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      Association between health related quality of life and progression of chronic kidney disease

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          Abstract

          The impact of health-related quality of life (HRQOL) on outcomes remains unclear in chronic kidney disease (CKD) patients despite its importance in socioeconomic aspects and individual health. We aim to identify the relationship between HRQOL and progression of CKD in pre-dialysis patients. A total 1622 patients with CKD were analyzed in the KoreaN cohort Study for Outcomes in patients With Chronic Kidney Disease, a prospective cohort study. CKD progression was defined as one or more of the following: initiation of dialysis or transplantation, a two-fold increase in baseline serum creatinine levels, or a 50% decline in the estimated glomerular filtration rate during the follow-up period. The group with CKD progression had lower scores of HRQOL than the group without CKD progression. A fully adjusted Cox proportional hazard ratio model showed that each low baseline physical and mental component summary score was associated with a higher risk of CKD progression. In Kaplan-Meier survival analysis using propensity score matched data, only low physical component summary scores showed statistical significance with CKD progression. Our study highlights low physical component summary score for an important prognostic factor of CKD progression. Risk-modification interventions for high-risk patients may provide benefits to individuals.

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          GFR decline as an end point for clinical trials in CKD: a scientific workshop sponsored by the National Kidney Foundation and the US Food and Drug Administration.

          Andrew Levey, Lesley A. Inker, Kunihiro Matsushita … (2014)
          The US Food and Drug Administration currently accepts halving of glomerular filtration rate (GFR), assessed as doubling of serum creatinine level, as a surrogate end point for the development of kidney failure in clinical trials of kidney disease progression. A doubling of serum creatinine level generally is a late event in chronic kidney disease (CKD); thus, there is great interest in considering alternative end points for clinical trials to shorten their duration, reduce sample size, and extend their conduct to patients with earlier stages of CKD. However, the relationship between lesser declines in GFR and the subsequent development of kidney failure has not been well characterized. The National Kidney Foundation and Food and Drug Administration sponsored a scientific workshop to critically examine available data to determine whether alternative GFR-based end points have sufficiently strong relationships with important clinical outcomes of CKD to be used in clinical trials. Based on a series of meta-analyses of cohorts and clinical trials and simulations of trial designs and analytic methods, the workshop concluded that a confirmed decline in estimated GFR of 30% over 2 to 3 years may be an acceptable surrogate end point in some circumstances, but the pattern of treatment effects on GFR must be examined, specifically acute effects on estimated GFR. An estimated GFR decline of 40% may be more broadly acceptable than a 30% decline across a wider range of baseline GFRs and patterns of treatment effects on GFR. However, there are other circumstances in which these end points could lead to a reduction in statistical power or erroneous conclusions regarding benefits or harms of interventions. We encourage careful consideration of these alternative end points in the design of future clinical trials.
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            Association among SF36 quality of life measures and nutrition, hospitalization, and mortality in hemodialysis.

            H Humphreys, G Block, K. Kalantar-Zadeh … (2001)
            Patients on maintenance hemodialysis (MHD) often show substantial reductions in quality of life (QoL). The SF36 (Short Form with 36 questions), a well-documented, self-administered QoL scoring system that includes eight independent scales and two main dimensions, has been widely used and validated. In 65 adult outpatients on MHD, the SF36 and its scales and dimensions, scored as a number between 0 and 100, and the nutritional and inflammatory state measured by subjective global assessment, near-infrared (NIR) body fat, body mass index (BMI), and pertinent laboratory values, including hemoglobin, albumin, and C-reactive protein were assessed. Twelve-month prospective hospitalization rates and mortality were used as the clinical outcomes. Multivariate (case-mix) adjusted correlation coefficients were statistically significant between SF36 scores and serum albumin and hemoglobin concentrations. There were significant inverse correlations between SF36 scores and the BMI and NIR body fat percentage. Hypoalbuminemic, anemic, and obese patients on MHD had a worse QoL. Prospective hospitalizations correlated significantly with the SF36 total score and its two main dimensions (r between -0.28 and -0.40). The Cox proportional regression relative risk of death for each 10 unit decrease in SF36 was 2.07 (95% CI, 1.08 to 3.98; P = 0.02). Of the eight components and two dimensions of the SF36, the Mental Health dimension and the SF36 total score had the strongest predictive value for mortality. Thus, in patients on MHD the SF36 appears to have significant associations with measures of nutritional status, anemia, and clinical outcomes, including prospective hospitalization and mortality. Even though obesity, unlike undernutrition, is not generally an indicator of poor outcome in MHD, the SF36 may detect obese patients on MHD at higher risk for morbidity and mortality.
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              KNOW-CKD (KoreaN cohort study for Outcome in patients With Chronic Kidney Disease): design and methods

