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Background: There have been few quality of life (QoL) studies of patients with restless legs syndrome (RLS) in Asian countries. We studied the QoL of patients with RLS and compared it to normal controls and patients with hypertension, type 2 diabetes, or osteoarthritis in Korea., Methods: A total of 215 RLS patients (141 female; mean age 51.7 ± 13.5) were enrolled. All patients completed the questionnaires, including all the Korean versions of SF-36, RLS QoL, the International RLS Severity scale (IRLS), the Pittsburgh Sleep Quality Index (PSQI), and the Beck Depression Inventory-2 (BDI-2). These results were compared with the scores from normal controls (N=214) and from patients with hypertension (196), uncomplicated type 2 diabetes (185), or osteoarthritis of the knee (177)., Results: The SF-36 QoL in patients with RLS was lower than that of the normal controls, and even lower than patients with hypertension or diabetes, but higher than those with osteoarthritis. The SF-36 Qol of RLS patients showed a significantly negative correlation with the severity of RLS symptoms(r=-0.430, p<0.001) and the severity of depression (r=-0.565, p<0.001), but was not significantly related to gender, age, or age-of-symptom onset (early or late-onset). Step-wise multiple regression identified three factors related to SF-36 QoL: depression (46.5% of RLS had responses on BDI-2 indicating depression) (β=-.899, p<0.001), RLS symptom severity (K-IRLS) (β=-.718, p<0.001), and gender (female) (β=-6.128, p=0.007)., Conclusions: These findings show that RLS has a considerable impact on the QoL of Koreans, which is comparable with studies of western countries. The QoL impairment relates to the degree of depression with RLS for Koreans., (Copyright © 2012 Elsevier B.V. All rights reserved.)

Background: Pramipexole is an effective treatment for restless legs syndrome (RLS), but no controlled studies have lasted >12 weeks., Methods: RLS patients (N=331) with pretreatment serum ferritin >30 ng/mL were randomly assigned to take double-blind optimized pramipexole (0.125-0.75 mg/d) or placebo for 26 weeks. The primary efficacy endpoint was change in International RLS Study Group Rating Scale (IRLS) score. Other endpoints assessed global change, symptoms, and QoL. Patients maintained symptom diaries. Cases meeting predefined criteria for suspected augmentation were reviewed by a blinded expert panel, which used a predefined algorithm., Results: Among 321 patients providing post-baseline data, of whom 234 completed 26 weeks, pramipexole was more effective than placebo by multiple endpoints, including an adjusted mean IRLS score change of -13.7 vs. -11.1 (p=0.0077) and an IRLS responder rate (≥50% score reduction) of 58.6% vs. 42.8% (p=0.0044). Efficacy showed considerable country-to-country variability. Six-month incidence of confirmed augmentation was 9.2% for pramipexole and 6.0% for placebo. The rate increased with treatment duration for pramipexole but not placebo. Treatment-related adverse events (AEs) were more likely for pramipexole than for placebo, but discontinuation due to AEs was less likely., Conclusions: During a 6-month period, pramipexole was effective, safe, and generally well tolerated. Because risk of augmentation may have increased over 6 months, it should be studied in longer trials. Beginning or mild augmentation is difficult to distinguish from natural RLS fluctuation, at least in a non-iron-deficient population., (Copyright © 2011 Elsevier B.V. All rights reserved.)

