ࡱ> q Ebjbjt+t+ AAB@]4x $  % ' ' ' ' ' ' $`K -$$$K $% $%   % 4A  Other KDQOL Publications abstracts (in alphabetical order by last name of first author) Agarwal R, Rizkala AR, Bastani B, Kaskas MO, Leehey DJ, & Besarab A. (2006). A randomized controlled trial of oral versus intravenous iron in chronic kidney disease. Am J Nephrol, 26(5): 445-54. Indiana University School of Medicine, Richard L. Roudebush VA Medical Center, Indianapolis, IN 46202, USA. ragarwal@iupui.edu BACKGROUND: It is unknown whether intravenous iron or oral iron repletion alone can correct anemia associated with chronic kidney disease (CKD). We conducted a randomized multicenter controlled trial in adult anemic, iron-deficient non-dialysis CKD (ND-CKD) patients (>or=stage 3) not receiving erythropoiesis-stimulating agents (ESAs). METHODS: The participants were randomized to receive either a sodium ferric gluconate complex (intravenous iron) 250 mg i.v. weekly x 4 or ferrous sulfate (oral iron) 325 mg t.i.d. x 42 days. Hemoglobin (Hgb), ferritin and transferrin saturation (TSAT) were measured serially, and the Kidney Disease Quality of Life (KDQoL) questionnaire was administered on days 1 and 43. The primary outcome variable was change from baseline (CFB) to endpoint in Hgb values. RESULTS: Seventy-five patients were analyzed (intravenous iron n = 36, oral iron n = 39). CFB in Hgb was similar in the two groups (intravenous iron 0.4 g/dl vs. oral iron 0.2 g/dl, p = n.s.). However, the increase in Hgb was only significant with intravenous iron (p < 0.01). In comparison to oral iron, intravenous iron achieved greater improvements in ferritin (232.0 +/- 160.8 vs. 55.9 +/- 236.2 ng/ml, p < 0.001) and TSAT (8.3 +/- 7.5 vs. 2.9 +/- 8.8%, p = 0.007). Intravenous iron caused greater improvements in KDQoL scores than oral iron (p < 0.05). The most common side effect reported with intravenous iron was hypotension, while constipation was more common with oral iron. CONCLUSIONS: Oral and intravenous iron similarly increase Hgb in anemic iron-depleted ND-CKD patients not receiving ESAs. Although in comparison to oral iron, intravenous iron may result in a more rapid repletion of iron stores and greater improvement in quality of life, it exposes the patients to a greater risk of adverse effects and increases inconvenience and cost. Copyright (c) 2006 S. Karger AG, Basel. Barotfi S, Molnar MZ, Almasi C, Kovacs AZ, Remport A, Szeifert L, Szentkiralyi A, Vamos E, Zoller R, Eremenco S, Novak M, Mucsi I. (2006). Validation of the Kidney Disease Quality of Life-Short Form questionnaire in kidney transplant patients. J Psychosom Res, 60(5): 495-504. Institute of Behavioral Sciences, Semmelweis University, Budapest, Hungary. OBJECTIVE: The aim of this study was to determine the basic psychometric properties, reliability, and validity of the Kidney Disease Quality of Life-Short Form (KDQOL-SF) questionnaire in kidney transplant patients. METHODS: The reliability and validity of the instrument were determined in 418 kidney transplant patients followed in a single outpatient transplant centre. RESULTS: Internal consistency of all the Medical Outcome Study Short Form 36 (SF-36) domains was very good, and the Cronbach's alpha value was above .70 for all but three of the disease-specific subscales. We found significant, moderate to strong negative correlations between most of the KDQOL-SF domains and the Center for Epidemiologic Studies-Depression (CES-D) scores. Finally, substantial differences in KDQOL-SF scores were seen between groups of transplanted patients who were expected to be clinically different, supporting the discriminant validity of the KDQOL-SF instrument. CONCLUSION: We propose that the KDQOL-SF is a reliable and valid tool and most of its subscales can be used to assess health-related quality of life (HRQOL) in kidney transplant patients and to compare HRQOL between different end stage renal disease (ESRD) patient populations. J Nephrol. 2003 Nov-Dec;16(6):878-85.  HYPERLINK "http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Display&dopt=pubmed_pubmed&from_uid=14736016" Related Articles Improved health-related quality of life and left ventricular hypertrophy among dialysis patients treated with parathyroidectomy. Chow KM, Szeto CC, Kum LC, Kwan BC, Fung TM, Wong TY, Leung CB, Li PK. Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong SAR, China. BACKGROUND: We prospectively studied changes in the perception of health-related quality of life, pruritus, and degree of left ventricular hypertrophy in end-stage renal disease patients with tertiary hyperparathyroid disorder, before and 6 months after total parathyroidectomy treatment. METHODS: A series of 12 consecutive patients were enrolled. Throughout the follow-up period, all subjects completed the Kidney Disease Quality of Life Short Form-36 (KDQOL SF-36) questionnaire at inclusion and after 6 months. Serial clinical and physiological parameters including uremic pruritus, blood pressure control and left ventricular hypertrophy measured by echocardiography were recorded. RESULTS: Mean scores of the KDQOL SF-36 questionnaires were substantially higher 6 months after parathyroidectomy, with reference to physical functioning, bodily pain, role-physical, role-emotional, symptom list and burden of kidney disease. Parathyroidectomy resulted in a 22% reduction in left ventricular mass index, with significant improvement from the baseline value of 246 +/- 131 to 192 +/- 131 g/m2 (p = 0.03). CONCLUSION: Our findings highlight the potential importance of parathyroidectomy in improving health-related quality of life and left ventricular hypertrophy among dialysis patients with tertiary hyperparathyroidism. Kidney International, Vol. 68 (2005), pp. 17931800 Effects of the calcimimetic cinacalcet HCl on cardiovascular disease, fracture, and health-related quality of life in secondary hyperparathyroidism JOHN CUNNINGHAM, MARK DANESE, KURT OLSON, PRESTON KLASSEN, and GLENN M. CHERTOW University College London, The Middlesex Hospital, London, UK; Outcomes Insights, Inc., Newbury Park, California; Amgen, Inc., Thousand Oaks, California; and Department of Medicine, University of California, San Francisco, California Background. Secondary hyperparathyroidism (HPT) and abnormal mineral metabolism are thought to play an important role in bone and cardiovascular disease in patients with chronic kidney disease. Cinacalcet, a calcimimetic that modulates the calcium-sensing receptor, reduces parathyroid hormone (PTH) secretion and lowers serum calcium and phosphorus concentrations in patients with end-stage renal disease (ESRD) and secondary HPT. Methods. We undertook a combined analysis of safety data (parathyroidectomy, fracture, hospitalizations, and mortality) from 4 similarly designed randomized, double-blind, placebo-controlled clinical trials enrolling 1184 subjects (697 cinacalcet, 487 control) with ESRD and uncontrolled secondary HPT (intact PTHe"300 pg/mL). Cinacalcet or placebo was administered to subjects receiving standard care for hyperphosphatemia and secondary HPT (phosphate binders and vitamin D). Relative risks (RR) and 95% CI were calculated using proportional hazards regression with follow-up times from 6 to 12 months. Health-related quality-of-life (HRQOL) data were obtained from the Medical Outcomes Study Short Form-36 (SF-36), and the Cognitive Functioning scale from the Kidney Disease Quality of Life instrument (KDQOL-CF). Results. Randomization to cinacalcet resulted in significant reductions in the risk of parathyroidectomy (RR 0.07, 95% CI 0.010.55), fracture (RR 0.46, 95% CI 0.220.95), and cardiovascular hospitalization (RR 0.61, 95% CI 0.430.86) compared with placebo. Changes in HRQOL favored cinacalcet, with significant changes observed for the SF-36 Physical Component Summary score and the specific domains of Bodily Pain and General Health Perception. Conclusion. Combining results from 4 clinical trials, randomization to cinacalcet led to significant reductions in the risk of parathyroidectomy, fracture, and cardiovascular hospitalization, along with improvements in self-reported physical function and diminished pain. These data suggest that, in addition to its effects on PTH and mineral metabolism, cinacalcet had favorable effects on important clinical outcomes. Keywords: calcimimetics, cinacalcet, outcomes, PTH, secondary hyperparathyroidism. Davison SN, Jhangri GS, Johnson JA. (2006). Cross-sectional validity of a modified Edmonton symptom assessment system in dialysis patients: a simple assessment of symptom burden. Kidney Int, 69(9): 1621-5. Department of Medicine, University of Alberta, Edmonton, Alberta, Canada. sara.davidson@ualberta.ca Subjective symptom assessment should be a fundamental component of health-related quality of life (HRQL) assessment in end-stage renal disease (ESRD). Unfortunately, no symptom checklist has established reliability or validity in ESRD. We report the validation of a modified Edmonton Symptom Assessment System (ESAS) in 507 dialysis patients who concurrently completed the Kidney Dialysis Quality of Life-Short Form (KDQOL-SF) questionnaire. The ESAS demonstrated a mean of 7.5+/-2.5 symptoms. The symptoms reported as most severe were tiredness, well-being, appetite, and pain. The overall symptom distress score was strongly correlated with the KDQOL-SF subscales symptom/problem list (r=-0.69, P<0.01), effects of kidney disease (r=-0.52, P<0.01), and burden of kidney disease (r=-0.50, P<0.01), as well as lower RAND-12 physical health composite (PHC) (r=-0.54, P<0.01) and lower RAND-12 mental health composite (MHC) (r=-0.62, P<0.001). In the multivariate regression analysis, after controlling for potential confounding variables including comorbidity using the modified Charlson Comorbidity Index, the ESAS symptom distress score remained strongly associated with the MHC (slope=-0.82+/-0.07, P<0.01) and PHC (slope=-0.48+/-0.07, P<0.01). The ESAS symptom distress score accounted for 29% of the impairment in PHC and 39% of the