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• W2565339972 abstract "Related Article, p. 41 Related Article, p. 41 Recently, there has been increasing interest in better understanding the transition from the pre−end-stage renal disease (ESRD) phase to the ESRD phase of chronic kidney disease (CKD), defined operationally as before and after initiation of long-term renal replacement therapy. For example, this transition is the focus of a new US Renal Data Systems (USRDS) Special Study, which published a chapter on “transition of care” in the 2015 USRDS Annual Data Report.1Saran R. Li Y. Robinson B. et al.US Renal Data System 2015 Annual Data Report: epidemiology of kidney disease in the United States.Am J Kidney Dis. 2016; 67: S1-S434PubMed Google Scholar During this transition, patients are at a very vulnerable state and rates of adverse events are very high. It is also a period when nephrologists make many critical management decisions. Although a sizeable literature has been published regarding the association between timing of initiation of dialysis therapy and adverse outcomes,2Susantitaphong P. Altamimi S. Ashkar M. et al.GFR at initiation of dialysis and mortality in CKD: a meta-analysis.Am J Kidney Dis. 2012; 59: 829-840Abstract Full Text Full Text PDF PubMed Scopus (90) Google Scholar less is known about the impact of reasons for initiation of dialysis therapy. In this issue of AJKD, Rivara et al3Rivara M.B. Chen C.H. Nair A. Cobb D. Himmelfarb J. Mehrotra R. Indication for dialysis initiation and mortality in patients with chronic kidney failure: a retrospective cohort study.Am J Kidney Dis. 2017; 69: 41-50Abstract Full Text Full Text PDF PubMed Scopus (27) Google Scholar add provocative new information to the field. The authors retrospectively reviewed the medical records of 461 patients who initiated maintenance dialysis (mostly hemodialysis) therapy in the Seattle region. During a median follow-up of 2.4 years, they observed 183 (40%) deaths. Rivara et al found that patients initiating dialysis therapy due to volume overload have increased risk for mortality compared with patients initiating dialysis therapy for all other reasons, even after adjusting for observed differences in patient characteristics (adjusted hazard ratio, 1.69; 95% confidence interval, 1.02-2.80). Those who initiated dialysis therapy primarily for uremic symptoms or for other/unknown reasons had similar risks compared with patients who initiated dialysis therapy primarily for laboratory evidence of kidney function decline (the reference group). Interestingly, this effect appeared to vary by subgroup: higher risk for death among those who initiated dialysis therapy due to volume overload was seen in the subset of patients who initiated dialysis therapy via a permanent vascular access, in those deemed to have nonurgent starts, and in those who initiated in an outpatient setting. However, this phenomenon was not observed in those who initiated dialysis therapy by a central venous catheter, those deemed to have urgent starts, and those who initiated in an inpatient setting. This study adds to the growing literature indicating that clinical events and medical management during the pre-ESRD phase of CKD have an important impact on outcomes after the onset of ESRD. Although it has been appreciated for a number of years that clinical events and medical management during the pre-ESRD phase of CKD could affect outcomes after the onset of ESRD,4Pereira B.J.G. Optimization of pre-ESRD care: the key to improved dialysis outcomes.Kidney Int. 2000; 57: 351-365Abstract Full Text Full Text PDF PubMed Scopus (130) Google Scholar the available data sources to study these connections rigorously have been relatively limited. An important reason has been that studies of incident patients with ESRD, such as the Choices for Healthy Outcomes in Caring for End-Stage Renal Disease (CHOICE), the Comprehensive Dialysis Study (CDS), or the Dialysis Outcomes and Practice Patterns Study (DOPPS), begin collecting data at or following dialysis therapy initiation and do not assess the years prior to dialysis therapy initiation. Meanwhile, the original design for prospective studies of CKD, such as the Modification of Diet in Renal Disease (MDRD) Study or the African-American Study of Kidney Disease and Hypertension (AASK), ended follow-up at the start of ESRD and did not continue to follow up study participants into the ESRD phase of the disease. Table 1 describes a number of alternative data sources that investigators have instead relied on in the past to study the pre-ESRD to ESRD transition. These approaches have different strengths and weaknesses, as outlined. In this context, the study by Rivara et al occupies an interesting niche: a modest-sized local chart review study (akin to Traynor et al5Traynor J.P. Simpson K. Geddes C.C. Deighan C.J. Fox J.G. Early initiation of dialysis fails to prolong survival in patients with end-stage renal failure.J Am Soc Nephrol. 