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Abstract

Background:

To identify and summarize the global research literature on validation of automated noninvasive blood pressure measurement devices (BPMDs) with upper arm cuff, develop a repository of validated BPMDs in compliance with the 2020 World Health Organization technical specifications, and identify challenges and gaps in evidence base on validated BPMDs.

Methods:

A scoping review was conducted. Primary research validating BPMDs complying with the 2020 World Health Organization technical specifications (ie, semiautomated/automated noninvasive devices with upper arm cuff), published in English between January 2000 and December 2021, was included. We searched MEDLINE, Web of Science, Scopus, EMBASE, CINAHL, CENTRAL, ProQuest and the dabl website.

Results:

We included 269 studies validating 251 BPMDs across 89 manufacturers. Omron (29%), Microlife (10%), and A&D Company (8%) were the top 3 manufacturers. The 3 most frequently used validation protocols were the European Society of Hypertension-international protocol 2002 (27%), European Society of Hypertension-international protocol 2010 (25%), and modified British Hypertension Society protocol 1993 (16%), respectively. Nearly 45% of the validated BPMDs were intended for use in clinical settings, 38% were for home or self-measurement use, and 48% were for general adults. Most studies reported that BPMDs passed the validation criteria. There was inadequate reporting across studies, especially pertaining to validation settings.

Conclusions:

Most BPMDs fulfilled the validation criteria. However, there are considerable gaps in BPMD research in terms of geographical representation, including specific target populations and diseases/conditions, and a range of arm circumferences. Additionally, a potential strategy is required to accelerate the adoption of the Association for the Advancement of Medical Instrumentation (AAMI)/European Society of Hypertension/International Organization for Standardization Universal Standard (International Organization for Standardization 81060-2:2018) for BPMD validation.
Early and accurate diagnosis of hypertension is vital to control hypertension and diseases including stroke, ischemic heart disease, renal dysfunction, cerebral cardiovascular diseases, and dementia.1,2 Following from this, inaccurate blood pressure (BP) measurement either over or underestimates true BP. Misdiagnosis of cardiovascular risks, or an increased risk of over medication directly follow from the real possibilities of such inaccurate measurements.3,4 Ultimately, this can impede the attainment of the 2025 target of reducing the prevalence of raised BP by 25%, envisioned in the global monitoring framework.5,6
To assess precision and accuracy against a reference standard, BP measurement devices (BPMDs) in combination with their cuffs need to be clinically validated before marketing.7 Over the years, various clinical validation protocols for the BPMDs have been proposed by international organizations. These protocols have been used as guiding statements to test the precision and accuracy of the BPMDs.8 These protocols include, but are not restricted to, the US Association for the Advancement of Medical Instrumentation (AAMI), British Hypertension Society (BHS), European Society of Hypertension-international protocol (ESH-IP), European Committee for Standardization, International Organization for Standardization (ISO), American National Standards Institute/AAMI/ISO, and AAMI/European Society of Hypertension (ESH)/ISO.8–19
The 2020 World Health Organization (WHO) specifications guides stakeholders (eg, governments, manufacturers, heath care providers, health care organizations, consumers) on implementing the recommendations, ensuring accurate BP measurement and to make informed decisions about the procurement of automated noninvasive BPMDs with cuffs.20,21 Our previous article details the WHO specifications, and we briefly summarize it here.20,21 The WHO specifications pertain to clinical, home/self-measurement, and ambulatory BPMDs and recommend the use of automated BPMDs with an upper arm cuff that have passed accepted international validation standards for routine clinical purposes.20,21 Validation requirements encompass all general requirements namely the environment, equipment, test device, which are concerned with study observers, supervisors, and study participants. It further emphasizes standardized patient preparation and measurement techniques in a quiet, comfortable setting.20,21
Validation studies have been conducted worldwide by manufacturers to assess the accuracy of BP devices in the market.22 However, not all of the 3000+ commercially sold BP devices in the global market have publicly available validation reports on their accuracy, especially for the regions where they are marketed.4 Given this scenario, it can be difficult to choose appropriate BPMDs for clinical settings.23
Key objectives of this article thus included the following: (1) mapping the global research evidence available on validation of BMPDs with upper arm cuffs, (2) identifying the gaps and providing recommendations for the available research evidence on validation of BPMDs, and (3) developing a repository of validated BPMDs in compliance with the 2020 WHO technical specifications. A scoping review is a relevant and important methodology to consolidate the literature on BPMD validation research in the wake of increasing hypertension, obesity, and noncommunicable disease burden. Previous reviews have been focused on validation studies on specific populations (eg, pregnancy and preeclampsia,24 populations with obesity and large upper arm circumference25), validation of specific types of BPMDs (eg, ambulatory BP monitors26), or diagnostic accuracy studies.25 Our review, while exhaustively scoping the length and breadth of BPMD literature, will provide valuable information on gaps in current research to serve as inputs to the key players. This is particularly timely considering the WHO intent to hold stakeholder discussions with private sector entities involved in the marketing of BPMDs in addition to entities adhering to WHO technical specifications.

