A Call to Action and a Lifecourse Strategy to Address the Global Burden of Raised Blood Pressure on Current and Future Generations: The Lancet Commission on Hypertension

Background Automated-entry consumer devices that collect and transmit patient-generated health data (PGHD) are being evaluated as potential tools to aid in the management of chronic diseases. The need exists to evaluate the evidence regarding consumer PGHD technologies, particularly for devices that have not gone through Food and Drug Administration evaluation. Purpose To summarize the research related to automated-entry consumer health technologies that provide PGHD for the prevention or management of 11 chronic diseases. Methods The project scope was determined through discussions with Key Informants. We searched MEDLINE and EMBASE (via EMBASE.com ), In-Process MEDLINE and PubMed unique content (via PubMed.gov ), and the Cochrane Database of Systematic Reviews for systematic reviews or controlled trials. We also searched ClinicalTrials.gov for ongoing studies. We assessed risk of bias and extracted data on health outcomes, surrogate outcomes, usability, sustainability, cost-effectiveness outcomes (quantifying the tradeoffs between health effects and cost), process outcomes, and other characteristics related to PGHD technologies. For isolated effects on health outcomes, we classified the results in one of four categories: (1) likely no effect, (2) unclear, (3) possible positive effect, or (4) likely positive effect. When we categorized the data as “unclear” based solely on health outcomes, we then examined and classified surrogate outcomes for that particular clinical condition. Findings We identified 114 unique studies that met inclusion criteria. The largest number of studies addressed patients with hypertension (51 studies) and obesity (43 studies). Eighty-four trials used a single PGHD device, 23 used 2 PGHD devices, and the other 7 used 3 or more PGHD devices. Pedometers, blood pressure (BP) monitors, and scales were commonly used in the same studies. Overall, we found a “possible positive effect” of PGHD interventions on health outcomes for coronary artery disease, heart failure, and asthma. For obesity, we rated the health outcomes as unclear, and the surrogate outcomes (body mass index/weight) as likely no effect. For hypertension, we rated the health outcomes as unclear, and the surrogate outcomes (systolic BP/diastolic BP) as possible positive effect. For cardiac arrhythmias or conduction abnormalities we rated the health outcomes as unclear and the surrogate outcome (time to arrhythmia detection) as likely positive effect. The findings were “unclear” regarding PGHD interventions for diabetes prevention, sleep apnea, stroke, Parkinson’s disease, and chronic obstructive pulmonary disease. Most studies did not report harms related to PGHD interventions; the relatively few harms reported were minor and transient, with event rates usually comparable to harms in the control groups. Few studies reported cost-effectiveness analyses, and only for PGHD interventions for hypertension, coronary artery disease, and chronic obstructive pulmonary disease; the findings were variable across different chronic conditions and devices. Patient adherence to PGHD interventions was highly variable across studies, but patient acceptance/satisfaction and usability was generally fair to good. However, device engineers independently evaluated consumer wearable and handheld BP monitors and considered the user experience to be poor, while their assessment of smartphone-based electrocardiogram monitors found the user experience to be good. Student volunteers involved in device usability testing of the Weight Watchers Online app found it well-designed and relatively easy to use. Implications Multiple randomized controlled trials (RCTs) have evaluated some PGHD technologies (e.g., pedometers, scales, BP monitors), particularly for obesity and hypertension, but health outcomes were generally underreported. We found evidence suggesting a possible positive effect of PGHD interventions on health outcomes for four chronic conditions. Lack of reporting of health outcomes and insufficient statistical power to assess these outcomes were the main reasons for “unclear” ratings. The majority of studies on PGHD technologies still focus on non-health-related outcomes. Future RCTs should focus on measurement of health outcomes. Furthermore,future RCTs should be designed to isolate the effect of the PGHD intervention from other components in a multicomponent intervention.

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Automated-Entry Patient-Generated Health Data for Chronic Conditions: The Evidence on Health Outcomes

Objective: Treatment-resistant hypertension (TRH) has regained attention with development of new methods for treatment. However, the prevalence of TRH varies considerably from primary to secondary and tertiary care. We aimed to assess the prevalence of true TRH in a population of patients with apparent TRH in a university hospital setting of tertiary work-up and also investigate reasons for poor BP control and evaluate how work-up can be performed in general practice and secondary care.Methods: In this cohort study, we characterize a study population from Oslo Renal Denervation (RDN) Study. Patients (n = 83) were referred for RDN from secondary care. All patients underwent thorough medical investigation and 24-h ambulatory blood pressure measurements (24ABPM) after directly observed therapy (DOT). We then assessed reasons for lack of BP control.Results: Fifty-three of 83 patients did not have true TRH. Main reasons for non-TRH were poor drug adherence (32%), secondary hypertension (30%) and white ...

