Search

Background/Objectives : Gestational hypertensive disorders (GHD) pose significant maternal and fetal health risks during pregnancy. Preconception physical exercise has been associated with a lower incidence of GHD, but insights into the cardiovascular mechanisms remain limited. This study aimed to evaluate the effect of preconception physical exercise on the complete cardiovascular functions of women at risk for GHD in a subsequent pregnancy. Methods : A non-invasive hemodynamics assessment of arteries, veins, and the heart was performed on 40 non-pregnant women at risk for developing GHD in a subsequent pregnancy. Measurements of an electrocardiogram Doppler ultrasound, impedance cardiography and bio-impedance spectrum analysis were taken before and after they engaged in physical exercise (30-50 min, 3×/week, 4-6 months). Results : After a mean physical exercise period of 29.80 weeks, the total peripheral resistance (TPR), diastolic blood pressure and mean arterial pressure decreased in the total study population, without changing cardiac output (CO). However, in 42% (9/21) of women categorized with high or low baseline CO (>P75 or

Background: The peripartum period, defined as the period from the beginning of the gestation until 1 year after the delivery, has long been shown to be potentially associated with increased levels of stress and anxiety with regard to one's transition to the status of parent and the accompanying parental tasks. Yet, no research to date has investigated changes in intrapersonal factors during the peripartum period in women at risk for pregnancy-induced hypertension (PIH)., Objective: The aim of this study is to explore and describe changes in intrapersonal factors in participants at risk for PIH., Methods: We used an explorative design in which 3 questionnaires were sent by email to 110 participants the day following enrollment in the Pregnancy Remote Monitoring program for pregnant women at risk for PIH. Women were invited to complete the questionnaires at the beginning of their participation in the Pregnancy Remote Monitoring project (mostly at 14 weeks of gestation) and after approaching 32 weeks of gestational age (GA). The Generalized Anxiety Disorder-7 Scale (GAD-7) and the Patient Health Questionnaire-9 were used to assess anxiety and depression, and adaptation of the Pain Catastrophizing Scale was used to measure trait pain catastrophizing., Results: Scores were significantly higher at 32 weeks of GA than at the moment of enrollment (GAD-7 score=7, range 4-11 vs 5, range 3-8; P=.01; and Patient Health Questionnaire-9 score=6, range 4-10 vs 4, range 2-7; P<.001). The subscale scores of the Pain Catastrophizing Scale were all lower at 32 weeks of GA compared with 14 weeks of GA (rumination: 4, range 1-6 vs 5, range 2-9.5; P=.11; magnification: 3, range 1-5.5 vs 4, range 3-7; P=.04; and helplessness: 5, range 2-9 vs 6, range 3.5-12; P=.06). The proportion of women with a risk for depression (GAD-7 score >10) was 13.3% (10/75) at enrollment and had increased to 35.6% (26/75) at 32 weeks of GA., Conclusions: This study shows that pregnant women at risk for PIH have higher levels of stress and anxiety at 32 weeks of GA than at the moment of enrollment. Further research is recommended to investigate potential strategies to help pregnant women at risk for PIH manage feelings of stress and anxiety., Trial Registration: ClinicalTrials.gov NCT03246737; https://clinicaltrials.gov/study/NCT03246737., (©Dorien Lanssens, Thijs Vandenberk, Valerie Storms, Inge Thijs, Lars Grieten, Lotte Bamelis, Wilfried Gyselaers, Eileen Tang, Patrick Luyten. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 06.09.2023.)

