Pilot study of Restless Leg Syndrome in Kaiser Permanente

(In conjunction with Stanford University, Funded by: Restless Legs Syndrome Foundation)

A reliable and valid assessment tool for diagnosing RLS is essential for determining accurate estimates of disease frequency. The variability in RLS prevalence is in part due to methodological differences in case definition criteria and instruments used for diagnosing RLS. Experts have recommended the use of a minimum set of four questions; however, the reliability and validity of these minimal set of questions has not been adequately assessed. This pilot study will evaluate the performance of these questions and concurrently develop and evaluate the utility of an expanded questionnaire. We are conducting the study in the Kaiser Permanente Medical Care Program (KPMCP) of Northern California. A random sample of subjects will be administered the four questions alone or the expanded version in a telephone-based interview or as a self-administered questionnaire. Reliability of the instruments will be evaluated by re-administering the same questionnaire to subjects. A consensus diagnostic review by a panel of three movement disorder specialists is being used as the “gold standard” for validating RLS diagnosis. Validity of the questionnaires will be evaluated by comparing each to this “gold standard.” This pilot study will serve as a foundation for the larger epidemiological study to determine incidence, prevalence, and risk factors of RLS.

This study is beginning to identify study participants. Data collection has not yet begun.