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

Abstract

Study objectives: 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.

Design: Cross-sectional self-report study.

Setting: Academic medical center and participant homes.

Participants: One thousand nine hundred ninety-three adults recruited from an Internet polling sample and 259 adults recruited from medical, psychiatric, and sleep clinics.

Interventions: None.

Measurements and results: 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.

Conclusions: 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.

Figure 1

Development of PROMIS sleep-wake function item banks. The flow chart on the left illustrates the major steps in the development of the Patient-Reported Outcomes Information System (PROMIS) sleep-wake function instruments. The table on the right side indicates the number of categories, subcategories, and items at each stage of the item bank development. EFA refers to exploratory factor analysis; CFA, confirmatory factor analysis.