We describe a potential new treatment option for patients suffering from restless legs syndrome. Contemporary treatment for restless legs syndrome consists mostly of dopaminergic drugs that leave some patients feeling nauseated and dizzy. A non-invasive, drug-free option would open new doors for patients suffering from restless legs syndrome.
A 69-year-old Caucasian woman met International Restless Legs Syndrome Study Group criteria for the diagnosis of restless legs syndrome. She had been afflicted with restless legs syndrome for over 30 years and tried many of the available pharmaceutical remedies without success. For this study she received 30-minute treatment sessions with near-infrared light, three times a week for four weeks. The restless legs syndrome rating scale was used to track symptom changes; at baseline she scored "27" on the 0 to 40 point scale, which is considered to be "severe". Our patient was almost symptom free at week two, indicated by a score of "2" on the rating scale. By week four she was completely symptom free. The symptoms slowly returned during week three post treatment.
The findings suggest that near-infrared light may be a feasible method for treating patients suffering from restless legs syndrome. Undesirable side-effects from medication are non-existent. This study might revive the neglected vascular mechanism theory behind restless legs syndrome and encourage further research into this area.
OBJECTIVE: 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.
Gabapentin enacarbil at 1200 mg maintained improvements in restless legs syndrome symptoms compared with placebo and showed long-term tolerability in adults with moderate to severe primary restless legs syndrome for up to 9 months of treatment; no clinically relevant changes were observed in laboratory values, in vital signs, or on electrocardiograms.
Aims and Objectives:
Translation of the Insomnia Severity Index from English to Hindi and Validation of the Hindi version.
Materials and Methods:
The translation process of the Insomnia Severity Index was initiated after obtaining due permission from the author of the original version of the same. Translation was carried out by using standard translation procedures, such as combined translation, decentering, and pretest method. The final version of the Insomnia Severity Index in Hindi was finally validated. A randomly selected sample size of 65 subjects was enrolled for the purpose of validation and testing the reliability of Hindi version of the Insomnia Severity Index. Insomnia was present in 45 subjects and they constituted the insomnia group. The rest 20 subjects did not have insomnia and were included in the control group. The Hindi version of the Insomnia Severity Index was applied to both the groups.
The total sample constituted of 50.8% males and 49.2% females. The mean age in the control group was 30.8±8.3 years and that in the insomnia group was 40.3±4 years (t=3.04; P=0.001). The translated version of the Insomnia Severity Index showed a reliability of 0.91 (Cronbach's α=0.91). This was not just simple translation, but many of the words were changed to adapt it for the local population.
The Hindi version of the Insomnia Severity Index is a valid and reliable tool that can be administered for the assessment of severity of insomnia.
Hindi; insomnia; insomnia severity index; validation
Restless legs syndrome (RLS) affects 5–15% of adults, but is often unrecognized and consequently misdiagnosed. The International Restless Legs Scale (IRLS) has been developed and validated to assess the severity of RLS. Currently, the most common treatment for RLS is levodopa, but this may lead to augmentation of symptoms. Pramipexole has been developed as an alternative treatment for patients diagnosed with RLS.
The objective of this article is to review the evidence of the effectiveness of pramipexole for the clinical management of patients with RLS.
There is clear evidence that pramipexole reduces the leg movements associated with RLS, as measured by improvements in both the IRLS and the Clinical Global Impression (CGI) score. There is also moderate evidence that the drug improves sleep quality. Pramipexole clearly improves the anxiety and depression often associated with RLS. Augmentation may be associated with pramipexole treatment, but the evidence is contradictory and augmentation may be more associated with patients pretreated with levodopa or with patients with primary RLS rather than those with secondary RLS. Pramipexole therapy appears to be well tolerated, with only mild-to-moderate adverse events reported.
Pramipexole reduces leg movements in RLS, and is well tolerated. Further investigation is required to confirm the preliminary evidence that pramipexole restores normal sleep architecture and restores a normal quality of life in patients with RLS. Health economic studies would be valuable in demonstrating the true impact of pramipexole on the social burden of RLS.
restless legs syndrome (RLS); pramipexole; outcomes; evidence
Earlier studies conducted among migraineurs have shown an association between migraine and restless legs syndrome (RLS). We chose RLS patients and looked for migraine to exclude sample bias.
