Abstract
BackgroundChronic 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/designThe 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.DiscussionKnowledge 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 registrationClinicalTrials.gov identifier: NCT03131362. Registered on 20 March 2017.
Highlights
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
The REAL study will provide reliable information on COPD management, outcomes, and risk factors that may help improve the standard of care in China
In China, many clinicians and patients have a low level of knowledge of the management, prevention, and risk factors for COPD [7, 20, 21]
Summary
In China, many clinicians and patients have a low level of knowledge of the management, prevention, and risk factors for COPD [7, 20, 21]. The REAL study has opted to use the mMRC [15] and the CAT [14] to assess the level of health status impairment. A further analysis of this cohort showed the mean annual direct medical (DMC), direct non-medical (DNMC), and indirect (IC) costs per COPD patient were 11, 968 yuan (US$ 1853), 539 yuan (US$ 83), and 2087 yuan (US$ 323), respectively, with over half (56.7%) of total costs due to hospitalization [41] While these data are somewhat dated, they do offer some degree of insight into the high cost burden of COPD in China and will be interesting to compare with the results from the larger REAL cohort. The first patients were recruited to REAL on June 2017 and the estimated primary completion date is January 2020
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