Department of Dermatology, Zhongshan Hospital Fudan University, Shanghai, China.
Fudan University, Shanghai, China.
RMD Open. 2023 Nov 23;9(4):e003512. doi: 10.1136/rmdopen-2023-003512.
To determine the validity of a hardness sensor to objectively assess skin induration in patients with systemic sclerosis, and to compare the hardness sensor with the modified Rodnan skin score (MRSS) and a durometer.
The skin induration was measured in two assessments: a Latin square experiment to examine the hardness sensor's intraobserver and interobserver reliability; and a longitudinal cohort to evaluate the distribution of hardness sensor measurements, the correlation between hardness sensor, durometer and MRSS, and the sensitivity to change in skin hardness. Other outcome data collected included the health assessment questionnaire (HAQ) disability index and Keitel function test (KTF) score.
The reliability of the hardness sensor was excellent, with high intraobserver and interobserver intraclass correlation coefficients (0.97; 0.96), which was higher than MRSS (0.86; 0.74). Interobserver reproducibility of hardness sensor was only poor in abdomen (0.38), yet for durometer it was poor in face (0.11) and abdomen (0.33). The hardness sensor score provided a greater dynamic evaluation range than MRSS. Total hardness sensor score correlated well with MRSS (r=0.90, p<0.001), total durometer score (r=0.95, p<0.001), HAQ disability index (r=0.70, p<0.001) and KTF score (r=0.66, p<0.001). Change in hardness sensor score also correlated with change in MRSS (r=0.78, p<0.001), total durometer score (r=0.85, p<0.001), HAQ disability index (r=0.76, p<0.001) and KTF score (r=0.67, p<0.001).
The hardness sensor showed greater reproducibility and accuracy than MRSS, and more application sites than durometer; it can also reflect patients' self-assessments and function test outcomes.
确定硬度传感器在评估系统性硬化症患者皮肤硬度方面的有效性，并将其与改良罗德南皮肤评分（MRSS）和硬度计进行比较。
在两项评估中测量皮肤硬度：拉丁方实验以检验硬度传感器的观察者内和观察者间可靠性；纵向队列评估硬度传感器测量值的分布、硬度传感器与硬度计和 MRSS 之间的相关性，以及皮肤硬度变化的敏感性。收集的其他结果数据包括健康评估问卷（HAQ）残疾指数和基特尔功能测试（KTF）评分。
硬度传感器的可靠性非常好，观察者内和观察者间的组内相关系数均很高（0.97；0.96），高于 MRSS（0.86；0.74）。硬度传感器的观察者间再现性仅在腹部较差（0.38），而硬度计在面部（0.11）和腹部（0.33）较差。硬度传感器评分提供了比 MRSS 更大的动态评估范围。总硬度传感器评分与 MRSS （r=0.90，p<0.001）、总硬度计评分（r=0.95，p<0.001）、HAQ 残疾指数（r=0.70，p<0.001）和 KTF 评分（r=0.66，p<0.001）高度相关。硬度传感器评分的变化也与 MRSS（r=0.78，p<0.001）、总硬度计评分（r=0.85，p<0.001）、HAQ 残疾指数（r=0.76，p<0.001）和 KTF 评分（r=0.67，p<0.001）的变化相关。
与 MRSS 相比，硬度传感器具有更高的可重复性和准确性，比硬度计具有更多的应用部位，也可以反映患者的自我评估和功能测试结果。