Materials and Methods:
99 consecutive subjects of idiopathic RLS were recruited from the sleep clinic during four months period. Physician diagnosis of headache and depressive disorder was made with the help of ICHD-2 and DSM-IV-TR criteria, respectively. Sleep history was gathered. Severity of RLS and insomnia was measured using IRLS (Hindi version) and insomnia severity index Hindi version, respectively. Chi-square test, one way ANOVA and t-test were applied to find out the significance.
Primary headache was seen in 51.5% cases of RLS. Migraine was reported by 44.4% subjects and other types of ‘primary headaches’ were reported by 7.1% subjects. Subjects were divided into- RLS; RLS with migraine and RLS with other headache. Females outnumbered in migraine subgroup (χ2=16.46, P<0.001). Prevalence of depression (χ2=3.12, P=0.21) and family history of RLS (χ2=2.65, P=0.26) were not different among groups. Severity of RLS (P=0.22) or insomnia (P=0.43) were also similar.
Migraine is frequently found in RLS patients in clinic based samples. Females with RLS are prone to develop migraine. Depression and severity of RLS or insomnia do not affect development of headache.
Migraine; primary headache; restless legs syndrome
Primary restless leg syndrome (RLS) is a common sensory-motor disorder that is characterized by an irresistible urge to move the limbs and unpleasant sensations in the legs, which affects 1.9%–4.6% adults. Pramipexole, a potent dopamine D2/3 agonist, is recommended as “effective” in the short-term and “possibly effective” in the long-term treatment of primary RLS in the European guidelines on management of RLS. In this meta-analysis, we summarized the efficacy and tolerability of pramipexole in treatment for primary RLS. Results of this meta-analysis showed a favorable effect of pramipexole versus placebo on RLS symptoms (mean change on International RLS Study Group Rating Scale [IRLS] score: mean difference [MD] = −5.96; 95% confidence interval [CI]: −7.79 to −4.41, P < 0.00001) and sleep quality (pooled standard mean difference [SMD] = −0.48, 95% CI: −0.61 to −0.35, P < 0.00001). Nausea (relative risk [RR] = 2.68, 95% CI: 1.82 to 3.95, P < 0.001) and fatigue (RR = 1.82, 95% CI: 1.14 to 2.93, P = 0.013) were the most common adverse events, but, by and large, pramipexole was well-tolerated in patients with primary RLS. Nevertheless, long-term studies and more evidence of head-to-head comparisons of pramipexole with other dopamine agonists, anticonvulsants, and levodopa are needed.
restless legs syndrome; pramipexole; meta-analysis
Because of the subjective nature of Restless Legs Syndrome (RLS) symptoms and the impact of these symptoms on sleep, patient-reported outcomes (PROs) play a prominent role as study endpoints in clinical trials investigating RLS treatments. The objective of this study was to validate a new measure, the Post Sleep Questionnaire (PSQ), to assess sleep dysfunction in subjects with moderate-to-severe RLS symptoms.
Pooled data were analyzed from two 12-week, randomized, placebo-controlled trials of gabapentin enacarbil (N = 540). At baseline and Week 12, subjects completed the PSQ and other validated health surveys: IRLS Rating Scale, Clinical Global Impression of Improvement (CGI-I), Profile of Mood States (POMS), Medical Outcomes Study Scale-Sleep (MOS-Sleep), and RLS-Quality of Life (RLSQoL). Pooled data were used post hoc to examine the convergent, divergent, known-group validity and the responsiveness of the PSQ.
Convergent validity was demonstrated by significant correlations between baseline PSQ items and total scores of IRLS, POMS, RLSQoL, and the MOS-Sleep Scale (p ≤ 0.007 each). Divergent validity was demonstrated through the lack of significant correlations between PSQ items and demographic characteristics. Correlations (p < 0.0001) between RLS severity groups and PSQ items demonstrated known-group validity. Mean changes in investigator- and subject-rated CGI-I scores for each PSQ item (p < 0.0001) demonstrated the PSQ's responsiveness to patient change as reported by their care provider.
