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Validation of an Automated and Adjustable Blood Pressure System for Use with a Public Health Station
OBJECTIVE: A new automated and adjustable blood pressure (BP) system has been developed to improve the accuracy of BP measurements on public-use health stations. This self-fitting BP system includes a mechanical cuff that wraps down to the user’s arm prior to bladder inflation. The purpose of this s...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7154042/ https://www.ncbi.nlm.nih.gov/pubmed/32308406 http://dx.doi.org/10.2147/VHRM.S246401 |
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author | Macaulay, Timothy R Erceg, David N McMillan, Bjorn Ramirez, Joel E Dominguez, Jesus F Vallejo, Alberto F Schroeder, E Todd |
author_facet | Macaulay, Timothy R Erceg, David N McMillan, Bjorn Ramirez, Joel E Dominguez, Jesus F Vallejo, Alberto F Schroeder, E Todd |
author_sort | Macaulay, Timothy R |
collection | PubMed |
description | OBJECTIVE: A new automated and adjustable blood pressure (BP) system has been developed to improve the accuracy of BP measurements on public-use health stations. This self-fitting BP system includes a mechanical cuff that wraps down to the user’s arm prior to bladder inflation. The purpose of this study was to validate the adaptable BP system (ABPS) using the current standards from the Association for the Advancement of Medical Instrumentation (AAMI). METHODS: The AAMI/ISO 81060:2013 standards for clinical validation of non-invasive automated arterial BP measurement devices were followed precisely using the same arm sequential method. For each participant, BP was measured over multiple trials by trained observers alternating a reference sphygmomanometer with the ABPS. All study requirements were met with 85 qualifying participants, each with 3 valid paired determinations. RESULTS: The mean difference between ABPS BP and reference BP using all 255 paired determinations was −2.4 ± 7.7 mmHg for systolic and 1.7 ± 5.7 mmHg for diastolic. The standard deviation of the averaged paired determinations per participant was 6.3 mmHg for systolic and 5.2 mmHg for diastolic. Arm circumference measurements had a mean error of −2.1 ± 2.4 cm (R(2) = 0.87). A new prediction model for arm circumference was validated using a holdout dataset (R(2) = 0.94). CONCLUSION: The results of the study confirm that the ABPS met all benchmarks established by the AAMI. The device accurately measures BP across a wide range of arm circumferences (24–44 cm) and is suitable for use by individuals to self-monitor BP. |
format | Online Article Text |
id | pubmed-7154042 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Dove |
record_format | MEDLINE/PubMed |
spelling | pubmed-71540422020-04-17 Validation of an Automated and Adjustable Blood Pressure System for Use with a Public Health Station Macaulay, Timothy R Erceg, David N McMillan, Bjorn Ramirez, Joel E Dominguez, Jesus F Vallejo, Alberto F Schroeder, E Todd Vasc Health Risk Manag Original Research OBJECTIVE: A new automated and adjustable blood pressure (BP) system has been developed to improve the accuracy of BP measurements on public-use health stations. This self-fitting BP system includes a mechanical cuff that wraps down to the user’s arm prior to bladder inflation. The purpose of this study was to validate the adaptable BP system (ABPS) using the current standards from the Association for the Advancement of Medical Instrumentation (AAMI). METHODS: The AAMI/ISO 81060:2013 standards for clinical validation of non-invasive automated arterial BP measurement devices were followed precisely using the same arm sequential method. For each participant, BP was measured over multiple trials by trained observers alternating a reference sphygmomanometer with the ABPS. All study requirements were met with 85 qualifying participants, each with 3 valid paired determinations. RESULTS: The mean difference between ABPS BP and reference BP using all 255 paired determinations was −2.4 ± 7.7 mmHg for systolic and 1.7 ± 5.7 mmHg for diastolic. The standard deviation of the averaged paired determinations per participant was 6.3 mmHg for systolic and 5.2 mmHg for diastolic. Arm circumference measurements had a mean error of −2.1 ± 2.4 cm (R(2) = 0.87). A new prediction model for arm circumference was validated using a holdout dataset (R(2) = 0.94). CONCLUSION: The results of the study confirm that the ABPS met all benchmarks established by the AAMI. The device accurately measures BP across a wide range of arm circumferences (24–44 cm) and is suitable for use by individuals to self-monitor BP. Dove 2020-04-09 /pmc/articles/PMC7154042/ /pubmed/32308406 http://dx.doi.org/10.2147/VHRM.S246401 Text en © 2020 Macaulay et al. http://creativecommons.org/licenses/by-nc/3.0/ This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). |
spellingShingle | Original Research Macaulay, Timothy R Erceg, David N McMillan, Bjorn Ramirez, Joel E Dominguez, Jesus F Vallejo, Alberto F Schroeder, E Todd Validation of an Automated and Adjustable Blood Pressure System for Use with a Public Health Station |
title | Validation of an Automated and Adjustable Blood Pressure System for Use with a Public Health Station |
title_full | Validation of an Automated and Adjustable Blood Pressure System for Use with a Public Health Station |
title_fullStr | Validation of an Automated and Adjustable Blood Pressure System for Use with a Public Health Station |
title_full_unstemmed | Validation of an Automated and Adjustable Blood Pressure System for Use with a Public Health Station |
title_short | Validation of an Automated and Adjustable Blood Pressure System for Use with a Public Health Station |
title_sort | validation of an automated and adjustable blood pressure system for use with a public health station |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7154042/ https://www.ncbi.nlm.nih.gov/pubmed/32308406 http://dx.doi.org/10.2147/VHRM.S246401 |
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