Methods

This scoping review was designed and conducted using the Joanna Briggs Institute approach to scoping reviews.27,28

Eligibility Criteria

Publications between January 1, 2000, and December 21, 2021, were included to identify the latest policy-relevant research literature. Primary research published in English as journal articles, thesis/dissertation, books, organizational reports, and case reports that provided primary data on validation of BPMDs were included. Qualitative studies, perspectives, commentaries, opinion papers, letters to the editor, review articles, patents, conference abstracts, guidelines, and secondary research were excluded. In addition, modeling studies that were based on secondary data sources were excluded.
The Population, Concept, Context notation of Joanna Briggs Institute28 was used to define the eligibility criteria for studies.
Population: studies that validated BMPDs on humans including children, adolescents, general adult population, elderly, pregnant women, and people with conditions (eg, obesity, chronic kidney disease, diabetes).
Concept: studies on validation of automated and semiautomated noninvasive BPMDs with an upper arm cuff (ie, as specified in the WHO technical specifications for automated noninvasive BP-measuring devices with cuff20,21).
Context: studies from any location or setting were eligible for inclusion in our review. Settings where BPMDs were validated could include home/self, clinical, research, ambulatory, kiosk/public use, so on, and so forth.

Searches

Electronic searches were conducted on MEDLINE (via PubMed), Web of Science, Scopus, EMBASE, CINAHL, CENTRAL, ProQuest, and dabl Educational Trust website. Population, concept, context guided the 3 domains for search, and each domain was combined with the Boolean operator AND. Keywords within each domain were combined using the Boolean operator OR. The Dabl Educational Trust website was designed to provide updated information to consumers on validation results of BP monitors.29 A search strategy was developed on PubMed and subsequently translated to other databases. The electronic search strategies for all databases can be accessed on Open Science Framework.30 The date of the last search was December 21, 2021.

Study Selection

Retrieved reports were exported to PICO Portal31—an online review platform that facilitated study selection and preliminary data extraction for our review. The portal facilitated automatic deduplication of records. Screening was performed in 2 stages: title-abstract and full-text screening. A screening protocol was drafted and revised following multiple internal team discussions. The reviewers performing the screening (K.S., P.K., and R.J.) were trained and calibrated in the screening process for both the stages of screening by S.M. and E.R. Given our scope and objectives, and to minimize the risk of excluding potentially relevant studies, we were overinclusive in the title-abstract stage. Full texts were retrieved by S.M. and E.R. References to validation reports in the dabl website were screened for eligibility. Three reviewers (K.S., P.K., and R.J.) screened the title-abstracts and full texts in duplicate. Two reviewers (S.M. and E.R.) resolved conflicts through discussion and reaching consensus where required.

Data Charting

Data extraction was first done by 4 trained reviewers in single. Three of these reviewers (P.K., K.S., and R.J.) extracted data for peer-reviewed articles, and 1 reviewer (R.R.) extracted data for the website reports. The 4 reviewers subsequently cross-checked the data extracted by the other reviewers. Two senior reviewers (S.M. and E.R.) verified 10% of the extracted data randomly for quality (eg, accuracy, completeness) and flagged errors or conflicts, if any, in the verified data set. Disagreements were resolved via discussion and consensus or consultation with the senior review authors.

