Status: Finalised
First registered on:
13/06/2013
Last updated on:
11/12/2018
1. Study identification
EU PAS Register NumberEUPAS4117
Official titleRealization of the clinical practice guidelines for diabetes in Finland – A case study of the usability of electronic patient information systems and national registers to support evidence based decision making in health care
Study title acronymER12-9451
Study typeObservational study
Brief description of the studyThis is a retrospective database linkage study using patient information system data from selected primary and specialty health care organisations with linkage to nationwide registers. The overall objective of the study is to evaluate whether the electronic patient information systems and national registers can be used to support evidence based decision making in health care. The specific scientific objectives are to evaluate how the key elements of the Current Care guideline for diabetes (by the Finnish Medical Society Duodecim) are realized in practice and to investigate which factors explain successful implementation of treatment recommendations.
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 group
Organisation/affiliationEPID Research Oy
Details of (Primary) lead investigator
Title Dr
Last name Korhonen
First name Pasi
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
Finland
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed27/12/2012
Start date of data collection03/03/201426/02/2014
Start date of data analysis31/05/2016
Date of interim report, if expected
Date of final study report30/09/201609/08/2017
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
Otherassociation: Pharma Industry Finland100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Korhonen
First name Pasi
Address line 1EPID Research Oy
Address line 2Metsänneidonkuja 12
Address line 3
CityEspoo
Postcode02130
CountryFinland
Phone number (incl. country code)358-50-3652990
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Korhonen
First name Pasi
Address line 1EPID Research Oy
Address line 2Metsänneidonkuja 12
Address line 3
CityEspoo
Postcode02130
CountryFinland
Phone number (incl. country code)358-50-3652990
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Substance class (ATC Code)A10A (INSULINS AND ANALOGUES)
Substance class (ATC Code)A10B (BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS)
7. Medical conditions to be studied
Medical condition(s)Yes
Type 2 diabetes mellitus
8. Population under study
Age
Children (2 - 11 years)
Adolescents (12 - 17 years)
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 subjects89000
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Prescription event monitoring
Administrative database, e.g. claims database
Routine primary care electronic patient registry
Pharmacy dispensing records
Nationwide registers:
Register for reimbursed medications
Health insurance
Sickness allowance register
Hospital care register (discharge register)
Hospital benchmarking database
Causes of death registry
11. Scope of the study
What is the scope of the study?
methodological, to study treatment guideline implementation
Primary scope : methodological, to study treatment guideline implementation
12. Main objective(s)
What is the main objective of the study?
To evaluate whether the electronic patient information systems and national registers can be used to support evidence based decision making in health care. To evaluate how the key elements of the Current Care guideline for diabetes are realized in practice and to investigate which factors explain successful implementa of treatment recommendations.
Are there primary outcomes?Yes
- Diabetes medications and related measurements
- Frequency of follow-up measurements - HbA1c and S-LDL
- Follow-up measurements every 12 to 15 months
- Follow-up measurements every 1-3 years
- Treatment decisions (other than diabetes treatment) based on follow-up measurements
Are there secondary outcomes?Yes
- Mortality
- Health care resource use: visits, contacts and hospital/PHC inpatient admissions.
- Amputations of the lower extremities
- Absence from work
- Severe hypoglycemic events
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
The follow-up of the patients starts on the index date (after the cohort entry in 2009-2012), and ends on 31.12.2013, at time of death or at time of emigration whichever occurs first. This is a register-based study and the patients will not be contacted.
15. Data analysis plan
Please provide a brief summary of the analysis method
The baseline characteristics will be presented as number of cases and percentages separately for each study site and for all sites combined. Appropriate statistical tests will be applied to statistically quantify any between site differences. Baseline characteristics include:
• Age
• Gender
• Smoking
• BMI
• Dietary habits
• Physical exercise
• Concomitant disease
• Concomitant medication
• Laboratory measurements
Realization of current care guidelines will be evaluated for each site separately and for all sites combined. Appropriate statistical tests will be applied to statistically quantify between site differences.
A (multi) logistic regression model will be used to model the study end-points with respect to the baseline covariates and study sites. When possible a binomial endpoint will be used (i.e., never vs. ever start of metformin or under 1 month vs. over 1 month to start of metformin).
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
Niskanen L., Hahl J., Haukka J., Leppä E., Miettinen T., Mushnikov V., Sipilä R., Tamminen N., Vattulainen P., Korhonen P. Type 2 diabetes and treatment intensification in primary care in Finland. Acta Diabetol (2018) 55: 1171.https://doi.org/10.1007/s00592-018-1199-7
Sulamaa A., Prami T., Sipilä R., Linna M., Hahl J., Miettinen T., Leppä E., Haukka J., Tuomilehto J., Enlund H., Niskanen L., Korhonen P. Description of the permit process for a
national registry study – implementation
of the Current Care Guideline for diabetes
mellitus as an example. Suomen Lääkärilehti (2014) 69(46): 3085-89.
19. Other relevant documents
Other documents
DescriptionDocumentLatest version
Signed Code of
Conduct Checklist
Submitted
Signed Code of Conduct Declaration
Submitted
Signed Checklist for Study
Protocols
Submitted
