0612 Using Multiple Anchor-based And Distribution-based Estimates To Determine The Minimal Important Difference (MID) For The FOSQ-10. (27th April 2018)

• Record Type: Journal Article
• Authors: Weaver, T E; Crosby, R D; Bron, M; Menno, D; Mathias, S D
• Is Part Of: Sleep. Volume 41(2018)Supplement 1
• Page Start: A227
• Page End: A227
• Publication Date: 2018-04-27
• Subjects: Sleep -- Physiological aspects -- Periodicals; Sleep disorders -- Periodicals; Sommeil -- Aspect physiologique -- Périodiques; Sommeil, Troubles du -- Périodiques; Sleep disorders; Sleep -- Physiological aspects; Sleep -- physiological aspects; Sleep Wake Disorders; Psychophysiology; Electronic journals; Periodicals; 616.8498
• DOI: 10.1093/sleep/zsy061.611
• Languages: English
• ISSNs: 0161-8105

Abstract

Abstract: Introduction: An abbreviated 10-item version of the Functional Outcomes of Sleep Questionnaire, the FOSQ-10, is a patient-reported outcome (PRO) measure ideal for use in clinical practice or clinical studies. It assesses the impact of sleepiness in terms of general productivity, activity level, vigilance, social outcome, and sexual relationships (score range, 5–20). Its reliability, validity, and responsiveness have been demonstrated; however, an estimate of how much change is clinically meaningful, otherwise known as Minimal Important Difference (MID), is not available. Methods: Subjects with excessive sleepiness with narcolepsy or obstructive sleep apnea enrolled in one of two Phase 3 multicenter, randomized, 12-week, double-blind studies of solriamfetol (JZP-110) completed the FOSQ-10 and other PRO 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 subject. Data from the two studies were analyzed separately, both without regard to treatment assignment. MIDs were determined through both anchor-based and distribution-based approaches (ie, standard error of measurement [SEM], Cohen's d, and Guyatt's statistic). Results: 690 subjects (47% female, mean age 48 years [range: 18–75], 77% Caucasian, 91% from the United States) were enrolled. Spearman correlations between change in FOSQ-10 scores and the two potential clinical anchors (PGI-C and CGI-C) ranged from 0.370 to 0.568, confirming that both anchors were suitable for MID analysis. Mean FOSQ-10 changes for the response category of "minimally improved" ranged from 2.00 to 2.06 and 1.64 to 1.74 for the PGI-C and CGI-C ratings, respectively. Data from the three distribution-based approaches provided an MID estimate ranging from 1.26 to 1.93. Integrating these data with results from the two anchor-based approaches resulted in a FOSQ-10 MID estimate ranging from 1.7 to 2.0 points. Conclusion: Using anchor-based and distribution-based methods, the MID for the FOSQ-10 ranges from 1.7 to 2.0 points for a population of adults with excessive sleepiness with narcolepsy or obstructive sleep apnea. These estimates will be valuable for interpreting changes over time and defining a clinical responder. Support (If Any): Jazz Pharmaceuticals.