Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Dec 14, 2018
Date Accepted: Jan 3, 2019
Validation of the iHealth Track blood pressure monitor, for Self-Measurement, according to the European Society of Hypertension International Protocol Revision 2010 in the general population
ABSTRACT
Background:
High blood pressure is one of the most common causes that patients present in daily clinical practice.
Objective:
Following the European Society of Hypertension International Protocol (ESH-IP) Revision 2010, Ihealth Track oscillometric device was evaluated in the general population for self-blood pressure (BP) and Heart rate (HR) measurement at the brachial level.
Methods:
The ESH-IP Revision 2010 includes a total number of 33 subjects. For each measure, the difference between observer and device BP and HR values was calculated. In all, 99 pairs of BP differences are classified into three categories (≤5, ≤10, and ≤15 mmHg) and 99 pairs of HR differences are classified into three categories ≤3, ≤5, and ≤8 bpm). The protocol procedures were followed.
Results:
IHealth Track fulfilled the requirements of the ESH-IP and passed the validation process successfully. A total of 75 out of 99 comparisons for systolic blood pressure (SBP) showed an absolute difference within 5 mmHg, 78 out of 99 for diastolic blood pressure (DBP) and 89 out of 99 for HR. The mean differences between the test and standard readings were 4.19 ±4.48 mmHg for SBP, 3.74±4.55 mmHg for DBP and 1.95±3.27 bpm for HR. With regard to part 2 of ESH-IP 2010, 29 out of 33 subjects had a minimum of two out of three measurements within 5 mmHg difference for SBP, 26 out of 33 subjects for DBP and 30 out of 33 subjects had a minimum of two out of three measurements within 3 bpm difference for HR.
Conclusions:
Ihealth Track readings differing from the standard by <5, 10, and 15 mmHg fulfill the ESH-IP Revision 2010 requirements. Consequently, this device is suitable for use in the general population. Clinical Trial: Not Applicable
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