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.

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.

Reducing cost and time to diagnosis and treatment of obstructive sleep apnea using ambulatory sleep study: a Singapore sleep centre experience.

PURPOSE: The current gold standard for diagnosis of obstructive sleep apnea (OSA) is overnight in laboratory polysomnography (PSG). However, PSGs are expensive, labor-intensive, and have long wait times. An ambulatory sleep study device, the WatchPAT, has been shown to have high correlation for sleep indices measured compared with PSG (AASM, 2016). Use of the WatchPAT could potentially lead to shorter waiting times and earlier diagnosis of OSA (Lancet Resp Med 3:310-8, 2015). Our study aimed to investigate if WatchPAT reduces time to diagnosis and treatment of OSA in a tertiary healthcare setting. A secondary aim was to investigate the cost-benefit of an ambulatory sleep study. METHODS: All patients who underwent diagnostic sleep studies in a single tertiary institution from 2014 to 2017 were retrospectively reviewed. Baseline characteristics and time from ordering of sleep study to prescription of continuous positive airway pressure were recorded. Data were categorized into two groups by type of diagnostic sleep study, PSG, and WatchPAT. The time to treatment and cost for diagnosis of OSA were compared between groups with the Paired T test/Wilcoxon signed-rank test. RESULTS: Of 1898 patients who had diagnostic sleep studies over a 4-year period, 1660 patients (88%) underwent PSG and 238 patients (12%) underwent WatchPAT. Patients in the WatchPAT group had a shorter time to diagnosis (21 days versus 79.8 days, p < 0.001) and treatment (46.3 days versus 118.4 days, p < 0.001) compared to the PSG group. Cost-benefit calculation showed that this earlier treatment led to cost-saving of US $1179.50 per patient. CONCLUSION: An ambulatory sleep study is an option for earlier access to diagnosis and treatment of OSA with the potential of considerable cost savings.

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.

Evaluating the Impact of Freespira on Panic Disorder Patients' Health Outcomes and Healthcare Costs within the Allegheny Health Network.

Panic disorder (PD) is a debilitating condition that drives medical spending at least twice as high as medically matched controls. Excessive utilization of healthcare resources comes from emergency department (ED), medications, diagnostic testing, and physician visits. Freespira is an FDA-cleared digital therapeutic that treats PD and panic attacks (PA) by correcting underlying abnormal respiratory physiology. Efficacy of Freespira has been established in prior studies. This paper reports on a quality improvement program that investigated whether treating PD patients with Freespira would reduce medical costs and improve outcomes over 12-months. Panic symptoms were assessed using the Panic Disorder Severity Scale (PDSS). Pre-and post-treatment insurance claims determined costs. At baseline, mean Clinician Global Impression (CGI-S) was 4.4 (moderately/markedly ill), mean PDSS was 14.4 and mean PA frequency/week was 2 (range 0-5). Immediately post-treatment (week 5) mean CGI-S, PDSS and weekly PA frequency declined to 2.8 (borderline/mildly ill, 4.9 (remission) and 0.2 (range 0-2) respectively, p < 0.001. 82% reported PDSS decrease of ≥ 40% (clinically significant), 86% were PA-free. One-year post treatment mean CGI-S, PDSS and PA remained low at 2.1, 4.4, and 0.3 (range 0-1) respectively. 91% had PDSS decrease of ≥ 40%, 73% were PA-free. The majority of patients were panic attack free and/or reduced their symptoms and avoidance behaviors 1-year post Freespira treatment. Mean overall medical costs were reduced by 35% from $548 to $358 PMPM (per member per month) or an annual reduction of $2280. at 12 months post-treatment. There was a 65% reduction in ED costs from $87 to $30 PMPM. Median pharmacy costs were reduced by 68% from $73 to $23 PMPM.

DYSKIMOT: An Ultra-Low-Cost Inertial Sensor to Assess Head's Rotational Kinematics in Adults during the Didren-Laser Test.

