Search

BACKGROUND AND OBJECTIVES Physical activity has been associated with better health status in diverse populations, but the association in patients on maintenance hemodialysis is less established. Patient-reported physical activities and associations with mortality, health-related quality of life, and depression symptoms in patients on maintenance hemodialysis in 12 countries were examined. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS In total, 5763 patients enrolled in phase 4 of the Dialysis Outcomes and Practice Patterns Study (2009-2011) were classified into five aerobic physical activity categories (never/rarely active to very active) and by muscle strength/flexibility activity using the Rapid Assessment of Physical Activity questionnaire. The Kidney Disease Quality of Life scale was used for health-related quality of life. The Center for Epidemiologic Studies Depression scale was used for depression symptoms. Linear regression was used for associations of physical activity with health-related quality of life and depression symptoms scores. Cox regression was used for association of physical activity with mortality. RESULTS The median (interquartile range) of follow-up was 1.6 (0.9-2.5) years; 29% of patients were classified as never/rarely active, 20% of patients were classified as very active, and 20.5% of patients reported strength/flexibility activities. Percentages of very active patients were greater in clinics offering exercise programs. Aerobic activity, but not strength/flexibility activity, was associated positively with health-related quality of life and inversely with depression symptoms and mortality (adjusted hazard ratio of death for very active versus never/rarely active, 0.60; 95% confidence interval, 0.47 to 0.77). Similar associations with aerobic activity were observed in strata of age, sex, time on dialysis, and diabetes status. CONCLUSIONS The findings are consistent with the health benefits of aerobic physical activity for patients on maintenance hemodialysis. Greater physical activity was observed in facilities providing exercise programs, suggesting a possible opportunity for improving patient outcomes.

Texto completo: acesso restrito. p. 1163-1170 Submitted by Suelen Reis (suziy.ellen@gmail.com) on 2014-01-31T14:34:16Z No. of bitstreams: 1 10.1093ndt-gfl755.pdf: 130083 bytes, checksum: 014945e9814db5d9f30b3ea19c220423 (MD5) Approved for entry into archive by Rodrigo Meirelles (rodrigomei@ufba.br) on 2014-09-09T15:59:36Z (GMT) No. of bitstreams: 1 10.1093ndt-gfl755.pdf: 130083 bytes, checksum: 014945e9814db5d9f30b3ea19c220423 (MD5) Made available in DSpace on 2014-09-09T15:59:36Z (GMT). No. of bitstreams: 1 10.1093ndt-gfl755.pdf: 130083 bytes, checksum: 014945e9814db5d9f30b3ea19c220423 (MD5) Previous issue date: 2007 Background. The relationship between medication prescription and sexual dysfunction (SD) in dialysis patients is unclear. Methods. We studied antihypertensive and antidepressive agents prescribed for 7346 patients in the Dialysis Outcomes and Practice Patterns Study phase 1 (DOPPS I) and 8891 patients in DOPPS II. At baseline, DOPPS I patients completed a quality of life survey, including four questions about sexual functioning, from which we created a composite SD scale. DOPPS II patients were asked only one question about SD. We examined predictors of SD with logistic regression, using numerous patient characteristics, comorbid conditions and additional variables. Results. Reported SD ranged from 66.4% (France) to 84.5% (Spain). The mean composite SD score ranged from 6.4 (Spain) to 7.9 (Germany) (on a 3–15 scale). Peripheral α-blockers increased odds of DOPPS I patients having their sex life bothered by end-stage renal disease (ESRD) (OR = 1.18), and there were elevated odds of arousal problems with central antagonists, loop diuretics and peripheral α-blockers (OR = 1.19, 1.24 and 1.29, respectively). Selective serotonin reuptake inhibitors (SSRIs) and benzodiazepines increased odds of problems with enjoyment (OR = 1.59 and 1.26, respectively) and arousal (OR = 1.70 and 1.24, respectively), and having sex life bothered by ESRD (DOPPS I: OR = 1.36 and 1.24; DOPPS II: 1.30 and 1.31, respectively). Vasodilators reduced the odds of sexual enjoyment problems (OR = 0.75). Composite SD scores worsened with peripheral α-blockers (+0.41), tricyclics (+0.78), SSRIs (+0.80) and benzodiazepines (+0.50), but not with vasodilators (−0.57). Conclusions. Awareness of associations between SD and prescribed medications may offer opportunities for intervention.

Background. Recent studies suggest a high prevalence of cognitive impairment and dementia in persons with end-stage renal disease (ESRD), yet risk factors for dementia and its prognostic significance in persons with ESRD remain unclear. The goals of this study were to determine the prevalence, correlates and dialysis-related outcomes of dementia in an international sample of haemodialysis patients. Methods. We analysed data collected from a cohort of 16 694 patients in the Dialysis Outcomes and Practice Patterns Study. Dementia was defined as a diagnosis of dementia documented in the medical record. We used logistic regression to determine the baseline correlates of dementia and Cox proportional hazards models to determine the relative risk (RR) of death and dialysis withdrawal for patients with dementia, while adjusting for a number of confounding factors. Results. Overall, 4% of the cohort had a recorded diagnosis of dementia. In the cross-sectional analyses, risk factors for dementia in the general population including age, black race, low educational attainment, cerebrovascular disease and diabetes, as well as modifiable uraemia-related factors, including markers of malnutrition and anaemia, were independently associated with dementia. After adjustment for a number of confounding factors, dementia was associated with an increased risk of death [RR 1.48, 95% confidence interval (CI) 1.32–1.66] and dialysis withdrawal (RR 2.01, 95% CI 1.57–2.57). Conclusions. Dementia is associated with adverse outcomes among ESRD patients. Dialysis providers should consider instituting routine screening for cognitive impairment among elderly patients in order to identify those at risk for associated adverse outcomes.

Longer treatment time (TT) and slower ultrafiltration rate (UFR) are considered advantageous for hemodialysis (HD) patients. The study included 22,000 HD patients from seven countries in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Logistic regression was used to study predictors of TT240 min and UFR10 ml/h/kg bodyweight. Cox regression was used for survival analyses. Statistical adjustments were made for patient demographics, comorbidities, dose of dialysis (Kt/V), and body size. Europe and Japan had significantly longer (P0.0001) average TT than the US (232 and 244 min vs 211 in DOPPS I; 235 and 240 min vs 221 in DOPPS II). Kt/V increased concomitantly with TT in all three regions with the largest absolute difference observed in Japan. TT240 min was independently associated with significantly lower relative risk (RR) of mortality (RR = 0.81; P = 0.0005). Every 30 min longer on HD was associated with a 7% lower RR of mortality (RR = 0.93; P0.0001). The RR reduction with longer TT was greatest in Japan. A synergistic interaction occurred between Kt/V and TT (P = 0.007) toward mortality reduction. UFR10 ml/h/kg was associated with higher odds of intradialytic hypotension (odds ratio = 1.30; P = 0.045) and a higher risk of mortality (RR = 1.09; P = 0.02). Longer TT and higher Kt/V were independently as well as synergistically associated with lower mortality. Rapid UFR during HD was also associated with higher mortality risk. These results warrant a randomized clinical trial of longer dialysis sessions in thrice-weekly HD.

Screening for depression in hemodialysis patients: Associations with diagnosis, treatment, and outcomes in the DOPPS. Background Depressive symptoms and depression are the most frequent psychologic problems reported by hemodialysis patients. We assessed the prevalence of depressive symptoms and physician-diagnosed depression, their variations by country, and associations with treatment by antidepressants among hemodialysis patients. We also assessed whether depressive symptoms were independently associated with mortality, hospitalization, and dialysis withdrawal. Methods The sample was represented by 9382 hemodialysis patients randomly selected from dialysis centers of 12 countries enrolled in the Dialysis Outcomes and Practice Patterns Study (DOPPS II). Depressive symptoms were assessed by the short version of the Center for Epidemiological Studies Depression Screening Index (CES-D), using ≥10 CES-D score as the cut-off value. Results Overall prevalence of physician-diagnosed depression was 13.9%, and percentage of CES-D score ≥10 43.0%. While the smallest prevalence of physician-diagnosed depression was observed in Japan (2.0%) and France (10.6%), the percentage of CES-D score ≥10 in these counties was similar to the whole sample. Patients on antidepressants also varied by country, 34.9% and 17.3% among those with physician-diagnosed depression and CES-D scores ≥10, respectively. In Cox models adjusted for several comorbidities, CES-D scores ≥10 were associated with significantly higher relative risks (RR) of death (RR = 1.42; 95% CI=1.29 to 1.57), hospitalization (RR = 1.12; 95% CI=1.03 to 1.22), and dialysis withdrawal (RR = 1.55; 95% CI=1.29 to 1.85). Conclusion The data suggest that depression is underdiagnosed and undertreated among hemodialysis patients. CES-D can help identify hemodialysis patients who are at higher risk of death and hospitalization. Interventions should target these patients with the goal to improve survival and reduce hospitalizations.

Background: Health-related quality of life (HRQOL), a validated system of measuring patients' physical, mental, and social well-being, can be of particular use in populations with chronic conditions, such as end-stage renal disease (ESRD). Methods: The Dialysis Outcomes and Practice Patterns Study (DOPPS) has used the Kidney Disease Quality of Life Short Form (KDQOL-SF) to measure ESRD patients' self-assessment of functioning and well-being, as measured by 3 component scores: physical component summary (PCS, 4 subscales), mental component summary (4 subscales), and kidney disease component summary (11 subscales). Several DOPPS studies examined HRQOL's associations with mortality and hospitalization by country, ethnicity (United States only), and in comparison with serum albumin levels; international variations in HRQOL of ESRD patients were also evaluated. Results: Lower scores for all 3 summary scores were strongly associated with higher risk of death and hospitalization; these measures, especially PCS, may better identify patients at risk for death and hospitalization than serum albumin level. Japanese patients reported a greater burden of kidney disease but higher physical functioning than patients in Europe or the United States; many other significant regional differences in HRQOL were found. In the United States, all summary scores were significantly associated with mortality risk, regardless of ethnicity. Compared with whites, blacks had higher scores for all 3 summary scores, Asians and Hispanics had higher PCS scores, and Native Americans had lower mental component summary scores. Conclusion: Among ESRD patients, HRQOL displays an important predictive power for adverse events. Identifying effective interventions to improve the HRQOL of patients with ESRD should be viewed as a valued health care goal.

