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Statistical considerations for testing automated sphygmomanometers in special patient populations
Bruce S Alpert1, Paul Matsumura2, Colin O Wu3
1Department of Pediatrics, University of Tennessee Health Science Center, Memphis, Tennessee.
Abstract:
The International Standards Organization 81060-2:2018 is the current global Standard for the validation of automated sphygmomanometers. It specifies the requirements for clinical studies on the general population, as well as additional requirements for special populations, which might have physiologic characteristics that affect the accuracy of blood pressure measurements. This paper summarizes the statistical methodology behind the sample size required to test automated sphygmomanometers in these special populations and specifically addresses the pregnant patient population.
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