Identification of type 2 diabetes cases in a set of databases participating to the EMIF project

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/21959
• EU PAS number:
  EUPAS11157
• Study ID:
  21959
• Official title and acronym:
  Identification of type 2 diabetes cases in a set of databases participating to the EMIF project
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Estonia

  Italy

  Netherlands

  Spain

  United Kingdom
• Study description:
  The 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.
• Study status:
  Finalised

Research institution and networks

Institutions

Agenzia regionale di sanità della Toscana (ARS)

Italy

Epidemiology (Rotterdam Study), Erasmus Medical Center (ErasmusMC)

Netherlands

The PHARMO Institute for Drug Outcomes Research (PHARMO Institute)

Netherlands

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, Arsenàl.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

Networks

European Medical Information Framework (EMIF)

European Union

Contact details

Roberto Giuseppe

Study contact

[e-mail]

Roberto Giuseppe

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual: 01/01/2013

Data collection

Actual: 30/04/2014

Date of final study report

Planned: 31/01/2016

Actual: 01/02/2016

Sources of funding

Other

More details on funding

EU/EFPIA

Study protocol

Initial protocol

Protocol T2DM_V 1.5

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable