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Developing a classification system for haemoglobin management in patients with end-stage renal disease on haemodialysis: a secondary data analysis.

ABSTRACT: BACKGROUND:Ongoing discussion on anaemia management and target haemoglobin (Hb) levels in patients on haemodialysis with erythropoietin treatment require a systematic approach in evaluating current practice. Aim of the present study was to develop a new classification system to easily monitor Hb trajectories and categorise patients on haemodialysis. METHODS:Routine data from five dialysis centres in the USA collected between 2010 and 2016. Data were anonymised and only those from patients with fortnightly Hb values were included in the analysis. Entries on blood parameters and medication were standardised to achieve overall comparability. Data from each patient was grouped in periods of 120 days. Hb values above or below the target level of 10-12?g/dL were counted for each period. Periods were then assigned to Hb-classes according to the number of Hb values out of range per period: Hb-class I with 0-2, Hb-class II for 3-5 and Hb-class III for ?6 values out of range. RESULTS:Records from 3349 patients with fortnightly Hb values, information on haemodialysis data, laboratory parameters correlated to red blood cells and data on medication with erythropoiesis-stimulating agents (ESAs) were available. Patients were 64.4±15.9 years old; 55.0% were men. Statistical analysis revealed significant differences between Hb-classes in all of the examined parameters, except erythrocytes mean corpuscular volume and C reactive protein above the threshold, with more critical values in higher Hb-classes. The usage of ESAs showed a mean difference between Hb-class III and Hb-class I of 6.4 units/day and kilogram body weight in a 120-day period. CONCLUSION:Our classification system allows an easily achievable overview of the patients' responsiveness and performance of Hb management. Integrated into a disease management programme or continuous quality improvement, the classification delivers an instant appraisal without complex statistical or mathematical processing.

SUBMITTER: Kesztyus T

PROVIDER: S-EPMC5695337 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Developing a classification system for haemoglobin management in patients with end-stage renal disease on haemodialysis: a secondary data analysis.

Kesztyüs Tibor T Simonsmeier Ulrich U Kesztyüs Dorothea D

BMJ open 20171108 11

<h4>Background</h4>Ongoing discussion on anaemia management and target haemoglobin (Hb) levels in patients on haemodialysis with erythropoietin treatment require a systematic approach in evaluating current practice. Aim of the present study was to develop a new classification system to easily monitor Hb trajectories and categorise patients on haemodialysis.<h4>Methods</h4>Routine data from five dialysis centres in the USA collected between 2010 and 2016. Data were anonymised and only those from ...[more]

PMID: 29122793

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Project description:IntroductionHaemodialysis (HD) is the cornerstone treatment for patients with end-stage renal disease (ESRD). However, highly protein bound or large molecular weight uremic toxins such as phenolic and indolic compounds and homocysteine, which are associated with adverse outcomes such as cardiovascular disease of patients with ESRD, are difficult to remove via HD but can be effectively eliminates by haemoperfusion (HP). The proposed trial (referred to as HD/HP vs HD below) is a randomised, open-label, multicentre trial comparing HD plus HP versus HD alone in adult patients with ESRD. The primary endpoint measure is all-cause mortality.Methods and analysisWe plan to enrol 1364 maintenance HD patients from 11 medical centres in Shanghai. Participants will be randomised to receive HD plus HP or HD alone at a 1:1 ratio after 1-month run-in period. In both arms, patients will receive low-flux HD at a frequency of two times a week and haemodiafiltration at a frequency of once a week. In the intervention group, subjects also received HP once every 2 weeks. Follow-up is scheduled at 3, 6, 12, 18 and 24 months after randomisation, and will consist the following: routine physical examinations, standard lab panels (blood routine, liver/residual kidney functions, tests of the coagulation system, etc), dialysis adequacy (standard Kt/V), chest X-ray, ECG, echocardiography, heart function rating. Adverse events will be assessed according to the international conference on harmonisation guidelines. The primary outcome is 24-month all-cause mortality. Secondary outcomes will include cardiovascular-related mortality, the occurrence of major cardiovascular events and the quality of life.Ethics and disseminationThe study protocol has been approved by the Ethical Committees of all 11 participating centres. Clinical Research Unit of Xin Hua Hospital will oversee the study. The results will be presented at national and international academic meetings, and submitted to peer-reviewed journals for publications.Trial registration numberNCT03227770; Pre-results.