Health-related quality of life as a predictor of mortality and hospitalization: The Dialysis Outcomes and Practice Patterns Study (DOPPS).BackgroundWe investigated whether indicators of health-related quality of life (HRQOL) may predict the risk of death and hospitalization among hemodialysis patients treated in seven countries, taking into account serum albumin concentration and several other risk factors for death and hospitalization. We also compared HRQOL measures with serum albumin regarding their power to predict outcomes.MethodsWe analyzed data from the Dialysis Outcomes and Practice Patterns Study (DOPPS), an international, prospective, observational study of randomly selected hemodialysis patients in the United States (148 facilities), five European countries (101 facilities), and Japan (65 facilities). The total sample size was composed of 17,236 patients. Using the Kidney Disease Quality of Life Short Form (KDQOL-SFTM), we determined scores for three components of HRQOL: (1) physical component summary (PCS), (2) mental component summary (MCS), and (3) kidney disease component summary (KDCS). Complete responses on HRQOL measures were obtained from 10,030 patients. Cox models were used to assess associations between HRQOL and the risk of death and hospitalization, adjusted for multiple sociodemographic variables, comorbidities, and laboratory factors.ResultsFor patients in the lowest quintile of PCS, the adjusted risk (RR) of death was 93% higher (RR = 1.93, P < 0.001) and the risk of hospitalization was 56% higher (RR = 1.56, P < 0.001) than it was for patients in the highest quintile level. The adjusted relative risk values of mortality per 10-point lower HRQOL score were 1.13 for MCS, 1.25 for PCS, and 1.11 for KDCS. The corresponding adjusted values for RR for first hospitalization were 1.06 for MCS, 1.15 for PCS, and 1.07 for KDCS. Each RR differed significantly from 1 (P < 0.001). For 1g/dL lower serum albumin concentration, the RR of death adjusted for PCS, MCS, and KDCS and the other covariates was 1.17 (P < 0.01). Albumin was not significantly associated with hospitalization (RR = 1.03, P> 0.5).ConclusionLower scores for the three major components of HRQOL were strongly associated with higher risk of death and hospitalization in hemodialysis patients, independent of a series of demographic and comorbid factors. A 10-point lower PCS score was associated with higher elevation in the adjusted mortality risk, as was a 1g/dL lower serum albumin level. More research is needed to assess whether interventions to improve quality of life lower these risks among hemodialysis patients.

Background The Kidney Disease Quality of Life Instrument (KDQOL ™ ) was developed to provide clinicians with a comprehensive assessment of the important domains of health-related quality of life (HRQOL) for patients with end-stage renal disease who are undergoing hemodialysis. Objective The purpose of this study was to develop subscales from the 55 items comprising the Symptoms/Problems and Effects of Kidney Disease scales of the KDQOL and to measure the internal consistency reliability of these subscales. Methods The 55 items from the Symptoms/Problems and Effects of Kidney Disease scales were arranged into substantively meaningful clusters using an affinity mapping procedure. The resulting subscales were assessed for internal consistency reliability using data from a sample of 165 individuals with kidney disease who had completed the KDQOL. Results Eleven multi-item subscales were identified: pain, psychological dependency, cognitive functioning, social functioning, dialysis-related symptoms, cardiopulmonary symptoms, sleep, energy, cramps, diet, and appetite. Four items (clotting or other problems with access site, high blood pressure, numbness in hands or feet, and blurred vision) were not included in any of these subscales. Internal consistency reliability estimates for the 11 subscales ranged from 0.66 to 0.92. These subscales correlated with the scales from the 36-Item Short-Form Health Survey as hypothesized (ie, corresponding pain, energy, and social functioning scales had the highest correlations). In addition, several subscales were significantly associated, as hypothesized, with other variables such as the number of disability days. Conclusions The results of this study further support the reliability and validity of the KDQOL. The 11 subscales identified yield more detailed information on the HRQOL of patients with kidney disease and provide a basis for specific improvements in the quality of care delivered to these patients.

The Dialysis Outcomes and Practice Patterns Study (DOPPS): An international hemodialysis study. The Dialysis Outcomes and Practice Patterns Study (DOPPS) is a prospective, longitudinal, observational study of hemodialysis patients and facilities in seven countries with large populations of dialysis patients: France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States. This paper describes the study design, analytic methods, and preliminary findings of the DOPPS. The goal of the study is to determine which practice patterns are associated with the best patient outcomes, with adjustment for a wide range of patient case-mix characteristics. The primary outcomes of interest are mortality, hospitalization, quality of life, and vascular access events. The facility sample from the seven countries consists of 327 hemodialysis centers in which 24,392 patients were treated when the study began. A random sample of 10,332 patients has been selected thus far for more detailed longitudinal data collection. Departing patients are replaced during the study using random selection. A study coordinator at each dialysis facility collects baseline and longitudinal patient data. Patients are asked to complete a questionnaire that addresses quality of life on a yearly basis. The medical director and nurse manager in each facility complete a practice pattern questionnaire. Preliminary data are presented concerning the sample facilities and the census of patients treated in each facility at the start of the study. Dialysis facilities vary widely in size and type (freestanding vs. institutionally-based) across countries. Variation is also seen in patient age, sex distribution, and diabetes mellitus as the attributed cause of end-stage renal disease (ESRD). At this early phase, the DOPPS has proved to be technically feasible and has revealed basic differences in hemodialysis facilities and patients across the seven participating countries.