              Kook-Hwan Oh, Sue Park, Hayne Park … (2014)
              Background The progression and complications of chronic kidney disease should differ depending on the cause (C), glomerular filtration rate category (G), and albuminuria (A). The KNOW-CKD (KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease), which is a prospective cohort study, enrolls subjects with chronic kidney disease stages 1 to 5 (predialysis). Methods/Design Nine nephrology centers in major university hospitals throughout Korea will enroll approximately 2,450 adults with chronic kidney disease over a 5-year period from 2011 to 2015. The participating individuals will be monitored for approximately 10 years until death or until end-stage renal disease occurs. The subjects will be classified into subgroups based on the following specific causes of chronic kidney disease: glomerulonephritis, diabetic nephropathy, hypertensive nephropathy, polycystic kidney disease, and others. The eligible subjects will be evaluated at baseline for socio-demographic information, detailed personal/family history, office BP, quality of life, and health behaviors. After enrollment in the study, thorough assessments, including laboratory tests, cardiac evaluation and radiologic imaging, will be performed according to the standardized protocol. The biospecimen samples will be collected regularly. A renal event is defined by >50% decrease in estimated GFR (eGFR) from the baseline values, doubling of serum creatinine, or end-stage renal disease. The primary composite outcome consists of renal events, cardiovascular events, and death. As of September 2013, 1,470 adult chronic kidney disease subjects were enrolled in the study, including 543 subjects with glomerulonephritis, 317 with diabetic nephropathy, 294 with hypertensive nephropathy and 249 with polycystic kidney disease. Discussion As the first large-scale chronic kidney disease cohort study to be established and maintained longitudinally for up to 10 years, the KNOW-CKD will help to clarify the natural course, complication profiles, and risk factors of Asian populations with chronic kidney disease. Trial registration No. NCT01630486 at http://www.clinicaltrials.gov.
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                Author and article information

                Contributors
                Soo Wan Kim:
                ORCID: http://orcid.org/0000-0002-3540-9004
                skimw@chonnam.ac.kr
                Seong Kwon Ma: drmsk@hanmail.net
                Journal
                Journal ID (nlm-ta): Sci Rep
                Journal ID (iso-abbrev): Sci Rep
                Title: Scientific Reports
                Publisher: Nature Publishing Group UK (London )
                ISSN (Electronic): 2045-2322
                Publication date (Electronic): 20 December 2019
                Publication date PMC-release: 20 December 2019
                Publication date Collection: 2019
                Volume: 9
                Electronic Location Identifier: 19595
                Affiliations
                [1 ]ISNI 0000 0001 0356 9399, GRID grid.14005.30, Department of Internal Medicine, , Chonnam National University Medical School, ; Gwangju, Korea
                [2 ]ISNI 0000 0004 0470 5905, GRID grid.31501.36, Department of Internal Medicine, , Seoul National University College of Medicine, ; Seoul, Korea
                [3 ]ISNI 0000 0004 0470 4224, GRID grid.411947.e, Department of Internal Medicine, , The Catholic University of Korea, Seoul St. Mary’s Hospital, ; Seoul, Korea
                [4 ]ISNI 0000 0004 0470 5454, GRID grid.15444.30, Department of Internal Medicine, , College of Medicine, Institute of Kidney Disease Research, Yonsei University, ; Seoul, Korea
                Author information
                http://orcid.org/0000-0002-3540-9004
                Article
                Publisher ID: 56102
                DOI: 10.1038/s41598-019-56102-w
                PMC ID: 6925203
                PubMed ID: 31863079
                SO-VID: b953c866-eddb-407b-8ab0-b1c4b6caa788
                Copyright © © The Author(s) 2019
                License:

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.

                History
                Date received : 13 March 2019
                Date accepted : 6 December 2019
                Funding
                Funded by: This research was supported by the Research Program funded by the Korea Centers for Disease Control and Prevention (2011E3300300, 2012E3301100, 2013E3301600, 2013E3301601, 2013E3301602, 2016E3300200, 2019E320100), by the Bio & Medical Technology Development Program of the National Research Foundation (NRF) funded by the Korean government (MSIT) (2017M3A9E8023001), and by a grant (BCRI18027) Chonnam National University Hospital Biomedical Research Institute.
                Funded by: This research was supported by a grant (CRI 18016-1) Chonnam National University Hospital Biomedical Research Institute.
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                Subject: Article
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                ScienceOpen disciplines: Uncategorized
                Keywords: quality of life,end-stage renal disease
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                ScienceOpen disciplines: Uncategorized
                Keywords: quality of life, end-stage renal disease

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