Telemedicine Chapter 9: Telemedicine and Dialysis

This chapter is part of Literature reviews carried out for the Heath Service Executive National Telehealth Steering Group April – July 2020

Systematic Reviews

Cartwright, EJ et al (2020) [Systematic Review] eHealth Interventions to Support Patients in Delivering and Managing Peritoneal Dialysis at Home: A Systematic Review1

Peritoneal dialysis (PD) requires patients to develop a variety of selfmanagement skills in order to effectively deliver and manage their dialysis at home. eHealth interventions may provide patients with accessible information to develop the skills and knowledge they require to manage their treatment. This review aims to identify and evaluate ‘active’ eHealth interventions in supporting patients on PD. Six databases were included within the review using the terms Peritoneal Dialysis, eHealth, telemedicine and remote consultation. Studies which explored patients who were delivering PD, an intervention where the main component involved a digital device and required active engagement from patients were included. The primary outcomes examined were identified using the core outcomes recommended by the Standardised Outcomes in Nephrology in Peritoneal Dialysis initiative (PD infection, cardiovascular disease, mortality, PD failure and life participation). Hospitalisation rates were also considered as a primary outcome. Secondary outcomes included quality of life, patient skills, patient knowledge and satisfaction. Using the inclusion criteria, 15 studies [1,334 participants] were included in the study. The effectiveness of eHealth interventions was mixed. Due to high heterogeneity, a meta-analysis was not possible, and quality of evidence was low. Risk of bias across the randomised studies was unclear but bias across non-randomised studies was identified as critical. There were no reported adverse effects of eHealth interventions within the included studies. Despite the high interest of eHealth interventions in PD, good quality evidence is needed to explore their effectiveness before a wider application of eHealth interventions.

Scotland, Graham et al (2018) [Systematic Review] Multiple-frequency Bioimpedance Devices for Fluid Management in People With Chronic Kidney Disease Receiving Dialysis: A Systematic Review and Economic Evaluation2

Background: Chronic kidney disease (CKD)is a long-term condition requiring treatment such as conservative management, kidney transplantation or dialysis. To optimise the volume of fluid removed during dialysis to avoid under-hydration or over-hydration, people are assigned a ‘target weight’, which is commonly assessed using clinical methods, such as weight gain between dialysis sessions, pre-and post-dialysis blood pressure and patient-reported symptoms. However, these methods are not precise, and measurement devices based on bioimpedance technology are increasingly used in dialysis centres. Current evidence on the role of bioimpedance devices for fluid management in people with CKD receiving dialysis is limited. Objectives: To evaluate the clinical effectiveness and cost-effectiveness of multiple-frequency bioimpedance devices versus standard clinical assessment for fluid management in people with CKD receiving dialysis. Data sources: We searched major electronic databases [eg MEDLINE, MEDLINE In-process and Other Non-Indexed Citations, EMBASE, Science Citation Index and Cochrane Central Register of Controlled Trials (CENTRAL)] conference abstracts and ongoing studies. There were no date restrictions. Searches were undertaken between June and October 2016.

Review methods: Evidence was considered from randomised controlled trials comparing fluid management by multiple-frequency bioimpedance devices and standard clinical assessment in people receiving dialysis, and non-randomised studies evaluating the use of the devices for fluid management in people receiving dialysis. One reviewer extracted data and assessed the risk of bias of included studies. A second reviewer cross-checked the extracted data. Standard meta-analyses techniques were used to combine results from included studies. A Markov model was developed to assess the cost-effectiveness of the interventions. Results: Five RCTs (with 904 adult participants) and eight non-randomised studies (with 4,915 adult participants) assessing the use of the Body Composition Monitor (BCM) were included. Both absolute over-hydration and relative over-hydration were significantly lower in patients evaluated using BCM measurements than for those evaluated using standard clinical methods [weighted mean difference -0.44, 95% confidence interval (CI) -0.72 to -0.15, p = 0.003, I2 = 49%; and weighted mean difference -1.84, 95% CI -3.65 to -0.03; p = 0.05, I2 = 52%, respectively]. Pooled effects of bioimpedance monitoring on systolic blood pressure (SBP)(mean difference -2.46 mmHg, 95% CI -5.07 to 0.15 mmHg; p = 0.06, I2 = 0%), arterial stiffness (mean difference -1.18, 95% CI -3.14 to 0.78; p = 0.24, I2 = 92%) and mortality (hazard ratio = 0.689, 95% CI 0.23 to 2.08; p = 0.51) were not statistically significant. The economic evaluation showed that, when dialysis costs were included in the model, the probability of bioimpedance monitoring being cost-effective ranged from 13% to 26% at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained. With dialysis costs excluded, the corresponding probabilities of cost-effectiveness ranged from 61% to 67%.

Limitations: Lack of evidence on clinically relevant outcomes, children receiving dialysis, and any multifrequency bioimpedance devices, other than the BCM. Conclusions: BCM used in addition to clinical assessment may lower over-hydration and potentially improve intermediate outcomes, such as SBP, but effects on mortality have not been demonstrated. If dialysis costs are not considered, the incremental cost-effectiveness ratio falls below £20,000, with modest effects on mortality and/or hospitalisation rates. The current findings are not generalisable to paediatric populations nor across other multifrequency bioimpedance devices. Future work: Services that routinely use the BCM should report clinically relevant intermediate and long-term outcomes before and after introduction of the device to extend the current evidence base. Study registration: This study is registered as PROSPERO CRD42016041785.

Funding: The National Institute for Health Research Health Technology Assessment programme.


Randomised Controlled Trials

Cao, F et al (2018) [Randomised Controlled Trial] Application of Instant Messaging Software in the Follow-Up of Patients Using Peritoneal Dialysis, a Randomised Controlled Trial3

Aims and Objectives: This study aims to investigate the application value of Internet-based instant messaging software in the follow-up of patients using peritoneal dialysis. Background: Peritoneal dialysis is an effective renal replacement treatment for end-stage renal disease. The clinical usefulness of Internet-based instant messaging software in the follow-up of peritoneal dialysis patients, including the incidence of peritonitis and exit-site infection, the levels of albumin and electrolytes and the degree of patients’ satisfaction, remains unknown. Design: Between January 2009-April 2016, a total of 160 patients underwent continuous peritoneal dialysis in the Department of Nephrology, Fujian Provincial Hospital were invited to participate voluntarily in this study. The patients were randomly assigned to the instant messenger (QQ)follow-up group (n = 80) and the traditional follow-up group (n = 80). The differences in death, hospitalisation, peritonitis, exit-site infection, and patients’ satisfaction were investigated during 1 year of follow-up. The mean followup duration is 11.4 ± 1.5 months.

