Identifying clinically important difference on the Epworth Sleepiness Scale: results from a narcolepsy clinical trial of JZP-110

Scrima, Lawrence; Emsellem, Hélène A.; Becker, Philip M.; Ruoff, Chad; Lankford, Alan; Bream, Gary; Khayrallah, M.; Lü, Yuan; Black, Jed

doi:10.1016/j.sleep.2017.07.006

Cited by 18 publications

(12 citation statements)

References 8 publications

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“…Using an MID that is larger than the ‘true’ MID in a sample size calculation for an RCT would also result in a smaller sample size requirement that would then lack the power to see a statistically and clinically significant effect. One study that investigated the ESS in narcolepsy suggested a 25% change from baseline to be the threshold for improvement 31. Applied to the three RCTs in our study, this would equate to a change of 2 points in Provent and MOSAIC, which are in agreement with our MID estimate, and 3.3 points in autoCPAP, which is higher than our estimate.…”

Section: Discussionsupporting

confidence: 84%

Minimum important difference of the Epworth Sleepiness Scale in obstructive sleep apnoea: estimation from three randomised controlled trials

Crook

Sievi

Bloch

et al. 2018

Thorax

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BackgroundThe Epworth Sleepiness Scale (ESS) is a widely used tool for assessing sleepiness in patients with obstructive sleep apnoea (OSA). We aimed to estimate the minimal important difference (MID) in patients with OSA.MethodsWe used individual data from three randomised controlled trials (RCTs) in patients with OSA where the preintervention to postintervention change in ESS was used as a primary outcome. We used anchor-based linear regression and responder analysis approaches to estimate the MID. For anchors, we used the change in domains of the Functional Outcomes of Sleep Questionnaire and 36-Item Short Form Health Survey. We also used the distribution-based approaches Cohen’s effect size, SE of measurement and empirical rule effect size to support the anchor-based estimates. The final MID was determined by triangulating all estimates to a single MID.FindingsA total of 639 patients with OSA were included in our analyses across the three RCTs with a median (IQR) baseline ESS score of 10 (6–13). The median (IQR) ESS change score overall was −2 (−5 to 1). The anchor-based estimates of the MID were between −1.74 and −4.21 points and estimates from the responder analysis were between −1 and −3 points. Distribution-based estimates were smaller, ranging from −1.46 to −2.36.InterpretationWe propose an MID for the ESS of 2 points in patients with OSA with a disease severity from mild to severe. This estimate provides the means to plan trials and interpret the clinical relevance of changes in ESS.Trial registration numberProvent, NCT01332175; autoCPAP trial, NCT00280800; MOSAIC,ISRCTN (3416388).

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Section: Discussionsupporting

confidence: 84%

Minimum important difference of the Epworth Sleepiness Scale in obstructive sleep apnoea: estimation from three randomised controlled trials

Crook

Sievi

Bloch

et al. 2018

Thorax

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“…The Pittsburgh Sleep Quality Index scores were considered to show meaningful changes 21 because there were large average reductions after treatment with a large effect size. The Epworth Sleepiness Scale scores were also considered to show meaningful changes 22 because there were large average reductions after treatment, but effect size was small.…”

Section: Discussionmentioning

confidence: 99%

Benefits of adding stretching to a moderate-intensity aerobic exercise programme in women with fibromyalgia: a randomized controlled trial

