Klemens B. Meyer

Changes in Quality of Life during Hemodialysis and Peritoneal Dialysis Treatment: Generic and Disease Specific Measures

Despite more than 20 yr of use, relative differences in health-related quality of life (HRQOL) between hemodialysis (HD) and peritoneal dialysis (PD) are not clearly known. The objective of this study was to compare self-reported HRQOL and overall health status for HD and PD patients at the initiation of dialysis therapy and 1 yr later. A prospective cohort of incident ESRD patients was enrolled between October 1995 and June 1998 at 81 outpatient dialysis units in 19 states and included 698 HD and 230 PD patients who completed a baseline CHOICE Health Experience Questionnaire. The main outcome measured was change in qualify-of-life scores from start of dialysis to 1 yr on dialysis and overall health status. Of 928 patients who completed the baseline questionnaire, 585 also completed the 12-mo questionnaire; 101 had died, 55 had received a kidney transplant, and 88 had moved to a new dialysis clinic. PD patients were slightly younger, were more likely to be white, were well-educated, were employed, were married, had less comorbidity, and had higher hematocrit. Unadjusted baseline scores showed better HRQOL for PD patients in both generic and ESRD domains (bodily pain, travel, diet restrictions, and dialysis access [P < 0.05]). At 1 yr, SF-36 scores improved, whereas some ESRD domains improved and others deteriorated. HD patients had greater improvements in two SF-36 domains (physical functioning and general health perception) than PD patients, but results were mixed for ESRD domains (PD is better for finances, HD is better for sleep and overall quality of life). HD and PD patients did not differ in change in overall health status. HD and PD are associated with similar HRQOL outcomes at 1 yr. Generic HRQOL in two domains improved more for HD patients. However, for ESRD-specific HRQOL, results were not consistent; some domains were better for PD patients whereas others were better for HD patients. In advising patients about modality choices, trade-offs should be discussed and individual preferences for specific aspects of HRQOL should be elicited.

Changing Relationship of Blood Pressure with Mortality over Time among Hemodialysis Patients

High BP is a major risk factor for atherosclerotic cardiovascular disease mortality in the general population. Surprising, studies that have been conducted among hemodialysis (HD) patients have yielded conflicting data on the relationship between BP and mortality. This study explores two hypotheses among HD patients: (1) The relationship between BP and mortality changes over time, and (2) mild to moderate hypertension is well tolerated. Incident HD patients who were treated at Dialysis Clinic Inc. facilities between 1993 and 2003 were studied. Primary end points were atherosclerotic cardiovascular disease and all-cause mortality. The relationship between BP and mortality was analyzed in two sets of Cox proportional hazards models. Model-B explored the relationship between baseline BP and mortality in sequential time periods. Model-TV assessed the relationship between BP, treated as time-varying, and mortality. The study sample (n = 16,959) was similar in characteristics to the United States Renal Data Systems population, although black patients were slightly overrepresented. Model-B demonstrated that the relationship between baseline BP and mortality changes over time. Low systolic BP (<120 mmHg) was associated with increased mortality in years 1 and 2. High systolic BP (> or =150 mmHg) was associated with increased mortality among patients who survived > or =3 yr. Low pulse pressure was associated with increased mortality. Model-TV demonstrated that mild to moderate systolic hypertension may be relatively well tolerated. In conclusion, the relationship between baseline BP and mortality changes over time. Mild to moderate systolic hypertension was associated with only modest increases in mortality.

Choices for Healthy Outcomes In Caring for End Stage Renal Disease

In the CHOICE study, a multidisciplinary research team is conducting several complementary research projects designed to better understand how dialysis care practice influences health outcomes and costs. The study places a special emphasis on the perspective of the patient. The effort includes the development of patient‐centered instruments for assessment of health‐related quality of life, patient preferences and patient satisfaction. Our hope is to provide information and tools to guide physicians and providers in selecting optimal dialysis practices for their patients with ESRD.

Which Targets in Clinical Practice Guidelines Are Associated with Improved Survival in a Large Dialysis Organization

Professional organizations have developed practice guidelines in the hope of improving clinical outcomes. The National Kidney Foundations Kidney Disease Outcomes Quality Initiative (KDOQI) has set targets for dialysis dosage (single-pool Kt/V), hematocrit, serum albumin, calcium, phosphorus, parathyroid hormone, and BP for hemodialysis (HD) patients. Several guidelines are largely based on results from observational studies. In contrast to other parameters, BP values within the KDOQI guidelines have been associated with increased mortality. Therefore, it was postulated that having multiple parameters that satisfy the current guidelines, except those for BP, is associated with improved survival among HD patients. A retrospective analysis was conducted of incident HD patients who were treated at facilities operated by Dialysis Clinic Inc., a not-for-profit dialysis provider, between January 1, 1998, and December 31, 2004 (n = 13,792). Cox proportional hazards models were used to assess the association between satisfying guidelines and mortality. Values within guidelines for single-pool Kt/V, hematocrit, serum albumin, calcium, phosphorus, and parathyroid hormone were associated with decreased mortality (P < or = 0.0001). The largest survival benefit was found for serum albumin (hazard ratio [HR] 0.27; 95% confidence interval [CI] 0.24 to 0.31). Satisfying these six guidelines simultaneously was associated with an 89% reduction in mortality (HR 0.11; 95% CI 0.06 to 0.19]). Conversely, BP values satisfying the guideline were associated with increased mortality (HR 1.90; 95% CI 1.73 to 2.10). Because this target was largely extrapolated from the general population, a randomized, controlled trial is needed to identify the optimal BP for HD patients.

Comorbidity Assessment in Hemodialysis and Peritoneal Dialysis Using the Index of Coexistent Disease

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.

Assessing health and quality of life outcomes in dialysis: A report on an institute of medicine workshop

I N DECEMBER 1994, the Institute of Medicine (IOM) convened a workshop to evaluate instruments for the measurement of functional status, health status, and health-related quality of life (QOL) for use in the end-stage renal disease (ESRD) clinical setting, especially with dialysis patients. The workshop had been preceded by a 1991 IOM report, Kidney Failure and the Federal Government,’ and by a 1993 IOM conference on “Measuring, Managing, and Improving Quality in the End-Stage Renal Disease Treatment Setting.“2-4 That conference had recommended that a workshop be convened “to develop criteria for evaluation of QOL measurement tools; to generate a guide to the various measurements of functional outcome, health status, and health-related QOL; and to report this information back to ESRD treatment units.“4’5* This article reports on that workshop.

Correlates and Outcomes of Fatigue among Incident Dialysis Patients

BACKGROUND & OBJECTIVES Fatigue is a debilitating symptom experienced by patients undergoing dialysis, but there is only limited information on its prevalence and its association with patient outcomes. This study examines the correlates of self-reported fatigue at initiation of dialysis and after 1 yr and assesses the extent to which fatigue was associated with health-related quality of life and survival. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS A longitudinal cohort of 917 incident hemodialysis and peritoneal dialysis patients who completed the CHOICE Health Experience Questionnaire (CHEQ) participated in the study. Fatigue was assessed using the SF-36 vitality scale. Known predictors of fatigue including sociodemographic and psychosocial factors, dialysis-related factors, biochemical variables including inflammatory markers, comorbidities, and medications were used as covariates. RESULTS A low vitality score was independently associated with white race, higher Index of Coexistent Disease score, higher body mass index, lack of physical exercise, antidepressant use, and higher C-reactive protein levels (CRP). A lower vitality score was strongly associated with lower SF-36 physical functioning, mental health, bodily pain scores, and decreased sleep quality (all P < 0.001) at baseline. Among surviving participants, higher serum creatinine at baseline was associated with preserved vitality at 1 yr. Patients with the highest baseline vitality scores were associated with longer survival (hazard ratio 0.75; 95% CI 0.58 to 0.96, P = 0.03). CONCLUSIONS The findings of this study demonstrate that ESRD patients experience profound levels of fatigue and elucidate its correlates. Also, the association of fatigue with survival may have significant implications for this population.

The Influence of Age on Changes in Health-Related Quality of Life over Three Years in a Cohort Undergoing Hemodialysis

OBJECTIVES: To assess the extent to which persons aged 70 and older undergoing hemodialysis (HD) had greater changes in health‐related quality of life (HRQOL) over 3 years than younger patients undergoing HD.

Oral Intradialytic Nutritional Supplement Use and Mortality in Hemodialysis Patients

BACKGROUND Hemodialysis patients have high mortality rates, potentially reflecting underlying comorbid conditions and ongoing catabolism. Intradialytic oral nutritional supplements may reduce this risk. STUDY DESIGN Retrospective propensity-matched cohort. SETTING & PARTICIPANTS Maintenance hemodialysis patients treated at Dialysis Clinic Inc facilities who were initiated on a nutritional supplement protocol in September to October 2010 were matched using a propensity score to patients at facilities at which the protocol was not used. PREDICTORS Prescription of the protocol, whereby hemodialysis patients with serum albumin levels ≤3.5g/dL would initiate oral protein supplementation during the dialysis procedure. Sensitivity analyses matched on actual supplement intake during the first 3 study months. Covariates included patient and facility characteristics, which were used to develop the propensity scores and adjust multivariable models. OUTCOMES All-cause mortality, ascertained though March 2012. RESULTS Of 6,453 eligible patients in 101 eligible hemodialysis facilities, the protocol was prescribed to 2,700, and 1,278 of these were propensity matched to controls. Mean age was 61 ± 15 (SD) years and median dialysis vintage was 34 months. There were 258 deaths among protocol assignees versus 310 among matched controls during a mean follow-up of 14 months. In matched analyses, protocol prescription was associated with a 29% reduction in the hazard of all-cause mortality (HR, 0.71; 95% CI, 0.58-0.86); adjustment had minimal impact on models. In time-dependent models incorporating change in albumin level, protocol status remained significant but was attenuated in models incorporating a 30-day lag. Similar results were seen in sensitivity analyses of 439 patients receiving supplements who were propensity-matched to controls, with 116 deaths among supplement users versus 140 among controls (HR, 0.79; 95% CI, 0.60-1.05), achieving statistical significance in adjusted models. LIMITATIONS Observational design, potential residual confounding. CONCLUSIONS Prescription of an oral nutritional supplement protocol and use of oral protein nutritional supplements during hemodialysis are associated with reduced mortality among in-center maintenance hemodialysis patients, an effect likely not mediated by change in serum albumin levels.

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.