Transdermal sensor features correlate with ecological momentary assessment drinking reports and predict alcohol-related consequences in young adults' natural settings.

BACKGROUND: Wearable transdermal alcohol concentration (TAC) sensors allow passive monitoring of alcohol concentration in natural settings and measurement of multiple features from drinking episodes, including peak intoxication level, speed of intoxication (absorption rate) and elimination, and duration. These passively collected features extend commonly used self-reported drink counts and may facilitate the prediction of alcohol-related consequences in natural settings, aiding risk stratification and prevention efforts. METHOD: A total of 222 young adults aged 21-29 (M age = 22.3, 64% female, 79% non-Hispanic white, 84% undergraduates) who regularly drink heavily participated in a 5-day study that included the ecological momentary assessment (EMA) of alcohol consumption (daily morning reports and participant-initiated episodic EMA sequences) and the wearing of TAC sensors (SCRAM-CAM anklets). The analytic sample contained 218 participants and 1274 days (including 554 self-reported drinking days). Five features-area under the curve (AUC), peak TAC, rise rate (rate of absorption), fall rate (rate of elimination), and duration-were extracted from TAC-positive trajectories for each drinking day. Day- and person-level associations of TAC features with drink counts (morning and episodic EMA) and alcohol-related consequences were tested using multilevel modeling. RESULTS: TAC features were strongly associated with morning drink reports (r = 0.6-0.7) but only moderately associated with episodic EMA drink counts (r = 0.3-0.5) at both day and person levels. Higher peaks, larger AUCs, faster rise rates, and faster fall rates were significantly predictive of day-level alcohol-related consequences after adjusting for both morning and episodic EMA drink counts in separate models. Person means of TAC features added little above daily scores to the prediction of alcohol-related consequences. CONCLUSIONS: These results support the utility of TAC sensors in studies of alcohol misuse among young adults in natural settings and outline the specific TAC features that contribute to the day-level prediction of alcohol-related consequences. TAC sensors provide a passive option for obtaining valid and unique information predictive of drinking risk in natural settings.

Rationale and design of a digital trial using smartphones to detect subclinical atrial fibrillation in a population at risk: The eHealth-based bavarian alternative detection of Atrial Fibrillation (eBRAVE-AF) trial.

Current guidelines recommend opportunistic screening for subclinical atrial fibrillation (AF) taking advantage of e-health-based technologies. However, the efficacy of a fully scalable e-health-based strategy for AF detection in a head-to-head comparison with routine symptom-based screening is unknown. eBRAVE-AF is an investigator-initiated, digital, prospective, randomized, siteless, open-label, cross-over study to evaluate an e-health-based strategy for detection of AF in a real-world setting. 67,488 policyholders of a large German health insurance company (Versicherungskammer Bayern, Germany) selected by age ≥ 50 years and a CHA2DS2-VASc score ≥ 1 (females ≥2) are invited to participate. Subjects with known AF or on treatment with oral anticoagulation are excluded. After obtaining electronic informed consent, at least 4,400 participants will be randomly assigned to an e-health-based screening strategy or routine symptom-based screening. The e-health-based strategy consists of repetitive one-minute photoplethysmographic (PPG) pulse wave assessments using a certified smartphone app (Preventicus Heartbeats, Preventicus, Jena, Germany), followed by a confirmatory 14-day ECG patch (CardioMem CM 100 XT, Getemed, Teltow, Germany) in case of abnormal findings. After 6 months, participants are crossed over to the other study arm. Primary endpoint is the incidence of newly diagnosed AF leading to oral anticoagulation indicated by an independent physician. Clinical follow-up will be at least 12 months. In both groups, follow-up is performed by 4-week app-based questionnaires, personal contact in case of abnormal findings, and matching with claim-based insurance data and medical reports. At time of writing enrollment is completed. First results are expected to be available in mid-2021.

Cost-Effectiveness of Vioptix versus Clinical Examination for Flap Monitoring of Autologous Free Tissue Breast Reconstruction.

