Facultad de Enfermería, Fisioterapia y Podología, Universidad Complutense de Madrid, Madrid, Spain.
Faculty of Health Sciences, Universidad Rey Juan Carlos, Alcorcón, Spain.
JMIR Mhealth Uhealth. 2019 Mar 19;7(3):e13137. doi: 10.2196/13137.
High blood pressure is one of the most common reasons why patients seek assistance in daily clinical practice. Screening for hypertension is fundamental and, because hypertension is identified only when blood pressure is measured, accurate measurements are key to the diagnosis and management of this disease. The European Society of Hypertension International Protocol revision 2010 (ESH-IP2) was developed to assess the validity of automatic blood pressure measuring devices that are increasingly being used to replace mercury sphygmomanometers.
We sought to determine whether the iHealth Track blood pressure monitor meets ESH-IP2 requirements for self-measurement of blood pressure and heart rate at the brachial level and is appropriate for use in the general population.
This study was a descriptive investigation. ESH-IP2 requires a total number of 33 participants. For each measure, the difference between observer and device blood pressure and heart rate values is calculated. In all, 99 pairs of blood pressure differences are classified into 3 categories (≤5, ≤10, and ≤15 mm Hg), and 99 pairs of heart rate differences are classified into 3 categories (≤3, ≤5, and ≤8 beats/min). We followed these protocol procedures in a convenience sample of 33 participants.
iHealth Track fulfilled ESH-IP2 requirements and passed the validation process successfully. We observed an absolute difference within 5 mm Hg in 75 of 99 comparisons for systolic blood pressure, 78 of 99 comparisons for diastolic blood pressure, and 89 of 99 comparisons for heart rate. The mean differences between the test and standard readings were 4.19 (SD 4.48) mm Hg for systolic blood pressure, 3.74 (SD 4.55) mm Hg for diastolic blood pressure, and 1.95 (SD 3.27) beats/min for heart rate. With regard to part 2 of ESH-IP2, we observed a minimum of 2 of 3 measurements within a 5-mm Hg difference in 29 of 33 participants for systolic blood pressure and 26 of 33 for diastolic blood pressure, and a minimum of 2 of 3 measurements within a 3-beat/min difference in 30 of 33 participants for heart rate.
iHealth Track readings differed from the standard by less than 5, 10, and 15 mm Hg, fulfilling ESH-IP2 requirements. Consequently, this device is suitable for use in the general population.
高血压是患者在日常临床实践中寻求帮助的最常见原因之一。筛查高血压至关重要，因为只有在测量血压时才能发现高血压，因此准确测量是诊断和管理这种疾病的关键。2010 年欧洲高血压学会国际方案修订版（ESH-IP2）旨在评估越来越多地用于替代汞柱血压计的自动血压测量设备的有效性。
我们旨在确定 iHealth Track 血压监测仪是否符合 ESH-IP2 关于肱动脉水平的自我血压和心率测量的要求，以及是否适合在一般人群中使用。
本研究为描述性研究。ESH-IP2 需要总共 33 名参与者。对于每一次测量，计算观察者和设备血压和心率值之间的差异。总共对 99 对血压差异进行分类（≤5、≤10 和≤15mmHg），对 99 对心率差异进行分类（≤3、≤5 和≤8 次/分钟）。我们在 33 名参与者的方便样本中遵循了这些方案程序。
iHealth Track 满足 ESH-IP2 要求，并成功通过了验证过程。我们观察到，在收缩压的 99 次比较中有 75 次，舒张压的 99 次比较中有 78 次，心率的 99 次比较中有 89 次，绝对差值在 5mmHg 以内。测试和标准读数之间的平均差异分别为收缩压 4.19（SD 4.48）mmHg、舒张压 3.74（SD 4.55）mmHg 和心率 1.95（SD 3.27）次/分钟。关于 ESH-IP2 的第 2 部分，我们观察到，在 33 名参与者中有 29 名收缩压和 26 名舒张压的 3 次测量中有 2 次差值在 5mmHg 以内，有 30 名参与者中有 3 次测量中有 2 次差值在 3 次/分钟以内。
iHealth Track 的读数与标准值相差小于 5、10 和 15mmHg，符合 ESH-IP2 的要求。因此，该设备适用于一般人群。
