Abstract
BackgroundNon-invasive 3-dimensional (3D) ultrasound (US) has emerged as the predominant approach for evaluating the progression of carotid atherosclerosis and its response to treatment. The aim of this study was to investigate the quality of a central reading procedure concerning plaque volume (PV), measured by 3D US in a multinational US trial.MethodsTwo data sets of 45 and 60 3D US patient images of plaques (mean PV, 71.8 and 39.8 μl, respectively) were used. PV was assessed by means of manual planimetry. The intraclass correlation coefficient (ICC) was applied to determine reader variabilities. The repeatability coefficient (RC) and the coefficient of variation (CV) were used to investigate the effect of number of slices (S) in manual planimetry and plaque size on measurement variability.ResultsIntra-reader variability was small as reflected by ICCs of 0.985, 0.967 and 0.969 for 3 appointed readers. The ICC value generated between the 3 readers was 0.964, indicating that inter-reader variability was small, too. Subgroup analyses showed that both intra- and inter-reader variabilities were lower for larger than for smaller plaques. Mean CVs were similar for the 5S- and 10S-methods with a RC of 4.7 μl. The RC between both methods as well as the CVs were comparatively lower for larger plaques.ConclusionBy implementing standardised central 3D US reading protocols and strict quality control procedures highly reliable ultrasonic re-readings of plaque images can be achieved in large multicentre trials.
Highlights
Measurement of carotid atherosclerosis burden and progression is an important tool for research and patient management [1]. 2-dimensional (2D) B-mode ultrasound (US) has been shown to be a sensitive and reproducible method to detect pre intrusive thickening of artery walls and to measure intima-media thickness (IMT) in the carotid artery [2,3]
Determined IMT has been used as a marker of atherosclerosis elsewhere in the arterial system and randomised imaging studies have examined the effects of blood pressure- and lipid-lowering therapies on carotid IMT changes [4]
The intraclass correlation coefficient (ICC) value generated between the 3 readers was 0.964 indicating that interreader variability was small, too (Table 1)
Summary
Measurement of carotid atherosclerosis burden and progression is an important tool for research and patient management [1]. 2-dimensional (2D) B-mode ultrasound (US) has been shown to be a sensitive and reproducible method to detect pre intrusive thickening of artery walls and to measure intima-media thickness (IMT) in the carotid artery [2,3]. Atherosclerotic plaque volume assessed by 3-dimensional (3D) US [7] may represent a more reliable measure of atherosclerosis than IMT [8] and more recently non-invasive 3D US imaging has ermerged as the predominant approach for evaluating the progression of carotid atherosclerosis [1,9,10,11,12]. A recent randomised trial in hypertensive patients using carotid 3D US has successfully investigated the effects of two different classes of antihypertensive agents on plaque volume changes and demonstrated the suitability of the 3D US method for tracking progression or regression of plaque volume over time [13]. Non-invasive 3-dimensional (3D) ultrasound (US) has emerged as the predominant approach for evaluating the progression of carotid atherosclerosis and its response to treatment. The aim of this study was to investigate the quality of a central reading procedure concerning plaque volume (PV), measured by 3D US in a multinational US trial
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