Various noninvasive measurement devices can be used to assess cervical motion. The size, complexity, and cost of gold-standard systems make them not suited to clinical practice, and actually difficult to use outside a dedicated laboratory. Nowadays, ultra-low-cost inertial measurement units are available, but without any packaging or a user-friendly interface. The so-called DYSKIMOT is a home-designed, small-sized, motion sensor based on the latter technology, aiming at being used by clinicians in "real-life situations". DYSKIMOT was compared with a gold-standard optoelectronic system (Elite). Our goal was to evaluate the DYSKIMOT accuracy in assessing fast head rotations kinematics. Kinematics was simultaneously recorded by systems during the execution of the DidRen Laser test and performed by 15 participants and nine patients. Kinematic variables were computed from the position, speed and acceleration time series. Two-way ANOVA, Passing-Bablok regressions, and dynamic time warping analysis showed good to excellent agreement between Elite and DYSKIMOT, both at the qualitative level of the time series shape and at the quantitative level of peculiar kinematical events' measured values. In conclusion, DYSKIMOT sensor is as relevant as a gold-standard system to assess kinematical features during fast head rotations in participants and patients, demonstrating its usefulness in both clinical practice and research environments.

Is telehealthcare for heart failure patients cost-effective? An economic evaluation alongside the Danish TeleCare North heart failure trial.

OBJECTIVE: This study aimed to assess the cost-effectiveness of telehealthcare in heart failure patients as add-on to usual care. DESIGN: A cost-utility analysis was conducted from a public payer perspective alongside the randomised controlled TeleCare North trial. SETTING: The North Denmark Region, Denmark. PARTICIPANTS: The study included 274 heart failure patients with self-reported New York Heart Association class II-IV. INTERVENTIONS: Patients in the intervention group were provided with a Telekit consisting of a tablet, a digital blood pressure monitor, and a scale and were instructed to perform measurements one to two times a week. The responsibility of the education, instructions and monitoring of the heart failure (HF) patients was placed on municipality nurses trained in HF and telemonitoring. Both groups received usual care. OUTCOME MEASURES: Cost-effectiveness was reported as incremental net monetary benefit (NMB). A micro-costing approach was applied to evaluate the derived savings in the first year in the public health sector. Quality-adjusted life-years (QALY) gained were estimated using the EuroQol 5-Dimensions 5-Levels questionnaire at baseline and at a 1-year follow-up. RESULTS: Data for 274 patients were included in the main analysis. The telehealthcare solution provided a positive incremental NMB of £5164. The 1-year adjusted QALY difference between the telehealthcare solution and the usual care group was 0.0034 (95% CI: -0.0711 to 0.0780). The adjusted difference in costs was -£5096 (95% CI: -8736 to -1456) corresponding to a reduction in total healthcare costs by 35%. All sensitivity analyses showed the main results were robust. CONCLUSIONS: The TeleCare North solution for monitoring HF was highly cost-effective. There were significant cost savings on hospitalisations, primary care contacts and total costs. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT02860013.

A nurse-led implantable loop recorder service is safe and cost effective.

INTRODUCTION: Implantable loop recorders (ILR) are predominantly implanted by cardiologists in the catheter laboratory. We developed a nurse-delivered service for the implantation of LINQ (Medtronic; Minnesota) ILRs in the outpatient setting. This study compared the safety and cost-effectiveness of the introduction of this nurse-delivered ILR service with contemporaneous physician-led procedures. METHODS: Consecutive patients undergoing an ILR at our institution between 1st July 2016 and 4th June 2018 were included. Data were prospectively entered into a computerized database, which was retrospectively analyzed. RESULTS: A total of 475 patients underwent ILR implantation, 271 (57%) of these were implanted by physicians in the catheter laboratory and 204 (43%) by nurses in the outpatient setting. Six complications occurred in physician-implants and two in nurse-implants (P = .3). Procedural time for physician-implants (13.4 ± 8.0 minutes) and nurse-implants (14.2 ± 10.1 minutes) were comparable (P = .98). The procedural cost was estimated as £576.02 for physician-implants against £279.95 with nurse-implants, equating to a 57.3% cost reduction. In our center, the total cost of ILR implantation in the catheter laboratory by physicians was £10 513.13 p.a. vs £6661.55 p.a. with a nurse-delivered model. When overheads for running, cleaning, and maintaining were accounted for, we estimated a saving of £68 685.75 was performed by moving to a nurse-delivered model for ILR implants. Over 133 catheter laboratory and implanting physician hours were saved and utilized for other more complex procedures. CONCLUSION: ILR implantation in the outpatient setting by suitably trained nurses is safe and leads to significant financial savings.

Cost-Effectiveness of Pain Management Strategies in Advanced Cancer.

