科嫩不安腿综合征生活质量量表的验证
Validation of the Kohnen Restless Legs Syndrome-Quality of Life instrument.
作者信息
Kohnen Ralf, Martinez-Martin Pablo, Benes Heike, Trenkwalder Claudia, Högl Birgit, Dunkl Elmar, Walters Arthur S
机构信息
Posthumously, Research Pharmaceutical Services, Inc, Fort Washington, PA, USA; University of Erlangen, Nuremberg, Germany.
National Center of Epidemiology and CIBERNED, Carlos III Institute of Health, Madrid, Spain.
出版信息
Sleep Med. 2016 Aug;24:10-17. doi: 10.1016/j.sleep.2016.04.019. Epub 2016 Aug 3.
BACKGROUND
Due to the symptoms and the sleep disturbances it causes, Restless Legs Syndrome (RLS) has a negative impact on quality of life. Measurement of such impact can be performed by means of questionnaires, such as the Kohnen Restless Legs Syndrome-Quality of Life questionnaire (KRLS-QoL), a specific 12-item instrument that is self-applied by patients. The present study is aimed at performing a first formal validation study of this instrument.
METHODS
Eight hundred ninety-one patients were included for analysis. RLS severity was assessed by the International Restless Legs Scale (IRLS), Restless Legs Syndrome-6 scales (RLS-6), and Clinical Global Impression of Severity. In addition the Epworth Sleepiness Scale (ESS) was assessed. Acceptability, dimensionality, scaling assumptions, reliability, precision, hypotheses-related validity, and responsiveness were tested.
RESULTS
There were missing data in 3.58% patients. Floor and ceiling effects were low for the subscales, global evaluation, and summary index derived from items 1 to 11 after checking that scaling assumptions were met. Exploratory parallel factor analysis showed that the KRLS-QoL may be deemed unidimensional, ie, that all components of the scale are part of one overall general quality of life factor. Indexes of internal consistency (alpha = 0.88), item-total correlation (r = 0.32-0.71), item homogeneity coefficient (0.41), and scale stability (ICC = 0.73) demonstrated a satisfactory reliability of the KRLS-QoL. Moderate or high correlations were obtained between KRLS-QoL scores and the IRLS, some components of the RLS-6, inter-KRLS-QoL domains, and global evaluations. Known-groups validity for severity levels grouping and responsiveness analysis results were satisfactory, the latter showing higher magnitudes of response for treated than for placebo arms.
CONCLUSIONS
The KRLS-QoL was proven an acceptable, reliable, valid, and responsive measure to assess the impact of the RLS on quality of life.
背景
由于不安腿综合征（RLS）的症状及其所导致的睡眠障碍，它会对生活质量产生负面影响。这种影响可以通过问卷调查来衡量，比如科嫩不安腿综合征生活质量问卷（KRLS-QoL），这是一种由患者自行填写的包含12个条目的特定工具。本研究旨在对该工具进行首次正式的效度验证研究。
方法
纳入891例患者进行分析。通过国际不安腿量表（IRLS）、不安腿综合征6分量表（RLS-6）和临床总体严重程度印象来评估RLS的严重程度。此外，还评估了爱泼沃斯嗜睡量表（ESS）。对可接受性、维度性、量表假设、信度、精度、与假设相关的效度和反应性进行了测试。
结果
3.58%的患者存在缺失数据。在检查量表假设得到满足后，各分量表、总体评价以及由第1至11项得出的汇总指标的地板效应和天花板效应较低。探索性平行因子分析表明，KRLS-QoL可被视为单维的，即该量表的所有组成部分都是一个总体生活质量因子的一部分。内部一致性指标（α = 0.88）、项目与总分相关性（r = 0.32 - 0.71）、项目同质性系数（0.41）和量表稳定性（ICC = 0.73）表明KRLS-QoL具有令人满意的信度。KRLS-QoL得分与IRLS、RLS-6的某些组成部分、KRLS-QoL各领域之间以及总体评价之间获得了中度或高度相关性。严重程度分组的已知群体效度和反应性分析结果令人满意，后者显示治疗组的反应幅度高于安慰剂组。
结论
KRLS-QoL被证明是一种可接受、可靠、有效的测量工具，能够评估RLS对生活质量的影响。
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