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Comparison of Information Recorded in MINAP, GPRD and HES: a CALIBER Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01569139
First Posted: April 2, 2012
Last Update Posted: October 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University College, London
General Practice Research Database
Information provided by (Responsible Party):
Emily Herrett, London School of Hygiene and Tropical Medicine
  Purpose
Medical information is increasingly processed electronically. This study will describe the similarities and differences in the data recorded by different databases of electronic healthcare database. These will include the General Practice Research Database (GPRD) and the Myocardial Ischaemia National Audit Project (MINAP) and hospital episode statistics (HES).

Condition
Myocardial Infarction

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Comparison of the Information Recorded in the Myocardial Ischaemia National Audit Project, the General Practice Research Database and Hospital Episode Statistics: a CALIBER Study

Resource links provided by NLM:


Further study details as provided by Emily Herrett, London School of Hygiene and Tropical Medicine:

Enrollment: 21000
Study Start Date: December 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
GPRD MI
Myocardial infarction, as identified in the GPRD data.
MINAP MI
Myocardial infarction, as identified in MINAP data.
HES MI
Myocardial infarction, as identified in HES data.

Detailed Description:

This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (GPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).

Specific aims are as follows:

  1. To validate the linkage between the three databases (General Practice Research Database (GPRD), Myocardial Ischaemia National Audit Project (MINAP), Hospital Episode Statistics (HES)) (checking age, sex and unique identifiers across databases) and establish a cohort of patients with acceptable registration status for further analysis.
  2. To describe the ways that MIs are recorded between the three datasets based on the 'best case definition' in each database.

    1. Starting from a 'best case definition' MINAP MI definition (based on the CALIBER phenotype algorithm, which itself is based on the international definition of MI), to examine the way in which the MINAP MI is recorded in GPRD and HES. This analysis will examine STEMI and NSTEMI separately.
    2. Starting from a 'best case definition' algorithm for MI in GPRD (to be decided by GPRD/LSHTM/UCL), to examine the ways in which this MI is recorded in MINAP and HES.
    3. Starting from a 'best case definition' choice of ICD-10 codes for MI in HES, to examine the ways in which this MI is recorded in MINAP and GPRD.
  3. To examine predictors of non-concordance between the three datasets.
  4. To develop recommendations for a new gold standard definition of MI in each of the databases, based on aims 1-3.

A detailed protocol for this study is available on request. This study has been approved by the Independent Scientific Advisory Committee (ISAC) and by the MINAP Academic Group (MAG).

Study investigators:

R. Boggon, GPRD; Dr S. Denaxas, UCL; Professor H. Hemingway, UCL; E. Herrett, LSHTM; Dr A. Shah, UCL; Professor A. Timmis; Professor T. van Staa, GPRD.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population is comprised of "acceptable" patients registered at those GPRD practices that agreed to the linkage with MINAP and HES, whose practices are "up to standard" according to GPRD criteria. Practices taking part in the GPRD are chosen to be representative of UK practices, and 98% of people in the UK are registered with a GP. Therefore the GPRD should be a representative sample of the UK population.
Criteria

Inclusion Criteria:

  • Aged 18+
  • Patients in GPRD practices which are deemed "up to standard" by GPRD criteria
  • Patients in GPRD whose practice agreed to be linked to the MINAP and HES datasets.
  • Patients whose records are deemed "acceptable" by GPRD criteria
  • Patients whose age and sex, as recorded in GPRD is the same as that recorded in HES and MINAP.
  • Patients with evidence of myocardial infarction in one of the datasets (HES, MINAP, GPRD, ONS) between 1st January 2003 and 6th August 2009.

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569139


Locations
United Kingdom
London School of Hygiene and Tropical Medicine
London, United Kingdom, WC1E 7HT
General Practice Research Database
London, United Kingdom
University College, London
London, United Kingdom
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
University College, London
General Practice Research Database
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Emily Herrett, Research Degree Student, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01569139     History of Changes
Other Study ID Numbers: Validation of CALIBER linkage
086091/Z/08/Z ( Other Grant/Funding Number: Wellcome )
First Submitted: March 30, 2012
First Posted: April 2, 2012
Last Update Posted: October 2, 2015
Last Verified: October 2015

Keywords provided by Emily Herrett, London School of Hygiene and Tropical Medicine:
Validation
Concordance
Myocardial infarction
Myocardial Ischaemia National Audit Project
General Practice Research Database
Hospital Episode Statistics
ONS mortality

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Myocardial Ischemia
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases