Mazoteras-Pardo Victoria, Becerro-De-Bengoa-Vallejo Ricardo, Losa-Iglesias Marta Elena, López-López Daniel, Palomo-López Patricia, Rodríguez-Sanz David, Calvo-Lobo César
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. 2018 Oct 25;6(10):e11632. doi: 10.2196/11632.
Obesity and high blood pressure (HBP) pose high cardiovascular risks, and they are frequent causes of cardiovascular disease.
The aim of this study was to validate the mobile app QardioArm for high blood pressure monitoring in obese subjects (body mass index ≥30 kg/m) according to guidelines in the European Society of Hypertension-International Protocol 2 (ESH-IP2).
We recruited 33 obese subjects and measured their blood pressure using QardioArm (test device) and Omron M3 Intellisense (Omron Healthcare, Kyoto, Japan; standard device). We compared systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR) according to the ESH-IP2.
A total of 95 of 99 differences for SBP and 91 of 99 for DBP displayed absolute differences within 10 mm Hg. A total of 98 of 99 differences for SBP and 98 of 99 for DBP exhibited absolute differences within 15 mm Hg. This result satisfied requirements for part 1 of the ESH-IP2. A total of 27 out of 33 individuals for SBP and 30 out of 33 individuals for DBP had a minimum of 2 of 3 comparisons within 5 mm Hg difference. None of the subjects had 3 differences outside 5 mm Hg for SBP and DBP, satisfying part 2 of the ESH-IP2. For HR measurements, a total of 90 of 99 differences had absolute differences within 3 beats per minute (bpm), and a total of 94 or 99 differences had absolute differences within 5 bpm. A total of 98 of 99 differences had absolute differences within 8 bpm. Therefore, the test device satisfied part 1 of ESH-IP2 criteria for HR. For part 2 of ESH-IP2, 31 of 33 individuals had a minimum of 2 of 3 comparisons within 3 bpm difference for HR. Only 1 of 33 subjects had 3 differences outside 3 bpm.
To the best of our knowledge, this was the first study to show that an app that measures blood pressure and HR meets the requirements of the ESH-IP2 in an obese population. We believe the ESH-IP2 should publish explicit criteria for validation of blood pressure devices in specific populations.
肥胖和高血压会带来较高的心血管风险，是心血管疾病的常见病因。
本研究旨在根据欧洲高血压学会国际 protocol 2（ESH-IP2）指南，验证移动应用程序 QardioArm 在肥胖受试者（体重指数≥30 kg/m²）中用于高血压监测的效果。
我们招募了 33 名肥胖受试者，使用 QardioArm（测试设备）和欧姆龙 M3 Intellisense（日本京都欧姆龙医疗保健公司；标准设备）测量他们的血压。我们根据 ESH-IP2 比较收缩压（SBP）、舒张压（DBP）和心率（HR）。
SBP 的 99 个差异中有 95 个、DBP 的 99 个差异中有 91 个的绝对差异在 10 mmHg 以内。SBP 的 99 个差异中有 98 个、DBP 的 99 个差异中有 98 个的绝对差异在 15 mmHg 以内。这一结果符合 ESH-IP2 第 1 部分的要求。SBP 方面，33 名个体中有 27 名、DBP 方面，33 名个体中有 30 名在 3 次比较中至少有 2 次差异在 5 mmHg 以内。没有受试者的 SBP 和 DBP 的 3 个差异超出 5 mmHg，符合 ESH-IP2 第 2 部分的要求。对于 HR 测量，99 个差异中有 90 个的绝对差异在每分钟 3 次心跳（bpm）以内，99 个差异中有 94 个或 99 个的绝对差异在 5 bpm 以内。99 个差异中有 98 个的绝对差异在 8 bpm 以内。因此，测试设备符合 ESH-IP2 关于 HR 的第 1 部分标准。对于 ESH-IP2 的第 2 部分，33 名个体中有 31 名在 HR 的 3 次比较中至少有 2 次差异在 3 bpm 以内。33 名受试者中只有 1 名的 3 个差异超出 3 bpm。
据我们所知，这是第一项表明测量血压和 HR 的应用程序在肥胖人群中符合 ESH-IP2 要求的研究。我们认为 ESH-IP2 应公布针对特定人群血压设备验证的明确标准。
