Psychometric evaluation and tests of validity of the Medical Outcomes Study 12-item Sleep Scale (MOS sleep)

Allen, Richard P.; Kosinski, Mark; Hill-Zabala, Christina; Calloway, Michael

doi:10.1016/j.sleep.2008.06.003

Cited by 104 publications

(84 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Relapse was defined as the worsening of RLS symptoms (an increase of at least 6 points in the IRLS total score from DB baseline [week 24, randomization] to a score of at least 15 points and a rating of "much worse" or "very much worse" on the investigator-rated Clinical Global Impression of Change [CGI-C] scale on 2 consecutive visits at least 1 week apart) or withdrawal because of lack of efficacy. Secondary outcome end points during the DB phase included the time to relapse (the first date on which relapse criteria were met or the date of withdrawal because of lack of efficacy) for weeks 24 to 36; change from randomization in IRLS total score at week 36; proportion of patients rated as responders on the investigator-rated CGI-C scale (response since randomization defined as "very much improved," "much improved," "minimally improved," or "no change") and patientrated CGI-I (response since randomization defined as "much improved" or "very much improved") at week 36; change from randomization to week 36 in domains of the Medical Outcomes Study (MOS) Sleep Scale 29,30 ; responses on the investigator-designed Post-Sleep Questionnaire (PSQ) at week 36 24 ; change from randomization to week 36 in the RLS Quality of Life (QoL) questionnaire overall life-impact score 31 ; and the onset and severity of RLS symptoms at week 36 recorded by a 24-hour RLS diary (beginning at 8 am daily).…”

Section: Outcome Measuresmentioning

confidence: 99%

Long-term Maintenance Treatment of Restless Legs Syndrome With Gabapentin Enacarbil: A Randomized Controlled Study

Bogan

Bornemann

Kushida

et al. 2010

Mayo Clinic Proceedings

View full text Add to dashboard Cite

for the XP060 Study GroupObjective: To assess maintenance of efficacy and tolerability of gabapentin enacarbil in patients with moderate to severe primary restless legs syndrome (RLS). Patients and MethOds:This study (conducted April 18, 2006, to November 14, 2007) comprised a 24-week, single-blind (SB) treatment phase (gabapentin enacarbil, 1200 mg) followed by a 12-week randomized, double-blind (DB) phase. Responders from the SB phase (patients with improvements on the International Restless Legs Scale [IRLS] and investigator-rated Clinical Global Impression-Improvement scale at week 24 and stable while taking a gabapentin enacarbil dose of 1200 mg for at least 1 month before randomization) were randomized to gabapentin enacarbil, 1200 mg, or placebo once daily at 5 pm with food. The primary end point was the proportion of patients experiencing relapse (worse scores on the IRLS and investigator-rated Clinical Global Impression of Change scale on 2 consecutive visits at least 1 week apart or withdrawal because of lack of efficacy) during the DB phase.Results: A total of 221 of 327 patients completed the SB phase, 194 (96 in the gabapentin enacarbil group and 98 in the placebo group) were randomized to DB treatment, and 168 (84 in the gabapentin enacarbil group and 84 in the placebo group) completed the DB phase. A significantly smaller proportion of patients treated with gabapentin enacarbil (9/96 [9%]) experienced relapse compared with the placebo-treated patients (22/97 [23%]) (odds ratio, 0.353; 95% confidence interval, 0.2-0.8; P=.02). Somnolence and dizziness were the most common adverse events. One death occurred (unintentional choking during the SB phase) and was judged as being unrelated to the study drug. No clinically relevant changes were observed in laboratory values, in vital signs, or on electrocardiograms.cOnclusiOn: Gabapentin enacarbil, 1200 mg, maintained improvements in RLS symptoms compared with placebo and showed long-term tolerability in adults with moderate to severe primary RLS for up to 9 months of treatment. the study was funded by XenoPort inc, santa clara, ca. Research funding for the design and conduct of this study and the collection, management, analysis, and interpretation of the data were sponsored by XenoPort. Preparation, review, and approval of the submitted manuscript were sponsored by GlaxosmithKline, Research triangle Park, nc. dr bogan is a shareholder and employee of sleepMed; he has received consultancy fees from cephalon, GlaxosmithKline, and jazz Pharmaceuticals; has received research funding from actelion Pharmaceuticals, addrenex Pharmaceuticals, apnicure, arena Pharmaceuticals, boehringer ingelheim, cephalon, GlaxosmithKline, evotec, eli lilly and company, johnson & johnson, Merck & co, neurogen, Pfizer, novartis Pharmaceuticals, Philips, ResMed, sanofi-aventis, schwarz Pharma, sensory Medical, sepracor, vanda Pharmaceuticals, ventus Medical, and XenoPort; and has participated in speakers' bureaus for sanofi-aventis, sepracor, cephalon, and jazz Pharmaceuticals. ...

