Validity of Wrist and Forehead Temperature in Temperature

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Validity of Wrist and Forehead Temperature in Temperature

Transcript Of Validity of Wrist and Forehead Temperature in Temperature

medRxiv preprint doi: https://doi.org/10.1101/2020.03.02.20030148; this version posted March 6, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.
1 Validity of Wrist and Forehead Temperature in Temperature Screening in the General 2 Population During the Outbreak of 2019 Novel Coronavirus: a prospective real-world 3 study 4 5 (Validity of Wrist and Forehead Temperature in Temperature Screening in the General 6 Population During the Outbreak of COVID-19) 7 8 Ge Chen1,8, Jiarong Xie2,3,8, Guangli Dai1, Peijun Zheng4, Xiaqing Hu5, Hongpeng Lu2,3, Lei 9 Xu2,3, Xueqin Chen6*, Xiaomin Chen2,7* 10 11 1Department of Clinical Engineering, Ningbo First Hospital, Ningbo, Zhejiang Province, 12 China; 13 2Department of General Internal Medicine, Ningbo First Hospital, Ningbo, Zhejiang Province, 14 China; 15 3Department of Gastroenterology, Ningbo First Hospital, Ningbo, Zhejiang Province, China; 16 4Department of Nursing, Ningbo First Hospital, Ningbo, Zhejiang Province, China; 17 5Department of Emergency, Ningbo First Hospital, Ningbo, Zhejiang Province, China; 18 6Department of Chinese Traditional Medicine, Ningbo First Hospital, Ningbo, Zhejiang 19 Province, China; 20 7Department of Cardiology, Ningbo First Hospital, Ningbo, Zhejiang Province, China; 21 8These authors contributed equally to this work. 22 * Corresponding authors 23 24 Abbreviations: 2019-nCoV, 2019 Novel Coronavirus; NCIT, Non-contact infrared 25 thermometer; IRTT, infrared tympanic thermometers; ROC, receiver–operator characteristic.
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NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.

medRxiv preprint doi: https://doi.org/10.1101/2020.03.02.20030148; this version posted March 6, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.
26 27 Key words: 2019 Novel Coronavirus; wrist temperature; non-contact infrared thermometer; 28
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medRxiv preprint doi: https://doi.org/10.1101/2020.03.02.20030148; this version posted March 6, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.
29 Abstract° 30 Aims: Temperature screening is important in the population during the outbreak of 2019 31 Novel Coronavirus (COVID-19). This study aimed to compare the accuracy and precision of 32 wrist and forehead temperature with tympanic temperature under different circumstances. 33 Methods: We performed a prospective observational study in a real-life population. We 34 consecutively collected wrist and forehead temperatures in Celsius (°C) using a non-contact 35 infrared thermometer (NCIT). We also measured the tympanic temperature using a tympanic
36 thermometers (IRTT) and defined fever as a tympanic temperature ≥37.3°C.
37 Results: We enrolled a total of 528 participants including 261 indoor and 267 outdoor 38 participants. We divided outdoor participants into four types according to their means of 39 transportation to the hospital as walk, bicycle, electric vehicle, car, and inside the car. Under 40 different circumstance, the mean difference ranged from -1.72 to -0.56°C in different groups 41 for the forehead measurements, and -0.96 to -0.61°C for the wrist measurements. Both 42 measurements had high fever screening abilities in inpatients (wrist: AUC 0.790; 95% CI: 43 0.725-0.854, P <0.001; forehead: AUC 0.816; 95% CI: 0.757-0.876, P <0.001). The cut-off
44 value of wrist measurement for detecting tympanic temperature ≥37.3°C was 36.2°C with a
45 86.4% sensitivity and a 67.0% specificity, and the best threshold of forehead measurement 46 was also 36.2°C with a 93.2% sensitivity and a 60.0% specificity. 47 Conclusions: Wrist measurement is more stable than forehead measurement under different 48 circumstance. Both measurements have great fever screening abilities for indoor patients. The 49 cut-off value of both measurements was 36.2°C. (ClinicalTrials.gov number: NCT04274621) 50
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medRxiv preprint doi: https://doi.org/10.1101/2020.03.02.20030148; this version posted March 6, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.

51 Introduction

52

The outbreaks of 2019 novel coronavirus COVID-19 (previously known as 2019-nCoV)

53 has attracted global attention, due to its strong transmission ability and certain fatality (1, 2).

54 Some studies reported that fever, fatigue and dry cough are common symptoms of

55 COVID-19 patients (3, 4), and 43.8% of the patients showed fever before admission with it

56 largely being the first symptom (5). Therefore, temperature screening in the high-risk

57 population is important for early identification of COVID-19 infection and thereby reducing

58 the risk of cross infection.

59

During the epidemic, infrared tympanic thermometers (IRTT) and non-contact infrared

60 thermometer (NCIT) are being applied to temperature screening in the general population (6).

