Chun-Yin Yeh 1,2 , Yi-Ting Chung 2 , Kun-Ta Chuang 1 , Yu-Chen Shu 3 , Hung-Yu Kao 1 , Po-Lin Chen 4,5,6 , Wen-Chien Ko 4,6 , Nai-Ying Ko 2,7 Show Affiliations »
Abstract
BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: The findings of our study show the validation of HEARThermo for the continuous monitoring of body surface temperatures in humans. ©Chun-Yin Yeh, Yi-Ting Chung, Kun-Ta Chuang, Yu-Chen Shu, Hung-Yu Kao, Po-Lin Chen, Wen-Chien Ko, Nai-Ying Ko. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 10.02.2021.
BACKGROUND: 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 . OBJECTIVE: 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 . METHODS: 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. RESULTS: 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. CONCLUSIONS: The findings of our study show the validation of HEARThermo for the continuous monitoring of body surface temperatures in humans . ©Chun-Yin Yeh, Yi-Ting Chung, Kun-Ta Chuang, Yu-Chen Shu, Hung-Yu Kao, Po-Lin Chen, Wen-Chien Ko, Nai-Ying Ko. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 10.02.2021.
Entities: Chemical
Disease
Gene
Species
Keywords:
body surface temperature; continuous monitoring; validation; wearable device
Year: 2021
PMID： 33565990 PMCID： PMC7904403 DOI： 10.2196/19210
Source DB: PubMed Journal: JMIR Mhealth Uhealth ISSN： 2291-5222 Impact factor: 4.773