1. Study identification
EU PAS Register NumberEUPAS11157
Official titleIdentification of type 2 diabetes cases in a set of databases participating to the EMIF project
Study title acronym
Study typeObservational study
Brief description of the studyThe European Medical Information Framework (EMIF) project has the main objective of building an infrastructure for the efficient re-use of existing health care data for epidemiological research. Within the project, the EMIF-Platform represents a federation of heterogeneous sources of health data (e.g. administrative, hospital or primary care databases, disease registries, biobanks). One of the major challenges for the EMIF project is to deal with the different characteristics of the participating data sources in order to facilitate the execution of large multi-data base observational studies and generate high quality. For this purpose, a template data derivation process was specifically developed and the identification of Type 2 diabetes mellitus (T2DM) was used as a test case.
The objectives of this study are: a) to establish a set of standard algorithms, each based on a single data domain, that will be used for the identification of patients with type 2 diabetes (T2DM) across heterogeneous sources of health data, b) to describe the data source-tailored combinations of standard algorithms recommended by the relevant local data base experts, c) to assess the impact of individual standard algorithms on the population of cases identified across different data sources.
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 to which the investigator belongsARS
Department/Research groupOsservatorio di Epidemiologia
Organisation/affiliationAgenzia regionale di sanità della Toscana (ARS)
Details of (Primary) lead investigator
Title Dr
Last name Giuseppe
First name Roberto
Is this study being carried out with the collaboration of a research network?
Yes
European Medical Information Framework (EMIF)
Other centres where this study is being conducted
Multiple centres
In total how many centres are involved in this Study?9
IMIM-Hospital del Mar Medical Research Institute and Universitat Pompeu Fabra, Barcelona, Spain
The Health Improvement Network, Cegedim Strategic Data Medical Research Ltd, London, United Kingdom
Arsenà l.IT Consortium, Veneto's Research Centre for eHealth Innovation, Treviso, Italy
Health Search, Italian College of General Practitioners and Primary Care, Florence, Italy
Department of Clinical Epidemiology, Aarhus University Hosptial, Aarhus, Denmark
Quretec, Software Technology and Applications Competence Center, University of Tartu, Tartu, Estonia
Countries in which this study is being conducted
International study
Denmark
Estonia
Italy
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/01/2013
Start date of data collection30/04/2014
Start date of data analysis
Date of interim report, if expected
Date of final study report31/01/201601/02/2016
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
OtherEU/EFPIA100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Giuseppe
First name Roberto
Address line 1Via Pietro Dazzi 1
Address line 250141
Address line 3
CityFlorence
Postcode50141
CountryItaly
Phone number (incl. country code)39-0554624341
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Giuseppe
First name Roberto
Address line 1Via Pietro Dazzi 1
Address line 250141
Address line 3
CityFlorence
Postcode50141
CountryItaly
Phone number (incl. country code)39-0554624341
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
8. Population under study
Age
Term newborns (0-27 days)
Infants and toddlers (28 days - 23 months)
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 subjects12000000
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Data sources not registered with ENCePP
IMASIS, Spain
EGCUT, Estonia
Pedianet, Italy
AUH, Denmark
Sources of data
Administrative database, e.g. claims database
Routine primary care electronic patient registry
Pharmacy dispensing records
11. Scope of the study
What is the scope of the study?
Proof of concept study to test a data derivation workflow designed to identify any event of interest from data sources with heterogeneous characteristics
Primary scope : Proof of concept study to test a data derivation workflow designed to identify any event of interest from data sources with heterogeneous characteristics
12. Main objective(s)
What is the main objective of the study?
- to establish a set of standard algorithms useful to identify of patients with type 2 diabetes (T2DM) across heterogeneous sources of health data
- to describe the data source-tailored combinations of standard algorithms recommended by the relevant local data base experts
- to assess the impact of individual standard algorithms on the population of cases identified across different data sources
Are there primary outcomes?No
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cross-sectional 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
This is a descriptive, cross-sectional, retrospective multi-database study. The study population will include all active subjects in the participating databases at two distinct index dates: 1st January 2009 and 1st January 2012, respectively.
Results from case-identification algorithms will be computed and presented as age band distribution of the percentage of the data base population identified.
A validation of the records extracted in the databases will not be performed, since this is out of the scope of this study. Results will not be intended as disease frequency estimates.