Project description:BackgroundPatients with end-stage renal disease on hemodialysis (ESRD-HD) and aortic stenosis have poor prognosis. The role of transcatheter aortic valve replacement (TAVR) in this high-risk population is debated.MethodsWe compared the outcomes among ESRD-HD Medicare beneficiaries who were managed with TAVR, surgical AVR (SAVR), or conservative management for aortic stenosis between 2015 and 2017, using overlap propensity score weighting analysis to control for differences in treatment assignment. The primary outcome was all-cause mortality and was compared between treatment groups as well as to age-sex matched mortality for ESRD-HD in the US population. Secondary outcomes included trend of heart failure hospitalizations.ResultsA total of 8107 ESRD-HD patients with aortic stenosis were included, 4130 (50%) underwent TAVR, 2565 (31.6%) underwent SAVR, and 1412 (17.4%) were managed conservatively. TAVR patients had more comorbidities and higher frailty compared with the other 2 groups. Thirty-day mortality was lower with TAVR compared with SAVR (4.6% versus 12.8%, P<0.01). After a median follow-up of 465 days (interquartile range, 261-759), on overlap propensity score weighting analysis, there was no difference in mortality between TAVR and SAVR (adjusted hazard ratio, 1.02 [95% CI, 0.91-1.15], P=0.7), and mortality was lower with TAVR compared with conservative management (adjusted hazard ratio, 0.53 [95% CI, 0.47-0.60], P<0.001). Standardized mortality ratios with TAVR, SAVR, and conservative management compared with age-sex matched ESRD-HD US population were 1.24, 1.27, and 1.83, respectively. The rate of heart failure admissions declined after TAVR (incidence rate ratio, 0.55 [95% CI, 0.48-0.62], P<0.001) and SAVR (incidence rate ratio, 0.76 [95% CI, 0.65-0.88], P<0.001).ConclusionsIn ESRD-HD patients with aortic stenosis, mortality was lower in the short-term with TAVR compared with SAVR but comparable in the mid-term. AVR is associated with an improvement in survival and reduction in heart failure hospitalizations compared with conservative management.

Project description:BackgroundHaemodialysis (HD) is one of the life-saving options for patients with end stage renal disease but demand for this treatment exceeds capacity in publicly funded hospitals. One novel approach to addressing this problem is through a shared-care model whereby government hospitals partner with qualified private HD service providers to increase the accessibility of HD for needy patients. The aim of this study is to evaluate and enhance the quality of care (QOC) provided in such a shared-care programme in Hong Kong, the Haemodialysis Public-Private Partnership Programme (HD-PPP).Methods/designThis is a longitudinal study based on Action Learning and Audit Spiral methodologies to measure the achievement of pre-set target standards for the HD-PPP programme over three evaluation cycles. The QOC evaluation framework is comprised of structure, process and outcome criteria with target standards in each domain developed from review of the evidence and in close collaboration with the HD-PPP working group. During each evaluation cycle, coordinators of each study site complete a questionnaire to determine adherence with structural criteria of care. Process and clinical outcomes, such as adverse events and dialysis adequacy, are extracted from the patient records of consenting study participants while face-to-face interviews are conducted to ascertain patient-reported outcomes such as self-efficacy and health-related quality of life.DiscussionThe study relies on the successful implementation of partnership-based action research to develop an evidence-based and pragmatic framework for evaluation of quality of care in an iterative fashion, and to use it to identify possible areas of quality enhancements in a shared-care programme for HD patients. The approach we take in this study emphasizes partnership and engagement with the clinical and administrative programme team, a robust but flexible evaluation framework, direct observation and the potential to realize positive change. The experience will be useful to inform the process of coordinating research studies involving multiple stakeholders and results will help to guide service planning and policy decision making.Trial registrationUS Clinical Trial Registry NCT02307903.

Dataset Information

Developing a classification system for haemoglobin management in patients with end-stage renal disease on haemodialysis: a secondary data analysis.

Publications

Developing a classification system for haemoglobin management in patients with end-stage renal disease on haemodialysis: a secondary data analysis.

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