Systematic Review of Consumer Devices for Patient Generated Health Data Using Blood Pressure Monitors for Managing Hypertension (Preprint)

UNSTRUCTURED In the era of digital health information technology, the approach to managing and monitoring blood pressure out-of-office has led to a proliferation of devices collecting patient generated health data (PGHD), including consumer blood pressure (BP) monitors. Despite abundant usage, it remains unclear whether such devices improve health outcomes. We performed a systematic review of consumer blood pressure monitors collecting PGHD to summarize their clinical impact on health and surrogate outcomes. We also summarize process and consumer experience outcomes. An information specialist searched Pubmed, MEDLINE, and EMBASE for controlled studies published up to May 12, 2020. The 49 included studies used 41 different BP monitors. Device engineers judged 38 out of 41 of those as similar to currently available consumer BP monitors. Seventeen of the included studies were designed to isolate the clinical effect of BP monitoring. Six of these studies evaluated health outcomes, and the corresponding data were unclear. All 17 studies that isolated the effect of BP monitors measured systolic and diastolic BP and generally demonstrated a decrease of 2-4 mmHg compared to non-PGHD groups. Adherence to using consumer BP monitors ranged from 38% to 89% and ease of use and satisfaction ratings were generally high. Harms were infrequent, but there were a few technical device problems (e.g., incorrect device alerts). Overall, we found these devices to offer small benefits in blood pressure reduction; however the health impact of these devices continue to remain unclear.