Data Charting Form

A data extraction form was drafted by SM and subsequently pilot tested on 10 records by R.J. and R.R. The form was refined by S.M. and E.R. following the pilot-testing exercise. Information on the following items was charted: bibliographic details such as author and publication details; study details such as objective of the study, geographical location, participant characteristics, validation details (eg, protocol used, result of validation, setting), BPMD details (eg, manufacturer/company, location of the manufacturer, model/device made, type of device), comparator details, applicability of the device to population and settings for use, funding, and conflicts of interest.
Data were captured as reported in the included studies to minimize the bias due to reviewer subjectivity or assumptions. Any missing or unclear information was treated as not specified or unclear during the data charting process. We particularly highlight this for the data regarding applicability of the BPMD after validation. The included studies had to unambiguously and explicitly mention the applicability (setting and population) of the validated BPMD for it to be considered in our review. Instances where the nonapplicability of the BPMD for a certain population group or setting was captured in our review. For example, where the country of validation was not reported, the country of recruitment was used as a proxy for the country of validation. This logic was based on our assumption that investigators of BPMD validation studies would typically prefer to validate the BPMD where people were recruited, especially for clinical settings.
The countries were then mapped to WHO regions: the Americas, Africas, Eastern Mediterranean, Europe, South East Asia, and Western Pacific.32 Data charting was performed on Microsoft Excel 2016.

Data Synthesis and Reporting

Data were exported from the PICO portal to Microsoft Excel. Subsequently, data were cleaned, managed, and analyzed descriptively using frequencies and percentages on Microsoft Excel (S.M., E.R., and R.R.). Geographical locations were mapped to create a visual summary on Tableau Desktop Public Edition, V.2021 (S.M. and R.R.).33 The results have been summarized narratively and supplemented with tables and figures in the Supplemental Material. The scoping review has been reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews Checklist.34

Results

Summary of Search Results

Of the total 11 825 search results, there was a total of 4126 duplicates. Following deduplication, 7133 titles and abstracts were found to be irrelevant and excluded after title and abstract screening. Of the 566 full-text records (eligible for full-text screening), 28 reports could not be retrieved. At the full-text screening stage, of 538 full-text articles, 280 articles were excluded because of non-English language (n=1), study population not humans (n=6), study designs such as qualitative studies, narrative reviews, modeling studies of secondary data (n=69), and studies that were nonvalidation studies for automated/semiautomated BPMDs (n=203). Therefore, a total of 258 studies from electronic databases were included in the review. From the additional resources (dabl website and backward citation screening), a total of 264 full texts were identified, and 260 full texts were screened for eligibility. Of these, 249 full texts were excluded due to not being in English (n=4), publication date before 2000 (n=16), and 229 full texts were excluded as these were equivalence studies or trials (trials that assess similarity between 2 interventions) and not clinical validation studies. Finally, a total of 269 studies (258 from electronic databases and 11 from additional resources) were included in the review (Table S1). The study flow and reasons for exclusion are displayed in Figure S1. The characteristics of included studies can be accessed on Open Science Framework.30 As shown in Figure S2, 2001 had the minimum number of studies (n=4). The maximum number of studies (n=21 each) were published in 2007 and 2008.

Device Being Validated

We identified 89 BPMD manufacturers and 251 BPMD models from the included studies. Omron (29%; 59 models), Microlife (10%; 12 models), and A&D Company (8%; 20 models) were the top 3 BPMD manufacturers. The device manufacturer was not specified in 36 (13%) validation studies. Complete lists of identified BPMD manufacturers and BPMD models are provided in Tables S2 and S3. Around 91% and 87% of the devices being validated were automated and oscillometric BPMDs, respectively.

Settings of Validation

Of 269 validation studies, 189 studies mentioned only one country as the country of population recruitment, in 8 studies, multicountry recruitment was performed, and 72 studies did not clearly specify the country of recruitment. The distribution of studies for country of recruitment is given in Figure S3, with 40 studies reporting China as the country of population recruitment for validation studies. This was followed by the United Kingdom (n=23) and the United States (n=21). Among the validation studies reporting multicountry recruitment, 2 studies were conducted in the United Kingdom and South Africa. While most validation studies reported the country from which the participants were recruited, the settings of validation were unclear. For the purposes of our review, we assumed that the country of recruitment was the country where the BPMD was validated.
China (20%), United Kingdom (13%), and the United States (12%) were the top 3 countries where validation studies were undertaken (Figure S3). A heat map representing the 6 WHO regions (based on frequency distribution) among the included validation studies is provided in Figure S4. One-third of the validation studies were conducted in the WHO region of Europe (n=84; 31%), followed by Western Pacific (n=60; 22%) and the Americas (n=34; 13%). Three studies were multiregion validations. The WHO region of validation was unclear in one-fourth of the studies (Figure S4).
Approximately 45% (n=140) and 38% (n=118) of the BPMDs were validated for clinical and home use, respectively (Figure S5); some devices were validated for use in >1 setting. The other settings of BPMD use reported by study authors included research/epidemiological purposes (n=13), ambulatory (n=10), prehospital (n=10), patient use or monitoring (n=4), community/low resource (n=5), and nonmedical public use (n=1). The settings of use were unclear for 46 BPMDs.

