BeamMed Sunlight Omnisense 7000S, User Manual

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Omnisense 7000S/8000S
2-15
Clinical Studies
Reproducibility of Repeated Measurements
In this type of study the SOS of each subject was measured at
the given skeletal site using the appropriate probe type twice by
three different operators. Probes were repositioned between
each measurement. The CV was reported for all measurements,
as well as stratified by operator and by menopausal status. The
variance of each CV was also calculated so that 95% confi-
dence intervals could be reported. Fifteen subjects were mea-
sured, 10 premenopausal women and 5 postmenopausal
women. This kind of precision result is often called "Short
Term Precision".
Since there were 15 subjects measured by three different opera-
tors, a total of 45 pairs of repeated SOS measurements are
available to assess the reproducibility of repeated measure-
ments. The overall CV for the Radius was 0.40% (95% CI:
0.39% to 0.41%). For pre-menopausal women (mean age 29.4
± 7.6 years) the Radius CV was 0.29% and for postmenopausal
women (mean age 57.6 ± 5.9 years) the CV was 0.57%. The
overall precision of the radius T-score (TSD) is 0.164 (16.4%).
For pre-menopausal women the radius TSD was 0.119 (11.9%)
and for post-menopausal women the radius TSD was 0.229
(22.9%).
The short term precision results for all skeletal sites is shown in
Table 2.5.
Table 2.5 Precision Test Results for Each of the Skeletal Sites
Conclusions
The in vivo precision (reproducibility), expressed by CV, for the
Skeletal Site
RMS Intra
Operator CV
(%) T-Score
Precision
(%)
Radius 0.40 16.4
Phalanx 0.81 19.0
Metatarsal 0.66 11.8