To (1) identify and summarize the global research literature on validation of automated non-invasive blood pressure measurement devices (BPMD) with upper arm cuff, (2) develop a repository of validated BPMD in compliance 2020 WHO technical specifications (3) identify challenges and gaps in evidence base on validated BPMD and develop novel strategies to address them.
Design and method:
A scoping review was conducted according to the Joanna Briggs Institute methodology using ‘Population, Concept, Context’ concept. Empirical studies validating BPMD complying with the 2020 WHO technical specifications (i.e. semi-automated/automated non-invasive with upper arm cuff), published in English between 2000 and 2022 were eligible for inclusion in the review. We searched MEDLINE, Web of Science, Scopus, EMBASE, CINAHL, CENTRAL, ProQuest and daBL website. We snowballed references from website reports. Title-abstract, full-text screening, and data extraction was conducted in duplicate by four reviewers (PICOPortal, MS Excel). Descriptive data analysis was performed on MS Excel and Tableau.
Of 11,825 identified records, we included 269 studies that fulfilled the inclusion criteria. A total of 251 BPMD from 89 manufacturers were assessed for validation methods. Omron (29%), Microlife (10%) and A&D Company (8%) were the top three BPMD manufacturers that underwent validations. China (20%), UK (13%) and USA (12%) were the top three countries where these validations were undertaken. The three most frequently used validation protocols were (Figure1): European Society of Hypertension-International protocol (ESH-IP) 2002 (27%), ESH-IP 2010 (25%) and Modified British Hypertension Society 1993 (16%). Nearly 50%, 40% and 48% of the validated BPMD were intended for use in clinical- and home/self-measurement, and for general adults, respectively. Of the 55% studies that were funded, 72% received support (finances/ BPMD) from device manufacturers. The publications did not reveal details about the following: device manufacturer (13%), country of validation (26%), settings for intended BPMD use (29%), and the target population for BPMD use (22%).
While most (89%) of the BPMD included in the review fulfilled the validation criteria, there are considerable gaps in terms of the settings and countries of validation. In designing validation studies, research methods should focus on validating BPMD for specific target population and conditions (e.g. pregnancy or children), and take range of arm circumferences into considerations. Finally, we call for improvement in quality of reporting the validation studies to improve transparency and comparability. This could be best achieved by initiating a dialogue with all stakeholders in blood pressure research and practice.