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


METHODS
Cross-sectional self-report study.


METHODS
Academic medical center and participant homes.


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


METHODS
None.


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.
Buysse
Daniel J
DJ
Department of Psychiatry, University of Pittsburgh School of Medicine, PA, USA. buyssedj@upmc.edu
Yu
Lan
L
Moul
Douglas E
DE
Germain
Anne
A
Stover
Angela
A
Dodds
Nathan E
NE
Johnston
Kelly L
KL
Shablesky-Cade
Melissa A
MA
Pilkonis
Paul A
PA
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003430:Cross-Sectional Studies; D005163:Factor Analysis, Statistical; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011594:Psychometrics; D015203:Reproducibility of Results; D012650:Self Disclosure; D012893:Sleep Wake Disorders / Q000175:diagnosis*; D011795:Surveys and Questionnaires; D055815:Young Adult