Adequacy of validation of wide-range cuffs used with home blood pressure monitors: a systematic review

Abstract

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.