Search

Background: Patient-reported outcome measures that are more practical and clinically useful are needed for patients with CKD. We compared a new CKD-specific quality-of-life impact scale (CKD-QOL) with currently used measures., Methods: Patients ( n =485) in different treatment groups (nondialysis stages 3-5, on dialysis, or post-transplant) completed the kidney-specific CKD-QOL and Kidney Disease Quality of Life-36 (KDQOL-36) forms and the generic SF-12 Health Survey at baseline and 3 months. New items summarizing quality of life (QOL) impact attributed to CKD across six QOL domains yielded single impact scores from a six-item static (fixed-length) form and from computerized adaptive tests (CATs) with three to six items. Validity tests compared the CKD-QOL, KDQOL-36 (Burden, Effects, and Symptoms/Problems subscales), and generic SF-12 measures across groups in four tests of clinical status and clinician assessment of change (CKD-specific tests), and number of comorbidities. ANOVA was used to test for group mean differences, variances in each measure explained by groups, and relative validity (RV) in comparison with the referent KDQOL-36 Burden subscale., Results: KDQOL-36 and CKD-QOL measures generally discriminated better than generic SF-12v2 measures. The pattern of variances across CKD-specific tests comparing validity favored CKD-QOL two-fold over KDQOL-36. Two RV test results confirmed CKD-QOL improvements over the referent KDQOL scale. Results for static and CAT CKD-QOL forms were similar. SF-12 Physical and KDQOL-36 Symptoms scores worsened with increasing comorbid condition counts., Conclusions: Overall, compared with the KDQOL-36, the new approach to summarizing CKD-specific QOL impact performed better across multiple tests of validity. CAT surveys were more efficient than static surveys., (Copyright © 2019 by the American Society of Nephrology.)

BACKGROUND Long-term consequences of donor nephrectomy might be reduced kidney function, increased risk for cardiovascular disease, impaired quality of life, and fatigue. Few studies have investigated associations between clinical and self-reported outcomes in a long-term perspective. Thus, we aimed to investigate relationships between clinical, self-reported, and donation-specific outcomes in a nationwide cohort. MATERIAL AND METHODS We conducted a prospective follow-up study and assessed pre- and post-donation data from 202 donors who donated in 2001-2004. During 2012-2013, data on donors' self-reported (quality of life and fatigue) and donor-specific outcomes were collected. We performed linear regression for each component score of the generic instrument Short-Form, SF36v2, measuring quality of life, and the 5 domains of fatigue. Clinical parameters tested as independent variables were medical treatment of hyperlipidemia or hypertension, current smoking status, BMI, hemoglobin, and eGFR. Data were adjusted for age and gender. RESULTS Approximately 10 years after donation, 67 donors were hypertensive and 54 donors had eGFR <60 ml/min/1.73 m². Mean increase in plasma creatinine was 16.6 µmol/l (SD=16.3). None of the clinical parameters were significant predictors for QoL. Female gender was significantly associated with general fatigue. There was a significant difference in perception of recognition from health personnel between donors with hypertension and donors without hypertension. CONCLUSIONS Our results show no associations between clinical and self-reported outcomes. However, we found a significant relationship between hypertension and donation-specific outcomes. Hypertension or reduced kidney function was identified in a minority of the donors. The increased risk for fatigue among female donors needs more investigation.

Background and Objectives: Health-related quality of life (HRQOL) is a measure of the well being of hemodialysis patients and an independent prognostic predictor. Our aim was to determine whether HRQOL among hemodialysis patients has changed over time., Design, Setting, Participants, & Measurements: We retrospectively analyzed data collected by Dialysis Clinic, Inc. from adult patients starting hemodialysis between January 1, 1997 and May 31, 2006. The primary outcome was HRQOL assessed by Short Form 36, 6 to 18 months after and closest to the 1-year anniversary of starting hemodialysis. Secular trends were analyzed by linear regression for continuous variables and logistic regression for categorical ones. Year of starting dialysis was the predictor. A five-point difference on a 0 to 100 scale was considered clinically significant., Results: Short Form 36 scores were available for 11,079 patients. Role physical, general health, vitality, social functioning, and physical component summary scores were unchanged among patients over the study period. Statistically significant (P < 0.05) but clinically insignificant changes were observed in physical functioning (-0.2 points/yr), bodily pain (+0.2 points/yr), mental health (+0.15 points/yr), and mental component summary scores (+0.13 points/yr). Only role emotional showed clinically significant improvement. Trends were unchanged after adjusting for age, gender, race, diabetes, hemoglobin, phosphorous, Kt/V, and albumin., Conclusions: Most HRQOL domains showed either no statistically significant change or statistically but not clinically significant change over almost a decade. These results suggest that, despite important developments in hemodialysis care since 1997, little progress was made in improving HRQOL of hemodialysis 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.

