Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Am J Hypertens. 2023 May 21;36(6):341-347. doi: 10.1093/ajh/hpad004.
The Ideal Life Blood Pressure Manager measures blood pressure (BP) and automatically transmits results to the patient's medical record independent of internet access, but has not been validated. Our objective was to conduct a validation study of the Ideal Life BP Manager in pregnant women using a validation protocol.
Pregnant participants were enrolled into three subgroups per the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization protocol: normotensive (systolic blood pressure (SBP) < 140 and diastolic blood pressure (DBP) < 90), hypertensive without proteinuria (SBP ≥ 140 or DBP ≥ 90), and preeclampsia (SBP ≥ 140 or DBP ≥ 90 with proteinuria). Two trained research staff used a mercury sphygmomanometer to validate the device, alternating sphygmomanometer, and device readings for a total of 9 measurements.
Among 51 participants, the mean SBP and DBP differences and standard deviations between the device and the mean staff measurements for all participants were 1.7 ± 7.1 and 1.5 ± 7.0 mm Hg, respectively. The standard deviations of the individual participant's paired device and mean staff SBP and DBP measurements were 6.0 and 6.4 mm Hg, respectively. The device was more likely to overestimate rather than underestimate BP (SBP: mean difference = 1.67, 95% CI [-12.15 to 15.49]; DBP: mean difference = 1.51, 95% CI [-12.26 to 15.28]). Most paired readings had a difference of less than 10 mm Hg across averaged paired readings.
The Ideal Life BP Manager met internationally recognized validity criteria in this sample of pregnant women.
理想生活血压管理器可测量血压（BP）并自动将结果传输到患者的病历中，无需联网，但尚未经过验证。我们的目标是使用验证方案对孕妇进行理想生活 BP 管理器的验证研究。
根据美国医疗器械促进协会/欧洲高血压学会/国际标准化组织协议，将孕妇分为三组：正常血压（收缩压（SBP）<140mmHg 且舒张压（DBP）<90mmHg）、无蛋白尿的高血压（SBP≥140mmHg 或 DBP≥90mmHg）和子痫前期（SBP≥140mmHg 或 DBP≥90mmHg 伴有蛋白尿）。两名经过培训的研究人员使用汞柱血压计对设备进行验证，交替使用血压计和设备读数，总共进行了 9 次测量。
在 51 名参与者中，所有参与者的设备和平均工作人员测量的平均 SBP 和 DBP 差异和标准差分别为 1.7±7.1mmHg 和 1.5±7.0mmHg。个别参与者配对设备和平均工作人员 SBP 和 DBP 测量值的标准差分别为 6.0mmHg 和 6.4mmHg。设备更倾向于高估而不是低估 BP（SBP：平均差异=1.67，95%置信区间[-12.15 至 15.49]；DBP：平均差异=1.51，95%置信区间[-12.26 至 15.28]）。大多数配对读数的平均配对读数差异小于 10mmHg。
在该组孕妇中，理想生活血压管理器符合国际公认的有效性标准。
