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1.  Hindi translation and validation of Cambridge-Hopkins Diagnostic Questionnaire for RLS (CHRLSq) 
Restless legs syndrome also known as Willis-Ekbom's Disease (RLS/WED) is a common illness. Cambridge-Hopkins diagnostic questionnaire for RLS (CHRLSq) is a good diagnostic tool and can be used in the epidemiological studies. However, its Hindi version is not available. Thus, this study was conducted to translate and validate it in the Hindi speaking population.
Materials and Methods:
After obtaining the permission from the author of the CHRLSq, it was translated into Hindi language by two independent translators. After a series of forward and back translations, the finalized Hindi version was administered to two groups by one of the authors, who were blinded to the clinical diagnosis. First group consisted of RLS/WED patients, where diagnosis was made upon face to face interview and the other group — the control group included subjects with somatic symptoms disorders or exertional myalgia or chronic insomnia. Each group had 30 subjects. Diagnosis made on CHRLSq was compared with the clinical diagnosis.
Statistical Analysis:
Analysis was done using Statistical Package for Social Sciences (SPSS) v 21.0. Descriptive statistics was calculated. Proportions were compared using chi-square test; whereas, categorical variables were compared using independent sample t-test. Sensitivity, specificity, and positive predictive value of the translated version of questionnaire were calculated.
Average age was comparable between the cases and control group (RLS/WED = 39.1 ± 10.1 years vs 36.2 ± 11.4 years in controls; P = 0.29). Women outnumbered men in the RLS/WED group (87% in RLS/WED group vs 57% among controls; χ2 = 6.64; P = 0.01). Both the sensitivity and specificity of the translated version was 83.3%. It had the positive predictive value of 86.6%.
Hindi version of CHRLSq has positive predictive value of 87% and it can be used to diagnose RLS in Hindi speaking population.
PMCID: PMC4564465  PMID: 26425008
CHRLSq; restless legs syndrome; translation; validation; Willis-Ekbom's disease
2.  Validation of Hindi Translation of SRPB Facets of WHOQOL-SRPB Scale 
World Health Organization's Quality of Life – Spirituality, Religiousness and Personal Beliefs Scale (WHOQOL SRPB) is a valuable instrument for assessing spirituality and religiousness. The absence of this self-administered instrument in Hindi, which is a major language in India, is an important limitation in using this scale.
To translate the English version of the SRPB facets of WHOQOL-SRPB scale to Hindi and evaluate its psychometric properties.
Materials and Methods:
The SRPB facets were translated into Hindi using the World Health Organisation's translation methodology. The translated Hindi version was evaluated for cross-language equivalence, test-retest reliability, internal consistency, and split half reliability.
Hindi version was found to have good cross-language equivalence and test-retest reliability at the level of facets. Twenty-six of the 32 items and 30 of the 32 items had a significant correlation (ρ<0.001) in cross language concordance and test-retest reliability data, respectively. The Cronbach's alpha was 0.93, and the Spearman-Brown Sphericity value was 0.91 for the Hindi version of SRPB.
The present study shows that cross-language equivalence, internal consistency, split-half reliability, and test-retest reliability of the Hindi version of SRPB (of WHOQOL-SRPB) are excellent. Thus, the Hindi version of WHOQOL-SRPB as translated in this study is a valid instrument.
PMCID: PMC3868086  PMID: 24379495
Hindi translation; religiousness; spirituality; WHOQOL-SRPB
3.  Cultural Adaptation of the Cardiff Acne Disability Index to a Hindi Speaking Population: A Pilot Study 
Acne vulgaris is known to impair many aspects of the quality of life (QoL) of its patients.
To translate the Cardiff Acne Disability Index (CADI) from English into Hindi and to assess its validity and reliability in Hindi speaking patients with acne from India.
Hindi version of CADI, translated and linguistically validated as per published international guidelines, along with a previously translated Hindi version of dermatology life quality index (DLQI) and a demographic questionnaire were administered to acne patients. The internal consistency reliability of the Hindi version of CADI and its concurrent validity were assessed by Cronbach's alpha co-efficient and Spearman's correlation co-efficient respectively. Construct validity was examined by factor analysis. Statistical analysis was carried out using the Statistical Package for the Social Sciences (SPSS) version 20 (SPSS Inc., Chicago, IL, USA) for Windows.