Results: Compared with the patients in the traditional follow-up group, patients in the QQ follow-up group showed higher levels of serum albumin (p = .009) and haemoglobin (p = .009), lower levels of phosphorus (p < .001) and calcium-phosphorus product (p = .001), and better degree of satisfaction (p < .001). Relevance to Clinical Practice: Internet-based follow-up by instant messaging software appears to be a feasible and acceptable method of delivering peritoneal dialysis treatment for patients with end-stage renal disease.


Miscellaneous

Dang, BV et al (2020) Toward Portable Artificial Kidneys: The Role of Advanced Microfluidics and Membrane Technologies in Implantable Systems4

Globally, around 2.6 million people receive renal replacement therapy (RRT), and a further 4.9-9.7 million people need, but do not have access to, RRT. The next generation RRT devices will certainly be in demand due to the increasing occurrence of diabetes, atherosclerosis and the growing population of older citizens. This review provides a comprehensive, yet concise overview of the cleared and remaining hurdles in the development of artificial kidneys to move beyond traditional dialysis technology-the current baseline of renal failure treatment. It compares and contrasts the state-ofthe-art in ‘cell-based’ and ‘non-cell-based’ approaches. Based on this study, a new engineering perspective on the future of artificial kidneys is described. This review suggests that stem-cell-based artificial kidneys represent a long-term, complete solution but it can take years of development due to the limitations of current cell seeding technology, viability and complicated behaviour control. Alternatively, there is much potential for near- and medium- term solutions with the development of non-cell-based wearable and implantable devices to support current therapies. Based on recent fundamental advances in microfluidics, membranes and related research, it may be possible to integrate these technologies to enable implantable artificial kidneys (iAK)in the near future.

Hojs, N et al (2020) [Review] Ambulatory Hemodialysis-Technology Landscape and Potential for Patient-Centered Treatment5

CKD is a worldwide health problem and the number of patients requiring kidney replacement therapy is rising. In the United States, most patients with ESKD rely on in-center hemodialysis, which is burdensome and does not provide the same long-term benefits as kidney transplantation. Intensive hemodialysis treatments have demonstrated improved clinical outcomes, but its wider adoption is limited by equipment complexity and patient apprehension. Ambulatory devices for hemodialysis offer the potential for self-care treatment outside the clinical setting as well as frequent and prolonged sessions. This article explains the motivation for ambulatory hemodialysis and provides an overview of the necessary features of key technologies that will be the basis for new wearable and implantable devices. Early work by pioneers of hemodialysis is described followed by recent experience using a wearable unit on patients. Finally, ongoing efforts to develop an implantable device for kidney replacement and its potential for implantable hemodialysis are presented.

Kooman, JP et al (2020) [Review] Wearable Health Devices and Personal Area Networks: Can They Improve Outcomes in Haemodialysis Patients?6

Wearable devices are becoming widespread in a wide range of applications, from healthcare to biomedical monitoring systems, which enable continuous measurement of critical biomarkers for medical diagnostics, physiological health monitoring and evaluation. Especially as the elderly population grows globally, various chronic and acute diseases become increasingly important, and the medical industry is changing dramatically due to the need for pointof-care (POC) diagnosis and real-time monitoring of long-term health conditions. Wearable devices have evolved gradually in the form of accessories, integrated clothing, body attachments and body inserts. Over the past few decades, the tremendous development of electronics, biocompatible materials and nanomaterials has resulted in the development of implantable devices that enable the diagnosis and prognosis through small sensors and biomedical devices, and greatly improve the quality and efficacy of medical services. This article summarizes the wearable devices that have been developed to date, and provides a review of their clinical applications. We will also discuss the technical barriers and challenges in the development of wearable devices, and discuss future prospects on wearable biosensors for prevention, personalized medicine and real-time health monitoring.

Ray, A et al (2020) Measurement of Serum Phosphate Levels Using a Mobile Sensor7

The measurement of serum phosphate concentration is crucial for patients with advanced chronic kidney disease (CKD) and those on maintenance dialysis, as abnormal phosphate levels may be associated with severe health risks. It is important to monitor serum phosphate levels on a regular basis in these patients; however, such measurements are generally limited to every 0.5-3 months, depending on the severity of CKD. This is due to the fact that serum phosphate measurements can only be performed at regular clinic visits, in addition to cost considerations. Here we present a portable and cost-effective point-of-care device capable of measuring serum phosphate levels using a single drop of blood (<60 μl). This is achieved by integrating a paper-based microfluidic platform with a custom-designed smartphone reader. This mobile sensor was tested on patients undergoing dialysis, where whole blood samples were acquired before starting the hemodialysis and during the three-hour treatment. This sampling during the hemodialysis, under patient consent, allowed us to test blood samples with a wide range of phosphate concentrations, and our results showed a strong correlation with the ground truth laboratory tests performed on the same patient samples (Pearson coefficient r = 0.95 and p < 0.001). Our 3D-printed smartphone attachment weighs about 400 g and costs less than 80 USD, whereas the material cost for the disposable test is <3.5 USD (under low volume manufacturing). This low-cost and easy-to-operate system can be used to measure serum phosphate levels at the point-of-care in about 45 min and can potentially be used on a daily basis by patients at home.

Viglino, G et al (2020) Videodialysis: A Pilot Experience of Telecare for Assisted Peritoneal Dialysis8

Background: We report our experience with Videodialysis (VD), a new telemedicine system created in our Center to overcome physical, cognitive and psychological barriers to PD. Methods: We analyzed the technical and clinical care results of VD in the period from 01/01/2009 to 12/31/2018. Results: The VD components are: a Remote Station at the patient’s home (video camera, monitor, microphone, technological connectivity box), and a Control Station in the Center (PC with high resolution monitor, webcam, speakerphone) with software that manages 6 audio-video connections simultaneously as well as the Remote Station video cameras. In 2015 a second model of VD was designed to further improve ease of transport, installation, user interface, software functionality and connectivity. VD proved to be highly reliable during 21,000 connections, and easy to use by patients/caregivers without technological skills. During the observational period, 107 patients started PD; of these 77 had barriers to PD: in 15 we overcame the barriers by VD-Assisted PD and in 62 we used other modalities of Assisted PD. During a follow-up of 285 months on VD-Assisted, 5 patients died, 3 were transferred to HD (UFF; leakage; onset of barriers insurmountable with VD), 3 to traditional Assisted PD and 4 remained on VD-Assisted PD. Peritonitis incidence in VD-Assisted PD was 1/84.2 pt/mths, not significantly different to that of the patients not using VD. Sense of confidence was the aspect most highly-appreciated by VD-Assisted PD patients. Conclusions: VD-Assisted PD is a reliable, safe system which requires no technological know-how and it is easy to use when self-care is not possible due to physical, cognitive or psychological barriers.

Yang, Y et al (2020) [Scoping Review] Intervention and Evaluation of Mobile Health Technologies in Management of Patients Undergoing Chronic Dialysis: Scoping Review9

Background: Studies have shown the effectiveness and user acceptance of mobile health (mHealth)technologies in managing patients with chronic kidney disease (CKD). However, incorporating mHealth technology into the standard care of patients with CKD still faces many challenges. To our knowledge, there are no reviews on mHealth interventions and their assessments concerning the management of patients undergoing dialysis. Objective: This study provided a scoping review on existing apps and interventions of mHealth technologies in adult patients undergoing chronic dialysis and identified the gaps in patient outcome assessment of mHealth technologies in the literature.

Methods:We systematically searched PubMed (MEDLINE), Scopus, and the Cumulative Index to Nursing and Allied Health Literature databases, as well as gray literature sources. Two keywords, “mHealth” and “dialysis,” were combined to address the main concepts of the objectives. Inclusion criteria were as follows: 1. mHealth interventions, which are on a smartphone, tablet, or web-based portals that are accessible through mobile devices; and 2. adult patients (age ≥18 years) on chronic dialysis. Only English papers published from January 2008 to October 2018 were included. Studies with mHealth apps for other chronic conditions, based on e-consultation or videoconferencing, non-English publications, and review papers were excluded.

Results: Of the 1054 papers identified, 22 met the inclusion and exclusion criteria. Most studies (n=20) were randomized controlled trials and cohort studies. These studies were carried out in 7 countries. The main purposes of these mHealth interventions were as follows: nutrition or dietary selfmonitoring (n=7), remote biometric monitoring (n=7), web-based portal (n=4), self-monitoring of in-session dialysis-specific information (n=3), and self-monitoring of lifestyle or behavioral change (n=1). The outcomes of the 22 included studies were organized into five categories: 1. patient satisfaction and acceptance, 2. clinical effectiveness, 3. economic assessment, 4. health-related quality of life, and 5. impact on lifestyle or behavioral change. The mHealth interventions showed neutral to positive results in chronic dialysis patient management, reporting no to significant improvement of dialysis-specific measurements and some components of the overall quality of life assessment. Evaluation of these mHealth interventions consistently demonstrated evidence in patients’ satisfaction, high level of user acceptance, and reduced use of health resources and cost savings to health care services. However, there is a lack of studies evaluating safety, organizational, sociocultural, ethical, and legal aspects of mHealth technologies. Furthermore, a comprehensive cost-effectiveness and cost-benefit analysis of adopting mHealth technologies was not found in the literature.

Conclusions:The gaps identified in this study will inform the creation of health policies and organizational support for mHealth implementation in patients undergoing dialysis. The findings of this review will inform the development of a comprehensive service model that utilizes mHealth technologies for home monitoring and self-management of patients undergoing chronic dialysis.

Yeter, HH et al (2020) [Observational Study] Automated Remote Monitoring for Peritoneal Dialysis and Its Impact on Blood Pressure10

Introduction: Peritoneal dialysis (PD) provides a safe, home-based continuous renal replacement therapy for patients. The adherence of the patients to the prescribed dialysis fluids cannot always be monitored by physicians. Remote monitoring automated peritoneal dialysis (RM-APD) can affect patients’ compliance with treatment and, thus, clinical outcomes. Objective: We aimed to evaluate the clinical outcomes of patients with a remote access program.

Methods: This was an observational study. We analyzed the effect of RMAPD on treatment adherence, dialysis adequacy, and change in blood pressure control, sleep quality, and health-related quality of life during the 6 months of follow-up.

Results: A total of 15 patients were enrolled in this study. It was found that there was a significant decrease (99 ± 19 vs. 89 ± 11 mm Hg)in mean arterial blood pressure of patients, and a considerable increase in Kt/V was observed in the sixth month after the RM-APD switch (2.11 ± 0.4 vs. 2.25 ± 0.5). A significant increase was found when comparing the 3-month and 6-month ultrafiltration amounts before RM-APD and the ultrafiltration amount within 6 months after RM-APD (800 mL [500-1,000] and 752 mL [490-986] vs. 824 mL [537-1,183]). The daily antihypertensive pill need (4 [0-7] vs. 2 [0-6]) and alarms received from the device decreased (from 4 [3-8]to 2 [0-3]) at the sixth month of the switch. There was no significant change in sleep quality and health-related quality of life within 6 months.

Conclusion: This study showed that treatment adherence and ultrafiltration amounts of patients increased with the use of RM-APD, as well as better blood pressure control with fewer antihypertensive drugs.

Castro, A et al (2019) [Review] How Can We Advance in Renal Replacement Therapy Techniques?11

End-Stage Renal Disease (ESRD)is one of the major causes of morbidity and mortality worldwide. Although the incidence of ESRD is relatively stable, the prevalence of maintenance dialysis is increasing, and it is expected to reach a staggering 5439 million patients worldwide by 2030. Despite the great technological evolution that has taken place in recent years, most patients are still treated with in-centre haemodialysis and their prognosis remains far from desirable. Since 1980, there has been an increasing interest in the development of a portable device for renal replacement therapy (RRT), which ultimately led to the creation of the Wearable Artificial Kidney (WAK) and the Wearable Ultrafiltration (WUF) system. Portable RRT devices may be acceptable alternatives that deal with several unmet clinical needs of ESRD patients. So far, 3 important human studies with WAK and WUF have been carried out and, although these devices require considerable technological improvement, their safety and efficacy in solute clearance and fluid removal is undeniable. In this article, we review the evolution of the WAK and the WUF and the main clinical trials performed, highlighting some of their technical features. Some of the main possible clinical advantages that could be achieved with these devices, as well as some economic aspects, are also pointed out. In the future, all renal replacement therapy techniques should evolve to perfectly match the clinical and personal needs of each patient, allowing for an improved health-related quality of life.

Chen, WL et al (2019) [Feasibility Study] Feasibility of smart hemodialysis patient care using sensors embedded in personalized 3D printing cast12

This project is to design a wearable medical device which can measure and monitor the fluid dynamics of the dialysis access using sensor of phonoangiography (PAG)for exploring vascular pitch pattern and sensor of Photoplethysmography (PPG)for estimating the flow volume as a double checking of the AV access condition. We use arteriovenous access (AVA) stenosis detector based on phonoangiography technique and autoregressive model to detect access stenosis and simultaneously estimate the status of AVA life cycle by tracking and obtaining changes in frequency spectra domain. It helps hemodialysis patients to be aware earlier of the dysfunction of AVA and reminds them to make a return visit. The purpose of the complement deployment of vital sign sensors is to improve the prognosis and optimize overall health by providing analysis of physiological signals, including water content index, pulse oximetry, and blood pressure at the same time. With these sensors, the concept of holistic hemodialysis patient care (HHPC) might be proved.

Hueso, M et al (2019) [Review] Progress in the Development and Challenges for the Use of Artificial Kidneys and Wearable Dialysis Devices13

Background:Renal transplantation is the treatment of choice for chronic kidney disease (CKD) patients, but the shortage of kidneys and the disabling medical conditions these patients suffer from make dialysis essential for most of them. Since dialysis drastically affects the patients’ lifestyle, there are great expectations for the development of wearable artificial kidneys, although their use is currently impeded by major concerns about safety. On the other hand, dialysis patients with hemodynamic instability do not usually tolerate intermittent dialysis therapy because of their inability to adapt to a changing scenario of unforeseen events. Thus, the development of novel wearable dialysis devices and the improvement of clinical tolerance will need contributions from new branches of engineering such as artificial intelligence (AI) and machine learning (ML)for the real-time analysis of equipment alarms, dialysis parameters, and patient-related data with a realtime feedback response. These technologies are endowed with abilities normally associated with human intelligence such as learning, problem solving, human speech understanding, or planning and decision-making. Examples of common applications of AI are visual perception (computer vision), speech recognition, and language translation. In this review, we discuss recent progresses in the area of dialysis and challenges for the use of AI in the development of artificial kidneys. great opportunities for dialysis therapy, but much innovation is needed before we achieve a smart dialysis machine able to analyze and understand changes in patient homeostasis and to respond appropriately in real time. Great efforts are being made in the fields of tissue engineering and regenerative medicine to provide alternative cell-based approaches for the treatment of renal failure, including bioartificial renal systems and the implantation of bioengineered kidney constructs.

Lew, SQ et al (2019) Impact of Remote Biometric Monitoringon Cost and Hospitalization Outcomes in Peritoneal Dialysis14

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.

Milan Manani, Set al (2019) Longitudinal Experience With Remote Monitoring for Automated Peritoneal Dialysis Patients15

Background: Peritoneal dialysis (PD)is an ideal model for testing remote monitoring (RM). In this study, we evaluated the RM application longitudinally in stable patients undergoing automated PD (APD). Methods: This was an observational study, comparing outcomes in patients with [current patients] and without [historical data] exposure of RM. We analyzed cost-effectiveness of RM-APD measuring the number of night alarms, number of hospital visits, direct and indirect costs.

Results: Changes in APD prescription were almost double in the case group (RM) compared to the control group (p = 0.0005). The need for in-person visits and nocturnal alarms was significantly less in RM-APD than in traditional APD (p = 0.01 and p = 0.002, respectively). The distance traveled by patients in the case of RM-APD was reduced by 1,134 km with a time saving of 1,554 min for patients. The overall cost reduction for the PD center in terms of time/nurse and time/physician was 2,647 and 3,673 min, respectively. All these advantages were obtained in the presence of an improved technique survival with a significant reduction of dropouts. All patients found that it is easy to use the RM system and were satisfied with the high level of interaction with the care team and with the possibility of timely resolving technical problems.

Conclusion: These data confirm the long-term benefits of RM applied to APD. RM-APD is cost-effective; it allows early detection and resolution of problems, improved treatment compliance, reduction of patient’s access to hospital center for technical and clinical complications with consequent savings, and improved patient’s quality of life.

Olivares-Gandy, HJ et al (2019) A Telemonitoring System for Nutritional Intake in Patients With Chronic Kidney Disease Receiving Peritoneal Dialysis Therapy16

Patients undergoing peritoneal dialysis (PD)therapy may present complications of protein-energy wasting, which may be partially produced by inadequate nutrition management and a protein or energy deficiency in the predialytic phase. Therefore, accurate monitoring of the nutrition status during PD therapy can prevent risk conditions in patients with chronic kidney disease (CKD). In this study, we present the analysis, design, and development of a telemonitoring system for the nutritional intake of patients with CKD receiving PD therapy. The proposed system consists of a mobile web application addressed to the nutrition specialist and a native Android application aimed at patients undergoing PD. Our system optimizes nutrition administration by providing services that allow the nutritionist to monitor the patient, assign a nutrition scheme based on the patient profile, manage intake phases and send recommendations to the patient. Furthermore, the system allows the patient to record the intake data daily, receive updates on diets generated by the nutritionist and communicate with the nutritionist through a consultation module. Finally, we performed a usability assessment of our system based on a laboratory study with two users: a nutritionist and a patient undergoing peritoneal dialysis treatment. Based on the obtained results, our telemonitoring system shows a favorable opinion in terms of usability from the perspectives of the patient and nutritionist.

Panda, B et al (2019) Flexible, Skin Coupled Microphone Array for Point of Care Vascular Access Monitoring17

Point-of-care screening for hemodialysis vascular access dysfunction requires tools that are objective and efficient. Listening for bruits during physical exam is a subjective examination which can detect stenosis [vascular narrowing] when properly performed. Phonoangiograms (PAGs)- mathematical analysis of bruits-increases the objectivity and sensitivity and permits quantification of stenosis location and degree of stenosis (DOS). This work describes a flexible and body-conformal multi-channel sensor and associated signal processing methods for automated DOS characterization of vascular access. The sensor used an array of thin-film PVDF microphones integrated on polyimide to record bruits at multiple sites along a vascular access. Nonlinear signal processing was used to extract spectral features, and cardiac cycle segmentation was used to improve sensitivity. PAG signal processing algorithms to detect stenosis location and severity are also presented. Experimental results using microphone arrays on a vascular access phantom demonstrated that stenotic lesions were detected within 1 cm of the actual location and graded to three levels (mild, moderate, or severe). Additional PAG features were also used to define a simple binary classifier aimed at patients with failing vascular accesses. The classifier achieved 90% accuracy, 92% specificity, and 91% sensitivity at detecting stenosis greater than 50%. These results suggest that point-of-care screening using microphone arrays can identify at-risk patients using automated signal analysis.

Castro, AC et al (2018) [Review] Wearable Artificial Kidney and Wearable Ultrafiltration Device Vascular Access-Future Directions18

Background: Since 2005, three human clinical trials have been performed with the Wearable Artificial Kidney (WAK) and Wearable Ultrafiltration (WUF) device. The lack of an adequate vascular access (VA) has been pointed out as the main limitation to their implementation. Based on the current level of understanding, we will make the first conceptual proposal of an adequate VA suitable for the WAK and the WUF.

Methods: All the literature related to WAK and WUF was reviewed. Based on eight main publications the VA major characteristics were defined: a mean blood flow of 100 mL/min; the capability to allow prolonged and frequent dialysis treatments, withoutinterfering in activities of daily living (ADL); safe and convenient connection/disconnection systems; reduced risk of biofilm formation and coagulation; high biocompatibility. A research was done in order to answer to each necessary technological prerequisites.

Results: The use of a device similar to a CVC with a 5Fr lumen, seems to be the most feasible option. Totally subcutaneous port devices such as the LifeSite(R) or Dialock (R) systems can be a solution to allow WAK or WUF to operate continuously while patients carry out their ADL. Recently, macromolecules that reduce the risk of thrombosis and infection and are integrated into a CVC have been developed and have the capability of overcoming these major limitations.

Conclusion: With an adequate VA, portable HD devices can be acceptable options to address several unmet clinical needs of HD patients.

Drepper, VJ et al (2018) [Case Report] Remote Patient Management in Automated Peritoneal Dialysis: A Promising New Tool19

Remote patient management (RPM) has the potential to help clinicians detect early issues, allowing intervention prior to development of more significant problems. A 23-year-old end-stage kidney disease patient required urgent start of renal replacement therapy. A newly available automated peritoneal dialysis (APD) RPM system with cloud-based connectivity was implemented in her care. Pre-defined RPM threshold parameters were set to identify clinically relevant issues. Red flag dashboard alerts heralded prolonged drain times leading to clinical evaluation with subsequent diagnosis of and surgical repositioning for catheter displacement, although it took several days for newly-RPMexposed staff to recognize this issue. Post-PD catheter repositioning, drain times were again normal as indicated by disappearance of flag alerts and unremarkable cycle volume profiles. Identification of < 90% adherence to prescribed PD therapy was then documented with the RPM system, alerting the clinical staff to address this important issue given its association with significant negative clinical outcomes. Healthcare providers face a “learning curve” to effect optimal utilization of the RPM tool. Larger scale observational studies will determine the impact of RPM on APD technique survival and resource utilization.

Garcia, Marcos Antonio Martinez et al (2018) [Observational Study]
Telemonitoring System for Patients With Chronic Kidney Disease Undergoing Peritoneal Dialysis: Usability Assessment Based on a Case Study20

There are two million people with chronic kidney disease (CKD) worldwide. In Mexico, it is estimated that by 2025, there will be 212 thousand CKD cases. Among the renal replacement treatments, peritoneal dialysis (PD) exists either in the continuous ambulatory (CAPD) or automated (APD) mode, which requires continuous monitoring and strict control. Thus, several software systems have been proposed to perform reliable remote monitoring of patients using PD but also to achieve the goal with effectiveness, efficiency and satisfaction; ie, in software engineering, this is called usability. However, few studies have addressed usability issues using case studies with patients and medical staff in real domains. In this paper, we present a usability assessment of a telemonitoring system for patients with CKD on peritoneal dialysis treatment through a case study with patients and medical staff of the Mexican Institute of Social Security (IMSS). The usability evaluation was carried out through the application of two satisfaction instruments. These instruments evaluated multiple usability criteria, such as navigability, interactivity, motivation, satisfaction, and applicability. The results obtained from the usability evaluation show that, on average, the services offered by the system have 91.3% acceptance by users (patient-doctors), with the APD and CAPD exchange data registration services having the highest acceptance for patients, with a positive perception of 94.5% and 92.3%, respectively. Meanwhile, for the doctors and nurses, the alarm reception for patients in a risk situation was highest with 95% acceptance. Based on the obtained results, the evaluated telemonitoring system holds wide acceptance, satisfaction, and applicability from patients’ and doctors’ perspectives. It is also noted that the evaluated system considers and satisfies the requirements and suitable parameters that should be monitored in PD treatment according to studies presented in the literature.

Makhija, Dilip et al (2018) [Simulation Study] Remote Monitoring of Automated Peritoneal Dialysis Patients: Assessing Clinical and Economic Value21

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 with one nephrologist and one nurse were the 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.

Milan Malani, S et al (2018) [Observational Study] Remote Monitoring of Automated Peritoneal Dialysis Improves Personalization of Dialytic
Prescription and Patient’s Independence22

Background: Remote monitoring (RM) supports a healthcare model that enhances patients’ self-management. We evaluated the utility of RM in patients undergoing automated peritoneal dialysis (APD). Methods: We observed 37 -RM-APD patients, 16 incidents, and 21 prevalents switched from traditional APD (T-APD). We observed the number of changes for APD prescription, the frequency of visits, and PD adequacy parameters during 1 year of RM utilization in APD. Results: The APD prescriptions were modified more frequently in RM-APD vs. T-APD in incident (p = 0.002) and prevalent patients (p = 0.045). Visits were significant less in -RM-APD than in T-APD for incident patient (p = 0.008). No significant difference was found between prevalent populations. PD adequacy was similar in both groups. Conclusions: Our results demonstrate that RM allows an efficient use of healthcare resources, helping to improve personalization of APD prescription and to intervene early with troubleshooting, thereby reducing the frequency of in-person visits for emergency problems.

Panda, B et al (2018) Skin-coupled PVDF microphones for noninvasive vascular blood sound monitoring23

Vascular access is the “Achilles Heel” of hemodialysis, as maintaining high flow characteristics [access patency]is critical to achieving efficient dialysis treatment. Thus, monitoring of vascular access is essential for maintaining long-term dialysis success. Blood sounds change in the presence of stenosis and can be analyzed digitally as phonoangiograms (PAGs)to determine changes in hemodynamic flow. We propose a multi-channel PAG recording sensor suitable for rapid, non-invasive vascular access monitoring. Here we present the initial design and characterization of sensors appropriate for recording PAGs from the skin surface. An optimized sensor size and backing material was selected to improve sensitivity and to provide a neutral frequency response. The sensor performance was finally compared with a conventional stethoscope on a controlled blood flow stenosis benchtop phantom.

Uchiyama, K et al (2018) [Simulation Study] The Impact of a Remote Monitoring System of Healthcare Resource Consumption in Patients on Automated Peritoneal Dialysis (APD): A Simulation Study24

Aims: Remote monitoring (RM) can improve management of chronic diseases. We evaluated the impact of RM in automated peritoneal dialysis (APD)in a simulation study. Materials and methods: We simulated 12 patient scenarios with common clinical problems and estimated the likely healthcare resource consumption with and without the availability of RM (RM+ and RM- groups, respectively). Scenarios were evaluated 4 times by randomly allocated nephrologist-nurse teams or nephrologist-alone assessors. Results: The RM+ group was assessed as having significantly lower total healthcare resource consumption compared with the RM- group (36.8 vs. 107.5 total episodes of resource consumption, p = 0.002). The RM+ group showed significantly lower “unplanned hospital visits” (2.3 vs. 11.3, p = 0.005), “emergency room visits” (0.5 vs. 5.3, p = 0.003), “home visits” (0.5 vs. 5.8, p = 0.016), “exchanges over the telephone” (18.5 vs. 57.8, p = 0.002), and “change to hemodialysis” (0.5 vs. 2.5, p = 0.003). Evaluations did not differ between nephrologist-nurse teams vs. nephrologist-alone assessors. Conclusion: RM can be expected to reduce healthcare resource consumption in APD patients.

Weinhandl, ED,Collins, AJ (2018) Relative Risk of Home Hemodialysis Attrition in Patients Using a Telehealth Platform25

Introduction: Home hemodialysis (HHD)facilitates increased treatment frequency, which may improve patient outcomes. However, attrition due to technique failure limits the clinical effectiveness of the modality. Nx2me Connected Health is a telehealth platform that enables ongoing assessment of HHD patients using NxStage equipment, and that may reduce patient burden. We aimed to assess whether use of Nx2me was associated with risk of HHD attrition.

Methods: We compared risks of all-cause attrition, dialysis cessation (ie, death or transplant), and technique failure in Nx2me users and matched control patients, using a retrospective cohort study. We also compared the likelihood of HHD training graduation in patients who initiated use of Nx2me during training with the likelihood in matched control patients. Matching factors included date of HHD initiation, NxStage treatment duration at initiation of follow-up, and prescribed treatment frequency. We used stratified Fine-Gray and Cox regression to compare risks, with adjustment for demographic factors and vascular access modality, and stratification by matched cluster.

Findings: We identified 606 Nx2me users; 49.5% initiated use of Nx2me in <3 months after initiation of HHD with NxStage equipment. Adjusted hazard ratios (AHRs) of all-cause attrition, dialysis cessation, and technique failure were 0.80 (95% confidence interval, 0.68-0.95), 1.10 (0.86-1.41), and 0.71 (0.57-0.87), respectively, for Nx2me users vs. matched controls. AHRs were similar in patients who initiated use of Nx2me in <3 months after initiation of HHD. The AHR of HHD training graduation was 1.61 (1.10-2.36)in patients who initiated use of Nx2me within 2 weeks of training initiation vs. matched controls.

Discussion: Use of Nx2me was associated with lower risk of all-cause attrition, lower risk of technique failure, and higher likelihood of HHD training graduation. Further studies are needed to identify the mechanisms by which use of a telehealth platform may improve clinical outcomes and reduce patient burden.

Bernardo, AA et al (2017) Clinical Safety and Performance of VIVIA: A Novel Home Hemodialysis System26

Background: The VIVIA Hemodialysis System (Baxter Healthcare Corporation, Deerfield, IL, USA) was designed for patient use at home to reduce the burden of treatment and improve patient safety. It has unique features including extended use of the dialyzer and blood set through in situ hotwater disinfection between treatments; generation of on-line infusiblequality dialysate for automated priming, rinseback and hemodynamic support during hypotension and a fully integrated access disconnect sensor.

Methods: The safety and performance of VIVIA were assessed in two clinical studies. A first-in-man study was a prospective, single-arm study that involved 22 prevalent hemodialysis (HD) patients who were treated for ∼4 h, four times a week, for 10 weeks. A second clinical study was a prospective, single-arm study (6-8 h of dialysis treatment at night three times a week) that involved 17 prevalent patients treated for 6 weeks.

Results: There were 1,114 treatments from the two studies (first-in-man study, 816; extended duration study, 298). Adverse events (AEs) were similar in the two studies to those expected for prevalent HD patients. No deaths and no device-related serious AEs occurred. Adequacy of dialysis ( Kt / V ) urea in both clinical trials was well above the clinical guidelines. VIVIA performed ultrafiltration accurately as prescribed in the two studies. The majority of patients achieved 10 or more uses of the dialyzer. Endotoxin levels and bacterial dialysate sampling met infusible-quality dialysate standards.

Conclusion: These results confirm the safety and expected performance of VIVIA.

Ditchburn, JL, Marshall, A (2017) Renal Telemedicine Through Video-As-A-Service Delivered to Patients on Home Dialysis: A Qualitative Study on the Renal Care Team Members’ Experience27

Background: The Lancashire Teaching Hospitals NHS Trust in the UK has been providing renal care through video-as-a-service (VAAS)to patients since 2013, with support from the North West NHS Shared Infrastructure Service, a collaborative team that supports information and communication technology use in the UK National Health Service. Introduction: Renal telemedicine offered remotely to patients on home dialysis supports renal care through the provision of a live high-quality video link directly to unsupported patients undergoing haemodialysis at home. Home haemodialysis is known to provide benefits to patients, particularly in making them more independent. The use of a telemedicine video-link in Lancashire and South Cumbria, UK, further reduces patient dependence on the professional team.

Objective: The purpose of this paper is to present the perspectives of the renal care team members using the renal telemedicine service to understand the perceived benefits and issues with the service.

Method: Ten semi-structured interviews with members of the renal care team [two renal specialists, one matron, two renal nurses, one business manager, one renal technical services manager, two IT technicians and one hardware maintenance technician] were conducted. Thematic analysis was undertaken to analyse the qualitative data.

Results: A range of incremental benefits to the renal team members were reported, including more efficient use of staff time, reduced travel, peace of mind and a strong sense of job satisfaction. Healthcare staff believed that remote renal care through video was useful, encouraged concordance and could nurture confidence in patients. Key technological issues and adjustments which would improve the renal telemedicine service were also identified.

Conclusion: The impact of renal telemedicine was positive on the renal team members. The use of telemedicine has been demonstrated to make home dialysis delivery more efficient and safe. The learning from staff feedback could inform development of services elsewhere.

Imtiaz, R et al (2017) [Pilot Study] A Pilot Study of OkKidney, a Phosphate Counting Application in Patients on Peritoneal Dialysis28

Background: Hyperphosphatemia is associated with adverse outcomes in patients treated with peritoneal dialysis (PD). We have shown that a fixed meal phosphate binder dosing schedule is not appropriate. The purpose of this study was to evaluate the beta version of OkKidney, a phosphate counting app that matches meal phosphate content with binder dose. Methods: A convenience sample of adult patients treated with PD completed a pre-survey thatincluded the technology readiness index (TRI 2.0). After a short information session, patients used OkKidney for 30 days. Pre- and post-intervention serum calcium, serum phosphate, and calcium carbonate binder intake were collected and compared using a paired t-test. A postintervention survey using a 5-point Likert scale was used to gather patient feedback. Results: Ten patients (5M, 5F) completed the study protocol. Participants were 55 ± 17 years old, predominately Caucasian, retired (60%), and owned a smartphone (70%). The median TRI score was 3.66 (max 5), indicating a moderate level of readiness. The post-survey results indicated a favorable rating for ease of use (μ = 4.4 ± 0.84) and usefulness (μ = 4.3 ± 0.68) of OkKidney. The average serum phosphate (p = 0.99) and calcium (p = 0.68) were not different pre-/post-intervention, but calcium carbonate intake tended to decrease (p = 0.12). Conclusion: Patients reported a positive experience with OkKidney. Further patient-specific adjustments of the binder dose to meal phosphate content may be required to demonstrate a statistically significant decrease in phosphate levels. We believe a larger trial is warranted to investigate the clinical implications of this app.

Lew, SQ et al (2017) Adoption of Telehealth: Remote Biometric Monitoring Among Peritoneal Dialysis Patients in the United States29

We examined participant uptake and utilization of remote monitoring devices, and the relationship between remote biometric monitoring (RBM) of weight (Wt) and blood pressure (BP) with self-monitoring requirements. Participants on peritoneal dialysis (PD)(n= 269) participated in a Telehealth pilot study of which 253 used remote monitoring of BP and 255 for Wt. Blood pressure and Wt readings were transmitted in real time to a Telehealth call center, which were then forwarded to the PD nurses for real-time review. Uptake of RBM was substantial, with 89.7% accepting RBM, generating 74,266 BP and 52,880 Wt measurements over the study period. We found no significant correlates of RBM uptake with regard to gender, marital, educational, socio-economic or employment status, or baseline experience with computers; frequency of use of BP RBM by Black participants was less than non-Black participants, as was Wt RBM, and participants over 55 years old were more likely to use the Wt RBM than their younger counterparts. Having any review of the breach by a nurse was associated with reduced odds of a subsequent BP breach after adjusting for sex, age, and race. Remote biometric monitoring was associated with adherence to self-monitoring BP and Wt requirements associated with PD. Remote biometric monitoring was feasible, allowing for increased communication between patient and PD clinical staff with real-time patient data for providers to act on to potentially improve adherence and outcomes.

Liu, Net al (2017) Remote Monitoring Systems for Chronic Patients on Home Hemodialysis: Field Test of a Copresence-Enhanced Design30

Background: Patients undertaking long-term and chronic home hemodialysis (HHD) are subject to feelings of isolation and anxiety due to the absence of physical contact with their health care professionals and lack of feedback in regards to their dialysis treatments. Therefore, it is important for these patients to feel the “presence” of the health care professionals remotely while on hemodialysis at home for better compliance with the dialysis regime and to feel connected with health care professionals.

Objective: This study presents an HHD system design for hemodialysis patients with features to enhance patient’s perceived “copresence” with their health care professionals. Various mechanisms to enhance this perception were designed and implemented, including digital logbooks, emotion sharing, and feedback tools. The mechanism in our HHD system aims to address the limitations associated with existing self-monitoring tools for HHD patients.

Methods: A field trial involving 3 nurses and 74 patients was conducted to test the pilot implementation of the copresence design in our HHD system. Mixed method research was conducted to evaluate the system, including surveys, interviews, and analysis of system data.

Results: Patients created 2757 entries of dialysis cases during the period of study. Altogether there were 492 entries submitted with very happy as the emotional status, 2167 entries with a happy status, 56 entries with a neutral status, 18 entries with an unhappy status, and 24 entries with a very unhappy status. Patients felt assured to share their emotions with health care professionals. Health care professionals were able to prioritize the review of the entries based on the emotional status and also felt assured to see patients’ change in mood. There were 989 entries sent with short notes. Entries with negative emotions had a higher percentage of supplementary notes entered compared to the entries with positive and neutral emotions. The qualitative data further showed that the HHD system was able to improve patients’ feelings of being connected with their health care professionals and thus enhance their self-care on HHD. The health care professionals felt better assured with patients’ status with the use of the system and reported improved productivity and satisfaction with the copresence enhancement mechanism. The survey on the system usability indicated a high level of satisfaction among patients and nurses.

Conclusions: The copresence enhancement design complements the conventional use of a digitized HHD logbook and will further benefit the design of future telehealth systems.

Wallace, EL et al (2017) [Review] Remote Patient Management for Home Dialysis Patients31

Remote patient management (RPM) offers renal health care providers and patients with end-stage kidney disease opportunities to embrace home dialysis therapies with greater confidence and the potential to obtain better clinical outcomes. Barriers and evidence required to increase adoption of RPM by the nephrology community need to be clearly defined. Ten health care providers from specialties including nephrology, cardiology, pediatrics, epidemiology, nursing, and health informatics with experience in home dialysis and the use of RPM systems gathered in Vienna, Austria to discuss opportunities for, barriers to, and system requirements of RPM as it applies to the home dialysis patient. Although improved outcomes and costeffectiveness of RPM have been demonstrated in patients with diabetes mellitus and heart disease, only observational data on RPM have been gathered in patients on dialysis. The current review focused on RPM systems currently in use, on how RPM should be integrated into future care, and on the evidence needed for optimized implementation to improve clinical and economic outcomes. Randomized controlled trials and/or large observational studies could inform the most effective and economical use of RPM in home dialysis. These studies are needed to establish the value of existing and/or future RPM models among patients, policy makers, and health care providers.

Yasin, OZ et al (2017) Noninvasive Blood Potassium Measurement Using Signal-Processed, Single-Lead Ecg Acquired From a Handheld Smartphone32

Objective:We have previously used a 12-lead, signal-processed ECG to calculate blood potassium levels. We now assess the feasibility of doing so with a smartphone-enabled single lead, to permit remote monitoring. Patients and Methods: Twenty-one hemodialysis patients held a smartphone equipped with inexpensive FDA-approved electrodes for three 2min intervals during hemodialysis. Individualized potassium estimation models were generated for each patient. ECG-calculated potassium values were compared to blood potassium results at subsequent visits to evaluate the accuracy of the potassium estimation models. Results: The mean absolute error between the estimated potassium and blood potassium 0.38±0.32 mEq/L (9% of average potassium level) decreasing to 0.6 mEq/L using predictors of poor signal.

Conclusions:A single-lead ECG acquired using electrodes attached to a smartphone device can be processed to calculate the serum potassium with an error of 9% in patients undergoing hemodialysis. Summary:A single-lead ECG acquired using electrodes attached to a smartphone can be processed to calculate the serum potassium in patients undergoing hemodialysis remotely.

Attia, ZI et al (2016) Novel Bloodless Potassium Determination Using a Signal-Processed Single-Lead ECG33

Background: Hyper- and hypokalemia are clinically silent, common in patients with renal or cardiac disease, and are life threatening. A noninvasive, unobtrusive, blood-free method for tracking potassium would be an important clinical advance.

Methods and Results: Two groups of hemodialysis patients (development group, n=26; validation group, n=19) underwent high-resolution digital ECG recordings and had 2 to 3 blood tests during dialysis. Using advanced signal processing, we developed a personalized regression model for each patient to noninvasively calculate potassium values during the second and third dialysis sessions using only the processed single-channel ECG. In addition, by analyzing the entire development group’s first-visit data, we created a global model for all patients that was validated against subsequent sessions in the development group and in a separate validation group. This global model sought to predict potassium, based on the T wave characteristics, with no blood tests required. For the personalized model, we successfully calculated potassium values with an absolute error of 0.36±0.34 mmol/L (or 10% of the measured blood potassium). For the global model, potassium prediction was also accurate, with an absolute error of 0.44±0.47 mmol/L for the training group (or 11% of the measured blood potassium) and 0.5±0.42 for the validation set (or 12% of the measured blood potassium).

Conclusions: The signal-processed ECG derived from a single lead can be used to calculate potassium values with clinically meaningful resolution using a strategy that requires no blood tests. This enables a cost-effective, noninvasive, unobtrusive strategy for potassium assessment that can be
used during remote monitoring.

Bonnet, Set al (2016) Wearable Impedance Monitoring System for Dialysis Patients34

This paper describes the development and the validation of a prototype wearable miniaturized impedance monitoring system for remote monitoring in home-based dialysis patients. This device is intended to assess the hydration status of dialysis patients using calf impedance measurements. The system is based on the low-power AD8302 component. The impedance calibration procedure is described together with the Cole parameter estimation and the hydric volume estimation. Results are given on a test cell to validate the design and on preliminary calf measurements showing Cole parameter variations during hemodialysis.

Montalibet, A et al (2016)Design and Development of an Impedimetric-Based System for the Remote Monitoring of Home-Based Dialysis Patients35

A key clinical challenge is to determine the desired ‘dry weight’ of a patient in order to terminate the dialysis procedure at the optimal moment and thus avoid the effects of over- and under-hydration. It has been found that the effects of haemodialysis on patients can be conveniently monitored using whole-body bioimpedance measurements. The identified need of assessing the hydrational status of patients undergoing haemodialysis at home gave rise to the present Dialydom (DIALYse à DOMicile) project. The aim of the project is to develop a convenient miniaturised impedance monitoring device for localised measurements (on the calf)in order to estimate an impedimetric hydrational index of the home-based patient, and to transmit this and other parameters to a remote clinical site. Many challenges must be overcome to develop a robust and valid home-based device. Some of these are presented in the paper.

Nayak, KS et al (2016) [Review] Telemedicine and Remote Monitoring:Supporting the Patient on Peritoneal Dialysis36

This review describes telemedicine platforms used to support home dialysis therapies, specifically peritoneal dialysis (PD), which can support patients living in remote areas and help them maintain a good level of independence while ensuring good outcomes.

Nicdao, MA et al (2016) ‘My Home Hemo’ app – a new telehealth tool for remote monitoring of patients on home haemodialysis37

As opposed to institutional and satellite dialysis, home dialysis is advocated as the preferred and cost-effective alternative to provide dialysis to a rising number of patients with end-stage kidney failure. Ongoing support to ensure success of a home dialysis program can be challenging because of limited nursing resources to visit patients who are often distributed over large geographical areas. Since patients on home haemodialysis (HHD) are reviewed much less frequently compared to those on institutional or satellite haemodialysis, we developed a telehealth information system, the Home Haemodialysis Remote Monitoring System (HHD-RMS), comprising of a mobile device application named ‘My Home Hemo’ app and a web portal for remote monitoring of patients’ dialysis parameters. This study reports our findings from analysing the dialysis data from the app, collected and reviewed on 74 patients over 21 weeks. Using this data increased occasions of patient review by 270% as compared to the previous two years, with an average of 12 patients’ dialysis data being remotely reviewed per week, resulting in 26 changes to dialysis prescriptions during the study period, and significant reduction in nursing and patient times associated with consultations and travel. Both patients and nursing staff reported high levels of satisfaction and ease of use. We conclude that this remote monitoring telehealth tool enabled nurses to remotely monitor dialysis parameters of patients on HHD, resulting in improved nursing efficiencies. The data allowed changes to be made to haemodialysis prescriptions and led to savings associated with patient and nursing time from the reduced need for travel. Anecdotally, the app also improved patient and staff satisfaction. This system has the potential for major health benefits to patients and cost savings to health services.

Tangaro, S et al (2016) Computer Aided Detection System for Prediction of the Malaise During Hemodialysis38

Monitoring of dialysis sessions is crucial as different stress factors can yield suffering or critical situations. Specialized personnel is usually required for the administration of this medical treatment; nevertheless, subjects whose clinical status can be considered stable require different monitoring strategies when compared with subjects with critical clinical conditions. In this case domiciliary treatment or monitoring can substantially improve the quality of life of patients undergoing dialysis. In this work, we present a Computer Aided Detection (CAD) system for the telemonitoring of patients’ clinical parameters. The CAD was mainly designed to predict the insurgence of critical events; it consisted of two Random Forest (RF) classifiers: the first one (RF1) predicting the onset of any malaise one hour after the treatment start and the second one (RF2) again two hours later. The developed system shows an accurate classification performance in terms of both sensitivity and specificity. The specificity in the identification of nonsymptomatic sessions and the sensitivity in the identification of symptomatic sessions for RF2 are equal to 86.60% and 71.40%, respectively, thus suggesting the CAD as an effective tool to support expert nephrologists in telemonitoring the patients.

Armignacco, P et al (2015) [Review] Wearable Devices for Blood Purification: Principles, Miniaturization, and Technical Challenges39

The prevalence of end-stage renal disease (ESRD) and renal replacement therapy (RRT) continue to increase, imposing staggering costs on providers. Strategies to optimize the treatment and improve survival are of fundamental importance. The development of the wearable artificial kidney (WAK) requires incorporation of basic components of a dialysis system into a wearable device that allows mobility, miniaturization, and, above all, patientoriented management. The technical requirements necessary for WAK can be divided into the following broad categories: dialysis membranes; dialysis regeneration; vascular access; patient monitoring systems; and power sources. Pumping systems for blood and other fluids are the most critical components of the device.


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