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《神经睡眠指数-多发性硬化症》的德语翻译、针对奥地利的文化调适及验证

German translation, cultural adaptation for Austria, and validation of the Neurological Sleep Index-Multiple Sclerosis.

作者信息

Seebacher Barbara, Mildner Sarah, Monschein Tobias, Schillerwein-Kral Cornelia, Bsteh Gabriel, Fasching Bernhard, Voggenberger Lisa, Ziai Jawed, Mills Roger J, Horton Mike C, Brenneis Christian, Berger Thomas, Leutmezer Fritz, Seidel Stefan

机构信息

Clinical Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.

Department of Rehabilitation Science, Clinic for Rehabilitation Muenster, Muenster, Austria.

出版信息

J Clin Sleep Med. 2024 Dec 1;20(12):1923-1935. doi: 10.5664/jcsm.11286.

Abstract

STUDY OBJECTIVES

To translate, culturally adapt, and validate the Neurological Sleep Index-Multiple Sclerosis (NSI-MS) for use in Austrian German-speaking populations with multiple sclerosis.

METHODS

Following established guidelines, the NSI-MS diurnal sleepiness, nonrestorative nocturnal sleep, and fragmented nocturnal sleep scales underwent forward-backward translation, with content and face validity, and cultural adaptation to Austria established. Construct validity was evaluated using Rasch analysis. Known-groups validity was examined, and comparisons were made with scales measuring multiple sclerosis fatigue, daytime sleepiness, sleep quality, anxiety, and depression. Reliability was assessed through Cronbach's alpha, Person Separation Index, Lin's concordance correlation coefficient, measurement error, and floor and ceiling effects. Data were merged with a historic English dataset for comparison between English and German language versions.

RESULTS

The translation and cultural adaptation of the NSI-MS-German version were successful. Pretesting involved 30 populations with multiple sclerosis, while the validation included 400 populations with multiple sclerosis with mild-to-severe disability. The diurnal sleepiness, nonrestorative nocturnal sleep, and fragmented nocturnal sleep scales exhibited good fit parameters, were unidimensional, and invariant. NSI-MS-German version scales demonstrated excellent convergent and known-groups validity, internal consistency, person separation reliability, test-retest reliability, adequate measurement error, and low floor and ceiling effects. Pooling English and German datasets revealed that person estimates for the nonrestorative nocturnal sleep and fragmented nocturnal sleep scales are equivalent across versions, unlike the diurnal sleepiness scale.

CONCLUSIONS

The NSI-MS-German version demonstrates validity, reliability, and responsiveness in assessing diurnal sleepiness, nonrestorative nocturnal sleep, and fragmented nocturnal sleep in populations with multiple sclerosis, generating interval-level data, and shows equivalence between its English and German versions.

CLINICAL TRIAL REGISTRATION

Registry: German Clinical Trials Register (DRKS); Name: German translation, cultural adaptation for Austria and validation of the Neurological Sleep Index - Multiple Sclerosis (NSI-MS); URL: https://drks.de/search/en/trial/DRKS00025573; Identifier: DRKS00025573.

CITATION

Seebacher B, Mildner S, Monschein T, et al. German translation, cultural adaptation for Austria, and validation of the Neurological Sleep Index-Multiple Sclerosis. . 2024;20(12):1923-1935.

摘要

研究目的

对神经睡眠指数-多发性硬化症(NSI-MS)进行翻译、文化调适并验证,以用于奥地利德语区的多发性硬化症患者群体。

方法

按照既定指南,对NSI-MS的日间嗜睡、夜间睡眠无恢复感及夜间睡眠碎片化量表进行了正反翻译,确立了内容效度、表面效度,并进行了针对奥地利的文化调适。使用拉施分析评估结构效度。检验已知组效度,并与测量多发性硬化症疲劳、日间嗜睡、睡眠质量、焦虑和抑郁的量表进行比较。通过克朗巴哈系数、个人分离指数、林氏一致性相关系数、测量误差以及地板效应和天花板效应评估信度。将数据与一个历史性的英文数据集合并,以比较英文和德文版本。

结果

NSI-MS德文版的翻译和文化调适取得成功。预测试涉及30名多发性硬化症患者,而验证纳入了400名轻度至重度残疾的多发性硬化症患者。日间嗜睡、夜间睡眠无恢复感及夜间睡眠碎片化量表显示出良好的拟合参数,具有单维度性且不变。NSI-MS德文版量表显示出出色的收敛效度和已知组效度、内部一致性、个人分离信度、重测信度、足够的测量误差以及低地板效应和天花板效应。合并英文和德文数据集显示,夜间睡眠无恢复感及夜间睡眠碎片化量表的个人估计值在不同版本间相当,而日间嗜睡量表则不然。

结论

NSI-MS德文版在评估多发性硬化症患者的日间嗜睡、夜间睡眠无恢复感及夜间睡眠碎片化方面显示出效度、信度和反应性,能生成区间水平数据,且其英文和德文版本具有等效性。

临床试验注册

注册机构:德国临床试验注册中心(DRKS);名称:神经睡眠指数-多发性硬化症(NSI-MS)的德文翻译、针对奥地利的文化调适及验证;网址:https://drks.de/search/en/trial/DRKS00025573;标识符:DRKS00025573。

引用文献

Seebacher B, Mildner S, Monschein T,等。神经睡眠指数-多发性硬化症的德文翻译、针对奥地利的文化调适及验证。. 2024;20(12):1923 - 1935。

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