Note on Terminologies Used for Settings of Use

We retained the term ambulatory use as reported in included studies or for monitors worn by the patient throughout the day. These could indicate BPMDs that are programmed to measure BP at various intervals throughout the day and night over a 24-hour period while the patient is performing routine activities.35,36 Home monitoring or self-measurement referred to BP monitors that were used for self-measurement at home or work, typically by the patients or lay population. Prehospital use was captured as reported in the included studies and typically referred to the ambulance transport of critically ill patients. Similarly, patient use was captured as reported in studies, with no elaboration on the definitions including that for the device applicability and did not include the terms clinical, office, home, or self use in the study results, discussion, or concluding remarks of the study.
The applicability of the validated BMPDs for use in the target population was unclear for 6 BPMDs. Poor reporting practices in the included studies made determining exactly how many BPMDs were applicable among the general adult or patient population particularly challenging. Unclear or incomplete information on what the study set out to do versus what was finally achieved related to the population or setting of actual use is one such example or suboptimal reporting practices. Nonetheless, 139 BMPDs were applicable for use in the adult population (excluding pregnant women); 58 of these BPMDs were reported to be applicable specifically among the general adult population (Table S4). Twenty-five BPMDs were applicable for use in infants, children, and adolescents, whereas 21 BPMDs were applicable for use in pregnancy or preeclampsia. Specific information including whether patients or nonpatients were recruited were unclear for 126 BPMD validations. These numbers are not mutually exclusive as there was a mix of patient and nonpatient population in the included studies. The applicable arm circumference typically ranged from 14 to 52 cm.

Validation Protocols

The identified studies used a plethora of validation protocols for the various BPMDs (Figure S6). The three most commonly used protocols were the ESH-IP 2002, ESH-IP 2010, and the modified BHS 1993 protocol. The ESH-IP 2002 was used in 77 (29%) validation studies, where 72 studies exclusively used ESH-IP 2002 and 5 studies used ESH-IP in combination with other validation protocols. ESH-IP 2010 was used in 69 (26%) validation studies (as a single protocol in 66 studies and in combination with other protocols in 3 studies), and the modified BHS 1993 was used in a total of 69 (25%) validation studies (as the only protocol in 44 studies and in combination with other protocols in 25 studies). The AAMI/ESH/ISO universal standard (ISO 81060-2:2018) was used in 7 studies. Around 36 validation studies used >1 protocol for validation of the BPMDs. Nearly 9% (n=29) of the devices being validated were reported by study authors as not fulfilling the validation criteria (Table S3). The types and numbers of different validation protocols across studies are given in Figure S6.

Funding and Conflicts of Interest

A relative majority of the studies reported funding (partial/complete) for the studies; of these, 72% received support from the BPMD manufacturers. Over a fifth (22%) of manufacturers donated or loaned devices for validation. Eleven percent of the studies declared potential conflicts of interest.