There is limited information about the clinical and prognostic significance of patient-reported recovery time.Prospective cohort study.6,040 patients in the DOPPS (Dialysis Outcomes and Practice Patterns Study).Answer to question "How long does it take you to recover from a dialysis session?" categorized as follows: fewer than 2, 2-6, 7-12, or longer than 12 hours.Cross-sectional and longitudinal associations between recovery time and patient characteristics, hemodialysis treatment variables, health-related quality of life (HRQoL), and hospitalization and mortality.32% reported recovery time shorter than 2 hours; 41%, 2-6 hours; 17%, 7-12 hours; and 10%, longer than 12 hours. Using proportional odds (ordinal) logistic regression, shorter recovery time was associated with male sex, full-time employment, and higher serum albumin level. Longer recovery time was associated with older age, dialysis vintage, body mass index, diabetes, and psychiatric disorder. Greater intradialytic weight loss, longer dialysis session length, and lower dialysate sodium concentration were associated with longer recovery time. In facilities that used uniform dialysate sodium concentrations for ≥90% of patients, the adjusted OR of longer recovery time, comparing dialysate sodium concentration140 vs 140 mEq/L, was 1.72 (95% CI, 1.37-2.16). Recovery time was correlated positively with symptoms of kidney failure and kidney disease burden score and inversely with HRQoL mental and physical component summary scores. Using Cox regression, adjusting for potential confounders not influenced by recovery time, it was associated positively with first hospitalization and mortality (adjusted HRs for recovery time12 vs 2-6 hours 1.22 [95% CI, 1.09-1.37] and 1.47 [95% CI, 1.19-1.83], respectively).Answers are subjective and not supported by physiologic measurements.Recovery time can be used to identify patients with poorer HRQoL and higher risks of hospitalization and mortality. Interventions to reduce recovery time and possibly improve clinical outcomes, such as increasing dialysate sodium concentration, need to be tested in randomized trials.

Postmarketing clinical trials are conducted with some important differences in the biotechnology industry versus the pharmaceutical industry. Most of these differences are related to the differences between biotechnology and pharmaceutical companies in size, management philosophy, structure, research orientation, and types of products. In biotechnology, more emphasis is placed on teamwork, open communication, and consensus building in planning and conducting Phase IV studies. Risk-taking and the willingness both to try different approaches and to change are cornerstones of biotechnology's philosophy of management. Rather than being the end of the line, product approval is a renewal of the product development process in the biotechnology industry. Because the products of biotechnology research often have a substantial impact on health care when they reach clinicians in the real world, it is essential that program planning emphasize involving end users, the practitioners who will be prescribing the products...

Summary Background and objectives This study aimed to investigate the influence of social support and other psychosocial factors on mortality, adherence to medical care recommendations, and physical quality of life among hemodialysis patients. Design, setting, participants, & measurements Data on 32,332 hemodialysis patients enrolled in the Dialysis Outcomes and Practice Patterns Study (1996 to 2008) in 12 countries were analyzed. Social support and other psychosocial factors related to ESRD and its treatment were measured by patient self-reports of health interference with social activities, isolation, feeling like a burden, and support from family and dialysis staff. Cox regression and logistic regression were used to examine associations of baseline social support and other psychosocial factors with all-cause mortality and with other measured outcomes at baseline, adjusting for potential confounders. Results Mortality was higher among patients reporting that their health interfered with social activities, were isolated, felt like a burden, and were dissatisfied with family support. Poorer family support and several psychosocial measures also were associated with lower adherence to the prescribed hemodialysis length and the recommended weight gain between sessions. Some international differences were observed. Poorer self-reported social support and other psychosocial factors were associated with poor physical quality of life. Conclusions Poorer social support and other psychosocial factors are associated with higher mortality risk, lower adherence to medical care, and poorer physical quality of life in hemodialysis patients. More research is needed to assess whether interventions to improve social support and other psychosocial factors will lengthen survival and enhance quality of life.

Outcomes among dialysis patients vary considerably internationally and across regions within the United States. The Dialysis Outcomes and Practice Patterns Study (DOPPS) is a large, prospective, observational study of representative samples of hemodialysis patients in France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States. The DOPPS collects a wealth of data regarding the patients' demographic characteristics, medical histories, laboratory values, prescriptions, dialysis unit practices, and outcomes. The study seeks to clarify which dialysis practices contribute to improved mortality rates, hospitalization rates, health related quality of life, and vascular access outcomes, after adjusting for the effects of comorbid disease and demographic variables. Over 18,000 patients have been enrolled to date. This paper describes the initial findings and outlines the plans to expand the trial.

