Background: Self-measurement of blood pressure (BP) has been increasingly encouraged as a supplement to measurements in the clinic.
Objective: The main objective of this study is to clinically evaluate a new device for self-measurement of BP according to the International Protocol of the European Society of Hypertension (2002).
Methods: Measurements of systolic and diastolic BP in 33 volunteers (15 for phase 1 and a further 18 for phase 2 providing 99 measurements) were obtained using the mercury sphygmomanometer (HgS; Baumanometer) and the Braun BP VitalScan Plus 1650 device. Nine sequential same-arm measurements between the test device and the standard HgS were carried out according to the International Protocol of the European Society of Hypertension in two phases (phase 1, phase 2.1 and phase 2.2).
Results: The device passed phase 1 as 30 systolic and 33 diastolic readings fell within 5 mmHg exceeding the 25 required. In addition, the equipment also passed phase 2.1 as 74 systolic and 77 diastolic readings fell within 5 mmHg exceeding the 65 required for being approved. Finally, it also passed the phase 2.2 as 25 volunteers for systolic and 28 for diastolic had at least 2/3 of their comparisons falling within 5 mmHg (exceeding the 22 required) and only two of the 33 volunteers had their three comparisons over 5 mmHg apart (at the most three are required). The difference-against-mean plots showed that the disagreement between the HgS and the device was -2.57+/-4.36 mmHg for systolic BP and +0.83+/-4.97 mmHg for diastolic BP, respectively.
Conclusion: The equipment passed the different phases satisfactorily and the study suggests that it can be used for self-BP monitoring. The device, however, needs to be used with care by the patients following the instructions, because even when it may be accurate in a laboratory setting, there is potential for them to be used inaccurately in the home setting.