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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
- Source :
- BMC Pulmonary Medicine, Vol 20, Iss 1, Pp 1-8 (2020), BMC Pulmonary Medicine
- Publication Year :
- 2020
- Publisher :
- BMC, 2020.
-
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.
- Subjects :
- Pulmonary and Respiratory Medicine
medicine.medical_specialty
China
Exacerbation
Population
Medication Adherence
03 medical and health sciences
Study Protocol
Pulmonary Disease, Chronic Obstructive
0302 clinical medicine
Risk Factors
medicine
Humans
Multicenter Studies as Topic
030212 general & internal medicine
Prospective Studies
GOLD
Prospective cohort study
education
lcsh:RC705-779
COPD
education.field_of_study
business.industry
Chronic obstructive pulmonary disease
Disease Management
lcsh:Diseases of the respiratory system
Observational trial
medicine.disease
Obstructive lung disease
Patient recruitment
Hospitalization
Observational Studies as Topic
030228 respiratory system
Telephone interview
Real-world
Research Design
Emergency medicine
Disease Progression
Observational study
business
Prospective trial
Subjects
Details
- Language :
- English
- ISSN :
- 14712466
- Volume :
- 20
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- BMC Pulmonary Medicine
- Accession number :
- edsair.doi.dedup.....5e779ec600721774e159fe77cf69fe0b