2002; 13: 2125-2132Crossref PubMed Scopus (215) Google Scholar) that provides unique insights into the CKD-ESRD transition, including motivation of physicians making key decisions. Gaining insights into physician decision making is very valuable,6O'Hare A.M. Wong S.P. Yu M.K. et al.Trends in the timing and clinical context of maintenance dialysis initiation.J Am Soc Nephrol. 2015; 26: 1975-1981Crossref PubMed Scopus (33) Google Scholar, 7Wong S.P.Y. Vig E.K. Taylor J.S. et al.Timing of initiation of maintenance dialysis: a qualitative analysis of the electronic medical records of a national cohort of patients from the Department of Veterans Affairs.JAMA Intern Med. 2016; 176: 228-235Crossref PubMed Scopus (58) Google Scholar but not straightforward. Although the medical record may not completely capture all factors being taken into account, there seems to be no more accurate or efficient approach other than labor-intensive manual review of hundreds of charts,6O'Hare A.M. Wong S.P. Yu M.K. et al.Trends in the timing and clinical context of maintenance dialysis initiation.J Am Soc Nephrol. 2015; 26: 1975-1981Crossref PubMed Scopus (33) Google Scholar, 7Wong S.P.Y. Vig E.K. Taylor J.S. et al.Timing of initiation of maintenance dialysis: a qualitative analysis of the electronic medical records of a national cohort of patients from the Department of Veterans Affairs.JAMA Intern Med. 2016; 176: 228-235Crossref PubMed Scopus (58) Google Scholar as was done by Rivara et al.Table 1Data Sources for Studies Spanning the Pre-ESRD to ESRD TransitionData Source and Examples of Peer-Review PublicationsStrengthsLimitationsCMS Medical Evidence Report (CMS-2728)11Khan S.S. Xue J.L. Kazmi W.H. et al.Does predialysis nephrology care influence patient survival after initiation of dialysis?.Kidney Int. 2005; 67: 1038-1046Abstract Full Text Full Text PDF PubMed Scopus (107) Google Scholar, 12Slinin Y. Guo H.F. Gilbertson D.T. et al.Prehemodialysis care by dietitians and first-year mortality after initiation of hemodialysis.Am J Kidney Dis. 2011; 58: 583-590Abstract Full Text Full Text PDF PubMed Scopus (55) Google ScholarLarge sample size; data available nationally in all incident dialysis patientsSuboptimal accuracy13Longenecker J.C. Coresh J. Klag M.J. et al.Validation of comorbid conditions on the end-stage renal disease medical evidence report: the CHOICE study. Choices for Healthy Outcomes in Caring for ESRD.J Am Soc Nephrol. 2000; 11: 520-529Crossref PubMed Google Scholar, 14Kim J.P. Desai M. Chertow G.M. Winkelmayer W.C. Validation of reported predialysis nephrology care of older patients initiating dialysis.J Am Soc Nephrol. 2012; 23: 1078-1085Crossref PubMed Scopus (37) Google Scholar, 15Beaubrun A.C. Kanda E. Bond T.C. McClellan W.M. Form CMS-2728 data versus erythropoietin claims data: implications for quality of care studies.Ren Fail. 2013; 35: 320-326Crossref PubMed Scopus (7) Google Scholar; provides only data very proximal to dialysis initiation (eg, serum albumin concentration within 45 d)Medicare data16Chang T.I. Zheng Y. Montez-Rath M.E. Winkelmayer W.C. Antihypertensive medication use in older patients transitioning from chronic kidney disease to end-stage renal disease on dialysis.Clin J Am Soc Nephrol. 2016; 11: 1401-1412Crossref PubMed Scopus (21) Google ScholarLarge sample size; national in scopeAvailable for only elderly Medicare beneficiaries; look-back period typically not >2 y prior to dialysis initiation (to avoid further limiting age range); only billing/administrative data available, no information regarding actual clinical parameters; reliance on data generated as part of routine health care, so density of data varies by factors such as burden of disease, leading to ascertainment biasMedical records from integrated health care systems such as VA6O'Hare A.M. Wong S.P. Yu M.K. et al.Trends in the timing and clinical context of maintenance dialysis initiation.J Am Soc Nephrol. 