Hans van den Heuvel

Does the platform meet the defined technical specifications, such as connectivity? Is the alert system accurate and free of errors? Is the system usable by the end-users and does it fit within their workflow? 5 Therefore we performed a so-called feasibility study (Chapter 4). Once established the platform’s usability and feasibility, we could continue our studies to measure impact and observed changes in outcome, and attribute these to the digital health platform. Results of our SAFE@HOME studies show that telemonitoring of blood pressure and preeclampsia symptom is feasible in a high-risk pregnant population. The use of the digital platform, combined with a reduced antenatal visit schedule was associated with a reduction of health care consumption, without compromising perinatal outcomes in our selected study population. Other recent studies describe a variety of home- and self-monitoring blood pressure strategies. 6-9 In general, most studies find a reduction in clinic visits and/or admissions, with help of out-of-office measurements. At the same time, this shift to home- based care in this risk group up to now does not seem to have a negative effect on pregnancy outcomes, such as incidence of preeclampsia, severe hypertension, mode of delivery and neonatal outcomes. However, in this field of digitally enhanced prenatal care, no randomized controlled trials of sufficient sample size have been conducted yet. The available evidence is mostly derived from underpowered retrospective or prospective cohort studies. Telemonitoring of maternal and fetal condition: what is known A solid technical infrastructure is required before research of digital health innovation in clinical settings. As found in our literature review, multiple devices and integrated systems are developed lately for wireless fetal monitoring from a distance. 10-13 Telemonitoring of cardiotocography has the potential to increase access to care, i.e. in rural areas, or to replace traditional monitoring in the hospital to a home setting. In the Netherlands, self- recorded cardiotocography is available with specially designed systems. Tracings are saved using Bluetooth and a tablet computer and sent to the hospital for the health care provider. Several systems have been tested in published studies for functionality, acceptability and usability. 14-17 Three pilot studies from both high and low income countries found the system to be acceptable for pregnant women and HCPs, and clinically useful. They describe its potential for use of telemedicine of maternity unites in underserved areas, as well as for inpatient settings, which has to be tested in feasibility studies. Before the start of a telemonitoring pilot, we compared fetal heart rate tracings with our general hospital equipment and found similar tracings. In the setting of the HOTEL trial high-risk pregnant women are trained by midwives to use the system at home. Separate from the hospital’s own electronic health record system, the data are visible for health care providers in a secured web-portal. Since recently it is possible to integrate the tracings into general electronic health record software. This integration is beneficial for a more secured way of communication if the system is to be used on a large scale. As the tracings are visible within one single system, this integration enhances daily medical decision making. CHAPTER 11 182

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