Skip to main content

Table 6 Variables, measures, and methods of analysis

From: Efficacy and safety of Jia Wei Bushen Yiqi formulas as an adjunct therapy to systemic glucocorticoids on acute exacerbation of COPD: study protocol for a randomized, double-blinded, multi-center, placebo-controlled clinical trial

Outcomes

Hypothesis

Outcome measurement

Analysis method

Primary

TCM improved outcomes from baseline to 10 days

  

 Interval time to next exacerbation

 

Telephone visit (continuous)

GLM

 CAT

 

Questionnaire score (continuous)

MENM

Secondary

Improved occurred

  

 Duration of COPD exacerbation

 

Calculating days in dairy (continuous)

GLM

 TCM syndrome assessment

 

Questionnaire score (continuous)

GLM

 Lung function

 

FEV1, FVC, PEF (continuous)

GLM

 Blood gas analysis

 

Pa (CO2), Pa(O2) (continuous)

GLM

 Infection index

 

EOS count, CRP, proclamation (continuous)

GLM

 Inflammation cytokine

 

IL-6, IL-8, IL-10(continuous)

GLM

 HPA axis

 

ACTH, CRH, CORT (continuous)

GLM

Subgroup analysis

Effects adherence

Groups

 

 Age (in years)

 

< 64, ≥ 64

 

 Gender

 

Male, female

 

 Body mass index (kg/m2)

 

< 18.5, ≥ 18.5 to < 24, ≥ 24

 

 Smoking history

 

Ex-smoker, current smoker

 

 GOLD stage

 

I-II, III, IV

 

 Infectious

 

Infectious, un-infectious

 

 EOS count

 

< 300/μl, ≥ 300/μl

Â