2015; 26: 1975-1981Crossref PubMed Scopus (33) Google Scholar, 7Wong S.P.Y. Vig E.K. Taylor J.S. et al.Timing of initiation of maintenance dialysis: a qualitative analysis of the electronic medical records of a national cohort of patients from the Department of Veterans Affairs.JAMA Intern Med. 2016; 176: 228-235Crossref PubMed Scopus (58) Google Scholar, 17O'Hare A.M. Batten A. Burrows N.R. et al.Trajectories of kidney function decline in the 2 years before initiation of long-term dialysis.Am J Kidney Dis. 2012; 59: 513-522Abstract Full Text Full Text PDF PubMed Scopus (180) Google ScholarLarge sample size; availability of clinical data including physician notes, laboratory values, and information on medicationsLess generalizable (eg, men over-represented in VA); reliance on data generated as part of routine health care so density of data varies by factors such as burden of disease, leading to ascertainment biasProspective studies such as CRIC9Hsu R.K. Chai B. Roy J.A. et al.Abrupt decline in kidney function before initiating hemodialysis and all-cause mortality: the Chronic Renal Insufficiency Cohort (CRIC) study.Am J Kidney Dis. 2016; 68: 193-202Abstract Full Text Full Text PDF PubMed Scopus (31) Google Scholar, 18Bansal N. Keane M. Delafontaine P. et al.A longitudinal study of left ventricular function and structure from CKD to ESRD: the CRIC study.Clin J Am Soc Nephrol. 2013; 8: 355-362Crossref Scopus (84) Google Scholar study or IDEAL trial19Whalley G.A. Marwick T.H. Doughty R.N. et al.Effect of early initiation of dialysis on cardiac structure and function: results from the echo substudy of the IDEAL trial.Am J Kidney Dis. 2013; 61: 262-270Abstract Full Text Full Text PDF PubMed Scopus (43) Google ScholarAscertainment of CKD trajectory/natural history at prespecified times according to research protocol to reduce ascertainment bias; potentially deeper phenotyping than that done in routine clinical care (eg, availability of imaging or genomic data)Small sample size; research volunteers only, which may limit generalizability; density of data can be less compared with clinical records (eg, only 1 in-person visit per year in CRIC)Abbreviations: CKD, chronic kidney disease; CMS, Centers for Medicare & Medicaid Services; CRIC, Chronic Renal Insufficiency Cohort; ESRD, end-stage renal disease; IDEAL, Initiating Dialysis Early and Late; VA, Veterans Affairs. Open table in a new tab Abbreviations: CKD, chronic kidney disease; CMS, Centers for Medicare & Medicaid Services; CRIC, Chronic Renal Insufficiency Cohort; ESRD, end-stage renal disease; IDEAL, Initiating Dialysis Early and Late; VA, Veterans Affairs. More recently, data have emerged from analyses of longitudinal studies that dovetail with the current article by Rivara et al to highlight how clinical events and medical management during the pre-ESRD phase of the disease can have a major impact on outcomes after the onset of ESRD. In a study crosslinking the MDRD Study cohort with the USRDS, Ku et al8Ku E. Glidden D.V. Johansen K.L. et al.Association between strict blood pressure control during chronic kidney disease and lower mortality after onset of end-stage renal disease.Kidney Int. 2015; 87: 1055-1060Abstract Full Text Full Text PDF PubMed Scopus (55) Google Scholar showed that although targeting tight blood pressure control among patients with CKD (mean arterial pressure ≤ 92-98 vs 107-113 mm Hg) did not lower the risk for kidney failure (consistent with the primary findings of the MDRD Study), it was associated with a lower risk for death after the onset of ESRD. In the subset of patients who developed ESRD after 1995 and thus had data captured in more recent versions of the Centers for Medicare & Medicaid Services (CMS) Medical Evidence Report (CMS Form 2728), those who had been targeted for lower blood pressure appeared to have less burden of cardiovascular disease documented at dialysis therapy initiation, thus providing a potential mechanism for the mortality benefit.8Ku E. Glidden D.V. Johansen K.L. et al.Association between strict blood pressure control during chronic kidney disease and lower mortality after onset of end-stage renal disease.Kidney Int. 2015; 87: 1055-1060Abstract Full Text Full Text PDF PubMed Scopus (55) Google Scholar A strength of this study is that it was based on an interventional trial that randomly allocated study participants to different blood pressure targets. In contrast, an observational study that found that