This Article Full Text Full Text (PDF) All Versions of this Article: 48/5/e105    most recent 01.HYP.0000242421.27697.81v1 Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Ferrario, C. M. Articles by Smith, R. D. Search for Related Content PubMed PubMed Citation Articles by Ferrario, C. M. Articles by Smith, R. D. Related Collections Other hypertension

(Hypertension. 2006;48:e105.)
© 2006 American Heart Association, Inc.

Letters to the Editor

Response to Reduction of Blood Pressure Levels Study Group

Hypertension and Vascular Disease Center, Wake Forest University School of Medicine, Winston-Salem, NC

An extract of the first 250 words of the full text is provided, because this article has no abstract.

We appreciate Dr Mann’s¹ question about whether the lack of home or ambulatory blood pressure (BP) measurements in the Consideration of Noninvasive Hemodynamic Monitoring to Target Reduction of Blood Pressure Levels (CONTROL) trial prevents the results from being considered definitive. In actuality, our study design minimized potential observer- and subject-expectation bias in the measurement of office BP. Therefore, the addition of either home or ambulatory BP would not have changed the study conclusion that impedance cardiography-guided therapy substantially improves BP control.

It is important to underscore that device-based, therapeutic management trials typically require an unblinded design and are not a placebo-controlled arm. In our design, the use of a standard care as the comparator group was the most appropriate approach to evaluate differences. Inherently, these types of trials require an unblinded physician and subject who are engaged in the strategy under evaluation. Thus, the design of our study minimized potential observer- and subject-expectation bias.

Our study did address the potential for observer-expectation bias in the recording of office BP through the use of an automatic oscillometric BP cuff, performed and recorded under strict protocol by a technician who was not involved in patient management. If we had used patient-administered, home-BP measurements, it may have introduced more methodologic variation and patient bias in recording the values, as has been shown in other studies.²

Although ambulatory BP measurements have been used in trials to attempt to minimize subject-expectation bias, studies have demonstrated a reduction in both office and ambulatory BP measurements with . . . [Full Text of this Article]