title: Data integrity of the Pediatric Cardiac Critical Care Consortium (PC4) clinical registry.
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.
authors.affiliation: 1Department 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.
authors.forename: Michael
authors.initials: M
authors.lastname: Gaies
authors.affiliation: 2Michigan Congenital Heart Outcomes Research and Discovery (MCHORD) Unit,University of Michigan Congenital Heart Center,Ann Arbor,Minnesota,United States of America.
authors.forename: Janet E
authors.initials: JE
authors.lastname: Donohue
authors.affiliation: 2Michigan Congenital Heart Outcomes Research and Discovery (MCHORD) Unit,University of Michigan Congenital Heart Center,Ann Arbor,Minnesota,United States of America.
authors.forename: Gina M
authors.initials: GM
authors.lastname: Willis
authors.affiliation: 3The Cardiac Center,The Children's Hospital of Philadelphia,Philadelphia,Pennsylvania,United States of America.
authors.forename: Andrea T
authors.initials: AT
authors.lastname: Kennedy
authors.affiliation: 4Heart Institute,Cincinnati Children's Hospital Medical Center,Cincinnati,Ohio,United States of America.
authors.forename: John
authors.initials: J
authors.lastname: Butcher
authors.affiliation: 5Department of Pediatrics,Division of Cardiology,Medical University of South Carolina,Charleston,South Carolina,United States of America.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Scheurer
authors.affiliation: 6Department of Pediatrics,Division of Critical Care,University of Alabama at Birmingham,Birmingham,Alabama,United States of America.
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Alten
authors.affiliation: 7Division 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.
authors.forename: J
authors.initials: J
authors.lastname: William Gaynor
authors.affiliation: 8Department of Critical Care Medicine and Cardiology,Children's National Medical Center,Washington,District of Columbia,United States of America.
authors.forename: Jennifer J
authors.initials: JJ
authors.lastname: Schuette
authors.affiliation: 4Heart Institute,Cincinnati Children's Hospital Medical Center,Cincinnati,Ohio,United States of America.
authors.forename: David S
authors.initials: DS
authors.lastname: Cooper
authors.affiliation: 9Department of Surgery,Division of Cardiac Surgery,Johns Hopkins University School of Medicine,Baltimore,Maryland,United States of America.
authors.forename: Jeffrey P
authors.initials: JP
authors.lastname: Jacobs
authors.affiliation: 1Department 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.
authors.forename: Sara K
authors.initials: SK
authors.lastname: Pasquali
authors.affiliation: 10Department of Pediatrics,Benioff Children's Hospital,University of California San Francisco School of Medicine,California,United States of America.
authors.forename: Sarah
authors.initials: S
authors.lastname: Tabbutt
mesh_terms: D002309:Cardiology; D054869:Clinical Audit; D003299:Cooperative Behavior; D003422:Critical Care / Q000592:standards; D000068598:Data Accuracy; D016208:Databases, Factual / Q000592:standards*; D006761:Hospitals / Q000706:statistics & numerical data; D010372:Pediatrics; D058996:Quality Improvement; D012042:Registries / Q000592:standards*; D014481:United States
keywords: Cardiac; audit; critical care; database; paediatric