Study type

Study topic

Disease /health condition

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Chronic obstructive pulmonary disease
Population studied

Short description of the study population

Primary care COPD patients

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Chronic obstructive pulmonary disease (COPD) patients

Estimated number of subjects

5116
Study design details

Main study objective

To evaluate the Dyspnoea, Obstruction, Smoking, Exacerbation (DOSE) and the Age, Dyspnoea, Obstruction (ADO) indices and GOLD categories as measures of current health status and future outcomes in COPD patients.

Outcomes

DOSE and ADO associations with health status measured by the CCQ and SGRQ, Current symptoms, exacerbations and hospital admissions, Future events of exacerbations, admissions and mortality, Distribution of GOLD categories according to different methods of calculation

Data analysis plan

Spearmans rank correlation was used to assess the association between each of the DOSE and ADO indices and the health status measures and markers of healthcare consumption in each of the 3 datasets. Logistic regression analysis was used to calculate the unadjusted odds ratio for 1 or more hospital admissions and for 1 or more exacerbations in the subsequent year for a unit increase in the DOSE or ADO indices. ROC analyses and AUC were produced for DOSE and ADO indices in relation to the prediction of future risk of exacerbations and admissions. Negative binomial regression models and Cox regression were also used.