BACKGROUND: Vioptix is a near-infrared spectroscopy tissue oximetry technology that allows for noninvasive monitoring of flap perfusion. Despite the reported benefits of Vioptix, the cost-effectiveness of this flap monitoring technology has not been compared to clinical examination alone. METHODS: A cost-effectiveness model, from the patient perspective, was constructed with two treatment arms: clinical examination versus clinical examination combined with Vioptix for flap monitoring after autologous, free flap breast reconstruction. Costs, utilities, and other model inputs were identified from the literature. One-way and probabilistic sensitivity analyses were performed. Gamma distributions were created for cost variables, and beta distributions were created for probability variables. An incremental cost-effectiveness ratio under $50,000 per quality-adjusted life-year (QALY) was considered cost-effective. All analyses were performed using TreeAge Pro (Williamstown, Mass.). RESULTS: Mean cost of autologous free tissue transfer breast reconstruction with clinical examination-based flap monitoring was found to be $37,561 with an effectiveness of 0.79, whereas the mean cost of clinical examination with Vioptix for flap monitoring was $39,361 with effectiveness of 0.82. This yielded an incremental cost-effectiveness ratio of $60,507 for clinical examination combined with Vioptix for flap monitoring. One-way sensitivity analysis revealed that clinical examination with Vioptix became cost-effective when the cost of Vioptix was less than $1487. Probabilistic sensitivity analysis found that clinical examination was cost-effective in 86.5 percent of cases. CONCLUSION: Although clinical examination combined with Vioptix is minimally more effective for flap monitoring after autologous, free flap breast reconstruction, clinical examination alone is the more cost-effective flap monitoring option.

Gain in real-world cardiac resynchronization therapy efficacy with SyncAV dynamic optimization: Heart failure hospitalizations and costs.

BACKGROUND: SyncAV, a device-based cardiac resynchronization therapy (CRT) algorithm, promotes electrical optimization by dynamically adjusting atrioventricular intervals. OBJECTIVE: The purpose of this study was to evaluate the impact of SyncAV on heart failure hospitalizations (HFHs) and related costs in a real-world CRT cohort. METHODS: Patients with SyncAV-capable CRT devices followed by remote monitoring and enrolled in Medicare fee-for-service for at least 1 year preimplant and up to 2 years postimplant were studied. Patients with SyncAV OFF were 4:1 matched to those with SyncAV ON on preimplant HFH rate, demographics, comorbidities, disease etiology, and left bundle branch block. HFHs were determined from the primary diagnosis of inpatient hospitalizations, and the cost for each event was the sum of Medicare, supplemental insurance, and patient payment. RESULTS: After 4:1 propensity score matching, 3630 patients were studied (mean age 75 ± 8 years; 1386 [38%] female), including 726 (25%) patients with SyncAV ON. The pre-CRT HFH rate was 0.338 HFH events per patient-year. Overall, CRT diminished the HFH rate to 0.204 events per patient-year (P < .001). SyncAV elicited a larger reduction in HFH rate (SyncAV ON: hazard ratio [HR] 0.52; 95% confidence interval [CI] 0.41-0.66; P < .001 and SyncAV OFF: HR 0.68; 95% CI 0.59-0.77; P < .001). After 2 years, the HFH rate was lower in the SyncAV ON group than in the SyncAV OFF group (0.143 HFHs per patient-year vs 0.193 HFHs per patient-year; HR 0.70; 95% CI 0.55-0.89; P = .003) and fewer HFHs were followed by 30-day HFH readmissions (4.41% vs 7.68%; P = .003) and 30-day all-cause hospital readmissions (7.04% vs 10.01%; P = .010). The total 2-year HFH-associated costs per patient were lower with SyncAV ON (difference $1135; 90% CI $93-$2109; P = .038). CONCLUSION: This large, real-world, propensity score-matched study demonstrates that SyncAV CRT is associated with significantly reduced HFHs and associated costs, incremental to standard CRT.

Monitoring patients with juvenile idiopathic arthritis using health-related quality of life.

BACKGROUND: Pediatric patients with juvenile idiopathic arthritis (JIA) are at risk for a lower health-related quality of life compared to their healthy peers. Remote monitoring of health-related quality of life using electronic patient-reported outcomes could provide important information to treating physicians. The aim of this study was to investigate if self-assessment with the EuroQol five-dimensional 'youth' questionnaire with five levels (EQ-5D-Y-5 L) inside a mobile E-health application could identify JIA patients in need of possible treatment adjustments. METHODS: The EQ-5D-Y-5 L was completed via a mobile application (Reuma2Go) between October 2017 and January 2019. The clinical juvenile arthritis disease activity score with 71 joint count (cJADAS-71) was reported at every corresponding visit as reference for disease activity. Previously described cJADAS-71 thresholds were used to identify patients in possible need of treatment adjustments. Discriminatory power of the EQ-5D-Y-5 L was assessed by ROC-curves and diagnostic characteristics. RESULTS: Sixty-eight JIA patients completed the EQ-5D-Y-5 L questionnaire. Median cJADAS-71 indicated low disease activity overall in the studied population. ROC curves and diagnostic characteristics demonstrated that self-assessment with the EQ-5D-Y-5 L could distinguish between patients with inactive disease (or minimal disease activity) and moderate to high disease activity with good accuracy (87%), sensitivity (85%), specificity (89%) and negative predictive value (86%). CONCLUSIONS: Results demonstrate that the EQ-5D-Y-5 L was able to identify JIA patients in need of possible treatment adjustments in our studied population. Remote monitoring of health-related quality of life and patient-reported outcomes via E-health applications could provide important additional information to determine the frequency of clinical visits, assess therapeutic efficacy and guide treat-to-target strategies in pediatric patients with JIA.

Ambulatory EEG to Classify the Epilepsy Syndrome.

SUMMARY: Recording of interictal epileptiform discharges to classify the epilepsy syndrome is one of the most common indications for ambulatory EEG. Ambulatory EEG has superior sampling compared with standard EEG recordings and advantages in terms of cost-effectiveness and convenience compared with a prolonged inpatient EEG study. Ambulatory EEG allows for EEG recording in all sleep stages and transitional states, which can be very helpful in capturing interictal epileptiform discharges. In the absence of interictal epileptiform discharges or in patients with atypical events, the characterization of an epilepsy syndrome may require recording of the habitual events. Diagnostic ambulatory EEG can be a useful alternative to inpatient video-EEG monitoring in a selected number of patients with frequent events who do not require medication taper or seizure testing for surgical localization.

Fall risk assessment in the wild: A critical examination of wearable sensor use in free-living conditions.

BACKGROUND: Despite advances in laboratory-based supervised fall risk assessment methods (FRAs), falls still remain a major public health problem. This can be due to the alteration of behavior in laboratory due to the awareness of being observed (i.e., Hawthorne effect), the multifactorial complex etiology of falls, and our limited understanding of human behaviour in natural environments, or in the' wild'. To address these imitations, a growing body of literature has focused on free-living wearable-sensor-based FRAs. The objective of this narrative literature review is to discuss papers investigating natural data collected by wearable sensors for a duration of at least 24 h to identify fall-prone older adults. METHODS: Databases (Scopus, PubMed and Google Scholar) were searched for studies based on a rigorous search strategy. RESULTS: Twenty-four journal papers were selected, in which inertial sensors were the only wearable system employed for FRA in the wild. Gait was the most-investigated activity; but sitting, standing, lying, transitions and gait events, such as turns and missteps, were also explored. A multitude of free-living fall predictors (FLFPs), e.g., the quantity of daily steps, were extracted from activity bouts and events. FLFPs were further categorized into discrete domains (e.g., pace, complexity) defined by conceptual or data-driven models. Heterogeneity was found within the reviewed studies, which includes variance in: terminology (e.g., quantity vs macro), hyperparameters to define/estimate FLFPs, models and domains, and data processing approaches (e.g., the cut-off thresholds to define an ambulatory bout). These inconsistencies led to different results for similar FLFPs, limiting the ability to interpret and compare the evidence. CONCLUSION: Free-living FRA is a promising avenue for fall prevention. Achieving a harmonized model is necessary to systematically address the inconsistencies in the field and identify FLFPs with the highest predictive values for falls to eventually address intervention programs and fall prevention.