Background Limited data exist describing vascular access conversions during the first year on dialysis therapy or the effect of converting to and from a catheter on subsequent mortality risk. Study Design Retrospective cohort study. Setting & Participants We studied a random sample of incident US hemodialysis patients (initiated long-term dialysis Predictors At dialysis therapy initiation, we assessed vascular access type in use (arteriovenous fistula [AVF], arteriovenous graft [AVG], or catheter) and other patient characteristics. We characterized changes in vascular access type (conversions) by using regularly collected functional status information. Outcome & Measurements We assessed time to all-cause mortality. We first described conversions, then used time-dependent Cox regression to estimate mortality hazard ratios (HRs) for conversions from a catheter to a permanent vascular access (versus no conversion) and conversions from a permanent vascular access to a catheter (versus no conversion). Results The study included 4,532 patients; 69.2% were dialyzing with a catheter; 17.6%, with an AVG; and 13.1%, with an AVF. In patients initiating therapy with an AVF or AVG, 22% experienced a conversion (failure), and median times to first failure were 62 and 84 days, respectively. In catheter patients, 59% converted to an AVF/AVG (predominantly AVG [57%]); median times to first conversion were 92 and 66 days, respectively. Conversion to a permanent access was associated with an adjusted mortality HR of 0.69 (95% confidence interval, 0.55 to 0.85). The effect was similar for conversion to an AVF or AVG, and these persisted across demographic groups and facilities with different conversion practices. Conversion from a permanent vascular access to a catheter was associated with an adjusted mortality HR of 1.81 (95% confidence interval, 1.22 to 2.68). Limitations Potential for residual confounding because of unmeasured factors influencing decision to convert. Conclusion Vascular access conversions are common in incident patients. Continued efforts to increase early nephrologist referral and permanent vascular access placement may help decrease mortality risk in incident dialysis patients.

Background. Identification of haemodialysis patients with problems related to lack of appetite should help prevent adverse outcomes. We studied whether a single question about being bothered by lack of appetite within the prior 4 weeks is related to nutritional status, inflammation and risks of death and hospitalization. Additionally, we assessed associations of lack of appetite with depression, dialysis dose and length of haemodialysis. Methods. This study is an analysis of baseline and longitudinal data from 14 406 patients enrolled in the Dialysis Outcomes and Practice Pattern Study. Cox regression was used to assess whether the degree (not, somewhat, moderately, very much, extremely) that patients were bothered by lack of appetite is an independent predictor of death and hospitalization. Logistic regression was used to identify baseline characteristics associated with being bothered by lack of appetite. Results. The risk of death was more than 2-fold higher [relative risk (RR) ¼ 2.23; 95% confidence interval (CI) ¼ 1.90–2.62] and the risk of hospitalization 33% higher (RR ¼ 1.33; 95% CI ¼ 1.19–1.48) among patients extremely bothered, compared with not bothered, by lack of appetite. These associations followed a dose–response fashion and remained statistically significant after adjustments for 14 comorbidities. Depression, shorter haemodialysis session, hypoalbuminaemia, lower concentration of serum creatinine and normalized protein catabolic rate, lower body mass index and higher leucocyte and neutrophil counts were independently associated with higher odds of being bothered by lack of appetite. Conclusions. The data suggest that a single question about lack of appetite helps identify haemodialysis patients with poorer nutritional status, inflammation, depression and higher risks of hospitalization and death. The study calls attention to a possible beneficial effect of longer haemodialysis on appetite.

Texto completo: acesso restrito. p. 545-557 Submitted by Suelen Reis (suziy.ellen@gmail.com) on 2014-01-24T15:50:32Z No. of bitstreams: 1 art%3A10.1007%2Fs11136-006-9143-7.pdf: 191775 bytes, checksum: bca7bf4b36e1915b707d6bf08f97eb3d (MD5) Approved for entry into archive by Solange Gomes (soldella@ufba.br) on 2014-08-11T19:18:19Z (GMT) No. of bitstreams: 1 art%3A10.1007%2Fs11136-006-9143-7.pdf: 191775 bytes, checksum: bca7bf4b36e1915b707d6bf08f97eb3d (MD5) Made available in DSpace on 2014-08-11T19:18:19Z (GMT). No. of bitstreams: 1 art%3A10.1007%2Fs11136-006-9143-7.pdf: 191775 bytes, checksum: bca7bf4b36e1915b707d6bf08f97eb3d (MD5) Previous issue date: 2007 Objective: To identify modifiable factors associated with health-related quality of life (HRQOL) among chronic hemodialysis patients. Methods: Analysis of baseline data of 9,526 hemodialysis patients from seven countries enrolled in phase I of the Dialysis Outcomes and Practice Patterns Study (DOPPS). Using the Kidney Disease Quality of Life Short Form (KDQOL-SFTM), we determined scores for 8 generic scale summaries derived from these scales, i.e., the physical component summary [PCS] and mental component summary [MCS], and 11 kidney disease-targeted scales. Regression models were used to adjust for differences in comorbidities and sociodemographic and treatment factors. The Benjamin-Hochberg procedure was used to correct P-values for multiple comparisons. Results: Unemployment and psychiatric disease were independently and significantly associated with lower scores for all generic and several kidney disease-targeted HRQOL measures. Several other comorbidities, lower educational level, lower income, and hypoalbuminemia were also independently and significantly associated with lower scores of PCS and/or MCS and several generic and kidney disease-targeted scales. Hemodialysis by catheter was associated with significantly lower PCS scores, partially explained by the correlation with covariates. Conclusion: Associations of poorer HRQOL with preventable or controllable factors support a greater focus on psychosocial and medical interventions to improve the well-being of hemodialysis patients.