OBJECTIVES: Uncontrolled pain in advanced cancer is a common problem and has significant impact on individuals' quality of life and use of healthcare resources. Interventions to help manage pain at the end of life are available, but there is limited economic evidence to support their wider implementation. We conducted a case study economic evaluation of two pain self-management interventions (PainCheck and Tackling Cancer Pain Toolkit [TCPT]) compared with usual care. METHODS: We generated a decision-analytic model to facilitate the evaluation. This modelled the survival of individuals at the end of life as they moved through pain severity categories. Intervention effectiveness was based on published meta-analyses results. The evaluation was conducted from the perspective of the U.K. health service provider and reported cost per quality-adjusted life-year (QALY). RESULTS: PainCheck and TCPT were cheaper (respective incremental costs -GBP148 [-EUR168.53] and -GBP474 [-EUR539.74]) and more effective (respective incremental QALYs of 0.010 and 0.013) than usual care. There was a 65 percent and 99.5 percent chance of cost-effectiveness for PainCheck and TCPT, respectively. Results were relatively robust to sensitivity analyses. The most important driver of cost-effectiveness was level of pain reduction (intervention effectiveness). Although cost savings were modest per patient, these were considerable when accounting for the number of potential intervention beneficiaries. CONCLUSIONS: Educational and monitoring/feedback interventions have the potential to be cost-effective. Economic evaluations based on estimates of effectiveness from published meta-analyses and using a decision modeling approach can support commissioning decisions and implementation of pain management strategies.

Reviewing Mobile Apps to Control Heart Rate in Literature and Virtual Stores.

BACKGROUND: Information and communications technologies are transforming our social interactions and life-styles. One of the most promising applications of information technology is healthcare and wellness management that characterized by early detection of conditions, prevention, and long-term healthcare management. OBJECTIVE: The main purpose of this document is to do a study, first about the actual literature about mobile phone applications to measure and control heart-rate and second a study about these applications themselves, analyzing the different app stores more popular nowadays, Google Play Store and iTunes (for Android and iOS devices respectively). METHODS: The Web portals and databases that were used to perform the searches are IEEE Xplore, National Center for Biotechnology Information, Springer, ResearchGate, Science Direct and Scopus, taking into account the date of publication from 2010 to 2018, publications in English and Spanish. RESULTS: 40 relevant papers have been found related to mobile phone apps to measure and control heart rate. The results show that of a total of 400 applications found 61.25% of them are in the Play Store (Android systems) and the remaining 38.75% were found in the iTunes Store (iOS systems). CONCLUSIONS: From the review of the research articles analyzed, it can be said that the most applications found are for Android devices. They occupy 76.53% of the world mobile phone market, while iOS only owns 18.97%.

Home Telemonitoring of Community-Dwelling Heart Failure Patients After Home Care Discharge.

Background: Home telemonitoring (HTM) is a promising approach to improve quality of life (QoL) and decrease hospital utilization. Methods: This randomized-controlled study followed 89 community-dwelling Medicare outpatients with heart failure (HF) after discharge from home care for 6 months. Patients were randomized to HTM or comprehensive outpatient management (COM). HTM received weekly (video) televisits with daily vital sign monitoring. COM was contacted weekly by telephone. Outcomes included emergency department (ED) and inpatient utilization and QoL. Results : Average age at enrollment was 81.4 for HTM and 84.9 for COM. Thirty-eight percent of HTM had ≥1 ED visit versus 60% of COM (p = 0.04), while 48% of HTM had ≥1 hospitalization versus 55% of COM (p = 0.47). Length of stay (LOS) (days) was 4.0 for HTM versus 7.4 for COM (p = 0.39). Costs were $38,990 for HTM versus $50,943 for COM (p = 0.91). QoL improved by -9.66 for HTM and -3.56 for COM (p = 0.02). Although HF-related utilization did not differ between groups, HTM patients who were highly adherent obtained better all-cause outcomes than those with low adherence. Conclusions: Significantly improved all-cause ED utilization, LOS, and QoL were found for HTM; other differences were not significant. More research is needed to determine how to best utilize this technology to improve patient outcomes.

Remote consulting with telemonitoring of continuous positive airway pressure usage data for the routine review of people with obstructive sleep apnoea hypopnoea syndrome: A systematic review.

