Summary
Quantitative coronary arteriography (QCA) has become an essential part of centralized core laboratory evaluations for clinical investigations. Most evaluations of variability of quantitative arteriography have been internally controlled studies with little relevancy to factors associated with core laboratory analyses of large populations. We therefore investigated the variability of repetitive quantitative analyses performed on randomly chosen films from ongoing clinical trials, comparing the relative and absolute parameters determined from internally and externally controlled evaluations. In addition, as quantitative methods and systems are known to vary among core facilities, we evaluated the variability of differing frame selection methods and assessed inter-laboratory variability on differing automated quantitative systems.
Assessments of variability between externally and internally controlled evaluations were found to be dissimilar. The variability (standard deviation) of relative assessment parameters (percent diameter stenosis) in the externally controlled evaluations was 56% greater than the variability of the internally controlled evaluations and absolute parameter variability was found to be 70% greater. Averaged minimal lumen diameter (MLD) from orthogonal projections was found to be the least variable parameter.
Frame selection methodology was not found to be of consequence to the variability of quantitative assessments. No significant differences were found between analyses performed on frames chosen by differing methods, or between frames of each method and frames selected from end-diastole, end-systole, or end-diastasis.
Inter-laboratory variability was determined from automated computer analysis of the randomly chosen frames performed by independent laboratories. Subjectively defined reference diameter values correlated poorly with automated computer reference values (r = 0.66). Consequently, percent diameter stenosis comparisons were found to reflect this variability. In addition, differences in MLD values between laboratories (0.23 ± 0.37 mm) were found to be significantly different (p < 0.05), despite similar assessment techniques.
These studies of core laboratory variability emphasize the need for independent and externally controlled evaluations of core laboratory performance, and standardization of QCA calibration and validation techniques.
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Beauman, G.J., Reiber, J.H.C., Koning, G., Vogel, R.A. (1993). Variability of QCA-core laboratory assessments of coronary anatomy. In: Reiber, J.H.C., Serruys, P.W. (eds) Advances in Quantitative Coronary Arteriography. Developments in Cardiovascular Medicine, vol 137. Springer, Dordrecht. https://doi.org/10.1007/978-94-011-1854-5_8
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DOI: https://doi.org/10.1007/978-94-011-1854-5_8
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