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Published ahead of print on May 3, 2006
Clin J Am Soc Nephrol 1: 774-779, 2006
© 2006 American Society of Nephrology
doi: 10.2215/CJN.00580705
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Epidemiology and Outcomes

Mortality by Dialysis Modality among Patients Who Have End-Stage Renal Disease and Are Awaiting Renal Transplantation

Jula K. Inrig*, Jie L. Sun{dagger}, Qinghong Yang{dagger}, Libbie P. Briley*, and Lynda A. Szczech*

* Department of Medicine, Division of Nephrology, Duke University Medical Center; and {dagger} Department of Statistics, Duke Clinical Research Institute, Durham, North Carolina

Address correspondence to: Dr. Jula K. Inrig, Duke University Medical Center, North Pavilion, 2400 Pratt Street, Box 3646, Durham, NC 27705. Phone: 919-668-7516; Fax: 919-668-7128; inrig001{at}mc.duke.edu


   Abstract
Top
 Abstract
Introduction
 Materials and Methods
 Results
 Discussion
 Conclusion
 References
 
Comparing outcomes related to dialysis modality is complicated by selection bias introduced by patients and physicians. To address the impact of selection bias, this study compared mortality by initial dialysis modality among patients who had ESRD and were placed on the transplant waiting list. This study was a historical prospective cohort of 12,568 patients in the United States who initiated dialysis between May 1, 1995, and October 31, 1998, and were placed on the transplant waiting list before dialysis initiation. Two-year mortality was compared using Kaplan-Meier curves and Cox proportional hazards models that analyzed patients primarily using an intention-to-treat approach and separately censored patients on a modality switch. At 2 yr, the unadjusted mortality rate was 6.6% among peritoneal dialysis (PD) patients compared with 6.9% among hemodialysis (HD) patients (hazard ratio [HR] 1.01; 95% confidence interval [CI] 0.82 to 1.23). After controlling for differences in baseline characteristics, comorbidities, and laboratory variables, the selection of PD versus HD remained associated with a similar 2-yr mortality risk (HR 1.03; 95% CI 0.83 to 1.28). In separate models, 2-yr mortality associated with PD versus HD was significant among patients with body mass index (BMI) ≥26 kg/m2 (HR 1.37; 95% CI 1.01 to 1.83) but not among patients with BMI <26 kg/m2 (HR 0.81; 95% CI 0.61 to 1.07). Results were similar after censoring on a modality switch. In conclusion, although choice of initial dialysis modality seems to be associated with equivalent outcomes among patients who have ESRD and are placed on the transplant waiting list, patients with BMI ≥26 kg/m2 have increased 2-yr mortality associated with the selection of PD versus HD. Because the interpretation of observational data is highly affected by residual confounding and selection bias, further efforts should focus on the formation and testing of hypotheses to improve dialysis delivery.


   Introduction
Top
 Abstract
 Introduction
Materials and Methods
 Results
 Discussion
 Conclusion
 References
 
Outcomes among patients who are on hemodialysis (HD) and peritoneal dialysis (PD) have been compared in numerous conflicting studies (1–17). Disparate findings likely are a result of various sources of bias that threaten the validity of observational studies. Analyzing significant differences in baseline patient characteristics, choice of study design, and methods are a few of the significant hurdles in comparing outcomes in patients who initiate PD compared with HD (18).

Selection bias introduced by patients and physicians in choosing the appropriate dialysis modality is a significant limitation that results in prognostic differences in groups at baseline. Although previous studies have shown that patients who select PD have favorable clinical conditions at the onset of dialysis (11,19), the mere presence or absence of a given risk factor or comorbid condition does not describe adequately the spectrum of disease severity and the true mortality risk that is associated with the level to which the patient is affected. Although the optimal design to detect differences in outcome on the basis of modality selection is a randomized, controlled trial, the single attempt at this was halted for logistic reasons, financial concerns, and low patient enrollment (20). Therefore, the only feasible alternative is to use optimally robust statistical methods to analyze outcomes that are based on observational data.

