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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    • "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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    ABSTRACT: Background: Two item banks for substance use were developed as part of the Patient-Reported Outcomes Measurement Information System (PROMIS(®)): severity of substance use and positive appeal of substance use. Methods: Qualitative item analysis (including focus groups, cognitive interviewing, expert review, and item revision) reduced an initial pool of more than 5300 items for substance use to 119 items included in field testing. Items were written in a first-person, past-tense format, with 5 response options reflecting frequency or severity. Both 30-day and 3-month time frames were tested. The calibration sample of 1336 respondents included 875 individuals from the general population (ascertained through an internet panel) and 461 patients from addiction treatment centers participating in the National Drug Abuse Treatment Clinical Trials Network. Results: Final banks of 37 and 18 items were calibrated for severity of substance use and positive appeal of substance use, respectively, using the two-parameter graded response model from item response theory (IRT). Initial calibrations were similar for the 30-day and 3-month time frames, and final calibrations used data combined across the time frames, making the items applicable with either interval. Seven-item static short forms were also developed from each item bank. Conclusions: Test information curves showed that the PROMIS item banks provided substantial information in a broad range of severity, making them suitable for treatment, observational, and epidemiological research in both clinical and community settings.
    Drug and alcohol dependence 10/2015; 156. DOI:10.1016/j.drugalcdep.2015.09.008 · 3.42 Impact Factor
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    • "Like self-reported PA, selfreported sleep duration is subject to cognitive challenges and other sources of measurement error (Kessler et al., 2010; Lewandowski et al., 2011). Nevertheless, many studies suggest that valid and reliable estimates of sleep duration and sleep quality can be collected via self report in adults (e.g., Beaudreau et al., 2012; Buysse et al., 2010; Spira et al., 2012) and children (reviewed in Spruyt and Gozal, 2011). Variable results of past studies on the bidirectional associations between sleep and PA could be clarified or resolved with better measurement (Atkinson and Davenne, 2007; Lambiase et al., 2013). "
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    ABSTRACT: Objective: To examine the associations between objectively measured physical activity (PA) or sedentary behavior and self-reported sleep duration or daytime sleepiness in a nationally representative sample of healthy US adults (N=2128). Methods: We report analyses of four aspects of sedentary behavior and PA derived from accelerometry data (minutes of sedentary time, activity counts/minute, Minutes of Moderate and Vigorous PA [MVPA], and MVPA in 10-minute bouts) versus self-report of sleep duration and frequency of daytime sleepiness from the 2005-2006 National Health and Nutrition Examination Survey. Results: Age and sex dependence of associations between PA and sleep were observed. Aspects of PA were significantly lower in adults reporting more frequent daytime sleepiness in younger (20-39) and older (≥ 60) age groups, but not in middle-aged (40-59), respondents. In younger respondents, PA increased with sleep duration, but in middle aged and older respondents PA was either unrelated to sleep duration or lower in those reporting ≥ 8 h of sleep. Objectively measured sedentary time showed limited evidence of associations with sleep duration. Conclusions: Further research delineating the relationships between sleep and PA is important because both activities have been implicated in diverse health outcomes as well as in the etiology of obesity.
    Preventive Medicine 06/2014; 66. DOI:10.1016/j.ypmed.2014.06.003 · 3.09 Impact Factor
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    • "The Patient-Reported Outcomes Measurement Information System (PROMIS ® ) is an NIH Roadmap initiative devoted to developing better measurement tools for assessing constructs relevant to the clinical investigation and treatment of all diseasesdconstructs such as pain, fatigue, emotional distress, sleep, physical functioning , and social participation (Buysse et al., 2010; Cella et al., 2010, 2007b; Fries et al., 2009; Fries et al., 2014; Pilkonis et al., 2011; Revicki et al., 2009). PROMIS has created and refined a comprehensive methodology for developing item banks of these health-related constructs using both qualitative and quantitative techniques and modern psychometric methods (item response theory, IRT) (Cella et al., 2007a, 2010; Hilton, 2011; Reeve et al., 2007). "
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    ABSTRACT: The Patient-Reported Outcomes Measurement Information System (PROMIS(®)) is an NIH Roadmap initiative devoted to developing better measurement tools for assessing constructs relevant to the clinical investigation and treatment of all diseases-constructs such as pain, fatigue, emotional distress, sleep, physical functioning, and social participation. Following creation of item banks for these constructs, our priority has been to validate them, most often in short-term observational studies. We report here on a three-month prospective observational study with depressed outpatients in the early stages of a new treatment episode (with assessments at intake, one-month follow-up, and three-month follow-up). The protocol was designed to compare the psychometric properties of the PROMIS depression item bank (administered as a computerized adaptive test, CAT) with two legacy self-report instruments: the Center for Epidemiological Studies Depression scale (CESD; Radloff, 1977) and the Patient Health Questionnaire (PHQ-9; Spitzer et al., 1999). PROMIS depression demonstrated strong convergent validity with the CESD and the PHQ-9 (with correlations in a range from .72 to .84 across all time points), as well as responsiveness to change when characterizing symptom severity in a clinical outpatient sample. Identification of patients as "recovered" varied across the measures, with the PHQ-9 being the most conservative. The use of calibrations based on models from item response theory (IRT) provides advantages for PROMIS depression both psychometrically (creating the possibility of adaptive testing, providing a broader effective range of measurement, and generating greater precision) and practically (these psychometric advantages can be achieved with fewer items-a median of 4 items administered by CAT-resulting in less patient burden).
    Journal of Psychiatric Research 05/2014; 56(1). DOI:10.1016/j.jpsychires.2014.05.010 · 3.96 Impact Factor
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