Quality Control and Validation of Oscillometric Blood Pressure Measurements Taken During an Epidemiological Investigation
Open Access
- 1 September 2015
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in Medicine
- Vol. 94 (37), e1475
- https://doi.org/10.1097/md.0000000000001475
Abstract
This study aims to validate blood pressure (BP) values measured by an oscillometric BP monitor and seek possible calibration methods if discrepancies exist. Noninvasive BP measurement outcomes were determined using an oscillometric BP monitor (Omron HBP-1300) versus a mercury sphygmomanometer (standard device). Two percent of subjects enrolled in an epidemiological investigation were systematically sampled in this study. Intraclass correlation coefficient (ICC) was used to evaluate measurement reliability, paired t-test was used to evaluate trueness, and linear regression was used for calibration. The Association for the Advancement of Medical Instrumentation (AAMI) standards and British Hypertension Society (BHS) protocols were used for validation quality assessment. Both mercury sphygmomanometer (standard device) and oscillometric BP monitor (test device) displayed high reliability. A significant difference in systolic blood pressure (SBP) was observed between devices. SBP calibration was achieved by using an effective linear regression model (B = 0.803 and constant = 19.592, P < 0.001). The calibrated model was corroborated by verification samples (P = 0.120) and was found to pass AAMI standards and BHS protocol requirements. Calibrated SBP measurements from the Omron HBP-1300 device were valid. Use of a combination of statistical methods, such as ICC for reliability assessment as well as paired t-test for trueness evaluation can be used to validate data from the oscillometric BP monitors.Keywords
This publication has 26 references indexed in Scilit:
- Glossary of Analytical and Metrological Terms from the International Vocabulary of Metrology (2008)Geostandards and Geoanalytical Research, 2012
- Impact of applying the more stringent validation criteria of the revised European Society of Hypertension International Protocol 2010 on earlier validation studiesBlood Pressure Monitoring, 2011
- Use of automated blood pressure measurements in clinical trials and registration studies: data from the VALTOP StudyBlood Pressure Monitoring, 2010
- European Society of Hypertension International Protocol revision 2010 for the validation of blood pressure measuring devices in adultsBlood Pressure Monitoring, 2010
- Validation of the Omron M5-I, R5-I and HEM-907 automated blood pressure monitors in elderly individuals according to the International Protocol of the European Society of HypertensionBlood Pressure Monitoring, 2007
- Comparison of Concordance Correlation Coefficient and Coefficient of Individual Agreement in Assessing AgreementJournal of Biopharmaceutical Statistics, 2007
- A comparison of two sphygmomanometers that may replace the traditional mercury column in the healthcare workplaceBlood Pressure Monitoring, 2007
- National standard for measurement of resting and ambulatory blood pressures with automated sphygmomanometers.Hypertension, 1993
- STATISTICAL METHODS FOR ASSESSING AGREEMENT BETWEEN TWO METHODS OF CLINICAL MEASUREMENTThe Lancet, 1986
- Intraclass correlations: Uses in assessing rater reliability.Psychological Bulletin, 1979