One hundred Hindi speaking patients with various grades of acne participated in the study. Hindi version of CADI showed high internal consistency reliability (Cronbach's alpha co-efficient = 0.722). Mean item-to-total correlation co-efficient ranged from 0.502 to 0.760. Concurrent validity of the scale was supported by a significant correlation with the Hindi DLQI. Factor analysis revealed the presence of two dimensions underlying the factor structure of the scale.
Hindi CADI is equivalent to the original English version and constitutes a reliable and valid tool for clinical assessment of the impact of acne on QoL.
PMCID: PMC4533552  PMID: 26288422
Acne vulgaris; Cardiff Acne Disability Index; linguistic validation; quality of life
4.  Adaptation and validation of stroke-aphasia quality of life (SAQOL-39) scale to Hindi 
Stroke is a major detriment to the quality of life (QOL) in its victims. Several functional limitations following stroke contribute to the denigrated QOL in this population. Aphasia, a disturbance in the comprehension, processing, and/or expression of language, is a common consequence of stroke. Yet, in most Indian languages, including the national language (Hindi), there are no published tools to measure the QOL of persons with stroke-aphasia.
The current study was carried out to adapt and validate a well-known tool to measure the QOL (i.e., Stroke-Aphasia Quality of Life-39; SAQOL-39) to Hindi.
Materials and Methods:
We presented the original (English) version of the SAQOL-39 to a group of six Hindi-speaking Speech Language Pathologists hailing from the central and northern regions of India to examine the sociocultural suitability of items and indicate modifications, if any. The linguistic adaptation was performed through a forward-backward translation scheme. The socioculturally and linguistically adapted (to Hindi) version was then administered on a group of 84 Hindi-speaking persons with aphasia to examine the acceptability, test-retest reliability as well as the internal consistency of the instrument.
The SAQOL-39 in Hindi exhibited high test-retest reliability (ICC = 0.9) as well as acceptability with minimal missing data. This instrument exhibited high internal consistency (Chronbach's ∝ = 0.98) as well as the both item-to-total and inter-domain correlations.
The socioculturally and linguistically adapted Hindi version of SAQOL-39 is a robust tool to measure the QOL of persons with stroke-aphasia. It may serve as an essential tool to measure the QOL in this population for both clinical and research purposes.
PMCID: PMC4350210  PMID: 25745307
Aphasia; Hindi; India; stroke; quality of life
5.  The reliability, validity and responsiveness of the Restless Legs Syndrome Quality of Life questionnaire (RLSQoL) in a trial population 
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.
PMCID: PMC1322229  PMID: 16329756
6.  Ropinirole in the treatment of restless legs syndrome: results from the TREAT RLS 1 study, a 12 week, randomised, placebo controlled study in 10 European countries 
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.
PMCID: PMC1757460  PMID: 14707315
7.  Translation and Validation of the Insomnia Severity Index in Hindi Language 
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.
PMCID: PMC3271495  PMID: 22345845
Hindi; insomnia; insomnia severity index; validation
8.  Primary headaches in restless legs syndrome patients 
Annals of Indian Academy of Neurology  2012;15(Suppl 1):S104-S108.
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.
PMCID: PMC3444227  PMID: 23024558
Migraine; primary headache; restless legs syndrome
9.  Iron for restless legs syndrome 
Restless legs syndrome (RLS) is a common neurologic syndrome and is associated with iron deficiency in many patients. It is unclear whether iron therapy is effective treatment for RLS.
The objective of this review was to assess the effects of iron supplementation (oral or intravenous) for patients with RLS.
Search methods
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Jan 1995 to April 2011); EMBASE (Jan 1995 to April 2011); PsycINFO (Jan 1995 to April 2011); and CINAHL (Jan 1995 to April 2011). Corresponding authors of included trials and additional members of the International Restless Legs Syndrome Study Group were contacted to locate additional published or unpublished trials.
Selection criteria
Controlled trials comparing any formulation of iron with placebo, other medications, or no treatment in adults diagnosed with RLS according to expert clinical interview or explicit diagnostic criteria.
Data collection and analysis
Two review authors extracted data and at least two authors assessed trial quality. We contacted trial authors for missing data.
