The aim of this study is to provide high quality data and give a comprehensive overview of characteristics, clinical features, management and prognosis during exacerbations and stable periods among inpatients with acute exacerbation of chronic obstructive pulmonary disease in real-world China.
Objective: The aim of this study is to provide high quality data and give a comprehensive overview of characteristics, clinical features, management and prognosis during exacerbations and stable periods among inpatients with acute exacerbation of chronic obstructive pulmonary disease in real-world China. Eligibility Criteria: Details are shown in the Eligibility Criteria part. Procedures and Measurements: At admission, each eligible subject will be given an in-depth interview to collect the demographics, smoking history, medical history, management of disease during stable period, etc. During hospitalization, treatment and auxiliary examination results including laboratory and lung function tests will be recorded if available. To ensure the quality and uniformity of spirometry data, training on performing spirometry will be provided to each study site by professional doctors from central site. At discharge, physicians will record the discharge diagnoses and clinical outcomes including death, intensive care unit admission, chronic obstructive pulmonary disease assessment test (CAT) score and total direct cost for each participant. During follow-ups, clinical outcomes including death and exacerbation events, change of medication, new-developed complications, auxiliary examination results, and economic burden will be collected.
Study Type
OBSERVATIONAL
Enrollment
1,500
All-cause in-hospital mortality
All-cause mortality during hospitalization
Time frame: From date of admission to date of discharge, an expected median of 10 days
Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease within 30 days after discharge
Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) within 30 days after discharge
Time frame: 30 days after day of discharge
All-cause mortality
All-cause mortality during follow-ups
Time frame: 30 days and 1 year after day of discharge
Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease within 1 year after discharge
Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) within 1 year after discharge
Time frame: 1 year after day of discharge
Time to the first readmission due to acute exacerbation of chronic obstructive pulmonary disease
Time to the first readmission due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) during follow-ups
Time frame: 30 days, 1 year after day of discharge
Post-bronchodilator forced expiratory volume in one second (L)
Post-bronchodilator forced expiratory volume in one second (L) during follow-ups
Time frame: 30 days, 1 year after day of discharge
Predicted post-bronchodilator forced expiratory volume in one second (%)
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Predicted post-bronchodilator forced expiratory volume in one second (%) during follow-ups
Time frame: 30 days, 1 year after day of discharge
Post-bronchodilator forced vital capacity (L)
Post-bronchodilator forced vital capacity (L) during follow-ups
Time frame: 30 days, 1 year after day of discharge
Post-bronchodilator forced expiratory volume in one second to forced vital capacity
Post-bronchodilator forced expiratory volume in one second to forced vital capacity during follow-ups
Time frame: 30 days, 1 year after day of discharge
Chronic obstructive pulmonary disease assessment test (CAT) score
Chronic obstructive pulmonary disease assessment test (CAT) score at day of discharge and during follow-ups. CAT is an 8-item questionnaire used to measure the impact of respiratory disease on patients' health status. The score of CAT ranges from 0 to 40, with 0 indicating the best health status while 40 as the worst.
Time frame: At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge
Modified medical research council (mMRC) dyspnea scale
Modified medical research council (mMRC) dyspnea scale at day of discharge and during follow-ups. mMRC includes 5 grades (0, 1, 2, 3 and 4), where higher grade reflects worse health-related quality of life and higher symptom burden.
Time frame: At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge
Direct total cost of chronic obstructive pulmonary disease management
Direct total cost of chronic obstructive pulmonary disease management during hospitalization and follow-ups.
Time frame: At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge