The British Hypertension kociety protocol for the evaluation of blood preskure measuring devices

Michael de Swiet*§, Paul L. ~adfie~dq, Douglas G. AltmanE, Martin Blandg, Andrew k oatss and Neil Atkins . Ba-und: With the increasing market~ng of automated and semi-automated devices for the measurement of blood pressuk, there is a need for potential pudhasen to be able to satisfy themselves that such dhices have been evaluated according to agreed criteria. To fulfil this need, the ~ritisk Hypertension Society (BHS) published a protocol of requirements for the evaluatian of blood pressure measuring devices with special reference to ambulatory d w i d in 1990. This protocol has been used to evaluate a variety of blood pressure measuiing devices, including eight ambulatory dwices, and comments have been receiSed from many interested parties, This experience has demonstrated certain deficiedcies in the original protocol, which merit modification. Therefore, the BHS Working Party has revised its protocol in the interests of providing a comprehensive procedure for the evaluation of all blood prksure measuring devices, including those for intermittent 24-h blood pressure measurement. Changes: The major changes in the revised protocol include simplification of the validation methodology, its applicability to all blood pressure measuring devices, consideration of the accuracy of the device ih low, medlum and high pressure ranges, provision for validation in special groups such as the elderly, and provisibn for validaion under special circumstances, such as during exercise. Grading: The final report for a dwice should specify the grading achieved for both systolic and diastolic blood pressures in the overall blood pressure range. This grading will determine the overall accuracy of the device, on, which recommendations for clinical use may be based. Grading criteria should alsc,be provided for low, medium and high pressure ranges in order to provide an assessment of accuracy in the &fierent pressure ranges in which the dwice may be used. AA assessment of accuracy and performance for special &ups and e r validation under special circumstances should also be provided, although it is emphasized that as experience and the data on Which to base validation criteria are limited at present the results of such assessments must be interpreted cautiously. I