Dataset Information

The reliability, validity and responsiveness of the Restless Legs Syndrome Quality of Life questionnaire (RLSQoL) in a trial population.

ABSTRACT:

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.

SUBMITTER: Abetz L

PROVIDER: S-EPMC1322229 | biostudies-literature | 2005 Dec

REPOSITORIES: biostudies-literature

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Publications

The reliability, validity and responsiveness of the Restless Legs Syndrome Quality of Life questionnaire (RLSQoL) in a trial population.

Abetz Linda L Arbuckle Robert R Allen Richard P RP Mavraki Elena E Kirsch Jeffrey J

Health and quality of life outcomes 20051205

<h4>Background</h4>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.<h4>Methods</h4>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. Resp ...[more]

PMID: 16329756

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Project description:BackgroundThe Anterior Cruciate Ligament-Quality of Life (ACL-QoL) questionnaire is a valid and reliable injury-specific instrument to assess the impact of an ACL rupture on the daily life of a patient.PurposeTo translate the ACL-QoL into Dutch (ACL-QoL-NL) and to study its psychometric properties in patients with an ACL rupture.Study designCohort study (diagnosis); Level of evidence, 2.MethodsThe original ACL-QoL questionnaire was translated from English to Dutch according to international guidelines. The study population consisted of 122 patients with a confirmed ACL rupture who completed the ACL-QoL-NL as well as 4 questionnaires: the International Knee Documentation Committee subjective score, Knee injury and Osteoarthritis Outcome Score, 36-item Short Form Health Survey, and Lysholm Knee Score. We determined the internal consistency, construct validity, and prevalence of floor and ceiling effects of the ACL-QoL-NL total score as well as its 5 subscales. To determine test-retest reliability, we analyzed the data of 68 patients who had a stable knee condition and who completed the ACL-QoL-NL a second time after a 2-week interval.ResultsThe confirmatory factor analysis showed that the original structure of the ACL-QoL-NL was confirmed, except for 4 of 31 items. Internal consistency of the total scale and all 5 subscales was good. More than 75% of the predefined hypotheses on the correlations between the ACL-QoL-NL and the 4 questionnaires were met, indicating good construct validity. No significant floor or ceiling effects were observed. Test-retest reliability was good, and no systematic bias between test and retest was found. Standard error of measurement for the total score was 4.8 points out of 100, and the smallest detectable changes at the group and individual levels were 1.6 and 13.2 points, respectively.ConclusionThe ACL-QoL-NL questionnaire was successfully translated from English to Dutch and demonstrated good internal consistency, validity, and reliability, with no presence of floor or ceiling effects.

Dataset Information

The reliability, validity and responsiveness of the Restless Legs Syndrome Quality of Life questionnaire (RLSQoL) in a trial population.

Background

Methods

Results

Conclusion

Publications

The reliability, validity and responsiveness of the Restless Legs Syndrome Quality of Life questionnaire (RLSQoL) in a trial population.

Similar Datasets

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