A systematic review of blood pressure monitor validation studies

Clinical Snapshot

Key Findings

• P Value: Not applicable - descriptive study

• Effect Size: 74% of validations met all protocol criteria

• Primary Outcome: Proportion of BP monitor validations meeting full protocol criteria

• Nnt Or Sensitivity: 26% of published 'successful' validations were inadequate on independent review

• Confidence Interval: Not reported

Clinical Application

Highly feasible - supports existing independent validation processes and procurement decisions Directly relevant to TGA device approval processes, PBS subsidised monitor selection, and RACGP hypertension management guidelines. Supports need for independent validation review similar to UK BIHS approach Healthcare professionals, procurement officers, and patients requiring accurate BP monitoring devices

Abstract

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.

References

1. 1.Cross, R., Porter, I., McDonagh, S., Roberts, N., Lacy, P., Chapman, N., Lewis, P., McDonnell, B., Chowienczyk, P., Curneen, J., Santosh, T., McManus, R., Clark, C., & Mcleish, H. (2026). A systematic review of blood pressure monitor validation studies. British Journal of General Practice. https://doi.org/10.3399/bjgp26X745497