Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. Sleep

Department of Psychiatry, University of Pittsburgh School of Medicine, PA, USA.
Sleep (Impact Factor: 4.59). 06/2010; 33(6):781-92.
Source: PubMed


To develop an archive of self-report questions assessing sleep disturbance and sleep-related impairments (SRI), to develop item banks from this archive, and to validate and calibrate the item banks using classic validation techniques and item response theory analyses in a sample of clinical and community participants.
Cross-sectional self-report study.
Academic medical center and participant homes.
One thousand nine hundred ninety-three adults recruited from an Internet polling sample and 259 adults recruited from medical, psychiatric, and sleep clinics.
This study was part of PROMIS (Patient-Reported Outcomes Information System), a National Institutes of Health Roadmap initiative. Self-report item banks were developed through an iterative process of literature searches, collecting and sorting items, expert content review, qualitative patient research, and pilot testing. Internal consistency, convergent validity, and exploratory and confirmatory factor analysis were examined in the resulting item banks. Factor analyses identified 2 preliminary item banks, sleep disturbance and SRI. Item response theory analyses and expert content review narrowed the item banks to 27 and 16 items, respectively. Validity of the item banks was supported by moderate to high correlations with existing scales and by significant differences in sleep disturbance and SRI scores between participants with and without sleep disorders.
The PROMIS sleep disturbance and SRI item banks have excellent measurement properties and may prove to be useful for assessing general aspects of sleep and SRI with various groups of patients and interventions.

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    • "The PROMIS had been validated in several languages (for detailed information, see including English, French and Spanish (internal consistency: >0.9; construct validity: product-moment correlations ≥ 0.96) (Buysse et al., 2010; Yu et al., 2011). A total score ranging from 0 to 2 was obtained by summing up the answers to the two questions, a score of 1 or more indicating the presence of sleep disturbance. "
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    • "outcomes using state-of-the-art psychometric methods (see www. PROMIS item banks provide a comprehensive profile of health status, including physical functioning, pain, fatigue, sleep disturbance, emotional distress, alcohol use, and social participation (Buysse et al., 2010; Cella et al., 2010; Fries et al., 2009; Pilkonis et al., 2011, 2013; Revicki et al., 2009). PROMIS is the most ambitious attempt to date to apply models from item response theory (IRT) to health-related assessment (Cella et al., 2010; Hilton, 2011; Reeve et al., 2007). "
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