Background: There has been an exponential growth in the availability of apps, resulting in increased use of pregnancy apps. However, information on resources and use of apps among pregnant women is relatively limited., Objective: The aim of this study is to map the current information resources and the use of pregnancy apps among pregnant women in Flanders., Methods: A cross-sectional study was conducted, using a semistructured survey (April-June 2019) consisting of four different domains: (1) demographics; (2) use of devices; (3) sources of information; and (4) use of pregnancy apps. Women were recruited by social media, flyers, and paper questionnaires at prenatal consultations. Statistical analysis was mainly focused on descriptive statistics. Differences in continuous and categorical variables were tested using independent Student t tests and chi-square tests. Correlations were investigated between maternal characteristics and the women's responses., Results: In total, 311 women completed the entire questionnaire. Obstetricians were the primary source of information (268/311, 86.2%) for pregnant women, followed by websites/internet (267/311, 85.9%) and apps (233/311, 74.9%). The information that was most searched for was information about the development of the baby (275/311, 88.5%), discomfort/complaints (251/311, 80.7%) and health during pregnancy (248/311, 79.7%), administrative/practical issues (233/311, 74.9%), and breastfeeding (176/311, 56.6%). About half of the women (172/311, 55.3%) downloaded a pregnancy app, and primarily searched app stores (133/311, 43.0%). Pregnant women who are single asked their mothers (22/30, 73.3%) or other family members (13/30, 43.3%) for significantly more information than did married women (mother [in law]: 82/160, 51.3%, P=.02; family members: 35/160, 21.9%, P=.01). Pregnant women with lower education were significantly more likely to have a PC or laptop than those with higher education (72/73, 98.6% vs 203/237, 85.5%; P=.008), and to consult other family members for pregnancy information (30/73, 41.1% vs 55/237, 23.1%; P<.001), but were less likely to consult a gynecologist (70/73, 95.9% vs 198/237, 83.5%; P=.001). They also followed more prenatal sessions (59/73, 80.8% vs 77/237, 32.5%; P=.04) and were more likely to search for information regarding discomfort/complaints during pregnancy (65/73, 89% vs 188/237, 79.5%; P=.02). Compared to multigravida, primigravida were more likely to solicit advice about their pregnancy from other women in their social networks (family members: primigravida 44/109, 40.4% vs multigravida 40/199, 20.1%; P<.001; other pregnant women: primigravida 58/109, 53.2% vs multigravida 80/199, 40.2%; P<.03)., Conclusions: Health care professionals need to be aware that apps are important and are a growing source of information for pregnant women. Concerns rise about the quality and safety of those apps, as only a limited number of apps are subjected to an external quality check. Therefore, it is important that health care providers refer to high-quality digital resources and take the opportunity to discuss digital information with pregnant women., (©Dorien Lanssens, Inge M Thijs, Pauline Dreesen, Ann Van Hecke, Pascal Coorevits, Gitte Gaethofs, Joyce Derycke, Inge Tency. Originally published in JMIR Formative Research (https://formative.jmir.org), 11.10.2022.)

Introduction: Evidence-based practice (EBP) leads to improved health outcomes and reduces variability in the quality of care. However, literature on the knowledge, attitudes and use of EBP among midwives is scarce internationally and in Belgium., Methods: A cross-sectional study using an online semi-structured questionnaire explored practice, attitudes and barriers on EBP and clinical practice guidelines. Midwives (n=251) working in university and non-university hospitals, primary care, and midwifery education, in Flanders (Belgium) were included., Results: Midwives with a Master's degree (57.7% vs 37.8%; p=0.004), ≤15 years since graduation (50.8% vs 35.5%; p=0.015) and aged <40 years (49.7% vs 34.6%; p=0.02), had better knowledge of the EBP-definition. The majority searched for literature (80.1%), mainly evidence-based (EB) clinical practice guidelines (50.6%), randomized controlled trials (45.0%) and systematic reviews (43.0%). Midwives found EBP necessary and realistic to apply in daily practice and support decision-making. They were willing to improve EBP-knowledge and skills but assumed to be competent in providing evidence-based care. Most respondents were convinced of the importance of EB clinical practice guidelines but did not believe guidelines facilitated their practices or enabled them to consider patient preferences adequately. Half of the midwives (55.8%) experienced barriers to EB clinical practice guideline use, mainly lack of time (35.9%), access (19.5%), and support (17.9%)., Conclusions: Although midwives showed a positive attitude towards EBP, education programs to promote EBP and improve EBP-related knowledge and skills are needed. Future efforts should focus on developing strategies for overcoming barriers and enhancing the consistency of EBP implementation., Competing Interests: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none was reported., (© 2022 Lanssens D. et al.)

