Department of Intensive Care Medicine, Eastern Health, Melbourne, Vic., Australia.
School of Public Health and Preventive Medicine, Monash University, Melbourne, Vic., Australia.
Anaesthesia. 2022 Nov;77(11):1268-1280. doi: 10.1111/anae.15834. Epub 2022 Aug 10.
We performed a systematic review and meta-analysis to identify, classify and evaluate the body of evidence on novel wearable and contactless devices that measure heart rate, respiratory rate and oxygen saturations in the clinical setting. We included any studies of hospital inpatients, including sleep study clinics. Eighty-four studies were included in the final review. There were 56 studies of wearable devices and 29 of contactless devices. One study assessed both types of device. A high risk of patient selection and rater bias was present in proportionally more studies assessing contactless devices compared with studies assessing wearable devices (p = 0.023 and p < 0.0001, respectively). There was high but equivalent likelihood of blinding bias between the two types of studies (p = 0.076). Wearable device studies were commercially available devices validated in acute clinical settings by clinical staff and had more real-time data analysis (p = 0.04). Contactless devices were more experimental, and data were analysed post-hoc. Pooled estimates of mean (95%CI) heart rate and respiratory rate bias in wearable devices were 1.25 (-0.31-2.82) beats.min (pooled 95% limits of agreement -9.36-10.08) and 0.68 (0.05-1.32) breaths.min (pooled 95% limits of agreement -5.65-6.85). The pooled estimate for mean (95%CI) heart rate and respiratory rate bias in contactless devices was 2.18 (3.31-7.66) beats.min (pooled limits of agreement -6.71-10.88) and 0.30 (-0.26-0.87) breaths.min (pooled 95% limits of agreement -3.94-4.29). Only two studies of wearable devices measured S O ; these reported mean measurement biases of 3.54% (limits of agreement -5.65-11.45%) and 2.9% (-7.4-1.7%). Heterogeneity was observed across studies, but absent when devices were grouped by measurement modality and reference standard. We conclude that, while studies of wearable devices were of slightly better quality than contactless devices, in general all studies of novel devices were of low quality, with small (< 100) patient datasets, typically not blinded and often using inappropriate statistical techniques. Both types of devices were statistically equivalent in accuracy and precision, but wearable devices demonstrated less measurement bias and more precision at extreme vital signs. The statistical variability in precision and accuracy between studies is partially explained by differences in reference standards.
我们进行了系统评价和荟萃分析，以确定、分类和评估在临床环境中测量心率、呼吸率和血氧饱和度的新型可穿戴和非接触式设备的证据体。我们纳入了任何关于医院住院患者的研究，包括睡眠研究诊所。最终综述纳入了 84 项研究。其中 56 项为可穿戴设备研究，29 项为非接触式设备研究。一项研究评估了这两种类型的设备。与评估可穿戴设备的研究相比，评估非接触式设备的研究中患者选择和评分者偏倚的高风险比例更高（p=0.023 和 p<0.0001）。两种类型的研究之间存在高度但相当的可能性出现盲法偏倚（p=0.076）。可穿戴设备研究是由临床工作人员在急性临床环境中验证的商业上可用的设备，具有更多的实时数据分析（p=0.04）。非接触式设备更具实验性，数据是事后分析的。可穿戴设备的平均（95%置信区间）心率和呼吸率偏差的汇总估计值为 1.25（-0.31-2.82）次.min（汇总 95%界限协议为-9.36-10.08）和 0.68（0.05-1.32）次.min（汇总 95%界限协议为-5.65-6.85）。非接触式设备的平均（95%置信区间）心率和呼吸率偏差的汇总估计值为 2.18（3.31-7.66）次.min（汇总界限协议为-6.71-10.88）和 0.30（-0.26-0.87）次.min（汇总 95%界限协议为-3.94-4.29）。只有两项可穿戴设备的研究测量了 S O；这些研究报告的平均测量偏差为 3.54%（界限协议为-5.65-11.45%）和 2.9%（-7.4-1.7%）。观察到研究之间存在异质性，但当按测量方式和参考标准对设备进行分组时，异质性不存在。我们得出结论，虽然可穿戴设备的研究质量略高于非接触式设备，但总体而言，所有新型设备的研究质量都较低，患者数据集较小（<100），通常未设盲，且经常使用不适当的统计技术。两种类型的设备在准确性和精密度方面都具有统计学等效性，但可穿戴设备在极端生命体征方面表现出较小的测量偏差和更高的精密度。研究之间的精度和准确性的统计可变性部分由参考标准的差异解释。