INTRODUCTION: Telehealth has the potential to offer more convenient care and reduce travel. We aimed to systematically review studies that assessed the effectiveness of teleconsultation plus telemonitoring in the review of people with obstructive sleep apnoea hypopnoea syndrome receiving continuous positive airway pressure therapy versus face-to-face care. METHODS: Following Cochrane methodology, we searched 10 electronic databases (November 2015), trial registries, and reference lists of included studies, for trials testing interventions that combined remote consultations with telemonitoring of usage/continuous positive airway pressure data. Outcomes measures were: proportion reviewed, continuous positive airway pressure adherence, symptom control, and satisfaction/acceptability and cost effectiveness. RESULTS: From 362 potentially relevant papers, we identified five randomised controlled trials ( n = 269 patients): four from North America and one from Spain. Risk of bias was moderate in one, and moderate/high in four trials. Two trials reported number/duration of reviews with inconsistent results. The teleconsultation/telemonitoring improved continuous positive airway pressure adherence in two trials ( n = 19; n = 75); two ( n = 114 and n = 75) reported no between-groups differences. Two studies, both at moderate/high risk of bias, showed no between-group difference in the Epworth Sleepiness Score. Satisfaction was generally reported positively in all five trials; one trial reported that the teleconsultation/telemonitoring patients were 'more likely to continue' with continuous positive airway pressure therapy treatment. One study reported teleconsultation/telemonitoring as cost effective. DISCUSSION: The evidence for teleconsultation/telemonitoring in continuous positive airway pressure users is limited; however, no safety concerns have been raised. Adequately powered, well-designed trials are needed to establish whether real-time telemonitoring and remote teleconsultation is a clinically and cost effective option for people using continuous positive airway pressure therapy.

Impact of remote biometric monitoring on cost and hospitalization outcomes in peritoneal dialysis.

INTRODUCTION: Peritoneal dialysis is a home-based therapy for individuals with end-stage renal disease. Telehealth, and in particular - remote monitoring, is making inroads in managing this cohort. METHODS: We examined whether daily remote biometric monitoring (RBM) of blood pressure and weight among peritoneal dialysis patients was associated with changes in hospitalization rate and hospital length of stay, as well as outpatient, inpatient and overall cost of care. RESULTS: Outpatient visit claim payment amounts (in US dollars derived from CMS data) decreased post-intervention relative to pre-intervention for those at age 18-54 years. For certain subgroups, non- or nearly-significant changes were found among female and Black participants. There was no change in inpatient costs post-intervention relative to pre-intervention for females and while the overall visit claim payment amounts increased in the outpatient setting slightly (US$511.41 (1990.30) vs. US$652.61 (2319.02), p = 0.0783) and decreased in the inpatient setting (US$10,835.30 (6488.66) vs. US$10,678.88 (15,308.17), p = 0.4588), these differences were not statistically significant. Overall cost was lower if RBM was used for assessment of blood pressure and/or weight (US$-734.51, p < 0.05). Use of RBM collected weight was associated with fewer hospitalizations (adjusted odds ratio 0.54, 95% confidence interval 0.33-0.89) and fewer days hospitalized (adjusted odds ratio 0.46, 95% confidence interval 0.26-0.81). Use of RBM collected blood pressure was associated with increased days of hospitalization and increased odds of hospitalization. CONCLUSIONS: RBM offers a powerful opportunity to provide care to those receiving home therapies such as peritoneal dialysis. RBM may be associated with reduction in both inpatient and outpatient costs for specific sub-groups receiving peritoneal dialysis.

Remote Monitoring of Implantable Cardioverter-Defibrillators, Cardiac Resynchronization Therapy and Permanent Pacemakers: A Health Technology Assessment.

