Herbst Timothy, Anis-Anwar Yusra, Giacco Sharon, White William B
Section of Hypertension and Clinical Pharmacology, University of Connecticut School of Medicine, Farmington, 06030-3940, USA.
Blood Press Monit. 2002 Oct;7(5):285-8. doi: 10.1097/00126097-200210000-00007.
Non-invasive blood pressure (BP) devices should be independently evaluated before being used in special populations. The objective of this study was to assess the accuracy of the Welch-Allyn transtelephonic home blood pressure monitor in adults with Parkinson's disease to evaluate the device for use in a large clinical trial involving the safety and efficacy of a monoamine oxidase inhibitor.
BP measurements taken with the device were compared with the results obtained by two experienced observers using a mercury sphygmomanometer in patients with Parkinson's disease. The limits of agreement were then calculated for the device and compared with the results of the two observers.
The agreement parameters between the two observers were -0.5 +/- 2.6 mmHg for systolic BP and 0.1 +/- 2.2 mmHg for diastolic BP. The agreement between the Welch-Allyn transtelephonic device and the observers was -2.6 +/- 4.5 mmHg and -1.9 +/- 3.2 mmHg for systolic and diastolic BP respectively. Nearly 90% of the readings were within 10 mmHg of the observers for both systolic and diastolic BP. Mild tremor had a moderate effect on the validity of the device.
The Welch-Allyn transtelephonic device demonstrated acceptable precision in this cohort of patients with Parkinson's disease and is considered valid for use in a clinical trial involving these patients.
无创血压（BP）设备在用于特殊人群之前应进行独立评估。本研究的目的是评估Welch-Allyn远程家用血压监测仪在帕金森病成人患者中的准确性，以评估该设备在一项涉及单胺氧化酶抑制剂安全性和有效性的大型临床试验中的适用性。
将该设备所测血压与两名经验丰富的观察者使用汞柱式血压计在帕金森病患者中测得的结果进行比较。然后计算该设备的一致性界限，并与两名观察者的结果进行比较。
两名观察者之间收缩压的一致性参数为-0.5±2.6 mmHg，舒张压为0.1±2.2 mmHg。Welch-Allyn远程设备与观察者之间收缩压和舒张压的一致性分别为-2.6±4.5 mmHg和-1.9±3.2 mmHg。收缩压和舒张压的读数中近90%与观察者的读数相差在10 mmHg以内。轻度震颤对该设备的有效性有中度影响。
Welch-Allyn远程设备在该组帕金森病患者中显示出可接受的精度，被认为可用于涉及这些患者的临床试验。