Although these analyses were potentially limited by the use of clinical trial data and not prospective data from a study conducted solely for validation purposes, the PSQ demonstrated robust psychometric properties and is a valid instrument for assessing sleep and sleep improvements in subjects with moderate-to-severe RLS symptoms.
This study analyzed data from two registered trials, NCT00298623 and NCT00365352.
The European Restless Legs Syndrome (RLS) Study Group performed the first multi-center, long-term study systematically evaluating RLS augmentation under levodopa treatment. This prospective, open-label 6-month study was conducted in six European countries and included 65 patients (85% treatment naive) with idiopathic RLS. Levodopa was flexibly up-titrated to a maximum dose of 600 mg/day. Presence of augmentation was diagnosed independently by two international experts using established criteria. In addition to the augmentation severity rating scale (ASRS), changes in RLS severity (International RLS severity rating scale (IRLS), clinical global impression (CGI)) were analyzed. Sixty patients provided evaluable data, 35 completed the trial and 25 dropped out. Augmentation occurred in 60% (36/60) of patients, causing 11.7% (7/60) to drop out. Median time to occurrence of augmentation was 71 days. The mean maximum dose of levodopa was 311 mg/day (SD: 105). Patients with augmentation compared to those without were significantly more likely to be on higher doses of levodopa (≥300 mg, 83 vs. 54%, P = 0.03) and to show less improvement of symptom severity (IRLS, P = 0.039). Augmentation was common with levodopa, but could be tolerated by most patients during this 6-month trial. Patients should be followed over longer periods to determine if dropout rates increase with time.
Restless legs syndrome (RLS); Augmentation; Diagnosis; Rating scale; Clinical study
Limited research suggests a relationship between Restless Legs Syndrome and hypertension. We, therefore, assessed the relationship between restless legs syndrome and hypertension among middle-aged women.
This is a cross-sectional study including 65,544 women (aged 41-58 years) participating in Nurses Health Study II. The participants with diabetes and arthritis were excluded as these conditions can mimic restless legs syndrome. Restless legs syndrome was assessed by a self-administered questionnaire based on the International Restless Legs Study Group criteria. Information on diagnosis of hypertension and blood pressure values were collected via questionnaires. Multivariable logistic regression models were used to analyze the relation between restless legs syndrome and hypertension, with adjustment for age, race, body mass index, physical activity, menopausal status, smoking, use of analgesics, and intake of alcohol, caffeine, folate, and iron.
Compared to women with no restless legs symptoms, the multiple adjusted odds of having hypertension were 1.20 (95% CI: 1.10-1.30; P<0.0001) times higher among women with restless legs symptoms. The adjusted odds ratios for women who reported restless legs symptoms 5-14 times/month and ≥15 times/month were 1.06 (95% CI 0.94-1.18) and 1.41 (95% CI 1.24-1.61) respectively, compared to those without the symptoms (P trend <0.0001). Greater frequency of restless legs symptoms was associated with higher concurrent systolic and diastolic blood pressures (P trend<0.0001 for both).
Women with restless legs syndrome have a higher prevalence of hypertension, and this prevalence increases with more frequent restless legs symptoms.
Restless legs syndrome; Hypertension; Sleep; Cardiovascular disease; Women
Rotigotine is a unique dopamine agonist with activity across D1 through D5 receptors as well as select adrenergic and serotonergic sites. This study reports the 2-year follow-up safety and efficacy data of an ongoing open-label multicenter extension study (NCT00498186) of transdermal rotigotine in patients with moderate to severe restless legs syndrome (RLS).
Patients received a once-daily patch application of an individually optimized dose of rotigotine between 0.5 mg/24 h to 4 mg/24 h. Safety assessments included adverse events (AEs) and efficacy was measured by the International RLS Study Group Severity Rating Scale (IRLS), RLS-6 scales and Clinical Global Impression (CGI). Quality of life (QoL) was measured by QoL-RLS.