Remote-only monitoring for patients with cardiac implantable electronic devices: a before-and-after pilot study.

BACKGROUND: Outcomes for patients with cardiac implantable electronic devices are better when follow-up incorporates remote monitoring technology in addition to in-clinic visits. For patients with implantable devices, we sought to determine the feasibility, safety and associated health care utilization of remote-only follow-up, along with its effects on patients' quality of life and costs. METHODS: This multicentre before-and-after pilot study involved patients with new or existing pacemakers or implantable cardioverter defibrillators. The "before" phase of the study spanned the period October 2015 to February 2017; the "after" phase spanned the period October 2016 to February 2018. The exposure was remote-only follow-up in combination with Remote View, a service that facilitates access to device data, allowing device settings to be viewed remotely to facilitate remote programming. Outcomes at 12 months were feasibility (adherence to remote monitoring), safety (rate of adverse events) and health care utilization (remote and in-clinic appointments). We also assessed quality of life, using 3 validated scales, and costs, taking into account both health care system and patient costs. RESULTS: A total of 176 patients were enrolled. Adherence (defined as at least 1 successful remote transmission during follow-up) was 87% over a mean follow-up of 11.7 (standard deviation 2.2) months. There was a reduction in in-clinic visits at specialized sites among patients with both implantable defibrillators (26 v. 5, p < 0.001, n = 48) and pacemakers (42 v. 10, p < 0.001, n = 51). There was no significant change in visits to community sites for patients with defibrillators (13 v. 17, p = 0.3, n = 48). The composite rate of death, stroke, cardiovascular hospitalization and device-related hospitalization was 7% (n = 164). No adverse events were linked to the intervention. There was no change in quality-of-life scales between baseline and 12 months. Health care costs were reduced by 31% for patients with defibrillators and by 44% for those with pacemakers. INTERPRETATION: This pilot study showed the feasibility of remote-only follow-up, with no increase in adverse clinical outcomes and no effect on quality of life, but with reductions in costs and health care utilization. These results support progression to a larger-scale study of whether superior effectiveness and reduced cost can be achieved, with preservation of safety, through use of remote-only follow-up. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT02585817.

Screening accuracy of a 14-day smartphone ambulatory assessment of depression symptoms and mood dynamics in a general population sample: Comparison with the PHQ-9 depression screening.

INTRODUCTION: Major depression affects over 300 million people worldwide, but cases are often detected late or remain undetected. This increases the risk of symptom deterioration and chronification. Consequently, there is a high demand for low threshold but clinically sound approaches to depression detection. Recent studies show a great willingness among users of mobile health apps to assess daily depression symptoms. In this pilot study, we present a provisional validation of the depression screening app Moodpath. The app offers a 14-day ambulatory assessment (AA) of depression symptoms based on the ICD-10 criteria as well as ecologically momentary mood ratings that allow the study of short-term mood dynamics. MATERIALS AND METHODS: N = 113 Moodpath users were selected through consecutive sampling and filled out the Patient Health Questionnaire (PHQ-9) after completing 14 days of AA with 3 question blocks (morning, midday, and evening) per day. The psychometric properties (sensitivity, specificity, accuracy) of the ambulatory Moodpath screening were assessed based on the retrospective PHQ-9 screening result. In addition, several indicators of mood dynamics (e.g. average, inertia, instability), were calculated and investigated for their individual and incremental predictive value using regression models. RESULTS: We found a strong linear relationship between the PHQ-9 score and the AA Moodpath depression score (r = .76, p < .001). The app-based screening demonstrated a high sensitivity (.879) and acceptable specificity (.745). Different indicators of mood dynamics covered substantial amounts of PHQ-9 variance, depending on the number of days with mood data that were included in the analyses. DISCUSSION: AA and PHQ-9 shared a large proportion of variance but may not measure exactly the same construct. This may be due to the differences in the underlying diagnostic systems or due to differences in momentary and retrospective assessments. Further validation through structured clinical interviews is indicated. The results suggest that ambulatory assessed mood indicators are a promising addition to multimodal depression screening tools. Improving app-based AA screenings requires adapted screening algorithms and corresponding methods for the analysis of dynamic processes over time.

