Chausiaux Oriane, Williams Gareth, Nieznański Michał, Bagdu Adem, Downer Philip, Keyser Melanie, Husheer Shamus
Heartfelt Technologies Ltd, Cambridge, UK.
Warwick Medical School, University of Warwick, Coventry, UK.
Med Devices (Auckl). 2021 Apr 13;14:105-118. doi: 10.2147/MDER.S297713. eCollection 2021.
Peripheral edema, change in foot volume, is a marker of congestion which is regularly assessed in routine clinical care. A novel video and Artificial Intelligence (AI)-based solution used to measure anatomical parameters, including volume and foot length, Heartfelt HF-1, is compared to the laboratory gold standard (water displacement) and a medical disposable measuring tape.
58 healthy volunteers were measured with the Heartfelt device; 22 were also measured with the water displacement method and 19 with the medical tape. Bland-Altman analysis was performed for both volumes and foot lengths. Left/right foot differences provided covariance-corrected standard error of measurement (ccSEM) and minimum detectable difference (MDD) for each measurement method.
Heartfelt device measured volumes displayed excellent correlation to the gold standard (water displacement), with Bland-Altman bias of +32mL ±81mL (1 std.dev). Clinically important change in foot volume is approximately 13%. Water displacement yielded ccSEM of ± 32.1mL and MDD of 90mL (6.7% of average foot volume), while the Heartfelt device measurements yielded ccSEM of ±12.6mL and MDD of 35.3mL (2.6% of average foot volume). The majority of differences were attributable to manual positioning of the patient foot in the waterbath.
This study finds that in clinical and non-clinical settings, the Heartfelt device measures foot volume and length more precisely than either the water displacement technique or manual foot length measurements using a medical disposable tape, while having an excellent agreement with these methods.
外周水肿,即足部体积变化,是充血的一个指标,在常规临床护理中会定期评估。将一种用于测量包括体积和足长在内的解剖学参数的新型视频和基于人工智能(AI)的解决方案Heartfelt HF-1与实验室金标准(排水法)和医用一次性卷尺进行比较。
设计、设置、参与者与测量:使用Heartfelt设备对58名健康志愿者进行测量;其中22人还采用排水法进行测量,19人使用医用卷尺测量。对体积和足长均进行了Bland-Altman分析。左右脚差异为每种测量方法提供了协方差校正测量标准误差(ccSEM)和最小可检测差异(MDD)。
Heartfelt设备测量的体积与金标准(排水法)显示出极佳的相关性,Bland-Altman偏差为+32mL±81mL(1个标准差)。足部体积临床上的重要变化约为13%。排水法得出的ccSEM为±32.1mL,MDD为90mL(平均足部体积的6.7%),而Heartfelt设备测量得出的ccSEM为±12.6mL,MDD为35.3mL(平均足部体积的2.6%)。大多数差异归因于患者足部在水浴中的手动定位。
本研究发现,在临床和非临床环境中,Heartfelt设备测量足部体积和长度比排水技术或使用医用一次性卷尺进行的手动足长测量更精确,同时与这些方法具有极佳的一致性。