The validity of blood pressure kiosk validation studies: a systematic review.

OBJECTIVE: Public-use blood pressure (BP) kiosks are commonly used, and yet their accuracy has been questioned on the basis of the results of the published validation studies. However, the adherence of these studies to established validation standards has not been studied. We carried out a systematic review of the published peer-reviewed literature on the validity of public-use BP kiosks to assess their adherence to validation standards.
METHODS: With medical librarian assistance, the literature was searched systematically for studies claiming to validate kiosks up to June 2012. Studies were limited to English articles that studied adult patients and were excluded if they were carried out solely on pregnant women. Two authors independently compared the study methods with those recommended in the Association for the Advancement of Medical Instrumentation, British Hypertension Society and the European Society of Hypertension International Protocol validation standards.
RESULTS: Nine studies were identified, of which only one came close to adhering to selected validation standard criteria, and found the device to be accurate. One study found device accuracy with poor adherence to standards, whereas the remaining seven found device inaccuracy with poor adherence to standards, therefore potentially reporting false conclusions.
CONCLUSION: The majority of the reviewed studies validating public-use BP kiosks did not adhere to existing validation standards and therefore may have reported false conclusions. The one study that came close to following the validation standards found the device tested to be accurate. Readers must critically appraise the quality of validation studies published on these devices before interpreting their accuracy, and future studies should better adhere to existing validation standards to reduce the risk of reporting potentially false conclusions.