Patient-reported outcomes in insomnia: development of a conceptual framework and endpoint model.
This article describes qualitative research conducted with patients with clinical diagnoses of insomnia and focuses on the development of a conceptual framework and endpoint model that identifies a hierarchy and interrelationships of potential outcomes in insomnia research. Focus groups were convened to discuss how patients experience insomnia and to generate items for patient-reported questionnaires on insomnia and associated daytime consequences. Results for the focus group produced two conceptual frameworks: one for sleep and one for daytime impairment. Each conceptual framework consists of hypothesized domains and items in each domain based on patient language taken from the focus group. These item pools may ultimately serve as a basis to develop new questionnaires to assess insomnia.
United BioSource Corporation, Seattle, WA 98101, USA. leah.kleinman@unitedbiosource.com
Leah
L
Kleinman
Daniel J
DJ
Buysse
Gale
G
Harding
Kenneth
K
Lichstein
Anupama
A
Kalsekar
Thomas
T
Roth
D001294:Attitude to Health; D005260:Female; D017144:Focus Groups; D006801:Humans; D008297:Male; D008875:Middle Aged; D008960:Models, Psychological; D036301:Qualitative Research; D057566:Self Report; D012720:Severity of Illness Index; D007319:Sleep Initiation and Maintenance Disorders / Q000175:diagnosis / Q000503:physiopathology* / Q000523:psychology*; D011795:Surveys and Questionnaires