scholarly journals Benefits and harms of high-dose haemodiafiltration versus high-flux haemodialysis: the comparison of high-dose haemodiafiltration with high-flux haemodialysis (CONVINCE) trial protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e033228 ◽  
Author(s):  
Peter J Blankestijn ◽  
Kathrin I Fischer ◽  
Claudia Barth ◽  
Krister Cromm ◽  
Bernard Canaud ◽  
...  

IntroductionEnd-stage kidney disease (ESKD) is a major public health problem affecting more than 2 million people worldwide. It is one of the most severe chronic non-communicable diseases. Haemodialysis (HD) is the most common therapeutic option but is also associated with a risk of cardiovascular events, hospitalisation and suboptimal quality of life. Over the past decades, haemodiafiltration (HDF) has become available. Although high-dose HDF has shown some promising survival advantage compared to conventional HD, the evidence remains controversial. A Cochrane systematic review found, in low-quality trials, with various convective forms of dialysis, a reduction in cardiovascular, but not all-cause mortality and the effects on non-fatal cardiovascular events and hospitalisation were uncertain. In contrast, an individual patient data analysis suggested that high-dose HDF reduced both all-cause and cardiovascular mortality compared to HD. In view of these discrepant results, a definitive trial is required to determine whether high-dose HDF is preferable to high-flux HD. The comparison of high-dose HDF with high-flux HD (CONVINCE) study will assess the benefits and harms of high-dose HDF versus a conventional high-flux HD in adults with ESKD.Methods and analysisThis international, prospective, open label, randomised controlled trial aims to recruit 1800 ESKD adults treated with HD in nine European countries. Patients will be randomised 1:1 to high-dose HDF versus continuation of conventional high-flux HD. The primary outcome will be all-cause mortality at 3 years’ follow-up. Secondary outcomes will include cause-specific mortality, cardiovascular events, all-cause and infection-related hospitalisations, patient-reported outcomes (eg, health-related quality of life) and cost-effectiveness.Ethics and disseminationThe CONVINCE study will address the question of benefits and harms of high-dose HDF compared to high-flux HD for kidney replacement therapy in patients with ESKD with a focus on survival, patient perspectives and cost-effectiveness.Trial registration numberNetherlands National Trial Register (NTR 7138).

Author(s):  
Stephen L. Brown ◽  
Peter L. Fisher ◽  
Laura Hope-Stone ◽  
Heinrich Heimann ◽  
Rumana Hussain ◽  
...  

AbstractA number of patient-reported outcomes (PROs) predict increased mortality after primary cancer treatment. Studies, though, are sometimes affected by methodological limitations. They often use control variables that poorly predict life expectancy, examine only one or two PROs thus not controlling potential confounding by unmeasured PROs, and observe PROs at only a single point in time. To predict all-cause mortality, this study used control variables affording good estimates of life expectancy, conducted multivariate analyses of multiple PROs to identify independent predictors, and monitored PROs two years after diagnosis. We recruited a consecutive sample of 824 patients with uveal melanoma between April 2008 and December 2014. PROs were variables shown to predict mortality in previous studies; anxiety, depression, visual and ocular symptoms, visual function impairment, worry about cancer recurrence, and physical, emotional, social and functional quality of life (QoL), measured 6, 12 and 24 months after diagnosis. We conducted Cox regression analyses with a census date of December 2018. Covariates were age, gender, marital and employment status, self-reported co-morbidities, tumor diameter and thickness, treatment modality and chromosome 3 mutation status, the latter a genetic mutation strongly associated with mortality. Single predictor analyses (with covariates), showed 6-month depression and poorer functional QoL predicting mortality, as did 6–12 month increases in anxiety and 6–12 month decreases in physical and functional QoL. Multivariate analyses using all PROs showed independent prediction by 6-month depression and decreasing QoL over 6–12 months and 12–24 months. Elevated depression scores six months post-diagnosis constituted an increased mortality risk. Early intervention for depressive symptoms may reduce mortality.


2021 ◽  
Vol 7 (1) ◽  
pp. 25
Author(s):  
Patricia Concheiro-Moscoso ◽  
Betania Groba ◽  
Sílvia Monteiro-Fonseca ◽  
Nereida Canosa ◽  
Cristina Queirós

(1) Background: Stress is a major public health problem due to its relevant health, social and economic repercussions. Moreover, stress can be associated with work; when stress increases over time, burnout can occur, an occupational phenomenon recognized by the WHO in 2019. There is interest in the use of wearable devices to monitor and control stressors and their influence on the condition of workers. This study aims to identify the level of job stress and its influence on the quality of life of workers. (2) Methods:This longitudinal study was carried out between the end of May and mid-July 2021. Three assessment tools along with a daily and a weekly questionnaire were computerized through the RedCap platform. The participants had to fill out the diary and weekly questionnaires and wear a Xiaomi Mi Band 5 during the project. (3) Results and discussion: Thirty-six workers from the University of Coruña and from the University of Porto participated in the project. This study promotes the awareness of workers regarding their work stress and the influence of this factor on their quality of life using physiological (e.g., activity, sleep, and heart rate) and psychological indicators (self-report questionnaires in different moments).


Author(s):  
R. Ratheesh ◽  
Bindu Mohandas ◽  
P. P. Venugopalan ◽  
A. K. Sarada ◽  
Suprej K. ◽  
...  

Background: Quality of life (QOL) is individuals' perceptions of their position in life. QOL of alcohol dependent patients is an area that has received relatively less attention compared to other alcohol related problems.Methods: A deaddiction centre based cross sectional study was done on 370 individuals using a predesigned questionnaire during the period of 2012-2013. The data was analyzed using SPSS version 17. Spearman’s rank correlation test was used to find association between the study variables.Results: The mean age of the study subjects was 38.08±8.46 years. The mean duration of drinking was 12.62±7.47 years. The overall score of the QOL and the perceived health in alcohol dependent patients was 3.19±0.89 and 3.01±0.98 respectively. The mean of the transformed scores of physical, psychological, social and environmental domains are 69.12±12.82, 57.84±12.81, 58.52±17.05, 68.62±10.23 respectively. Statistical analysis of age with physical, environmental and social domains showed a significant negative correlation; literacy status with QOL, perceived health, physical, psychological, social and environmental domains showed a significant positive correlation; socio economic status with QOL and psychological domain showed a significant positive correlation; duration of drinking with QOL, perceived health, physical and psychological domain showed a significant negative correlation.Conclusions: Harm from alcohol use is a major public health problem. Reducing the level of social and health harms from alcohol requires preparation and planning.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Jarrin Penny ◽  
Fabio R Salerno ◽  
Lisa Hur ◽  
Christopher McIntyre

Abstract Background and Aims High flux dialysis membranes sufficiently remove smaller sized uremic toxins however, the accumulation and retention of larger middle molecular weight toxins, which are associated with chronic inflammation, cardiovascular disease and suboptimal outcomes are poorly cleared. The recent advent of medium-cut-off dialysis membranes, labelled “expanded dialysis” (HDx) are permeable to molecules of larger size responsible for poor clinical outcomes. However, it remains unclear if HDx can directly impact the symptoms associated with hemodialysis (HD). Symptom burden plays a significant role in quality of life (QOL) and mortality rates in the HD population. The London Evaluation of Illness (LEVIL), an application-based platform has been developed to measure patient reported outcomes (PROM). In comparison to cross-sectional PROM’s, LEVIL more accurately represents the fluctuations in daily symptoms and the impact of intervention. LEVIL evaluates general well-being, energy, sleep, appetite, pain and breathing, all of which are outcomes of interest on symptom burden in chronic kidney disease. Our aim was to determine if HDx therapy had any effect on symtoms/QOL domains using LEVIL. Method 28 patients from two dialysis centers in London Ontario were consented to participate. Patients were required to be over 18 years of age and on conventional thrice weekly maintenance HD for at least three months. 23 participants completed study and analyzed (five lost for various reasons). Baseline (BL) symptom characteristics were obtained while using high flux membrane for two weeks. Symptoms continued to be measured throughout the 12 weeks of HDx therapy two-three times weekly using LEVIL. Laboratory biomarkers including beta-2 microglobulin and free-light chains were collected at baseline and after 12 weeks of HDx therapy. Results Patients were stratified into tertiles (high/middle/low) using mean values of BL symptoms scores in each domain (wellbeing, energy, sleep, appetite, pain, breathing). Those in the high BL group were labeled as “control”. Low and middle BL measures were further stratified into responders vs. non-responders (responders were considered to have a 50% increase in any symptom domain by ≥50%). Of those domains which responded to HDx, 76% also had low BL scores with 27% having middle BL scores. General wellbeing, energy and sleep were domains with the greatest response reaching statistical significance after eight weeks of therapy. HDx had limited effect on appetite, pain and breathing. Although stratification was per domain, overall, 74% of the population studied did respond in at least one domain, with some responding in as many as five. Conclusion HDx using Theranova (Baxter) shows the most benefit in domains with low BL measures. Additionally, not everyone who had low BL scores responded after 12 weeks of therapy, leaving us to question whether HDx may have a latent effect in some individuals/populations. Those who had no response to therapy in certain domains also had greater baseline quality of life respectively. This information may assist in decision making/rationale for the utilization and implementation of such therapy. Although more work is required to further stratify symptoms in relation to demographic/biochemical finding and clinical outcomes. It is evident that HDx improves patient reported symptoms and QOL.


2020 ◽  
pp. 1-9
Author(s):  
Juan Carlos Alarcon ◽  
Alfonso Bunch ◽  
Freddy Ardila ◽  
Eduardo Zuñiga ◽  
Jasmin I. Vesga ◽  
...  

<b><i>Introduction:</i></b> A new generation of hemodialysis (HD) membranes called medium cut-off (MCO) membranes possesses enhanced capacities for middle molecule clearance, which have been associated with adverse outcomes in this population. These improvements could potentially positively impact patient-reported outcomes (PROs). <b><i>Objective:</i></b> The objective of this study was to evaluate the impact of MCO membranes on PROs in a cohort of HD patients in Colombia. <b><i>Methods:</i></b> This was a prospective, multicenter, observational cohort study of 992 patients from 12 renal clinics in Colombia who were switched from high-flux HD to MCO therapy and observed for 12 months. Changes in Kidney Disease Quality of Life 36-Item Short Form Survey (KDQoL-SF36) domains, Dialysis Symptom Index (DSI), and restless legs syndrome (RLS) 12 months after switching to MCO membranes were compared with time on high-flux membranes. Repeated measures of ANOVA were used to evaluate changes in KDQoL-SF36 scores; severity scoring was used to assess DSI changes over time; Cochran’s Q test was used to evaluate changes in frequency of diagnostic criteria of RLS. <b><i>Results:</i></b> During 12 months of follow-up, 3 of 5 KDQoL-SF36 domains improved compared with baseline: symptoms (<i>p</i> &#x3c; 0.0001), effects of kidney disease (<i>p</i> &#x3c; 0.0001), and burden of kidney disease (<i>p</i> &#x3c; 0.001). The proportion of patients diagnosed with RLS significantly decreased from 22.1% at baseline to 10% at 12 months (<i>p</i> &#x3c; 0.0001). No significant differences in the number of symptoms (DSI, <i>p =</i> 0.1) were observed, although their severity decreased (<i>p</i> = 0.009). <b><i>Conclusions:</i></b> In conventional HD patients, the expanded clearance of large middle molecules with MCO-HD membranes was associated with higher health-related quality of life scores and a decrease in the prevalence of RLS.


2019 ◽  
Vol 7 (5) ◽  
pp. 824-830 ◽  
Author(s):  
Mahdi Moshki ◽  
Abdoljavad Khajavi ◽  
Haydeh Hashemizadeh ◽  
Farveh Vakilian ◽  
Shima Minaee ◽  
...  

BACKGROUND: Heart failure (HF) is a major public health problem in different societies and has numerous impacts on quality of life (QOL). AIM: The present study was carried out with the aim to explore the experience of HF patients regarding the negative effects of the disease on their QOL. METHODS: In this qualitative exploratory study data collection was performed through face-to-face, semi-structured, in-depth interviews with 19 patients with HF, who were selected through purposive sampling method from April to September 2017. Data analysis was carried out based on the framework analysis method. RESULTS: The negative consequences of HF on QOL emerged in the form of 6 main themes including symptoms, disease complications, cognitive impairment, psychological distress, functional limitations and economic problems. Most of the participants (14 out of 19) assessed their QOL as well or very well. CONCLUSION: The majority of the patients in this study, despite the many negative impacts of HF, had a high QOL that could indicate their satisfaction and effective coping with HF by creating a positive outlook and the perceived positive effects of the disease.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Kazuyoshi Okada ◽  
Hiroyuki Michiwaki ◽  
Manabu Tashiro ◽  
Tomoko Inoue ◽  
Hisato Shima ◽  
...  

Abstract Background All-cause mortality can be reduced in patients receiving European-style high-volume post-dilution online hemodiafiltration (post-OHDF) compared with hemodialysis (HD). Japanese-style high-volume pre-dilution online hemodiafiltration (pre-OHDF) can also decrease all-cause mortality. No studies have investigated survival in patients receiving Japanese-style post-OHDF, and directly compared survival between pre-OHDF and post-OHDF. This study sought to clarify these issues. Methods We conducted this retrospective observational study at multiple facilities of our medical corporation, which have similar quality of healthcare management, from July 1, 2017 to July 1, 2020. Japanese-style OHDF included pre-OHDF and post-OHDF. Pre-OHDF and post-OHDF were each divided into high-volume and low-volume subgroups. We compared 3-year all-cause mortality and cardiovascular events between OHDF and high-flux HD using propensity score matching. In addition, we examined the effects of different modalities through comparisons between high-volume and low-volume pre-OHDF and between pre-OHDF and post-OHDF. Results Post-OHDF was associated with significantly lower all-cause mortality (P = 0.004, log-rank test; hazard ratio [HR] 0.257, 95% confidence interval [CI] 0.094–0.701) and cardiovascular events during all 3 years (P < 0.05) compared with HD. High-volume post-OHDF was associated with lower all-cause mortality compared with hemodialysis (log-rank test P = 0.022) but low-volume post-OHDF was not. Pre-OHDF was also associated with lower all-cause mortality (P < 0.001, log-rank test; HR 0.316; 95% CI 0.212–0.472) compared with HD but was not associated with cardiovascular events. All-cause mortality did not significantly differ between post-OHDF and pre-OHDF. Conclusions These findings suggest that Japanese-style post-OHDF may improve all-cause mortality to a level similar to that of pre-OHDF and that post-OHDF, particularly high-volume post-OHDF may reduce cardiovascular events.


Author(s):  
Danielle M. Gillard ◽  
Jeffrey D. Sharon

Abstract Purpose of Review To summarize and critically review recent literature on the relative cost-effectiveness of hearing augmentation versus stapes surgery for the treatment of otosclerosis. Recent Findings Otosclerosis leads to reduced patient quality of life, which can be ameliorated by either stapes surgery, or hearing aid usage. The success of stapes surgery is high, and the risks of serious postoperative complications are low. Hearing aids don’t have the complications of surgery but are associated with long-term costs. Cost-effectiveness models have shown that stapes surgery is a cost-effective method for treating otosclerosis. Summary Both stapes surgery and hearing aids can improve patient-reported quality of life in otosclerosis. Stapes surgery has larger upfront costs and surgical risks, but hearing aids are associated with longer lifetime costs. Stapes surgery is cost-effective for the treatment of otosclerosis.


2021 ◽  
Vol 50 (Supplement_1) ◽  
Author(s):  
Aung Zaw Zaw Phyo ◽  
Joanne Ryan ◽  
David Gonzalez-Chica ◽  
John McNeil ◽  
Robyn Woods ◽  
...  

Abstract Background Health-related quality of life (HRQoL) is a measure of an individual’s self-perceived health status. Few studies have examined HRQoL as a risk factor for mortality. This study examined whether HRQoL predicts all-cause mortality in older community-dwelling individuals from Australia and the United States enrolled in the Aspirin in Reducing Events in the Elderly (ASPREE) trial, and if this association varies across gender. Methods The 19,106 persons aged 65–98 years and free of known major life-limiting disease, who completed the 12-item short form (SF-12) HRQoL at ASPREE-baseline (2010–2014) were followed prospectively until 2017 for all-cause mortality. Cox proportional-hazard models were used to determine the association between the physical (PCS) and mental component scores (MCS) of HRQoL and all-cause mortality, adjusting for sociodemographic factors, health-related behaviours, and clinical measures. Results There were 1,052 deaths over a median 4.7-year of follow-up, with 11.9 events per 1,000 person-years. A 10-unit increase in PCS was associated with a 17% decrease in all-cause mortality (95%CI: 0.77, 0.89). MCS was not associated with all-cause mortality. There was no evidence these associations were different between males and females (P-values for interaction: PCS 0.13 and MCS 0.44). Conclusions PCS, but not MCS, was inversely associated with all-cause mortality in this large cohort of healthy older individuals. Key messages Our findings support the decision of the Australian Commission on Safety and Quality in Health Care to incorporate the SF-12 into the routine collection of Patient Reported Outcome Measures as a policy goal for the Australian health system.


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