61 As a screening tool, it is quick for mass screening and allows a faster triage (7). However, we

62 need to consume a lot of disposable plastic covers when we use IRTT. It may increase the

63 financial burden in the widespread use of population screening. Furthermore, indirect

64 contacts with infected individuals may increase the risk of cross infection. NCIT meets the

65 clinical requirements for mass screening in terms of detection efficiency, safety and

66 cost-performance. Besides, it takes less time than IRTT. Forehead is one of the key targets of

67 thermography. However, forehead temperature is affected by physiological and

68 environmental conditions (8). It should be measured in a relatively temperature-controlled

69 environment. A previous study suggested to acclimate to the indoor temperature for at least

70 10 min for those who were exposed to the cold before taking body temperature readings (8).

71 However, it is not practical for mass screening in winter during the outbreak of COVID-19.

72

Wrist temperature in this outbreak is under consideration. Before testing, they just need

73 to roll up their sleeves at 10 cm above the palmar side of the wrist. Considering this area is

74 covered with clothing, the wrist temperatures may keep stable. Previous study showed

75 wearable devices (WD) on the wrist were applied in temperature monitoring in clinical

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medRxiv preprint doi: https://doi.org/10.1101/2020.03.02.20030148; this version posted March 6, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.

76 practice (9). It brings a challenge whether it can be used as an accurate, safe and

77 cost-effective screening tool in this outbreak.

78

In this study, we explored the accuracy and advantages of wrist temperature

79 measurement in a real-life population in different environments and conditions. We aimed to

80 find the thresholds of this key technique for diagnosis of fever. It may assist to improve the

81 standardization of both practical use and performance, especially indispensable in the

82 pandemic 2019-nCoV situation.

83

84

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medRxiv preprint doi: https://doi.org/10.1101/2020.03.02.20030148; this version posted March 6, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.

85 Materials and Methods

86 Study population

87

This was a prospective observational study in a real-life population. We consecutively

88 enrolled a total of 572 participants at Ningbo First Hospital in China in this study (Figure 1).

89 The exclusion criteria included: (i) Age ≤ 18 years (n = 6); (ii) Wearing hearing aid, or

90 having a cerumen (n = 7); (iii) Participants with soft tissue infection or trauma (n =3); (iv)

91 Missing data of wrist, forehead, and tympanic temperature (n = 4); and (v) Participants whose

92 forehead temperature measurements showed “low” (n = 23). We finally enrolled 528 eligible

93 participants for the final analysis, including 261 indoor and 267 outdoor participants. The 261

94 indoor participants were from the fever clinic and emergency department, and the 267

95 outdoor participants included patients and accompanying family members. The data of indoor

96 participants were collected consecutively between February 14th and February 20th, 2020.

97 The data of outdoor participants were collected on February 14th, 15th, 17th, 2020.

98 Temperature readings were taken by trained and experienced nurses. Each participant was

99 measured for wrist, forehead, and tympanic temperature twice. The temperatures were

100 recorded by mean wrist temperature, forehead, and tympanic temperature, respectively. Data

101 regarding age, gender, transportation, occupation, and temperature were recorded

102 immediately by the nurse to pre-printed files.

103

The study was approved by Ningbo First Hospital Ethics Committee. All participants

104 were asked verbally. They gave their oral informed consent in this study. The study was

105 registered in ClinicalTrials.gov with identifier number: NCT04274621.

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107 Assessment of environment

108

Indoor patients at the fever clinic and emergency department were those who has been

109 indoors for at least a few minutes. The outdoor participants were divided into four type

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medRxiv preprint doi: https://doi.org/10.1101/2020.03.02.20030148; this version posted March 6, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.

110 according to their means of transportation to the hospital as walk, bicycle/electric vehicle, car,

111 and inside the car.

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113 Measurement of temperature

114

Tympanic temperature was measured using IRTT (Braun ThermoScan PRO 6000). Wrist

115 and forehead temperature were measured using NCIT. The NCIT was ranged 32.0–42.9°C.

116 The accuracy was ± 0.2°C. NCIT measurements were taken following the manufacturer's

117 instructions in the mid-forehead and a region at 10 cm above the palmar side of the wrist.

118 After pulling the pinna backward, the nurse inserted IRTT into the external auditory meatus.

119 The probe was held in the same position until the “beep” was heard. Temperature readings

120 were taken by the same trained nurse in the following order: forehead, forehead (the second

121 time), left wrist, right wrist, left tympanic, and right tympanic. The data were recorded by

122 another researcher in pre-printed files. Tympanic membrane is in close proximity to the

123 hypothalamus and the internal carotid artery (10). Thus, tympanic temperature is considered

124 to directly reflect core temperature (11), and was defined as the gold standard in this study.