et al. 2019

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Objective: To investigate the effects of adding stretching to a moderate-intensity aerobic exercise programme in women with fibromyalgia. Design: Randomized controlled trial. Subjects: Sixty-four female patients who were diagnosed with fibromyalgia syndrome based on the American College of Rheumatology criteria were recruited (mean age: 54.27 ± 6.94 years). Interventions: The control group ( n = 32) underwent supervised moderate-intensity cycling (50%–70% of the age-predicted maximum heart rate) three times per week for 12 weeks. The experimental group ( n = 32) underwent the same exercise programme plus a stretching programme once per week for 12 weeks. Main measures: The main measures of this study were sleep quality assessed by the Pittsburgh Sleep Quality Index and the Epworth Sleepiness Scale, the impact of fibromyalgia on quality of life assessed by the Fibromyalgia Impact Questionnaire, and pain perception assessed by the visual analogue scale at baseline, after 4 weeks, and after 12 weeks. Results: The experimental group experienced significant improvements at 4-week measure compared with control group: Pittsburgh Sleep Quality Index ( P < 0.001); Epworth Sleepiness Scale ( P = 0.002); Fibromyalgia Impact Questionnaire (0.93 ± 7.39, P < 0.001); and visual analogue scale (0.52 ± 0.05, P < 0.001). Also at 12-week measure, experimental group experienced significant improvements compared with control group: Pittsburgh Sleep Quality Index ( P < 0.001), Epworth Sleepiness Scale ( P < 0.001); Fibromyalgia Impact Questionnaire (1.15 ± 9.11, P < 0.001); and visual analogue scale (0.81 ± 0.62, P < 0.001). Conclusion: Adding stretching to a moderate-intensity aerobic exercise programme increased sleep quality, decreased the impact of fibromyalgia on the quality of life, and reduced pain compared with just a moderate-intensity aerobic exercise programme in our sample of women with fibromyalgia.

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“…Next, an anchor-based approach that incorporated either PGI-C or CGI-C (as assessed at week 12) as the anchor was used to determine what magnitude of change on the FOSQ-10 represented a meaningful change from the patient’s or clinician’s perspective. This type of approach has previously been used for interpreting changes that are meaningful on the ESS and other patient-reported outcomes [ 20 , 21 ].…”

Section: Methodsmentioning

confidence: 99%

Determination of thresholds for minimally important difference and clinically important response on the functional outcomes of sleep questionnaire short version in adults with narcolepsy or obstructive sleep apnea

et al. 2021

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Purpose This study estimated thresholds for clinically important responses and minimally important differences for two indicators of improvement for the 10-item version of the functional outcomes of sleep questionnaire (FOSQ-10). Methods Participants with excessive daytime sleepiness with narcolepsy or obstructive sleep apnea received 12 weeks of solriamfetol treatment. Participants completed the FOSQ-10 and other patient-reported outcome measures, including the single-item patient global impression of change (PGI-C) assessment. Clinicians completed the single-item clinician global impression of change (CGI-C) for each participant. Data from the two studies were analyzed separately, both without regard to treatment assignment. In total, 690 participants (47% female, mean age 48 years, 77% Caucasian, 91% from North America) were enrolled. Two clinically important changes, defined as a minimally important difference and a clinically important response, were determined using distribution and anchor-based analyses. A receiver operating characteristic analysis was used to determine the optimal FOSQ-10 change threshold. Results Spearman correlations between change in FOSQ-10 scores and PGI-C and CGI-C were − 0.57 and − 0.49 for participants with narcolepsy and − 0.42 and − 0.37 for participants with obstructive sleep apnea. Receiver operating characteristic analysis suggested minimally important difference and clinically important response estimates of 1.7 and 2.5 and 1.8 and 2.2 points in narcolepsy and obstructive sleep apnea, respectively. Conclusions Minimally important difference and clinically important response estimates for the FOSQ-10 for adults with excessive daytime sleepiness in narcolepsy or obstructive sleep apnea will be helpful for interpreting changes over time and defining a clinical responder. ClinicalTrials.gov identifiers NCT02348593 (first submitted January 15, 2015) and NCT02348606 (first submitted January 15, 2015)

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Identifying clinically important difference on the Epworth Sleepiness Scale: results from a narcolepsy clinical trial of JZP-110

Abstract: A ≥25% reduction in patients' subjective ESS score may be useful as a threshold to identify patients with narcolepsy who respond to JZP-110 treatment.

Cited by 18 publications

References 8 publications

Minimum important difference of the Epworth Sleepiness Scale in obstructive sleep apnoea: estimation from three randomised controlled trials

Minimum important difference of the Epworth Sleepiness Scale in obstructive sleep apnoea: estimation from three randomised controlled trials

Benefits of adding stretching to a moderate-intensity aerobic exercise programme in women with fibromyalgia: a randomized controlled trial

Determination of thresholds for minimally important difference and clinically important response on the functional outcomes of sleep questionnaire short version in adults with narcolepsy or obstructive sleep apnea

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