The Restless Legs Syndrome (RLS) is a sensorimotor disorder that has only recently been extensively investigated by validated methods. Following the first presentation of diagnostic criteria by the International RLS Study Group in 1995, several methods were specifically developed for clinical trials in RLS or adapted from other areas of medicine and health sciences. We present a critical overview on validated methods to assess (1) severity of RLS symptoms [International RLS Rating Scale (IRLS), John Hopkins RLS Severity Scale (JHRLSSS), the RLS-6 scales, and the investigator-based Clincial Global Impressions (CGI)]; (2) quality of life [RLS Quality of Life Instrument (RLS-QLI), Hopkins RLS Quality of Life Questionnaire (RLSQoL), and the RLS Quality of Life Questionnaire (QoL-RLS)]; (3) sleep disturbances and sudden onset of sleep; (4) sleep laboratory methods (polysomnography, limb activity monitoring by actigraphy) to evaluate sleep and periodic leg movements (including the "suggested immobilization test"); and (5) severity of augmentation (Augmentation Severity Rating Scale, ASRS). It is concluded that several validated methods are available to investigate the main features of RLS in practice and in clinical trials; however, further developments are needed to address new questions like the consequences of RLS on life functioning in areas such as ability to travel, days missed at work or impaired work performance.

While the restless legs syndrome (RLS) may have been known in antiquity, it has only recently come to medical attention. Individuals with RLS fall along a spectrum from mild, infrequent symptoms to those with severe daily life-impairing discomforts and sleep disruption. These problems can cause impaired mood, daytime fatigue, cognitive difficulties, and inability to participate in a variety of quiet activities. This leads to a general reduction in quality of life similar to other significant psychiatric and medical disorders. Recent studies suggest that RLS may be a risk factor for developing both psychiatric disorders (such as major depression and anxiety) and somatic diseases (such as hypertension and cardiovascular disease). In dialysis patients, RLS has been found to be a risk factor for mortality. Therefore, those with RLS who have clinically significant symptoms suffer increased morbidity and are at risk for impaired long-term medical outcomes.

Background and Purpose: To explore aspects of restless legs syndrome (RLS) associated with detrimental impact on health-related quality of life (HRQoL)., Patients and Methods: The RLS epidemiology, symptoms, and treatment (REST) survey included SF-36 data on adults with RLS symptoms in the USA and five European countries. Linear regression models on each SF-36 dimension score explored factors influencing HRQoL in this population., Results: Of 16,202 people surveyed, 7% screened positively for RLS. Severity of RLS symptoms was strongly associated with impaired physical and mental HRQoL in both the cohorts from the USA and Europe. Distress and symptom frequency also had predictive capability. In addition, significantly diminished HRQoL was associated with the use of prescription medication for RLS symptoms. Age, number of comorbidities, and number of physician visits were statistically associated with lower HRQoL in respondents with RLS., Conclusions: Diminished HRQoL was partly accounted for by a number of RLS-related factors, including frequency, severity, and distress from symptoms. The negative impact of prescription medications on HRQoL, in contrast to demonstrated improvements with dopamine agonists, suggests inappropriate or ineffective medications are being used in this population. Our results strongly support the need for better physician education, both to diagnose the condition and importantly provide appropriate treatment with dopamine agonists, the only class of medication, that has been shown to improve the HRQoL of patients with RLS.

Background: The aim of this study was to determine the reliability, validity and responsiveness of the Restless Legs Syndrome Quality of Life questionnaire (RLSQoL) in a clinical trial setting., Methods: Two matching, placebo-controlled, multinational studies assessing the effectiveness and safety of ropinirole for treating moderate-to-severe Restless Legs Syndrome (RLS) formed the basis of this psychometric assessment. Validity and reliability were assessed using baseline data. Responsiveness was determined using longitudinal data collected at baseline and 12 weeks., Results: A total of 547 subjects formed the baseline validation population; 519 were used for assessing responsiveness (n = 284/263 and 271/248 for both studies, respectively). Construct validity assessment confirmed that an overall life impact score could be calculated. All item-scale correlations were = 0.4, except items 1 (r = 0.36) and 5 (r = 0.35) in one study. Floor and ceiling effects were minimal. Cronbach's alpha values were 0.82 and 0.87, respectively, confirming internal consistency reliability. Correlations with the International Restless Legs Syndrome Study Group's severity rating scale (International Restless Legs Scale; IRLS) were moderate (r = -0.68 and -0.67, respectively; p < 0.0001). The RLSQoL was able to discriminate between levels of sleep problems (p < 0.0001) and between levels of global health status determined by a Clinical Global Impression of severity (CGI-S) (p < 0.0001). Responsiveness was demonstrated by significant differences in overall life impact change scores between CGI improvement levels after 12 weeks (p < 0.0001)., Conclusion: The RLSQoL is a valid, reliable and responsive measure of quality of life for patients with RLS, in a clinical trial setting where group comparisons are anticipated.

