Twenty years of COPD primary care: Patterns of management of high-risk COPD and opportunities for optimising care in the United Kingdom 2000-2019: Study Protocol (CONQUEST UK Opportunity Analysis)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Observational, longitudinal descriptive study

Study drug and medical condition

• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  The study involved active (alive, have not left practice) patients aged 40 years or older diagnosed with COPD, undiagnosed patients with a smoking history that suggests potential COPD and patients who are at high- risk for future exacerbations identified between 2000 and 2019 from the Optimum Patient Care Research Database (OPCRD). ; Inclusion criteria: ; • Age 40 or older; • High risk criteria for exacerbation: 2 or more moderate or 1 or more severe exacerbation in the baseline period; Alive and no deregistration/leaving database. In addition, patients will be categorized as:; 1. Undiagnosed patients with potential COPD ; • Patients without a COPD diagnosis code ever in their electronic record prior to the index date (1st January) in that year; • And Current or ex-smoker with either 10 years smoking duration or 10 pack years; 2. Patients newly diagnosed with COPD since baseline; • Patients where the first record of a COPD diagnosis occurs within the 12-month baseline period (prior to the index date).; 3. COPD already diagnosed ; • Patients diagnosed with COPD at any point in their history before the baseline period preceding index date ; ; Exclusion criteria:; • Patients with indicator of active asthma: a clinical asthma consultation code in 12m before index date • Patients with diagnoses suggesting conflicting morbidities requiring a more holistic complex management approach:; a) Other significant lung disease which is being actively managed; b) Active cancer (except non-invasive skin cancer); • Undiagnosed patients only: No previous diagnostic assessment for COPD in the year prior to the baseline year. That is, patients with any of below recorded in the year prior to the start of the baseline period. ; a) Spirometry performed - EMR codes (FEV1, FVC, FEV1/FVC)
• 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:
  Patients with chronic obstructive pulmonary disease
• Estimated number of subjects:
  49000

Study design details

• Main study objective:
  To describe real-world UK practice in COPD care over the period 2000-2019 in the light of carefully developed Quality Standards (QS), in patient populations with modifiable high-risk COPD which is either diagnosed or undiagnosed.
• Outcomes:
  Assessment of: active identification of undiagnosed patients with potential modifiable high-risk (MHR) COPD, disease & quantification of future risk in newly diagnosed patients, appropriate pharmacological and non-pharmacological therapy provision in newly-diagnosed patients and already-diagnosed patients, whether MHR COPD patients are followed up appropriately over a 12m period after index date. To examine associations of (2015-2019) quality of COPD care by patient types, using key indicators under QS objectives 1-4.
• Data analysis plan:
  Descriptive analyses will be performed on the characteristics of high-risk patients and of medical management of COPD in each patients group (undiagnosed, newly-diagnosed, already diagnosed). All summary statistics will be presented as percentages with counts (categorical variables) and mean/medians with standard deviation/interquartile ranges for normally and non-normally distributed continuous variables respectively. The yearly trends in UK practice in COPD care over time will be described for a set of characteristics. Data illustrating current treatment practices (2000-2019) will be initially described in tables, and graphs will be produced to show the trends for key outcomes longitudinally over the 20-year assessment period. We will develop univariate & multivariate linear & logistic regression models to calculate influence of patient and practice variables on study outcomes. These trends will be analysed to show whether the characteristics have shown to change over time.