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A systematic review of blood pressure monitor validation studies
Rosina Cross1, Ian Porter1, Sinead McDonagh1
1University of Exeter, Exeter, UK.
Insights
Accurate blood pressure (BP) monitoring is crucial for hypertension care. Many published BP monitor validations, even those using universal protocols, fail to meet essential criteria, impacting reliable hypertension management.
Area of Science:
- Cardiology
- Medical Devices
- Health Informatics
Background:
- Accurate blood pressure (BP) measurement is essential for effective hypertension management.
- Validated BP monitors ensure reliable readings, guiding clinical decisions and public health initiatives.
- The British and Irish Hypertension Society provides an independent list of validated BP monitors.
Purpose of the Study:
- To review current BP monitor validation protocols and their adherence to the 2018 universal standard.
- To assess the proportion of recent BP monitor validation studies that meet established protocol criteria.
Main Methods:
- Systematic review of Medline and Embase databases for BP monitor validation studies published from 2018 to September 2025.
- Independent screening of citations and full texts by two authors.
- Independent data extraction and review against protocol criteria checklists.
Main Results:
- Of 197 device validation studies reviewed, 104 (63%) utilized universal protocols.
- While 93% of validations were reported as successful by authors, only 74% met all protocol criteria upon review.
- A significant 26% of published successful validations were deemed inadequate due to unmet criteria or protocol violations.
Conclusions:
- Current journal peer-review processes for BP monitor validation studies show inadequacies.
- Impartial guidance is necessary for healthcare professionals, purchasers, and the public regarding BP monitor accuracy.
- Ensuring adherence to validation protocols is critical for reliable hypertension care.
Background:
Good hypertension care requires accurate blood pressure (BP) measurement with BP monitors validated as accurate. The British and Irish Hypertension Society maintains a peer-reviewed list of validated monitors, independent of commercial interests. The list informs National Institute for Health and Care Excellence hypertension guidance and NHS monitor procurement. An updated universal standard protocol for BP device validation was introduced in 2018.
Aim:
Review the literature to establish which validation protocols are now being used; has this changed since publication of the universal protocol, and what proportion of recently published BP monitor validations fully meet protocol validation criteria?
Method:
Systematic review searches of Medline and Embase from 2018 to September 2025 identified BP monitor validation studies. Citations and full texts were screened independently by two authors. Included studies were reviewed independently by two authors against checklists of protocol criteria. Disagreements were resolved through discussion and/or arbitration by lead authors.
Results:
Seven reviewers screened 1780 unique citations, reviewing 216 full texts to date. Nine reviewers have double-extracted data from 157 publications reporting 197 device validation studies. Overall, 104 (63%) used universal protocols. While 184 (93%) validations were reported as successful by authors, only 146 (74%) fulfilled all protocol criteria on review. Thus, we considered 51 (26%) published successful validations inadequate, due to non-fulfilment of key validation criteria and/or violations of BP measurement protocols such as incomplete BP range coverage.
Conclusion:
This review highlights inadequacies in current journal peer-review processes, justifying our approach to provide impartial guidance for health professionals, purchasers, and the public.
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Prepare for the Procedure:
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