EuCliD® – A Medical Registry

Steil, H.; Amato, Claudia; Carioni, C.; Kirchgessner, Judith; Marcelli, Daniele; Mitteregger, Alexander; Moscardo, Victor; Orlandini, G; Gatti, Emanuele

doi:10.1055/s-0038-1633841

Cited by 45 publications

(8 citation statements)

References 2 publications

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“…Raw, anonymised electronic patient‐level data,25 captured as part of normal clinical care, extracted and supplied quarterly, were limited to chronic HD patients (≥10 contiguous dialysis sessions) with accompanying laboratory data. Data were further restricted in this study to non‐parathyroidectomised, cinacalcet‐naïve (no cinacalcet use to the end of the first 90 days of follow‐up) patients who remained on study for ≥90 days.…”

Section: Methodsmentioning

confidence: 99%

Propensity score matching and persistence correction to reduce bias in comparative effectiveness: the effect of cinacalcet use on all‐cause mortality

Gillespie

Floege

Gioni

et al. 2015

Pharmacoepidemiol Drug Saf

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PurposeThe generalisability of randomised controlled trials (RCTs) may be limited by restrictive entry criteria or by their experimental nature. Observational research can provide complementary findings but is prone to bias. Employing propensity score matching, to reduce such bias, we compared the real‐life effect of cinacalcet use on all‐cause mortality (ACM) with findings from the Evaluation of Cinacalcet Therapy to Lower Cardiovascular Events (EVOLVE) RCT in chronic haemodialysis patients.MethodsIncident adult haemodialysis patients receiving cinacalcet, recruited in a prospective observational cohort from 2007–2009 (AROii; n = 10,488), were matched to non‐exposed patients regardless of future exposure status. The effect of treatment crossover was investigated with inverse probability of censoring weighted and lag‐censored analyses. EVOLVE ACM data were analysed largely as described for the primary composite endpoint.ResultsAROii patients receiving cinacalcet (n = 532) were matched to 1790 non‐exposed patients. The treatment effect of cinacalcet on ACM in the main AROii analysis (hazard ratio 1.03 [95% confidence interval (CI) 0.78–1.35]) was closer to the null than for the Intention to Treat (ITT) analysis of EVOLVE (0.94 [95%CI 0.85–1.04]). Adjusting for non‐persistence by 0‐ and 6‐month lag‐censoring and by inverse probability of censoring weight, the hazard ratios in AROii (0.76 [95%CI 0.51–1.15], 0.84 [95%CI 0.60–1.18] and 0.79 [95%CI 0.56–1.11], respectively) were comparable with those of EVOLVE (0.82 [95%CI 0.67–1.01], 0.83 [95%CI 0.73–0.96] and 0.87 [95%CI 0.71–1.06], respectively).ConclusionsCorrecting for treatment crossover, we observed results in the ‘real‐life’ setting of the AROii observational cohort that closely mirrored the results of the EVOLVE RCT. Persistence‐corrected analyses revealed a trend towards reduced ACM in haemodialysis patients receiving cinacalcet therapy. © 2015 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

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Section: Methodsmentioning

confidence: 99%

Propensity score matching and persistence correction to reduce bias in comparative effectiveness: the effect of cinacalcet use on all‐cause mortality

Gillespie

Floege

Gioni

et al. 2015

Pharmacoepidemiol Drug Saf

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“…The analysis of data from a retrospective cohort study used records from the European Clinical Database (EuCliD), a registry of medical data from HD patients at EU-FME dialysis centres, methodological details of which have been previously described [19]. Briefly, EuCliD contains detailed patient-level information on medical and drug history for all HD patients registered with the EU-FME, including records of key biochemical measurements and medications, and data on patient diagnoses, hospitalisations, and death codes based on the World Health Organization’s International Classification of Diseases, 10 th Revision (ICD-10) coding scheme.…”

Section: Methodsmentioning

confidence: 99%

Impact of mineral and bone disorder on healthcare resource use and associated costs in the European Fresenius medical care dialysis population: a retrospective cohort study

et al. 2012

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BackgroundSecondary hyperparathyroidism (SHPT) is associated with mortality in patients with chronic kidney disease (CKD), but the economic consequences of SHPT have not been adequately studied in the European population. We assessed the relationship between SHPT parameters (intact parathyroid hormone [iPTH], calcium, and phosphate) and hospitalisations, medication use, and associated costs among CKD patients in Europe.MethodsThe analysis of this retrospective cohort study used records of randomly selected patients who underwent haemodialysis between January 1, 2005 and December 31, 2006 at participating European Fresenius Medical Care facilities in 10 countries. Patients had ≥ 1 iPTH value recorded, and ≥ 1 month of follow-up after a 3-month baseline period during which SHPT parameters were assessed. Time at risk was post-baseline until death, successful renal transplantation, loss to follow-up, or the end of follow-up. Outcomes included cost per patient-month, rates of hospitalisations (cardiovascular disease [CVD], fractures, and parathyroidectomy [PTX]), and use of SHPT-, diabetes-, and CVD-related medications. National costs were applied to hospitalisations and medication use. Generalised linear models compared costs across strata of iPTH, total calcium, and phosphate, adjusting for baseline covariates.ResultsThere were 6369 patients included in the analysis. Mean ± SD person-time at risk was 13.1 ± 6.4 months. Patients with iPTH > 600 pg/mL had a higher hospitalisation rate than those with lower iPTH. Hospitalisation rates varied little across calcium and phosphate levels. SHPT-related medication use varied with iPTH, calcium, and phosphate. After adjusting for demographic and clinical variables, patients with baseline iPTH > 600 pg/mL had 41% (95% CI: 25%, 59%) higher monthly total healthcare costs compared with those with iPTH in the K/DOQI target range (150–300 pg/mL). Patients with baseline phosphate and total calcium levels above target ranges (1.13–1.78 mmol/L and 2.10–2.37 mmol/L, respectively) had 38% (95% CI: 27%, 50%) and 8% (95% CI: 0%, 17%) higher adjusted monthly costs, respectively. Adjusted costs were 25% (95% CI: 18%, 32%) lower among patients with baseline phosphate levels below the target range. Results were consistent in sensitivity analyses.ConclusionsThese data suggest that elevated SHPT parameters increase the economic burden of CKD in Europe.

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“…Data were obtained from the FMC clinical database EuCliD®, as previously described [25,26,27]. All patients signed informed consent for data evaluation at their entry into the FMC centers.…”

Section: Methodsmentioning

confidence: 99%

Type of Vascular Access and Survival among Very Elderly Hemodialysis Patients

et al. 2013

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The use of central venous catheters (CVC) for hemodialysis (HD) is associated with higher mortality compared to arteriovenous access (AV). However, studies analyzing the influence of the type of vascular access on the survival of very elderly patients (≥75 years) initiating HD are few and involve only a limited number of patients. We studied a cohort of 5,466 incident patients who started HD; of these, 1,841 were aged ≥75. Types of vascular access for HD were classified as either CVC, which included both tunneled and non-tunneled catheters, or AV, which included AV fistula and grafts. The outcome of the study was all-cause mortality during the follow-up period. In the whole cohort, AV use was associated with a survival advantage over CVC use (88 and 63% at 2 and 5 years, respectively, in patients with an AV as compared to 75 and 48% in patients with a CVC) (p < 0.0001). Among patients ≥75, CVC use was associated with a higher number of deaths compared to AV use. Patients ≥75 with an AV showed a greater survival as compared to patients ≥75 with a CVC (80 and 53% at 2 and 5 years, respectively, vs. 68 and 43%; p < 0.0001). Multivariate analysis revealed that CVC use and the presence of arrhythmia were independent risk factors of death in patients ≥75, whereas obesity was associated with greater survival. In conclusion, the type of vascular access has a significant influence on the survival of very elderly patients (≥75) initiating HD. CVC use was associated with poorer survival compared to AV access.

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EuCliD® – A Medical Registry

Cited by 45 publications

References 2 publications

Propensity score matching and persistence correction to reduce bias in comparative effectiveness: the effect of cinacalcet use on all‐cause mortality

Propensity score matching and persistence correction to reduce bias in comparative effectiveness: the effect of cinacalcet use on all‐cause mortality

Impact of mineral and bone disorder on healthcare resource use and associated costs in the European Fresenius medical care dialysis population: a retrospective cohort study

Type of Vascular Access and Survival among Very Elderly Hemodialysis Patients

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