Construct Validity and Reproducibility of Handheld Ultrasound Devices in Carotid Artery Diameter Measurement.

Abstract

The construct validity and reproducibility of three commonly used handheld ultrasound (US) devices in measuring carotid arterial diameter was evaluated: Telemed MicrUs EXT-1H (Telemed, Vilnius, Lithuania), Butterfly iQ (Butterfly Network, Inc., Guilford, CT, USA) and Philips Lumify (Philips Healthcare, Best, The Netherlands). An in vitro setup was built to evaluate construct validity, compared with high-end US, and intra-observer variability of handheld US devices. Handheld devices showed a mean difference of 0.023 ± 0.030 cm, 0.012 ± 0.037 cm and 0.009 ± 0.046 cm for, respectively, Telemed, Butterfly and Lumify in comparison with high-end US devices. Intraclass agreement with the high-end system as well as intra-observer variability for handheld US devices was classified as excellent, with all values greater than 0.95. Subsequently, inter-observer variability of handheld US devices was investigated in an in vivo setup with 20 healthy volunteers. Inter-observer variability was classified as excellent for Telemed (0.901), good for Lumify (0.827) and moderate for Butterfly (0.684) with a difference of, respectively, 0.005 ± 0.031 cm, 0.020 ± 0.050 cm and -0.003 ± 0.033 cm. In conclusion, handheld US devices demonstrated an excellent construct validity and intra-observer variability. Additionally, excellent-to-good inter-observer variability for Telemed and Lumify was observed, and Butterfly demonstrated a moderate inter-observer agreement. These results indicate that handheld US devices are effective for measuring carotid arterial diameter.