impairment in MHC. The intraclass correlation coefficient for the total symptom distress score in a 1-week test-retest was 0.70, P<0.01. Symptom burden is high and adversely affects HRQL in dialysis patients. The modified ESAS is a reliable, valid, simple, and useful method for regular symptom assessment in this patient population. Davison SN, Jhangri GS, Johnson JA. (2006). Longitudinal validation of a modified Edmonton symptom assessment system (ESAS) in haemodialysis patients. Nephrol Dial Transplant, 21(11): 3189-95. Division of Nephrology & Immunology, Department of Public Health Sciences, Institute of Health Economics, University of Alberta, Edmonton, Canada, T6G 2G3. sara.davison@ualberta.ca BACKGROUND: Health-related quality of life (HRQL) is an important outcome in the treatment of end-stage renal disease (ESRD) and appears to be highly associated with patient self-report of symptom burden. This study examines the longitudinal validity of the modified Edmonton symptom assessment system (ESAS) to determine the impact of change in symptom burden on the change in HRQL of haemodialysis (HD) patients. METHODS: 261 haemodialysis patients completed the Kidney Disease Quality of Life-Short Form (KDQOL-SF) and the ESAS at baseline and at 6 months. RESULTS: The change in overall symptom distress score was strongly correlated with the change in KDQOL-SF subscales symptom/problem list (R=-0.73, P<0.01), effects of kidney disease (R=-0.53, P<0.01), and burden of kidney disease (R=-0.46, P<0.01) as well as overall physical health composite (R=-0.58, P<0.01) and overall mental health composite (R=-0.68, P<0.01). The change in symptom burden, as described by the ESAS, accounted for 46% of the change in the mental HRQL and 34% of the change in the physical HRQL. There was no correlation between baseline demographics, comorbidity or changes in biochemical markers with changes in either the ESAS or HRQL scores. CONCLUSION: The modified ESAS is a simple, valid tool for the longitudinal assessment of physical and psychological symptom burden in ESRD and is responsive to change in HD patients. The use of this symptom assessment scale and improved management of patient symptoms would be expected to positively impact HD patients' HRQL. Cultural adaptation and validation of the "Kidney Disease and Quality of Life--Short Form (KDQOL-SF 1.3)" in Brazil. Duarte PS, Ciconelli RM, Sesso R. Departamento de Medicina, Escola Paulista de Medicina, Universidade Federal de Sao Paulo, Sao Paulo, SP, Brazil. psduarte@nefro.epm.br The objective of the present study was to translate the Kidney Disease Quality of Life -- Short Form (KDQOL-SF 1.3) questionnaire into Portuguese to adapt it culturally and validate it for the Brazilian population. The KDQOL-SF was translated into Portuguese and back-translated twice into English. Patient difficulties in understanding the questionnaire were evaluated by a panel of experts and solved. Measurement properties such as reliability and validity were determined by applying the questionnaire to 94 end-stage renal disease patients on chronic dialysis. The Nottingham Health Profile Questionnaire, the Karnofsky Performance Scale and the Kidney Disease Questionnaire were administered to test validity. Some activities included in the original instrument were considered to be incompatible with the activities usually performed by the Brazilian population and were replaced. The mean scores for the 19 components of the KDQOL-SF questionnaire in Portuguese ranged from 22 to 91. The components "Social support" and "Dialysis staff encouragement" had the highest scores (86.7 and 90.8, respectively). The test-retest reliability and the inter-observer reliability of the instrument were evaluated by the intraclass correlation coefficient. The coefficients for both reliability tests were statistically significant for all scales of the KDQOL-SF (P < 0.001), ranging from 0.492 to 0.936 for test-retest reliability and from 0.337 to 0.994 for inter-observer reliability. The Cronbach's alpha coefficient was higher than 0.80 for most of components. The Portuguese version of the KDQOL-SF questionnaire proved to be valid and reliable for the evaluation of quality of life of Brazilian patients with end-stage renal disease on chronic dialysis. Rev Assoc Med Bras. 2003 Oct-Dec;49(4):375-81. Epub 2004 Feb 04. HYPERLINK "http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14963582"Related Articles [Translation and cultural adaptation of the quality of life assessment instrument for chronic renal patients (KDQOL-SF) [Article in Portuguese] Duarte PS, Miyazaki MC, Ciconelli RM, Sesso R. Universidade Federal de Sao Paulo, Escola Paulista de Medicina, Faculdade de Medicina de Sao Jose do Rio Preto, SP. psduarte@nefro.epm.br BACKGROUND: The objective of this study was to translate from English into Portuguese and to perform cultural adaptation of the Kidney Disease Quality of Life Short Form--KDQOL-SF to make possible its validation in Brazil. METHODS: This instrument was translated from the original English version into Portuguese language by the authors and it was also translated by a certified translator and revised by a specialized translator who evaluated the level of difficulty for translation. Thirty end-stage renal disease patients undergoing dialysis were randomly selected to participate in the study. RESULTS: The mean age of patients was 47 +/- 9 years (23 to 60 yr), and the predominant education level was incomplete elementary school (1st to 8th grade=53%); 60% of the patients were female. The majority of patients (63%) were undergoing hemodialysis and the period of treatment within the last 30 days was 12 hours or more per week. The time of dialysis treatment was 0-2 years for 70% of the patients. The feasibility of the instrument and the difficulties found by the patients were evaluated by a panel of experts and changes were made regarding difficulties of comprehension. Some activities were substituted since they were not regular for the Brazilian population. There were modifications in expressions of translation for terms suggested by patients and Brazilian experts and, for five items it was suggested to include an explanation in parentheses. Common words used in the Portuguese language were chosen. CONCLUSIONS: The translation and cross-cultural adaptation of the KDQOL questionnaire to Portuguese were concluded, having been accomplished this important stage for its validation and use in our environment. Health Qual Life Outcomes. 2004 Jan 8;2(1):2.  HYPERLINK "http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Display&dopt=pubmed_pubmed&from_uid=14713316" Related Articles Health-related quality of life outcomes after kidney transplantation. Fiebiger W, Mitterbauer C, Oberbauer R. Department of Nephrology, University of Vienna, Austria. rainer.oberbauer@akh- wien.ac.at With the improvements in short and long term graft and patient survival after renal transplantation over the last two decades Health-Related Quality of Life (HRQL) is becoming an important additional outcome parameter. Global and disease specific instruments are available to evaluate objective and subjective QOL. Among the most popular global tools is the SF-36, examples of disease specific instruments are the Kidney Transplant Questionnaire (KTQ), the Kidney Disease Questionnaire (KDQ) and the Kidney Disease-Quality of Life (KDQOL). It is generally accepted that HRQL improves dramatically after successful renal transplantation compared to patients maintained on dialysis treatment but listed for a transplant. It is less clear however which immunosuppressive regimen confers the best QOL. Only few studies compared the different regimens in terms of QOL outcomes. Although limited in number, these studies seem to favour non-cyclosporine based protocols. The main differences that could be observed between patients on cyclosporine versus tacrolimus or sirolimus therapy concern the domains of appearance and fatigue. This may be explained by two common adverse effects occurring under cyclosporine therapy, gingival hyperplasia and hair growth. Another more frequently occurring side effect under calcineurin inhibitor therapy is tremor, which may favour CNI free protocols. This hypothesis, however, has not been formally evaluated in a randomised trial using HRQL measurements.In summary HRQL is becoming more of an issue after renal transplantation. Whether a specific immunosuppressive protocol is superior to others in terms of HRQL remains to be determined. Frimat L, Durand PY, Loos-Ayav C, Villar E, Panescu V, Briancon S, Kessler M. (2006). Impact of first dialysis modality on outcome of patients contraindicated for kidney transplant. Perit Dial Int, 26(2): 231-9. Department of Nephrology, University Hospital of Nancy, France. L.frimat@chu-nancy.fr BACKGROUND: We compared, in patients contraindicated for kidney transplant, outcomes between those patients who were only on hemodialysis (HD) and those who were given peritoneal dialysis (PD) as first renal replacement therapy (RRT). DESIGN: Prospective, population-based cohort study of incident cases of end-stage renal disease between June 1997 and June 1999. SETTING: A network of dialysis care: NEPHROLOR, that is, all the renal units in Lorraine, one of the 22 French administrative regions (population over 2.3 million people). PARTICIPANTS: 387 patients were contraindicated for kidney transplant during the first 2 years of RRT: 284 were on HD, 103 on PD. Mean age was 67.6 +/- 11.3 years for HD patients and 70.8 +/- 11.4 years for PD patients (p = 0.015). MAIN OUTCOME MEASURES: Mortality until June 2003, hospitalization over the 2 first years of RRT, and Kidney Disease and Quality of Life Short Form (KDQOL-SF) 6 and 12 months after initiation of RRT. RESULTS: HD patients were more likely to die from cardiac or cerebrovascular causes, PD from cachexia or withdrawal from dialysis. Whatever mode of RRT, the unadjusted 2-year and 5-year survival rates were similar (p = 0.98). The rate of total duration of hospital stay per month of RRT was similarin HD and PD groups: 2.7 +/- 4.5 and 2.9 +/- 4.2 days respectively (p = 0.7). PD was associated with better quality of life than HD. The dimensions Role limitation due to emotional function, Burden of kidney disease, and Role limitation due to physical function ranked first, second, and third for PD. CONCLUSION: In Lorraine, end-stage renal disease patients who were given PD as first-line RRT had no excess of death risk or hospitalizations, and better quality of life the first year of RRT. Nefrologia. 