Key result
This paper summarizes the statistical methodology behind the sample size required to test automated sphygmomanometers in special populations, specifically addressing pregnant patients.
Why the study?
Special populations may have physiologic characteristics affecting blood pressure measurement accuracy under the ISO 81060-2:2018 validation standard.
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Provides methodological guidance on sample size calculations for validating automated blood pressure monitors in special populations like pregnant patients.
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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Alpert et al. (2023) conducted a review in Special patient populations (specifically pregnant patients). Automated sphygmomanometers was evaluated. This paper summarizes the statistical methodology behind the sample size required to test automated sphygmomanometers in special populations, specifically addressing pregnant patients.
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