Hidden Severe Asthma in Primary Care versus ISAR Cohort

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

Study drug and medical condition

• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  Patients with potentially severe asthma in a primary care setting in UK.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Asthma patients
• Estimated number of subjects:
  200000

Study design details

• Main study objective:
  Primary:Construct criteria to identify severe asthma in primary care EMR databases based on their treatment and measures of control.Compare the characteristics of “hidden” patients with severe asthma in primary care to those managed in specialist care (ISAR).Secondary:To describe the hidden patients with severe asthmaTo create a template for identifying these patients in other countries
• Outcomes:
  Patients with severe asthma who are hidden from specialist care will be described according to their:Age, Sex, Smoking status, exacerbations, level of control, blood eosinophil count, adherence, prescribed medication and co-morbidites
• Data analysis plan:
  Descriptive statistics on demographic and clinical characteristics will be provided for continuous and categorical variables. Summary statistics for continuous variables will be:Sample size (n)Percentage non missingMeanVariance/standard deviationRange (minimum- maximum)MedianInter-quartile range (25th and 75th percentile)Summary statistics for categorical variables will include:Sample size (n)Range (if applicable)Count and percentage by category (distribution)Characteristics of patients with severe asthma in primary care and ISAR will be compared, group difference will be tested for statistical significance via Chi-square tests. Student t-test or one-way analysis of variance (ANOVA) will be applied to test for statistical significance for comparison of means. Statistical significance will be defined as p<0.05