Assessment of the perceptions of health-related quality of life in Greek patients undergoing automated peritoneal dialysis with remote monitoring: A qualitative study.

BACKGROUND: This study aimed to explore in depth the lived experience and quality of life outcomes in patients receiving automated peritoneal dialysis (APD) treatment. METHODS: The study adhered to the standards of the Consolidated Criteria for Reporting Qualitative Research. A total of 19 APD patients were recruited and assessed using in-depth semi-structured interviews on various aspects of life with respect to APD modality. The interviews were transcribed verbatim and analyzed using Interpretive Phenomenological Analysis. RESULTS: Study findings generated five superordinate themes: (a) treatment-free daily routine, (b) sleep disturbances, (c) remote care, (d) limitations of peritoneal dialysis, and (e) the dimension of chronic disease. Further analysis of the material revealed the relationship of these themes with individual patient characteristics. CONCLUSIONS: Overall, our findings suggest that APD characteristics contribute to the perceptions of quality of life in patients under dialysis considerably.

Impact of telemedical management on hospitalization and mortality in heart failure patients with diabetes: a post-hoc subgroup analysis of the TIM-HF2 trial.

BACKGROUND: The TIM-HF2 study demonstrated that remote patient management (RPM) in a well-defined heart failure (HF) population reduced the percentage of days lost due to unplanned cardiovascular hospital admissions or all-cause death during 1-year follow-up (hazard ratio 0.80) and all-cause mortality alone (HR 0.70). Higher rates of hospital admissions and mortality have been reported in HF patients with diabetes compared with HF patients without diabetes. Therefore, in a post-hoc analysis of the TIM-HF2 study, we investigated the efficacy of RPM in HF patients with diabetes. METHODS: TIM-HF2 study was a randomized, controlled, unmasked (concealed randomization), multicentre trial, performed in Germany between August 2013 and May 2018. HF-Patients in NYHA class II/III who had a HF-related hospital admission within the previous 12 months, irrespective of left ventricular ejection fraction, and were randomized to usual care with or without added RPM and followed for 1 year. The primary endpoint was days lost due to unplanned cardiovascular hospitalization or due to death of any cause. This post-hoc analysis included 707 HF patients with diabetes. RESULTS: In HF patients with diabetes, RPM reduced the percentage of days lost due to cardiovascular hospitalization or death compared with usual care (HR 0.66, 95% CI 0.48-0.90), and the rate of all-cause mortality alone (HR 0.52, 95% CI 0.32-0.85). RPM was also associated with an improvement in quality of life (mean difference in change in global score of Minnesota Living with Heart Failure Questionnaire score (MLHFQ): - 3.4, 95% CI - 6.2 to - 0.6). CONCLUSION: These results support the use of RPM in HF patients with diabetes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT01878630.

Tailoring remote patient management in cardiovascular risk management for healthcare professionals using panel management: a qualitative study.

BACKGROUND: While remote patient management (RPM) has the potential to assist in achieving treatment targets for cardiovascular risk factors in primary care, its effectiveness may vary among different patient subgroups. Panel management, which involves proactive care for specific patient risk groups, could offer a promising approach to tailor RPM to these groups. This study aims to (i) assess the perception of healthcare professionals and other stakeholders regarding the adoption and (ii) identify the barriers and facilitators for successfully implementing such a panel management approach. METHODS: In total, nineteen semi-structured interviews and two focus groups were conducted in the Netherlands. Three authors reviewed the audited transcripts. The Consolidated Framework for Implementation Strategies (CFIR) domains were used for the thematic analysis. RESULTS: A total of 24 participants (GPs, nurses, health insurers, project managers, and IT consultants) participated. Overall, a panel management approach to RPM in primary care was considered valuable by various stakeholders. Implementation barriers encompassed concerns about missing necessary risk factors for patient stratification, additional clinical and technical tasks for nurses, and reimbursement agreements. Facilitators included tailoring consultation frequency and early detection of at-risk patients, an implementation manager accountable for supervising project procedures and establishing agreements on assessing implementation metrics, and ambassador roles. CONCLUSION: Panel management could enhance proactive care and accurately identify which patients could benefit most from RPM to mitigate CVD risk. For successful implementation, we recommend having clear agreements on technical support, financial infrastructure and the criteria for measuring evaluation outcomes.

An Era of Digital Healthcare-A Comprehensive Review of Sensor Technologies and Telehealth Advancements in Chronic Heart Failure Management.

Heart failure (HF) is a multi-faceted, complex clinical syndrome characterized by significant morbidity, high mortality rate, reduced quality of life, and rapidly increasing healthcare costs. A larger proportion of these costs comprise both ambulatory and emergency department visits, as well as hospital admissions. Despite the methods used by telehealth (TH) to improve self-care and quality of life, patient outcomes remain poor. HF management is associated with numerous challenges, such as conflicting evidence from clinical trials, heterogeneity of TH devices, variability in patient inclusion and exclusion criteria, and discrepancies between healthcare systems. A growing body of evidence suggests there is an unmet need for increased individualization of in-hospital management, continuous remote monitoring of patients pre and post-hospital admission, and continuation of treatment post-discharge in order to reduce re-hospitalizations and improve long-term outcomes. This review summarizes the current state-of-the-art for HF and associated novel technologies and advancements in the most frequently used types of TH (implantable sensors), categorizing devices in their preclinical and clinical stage, bench-to-bedside implementation challenges, and future perspectives on remote HF management to improve long-term outcomes of HF patients. The Review also highlights recent advancements in non-invasive remote monitoring technologies demonstrated by a few pilot observational prospective cohort studies.

The Effect of Using a Remote Patient Management Platform in Optimizing Guideline-Directed Medical Therapy in Heart Failure Patients: A Randomized Controlled Trial.

BACKGROUND: Guideline-directed medical therapy (GDMT) remains underutilized in patients with heart failure with reduced ejection fraction, leading to morbidity and mortality. OBJECTIVES: The Medly Titrate (Use of Telemonitoring to Facilitate Heart Failure Mediation Titration) study was an open-label, randomized controlled trial to determine whether remote medication titration for patients with heart failure with reduced ejection fraction was more effective than usual care (UC). METHODS: In this study, 108 patients were randomized to remote GDMT titration through the Medly heart failure program (n = 56) vs UC (n = 52). The primary outcome was the proportion of patients completing GDMT titration at 6 months. Secondary outcomes included the number of clinic visits and time required to achieve titration, patient health outcomes, and health care utilization, including urgent clinic/emergency department visits and hospitalization. RESULTS: At 6 months, GDMT titration was completed in 82.1% (95% CI: 71.2%-90.8%) of patients in the intervention arm vs 53.8% in UC (95% CI: 41.1%-67.7%; P = 0.001). Remote titration required fewer in-person (1.62 ± 1.09 vs 2.42 ± 1.65; P = 0.004) and virtual clinic visits (0.50 ± 1.08 vs 1.29 ± 1.86; P = 0.009) to complete titration. Median time to optimization was shorter with remote titration (3.42 months [Q1-Q3: 2.99-4.04 months] vs 5.47 months [Q1-Q3: 4.14-7.33 months]; P < 0.001). The number of urgent clinic/emergency department visits (incidence rate ratio of remote vs control groups: 0.90 [95% CI: 0.53-1.56]; P = 0.70) were similar between groups, with a reduction in all-cause hospitalization with remote titration (incidence rate ratio: 0.55 [95% CI: 0.31-0.97]; P = 0.042). CONCLUSIONS: Remote titration of GDMT in heart failure with reduced ejection fraction was effective, safe, feasible, and increased the proportion of patients achieving target doses, in a shorter period of time with no excess adverse events compared with UC. (Use of Telemonitoring to Facilitate Heart Failure Mediation Titration [Medly Titrate]; NCT04205513).

Telerehabilitation in patients with recent hospitalisation due to acute decompensated heart failure: protocol for the Tele-ADHF randomised controlled trial.

BACKGROUND: Cardiac rehabilitation in patients with chronic heart failure (CHF) has favourable effects on exercise capacity, the risk at hospital (re-)admission and quality of life. Although cardiac rehabilitation is generally recommended it is still under-utilised in daily clinical practice, particularly in frail elderly patients after hospital admission, mainly due to low referral and patient-related barriers. Cardiac telerehabilitation (CTR) has the potential to partially solve these barriers. The purpose of this study is to evaluate the effects of CTR as compared to standard remote care after hospital admission on physical functional capacity in CHF patients. METHODS: In this randomised controlled trial, 64 CHF patients will be recruited during hospitalisation for acute decompensated heart failure, and randomised to CTR combined with remote patient management (RPM) or RPM alone (1:1). All participants will start with RPM after hospital discharge for early detection of deterioration, and will be up titrated to optimal medical therapy before being randomised. CTR will start after randomisation and consists of an 18-week multidisciplinary programme with exercise training by physical and occupational therapists, supported by a (remote) technology-assisted dietary intervention and mental health guiding by a physiologist. The training programme consists of three centre-based and two home-based video exercise training sessions followed by weekly video coaching. The mental health and dietary programme are executed using individual and group video sessions. A wrist-worn device enables remote coaching by the physical therapist. The web application is used for promoting self-management by the following modules: 1) goal setting, 2) progress tracking, 3) education, and 4) video and chat communication. The primary outcome measure is physical functional capacity evaluated by the Short Physical Performance Battery (SPPB) score. Secondary outcome measures include frailty scoring, recovery after submaximal exercise, subjective health status, compliance and acceptance to the rehabilitation programme, and readmission rate. DISCUSSION: The Tele-ADHF trial is the first prospective randomised controlled trial designed for evaluating the effects of a comprehensive combined RPM and CTR programme in recently hospitalised CHF patients. We hypothesize that this intervention has superior effects on physical functional capacity than RPM alone. TRIAL REGISTRATION: Netherlands Trial Registry (NTR) NL9619, registered 21 July 2021.

Remote patient management of heart failure across the ejection fraction spectrum: A pre-specified analysis of the TIM-HF2 trial.

AIMS: The benefit of non-invasive remote patient management (RPM) for patients with heart failure (HF) has been demonstrated. We evaluated the effect of left ventricular ejection fraction (LVEF) on treatment outcomes in the TIM-HF2 (Telemedical Interventional Management in Heart Failure II; NCT01878630) randomized trial. METHODS AND RESULTS: TIM-HF2 was a prospective, randomized, multicentre trial investigating the effect of a structured RPM intervention versus usual care in patients who had been hospitalized for HF within 12 months before randomization. The primary endpoint was the percentage of days lost due to all-cause death or unplanned cardiovascular hospitalization. Key secondary endpoints were all-cause and cardiovascular mortality. Outcomes were assessed by LVEF in guideline-defined subgroups of ≤40% (HF with reduced EF [HFrEF]), 41-49% (HF with mildly reduced EF [HFmrEF]), and ≥50% (HF with preserved EF [HFpEF]). Out of 1538 participants, 818 (53%) had HFrEF, 224 (15%) had HFmrEF, and 496 (32%) had HFpEF. Within each LVEF subgroup, the primary endpoint was lower in the treatment group, i.e. the incidence rate ratio [IRR] remained below 1.0. Comparing intervention and control group, the percentage of days lost was 5.4% versus 7.6% for HFrEF (IRR 0.72, 95% confidence interval [CI] 0.54-0.97), 3.3% versus 5.9% for HFmrEF (IRR 0.85, 95% CI 0.48-1.50) and 4.7% versus 5.4% for HFpEF (IRR 0.93, 95% CI 0.64-1.36). No interaction between LVEF and the randomized group became apparent. All-cause and cardiovascular mortality were also reduced by RPM in each subgroup with hazard ratios <1.0 across the LVEF spectrum for both endpoints. CONCLUSION: In the clinical set-up deployed in the TIM-HF2 trial, RPM appeared effective irrespective of the LVEF-based HF phenotype.

Effects of remote patient management on self-care behaviour in heart failure patients: results from the randomized TIM-HF2 trial.

AIMS: Remote patient management (RPM) in heart failure (HF) patients has beneficial clinical effects. This analysis investigates the effects of RPM used in the Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial on HF-specific self-care. METHODS AND RESULTS: From 2013 to 2017, 1538 HF outpatients (age 70.3 ± 10.5 years, 70% men, 52%/47% NYHA II/III, 65% LVEF ≤45%) with a recent HF hospitalization were included to the study and randomized to usual care (UC) plus RPM (n = 796) or UC only (n = 775), with a 12-month follow-up. Self-reported self-care behaviour at baseline and at end of study was assessed with the 9-item European Heart Failure Self-care Behaviour Scale (EHFScBS-9), obtaining 1321 patients with valid baseline and follow-up questionnaires for the analysis. EHFScBS-9 sum scores increased in the RPM group (n = 667) from 78.7 ± 17 to 84.5 ± 14 and in the UC group (n = 654) from 79.0 ± 17 to 80.0 ± 16 from baseline to 12 months [difference in means (MD) 4.58 (3.02, 6.14); P < 0.001] with highest improvement [8.66 (3.52; 13.81)] in patients living alone and having an inadequate (<70) baseline EHFScBS-9. There were differences between both groups in item 'I weight myself every day' [MD -1.13 (-1.24, -1.02); P < 0.001] and item 'I take my medication as prescribed' [MD -0.06 (-0.10, -0.01); P = 0.014]. No correlation was found between the EHFScBS-9 score and the efficacy of RPM on the TIM-HF2 primary endpoint of percentage of days lost due to unplanned cardiovascular hospitalization or death of any cause. CONCLUSIONS: RPM improves HF-specific self-care behaviour by achieving a better adherence to recommended HF regimen. REGISTRATION: ClinicalTrials.gov: NCT01878630.

Longer-Term Effects of Remote Patient Management Following Hospital Discharge After Acute Systolic Heart Failure: The Randomized E-INH Trial.

BACKGROUND: The randomized INH (Interdisciplinary Network Heart Failure) trial (N = 715) reported that 6 months' remote patient management (RPM) (HeartNetCare-HF) did not reduce the primary outcome (time to all-cause death/rehospitalization) vs usual care (UC) in patients discharged after admission for acute heart failure, but suggested lower mortality and better quality of life in the RPM group. OBJECTIVES: The Extended (E)-INH trial investigated the effects of 18 months' HeartNetCare-HF on the same primary outcome in an expanded population (N = 1,022) and followed survivors up to 60 months (primary outcome events) or up to 120 months (mortality) after RPM termination. METHODS: Eligible patients aged ≥18 years, hospitalized for acute heart failure, and with predischarge ejection fraction ≤40% were randomized to RPM (RPM+UC; n = 509) or control (UC; n = 513). Follow-up visits were every 6 months during RPM, and then at 36, 60, and 120 months. RESULTS: The primary outcome did not differ between groups at 18 months (60.7% [95% CI: 56.5%-65.0%] vs 61.2% [95% CI: 57.0%-65.4%]) or 60 months (78.1% [95% CI: 74.4%-81.6%] vs 82.8% [95% CI: 79.5%-86.0%]). At 60 and 120 months, all-cause mortality was lower in patients previously undergoing RPM (41.1% [95% CI: 37.0%-45.5%] vs 47.4% [95% CI: 43.2%-51.8%]; P = 0.040 and 64.0% [95% CI: 59.8%-68.2%] vs 69.6% [95% CI: 65.6%-73.5%]; P = 0.019). At all visits, health-related quality of life was better in patients exposed to HeartNetCare-HF vs UC. CONCLUSIONS: Although 18 months' HeartNetCare-HF did not significantly reduce the primary outcome of death or rehospitalization at 60 months, lower 120-month mortality in patients previously undergoing HeartNetCare-HF suggested beneficial longer-term effects, although the possibility of a chance finding remains.

Digital Health Applications to Establish a Remote Diagnosis of Orthopedic Knee Disorders: Scoping Review.

BACKGROUND: Knee pain is highly prevalent worldwide, and this number is expected to rise in the future. The COVID-19 outbreak, in combination with the aging population, rising health care costs, and the need to make health care more accessible worldwide, has led to an increasing demand for digital health care applications to deliver care for patients with musculoskeletal conditions. Digital health and other forms of telemedicine can add value in optimizing health care for patients and health care providers. This might reduce health care costs and make health care more accessible while maintaining a high level of quality. Although expectations are high, there is currently no overview comparing digital health applications with face-to-face contact in clinical trials to establish a primary knee diagnosis in orthopedic surgery. OBJECTIVE: This study aimed to investigate the currently available digital health and telemedicine applications to establish a primary knee diagnosis in orthopedic surgery in the general population in comparison with imaging or face-to-face contact between patients and physicians. METHODS: A scoping review was conducted using the PubMed and Embase databases according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) statement. The inclusion criteria were studies reporting methods to determine a primary knee diagnosis in orthopedic surgery using digital health or telemedicine. On April 28 and 29, 2021, searches were conducted in PubMed (MEDLINE) and Embase. Data charting was conducted using a predefined form and included details on general study information, study population, type of application, comparator, analyses, and key findings. A risk-of-bias analysis was not deemed relevant considering the scoping review design of the study. RESULTS: After screening 5639 articles, 7 (0.12%) were included. In total, 2 categories to determine a primary diagnosis were identified: screening studies (4/7, 57%) and decision support studies (3/7, 43%). There was great heterogeneity in the included studies in algorithms used, disorders, input parameters, and outcome measurements. No more than 25 knee disorders were included in the studies. The included studies showed a relatively high sensitivity (67%-91%). The accuracy of the different studies was generally lower, with a specificity of 27% to 48% for decision support studies and 73% to 96% for screening studies. CONCLUSIONS: This scoping review shows that there are a limited number of available applications to establish a remote diagnosis of knee disorders in orthopedic surgery. To date, there is limited evidence that digital health applications can assist patients or orthopedic surgeons in establishing the primary diagnosis of knee disorders. Future research should aim to integrate multiple sources of information and a standardized study design with close collaboration among clinicians, data scientists, data managers, lawyers, and service users to create reliable and secure databases.

Patient reported experience and adherence to remote patient management in chronic heart failure patients: a posthoc analysis of the TIM-HF2 trial.

AIMS: Remote patient management (RPM) enables early detection and prevention of deterioration in heart failure (HF) patients by measuring vital parameters. The analysis objective is to assess patient reported experience with RPM, adherence to daily measurements, and outline affecting factors both. METHODS AND RESULTS: Telemedical interventional management in-HF2 was conducted in 2013-18 with 1 538 HF patients with a 12-month follow-up. Under guidance of HF nurses, patients had to measure daily weight, blood pressure, electrocardiogram, and self-rated health status. At the end of the study, patients received a programme survey to analyse patient perceptions and satisfaction with telemedicine care and study organization. Adherence was distinguished between measurement of at least one [incomplete adherence (IA)] and all vital parameters [complete adherence (CA)] and defined as ratio of the number of days of measurements taken divided by the number of days of possible measurements. All data and group differences were analysed descriptively (mean ± SD) and by analysis of variance and t-test. Survey response rate was 79.7%. Patients were satisfied with the programme and device usability. CA was 89.1 ± 14.1%, consistently high over the study course and independent of severity of disease (left ventricular ejection fraction, N terminals pro brain natriuretic peptide, New York Heart Association). Lower IA was found with patients <70 years and prior to unplanned cardiovascular (CV) hospitalizations (difference by -5.2 ± 20.5%) and after unplanned CV hospitalizations compared with the entire study period (lower by -12.8 ± 24.7%). Patients from rural areas were found to have higher CA than patients from urban regions. CONCLUSIONS: With user-friendly devices, pre-interventional patient training, regular patient contact and close cooperation between primary physicians and telemedical centre, a long-lasting high adherence and satisfaction could be achieved. A change in adherence might detect health deterioration and indicate the need to intensify RPM. REGISTRATION: ClinicalTrials.gov (NCT01878630) and Deutsches Register Klinischer Studien (DRKS00010239).

Design and Haemodynamic Analysis of a Novel Anchoring System for Central Venous Pressure Measurement.

BACKGROUND/OBJECTIVE: In recent years, treatment of heart failure patients has proved to benefit from implantation of pressure sensors in the pulmonary artery (PA). While longitudinal measurement of PA pressure profoundly improves a clinician's ability to manage HF, the full potential of central venous pressure as a clinical tool has yet to be unlocked. Central venous pressure serves as a surrogate for the right atrial pressure, and thus could potentially predict a wider range of heart failure conditions. However, it is unclear if current sensor anchoring methods, designed for the PA, are suitable to hold pressure sensors safely in the inferior vena cava. The purpose of this study was to design an anchoring system for accurate apposition in inferior vena cava and evaluate whether it is a potential site for central venous pressure measurement. MATERIALS AND METHODS: A location inferior to the renal veins was selected as an optimal site based on a CT scan analysis. Three anchor designs, a 10-strut anchor, and 5-struts with and without loops, were tested on a custom-made silicone bench model of Vena Cava targeting the infra-renal vena cava. The model was connected to a pulsatile pump system and a heated water bath that constituted an in-vitro simulation unit. Delivery of the inferior vena cava implant was accomplished using a preloaded introducer and a dilator as a push rod to deploy the device at the target area. The anchors were subjected to manual compression tests to evaluate their stability against dislodgement. Computational Fluid Dynamics (CFD) analysis was completed to characterize blood flow in the anchor's environment using pressure-based transient solver. Any potential recirculation zones or disturbances in the blood flow caused by the struts were identified. RESULTS: We demonstrated successful anchorage and deployment of the 10-strut anchor in the Vena Cava bench model. The 10-strut anchor remained stable during several compression attempts as compared with the other two 5-strut anchor designs. The 10-strut design provided the maximum number of contact points with the vessel in a circular layout and was less susceptible to movement or dislodgement during compression tests. Furthermore, the CFD simulation provided haemodynamic analysis of the optimum 10-strut anchor design. CONCLUSIONS: This study successfully demonstrated the design and deployment of an inferior vena cava anchoring system in a bench test model. The 10-strut anchor is an optimal design as compared with the two other 5-strut designs; however, substantial in-vivo experiments are required to validate the safety and accuracy of such implants. The CFD simulation enabled better understanding of the haemodynamic parameters and any disturbances in the blood flow due to the presence of the anchor. The ability to place a sensor technology in the vena cava could provide a simple and minimally invasive approach for heart failure patients.

The Value of Technology to Support Dyadic Caregiving for Individuals Living With Heart Failure: Qualitative Descriptive Study.

BACKGROUND: The demand for health services to meet the chronic health needs of the aging population is significant and remains unmet because of the limited supply of clinical resources. Specifically, in managing heart failure (HF), digital health sought to address this gap during the COVID-19 pandemic but highlighted an access issue for those who could not use technology-mediated health care services without the support of their informal caregivers (ICs). The complexity of managing HF symptoms and recurrent exacerbations requires many patients to comanage their illness with their ICs in a care dyad, working together to optimize patient outcomes and health-related quality of life. However, most HF programs have missed the opportunity to consider the dyadic perspective despite interdependencies on HF outcomes. OBJECTIVE: This study aims to characterize the value of technology in supporting caregiving for individuals living with HF. METHODS: Motivated by an observed unique pattern of engagement in patients enrolled in our Medly HF management program at the Peter Munk Cardiac Centre in Toronto, Canada, we conducted 20 semistructured interviews with a convenience sample of ICs. All interviews were analyzed using the iterative refinement of a codeveloped codebook. The team maintained reflexivity journals to reflect the impact of their positionality on their coding. Themes were first derived deductively using HF typologies (patient-oriented dyads, caregiver-oriented dyads, and collaboratively oriented dyads) and then inductively refined and recategorized based on concepts from the van Houtven et al framework. RESULTS: We believe that there is a need to formally and intentionally expand HF technologies to include dyadic needs and goals. We suggest defining 3 opportunities in which value can be added to technological design. First, identify how technology may be leveraged to increase psychological bandwidth by reducing uncertainty and providing peace of mind. We found that actionable feedback was highly desired by both partners. Second, develop technology that can serve as a member of the dyad's support system. In our experience, automated prompts for patients to take measurements can mimic the support typically provided by ICs and ease their workload. Third, consider how technology can mitigate the dyad's clinical knowledge requirements and learning curve. Our approach includes real-time actionable feedback paired with a human-in-the-loop, nurse-led model of care. CONCLUSIONS: Our findings identified a need to focus on improving the dyadic experience as a whole by building IC functionality into digital health self-management interventions. Through a shared model of care that supports the role of the patient in their own HF management, includes ICs to expand and enhance the patient's capacity to care, and acknowledges the need of ICs to care for themselves, we anticipate improved outcomes for both partners.

Telemedicine and Clinical Outcomes in Peritoneal Dialysis: A Propensity-Matched Study.

INTRODUCTION: Telemedicine (TM) has shown to provide potential benefits on clinical outcomes in patients with chronic kidney disease but limited evidences published in the peritoneal dialysis (PD) population. This study aimed to explore the long-term effects of TM on the mortality and technique failure. METHODS: The Peritoneal Dialysis Telemedicine-assisted Platform Cohort Study (PDTAP Study) was conducted prospectively in 27 hospitals in China since 2016. Patient and practice data were collected through the doctor-end of the TM app (Manburs) for all participants. TM including self-monitoring records, on-line education materials, and real-time physician-patient contact was only performed for the patient-end users of the Manburs. The primary outcome was all-cause mortality. The secondary outcomes were cause-specific mortality and all-cause and cause-specific permanent transfer to hemodialysis. RESULTS: A total of 7,539 PD patients were enrolled between June 2016 and April 2019, with follow-up till December 2020. Patients were divided into two cohorts: TM group (39.1%) and non-TM group (60.9%). A propensity score was used to create 2,160 matched pairs in which the baseline covariates were well-balanced. There were significantly lower risks of all-cause mortality (HR 0.59 [0.51, 0.67], p < 0.001), CVD mortality (HR 0.59 [0.49, 0.70], p < 0.001), all-cause transfer to hemodialysis (0.57 [0.48, 0.67], p < 0.001), transfer to hemodialysis from PD-related infection (0.67 [0.51, 0.88], p = 0.003), severe fluid overload (0.40 [0.30, 0.55], p < 0.001), inadequate solute clearance (0.49 [0.26, 0.92], p = 0.026), and catheter-related noninfectious complications (0.41 [0.17, 0.97], p = 0.041) in the TM group compared with the non-TM group. CONCLUSION: This study indicated real-world associations between TM usage and reduction in patient survival and technique survival through a multicenter prospective cohort.

Use of digital health applications for the detection of atrial fibrillation.

The advances in health care technologies over the last decade have led to improved capabilities in the use of digital health applications (DiHA) for the detection of atrial fibrillation (AFib). Thus, home-based remote heart rhythm monitoring is facilitated by smartphones or smartwatches alone or combined with external sensors. The available products differ in terms of type of application (wearable vs. handheld) and the technique used for rhythm detection (electrocardiography [ECG] vs. photoplethysmography [PPG]). While ECG-based algorithms often require additional sensors, PPG utilizes techniques integrated in smartphones or smartwatches. Algorithms based on artificial intelligence allow for the automated diagnosis of AFib, enabling high diagnostic accuracy for both ECG-based and PPG-based DiHA. Advantages for clinical use result from the widespread accessibility of rhythm monitoring, thereby permitting earlier diagnosis and higher AFib detection rates. DiHA are also useful for the follow-up of patients with known AFib by monitoring the success of therapeutic interventions to restore sinus rhythm, e.g. catheter ablation. Although some studies strongly suggest a potential benefit for the use of DiHA in the setting of AFib, the overall evidence for an improvement in hard, clinical endpoints and positive effects on clinical care is scarce. To enhance the acceptance of DiHA use in daily practice, more studies evaluating their clinical benefits for the detection of AFib are required. Moreover, most of the applications are still not reimbursable, although the German Digital Health Care Act (Digitale-Versorgung-Gesetz, DVG) made reimbursement possible in principle in 2019.

Hurdles to developing and scaling remote patients' health management tools and systems: a scoping review.

BACKGROUND: Despite all the excitement and hype generated regarding the expected transformative impact of digital technology on the healthcare industry, traditional healthcare systems around the world have largely remained unchanged and resultant improvements in developed countries are slower than anticipated. One area which was expected to significantly improve the quality of and access to primary healthcare services in particular is remote patient monitoring and management. Based on a combination of rapid advances in body sensors and information and communication technologies (ICT), it was hoped that remote patient management tools and systems (RPMTSs) would significantly reduce the care burden on traditional healthcare systems as well as health-related costs. However, the uptake or adoption of above systems has been extremely slow and their roll out has not yet properly taken off especially in developing countries where they ought to have made the greatest positive impact. AIM: The aim of the study was to assess whether or not recent, relevant literature would support the development of in-community, design, deployment and implementation framework based on three factors thought to be important drivers and levers of RPMTS's adoption and scalability. METHODS: A rapid, scoping review conducted on relevant articles obtained from PubMed, MEDLINE, PMC and Cochrane databases and grey literature on Google and published between 2012 and May 2020, by combining a number of relevant search terms and phrases. RESULTS: Most RPMTSs are targeted at and focused on a single disease, do not extensively involve patients and clinicians in their early planning and design phases, are not designed to best serve a specific catchment area and are mainly directed at post-hospital, disease management settings. This may be leading to a situation where patients, potential patients and clinicians simply do not make use of these tools, leading to low adoption and scalability thereof. CONCLUSION: The development of a user-centred, context-dependent, customizable design and deployment framework could potentially increase the adoption and scalability of RPMTSs, if such framework addressed a combination of diseases, prevalent in a given specific catchment area, especially in developing countries with limited financial resources.

Remote Patient Management May Reduce All-Cause Mortality in Patients With Heart-Failure and Renal Impairment.

Background: Remote patient management (RPM) in heart failure (HF) patients has been investigated in several prospective randomized trials. The Telemedical Interventional Management in Heart Failure II (TIM-HF2)-trial showed reduced all-cause mortality and hospitalizations in heart failure (HF) patients using remote patient management (RPM) vs. usual care (UC). We report the trial's results for prespecified eGFR-subgroups. Methods: TIM-HF2 was a prospective, randomized, controlled, parallel-group, unmasked (with randomization concealment), multicenter trial. A total of 1,538 patients with stable HF were enrolled in Germany from 2013 to 2017 and randomized to RPM (+UC) or UC. Using CKD-EPI-formula at baseline, prespecified subgroups were defined. In RPM, patients transmitted their vital parameters daily. The telemedical center reviewed and co-operated with the patient's General Practitioner (GP) and cardiologist. In UC, patients were treated by their GPs or cardiologist applying the current guidelines for HF management and treatment. The primary endpoint was the percentage of days lost due to unplanned cardiovascular hospitalizations or death, secondary outcomes included hospitalizations, all-cause, and cardiovascular mortality. Results: Our sub analysis showed no difference between RPM and UC in both eGFR-subgroups for the primary endpoint (<60 ml/min/1.73 m2: 40.9% vs. 43.6%, p = 0.1, ≥60 ml/min/1.73 m2 26.5 vs. 29.3%, p = 0.36). In patients with eGFR < 60 ml/min/1.73 m2, 1-year-survival was higher in RPM than UC (89.4 vs. 84.6%, p = 0.02) with an incident rate ratio (IRR) 0.67 (p = 0.03). In the recurrent event analysis, HF hospitalizations and all-cause death were lower in RPM than UC in both eGFR-subgroups (<60 ml/min/1.73 m2: IRR 0.70, p = 0.02; ≥60 ml/min/1.73 m2: IRR 0.64, p = 0.04). In a cox regression analysis, age, NT-pro BNP, eGFR, and BMI were associated with all-cause mortality. Conclusion: RPM may reduce all-cause mortality and HF hospitalizations in patients with HF and eGFR < 60 ml/min/1.73 m2. HF hospitalizations and all-cause death were lower in RPM in both eGFR-subgroups in the recurrent event analysis. Further studies are needed to investigate and confirm this finding.

Using Facebook™ as a Platform for Remote Patient Care to Address Rehabilitation Needs in a Resource-Limited Environment During a Crisis.

The Covid 19 Pandemic affected Physiotherapy Clinics as much as it did all Clinical Services Provisions all over the world. This paper discusses a model where Facebook social media platform was successfully used as an emergency platform to deliver clinical services to the clients of a Physiotherapy Clinic in a Developing Country, during the Covid 19 pandemic.

Cost-effectiveness of noninvasive telemedical interventional management in patients with heart failure: health economic analysis of the TIM-HF2 trial.

BACKGROUND: Noninvasive remote patient management (RPM) in patients with heart failure (HF) has been shown to reduce the days lost due to unplanned cardiovascular hospital admissions and all-cause mortality in the Telemedical Interventional Management in Heart Failure II trial (TIM-HF2). The health economic implications of these findings are the focus of the present analyses from the payer perspective. METHODS AND RESULTS: A total of 1538 participants of the TIM-HF2 randomized controlled trial were assigned to the RPM and Usual Care group. Health claims data were available for 1450 patients (n = 715 RPM group, n = 735 Usual Care group), which represents 94.3% of the original TIM-HF2 patient population, were linked to primary data from the study documentation and evaluated in terms of the health care cost, total cost (accounting for intervention costs), costs per day alive and out of hospital (DAOH), and cost per quality-adjusted life year (QALY). The average health care costs per patient year amounted to € 14,412 (95% CI 13,284-15,539) in the RPM group and € 17,537 (95% CI 16,179-18,894) in the UC group. RPM led to cost savings of € 3125 per patient year (p = 0.001). After including the intervention costs, a cost saving of € 1758 per patient year remained (p = 0.048). CONCLUSION: The additional noninvasive telemedical interventional management in patients with HF was cost-effective compared to standard care alone, since such intervention was associated with overall cost savings and superior clinical effectiveness.

Early detection of atrial fibrillation in patients with heart failure reduces the risk of subsequent hospitalization: a subanalysis of the randomized TIM-HF2 trial.

Aims: To evaluate the rate of new-onset atrial fibrillation (AF) and the potential improved outcome in heart failure (HF) patients using non-invasive remote patient management (RPM) compared with usual care (UC). Methods and results: This analysis assessed a subgroup of 1538 patients of the TIM-HF2 trial with chronic HF, New York Heart Association Class II or III, admission to hospital for HF within 12 months before randomization, and a left ventricular ejection fraction (LVEF) of 45% or lower. Patients with AF in the baseline electrocardiogram (ECG), with an implanted cardiac device, a history of ablation therapy, and recent anticoagulation were excluded, leaving 347 patients for final analysis (RPM = 175; UC = 172). The percentage of days lost due to unplanned cardiovascular hospitalization or death of any cause (primary endpoint of TIM-HF2), the rate of newly detected AF, and the hospitalization rate due to AF were analysed. For patients with new AF, there was a significant reduction for the primary endpoint in the RPM group [5.5%, 95% confidence interval (CI) 0-11.6 vs. UC: 14.6%, 95% CI 8.0-21.2; P < 0.001]. Within the first 3 months, the detection rate of new AF was significantly higher in the RPM group (5.1%) compared with UC (1.2%), P = 0.035. After 1 year, 23 patients (13.1%) assigned to RPM and 12 patients (7.0%) assigned to UC had newly detected AF, P = 0.056. Unplanned hospitalizations related to AF were significantly lower in the RPM group (2 out of 23 patients vs. UC: 10 out of 12 patients; P < 0.001). Conclusion: In this subgroup of HF patients in the TIM-HF2 trial, non-invasive daily ECG transmission leads to a four times higher detection rate of new AF compared with UC. This was associated with a significant reduction of days lost due to unplanned cardiovascular hospitalizations, especially hospitalizations related to AF.