Kanazawa T, Nakagami G, Goto T, Noguchi H, Oe M, Miyagaki T, Hayashi A, Sasaki S, Sanada H
Department of Gerontological Nursing/Wound Care Management, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Department of Life Support Technology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
J Wound Care. 2016 Apr;25(4):177-80, 182. doi: 10.12968/jowc.2016.25.4.177.
To verify the reliability and validity of FLIR ONE, a device connected to a smartphone, for the assessment of inflammation based on relative temperature increase compared with the thermography routinely used in pressure ulcer (PU) and diabetic foot assessment.
Participants in this pilot cross-sectional observational study were recruited from the patients in the PU team rounds and the diabetic foot outpatient clinic at the university hospital in January 2015. Cohen's kappa coefficient with its 95% confidence intervals was used to evaluate the criterion-related validity and inter- and intra-rater reliability for the thermal imaging assessment. For assessing criterion-related validity, a hand-held high-end infrared thermography device was used to provide reference data. Comparison of thermal images between the smartphone-connected device and the hand-held device was performed with both a 'predetermined range' and an 'automatically-set range.' For assessing inter-rater reliability, two assessors evaluated the thermal images taken by the mobile thermography. For assessing intra-rater reliability, one assessor evaluated the thermal images twice. The thermal images were shown to the assessors at random.
Among 16 thermal images obtained from eight patients, kappa coefficients for each value were as follows: for the predetermined range and automatically-set range, respectively, the criterion-related validity was 1.00 (95% confidence interval 1.00-1.00) and 1.00 (95% confidence interval 1.00-1.00); the inter-rater reliability was 1.00 (95% confidence interval 1.00-1.00) and 1.00 (95% confidence interval 1.00-1.00); and the intra-rater reliability was 1.00 (95% confidence interval 1.00-1.00) and 1.00 (95% confidence interval 1.00-1.00).
This pilot study suggests that FLIR ONE can work as an alternative device for assessing subclinical inflammation in PUs and the diabetic foot in clinical settings. Our results may facilitate clinicians in accepting the routine use of thermal imaging assessment at the patients' bedside.
验证与智能手机相连的FLIR ONE设备基于相对温度升高评估炎症的可靠性和有效性，该评估方法与压力性溃疡（PU）和糖尿病足评估中常规使用的热成像法相比。
本试点横断面观察性研究的参与者于2015年1月从大学医院PU团队查房患者和糖尿病足门诊招募。采用Cohen's kappa系数及其95%置信区间评估热成像评估的标准关联效度以及评估者间和评估者内信度。为评估标准关联效度，使用手持式高端红外热成像设备提供参考数据。将与智能手机相连的设备和手持式设备的热图像在“预定范围”和“自动设置范围”下进行比较。为评估评估者间信度，两名评估者对移动热成像拍摄的热图像进行评估。为评估评估者内信度，一名评估者对热图像进行两次评估。热图像随机展示给评估者。
从8名患者获得的16张热图像中，各值的kappa系数如下：对于预定范围和自动设置范围，标准关联效度分别为1.00（95%置信区间1.00 - 1.00）和1.00（95%置信区间1.00 - 1.00）；评估者间信度为1.00（95%置信区间1.00 - 1.00）和1.00（95%置信区间1.00 - 1.00）；评估者内信度为1.00（95%置信区间1.00 - 1.00）和1.00（95%置信区间1.00 - 1.00）。
本试点研究表明，FLIR ONE可作为临床环境中评估PU和糖尿病足亚临床炎症的替代设备。我们的结果可能有助于临床医生接受在患者床边常规使用热成像评估。
