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When the OMAS
scale was compared to the NCI scale in a test of accuracy, the
measures of symptoms were well correlated. In fact, the OMAS and
NCI scores were virtually superimposable. The data as a whole
indicate that both the mean mucositis score and the extent of
severe mucositis score, calculated over time either as the area
under the curve or as the average of the 3 highest values, produced
scores that were reproducible and responsive to change. This scale,
however, is not sensitive to low grades of oral mucositis. This
finding would not appear to impact on the scale's utility as applied
to clinical trials because, generally, efficacy of a study drug
is measured by changes in clinically significant mucositis (Sonis
et al., 1999).
The OMAS scale
was tested for ease of use by investigators, tolerability by patients,
interobserver reproducibility, and correlation between investigators.
Investigators reported that the scale was used easily and that
evaluations were completed in less than five minutes. However,
the repetitive examinations proved to be difficult for patients
with severe mucositis. Investigators showed high correlation in
scores over time. Interobserver reproducibility demonstrated acceptable
correlations. In addition, future use of this scale may not need
concomitant symptomatic measurements by VAS and questionnaires
because there was a strong correlation between objective findings
and pain, difficulty swallowing, and eating (Sonis
et al., 1999).
The OMAS scale
is one of a few scales created as a research tool, but regardless
of which scale is used for assessing oral mucositis, training
the research team is essential in obtaining reliable data. Training
sessions to master the understanding of the implemented scales
and to calibrate scores among various raters are essential for
producing accurate data. The FDA may require the simultaneous
use of at least two scales to ensure consistency, which may be
confusing if raters are not trained (Sonis
et al., 1999).
Despite attempts
to find the perfect mucositis scale, researchers have not reached
a consensus regarding an easily-used, easily interpreted, accurate,
and reproducible scoring system.
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