patients achieving more strict blood pressure control during the pre-ESRD phase of CKD had better survival after the onset of ESRD could be potentially explained away by differences in adherence to medical therapy, access to health care, health literacy, or other (unobserved) factors. This type of confounding would affect any observational study linking achieved therapeutic target during the pre-ESRD phase of CKD and outcomes after ESRD and weakens the ability to draw causal inference to guide clinical management. In another recent publication, Hsu et al9Hsu R.K. Chai B. Roy J.A. et al.Abrupt decline in kidney function before initiating hemodialysis and all-cause mortality: the Chronic Renal Insufficiency Cohort (CRIC) study.Am J Kidney Dis. 2016; 68: 193-202Abstract Full Text Full Text PDF PubMed Scopus (31) Google Scholar reported a strong association between abrupt declines in kidney function preceding hemodialysis therapy initiation and mortality after the onset of ESRD. This study was performed among participants of the Chronic Renal Insufficiency Cohort (CRIC) Study, which has been following up patients with CKD prospectively through the transition to the ESRD phase. Abrupt decline was deemed to have occurred in a patient if estimated glomerular filtration rate was extrapolated to have been ≥30 mL/min/1.73 m2 3 months prior to the initiation of dialysis therapy. The authors observed a 3-fold higher risk for death within the first year of ESRD in patients with an abrupt decline in estimated glomerular filtration rate compared with those with a more gradual decline. A strength of the study was its reliance on systematic data collection built into the prospective CRIC cohort. The use of a structured research protocol reduced the possibility of ascertainment bias from reliance on medical records, in which there may be more frequent kidney function testing in those with unstable laboratory or clinical parameters during pre-ESRD CKD and who may be expected to do worse after the onset of ESRD. Interestingly, Hsu et al noted that heart failure−related events in the last 3 months prior to hemodialysis were more common among those who had an abrupt decline in kidney function, which is consistent with the findings by Rivara et al regarding the poor prognosis associated with volume overload. To conclude, the pre-ESRD and ESRD phases of CKD are along the continuum of the same disease process, but for too long, researchers have largely focused only on one or another end of the continuum. Almost all patients with ESRD were previously in the pre-ESRD phase of CKD, so it is very reasonable to believe that clinical events and medical management during the pre-ESRD phase would have an important impact on outcomes after the onset of ESRD. One of the key objectives of Healthy People 2020 is to reduce deaths in persons with ESRD10Office of Disease Prevention and Health Promotion. Healthy People 2020. http://www.healthypeople.gov/2020/topics-objectives/topic/chronic-kidney-disease/objectives. Accessed August 13, 2016.Google Scholar; specifically to reduce the total number and cardiovascular-related deaths for persons receiving maintenance dialysis and to reduce early death. Improved understanding of the natural history of the pre-ESRD to ESRD transition may potentially help physicians identify opportunities to apply targeted interventions at the most opportune time points along the disease progression trajectory to reduce morbidity and mortality. Support: Drs Sharief and Hsu were supported by National Institute of Diabetes and Digestive and Kidney Disease grants T32DK007219 and K24DK092291, respectively. Financial Disclosure: The authors declare that they have no other relevant financial interests. Peer Review: Evaluated by a Co-Editor and Editor-in-Chief Levey. Indication for Dialysis Initiation and Mortality in Patients With Chronic Kidney Failure: A Retrospective Cohort StudyAmerican Journal of Kidney DiseasesVol. 69Issue 1PreviewInitiation of maintenance dialysis therapy for patients with chronic kidney failure is a period of high risk for adverse patient outcomes. Whether indications for dialysis therapy initiation are associated with mortality in this population is unknown. Full-Text PDF" @default.
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• W2565339972 title "The Transition From the Pre-ESRD to ESRD Phase of CKD: Much Remains to Be Learned" @default.
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