Objective: The market for wrist devices for self-measurement is growing and these devices are becoming popular among the patients. Despite widespread use of these devices, there is limited published evidence for their accuracy and reliability in the different patient groups. The objective of this study was to evaluate the accuracy of the Omron 637IT (Omron Healthcare Europe B.V, Hoofddorp, Netherlands) wrist blood pressure device against the mercury sphygmomanometer in the elderly according to the International Protocol criteria.
Methods: Seventy-six patients older than 65 years of age were studied and classified on the basis of the range of the International Protocol. Blood pressure measurements at the wrist with the Omron 637IT were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential blood pressure measurements were taken. A total of 33 participants with arm circumference distributed randomly were selected for the validation study. During the validation study, 99 measurements were obtained for comparison in the 33 participants. The first phase was performed on 15 participants, and if the device passed this phase, 18 more participants were selected.
Results: Mean discrepancies and standard deviations of the sphygmomanometer device were -0.3+/-6.5 mmHg for systolic blood pressure and 2.8+/-4.8 mmHg for diastolic blood pressure in the study group. The device passed phase 1 in 15 participants. In phase 2.1, from the total 99 comparisons, 66, 87, and 95 for systolic blood pressure and 69, 92, and 97 for diastolic blood pressure were <5, <10, and <15 mmHg, respectively. In phase 2.2, 24 participants had at least two of the differences within 5 mmHg and three participants had no differences within 5 mmHg for systolic blood pressure. For diastolic blood pressure, 24 participants had at least two of the differences within 5 mmHg and three participants had no differences within 5 mmHg. The Omron 637 IT passed the phase 2.1 and 2.2 in the elderly group.
Conclusion: The Omron 637IT wrist blood pressure device passed according to the International Protocol criteria and can be recommended for use in the elderly.