Because the designation of a patient as being medically appropriate for renal transplantation may be viewed as a functional marker for a given set of comorbidities that may better describe baseline mortality risk (21), we hypothesized that they represent a potential cohort of patients who would be eligible and may consent for a trial to compare outcomes on the basis of modality. In this investigation, we compared mortality for patients who were placed on the renal transplant waiting list and were incident to renal replacement therapy on the basis of initial choice of dialysis modality. By isolating a population that was believed to be medically appropriate for renal transplantation, this study sought to define a less heterogeneous population with similar functional status in whom the effect of modality could be assessed, to minimize the limitations of observational data and the effect of selection bias.


   Materials and Methods
Top
 Abstract
 Introduction
 Materials and Methods
Results
 Discussion
 Conclusion
 References
 
Data Source
This study was a historical prospective cohort of incident patients who had ESRD in the United States and initiated dialysis between May 1, 1995, and October 31, 1998. Data were obtained from the Standard Analytic Files (SAF) of the United States Renal Data System (USRDS) for this analysis (22). SAF contain information on demographic characteristics (age, gender, race, and ethnicity), comorbid conditions (hypertension, cardiac dysrhythmia, cardiac arrest, congestive heart failure, anemia, malignancy, peripheral vascular disease, tobacco use, diabetes, primary cause of ESRD, myocardial infarction, chronic obstructive pulmonary disease, and cerebrovascular disease), laboratory variables at dialysis initiation (albumin, creatinine, and hematocrit), year of dialysis initiation, treatment center, and dialysis modality for all incident patients. Body mass index (BMI) calculated by weight (kg)/height (m2) was included in all analyses.

Treatment modality for each patient was determined from the USRDS Treatment History SAF. The USRDS determines modality at dialysis initiation and at any point thereafter by using a number of data sources, including the Medical Evidence Form, the Quarterly Dialysis File, and the Medicare Claim Files. Any changes in dialysis modality during follow-up are recorded in the data files. According to the USRDS, a patient’s dialysis modality was defined as changed when the patient was on a new modality for at least 60 d. The Medical Evidence and Treatment History data sets were merged with mortality and transplantation data from the USRDS to provide information on date of death and date of transplant by USRDS number for each patient.

Patient Population
A total of 281,043 patients were incident to dialysis from May 1, 1995, to October 31, 1998. Patients were considered to be incident to dialysis on their 90th day of ESRD. The dialysis modality that was being used on the 90th day of dialysis was considered each patient’s treatment group. The study start date for all patients was defined as day 90 for two reasons: (1) Most patients who are younger than 65 yr are not eligible for Medicare for up to 90 d and are not included in the data set until day 90, and (2) patients who chose PD may start on HD initially and switch to PD after appropriate training has occurred. Patients were excluded when they died, they underwent transplant, their dialysis modality could not be determined at day 90, or they were younger than 18 yr before day 90 of ESRD. Of the remaining 246,827 patients, 18,569 were placed on a renal transplant waiting list before dialysis initiation and were available for analyses.

Statistical Analyses
Continuous and categorical variables were compared using the nonparametric Wilcoxon rank-sum test and {chi}2 test, respectively. Patients were censored at death, loss to follow-up, transplantation, or the end of 24 mo, whichever came first. Overall patient survival was described using the Kaplan-Meier method based on dialysis modality. Cox proportional hazards regression was used to compare outcomes on the basis of dialysis modality, adjusting for covariates. Proportional hazards assumptions and linearity assumptions for continuous variables were assessed. Because of a nonlinear association between BMI and log hazards ratio, a two-piecewise linear spline was used to represent the BMI effect. BMI was spliced at 26 kg/m2 because of changes in the slope of the relationship with log hazards ratio at this point. The correlation within treatment center was taken into account with the use of robust-sandwich standard error estimate for the regression coefficients in Cox proportional hazards models. A stepwise elimination selection method was performed to generate the fully adjusted model for modality using a P < 0.10 as inclusion and exclusion criteria for the aforementioned variables. Interaction terms between dialysis modality and age; BMI; gender; race; and history of diabetes, congestive heart disease, or myocardial infarction were tested on the basis of previously reported significance (8,23–25). Further analyses included stratifying patients on the basis of variables with significant interactions with dialysis modality.

