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Blood Pressure Monitoring Oct 2018Wide-range 'one-size-fits-all' blood pressure (BP) cuffs are commonly sold with home BP monitors. Assessment of the accuracy of these cuffs is important because they do...
OBJECTIVES
Wide-range 'one-size-fits-all' blood pressure (BP) cuffs are commonly sold with home BP monitors. Assessment of the accuracy of these cuffs is important because they do not adhere to the basic principles of proper cuffing. The aim of this systematic review was to review the published validation data evaluating the accuracy of wide-range cuffs.
METHODS
Medline (1946-2017) and the Web of Science (2002-2017) were searched for home BP device validation studies carried out according to an established validation protocol and published in English. Studies that included assessment of a wide-range cuff (defined as a cuff with a range of 15 cm or greater) were sought. The quality of wide-range cuff assessment was scored on a three-point scale, with one point assigned each for (a) passing validation criteria, (b) full evaluation across the entire cuff range, and (c) reporting of results stratified by arm circumference.
RESULTS
Twenty-five validation studies were identified, reporting data on 28 device/wide-range cuff combinations. Study quality was poor - 21 studies received a score of one and four studies received a score of two. All studies were awarded one point because the device-cuff combination passed the chosen validation protocol. Only two studies ensured full assessment of the cuff range; however, neither study reported results stratified by arm circumference. Of the two studies that did report results by arm circumference, one showed a potentially direct linear relationship between arm circumference and device-observer error.
CONCLUSION
Despite their widespread use, the evidence supporting use of wide-range home BP cuffs is inadequate.
Topics: Adult; Arm; Blood Pressure; Blood Pressure Determination; Blood Pressure Monitors; Humans; Sphygmomanometers; Validation Studies as Topic
PubMed: 30074520
DOI: 10.1097/MBP.0000000000000344 -
Journal of Hypertension Mar 2018The European Society of Hypertension (ESH) International Protocol (ESH-IP) for the validation of blood pressure (BP) measuring devices was published in 2002, with the...
Improving the accuracy of blood pressure measurement: the influence of the European Society of Hypertension International Protocol (ESH-IP) for the validation of blood pressure measuring devices and future perspectives.
INTRODUCTION
The European Society of Hypertension (ESH) International Protocol (ESH-IP) for the validation of blood pressure (BP) measuring devices was published in 2002, with the main objective of simplifying the validation procedures, so that more BP monitors would be subjected to independent validation. This article provides an overview of the international impact of the ESH-IP and of the lessons learned from its use, to be able to justify further developments in validation protocols.
METHODS
A review of published (PubMed) validation studies from 2002 to 2017 was performed.
RESULTS
One hundred and seventy-seven validation studies using the ESH-IP, 59 using the British Hypertension Society protocol, 46 using the Association for the Advancement of Medical Instrumentation (AAMI) standard and 23 using the International Organization for Standardization (ISO) standard were identified. Lists of validated office-clinic, home and ambulatory BP monitors are provided. Of the ESH-IP studies, 93% tested oscillometric devices, 80% upper arm, 71% home, 25% office and 7% ambulatory monitors (some had more than one function).
CONCLUSION
The original goal of the ESH-IP has been fulfilled in that in the last decade the number of published validation studies has more than doubled. It is now recognized that the provision of accurate devices would be best served by having a universal protocol. An international initiative has been put in place by AAMI, ESH and ISO experts aiming to reach consensus for a universal validation protocol to be accepted worldwide, which will allow a more thorough evaluation of the accuracy and performance of future BP monitors.
Topics: Blood Pressure; Blood Pressure Determination; Blood Pressure Monitoring, Ambulatory; Humans; Hypertension; Reproducibility of Results; Research Design; Sphygmomanometers; Validation Studies as Topic
PubMed: 29384984
DOI: 10.1097/HJH.0000000000001635