Background: Restless legs syndrome (RLS), a common sensorimotor disorder, has a wide range of severity from merely annoying to affecting sleep and quality of life severely enough to warrant medical treatment. Previous epidemiological studies, however, have failed to determine the prevalence of those with clinically significant RLS symptoms and to examine the life effects and medical experiences of this group., Methods: A total of 16 202 adults (aged >/=18 years) were interviewed using validated diagnostic questions to determine the presence, frequency, and severity of RLS symptoms; respondents reporting RLS symptoms were asked about medical diagnoses and the impact of the disorder and completed the Short Form-36 Health Survey (SF-36). Criteria determined by RLS experts for medically significant RLS (frequency at least twice a week, distress at least moderate) defined "RLS sufferers" as a group most likely to warrant medical treatment., Results: In all, 15 391 fully completed questionnaires were obtained; in the past year, RLS symptoms of any frequency were reported by 1114 (7.2%). Symptoms occurred at least weekly for 773 respondents (5.0%); they occurred at least 2 times per week and were reported as moderately or severely distressing by 416 (2.7%). Of those 416 (termed RLS sufferers), 337 (81.0%) reported discussing their symptoms with a primary care physician, and only 21 (6.2%) were given a diagnosis of RLS. The SF-36 scores for RLS sufferers were significantly below population norms, matching those of patients with other chronic medical conditions., Conclusion: Clinically significant RLS is common (prevalence, 2.7%), is underdiagnosed, and significantly affects sleep and quality of life.

The objective of this study is to examine the causal relationships between the symptoms of restless legs syndrome (RLS) and specific clinical and subjective health-related, quality of life consequences. Structural equation modeling was applied to data from a questionnaire-based observational study. The RLS morbidities of decreased functional alertness and emotional distress in our sample of patients appear to be mostly secondary to the sleep disturbance associated with RLS. There was no clear indication of any other feature of RLS affecting these two aspects of RLS morbidity. A primary treatment goal should be the reduction of the sleep disturbance of RLS, both to decrease the RLS-related nocturnal distress and to improve daytime functioning.

Objectives: To assess the frequency, impact, and medical response to the restless legs syndrome (RLS) in a large multi-national primary care population., Method: Questionnaire surveys of matched patients and primary care physicians (PCPs) in five modern industrialized western countries., Results: An RLS screening questionnaire was completed by 23,052 patients: 2223 (9.6%) reported weekly RLS symptoms; 1557 of these patients had medical follow-up questionnaires completed both by themselves and by their physician. An RLS sufferer subgroup (n=551) likely warranting treatment was defined as reporting at least twice weekly symptoms with appreciable negative impact on quality of life. A total of 88.4% of RLS sufferers reported at least one sleep-related symptom. Most reported impaired sleep consistent with a diagnosis of insomnia. Out of 551 sufferers, 357 (64.8%) reported consulting a physician about their RLS symptoms, but only 46 of these 357 (12.9%) reported having been given a diagnosis. PCPs reported that 209 (37.9%) RLS sufferers consulted them about RLS symptoms, but only 52 (24.9%) were given an RLS diagnosis. In most countries, sufferers, regardless of diagnosis, were prescribed therapies not known to be effective in RLS., Conclusions: RLS significantly impairs patients' lives, often by severely disrupting sleep. The marked under-diagnosis and inappropriate treatment of RLS indicates that PCPs need better education about this condition. Recognizing how often disrupted sleep results from RLS should improve diagnosis.