Patients with missing clinical or demographic characteristics were excluded from the final model, and values were not imputed. The final cohort consisted of 12,568 patients. Comparisons were made between baseline characteristics and unadjusted outcomes between patients with and without missing data.

Initially, patients were analyzed in an intention-to-treat manner; patients were not censored if they changed treatment assignment during follow-up, and death was attributed to the initial dialysis modality. A subsequent sensitivity analysis was performed censoring patients 60 d after a switch of dialysis modality. Statistical analyses were performed using SAS statistical software (Version 9.1; SAS Institute, Cary, NC).


   Results
Top
 Abstract
 Introduction
 Materials and Methods
 Results
Discussion
 Conclusion
 References
 
Baseline Characteristics
Among the cohort overall, the mean age of onset of ESRD was 47.0 (±12.44 yr), 63% were white, 59% were male, and 36% had diabetes as the primary cause of ESRD (Table 1). HD was the initial dialysis modality for 9503 (75.6%) patients, and PD was the initial modality for 3065 (24.4%) patients.


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  		Table 1. Baseline characteristics at ESRD onseta

 
In general, HD patients were more likely to be older, nonwhite, of Hispanic ethnicity, and male. The HD patients had a lower prevalence of diabetes as the primary cause of ESRD and as a comorbid condition. However, the HD patients had a higher prevalence of congestive heart failure, myocardial infarction, and peripheral vascular disease. The HD patients also had lower serum albumin and lower hematocrit values but higher serum creatinine and higher BMI compared with patients who were on PD. There was no difference in clinical or demographic characteristics between patients with missing variables and patients with complete data.

Patient Survival by Dialysis Modality
During the 2-yr follow-up, the unadjusted mortality rate was 6.6% among patients who were on PD compared with 6.9% among HD patients (unadjusted hazard ratio [HR] 1.01; 95% confidence interval [CI] 0.82 to 1.23). No difference in unadjusted outcomes between the entire cohort and patients with complete demographic data was found. After adjustment for other significant predictors of mortality, dialysis modality was not associated with a difference in 2-yr all-cause mortality (HR 1.03; 95% CI 0.84 to 1.26, PD versus HD; Table 2).


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  		Table 2. Associations between clinical and demographic variables and 2-yr mortalitya

 
Predictors of mortality included lower serum albumin, increasing age, white race, history of malignancy or peripheral vascular disease, diabetes as primary cause of ESRD, and diabetes as a comorbid condition. Variables that were associated with decreased mortality risk included Hispanic ethnicity and higher serum creatinine. Higher BMI was associated with improved survival in patients whose baseline BMI was <26 kg/m2; however, among patients with BMI ≥26 kg/m2, increasing BMI was not associated with any change in survival.

Dialysis modality interacted with diabetes as a primary cause of ESRD (P = 0.03) and BMI (P = 0.03) but did not interact with age (P = 0.83), race (P = 0.49), gender (P = 0.33), history of congestive heart failure (P = 0.93), or myocardial infarction (P = 0.25). Among patients with BMI ≥26 kg/m2, the selection of PD versus HD was associated with a significantly increased hazard of death at 2 yr (adjusted HR 1.37; 95% CI 1.01 to 1.83) that was not present among patients with BMI <26 kg/m2 (adjusted HR 0.81; 95% CI 0.62 to 1.07; Table 3). However, there was no significant association between dialysis modality and mortality among patients with diabetes as cause of ESRD (adjusted HR 1.23; 95% CI 0.96 to 1.58, PD versus HD) or among patients without diabetes (adjusted HR 0.76; CI 0.53 to 1.07, PD versus HD).