Background: Observational data from the retrospective, non-randomized Pregnancy REmote MOnitoring I (PREMOM I) study showed that remote monitoring (RM) may be beneficial for prenatal observation of women at risk for gestational hypertensive disorders (GHD) in terms of clinical outcomes, health economics, and stakeholder perceptions. PREMOM II is a prospective, randomized, multicenter follow-up study that was performed to explore these promising results., Methods: After providing written consent, 3922 pregnant women aged ≥18 years who are at increased risk of developing GHD will be randomized (1:1:1 ratio) to (a) conventional care (control group), (b) a patient self-monitoring group, and (c) a midwife-assisted RM group. The women in each group will be further divided (1:1 ratio) to evaluate the outcomes of targeted or non-targeted (conventional) antihypertensive medication. Women will be recruited in five hospitals in Flanders, Belgium: Ziekenhuis Oost-Limburg, Universitaire Ziekenhuis Antwerpen, Universitaire Ziekenhuis Leuven, AZ Sint Jan Brugge-Oostende, and AZ Sint Lucas Brugge. The primary outcomes are: (1) numbers and types of prenatal visits; (2) maternal outcomes; (3) neonatal outcomes; (4) the applicability and performance of RM; and (5) compliance with RM and self-monitoring. The secondary outcomes are: (1) cost-effectiveness and willingness to pay; (2) patient-reported outcome measures (PROMS) questionnaires on the experiences of the participants; and (3) the maternal and perinatal outcomes according to the type of antihypertensive medication. Demographic, and maternal and neonatal outcomes are collected from the patients' electronic records. Blood pressure and compliance rate will be obtained from an online digital coordination platform for remote data handling. Information about the healthcare-related costs will be obtained from the National Coordination Committee of Belgian Health Insurance Companies (Intermutualistisch Agentschap). PROMS will be assessed using validated questionnaires., Discussion: To our knowledge, this is the first randomized trial comparing midwife-assisted RM and self-monitoring of prenatal blood pressure versus conventional management among women at increased risk of GHD. Positive results of this study may lead to a practical framework for caregivers, hospital management, and payers to introduce RM into the prenatal care programs of high-risk pregnancies., Trial Registration: This study was registered on clinicaltrials.gov , identification number NCT04031430. Registered 24 July 2019, https://clinicaltrials.gov/ct2/show/NCT04031430?cond=premom+ii&draw=2&rank=1 .

Background: Medical smartphone apps and mobile health devices are rapidly entering mainstream use because of the rising number of smartphone users. Consequently, a large amount of consumer-generated data is being collected. Technological advances in innovative sensory systems have enabled data connectivity and aggregation to become cornerstones in developing workable solutions for remote monitoring systems in clinical practice. However, few systems are currently available to handle such data, especially for clinical use., Objective: The aim of this study was to develop and implement the digital health research platform for mobile health (DHARMA) that combines data saved in different formats from a variety of sources into a single integrated digital platform suitable for mobile remote monitoring studies., Methods: DHARMA comprises a smartphone app, a Web-based platform, and custom middleware and has been developed to collect, store, process, and visualize data from different vendor-specific sensors. The middleware is a component-based system with independent building blocks for user authentication, study and patient administration, data handling, questionnaire management, patient files, and reporting., Results: A prototype version of the research platform has been tested and deployed in multiple clinical studies. In this study, we used the platform for the follow-up of pregnant women at risk of developing pre-eclampsia. The patients' blood pressure, weight, and activity were semi-automatically captured at home using different devices. DHARMA automatically collected and stored data from each source and enabled data processing for the end users in terms of study-specific parameters, thresholds, and visualization., Conclusions: The increasing use of mobile health apps and connected medical devices is leading to a large amount of data for collection. There has been limited investment in handling and aggregating data from different sources for use in academic and clinical research focusing on remote monitoring studies. In this study, we created a modular mobile health research platform to collect and integrate data from a variety of third-party devices in several patient populations. The functionality of the platform was demonstrated in a real-life setting among women with high-risk pregnancies., (©Thijs Vandenberk, Valerie Storms, Dorien Lanssens, Hélène De Cannière, Christophe JP Smeets, Inge M Thijs, Tooba Batool, Yves Vanrompay, Pieter M Vandervoort, Lars Grieten. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 29.10.2019.)

