Estimating prevalence and incidence of acute myocardial infarction in a set of heterogeneous sources of observational health data collaborating in the EMIF Platform

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28093
• EU PAS number:
  EUPAS14060
• Study ID:
  28093
• Official title and acronym:
  Estimating prevalence and incidence of acute myocardial infarction in a set of heterogeneous sources of observational health data collaborating in the EMIF Platform
• 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-national, multi-data source observational studies and generate high quality evidence. For this purpose, a template data derivation procedure was specifically developed. In this proof-of-concept study, the standard procedure will be applied for the identification of patients with acute myocardial infarction (AMI) in a set of heterogeneous sources of observational health data. Validity indices (sensitivity, PPV) of the data source-tailored case-finding algorithms will be estimated from available evidence, and adjusted prevalence and incidence of AMI will be estimated from the participating data sources.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Agenzia regionale di sanità della Toscana (ARS)

Italy

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

Netherlands

Health Search, Italian College of General Practicioners

Italy

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

The PHARMO Institute for Drug Outcomes Research (PHARMO Institute)

Netherlands

Cegedim Strategic Data Medical Research UK

United Kingdom

University of Tartu

Estonia

Aarhus University & Aarhus University Hospital DEPARTMENT OF CLINICAL EPIDEMIOLOGY

Denmark

Aarhus University Hospital

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, Quretec, Software Technology and Applications Competence Center, University of Tartu Tartu, Estonia, Department of Clinical Epidemiology, Aarhus University Hosptial Aarhus, Denmark

Networks

European Medical Information Framework (EMIF)

European Union

Study timelines

Date when funding contract was signed

Planned: 01/01/2013

Actual: 01/01/2013

Study start date

Planned: 21/11/2016

Actual: 01/02/2017

Date of final study report

Planned: 31/07/2019

Sources of funding

Other

More details on funding

EU/EFPIA

Study protocol

Initial protocol

Protocol_AMI_v1.1

Updated protocol

Protocol_AMI_v1.2

Regulatory

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