To identify modifiable factors associated with health-related quality of life (HRQOL) among chronic hemodialysis patients.Analysis of baseline data of 9,526 hemodialysis patients from seven countries enrolled in phase I of the Dialysis Outcomes and Practice Patterns Study (DOPPS). Using the Kidney Disease Quality of Life Short Form (KDQOL-SF(TM)), we determined scores for 8 generic scale summaries derived from these scales, i.e., the physical component summary [PCS] and mental component summary [MCS], and 11 kidney disease- targeted scales. Regression models were used to adjust for differences in comorbidities and sociodemographic and treatment factors. The Benjamini-Hochberg procedure was used to correct P-values for multiple comparisons.Unemployment and psychiatric disease were independently and significantly associated with lower scores for all generic and several kidney disease-targeted HRQOL measures. Several other comorbidities, lower educational level, lower income, and hypoalbuminemia were also independently and significantly associated with lower scores of PCS and/or MCS and several generic and kidney disease-targeted scales. Hemodialysis by catheter was associated with significantly lower PCS scores, partially explained by the correlation with covariates.Associations of poorer HRQOL with preventable or controllable factors support a greater focus on psychosocial and medical interventions to improve the well-being of hemodialysis patients.

A preponderance of data highlights significant improvements in outcomes when patients dialyze with arteriovenous fistulae compared with either catheters or grafts. "Fistula First" is a nationwide, evidence-based, quality improvement effort that is striving to improve vascular access outcomes by increasing the percentage of patients who dialyze with arteriovenous fistulae. Nephrology nurses will have a profound effect on achieving the goals outlined by Fistula First, including both the choice and longevity of vascular accesses.

The management and appropriate treatment of chronic disease are ongoing challenges in health care. As the population ages, the prevalence of chronic disease can be expected to increase. Since by definition there is no cure for chronic disease, controlling, minimizing, or managing its negative effects becomes a primary goal. In the self-management perspective, it is neither clinicians nor health care systems who must accomplish the bulk of chronic disease management but rather the patients themselves. Moreover, self-management has been shown to be associated with improved outcomes. Self-management is comprised of two domains: self-management of health care and self management of everyday life. Self-management of health care includes self-care activity, partnership in care, communication, self-care self-efficacy, and adherence. Self-management of everyday life entails achieving/maintaining "normality" in everyday roles and functioning. End stage renal disease (ESRD) is a chronic disease for which self-management is particularly relevant. Understanding the components of self-management may help patients and clinicians to embrace this approach, to enter the mutual relationship it requires, and to maximize positive outcomes for patients with ESRD.

Reliable and valid tools are needed to assist nurses to prospectively identify high-risk patients with kidney failure. Early identification of high-risk patients permits targeting of nursing interventions and resources to improve quality and cost outcomes. A 16-item risk assessment tool Risk for Outcomes Adverse to Dialysis (ROAD), was developed based on a comprehensive review of the literature on risk factors associated with adverse outcomes with kidney failure Reliability and validity of the ROAD was tested on a random sample of 253 participants in the Anemia Management Demonstration Project. High risk scores on the ROAD were significantly associated with hospitalization 1 to 6 months following risk assessment and inversely correlated with physical and mental components of quality of life. The results indicate that the ROAD provides a useful tool to identify patients on hemodialysis at risk of poor outcomes.

Background: In the United States, an association between mortality risk and ethnicity has been observed among hemodialysis patients. This study was developed to assess whether health-related quality of life (HRQOL) scores also vary among patients of different ethnic backgrounds. Associations between HRQOL and adverse dialysis outcomes (ie, death and hospitalization) also were assessed for all patients and by ethnicity. Methods: Data are from the Dialysis Outcomes and Practice Patterns Study for 6,151 hemodialysis patients treated in 148 US dialysis facilities who filled out the Kidney Disease Quality of Life Short Form. We determined scores for three components of HRQOL: Physical Component Summary (PCS), Mental Component Summary (MCS), and Kidney Disease Component Summary (KDCS). Patients were classified by ethnicity as Hispanic and five non-Hispanic categories: white, African American, Asian, Native American, and other. Multiple linear regression models were used to estimate differences in HRQOL scores among ethnic groups, using whites as the referent category. Cox regression models were used for associations between HRQOL and outcomes. Regression models were adjusted for sociodemographic variables, delivered dialysis dose (equilibrated Kt/V), body mass index, years on dialysis therapy, and several laboratory/comorbidity variables. Results: Compared with whites, African Americans showed higher HRQOL scores for all three components (MCS, PCS, and KDCS). Asians had higher adjusted PCS scores than whites, but did not differ for MCS or KDCS scores. Compared with whites, Hispanic patients had significantly higher PCS scores and lower MCS and KDCS scores. Native Americans showed significantly lower adjusted MCS scores than whites. The three major components of HRQOL were significantly associated with death and hospitalization for the entire pooled population, independent of ethnicity. Conclusion: The data indicate important differences in HRQOL among patients of different ethnic groups in the United States. Furthermore, HRQOL scores predict death and hospitalization among these patients. Am J Kidney Dis 41:605-615. © 2003 by the National Kidney Foundation, Inc.

