To quantify the within-and between-reader agreement of carotid B-mode ultrasonography and angiography interpretation, images from 117 patients examined by both modalities were read multiple times. Angiographic measurements were more reproducible than those of B-mode scans for all parameters except lesion width, but variations for B-mode scan measurements were similar to those for angiographic measurements. Within-reader agreement on the presence of u Ice rat ion was substantial for both modalities, whereas between-reader agreement was poor for B-mode scan and only moderate for angiography. (Stroke 1987;18:1011-1017 V ascular ultrasonography is a minimally invasive technique, with no known risks, that can be used to evaluate individuals for clinically significant atherosclerosis and possibly to measure and track atherosclerosis in nonsymptomatic populations. To establish the capabilities of high-resolution B-mode ultrasound imaging (B scans) for detecting and quantifying atherosclerotic lesions in carotid and iliofemoral arteries of humans and animal models, a multicenter contract was issued by the National Heart, Lung, and Blood Institute (NHLBI). Five clinical centers received contract awards. An additional contract was awarded for a parallel study in primates and another for a data coordinating center. A 5-year research plan was begun in May 1981. The program was divided into 5 phases: protocol development (6 months), pilot studies (6 months), data collection including follow-up studies (36 months), and data analysis and manuscript preparation (12 months).A Steering Committee composed of the principal investigators from each institution and scientific representatives from the NHLBI first met in June 1981 to begin developing formal hypotheses, common proto- Received January 5, 1987; accepted June 24, 1987. cols, operation manuals, and criteria for patient eligibility. The following goals were established: 1) determination of the sensitivity, specificity, and accuracy of B scan with respect to angiography; 2) determination of the sensitivity, specificity, and accuracy of B scan and angiography with respect to pathologic specimen measurements; 3) evaluation of capabilities of B scan and angiography for detecting lesions of varying composition based on gross and microscopic examination of specimens; and 4) establishment of reproducibility in interpreting B scans and angiograms.
Subjects and Methods
Study DesignTwo studies were initiated. The first was a sensitivity/specificity (S/S) study that was designed to compare results between ultrasonography, angiography, and pathology. The results of the S/S study are reported separately.' The second was a repeatability/variability (R/V) study to evaluate within-reader variation (repeatability) and between-reader variation (variability) within a modality. This paper details the results of this second study, which was designed to determine the capabilities of different diagnostic methodologies. These results are based on multiple readings of single images, and thus the t...