Tertiary work-up of apparent treatment-resistant hypertension.

Besides the standard 12-lead ECG and the Holter monitor, today the market offers a wide range of modern ECG devices and services supported by the latest developments in ICT. This chapter is devoted to the current state-of-the-art from the area of ECG with a reduced number of leads. We focus on ECG wireless body sensors, differentiating between those that measure only heart rate and are used just for entertainment or during sport activities, and those that actually measure and analyze the ECG signal, with all its waveforms. The latter are elaborated in more detail, particularly our differential ECG sensor and its commercial version Savvy, for which we provide also a comprehensive comparison to other state-of-the-art sensors in that field. It is, however, inevitable that the state-of-the art will change in the future. The constant progress in ICT will always drive the development of new and improved ECG devices.

Commercial ECG Systems

Noninvasive Hemodynamic Monitoring as a Guide to Drug Treatment of Uncontrolled Hypertensive Patients

Background:In the BEtter control of BP in hypertensive pAtients monitored Using the HOTMAN sYstem study, we investigated whether utilizing noninvasive monitoring of hemodynamic parameters combined with a drug selection algorithm (integrated hemodynamic management – IHM) compared with conventional dr

A randomized and controlled study of noninvasive hemodynamic monitoring as a guide to drug treatment of uncontrolled hypertensive patients.

Background: In the BEAUTY study we investigated whether utilizing non-invasive monitoring of hemodynamic parameters combined with a drug selection algorithm (integrated hemodynamic management-IHM) compared to conventional drug selection may improve home BP in patients with uncontrolled hypertension.Methods: Uncontrolled (office systolic blood pressure (SBP) > 140 mmHg and ambulatory daytime SBP >135 mmHg while taking ≥2 antihypertensive drugs) essential hypertensive patients were referred to 5 European Hypertension Excellence Centers and, if eligible, were randomized into IHM-guided vs conventional treatment adjustment. Home blood pressure (BP) was taken with 2 repeated readings at 1–2 min intervals in the morning and in the evening (before drug intake and eating) during the week preceding the visit at the outpatient clinic after 5 min rest using a validated semi-automatic oscillometric arm cuff device and with a correct cuff bladder placement. Home blood pressure was measured in a sub-group of pa...

Non-invasive hemodynamic monitoring as a guide to drug treatment of uncontrolled hypertensive patients: effects on home blood pressure in the BEAUTY study.

Background: Disease management is mandatory for the home care of most patients with chronic heart failure. We report the results of ICAROS (Integrated care vs Conventional intervention in cArdiac failure patients: Randomized Open label Study), an Italian trial of telemonitoring and telecare combining wireless and mobile technologies to obtain optimal therapeutic control, fast and effective interpretation of clinical data and improved patients’ adherence.Methods: Eighty patients were randomized before hospital discharge after an episode of acute heart failure, to a usual care group (UC) (n=40: follow-up at our Outpatients’ clinic) or to an integrated management group (IM) (n=40: patients learned to use a PDA computer and kept in touch daily with our Centre to receive instructions, encouragement, clinical and psychological assistance. Results: At enrolment, groups were similar for age (UC 73 ± 3 years; IM 71 ± 2 years); NYHA class (UC 2.90 ± 0.69; IM 3.08 ± 0.57), left ventricular function (EF%) (UC 32 ± 8%; IM 32 ± 7%), plasma levels of BNP (UC 361 ± 72 pg/ml; IM 314 ± 94 pg/ml). At one-year follow-up, IM patients showed better adherence, reduction of anxiety and depression and lower NYHA class and plasma levels of BNP with respect to UC patients (NYHA: 2.08 ± 0.38; BNP: 202 ± 127 pg/ml, p<0.05 vs UC patients). Mortality and hospital re-admissions for congestive heart failure were also reduced in IM patients (p<0.05).Conclusions: In ICAROS, regular acquisition by wireless technologies of clinical and psychological data provided a good model for clinical decision-making, determining better quality of life and reducing mortality and hospitalizations.

https://www.longdom.org/open-access/clinical-and-psycological-telemonitoring-and-telecare-of-high-risk-patientswith-chronic-heart-failure-through-wireless-technologies-the-icaros-project-2155-9880.1000260.pdf

Clinical and Psycological Telemonitoring and Telecare of High Risk Patientswith Chronic Heart Failure through Wireless Technologies: The Icaros Project

Tommaso Comotti

Papers

A randomized and controlled study of noninvasive hemodynamic monitoring as a guide to drug treatment of uncontrolled hypertensive patients.

Non-invasive hemodynamic monitoring as a guide to drug treatment of uncontrolled hypertensive patients: effects on home blood pressure in the BEAUTY study.

Clinical and Psycological Telemonitoring and Telecare of High Risk Patientswith Chronic Heart Failure through Wireless Technologies: The Icaros Project