IRLS: Measuring Restless Legs Syndrome Severity
The IRLS rates the severity of restless legs syndrome over the past week across ten items. It is the standard primary endpoint in restless legs treatment trials.
International Restless Legs Syndrome Rating Scale (IRLS)
The International Restless Legs Syndrome Study Group Rating Scale is a ten item measure of restless legs syndrome severity over the preceding week. It covers the intensity and frequency of symptoms, their effect on sleep, and their impact on mood and daily life, giving a total from 0 to 40. It is used only once the diagnosis has been established.
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Disease
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What is the International Restless Legs Syndrome Rating Scale
Each of the ten items is rated from 0, none, to 4, very severe. The items ask about the discomfort in the legs or arms, the urge to move, how much relief movement brings, how much sleep is disturbed, how tired or sleepy the person is during the day, how severe the condition is overall, how often symptoms occur, how long they last on an average day, and how much they affect daily activities and mood. The scale is completed only by people who already meet the diagnostic criteria for restless legs syndrome; it grades severity, it does not screen for the condition.
The International Restless Legs Syndrome Study Group developed and validated it, and it has since become the primary efficacy endpoint in most treatment trials for the condition. The items fall broadly into two groups, symptoms and their impact, and some analyses report the two separately because a treatment can reduce the urge to move without restoring sleep.
The ten item scores are summed for a total from 0 to 40. Totals of 1 to 10 are commonly described as mild, 11 to 20 moderate, 21 to 30 severe and 31 to 40 very severe. Change from baseline in the total is the usual trial endpoint, often alongside the proportion of participants rated much or very much improved on a clinical global impression scale.
Two issues shape how results should be read. Restless legs trials show a large placebo response, so an uncontrolled fall in the total says little about a treatment's effect. And long term dopaminergic treatment can cause augmentation, a worsening of symptoms that spread earlier in the day or to other body parts; the IRLS was not designed to detect augmentation, which needs its own assessment. The scale is copyrighted by the Study Group and licensed through the Mapi Research Trust, so use in a study requires permission.
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Digital counterpart
Digital biomarkers that measure the same thing with sensors rather than a questionnaire.
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