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., Design: Longitudinal., Setting: The Hemodialysis Study (HEMO Study) was a randomized, clinical trial of the effects of HD dose and membrane flux on mortality and morbidity in patients undergoing chronic dialysis., Participants: Secondary analysis of the HEMO Study., Measurements: Participants completed the Index of Well-Being (IWB) and the Kidney Disease Quality of Life-Long Form (KDQOL-LF), which also includes the Medical Outcomes Study 36-item Short Form Questionnaire (SF-36) annually. Changes in subjects those aged 70 and older were compared with changes in subjects aged 55 to 69 and 18 to 54., Results: At baseline, 1,813 (98%) of HEMO participants completed HRQOL surveys. Their mean age was 58, 56% were female, 64% were black, and mean duration of dialysis was 3.8 years. In subjects with HRQOL data at the first three annual assessments, there were no substantial mean declines in the SF-36 Physical or Mental Component Summary scales over 3 years. In models incorporating effects of attrition, the differences in average change over 3 years between patients undergoing HD aged 70 and older and the younger cohorts were small in magnitude. There were high rates of adverse HRQOL events in all age groups and significantly higher composite event rates of death or clinically significant decline in HRQOL over 3 years was found in subjects aged 70 and older., Conclusion: Although HRQOL was impaired in the population undergoing HD, HRQOL scores at baseline reflect a better-preserved multidimensional quality of life in respondents in the HEMO Study aged 70 and older than in younger patients undergoing HD. There was no substantial relationship between age and average decline in HRQOL score over 3 years in participants in the HEMO Study.

Objective: We sought to examine the relation between meeting or exceeding the current minimum guideline for hemoglobin (11 g/dl) in dialysis patients and generic and disease-specific QOL scores at 1 year., Methods: In 438 incident hemodialysis patients from a national prospective cohort study, we used regression models to predict QOL score (all scaled 0-100) at 1 year using 6-month values of hemoglobin, adjusting for potential confounders., Results: Compared to values < 11 g/dl, hemoglobin > or = 11 g/dl at 6 months was associated with higher scores for the general domains of physical functioning, role physical, mental health, social functioning, and bodily pain at 1 year; cognitive function, diet restriction, and dialysis access dialysis-specific domain scores were also higher for these patients. Each 1 g/dl greater hemoglobin was also statistically significantly associated with higher QOL scores for most domains. In longitudinal analyses, most of the domains showed that, with each 1 g/dl increase in hemoglobin concentration from baseline to 6 months, QOL score increased significantly over the first year., Conclusions: Hemodialysis patients who attain higher hemoglobin concentration at 6 months, especially > or = 11 g/dl, have better QOL at 1 year, with regard to important physical, mental, social, and cognitive domains.

Background: It has been widely supposed that high dose and high flux hemodialysis would affect the quality as well as the length of life of patients treated by maintenance hemodialysis. The HEMO Study examined changes in health-related quality of life as a secondary study outcome. Specific hypotheses were that study interventions would affect physical functioning, vitality, Short Form-36 Health Survey (SF-36) physical and mental component summary scores, symptoms and problems associated with kidney disease, and sleep quality., Methods: At baseline and annually, subjects responded to both the Index of Well-Being and the Kidney Disease Quality of Life-Long Form questionnaires. The interventions were assessed on the basis of their average effects over 3 years., Results: At baseline, the SF-36 physical component summary score was lower than in healthy populations, but the mental component score was nearly normal. Over 3-year follow-up, physical health continued to decline; mental health and kidney disease-targeted scores remained relatively stable. The high dose hemodialysis intervention was associated with significantly less pain (4.49 points, P < 0.001) and higher physical component scores (1.23 points P= 0.007), but these effects were small compared to the natural variability in scores. High flux membranes were not associated with statistically significant differences in health-related quality of life., Conclusion: The HEMO Study results demonstrate the marked burden of chronic kidney failure and hemodialysis treatment on daily life. In this trial among patients undergoing maintenance three times a week hemodialysis, the SF-36 physical component summary score and pain scale showed significant but very small clinical effects favoring the higher dialysis dose. No clinically meaningful benefits or either the dose or flux interventions were observed for other indices of health-related quality of life.

