CARDIO-PULSE: CARDIOvascular disease and Chronic Obstructive PULmonary DiseaSE: a real-world observational study in Australian primary care

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Primary data collection

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:
  The population will comprise adults aged ≥40 years with COPD, defined as a documented diagnosis of COPD and a prescription for COPD medication in the previous 2 years, who are clinically active (prescription and/or consultation data) on the OPCRDA database from 1 January 2021
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  5500

Study design details

• Study design:
  The study will be an observational cohort study using data from Australian primary care electronic medical records from the Optimum Patient Care Research Database Australia (OPCRDA) The OPCRDA is a real-world, longitudinal, research database that is maintained by Optimum Patient Care Australia (OPCA
• Main study objective:
  The overarching aim of this study is to identify priority areas of action in relation to people with comorbid COPD-CVD and people with COPD at risk of developing CVD. This includes exploring the risk of CVD among high-risk COPD patients and how CVD risk assessments can be used to optimise prevention and treatment strategies.
• Setting:
  Study data will be extracted through the OPCRDA, which contains anonymised, research quality data from Australian general practice centers. The population will comprise adults aged ≥40 years with COPD, defined as a documented diagnosis of COPD and a prescription for COPD medication in the previous 2 years, who are clinically active (prescription and/or consultation data) on the OPCRDA database from 1 January 2021.The study will have 2 study aims.; ; For the first study aim, people with COPD will be matched by age/gender/smoking status to a cohort of individuals without COPD. Individuals will be followed up from 1 January 2021 for 3–5 years and incidence of new-onset cardiovascular disease (CVD) events, CVD risk score assessments and absolute risk scores will be compared and the predictors of future CVD events in high-risk COPD will be explored.; ; For the second study aim, the cohort will be restricted to individuals who are at high risk (i.e. have ≥2 exacerbations in the previous 24 months) and have at least one exacerbation within the follow-up period. The first exacerbation will be taken as the index date. People with pre-existing CVD (defined as stroke, myocardial infarction, angina, peripheral arterial disease, atrial fibrillation, and/or heart failure) will be compared to those without CVD in relation to time to COPD maintenance therapy change and incidence of new-onset CVD.
• Outcomes:
  Primary outcomes will be new onset CVD events, CVD risk assessment and COPD medication therapy change
• Data analysis plan:
  We will use Poisson regression (or negative binomial if overdispersion is present) to calculate IRR (95% CI) of new-onset CVD events by COPD status (Objective 1a), also describing the influence of clinical characteristics, previous exacerbations and drug therapy class (Objective 1e).; ; ; We will describe CV risk assessments used and calculate the prevalence rate ratio (Poisson/negative binomial regression) of CVD risk score assessments and absolute risk scores by COPD status (Objectives 1b,1c). The influence of clinical characteristics, previous exacerbations and drug therapy class will also be investigated (Objective 1d).; ; Time from COPD exacerbations to COPD maintenance therapy change (Objectives 2a,2b) by comorbid CVD status will be assessed using time-to-event analyses (Cox regression and Kaplan-Meier plots), also stratified by therapy class at baseline and class regimen. No therapy changes will be treated as censored data at 12 months post-index date. The findings will be presented using graphs and hazard ratios (HR), with 95% confidence intervals (CI).