Nighttime agitation or "sundowning" is challenging for clinicians and caregivers to manage in older adults in the dementia stage of Alzheimer's disease (AD-D). Our research previously revealed that nighttime agitation might be a manifestation of restless legs syndrome (RLS). The current study aims to describe the characteristics of older adults with AD-D, nighttime agitation, and RLS, and to evaluate sleep disturbance and iron status in relation to nighttime agitation severity. An observational study with baseline descriptive and correlational data from a clinical trial. Long-term care (n = 69) and independent living (n = 7); age 82.91 ± 9.46 years, with AD-D, nighttime agitation, and RLS. Trained observers counted nighttime agitation behaviors. Independent variables were age; cognition measured by the Mini-Mental State Examination; minutes slept from actigraphy; transferrin saturation percentage (TS%) and transferrin from fasting blood samples; and illness severity using the Cumulative Illness Rating Scale for Geriatrics. Bivariate and multivariable linear regression models were generated. In the multivariable model, sleep minutes (P =.002) and TS% (P =.003) were negatively associated with frequency of nighttime agitation behaviors, and they explained 20% of the variance. Seventy-nine percent received 1 or more medications that worsen RLS symptoms, such as antihistamines and serotonin reuptake inhibitors. We encourage clinicians to consider nighttime agitation as a manifestation of RLS. Treatment of iron deficiency indicated by low TS% and deprescribing medications that exacerbate RLS may decrease nighttime agitation, improve sleep, and enhance quality of life in older adults with AD-D. [ABSTRACT FROM AUTHOR]

Background: Restless Legs Syndrome (RLS) is characterized by uncomfortable nocturnal sensations in the legs making sedentary activities and sleep difficult, and is thus linked with psychosocial distress. Due to the symptomatology and neurobiology of RLS (disrupting brain iron and dopamine) it is likely that RLS associates with poorer health-related quality of life (HRQL) and depressive disorder. The objective of this study was to investigate the RLS-HRQL and the RLS-depressive disorder links in a generally healthy population that is not biased by medications.Methods: Complete data, including the Cambridge-Hopkins RLS questionnaire, the 12-item short-form standardized health survey (SF-12), the Major Depression Inventory (MDI), body mass index, smoking status, alcohol consumption, and education were available for 24,707 participants enrolled in the Danish Blood Donor Study from May 1, 2015 to February 1, 2017. Information on quality of sleep was available for all RLS cases. T-tests and multivariable logistic regression models were applied to examine the associations of RLS and MDI scores, and the physical and mental component scores (PCS and MCS) of SF-12, respectively. Analyses were conducted separately for men and women.Results: RLS associated with poorer MCS and poorer PCS. Moreover, Participants with RLS were more likely to classify with depressive disorder. Poor quality of sleep was associated with depressive disorder and poorer MCS among RLS cases, and with poorer PCS in female RLS cases.Conclusion: Thus, we demonstrated that RLS is associated with a significantly lower HRQL and a higher prevalence of depressive disorder among otherwise healthy individuals. [ABSTRACT FROM AUTHOR]

Summary: Sleep is an essential human behavior that shows prominent gender differences. Disturbed sleep, in particular, is much more prevalent in females than males. Restless legs syndrome (RLS) as one cause of disturbed sleep was observed to be somewhat more common among women than men in Ekbom''s 1945 seminal series of clinical cases with the disease. He, however, reported this gender difference mainly for those with more severe symptoms. Since then numerous studies have reported that women are affected by RLS about twice as often as males for mild as well as moderate to severe RLS. The present review focuses on RLS in females from the perspectives of both epidemiology and pathophysiology. RLS will generally become worse or might appear for the first time during pregnancy. Parity increases the risk of RLS later in life suggesting that pregnancy is a specific behavioral risk factor for developing RLS. Some evidence suggests that dysfunction in iron metabolism and high estrogen levels might contribute to RLS during pregnancy. But, menopause does not lower the incidence of RLS nor does hormone replacement therapy lead to an increase, suggesting a quite complex uncertain role of hormones in the pathophysiology of RLS. Therefore, further, preferably longitudinal studies are needed to unravel the factors causing RLS in women. These studies should include genetic, clinical and polysomnographic variables, as well as hormonal measures and variables assessing iron metabolism. [Copyright &y& Elsevier]