2003 Nov-Dec;23(6):528-37.  HYPERLINK "http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Display&dopt=pubmed_pubmed&from_uid=15002788" Related Articles Health-related quality of life in elderly patients in haemodialysis [Article in Spanish] Gil Cunqueiro JM, Garcia Cortes MJ, Foronda J, Borrego JF, Sanchez Perales MC, Perez del Barrio P, Borrego J, Viedma G, Liebana A, Ortega S, Perez Banasco V. Servicio de Nefrologia, Complejo Hospitalario Ciudad de Jaen, Jaen. INTRODUCTION: In view of the increasing interest in measuring health-related quality of life (HRQOL) and that is widely accepted Quality of life (QL) is a valid marker of results of treatment in chronic dialysis, we marked the aim to determine QL of the patients > or = 75 years in chronic haemodialysis and to determine the influence of different factors (comorbidity, analytical, cognitive deterioration, depression and self-sufficiency) over the results. METHODS: We used the Kidney Disease Quality of Life (KDQOL-SF), questionnaire of health that has been become an useful instrument for measuring CV into this population. Demographic and analytical data, comorbidity (Charlson Index), depression (Yesavage), self-sufficiency (Karnofsky) and impaired cognitive function (Cognitive Mini-Exam) were collected. We evaluated the influence of these factors on the different dimensions of the KDQOI-SF and compared our scores with general Spanish population scores standardised according to age and sex. RESULTS: We included 51 patients (24 men) with a mean age 79.5 +/- 3.7 years and 39 +/- 56 months in dialysis. Women had lower scores than men in all scales of KDQOL-SF. We found that months in dialysis, depression scale, Karnofsky scale and cognitive deterioration test were also influencing about these scores. Multivariate analysis showed that CV is especially associated with sex, depression, cognitive deterioration and self-sufficiency. After we calculated standardised scores according to age and gender, out population showed a level of CV lower than general population, especially in female gender. CONCLUSIONS: In our population the women had worse CV than men. The CV of the elders in HD is lower than general population of equal sex and age and it was not modified with factors related to the end-stage renal disease and its treatment. Suffering from cognitive deterioration or depression had an important impact on the well-being of our patients, which would justify a wider diagnostic and therapeutic boarding in these patients. Kidney International, Vol. 68 (2005), pp. 28012808 Health-related quality of life and estimates of utility in chronic kidney disease IRINA GORODETSKAYA, STEFANOS ZENIOS, CHARLES E. MCCULLOCH, ALAN BOSTROM, CHI-YUAN HSU, ANDREW B. BINDMAN, ALAN S. GO, and GLENN M. CHERTOW Divisions of Nephrology and General Internal Medicine, Departments of Medicine, Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California; Graduate School of Business, Stanford University, Stanford, California; and Division of Research, Kaiser Permanente of Northern California, Oakland, California Background. Health-related quality of life and estimates of utility have been carefully evaluated in persons with end-stage renal disease. Fewer studies have examined these parameters in persons with chronic kidney disease (CKD). Methods. To determine the relations among kidney function, health-related quality of life, and estimates of utility, we administered the Kidney Disease Quality of Life Short Form 36 (KDQOL-36TM), Health Utilities Index (HUI)-3, and Time Trade-off (TTO) questionnaires to 205 persons with CKD. Persons with CKD stages 4 and 5 (estimated GFR <30 mL/min/1.73 m2, N = 115) were tested two to eight times over the subsequent two years. The relations among estimated glomerular filtration rate (eGFR), and changes in health-related quality of life and utility over time were estimated using mixed effect regression models. Models were adjusted for age, sex, race, and diabetes. Results. Mean scores on the KDQOL-36TM generic components, HUI-3, and TTO suggested considerable loss of function and well-being in CKD relative to population norms. On cross-sectional analysis, lower levels of kidney function were associated with significantly lower scores on the SF-12 Physical Health Composite (P = 0.002), the Burden of Kidney Disease subscale (P < 0.0001), and the Effects of Kidney Disease subscale (P < 0.0001) of the KDQOL-36TM. Kidney function was significantly associated with the TTO (P = 0.008) and global HUI-3 utility (P = 0.016) although these associations were attenuated after adjustment for diabetes. A decline in eGFR was associated with a significant increase in the reported Burden of Kidney Disease (5.0 point change per year per mL/min/1.73 m2 decline in eGFR) and with marginally significant changes in the Dexterity and Pain attributes of the HUI-3. Mean HUI-3 scores for persons with CKD stages 4 and 5, absent dialysis, were in the range previously reported for persons with stroke and severe peripheral vascular disease. Conclusion. Health-related quality of life and estimates of utility are distressingly low in persons with CKD. Self-reported outcomes should be considered when evaluating health policy decisions that affect this population. Keywords: chronic kidney disease, estimated glomerular filtration rate, health-related quality of life, utility, Health Utilities Index, KDQOL. Early quality of life benefits of icodextrin in peritoneal dialysis. Kidney Int Suppl 2002 Oct;(81):S72-9 Guo A, Wolfson M, Holt R. Renal Division, Baxter Healthcare Corporation, Deerfield, Illinois 60015, USA. amy_guo@baxter.com Early quality of life benefits of icodextrin in peritoneal dialysis. BACKGROUND: The impact of new therapies on patient quality of life (QOL) is emerging as an important indicator of the value of these therapies. In patients on dialysis, previous QOL evaluations have focused mainly on comparative approaches between modalities, or on longitudinal trends within a modality, but few have evaluated technical innovations or introduction of new therapies. The aim of the present study was to assess the early effects of a new dialysis solution (icodextrin) on the QOL of peritoneal dialysis patients. The QOL is compared with that of patients on dextrose, and the impact of demographic, and clinical characteristics on patients' QOL is examined. METHODS: The kidney disease quality of life questionnaire (KDQOL) was administered to patients who participated in a phase III double-blind, parallel group, active-controlled trial to evaluate the efficacy and safety of a peritoneal dialysis (PD) solution containing icodextrin in comparison with dextrose PD solution. A total of 93 patients (58 icodextrin, and 35 dextrose) completed the questionnaire at both baseline and after 13 weeks. In addition to patients QOL, patients' demographic and clinical characteristics were recorded at both baseline and 13 weeks. RESULTS: Mean change scores from baseline to 13 weeks of icodextrin patients were substantially higher (> or =5) than dextrose, particularly with respect to general health perception, physical functioning, role-physical, and many KDQOL symptom items such as lack of strength, washed out or drained, lack of appetite, faintness or dizziness, dry skin, cramps after an exchange or treatment, cramps during an exchange or treatment, and muscle spasms or twitching. At 13 weeks, icodextrin patients had significantly improved symptoms, and rated their health in general higher than those patients in the dextrose group. Upon multivariate analysis, icodextrin contributed significantly to the improvement of patients' mental health, general health, and symptoms such as muscle spasms or twitching, cramps during an exchange or treatment, cramps after an exchange or treatment, itchy skin, and faintness or dizziness. CONCLUSIONS: Peritoneal dialysis patients treated with icodextrin experienced substantial quality of life improvement at 13 weeks after the start of treatment when compared to dextrose patients. Further research is necessary to determine patients' quality of life over time in a longitudinal study setting. Clinical outcomes and quality of life in elderly patients on peritoneal dialysis versus hemodialysis. Perit Dial Int 2002 Jul-Aug;22(4):463-70 Harris SA, Lamping DL, Brown EA, Constantinovici N; North Thames Dialysis Study (NTDS) Group. Department of Renal Medicine, Charing Cross Hospital, London, United Kingdom. OBJECTIVE: To compare clinical outcomes and quality of life (QOL) in elderly patients on peritoneal dialysis (PD) and hemodialysis (HD) in the North Thames Dialysis Study. DESIGN: A 12-month prospective cohort study. SETTING: Four hospital-based renal units in London, UK. PATIENTS: 174 patients that were 70 years or older at the start of dialysis, separated into two cohorts: 78 new patients (36 PD, 42 HD) that were recruited after 90 days of chronic dialysis; and 96 stock patients (42 PD, 54 HD) that were already on dialysis during the recruitment period. MAIN OUTCOME MEASURES: 12-month survival and hospitalization rate, and QOL assessed at baseline and at 6 and 12 months by the SF-36 and the Symptoms/Problems scale of the Kidney Disease Quality of Life Questionnaire (KDQOL). RESULTS: Peritoneal dialysis and HD patients were similar for sociodemographic and clinical characteristics. Annual mortality and hospitalization rates in PD versus HD patients were 26.1 versus 26.4 deaths/100 person-years and 1.9 versus 2.0 admissions/person-year, respectively. Adjusted relative risks showed no effect of modality on clinical outcomes. Multiple linear regression analyses of OOL at baseline showed similar SF-36 scores between PD and HD patients, but higher KDQOL scores in PD patients (3.5 points higher, 95% confidence interval 0.3-6.6). There was, however, no effect of dialysis modality on QOL at 6 or 12 months. CONCLUSIONS: Clinical outcomes and QOL are similar in elderly people on PD and HD. Peritoneal dialysis is a viable option for more than a carefully selected minority of elderly people requiring dialysis. Ther Apher. 