Hans van den Heuvel

3 Table 2. Pass requirements and validation results for iHealth Track automated BP device according to the European Society of Hypertension International Protocol Revision 2010. Results are in absolute numbers (measurements in Part 1, subjects in Part 2). Part 1 ≤ 5 mmHg ≤ 10 mmHg ≤ 15 mmHg Grade 1 Mean difference SD Required Two of 73 87 96 All of 65 81 93 Achieved SBP 86 98 99 PASS -0,1 mmHg 3,4 mmHg DBP 88 96 98 PASS -0,1 mmHg 4,0 mmHg Part 2 2/3 ≤ 5 mmHg 0/3 ≤ 5 mmHg Grade 2 Grade 3 Required ≥ 24 ≤ 3 Achieved SBP 31 1 PASS PASS DBP 31 1 PASS PASS Part 3 PASS Legend: DBP, diastolic blood pressure; SBP, systolic blood pressure; SD, standard deviation In the group of 33 women, the iHealth Track passed the EHS 2010 validation criteria with 86/98/99 of 99 device-observer SBP measurement comparisons and 88/96/98 of 99 device – observer DBP measurement comparisons within the 5/10/15 mmHg boundaries respectively (See Table 2 for pass requirements and results). The mean difference (SD) between the observers and the iHealth Track was -0.1 (3.4) for systolic BP and -0.1 (4.0) for diastolic PB measurements, respectively. Bland-Altman plots of the results are shown for both systolic and diastolic blood pressure (Fig. 1) and present the differences between the iHealth Track readings and its corresponding observer readings (the better of the previous and next observer readings) plotted against the mean of the device and the better observer measurements. VALIDATION STUDY OF TWO BLOOD PRESSURE MONITORS IN PREGNANCY 45