Main results
Six studies (192 total subjects) were identified and included in this analysis. The quality of trials was variable. Our primary outcome was restlessness or uncomfortable leg sensations, which was quantified using the IRLS severity scale in four trials and another RLS symptom scale in a fifth trial. Combining data from the four trials using the IRLS severity scale, there was no clear benefit from iron therapy (mean difference in IRLS severity scores of -3.79, 95% CI: -7.68 to 0.10, p = 0.06). However, the fifth trial did find iron therapy to be beneficial (median decrease of 3 points in the iron group and no change in the placebo group on a 10 point scale of RLS symptoms, p = 0.01). Quality of life was improved in the iron group relative to placebo in some studies but not others. Changes in periodic limb movements were not different between groups (measured in two studies). Objective sleep quality, subjective sleep quality and daytime functioning were not different between treatment groups in the studies that assessed them. The single study of subjects with end stage renal disease did show a benefit of therapy. Most trials did not require subjects to have co-morbid iron deficiency and several excluded patients with severe anemia. The single study that was limited to iron deficient subjects did not show clear benefit of iron supplementation on RLS symptoms. There was no clear superiority of oral or intravenous delivery of iron. Iron therapy did not result in significantly more side effects than placebo (RR 1.39, 95% CI 0.85 to 2.27).
Authors' conclusions
There is insufficient evidence to determine whether iron therapy is beneficial for the treatment of RLS. Further research to determine whether some or all types of RLS patients may benefit from iron therapy, as well as the best route of iron administration, is needed.
PMCID: PMC4070449  PMID: 22592724
Iron [deficiency; *therapeutic use]; Iron, Dietary [therapeutic use]; Quality of Life; Randomized Controlled Trials as Topic; Restless Legs Syndrome [*drug therapy; etiology]; Severity of Illness Index; Sleep [physiology]; Treatment Outcome; Humans
10.  Treatment of moderate to severe restless legs syndrome: 2-year safety and efficacy of rotigotine transdermal patch 
BMC Neurology  2010;10:86.
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.
Trial registration
PMCID: PMC2958158  PMID: 20920156
11.  A Hindi version of the Composite Scale of Morningness 
Asian journal of psychiatry  2013;6(6):581-584.
Several pen and paper measures of human circadian preference are available in English, but none are available in Hindi, hampering research in circadian behavior among Hindi speaking populations in India and elsewhere. The present study describes a Hindi version of the Composite Scale of Morningness (CSM), a self reported questionnaire widely used to assess morningness/eveningness (M/E). M/E has been used a proxy for circadian phase in lieu of cumbersome and expensive laboratory studies.
The thirteen item English version of the CSM was translated into Hindi and independently back translated into English. Inconsistencies between the original and back translated versions were then resolved. Both versions were next administered to bilingual persons at Delhi, India (N = 130). After intra-class correlations between the Hindi and the English versions were examined, the Hindi version was administered to community based participants representing different age groups (N = 310).
There was satisfactory intra-class correlation (ICC) between the total scores for the Hindi and the English versions of the CSM (Cronbach’s alpha = 0.873), with variation for individual items scores. Total CSM scores in the second sample suggested a significant association with age, consistent with published reports with the English CSM, i.e., morningness tendencies were more likely to be reported by older adults. Significant associations with gender or educational status were not observed.
The Hindi CSM is a brief questionnaire that provides behavioral measures of diurnal preference. It is freely available for research in Hindi speaking populations.
PMCID: PMC4026194  PMID: 24309877
Circadian rhythm; Morningness-Eveningnes; Composite scale; Hindi Version of CSM
12.  New Modified English and Hindi Oswestry Disability Index in Low Back Pain Patients Treated Conservatively in Indian Population 
Asian Spine Journal  2014;8(5):632-638.
Study Design
Prospective cohort study along with questionnaire.
To measure the correlation of the visual analogue score (VAS), with (Oswestry disability Index [ODI], version 2.1a) in English, and modified ODI (English and Hindi version). To validate translated version of the modified ODI in English version to Hindi.
Overview of Literature
Conflicting evidence in literature regarding the ability for existing ODI score to accurately measure the pain associated disability.
One hundred and three patients conservatively treated for low back pain were enrolled in the study. The Pearson correlation coefficient for VAS and ODI along with the Cronbach α and test-retest reliability for Hindi version using the intraclass correlation coefficient was recorded. The new proposed translated Hindi version of ODI was carried out with established guidelines.
