Objective: To devise a method of blood pressure measurement capable of being substituted for the fallible human observer in validation of blood pressure measuring devices.
Design: A number of components used to measure blood pressure have been combined innovatively with audiovisual recording technology to produce a system, named the Sphygmocorder, which consists of a mercury sphygmomanometer, an occluding cuff, an inflation source, a stethoscope, a microphone capable of detecting Korotkoff sounds, a camcorder and a display screen.
Methods: To determine the accuracy of the Sphygmocorder against the trained human observer, the Sphygmocorder has been validated in three separate studies in which three devices for self-measurement of blood pressure, the Omron HEM-705CP, the Phillips HP5332 and the Nissei DS-175, were being validated against two trained observers in 85 subjects with a wide range of blood pressure according to the protocol of the British Hypertension Society.
Results: The Sphygmocorder was as accurate as at least one of the observers in each of the validation studies and therefore allows replacement of trained observers by the new device.
Conclusion: The Sphygmocorder, which retains the time-honoured technique of blood pressure measurement with a mercury sphygmomanometer and an auscultating observer, and provides, in addition, objective evidence of the measurement recorded, which can be stored and re-examined, can be used as a substitute for human observers in validation studies of blood pressure-measuring devices.
(C) Lippincott-Raven Publishers.