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^-1 (pooled 95% limits of agreement −9.36–10.08) and 0.68 (0.05–1.32) breaths.min^-1 (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^-1 (pooled limits of agreement −6.71–10.88) and 0.30 (−0.26–0.87) breaths.min^-1 (pooled 95% limits of agreement −3.94–4.29). Only two studies of wearable devices measured S_pO₂; 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.

中文翻译：

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新型可穿戴和非接触式心率、呼吸频率和氧饱和度监测设备：系统评价和荟萃分析

我们进行了系统回顾和荟萃分析，以识别、分类和评估在临床环境中测量心率、呼吸频率和氧饱和度的新型可穿戴和非接触式设备的证据。我们纳入了对住院患者的任何研究，包括睡眠研究诊所。84 项研究被纳入最终审查。有 56 项关于可穿戴设备的研究和 29 项关于非接触式设备的研究。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按比例增加了患者选择和评估者偏倚的高风险（分别为 p = 0.023 和 p < 0.0001）。两种类型的研究之间存在很高但相同的致盲偏倚可能性（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用设备，并且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。可穿戴设备中平均 (95%CI) 心率和呼吸频率偏差的汇总估计值为 1.25 (-0.31–2.82) 次.min^-1（合并 95% 的一致性限制 -9.36-10.08）和 0.68 (0.05-1.32) 次呼吸.min ^-1（合并 95% 的一致性限制 -5.65-6.85）。非接触式设备中平均 (95%CI) 心率和呼吸频率偏差的汇总估计值为 2.18 (3.31–7.66) beats.min ^-1（合并一致极限 -6.71–10.88）和 0.30 (-0.26–0.87) 次呼吸.min ^-1（合并 95% 的一致性限制 -3.94–4.29）。只有两项可穿戴设备研究测量了 S _p O ₂; 这些报告的平均测量偏差为 3.54%（一致性极限 -5.65-11.45%）和 2.9%（-7.4-1.7%）。在研究中观察到异质性，但在按测量方式和参考标准对设备进行分组时不存在。我们得出的结论是，虽然可穿戴设备的研究质量略好于非接触式设备，但总体而言，所有关于新型设备的研究质量都很低，患者数据集较小（< 100），通常不设盲，并且经常使用不适当的统计技术。两种类型的设备在准确度和精度上在统计上相当，但可穿戴设备在极端生命体征方面表现出更少的测量偏差和更高的精度。研究之间的精密度和准确度的统计差异部分可以通过参考标准的差异来解释。