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  		Table 3. Associations between modality and outcome among patients on the basis of clinical and demographic featuresa

 
Sensitivity Analyses
The mortality rate among patients who were censored after a switch in dialysis modality was similar to the intention-to-treat analysis. Two-year mortality was 6.7% among PD patients versus 6.8% among HD patients (unadjusted HR 1.00; 95% CI 0.81 to 1.23). In multivariable models, the choice of PD compared with HD was not associated with a significant difference in 2-yr mortality (HR 1.03; 95% CI 0.83 to 1.28).


   Discussion
Top
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
Conclusion
 References
 
In this historical prospective cohort of incident patients who had ESRD and were on the waiting list for renal transplant, dialysis modality was not associated with 2-yr all-cause mortality. However, although the association between modality and outcomes was not present among the cohort overall, patients whose baseline BMI were ≥26 kg/m2 had increased mortality associated with the selection of PD versus HD.

Previous studies both agree (5,9,16,17,24,26,27) and disagree (1,2,4,7,12,14,23,25,28) with these results; however, the concordance and discordance of results must be interpreted with considerations of the differences in patient populations and analytic techniques. Although a randomized, controlled trial is necessary to solve the differential findings in observational studies, an initial attempt at a trial was not successful (20). Therefore, observational studies with robust statistical methods are the only feasible alternative. With the inherent limitations of observational studies, our analysis attempted to control for selection bias by analyzing a patient cohort with similar functional status: Patients who were on the waiting list for renal transplant. Previous studies have suggested that there is a patient- and physician-directed selection of healthier patients to PD, making comparisons between modalities difficult (3,11,19). Nonclinical and social factors may influence a physician to direct sicker patients away from PD, and patients may select PD over HD for socioeconomic-related issues (19), all factors that are difficult to control for in analyses that compare dialysis modality; yet, many of these same issues direct patients and physicians to pursue renal transplantation. Therefore, the comparison of mortality differences by dialysis modality in patients who are on the transplant waiting list may be an appropriate method to attempt to minimize the effect of selection bias.

Although the prevalence of comorbid conditions was low in our cohort, patients who selected PD as their initial dialysis modality had a more favorable comorbidity profile compared with HD patients. These differences at baseline may represent why some studies that did not control for case mix and comorbidities found PD to be associated with a survival benefit (10,15). The differences in baseline characteristics despite our choice of a more homogeneous patient population further emphasizes the selection of healthier patients to PD and the inherent selection bias in observational studies that compare outcomes by dialysis modality.

In comparison with our analysis, a recently published study by Jaar et al. (28), using a prospective cohort of 1041 incident US dialysis patients, found the choice of PD versus HD to be associated with increased mortality among patients with ESRD after their second year of dialysis. However, 2-yr mortality rates and the prevalence of comorbid conditions among our cohort were significantly lower than those in the patients who were analyzed by Jaar et al. (28), making significant comparisons difficult. It is interesting that Jaar et al. (28) analyzed a subgroup of patients in the highest tertile of propensity for receiving PD (mostly patients with a better overall case-mix profile, which may be more reflective of our cohort) and found that the risk for death did not differ on the basis of initial dialysis modality (28).

