Author:
Yang Ting,Cai Baiqiang,Cao Bin,Kang Jian,Wen Fuqiang,Yao Wanzhen,Zheng Jinping,Ling Xia,Shang Hongyan,Wang Chen
Abstract
Abstract
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.
Trial registration
ClinicalTrials.gov identifier: NCT03131362. Registered on 20 March 2017.
Publisher
Springer Science and Business Media LLC
Subject
Pulmonary and Respiratory Medicine
Reference44 articles.
1. GOLD. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease report. 2017. http://goldcopd.org/. Accessed 02 Oct 2017.
2. GBD 2015 Mortality and Causes of Death Collaborators. Global, regional, and national life expectancy, all-cause mortality, and cause-specific mortality for 249 causes of death, 1980–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388:1459–544.
3. Fang X, Wang X, Bai C. COPD in China: the burden and importance of proper management. Chest. 2011;139:920–9.
4. Zhong N, Wang C, Yao W, Chen P, Kang J, Huang S, et al. Prevalence of chronic obstructive pulmonary disease in China: a large, population-based survey. Am J Respir Crit Care Med. 2007;176:753–60.
5. Chinese Society of Respiratory Disease. The guideline for the diagnosis and treatment of chronic obstructive pulmonary disease (2013 revision). Zhonghua Jie He He Hu Xi Za Zhi. 2013;36:255–64.
Cited by
9 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献