Impact of choosing the closest rather than the mean auscultatory blood pressure value on the European Society of Hypertension International Protocol device validation results.

Abstract:

OBJECTIVE:When calculating the difference between alternating auscultatory reference standard (ARS) and the automated device-under-test (DUT) blood pressure (BP) measurements, the European Society of Hypertension International Protocol (ESH-IP) allows investigators to choose the closest ARS value to the DUT value, rather than using the mean of the ARS readings [which is mandated by the International Organization for Standardization (ISO)]. The impact of this rule on ESH-IP validation study results is unknown and was assessed. DESIGN AND METHODS:Nine alternating BP measurements performed according to the ISO protocol were obtained in 94 subjects. The impact of using the closest rather than the mean ARS reading on mean error, SD of the difference, and proportion of readings with DUT-ARS differences within 5, 10, and 15 mmHg was determined. RESULTS:Mean age was 58.6 ± 18.3 years, screening BP was 126.4/77.7 mmHg, and arm circumference was 32.0 ± 4.7 cm. DUT-ARS difference was 0.0 ± 5.3/-0.5 ± 5.0 mmHg using the closest ARS and -0.2 ± 6.5/-0.7 ± 5.9 mmHg using the mean ARS. When using the closest rather than the mean ARS value, the proportion of systolic readings with absolute DUT-ARS differences ≤5 mmHg was 73% (vs. 60% for the mean ARS method), ≤10 mmHg was 93% (vs. 88%), and ≤15 mmHg was 99% (vs. 98%). Corresponding values for diastolic BP were 73% (vs. 62%) for differences ≤5 mmHg, 94% (vs. 91%) for ≤10 mmHg, and 99% (vs. 99%) for ≤15 mmHg. CONCLUSION:Using the closest rather than the mean ARS value results in more favourable validation study results and increases likelihood of passing.

journal_name

Blood Press Monit

authors

Padwal R,Wood PW,McLean D,Ringrose JS

doi

10.1097/MBP.0000000000000454

subject

Has Abstract

pub_date

2020-08-01 00:00:00

pages

224-226

issue

4

eissn

1359-5237

issn

1473-5725

journal_volume

25

pub_type

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