automated blood pressure measurement in public places

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THE JOURNAL OF CLINICAL HYPERTENSION VOL. 7 NO. 10 OCTOBER 2005 620 W ithin the past few decades, automated blood pressure (BP) devices began appearing in public places, such as pharmacies and supermar- kets, with the goal of detecting undiagnosed, untreated, or inadequately treated hypertension (HTN). The widespread use of such devices in public places raises two important questions: 1) how accurate is this technique in diagnosing HTN? and 2) how effective is this public health strategy in accomplishing its objectives? There are two published guidelines for the vali- dation of automated BP measurement devices, one by the British Hypertension Society 1 and one by the American Association for the Advancement of Medical Instrumentation, which has been adopted by the FDA. 2 Many automated BP measurement devices are commercially available, yet only a frac- tion of them have been independently validated. 3,4 Furthermore, even among those devices that have been validated in controlled settings, few have been formally tested in the environments in which they are now commonly being used. In one study that used two automated devices in pharmacies in Toronto, Canada, investigators measured the BP of volunteers according to a strict protocol (i.e., seated, after resting for 2 minutes and excluding subjects with large arm circumferences) and found that neither device met criteria for precision accord- ing to either the British or American standards. 5,6 A similar study, performed in grocery stores in Denver, CO, found the device in question to be inconsistent and inaccurate, with a sensitivity of 26% and a negative predictive value of 45% for diagnosing HTN. 7 The accuracy of such devices is even more uncertain when utilized in an uncon- trolled fashion where there is no standardization for subject position (i.e., sitting vs. standing), arm posi- tion (i.e., at the level of the heart), activity level (i.e., at rest), noise level, and arm circumference. Indeed, based on data from the Third National Health and Nutrition Examination Survey (NAHNES III), it is estimated that nearly half of all Americans with HTN have arm circumferences above the limits of one commonly used device. 8 Only one study we could find has attempted to measure the efficacy of this public health strat- egy as a screening tool. 9 In this study, automated devices were placed in 13 public places in Exeter, England (including post offices, supermarkets, and homeless shelters) for up to 18 weeks. Of the 769 people who used the devices, 221 recorded elevated BPs (defined as >135/85 mm Hg or sys- tolic BP >160 mm Hg), among whom only 58 were available for follow-up and only 36 subsequently had formal BP measurements by a health care pro- vider. Of this group, 11 subjects (1.4% of all users) were diagnosed with HTN, five of whom started antihypertensive therapy. Another 11 subjects were identified with inadequately treated HTN and five had adjustments made to their antihypertensive regimen, although it is unclear as to whether these From the Department of Medicine, Hypertension Program, University of Pennsylvania School of Medicine, Philadelphia, PA Address for correspondence: Raymond R. Townsend, MD, Department of Medicine, Hypertension Program, University of Pennsylvania School of Medicine, White Building, 3400 Spruce Street, Philadelphia, PA 19104 Common Questions and Answers in the Management of Hypertension Raymond R. Townsend, MD, Section Editor www.lejacq.com ID: 4136 Automated Blood Pressure Measurement in Public Places Ari Mosenkis, MD; Raymond R. Townsend, MD The Journal of Clinical Hypertension® (ISSN 1524-6175) is published monthly by Le Jacq Ltd., Three Parklands Drive, Darien, CT 06820-3652. Copyright ©2005 by Le Jacq Ltd., All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without permission in writing from the publishers. The opinions and ideas expressed in this publication are those of the authors and do not necessarily reflect those of the Editors or Publisher. For copies in excess of 25 or for commercial purposes, please contact Sarah Howell at [email protected] or 203.656.1711 x106.

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Page 1: Automated Blood Pressure Measurement in Public Places

THE JOURNAL OF CLINICAL HYPERTENSION VOL. 7 NO. 10 OCTOBER 2005620

Within the past few decades, automated blood pressure (BP) devices began appearing in

public places, such as pharmacies and supermar-kets, with the goal of detecting undiagnosed, untreated, or inadequately treated hypertension (HTN). The widespread use of such devices in public places raises two important questions: 1) how accurate is this technique in diagnosing HTN? and 2) how effective is this public health strategy in accomplishing its objectives?

There are two published guidelines for the vali-dation of automated BP measurement devices, one by the British Hypertension Society1 and one by the American Association for the Advancement of Medical Instrumentation, which has been adopted by the FDA.2 Many automated BP measurement devices are commercially available, yet only a frac-tion of them have been independently validated.3,4 Furthermore, even among those devices that have been validated in controlled settings, few have been formally tested in the environments in which they are now commonly being used. In one study that used two automated devices in pharmacies in Toronto, Canada, investigators measured the BP of volunteers according to a strict protocol (i.e., seated, after resting for 2 minutes and excluding

subjects with large arm circumferences) and found that neither device met criteria for precision accord-ing to either the British or American standards.5,6 A similar study, performed in grocery stores in Denver, CO, found the device in question to be inconsistent and inaccurate, with a sensitivity of 26% and a negative predictive value of 45% for diagnosing HTN.7 The accuracy of such devices is even more uncertain when utilized in an uncon-trolled fashion where there is no standardization for subject position (i.e., sitting vs. standing), arm posi-tion (i.e., at the level of the heart), activity level (i.e., at rest), noise level, and arm circumference. Indeed, based on data from the Third National Health and Nutrition Examination Survey (NAHNES III), it is estimated that nearly half of all Americans with HTN have arm circumferences above the limits of one commonly used device.8

