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可食用温度胶囊 myTemp 的有效性和可靠性。

Validity and reliability of the myTemp ingestible temperature capsule.

机构信息

Radboud Institute for Health Sciences, Radboud University Medical Center, Department of Physiology, The Netherlands.

Radboud Institute for Health Sciences, Radboud University Medical Center, Department of Physiology, The Netherlands; Liverpool John Moores University, United Kingdom.

出版信息

J Sci Med Sport. 2018 Mar;21(3):322-326. doi: 10.1016/j.jsams.2017.06.006. Epub 2017 Jun 8.

Abstract

OBJECTIVES

An accurate and non-invasive measurement of core body temperature (Tc) is of great importance to quantify exercise-induced increases in Tc in athletes or to assess changes in Tc in patient populations. The use of ingestible gastrointestinal telemetric temperature capsules is widely accepted as a surrogate marker for Tc, but widespread implementation is lacking due to the high costs of these disposable capsules. A new and cheaper temperature capsule system (i.e. myTemp) was recently introduced. The aim of present study is to determine the validity and test-retest reliability of the myTemp system.

DESIGN

Ex-vivo experimental study.

METHODS

Fifteen ingestible temperature capsules (myTemp, Nijmegen, Netherlands) were tested in a highly temperature controlled water bath, in which the water temperature gradually increased from 34°C to 44°C. The study protocol was performed twice for each temperature capsule.

RESULTS

Mean difference between myTemp temperature and water bath temperature was -0.001±0.005°C (Limit of Agreement (LOA): ±0.011°C) during Trial 1 (p=0.11) and -0.001±0.006°C (LOA: ±0.012°C) during Trial 2 (p=0.039). Furthermore, an Intraclass Correlation Coefficient (ICC) of 1.00 was found for both trials. A systematic difference between Trials 1 and 2 of 0.004±0.008°C (LOA: ±0.015°C) was found (p<0.001), whereas the ICC between both trials was 1.00 and the standard error of measurement was 0.005°C.

CONCLUSIONS

Although we found a systematic bias for the sensitivity (-0.001°C) and reliability (0.004°C), these values can be considered insignificant from a physiological and clinical perspective. Thus, the myTemp ingestible temperature capsule is a valid technique to measure (water) temperature under controlled circumstances.

摘要

目的

准确、无创地测量核心体温(Tc)对于量化运动员运动引起的 Tc 升高或评估患者人群 Tc 的变化非常重要。可口服的胃肠道遥测温度胶囊被广泛认为是 Tc 的替代标志物,但由于这些一次性胶囊成本高昂,因此尚未广泛应用。最近推出了一种新的、更便宜的温度胶囊系统(即 myTemp)。本研究旨在确定 myTemp 系统的有效性和重测信度。

设计

离体实验研究。

方法

在高度控温水浴中测试了 15 个可口服的温度胶囊(myTemp,奈梅亨,荷兰),水温逐渐从 34°C 升高到 44°C。每个温度胶囊的研究方案均进行了两次测试。

结果

在第一次试验中,myTemp 温度与水浴温度之间的平均差值为-0.001±0.005°C(允许误差:±0.011°C)(p=0.11),在第二次试验中,差值为-0.001±0.006°C(允许误差:±0.012°C)(p=0.039)。此外,两次试验的组内相关系数(ICC)均为 1.00。在第一次和第二次试验之间发现了 0.004±0.008°C(允许误差:±0.015°C)的系统差异(p<0.001),而两次试验之间的 ICC 为 1.00,测量的标准误差为 0.005°C。

结论

尽管我们发现灵敏度(-0.001°C)和可靠性(0.004°C)存在系统偏差,但从生理和临床角度来看,这些值可以认为是微不足道的。因此,myTemp 可口服温度胶囊是一种在受控环境下测量(水)温度的有效技术。

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