Background: Pregnancy-induced hypertension (PIH) is associated with high levels of morbidity and mortality in mothers, fetuses, and newborns. New technologies, such as remote monitoring (RM), were introduced in 2015 into the care of patients at risk of PIH in Ziekenhuis Oost-Limburg (Genk, Belgium) to improve both maternal and neonatal outcomes. In developing new strategies for obstetric care in pregnant women, including RM, it is important to understand the psychosocial characteristics associated with adherence to RM to optimize care., Objective: The aim of this study was to explore the role of patients' psychosocial characteristics (severity of depression or anxiety, cognitive factors, attachment styles, and personality traits) in their adherence to RM., Methods: Questionnaires were sent by email to 108 mothers the day after they entered an RM program for pregnant women at risk of PIH. The Generalized Anxiety Disorder Assessment-7 and Patient Health Questionnaire-9 (PHQ-9) were used to assess anxiety and the severity of depression, respectively; an adaptation of the Pain Catastrophizing Scale was used to assess cognitive factors; and attachment and personality were measured with the Experiences in Close Relationships-Revised Scale (ECR-R), the Depressive Experiences Questionnaire, and the Multidimensional Perfectionism Scale, respectively., Results: The moderate adherence group showed significantly higher levels of anxiety and depression, negative cognitions, and insecure attachment styles, especially compared with the over adherence group. The low adherence group scored significantly higher than the other groups on other-oriented perfectionism. There were no significant differences between the good and over adherence groups. Single linear regression showed that the answers on the PHQ-9 and ECR-R questionnaires were significantly related to the adherence rate., Conclusions: This study demonstrates the relationships between adherence to RM and patient characteristics in women at risk of PIH. Alertness toward the group of women who show less than optimal adherence is essential. These findings call for further research on the management of PIH and the importance of individual tailoring of RM in this patient group., Trial Registration: ClinicalTrials.gov NCT03509272; https://clinicaltrials.gov/ct2/show/NCT03509272., (©Thijs Vandenberk, Dorien Lanssens, Valerie Storms, Inge M Thijs, Lotte Bamelis, Lars Grieten, Wilfried Gyselaers, Eileen Tang, Patrick Luyten. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 28.08.2019.)

Introduction : Telemonitoring of hypertension in pregnancy is becoming increasingly common. Several small studies have described the potential benefits of patient-led remote monitoring, including fewer hospital visits, better blood pressure control, and cost savings. Areas covered : This review summarises the principles of prenatal remote monitoring of hypertension as well as the types of devices and applications currently in use. We summarise current evidence regarding the potential benefits and pitfalls with respect to outcomes for mothers, neonates and wider population health. Core topics for ongoing and future research are discussed, with special emphasis on feasibility and validation of technologies, methodological standardization, patient safety, privacy and acceptability, and health economics and governance. Expert opinion : Telemonitoring of hypertension in pregnancy is likely to become commonplace in the next five to ten years and research now must be directed to ensure it is used in the safest way before its general introduction into daily clinical practice can be recommended. Raising women's awareness of their health condition could improve both pregnancy and long-term health outcomes.

Background: To investigate the possibility of using maternal biophysical parameters only in screening for the different types of gestational hypertensive diseases., Methods: A total of 969 pregnant women were randomly screened in first and second trimester, of which 8 developed Early-onset Preeclampsia, 29 Late-onset Preeclampsia, 35 Gestational Hypertension and 897 women had a normal outcome. An observational maternal hemodynamics assessment was done via standardized electrocardiogram-Doppler ultrasonography, Impedance Cardiography and bio-impedance, acquiring functional information on heart, arteries, veins and body fluid. Preliminary prediction models were developed to test the screening potential for early preeclampsia, late preeclampsia and gestational hypertension using a Partial Least Square Discriminant Analysis., Results: A combined model using maternal characteristics with cardiovascular parameters in first and second trimester offers high screening performance with Area Under the Curve of 99,9% for Early-onset Preeclampsia, 95,3% for Late-onset Preeclampsia and 94% for Gestational Hypertension., Conclusions: Using biophysical parameters as fundament for a new prediction model, without the need of biochemical parameters, seems feasible. However, validation in a large prospective study will reveal its true potential.

