Evaluation of the European spine phantom in a multi-centre clinical trial |
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Authors: | B Lees S W Garland C Walton J C Stevenson |
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Institution: | (1) Wynn Division of Metabolic Medicine, Imperial College School of Medicine at the National Heart and Lung Institute, 21 Wellington Road, NW8 9SQ London, UK |
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Abstract: | The European Spine Phantom (ESP) has recently been developed as a universal standard for instruments measuring bone density.
The ESP is composed of three semi-anthropomorphic hydroxyapatite vertebrae of varying densities surrounded by soft tissue
equivalent plastic designed to resemble human bone and soft tissue when scanned on bone densitometers. In multi-centre studies
it is particularly important to verify that each participating bone densitometer is performing in a stable and linear fashion.
The aim of this study was to evaluate the ESP within the context of a multi-centre clinical trial. Eighteen centres in the
UK and Canada with dual-energy X-ray absorptiometry (DXA) instruments (Lunar DPX, DPX-alpha and DPX-L) participated in the
study. The ESP was scanned 10 times on each instrument without repositioning using standardized protocols. The precision of
the bone mineral density (BMD) measurements (L1–3) expressed as a coefficient of variation ranged from 0.4% to 1.1% (mean
0.7%). The mean BMD of each instrument was expressed as a percentage difference from the overall mean and ranged from −1.33%
to 1.33%. Linear regression analysis showed that all instruments behaved in a linear fashion across the range of densities
with correlation coefficients all ≥0.999 and standard errors of the estimate <1.5% of the mean BMD ESP value. The data from
this study demonstrate that the ESP is a useful phantom for assessing the linearity, stability and differences between DXA
instruments from one manufacturer. |
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Keywords: | Bone densitometry Dual-energy X-ray absorptiometry (DXA) Phantoms Precision |
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