This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
BackgroundKnowledge of the biological variation of serum or plasma creatinine (Cr) and the estimated glomerular filtration rate (eGFR) is important for understanding disease dynamics in Chronic Kidney Disease (CKD). The aim of our study was to determine the magnitude of random fluctuation of eGFR by determining its reference change value (RCV).MethodsWe performed a systematic review and meta-analysis of studies on biological variation of Cr. Relevant studies were identified by systematic literature search on PubMed. Additional studies were retrieved from the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Biological Variation Database. Random-effects meta-analysis was conducted to derive an overall estimate of intra-individual variation of creatinine (CVICr). Based on our estimate of CVICr and RCV for Cr, the RCV for the eGFR was determined.ResultsAmong identified studies, 37 met our inclusion criteria. Meta-analysis of all studies yielded a CVICr of 5.2% (95% confidence interval [CI] 4.6–5.8%), however high between-study heterogeneity (I2 = 82.3%) was found. Exclusion of outliers led to a significant reduction of heterogeneity while still including 85% of all studies and resulted in a slightly lower CVICr of 5.0% (95% CI 4.7–5.4%). Assuming an analytical variation of CVA 1.1%, we found an overall RCV for eGFR of ±16.5%. After exclusion of outlier studies, we found a minimum conservative RCV for eGFR of ±12.5%.ConclusionThe RCV of the eGFR represents a valuable tool for clinicians to discern true changes in kidney function from random fluctuation.
Background and Aims PROVALID is a prospective, observational, multinational cohort study in 4000 patients with type 2 diabetes mellitus. Our aim was to determine the incidence rate of renal and cardiovascular endpoints, as well as all-cause-mortality in different European countries and to identify risk factors associated with the investigated outcomes. Method Potential risk factors associated with the investigated outcomes were identified by calculation of the incidence rate ratio. Crude and adjusted incidence rates for every country were estimated using generalized linear (poisson) regression models and corresponding 95 % confidence intervals were computed. Incidence rates were adjusted for different risk factors including age, sex, estimated GFR, albuminuria, HbA1c, LDL, HDL, total cholesterol, systolic blood pressure, BMI and cardiovascular and renal comorbidities; among these several show significant impact on outcomes. The renal outcome was a composite of a sustained decline in the estimated GFR of at least 40%, a sustained increase in albuminuria of at least 30 % including the progression from normo- to micro- or macroalbuminuria, end-stage kidney disease, or death from renal causes. The cardiovascular composite endpoint was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Results 3461 participants of four European countries (Austria 18 %, Hungary 41 %, Netherlands 26 % and Scotland 15 %) with a mean follow up time of 3.9 years were included into this study. Participants from Poland were excluded due to missing follow-up data. In total, 9.2 % and 6.4 % participants reached the renal and cardiovascular composite endpoint, respectively. 7.0 % of the participants died within this timeframe. The adjusted incidence rate for the renal endpoint ranged from 14.5 to 25.3 (per 1000 patient-years) with no significant differences between countries. On average, the incidence rate was lower in Scotland (IR, 14.5; 95 % CI, 8.7 to 22.5) and in the Netherlands (IR, 15.7; 95 % CI, 10.9 to 21.8) compared to Hungary (IR, 25.3; 95 % CI, 20.7 to 30.6) and Austria (IR 21.3; 95 % CI, 16.2 to 27.5). The adjusted incidence rate for the cardiovascular endpoint ranged from 7.0 to 20.3 and was significantly lower in Hungary (IR, 7.0; 95 % CI, 5.1 to 9.3) and the Netherlands (IR, 7.6; 95 % CI, 4.4 to 12.2) compared to Austria (IR, 16.7; 95 % CI, 12.4 to 22.1) and Scotland (IR, 20.3; 95 % CI, 13.8 to 28.9). The adjusted incidence rate for all-cause-mortality ranged from 4.2 to 15.9 and was significantly lower in the Netherlands (IR, 4.2; 95 % CI, 2.2 to 7.6) compared to Scotland (IR, 15.9; 95 % CI, 10.9 to 22.6). No significant difference in the incidence rates between Austria (IR, 9.8; 95 % CI, 7.0 to 13.4) and Hungary (IR, 9.3; 95 % CI, 6.8 to 12.4) was found. Conclusion After adjustment for known risk factors, incidence rates of cardiovascular endpoints, as well as all-cause-mortality still vary significantly between four European countries. This may be due to manifold reasons. Further analysis of the national therapeutic practice pattern within the PROVALID cohort may provide additional information.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.