We conclude that comorbidity assessment using the ICED is feasible in multicenter clinical trials of dialysis patients. There is a large burden of comorbidity in dialysis patients, which is not well explained by the cause of renal disease, demographic, and socioeconomic factors and common clinical and laboratory measurements. These variables should not be considered substitutes for comorbid conditions in case-mix adjustment. Comorbidity assessment is useful to describe the sample population, to improve the precision of the treatment effect, and to use possibly as an outcome measurement.

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The purpose of this paper is to describe the ICED, summarize outcomes of prior studies in which it was used, and describe the adaptations that have lead to the present instrument. We will then demonstrate its use in quantifying the burden of comorbid conditions in a sample of hemodialysis and peritoneal dialysis patients from our center, and show the relationship between ICED levels and outcomes in peritoneal dialysis patients.

Abstract. Examined is the relationship of patient-reported health-related quality of life (HRQOL) to the mode of survey administration in the Hemodialysis Study. In addition to selfadministered surveys to assess HRQOL, interviewer-administered surveys were made available to include patients with poor vision, decreased manual dexterity, or strong preference. For examining the predictors of participation by self-administration of the survey, multiple logistic regression was performed. For examining the relationship of HRQOL results to mode of survey administration, adjusted differences between the selfadministered and interviewer-administered groups were obtained from multiple linear regression models accounting for sociodemographic and case-mix factors. A total of 978 of the first 1000 subjects in the Hemodialysis Study completed the survey by interview (n ϭ 427) or by self-administration (n ϭ 551). The interviewer-administered group was older, was more likely black, had longer duration of ESRD, had a higher prevalence of diabetes, and had more severe comorbidity (all P Ͻ 0.01). After adjustment for these differences, patients in the interviewer-administered group had higher scores on scales that measured Role-Physical, Role-Emotional, and Effects of Kidney Disease (all P Ͻ 0.001). Dialysis studies that restrict HRQOL measurement to patients who are able to complete surveys without assistance will not accurately represent the health of the overall hemodialysis population. Clinical studies and clinical practices using HRQOL as an outcome should include interviewer administration or risk a selection bias against subjects with older age, minority status, and higher level of comorbidity. Future investigation should include research of survey modalities with a low response burden such as telephone interview, computer-assisted interview, and proxy administration.Patient reports of health-related quality of life (HRQOL) are recognized as providing important information about the impact of ESRD and its treatment on daily life (1-6). HRQOL questionnaires are used increasingly in studies of ESRD patients (7) and by dialysis providers (8,9). HRQOL surveys may be used in clinical care to screen for potential problems, to prioritize problems, to facilitate communication between health care workers and patients, and to monitor response to treatment (10,11). However, there is little guidance about how best to gather HRQOL information from patients with kidney failure.HRQOL surveys may be self-administered, but other alternatives, such as interviewer administration of surveys, may be particularly important in the ESRD population, because many of these patients are advanced in age and have comorbid conditions that preclude traditional questionnaire self-administration. It is precisely these older and sicker patients for whom HRQOL measures may be most needed (12). Although HRQOL assessment has become a commonly reported outcome in ESRD, we are unaware of previous studies examining the influence of mode of survey administration on...

BackgroundElevated serum phosphorus concentrations are common among maintenance hemodialysis patients. Protein is a major source of dietary phosphate, but restriction of protein intake can result in hypoalbuminemia and protein-energy wasting. We hypothesized that sucroferric oxyhydroxide (SO), a potent phosphate binder with a low pill burden, may reduce serum phosphorus levels in hemodialysis patients with hypoalbuminemia without adversely impacting albumin levels or dietary intake of protein.MethodsWe retrospectively examined de-identified data from 79 adult, in-center hemodialysis patients with baseline hypoalbuminemia (≤ 3.5 g/dL) switched to SO as part of routine clinical care for at least 1 year. Temporal changes (3-month intervals from baseline through Q4) in phosphate binder pill burden, serum phosphorous levels, nutritional markers, and equilibrated Kt/V were analyzed. Data from a matched reference group of non-hypoalbuminemic patients (N = 79) switched to SO were also examined.ResultsSO therapy was associated with a mean reduction of 45.7 and 45.1% in daily phosphate binder pill burden, and a mean reduction of 0.4 mg/dL and 0.51 mg/dL in serum phosphorus levels for the hypoalbuminemic and non-hypoalbuminemic patients, respectively. Hypoalbuminemic patients demonstrated significant increases in mean serum albumin levels from 3.50 mg/dL at baseline to 3.69, 3.74, 3.70, and 3.69 mg/dL during Q1 through Q4, respectively (P < 0.0001), whereas serum albumin levels remained unchanged in the non-hypoalbuminemic group.ConclusionsBoth hypoalbuminemic and non-hypoalbuminemic patients switching to SO exhibited significant reductions in serum phosphorus concentrations and daily phosphate binder pill burden. Among hypoalbuminemic patients, the initiation of SO therapy was also associated with increases in serum albumin, suggesting therapy may have allowed patients to increase their dietary intake of protein.