Of 310 patients who completed a 6-week placebo-controlled trial (SP709), 295 (mean age 58 ± 10 years, 66% females) were included in the open-label trial SP710. 64.7% (190/295 patients) completed the 2-year follow-up; 29 patients discontinued during the second year. Mean daily rotigotine dose after 2 years was 2.93 ± 1.14 mg/24 h with a 2.9% dose increase from year 1. Rotigotine was generally well tolerated. The rate of typical dopaminergic side effects, nausea and fatigue, was low (0.9% and 2.3%, respectively) during the second year; application site reactions were frequent but lower than in year 1 (16.4% vs. 34.5%). The IRLS total score improved from baseline of SP709 (27.8 ± 5.9) by 17.2 ± 9.2 in year 2 completers. Similar improvements were observed in RLS-6 scales, CGI scores and QoL-RLS. The responder rate in the CGI change item 2 ("much" and "very much" improved) was 95% after year 2.
Transdermal rotigotine is an efficacious and well-tolerated long-term treatment option for patients with moderate to severe RLS with a high retention rate during 2 years of therapy.
Objective: To assess the efficacy, safety, and tolerability of ropinirole in the treatment of patients with restless legs syndrome.
Methods: A 12 week, prospective, double blind, randomised comparison involving 284 patients from 10 European countries. All participants had a score of ⩾15 on the international restless legs scale (IRLS). Patients were randomised (1:1) to receive either ropinirole 0.25–4.0 mg once daily or placebo. The primary efficacy end point was mean change from baseline to week 12 in total IRLS score. Global improvements (clinical global impression (CGI) scale) and improvements in sleep, health related quality of life (QoL; using generic and disease specific measures), work, and other activities were also assessed.
Results: 112/146 patients (76.7%) taking ropinirole and 109/138 (79.0%) taking placebo completed the study. Improvement in IRLS at week 12 with ropinirole (mean (SD) dose, 1.90 (1.13) mg/day) was greater than with placebo (mean (SE): -11.04 (0.719) v -8.03 (0.738) points; adjusted difference = -3.01 (95% confidence interval (CI), -5.03 to -0.99); p = 0.0036). More patients in the ropinirole group (53.4%) showed improvement on the CGI scale at week 12 than in the placebo group (40.9%; adjusted odds ratio = 1.7 (1.02 to 2.69); p = 0.0416). Significant differences on both IRLS and CGI scales favouring ropinirole were apparent by week 1. Ropinirole was also associated with significantly greater improvements in sleep and QoL end points. The most common adverse events were nausea and headache.
Conclusions: Ropinirole improves restless legs syndrome compared with placebo, with benefits apparent by week 1. It is generally well tolerated.
Restless Legs Syndrome is very common in hemodialysis patients however there are no comparative studies assessing the effectiveness of a non-pharmacological treatment to a classical treatment on parameters related to syndromes’ severity and quality of life.
In this randomized, partially double blind, placebo controlled trial, thirty two hemodialysis patients with restless legs syndrome were randomly assigned into three groups: 1) the exercise training group (N = 16), 2) the dopamine agonists group (ropinirole 0.25 mg/d) (N = 8) and 3) the placebo group (N = 8). The intervention programs lasted 6 months. Restless Legs Syndrome severity was assessed using the international severity scale, physical performance by a battery of tests, muscle size and composition by computed tomography, body composition by Dual Energy X Ray Absorptiometry, while depression score, sleep quality, daily sleepiness and quality of life were assessed through questionnaires.
Exercise training and dopamine agonists were effective in reducing syndrome’s symptoms by 46% (P = 0.009) and 54% (P = 0.001) respectively. Within group changes revealed that both approaches significantly improved quality of life (P < 0.05), however, only the dopamine agonists significantly improved sleep quality (P = 0.009). Within group changes showed a tendency for lean body mass improvements with dopamine agonists, this reached statistical significance only with the exercise training (P = 0.014), which also reduced fat infiltration in muscles (P = 0.044) and improved physical performance (P > 0.05) in various tests. Between group changes detect significant improvements with both exercise and dopamine agonists in depression score (P = 0.003), while only the dopamine agonist treatment was able to significantly improve sleep quality, compared to exercise and placebo (P = 0.016).
A 6-month exercise training regime was as effective as a 6-month low dosage dopamine agonist treatment in reducing restless legs syndrome symptoms and improving depression score in uremic patients. Further research is needed in order to show whether a combination treatment could be more beneficial for the amelioration of RLS.
