Evolving quality standards for large-scale registries: the GARFIELD-AF experience
Eur Heart J Qual Care Clin Outcomes. 2016-11-15; : qcw058
DOI: 10.1093/EHJQCCO/QCW058
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1. Eur Heart J Qual Care Clin Outcomes. 2017 Apr 1;3(2):114-122. doi:
10.1093/ehjqcco/qcw058.
Evolving quality standards for large-scale registries: the GARFIELD-AF
experience.
Fox KAA(1), Gersh BJ(2), Traore S(3), John Camm A(4), Kayani G(3), Krogh A(3),
Shweta S(3), Kakkar AK(3)(5); GARFIELD-AF Investigators.
Author information:
(1)BHF Centre for Cardiovascular Science, University of Edinburgh, Queen’s
Medical Research Institute, 47 Little France Crescent, Edinburgh EH16 4TJ, UK.
(2)Mayo Clinic College of Medicine, Rochester, 200 1st St SW, Rochester, MN
55905, USA.
(3)Thrombosis Research Institute, Emmanuel Kaye Building, Manresa Road, Chelsea,
London SW3 6LR, UK.
(4)St. George’s University of London, Department of Cardiology, St. George s
Hospital, Crammer Terrace, London SW17 0RE, UK.
(5)University College London, Gower St, Kings Cross, London WC1E 6BT, UK.
Erratum in
Eur Heart J Qual Care Clin Outcomes. 2017 Oct 1;3(4):328.
Comment in
Eur Heart J Qual Care Clin Outcomes. 2017 Apr 1;3(2):99-100.
Aims: Registries have the potential to capture treatment practices and outcomes
in populations beyond the constraints of clinical trial settings. The value of
data obtained depend critically upon robust quality standards (including source
data verification [SDV] and training); features that are commonly absent from
registries. This article outlines the quality standards developed for Global
Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF).
Methods and Results: GARFIELD-AF comprises ∼57 000 patients prospectively
recruited over 6.5 years in 35 countries in five successive cohorts. The registry
employs a combination of remote and onsite monitoring to ascertain completeness
and accuracy of records and by design, SDV is performed on 20% of cases (i.e.
∼11 400 patients). Four performance measures for ranking sites according to data
quality and other performance indicators were evaluated (including data quality
for 13 quantifiable variables, late data locking, number of missing critical
variables, and history of poor data quality from the previous monitoring phase).
These criteria facilitated the identification of sites with potentially
suboptimal data quality for onsite monitoring. During early phases of the
registry, critical variables for data checking were also identified. SDV using
these variables (partial SDV in 902 patients) showed similar concordance to SDV
of all fields (110 patients): 94.4% vs. 93.1%, respectively. This standard formed
the baseline against which ongoing quality improvements were assessed,
facilitating corrective action on data quality issues. In consequence,
concordance was improved in the next monitoring phase (95.6%; n = 1172).
Conclusion: The quality standards in GARFIELD-AF have the potential to inform a
future ‘reference’ for registries.
Published on behalf of the European Society of Cardiology. All rights reserved. ©
The Author 2016. For Permissions, please email: .
DOI: 10.1093/ehjqcco/qcw058
PMID: 28927171 [Indexed for MEDLINE]