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

Abstract

IntroductionNarcolepsy 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).MethodsData 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).ResultsCorrelations 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.ConclusionSome 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.FundingJazz Pharmaceuticals.

Relationship between sleep efficacy endpoints and measures of functional status and health‐related quality of life in participants with narcolepsy or obstructive sleep apnea treated for excessive daytime sleepiness

“…The current study examines correlations between changes in measures of severity of EDS and those of functioning, productivity and HRQoL associated with OSA and narcolepsy. In both disorders, changes in severity on the ESS were most strongly correlated with the vitality, role physical and social functioning domains of the SF-36(Bogan et al, 2016(Bogan et al, , 2017. Although we did not examine the correlation with the social functioning domain, our results are consistent with those found for the vitality and role physical domains, for which we observed moderate to high correlations between changes in ESS scores and changes in those domains.…”

“…In general, correlations between change in the ESS and change in other measures were as high or higher in participants with narcolepsy compared with those with OSA. Other researchers have previously observed in participants with narcolepsy that treatment for EDS correlates most strongly with the vitality, role physical and social functioning domains of the SF‐36 (Bogan et al., 2016, 2017). Although we did not examine the correlation with the social functioning domain, our results are consistent with those found for the vitality and role physical domains, for which we observed moderate to high correlations between changes in ESS scores and changes in those domains.…”

Health‐related quality of life in narcolepsy: A systematic review and meta‐analysis

“…The 30 included studies originated from 13 different countries (Table 1). Studies were predominantly based in North America and Europe (80.00%), and approximately one‐third of studies ( n = 8) were published in the USA (Becker, Schwartz, Feldman, & Hughes, 2004; Beusterien et al., 1999; Bogan et al., 2017; Emsellem et al., 2020; Flores et al., 2016; Kapella et al., 2015; Mitler, Harsh, Hirshkowitz, & Guilleminault, 2000; Weaver & Cuellar, 2006). Four studies were published in France (Dauvilliers et al., ,2009, 2011, 2017, 2019) and Italy (Ingravallo et al., ,2008, 2012; Vignatelli et al., 2004; Vignatelli, Plazzi, Peschechera, Delaj, & D’Alessandro, 2011), respectively.…”

The Impact of Symptom Severity on Health-Related Quality of Life in Patients with Narcolepsy

“…Previous studies provide evidence that EDS (measured by ESS) has a great impact on HRQoL, rather evidently more than other symptoms, such as cataplexy, hypnagogic/hypnopompic hallucinations and sleep paralysis (7)(8)(9). The constancy of EDS was cited as a key factor in contributing to poor HRQoL.…”