Completeness and Accuracy of Local Clinical Registry Data for Children Undergoing Heart Surgery

摘要

Background Data routinely captured in clinical registries may be leveraged to enhance efficiency of prospective research. The quality of registry data for this purpose has not been studied, however. We evaluated the completeness and accuracy of perioperative data within congenital heart centers’ local surgical registries.;Methods Within 12 Pediatric Heart Network (PHN) sites, we evaluated 31 perioperative variables (and their subcategories, totaling 113 unique fields) collected via sites’ local clinical registries for submission to The Society of Thoracic Surgeons Database, compared with chart review by PHN research coordinators. Both used standard STS definitions. Data were collected on 10 subjects for 2 to 5 procedures/site and adjudicated by the study team. Completeness and accuracy (agreement of registry data with medical record review by PHN coordinator, adjudicated by the study team) were evaluated.;Results A total of 56,500 data elements were collected on 500 subjects. With regard to data completeness, 3.1% of data elements were missing from the registry, 0.6% from coordinator-collected data, and 0.4% from both. Overall, registry data accuracy was 98%. In total, 94.7% of data elements were both completeon-missing and accurate within the registry, although there was variation across data fields and sites. Mean total time for coordinator chart review per site was 49.1 hours versus 7.0 hours for registry query.;Conclusions This study suggests that existing surgical registry data constitute a complete, accurate, and efficient information source for prospective research. Variability across data fields and sites also suggest areas for improvement in some areas of data quality.;;Mr White discloses a financial relationship with CardioAccess.;Jump to SectionPatients and MethodsOverviewSources of DataLocal surgical registry dataCoordinator-collected dataStudy PopulationVariable SelectionAdjudicationAnalysisResultsStudy PopulationRegistry Data Completeness and AccuracyVariation Across Data Fields and SitesTime AnalysisCommentLimitationsConclusionsReferences;In this retrospective study (Fig 1Fig 1), perioperative data collected through two different methods were evaluated: (1) existing data in sites’ local surgical registries collected for submission to the STS-CHSD and (2) chart review by PHN research coordinators. Both used standard STS-CHSD definitions. Twelve US sites participating in both the PHN (9 core, 3 auxiliary sites) and STS-CHSD were included. Each site received institutional review board approval with waiver of informed consent.Fig 1Schematic diagram of study. (ASO?= arterial switch operation; AVSD?= atrioventricular septal defect; PI?= principal investigator; TOF/PS?= tetralogy of Fallot / pulmonary stenosis; VSD?= ventricular septal defect.);Jump to SectionPatients and MethodsOverviewSources of DataLocal surgical registry dataCoordinator-collected dataStudy PopulationVariable SelectionAdjudicationAnalysisResultsStudy PopulationRegistry Data Completeness and AccuracyVariation Across Data Fields and SitesTime AnalysisCommentLimitationsConclusionsReferences;Registry data were obtained by querying sites’ local surgical registries containing data collected and submitted to the STS-CHSD. Although practices vary across centers, these data are generally collected by a combination of clinicians and trained data managers. Resources for data managers include a manual of detailed data specifications including definitions, standardized training materials, regular phone conferences, updates on the STS Web site, site audits, and an annual symposium. STS variables are captured using standard definitions and nomenclature from the International Pediatric and Congenital Cardiac Code and Multisocietal Database Project [9][9]. Standard queries were developed to ensure uniform data extraction from the registry regardless of the software used by the center.;Data on the same data fields were also collected separately by trained PHN resea