Extramyocellular lipids; Lean body mass; Muscle atrophy; Quality of life; Sleep
Background and Purpose
Dopamine agonists are first-line drugs for treating the symptoms of restless legs syndrome (RLS). However, few studies have investigated the effect of dopamine agonists on the quality of life (QoL) in RLS patients. We conducted a study to determine whether ropinirole exerts positive effects on the QoL in RLS patients and to analyze the underlying factors.
Primary RLS patients from eight medical centers were recruited in the study. They were evaluated in the baseline phase using various questionnaires including the Korean versions of the International Restless Legs Scale (K-IRLS), RLS QoL questionnaire (K-RLSQoL), and the Short Form 36 Health Survey (SF-36). After taking ropinirole for 8 weeks the same questionnaires were again completed as a re-evaluation. We analyzed the statistical difference using a paired t-test, a Pearson's correlation, and a stepwise multiple regression in order to identify the factors associated with the QoL change.
A total of 107 subjects, including 65 (60.7%) females, completed this study. They were aged 51.68±14.80 years (mean±SD) and had a symptom duration of 8.8±9.0 months. After treatment with ropinirole, there were significant improvements on the K-RLSQoL, SF-36, and K-IRLS. The Pearson's correlation analysis showed that the improvement of QoL in RLS patients was significantly correlated with the severity of RLS (r=0.236, p<0.014) at baseline.
The results from this study suggest that treatment with ropinirole can improve the QoL in RLS patients. The improvement in the QoL is more related with the improvement of RLS symptoms.
restless legs syndrome; dopamine agonists; quality of life; sleep
Restless legs syndrome (RLS) is a common neurological condition characterized by uncomfortable and unpleasant sensations in the legs that are relieved by movement. It is frequently idiopathic, sometimes associated with specific disorders such as malignancies. Because there is no study relevant to RLS in Multiple Myeloma (MM), we aimed to evaluate the frequency of RLS in MM patients during chemotherapy and examined the relationship between presence of RLS and depression and anxiety in these patients.
We enrolled a population of 62 adult MM patients for RLS features. RLS was ascertained in MM patients by both the presence of the four essential International RLS Study Group diagnostic criteria and neurological examination. The International RLS Study Group rating scale was used to measure RLS severity. Hospital Anxiety and Depression Scale (HADS) was used to evaluate the levels of depression and anxiety and Short Form-36 (SF-36) to evaluate health related quality of life (HRQOL).
A total of 62 MM patients were evaluated. Among them 11 were identified by the screening questionnaire to meet the criteria for RLS (17.74%). MM patients with RLS had higher levels of depression (P < 0.01) and anxiety (P < 0.01) and poorer HRQOL compared with those without RLS.
The frequency of RLS in MM patients is higher than that of expected in the general population. MM patients afflicted by RLS have significantly higher levels of depression, anxiety and poorer HRQOL. Recognition and treatment of RLS in MM patients may be an important target in clinical management and may improve overall health outcomes in these patients.
Restless legs syndrome; Multiple Myeloma; Depression; Anxiety; Frequency; Health related quality of life
Restless legs syndrome (RLS) is a neurological disorder with a lifetime prevalence of 3-10%. in European studies. However, the diagnosis of RLS in primary care remains low and mistreatment is common.
The current article reports on the considerations of RLS diagnosis and management that were made during a European Restless Legs Syndrome Study Group (EURLSSG)-sponsored task force consisting of experts and primary care practioners. The task force sought to develop a better understanding of barriers to diagnosis in primary care practice and overcome these barriers with diagnostic and treatment algorithms.
The barriers to diagnosis identified by the task force include the presentation of symptoms, the language used to describe them, the actual term "restless legs syndrome" and difficulties in the differential diagnosis of RLS.
The EURLSSG task force reached a consensus and agreed on the diagnostic and treatment algorithms published here.
Restless leg syndrome (RLS) is defined as an uncomfortable feeling in the limbs which is prominently sensed in legs. Dopamine system involvement is considered as the base of RLS's etiology. Because of safety, anti-oxidant and dopaminergic promoting action of selenium, this study aims to investigate the effect of selenium on restless leg syndrome treatment.