Our study demonstrates an increased risk for death associated with PD versus HD among ESRD patients who have BMI ≥26 kg/m2. Two previous investigations also suggested that overweight patients have a differential outcome associated with dialysis modality (24,26). Stack et al. (24), in a retrospective cohort of 134,728 incident USRDS patients, found that patients with diabetes and BMI >23.5 kg/m2 had increased 2-yr mortality associated with PD versus HD; however, in patients without diabetes, the increased mortality associated with PD versus HD was present only among patients with BMI ≥30 kg/m2. Similarly, Abbott et al. (26), in a retrospective cohort of 3337 incident USRDS patients, found 5-yr survival to be lower among patients who had BMI ≥30 kg/m2 and were on PD versus HD. Our study extends the previous research by analyzing by BMI ESRD patients who are on the transplant wait list. Similar to these studies, this investigation found patients with BMI ≥26 kg/m2, regardless of diabetes status, to have increased mortality associated with PD versus HD.

Similar to previous studies (5,8,10), we found a significant interaction between dialysis modality and diabetes, but we failed to find a statistical difference in outcomes on the basis of the presence or absence of diabetes. However, although neither HR was significant, the power to detect significant associations is diminished in these subgroups. Of interest, the direction of association is similar to previous studies (5,8,10) and suggests poorer outcomes for patients who have diabetes and better outcomes among patients who do not have diabetes and are treated with PD.

There are a number of hypotheses regarding why dialysis modality may be associated with mortality among incident patients who have ESRD, are on the transplant waiting list, and have higher BMI. Among overweight patients with BMI ≥26 kg/m2, the increased mortality associated with PD versus HD may be related to a greater risk for inadequate doses of dialysis or more difficult fluid management in these patients (24,26). Overweight patients, in particular, may have more difficulty achieving adequate dialysis with the gradual loss of residual renal function over time. The increased risk associated with PD over time supports this potential theory (9,17,25). Whereas the ADEMEX trial suggested that variations in peritoneal clearance do not affect long-term outcomes (29), underdialysis of overweight hemodialysis patients has been associated with poorer outcomes (30). Alternatively, higher rates of infectious complications, such as peritonitis, may play a role in the increased mortality among overweight PD patients compared with HD patients (31).

As with any observational study, this study has a number of limitations. First, data on dialysis adequacy, residual renal function, delivered dialysis dose, anemia management, and mineral metabolism parameters were not available. However, previous studies suggested that PD patients tend to have higher residual renal function over time (9,32), similar target hemoglobins (33), and inconsistent differences in nutritional parameters (17,34). These differences should bias toward the null hypothesis or toward improved outcomes in PD patients. Second, we lacked information on BMI and laboratory parameters over time, which may be changed by ultrafiltration or lowering of dry weight. However, any inaccuracy in laboratory parameters or overestimation of BMI should occur equally among patients who are on either modality. Third, it has been established that comorbid conditions are underreported on the Medical Evidence Form (35). However, to the extent that this should occur equally among patients who are on PD and HD, this also should bias results toward the null. Fourth, cause and effect cannot be established. Finally, our selection of transplant-eligible patients may limit the applicability of our results to the broad spectrum of patients with ESRD. However, our cohort was selected to try to match functional status and thereby try to minimize the effect of selection bias.


   Conclusion
Top
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 Conclusion
References
 
This study demonstrates that choice of dialysis modality may be equivalent among healthy cohorts, such as patients who are on the transplant waiting list and who select PD as an initial dialysis modality. However, overweight patients with ESRD (with BMI ≥26 mg/m2) seem to have increased 2-yr mortality associated with the selection of PD versus HD. With the inherent limitations of observation studies, further research efforts should focus on the formation and testing of hypotheses to improve dialysis delivery, particularly among overweight patients who select PD as a long-term dialysis modality.


   Acknowledgments
 
J.K.I. was supported by a clinical research fellowship endowment from Earl Dalbey and by the National Institutes of Health grant K12 RR-017630.

This study was presented in abstract form at the American Society of Nephrology Annual Meeting, November 12, 2005, Phidelphia, PA.


   Footnotes
 
Published online ahead of print. Publication date available at www.cjasn.org.

Received July 29, 2005. Accepted March 15, 2006.


   References
Top
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 Conclusion
 References
 

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