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Comparative effectiveness of early versus conventional timing of dialysis initiation in advanced CKD.

ABSTRACT: Previous observational studies examining outcomes associated with the timing of dialysis therapy initiation in the United States have often been limited by lead time and survivor bias.Retrospective cohort study comparing the effectiveness of early versus later (conventional) dialysis therapy initiation in advanced chronic kidney disease (CKD). The analysis used inverse probability weighting to account for an individual's contribution to different exposure groups over time in a pooled logistic regression model. Patients contributed risk to both exposure categories (early and later initiation) until there was a clear treatment strategy (ie, dialysis therapy was initiated early or estimated glomerular filtration rate [eGFR] decreased to <10mL/min/1.73m(2)).Patients with CKD who had at least one face-to-face outpatient encounter with a Cleveland Clinic health care provider as of January 1, 2005, and at least 3 eGFRs in the range of 20-30mL/min/1.73m(2) measured at least 180 days apart.Timing of dialysis therapy initiation as determined using model-based interpolation of eGFR trajectories over time. Timing was defined as early (interpolated eGFR at dialysis therapy initiation?10mL/min/1.73m(2)) or later (eGFR < 10mL/min/1.73m(2)) and was time-varying.Death from any cause occurring from the time that eGFR was equal to 20mL/min/1.73m(2) through September 15, 2009.The study population consisted of 652 patients meeting inclusion criteria. Most (71.3%) of the study population did not initiate dialysis therapy during follow-up. Patients who did not initiate dialysis therapy (n=465) were older, more likely to be white, and had more favorable laboratory profiles than those who started dialysis therapy. Overall, 146 initiated dialysis early and 80 had eGFRs decrease to <10mL/min/1.73m(2). Many participants (n=426) were censored prior to attaining a clear treatment strategy and were considered undeclared. There was no statistically significant survival difference for the early compared with later initiation strategy (OR, 0.85; 95% CI, 0.65-1.11).Interpolated eGFR, moderate sample size, and likely unmeasured confounders.In patients with advanced CKD, timing of dialysis therapy initiation was not associated with mortality when accounting for lead time bias and survivor bias.

SUBMITTER: Crews DC

PROVIDER: S-EPMC4117406 | biostudies-literature | 2014 May

REPOSITORIES: biostudies-literature

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Comparative effectiveness of early versus conventional timing of dialysis initiation in advanced CKD.

Crews Deidra C DC Scialla Julia J JJ Boulware L Ebony LE Navaneethan Sankar D SD Nally Joseph V JV Liu Xiaobo X Arrigain Susana S Schold Jesse D JD Ephraim Patti L PL Jolly Stacey E SE Sozio Stephen M SM Michels Wieneke M WM Miskulin Dana C DC Tangri Navdeep N Shafi Tariq T Wu Albert W AW Bandeen-Roche Karen K

American journal of kidney diseases : the official journal of the National Kidney Foundation 20140206 5

<h4>Background</h4>Previous observational studies examining outcomes associated with the timing of dialysis therapy initiation in the United States have often been limited by lead time and survivor bias.<h4>Study design</h4>Retrospective cohort study comparing the effectiveness of early versus later (conventional) dialysis therapy initiation in advanced chronic kidney disease (CKD). The analysis used inverse probability weighting to account for an individual's contribution to different exposure ...[more]

PMID: 24508475

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Project description:Background In participants with concomitant chronic coronary disease and advanced chronic kidney disease (CKD), the effect of treatment strategies on the timing of dialysis initiation is not well characterized. Methods and Results In ISCHEMIA-CKD (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches-Chronic Kidney Disease), 777 participants with advanced CKD and moderate or severe ischemia were randomized to either an initial invasive or conservative management strategy. Herein, we compare the proportion of randomized participants with non-dialysis-requiring CKD at baseline (n=362) who initiated dialysis and compare the time to dialysis initiation between invasive versus conservative management arms. Using multivariable Cox regression analysis, we also sought to identify the effect of invasive versus conservative chronic coronary disease management strategies on dialysis initiation. At a median follow-up of 23 months (25th-75th interquartile range, 14-32 months), dialysis was initiated in 18.9% of participants (36/190) in the invasive strategy and 16.9% of participants (29/172) in the conservative strategy (P=0.22). The median time to dialysis initiation was 6.0 months (interquartile range, 3.0-16.0 months) in the invasive group and 18.2 months (interquartile range, 12.2-25.0 months) in the conservative group (P=0.004), with no difference in procedural acute kidney injury rates between the groups (7.8% versus 5.4%; P=0.26). Baseline clinical factors associated with earlier dialysis initiation were lower baseline estimated glomerular filtration rate (hazard ratio [HR] associated with 5-unit decrease, 2.08 [95% CI, 1.72-2.56]; P<0.001), diabetes (HR, 2.30 [95% CI, 1.28-4.13]; P=0.005), hypertension (HR, 7.97 [95% CI, 1.09-58.21]; P=0.041), and Hispanic ethnicity (HR, 2.34 [95% CI, 1.22-4.47]; P=0.010). Conclusions In participants with non-dialysis-requiring CKD in ISCHEMIA-CKD, randomization to an invasive chronic coronary disease management strategy (relative to a conservative chronic coronary disease management strategy) is associated with an accelerated time to initiation of maintenance dialysis for kidney failure. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01985360.

Project description:ImportancePublished in 2010, the Initiating Dialysis Early and Late (IDEAL) randomized clinical trial, which randomized patients with an estimated glomerular filtration rate (GFR) between 10 and 15 mL/min/1.73 m2 to planned initiation of dialysis with an estimated GFR between 10 and 14 mL/min/1.73 m2 (early start) or an estimated GFR between 5 and 7 mL/min/1.73 m2 (late start), concluded that early initiation was not associated with improved survival or clinical outcomes.ObjectiveTo assess the association between the IDEAL trial results and the proportion of early dialysis starts over time.Design, setting, and participantsThis interrupted time series analysis used data from the Canadian Organ Replacement Register to study adult (≥18 years of age) patients with incident chronic dialysis between January 1, 2006, and December 31, 2015, in Canada, which has a universal health care system. Patients from the province of Quebec were excluded because its privacy laws preclude submission of deidentified data without first-person consent. The patients included in the study (n = 28 468) had at least 90 days of nephrologist care before starting dialysis and a recorded estimated GFR at dialysis initiation. Data analyses were performed from November 2016 to January 2019.Main outcomes and measuresThe primary outcome was the proportion of early dialysis starts (estimated GFR >10.5 mL/min/1.73 m2), and the secondary outcomes included the proportions of acute inpatient dialysis starts, patients who started dialysis using a home modality, and patients receiving hemodialysis who started with an arteriovenous access. Measures included the trend prior to the IDEAL trial publication, the change in this trend after publication, and the immediate consequence of publication.ResultsThe final cohort comprised 28 468 patients, of whom 17 342 (60.9%) were male and the mean (SD) age was 64.8 (14.6) years. Before the IDEAL trial, a statistically significant increasing trend was observed in the monthly proportion of early dialysis starts (adjusted rate ratio, 1.002; 95% CI, 1.001-1.004; P = .004). After the IDEAL trial, an immediate decrease was observed in the proportion of early dialysis starts (rate ratio, 0.874; 95% CI, 0.818-0.933; P < .001), along with a statistically significant change in trend between the pretrial and posttrial periods (rate ratio, 0.994; 95% CI, 0.992-0.996; P < .001). No statistically significant differences were found in acute inpatient dialysis initiations, the proportion of patients receiving home dialysis as the initial modality, or the proportion of arteriovenous access creation at hemodialysis initiation after the IDEAL trial publication.Conclusions and relevanceThe publication of the IDEAL trial appeared to be associated with an immediate and meaningful change in the timing of dialysis initiation in Canada.

