Validation of an automated home blood pressure measurement device in oldest-old populations

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Abstract

Despite the wide use of automated devices for the self-measurement of home blood pressure (BP), no evidence is available regarding the accuracy of such devices in oldest-old populations. The aim of this study was to validate the accuracy of the automated oscillometric upper arm-cuff BP-monitoring device according to an international protocol in oldest-old individuals. In 35 participants aged over 85 years old, BP was measured on the same arm sequentially using a mercury sphygmomanometer (by two observers) and an Omron HEM-7080IC. The difference between the test device and observer measurements and associated factors were evaluated according to the International Organization for Standardization (ISO) 81060-2:2013 protocol. A total of 105 pairs (three pairs per participant) of the test device and observer BP measurements were obtained. The mean (±standard deviation: SD) differences in systolic BP (SBP) and diastolic BP (DBP) between the methods were −0.7 ± 7.1 and −1.1 ± 4.5 mmHg, respectively, and those for each participant were −0.7 ± 5.8 mmHg for SBP and −1.1 ± 4.1 mmHg for DBP; the device therefore fulfilled the requirements of the ISO protocol. In the multivariate analysis with the linear mixed model, the difference was associated with the cuff size for SBP and pulse pressure for DBP. The Omron HEM-7080IC passed the ISO requirements for oldest-old individuals aged 85 years or older. This device can be recommended for clinical and self/home use in oldest-old populations.

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Acknowledgements

This study was supported by a research grant from Omron Healthcare Co., Ltd. We thank all patients who participated to this study. We would like to thank Drs. Takeya, Kurinami, and Akasaka from the Department of Geriatric Medicine, Osaka University Hospital for their cooperation with this study. We also thank Ms. Tuo, Mr. Akagi, and other members of the Health Science Division, Osaka University Graduate School of Medicine for their assistance in conducting this study.

Funding

KA, KK, and TO recieved research grants from Omron Healthcare Co., Ltd. The sponsor of this study was not involved in data collection or analysis.

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Correspondence to Kei Kamide.

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KSa is a salaried employee of Omron Healthcare Co., Ltd. The remaining authors declare that they have no conflict of interest.

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Keywords

  • Blood pressure
  • Validation
  • Oldest-old
  • Oscillometric device
  • ISO 81060-2