Sixty patients with primary RLS were enrolled in this clinical trial (Irct2011103015943n1). It was based on 3 periods of drug prescription with one month wash out period. As placebo, 50 and 200 μg of selenium were administered in each separated month. The diagnosis was based on criteria published by IRLSG (International RLS Study Group). The questionnaire included 10 questions while each question’s rating was between 0 and 4. Points between 1 and 10 were considered mild, 11 to 20 as moderate, 21 to 30 as severe and 31 to 40 as very severe. After end of each month of drug consumption, questionnaires were completed and each subject was asked to report the severity of disease and side effects of the drugs. At least 10 declines in scale were considered as appropriate responses.
Improvement (decline IRLS score >10) was significantly higher in selenium (50 and 200 μg) than placebo group.
Selenium prescription in daily recommended dose of 50 μg instead of a dopamine agonist would be an alternative treatment in improvement of RLS symptoms.
Restless leg syndrome; Selenium; Treatment
Previous studies have suggested that attention deficit/hyperactivity disorder (ADHD) and restless legs syndrome (RLS) could share some common genetic backgrounds, but the effect of these genetic components could be modest. To test this hypothesis, we conducted a large-scaled cross-sectional study to examine whether women with a child with ADHD had a higher risk of having RLS than women of unaffected children.
We included 65,554 women free of diabetes, arthritis, and pregnancy in the current analyses. Information on RLS was assessed using a set of standardized questions. Participants were considered to have RLS if they met four RLS diagnostic criteria recommended by the International RLS Study Group and had restless legs ≥5 times/month. Information on ADHD in offspring was collected via questionnaire.
We observed a significant association between presence of ADHD in the offspring and risk of having RLS; the multivariate-adjusted OR for RLS was 1.27 (95% CI: 1.15, 1.41; P<0.0001), after adjusting for age, body mass index, number of deliveries during life time and other covariates.
We found that mothers of children with ADHD had an increased risk of having RLS. Further studies are warranted to explore biological mechanisms underling this association.
Attention deficit/hyperactivity disorder; Restless legs syndrome; BTBD9; PTPRD; Iron deficiency; Dopamine
Sleep disturbances are commonly reported by patients with end- stage renal disease undergoing dialysis. The aim of this study was to assess sleep quality and quality of life and to examine the prevalence of sleep disorders in a group of uremic patients on maintenance dialysis.
Patients and methods
Enrolled were 92 patients on maintenance dialysis, to whom 5 different questionnaires were distributed, examining sleep characteristics and quality of life [Athens Insomnia Scale (AIS), Epworth Sleepiness Scale (ESS), Pittsburg Sleep Quality Index (PSQI), IRLS-Study group questionnaire, WHO-5 Well Being Index].
Low sleep quality was reported by 42 patients (45.7%), and insomnia by 28.3% (n=26). Additionally, Restless Legs Syndrome was reported by 42.4% (n=39). On the contrary, only one patient had an ESS score, indicative of excessive daytime sleepiness. Finally, 32 patients (34.8%) had a score indicative of low quality of life in WHO-5 questionnaire.
A significant presence of sleep disorders among haemodialysis patients was recorded. Still, further studies using polysomnographic records are necessary to confirm these results.
The objective of the study was to assess the reliability and validity of the Hindi translation of the Migraine Disability Assessment (MIDAS) and Headache Impact Test-6 (HIT-6) questionnaires.
Materials and Methods:
The study was conducted on the migraine patients. For test–retest reliability, the respondents filled the MIDAS and HIT-6 questionnaires twice, at an interval of three weeks. For validity, the same population of patients filled the headache diary for three months. After three months they filled the MIDAS and HIT-6 questionnaires again. The patients were subgrouped according to their occupation and level of education. The test–retest reliability and validity were calculated by the Pearson correlation coefficient. Internal consistency was calculated using the Cronbach alpha.
A total of 236 migraine patients were screened. Seventy-nine patients fulfilled the inclusion criteria. A total of 69 patients completed the study. The HIT-6 questionnaire was applicable to all the subgroups of patients and had better comprehensibility than the MIDAS. Housewives missed out on the first two questions of the MIDAS and had lower mean MIDAS scores than HIT-6. The test–retest correlation coefficients for the total MIDAS and HIT-6 scores were 0.94 and 0.81, respectively. The correlation coefficients between the total score in the headache diary equivalent and the MIDAS and HIT-6 total score were 0.91 and 0.77, respectively. Cronbach alpha, a measure of internal consistency for the MIDAS questionnaire was > 0.90 at all the compilations. For the HIT-6 questionnaire, it ranged from 0.67 to 0.79.
