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

Ting Yang, Baiqiang Cai, Bin Cao, Jian Kang, Fuqiang Wen, Wanzhen Yao, Jinping Zheng, Xia Ling, Hongyan Shang, Chen Wang, Ting Yang, Baiqiang Cai, Bin Cao, Jian Kang, Fuqiang Wen, Wanzhen Yao, Jinping Zheng, Xia Ling, Hongyan Shang, Chen Wang

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.

Keywords: China; Chronic obstructive pulmonary disease; GOLD; Observational trial; Prospective trial; Real-world.

Conflict of interest statement

TY, BCai, BCao, JK, FW, WY, JZ, and CW declare that they have no competing interests.

HS is an employee of AstraZeneca China. XL is a previous employee of AstraZeneca China.

AstraZeneca China will be involved in interpretation of the results.

Figures

Fig. 1
Fig. 1
Multi-stage, stratified, cluster sampling method. * All secondary and tertiary hospitals administered by NHFPC. † Excluding traditional Chinese medicine hospitals; the actual hospital number and the ratio of tertiary to secondary hospitals in each region may be adjusted based on the hospital distribution in the region; subject numbers may be adjusted according to COPD outpatient numbers at the site
Fig. 2
Fig. 2
Study flow chart

References

    1. GOLD . Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease report. 2017.
    1. 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;388:1459–1544. doi: 10.1016/S0140-6736(16)31012-1.
    1. Fang X, Wang X, Bai C. COPD in China: the burden and importance of proper management. Chest. 2011;139:920–929. doi: 10.1378/chest.10-1393.
    1. 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;176:753–760. doi: 10.1164/rccm.200612-1749OC.
    1. 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;36:255–264.
    1. GOLD . Global Strategy For The Diagnosis, Management, And Prevention Of Chronic Obstructive Pulmonary Disease Report. 2011.
    1. Fang X, Li S, Gao L, Zhao N, Wang X, Bai C. A short-term educational program improved physicians’ adherence to guidelines for COPD and asthma in Shanghai. Clin Transl Med. 2012;1:13. doi: 10.1186/2001-1326-1-13.
    1. Zhou XM, Wu C, Zhao L, Gao YZ, Yuan Y, Xiao XX, et al. A cross-sectional survey of the knowledge on chronic obstructive pulmonary disease in physicians of tertiary hospitals in northern China. Zhonghua Nei Ke Za Zhi. 2016;55:717–720.
    1. Liu S, Zhou Y, Wang X, Wang D, Lu J, Zheng J, et al. Biomass fuels are the probable risk factor for chronic obstructive pulmonary disease in rural South China. Thorax. 2007;62:889–897. doi: 10.1136/thx.2006.061457.
    1. Han R, Zou J, Shen X, Wu C, Guo Y, Feng Z, et al. The risk factors of chronic obstructive pulmonary disease in Heilongjiang province. Zhonghua Jie He He Hu Xi Za Zhi. 2015;38:93–98.
    1. Cho S, Lin H, Ghoshal AG, Bin AM, Thanaviratananich S, Bagga S, et al. Respiratory disease in the Asia-Pacific region: cough as a key symptom. Allergy Asthma Proc. 2016;37:131–140. doi: 10.2500/aap.2016.37.3925.
    1. Lin H, Cho S, Ghoshal AG, Muttalif ARBA, Thanaviratananich S, Bagga S, et al. Respiratory diseases and the impact of cough in Taiwan: results from the APBORD observational study. Medicine. 2016;95:e3854. doi: 10.1097/MD.0000000000003854.
    1. Xiao T, Chen XY, Wang N, Zhao Q, Fu CW, Xu B. Study on the situation of drug use in patients with chronic obstructive pulmonary diseases in the Chinese communities of large cities. Zhonghua Liu Xing Bing Xue Za Zhi. 2017;38:142–146.
    1. Jones PW, Harding G, Berry P, Wiklund I, Chen W, Kline Leidy N. Development and first validation of the COPD assessment test. Eur Respir J. 2009;34:648–654. doi: 10.1183/09031936.00102509.
    1. Fletcher CM. Standardised questionnaire on respiratory symptoms: a statement prepared and approved by the MRC Committee on the Aetiology of chronic bronchitis (MRC breathlessness score) Br Med J. 1960;2:1662.
    1. Maples P, Franks A, Ray S, Stevens AB, Wallace LS. Development and validation of a low-literacy chronic obstructive pulmonary disease knowledge questionnaire (COPD-Q) Patient Educ Couns. 2010;81:19–22. doi: 10.1016/j.pec.2009.11.020.
    1. GOLD . Global Strategy for Diagnosis, Management, and Prevention of COPD - 2016. 2016.
    1. Chan A, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Anthonisen NR, Manfreda J, Warren CP, Hershfield ES, Harding GK, Nelson NA. Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Ann Intern Med. 1987;106:196–204. doi: 10.7326/0003-4819-106-2-196.
    1. He Q, Zhou X, Xie CM, et al. The importance of health education and management on the diagnosis and treatment for COPD. Chin J Prev Contr Chron Dis. 2009;17:441–443.
    1. Chen Y, Yao W, Kang J, Cai B, Zhou X, Liu Z, et al. Attitudes and actions of chronic obstructive pulmonary disease patients on treatment: a national multi-center investigative study. Zhonghua Jie He He Hu Xi Za Zhi. 2010;33:750–753.