Background: The Pregnancy Remote Monitoring (PREMOM) study enrolled pregnant women at increased risk of developing hypertensive disorders of pregnancy and investigated the effect of remote monitoring in addition to their prenatal follow-up., Objective: The objective of this study was to investigate the perceptions and experiences of remote monitoring among mothers, midwives, and obstetricians who participated in the PREMOM study., Methods: We developed specific questionnaires for the mothers, midwives, and obstetricians addressing 5 domains: (1) prior knowledge and experience of remote monitoring, (2) reactions to abnormal values, (3) privacy, (4) quality and patient safety, and (5) financial aspects. We also questioned the health care providers about which issues they considered important when implementing remote monitoring. We used a 5-point Likert scale to provide objective scores. It was possible to add free-text feedback at every question., Results: A total of 91 participants completed the questionnaires. The mothers, midwives, and obstetricians reported positive experiences and perceptions of remote monitoring, although most of them had no or little prior experience with this technology. They supported a further rollout of remote monitoring in Belgium. Nearly three-quarters of the mothers (34/47, 72%) did not report any problems with taking the measurements at the required times. Almost half of the mothers (19/47, 40%) wanted to be contacted within 3 to 12 hours after abnormal measurement values, preferably by telephone., Conclusions: Although most of midwives and obstetricians had no or very little experience with remote monitoring before enrolling in the PREMOM study, they reported, based on their one-year experience, that remote monitoring was an important component in the follow-up of high-risk pregnancies and would recommend it to their colleagues and pregnant patients., Trial Registration: ClinicalTrials.gov NCT03246737; https://clinicaltrials.gov/ct2/show/NCT03246737 (Archived by WebCite at http://www.webcitation.org/76KVnHSYY)., (©Dorien Lanssens, Thijs Vandenberk, Joy Lodewijckx, Tessa Peeters, Valerie Storms, Inge M Thijs, Lars Grieten, Wilfried Gyselaers. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 15.04.2019.)

A combined assessment of heart, arteries, veins, and body fluid content throughout pregnancy has not yet been reported. We hypothesized that a gradual aggravation of circulatory dysfunction exists from the latent to the clinical phase of gestational hypertensive disease (GHD), and that pathways are unique for preeclampsia with early onset < 34 wk (EPE) and late onset ≥ 34 wk (LPE), and gestational hypertension (GH). Women with singleton pregnancy and no known diseases were invited for a prospective, observational study and had standardized sphygmomanometric blood pressure measurement, bioimpedance body water spectrum analysis, impedance cardiography for cardiac and arterial assessment, and combined Doppler-ECG of hepatic and renal interlobar veins and uterine arteries. Outcome was categorized as uncomplicated (UP, n = 1,700), EPE ( n = 87), LPE ( n = 218), or GH ( n = 188). A linear mixed model for repeated measurements, corrected for age, parity, and body mass index, was employed in SAS 9.4 to analyze trimestral changes within and between groups. From the first to the third trimester, body water increased in all groups, and an increasing number of abnormal parameters relative to UP occurred in all GHD. First-trimester blood pressure and peripheral resistance were higher in GHD than UP, together with increased uterine flow resistance and extracellular water in EPE, and with lower heart rate and aorta flow velocity in LPE. An overall gestational rise of body water volumes coexists with a gradual worsening of cardiovascular dysfunction in GHD, of which pathophysiological pathways are unique for EPE, LPE, and GH, respectively.

Objectives: To evaluate body water volumes and cardiac output in each trimester of pregnancies complicated with hypertension and/or poor fetal growth, relative to uncomplicated pregnancy., Methods: In this semi-longitudinal cohort study, a standardised non-invasive maternal hemodynamics assessment in first, second or third trimester was performed in 1068 women with uncomplicated pregnancy (UP), 75 with early onset (EPE) and 117 with late onset preeclampsia (LPE), 139 with gestational hypertension (GH), 129 with small for gestational age (SGA) neonates and 43 with essential hypertension (EH). Women with hypertension or SGA were included prior to onset of symptoms or at diagnosis of disease; 46% of women (758/1631) were assessed in ≥ 2 trimesters. Impedance cardiography and spectrum analysis were used to measure cardiac output, total body water (TBW), extracellular (ECW) and intracellular water (ICW). A linear mixed model was used for inter-trimestrial comparison of parity-, age- and BMI-corrected values within and between groups., Results: For all pregnancies, TBW is higher in each consecutive trimester, mainly due to increasing fraction of ECW (ECW%). Compared to first trimester UP, ECW and ECW% are higher in EPE whereas TBW, ECW and ICW are lower in SGA. Compared to inter-trimestrial differences in UP, abnormal changes for body water volumes are observed in GH, EPE and LPE and for CO in EPE and LPE. Changes in EH are not different from UP., Conclusions: This study is the first to show that concomitant gestational changes of ECW and CO are different from UP already in preclinical stages of pregnancies complicated with hypertension and/or poor fetal growth, except EH. This finding highlights the relevance of early gestational assessment of maternal body fluid status in pregnancies at risk for hypertension or poor fetal growth., Competing Interests: The authors have declared that no competing interests exist.

