Status: Finalised
First registered on:
13/09/2016
Last updated on:
19/12/2018
1. Study identification
EU PAS Register NumberEUPAS15175
Official titleAn observational historical cohort study to evaluate chronic disease onset associated with long-term oral corticosteroid and it’s cost impact on patients in the OPCRD / CPRD databases
Study title acronymNone
Study typeObservational study
Brief description of the studyA matched historical cohort study to determine side effects of long-term/intermittent use of oral corticosteroids (OCS) and to measure the mean time required for the onset of side effects in patients prescribed OCS.
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
Department/Research groupObservational and Pragmatic Research Institute Pte Ltd
Organisation/affiliationOPRI Pte Ltd
Details of (Primary) lead investigator
Title Professor
Last name Price
First name David
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 signed06/09/201606/09/2016
Start date of data collection01/11/201625/11/2016
Start date of data analysis20/12/2016
Date of interim report, if expected31/01/2017
Date of final study report29/09/201731/07/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 15a Coles Lane
Address line 2Oakington
Address line 3
CityCambridge
PostcodeCB24 3BA
CountryUnited Kingdom
Phone number (incl. country code)440-1223967582
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Price
First name David
Address line 15a Coles Lane
Address line 2Oakington
Address line 3
CityCambridge
PostcodeCB24 3BA
CountryUnited Kingdom
Phone number (incl. country code)440-1223967582
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
Type 2 diabetes mellitus
Hypertension
Osteoporosis
Sleep disorder
Sleep apnoea syndrome
Pneumonia
Glaucoma
Cataract
Depression
Anxiety
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 subjects108217
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?
Risk assessment
Primary scope : Risk assessment
12. Main objective(s)
What is the main objective of the study?
To establish the association between long term (total dose, total duration and average total daily dose and current measures (current dose and current use) of OCS exposure and incidence of related conditions such as type 2 diabetes mellitus, osteoporosis/ osteoporotic fractures, hypertension, glaucoma, sleep apnoea, weight gain and depression/anxiety.
Are there primary outcomes?Yes
type 2 diabetes, osteoporosis/osteoporotic fractures, hypertension, glaucoma, sleep apnoea, weight gain and depression/anxiety.
Are there secondary outcomes?Yes
pneumonia, cataracts, sleep disorders, cardiovascular disease, chronic kidney disease, dyslipidaemia and peptic ulcer disease.
Annualised healthcare resource utilisation and related cost
13. Study design
What is the design of the study?
Cohort study
Historical cohort database study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
In the corticosteroid treatment arm, patients will be followed up after the first prescription of OCS (index date), until death, leaving the primary care practice, or right censoring (end of the individual record).
In the control arm patients will be followed up starting one year after the first record in the database (index date) until the end of the individual record as defined above.
15. Data analysis plan
Please provide a brief summary of the analysis method
Different time-dependent OCS exposure measures will be explored, defined as current use (yes/no), current dose (mg/day), total dose (g), total duration of exposure (months) and average total daily dose (mg/day). For each corticosteroid related condition, multivariable Cox proportional hazard models will be fitted separately for each of the five time-dependent OCS exposure measures. To determine critical OCS dose thresholds, total dose and daily dose will be categorised into relevant levels and the risk of developing the outcome of interest will be compared between each category of corticosteroid treatment arm and control arm.
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