A point-in-time observational study was conducted in over 1,000 nephrology offices between November 1999 and December 2000 to determine the prevalence of anemia in patients with chronic kidney disease (CKD). Trends in hemoglobin (Hb) and serum creatinine (SCr) levels were assessed among 4,831 evaluable patients to determine the relationship between renal function and anemia. Results demonstrated that anemia is common in patients with CKD, with progressive increases in prevalence and severity as renal function deteriorates. Overall, 26.3% of these patients had Hb levels below 10 g/dL, 46.7% had Hb levels below 11 g/dL, and 63.9% had Hb levels below 12 g/dL. Despite the high percent of patients with anemia, only 31.3% were being treated for this condition. These data suggest that anemia is prevalent and undertreated in patients with CKD. Nephrology nurses can be influential in providing proactive management of anemia throughout the spectrum of CKD to improve anemia-related outcomes.

In this exploratory/descriptive study, the authors examined processes involved in some kidney patients’ability to survive on dialysis. Through long semistructured interviews with 18 dialysis survivors, they identified four self-affirmations that characterized participants’ restructuring of self and four sets of illness experiences that required restructuring within the context of their extant worlds. The denouement involved the participants’ transformation into comprehensive, active self-managers of their disease, its treatment, and its manifestations. The authors describe the participants’affirmations and adaptations leading to transformation. Understanding this process paves the way for research into the timing and sequence entailed in transformation and lays the groundwork for the development of interventions to guide kidney failure patients to the positive outcome of transformation: comprehensive, active self-management.

Health-related quality of life (HRQOL) is a critical issue in the treatment of end-stage renal disease (ESRD) patients. The variety of symptoms, comorbidities, and treatments of ESRD over the course of its chronic disease trajectory necessitate comprehensive assessment of the impact of interventions on HRQOL. A literature review of ESRD HRQOL studies was performed to provide an overview of the instruments used and to provide recommendations for HRQOL assessment in future studies. Instruments were classified based on the health domains they assess and whether they are generic or disease targeted. The instruments were judged in terms of their comprehensiveness, reliability, and validity.

Hemodialysis vascular access preferences and outcomes in the Dialysis Outcomes and Practice Patterns Study (DOPPS).BackgroundSynthetic grafts have generally been found to exhibit lower survival rates and higher complication rates than native arteriovenous fistulae. We investigated whether survival of grafts relative to fistulae was better in facilities with a preference for grafts, hypothesizing that such facilities may place more grafts because grafts produced superior outcomes.MethodsThe study was based on a national U.S. sample of 133 hemodialysis facilities participating in the Dialysis Outcomes and Practice Patterns Study (DOPPS), a prospective, observational study of dialysis treatment practices and outcomes. Vascular access preferences were ascertained from medical directors, nurse managers, and actual practice within each facility (% graft use among prevalent patients). Logistic regression was used to model the odds ratio (OR) of graft placement (vs. fistula) and Cox regression was used to model time from access creation to initial failure.ResultsGrafts were preferred by 21% of medical directors and 40% of nurse managers. Patients in facilities in which the medical director or nurse manager expressed a preference for grafts were more than twice as likely to have a graft than a fistula (AOR = 2.3, P < 0.01; reference group = facilities that did not prefer grafts), suggesting that facility preferences influence the type of access created. Overall, grafts were more prevalent than fistulae in dialysis facilities, but displayed a higher relative risk of failure (RR 1.33, P < 0.0001). However, the risk of graft versus fistula failure did not vary by expressed preference of the medical director: the relative risk of graft versus fistula failure was 1.39 in facilities in which the medical director preferred grafts and 1.39 in facilities in which the medical director preferred fistulae. Moreover, the relative risk of graft versus fistula failure was 1.57 in facilities that used more than the median percentage of grafts and 1.19 in facilities that used less than the median percentage of grafts.ConclusionsNo evidence was found that graft outcomes are superior in facilities that prefer grafts to fistulae. The observed variation in vascular access practice patterns suggests opportunities for quality improvement if optimal practices can be defined.

INTRODUCTION: CHRONIC KIDNEY disease (CKD) is a worldwide public health issue. In the United States, there is a rising incidence and prevalence of kidney failure (Fig 1), with poor outcomes and high cost. The prevalence of earlier stages of CKD is approximately 100 times greater than the prevalence of kidney failure, affecting almost 11% of adults in the United States. There is growing evidence that some of the adverse outcomes of CKD can be prevented or delayed by preventive measures, early detection, and treatment. Hypertension is a cause and complication of CKD. Hypertension in CKD increases the risk of important adverse outcomes, including loss of kidney function and kidney failure, early development and accelerated progression of cardiovascular disease (CVD), and premature death. In the ongoing effort to improve outcomes of CKD, the National Kidney Foundation (NKF) Kidney Disease Outcomes Quality Initiative (K/DOQI) appointed a Work Group and an Evidence Review Team in 2001 to develop clinical practice guidelines on hypertension and use of antihypertensive agents in CKD. During this same time, clinical practice guidelines on this topic relevant to CKD were also under development by other organizations, including the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) and the 2003 report of the American Diabetes Association (ADA) on the Treatment of Hypertension in Adults with Diabetes. The Work Group maintained contact with these organizations during development of these guidelines. The purpose of the Executive Summary is to provide a "stand-alone" summary of the background, scope, methods, and key recommendations, as well as the complete text of the guideline statements. Most tables and figures in the Executive Summary are taken from other sections of the document. BACKGROUND: Chronic Kidney Disease: Figure 2 is a conceptual model of CKD, which defines stages of CKD, as well as antecedent conditions, outcomes, risk factors for adverse outcomes, and actions to improve outcomes. CKD is defined as kidney damage, as confirmed by kidney biopsy or markers of damage, or glomerular filtration rate (GFR)