AMTRA: a multicentered experience of a web-based monitoring and tailored toxicity management system for cancer patients.

BACKGROUND: Technology-based interventions are increasingly being introduced in routine clinical cancer care. There is a need for reliable systems to monitor treatment-related toxicity in a standardized manner. Such electronic tools bridge the gap in providing quality home-based monitoring. METHODS: From July 2017 to December 2017, we performed a multicentered, non-randomized prospective cohort analysis with patients who were receiving routine chemotherapy for various solid tumors, using a web-based patient-reported toxicity registration, management, and intervention system called AMTRA (ambulatory Monitoring of cancer Therapy using an interactive Application) linked to the homecare nursing organization Remedus®. Twelve common toxicities plus pain and two biometrics could be registered daily or more frequently as required. These were processed centrally to generate tailored advice for lesser symptoms or a phone call from a dedicated nurse in case of severe or prolonged toxicity. A compliance tool to monitor oral therapies was incorporated in the system. RESULTS: One hundred sixty-eight patients (92%) were enrolled, with 31,514 registrations analyzed. One hundred eight patients reported severe toxicity (> 1461 registrations), resulting in 102 clinical interventions ranging from self-management advice, supplemental consultations to hospitalizations. Compliance to oral chemotherapy was high using AMTRA with a median of 98.7% (95 confidence interval (CI) [93.5-100.0%]). Seventy-nine percent of patients stated that the availability of AMTRA self-reports was useful in communication with the care provider, while 75% felt more in control while managing their treatment. CONCLUSIONS: The application of an interactive PRO-system in routine symptom management of cancer patients allowed standardized documentation of toxicities and recorded a high compliance with oral treatment. It allows for rapid interaction for toxicities and cancer-related symptoms experienced at home.

Glaucoma Home Monitoring Using a Tablet-Based Visual Field Test (Eyecatcher): An Assessment of Accuracy and Adherence Over 6 Months.

PURPOSE: To assess accuracy and adherence of visual field (VF) home monitoring in a pilot sample of patients with glaucoma. DESIGN: Prospective longitudinal feasibility and reliability study. METHODS: Twenty adults (median 71 years) with an established diagnosis of glaucoma were issued a tablet perimeter (Eyecatcher) and were asked to perform 1 VF home assessment per eye, per month, for 6 months (12 tests total). Before and after home monitoring, 2 VF assessments were performed in clinic using standard automated perimetry (4 tests total, per eye). RESULTS: All 20 participants could perform monthly home monitoring, though 1 participant stopped after 4 months (adherence: 98% of tests). There was good concordance between VFs measured at home and in the clinic (r = 0.94, P < .001). In 21 of 236 tests (9%), mean deviation deviated by more than ±3 dB from the median. Many of these anomalous tests could be identified by applying machine learning techniques to recordings from the tablets' front-facing camera (area under the receiver operating characteristic curve = 0.78). Adding home-monitoring data to 2 standard automated perimetry tests made 6 months apart reduced measurement error (between-test measurement variability) in 97% of eyes, with mean absolute error more than halving in 90% of eyes. Median test duration was 4.5 minutes (quartiles: 3.9-5.2 minutes). Substantial variations in ambient illumination had no observable effect on VF measurements (r = 0.07, P = .320). CONCLUSIONS: Home monitoring of VFs is viable for some patients and may provide clinically useful data.

Home Dialysis in the Coronavirus Disease 2019 Era.

The coronavirus disease 2019 pandemic has had a significant impact on patients with end-stage kidney disease and their care, especially given the potential for severe coronavirus disease 2019 in those with a depressed immune status. Patients receiving in-center hemodialysis have been particularly affected by this pandemic because of their need to travel multiple times a week to receive treatment. Although patients on home dialysis are able to avoid such exposure, they face their own unique challenges. In this review, we will discuss the challenges posed by the coronavirus disease 2019 pandemic for patients on home dialysis, the impact of coronavirus disease 2019 on various aspects of their care, and the resultant rapid adaptations in policy/health-care delivery mechanisms with implications for the future care of patients on home dialysis.