Discussion

This review systematically scopes the evidence base on validation of BPMDs complying with the 2020 WHO technical specifications.20,21 This evidence adds to the development of a repository of validated BPMDs in compliance with these specifications, while simultaneously identifying challenges and gaps in the evidence base for validated BPMDs.
The majority of the studies validated BPMDs for general adults in our review. Consistent with findings from the previous research, there is scope for more research in pregnancy and preeclampsia, populations at risk for cardiovascular diseases, neonates, children and adolescents, and on adults with a range of arm circumferences and shapes, and last, but not least, further research on the reliability of wide-ranged cuffs among different population subgroups and settings.24–26,37,38 Research suggests that factors like shape, slant angles, and, potentially, the cuff bladder are equally important considerations for accurate BP measurement, especially in obese individuals. There is an increasing demand for innovations in cuff design and validation protocols to be more inclusive across population subgroups and settings.37,38
Validation studies tended to be concentrated. Less than 10% (n=25) of the reviewed studies were conducted in the WHO regions of Eastern Mediterranean, Africas, and South East Asia combined. This is concerning because the burden of hypertension is 3× greater in low- and middle-income countries vis a vis high-income countries.5,39,40 A previous systematic review found 52% (n=141) of the studies conducted in the European continent. Asian and North American continents accounted for 33% and 27% of the implemented studies, respectively; studies in Asia were conducted in China and Japan.41 Validation research and related policy will additionally need to consider the differential hypertension prevalence among population subgroups geographically; it is the greatest among >60 years in high-income countries while ages between 40 and 59 years had the highest burden in low- and middle-income countries.42
Some experts recommend that at least 2 validation studies be conducted in different centers and among different population groups before their use in clinic and at home. While the ISO/AAMI facilitates this, both ESH and BHS protocols lack the provisions for validation in specific populations.43 Currently, the focus is primarily on the safety and accuracy of the BPMD irrespective of how or where BP measurement is performed.21 Further clarity is required regarding the recommended number of devices or study sites for establishing accuracy in the validation protocols.44
Potential reasons for the unequal distribution of BPMD validation research could potentially be related to several factors including resource constraints for biomedical research in developing economies or a dearth of vital policy-level initiatives for research capacity building in low- and middle-income countries.45,46 Several practical and historical reasons exist to explain the concentration of validation research in certain countries, such as the location of validation, which may be considered a function of the availability of validation centers and associated expertise, which tends to be concentrated in some regions of the world. Diversity is not necessarily mandated in validation protocols.
Nine percent of the studies reported a failure of the BPMDs to adhere to the validation criteria. This number is likely to be higher if publication bias is accounted for. Research additionally suggests that published studies passing validation criteria can in fact be erroneous and misleading.8,41,47,48 Similar to our findings, previous research has highlighted the use of multiple validation protocols, which can lead to, at a minimum, confusion, in addition to all kinds of issues.48,49 Since the use of all the 3 validation protocols from AAMI, BHS, and EHS in a single clinical validation study considerably increases the cost of validation of a single device, to make the process cost-effective, the BPMD manufacturers opt for either of 3 validation protocols for clinical validation of the devices.43 Also, each protocol has its own limitations and advantages thereby making it difficult for the manufacturers to compare and choose one protocol over the other.43
A universally accepted protocol worldwide is necessary—there has been a convergence of existing regulatory requirements, but a potential strategy to accelerate this is to mandate universal protocols, for example, more validation studies adopting the AAMI/ESH/ISO universal standard (ISO 81060-2:2018) and practical guidance documents to improve the quality of design, conduct, and reporting of validation of BPMDs.3,4,8,17,19,48 A randomized crossover trial reported that previously validated devices may be unreliable for use outside of validation settings, for example, in the emergency department.50 Given the challenges involved in BPMD validation for manufacturers and other stakeholders, the demand for a universally accepted single validation protocol for automated noninvasive BP devices has been growing over the years.8,23
Finally, BMPD research needs to improve in the quality of reporting to better understand generalizability and applicability of results. Clarity on the limitations, for example, of the choices made by device manufacturers behind the validation location, settings and the target population intended for BPMD use would be very helpful. Fianlly, clarity on the choice of which protocol was selected for validation would help refine future validation protocols as well. Use of guidance for conduct and reporting validation research such as that provided by Stergiou et al48,49 is a step in this direction and can extend the benefit to peer reviewers of validation studies of BPMDs by bringing objective standards for peer review, or at the very least, comparability of such studies of BMPDs.48–50

Strengths and Limitations

We included English language studies published since 2000, excluded conference abstracts, and did not contact study authors for additional information due to resource constraints. Since we did not include other gray literature sources, non–peer-reviewed studies, for example, those conducted by contract research organizations may not have been included. However, we assess minimal risk of missing potentially relevant studies for the following reasons: we adhered to a standardized review methodology, incorporated evidence-informed search strategies, and included 7 databases and the dabl educational website (though it does not have supervision or formal endorsement by a scientific organization). Furthermore, we incorporated quality assurance measures to minimize the exclusion of potentially relevant studies, such as multiple rounds of team training and calibration and quality checks by experienced review authors. Finally, the assessment of protocol violations/adherence was beyond the scope of this review.

