Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Academic Centre for Primary Care, University of Leuven, Leuven, Belgium.
Health Technol Assess. 2020 Oct;24(53):1-28. doi: 10.3310/hta24530.
Current options for temperature measurement in children presenting to primary care include either electronic axillary or infrared tympanic thermometers. Non-contact infrared thermometers could reduce both the distress of the child and the risk of cross-infection.
The objective of this study was to compare the use of non-contact thermometers with the use of electronic axillary and infrared tympanic thermometers in children presenting to primary care.
Method comparison study with a nested qualitative study.
Primary care in Oxfordshire.
Children aged ≤ 5 years attending with an acute illness.
Two types of non-contact infrared thermometers [i.e. Thermofocus (Tecnimed, Varese, Italy) and Firhealth (Firhealth, Shenzhen, China)] were compared with an electronic axillary thermometer and an infrared tympanic thermometer.
The primary outcome was agreement between the Thermofocus non-contact infrared thermometer and the axillary thermometer. Secondary outcomes included agreement between all other sets of thermometers, diagnostic accuracy for detecting fever, parental and child ratings of acceptability and discomfort, and themes arising from our qualitative interviews with parents.
A total of 401 children (203 boys) were recruited, with a median age of 1.6 years (interquartile range 0.79-3.38 years). The readings of the Thermofocus non-contact infrared thermometer differed from those of the axillary thermometer by -0.14 °C (95% confidence interval -0.21 to -0.06 °C) on average with the lower limit of agreement being -1.57 °C (95% confidence interval -1.69 to -1.44 °C) and the upper limit being 1.29 °C (95% confidence interval 1.16 to 1.42 °C). The readings of the Firhealth non-contact infrared thermometer differed from those of the axillary thermometer by -0.16 °C (95% confidence interval -0.23 to -0.09 °C) on average, with the lower limit of agreement being -1.54 °C (95% confidence interval -1.66 to -1.41 °C) and the upper limit being 1.22 °C (95% confidence interval 1.10 to 1.34 °C). The difference between the first and second readings of the Thermofocus was -0.04 °C (95% confidence interval -0.07 to -0.01 °C); the lower limit was -0.56 °C (95% confidence interval -0.60 to -0.51 °C) and the upper limit was 0.47 °C (95% confidence interval 0.43 to 0.52 °C). The difference between the first and second readings of the Firhealth thermometer was 0.01 °C (95% confidence interval -0.02 to 0.04 °C); the lower limit was -0.60 °C (95% confidence interval -0.65 to -0.54 °C) and the upper limit was 0.61 °C (95% confidence interval 0.56 to 0.67 °C). Sensitivity and specificity for the Thermofocus non-contact infrared thermometer were 66.7% (95% confidence interval 38.4% to 88.2%) and 98.0% (95% confidence interval 96.0% to 99.2%), respectively. For the Firhealth non-contact infrared thermometer, sensitivity was 12.5% (95% confidence interval 1.6% to 38.3%) and specificity was 99.4% (95% confidence interval 98.0% to 99.9%). The majority of parents found all methods to be acceptable, although discomfort ratings were highest for the axillary thermometer. The non-contact thermometers required fewer readings than the comparator thermometers.
A method comparison study does not compare new methods against a reference standard, which in this case would be central thermometry requiring the placement of a central line, which is not feasible or acceptable in primary care. Electronic axillary and infrared tympanic thermometers have been found to have moderate agreement themselves with central temperature measurements.
The 95% limits of agreement are > 1 °C for both non-contact infrared thermometers compared with electronic axillary and infrared tympanic thermometers, which could affect clinical decision-making. Sensitivity for fever was low to moderate for both non-contact thermometers.
Better methods for peripheral temperature measurement that agree well with central thermometry are needed.
Current Controlled Trials ISRCTN15413321.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 24, No. 53. See the NIHR Journals Library website for further project information.
目前，在初级保健机构中，儿童体温测量的选择包括电子腋下或红外鼓膜温度计。非接触式红外温度计可减少儿童的不适和交叉感染的风险。
本研究旨在比较非接触式温度计与电子腋下和红外鼓膜温度计在初级保健机构中使用的情况。
嵌套式定性研究的方法比较研究。
牛津郡的初级保健机构。
年龄在 5 岁以下、因急性疾病就诊的儿童。
两种非接触式红外温度计[即 Thermofocus（Tecnimed，Varese，意大利）和 Firhealth（Firhealth，深圳，中国）]与电子腋下温度计和红外鼓膜温度计进行比较。
Thermofocus 非接触式红外温度计与腋下温度计之间的一致性为主要结局。次要结局包括所有其他温度计组之间的一致性、检测发热的诊断准确性、家长和儿童对可接受性和不适的评分，以及来自我们对父母进行的定性访谈中出现的主题。
共纳入 401 名儿童（203 名男孩），中位年龄为 1.6 岁（四分位间距 0.79-3.38 岁）。Thermofocus 非接触式红外温度计的读数与腋下温度计的读数平均相差-0.14°C（95%置信区间-0.21 至-0.06°C），其下限为-1.57°C（95%置信区间-1.69 至-1.44°C），上限为 1.29°C（95%置信区间 1.16 至 1.42°C）。Firhealth 非接触式红外温度计的读数与腋下温度计的读数平均相差-0.16°C（95%置信区间-0.23 至-0.09°C），其下限为-1.54°C（95%置信区间-1.66 至-1.41°C），上限为 1.22°C（95%置信区间 1.10 至 1.34°C）。Thermofocus 温度计的第一次和第二次读数之间的差值为-0.04°C（95%置信区间-0.07 至-0.01°C）；下限为-0.56°C（95%置信区间-0.60 至-0.51°C），上限为 0.47°C（95%置信区间 0.43 至 0.52°C）。Firhealth 温度计的第一次和第二次读数之间的差值为 0.01°C（95%置信区间-0.02 至 0.04°C）；下限为-0.60°C（95%置信区间-0.65 至-0.54°C），上限为 0.61°C（95%置信区间 0.56 至 0.67°C）。Thermofocus 非接触式红外温度计的敏感性和特异性分别为 66.7%（95%置信区间 38.4%至 88.2%）和 98.0%（95%置信区间 96.0%至 99.2%）。对于 Firhealth 非接触式红外温度计，敏感性为 12.5%（95%置信区间 1.6%至 38.3%），特异性为 99.4%（95%置信区间 98.0%至 99.9%）。大多数家长认为所有方法都可以接受，尽管腋下温度计的不适评分最高。非接触式温度计的读数比比较温度计少。
方法比较研究并未将新方法与参考标准进行比较，而参考标准是需要放置中央导管的中心温度测量，这在初级保健中不可行或不可接受。电子腋下和红外鼓膜温度计本身已被发现与中心温度测量具有中度一致性。
两种非接触式红外温度计与电子腋下和红外鼓膜温度计相比，95%置信区间的差值均大于 1°C，这可能会影响临床决策。两种非接触式温度计检测发热的敏感性均为中低水平。
需要更好的外周温度测量方法，与中心体温测量有良好的一致性。
当前对照试验 ISRCTN8262431。
本项目由英国国家卫生与保健优化研究所（NIHR）卫生技术评估计划资助，全文将在 ; 第 24 卷，第 53 期。欲了解更多项目信息，请访问 NIHR 期刊库网站。
