Schmitz-Hübsch T, du Montcel S Tezenas, Baliko L, Berciano J, Boesch S, Depondt C, Giunti P, Globas C, Infante J, Kang J-S, Kremer B, Mariotti C, Melegh B, Pandolfo M, Rakowicz M, Ribai P, Rola R, Schöls L, Szymanski S, van de Warrenburg B P, Dürr A, Klockgether T, Fancellu Roberto
Department of Neurology, University Hospital of Bonn, Sigmund-Freud-Str. 25, D-53105 Bonn, Germany.
Neurology. 2006 Jun 13;66(11):1717-20. doi: 10.1212/01.wnl.0000219042.60538.92.
To develop a reliable and valid clinical scale measuring the severity of ataxia.
The authors devised the Scale for the Assessment and Rating of Ataxia (SARA) and tested it in two trials of 167 and 119 patients with spinocerebellar ataxia.
The mean time to administer SARA in patients was 14.2 +/- 7.5 minutes (range 5 to 40). Interrater reliability was high, with an intraclass coefficient (ICC) of 0.98. Test-retest reliability was high with an ICC of 0.90. Internal consistency was high as indicated by Cronbach's alpha of 0.94. Factorial analysis revealed that the rating results were determined by a single factor. SARA ratings showed a linear relation to global assessments using a visual analogue scale, suggesting linearity of the scale (p < 0.0001, r(2) = 0.98). SARA score increased with the disease stage (p < 0.001) and was closely correlated with the Barthel Index (r = -0.80, p < 0.001) and part IV (functional assessment) of the Unified Huntington's Disease Rating Scale (UHDRS-IV) (r = -0.89, p < 0.0001), whereas it had only a weak correlation with disease duration (r = 0.34, p < 0.0002).
The Scale for the Assessment and Rating of Ataxia is a reliable and valid measure of ataxia, making it an appropriate primary outcome measure for clinical trials.
开发一种可靠且有效的用于测量共济失调严重程度的临床量表。
作者设计了共济失调评估与分级量表(SARA),并在两项分别包含167例和119例脊髓小脑性共济失调患者的试验中对其进行测试。
对患者使用SARA量表进行评估的平均用时为14.2 +/- 7.5分钟(范围为5至40分钟)。评分者间信度较高,组内相关系数(ICC)为0.98。重测信度较高,ICC为0.90。Cronbach's α系数为0.94,表明内部一致性较高。因子分析显示评分结果由单一因子决定。SARA评分与使用视觉模拟量表进行的整体评估呈线性关系,表明该量表具有线性(p < 0.0001,r(2) = 0.98)。SARA评分随疾病阶段升高(p < 0.001),并与巴氏指数(r = -0.80,p < 0.001)以及统一亨廷顿病评定量表(UHDRS)第四部分(功能评估)密切相关(r = -0.89,p < 0.0001),而与疾病持续时间的相关性较弱(r = 0.34,p < 0.0002)。
共济失调评估与分级量表是一种可靠且有效的共济失调测量工具,使其成为临床试验合适的主要结局指标。