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.