OBJECTIVE: To quantify the total and unique burden of Restless Legs Syndrome (RLS) on patient-reported health-related quality of life (HRQoL).

METHODS: The disease burden that RLS places on HRQoL was estimated by comparing Short-Form (SF-36) scores between individuals with RLS and several patient and general populations in the US. Regression methods were applied to estimate SF-36 normative values from the general population sample and statistically adjust them to match age, gender and disease comorbidity characteristics of the RLS sample. Significance tests were then used to compare the means across samples.

RESULTS: All SF-36 measures were significantly below adjusted US general population norms. Five of the eight scales (physical functioning, role physical, bodily pain, general health, vitality) were below US norms by 0.8 or more standard deviations (SD), while the remaining three (social functioning, role emotional, mental health) were 0.5 SD below norm. The burden of RLS was greater on physical than on mental/emotional HRQoL (physical and mental summary scores were 1.08 and 0.40 SD below norm, respectively), and greater than that observed for type-2 diabetes.

CONCLUSION: After controlling for the impact of age, gender, and disease comorbidity, RLS was associated with unique burden on both physical and mental aspects of HRQoL.