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This paper aims to provide practical indications to healthcare professionals and manufacturers of ambulatory blood pressure monitoring (ABPM) devices on the characteristics and minimum required contents of a standard ABPM report to be used in the clinical practice. Such indications will help make ABPM reports more easily interpretable and independent from the ABPM device and software used. The first important and unavoidable step of ABPM reporting is a quality assessment: if a recording does not meet the minimum requirements for quality criteria, the reporting physician should advise the patient to repeat the test and should not further proceed to a diagnostic evaluation and interpretation of the recording. A basic clinical report must contain the list of each single reading, the graphical display of individual readings and hourly average values, the mean, minimum and maximum values, and SDs of blood pressure and heart rate values for the 24 h, daytime and night-time, day-night differences, and blood pressure loads. The final medical report should be prepared in a quite logically structured way, considering the following: (i) a judgment on the overall quality of the 24 h recording; (ii) an indication of whether average 24 h, daytime and night-time systolic, and diastolic blood pressure values are within or above the normal limits; and (iii) a description of the 24 h pattern of blood pressure fluctuations. A final general statement on the normotensive or hypertensive status and on the degree of blood pressure control in case of treated patients should also be provided.

Despite the increasing use of home blood pressure monitoring (HBPM) in daily practice and the growing awareness in the scientific community about its positive impact on the diagnostic and therapeutic management of patients with high blood pressure (BP), the potential advantages offered by HBPM have not yet been fully exploited. Indeed, use of the information offered by HBPM is often incomplete and imprecise, with the BP values reported by patients in handwritten logbooks being frequently inaccurate, illegible to physicians, or unreliable. Although a practical solution for improvement may come from the use of devices equipped with a storage memory, a step forward in this regard has been taken more recently with the introduction and refinement of systems for the remote telemonitoring of BP values measured at home. However, although several studies have provided evidence on the clinical usefulness of HBPM, only limited data are available on the clinical impact of home blood pressure (HBP) telemonitoring, because of a number of reasons. First, most of the available studies are characterized by a small sample size, and in some cases, the patients were neither randomized nor even matched with a control group. Moreover, technological solutions used in the different studies carried out so far are often heterogeneous, some of them being particularly difficult to use for the patients, thus limiting the effectiveness of the results. BP monitoring programmes, number of BP readings and transmission schedules are often different among the various studies. In addition, patient selection criteria are different from study to study. Finally, different study objectives and important diversities in the types of centres involved (ranging from general practices, to specialists' offices, hospitals or university centres) may have also influenced the quality of results. Large-scale randomized controlled studies, based on easy-to-use technologies, are thus still needed to show the superiority and clinical usefulness of HBP telemonitoring as compared with conventional HBPM. This study summarizes the evidence available on the clinical usefulness and current limitations of this approach, highlighting the results of meta-analyses and randomized controlled trials on this issue. The role of HBP teletransmission in the context of integrated patients' management programmes is also addressed, with indications for further progress in this field.

Although standard validation protocols provide assurance of the accuracy of blood pressure monitors (BPMs), there is no guidance for the consumer as to the overall quality of a device. The PA.NET International Quality Certification Protocol, developed by the Association for Research and Development of Biomedical Technologies and for Continuing Medical Education (ARSMED), a nonprofit organization, with the support of the Italian Society of Hypertension-Italian Hypertension League, and the dabl Educational Trust denotes additional criteria of quality for BPMs that fulfilled basic validation criteria, published in full in peer-reviewed medical journals. The certification is characterized by three phases: (i) to determine that the device fulfilled standard validation criteria; (ii) to determine the technical and functional characteristics of the device (e.g. operativity, display dimension, accessory functions, memory availability, etc.) and (iii) to determine the commercial characteristics (e.g. price-quality ratio, after-sale service, guarantee, etc.). At the end of the certification process, ARSMED attributes a quality index to the device, based on a scale ranging from 1 to 100, and a quality seal with four different grades (bronze, silver, gold and diamond) according to the achieved score. The seal is identified by a unique alphanumeric code. The quality seal may be used on the packaging of the appliance or in advertising. A quality certification is released to the manufacturer and published on www.pressionearteriosa.net and www.dableducational.org. The PA.NET International Quality Certification Protocol represents the first attempt to provide health care personnel and consumers with an independent and objective assessment of BPMs based on their quality.

Background: Electronic blood pressure monitoring devices are widely used by patients for monitoring their blood pressure at home. Few of them, however, have been validated against recognized protocols and proved to be accurate., Objective: This study aimed at verifying whether the automatic electronic oscillometric blood pressure measuring device, Artsana CS 410 (Artsana S.p.A., Grandate, Como, Italy), complied with the standard of accuracy indicated by the European Society of Hypertension (ESH) International Protocol., Methods: Sequential measurements of systolic and diastolic blood pressure were obtained in 33 patients (13 males, 20 females, mean age+/-SD 49+/-12 years) using the mercury sphygmomanometer (two observers) and the test device (one supervisor). A standard adult cuff was always used during the study. According to the ESH validation protocol, 99 pairs of test device and reference blood pressure measurements were obtained during the two phases of the study (three pairs of measurements for each of the 33 patients)., Results: The Artsana CS 410 device successfully passed phase 1 of study validation with the number of absolute differences between test and reference device never <35 within 5 mmHg, never <40 within 10 mmHg and never <42 within 15 mmHg. The test device also passed phase 2 of the validation study with a mean (+/-SD) device-observer difference of -0.9+/-5.9 mmHg for systolic and -1.0+/-3.1 mmHg for diastolic blood pressure., Conclusion: According to the results of the validation study, based on the ESH International Protocol, the Artsana CS 410 may be recommended for clinical use in adults.

