Understanding high-risk COPD: Analysis of real-world data to investigate characteristics and outcomes in patients with high-risk COPD. (OPRI 2306: High Risk COPD)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

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:
  At the time of writing OPCRD had circa 500,000 patients with a diagnosis of COPD
• Age groups:
  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  500000

Study design details

• Main study objective:
  This project will investigate the patient characteristics, treatments and comorbidities that are associated with patients with a high risk of COPD and worsening symptoms.
• Outcomes:
  Change of COPD exacerbations and symptoms
• Data analysis plan:
  Optimum Patient Care Research Database (OPCRD) and Optimum Patient Care Research Database Australia (OPCRDA) comprise of data extracted through the Optimum Patient Care (OPC) Clinical Service Evaluation, and patients data registered within our PREVAIL clinical trial. Patients with a EMR diagnosis of COPD and over 40years of age. Patient’s characteristics will be measured from the initial COPD diagnosis (ID) and over time and will include patient characteristics, clinical measures, prescribing and comorbidities. Data will be right censored at the end of data availability. Statistical analysis of the baseline variables by initial and future COPD clinical measure including exacerbations will be undertaken. Absolute and relative number of patients by COPD outcomes including frequency and severity of exacerbations and change in COPD clinical outcomes such as spirometry and self-reported outcomes measures (COPD CAT scores) will be reported.