2004 Aug;8(4):340-6.  HYPERLINK "http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Display&dopt=pubmed_pubmed&from_uid=15274687" Related Articles. Kidney disease quality of life of Japanese dialysis patients who desire administration of sildenafil and the treatment of erectile dysfunction using sildenafil. Hyodo T, Ishida H, Masui N, Taira T, Yamamoto S, Oka M, Uchida T, Endo T, Sakai T, Yoshida K, Baba S. Department of Urology, Kitasato University School of Medicine, Sagamihara, Japan. Erectile dysfunction (ED) is common among patients on dialysis therapy. In the present study, we attempted administration of sildenafil to Japanese patients undergoing dialysis. In order to diagnose ED before prescribing sildenafil, we assessed the hemodialysis patients who desired sildenafil by using the five items version of the International Index of Erectile Function (IIEF-5). In addition, the characteristics of the quality of life in Japanese hemodialysis patients who desired sildenafil were assessed using the kidney disease quality of life (KDQOL). To all 37 male subjects (mean age of 53.8 +/- 10.4 years) attending the Outpatient Hemodialysis Unit at Atsugi Clinic (Atsugi City, Japan), it was explained by their primary doctor that the treatment of ED with sildenafil was possible. As a result, 10 patients (27.0%) desired the treatment. For eight patients, ED was diagnosed by IIEF-5 prior to prescription of sildenafil. The mean IIEF-5 scores were 6.13 +/- 4.67 points. Sildenafil was prescribed to five patients (three diabetic, two non-diabetic) and sexual function was improved in three cases. The main adverse effect was found to be ventricular arrhythmia in one case. As for KDQOL, the group desiring sildenafil showed significantly high values in Dialysis Staff Encouragement and Patient Satisfaction. Among the other nine dialysis patients (five diabetic, four non- diabetic; mean age of 58.1 +/- 8.9 years) who visited the ED department of Ishida Hospital (Asahikawa City, Japan), sildenafil was effective for all non- diabetic patients (100%) and for only one diabetic patient (20%). Among all 14 patients at Atsugi Clinic and Ishida Hospital, sildenafil efficacy rates were 83.3% for non-diabetic patients and 37.5% for diabetic patients. Non-diabetic patients without the side-effects were all responders for the sildenafil treatment. The patients who relied on the dialysis staff and were more satisfied with the general treatment in the dialysis institute desired the administration of sildenafil under the present circumstances wherein the dialysis population had few experiences of sildenafil treatment. Diabetic status is thought to be a negative factor for the response of sildenafil treatment in dialysis patients. Int Urol Nephrol. 2004;36(2):263-7.  HYPERLINK "http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Display&dopt=pubmed_pubmed&from_uid=15368708" Related Articles, Links Evaluation of functional and mental state and quality of life in chronic haemodialysis patients. Janssen van Doorn K, Heylen M, Mets T, Verbeelen D. Department of Nephrology, Academisch Ziekenhuis AZ-VUB, Laarbeeklaan 101, 1090 Brussels, Belgium. Progressive increase of old patients with end stage renal disease (ESRD) with a high mortality and morbidity rate, receiving haemodialysis, increases the impact of psychosocial factors on the outcome. Depression is the most prevalent psychological problem in patients in haemodialysis and is associated with a high mortality. The purpose of this study was to evaluate the functional (ADL, IADL), mental (MMSE, SDS) state and the Quality of Life (KDQOL) in the chronic haemodialysis patients. Old patients can be successfully treated by haemodialysis and therefore age may never be used as exclusion for initiative haemodialysis. Formal geriatric assessment should be imperative for the older person with end stage renal disease since all elderly patients become dependent. The high prevalence of depression in our haemodialysis population needs further investigation. Kawauchi A, Inoue Y, Hashimoto T, Tachibana N, Shirakawa S, Mizutani Y, Ono T, & Miki T. (2006). Restless legs syndrome in hemodialysis patients: health-related quality of life and laboratory data analysis. Clin Nephrol., 66(6):440-6. Department of Urology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan. kawauchi@koto.kpu-m.ac.jp AIMS: To compare clinical data, sleep quality and health-related quality of life (HRQOL) with and without RLS in HD patients. MATERIALS AND METHODS: The international RLS study group diagnosis questionnaire was completed by 228 HD patients. The Pittsburg Sleep Quality Index (PSQI) for the evaluation of sleep quality and the Kidney Disease Quality of Life (KDQOL-SF) for the analysis of HRQOL were also used. RESULTS: 53 (23%) patients were diagnosed as RLS. Age and age at the initiation of HD were significantly younger in the RLS group. Serum calcium concentration (Ca) was significantly higher in the RLS group. Sleep quality evaluated by PSQI was significantly lower in the RLS group. In SF-36 domains of KDQOL-SF, bodily pain, general health perceptions, vitality, role functioning emotional, mental health and mental component score were significantly lower in the RLS group. In kidney targeted scales of KDQOL-SF, symptoms/problems, burden of kidney disease, cognitive function, quality of social interaction, sleep and patient satisfaction were significantly lower in the RLS group. CONCLUSION: High Ca was possibly connected to the pathophysiology of RLS which impaired sleep quality as well as HRQOL including mental health and many kidney disease related scales. Quality of Life Research (2005) 14: 19671975. Determining the basic psychometric properties of the Greek KDQOL-SFTM Nick Kontodimopoulos & Dimitris Niakas Hellenic Open University, Patras, Greece Abstract The aim of this study was to determine the basic psychometric properties, i.e. reliability and validity, of the Greek version of the Kidney Disease Quality of Life Short Form (KDQOL-SFTM). The instrument was self- administered to a homogenous group of 665 end stage renal disease patients in 20 dialysis units throughout Greece and the overall response rate was 72.6%. Reliability was demonstrated by Cronbachs alpha exceeding the recommended minimum value of 0.70 in all, except one, scales. Tests of item- internal consistency, after correction for overlap, resulted in correlations between items and their hypothesized scales, which exceeded the 0.40 standard in 94.5% of the cases. Item discriminant validity tests indicated 100% scaling success for six out of eight generic and disease- targeted scales. Validity was supported by the confirmation of expected correlations between scales and the overall health- rating item included in the instrument and with sociodemographic and self- reported health variables. Multiple stepwise linear regression analysis demonstrated that all disease-targeted scales were important predictors of SF-36 general health scales and the variance explained ranged from 37% to 57%. Overall, the psychometric properties of the KDQOL-SFTM, resulting from this first-time administration of the instrument to a Greek dialysis population, were good and the disease targeted scales were informative and of high internal consistency reliability. Cross-sectional construct validity is demonstrated, despite the lack of external validity criteria based on clinical ratings of severity. The results support administering the Greek KDQOL-SFTM in studies evaluating dialysis therapy and contribute to transnational comparison of findings. Key words: Dialysis, Greece, Health-related quality of life, Reliability, Validity, SF-36, KDQOL-SFTM Self-assessed sleep quality in chronic kidney disease Manjula Kurella1, Jennifer Luan1, James P. Lash2 & Glenn M. Chertow1 1-Division of Nephrology, Department of Medicine, University of California San Francisco, Moffitt-Long Hospitals, UCSF-Mt. Zion Medical Center, San Francisco, CA, USA; 2-Division of Nephrology, Department of Medicine, University of Chicago Illinois, Chicago, IL, USA Abstract. Background: Although sleep complaints are commonly reported in persons with end stage renal disease (ESRD), little is known about the prevalence of sleep complaints in chronic kidney disease (CKD), and the relation of sleep quality to the severity of kidney disease. Methods: We administered the Kidney Disease Quality of Life (KDQOL) sleep scale to 156 subjects, 78 with ESRD and 78 with CKD. Glomerular filtration rate (GFR) was estimated using the six variable Modification of Diet in Renal Disease (MDRD) equation and used to stratify subjects with CKD as mild-moderate (GFR >25 ml/min/1.73 m2) and advanced (GFR <25 ml/min/1.73 m2). We used multivariable linear regression to determine independent predictors of KDQOL sleep scale scores. Higher scores indicate higher self-reported quality of sleep. Results: Median scores on the KDQOL sleep scale were 59 (interquartile range 4080) in subjects with ESRD and 69 (interquartile range 5380) in subjects with CKD (P = 0.04). Thirty-four percent of subjects with ESRD, 27% of subjects with advanced CKD, and 14% of subjects with mild to moderate CKD had sleep maintenance disturbances (P = 0.05). Thirteen percent of subjects with ESRD, 11% of subjects with advanced CKD, and no subjects with mild-moderate CKD had complaints of daytime somnolence (P = 0.03). There was no significant difference in the prevalence of sleep adequacy complaints in persons with ESRD versus CKD. In multivariable analyses, only age and ESRD status (vs. CKD) were significant predictors of lower KDQOL sleep scores. Among subjects with CKD, there was a significant direct association between estimated GFR and scores on the KDQOL sleep scale in non-African American subjects (P = 0.01). Conclusions: Sleep complaints are common in persons with CKD and ESRD and may be associated with the severity of kidney disease. Key words: Chronic kidney disease, End stage renal disease, Sleep disturbance Kidney Int. 2004 Dec;66(6):2361-7.  