Project description:BackgroundPhysicians' perceptions and opinions may influence when to initiate dialysis.ObjectiveTo examine providers' perspectives and opinions regarding the timing of dialysis initiation.DesignOnline survey.SettingCommunity and academic dialysis practices in Canada.ParticipantsA nationally-representative sample of dialysis providers.Measurements and methodsDialysis providers opinions assessing reasons to initiate dialysis at low or high eGFR. Responses were obtained using a 9-point Likert scale. Early dialysis was defined as initiation of dialysis in an individual with an eGFR greater than or equal to 10.5 ml/min/m(2). A detailed survey was emailed to all members of the Canadian Society of Nephrology (CSN) in February 2013. The survey was designed and pre-tested to evaluate duration and ease of administration.ResultsOne hundred and forty one (25% response rate) physicians participated in the survey. The majority were from urban, academic centres and practiced in regionally administered renal programs. Very few respondents had a formal policy regarding the timing of dialysis initiation or formally reviewed new dialysis starts (N = 4, 3.1%). The majority of respondents were either neutral or disagreed that late compared to early dialysis initiation improved outcomes (85-88%), had a negative impact on quality of life (89%), worsened AVF or PD use (84-90%), led to sicker patients (83%) or was cost effective (61%). Fifty-seven percent of respondents felt uremic symptoms occurred earlier in patients with advancing age or co-morbid illness. Half (51.8%) of the respondents felt there was an absolute eGFR at which they would initiate dialysis in an asymptomatic patient. The majority of respondents would initiate dialysis for classic indications for dialysis, such as volume overload (90.1%) and cachexia (83.7%) however a significant number chose other factors that may lead them to early dialysis initiation including avoiding an emergency (28.4%), patient preference (21.3%) and non-compliance (8.5%).Limitations25% response rate.ConclusionsAlthough the majority of nephrologists in Canada who responded followed evidence-based practice regarding the timing of dialysis initiation, knowledge gaps and areas of clinical uncertainty exist. The implementation and evaluation of formal policies and knowledge translation activities may limit potentially unnecessary early dialysis initiation.

Project description:Rationale & objectiveDepression is prevalent and highly associated with mortality among patients with chronic kidney disease (CKD). Psychological flexibility can be captured as acceptance in psychology, and its improvement by behavioral therapy is associated with reduced depression in some clinical settings. However, no study has been reported on patients with CKD. This study aimed to examine the association between psychological flexibility and depression in patients with CKD.Study designCohort study.Setting & participantsThis multicenter study of 5 hospitals in Japan included patients with nondialysis stage 3-5 CKD or stage 5D CKD receiving hemodialysis or peritoneal dialysis.PredictorPsychological flexibility measured using the 7-item Acceptance and Action Questionnaire (AAQ-II).OutcomesThe prevalence and incidence of depression after 1 year, which was defined by a score ≥ 16 points on the Center for Epidemiologic Studies Depression (CES-D) questionnaire.Analytical approachGamma regression was used in the examination of correlates of the psychological flexibility value. Modified Poisson regression models were fit for the prevalence and incidence of depression.ResultsThe cross-sectional and longitudinal analyses included 433 and 191 patients, respectively. Lower (ie, worse) psychological flexibility levels were associated with hemodialysis and peritoneal dialysis. Higher (ie, better) psychological flexibility levels were associated with lower prevalence of depression (per 5-point increase; adjusted prevalence ratio, 0.75; 95% CI, 0.70-0.80) and lower incidence of depression (per 5-point increase; adjusted risk ratio, 0.72; 95% CI, 0.61-0.85).LimitationsDepression was assessed using the CES-D questionnaire. Cultural differences may exist in the interpretation of AAQ-II scores.ConclusionsBetter psychological flexibility was associated with lower prevalence and incidence of depression in patients with CKD. Further studies are warranted to determine the possible prevention and treatment of depression by the development of behavioral interventions to improve psychological flexibility.

