Proposal of a method for the evaluation of inaccuracy of home sphygmomanometers.

OBJECTIVE: There is no formal protocol for evaluating the individual accuracy of home sphygmomanometers. The aims of this study were to propose a method for achieving accuracy in automated home sphygmomanometers and to test the applicability of the defined method. The purposes of this method were to avoid major inaccuracies and to estimate the optimal circumstance for individual accuracy.
METHODS: The method has three stages and sequential measurement of blood pressure is used. The tested devices were categorized into four groups: accurate, acceptable, inaccurate and very inaccurate (major inaccuracy). The defined method takes approximately 10 min (excluding relaxation time) and was tested on three different occasions.
RESULTS: The application of the method has shown that inaccuracy is a common problem among non-tested devices, that validated devices are superior to those that are non-validated or whose validation status is unknown, that major inaccuracy is common, especially in non-tested devices and that validation does not guarantee individual accuracy.
CONCLUSION: A protocol addressing the accuracy of a particular sphygmomanometer in an individual patient is required, and a practical method has been suggested to achieve this. This method can be modified, but the main idea and approach should be preserved unless a better method is proposed. The purchase of validated devices and evaluation of accuracy for the purchased device in an individual patient will improve the monitoring of self-measurement of blood pressure at home. This study addresses device inaccuracy, but errors related to the patient, observer or blood pressure measurement technique should not be underestimated, and strict adherence to the manufacturer's instructions is essential.