Background Elevated serum phosphorus concentrations are common among maintenance hemodialysis patients. Protein is a major source of dietary phosphate, but restriction of protein intake can result in hypoalbuminemia and protein-energy wasting. We hypothesized that sucroferric oxyhydroxide (SO), a potent phosphate binder with a low pill burden, may reduce serum phosphorus levels in hemodialysis patients with hypoalbuminemia without adversely impacting albumin levels or dietary intake of protein.Methods We retrospectively examined de-identified data from 79 adult, in-center hemodialysis patients with baseline hypoalbuminemia (≤ 3.5 g/dL) switched to SO as part of routine clinical care for at least 1 year. Temporal changes (3-month intervals from baseline through Q4) in phosphate binder pill burden, serum phosphorous levels, nutritional markers, and equilibrated Kt/V were analyzed. Data from a matched reference group of non-hypoalbuminemic patients ( N = 79) switched to SO were also examined.Results SO therapy was associated with a mean reduction of 45.7% and 45.1% in daily phosphate binder pill burden, and a mean reduction of 0.4 mg/dL and 0.51 mg/dL in serum phosphorus levels for the hypoalbuminemic and non-hypoalbuminemic patients, respectively. Hypoalbuminemic patients demonstrated significant increases in mean serum albumin levels from 3.50 mg/dL at baseline to 3.69, 3.74, 3.70, and 3.69 mg/dL during Q1 through Q4, respectively ( P < 0.0001), whereas serum albumin levels remained unchanged in the non-hypoalbuminemic group.Conclusions Both hypoalbuminemic and non-hypoalbuminemic patients switching to SO exhibited significant reductions in serum phosphorus concentrations and daily phosphate binder pill burden. Among hypoalbuminemic patients, the initiation of SO therapy was also associated with increases in serum albumin, suggesting therapy may have allowed patients to increase their dietary intake of protein.

Background Elevated serum phosphorus concentrations are common among maintenance hemodialysis patients. Protein is a major source of dietary phosphate, but restriction of protein intake can result in hypoalbuminemia and protein-energy wasting. We hypothesized that sucroferric oxyhydroxide (SO), a potent phosphate binder with a low pill burden, may reduce serum phosphorus levels in hemodialysis patients with hypoalbuminemia without adversely impacting albumin levels or dietary intake of protein.Methods We retrospectively examined de-identified data from 79 adult, in-center hemodialysis patients with baseline hypoalbuminemia (≤ 3.5 g/dL) switched to SO as part of routine clinical care for at least 1 year. Temporal changes (3-month intervals from baseline through Q4) in phosphate binder pill burden, serum phosphorous levels, nutritional markers, and equilibrated Kt/V were analyzed. Data from a matched reference group of non-hypoalbuminemic patients ( N = 79) switched to SO were also examined.Results SO therapy was associated with a mean reduction of 45.7% and 45.1% in daily phosphate binder pill burden, and a mean reduction of 0.4 mg/dL and 0.51 mg/dL in serum phosphorus levels for the hypoalbuminemic and non-hypoalbuminemic patients, respectively. Hypoalbuminemic patients demonstrated significant increases in mean serum albumin levels from 3.50 mg/dL at baseline to 3.69, 3.74, 3.70, and 3.69 mg/dL during Q1 through Q4, respectively ( P < 0.0001), whereas serum albumin levels remained unchanged in the non-hypoalbuminemic group.Conclusions Both hypoalbuminemic and non-hypoalbuminemic patients switching to SO exhibited significant reductions in serum phosphorus concentrations and daily phosphate binder pill burden. Among hypoalbuminemic patients, the initiation of SO therapy was also associated with increases in serum albumin, suggesting therapy may have allowed patients to increase their dietary intake of protein.

Background Elevated serum phosphorus concentrations are common among maintenance hemodialysis patients. Protein is a major source of dietary phosphate, but restriction of protein intake can result in hypoalbuminemia and protein-energy wasting. We hypothesized that sucroferric oxyhydroxide (SO), a potent phosphate binder with a low pill burden, may reduce serum phosphorus levels in hemodialysis patients with hypoalbuminemia without adversely impacting albumin levels or dietary intake of protein.Methods We retrospectively examined de-identified data from 79 adult, in-center hemodialysis patients with baseline hypoalbuminemia (≤ 3.5 g/dL) switched to SO as part of routine clinical care for at least 1 year. Temporal changes (3-month intervals from baseline through Q4) in phosphate binder pill burden, serum phosphorous levels, nutritional markers, and equilibrated Kt/V were analyzed. Data from a matched reference group of non-hypoalbuminemic patients ( N = 79) switched to SO were also examined.Results SO therapy was associated with a mean reduction of 45.7% and 45.1% in daily phosphate binder pill burden, and a mean reduction of 0.4 mg/dL and 0.51 mg/dL in serum phosphorus levels for the hypoalbuminemic and non-hypoalbuminemic patients, respectively. Hypoalbuminemic patients demonstrated significant increases in mean serum albumin levels from 3.50 mg/dL at baseline to 3.69, 3.74, 3.70, and 3.69 mg/dL during Q1 through Q4, respectively ( P < 0.0001), whereas serum albumin levels remained unchanged in the non-hypoalbuminemic group.Conclusions Both hypoalbuminemic and non-hypoalbuminemic patients switching to SO exhibited significant reductions in serum phosphorus concentrations and daily phosphate binder pill burden. Among hypoalbuminemic patients, the initiation of SO therapy was also associated with increases in serum albumin, suggesting therapy may have allowed patients to increase their dietary intake of protein.