The mean age in English and Hindi version of ODI was 53.5 years and 58.5 years, respectively. The gender ration was 21:24 in the English version and 35:23 in the Hindi version. The mean follow-up in English and Hindi version of ODI was 3.4 months and 50.27 months, respectively. The Cronbach coefficient α=0.7541 for English ODI and 0.9913 for Hindi ODI was recorded for the both modified versions.
The new modified ODI is time saving and accurate, and it avoids the need to measure other scores and has stronger correlation with VAS score compared to the previous scores. We recommend this version for both English and Hindi speaking population as an assessment tool to measure the disability related to pain.
PMCID: PMC4206813  PMID: 25346816
Back pain; Oswestry disability index; Outcome measures; Validity; Reliability; Indian population
13.  BIS-11A -Hindi version: A preliminary study of impulsivity in rural and urban Indian adolescents 
Indian Journal of Psychiatry  2008;50(2):96-99.
Despite of there being a pressing need to gauge impulsivity scores, there is no behavioral instrument in India to assess the impulsivity in adolescents. No earlier studies have been done in India to access impulsivity in adolescents. Even in western countries, no study has been done in rural setting to access impulsivity, although segment of rural population is small in western nations with major population residing in urban areas.
To translate BIS-11A into Hindi from English in a culturally sensitive manner and to do preliminary study in rural and urban areas.
Settings and Design:
First translation of BIS-11 (as it is meant for adults) and cultural substitution resulted in Hindi adult version. Adolescent version was derived from adult version by replacing adult activities with adolescent activities.
Materials and Methods:
BIS-11 English version was translated into Hindi and a back translation was made. As BIS-11 was developed for adults, answering some of the questions poses challenges for adolescents, so to be used with adolescents, questions that do not fit into adolescent age group were substituted keeping in view the activities of adolescents. Besides, questions that were not suitable as per the Indian culture were modified. Initially, these changes were made hypothetically by discussion among the authors and later a group of 48 school students were interviewed about the questions. Based on the interviews of students a final version was prepared. Translation, back translation, cultural substitution -hypothetically, and in school by discussion were carried out. The questionnaire was given to 120 urban high school students (in Jaipur, northern India) and 50 rural students (at Kanota, 25 km from Jaipur, northern India) and the scores were calculated as per the scoring method provided with original BIS-11.
Statistical Analysis:
T-test (two-tailed, two sample unequal variance, i.e., type 3) was used.
T-test (two-tailed, two sample unequal variance, i.e., type 3) found no significant difference between impulsivity scores of adolescents of urban and rural areas t 0.05(2)1 = 0.57, |t| < t 0.05(2)1, P > 0.05, P = 12.706. There were no gender related differences either.
As impulsivity can lead to suicide and is implicated for substance abuse in disorders like Schizophrenia, it is important that culturally sensitive impulsivity studies are done in India on a large scale keeping in view the large size of population. Standardization of the BIS11-A Hindi version is being taken up. The work on Hindi version also generates necessity for other tasks if BIS-11(Hindi version) is to be used widely. Work on psychometric properties of Hindi version of BIS-11 A is being taken up. There is a need to devise a quick way to calculate impulsivity scores keeping in view the large population of India (1 billion out of which at least 33% is Hindi speaking, Census Survey of India, 2001). Besides, BIS-11A needs to be developed for other regional languages in India as there is a high-linguistic diversity in India.
PMCID: PMC2738344  PMID: 19742223
Adolescent; BIS-11 A; Hindi; rural; urban
14.  Validation of the post sleep questionnaire for assessing subjects with restless legs syndrome: results from two double-blind, multicenter, placebo-controlled clinical trials 
BMC Neurology  2011;11:48.
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.
Trial Registration
This study analyzed data from two registered trials, NCT00298623 and NCT00365352.
PMCID: PMC3120662  PMID: 21527006
15.  Long-term Maintenance Treatment of Restless Legs Syndrome With Gabapentin Enacarbil: A Randomized Controlled Study 
Mayo Clinic Proceedings  2010;85(6):512-521.
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.
PMCID: PMC2878254  PMID: 20511481
16.  The Effect of Ropinirole on the Quality of Life in Patients with Restless Legs Syndrome in Korea: An 8-Week, Multicenter, Prospective Study 
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.