HYPERLINK "http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Display&dopt=pubmed_pubmed&from_uid=15569327" Related Articles,  HYPERLINK "http://www.blackwell-synergy.com/openurl?genre=article&sid=nlm:pubmed&issn=0085-2538&date=2004&volume=66&issue=6&spage=2361" Links Validation of the Kidney Disease Quality of Life (KDQOL) cognitive function subscale. Kurella M, Luan J, Yaffe K, Chertow GM. Division of Nephrology, Department of Medicine, University of California San Francisco, San Francisco, California 94118-1211, USA. BACKGROUND: Formal cognitive function testing is cumbersome, and no self-administered instruments for estimating cognitive function in persons with chronic kidney disease (CKD) and end-stage renal disease (ESRD) have been validated. The goal of this study was to determine the validity of the Kidney Disease Quality of Life Cognitive Function scale (KDQOL-CF) for the assessment of cognitive impairment in persons with kidney disease. METHODS: We administered the KDQOL-CF to 157 subjects, 79 with ESRD and 78 with CKD participating in a cross-sectional study of cognitive function. Scores on the Modified Mini-Mental State Exam (3MS) were considered the gold standard measure of global cognitive function. Performance characteristics of the KDQOL-CF were assessed using correlation coefficients, Bland-Altman plots, and receiver operating characteristic curves. RESULTS: Median scores on the KDQOL-CF were 73 (interquartile range 60-87) for subjects with ESRD and 87 (interquartile range 73-100) for subjects with CKD (P < 0.0001). Scores on the KDQOL-CF were directly correlated with scores on the 3MS (r = 0.31, P = 0.0001). Defining global cognitive impairment as a 3MS score < 80, a cut-point of 60 on the KDQOL-CF accurately classified 76% of subjects, with 52% sensitivity and 81% specificity. On multivariable analysis, cerebral and peripheral vascular disease, benzodiazepine use, and higher serum phosphorus concentrations were associated with lower KDQOL-CF scores, while beta blocker use, education, and higher serum albumin concentrations were associated with higher KDQOL-CF scores. CONCLUSION: The KDQOL-CF is a valid instrument for estimating cognitive function in patients with CKD and ESRD. KDQOL-CF screening followed by 3MS testing in selected individuals may prove to be an effective and efficient strategy for identifying cognitive impairment in patients with kidney disease. CURRENT MEDICAL RESEARCH AND OPINION VOL. 21, NO. 11, 2005, 17771783 Characterisation and comparison of health-related quality of life for patients with renal failure Amanda J. Lee a, Christopher Ll. Morgan b, Pete Conway c and Craig J. Currie a,b a Cardiff Research Consortium, University Hospital of Wales, Cardiff, UK b Department of Medicine, School of Medicine, Cardiff University, UK Department of Medicine, School of Medicine, Cardiff University, UK c Wyeth Laboratories UK, Maidenhead, UK Address for correspondence: Dr. Craig Currie, Director, Cardiff Research Consortium, Heath Park, Cardiff CF14 4UJ, UK. Tel.: +44 2920682047; Fax: +44 2920750239; email: curriec@cardiff.ac.uk Key words: Dialysis Quality of life Renal failure Renal transplant Dialysis Quality of life Renal failure Renal transplant Objective: The objective of this study was to assess the health related quality of life (HRQOL) in patients with kidney failure who had received renal transplants compared to those receiving haemodialysis, peritoneal dialysis or were waiting to start dialysis. Research design and methods: The study was conducted at the University Hospital of Wales, Cardiff. HRQOL was measured using the EQ-5D, SF-36 and the Kidney Disease Quality of life questionnaire (KDQOL). Patients with kidney failure were identified from the renal unit departmental database and were surveyed by postal questionnaire or during their treatment. Results: Of 1251 people surveyed, 416 valid returns were received, a response rate of 33%. For renal transplant patients the mean EQ-5D index was 0.712 (SD 0.272), significantly higher than those in the other treatment groups (haemodialysis mean = 0.443 (SD 317), p< 0.001; peritoneal dialysis mean = 0.569 (SD 329), p< 0.001). This difference remained after controlling for age and co-morbidity. With the exception of pain, the SF-36 showed significantly higher scores across all domains for transplant patients compared to both dialysis groups. From the KDQOL there were significantly lower scores compared with the transplant patients for both groups of dialysis patients for the effects and burden of kidney disease and general symptoms and problems. However, overall health scores were significantly higher for dialysis patients compared with transplant patients. Conclusion: Kidney failure has a high cost in terms of health related quality of life. There was a large difference between patients who have received a functioning graft following kidney transplant versus the alternative methods of renal replacement therapy, that is, peritoneal dialysis and haemodialysis. Kidney transplant should be the treatment of choice, and every effort should be made to increase the availability of kidneys for transplantation. 1 AU - Lo CY AU - Li L AU - Lo WK AU - Chan ML AU - So E AU - Tang S AU - Yuen MC AU - Cheng IK AU - Chan TM TI - Benefits of exercise training in patients on continuous ambulatory peritoneal dialysis. AB - We examined the effects of a 12-week exercise program on the exercise tolerance, blood biochemistry, blood pressure (BP) control, cardiac function, and quality-of-life (QOL) scores in 13 patients undergoing continuous ambulatory peritoneal dialysis (CAPD; six men, seven women; mean age, 46.5+/-12.8 years; mean duration on dialysis, 4.8+/-3.8 years). The patients underwent exercise training on treadmill, bike, and arm ergometers thrice weekly. Seven CAPD patients matched for age, sex, and duration on dialysis served as controls. The mean peak aerobic capacity (VO2peak) of the exercisers increased by 16.2% after training (pre- and postexercise, 17.2+/-5.2 v 20.0+/-6.4 mL/kg/min; P=0.004) . Although there were no significant changes in serum urea, creatinine, albumin, and hematocrit levels; left ventricular diastolic/systolic diameters; and ejection fraction, an increasing trend of high-density lipoproteins (HDLs) was observed in the exercisers (baseline v postexercise, 33+ /-11 v 40+/-14 mg/dL; P=0.06). Twenty-four-hour ambulatory BP monitoring showed a significant increase in daytime systolic BP in the exercisers (pre- and postexercise, 142+ /-26 v 157+/-22 mm Hg; P=0.003), but no significant changes could be found in the ambulatory daytime diastolic BP, nocturnal BP, and resting clinic BP. The patients' QOL improved after training, with better scores in two Kidney Disease Quality of Life scales (KDQOL): burden of kidney disease and physical functioning. Two mild and uncomplicated hypotensive episodes were reported in two patients immediately after training. No changes occurred in exercise capacity, blood biochemistry, BP profile, and QOL scores in the controls. We conclude that structured aerobic exercise is safe and can improve the exercise tolerance and QOL outcomes in CAPD patients. MH - Exercise Therapy|*/SN MH - Peritoneal Dialysis, Continuous Ambulatory|*/SN SO - Am J Kidney Dis 1998 Dec; 32(6):1011-8 DP - 1998 Dec TA - Am J Kidney Dis PG - 1011-8 IP - 6 VI - 32 UI - 99072337 Clin Nephrol. 2003 Nov;60(5):341-51.  HYPERLINK "http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Display&dopt=pubmed_pubmed&from_uid=14640240" Related Articles Quality of life in patients treated with hemodialysis or peritoneal dialysis: what are the important determinants? Manns B, Johnson JA, Taub K, Mortis G, Ghali WA, Donaldson C. Department of Medicine, Foothills Medical Center, University of Calgary, Alberta, Canada. Braden.Manns@CalgaryHealthRegion.ca BACKGROUND: Patients with end-stage renal disease (ESRD) have significant impairments in health-related quality of life (HRQOL). In part, this is due to the intrusiveness of the treatment (hemodialysis or peritoneal dialysis) that is required. It is unclear whether hemodialysis or peritoneal dialysis is associated with a higher HRQOL. METHODS: 192 prevalent patients who self-selected treatment with hemodialysis (either in-center, satellite or home/self-care hemodialysis) or peritoneal dialysis were studied to determine whether treatment with hemodialysis or peritoneal dialysis is associated with a higher HRQOL. Demographic, laboratory and clinical information (including the presence of comorbid conditions using the Charlson comorbidity index) was assessed at baseline. The outcome of interest was HRQOL, which was measured using the Kidney Disease Quality of Life-Short Form (KDQOL-SF), the Short-Form 36 (SF-36) and the EuroQol EQ-5D at baseline and after 6 and 12 months of follow-up. RESULTS: There was no significant difference in HRQOL scores for the SF-36, the EQ-5D and for 9 of 11 KDQOL dimensions for patients treated with hemodialysis or peritoneal dialysis at baseline. As expected, HRQOL was significantly lower for patients who had more comorbid disease, required assistance with their daily care, and for patients with less than a grade 12 education. After controlling for the effect of other important variables, HRQOL (as measured by the EQ-5D visual analog or index scores) did not differ between hemodialysis and peritoneal dialysis patients. HRQOL was stable over time, both for patients who started on hemodialysis or peritoneal dialysis. CONCLUSIONS: There is no significant difference in HRQOL for prevalent ESRD patients treated with hemodialysis or peritoneal dialysis. It will be important to determine if this finding holds true for incident patients treated with hemodialysis or peritoneal dialysis. Scand J Urol Nephrol. 