Clements P, Lachenbruch P, Siebold J, White B, Weiner S, Martin R, Weinstein A, Weisman M, Mayes M, Collier D
University of California at Los Angeles, School of Medicine, Department of Medicine, USA.
J Rheumatol. 1995 Jul;22(7):1281-5.
Assessment of the inter and intraobserver variability of the modified Rodnan (m-Rodnan) total skin thickness score by clinical palpation [a commonly used outcome measure in trials of systemic sclerosis (SSc)].
Skin thickness was assessed by clinical palpation of 17 body areas on 0 to 3 scale (normal, mild, moderate, severe). The m-Rodnan total skin thickness score was derived by summation of the scores from all 17 body areas. Using the m-Rodnan, 6-7 investigators assessed skin thickness in 5-6 patients with SSc (22 patients and 23 examiners total) at each of 4 sessions for the determination of interobserver variability (accuracy). In addition 21 of the investigators then assessed m-Rodnan in 2-3 patients each (60 patients total) 3 times over a 2-8 week period to quantitate intraobserver variability (reliability).
Interobserver and intraobserver mean +/- within patient standard deviations (SD) for the m-Rodnan were found to be 17.7 +/- 4.6 and 20.7 +/- 2.45, respectively.
The m-Rodnan total skin thickness score is at least as reliable for measuring skin thickness in SSc as are the ARA and Ritchie joint tenderness counts for assessing joint disease in rheumatoid arthritis. These data are useful for the determination of sample size and for the definitions of clinically meaningful response. Assessment of skin score is sufficiently reproducible to include as a measure of disease outcome, especially if patients are serially evaluated by the same investigator.
通过临床触诊评估改良罗德南（m-Rodnan）总皮肤厚度评分的观察者间和观察者内变异性[系统性硬化症（SSc）试验中常用的一项结果指标]。
通过对17个身体部位进行临床触诊，按0至3级（正常、轻度、中度、重度）评估皮肤厚度。m-Rodnan总皮肤厚度评分通过将所有17个身体部位的评分相加得出。6至7名研究人员使用m-Rodnan在4个时间段的每个时间段对5至6例SSc患者（共22例患者和23名检查者）的皮肤厚度进行评估，以确定观察者间变异性（准确性）。此外，21名研究人员随后在2至8周的时间内对2至3例患者（共60例患者）每人进行3次m-Rodnan评估，以量化观察者内变异性（可靠性）。
发现m-Rodnan的观察者间和观察者内均值±患者内标准差（SD）分别为17.7±4.6和20.7±2.45。
m-Rodnan总皮肤厚度评分在测量SSc皮肤厚度方面至少与美国风湿病学会（ARA）和里奇关节压痛计数在评估类风湿关节炎关节疾病方面一样可靠。这些数据有助于确定样本量以及定义具有临床意义的反应。皮肤评分评估具有足够的可重复性，可作为疾病结果的一项指标，尤其是如果由同一名研究人员对患者进行连续评估时。