PMCID: PMC3543910  PMID: 23346161
restless legs syndrome; dopamine agonists; quality of life; sleep
17.  Translation and validation of Hindi version of Oral Health Impact Profile-14 
Title of the Study:
Validation of Hindi Version of Oral health Impact Profile (OHIP-14).
To validate the Hindi version of OHIP-14.
Settings and Design:
The study was carried out in K.M. Shah Dental College & Hospital, Vadodara.
Materials and Methods:
OHIP-14 was translated into Hindi language.102 participants were given English as well as Hindi versions of OHIP-14.
Statistical Analysis Used:
Individual question were analyzed using Pearson Chi-Square test, Likelihood Ratio test and Linear-by-Linear Association test. The entire questionnaire in English and Hindi language were comparatively analyzed using Unpaired T test & Pearson correlation coefficient test.
All the 14 questions showed no statistically significant difference between the English OHIP-14 and the translated Hindi version of OHIP-14. Results of Unpaired T test (P = 0.61) were statistically insignificant. Pearson Correlation coefficient test was 0.963 suggesting that the translated Hindi version was highly correlated to the original English version.
The translated Hindi version of OHIP-14 is hence established as a valid tool for conduction of oral health related & quality of life surveys in Hindi language which is the most commonly used language in the Indian subcontinent.
PMCID: PMC4439633  PMID: 26015674
Hindi version Oral Health Impact Profile-14; Oral Health Impact Profile-14; oral health quality of life; translation; validation
18.  Pramipexole in restless legs syndrome: an evidence-based review of its effectiveness on clinical outcomes 
Core Evidence  2005;1(1):35-42.
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.
Evidence review:
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.
Outcomes summary:
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.
PMCID: PMC3321653  PMID: 22496675
restless legs syndrome (RLS); pramipexole; outcomes; evidence
19.  Efficacy of an Eight-Week Yoga Intervention on Symptoms of Restless Legs Syndrome (RLS): A Pilot Study 
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.
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.
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.
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.
PMCID: PMC3673587  PMID: 23270319
20.  Hindi translation and validation of dysfunctional beliefs and attitudes about sleep (DBAS - 16) 
Industrial Psychiatry Journal  2013;22(1):80-85.
The objective of this study is to translate and validate the Dysfunctional Beliefs and Attitudes about Sleep Brief Version (DBAS-16)) in Hindi language.
Materials and Methods:
The scale was obtained online, and the permission for translation was obtained from the author. The translation of the scale was carried out following back translation method. The scale was applied on 63 participants attending the adult psychiatry OPD who were included in the study.
Thirty-two patients were having insomnia, and 31 patients were controls without insomnia. The results show that the translated version had good reliability with internal consistency (Chronbach alpha = 0.901).
The Hindi translation of DBAS-16 is a reliable tool for assessing the dysfunctional beliefs and attitude about sleep.
PMCID: PMC3895320  PMID: 24459381
Attitudes; dysfunctional beliefs; sleep; translation
21.  What patients do to counteract the symptoms of Willis-Ekbom disease (RLS/WED): Effect of gender and severity of illness 
This study was carried out to assess different counteracting strategies used by patients with idiopathic Willis-Ekbom disease (RLS/WED). Whether these strategies were influenced by gender or disease severity was also assessed.
Materials and Methods:
A total of 173 patients of idiopathic RLS/WED were included in this study. Their demographic data was recorded. Details regarding the RLS/WED and strategies that they used to counteract the symptoms were asked. The severity of RLS/WED was measured with the help of the Hindi version of international restless legs syndrome severity rating scale. They were asked to provide the details regarding the relief obtained from all the strategies they used on three-point scale: no relief, some relief, and complete relief.
Of the patients, 72% were females. Mean age of the subjects in this study was 39.6 ± 12.6 years, and male subjects were older than females. Four common strategies were reported by the patients to counter the sensations of RLS/WED: moving legs while in bed (85.5%), asking somebody to massage their legs or massaging legs themselves (76.9%), walking (53.2%), and tying a cloth/rope tightly on the legs (39.3%). Of all the patients who moved their legs, 6.7% did not experience any relief, 64.2% reported some relief, and 28.4% reported complete relief. Similarly, of all the patients who used “walking” to counteract symptoms, 50% reported complete relief, 44.5% reported some relief, and the rest did not experience any relief. Many of these patients reported that massage and tying a cloth/rope on legs brought greater relief than any of these strategies. Tying cloth on the leg was more common among females as compared to males (45.9% females vs. 23.5% males; χ2 = 7.54; P = 0.006), while patients with moderately severe to severe RLS/WED reported “moving legs in bed” (79.3% in mild to moderate RLS/WED; 91.8% in severe to very severe RLS; χ2 = 5.36; P = 0.02).
