Clements P J, Lachenbruch P A, Seibold J R, Zee B, Steen V D, Brennan P, Silman A J, Allegar N, Varga J, Massa M
Department of Medicine, UCLA School of Medicine.
J Rheumatol. 1993 Nov;20(11):1892-6.
Using data from 3 independent studies, to quantify the interobserver reliability of semi-quantitative skin scoring methods (the original and the modified Rodnan skin thickness scores) used to assess the degree and extent of cutaneous thickening in systemic sclerosis (SSc).
Interobserver variability of the original Rodnan skin thickness score method (cutaneous thickness assessed in 26 body surface areas using a 0-4 scale) was evaluated in one study. The modified Rodnan method (cutaneous thickness assessed in 17 body surface areas using a 0-3 scale) was evaluated in 2 studies. In all 3 studies, each patient's skin thickness was assessed by 6 or 7 observers in a blinded fashion.
The overall within patient standard deviations were not statistically different in all 3 studies (5.4, 4.6 and 4.6) irrespective of the overall mean skin thickness scores (26.6, 18.3 and 17.7). With the original Rodnan technique, the within patient standard deviation tended to be higher in patients with higher skin thickness scores. In the 2 studies which used the modified technique, no significant differences in within patient standard deviation were noted between high and low skin thickness scores.
Three independent studies demonstrate that the Rodnan skin thickness scoring techniques are reproducible among different observers (the within patient standard deviation being consistently about 5 units). Our data provide valuable information needed for sample size calculations for SSc trials in which skin thickness score is an outcome variable.
利用来自3项独立研究的数据,量化用于评估系统性硬化症(SSc)皮肤增厚程度和范围的半定量皮肤评分方法(原始和改良的Rodnan皮肤厚度评分)的观察者间可靠性。
在一项研究中评估了原始Rodnan皮肤厚度评分方法(使用0 - 4量表在26个身体表面积评估皮肤厚度)的观察者间变异性。在2项研究中评估了改良的Rodnan方法(使用0 - 3量表在17个身体表面积评估皮肤厚度)。在所有3项研究中,6名或7名观察者以盲法评估每位患者的皮肤厚度。
在所有3项研究中,无论总体平均皮肤厚度评分如何(分别为26.6、18.3和17.7),患者内总体标准差无统计学差异(分别为5.4、4.6和4.6)。采用原始Rodnan技术时,皮肤厚度评分较高的患者其患者内标准差往往更高。在使用改良技术的2项研究中,高皮肤厚度评分和低皮肤厚度评分患者的患者内标准差无显著差异。
3项独立研究表明,Rodnan皮肤厚度评分技术在不同观察者之间具有可重复性(患者内标准差始终约为5个单位)。我们的数据为以皮肤厚度评分为结局变量的SSc试验样本量计算提供了所需的有价值信息。