Ralf Kohnen1, Pablo Martinez-Martin2, Heike Benes3, Claudia Trenkwalder4, Birgit Högl5, Elmar Dunkl6, Arthur S Walters7. 1. Posthumously, Research Pharmaceutical Services, Inc., Fort Washington, PA, USA; University of Erlangen-Nuremberg, Genmany. 2. National Center of Epidemiology and CIBERNED, Carlos III Institute of Health, Madrid, Spain. 3. Somni Bene Institute for Medical Research and Sleep Medicine, Schwerin, Germany; Medical Center, University of Rostock, Rostock, Germany. 4. Department of Clinical Neurophysiology, University Medical Center, Goettingen, Germany; Paracelsus Elena Clinic, Kassel, Germany. 5. Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria. 6. PRA Health Sciences, Nuremberg, Germany. 7. Department of Neurology, Vanderbilt University School of Medicine, Nashville, TN, USA. Electronic address: arthur.walters@vanderbilt.edu.
Abstract
BACKGROUND: The International Restless Legs Scale (IRLS) is the most widely used of the scales rating the severity of restless legs syndrome/Willis-Ekbom disease (RLS/WED). It has been well validated and is the primary end point for most of the therapeutic and nontherapeutic studies of RLS/WED. It has excellent psychometric properties, although it does not capture the severity of RLS under a wide variety of circumstances and times of day. Moreover, the IRLS has a large placebo effect. METHODS: The Restless Legs Syndrome-6 Scale (RLS-6), however, takes another potentially valuable approach. Six items are rated on a 0-10 scale from no symptoms at 0 to very severe at 10. In addition to questions on satisfaction with sleep and sleepiness, the scale rates the severity of RLS for the past week under four separate circumstances: while falling asleep, during the night, during the day while sitting or lying, and during the day when moving around. The purpose of the current study is to report the validation of the RLS-6 under baseline and therapeutic conditions. RESULTS: The RLS-6 seems to be an acceptable, reliable, precise, valid, and responsive instrument for the assessment of RLS severity in a specific and pragmatic manner. CONCLUSIONS: At present, we view the RLS-6 not as a replacement for the IRLS but as a supplement, as each scale provides information not captured by the other.
BACKGROUND: The International Restless Legs Scale (IRLS) is the most widely used of the scales rating the severity of restless legs syndrome/Willis-Ekbom disease (RLS/WED). It has been well validated and is the primary end point for most of the therapeutic and nontherapeutic studies of RLS/WED. It has excellent psychometric properties, although it does not capture the severity of RLS under a wide variety of circumstances and times of day. Moreover, the IRLS has a large placebo effect. METHODS: The Restless Legs Syndrome-6 Scale (RLS-6), however, takes another potentially valuable approach. Six items are rated on a 0-10 scale from no symptoms at 0 to very severe at 10. In addition to questions on satisfaction with sleep and sleepiness, the scale rates the severity of RLS for the past week under four separate circumstances: while falling asleep, during the night, during the day while sitting or lying, and during the day when moving around. The purpose of the current study is to report the validation of the RLS-6 under baseline and therapeutic conditions. RESULTS: The RLS-6 seems to be an acceptable, reliable, precise, valid, and responsive instrument for the assessment of RLS severity in a specific and pragmatic manner. CONCLUSIONS: At present, we view the RLS-6 not as a replacement for the IRLS but as a supplement, as each scale provides information not captured by the other.
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