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Data integrity of the Pediatric Cardiac Critical Care Consortium (PC4) clinical registry

Published online by Cambridge University Press:  11 September 2015

Michael Gaies ,
Janet E. Donohue ,
Gina M. Willis ,
Andrea T. Kennedy ,
John Butcher ,
Mark A. Scheurer ,
Jeffrey A. Alten ,
J. William Gaynor ,
Jennifer J. Schuette  and
David S. Cooper
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Michael Gaies*
Affiliation:
Department of Pediatrics and Communicable Diseases, Division of Cardiology, C.S. Mott Children’s Hospital and University of Michigan Medical School, Ann Arbor, Minnesota, United States of America
Janet E. Donohue
Affiliation:
Michigan Congenital Heart Outcomes Research and Discovery (MCHORD) Unit, University of Michigan Congenital Heart Center, Ann Arbor, Minnesota, United States of America
Gina M. Willis
Affiliation:
Michigan Congenital Heart Outcomes Research and Discovery (MCHORD) Unit, University of Michigan Congenital Heart Center, Ann Arbor, Minnesota, United States of America
Andrea T. Kennedy
Affiliation:
The Cardiac Center, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania, United States of America
John Butcher
Affiliation:
Heart Institute, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, United States of America
Mark A. Scheurer
Affiliation:
Department of Pediatrics, Division of Cardiology, Medical University of South Carolina, Charleston, South Carolina, United States of America
Jeffrey A. Alten
Affiliation:
Department of Pediatrics, Division of Critical Care, University of Alabama at Birmingham, Birmingham, Alabama, United States of America
J. William Gaynor
Affiliation:
Division of Pediatric Cardiac Surgery, Department of Surgery, The Cardiac Center, The Children’s Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, United States of America
Jennifer J. Schuette
Affiliation:
Department of Critical Care Medicine and Cardiology, Children’s National Medical Center, Washington, District of Columbia, United States of America
David S. Cooper
Affiliation:
Heart Institute, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, United States of America
Jeffrey P. Jacobs
Affiliation:
Department of Surgery, Division of Cardiac Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America
Sara K. Pasquali
Affiliation:
Department of Pediatrics and Communicable Diseases, Division of Cardiology, C.S. Mott Children’s Hospital and University of Michigan Medical School, Ann Arbor, Minnesota, United States of America
Sarah Tabbutt
Affiliation:
Department of Pediatrics, Benioff Children’s Hospital, University of California San Francisco School of Medicine, California, United States of America
*
Correspondence to: M. Gaies, MD, MPH, Pediatric Cardiac Critical Care Consortium (PC4), C.S. Mott Children’s Hospital, University of Michigan Congenital Heart Center, 1540 E. Hospital Drive, Ann Arbor, MI 48109-4204, United States of America. Tel: +734 883 2986; Fax: +734 936 9470; E-mail: mgaies@med.umich.edu
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Abstract

Background

Clinical databases in congenital and paediatric cardiac care provide a foundation for quality improvement, research, policy evaluations and public reporting. Structured audits verifying data integrity allow database users to be confident in these endeavours. We report on the initial audit of the Pediatric Cardiac Critical Care Consortium (PC4) clinical registry.

Materials and methods

Participants reviewed the entire registry to determine key fields for audit, and defined major and minor discrepancies for the audited variables. In-person audits at the eight initial participating centres were conducted during a 12-month period. The data coordinating centre randomly selected intensive care encounters for review at each site. The audit consisted of source data verification and blinded chart abstraction, comparing findings by the auditors with those entered in the database. We also assessed completeness and timeliness of case submission. Quantitative evaluation of completeness, accuracy, and timeliness of case submission is reported.

Results

We audited 434 encounters and 29,476 data fields. The aggregate overall accuracy was 99.1%, and the major discrepancy rate was 0.62%. Across hospitals, the overall accuracy ranged from 96.3 to 99.5%, and the major discrepancy rate ranged from 0.3 to 0.9%; seven of the eight hospitals submitted >90% of cases within 1 month of hospital discharge. There was no evidence for selective case omission.

Conclusions

Based on a rigorous audit process, data submitted to the PC4 clinical registry appear complete, accurate, and timely. The collaborative will maintain ongoing efforts to verify the integrity of the data to promote science that advances quality improvement efforts.

Keywords

Cardiaccritical caredatabaseauditpaediatric
Type
Original Articles
Information
Cardiology in the Young , Volume 26 , Issue 6 , August 2016 , pp. 1090 - 1096
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Copyright
© Cambridge University Press 2015 

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References

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