Objective: This study aimed at verifying the accuracy of three automated electronic oscillometric blood pressure measuring devices, namely Omron M5-I (home use upper arm monitor), R5-I (home use wrist monitor) and HEM-907 (professional use upper arm monitor) according to the European Society of Hypertension International Protocol in elderly individuals., Methods: Sequential measurements of systolic and diastolic blood pressure were obtained in 33 participants (aged >or=75 years) using the mercury sphygmomanometer (two observers) and each of the tested devices (one supervisor). A standard adult cuff was always employed during the study because all participants had an arm circumference compatible with such a cuff. According to the European Society of Hypertension validation protocol 99 couples (three pairs per patient) of test device and reference blood pressure measurements were obtained during phase 1 (15 participants studied) and phase 2 (a further 18 participants) for each electronic monitor., Results: All devices successfully passed the validation study with a mean (+/-SD) device-observer difference for systolic and diastolic blood pressure of 0.2+/-3.6/0.2+/-3.9 mmHg (Omron M5-I), -1.5+/-6.2/-0.7+/-3.7 mmHg (Omron R5-I), and 0.1+/-5.1/-1.9+/-4.2 mmHg (Omron HEM-907). SD of the mean difference was lower and thus the precision was better for diastolic than for systolic blood pressure, and for the Omron M5-I than for the other two devices., Conclusions: According to the results of the validation study based on the European Society of Hypertension International Protocol the Omron M5-I, R5-I, and HEM-907 may be recommended for clinical use in elderly individuals, without atrial fibrillation or frequent ectopic beats.

Background: There is evidence that blood pressure measurement outside the doctor's office can provide valuable information for the diagnostic evaluation of hypertensive patients and for monitoring their response to treatment. Home blood pressure monitoring devices have a major role in this setting, provided that their accuracy in measuring blood pressure is demonstrated by validation studies., Objective: This study aimed at verifying whether the automatic electronic oscillometric blood pressure measuring device Artsana CSI 610 complied with the standard of accuracy indicated by the ESH International Protocol., Methods: Sequential measurements of systolic and diastolic blood pressure were obtained in 33 participants using the mercury sphygmomanometer (two observers) and the test device (one supervisor). A standard adult cuff was always employed during the study. According to the ESH validation protocol, 99 couples of test device and reference blood pressure measurements were obtained during the two phases of the study (three pairs for each of the 33 participants)., Results: The Artsana CSI 610 device successfully passed phase 1 of study validation with the number of absolute differences between test and reference device never <35 within 5 mmHg and never <40 within 10 and 15 mmHg. The test device also passed phase 2 of the validation study with a mean (+/-SD) device-observer difference of -1.4+/-4.8 mmHg for systolic and -0.9+/-3.5 mmHg for diastolic blood pressure., Conclusions: According to the results of the validation study on the basis of the ESH International Protocol, the Artsana CSI 610 can be recommended for clinical use in adults.

Use of ambulatory blood pressure monitoring (ABPM) techniques has revealed that blood pressure is characterized by a considerable degree of variability over a 24 h period as a result, not only of the well-known fluctuations that occur between wakefulness and sleep, but also of the minute-to-minute changes induced by a variety of behavioural conditions. The degree of these variations is also influenced by neural mechanisms responsible for cardiovascular regulation, such as the arterial baroreflex. Blood pressure variability increases with age and blood pressure values, and its magnitude has been shown to correlate independently with the target-organ damage of hypertension. This has stimulated both the development of antihypertensive drugs able to reduce blood pressure homogeneously over 24 h, and recent proposals to develop more accurate indices, such as the smoothness index, to quantify the distribution of the antihypertensive effect over the entire day and night. Despite the important information that ABPM can provide concerning daily-life blood pressure variations and their modification by treatment, international guidelines suggest that it should not yet be used routinely in daily practice, but rather reserved for selected patients.

The duration and homogeneity of the antihypertensive effect of a drug are commonly quantified by computation of the trough:peak ratio (T/P) from 24 h ambulatory blood pressure recordings [i.e. the ratio of the reduction in blood pressure at the end of the interval between doses (trough) and the reduction in blood pressure at the time of the maximal effect of a drug (peak)]. Although it is widely employed, this index has a lot of limitations: it makes use of only a small portion of a 24 h blood pressure recording; individual T/P values do not have a normal distribution, unless responders at peak are selected; it bears no relation to 24 h blood pressure variability; peak changes in blood pressure are affected by a placebo effect and thus T/P needs correction for effects of placebo; peak and trough changes in blood pressure are reproducible over time but T/P is not; and, finally, it was shown in the SAMPLE study that T/P is not correlated to changes in left ventricular mass induced by treatment, and thus has a limited clinical value.