East Yinghua Road, Chaoyang District,Beijing 100029, China
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