Project description:Rationale & objectivesDue to unmeasured confounding, observational studies have limitations when assessing whether dialysis initiation reduces mortality compared with conservative therapy among adults with advanced chronic kidney disease (CKD). We addressed this issue in this meta-analysis.Study designMeta-analysis with bias analysis for unmeasured confounding.Setting & study populationAdults with stage 4 or 5 CKD who had initiated dialysis or conservative treatment.Selection criteria for studiesProspective or retrospective cohort studies comparing survival of dialysis versus conservatively managed patients were searched on MEDLINE and Embase from January 2009 to March 20, 2019.Data extractionHRs of all-cause mortality associated with dialysis initiation compared with conservative treatment.Analytical approachWe pooled HRs using a random-effects model. We estimated the percentage of effect sizes more protective than HRs of 0.80 and severity of unmeasured confounding that could reduce this percentage to only 10%. Subgroup analysis was performed for studies with only older patients (aged ≥ 65 years).Results12 studies were included that involved 16,609 dialysis patients and 3,691 conservatively managed patients. A random-effects model suggested that dialysis initiation was associated with a mean mortality HR of 0.47 (95% CI, 0.34-0.64), in which 92% (95% CI, 50%-100%) of the true effects were more protective than HRs of 0.80. To reduce the percentage of HRs < 0.80 to 10%, unmeasured confounder(s) would need to be associated with both dialysis initiation and mortality by relative risks of 4.05 (95% CI, 2.39-4.15), which is equivalent to shifting each study's estimated HR by 2.31-fold (95% CI, 1.51-2.36). Restricting studies to include only older patients did not modify the results.LimitationsLimited number of studies and evidence on the absence of publication bias.ConclusionsOur findings suggest that dialysis initiation considerably reduces mortality among adults with advanced CKD. Future bias-adjusted meta-analyses need to assess outcomes beyond mortality.

Project description:ObjectiveTo identify the optimal estimated glomerular filtration rate (eGFR) at which to initiate dialysis in people with advanced chronic kidney disease.DesignNationwide observational cohort study.SettingNational Swedish Renal Registry of patients referred to nephrologists.ParticipantsPatients had a baseline eGFR between 10 and 20 mL/min/1.73 m2 and were included between 1 January 2007 and 31 December 2016, with follow-up until 1 June 2017.Main outcome measuresThe strict design criteria of a clinical trial were mimicked by using the cloning, censoring, and weighting method to eliminate immortal time bias, lead time bias, and survivor bias. A dynamic marginal structural model was used to estimate adjusted hazard ratios and absolute risks for five year all cause mortality and major adverse cardiovascular events (composite of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) for 15 dialysis initiation strategies with eGFR values between 4 and 19 mL/min/1.73 m2 in increments of 1 mL/min/1.73 m2. An eGFR between 6 and 7 mL/min/1.73 m2 (eGFR6-7) was taken as the reference.ResultsAmong 10 290 incident patients with advanced chronic kidney disease (median age 73 years; 3739 (36%) women; median eGFR 16.8 mL/min/1.73 m2), 3822 started dialysis, 4160 died, and 2446 had a major adverse cardiovascular event. A parabolic relation was observed for mortality, with the lowest risk for eGFR15-16. Compared with dialysis initiation at eGFR6-7, initiation at eGFR15-16 was associated with a 5.1% (95% confidence interval 2.5% to 6.9%) lower absolute five year mortality risk and 2.9% (0.2% to 5.5%) lower risk of a major adverse cardiovascular event, corresponding to hazard ratios of 0.89 (95% confidence interval 0.87 to 0.92) and 0.94 (0.91 to 0.98), respectively. This 5.1% absolute risk difference corresponded to a mean postponement of death of 1.6 months over five years of follow-up. However, dialysis would need to be started four years earlier. When emulating the intended strategies of the Initiating Dialysis Early and Late (IDEAL) trial (eGFR10-14 v eGFR5-7) and the achieved eGFRs in IDEAL (eGFR7-10 v eGFR5-7), hazard ratios for all cause mortality were 0.96 (0.94 to 0.99) and 0.97 (0.94 to 1.00), respectively, which are congruent with the findings of the randomised IDEAL trial.ConclusionsVery early initiation of dialysis was associated with a modest reduction in mortality and cardiovascular events. For most patients, such a reduction may not outweigh the burden of a substantially longer period spent on dialysis.

Dataset Information

Comparative effectiveness of early versus conventional timing of dialysis initiation in advanced CKD.

Publications

Comparative effectiveness of early versus conventional timing of dialysis initiation in advanced CKD.

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