Status: Planned
First registered on:
28/11/2019
Last updated on:
28/11/2019
1. Study identification
EU PAS Register NumberEUPAS32482
Official titleExploring differences in asthma disease severity and pathways: variation by ethnicity and socioeconomic status
Study title acronym
Study typeObservational study
Brief description of the studyThis is a retrospective cohort study using data from English general practices registered with the OPCRD. The specific aims are to:
• Explore differences in asthma severity, asthma control and asthma phenotype by ethnic and socioeconomic groups
• Explore patterns of medication usage and healthcare utilisation (scheduled and unscheduled) for asthma in different ethnic and socioeconomic groups
• To identify determinants of asthma severity in different ethnic and socioeconomic groups
• Investigate disparities in referral patterns for patients from different ethnic and socioeconomic groups
thnicity will be identified from GP ad/or HES records. Socioeconomic Status will be measured using Index of Multiple Deprivation. Asthma severity (assessed using medications), lung function, blood eosinophils, medication adherence, healthcare utilisation and specialist referral will be ascertained from GP records.
Descriptive statistics will be calculated for the entire cohort and for each ethnic and socioeconomic group separately.
Multivariable analysis accounting for differences in demographic and lifestyle factors (e.g. BMI, Smoking) will be conducted using appropriate regression models.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameQueens University Belfast
Centre locationBelfast, UK
Details of (Primary) lead investigator
Title Dr
Last name John
First name Busby
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed28/11/2019
Start date of data collection06/01/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report01/07/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherNo external funding100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name John
First name Busby
Address line 1Centre for Public Health
Address line 2Royal Victoria Hospital
Address line 3
CityBelfast
Postcode
CountryUnited Kingdom
Phone number (incl. country code)442890976019
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name John
First name Busby
Address line 1Centre for Public Health
Address line 2Royal Victoria Hospital
Address line 3
CityBelfast
Postcode
CountryUnited Kingdom
Phone number (incl. country code)442890976019
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Asthma
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects100000
Additional information
All patients with the asthma diagnosis with at least 3 years followup within the Optimum Patient Care Research Database. Final number to be determined during data anlaysis
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Routine primary care electronic patient registry
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
• Explore differences in asthma severity, control and phenotype by ethnic and socioeconomic groups
• Explore patterns of medication usage and healthcare utilisation in different ethnic and socioeconomic groups
• Identify determinants of asthma severity in different ethnic and socioeconomic groups
• Identify disparities in referrals for patients from different ethnic and socioeconomic groups
Are there primary outcomes?Yes
Asthma severity will be ascertained using medication prescription data. Patients will be categorised according to the treatment steps described by GINA
Are there secondary outcomes?Yes
Lung function measurements
Blood eosinophil counts
Hospital admissions
A&E attendances
GP consultations
Asthma exacerbations
Maintenance medication adherence
Time to treatment escalation
Time to specialist referral
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
Descriptive statistics: Descriptive statistics will be calculated for the entire cohort and separately for each ethnic and socioeconomic group
Severity prevalence: appropriate 95% confidence intervals calculated using the multinomial distribution. Multivariable analysis will be conducted using ordinal logistic regression.
Care pathways: The number of hospital admissions, A&E attendances, GP consultations and asthma exacerbations will be analysed using Poisson regression. Lung function measurements, blood eosinophil counts and the prescription possession ratio will be analysed using linear regression. Patients who have their treatment escalated following a loss of control will be investigated using logistic regression. The time between eligibility for specialist referral and attendance will be analysed using Cox regression.
Unadjusted analyses and adjusted analysis (accounting for difference in demographics, lifestyle factors etc.) will be presented
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