The Hindi versions of MIDAS and HIT-6 questionnaires were reliable and valid, but could not be interchanged. HIT-6 had better comprehensibility.
Headache Disability; HIT-6; migraine disability assessment; migraine; reliability; validity
A computer-assisted interview, the Global Mental Health Assessment Tool-validation (GMHAT/PC) has been developed to assist general practitioners and other health professionals to make a quick, convenient, yet reasonably comprehensive standardized mental health assessment. GMHAT/PC has been translated into various languages including Hindi. This is the first study conducted in India, using the Hindi version GMHAT/PC of the series of studies assessing its validity in different cultures.
The study aims to assess the feasibility of using a computer assisted diagnostic interview by health professionals and to examine the level of agreement between the Hindi version GMHAT/PC diagnosis and psychiatrists’ ICD-10 based clinical diagnosis.
Cross-sectional validation study.
Psychiatric clinic of a General Hospital and an out patient (Neurology) clinic in the Teaching General Hospital in Jaipur, India.
Materials and Methods:
All consecutive patients attending the psychiatric out patient clinic were interviewed using GMHAT/PC and psychiatrists made a diagnosis applying ICD-10 criteria for a period of six weeks. A small sample of subjects was interviewed in a similar way in a Neurology clinic for four weeks.
The mean duration of interview was under 17 minutes. Most patients were pleased that they were asked about every aspect of their mental health. The agreement between psychologists’ GMHAT/PC interview diagnoses and psychiatrists’ clinical diagnoses was excellent (Kappa 0.96, sensitivity 1.00, and specificity 0.94).
GMHAT/PC Hindi version detected mental disorders accurately and it was feasible to use GMHAT/PC in Indian settings.
GMHAT; mental health assessment; primary care mental health; psychiatric diagnosis
Recent published evidence suggests that restless legs syndrome (RLS) and periodic limb movement disorder (PLMD) are common condition in children and adolescents. It is likely that if left untreated, RLS and PLMD may lead to adverse cardiovascular and neurocognitive consequences. However, the diagnosis of RLS and PLMD in children is challenging, particularly because children are relatively unable to describe typical RLS symptoms. The International Restless Legs Study Group has recently published consensus criteria for the diagnosis of RLS and PLMD in children. In addition to clinical description of RLS symptoms, supportive evidence including the presence of clinical sleep disturbances, documented periodic limb movements in sleep from overnight sleep study and family history of restless legs syndrome may be required. Few if any controlled studies have addressed the management of RLS and PLMD, which may involve both non-pharmacologic and pharmacologic approaches. In this context, the importance of avoidance of aggravating factors and good sleep hygiene cannot be overemphasized. Children with evidence of low-iron storage, i.e., low-serum ferritin and/ or iron levels may likely benefit from iron therapy. While there is overall limited experience regarding the use of dopaminergic agents in children with RLS and PLMD, published reports suggesting efficacy of compounds such as levodopa, ropinirole, pramipexole and pergolide have emerged. Other medications including benzodiazepine, anti-convulsants, alpha-adrenergic and opioid medications have not been adequately studied in children. Children with RLS and PLMD should have regular follow-up visits to evaluate clinical improvement and to monitor adverse effects from the selected therapy. Based on aforementioned findings, it is clear that a substantial research effort is needed to evaluate the pathophysiology,
Restless legs syndrome; Periodic limb movement disorder; Dopaminergic medications; Iron therapy; Children; Attention-deficit hyperactivity disorder
OBJECTIVE: To conduct clinical and molecular genetic analyses of the members of an extended family in Central Indiana with a high prevalence of restless legs syndrome (RLS).
PARTICIPANTS AND METHODS: From February 1, 2006, through August 31, 2008, we collected data from members of this family, which is of English descent. Genealogical methods were used to expand the family tree, and family members were screened with an RLS questionnaire. Telephone interviews and personal examinations were performed at Mayo Clinic and during a field trip to Central Indiana. Blood samples were collected for molecular genetic analysis. A follow-up telephone interview was conducted 1 year later.
