Abetz Linda, Arbuckle Robert, Allen Richard P, Garcia-Borreguero Diego, Hening Wayne, Walters Arthur S, Mavraki Elena, Kirsch Jeffrey M
Mapi Values, Adelphi Mill, Grimshaw Lane, Bollington, Cheshire SK10 5JB, UK.
Sleep Med. 2006 Jun;7(4):340-9. doi: 10.1016/j.sleep.2005.12.011. Epub 2006 May 19.
To assess the reliability, validity, and responsiveness of the International Restless Legs Syndrome Study Group's rating scale (the International Restless Legs Scale (IRLS)) (V2.0), using pooled data from two matching, placebo-controlled studies of ropinirole for treating Restless Legs Syndrome (RLS).
Pooled patient samples comprised 550 patients in the baseline (validation) sample and 439 patients in the week 12 longitudinal (responsiveness) sample. Factor analysis revealed acceptability of the IRLS total score (accounting for 40% of the variance) and that nine of the 10 IRLS items could also be assigned to two distinct subscales, the symptoms or symptoms impact subscales. The IRLS total score, symptoms and symptoms impact subscales had acceptable construct validity, internal consistency reliability (alpha=0.81, 0.80, and 0.76, respectively), and concurrent validity (r=-0.68, -0.52, -0.70, respectively, with the Restless Legs Syndrome Quality of Life questionnaire (RLSQoL) overall life impact score). IRLS scores differed significantly between different levels of sleep problems and Clinical Global Impression (CGI) of health status (P<0.0001), indicating known groups and clinical validity, respectively. Changes in scores differed significantly among CGI 'global improvement' levels (P<0.0001), providing evidence of responsiveness.
The IRLS total score, symptoms, and symptoms impact subscales are reliable, valid, and responsive in a clinical trial setting.
为评估国际不宁腿综合征研究组评定量表（国际不宁腿量表（IRLS））（第2.0版）的信度、效度和反应度，使用了两项匹配合用、安慰剂对照的罗匹尼罗治疗不宁腿综合征（RLS）研究的汇总数据。
汇总的患者样本包括基线（效度验证）样本中的550名患者和第12周纵向（反应度）样本中的439名患者。因子分析显示IRLS总分可接受（解释40%的方差），且IRLS的10个项目中的9个也可分为两个不同的子量表，即症状子量表或症状影响子量表。IRLS总分、症状子量表和症状影响子量表具有可接受的结构效度、内部一致性信度（分别为α=0.81、0.80和0.76）以及同时效度（分别与不宁腿综合征生活质量问卷（RLSQoL）的总体生活影响得分相关系数为r=-0.68、-0.52、-0.70）。不同睡眠问题水平和健康状况的临床总体印象（CGI）之间的IRLS得分差异显著（P<0.0001），分别表明已知组效度和临床效度。CGI“总体改善”水平之间的得分变化差异显著（P<0.0001），提供了反应度的证据。
在临床试验环境中，IRLS总分、症状子量表和症状影响子量表是可靠、有效且具有反应度的。
