Hypertension Center STRIDE-7, School of Medicine, Third Department of Medicine, Sotiria Hospital, National and Kapodistrian University of Athens, Greece.
Stroke and Hypertension Unit, Connolly Hospital, Dublin, Ireland.
J Clin Hypertens (Greenwich). 2018 Jul;20(7):1122-1127. doi: 10.1111/jch.13296.
According to the established validation protocols, a typical validation study of a blood pressure (BP) monitor includes general population adults with normal or elevated BP. It is recognized, however, that the automated (oscillometric) BP monitors may have different accuracy or uses in some special populations compared with adults in the general population. Thus, an automated BP monitor with proven accuracy in a general population of adults may not be accurate in a special population, and therefore separate validation is needed. Recognized special populations deserving separate validation are those for which there is theoretical, and also clinical evidence, that the accuracy of BP monitors in these groups differs from that in the general population. Young children, pregnant women (including those with preeclampsia), individuals with arm circumference >42 cm, and patients with atrial fibrillation are regarded as special populations. Adolescents, individuals older than 80 years, and patients with end-stage renal disease or diabetes mellitus have also been considered as possible special groups, but there is still inadequate evidence of altered accuracy of BP monitors in these subjects. Validation studies should be performed in special populations and evaluated separately after the BP-measuring device has successfully undergone a validation study in a general population (unless the test device is intended only for a special population). This article discusses issues relating to the measurement of BP and the diagnosis of hypertension in selected special populations, as well as in low-resource settings, where a simplified yet efficient evaluation strategy is necessary.
根据既定的验证协议，血压（BP）监测仪的典型验证研究包括血压正常或升高的普通成年人群体。然而，人们认识到，与普通成年人群体中的成年人相比，自动（示波法）BP 监测仪在某些特殊人群中的准确性或用途可能有所不同。因此，在普通成年人群体中经过验证具有准确性的自动 BP 监测仪在特殊人群中可能不准确，因此需要单独进行验证。需要单独验证的公认特殊人群包括那些理论上以及临床证据表明，这些人群中的 BP 监测仪的准确性与普通人群中的准确性不同的人群。婴幼儿、孕妇（包括子痫前期孕妇）、臂围>42cm 的个体以及患有心房颤动的患者被视为特殊人群。青少年、80 岁以上的个体以及患有终末期肾病或糖尿病的患者也被认为是可能的特殊群体，但这些人群中 BP 监测仪准确性改变的证据仍然不足。验证研究应在特殊人群中进行，并在 BP 测量设备在普通人群中成功进行验证研究后单独进行评估（除非测试设备仅针对特殊人群）。本文讨论了与选定特殊人群以及资源匮乏环境中的 BP 测量和高血压诊断相关的问题，在这些环境中，需要简化但有效的评估策略。