show abstract

Section: Outcome Measuresmentioning

confidence: 99%

Long-term Maintenance Treatment of Restless Legs Syndrome With Gabapentin Enacarbil: A Randomized Controlled Study

Bogan

Bornemann

Kushida

et al. 2010

Mayo Clinic Proceedings

View full text Add to dashboard Cite

show abstract

“…50 These well-established scales have been shown to be sensitive to short-term behavioral interventions, and have been validated in a wide range of populations, including patients with RLS. [51][52][53][54][55][56][57][58][59][60] Blood pressure and heart rate were measured with subjects in a seated position following a 5-minute rest period; using the OMRON HEM-780 automatic blood pressure monitor, measurements were taken 3 times and averaged for a final score.…”

Section: Outcome Assessmentmentioning

confidence: 99%

Efficacy of an Eight-Week Yoga Intervention on Symptoms of Restless Legs Syndrome (RLS): A Pilot Study

Innes

Selfe

Agarwal

et al. 2013

The Journal of Alternative and Complementary Medicine

View full text Add to dashboard Cite

Background: Restless legs syndrome (RLS) is a common and highly burdensome sleep disorder. While relaxation therapies, including yoga, are often recommended for RLS management, rigorous supporting research is sparse. The goal of this preliminary study was to assess the effects of yoga on RLS symptoms and related outcomes in women with RLS. Methods: Participants were 13 nonsmoking women with moderate to severe RLS, who did not have diabetes, sleep apnea, or other serious concomitant chronic conditions, and who were not pregnant. The intervention was a gentle, 8-week Iyengar yoga program. Core outcomes assessed pre-and post-treatment were RLS symptoms and symptom severity (International RLS Scale [IRLS] and RLS ordinal scale), sleep quality (Medical Outcomes Study Sleep Scale), mood (Profile of Mood States), and perceived stress (Perceived Stress Scale). Participants also completed yoga logs and a brief exit questionnaire regarding their experience with the study. Results: Ten (10) women, aged 32-66 years, completed the study. Participants attended an average 13.4 -0.5 (of 16 possible) classes, and completed a mean of 4.1 -0.3 (of 5 possible) homework sessions/week. At follow-up, participants demonstrated striking reductions in RLS symptoms and symptom severity, with symptoms decreasing to minimal/mild in all but 1 woman and no participant scoring in the severe range by week 8. Effect sizes (Cohen's d) were large: 1.6 for IRLS total, and 2.2 for RLS ordinal scale. IRLS scores declined significantly with increasing minutes of homework practice per session (r = 0.70, p = 0.025) and total homework minutes (r = 0.64, p < 0.05), suggesting a possible dose-response relation. Participants also showed significant improvements in sleep, perceived stress, and mood (all p's £ 0.02), with effect sizes ranging from 1.0 to 1.6. Conclusions: These preliminary findings suggest that yoga may be effective in attenuating RLS symptoms and symptom severity, reducing perceived stress, and improving sleep and mood in women with RLS.

show abstract

“…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.…”

Section: Prisma 2009 Flow Diagrammentioning

confidence: 94%

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

View full text Add to dashboard Cite

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.

show abstract

Psychometric evaluation and tests of validity of the Medical Outcomes Study 12-item Sleep Scale (MOS sleep)

Cited by 104 publications

References 19 publications

Long-term Maintenance Treatment of Restless Legs Syndrome With Gabapentin Enacarbil: A Randomized Controlled Study

Long-term Maintenance Treatment of Restless Legs Syndrome With Gabapentin Enacarbil: A Randomized Controlled Study

Efficacy of an Eight-Week Yoga Intervention on Symptoms of Restless Legs Syndrome (RLS): A Pilot Study

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

Contact Info

Product

Resources

About