Clinical trials often rely on echocardiographic measures of left ventricular (LV) size and function as surrogate end-points. However, the quantitative impact of factors that affect reproducibility of these measures is unknown. To address this issue, the NHLBI-funded Pediatric Heart Network designed a longitudinal observational study of children with known or suspected dilated cardiomyopathy (DCM) aged 0–22 years from 8 pediatric clinical centers.
Methods
Clinical data were collected together with 150 echocardiographic indices of LV size and function. Separate observers performed duplicate echocardiographic imaging. Multiple observers performed measurements from three cardiac cycles to enable assessment of intra and interobserver variability. We studied the impact of beat averaging (BA), observer type (local vs. core) and variable type (areas, calculations, dimensions, slopes, time intervals and velocities) on measurement reproducibility. The outcome measure was %error (100 × difference/mean)
Results
Of 173 enrolled subjects, 131 met criteria for DCM. BA, variable type and observer type all impacted %error (p<0.0001). Core inter-observer %error (median 11.4, 10.2 and 9.3% for 1-, 2- and 3-BA, respectively) was approximately twice the intra-observer %error (median 6.3, 4.9 and 4.2% for 1-, 2- and 3-BA, respectively). Slopes and calculated variables exhibited high %error despite BA. Chamber dimensions, areas, velocities and time intervals exhibited low %error.
Conclusions
This comprehensive evaluation of quantitative echocardiographic methods will provide a valuable resource for design of future pediatric studies. BA and a single core lab observer improve reproducibility of echo measurements in children with DCM. Certain measurements are highly reproducible, while others, despite BA, are poorly reproducible.