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首页> 外文期刊>BMC Pulmonary Medicine >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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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

机译:中国稳定COPD管理的实现:一种多中心,前瞻性,观测研究,实现中国COPD患者现状(真实) - 理由,研究设计和协议

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摘要

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. 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. 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. ClinicalTrials.gov identifier: NCT03131362. Registered on 20 March 2017.
机译:慢性阻塞性肺病(COPD)是中国死亡的第五个主要原因,报告患病率为8.2%≥40岁。建议中国医生遵循全球慢性阻塞性肺病(金)和国家指南的倡议,但许多中国COPD患者仍未核糖。此外,错过了诊断和缺乏标准化的诊断和治疗仍然存在重大问题。缺乏对现实世界成果的大规模,长期前瞻性研究的情况进一步复杂化,包括加剧率,疾病严重程度,治疗疗效,以及中国的COPD患者的依从性。中国稳定COPD的实现和改善管理(Real)研究是一个52周的多中心,前瞻性,观察试验。真正的目标是招募大约5000岁的≥40岁的门诊患者,每年临床诊断2016年的COPD诊断。门诊意家将从大约50家随机选择的六个地理区域随机选择,以提供代表性人口。患者将通过治疗医生确定的常规医疗保健。主要目的是评估在当前临床实践的1年后肺功能,健康状况,恶化,住院治疗率和呼吸困难等COPD患者结果。次要目标是评估疾病严重程度,治疗模式,依赖于药物,以及相关的危险因素。数据将在两项研究访问中收集,患者通常的护理访问,并通过电话采访每3个月。中国医师在中国的科技知识差。实际研究将提供有关COPD管理,结果和风险因素的可靠信息,可能有助于提高中国的护理标准。患者招聘始于2017年6月30日,估计的主要完成日期为2019年7月30日。ClinicalTrials.gov标识符:NCT03131362。 2017年3月20日注册。

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