Department of Computer Science and Information Engineering, National Cheng Kung University, Tainan, Taiwan.
Department of Nursing, National Cheng Kung University, Tainan, Taiwan.
JMIR Mhealth Uhealth. 2021 Feb 10;9(2):e19210. doi: 10.2196/19210.
Variations in body temperature are highly informative during an illness. To date, there are not many adequate studies that have investigated the feasibility of a wearable wrist device for the continuous monitoring of body surface temperatures in humans.
The objective of this study was to validate the performance of HEARThermo, an innovative wearable device, which was developed to continuously monitor the body surface temperature in humans.
We implemented a multi-method research design in this study, which included 2 validation studies-one in the laboratory and one with human subjects. In validation study I, we evaluated the test-retest reliability of HEARThermo in the laboratory to measure the temperature and to correct the values recorded by each HEARThermo by using linear regression models. We conducted validation study II on human subjects who wore HEARThermo for the measurement of their body surface temperatures. Additionally, we compared the HEARThermo temperature recordings with those recorded by the infrared skin thermometer simultaneously. We used intraclass correlation coefficients (ICCs) and Bland-Altman plots to analyze the criterion validity and agreement between the 2 measurement tools.
A total of 66 participants (age range, 10-77 years) were recruited, and 152,881 completed data were analyzed in this study. The 2 validation studies in the laboratory and on human skin indicated that HEARThermo showed a good test-retest reliability (ICC 0.96-0.98) and adequate criterion validity with the infrared skin thermometer at room temperatures of 20°C-27.9°C (ICC 0.72, P<.001). The corrected measurement bias averaged -0.02°C, which was calibrated using a water bath ranging in temperature from 16°C to 40°C. The values of each HEARThermo improved by the regression models were not significantly different from the temperature of the water bath (P=.19). Bland-Altman plots showed no visualized systematic bias. HEARThermo had a bias of 1.51°C with a 95% limit of agreement between -1.34°C and 4.35°C.
The findings of our study show the validation of HEARThermo for the continuous monitoring of body surface temperatures in humans.
在患病期间，体温的变化是非常有意义的。迄今为止，很少有足够的研究调查可穿戴手腕设备在人体表面温度连续监测方面的可行性。
本研究的目的是验证 HEARThermo 的性能，这是一种创新的可穿戴设备，旨在连续监测人体的体表温度。
我们在这项研究中采用了多方法研究设计，包括两项验证研究，一项在实验室进行，另一项在人体上进行。在验证研究 I 中，我们评估了 HEARThermo 在实验室中测量温度的重测可靠性，并使用线性回归模型校正每个 HEARThermo 记录的值。我们在佩戴 HEARThermo 测量体表温度的人体上进行了验证研究 II。此外，我们同时将 HEARThermo 温度记录与红外皮肤温度计记录进行了比较。我们使用组内相关系数（ICC）和 Bland-Altman 图来分析两种测量工具的标准效度和一致性。
共招募了 66 名参与者（年龄范围 10-77 岁），本研究共分析了 152881 个完整数据。实验室和人体皮肤的两项验证研究表明，HEARThermo 显示出良好的重测可靠性（ICC 0.96-0.98），并且在室温为 20°C-27.9°C 时与红外皮肤温度计具有足够的标准效度（ICC 0.72，P<.001）。校正后的测量偏差平均为-0.02°C，使用温度范围为 16°C 至 40°C 的水浴进行校准。使用回归模型提高的每个 HEARThermo 值与水浴温度没有显著差异（P=.19）。Bland-Altman 图显示没有可视化的系统偏差。HEARThermo 的偏差为 1.51°C，95%一致性界限为-1.34°C 至 4.35°C。
本研究的结果表明，HEARThermo 可用于连续监测人体体表温度。