Abstract: Objective: Intravenous (IV) iron has been used as a treatment to reduce Restless Legs Syndrome (RLS) symptoms, but two double-blinded trials of a frequently prescribed IV iron formulation, iron sucrose, failed to show lasting efficacy. This study evaluates efficacy and safety of a new IV iron formulation (ferric carboxymaltose, FCM) with molecular properties that may make iron more available for uptake to the brain than iron sucrose does. Methods: In this 28-day, multi-centre, randomised, placebo-controlled trial 46 RLS patients were discontinued from all RLS treatment. Twenty-four received 500mg FCM in two doses 5days apart and 22 received a matching placebo. At day 28, those on placebo were given a single 1000mg IV FCM and those not responding to initial treatment were given a third dose of 500mg FCM. Patients were followed up for 24weeks or until needing added RLS treatment. Results: FCM significantly improved primary and secondary outcomes compared to placebo: International Restless Legs Syndrome study group severity scale (IRLS) average (SD) decrease of 8.9 (8.52) versus 4.0 (6.11), p =0.040; Clinical Global Inventory of Change (CGI-1) very much or much improved 48.3% versus 14.3%, p =0.004. Quality of life was also significantly improved. Of the 24 with initial iron treatment 45% responded and 29% remitted (IRLS⩽10) at day 28, and 25% continued free of other RLS medications at 24weeks after treatment. The single 1000mg dose on day 28 produced the same degree of treatment response as the divided dose, but the added 500mg dose for those not responding to the initial treatment showed little benefit. There were no significant adverse events. Conclusions: IV FCM provided a safe and effective treatment for RLS that lasted for at least 24weeks for some patients. Larger studies are needed to confirm these results. [Copyright &y& Elsevier]

Abstract: Background: Restless legs syndrome (RLS) is a medical condition with established neuropathology and genetic associations. Significant questions have, however, recently been raised about its true prevalence, medical significance and the degree to which it is under or over-diagnosed. This study therefore aimed to determine its prevalence, morbidity and adequacy of diagnosis based on physician evaluations of their own patients in primary care practice. Methods: Screening questionnaires were completed by adult patients attending 62 primary care practices across six western European countries within a one-week period. Patients screening positive for significant RLS symptoms were clinically evaluated for RLS by their physician. Physicians also classified the degree RLS affected the patient’s health and well-being. Patients independently completed the SF-36 Quality of Life and Medical Outcomes Study (MOS) sleep questionnaires. Results: Ten thousand five hundred and sixty-four patients completed the screening questionnaire; 804 responded positively to RLS symptoms and 630 of these were subsequently evaluated by their physician. The physicians diagnosed RLS in 365 patients. Ninety-one percent of these had not been previously diagnosed with RLS. In this cohort of adult primary care patients (without or with prorating for missed interviews) the estimated prevalence for diagnosed RLS was 3.5% or 4.4% and for medically-significant RLS 2.1% or 2.7%. A moderate to high degree of RLS negative impact on health related strongly to a lower vitality subscale on the SF-36 and short sleep times (5.2–5.4h) with more sleep disturbance on the MOS sleep scale. Conclusion: RLS in these western European countries is a common, clinically-significant medical condition that, despite all the publicity, remains largely undiagnosed. RLS evaluation is particularly recommended for patients complaining of insomnia. [Copyright &y& Elsevier]

