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      Dialyzer Reuse and Mortality Risk in Patients with End-Stage Renal Disease: A Systematic Review

      systematic-review

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          Abstract

          Background and Aim: Robust evidence about dialyzer reuse effects on mortality is not available. Our aim was to summarize the evidence for the effectiveness of dialyzer reuse compared to single use in patients with end-stage renal disease. Methods: We searched MEDLINE, Embase, CINAHL, SciELO, LILACS, USRDS ADR, universities’ theses databases and annals of congress from major nephrology societies. Reviewers performed the study selection and data extraction independently. We used the GRADE approach to assess the quality of the evidence. Mortality was the primary outcome. Results: A total of 1,190 studies were retrieved, and 14 were included in the review (n = 956,807 patients). The disinfectants used on dialyzer reprocessing were hypochlorite, formaldehyde, glutaraldehyde, and peracetic acid. The evidence available from the studies was of very low quality. Most studies found no differences between groups. In studies with statistically significant differences, these differences were not observed in all groups and they varied by the type of disinfectant, time of observation and treatment unit. Conclusions: No significant differences were identified for the superiority or inferiority of dialyzer reuse versus single use when assessing the mortality of patients with end-stage renal disease. Studies of higher quality, including randomized clinical trials, are required to provide conclusive evidence regarding the effectiveness and safety of dialyzer reuse.

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          Most cited references39

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          Association of CKD and cancer risk in older people.

          People with ESRD are at increased risk for cancer, but it is uncertain when this increased risk begins in the spectrum of chronic kidney disease (CKD). The aim of our study was to determine whether moderate CKD increases the risk for cancer among older people. We linked the Blue Mountains Eye Study, a prospective population-based cohort study of 3654 residents aged 49 to 97 yr, and the New South Wales Cancer Registry. During a mean follow-up of 10.1 yr, 711 (19.5%) cancers occurred in 3654 participants. Men but not women with at least stage 3 CKD had a significantly increased risk for cancer (test of interaction for gender P = 0.004). For men, the excess risk began at an estimated GFR (eGFR) of 55 ml/min per 1.73 m2 (adjusted hazard ratio [HR] 1.39; 95% confidence interval [CI] 1.00 to 1.92) and increased linearly as GFR declined. For every 10-ml/min decrement in eGFR, the risk for cancer increased by 29% (adjusted HR 1.29; 95% CI 1.10 to 1.53), with the greatest risk at an eGFR <40 ml/min per 1.73 m2 (adjusted HR 3.01; 95% CI 1.72 to 5.27). The risk for lung and urinary tract cancers but not prostate was higher among men with CKD. In conclusion, moderate CKD (stage 3) may be an independent risk factor for the development of cancer among older men but not women, and the effect of CKD on risk may vary for different types of cancer.
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            National surveillance of dialysis-associated diseases in the United States, 2002.

            In December 2002, all U.S. chronic hemodialysis centers were surveyed regarding selected patient care practices and dialysis-associated diseases. The results were compared with similar surveys conducted in previous years. In 2002, 85% of hemodialysis centers were free-standing and 81% operated for profit; the proportion of centers operating for profit has increased each year since 1985. During 1995-2002, the percentage of patients who received dialysis through central catheters increased from 13% to 26%; this trend is worrisome, as infections and antimicrobial use are higher among patients receiving dialysis through catheters. However, during the same period, the percentage of patients receiving dialysis through fistulas increased from 22% to 33%. The percentage of centers reporting one or more patients infected or colonized with vancomycin-resistant enterococci (VRE) increased from 12% in 1995 to 30% in 2002. During 1997-2002, the percentage of patients vaccinated against hepatitis B virus (HBV) infection increased from 47% to 56% and the percentage of staff vaccinated increased from 87% to 90%. In 2002, routine testing for antibody to hepatitis C virus (anti-HCV) was performed on patients at 64% of centers; anti-HCV was found in 7.8% of patients. In 2001, the Centers for Disease Control (CDC) published Recommendations for Preventing Transmission of Infections among Chronic Hemodialysis Patients. Centers were surveyed regarding their awareness of the recommendations and about a variety of infection control practices. In general, the incidence of HBV and HCV was not substantially different for the infection control practices evaluated, including where staff obtain clean supplies for patient treatment, reuse of unused and unopened supplies, and practices for changing external transducer filters/protectors. However, in 2002, the incidence of HBV infection was higher among patients in centers where injectable medications were prepared on a medication cart or medication area located in the treatment area compared to a dedicated medication room. Also, those centers that used a disposable container versus a nondisposable container for priming the dialyzer had a significantly lower incidence of HCV.
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              Issues regarding 'immortal time' in the analysis of the treatment effects in observational studies.

              In observational studies, treatment is often time dependent. Mishandling the time from the beginning of follow-up to treatment initiation can result in bias known as immortal time bias. Nephrology researchers who conduct observational research must be aware of how immortal time bias can be introduced into analyses. We review immortal time bias issues in time-to-event analyses in the biomedical literature and give examples from the nephrology literature. We also use simulations to quantify the bias in different methods of mishandling immortal time; intuitively explain how bias is introduced when immortal time is mishandled; raise issues regarding unadjusted treatment comparison, patient characteristics comparison, and confounder adjustment; and, using data from DaVita Inc., linked with the Centers for Medicare & Medicaid Services end-stage renal disease database, show that the severity of bias and the issues described can occur in actual data analyses of patients with end-stage renal disease. In the simulation examples, mishandling immortal time led to an underestimated hazard ratio (treatment vs. control), thus an overestimated treatment effect, by as much as 96%, and an overestimated hazard ratio by as much as 138%, depending on the distribution of 'survival' time and the method used. Results from the DaVita data were consistent with the simulation. Careful consideration of methodology is needed in observational analyses with time-dependent treatment.
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                Author and article information

                Journal
                AJN
                Am J Nephrol
                10.1159/issn.0250-8095
                American Journal of Nephrology
                S. Karger AG
                0250-8095
                1421-9670
                2012
                March 2012
                18 February 2012
                : 35
                : 3
                : 249-258
                Affiliations
                aFaculty of Medicine, University of Brasilia, Brasilia, bGetulio Vargas University Hospital, Federal University of Amazonas, Manaus, cMinistry of Health, Department of Science and Technology, Brasilia, and dFaculty of Pharmaceutical Sciences, Federal University of Amazonas, Manaus, Brazil
                Author notes
                *Tais Freire Galvao, Universidade de Brasilia, Campus Universitario, Faculdade de Medicina, Asa Norte, Brasilia, DF 70910-900 (Brazil), Tel. +55 61 3107 1894, E-Mail taisgalvao@gmail.com
                Article
                336532 Am J Nephrol 2012;35:249–258
                10.1159/000336532
                22353780
                278013b6-d297-45c5-9da4-ba129a7ce641
                © 2012 S. Karger AG, Basel

                Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                History
                : 19 December 2011
                : 14 January 2012
                Page count
                Figures: 1, Tables: 4, Pages: 10
                Categories
                In-Depth Topic Review

                Cardiovascular Medicine,Nephrology
                Chronic kidney failure,Systematic review,Reuse,Dialyzer,Mortality,Dialysis

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