Correlation of changes in patient-reported quality of life with physician-rated global impression of change in patients with narcolepsy participating in a clinical trial of sodium oxybate : a post hoc analysis
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Neurology and therapy ; vol. 6, no. 2, pp. 237-245.Publisher(s)
SpringerAuthor(s)
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Abstract(s)
Introduction: Narcolepsy patients report lower
health-related quality of life (HRQoL) than the
general population, as measured by the Short Form-36 Health Survey (SF-36). This analysis
evaluated whether changes in SF-36 correlated
with physician-rated Clinical Global Impression
of Change (CGI-C).
Methods: Data were from 209 of 228 narcolepsy patients participating in an 8-week
clinical trial of sodium oxybate. Changes from
baseline for SF-36 subscales (Physical Functioning, Role Physical, Bodily Pain, General Health,
Vitality, Social Functioning, Role Emotional,
and Mental Health) and the summary scores
were evaluated for correlation with CGI-C
overall and by treatment group. Correlations
were calculated using the Pearson product-moment correlation coefficient (r).
Results: Correlations described an inverse relationship in scores, but a direct relationship in
improvement; lower CGI-C scores (i.e., better)
were associated with higher SF-36 subscale
scores (i.e., improved HRQoL). Moderate and
significant correlations were observed for Vitality (r = -0.464; P\0.0001) and Role Physical
(r = -0.310; P\0.0001) subscales, but weak
correlations were observed with other subscales
including summary scores. Correlations were
stronger at higher sodium oxybate doses for
most SF-36 subscales. Conclusion: Some aspects of HRQoL, measured
by the SF-36, may be associated with narcolepsy. In particular, Vitality (indicative of
energy and tiredness) and Role Physical (impact
of physical function on daily roles) moderately correlated with overall change in status
observed by clinicians. However, lack of strong
correlations between SF-36 and CGI-C indicates
differences in patient and clinician perspectives
of disease, and suggest a need for broader
assessment of the impact of narcolepsy and its
treatment on patients.
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