Data Management and Quality Assurance for Dialysis Network

Marcelli, Daniele; Moscardo, Victor; Steil, H.; Day, Mark L.; Kirchgessner, Judith; Mitteregger, Alexander; Orlandini, G; Gatti, Emanuele

doi:10.1159/000060251

Cited by 27 publications

(22 citation statements)

References 1 publication

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“…A stepwise method was employed to obtain the best multivariate model. The -2 log likelihood ratio (-2 Log L) statistics were used for goodness of fit comparisons [8,9]. Estimated RRs and the hazards ratios (HR) for time to event analyses and their 95% confidence intervals (95% CIs) were calculated using estimated regression coefficients and their standard error.…”

Section: Statistical Analysesmentioning

confidence: 99%

Haemoglobin level and vascular access survival in haemodialysis patients

Garrancho¹,

Kirchgessner²,

Arranz³

et al. 2005

Nephrology Dialysis Transplantation

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Background. A full correction of anaemia in haemodialysis (HD) patients may lead to an increased risk of vascular access (VA) failure. We studied the relationship between haemoglobin (Hb) level and VA survival. Methods. Incident patients between January 2000 and December 2002 with <1 month on HD were considered. The relative risk (RR) of access failure was evaluated in four different groups of patients divided according to their Hb level (<10, 10-12, 12-13 and >13 g/dl). Other factors possibly influencing VA survival were also considered: age, gender, diabetes, vascular disease, intact parathyroid hormone (iPTH) and treatment with an angiotensin-converting enzyme (ACE) inhibitor, angiotensin receptor blocker (ARB) or recombinant human erythropoeitin therapy. Results. We studied 1254 patients (1057 with autologous fistulae, 75 grafts and 122 permanent catheters at admission). Based on Cox analysis, we found the next statistically significant RR of VA failure to be 2.3 times higher with grafts than with arterio-venous fistulae (AVFs) and 1.8 times higher in AVFs with Hb <10 g/dl than in AVFs of the next Hb group. There was no statistically significant difference in the RR of VA failure between patients with Hb 10-12 g/dl and those with Hb 12-13 g/dl or >13 g/dl. Diabetes (RR: 1.41, P ¼ 0.06), age >65 years (RR: 1.32; P ¼ 0.11) and iPTH (RR: 1.56; P ¼ 0.01) were identified as predictive factors for VA failure; ACE inhibitors or ARB (RR: 0.69; P ¼ 0.03) were found to be protective factors. Conclusions. In the studied population, the correction of Hb level to >12 g/dl was not associated with a higher incidence of VA thrombosis than in patients with Hb between 10 and 12 g/dl. ACE inhibitors or ARBs were found to be protective factors, and diabetes, age >65 years and iPTH >400 pg/ml were negative predictive factors for VA survival.

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Section: Statistical Analysesmentioning

confidence: 99%

Haemoglobin level and vascular access survival in haemodialysis patients

Garrancho¹,

Kirchgessner²,

Arranz³

et al. 2005

Nephrology Dialysis Transplantation

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“…All organizations have also established multiple levels of internal quality control in order to ensure data consistency and validity, to prevent implausible values and to reduce missing values [1,7,8,9,10]. Thus, at the level of the primary databases, the information is gathered in a consistent and uniform fashion and reflects the patient care as it is documented at the point of care.…”

Section: Resultsmentioning

confidence: 99%

“…The general structure as well as some aspects of the MONDO initiative have already been described [3]. In addition, the structure and content of some of the primary electronic databases that collaborate in the MONDO initiative have been reported previously [1,7,8,9,10]. …”

Section: Methodsmentioning

confidence: 99%

Monitoring Dialysis Outcomes across the World - The MONDO Global Database Consortium

Gersdorff¹,

Usvyat

Marcelli

et al. 2013

Blood Purif

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Background/Aims: Dialysis providers frequently collect detailed longitudinal and standardized patient data, providing valuable registries of routine care. However, even large organizations are restricted to certain regions, limiting their ability to separate effects of local practice from the pathophysiology shared by most dialysis patients. To overcome this limitation, the MONDO (MONitoring Dialysis Outcomes) research consortium has created a platform for the joint analysis of data from almost 200,000 dialysis patients worldwide. Methods: We examined design and operation of MONDO as well as its methodology with respect to patient inclusion, descriptive data and other study parameters. Results: MONDO partners contribute primary databases of anonymized patient data and collaboratively analyze populations across national and regional boundaries. To that end, datasets from different electronic health record systems are converted into a uniform structure. Patients are enrolled without systematic exclusions into open cohorts representing the diversity of patients. A large number of patient level treatment and outcome data is recorded frequently and can be analyzed with little delay. Detailed variable definitions are used to determine if a parameter can be studied in a subset or all databases. Conclusion: MONDO has created a large repository of validated dialysis data, expanding the opportunities for outcome studies in dialysis patients. The density of longitudinal information facilitates in particular trend analysis. Limitations include the paucity of uniform definitions and standards regarding descriptive information (e.g. comorbidities), which limits the identification of patient subsets. Through its global outreach, depth, breadth and size, MONDO advances the observational study of dialysis patients and care.

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“…Anonymized patient data were accessed through the European Clinical Database (EuCliD), which has been described elsewhere [9]. All patients consented that their data may be used for scientific research in the anonymised form.…”

Section: Methodsmentioning

confidence: 99%

Improved Survival of Incident Patients with High-Volume Haemodiafiltration: A Propensity-Matched Cohort Study with Inverse Probability of Censoring Weighting

Canaud

Bayh

Marcelli

et al. 2015

Nephron

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Background: Haemodiafiltration (HDF) is the preferred dialysis modality in many countries. The aim of the study was to compare the survival of incident patients on high-volume HDF (HV-HDF) with high-flux haemodialysis (HD) in a large-scale European dialysis population. Methods: The study population was extracted from 47,979 patients in 369 NephroCare centres throughout 12 countries. Baseline was six months after dialysis initiation; maximum follow-up was 5 years. Patients were either on HV-HDF (defined as with ≥21 litres substitution fluid volume per session) or on HD if on that treatment for ≥75% of the 3 months before baseline. The main predictor was treatment modality. Other parameters included country, age, gender, BMI, haemoglobin, albumin and Charlson comorbidity index. Propensity score matching and Inverse Probability of Censoring Weighting (IPCW) were applied to reduce bias by indication and consider modality crossover, respectively. Results: After propensity score matching, 1,590 incident patients remained. Kaplan-Meier and proportional Cox regression analyses revealed no significant survival advantage of HV-HDF. Results were biased by modality crossover: during the 5-year study period, 7% of HV-HDF patients switched to HD, and 55% of HD patients switched to HV-HDF. IPCW uncovered a statistically significant survival advantage of HV-HDF (OR 0.501; CI 0.366-0.684; p < 0.001). A higher benefit of HV-HDF for some subgroups was revealed, for example, non-diabetics, patients 65-74 years, patients with obesity or high blood pressure. Conclusions: This large-scale study supports the generalizability of previous RCT findings regarding the survival benefit of HV-HDF. Sub-group analysis showed that some sub-cohorts appear to benefit more from HV-HDF than others.

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Data Management and Quality Assurance for Dialysis Network

Cited by 27 publications

References 1 publication

Haemoglobin level and vascular access survival in haemodialysis patients

Haemoglobin level and vascular access survival in haemodialysis patients

Monitoring Dialysis Outcomes across the World - The MONDO Global Database Consortium

Improved Survival of Incident Patients with High-Volume Haemodiafiltration: A Propensity-Matched Cohort Study with Inverse Probability of Censoring Weighting

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