Pnl19 Validating the Restless Legs Syndrome Quality of Life Questionnaire (Rlsqol) in a Trial Patient Population

Abetz, Linda; Arbuckle, Robert; Allen, RP; Mavraki, Elena; Jm, Kirsch

doi:10.1016/s1098-3015(10)66125-6

Cited by 25 publications

(46 citation statements)

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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. The largest subscale, the "summary score," is comprised of ten of the 18 RLS-QoL questions and was administered prior to pad assignment and at the end of week 4.…”

Section: Outcome Measures Efficacymentioning

confidence: 99%

“…32 The MOS sleep inventory measures sleep disturbance in the following domains: sleep disturbance (four items), sleep adequacy (two items), sleep quantity (one item), somnolence (three items), snoring (one item), and shortness of breath (one item). Consisting of nine of the twelve MOS questions, the MOS-II scale is the most comprehensive scale in the sleep inventory.…”

Section: Outcome Measures Efficacymentioning

confidence: 99%

“…The IRLS scale has been shown to correlate with MOS and RLS-QoL scores. 32 In addition, clinicians examined each patient at the beginning and at the end of the 4-week trial and scored change in clinical status into three categories: "improved," "unimproved," and "uncertain. "…”

Section: Outcome Measures Efficacymentioning

confidence: 99%

“…All correlations were moderate in magnitude, statistically significant at the P # 0.0001 level, and comparable to published correlations. 32 …”

Section: Efficacy Correlation Among Standardized Instrumentsmentioning

confidence: 99%

See 3 more Smart Citations

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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Section: Outcome Measures Efficacymentioning

confidence: 99%

Section: Outcome Measures Efficacymentioning

confidence: 99%

Section: Outcome Measures Efficacymentioning

confidence: 99%

“…All correlations were moderate in magnitude, statistically significant at the P # 0.0001 level, and comparable to published correlations. 32 …”

Section: Efficacy Correlation Among Standardized Instrumentsmentioning

confidence: 99%

See 2 more Smart Citations

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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“…38 MOS scores correlate with overall quality of life and IRLS scores in patients with RLS. 39 The Medical Outcomes Study Sleep Problems Index II (MOS-II) scale is the most exhaustive measure of sleep difficulty in the MOS inventory and contains nine of the 12 inventory questions. The Medical Outcomes Study Sleep Disturbance Scale (SLPD4) is a subscale of the MOS-II scale, containing four inventory questions.…”

Section: Prisma 2009 Flow Diagrammentioning

confidence: 99%

Improving sleep for patients with restless legs syndrome. Part II: meta-analysis of vibration therapy and drugs approved by the FDA for treatment of restless legs syndrome

Burbank¹,

Buchfuhrer²,

Kopjar³

et al. 2013

JPRLS

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Background: Vibratory stimulation pads have been shown to improve sleep in patients with restless legs syndrome (RLS) to a greater extent than sham therapy. The current gold standard of treatment is drugs approved by the US Food and Drug Administration (FDA) for use in RLS. The aim of this meta-analysis was to compare the efficacy and safety of vibratory stimulation pads, sham pads, and drugs approved by the FDA for use in RLS. Methods: We searched the PubMed, Embase, and clinical trial websites to identify the relevant randomized, double-blind, and placebo-controlled or sham-controlled studies. Fifteen studies including a combined total of 3455 patients with at least moderately severe primary RLS met our search criteria. Efficacy was defined as the standardized mean difference in sleep improvement between treatment and controls. Safety was assessed by comparing the odds ratios of any adverse events and adverse events leading to study withdrawal between treatment and control subjects. Results: Improvement in Medical Outcomes Study (MOS) sleep inventory scores from baseline was significantly greater in patients treated with vibratory stimulation pads than in those receiving sham pads (Hedges's g, standardized mean difference −0.39, P # 0.02). There was no difference in improvement in sleep scores between patients treated with vibratory stimulation pads (−0.39) and those receiving an approved RLS drug (−0.44, P . 0.70). The risk of any adverse event or withdrawal because of an adverse event was not significantly different between patients treated with vibratory stimulation pads and those assigned to sham pads (Mantel-Haenszel odds ratio 2.16 [P . 0.14] and 1.39 [P . 0.80], respectively). The odds ratios for patients reporting any adverse events and adverse events leading to withdrawal were not significantly different between patients treated with vibratory stimulation pads (2.16 and 1.39, respectively) and those who received approved RLS drugs (2.11 [P . 0.89] and 2.07 [P . 0.82], respectively, mixed-effects model). Conclusion: For patients with moderately severe RLS, vibratory stimulation pads were more effective than sham pads for improving sleep, as effective as FDA-approved RLS drugs, and as safe as both sham pads and FDA-approved RLS drugs.

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Responsiveness of the ABILHAND questionnaire in measuring changes in rheumatoid arthritis patients

Batcho¹,

Durez²,

Thonnard³

2010

Arthritis Care & Research

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Objective. ABILHAND is a Rasch-built questionnaire that measures manual ability in rheumatoid arthritis (RA) patients. This study aimed to examine the test-retest reliability and the responsiveness of ABILHAND in RA patients. Methods. Eighty-eight patients underwent 3 evaluations: the first evaluation was at baseline (time 1), the second was 2 weeks later (time 2), and the third was 1 year later (time 3). Disease activity was assessed using the Disease Activity Score in 28 joints using the C-reactive protein level (DAS28-CRP). Patients rated the intensity of their RA-related pain using a 100-mm visual analog scale for pain and completed questionnaires based on their activity limitations (ABILHAND and the Health Assessment Questionnaire) and quality of life. Results. The responsiveness analyses were conducted by using global, group, and individual approaches. The global approach showed significant differences between the time 1 and time 3 scores of the DAS28-CRP (P ‫؍‬ 0.04) and ABILHAND (P ‫؍‬ 0.04). Based on the changes in disease activity scores and the European League Against Rheumatism response criteria, the sample was divided into 3 groups: deteriorated, stable, and improved. The mean ؎ SD changes in manual ability were higher in the deteriorated (؊1.23 ؎ 1.53 logit) and in the improved (1.22 ؎ 2.06 logits) groups than in the stable group (0.48 ؎ 1.09 logit). The effect size and standardized response mean confirmed that observation. The minimal clinically important difference was assessed in each group of patients. Conclusion. The ABILHAND questionnaire exhibited responsiveness in detecting slight changes in RA patients. Therefore, the ABILHAND tool can be used to evaluate the functional status of RA patients in clinical trials and settings.

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Pnl19 Validating the Restless Legs Syndrome Quality of Life Questionnaire (Rlsqol) in a Trial Patient Population

Cited by 25 publications

References 0 publications

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

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

Improving sleep for patients with restless legs syndrome. Part II: meta-analysis of vibration therapy and drugs approved by the FDA for treatment of restless legs syndrome

Responsiveness of the ABILHAND questionnaire in measuring changes in rheumatoid arthritis patients

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