2005; 39(6): 498-502. Reliability testing of the Danish version of the Kidney Disease Quality of Life Short Formtrade mark. Molsted S, Heaf J, Prescott L, Eidemak I. Department of Nephrology, Herlev Hospital, Herlev, Denmark. Objective. The questionnaire Kidney Disease Quality of Life Short Form version 1.3 (KDQOL-SF TM) is valuable for assessing the health-related quality of life in patients treated with chronic dialysis. The aim of this study was to translate and test the reliability of the KDQOL-SF for use in Denmark. Material and methods. Translation into Danish and back-translation into English were performed. Pilot, field and internal consistency reliability tests were performed. Results. Cronbach's alpha coefficients for the internal reliability test ranged from 0.77 to 0.93 for the eight generic scales. In a test involving all patients, two of the disease-specific scales had Cronbach's alpha coefficients of <0.70 ("social support" = 0.67; and "quality of social interaction" = 0.43). After removing one item from the scale "quality of social interaction", Cronbach's alpha reached 0.63. A test of the scores of peritoneal dialysis (PD) patients discovered low reliability for three disease-specific scales. The KDQOL-SF manual and the Danish manual for the Short Form 36 (SF36) differed in the scoring of four generic scales: "role limitation-physical", "bodily pain", "general health" and "social function". Conclusions. With the exception of the scale "quality of social interaction" the Danish translation of the KDQOL-SF achieved values in the internal consistency reliability test of the same level as the original U.S. version. When data were stratified according to dialysis treatment, the reliability of PD patients scores was lower. Generic data from the questionnaire SF36 should be scored according to the Danish SF36 manual. Parsons TL, Toffelmire EB, King-VanVlack CE. (2006). Excercise training during hemodialysis improves dialysis efficacy and physical performance. Arch Phys Med Rehabil, 87(5): 680-7. School of Rehabilitation Therapy, Queen's University, and Division of Nephrology, Kingston General Hospital, ON, Canada. OBJECTIVE: To determine the impact of a 20-week intradialytic exercise program, consisting of 60 minutes of cumulative duration, low-intensity exercise during the first 2 hours of dialysis, on dialysis efficacy, physical performance, and quality of life in self-care hemodialysis (HD) patients. DESIGN: One-group repeated measures. SETTING: Satellite HD units affiliated with a Canadian teaching hospital. PARTICIPANTS: A convenience sample of 13 self-care HD patients who were stable on dialysis for a minimum of 6 months and were medically screened for significant cardiac, pulmonary, and/or musculoskeletal pathology that would preclude exercise. INTERVENTION: A 5-month intradialytic exercise program in which subjects exercised 3 times a week (cycle ergometer, mini-stepper) for 30 minutes in each of the first 2 hours of HD. MAIN OUTCOME MEASURES: Dialysis efficacy (in single-pool model of urea kinetics [spKt/V]) was assessed prior to and at the end of each month of the exercise program. Physical function (6-minute walk test [6MWT]), and quality of life. (Kidney Disease Quality of Life-Short Form [KDQOL]) were determined at baseline and at weeks 10 and 20 of the exercise program. RESULTS: SpKt/V increased 11% at the end of the first month of the program (P<.05) and remained elevated for the duration of the program (18%-19%). Distance walked on the 6MWT increased by 14% at both weeks 10 and 20 (P<.05). No changes were noted in KDQOL scores. CONCLUSIONS: A low-intensity intradialytic exercise program is a viable adjunctive therapy, which improves HD efficacy and physical function in HD patients. J Nephrol. 2003 Mar-Apr;16(2):252-9. HYPERLINK "http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?db=PubMed&cmd=Display&dopt=pubmed_pubmed&from_uid=12768073"Related Articles. Assessment of health status in chronic hemodialysis patients. Perneger TV, Leski M, Chopard-Stoermann C, Martin PY. Division of Nephrology, Quality Care Unit, Geneva University Hospitals, Geneva - Switzerland - Institute of Social and Preventive Medicine, University of Geneva, Geneva - Switzerland. BACKGROUND: We compared three ways of assessing health status in chronic hemodialysis patients: generic questionnaire compared with population norms, disease-specific questionnaire, and open questions. METHODS: Hemodialysis patients (n=83) treated in Geneva canton, Switzerland, answered the Kidney Disease Quality of Life (KDQOL-SF) questionnaire, which combines 12 disease -specific scales with the generic Short-Form 36 (SF36) health survey, and open questions about the most disturbing and most positive aspects of having end -stage renal disease. SF36 scores were compared with those of the general population, and generic health scales were correlated with dialysis-specific scales. RESULTS: Hemodialysis patients had significantly lower scores than general population controls on 7 of 8 SF36 scales, especially physical functioning (-1.2 standard deviation (SD) units, p<0.001) and general health (-1.2 SD, p<0.001), but their mental health was similar (-0.2 SD, p=0.13). All 12 KDQOL dialysis-specific scores correlated significantly with the SF36 mental summary score, but only 6 correlated significantly with the SF36 physical summary score. Open comments suggested that dialysis itself is the chief problem confronting dialysis patients, but also that the predicament of end-stage renal disease may have a positive impact on the lives of some patients. CONCLUSIONS: While physical problems are the biggest difference between dialysis patients and controls, disease-specific scales and open comments highlighted the importance of psychosocial and treatment-related problems among hemodialysis patients. Generic and disease-specific questionnaires, and open comments provide different information about the health status of dialysis patients. PMID: 12768073 [PubMed - in process] Health Technology Assessment 2005 Jul; 9(24):1-178. An evaluation of the costs, effectiveness and quality of renal replacement therapy provision in renal satellite units in England and Wales P Roderick 1*, T Nicholson 1, A Armitage 2, R Mehta 1, M Mullee 1, K Gerard 1, N Drey 1, T Feest 2, R Greenwood 3, D Lamping 4, and J Townsend 5 1 Health Care Research Unit, University of Southampton, UK 2 Richard Bright Renal Unit, Southmead Hospital, Westbury-on-Trym, Bristol, UK 3 Department of Renal Medicine, Lister Hospital, Stevenage, UK 4 Health Services Research Unit, Department of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK 5 Public and Environmental Health Research Unit (PEHRU), London School of Hygiene and Tropical Medicine, London, UK * Corresponding author OBJECTIVES: To survey of the structure, processes and organisation of renal satellite units (RSUs) in England and Wales (Phase 1), and to compare the effectiveness, acceptability, accessibility and economic impact of chronic haemodialysis performed in RSUs compared to main renal units (MRUs) (Phase 2). DATA SOURCES: Phase 1: all renal satellite units in England and Wales. Phase 2: haemodialysis patients in a representative sample (based on geography, site, private--public ownership, medical input) of 12 RSUs and their MRUs. REVIEW METHODS: Phase 1 consisted of a questionnaire survey. Semi-structured interviews were held in a representative sample of 24 RSUs with the senior clinician, senior nurse and manager. Phase 2 consisted of a cross-sectional comparison of patients in these RSUs and patients in the parent MRUs deemed suitable for satellite care by senior staff. Clinical information was obtained from medical notes and unit computer systems. Generic and disease specific health-related quality of life (HRQoL) measures were used. Co-morbidity was assessed by the Wright/Khan Index, the Lister/Chandna score, the Modified Charlson Index, and the Karnofsky Performance Score. Statistical analyses compared RSU versus MRU patients and took account of the paired and clustered nature of the data. RESULTS: In Phase 1, responses were received from 74/80 (93%) of RSUs; 2600 patients were being treated in these RSUs. The interviews were generally positive about the impact of RSUs in terms of improved accessibility and a better environment for chronic haemodialysis (HD) patients, and in expanding renal replacement therapy patients (RRT) capacity. In Phase 2, some 82% of eligible patients took part, 394 patients in the 12 RSUs and 342 in the parent MRUs. The response rate was similar in both groups. There were no significant differences in clinical processes of care. Most clinical outcomes were similar, especially after pooled analysis, although a few parameters were statistically significantly different -- notably the proportion achieving Renal Association Standards for adequacy of dialysis as measured by the urea reduction ratio (URR) was higher in the RSU patients. Patient-specific quality of life did not differ except on the patient satisfaction questions from the KDQOL, which were scored higher by the RSU sample. Strength of preference for health status on and off dialysis was very similar between the groups, as were EQ-5D utilities. Major adverse events were not common in the RSU patients, although there were many hypotensive episodes on HD, a proportion of which affected the duration of the HD session. Of the costs measured, the only difference that was statistically significant was for District Nurse visits. Of particular note was that despite the MRU group having a higher proportion of patients hospitalised, this