Background: Symptoms of restless legs are common among patients treated with long-term hemodialysis. We investigated the relation between symptoms of restless legs, quality of life, and survival among incident hemodialysis and peritoneal dialysis patients., Methods: This report includes 894 dialysis patients who responded to an item regarding severity of restless legs symptoms in the Choices for Healthy Outcomes in Caring for End-Stage Renal Disease Study. We examined participant responses both as categorized by the 5-point symptoms of restless legs item and classified with severe symptoms of restless legs if they reported they were very or extremely bothered by symptoms. Independent predictors of restless legs symptoms were estimated using logistic regression. The association of restless legs symptoms with quality of life was examined by means of mixed-model regression, and adjusted mortality risk was estimated by means of Cox proportional hazards., Results: Fifteen percent of dialysis patients were classified as having severe restless legs. Those characterized by severe restless legs were significantly more likely to be administered benzodiazepines, antidepressants, and antiepileptics. Age and diabetes mellitus were independently associated with severe symptoms of restless legs. Symptoms of restless legs were associated with lower Physical and Mental Component Scores, vitality, bodily pain, and sleep quality (all P < 0.001). After adjustment, severe symptoms of restless legs were significantly associated with an increased mortality hazard ratio of 1.39 (95% confidence interval, 1.08 to 1.79)., Conclusion: Symptoms of restless legs were associated with lower quality of life and increased risk for death. The effect of treatment for symptoms of restless legs on quality of life and survival awaits additional study.

Unlabelled: BACKGROUND; Despite technical progress in therapy, hemodialysis patients continue to report health-related quality of life (HRQOL) substantially lower than that of the general population. While African Americans with end-stage renal disease (ESRD) survive longer than members of other races, few studies have compared the HRQOL of African Americans with that of non-African Americans., Methods: We examined differences in sociodemographic, clinical, and HRQOL variables by race. A multiple regression model assessed the extent to which race was associated with differences in HRQOL scores after adjustment for sociodemographic and clinical variables. Racial differences in the relationship between comorbid disease severity and HRQOL were explored. RESULTS; In adjusted models, African Americans had higher scores in the Index of Well-Being and burden of kidney disease, but lower scores in cognitive function (all P < 0.05). For scales reflecting symptoms and effects of kidney disease, sleep quality, and the Physical Component Summary, the fall in HRQOL with increasing comorbidity was significantly greater in non-African Americans (all P < 0.05). After adjustment, there were no racial differences in scores on the Mental Component Summary, social support, dialysis staff encouragement, or patient satisfaction., Conclusion: To our knowledge, ESRD is the only chronic illness for which African Americans report significantly better psychologic well being and a lower burden of disease than non-African Americans. Further research is needed to understand whether these experiences affect health care utilization, medical decision making, and patient survival. Clarification of the reasons for race differences may suggest measures to improve HRQOL for all patients with ESRD.

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.

The Choices for Healthy Outcomes in Caring for End-Stage Renal Disease ([ESRD] CHOICE) Study was designed to evaluate the effectiveness of alternative dialysis prescriptions. As part of CHOICE, we developed an instrument for measuring health-related quality of life (HRQOL) for patients with ESRD that would complement the Medical Outcomes Study 36-Item Short-Form Survey (SF-36) and be sensitive to differences in dialysis modality (hemodialysis [HD] and peritoneal dialysis [PD]) and dialysis dose. The selection of HRQOL domains to be included was based on: (1) a structured literature review of 47 articles describing 53 different instruments; (2) content analysis of five focus groups with HD and PD patients, nephrologists, and other providers; (3) a survey of 110 dialysis providers about features of different modalities that affect patient HRQOL; and (4) a semistructured survey of 25 patients with ESRD on the effects of dialysis on functioning and HRQOL. To help prioritize domains and items identified by these methods, a representative sample of 136 dialysis patients rated each item for frequency and bother. A panel of nephrologists provided advice about the salience of items to modality or dose. Items and scales were selected with a preference for existing measures tested in patients with ESRD and were tested for reliability and validity. The first four steps yielded 22 HRQOL domains that included 96 items: 8 generic domains in the SF-36 (health perceptions, physical, social, physical and emotional role function, pain, mental health, and energy); 8 additional generic domains (cognitive functioning, sexual functioning, sleep, work, recreation, travel, finances, and general quality of life); and 6 ESRD-specific domains (diet, freedom, time, body image, dialysis access [catheters and/or vascular], and symptoms). New items were developed or adapted to assess ESRD-specific domains. Scales for these items showed adequate internal consistency (Cronbach's alpha > 0.70, except for time [alpha = 0.57] and quality of life [alpha = 0.68]), as well as convergent and discriminant construct validity in a sample of 928 patients. The final questionnaire included 21 domains (time was deleted) and 83 items. We have designed a patient-centered instrument, the CHOICE Health Experience Questionnaire, that addresses domains that may be sensitive to differences in dialysis modality and dose and shows evidence for reliability and validity as a measure of HRQOL in ESRD.