RESULTS: The family tree spans 7 generations with 88 living members, 30 of whom meet the criteria for diagnosis of RLS established by the International Restless Legs Syndrome Study Group. Three affected family members also have Parkinson disease or essential tremor. The mode of RLS inheritance is compatible with an autosomal dominant pattern. The affected family members do not exhibit linkage to the 5 known RLS loci or mutations in the RLS susceptibility genes MEIS1 and BTBD9.
CONCLUSION: Of 88 members of this single extended family in Central Indiana, 30 were diagnosed as having RLS. Because our analysis shows that the disease is not linked to any of the known RLS loci or risk-associated genes, we postulate that members of this family may carry a gene mutation in a novel genetic locus.
Of 88 members of a single extended family, 30 were diagnosed as having restless legs syndrome; because this analysis shows that the disease is not linked to any of the known restless legs syndrome loci or risk-associated genes, members of this family may carry a gene mutation in a novel genetic locus.
To evaluate the association between restless legs syndrome (RLS) and incident cardiovascular disease (CVD).
Prospective cohort study.
Women's Health Study (WHS) and Physicians' Health Study (PHS), USA.
29 756 female health professionals aged ≥45 years and 19 182 male physicians aged ≥40 years at baseline.
Main outcome measures
Main outcome was incidence of major CVD; secondary outcomes were first incidence of myocardial infarction, stroke, death due to CVD or coronary revascularisation.
3487 (11.7%) women and 1373 (7.2%) men met International Restless Legs Study Group criteria for RLS. In the WHS 450 major CVD events occurred and 1064 major CVD events were confirmed in the PHS. In both cohorts, RLS was not associated with increased risk of major CVD, stroke, myocardial infarction, CVD death or coronary revascularisation. After adjustment for major vascular risk factors, the HRs (95% CI) for major CVD were 1.15 (0.88 to 1.50) in women and 1.01 (0.81 to 1.25) in men. Highest multivariable-adjusted HRs were 1.29 (0.91 to 1.82) for total stroke in women and 1.22 (0.87 to 1.70) for CVD death in men. Excluding participants with comorbidities potentially leading to RLS did not substantially change the effect estimates.
In these large prospective studies of female and male health professionals, RLS was not associated with an increased risk of any incident CVD event. The data do not support the hypothesis that RLS is a marker of increased risk of vascular disease.
The aim of this study is to evaluate the association between RLS and incident cardiovascular events in two large prospective cohort studies.
The results of our two large prospective cohorts do not suggest that either women or men suffering from RLS are at increased risk for any vascular disease event.
RLS should not be considered a marker for increased CVD risk.
Strengths and limitations of this study
Strengths of this study include the large number of participants and outcome events, the prospective study design, the standardised assessment of RLS according to the four minimal diagnostic criteria and confirmation of CVD cases by medical record review.
The following limitations should be considered: the information on RLS was self-reported and misclassification of cases is possible. No information on frequency, severity and duration of RLS symptoms was available and both cohorts consist of white health professionals, which may limit the generalisability of the results to other populations.
There is a growing consensus about the validity of human personality traits as important dispositions toward feelings and behaviors (Matthews, Deary, & Whiteman, 2003).
Materials and Methods:
Here we examine the reliability of the Hindi translation of the Eysenck Personality Questionnaire-Revised Short Form (EPQR-S; Eysenck, Eysenck, & Barrett, 1985), which consists of 48 items that assess neuroticism, extraversion, psychoticism, and lying. The questionnaire was first translated into Hindi and then back translated. Subsequently, it was administered to 202 students (78 men and 124 women) from Banaras Hindu University. The internal consistency of the scale was evaluated.
The findings provide satisfactory psychometric properties of the extraversion, neuroticism and lie scales. The psychoticism scale, however, was found to be less satisfactory.
It can be proposed that due to satisfactory internal consistency scores, the EPQRS-H is a reliable scale for the measurement of various personality traits.
EPQR - Short; Extraversion; Neuroticism; Psychoticism; Lie score
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.
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.
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).
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.