Factors confounding assessment of ambulatory blood pressure monitors, studied during formal evaluation of the tycos Quiet-Trak

The credibility of studies assessing ambulatory blood pressure monitoring (ABPM) devices will be enhanced by minimizing opportunities to manipulate the outcome through biased selection of patient volunteers, and by insuring that participants are representative of the target patient population. While subjecting the Welch Allyn Quiet-Trak to the British Hypertension Society (BHS) protocol, we examined the extent to which certain candidate characteristics might influence device assessment. The Quiet-Trak achieved an A grade overall. During its field testing, daytime physical activity measured with a wrist-mounted, piezoelectric accelerometer, influenced significantly the rate of measurement rejection. The tertiles of subjects with highest and lowest levels of daytime physical activity (64 +/- 16 and 35 +/- 10 activity units; P < .001) exhibited significantly different measurement rejection rates (10 +/- 3 and 3 +/- 2 daytime rejects; P < .001)). Most rejected readings occurred during episodes of high physical activity. During static evaluation (Phase V), the level of systolic BP influenced the accuracy of diastolic BP estimation; above 190 mm Hg systolic BP, estimates of diastolic BP differed significantly from manual measurements. Subjects' age and arm circumference influenced neither field nor static evaluation. Retrospective comparison of the study subjects with 120 consecutive ABPM clinic attenders revealed (1) that participants in field testing were younger, had lower BP but were equally active compared with clinic patients; and (2) that Phase V participants exhibited higher systolic (155 +/- 42 v 135 +/- 15 mm Hg; P < .001) but similar diastolic BP levels compared to controls. The reliability of ABPM validation protocols would be enhanced by: (a) incorporation of objective measurement of physical activity during field testing, demonstrating normal levels of activity; (b) requiring that field testing be conducted in representative patients rather than normal volunteers; and (c) a greater focus in both static and field testing on those levels of blood pressure that are relevant in clinical practice.