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Table 1 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure for the REAL study

From: 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

Month

Enrollment

Data collection

0

3 ± 1

6 ± 1

9 ± 1

/

12 ± 1

Visit

V0

TC1

TC2

TC3

UC

V1

Informed consent

X

     

Inclusion/exclusion criteria

X

     

Demography (date of birth, ethnicity, gender, education, marital status, socioeconomic status, insurance status, residence area, occupation)

X

     

Physical examination

X

    

X

Smoking history

X

     

COPD history

X

     

Disease severity GOLD 2016

X

    

X

Comorbidities, other respiratory diseases

X

X

X

X

X

X

Exacerbations

X

X

X

X

X

X

Symptoms

X

X

X

X

X

X

Spirometry and bronchial dilation if available

X

   

X

X

CAT, mMRC

X

X

X

X

 

X

COPD-Q

X

    

X

FENO if available

X

   

X

X

Chest CT imaging if available

X

   

X

X

Induced sputum test if available

X

   

X

X

Lab tests (blood gases, C-reactive protein and hematology) if available

X

   

X

X

COPD medications

X

X

X

X

X

X

COPD non-pharmacological treatment

X

X

X

X

X

X

Total COPD treatment expenses

X

X

X

X

X

X