Wearable Blood Pressure Monitoring Devices: Understanding Heterogeneity in Design and Evaluation.

OBJECTIVE

Rapid advances in cuffless blood pressure (BP) monitoring have the potential to radically transform clinical care for cardiovascular health. However, due to the large heterogeneity in device design and evaluation, it is difficult to critically and quantitatively evaluate research progress. In this two-part manuscript, we provide a principled way of describing and accounting for heterogeneity in device and study design.

METHODS

We first provide an overview of foundational elements and design principles of three critical aspects: 1) sensors and systems, 2) pre-processing and feature extraction, and 3) BP estimation algorithms. Then, we critically analyze the state-of-the-art methods via a systematic review.

RESULTS

First, we find large heterogeneity in study designs, making fair comparisons extremely challenging. Moreover, many study designs have data leakage and are underpowered. We suggest a first open-contribution BP estimation benchmark for standardization. Next, we observe that BP distribution in the study sample and the time between calibration and test in emerging personalized devices confound BP estimation error. We suggest accounting for these using a convenient metric coined "explained deviation". Finally, we complement this manuscript with a website, https://wearablebp.github.io, containing a bibliography, meta-analysis results, datasets, and benchmarks, providing a timely plaWorm to understand state-of-the-art devices.

CONCLUSION

There is large heterogeneity in device and study design, which should be carefully accounted for when designing, comparing, and contrasting studies.

SIGNIFICANCE

Our findings will allow readers to parse out the heterogeneous literature and move toward promising directions for safer and more reliable devices in clinical practice and beyond.