Adapting a home telemonitoring intervention for underserved Hispanic/Latino patients with type 2 diabetes: an acceptability and feasibility study.

BACKGROUND: Home telemonitoring is a promising approach to optimizing outcomes for patients with Type 2 Diabetes; however, this care strategy has not been adapted for use with understudied and underserved Hispanic/Latinos (H/L) patients with Type 2 Diabetes. METHODS: A formative, Community-Based Participatory Research approach was used to adapt a home telemonitoring intervention to facilitate acceptability and feasibility for vulnerable H/L patients. Utilizing the ADAPT-ITT framework, key stakeholders were engaged over an 8-month iterative process using a combination of strategies, including focus groups and structured interviews. Nine Community Advisory Board, Patient Advisory, and Provider Panel Committee focus group discussions were conducted, in English and Spanish, to garner stakeholder input before intervention implementation. Focus groups and structured interviews were also conducted with 12 patients enrolled in a 1-month pilot study, to obtain feedback from patients in the home to further adapt the intervention. Focus groups and structured interviews were approximately 2 hours and 30 min, respectively. All focus groups and structured interviews were audio-recorded and professionally transcribed. Structural coding was used to mark responses to topical questions in the moderator and interview guides. RESULTS: Two major themes emerged from qualitative analyses of Community Advisory Board/subcommittee focus group data. The first major theme involved intervention components to maximize acceptance/usability. Subthemes included tablet screens (e.g., privacy/identity concerns; enlarging font sizes; lighter tablet to facilitate portability); cultural incongruence (e.g., language translation/literacy, foods, actors "who look like me"); nursing staff (e.g., ensuring accessibility; appointment flexibility); and, educational videos (e.g., the importance of information repetition). A second major theme involved suggested changes to the randomized control trial study structure to maximize participation, including a major restructuring of the consenting process and changes designed to optimize recruitment strategies. Themes from pilot participant focus group/structured interviews were similar to those of the Community Advisory Board such as the need to address and simplify a burdensome consenting process, the importance of assuring privacy, and an accessible, culturally congruent nurse. CONCLUSIONS: These findings identify important adaptation recommendations from the stakeholder and potential user perspective that should be considered when implementing home telemonitoring for underserved patients with Type 2 Diabetes. TRIAL REGISTRATION: NCT03960424; ClinicalTrials.gov (US National Institutes of Health). Registered 23 May 2019. Registered prior to data collection. https://www.clinicaltrials.gov/ct2/show/NCT03960424?term=NCT03960424&draw=2&rank=1.

Research protocol for the validation of a new portable technology for real-time continuous monitoring of Early Warning Score (EWS) in hospital practice and for an early-stage multistakeholder assessment.

INTRODUCTION: The real-time continuous monitoring of vital parameters in patients affected by multiple chronic conditions and/or COVID-19 can lead to several benefits to the Italian National Healthcare System (IT-NHS). The UBiquitous Integrated CARE (UBICARE) technology is a novel health digital platform at the validation stage in hospital setting. UBICARE might support the urgent need for digitalisation and early intervention, as well as minimise the face-to-face delivery of care in both hospital and community-based care settings. This research protocol aims to design an early-stage assessment of the multidimensional impact induced by UBICARE within the IT-NHS alongside technology validation in a hospital ward. METHODS AND ANALYSIS: The targeted patients will be medium/high-risk hypertensive individuals as an illustrative first example of how UBICARE might bring benefits to susceptible patients. A mixed-method study will be applied to incorporate to the validation study a multistakeholder perspective, including perceived patient experiences and preferences, and facilitate technology adoption. First, semistructured interviews will be undertaken with a variety of stakeholders including clinicians, health managers and policy-makers to capture views on the likely technology utility, economic sustainability, impact of adoption in hospital practice and alternative adoption scenarios. Second, a monocentric, non-randomised and non-comparative clinical study, supplemented by the administration of standardised usability questionnaires to patients and health professionals, will validate the use of UBICARE in hospital practice. Finally, the results of the previous stages will be discussed in a multidisciplinary-facilitated workshop with IT-NHS relevant stakeholders to reconcile stakeholders' perspectives. Limitations include a non-random recruitment strategy in the clinical study, small sample size of the key stakeholders and potential stakeholder recruitment bias introduced by the research technique. ETHICS AND DISSEMINATION: The Ethics Committee for Clinical Experimentation of Tuscany Region approved the protocol. Participation in this study is voluntary. Study results will be disseminated through peer-reviewed publications and academic conferences.

