| Autor: |
Tanvi Chandel, Victor Miranda, Andrew Lowe, Tet Chuan Lee |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
|
| Zdroj: |
Technologies, Vol 12, Iss 4, p 44 (2024) |
| Druh dokumentu: |
article |
| ISSN: |
2227-7080 |
| DOI: |
10.3390/technologies12040044 |
| Popis: |
Inaccuracies from devices for non-invasive blood pressure measurements have been well reported with clinical consequences. International standards, such as ISO 81060-2 and the seminal AAMI/ANSI SP10, define protocols and acceptance criteria for these devices. Prior to applying these standards, a sample size of N >= 85 is mandatory, that is, the number of distinct subcjects used to calculate device inaccuracies. Often, it is not possible to gather such a large sample. Many studies apply these standards with a smaller sample. The objective of the paper is to introduce a methodology that broadens the method first developed by the AAMI Sphygmomanometer Committee for accepting a blood pressure measurement device. We study changes in the acceptance region for various sample sizes using the sampling distribution for proportions and introduce a methodology for estimating the exact probability of the acceptance of a device. This enables the comparison of the accuracies of existing device development techniques even if they were studied with a smaller sample size. The study is useful in assisting BP measurement device manufacturers. To assist clinicians, we present a newly developed “bpAcc” package in R to evaluate acceptance statistics for various sample sizes. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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