Background: Remote monitoring in obstetrics is relatively new; some studies have shown its effectiveness for both mother and child. However, few studies have evaluated the economic impact compared to conventional care, and no cost analysis of a remote monitoring prenatal follow-up program for women diagnosed with gestational hypertensive diseases (GHD) has been published., Objective: The aim of this study was to assess the costs of remote monitoring versus conventional care relative to reported benefits., Methods: Patient data from the Pregnancy Remote Monitoring (PREMOM) study were used. Health care costs were calculated from patient-specific hospital bills of Ziekenhuis Oost-Limburg (Genk, Belgium) in 2015. Cost comparison was made from three perspectives: the Belgian national health care system (HCS), the National Institution for Insurance of Disease and Disability (RIZIV), and costs for individual patients. The calculations were made for four major domains: prenatal follow-up, prenatal admission to the hospital, maternal and neonatal care at and after delivery, and total amount of costs. A simulation exercise was made in which it was calculated how much could be demanded of RIZIV for funding the remote monitoring service., Results: A total of 140 pregnancies were included, of which 43 received remote monitoring (30.7%) and 97 received conventional care (69.2%). From the three perspectives, there were no differences in costs for prenatal follow-up. Compared to conventional care, remote monitoring patients had 34.51% less HCS and 41.72% less RIZIV costs for laboratory test results (HCS: mean €0.00 [SD €55.34] vs mean €38.28 [SD € 44.08], P<.001; RIZIV: mean €21.09 [SD €27.94] vs mean €36.19 [SD €41.36], P<.001) and a reduction of 47.16% in HCS and 48.19% in RIZIV costs for neonatal care (HCS: mean €989.66 [SD €3020.22] vs mean €1872.92 [SD €5058.31], P<.001; RIZIV: mean €872.97 [SD €2761.64] vs mean €1684.86 [SD €4702.20], P<.001). HCS costs for medication were 1.92% lower in remote monitoring than conventional care (mean €209.22 [SD €213.32] vs mean €231.32 [SD 67.09], P=.02), but were 0.69% higher for RIZIV (mean €122.60 [SD €92.02] vs mean €121.78 [SD €20.77], P<.001). Overall HCS costs for remote monitoring were mean €4233.31 (SD €3463.31) per person and mean €4973.69 (SD €5219.00) per person for conventional care (P=.82), a reduction of €740.38 (14.89%) per person, with savings mainly for RIZIV of €848.97 per person (23.18%; mean €2797.42 [SD €2905.18] vs mean €3646.39 [SD €4878.47], P=.19). When an additional fee of €525.07 per month per pregnant woman for funding remote monitoring costs is demanded, remote monitoring is acceptable in their costs for HCS, RIZIV, and individual patients., Conclusions: In the current organization of Belgian health care, a remote monitoring prenatal follow-up of women with GHD is cost saving for the global health care system, mainly via savings for the insurance institution RIZIV., (©Dorien Lanssens, Thijs Vandenberk, Christophe JP Smeets, Hélène De Cannière, Sharona Vonck, Jade Claessens, Yenthel Heyrman, Dominique Vandijck, Valerie Storms, Inge M Thijs, Lars Grieten, Wilfried Gyselaers. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 26.03.2018.)