Design of the Pregnancy REmote MOnitoring II study (PREMOM II): a multicenter, randomized controlled trial of remote monitoring for gestational hypertensive disorders.

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 .

A Smart Service Platform for Cost Efficient Cardiac Health Monitoring.

AIM: In this study we have investigated the problem of cost effective wireless heart health monitoring from a service design perspective. SUBJECT AND METHODS: There is a great medical and economic need to support the diagnosis of a wide range of debilitating and indeed fatal non-communicable diseases, like Cardiovascular Disease (CVD), Atrial Fibrillation (AF), diabetes, and sleep disorders. To address this need, we put forward the idea that the combination of Heart Rate (HR) measurements, Internet of Things (IoT), and advanced Artificial Intelligence (AI), forms a Heart Health Monitoring Service Platform (HHMSP). This service platform can be used for multi-disease monitoring, where a distinct service meets the needs of patients having a specific disease. The service functionality is realized by combining common and distinct modules. This forms the technological basis which facilitates a hybrid diagnosis process where machines and practitioners work cooperatively to improve outcomes for patients. RESULTS: Human checks and balances on independent machine decisions maintain safety and reliability of the diagnosis. Cost efficiency comes from efficient signal processing and replacing manual analysis with AI based machine classification. To show the practicality of the proposed service platform, we have implemented an AF monitoring service. CONCLUSION: Having common modules allows us to harvest the economies of scale. That is an advantage, because the fixed cost for the infrastructure is shared among a large group of customers. Distinct modules define which AI models are used and how the communication with practitioners, caregivers and patients is handled. That makes the proposed HHMSP agile enough to address safety, reliability and functionality needs from healthcare providers.

WEARCON: wearable home monitoring in children with asthma reveals a strong association with hospital based assessment of asthma control.

BACKGROUND: Asthma is one of the most common chronic diseases in childhood. Regular follow-up of physiological parameters in the home setting, in relation to asthma symptoms, can provide complementary quantitative insights into the dynamics of the asthma status. Despite considerable interest in asthma home-monitoring in children, there is a paucity of scientific evidence, especially on multi-parameter monitoring approaches. Therefore, the aim of this study is to investigate whether asthma control can be accurately assessed in the home situation by combining parameters from respiratory physiology sensors. METHODS: Sixty asthmatic and thirty non-asthmatic children were enrolled in the observational WEARCON-study. Asthma control was assessed according to GINA guidelines by the paediatrician. All children were also evaluated during a 2-week home-monitoring period with wearable devices; a physical activity tracker, a handheld spirometer, smart inhalers, and an ambulatory electrocardiography device to monitor heart and respiratory rate. Multiple logistic regression analysis was used to determine which diagnostic measures were associated with asthma control. RESULTS: 24 of the 27 uncontrolled asthmatic children and 29 of the 32 controlled asthmatic children could be accurately identified with this model. The final model showed that a larger variation in pre-exercise lung function (OR = 1.34 95%-CI 1.07-1.68), an earlier wake-up-time (OR = 1.05 95%-CI 1.01-1.10), more reliever use (OR = 1.11 95%-CI 1.03-1.19) and a longer respiratory rate recovery time (OR = 1.12 95%-CI 1.05-1.20) were significant contributors to the probability of having uncontrolled asthma. CONCLUSIONS: Home-monitoring of physiological parameters correlates with paediatrician assessed asthma control. The constructed multivariate model identifies 88.9% of all uncontrolled asthmatic children, indicating a high potential for monitoring of asthma control. This may allow healthcare professionals to assess asthma control at home. TRIAL REGISTRATION: Netherlands Trail Register, NL6087 . Registered 14 February 2017.