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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University College, London
General Practice Research Database
Information provided by (Responsible Party):
Emily Herrett, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01569139
First received: March 30, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  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 London School of Hygiene and Tropical Medicine:

Estimated Enrollment: 5000000
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01569139

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

No publications provided by London School of Hygiene and Tropical Medicine

Additional 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
Study First Received: March 30, 2012
Last Updated: March 30, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by 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:
Myocardial Ischemia
Coronary Artery Disease
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on August 26, 2014