Background: The use of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices is expanding in the treatment of heart failure. Most of the current devices are equipped with remote monitoring functions, including bioimpedance for fluid status monitoring. The question remains whether bioimpedance measurements positively impact clinical outcome., Objective: The aim of this study was to provide a comprehensive overview of the clinical interventions taken based on remote bioimpedance monitoring alerts and their impact on clinical outcome., Methods: This is a single-center observational study of consecutive ICD and CRT patients (n=282) participating in protocol-driven remote follow-up. Bioimpedance alerts were analyzed with subsequently triggered interventions., Results: A total of 55.0% (155/282) of patients had an ICD or CRT device equipped with a remote bioimpedance algorithm. During 34 (SD 12) months of follow-up, 1751 remote monitoring alarm notifications were received (2.2 per patient-year of follow-up), comprising 2096 unique alerts (2.6 per patient-year of follow-up). Since 591 (28.2%) of all incoming alerts were bioimpedance-related, patients with an ICD or CRT including a bioimpedance algorithm had significantly more alerts (3.4 versus 1.8 alerts per patient-year of follow-up, P<.001). Bioimpedance-only alerts resulted in a phone contact in 91.0% (498/547) of cases, which triggered an actual intervention in 15.9% (87/547) of cases, since in 75.1% (411/547) of cases reenforcing heart failure education sufficed. Overall survival was lower in patients with a cardiovascular implantable electronic device with a bioimpedance algorithm; however, this difference was driven by differences in baseline characteristics (adjusted hazard ratio of 2.118, 95% CI 0.845-5.791). No significant differences between both groups were observed in terms of the number of follow-up visits in the outpatient heart failure clinic, the number of hospital admissions with a primary diagnosis of heart failure, or mean length of hospital stay., Conclusions: Bioimpedance-only alerts constituted a substantial amount of incoming alerts when turned on during remote follow-up and triggered an additional intervention in only 16% of cases since in 75% of cases, providing general heart failure education sufficed. The high frequency of heart failure education that was provided could have contributed to fewer heart failure-related hospitalizations despite significant differences in baseline characteristics., (©Christophe JP Smeets, Julie Vranken, Jo Van der Auwera, Frederik H Verbrugge, Wilfried Mullens, Matthias Dupont, Lars Grieten, Hélène De Cannière, Dorien Lanssens, Thijs Vandenberk, Valerie Storms, Inge M Thijs, Pieter M Vandervoort. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 23.11.2017.)

Background: Despite reported positive results of telemonitoring effectiveness in various health care domains, this new technology is rarely used in prenatal care. A few isolated investigations were performed in the past years but with conflicting results., Objective: The aim of this review was to (1) assess whether telemonitoring adds any substantial benefit to this patient population and (2) identify research gaps in this area to suggest goals for future research., Methods: This review includes studies exploring the effectiveness of telemonitoring interventions for pregnant women reported in the English language. Due to the paucity of research in this area, all reports including uncontrolled nonrandomized and randomized controlled studies were selected., Results: Fourteen studies, which performed their data collection from 1988 to 2010, met the inclusion criteria and were published from 1995 to present; four of the 14 published papers were multicenter randomized controlled trials (RCTs), five papers were single-center RCTs, three papers were retrospective studies, one paper was an observational study, and one paper was a qualitative study. Of the 14 papers, nine were available for a risk of bias assessment: three papers were classified as low risk, one as medium risk, and five as high risk. Furthermore, of those 14 papers, 13 focused on telemonitoring for maternal outcomes, and nine of the 14 papers focused on telemonitoring for fetal or neonatal outcomes. The studies reviewed report that telemonitoring can contribute to significant reductions in health care costs, (unscheduled) face-to-face visits, low neonatal birth weight, and admissions to the neonatal intensive care unit (NICU), as well as prolonged gestational age and improved feelings of maternal satisfaction when compared with a control group. When only studies with low risk of bias were taken into account, the added value of telemonitoring became less pronounced: the only added value of telemonitoring is for pregnant women who transmitted their uterine activity by telecommunication. They had significant prolonged pregnancy survivals, and the newborns were less likely to be of low birth weight or to be admitted to the NICU. Following these results, telemonitoring can only be recommended by pregnant women at risk for preterm delivery. It is however important to consider that these studies were published in the mid-90s, which limits their direct applicability given the current technologies and practice., Conclusions: This review shows that telemonitoring can be tentatively recommended for pregnant women at risk for preterm delivery. More recent RCTs with a blinded protocol are needed to strengthen the level of evidence around this topic and to have an insight in the added value of the technologies that are available nowadays. In addition, studies investigating patient satisfaction and economic effects in relation to telemonitoring are suggested for future research., (©Dorien Lanssens, Thijs Vandenberk, Inge M Thijs, Lars Grieten, Wilfried Gyselaers. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 27.09.2017.)