BACKGROUND: Under usual care, people with an implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy with or without a defibrillator (CRT-D and CRT-P, respectively), or a permanent pacemaker have follow-up in-person clinic visits. Remote monitoring of these devices allows the transfer of the information stored in the device so that it can be accessed by the clinic personnel via a secured website. METHODS: We completed a health technology assessment, which included an evaluation of clinical benefits and harms, value for money, and patient preferences for remote monitoring of ICDs, CRTs, and permanent pacemakers plus clinic visits compared with clinic visits alone. This is an update of a 2012 health technology assessment. In addition to the eligible randomized controlled trials (RCTs) from the 2012 publication, we included RCTs identified through a systematic literature search on June 1, 2017. We assessed the risk of bias of each study using the Cochrane risk of bias tool and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We conducted an economic evaluation to determine the cost-effectiveness of remote monitoring blended with in-clinic follow-up compared to in-clinic follow-up alone in patients with an ICD, a CRT-D, or a pacemaker. We determined the budget impact of blended remote monitoring in patients implanted with ICD, CRT-D, CRT-P, or pacemaker devices from the perspective of the Ontario Ministry of Health and Long-Term Care. To understand patient experiences with remote monitoring, we interviewed 16 patients and family members. RESULTS: Based on 15 RCTs in patients with implanted ICDs or CRT-Ds, remote monitoring plus clinic visits resulted in fewer patients with inappropriate ICD shocks within 12 to 37 months of follow-up (moderate quality evidence; absolute risk difference -0.04 [95% confidence interval -0.07 to -0.01]), fewer total clinic visits (moderate quality evidence), and a shorter time to detection and treatment of events (moderate quality evidence) compared with clinic visits alone. There was a similar risk of major adverse events (moderate quality evidence).Based on 6 RCTs in patients with pacemakers, remote monitoring plus clinic visits reduced the arrhythmia burden (high quality evidence), the time to detection and treatment of arrhythmias (high quality evidence), and the number of clinic visits (moderate quality evidence]) compared with clinic visits alone. Here again, there was a similar risk of major adverse events (high quality evidence).Results from the economic evaluation showed that among ICD and CRT-D recipients, blended remote monitoring (remote monitoring plus in-clinic follow ups) was more costly (incremental value of $4,354 per person) and more effective, providing higher quality-adjusted life years (incremental value of 0.19), compared to in-clinic follow-up alone. Among pacemaker recipients, blended remote monitoring was less costly (with an incremental saving of $2,370 per person) and more effective (with an incremental value of 0.12 quality-adjusted life years) than with in-clinic follow-up alone. We estimated that publicly funding remote monitoring could result in cost savings of $14 million over the first five years.Participants using remote monitoring reported that these devices provide important medical and safety benefits in managing their heart condition. Remote cardiac monitoring provides patients and their family members with an increased freedom. Their belief that the device will help with earlier detection of technical or clinical problems reduces the amount of stress and distraction their condition causes in their lives. CONCLUSIONS: Remote monitoring of ICDs, CRT-Ds, and pacemakers plus clinic visits resulted in improved outcomes without increasing the risk of major adverse events compared with clinic visits alone. Remote monitoring is a cost-effective option for patients implanted with cardiac electronic devices. Patients reported positive experiences using remote monitoring, and perceived that the device provided important medical and safety benefits.

Cost-effectiveness of Continuous Glucose Monitoring for Adults With Type 1 Diabetes Compared With Self-Monitoring of Blood Glucose: The DIAMOND Randomized Trial.

OBJECTIVE: This study evaluated the societal cost-effectiveness of continuous glucose monitoring (CGM) in patients with type 1 diabetes (T1D) using multiple insulin injections. RESEARCH DESIGN AND METHODS: In the Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes (DIAMOND) trial, 158 patients with T1D and HbA1c ≥7.5% were randomized in a 2:1 ratio to CGM or control. Participants were surveyed at baseline and 6 months. Within-trial and lifetime cost-effectiveness analyses were conducted. A modified Sheffield T1D policy model was used to simulate T1D complications. The main outcome was cost per quality-adjusted life-year (QALY) gained. RESULTS: Within the 6-month trial, the CGM group had similar QALYs to the control group (0.462 ± 0.05 vs. 0.455 ± 0.06 years, P = 0.61). The total 6-month costs were $11,032 (CGM) vs. $7,236 (control). The CGM group experienced reductions in HbA1c (0.60 ± 0.74% difference in difference [DiD]), P < 0.01), the daily rate of nonsevere hypoglycemia events (0.07 DiD, P = 0.013), and daily test strip use (0.55 ± 1.5 DiD, P = 0.04) compared with the control group. In the lifetime analysis, CGM was projected to reduce the risk of T1D complications and increase QALYs by 0.54. The incremental cost-effectiveness ratio (ICER) was $98,108 per QALY for the overall population. By extending sensor use from 7 to 10 days in a real-world scenario, the ICER was reduced to $33,459 per QALY. CONCLUSIONS: For adults with T1D using multiple insulin injections and still experiencing suboptimal glycemic control, CGM is cost-effective at the willingness-to-pay threshold of $100,000 per QALY, with improved glucose control and reductions in nonsevere hypoglycemia.

Telemonitoring-based feedback improves adherence to non-vitamin K antagonist oral anticoagulants intake in patients with atrial fibrillation.

