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

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

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
Documents
Study results
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