Mills R J, Tennant A, Young C A
Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK.
Swiss Paraplegic Research, Nottwil, Switzerland.
Mult Scler J Exp Transl Clin. 2016 Apr 7;2:2055217316642263. doi: 10.1177/2055217316642263. eCollection 2016 Jan-Dec.
The objective of this study was to develop patient-reported outcome measures for sleep dysfunction and sleepiness in multiple sclerosis (MS), since there are currently no MS-specific measurement tools for these clinically important entities.
Items were generated from semi-structured interviews followed by cognitive debrief. A 42-item pool was administered to patients with MS at three neuroscience centres in the UK. Comparator scales were co-administered. Constructs were validated by Rasch analysis, guided by initial exploratory factor analysis.
There were two supraordinate qualitative themes of diurnal sleepiness and non-restorative nocturnal sleep. Rasch analysis on 722 records produced three scales, which corresponded to diurnal sleepiness, non-restorative nocturnal sleep and fragmented nocturnal sleep. All had excellent fit parameters, were unidimensional and were free from differential item functioning. A summed raw score cut-point of 31/48 in the Diurnal Sleepiness Scale equated to the standard cut-point of 10 on the Epworth Sleepiness Scale (ESS).
Three high-quality measurement scales were developed, and together they compose the Neurological Sleep Index for MS (NSI-MS). The Diurnal Sleepiness Scale might provide an alternative to the ESS. The Non-Restorative Nocturnal Sleep Scale and the Fragmented Nocturnal Sleep Scale appear to be the only such measures for use in MS.
本研究的目的是开发用于评估多发性硬化症(MS)患者睡眠功能障碍和嗜睡情况的患者报告结局测量工具,因为目前尚无针对这些临床重要指标的MS特异性测量工具。
通过半结构化访谈生成条目,随后进行认知反馈。向英国三个神经科学中心的MS患者发放了一个包含42个条目的题库。同时发放了对照量表。在初始探索性因素分析的指导下,通过拉施分析对结构进行验证。
存在白天嗜睡和夜间睡眠无恢复感这两个上位质性主题。对722份记录进行的拉施分析产生了三个量表,分别对应白天嗜睡、夜间睡眠无恢复感和夜间睡眠碎片化。所有量表的拟合参数都非常好,具有单维度性,且不存在项目功能差异。白天嗜睡量表中原始总分切点为31/48,等同于埃普沃思嗜睡量表(ESS)上的标准切点10。
开发了三个高质量的测量量表,它们共同构成了MS神经睡眠指数(NSI-MS)。白天嗜睡量表可能是ESS的替代工具。夜间睡眠无恢复感量表和夜间睡眠碎片化量表似乎是MS中仅有的此类测量工具。