Conclusions

BP measurement using a validated BPMD is vital to control hypertension—a global public health issue and an independent risk factor for many noncommunicable diseases. Validation studies are invaluable to assess the accuracy of a BPMD across patient populations. While most of the BPMDs included in the review fulfilled the validation criteria, there are considerable gaps that BPMD research and policy can fill as suggested below.
Efforts are needed on 2 particular fronts considering the speculation on the quality of published reports and the challenges in validating BPMDs across protocols. One is on the research front: more equity-focused and contextual research is required to validate BPMDs for and from resource-constrained and primary care settings, specific target populations and conditions, and a range of arm circumferences. Furthermore, we call for improvement in the quality of reporting the validation studies to improve transparency and comparability. Second is the push for a potential strategy to accelerate the adoption of the AAMI/ESH/ISO universal standard (ISO 81060-2:2018) for BPMD validation (research). Tying both these efforts would be the adoption of an agenda at the policy, decision-making, and funding levels, ideally concurrently, to facilitate such an adoption and build research capacity, especially in resource-constrained settings. Finally, this may be best achieved by initiating a dialogue with all related stakeholders with the aim of making BPMD research, regulation, and practice more equitable.

Article Information

Supplemental Material

Table of Contents
Figures S1–S6
Tables S1–S4

Footnote

Nonstandard Abbreviations and Acronyms

AAMI
Association for the Advancement of Medical Instrumentation
BHS
British Hypertension Society
BP
blood pressure
BPMD
blood pressure measurement device
ESH
European Society of Hypertension
ESH-IP
European Society of Hypertension-international protocol
ISO
International Organization for Standardization
WHO
World Health Organization

Supplemental Material

File (hyp_hype-2022-20425_supp2.docx)

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Go to Hypertension
Go to Hypertension
Hypertension
Pages: 1110 - 1116
PubMed: 36912176

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Published online: 13 March 2023
Published in print: May 2023

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Keywords

  1. blood pressure
  2. blood pressure monitors
  3. review
  4. review literature as topic
  5. validation studies as topic

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The George Institute for Global Health, Hyderabad, India (S.M.).
The George Institute for Global Health, New Delhi, India (E.R., R.J., K.S., P.K., R.R., A.D., V.A.I., A.G.J.).
The George Institute for Global Health, New Delhi, India (E.R., R.J., K.S., P.K., R.R., A.D., V.A.I., A.G.J.).
The George Institute for Global Health, New Delhi, India (E.R., R.J., K.S., P.K., R.R., A.D., V.A.I., A.G.J.).
Prashanthi Kamath
The George Institute for Global Health, New Delhi, India (E.R., R.J., K.S., P.K., R.R., A.D., V.A.I., A.G.J.).
The George Institute for Global Health, New Delhi, India (E.R., R.J., K.S., P.K., R.R., A.D., V.A.I., A.G.J.).
The George Institute for Global Health, New Delhi, India (E.R., R.J., K.S., P.K., R.R., A.D., V.A.I., A.G.J.).
The George Institute for Global Health, New Delhi, India (E.R., R.J., K.S., P.K., R.R., A.D., V.A.I., A.G.J.).
FIND, Geneva, Switzerland (B.N.V.).
The George Institute for Global Health, New Delhi, India (E.R., R.J., K.S., P.K., R.R., A.D., V.A.I., A.G.J.).
The George Institute for Global Health, University of New South Wales, New Delhi, India (O.J.).
Prasanna School of Public Health, Manipal Academy of Higher Education, India (O.J.).

Notes

For Sources of Funding and Disclosures, see page 1115.
Supplemental Material is available at Supplemental Material.
Correspondence to: Oommen John, The George Institute for Global Health, 308, Third Floor, Elegance Tower, Plot No. 8, Jasola District Centre, New Delhi 110025, India. Email [email protected]

Disclosures

Disclosures None.

Sources of Funding

Funding for this work was provided by FIND Geneva through a grant from the Swiss Agency for Development and Cooperation.

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  1. Are previously validated blood pressure self-measurement devices accepted under the Universal Standard? A systematic review, Journal of Hypertension, 43, 1, (35-47), (2024).https://doi.org/10.1097/HJH.0000000000003859
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