Only one study we could find has attempted to measure the efficacy of this public health strat-egy as a screening tool.9 In this study, automated devices were placed in 13 public places in Exeter, England (including post offices, supermarkets, and homeless shelters) for up to 18 weeks. Of the 769 people who used the devices, 221 recorded elevated BPs (defined as >135/85 mm Hg or sys-tolic BP >160 mm Hg), among whom only 58 were available for follow-up and only 36 subsequently had formal BP measurements by a health care pro-vider. Of this group, 11 subjects (1.4% of all users) were diagnosed with HTN, five of whom started antihypertensive therapy. Another 11 subjects were identified with inadequately treated HTN and five had adjustments made to their antihypertensive regimen, although it is unclear as to whether these

From the Department of Medicine, Hypertension Program, University of Pennsylvania School of Medicine, Philadelphia, PAAddress for correspondence: Raymond R. Townsend, MD, Department of Medicine, Hypertension Program, University of Pennsylvania School of Medicine, White Building, 3400 Spruce Street, Philadelphia, PA 19104

C o m m o n Q u e s t i o n s a n d A n s w e r s i n t h e M a n a g e m e n t o f H y p e r t e n s i o nR a y m o n d R . T o w n s e n d , M D , S e c t i o n E d i t o r

www.lejacq.com ID: 4136

Automated Blood Pressure Measurement in Public Places

Ari Mosenkis, MD; Raymond R. Townsend, MD

The Journal of Clinical Hypertension® (ISSN 1524-6175) is published monthly by Le Jacq Ltd., Three Parklands Drive, Darien, CT 06820-3652. Copyright ©2005 by Le Jacq Ltd., All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without permission in writing from the publishers. The opinions and ideas expressed in this publication are those of the authors and do not necessarily reflect those of the Editors or Publisher. For copies in excess of 25 or for commercial purposes, please contact Sarah Howell at [email protected] or 203.656.1711 x106.

Page 2: Automated Blood Pressure Measurement in Public Places

VOL. 7 NO. 10 OCTOBER 2005 THE JOURNAL OF CLINICAL HYPERTENSION 621

changes were prompted by the study measure-ments. The authors contend that more diagnoses of HTN were likely made among the three quarters of subjects who did not live in Exeter and whose outcomes could not be determined in the study. Conversely, the investigators could not record the incidence of undiagnosed hypertension in patients whose BP readings may have been erroneously nor-mal in the study. Thus, the results of this approach to screening are unclear, since neither its sensitiv-ity nor its specificity is known. Another criticism of this strategy is that no effective protocol exists in most settings for the referral of patients with elevated BP readings to health care providers.

In conclusion, automated BP measurement in public places is of questionable accuracy and is of uncertain efficacy as a screening tool. Using such a strategy, some people might be incorrectly labeled as hypertensive and, of greater concern, some people who truly have HTN might be labeled as normal and might then be left with a false sense of security. Even if this strategy is effective in iden-tifying some people with previously undiagnosed HTN, referral systems of such patients to health care providers are not usually in place. There may, however, be a silver lining surrounding this issue. Even if only 1% of users are newly diagnosed with HTN, this may, potentially, represent thousands of new diagnoses and could result in prevention of large numbers of cardiovascular events, if patients

can be referred for follow-up care. At the very least, despite its problems, the measurement of BP in public places serves to promote awareness of HTN as a public health problem.

REFERENCES 1 O’Brien E, Petrie J, Littler W, et al. The British Hypertension

Society protocol for the evaluation of automated and semi-automated blood pressure measuring devices with special reference to ambulatory systems. J Hypertens. 1990;8(7):607–619.

2 Draft guidance for FDA staff and industry. Available at: http://www.fda.gov/ora/compliance_ref/cpg/cpgdev/cpg310-210.html. Accessed July 20, 2005.

3 O’Brien E, Beevers G, Lip GY. ABC of hypertension: Blood pressure measurement. Part IV-automated sphyg-momanometry: self blood pressure measurement. BMJ. 2001;322:1167–1170.

4 O’Brien E, Waeber B, Parati G, et al. Blood pressure mea-suring devices: recommendations of the European Society of Hypertension. BMJ. 2001;322:531–536.

5 Lewis JE, Boyle E, Magharious L, et al. Evaluation of a community-based automated blood pressure measuring device. CMAJ. 2002;166(9):1145–1148.

6 Chambers LW, Kaczorowski J, Levitt C, et al. Blood pres-sure self-monitoring in pharmacies. Building on existing resources. Can Fam Physician. 2002;48:1594–1595.

7 Whitcomb BL, Prochazka A, LoVerde M, et al. Failure of the community-based Vita-Stat automated blood pressure device to accurately measure blood pressure. Arch Fam Med. 1995;4(5):419–424.

8 Graves JW. Blood pressure measurement in public places. Am Fam Physician. 2005;71(5):851–852.

9 Hamilton W, Round A, Goodchild R, et al. Do community based self-reading sphygmomanometers improve detection of hypertension? A feasibility study. J Public Health Med. 2003;25(2):125–130.

The Journal of Clinical Hypertension® (ISSN 1524-6175) is published monthly by Le Jacq Ltd., Three Parklands Drive, Darien, CT 06820-3652. Copyright ©2005 by Le Jacq Ltd., All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without permission in writing from the publishers. The opinions and ideas expressed in this publication are those of the authors and do not necessarily reflect those of the Editors or Publisher. For copies in excess of 25 or for commercial purposes, please contact Sarah Howell at [email protected] or 203.656.1711 x106.