Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
Association of COPD Maintenance Medication Adherence With Resource Use and Cost Among COPD Patients-Retrospective Observational Cohort Study
The aim of this study is to examine the association of COPD maintenance inhalation medication (Inhaled Corticosteroid or ICS) adherence with COPD exacerbation healthcare resource utilization among COPD patients with exacerbation history.
Objectives: The primary objective of this study is to examine the association of COPD
maintenance inhalation medication (Inhaled Corticosteroid or ICS) adherence with COPD
exacerbation healthcare resource utilization among COPD patients with exacerbation history.
Study design: This study is a retrospective database analysis using 2014-2016 Guangzhou City
health insurance database.
Data Source(s): Guangzhou city health insurance database will be used for this study. All
outpatient and inpatient visits for one patient during 2014-2016 were available.
Study Population: This study will include patients with a physician COPD diagnosis in
Guangzhou city health insurance database during 2015 and with complete treatment data during
1 year before and 1 year after the index date. The rough sample size of the study population
was 49,000.
Outcome(s):
1. Indicators of COPD control: exacerbations;
2. Health resource utilization: annual number of inpatient days, inpatient visit number,
emergency department (ED) visit number;
3. Costs: COPD exacerbation hospitalization expenditures, all-cause hospitalization
expenditure.
Statistical Analysis:
Descriptive statistics will be used for all variables, as appropriate. Continuous variables
will be summarized by the number of observations, mean, standard deviation, median, minimum,
maximum, first quartile and third quartile. Categorical variables will be summarized by
frequency counts and percentages at each category. Number of patients and number of missing
for each variable will be summarized.
Logistic regression will be used to estimate the risk of any hospitalization. Generalized
Linear Models (GLMs) with a gamma distribution and log link will be used to approximate the
highly right-skewed distribution of medical expenditure.
For exploratory objectives, Propensity Score Matching (PSM) will be used to explore the
association of medication class and health resource utilization if applicable. The
interaction of medication class * adherence or subgroup analysis (by medication class) will
be considered when conducting the regression model.
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