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Published on: May 3, 2018
Determining which automatic digital blood pressure device performs adequately: a systematic review
1Department of Health Statistics, Fourth Military Medical University, Xi'an, China.
Automatic digital blood pressure (BP) devices show variable accuracy. Even devices passing validation protocols may have only 60% of readings within 5 mm Hg, necessitating multiple measurements for reliable clinical decisions.
Area of Science:
- Cardiology
- Biomedical Engineering
- Clinical Trials
Background:
- Automatic digital blood pressure (BP) devices are widely used for hypertension management.
- Ensuring the accuracy of these devices is crucial for reliable patient diagnosis and treatment.
Purpose of the Study:
- To systematically evaluate the accuracy of automatic digital BP devices based on published validation studies.
- To assess the proportion of accurate readings across different validation protocols.
Main Methods:
- Systematic review of published validation studies for automatic digital BP devices.
- Inclusion of studies using recognized validation protocols (BHS, AAMI, ESH-IP).
- Data summarization of BP differences and proportion of readings within 5 mm Hg.
Main Results:
- 113 studies from 79 articles involving 10,783 participants were analyzed.
- Device pass rates varied by protocol: 81% (BHS), 90% (AAMI), 97% (ESH-IP).
- Accuracy varied significantly between protocols for the same device, with some passing with only 60% of readings within 5 mm Hg.
Conclusions:
- Current validation protocols do not guarantee clinical accuracy for all automatic digital BP devices.
- High variation in readings exists even for devices with a zero mean difference.
- Multiple BP measurements are essential for accurate clinical decision-making.
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