Validation of the Restless Legs Syndrome Quality of Life questionnaire.
OBJECTIVE
The Restless Legs Syndrome Quality of Life questionnaire (RLSQoL) assesses the impact of RLS on daily life, emotional well-being, social life, and work life. This study investigates its validity and reliability.


METHODS
The RLSQoL was tested in 85 American adults with primary RLS. Patients were also asked to rate symptom severity with the International Restless Legs Scale (patient-reported version) and report on changes in symptoms over the 2-week period.


RESULTS
The RLSQoL summary scale score (range: 0-100) demonstrated acceptable internal consistency reliability (Cronbach's alpha = 0.92) and test-retest reliability (intraclass correlation coefficient = 0.84). All items indicated acceptable item-convergent validity. The RLSQoL distinguished between groups with mild, moderate, and severe symptoms (F = 52.22, P < 0.0001). It demonstrated preliminary responsiveness to changes in RLS status over 2 weeks (effect size: improvement, 0.25; deterioration, -0.32), indicating moderate scale changes consistent with the small clinical change over this time.


CONCLUSIONS
These findings support the conceptual framework of the RLSQoL. It is a valid and reliable measure of the impact of RLS on QoL and is responsive to short-term changes in symptom severity. The RLSQoL appears to be an appropriate tool for trial-based assessments of treatments for RLS.
Abetz
Linda
L
Mapi Values Ltd., Macclesfield, Cheshire, UK. Linda.Abetz@adelphi.co.uk
Vallow
Susan M
SM
Kirsch
Jeff
J
Allen
Richard P
RP
Washburn
Tinna
T
Earley
Christopher J
CJ
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011594:Psychometrics / Q000295:instrumentation*; D011788:Quality of Life; D012148:Restless Legs Syndrome / Q000503:physiopathology* / Q000523:psychology*; D012720:Severity of Illness Index; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires