What is the clinical evidence from this study?

Study design: Observational. Population: Hypertension (n=121). Intervention: Omron BP RS4 (wrist monitor) vs. Microlife WatchBP Home (upper-arm monitor). Primary outcome: Systolic blood pressure difference between wrist and upper-arm monitors (null, 95% CI null, p=<0.0001).

What type of study is this?

This is a Validation Study study.

What does this research mean for the field?

The wrist monitor overdiagnosed hypertension, identifying nearly twice as many hypertensive individuals compared to the upper-arm device. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.CHALLENGES_CONSENSUS.

What question did this study set out to answer?

This research aims to assess the accuracy and precision of two oscillometric devices for measuring blood pressure in a home-like environment.

January 10, 2026Hypertension Research0 citationsOpen Access

Comparison of two validated oscillometric devices in a home-like setup reveals pronounced blood pressure differences and reduced precision

Q: What are the key findings of this study?

The wrist monitor overdiagnosed hypertension, identifying nearly twice as many hypertensive individuals compared to the upper-arm device.

Q: What type of study is this?

This is a Validation Study study.

Q: What does this research mean for the field?

The wrist monitor overdiagnosed hypertension, identifying nearly twice as many hypertensive individuals compared to the upper-arm device. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.CHALLENGES_CONSENSUS.

Q: What question did this study set out to answer?

This research aims to assess the accuracy and precision of two oscillometric devices for measuring blood pressure in a home-like environment.

JZJoachim ZahndUniversity of Lausanne BTBrian ThompsonYale University PRPierre-Antonin RigonUniversity of Lausanne

Key Result

The wrist monitor overdiagnosed hypertension, identifying nearly twice as many hypertensive individuals compared to the upper-arm device.

Key Points

This research aims to assess the accuracy and precision of two oscillometric devices for measuring blood pressure in a home-like environment.
Compared wrist-based and upper-arm blood pressure monitors in a home-like setup
121 participants performed four concurrent blood pressure measurements
Conducted a crossover of devices between arms to compare results
Evaluated bias and precision of each device's measurements
Wrist monitor readings were consistently higher than upper-arm measurements
Both devices showed increased bias at higher blood pressure levels
Moderate agreement in hypertension classification (Cohen’s kappa=0.58)
Wrist monitor over-diagnosed hypertension and had greater variability compared to upper-arm device

Study Design

Type

Observational (n=121)

Multicenter

Structured PICO

Does a wrist-worn oscillometric blood pressure monitor provide accurate blood pressure measurements and hypertension classification compared to an upper-arm monitor when placed by patients in a home-like setup?

Population

121 adult participants across wide blood pressure ranges, mean age 48.5 years, 51.5% female, evaluated in a dedicated outpatient consultation room mimicking a home-like setup.

Intervention

Wrist-worn oscillometric blood pressure monitor placed by participants themselves.

Comparator

Reference upper-arm oscillometric blood pressure monitor placed by participants themselves.

Outcome

Agreement, bias, and precision of systolic and diastolic blood pressure measurements, and hypertension classification (threshold 135/85 mmHg).surrogate

Wrist-worn blood pressure monitors exhibit significant bias, reduced precision, and tend to overdiagnose hypertension compared to upper-arm monitors when used by patients in home-like settings.

Main Result

Effect estimate: null (95% CI null)

Absolute Event Rate: 47.1% vs 28.1%

p-value: p=<0.0001

Limitations

Participants were responsible for device placement, which may introduce bias.
Absence of office BP measurements to compare results in a controlled setting.
Absence of office blood pressure measurement that would have added insight of the setting effect
Absence of sensor may have introduced a bias through incorrect positioning of the wrist device
Did not record the error of position during the study

Abstract

Abstract Home blood pressure monitoring (HBPM) is essential for long-term hypertension management, but its accuracy and reliability is questionable due to user inconsistencies and non-standard usage conditions. This study compared two validated HBPM devices – a wrist-based and a reference upper-arm monitor – in a home-like setup where participants placed the devices themselves. A total of 121 participants underwent four concurrent blood pressure (BP) measurements, with two taken in each arm, followed by a crossover of devices between arms after the initial two readings. Wrist-derived BP readings were higher than upper-arm measurements. With higher blood pressure levels, both devices exhibited greater bias, accompanied by reduced precision in systolic BP measurements. Additionally, hypertension classification showed only moderate agreement (Cohen’s kappa=0.58). The wrist monitor tended to over-diagnose hypertension and exhibited greater variability than the upper-arm device. These findings highlight the need for more guidance and education as well as critical evaluation of home blood pressure measurements provided by patients.

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