Ambulatory blood pressure monitoring in clinical trials reduces the required sample size compared to sporadic clinic measurements, with the 24-hour mean providing an adequate estimator.
Ambulatory blood pressure monitoring reduces sample size requirements in antihypertensive trials by removing systematic bias seen in casual clinic measurements, with the 24-hour mean serving as an adequate estimator.
Non-invasive ambulatory blood pressure monitoring is an appropriate technique for the identification of the target population requiring antihypertensive treatment, since the systematic bias seen in casual clinic measurement is removed. The use of the technique in controlled clinical trials leads to a reduction in the sample size required to show a treatment difference in antihypertensive effect compared to sporadic single measurements, although in practice the number of recruited patients can considerably exceed the number of evaluable patients, due to poor compliance or incompleteness of data. In addition, the equality of observation essential in clinical trials cannot be controlled to the same degree as is possible with clinic measurements. Comparison of estimators of the overall characteristic blood pressure reveals that the 24-hour mean value produces an adequate estimator. A description of the individual blood pressure profile is obtained using smoothing procedures, the moving interval average providing a robust and simple approach. Clinically meaningful characteristics of the profile are difficult to define due to a dearth of information on prognostic importance of the features of the 24-hour blood pressure profile. Smoothed individual profiles can be combined to produce graphical descriptive treatment group summaries.
Dickson et al. (Wed,) conducted a review in Hypertension. Ambulatory blood pressure monitoring vs. Casual clinic measurement was evaluated. Ambulatory blood pressure monitoring in clinical trials reduces the required sample size compared to sporadic clinic measurements, with the 24-hour mean providing an adequate estimator.
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