Novel wearable and contactless heart rate, respiratory rate, and oxygen saturation monitoring devices: a systematic review and meta-analysis

Abstract

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_p O₂ ; 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.

Keywords: clinical monitoring; contactless devices; infrared; wearable devices.