McCauley S R, Levin H S, Vanier M, Mazaux J M, Boake C, Goldfader P R, Rockers D, Butters M, Kareken D A, Lambert J, Clifton G L
Department of Physical Medicine and Rehabilitation, Baylor College of Medicine, 6560 Fannin, Ste 1144, Houston, TX 77030, USA.
J Neurol Neurosurg Psychiatry. 2001 Nov;71(5):643-51. doi: 10.1136/jnnp.71.5.643.
To investigate the factor structure and psychometric properties of the neurobehavioural rating scale-revised (NRS-R) and to determine its usefulness in clinical trials.
A consecutive series of patients sustaining severe closed head injury were evacuated to one of 11 large regional North American trauma centres and entered into a randomised, phase III, multicentre clinical trial investigating the therapeutic use of moderate hypothermia. Acute care personnel were blinded to outcome and outcome personnel were blinded to treatment condition. The Glasgow outcome scale (GOS) was the primary outcome measure. Secondary outcome measures included the disability rating scale (DRS) and the NRS-R.
Exploratory factor analysis of NRS-R data collected at 6 months after injury (n=210) resulted in a five factor model including: (1) executive/cognition, (2) positive symptoms, (3) negative symptoms, (4) mood/affect, and (5) oral/motor. These factors showed acceptable internal consistency (0.62 to 0.88), low to moderate interfactor correlations (0.19 to 0.61), and discriminated well between GOS defined groups. Factor validity was demonstrated by significant correlations with specific neuropsychological domains. Significant change was measured from 3 to 6 months after injury for the total score (sum of all 29 item ratings) and all factor scores except mood/affect and positive symptoms. The total score and all factor scores correlated significantly with concurrent GOS and DRS scores.
The NRS-R is well suited as a secondary outcome measure for clinical trials as its completion rate exceeds that of neuropsychological assessment and it provides important neurobehavioural information complementary to that provided by global outcome and neuropsychological measures.
研究修订后的神经行为评定量表(NRS-R)的因子结构和心理测量特性,并确定其在临床试验中的效用。
一系列连续的重度闭合性颅脑损伤患者被转送至北美11个大型地区创伤中心之一,并纳入一项随机、III期、多中心临床试验,该试验旨在研究中度低温的治疗用途。急性护理人员对结果不知情,结果评估人员对治疗情况不知情。格拉斯哥预后量表(GOS)是主要的预后指标。次要预后指标包括残疾评定量表(DRS)和NRS-R。
对受伤6个月后收集的NRS-R数据(n = 210)进行探索性因子分析,得出一个五因子模型,包括:(1)执行功能/认知,(2)阳性症状,(3)阴性症状,(4)情绪/情感,以及(5)口腔/运动。这些因子显示出可接受的内部一致性(0.62至0.88),低至中度的因子间相关性(0.19至0.61),并且在GOS定义的组之间有良好的区分度。因子有效性通过与特定神经心理学领域的显著相关性得到证明。从受伤后3个月到6个月,总分(所有29项评分的总和)以及除情绪/情感和阳性症状外的所有因子得分均有显著变化。总分和所有因子得分与同期的GOS和DRS得分显著相关。
NRS-R非常适合作为临床试验的次要预后指标,因为其完成率超过了神经心理学评估,并且它提供了与整体预后和神经心理学测量所提供信息互补的重要神经行为信息。