Validation Process of a High-Resolution Database in a Pediatric Intensive Care Unit -- Describing the Perpetual Patient's Validation

Abstract

Objective: High data quality is essential to ensure the validity of clinical and research inferences based on it. However, these data quality assessments are often missing even though these data are used in daily practice and research. Our objective was to evaluate the data quality of our high-resolution electronic database (HRDB) implemented in our pediatric intensive care unit (PICU). Design: A prospective validation study of a HRDB. Setting: A 32-bed pediatric medical, surgical and cardiac PICU in a tertiary care freestanding maternal-child health center in Canada. Population: All patients admitted to the PICU with at least one vital sign monitored using a cardiorespiratory monitor connected to the central monitoring station. Interventions: None Measurements and Main Results: Between June 2017 and August 2018, data from 295 patient days were recorded from medical devices and 4,645 data points were video recorded and compared to the corresponding data collected in the HRDB. Statistical analysis showed an excellent overall correlation (R2=1), accuracy (100%), agreement (bias=0, limits of agreement=0), completeness (2% missing data) and reliability (ICC=1) between recorded and collected data within clinically significant pre-defined limits of agreement. Divergent points could all be explained. Conclusions: This prospective validation of a representative sample showed an excellent overall data quality.