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Data quality methods through remote source data verification auditing: results from the Congenital Cardiac Research Collaborative

Part of: Tetralogy of Fallot (TOF) Interventional Cardiology

Published online by Cambridge University Press:  17 March 2021

Joelle A. Pettus Open the ORCID record for Joelle A. Pettus [Opens in a new window] ,
Amy L. Pajk ,
Andrew C. Glatz ,
Christopher J. Petit ,
Bryan H. Goldstein ,
Athar M. Qureshi Open the ORCID record for Athar M. Qureshi [Opens in a new window] ,
George T. Nicholson Open the ORCID record for George T. Nicholson [Opens in a new window] ,
Jeffery J. Meadows ,
Jeffrey D. Zampi  and
Mark A. Law
...Show all authors
Joelle A. Pettus*
Affiliation:
Emory University School of Medicine, Department of Pediatrics, Children’s Healthcare of Atlanta, Atlanta, GA, USA
Amy L. Pajk
Affiliation:
The Heart Institute, Cincinnati Children’s Hospital and Department of Pediatrics, Cincinnati, OH, USA
Andrew C. Glatz
Affiliation:
The Cardiac Center, Department of Pediatrics, Children’s Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA
Christopher J. Petit
Affiliation:
Emory University School of Medicine, Department of Pediatrics, Children’s Healthcare of Atlanta, Atlanta, GA, USA
Bryan H. Goldstein
Affiliation:
Heart Institute, UPMC Children’s Hospital of Pittsburgh and Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA
Athar M. Qureshi
Affiliation:
The Lillie Frank Abercrombie Section of Cardiology, Department of Pediatrics, Texas Children’s Hospital, Baylor College of Medicine, Houston, TX, USA
George T. Nicholson
Affiliation:
Division of Cardiology, Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA
Jeffery J. Meadows
Affiliation:
Division of Cardiology, Department of Pediatrics, University of California San Francisco School of Medicine, San Francisco, CA, USA
Jeffrey D. Zampi
Affiliation:
Division of Cardiology, Department of Pediatrics, CS Mott Children’s Hospital, University of Michigan School of Medicine, Ann Arbor, MI, USA
Mark A. Law
Affiliation:
Division of Pediatric Cardiology, Department of Pediatrics, Children’s of Alabama, University of Alabama Birmingham School of Medicine, Birmingham, AL, USA
Shabana Shahanavaz
Affiliation:
Section of Pediatric Cardiology, Department of Pediatrics, Washington University School of Medicine, St Louis, MO, USA
Michael S. Kelleman
Affiliation:
Emory University School of Medicine, Department of Pediatrics, Children’s Healthcare of Atlanta, Atlanta, GA, USA
Courtney M. McCracken
Affiliation:
Emory University School of Medicine, Department of Pediatrics, Children’s Healthcare of Atlanta, Atlanta, GA, USA
*
Author for correspondence: Joelle A. Pettus, MPH, MSW, Emory University School of Medicine, Department of Pediatrics, 2015 Uppergate Drive, Atlanta, GA 30322, USA. Tel: 404-727-5198; Fax: 770-488-9015. E-mail: JPettus@emory.edu
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Abstract

Background:

Multicentre research databases can provide insights into healthcare processes to improve outcomes and make practice recommendations for novel approaches. Effective audits can establish a framework for reporting research efforts, ensuring accurate reporting, and spearheading quality improvement. Although a variety of data auditing models and standards exist, barriers to effective auditing including costs, regulatory requirements, travel, and design complexity must be considered.

Materials and methods:

The Congenital Cardiac Research Collaborative conducted a virtual data training initiative and remote source data verification audit on a retrospective multicentre dataset. CCRC investigators across nine institutions were trained to extract and enter data into a robust dataset on patients with tetralogy of Fallot who required neonatal intervention. Centres provided de-identified source files for a randomised 10% patient sample audit. Key auditing variables, discrepancy types, and severity levels were analysed across two study groups, primary repair and staged repair.

Results:

Of the total 572 study patients, data from 58 patients (31 staged repairs and 27 primary repairs) were source data verified. Amongst the 1790 variables audited, 45 discrepancies were discovered, resulting in an overall accuracy rate of 97.5%. High accuracy rates were consistent across all CCRC institutions ranging from 94.6% to 99.4% and were reported for both minor (1.5%) and major discrepancies type classifications (1.1%).

Conclusion:

Findings indicate that implementing a virtual multicentre training initiative and remote source data verification audit can identify data quality concerns and produce a reliable, high-quality dataset. Remote auditing capacity is especially important during the current COVID-19 pandemic.

Keywords

Auditdatabasequalitycardiacremote
Type
Original Article
Information
Cardiology in the Young , Volume 31 , Issue 11 , November 2021 , pp. 1829 - 1834
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Copyright
© The Author(s), 2021. Published by Cambridge University Press

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