    1. Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006;3:e442. doi: 10.1371/journal.pmed.0030442.
    1. Yin P, Jiang CQ, Cheng KK, Lam TH, Lam KH, Miller MR, et al. Passive smoking exposure and risk of COPD among adults in China: the Guangzhou biobank cohort study. Lancet. 2007;370:751–757. doi: 10.1016/S0140-6736(07)61378-6.
    1. Shen N, He B. Is the new GOLD classification applicable in China? Lancet Glob Health. 2013;1:e247–e248. doi: 10.1016/S2214-109X(13)70064-0.
    1. He W, Zhao Q, Ye R, Wei J. A preliminary investigation of pulmonary function in the diagnosis of chronic obstructive pulmonary disease in some provinces and cities in China. Zhonghua Jie He He Hu Xi Za Zhi. 2003;26:39–40.
    1. Shen N, Yao W, Zhu H. Patient’ s perspective of chronic obstructive pulmonary disease in Yanqing county of Beijing. Zhonghua Jie He He Hu Xi Za Zhi. 2008;31:206–208.
    1. Chan HP, Mukhopadhyay A, Chong PLP, Chin S, Wong XY, Ong V, et al. Prognostic utility of the 2011 GOLD classification and other multidimensional tools in Asian COPD patients: a prospective cohort study. Int J Chron Obstruct Pulmon Dis. 2016;11:823–829. doi: 10.2147/COPD.S96790.
    1. Jones PW. Health status measurement in chronic obstructive pulmonary disease. Thorax. 2001;56:880–887. doi: 10.1136/thorax.56.11.880.
    1. Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999;54:581–586. doi: 10.1136/thx.54.7.581.
    1. Karloh M, Fleig Mayer A, Maurici R, Pizzichini MMM, Jones PW, Pizzichini E. The COPD assessment test: what do we know so far?: a systematic review and meta-analysis about clinical outcomes prediction and classification of patients into GOLD stages. Chest. 2016;149:413–425. doi: 10.1378/chest.15-1752.
    1. Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's respiratory questionnaire. Am Rev Respir Dis. 1992;145:1321–1327. doi: 10.1164/ajrccm/145.6.1321.
    1. Agustí A, Soler JJ, Molina J, Muñoz MJ, García-Losa M, Roset M, et al. Is the CAT questionnaire sensitive to changes in health status in patients with severe COPD exacerbations? COPD. 2012;9:492–498. doi: 10.3109/15412555.2012.692409.
    1. Zhou Q, Mei J, He B, Huang S, Shi Y, Wen F, et al. Chronic obstructive pulmonary disease assessment test score correlated with dyspnea score in a large sample of Chinese patients. Chin Med J. 2013;126:11–15.
    1. Ray SM, Helmer RS, Stevens AB, Franks AS, Wallace LS. Clinical utility of the chronic obstructive pulmonary disease knowledge questionnaire. Fam Med. 2013;45:197–200.
    1. Puente-Maestu L, Chancafe-Morgan J, Calle M, Rodríguez-Hermosa JL, Malo DM, Ortega-González Á, et al. Validation of the Spanish version of the COPD-Q questionnaire on COPD knowledge. Arch Bronconeumol. 2016;52:12–16. doi: 10.1016/j.arbres.2015.03.013.
    1. Ye Y, Zhu B, Jiang L, Jiang Q, Wang M, Hua L, et al. A contemporary assessment of acute mechanical ventilation in Beijing: description, costs, and outcomes. Crit Care Med. 2017;45:1160–1167. doi: 10.1097/CCM.0000000000002360.
    1. Qiu YP, Zhao K, Li X, Shi LW, Guo WD, Qi XR, et al. Health economic evaluation of a 23 value pneumococcal polysaccharide vaccination pilot programme among elderly chronic obstructive pulmonary disease patients in China. Zhonghua Yu Fang Yi Xue Za Zhi. 2016;50:1074–1078.
    1. Song C, He J, Wu L, Jin T, Chen X, Li R, et al. Health burden attributable to ambient PM2.5 in China. Environ Pollut. 2017;223:575–586. doi: 10.1016/j.envpol.2017.01.060.
    1. Maji KJ, Arora M, Dikshit AK. Burden of disease attributed to ambient PM2.5 and PM10 exposure in 190 cities in China. Environ Sci Pollut Res Int. 2017;24:11559–11572. doi: 10.1007/s11356-017-8575-7.
    1. Wu M, Zhao Q, Chen Y, Fu C, Xu B. Quality of life and its association with direct medical costs for COPD in urban China. Health Qual Life Outcomes. 2015;13:57. doi: 10.1186/s12955-015-0241-5.
    1. Chen X, Wang N, Chen Y, Xiao T, Fu C, Xu B. Costs of chronic obstructive pulmonary disease in urban areas of China: a cross-sectional study in four cities. Int J Chron Obstruct Pulmon Dis. 2016;11:2625–2632. doi: 10.2147/COPD.S118523.
    1. Ding B, Small M, Bergström G, Holmgren U. COPD symptom burden: impact on health care resource utilization, and work and activity impairment. Int J Chron Obstruct Pulmon Dis. 2017;12:677–689. doi: 10.2147/COPD.S123896.
    1. Cao G, Li J, Li L, Li H, Wang F, Wang H, et al. Use of nonprescription medicines by patients with COPD: a survey in Chongqing municipality, China. Chron Respir Dis. 2012;9:77–81. doi: 10.1177/1479972312437852.
    1. Wilkinson TMA, Donaldson GC, Hurst JR, Seemungal TAR, Wedzicha JA. Early therapy improves outcomes of exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2004;169:1298–1303. doi: 10.1164/rccm.200310-1443OC.

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner