BACKGROUND: The auscultatory method is used as the reference standard in all prevalent protocols for validation of noninvasive blood pressure measuring devices, and a validation study is essentially based on the comparison between the device and observer measurements. Thus, the objectivity and accuracy of observer measurements are crucial to the validation result. METHODS: To provide observers with more objective information about an auscultatory measurement so that sufficient information to make measurements with greater potential objectivity and accuracy can be available, a computerized data acquisition and analysis system has been developed. It cannot only acquire and store Korotkoff sound, cuff pressure, and oscillometric pulse signals, as well as the sphygmomanometer image, but it also can display the waveforms of the three signals and the sphygmomanometer video while playing the synchronous Korotkoff sounds. With this system, observers can make their measurements via the visual auscultation method, that is to say, by watching those waveforms, instead of the sphygmomanometer, while listening for synchronized Korotkoff sounds. The system was validated according to the International Protocol (IP). RESULTS: The result showed that all the differences between system measurements by the visual auscultation method and observer measurements by the conventional auscultatory method were within 4 mm Hg. CONCLUSIONS: The visual auscultation method achieved a high degree of accuracy, and human observers can be replaced by the system in the validation study of blood pressure measuring devices.
BACKGROUND: The auscultatory method is used as the reference standard in all prevalent protocols for validation of noninvasive blood pressure measuring devices, and a validation study is essentially based on the comparison between the device and observer measurements. Thus, the objectivity and accuracy of observer measurements are crucial to the validation result. METHODS: To provide observers with more objective information about an auscultatory measurement so that sufficient information to make measurements with greater potential objectivity and accuracy can be available, a computerized data acquisition and analysis system has been developed. It cannot only acquire and store Korotkoff sound, cuff pressure, and oscillometric pulse signals, as well as the sphygmomanometer image, but it also can display the waveforms of the three signals and the sphygmomanometer video while playing the synchronous Korotkoff sounds. With this system, observers can make their measurements via the visual auscultation method, that is to say, by watching those waveforms, instead of the sphygmomanometer, while listening for synchronized Korotkoff sounds. The system was validated according to the International Protocol (IP). RESULTS: The result showed that all the differences between system measurements by the visual auscultation method and observer measurements by the conventional auscultatory method were within 4 mm Hg. CONCLUSIONS: The visual auscultation method achieved a high degree of accuracy, and human observers can be replaced by the system in the validation study of blood pressure measuring devices.