125 These thermometers were stabilized before measurements. Calibration of thermometers were

126 checked by the Quality and Technology Supervision Bureau, Ningbo, China. It was

127 according to Calibration Specification of Infrared Thermometers for Measurement of Human

128 Temperature (JJF1107-2003).

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130 Statistical analysis

131

Power calculation was performed for sample size. The following parameters were used: a

132 power of 90%, an α-error level of 0.05, estimating a standard deviation of 1°C and a potential

133 allowable error of 0.2°C. Considering a 10% possibility of dropouts and otherwise missing

134 data, at least 293 subjects were needed in our study.

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medRxiv preprint doi: https://doi.org/10.1101/2020.03.02.20030148; this version posted March 6, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.

135

Continuous variables were expressed as mean ± standard deviation (SD), and categorical

136 data in frequency and proportion. The agreements for each method versus

137 tympanic temperature were analyzed by Bland–Altman analysis (12). It also showed three

138 superimposed horizontal lines. Red dashed line highlighted mean bias among all the paired

139 measurements. Black dashed line marked upper and lower 95% Limits of Agreement (LoA).

140 A temperature deviation of 0.5°C was considered as clinically acceptable (13). A tympanic

141 temperature of ≥ 37.3°C was defined as the cut-off point for fever. Statistical analyses were

142 conducted using R version 3.5.1 (The R Foundation for Statistical Computing, Vienna,

143 Austria).

144

145

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medRxiv preprint doi: https://doi.org/10.1101/2020.03.02.20030148; this version posted March 6, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.

146 Results

147 Participants

148

In this prospective observational study, a total of 528 participants were enrolled. Figure 1

149 summarizes characteristics of the participants. The mean age was 46.7 ± 16.4 years. 69.4% (n

150 = 297) of participants were males, and 78.2% (n = 413) were patients (Table 1). Mean

151 forehead, wrist, tympanic measurements were 35.6 ± 1.2°C, 35.7 ± 0.8°C, and 36.6 ± 0.6°C,

152 respectively. There were 44 patients with fever in indoor patients. The data of outdoor

153 participants were collected on February 14th, 15th, 17th, 2020. Mean weather temperatures

154 were 13°C, 14°C, and 7°C, respectively.

155

156 Bland-Altman comparison among the participants under different environment

157

Table 2 showed mean temperatures and Bland-Altman analysis among the participants

158 under different environment. Compared with tympanic temperature as golden standard, the

159 mean difference ranged from -1.72 to -0.56°C for the forehead measurement, and -0.96 to

160 -0.61°C for the wrist measurement. We observed a lower variation in wrist than forehead

161 temperature measurements.

162

Outdoor participants were divided into four types as walk, bicycle or electric vehicle, car,

163 and inside the car. For those who walked, the agreement limits for wrist and tympanic was

164 between -2.05 and 0.34°C; -4.07 and 0.64°C for forehead and tympanic (Figure 2A, B). For

165 those who used bicycle or electric vehicle, the agreement limits for wrist and tympanic was

166 between -2.14 and 0.93°C; -3.82 and 0.84°C for forehead and tympanic (Figure 2C, D). For

167 those who were transported by car, the agreement limits for wrist and tympanic was between

168 -1.43 and -0.44°C; -1.47 and -0.36°C for forehead and tympanic (Figure 2E, F). For those

169 who were inside the car, the agreement limits for wrist and tympanic was between -1.54 and

170 -0.15°C; -2.41 and 0.16°C for forehead and tympanic (Figure 2G, H). It highlighted that wrist

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medRxiv preprint doi: https://doi.org/10.1101/2020.03.02.20030148; this version posted March 6, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.

171 temperature had narrower 95% limits of agreement than forehead. Wrist measurements had

172 the higher percentage of differences falling within ± 0.5°C than forehead measurements in

173 these four types.

174

For indoor patients, the agreement limits for wrist and tympanic was between -2.70 and

175 -0.77°C; -1.91 and 0.80°C for forehead and tympanic (Figure 3). 57.1% of forehead values

176 were included within ± 0.5°C, followed by wrist values (41.4%). We also explore the

177 agreement of left and right wrists (Figure S1). The mean bias is 0.00. The agreement limits

178 for wrist and tympanic was between -0.74 and 0.74°C. It showed good agreement between

179 right and left wrists.

180

181 The receiver–operator characteristic (ROC) curves for detection of fever

182

We performed a ROC curves in indoor patients for detecting tympanic temperature

183 ≥37.3°C. Figure 4 shows the comparison between wrist and forehead measurements for

184 detection of fever. Both measurement had significantly great abilities of screening patients

185 for fever (wrist: AUC 0.790; 95% CI: 0.725–0.854, P <0.001; forehead: AUC 0.816; 95% CI:

186 0.757–0.876, P <0.0001). The cut-off value of wrist measurement for detecting tympanic

187 temperature ≥37.3°C was 36.2°3 with a 86.4% sensitivity and a 67.0% specificity. And the

188 best threshold of forehead measurement was also 36.2°6 with a 93.2% sensitivity and a 60.0%

189 specificity.

190

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WristPreprintNingboStudyTympanic