Background: Photoplethysmography (PPG) is a proven way to measure heart rate (HR). This technology is already available in smartphones, which allows measuring HR only by using the smartphone. Given the widespread availability of smartphones, this creates a scalable way to enable mobile HR monitoring. An essential precondition is that these technologies are as reliable and accurate as the current clinical (gold) standards. At this moment, there is no consensus on a gold standard method for the validation of HR apps. This results in different validation processes that do not always reflect the veracious outcome of comparison., Objective: The aim of this paper was to investigate and describe the necessary elements in validating and comparing HR apps versus standard technology., Methods: The FibriCheck (Qompium) app was used in two separate prospective nonrandomized studies. In the first study, the HR of the FibriCheck app was consecutively compared with 2 different Food and Drug Administration (FDA)-cleared HR devices: the Nonin oximeter and the AliveCor Mobile ECG. In the second study, a next step in validation was performed by comparing the beat-to-beat intervals of the FibriCheck app to a synchronized ECG recording., Results: In the first study, the HR (BPM, beats per minute) of 88 random subjects consecutively measured with the 3 devices showed a correlation coefficient of .834 between FibriCheck and Nonin, .88 between FibriCheck and AliveCor, and .897 between Nonin and AliveCor. A single way analysis of variance (ANOVA; P=.61 was executed to test the hypothesis that there were no significant differences between the HRs as measured by the 3 devices. In the second study, 20,298 (ms) R-R intervals (RRI)-peak-to-peak intervals (PPI) from 229 subjects were analyzed. This resulted in a positive correlation (rs=.993, root mean square deviation [RMSE]=23.04 ms, and normalized root mean square error [NRMSE]=0.012) between the PPI from FibriCheck and the RRI from the wearable ECG. There was no significant difference (P=.92) between these intervals., Conclusions: Our findings suggest that the most suitable method for the validation of an HR app is a simultaneous measurement of the HR by the smartphone app and an ECG system, compared on the basis of beat-to-beat analysis. This approach could lead to more correct assessments of the accuracy of HR apps., (©Thijs Vandenberk, Jelle Stans, Gertjan Van Schelvergem, Caroline Pelckmans, Christophe JP Smeets, Dorien Lanssens, Hélène De Cannière, Valerie Storms, Inge M Thijs, Pieter M Vandervoort. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 25.08.2017.)

Background: Although remote monitoring (RM) has proven its added value in various health care domains, little is known about the remote follow-up of pregnant women diagnosed with a gestational hypertensive disorders (GHD)., Objective: The aim of this study was to evaluate the added value of a remote follow-up program for pregnant women diagnosed with GHD., Methods: A 1-year retrospective study was performed in the outpatient clinic of a 2nd level prenatal center where pregnant women with GHD received RM or conventional care (CC). Primary study endpoints include number of prenatal visits and admissions to the prenatal observation ward. Secondary outcomes include gestational outcome, mode of delivery, neonatal outcome, and admission to neonatal intensive care (NIC). Differences in continuous and categorical variables in maternal demographics and characteristics were tested using Unpaired Student's two sampled t test or Mann-Whitney U test and the chi-square test. Both a univariate and multivariate analysis were performed for analyzing prenatal follow-up and gestational outcomes. All statistical analyses were done at nominal level, Cronbach alpha=.05., Results: Of the 166 patients diagnosed with GHD, 53 received RM and 113 CC. After excluding 5 patients in the RM group and 15 in the CC group because of the missing data, 48 patients in RM group and 98 in CC group were taken into final analysis. The RM group had more women diagnosed with gestational hypertension, but less with preeclampsia when compared with CC (81.25% vs 42.86% and 14.58% vs 43.87%). Compared with CC, univariate analysis in RM showed less induction, more spontaneous labors, and less maternal and neonatal hospitalizations (48.98% vs 25.00%; 31.63% vs 60.42%; 74.49% vs 56.25%; and 27.55% vs 10.42%). This was also true in multivariate analysis, except for hospitalizations., Conclusions: An RM follow-up of women with GHD is a promising tool in the prenatal care. It opens the perspectives to reverse the current evolution of antenatal interventions leading to more interventions and as such to ever increasing medicalized antenatal care., (©Dorien Lanssens, Thijs Vandenberk, Christophe JP Smeets, Hélène De Cannière, Geert Molenberghs, Anne Van Moerbeke, Anne van den Hoogen, Tiziana Robijns, Sharona Vonck, Anneleen Staelens, Valerie Storms, Inge M Thijs, Lars Grieten, Wilfried Gyselaers. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 09.03.2017.)