Background The complaint of pain has largely been ignored in the diagnostic criteria for restless legs syndrome (RLS). The purpose of this study was to investigate the prevalence of painful symptoms in RLS, and to compare sleep-related characteristics between the patients who experienced the painful symptoms and those who did not. Methods The patients with RLS were retrospectively screened from July 2011 to December 2013 at a tertiary-care sleep center. For classifying those with pain and those without pain, more than three specialists separately observed the patients' reports and complaints of symptoms, and the final decision was made through consensus. The demographics and clinical characteristics, including sleep, psychiatric-related scales, and polysomnographic data were reviewed for the study. Results One hundred and sixty patients with RLS were selected, and 23.8% of them reported painful symptoms of RLS. Patients with RLS who experienced painful sensations were found to have lower ferritin levels, more severe RLS symptoms, anxiety and depressive symptoms, and a lower quality of life. The polysomnography data found that patients with RLS who experienced painful sensations had a longer latency to sleep onset and a lower periodic limb movement index (PLMI) ( p  <   0.05). Conclusions Patients who experienced painful sensations had more severe RLS symptoms and a trend toward lower PLMI during sleep. According to these results, an inference can be made that painful sensations may be one important point in determining the severity of RLS. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To develop a questionnaire to measure Pediatric Restless Legs Syndrome (P-RLS) symptoms and impact for use in clinical research. Methods: Questionnaire items were developed based on open-ended, qualitative interviews of 33 children and adolescents diagnosed with definite RLS (ages 6–17years) and their parents. The draft questionnaire was then tested through cognitive debriefing interviews with 21 of the same children/adolescents and 15 of their parents. This involved the children and parents answering the draft items and then interviewing them about the child’s ability to understand and interpret the questionnaire. Expert clinicians provided clinical guidance throughout. Results: Draft severity questions were generated to measure the four-symptom and four-impact domains identified from the concept elicitation interviews: RLS sensations, move/rub due to RLS, relief from move/rub, pain, and impact of RLS on sleep, awake activities, emotions, and tiredness. RLS descriptions, symptoms, and impact were compared between those who had comorbid attention-deficit/hyperactivity disorder and those who did not. Revisions to several questions were made based on the cognitive debriefing interviews and expert clinician review, resulting in a severity scale with 17 morning and 24 evening items. Caution regarding self-administration in children ages 6–8years is recommended. To complement the child/adolescent measures, a separate parent questionnaire was also developed. Conclusions: The P-RLS-SS was constructed based on detailed input from children and adolescents with RLS, their parents, and clinical experts, thus providing a scale with strong content validity that is intended to be comprehensive, clinically relevant, and important to patients. Validation of this scale is recommended. [Copyright &y& Elsevier]

The Restless Legs Syndrome Quality of Life questionnaire (RLSQoL) assesses the impact of RLS on daily life, emotional well-being, social life, and work life. This study investigates its validity and reliability.The RLSQoL was tested in 85 American adults with primary RLS. Patients were also asked to rate symptom severity with the International Restless Legs Scale (patient-reported version) and report on changes in symptoms over the 2-week period.The RLSQoL summary scale score (range: 0–100) demonstrated acceptable internal consistency reliability (Cronbach's alpha = 0.92) and test–retest reliability (intraclass correlation coefficient = 0.84). All items indicated acceptable item-convergent validity. The RLSQoL distinguished between groups with mild, moderate, and severe symptoms (F = 52.22,P < 0.0001). It demonstrated preliminary responsiveness to changes in RLS status over 2 weeks (effect size: improvement, 0.25; deterioration,−0.32), indicating moderate scale changes consistent with the small clinical change over this time.These findings support the conceptual framework of the RLSQoL. It is a valid and reliable measure of the impact of RLS on QoL and is responsive to short-term changes in symptom severity. The RLSQoL appears to be an appropriate tool for trial-based assessments of treatments for RLS. [ABSTRACT FROM AUTHOR]