Changes in serum albumin and other nutritional markers when using sucroferric oxyhydroxide as phosphate binder among hemodialysis patients: a historical cohort study.

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.

Bias in assessment of health-related quality of life in a hemodialysis population: a comparison of self-administered and interviewer-administered surveys in the HEMO study.

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 self-administered 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 self-administered 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 = 427) or by self-administration (n = 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 < 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 < 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.

Comorbidity and other factors associated with modality selection in incident dialysis patients: the CHOICE Study. Choices for Healthy Outcomes in Caring for End-Stage Renal Disease.

Case-mix factors influence both the selection of dialysis modality and outcomes in end-stage renal disease (ESRD). A detailed characterization of the case-mix differences between peritoneal dialysis (PD) and hemodialysis (HD) patients at the onset of dialysis therapy has not been performed, despite the importance of accounting for baseline differences in future comparisons of outcomes across modality groups. We compared baseline characteristics of 279 PD and 759 HD patients enrolled in the Choices for Healthy Outcomes in Caring for End-Stage Renal Disease (CHOICE) Cohort Study, a prospective study of incident dialysis patients. Comorbidity was assessed using the Index of Coexistent Diseases (ICED), consisting of a medical record review of 19 medical conditions and an observer-based assessment of 11 physical functions. ICED scores range from 0 to 3, with higher levels reflecting more severe comorbidity. Comorbidity was less severe in PD patients than in HD patients: the proportions of patients with ICED 0-1, ICED 2, and ICED 3 were 52%, 26%, and 22%, respectively, among the PD patients and 30%, 39%, and 31%, respectively, among the HD patients (P < 0.001). After controlling for all other factors, the differences in comorbidity remained significant. As compared with patients with ICED 0-1, the odds of being treated with PD for patients with ICED 2 and ICED 3 were less (odds ratio [OR] and 95% confidence intervals) 0.31 (0.17 to 0.56) and 0.50 (0.28 to 0.90), respectively. The number and severity of comorbid conditions at the onset of ESRD is significantly lower in patients choosing PD, independent of other factors influencing modality selection. The increased survival of PD patients reported in recent studies may simply reflect the self- or physician-directed selection of healthier patients to PD. Adjustment for case-mix differences in patients treated with PD versus HD is essential to the assessment of the independent effect of the dialysis modality on outcomes.