TY - JOUR
T1 - An innovative wearable device for monitoring continuous body surface temperature (HEARThermo)
T2 - Instrument validation study
AU - Yeh, Chun Yin
AU - Chung, Yi Ting
AU - Chuang, Kun Ta
AU - Shu, Yu Chen
AU - Kao, Hung Yu
AU - Chen, Po Lin
AU - Ko, Wen Chien
AU - Ko, Nai Ying
N1 - Funding Information:
This work was supported by the Ministry of Science and Technology, Taiwan (grant number: MOST 108-2634-F-006-00; MOST 109-2327-B-006-005-) and the National Health Research Institutes (grant number: NHRI-109A1-MRCO-02202014). We acknowledge the consultations from Professor Wen-Shiang Chen from National Taiwan University and Associate Research Fellow Ta-Chien Chan from Taiwan Academia Sinica. We sincerely thank the subjects who participated in this research.
Publisher Copyright:
© 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. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR mHealth and uHealth, is properly cited. The complete bibliographic information, a link to the original publication on http://mhealth.jmir.org/, as well as this copyright and license information must be included.
PY - 2021/2
Y1 - 2021/2
N2 - 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.
AB - 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.
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U2 - 10.2196/19210
DO - 10.2196/19210
M3 - Article
C2 - 33565990
AN - SCOPUS:85101000131
SN - 2291-5222
VL - 9
JO - JMIR mHealth and uHealth
JF - JMIR mHealth and uHealth
IS - 2
M1 - e19210
ER -