Patients with RLS/WED use a variety of strategies to counteract symptoms. These strategies may be influenced by gender, disease severity, and cultural practices.
PMCID: PMC4251013  PMID: 25506161
Counter-acting strategies; gender; severity; Willis-Ekbom disease (RLS/WED)
22.  Effects of Short- and Long-Term Variations in RLS Severity on Perceived Health Status – the COR-Study 
PLoS ONE  2014;9(4):e94821.
In a cohort study among 2751 members (71.5% females) of the German and Swiss RLS patient organizations changes in restless legs syndrome (RLS) severity over time was assessed and the impact on quality of life, sleep quality and depressive symptoms was analysed. A standard set of scales (RLS severity scale IRLS, SF-36, Pittsburgh Sleep Quality Index and the Centre for Epidemiologic Studies Depression Scale) in mailed questionnaires was repeatedly used to assess RLS severity and health status over time and a 7-day diary once to assess short-term variations. A clinically relevant change of the RLS severity was defined by a change of at least 5 points on the IRLS scale. During 36 months follow-up minimal improvement of RLS severity between assessments was observed. Men consistently reported higher severity scores. RLS severity increased with age reaching a plateau in the age group 45–54 years. During 3 years 60.2% of the participants had no relevant (±5 points) change in RLS severity. RLS worsening was significantly related to an increase in depressive symptoms and a decrease in sleep quality and quality of life. The short-term variation showed distinctive circadian patterns with rhythm magnitudes strongly related to RLS severity. The majority of participants had a stable course of severe RLS over three years. An increase in RLS severity was accompanied by a small to moderate negative, a decrease by a small positive influence on quality of life, depressive symptoms and sleep quality.
PMCID: PMC3990552  PMID: 24743353
23.  Use of near-infrared light to reduce symptoms associated with restless legs syndrome in a woman: a case report 
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.
Case presentation
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.
PMCID: PMC2936319  PMID: 20731851
24.  Progressive development of augmentation during long-term treatment with levodopa in restless legs syndrome: results of a prospective multi-center study 
Journal of Neurology  2009;257(2):230-237.
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.
PMCID: PMC3085743  PMID: 19756826
Restless legs syndrome (RLS); Augmentation; Diagnosis; Rating scale; Clinical study
25.  In vivo mesolimbic D2/3 receptor binding predicts posttherapeutic clinical responses in restless legs syndrome: a positron emission tomography study 
Although D2/3 agonists have been used as a first-line medication for idiopathic restless legs syndrome (iRLS), findings on D2/3 receptors have been inconsistent. Here, we aimed to clarify the contribution of D2/3 receptor function to the clinical symptoms of iRLS by comparing the binding potential (BPND) of [11C]raclopride with clinical improvements after D2/3 stimulation by pramipexole. Eight drug-naïve, iRLS patients and eight age-matched healthy subjects were scanned with positron emission tomography (PET). After PET scans, all patients received pramipexole (0.125 mg) orally for 2 weeks. Patients were evaluated every day with several standardized clinical tests. The BPND values were compared using regions of interest and voxel-based methods. Results showed that the mean magnitude of [11C]raclopride BPND in the mesolimbic dopamine region (nucleus accumbens (NA) and caudate) was significantly lower in the iRLS group. No significant differences between groups were observed in the putamen. The NA [11C]raclopride BPND levels correlated negatively with clinical severity scores and positively with the degree of posttreatment improvement in iRLS. The present results suggest that alterations in mesolimbic D2/3 receptor function reflect the pathophysiology of iRLS, and the baseline availability of D2/3 receptors may predict the clinical outcome after D2/3 agonist treatment.
PMCID: PMC3318153  PMID: 22234337
D2/3 agonist; D2/3 receptor; idiopathic restless legs syndrome; nucleus accumbens; positron emission tomography

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