BACKGROUND
Variations in body temperature are highly informative during illness. Researchers have not sufficiently investigated the feasibility of a wearable wrist device for the continuous monitoring of body surface temperature.
OBJECTIVE
The objective of this study is to develop and validate HEARThermo, an innovative wearable device, which intends to continuously monitor the body temperature on human subjects.
METHODS
We implemented a multi-method research design in this study, which included two validation studies in the laboratory and with human subjects. In Validation study I, we evaluated the test-retest reliability of HEARThermo in a laboratory to measure temperature and correct its values recorded by each HEARThermo by using linear regression models. We conducted Validation study II on human subjects who wore HEARThermo to measure their body surface temperatures. Additionally, we compared these values with the infrared skin thermometer simultaneously. We used the intraclass correlation coefficients (ICC) and Bland-Altman plots to analyze the criterion validity and agreement between the two measurement tools.
RESULTS
The two 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 thermometers at room temperatures of 20°C –27.9°C (ICC=0.72). The corrected measurement bias averaged -0.02°C, which was calibrated by using a water bath ranging in temperature from 16°C to 40°C. Bland-Altman plots showed no visualized systematic bias. HEARThermo had a bias of 1.51°C with 95% limit of agreement between -1.34°C and 4.35°C.
CONCLUSIONS
The study results provided validation for HEARThermo, an innovative wearable device, for the continuous monitoring of body surface temperature as a reference for developing future medical services.
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