did not translate into a statistically significant budgetary impact in terms of the total cost per patient of hospitalisations or mean cost per patient per hospitalisation. CONCLUSIONS: This study has shown that RSUs are an effective alternative to MRU HD for a wide spectrum of patients. They improve geographic access for more dispersed areas and reduce patients' travel time, and are generally more acceptable to patients on several criteria. There does not seem to be an adverse impact of care in the RSUs although comparative long-term prospective data are lacking. The evidence suggests that satellite development could be successfully expanded; not all MRUs have any satellites and many have only a few. No single RSU model can be recommended but key factors would include local geography, the likely catchment population and the type of patients to be treated. There is a need for more basic budgetary information linking activity and expenditure to be available and more transparent, to perform at least an insightful top-down costing of the two care settings. Other areas suggested for further research include: a comparison of adverse events occurring in MRUs and RSUs with longer duration and larger numbers to identify more severe events, along with the more research into the scope for preventing such events, and a study into the patients deemed ineligible for satellite care. International comparisons of satellite care would also be useful. Am J Kidney Dis. 2003 Nov;42(5):1020-35. HYPERLINK "http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Display&dopt=pubmed_pubmed&from_uid=14582046"Related Articles Long-term study of high-comorbidity ESRD patients converted from conventional to short daily hemodialysis. Ting GO, Kjellstrand C, Freitas T, Carrie BJ, Zarghamee S. El Camino Dialysis Services, Mountain View, CA, USA. ecrmg@pacbell.net BACKGROUND: Conventional hemodialysis (CHD) is associated with suboptimal clinical outcomes and high mortality rates. Daily hemodialysis (DHD) has been reported to improve outcomes and quality of life (QOL), predominantly in self- care or home dialysis populations. The effect of short DHD (sDHD) on patients with end-stage renal disease (ESRD) with high comorbidities has not been established. METHODS: This prospective study compared clinical outcomes and QOL in high-comorbidity patients with ESRD converted from CHD to sDHD while maintaining the same total weekly dialysis time. Study patients had 4.0 +/- 1.7 major comorbid conditions in addition to ESRD. Standard dialysis parameters, antihypertensive and erythropoietin (EPO) requirements, Kidney Disease Quality of Life (KDQOL) measurements, vascular access problems, and hospitalization rates were compared while on sDHD therapy versus the previous 12 months on CHD therapy. RESULTS: Forty-two patients were studied on sDHD therapy for 793 patient-months during a 72-month period. During sDHD, standard Kt/V increased 31%, hospitalization days decreased significantly by 34%, and vascular access problems did not increase. Cumulative survival was 33% at 6 years. In the 20 patients who remained on sDHD therapy for 12 months, after 1 year, we found significant improvements in KDQOL scores, a 69% reduction in antihypertensive medications with stable blood pressure, and a 45% reduction in EPO requirements with stable hematocrits. We hypothesize that these improvements are the result of the less extreme solute and fluid fluctuations and greater dialysis dose provided by sDHD, even when weekly dialysis time is unchanged. CONCLUSION: High-comorbidity patients with ESRD converted to sDHD therapy had significantly improved clinical outcomes and QOL and decreased hospitalizations, with no increase in vascular access problems. Adv Perit Dial. 2003;19:159-62.  HYPERLINK "http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Display&dopt=pubmed_pubmed&from_uid=14763054" Related Articles, Links The BDI and the SF36: which tool to use to screen for depression? Troidle L, Wuerth D, Finkelstein S, Kliger A, Finkelstein F. Renal Research Institute, Hospital of St. Raphael, New Haven, Connecticut, USA. Recent studies have suggested a relationship between depression--as assessed by the Beck Depression Inventory (BDI)--and mortality in end-stage renal disease (ESRD) patients. A recent study from the Dialysis Outcomes and Practice Patterns Study (DOPPS) indicated an association between mortality in a large cohort of hemodialysis patients and the patients' responses in the preceding 4 weeks to two questions on the Kidney Disease Quality of Life, Short Form (KDQOL-SF36): "Have you felt downhearted and blue?" and "Have you felt so down in the dumps that nothing could cheer you?" A BDI score > or = 11 and a score < or = 3 for the two questions on the SF36 were considered to suggest the presence of depressive symptoms; both scores have been associated with increased mortality in hemodialysis patients. We aimed to examine the relationship of the two SF36 questions with depressive symptoms as assessed by the BDI. All patients on chronic peritoneal dialysis (CPD) therapy and daily hemodialysis therapy in our units between June 2000 and January 2002 were asked to complete a BDI and an SF36. We recorded 135 tests in 80 CPD patients, and 76 tests in 17 daily hemodialysis patients. Correlation coefficients (r2 values) of the responses to the two questions on the SF36 and the BDI scores demonstrated a significant relationship between the scores. The r2 values for the CPD patients' two SF36 responses and the BDI scores were -0.622 and -0.506; the r2 values for the daily hemodialysis patients were -0.363 and -0.317. The sensitivity and specificity for each SF36 response to be < or = 3 when the BDI was > or = 11 were 82.4% and 68.6% for the "downhearted and blue" question and 65% and 67% for the "down in the dumps" question. Whether the two questions on the SF36 that suggest depression can replace the BDI as a screening tool requires further study. Furthermore, it is unclear if the two questions on the SF36 are predictive of mortality because of their association with clinical depression or because of other issues. Int Urol Nephrol. 2004;36(2):263-7. Evaluation of functional and mental state and quality of life in chronic haemodialysis patients. van Doorn KJ, Heylen M, Mets T, Verbeelen D. Department of Nephrology, Academisch Ziekenhuis AZ-VUB, Laarbeeklaan 101, 1090 Brussels, Belgium. Progressive increase of old patients with end stage renal disease (ESRD) with a high mortality and morbidity rate, receiving haemodialysis, increases the impact of psychosocial factors on the outcome. Depression is the most prevalent psychological problem in patients in haemodialysis and is associated with a high mortality. The purpose of this study was to evaluate the functional (ADL, IADL), mental (MMSE, SDS) state and the Quality of Life (KDQOL) in the chronic haemodialysis patients. Old patients can be successfully treated by haemodialysis and therefore age may never be used as exclusion for initiative haemodialysis. Formal geriatric assessment should be imperative for the older person with end stage renal disease since all elderly patients become dependent. The high prevalence of depression in our haemodialysis population needs further investigation Am Soc Nephrol. 2003 Feb;14(2):478-85. HYPERLINK "http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?db=PubMed&cmd=Display&dopt=pubmed_pubmed&from_uid=12538750"Related Articles. Adjustment for comorbidity in studies on health status in ESRD patients: which comorbidity index to use? Van Manen JG, Korevaar JC, Dekker FW, Boeschoten EW, Bossuyt PM, Krediet RT. Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. ABSTRACT. Health status can be an important outcome in studies on patients with end-stage renal disease (ESRD). In these studies, adjustment for prognostic factors, such as comorbidity, often has to be made. None of the comorbidity indices that are commonly used in research on ESRD patients has been validated for studies on health status. This study evaluated three existing indices (Khan, Davies, and Charlson) and four indices specifically developed for use in studies on health status. In a large prospective multi-center study (NECOSAD-2), new ESRD patients were included (n = 1041). Comorbidity was assessed at the start of dialysis. Health status was assessed with the physical and mental component summary score of the SF-36 (PCS and MCS), the symptoms dimension of the KDQOL -SF, and the Karnofsky Scale. Patient data were randomly allocated to a modeling or a testing set. The new indices were developed in the modeling set. The three existing indices explained about the same percentage of variance in the PCS (7 to 8%), MCS (1 to 3%), symptoms (2 to 4%), and Karnofsky (10 to 12%). The new indices performed better than the existing indices in the modeling population (13% PCS, 10% MCS, 10% symptoms, 18% Karnofsky), but not in the testing population (8% PCS, 1% MCS, 3% symptoms, 8% Karnofsky). Individual comorbidities explained more variance in PCS (10 to 15%), MCS (1 to 7%), symptoms (6 to 11%), and Karnofsky (11 to 18%) than comorbidity indices. The Khan, Davies, and the Charlson indices will adjust to the same extent for the potential confounding effect of comorbidity in studies with health status as an outcome. Separate comorbidity diagnoses will adjust best for comorbidity. E-mail:  HYPERLINK "mailto:j.g.vanmanen@amc.uva.nl" j.g.vanmanen@amc.uva.nl PMID: 12538750 [PubMed - in process] Nefrologia. 2004;24(2):167-78.  