Aims: To evaluate the effect of telemonitoring on adherence to non-vitamin K antagonist oral anticoagulants (NOACs) in atrial fibrillation (AF) patients. Methods and results: A randomized, single-blind, crossover, controlled trial in 48 AF patients on once or twice daily (OD or BID) NOAC. The Medication Event Monitoring System tracked NOAC intake during three phases of 3 months each: daily telemonitoring, telemonitoring with immediate telephone feedback in case of intake errors, and an observation phase without daily transmissions. Unprotected days were defined as ≥ 3 or ≥ 1 consecutively missed doses for a BID or OD NOAC, respectively, or excess dose intake. Cost-effectiveness was calculated based on anticipated stroke reduction derived from patients' risk profile and measured intake. Persistence over the entire study was 98%. Telemonitoring-only already led to very high taking and regimen adherence (97.4% respectively 93.8%). Nevertheless, direct feedback further improved both to 99.0% and 96.8%, respectively (P < 0.001 respectively P = 0.002). Observation without daily monitoring resulted in a significant waning of taking adherence (94.3%; P = 0.049). Taking adherence was significantly higher for OD compared to BID NOAC, although unprotected days were similar. Feedback intervention had an incremental cost of €344 289 to prevent one stroke, but this could be as low as €15 488 in high-risk patients with low adherence and optimized technology. Conclusion: Telemonitoring resulted in high NOAC adherence due to the notion of being watched, as evidenced by the rapid decline during the observation period. Feedback further optimized adherence. Telemonitoring with or without feedback may be a cost-effective approach in high-risk patients deemed poorly adherent.

Remote Monitoring of Automated Peritoneal Dialysis Patients: Assessing Clinical and Economic Value.

BACKGROUND: For chronic kidney disease patients who progress to end-stage renal disease, survival is dependent on renal replacement therapy in the form of kidney transplantation or chronic dialysis. Peritoneal dialysis (PD), which can be performed at home, is both more convenient and less costly than hemodialysis that requires three 4-h visits per week to the dialysis facility and complicated equipment. Remote therapy management (RTM), technologies that collect medical information and transmit it to healthcare providers for patient management, has the potential to improve the outcomes of patients receiving automated peritoneal dialysis (APD) at home. OBJECTIVE: Estimate through a simulation study the potential impact of RTM on APD patients use of healthcare resources and costs in the United States, Germany, and Italy. METHODS: Twelve APD patient profiles were developed to reflect potential clinical scenarios of APD therapy. Two versions of each profile were created to simulate healthcare resource use, one assuming use of RTM and one with no RTM. Eleven APD teams (one nephrologist, one nurse) estimated resources that would be used. RESULTS: Results from U.S., German, and Italian clinicians found that RTM could avoid use of 59, 49, and 16 resources over the 12 profiles, respectively. Estimated reduced utilization across the three countries ranged from one to two hospitalizations, one to four home visits, two to five emergency room visits, and four to eight unplanned clinic visits. Total savings across all scenarios were $23,364 in the United States, $11,477 in Germany, and $7,088 in Italy. CONCLUSION: In a simulated environment, early intervention enabled by RTM reduced healthcare resource utilization and associated costs.

Determining the cost of implementing and operating a remote patient monitoring programme for the elderly with chronic conditions: A systematic review of economic evaluations.

Introduction Remote patient monitoring (RPM) in conjunction with home nursing visits is becoming increasingly popular for the follow-up of patients with chronic conditions and evidence exists that it improves patients' health outcomes. Current cost data is reported inconsistently and often gathered from studies of poor methodological quality, making it difficult for decision-makers who consider implementing this service in their organizations. This study reviewed the cost of RPM programmes targeting elderly patients with chronic conditions. Methods After evaluation against the inclusion and exclusion criteria and appraisal against two criteria which are important for economic evaluations, data from selected studies were extracted and grouped into meaningful cost categories, then adjusted to reflect November 2015 US dollars. Results In the 13 selected studies, the newly-created cost category 'Combined intervention cost' (reflecting equipment purchasing, servicing and monitoring cost) for the various RPM programmes ranged from US$275-US$7963 per patient per year. The three main findings are: (a) RPM programme costs have decreased since 2004 due to cheaper technology; (b) monitoring a single vital sign is likely to be less costly than monitoring multiple vital signs; and (c) programmes targeting hypertension or congestive heart failure are less costly than those targeting respiratory diseases or multiple conditions. Conclusions This review recommends that future studies present their cost data with more granularity, that grouping of costs should be minimized and that any assumptions, such as amortization, should be made explicit. In addition, studies should compare programmes with similar characteristics in terms of type of conditions, number of vital signs monitored, etc. for more generalizable results.