Inter and intraobserver variability of total skin thickness score (modified Rodnan TSS) in systemic sclerosis.
Inter and intraobserver variability of total skin thickness score (modified Rodnan TSS) in systemic sclerosis.
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发表时间：
1995-07
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通讯作者：
P. Clements;P. Lachenbruch;J. Siebold;B. White;S. Weiner;Richard W. Martin;A. Weinstein;M. Weisman;M. Mayes;D. Collier;Fredrick Wigley;T. Medsger;V. Steen;L. Moreland;M. Dixon;M. Massa;E. Lally;D. McCloskey;J. Varga
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作者：
P. Clements;P. Lachenbruch;J. Siebold;B. White;S. Weiner;Richard W. Martin;A. Weinstein;M. Weisman;M. Mayes;D. Collier;Fredrick Wigley;T. Medsger;V. Steen;L. Moreland;M. Dixon;M. Massa;E. Lally;D. McCloskey;J. Varga
目的通过临床触诊评估改良Rodnan（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）试验中常用的结局指标]。方法采用临床触诊法对17个部位的皮肤厚度进行评估，分为正常、轻度、中度、重度4个等级。m-Rodnan总皮肤厚度评分是通过对所有17个身体区域的评分求和得出的。使用m-Rodnan，6-7名研究者在4个疗程中的每个疗程评估了5-6名SSc患者（共22名患者和23名检查者）的皮肤厚度，以确定观察者间的变异性（准确性）。此外，21名研究者在2-8周内对2-3名患者（共60名患者）进行了3次m-Rodnan评估，以定量观察者内变异性（可靠性）。结果：m-Rodnan的观察者间和观察者内平均值+/-患者内标准差（SD）分别为17.7 +/- 4.6和20.7 +/- 2.45。结论m-Rodnan总皮肤厚度评分在测量SSc皮肤厚度方面至少与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同样可靠。这些数据可用于确定样本量和定义有临床意义的缓解。皮肤评分的评估具有充分的可重复性，可作为疾病结局的指标，特别是如果患者由同一研究者进行连续评价。
OBJECTIVE 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)]. METHODS 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). RESULTS 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. CONCLUSION 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.