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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.
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| Measure | Description | Time Frame |
|---|---|---|
| All-cause in-hospital mortality | All-cause mortality during hospitalization | 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 | 30 days after day of discharge |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | All-cause mortality during follow-ups | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients hospitalized with acute exacerbation of chronic obstructive pulmonary disease will be consecutively recruited from target hospitals.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting Yang, Doctor | Contact | 13651380809 | dryangting@qq.com | |
| Chen Wang, Doctor | Contact | cyh-birm@263.net |
| Name | Affiliation | Role |
|---|---|---|
| Chen Wang, Doctor | Institue of Basic Medical Sciences Chinese Academy of Medical Sciences | Study Chair |
| Ting Yang, Doctor | China-Japan Friendship Hospital | Principal Investigator |
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De-identified individual participant data that underlie the results (text, tables, figures, and appendices) reported in the publication of summary data, study protocol, statistical analysis plan (SAP), analytic code will be shared from 1 to 3 years following the completion of data cleaning. All above could be shared with researches who provide a methodologically sound and feasible proposal approved by principal investigator (email address: cyh-birm@263.net, dryangting@qq.com) and a signed data access agreement.
From 1 to 3 years following the completion of data cleaning.
Researches should send a proposal to cyh-birm@263.net or dryangting@qq.com. If the proposal is methodologically sound, feasible and approved by the principal investigator, data requestor could gain access after signing a data access agreement.
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) within 1 year after discharge
| 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 | 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 | 30 days, 1 year after day of discharge |
| Predicted post-bronchodilator forced expiratory volume in one second (%) | Predicted post-bronchodilator forced expiratory volume in one second (%) during follow-ups | 30 days, 1 year after day of discharge |
| Post-bronchodilator forced vital capacity (L) | Post-bronchodilator forced vital capacity (L) during follow-ups | 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 | 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. | 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. | 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. | At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |