Search

Hemodiafiltration (HDF) is a renal replacement therapy that utilizes both diffusive clearance and convective transport to achieve greater clearance of middle-molecular-weight solutes. Among other factors, important prerequisites for the implementation of HDF include access to high-flux dialyzers, achievement of high blood flow rates, and availability of high volumes of sterile substitution/replacement fluids. Online hemodiafiltration (OL-HDF) is an established kidney replacement therapy, frequently used in many countries. Although in the United States, some prerequisites (e.g., access to high-flux dialyzers and achievement of high blood flow rates) for OL-HDF treatment are readily available; however, a machine capable of generating the online solution for OL-HDF is currently not available. As the clinical experience with HDF accumulates globally, it is worth examining the evidence for this kidney replacement therapy as used in routine clinical care. Such real-world evidence is increasingly recognized as valuable by clinicians and may inform regulatory decisions. In this review, we will focus on emerging global real-world data derived from routine clinical practices and examine how these data may complement those derived from clinical trials.

BACKGROUND AND AIMS Renal anemia management remains challenging for the nephrologist. Chronic inflammation, EPO resistance, uremia, malnutrition, iron deficiency, dialysis modalities, bleeding, infections, hydration status all interfere with erythropoiesis and erythrocytes half-life. Since 2013, >100 clinics in the FMC Nephrocare network have been using the Anemia Control Model (ACM), an artificial-intelligence based, certified medical device, decision support tool, to assist nephrologists in optimizing the monthly ESA and iron dose based on the specific characteristics of the patient and the amount of ESA dose already taken in the last 90 days. Based on this widespread experience, we sought to evaluate the real-world effectiveness of the use of ACM to facilitate hemoglobin target achievement among dialysis patients. METHOD In this historical cohort study, we analyzed electronic health records (EHR) of adult patients receiving in-center hemodialysis therapy in Fresenius Medical Care European dialysis clinics between 1 January 2015 and 31 December 2018 registered in the European Clinical Database (EuCliD®). We compared the rate of target achievement between patients treated with the ESA dose, suggested by ACM, against three control groups of patients treated in clinics without ACM and stratified by different target achievement rates for hemoglobin (Hb in the range of 10–12 g/dL or > 12 g/dL without ESA administration) (Fig. 1). To decrease indication bias, we matched patients belonging to the four comparison groups by a propensity-score assessing the likelihood of receiving the same dose suggested by ACM based on patients’ characteristics (i.e. demographic, comorbidities, anemia-related biomarkers and dialysis vintage). Centers where Hb target achievement 80% were classified as Tier 3 centers. Performance was evaluated in the month before the index date for all the patients in any given clinic. For each matched group, the index date corresponds to the date of dose suggestion (ACM group) or to the last Hb assessment date (for all matched patients belonging to other three control groups). The study endpoints were Hb target achievement, inappropriate ESA administration (ESA administration despite Hb > 12 g/dL) and severe anemia (Hb RESULTS After matching, we obtained four groups accounting for 8 5512 patient-months each. There were negligible differences in patients’ characteristics across the four matched groups (Table 1). In the ACM group, the Hb target achievement rate was 87.52/100 patient-months 95% confidence interval (95% CI): 86.89–88.15], inappropriate ESA use rate was 4.13/100 patient-months (95% CI: 3.99–4.27) and the incidence of severe anemia was 2.14/100 patient-months (95% CI: 2.04–2.24); the Hb target achievement rate ratio (95% CI) was 1.18 (1.17–1.2), 1.08 (1.07–1.09), 1.01 (1–1.02) for ACM versus Tier 1 centers, ACM versus Tier 2 centers and ACM versus Tier 3 centers, respectively. Rate ratio for inappropriate ESA administration were 0.37 (0.36–0.39), 0.49 (0.47–0.51), 0.66 (0.64–0.69) for ACM versus Tier 1 centers, ACM versus Tier 2 centers and ACM versus Tier 3 centers, respectively. The risk ratios for severe anemia were 0.43 (0.41–0.46), 0.65 (0.62–0.7), 0.95 (0.89–1.02) for ACM versus Tier 1 centers, ACM versus Tier 2 centers and ACM versus Tier 3 centers, respectively. CONCLUSION In this matched historical cohort study, we observed an increased hemoglobin target achievement rate, decreased inappropriate ESA usage and a decreased incidence of severe anemia among patients treated according to ACM suggestions. Target achievement rate among patients treated according to ACM suggestions was 87%. The magnitude of the effect in favor of ACM was larger in centers with a lower target achievement rate.

INTRODUCTION: Performance-based risk-sharing agreements (PBRSAs), between payers, health care providers, and technology manufacturers can be useful when there is uncertainty about the (cost-) effectiveness of a new technology or service. However, they can be challenging to design and implement. AREAS COVERED: A total of 18 performance-based agreements were identified through a literature review. All but two of the agreements identified were pay-for-performance schemes, agreed between providers and payers at the national level. No examples were found of agreements between health care providers and manufacturers at the local level. The potential for these local agreements was illustrated by hypothetical case studies of water quality management and an integrated chronic kidney disease program. EXPERT OPINION: Performance-based risk-sharing agreements can work to the advantage of patients, health care providers, payers, and technology manufacturers, particularly if they facilitate the introduction of technologies or systems of care that might not have been introduced otherwise. However, the design, conduct, and implementation of PBRSAs in renal care pose a number of challenges. Efforts should be made to overcome these challenges so that more renal care patients can benefit from technological advances and new models of care.

Objectives Comparative economic assessments of renal replacement therapies (RRT) are common and often used to inform national policy in the management of end-stage renal disease (ESRD). This study aimed to assess existing cost-effectiveness analyses of dialysis modalities and consider whether the methods applied and results obtained reflect the complexities of the real-world treatment pathway experienced by ESRD patients. Methods A systematic literature review (SLR) was conducted to identify cost-effectiveness studies of dialysis modalities from 2005 onward by searching Embase, MEDLINE, EBM reviews, and EconLit. Economic evaluations were included if they compared distinct dialysis modalities (e.g. in-centre haemodialysis [ICHD], home haemodialysis [HHD] and peritoneal dialysis [PD]). Results In total, 19 cost-effectiveness studies were identified. There was considerable heterogeneity in perspectives, time horizon, discounting, utility values, sources of clinical and economic data, and extent of clinical and economic elements included. The vast majority of studies included an incident dialysis patient population. All studies concluded that home dialysis treatment options were cost-effective interventions. Conclusions Despite similar findings across studies, there are a number of uncertainties about which dialysis modalities represent the most cost-effective options for patients at different points in the care pathway. Most studies included an incident patient cohort; however, in clinical practice, patients may switch between different treatment modalities over time according to their clinical need and personal circumstances. Promoting health policies through financial incentives in renal care should reflect the cost-effectiveness of a comprehensive approach that considers different RRTs along the patient pathway; however, no such evidence is currently available.

Background: Increasing healthcare expenditures have triggered a trend from volume to value by linking patient outcome to costs. This concept first described as value-based healthcare (VBHC) by Michael Porter is especially applicable for chronic conditions. This article aims to explore the applicability of the VBHC framework to the chronic kidney disease (CKD) care area. Methods: The 4 dimensions of VBHC (measure value; set and communicate value benchmarking; coordinate care; payment to reward value-add) were explored for the CKD care area. Available data was reviewed focusing on CKD initiatives in Europe to assess to what extent each of the 4 dimensions of VBHC have been applied in practice. Results: Translating VBHC into value-based renal care (VBRC) seems to be initiated to a limited extent in European health systems. In most cases not all dimensions of VBHC have been utilized in the renal care initiatives. Conclusion: The translation of VBHC into VBRC is possible and even desirable if an optimal treatment pathway for CKD patients could be achieved. This would require an organizational change in health system set up and should include a strategy focusing on full care responsibility. The patient outcome perspective and health economic analysis need to be the centre of attention.

Objectives: COVID-19 has emphasized the importance of home therapies, especially for dialysis patients requiring a continuous treatment preformed in a clinic given the high infection risk One major barrier for the provider is the economic impact in home hemodialysis (HHD) The study’s objective was to assess the quality and analyze the comprehensiveness of economic studies on HHD Methods: A systematic literature review (SLR) was conducted (February 2020) Publications were excluded with a patient no below 20, multiple baseline therapies and irrelevant comparators or outcomes The critical appraisal was performed using the Drummond checklist (1996) for economic evaluations (EE) and the Molinier checklist (2008) for costs/resources use studies Additionally, an appraisal was performed according to Petrovic et al 2020 to review cost components covered Results: The SLR identified 13 costs/resources use studies and 10 EEs The Molinier checklist highlighted that most studies didn’t discount costs nor tested major assumptions in a sensitivity analysis The Drummond checklist showed a) study design - no study justified choice of EE b) data collection – had the lowest average compliance c) analysis and interpretation of results – only one study provided details of statistical test(s) and confidence intervals The analysis of cost components showed 1) mixture between costs and reimbursement data 2) only one study accounted for patient’s productivity loss and none accounted for family/caregivers 3) none of the studies included costs of setting up a HHD program Conclusions: Most economic studies don’t report on all required criteria defined by the best practice checklists There are no economic studies that reflect all cost components associated with HHD Since reimbursement calculations also rely on accurate economic studies, this could lead to underrepresentation of costs when setting up HHD Uptake of HHD remains low and revised economic studies should be undertaken to increase uptake in the context of COVID-19

Objectives: Home therapies including Home Hemodialysis (HHD) are a priority on the policy agenda due to COVID-19 This study aims to evaluate the reimbursement landscape for HHD in Europe as a potential hurdle or accelerator to increase access to this therapy Methods: A systematic analysis of reimbursement schemes for HHD was performed in Europe (31 countries), according to 3 criteria: 1) existence of HHD reimbursement 2) HHD reimbursement level independently calculated 3) financially incentivized treatment schedule (FITS) Consequently, countries were matched with the uptake of HHD based on the ERA-EDTA registry and clustered according to these criteria Results: Of the 31 countries, 16 have a HHD reimbursement in place, of those 10 are independently calculated and had a FITS in place Unfortunately, not all countries included in the reimbursement analysis report into the ERA-EDTA registry For the countries meeting criteria 1 the average uptake of HHD was 0 9% (3 out of 6 countries) and for those meeting criteria 2/3 the average was 1 4% (8 out of 10 countries) Conclusions: The above results show that a limited number of countries have HHD reimbursement in place, which is the first hurdle to initiate treatment The countries that do have a reimbursement in place remain to have a low uptake irrespective of FITS Several reasons can underly this including;1) too low reimbursement level, which was excluded from this analysis, 2) hidden costs for HHD exist that are not reflected in the reimbursement 3) education of patients, healthcare staff and system is lacking Additionally, underreporting of HHD data in the ERA-EDTA registry could lead to misleading conclusions Therefore, our recommendation is to initiate best practice exchange and perform a micro-costing analysis for setting up a HHD program as a first step to increase uptake

Background: Professional truck drivers, as other shift workers, have been identified as a high-risk group for various health conditions including cardiovascular disease, obesity, diabetes, sleep apnoea and stress. Mobile health technologies can potentially improve the health and wellbeing of people with a sedentary lifestyle such as truck drivers. Yet, only a few studies on health promotion interventions related to mobile health technologies for truck drivers have been conducted. We aimed to explore professional truck drivers’ views on health promotion delivered via mobile health technologies such as wearable devices. Methods: We conducted a phenomenological qualitative study, consisting of four semi-structured focus groups with 34 full-time professional truck drivers in the UK. The focus groups were audio-taped, transcribed verbatim and analysed using thematic content analysis. We discussed drivers’ perceptions of their health, lifestyle and work environment, and their past experience and expectations from mobile health technologies. Results: The participants viewed their lifestyle as unhealthy and were aware of possible consequences. They expressed the need and wish to change their lifestyle, yet perceived it as an inherent, unavoidable outcome of their occupation. Current health improvement initiatives were not always aligned with their working conditions. The participants were generally willing to use mobile health technologies such as wearable devices, as a preventive measure to avoid prospect morbidity, particularly cardiovascular diseases. They were ambivalent about privacy and the risk of their employer’s monitoring their clinical data. Conclusions: Wearable devices may offer new possibilities for improving the health and wellbeing of truck drivers. Drivers were aware of their unhealthy lifestyle. They were interested in changing their lifestyle and health. Drivers raised concerns regarding being continuously monitored by their employer. Health improvement initiatives should be aligned with the unique working conditions of truck drivers. Future research is needed to examine the impact of wearable devices on improving the health and wellbeing of professional drivers. Published version