Although quality-of-life assessment is an important complement to conventional clinical evaluation, there are limited opportunities for researchers in end-stage renal disease (ESRD) to examine evidence for a range of quality-of-life measures. To better understand how quality of life has been conceptualized, measured, and evaluated for ESRD, we conducted a structured literature review. Eligible articles were identified from a MEDLINE search, expert input, and review of references from eligible articles. A standardized instrument was created for article review and included type of measure, instrument development process, study sample characteristics, quality-of-life domains, and reliability and validity testing. From 436 citations, 78 articles were eligible for final review, and of those, 47 articles contained evidence of reliability or validity testing. Within this set, there were 113 uses of 53 different instruments: 82% were generic and 18% were disease specific. Only 32% defined quality of life. The most frequently assessed domains were depression (41%), social functioning (32%), positive affect (30%), and role functioning (27%). Testing was completed for test-retest reliability (20%), interrater reliability (13%), internal consistency (22%), content validity (24%), construct validity (41%), criterion validity (55%), and responsiveness (59%). Few articles measuring quality of life in ESRD defined quality-of-life domains or adequately described instrument development and testing. Generic measures, such as the Sickness Impact Profile, and disease-specific measures, such as the Kidney Disease Questionnaire, had been tested more thoroughly than others. Standardized reporting and more rigorous testing could help researchers make informed choices about instruments that would best serve their own and their patients' needs.

Background: Patients with end-stage renal disease (ESRD) may have quality-of-life (QOL) concerns that are not fully appreciated by their providers. The authors conducted focus groups with dialysis patients and dialysis professionals to determine whether this qualitative method would reveal differences between patients' and providers' views about: 1) domains of QOL that are affected by ESRD and dialysis; and 2) aspects of dialysis that affect QOL., Methods: Separate focus group discussions were held with: 8 adult hemodialysis patients (mean age 50 years; 3 women; mean duration of dialysis 8.5 years), 5 adult peritoneal dialysis patients (mean age 54 years; 3 women; mean duration of dialysis 4.6 years), 8 nephrologists (mean of 12 years of dialysis practice), and 9 other health professionals involved in dialysis care (3 nurses, 2 dietitians, 2 social workers, and 2 technicians; mean of 10 years experience in dialysis care). Discussions were audiotaped, transcribed verbatim, and reviewed independently by three investigators to identify and categorize distinct thoughts., Results: 1,271 distinct thoughts were identified and grouped into 20 related categories, which included ten QOL domains and ten aspects of dialysis that affect QOL. Compared with the professionals, the patients identified one additional relevant QOL domain (10 vs 9), and one additional aspect of dialysis that affects QOL (10 vs 9), and expressed more thoughts per domain (p < 0.05), although the contents of their comments were frequently similar. Among QOL domains, the numbers of related thoughts identified by patients and professionals, respectively, were: freedom/control (60, 89); social relationships (36, 11); anxiety (37, 4); role function (24, 10); energy (12, 10); body image (16, 4); sex (11, 21); mental attitude (21, 0); sleep (15, 1), and cognitive function (13, 7). Among aspects of dialysis that affect QOL, the numbers of thoughts identified by patients and professionals were: general dialysis issues (159, 105); relationships with staff (62, 110); patient education (63, 68); diet (44, 40); scheduling (57, 3); vascular or peritoneal access issues (31, 17), adaptation to dialysis (16, 14); dialysis dose (18, 8); symptoms (25, 0), and self-care (5, 24)., Conclusions: Although health professionals have a good understanding of patient concerns about the effects of ESRD and dialysis, the focus group discussions revealed a breadth and depth of QOL concerns that they may not fully appreciate.