Revista clinica espanola · 2026
Clinical reliability of a wrist-worn oscillometric ambulatory blood pressure monitor: an independent agreement evaluation.
СтатьяНаблюдательное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Seoane-Casqueiro Ó, Vázquez-Agra N, Cruces-Sande A, López-Prado E, López-Paz J-E, Camafort M, Casariego-Vales E, Hermida-Ameijeiras Á, Pose-Reino A
Аннотация
OBJECTIVE: To evaluate the concordance between a novel wrist-worn oscillometric device and a validated ambulatory blood pressure monitor (ABPM) for blood pressure (BP) and heart rate (HR) assessment under real 24-h ABPM conditions.
METHODS: We conducted an observational concordance study in consecutive hypertensive outpatients requiring 24-h ABPM between May and October 2025. Participants simultaneously wore a validated reference device (SunTech Oscar 2) and the wrist-worn monitor (Huawei Watch D2). Mean BP and HR values for the 24-h, daytime, and nighttime periods were compared. Agreement was assessed using Bland-Altman analysis, intraclass correlation coefficients [ICC(A,1)], and the proportion of readings within ±5, ±10, and ±15 mmHg according to the AAMI/ESH/ISO criteria.
RESULTS: Forty-one patients were included (63% women; median age: 47 years). The wrist-worn device systematically underestimated systolic BP (SBP) during the 24-h and daytime periods and exhibited reduced variability compared with the reference device. Bland-Altman analysis showed a mean bias of -6.8 mmHg for SBP with wide limits of agreement. ICC values indicated poor concordance for SBP (0.38) and moderate concordance for DBP (0.54), while HR agreement was excellent (ICC 0.87). Only 47% of systolic and 61% of DBP readings fell within ±10 mmHg of the reference values, below the AAMI/ESH/ISO acceptability threshold.
CONCLUSIONS: The wrist-worn device did not demonstrate sufficient concordance for ambulatory BP monitoring, although HR performance was reliable. These findings support the need for independent evaluations before considering such devices for clinical BP assessment.
METHODS: We conducted an observational concordance study in consecutive hypertensive outpatients requiring 24-h ABPM between May and October 2025. Participants simultaneously wore a validated reference device (SunTech Oscar 2) and the wrist-worn monitor (Huawei Watch D2). Mean BP and HR values for the 24-h, daytime, and nighttime periods were compared. Agreement was assessed using Bland-Altman analysis, intraclass correlation coefficients [ICC(A,1)], and the proportion of readings within ±5, ±10, and ±15 mmHg according to the AAMI/ESH/ISO criteria.
RESULTS: Forty-one patients were included (63% women; median age: 47 years). The wrist-worn device systematically underestimated systolic BP (SBP) during the 24-h and daytime periods and exhibited reduced variability compared with the reference device. Bland-Altman analysis showed a mean bias of -6.8 mmHg for SBP with wide limits of agreement. ICC values indicated poor concordance for SBP (0.38) and moderate concordance for DBP (0.54), while HR agreement was excellent (ICC 0.87). Only 47% of systolic and 61% of DBP readings fell within ±10 mmHg of the reference values, below the AAMI/ESH/ISO acceptability threshold.
CONCLUSIONS: The wrist-worn device did not demonstrate sufficient concordance for ambulatory BP monitoring, although HR performance was reliable. These findings support the need for independent evaluations before considering such devices for clinical BP assessment.