The reliability, validity and responsiveness of the International Restless Legs Syndrome Study Group rating scale and subscales in a clinical-trial setting

Abetz, Linda; Arbuckle, Robert; Allen, Richard P.; Garcı́a-Borreguero, Diego; Hening, Wayne A.; Walters, Arthur S.; Mavraki, Elena; Jm, Kirsch

doi:10.1016/j.sleep.2005.12.011

Cited by 101 publications

(59 citation statements)

References 25 publications

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“…Nine of the 10 items investigate two dimensions of RLS severity, symptoms (six items), and symptoms effect (three items). This self-administered instrument was developed and validated by the IRLS Study Group (18,20) and has been used to test the efficacy of drugs developed for treatment of RLS (21,22). Responses are graded from 0 to 4, with a higher score reflecting higher severity.…”

Section: Assessment Of Rls and Symptoms Severitymentioning

confidence: 99%

Impact of Short Daily Hemodialysis on Restless Legs Symptoms and Sleep Disturbances

Jaber

Schiller

Burkart

et al. 2011

Clinical Journal of the American Society of Nephrology

101

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SummaryBackground and objectives Restless legs syndrome (RLS) and sleep disturbances are common among in-center hemodialysis patients and are associated with increased morbidity/mortality. Design, setting, participants, & measurementsThe FREEDOM study is an ongoing prospective cohort study investigating the benefits of home short daily hemodialysis (SDHD) (6 times/week). In this interim report, we examine the long-term effect of SDHD on the prevalence and severity of RLS, as measured by the International Restless Legs Syndrome (IRLS) Study Group rating scale, and sleep disturbances, as measured by the Medical Outcomes Study sleep survey.Results 235 participants were included in this report (intention-to-treat cohort), of which 127 completed the 12-month follow-up (per-protocol cohort). Mean age was 52 years, 55% had an arteriovenous fistula, and 40% suffered from RLS. In the per-protocol analysis, among patients with RLS, the mean IRLS score improved significantly at month 12, after adjustment for use of RLS-related medications (18 versus 11). Among patients with moderate-to-severe RLS (IRLS score Ն15), there was an even greater improvement in the IRLS score (23 versus 13). The intention-to-treat analysis yielded similar results. Over 12 months, there was decline in the percentage of patients reporting RLS (35% versus 26%) and those reporting moderate-to-severe RLS (59% versus 43%). There was a similar and sustained 12-month improvement in several scales of the sleep survey, after adjustment for presence of RLS and use of anxiolytics and hypnotics.Conclusions Home SDHD is associated with long-term improvement in the prevalence and severity of RLS and sleep disturbances.

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Section: Assessment Of Rls and Symptoms Severitymentioning

confidence: 99%

Impact of Short Daily Hemodialysis on Restless Legs Symptoms and Sleep Disturbances

Jaber

Schiller

Burkart

et al. 2011

Clinical Journal of the American Society of Nephrology

101

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“…This tool has been used in previous treatment studies of RLS and is described elsewhere [18]. The International RLS Study Group severity scale was used as secondary outcome measures (IRLS) [19,20] ).…”

Section: Questionnaires and Proceduresmentioning

confidence: 99%

A randomized, double-blind, placebo-controlled trial of intravenous iron sucrose in restless legs syndrome

et al. 2009

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Objective: The aim of this study was to ascertain whether high-dose intravenous (IV) iron sucrose could improve symptoms and change brain iron concentrations in idiopathic RLS. Methods:The study was a randomized, parallel-group double-blind study of 1000 mg iron sucrose given IV versus placebo. Primary measures of the clinical status were global rating scale (GRS) and periodic leg movements of sleep (PLMS). Primary measures of brain iron status were CSF ferritin and MRI-determined iron in the substantia nigra.Results: At the time of the interim analysis there were 7 placebo and 11 iron-treated subjects. At 2-weeks post-treatment, iron treatment resulted in a small but significant increase in CSF ferritin and decrease in RLS severity (GRS) but did not change PLMS or MRI iron index. None of the secondary outcomes changed with treatment. There was no single case of clear treatment benefit in any of the patients. This interim analysis revealed an effect size that was too small to allow for adequate power to find significant differences with the planed 36-subject enrollment for either the primary objective outcome of PLMS or any of the secondary outcomes. The study was stopped at this planned breakpoint given the lack of both adequate power and any indication for clinically significant benefit.Conclusions: High-dose IV iron failed to demonstrate the robust changes reported in three prior open-label studies. Differences in iron formulation, dosing regiment, and peripheral iron status may explain some of the discrepancies between this and previous IV iron treatment studies.

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“…29,[32][33][34] It correlates with IRLS and MOS scores. 32 The full survey contains 18 questions in seven subscales.…”

Section: Outcome Measures Efficacymentioning

confidence: 97%

“…The IRLS scale measures RLS severity [27][28][29] and was administered as a requirement of entry into the study and at the end of weeks 1 through 4. The IRLS scale consists of ten questions, with each question having a potential score of 0 to 4.…”

Section: Outcome Measures Efficacymentioning

confidence: 99%

Sleep improvement for restless legs syndrome patients. Part I: pooled analysis of two prospective, double-blind, sham-controlled, multi-center, randomized clinical studies of the effects of vibrating pads on RLS symptoms

Burbank¹,

Buchfuhrer²,

Kopjar³

2013

JPRLS

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The reliability, validity and responsiveness of the International Restless Legs Syndrome Study Group rating scale and subscales in a clinical-trial setting

Cited by 101 publications

References 25 publications

Impact of Short Daily Hemodialysis on Restless Legs Symptoms and Sleep Disturbances

Impact of Short Daily Hemodialysis on Restless Legs Symptoms and Sleep Disturbances

A randomized, double-blind, placebo-controlled trial of intravenous iron sucrose in restless legs syndrome

Sleep improvement for restless legs syndrome patients. Part I: pooled analysis of two prospective, double-blind, sham-controlled, multi-center, randomized clinical studies of the effects of vibrating pads on RLS symptoms

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