Assessing the validity of oscillometric device for blood pressure measurement in a large population-based epidemiologic study

Abstract

To evaluate the accuracy of the Omron HBP-1300, an automatic device for blood pressure (BP) measurement, compared with the standard auscultatory method with a mercury sphygmomanometer, we conducted a large population-based survey. From 2012 to 2015, a total of 500,000 participants were randomly selected from the 262 urban cities and rural counties in China, of them BP was measured three times simultaneously with mercury sphygmomanometer and Omron HBP-1300 in 37,816 participants. Bias was estimated as the average of the auscultatory measurements minus the average of the oscillometric measurements, with its corresponding 95% limits of agreement. The Association for the Advancement of Medical Instrumentation standards and British Hypertension Society protocols were used to evaluate the accuracy of the oscillometric device. The results showed that the Omron underestimated systolic BP by 1.0 mm Hg (95% limits of agreement: -9.2, 11.2) and underestimated diastolic BP by 0.2 mm Hg (95% limits of agreement: -8.5, 8.1). The bias in systolic BP values was related to heart rate, systolic BP, and pulse pressure level, while the bias in diastolic BP was related to the heart rate and pulse pressure level. Omron HBP-1300 passed the Association for the Advancement of Medical Instrumentation standards and British Hypertension Society protocol requirements. The sensitivity and specificity of the Omron HBP-1300 to detect hypertension were 86.2% and 98.0%, respectively. Our results showed that the Omron HBP-1300 could be used for measuring BP in large epidemiology studies. The bias of BP measurement was related to the age, systolic BP, and pulse pressure level.

Keywords: Blood pressure; China; epidemiologic study; measurement device; validation study.