HYPERLINK "http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Display&dopt=pubmed_pubmed&from_uid=15219092" Related Articles Differences in health-related quality of life between male and female hemodialysis patients [Article in Spanish] Vazquez I, Valderrabano F, Fort I, Jofre R, Lopez-Gomez JM, Moreno F, Sanz- Guajardo D; Groupo Cooperativo Espanol para el estudio de la Calidad de Vida del paciente renal de la Sociedad Espanola de Nefrologia. D. Psicologia Clinica y Psicobiologia, Faculta de Psicologia, Universidad de Santiago de Compostela. lbolanosc@senefro.org BACKGROUND: Previous studies in renal patients have reported that women perceive a lower health-related quality of life (HRQOL) than men: however, these studies have been carried out without taking into account the gender-related differences shown in general population samples. The aims of the present study are: a) to define the HRQOL dimensions in which there are differences between men and women on chronic hemodialysis (HD), correcting then the differences on the generic dimensions by means of standardization by age and gender of the obtained scores, using Spanish normative data, and b) to identify the variables that cause these possible gender-related differences on HRQOL. METHODS: A cross-sectional multi-center study was carried out with 152 patients (69 men and 83 women) receiving HD treatment in 43 Spanish centers, using the KDQOL-SF to evaluate their HRQOL. The generic KDQOL-SF scores were standardized by age and gender using Spanish normative data. Sociodemographic, clinical and psychosocial variables were also collected on each patient. A MANOVA was carried out to study the variables associated with the gender-related differences on HRQOL. The sociodemographic, clinical and psychosocial variables showing significant differences between men and women in the previous univariate analysis were entered as covariates. RESULTS: The KDQOL-SF scores showed statistically significant differences between men and women in four scales: physical functioning, emotional role limitation, social function and emotional well-being. In contrast, standardized scores showed no differences between men and women in the profile or degree of HRQOL impairment. Although statistically significant gender-related differences were shown in educational level, employment, haemoglobin, Kt/V, trait anxiety and depressive symptoms, only the last two variables showed an independent effect on the differences in HRQOL. CONCLUSION: Impaired HRQOL in women on HD reflects the gender-related differences that are also shown in the general population, and they are related to the higher prevalence of trait anxiety and depressive symptoms in women. Qual Life Res. 2005 Feb;14(1):179-90. Psychosocial factors and health-related quality of life in hemodialysis patients. Vazquez I, Valderrabano F, Fort J, Jofre R, Lopez-Gomez JM, Moreno F, Sanz- Guajardo D; Spanish Cooperative Renal Patients Quality of Life Study Group. Department of Clinical Psychology and Psychobiology, Psychology Faculty, Santiago de Compostela, Spain.  HYPERLINK mailto:lbolanosc@senefro.org lbolanosc@senefro.org. ABSTRACT: Several sociodemographic and clinical variables are known to influence the health-related quality of life (HRQOL) of patients with kidney disease, yet the relationship between psychological factors and the HRQOL measured by the Kidney Disease Quality of Life Short-Form (KDQOL-SF) is incompletely understood. The objective of this study was to examine the relationship between psychosocial status (depressive symptoms, trait anxiety, and social support) and KDQOL-SF scales in hemodialysis (HD) patients by controlling the effects of sociodemographic and clinical variables. The HRQOL of 194 patients from 43 dialysis centers in Spain was assessed by completing the KDQOL-SF, and evaluating depressive Symptoms (Cognitive Depression Index), trait anxiety (Trait Anxiety Inventory) and degree of social support (Scale of Perceived Social Support). We also recorded several sociodemographic and clinical variables. Two regression models were estimated for each of the 19 scales in the KDQOL-SF. In the first model, we only included sociodemographic and clinical-factors, while the second model also took into consideration psychosocial variables. These last factors (trait anxiety and depressive symptoms, not social support) were found to increase the proportion of explained variability, with highest standardized regression coefficients observed for most KDQOL-SF scales. Depressive symptoms were related to a poor HRQOL when there was a strong physical component, while trait anxiety was mainly related to emotional upset and social relationships. We were able to conclude that trait anxiety and depressive symptoms are strongly associated with the HRQOL assessed by the KDQOL-SF in HD patients. The effects of these factors should therefore be considered when evaluating the quality of life of this type of patient. J Nephrol. 2003 Nov-Dec;16(6):886-94. Psychosocial factors and quality of life in young hemodialysis patients with low comorbidity. Vazquez I, Valderrabano F, Jofre R, Fort J, Lopez-Gomez JM, Moreno F, Sanz- Guajardo D; Spanish Cooperative Renal Patients Quality of Life Study Group. Department of Clinical Psychology and Psychobiology, Psychology Faculty, Santiago de Compostela, Spain. lbolanosc@senefro.org BACKGROUND: The current predominance of older patients, diabetic patients and high-comorbidity patients among the hemodialysis (HD) population has probably influenced the definition of the effects of renal disease on health-related quality of life (HRQOL), and these effects can be different in the patient subgroup without these characteristics. This multicenter study aimed to assess HRQOL in non-diabetic HD patients, aged < 65 yrs and with low comorbidity, and to study the effects of the demographic, clinical and psychosocial characteristics on their HRQOL. METHODS: 117 patients from 43 Spanish HD centers participated in the study. Patients completed the Kidney Disease Quality of Life Short-Form questionnaire (KDQOL-SF) and screening for depressive symptoms, anxiety symptoms and social support. Various sociodemographic and clinical variables were also recorded. RESULTS: HD patients' HRQOL showed a profile similar to that of the general HD population, with low physical health scores, but normal mental health scores. Multivariate analysis demonstrated that gender, older age, non-working status, low social support and low levels of hemoglobin (Hb), Kt/V or protein catabolic rate (PCR), had a negative effects, but these effects were of relatively small magnitude and appeared only in some scales. The most important independent predictors of HRQOL were anxiety state and depressive symptoms. CONCLUSIONS: In non-diabetic HD patients, aged < or = 65 yrs and with low comorbidity, psychological factors (anxiety state and depressive symptoms) are crucial HRQOL determinants. These variables should be considered when assessing HRQOL in HD patients with these demographic and clinical characteristics. Yu E, Mera J, Iijima M, Fujita K, Eto F. (2006). Health-related quality of life factor in chronic hemodialysis patients. Nippon Ronen Igakkai Zasshi, 43(3): 383-9. Department of Rehabilitation Medicine, Graduate School of Medicine, University of Tokyo. AIM: The purpose of this study was to investigate the related factors of the health-related quality of life (HRQOL) measured by KDQOL-SF version 1.3 Japanese version) in chronic hemodialysis patients. METHODS: Using a cross-sectional survey design, we hand-delivered a self-administered questionnaire to the chronic hemodialysis patients and finally obtained 67 subjects' data to analyze. The response rate was 65.7%. Among the related factors, disease/dialysis-related factors and rehabilitation-related factors in addition to demographic factors were examined. The HRQOL was divided into a physical component summary (PCS) and a mental component summary (MCS). RESULTS: Multiple linear regression analysis revealed that the independent factors related to PCS were symptom score, serum albumin level, patients' satisfaction with dialysis care, and the work status. These four factors could explain 60% of PCS variance (adjusted R2 = 0.601). The independent factors related to MCS were revealed to be quality of social interaction and understanding of effectiveness of self-exercise. These two factors could explain only a quarter of MCS variance (adjusted R 2 = 0.223). CONCLUSION: These results suggest that highly satisfactory care of dialysis, improvement of dialysis-related symptoms, and good nutritional management are important for improving HRQOL in chronic hemodialysis patients, and that the promotion of social participation and interpersonal relationships as well as a positive attitude to self-exercise may lead to a beneficial outcome of rehabilitation for chronic hemodialysis patients. ASAIO J. 2003 Jul-Aug;49(4):426-9. Daily hemofiltration with a simplified method of delivery. Zimmerman DL, Swedko PJ, Posen GA, Burns KD. Department of Medicine, Division of Nephrology, Kidney Research Centre, University of Ottawa, Ottawa, ON, Canada. Observational studies of daily hemodialysis (HD) and intermittent hemofiltration (HF) therapy have been associated with improved outcomes for patients with endstage renal disease. We conducted a prospective study to evaluate the feasibility of daily HF as an alternative to intermittent HD using a simplified HF system (NxStage Medical). Each patient received 1 week of intermittent HD followed by 4 weeks of daily HF. Ringers lactate was used as the initial replacement solution; however, Hemosol LG2/L0 was used subsequently to simplify patient management. Changes in quality of life, nutrition, and laboratory values were assessed. Seven patients have completed 168 HF treatments with Hemosol. Their treatment time on HD was 232 minutes 3 days per week, and 132 minutes on HF 6 days per week. Single pool Kt/V per treatment for HD was 1.69 compared with 0.44 for HF (standard Kt/V 2.38 vs 1.93). Despite these weekly differences in urea clearance, potassium, calcium, phosphate, and nutrition remained stable. Beta-2 microglobulin tended to decline. All parameters of the Kidney Disease Quality of Life Instrument Short Form (KDQOL-SF) either remained stable or improved. In addition, blood pressure declined, allowing for a reduction in the number of antihypertensive medications. 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