Introduction: Chronic kidney disease as a public health problem. Chronic kidney disease is a worldwide public health problem. In the United States, there is a rising incidence and prevalence of kidney failure, with poor outcomes and high cost. There is an even higher prevalence of earlier stages of chronic kidney disease. Increasing evidence, accrued in the past decades, indicates that the adverse outcomes of chronic kidney disease, such as kidney failure, cardiovascular disease, and premature death, can be prevented or delayed. Earlier stages of chronic kidney disease can be detected through laboratory testing. Treatment of earlier stages of chronic kidney disease is effective in slowing the progression toward kidney failure. Initiation of treatment for cardiovascular risk factors at earlier stages of chronic kidney disease should be effective in reducing cardiovascular disease events both before and after the onset of kidney failure. Unfortunately, chronic kidney disease is "under-diagnosed" and "under-treated" in the United States, resulting in lost opportunities for prevention. One reason is the lack of agreement on a definition and classification of stages in the progression of chronic kidney disease. A clinically applicable classification would be based on laboratory evaluation of the severity of kidney disease, association of level of kidney function with complications, and stratification of risks for loss of kidney function and development of cardiovascular disease. Charge to the K/DOQI work group on chronic kidney disease. In 2000, the National Kidney Foundation (NKF) Kidney Disease Outcome Quality Initiative (K/DOQI) Advisory Board approved development of clinical practice guidelines to define chronic kidney disease and to classify stages in the progression of chronic kidney disease. The Work Group charged with developing the guidelines consisted of experts in nephrology, pediatric nephrology, epidemiology, laboratory medicine, nutrition, social work, gerontology, and family medicine. An Evidence Review Team, consisting of nephrologists and methodologists, was responsible for assembling the evidence. Defining chronic kidney disease and classifying the stages of severity would provide a common language for communication among providers, patients and their families, investigators, and policy-makers and a framework for developing a public health approach to affect care and improve outcomes of chronic kidney disease. A uniform terminology would permit: 1. More reliable estimates of the prevalence of earlier stages of disease and of the population at increased risk for development of chronic kidney disease 2. Recommendations for laboratory testing to detect earlier stages and progression to later stages 3. Associations of stages with clinical manifestations of disease 4. Evaluation of factors associated with a high risk of progression from one stage to the next or of development of other adverse outcomes 5. Evaluation of treatments to slow progression or prevent other adverse outcomes. Clinical practice guidelines, clinical performance measures, and continuous quality improvement efforts could then be directed to stages of chronic kidney disease. The Work Group did not specifically address evaluation and treatment for chronic kidney disease. However, this guideline contains brief reference to diagnosis and clinical interventions and can serve as a "road map" linking other clinical practice guidelines and pointing out where other guidelines need to be developed. Eventually, K/DOQI will include interventional guidelines. The first three of these, on bone disease, dyslipidemia, and blood pressure management are currently under development. Other guidelines on cardiovascular disease in dialysis patients and kidney biopsy will be initiated in the Winter of 2001. This report contains a summary of background information available at the time the Work Group began its deliberations, the 15 guidelines and the accompanying rationale, suggestions for clinical performance measures, a clinical approach to chronic kidney disease using these guidelines, and appendices to describe methods for the review of evidence. The guidelines are based on a systematic review of the literature and the consensus of the Work Group. The guidelines have been reviewed by the K/DOQI Advisory Board, a large number of professional organizations and societies, selected experts, and interested members of the public and have been approved by the Board of Directors of the NKF. Framework. The Work Group defined "chronic kidney disease" to include conditions that affect the kidney, with the potential to cause either progressive loss of kidney function or complications resulting from decreased kidney function. Chronic kidney disease was thus defined as the presence of kidney damage or decreased level of kidney function for three months or more, irrespective of diagnosis. The target population includes individuals with chronic kidney disease or at increased risk of developing chronic kidney disease. The majority of topics focus on adults (age ≥18 years). Many of the same principles apply to children as well. In particular, the classification of stages of disease and principles of diagnostic testing are similar. A subcommittee of the Work Group examined issues related to children and participated in development of the first six guidelines of the present document. However, there are sufficient differences between adults and children in the association of GFR with signs and symptoms of uremia and in stratification of risk for adverse outcomes that these latter issues are addressed only for adults. A separate set of guidelines for children will have to be developed by a later Work Group. The target audience includes a wide range of individuals: those who have or are at increased risk of developing chronic kidney disease (the target population) and their families; health care professionals caring for the target population; manufacturers of instruments and diagnostic laboratories performing measurements of kidney function; agencies and institutions planning, providing or paying for the health care needs of the target population; and investigators studying chronic kidney disease. There will be only brief reference to clinical interventions, sufficient to provide a basis for other clinical practice guidelines relevant to the evaluation and management of chronic kidney disease. Subsequent K/DOQI clinical practice guidelines will be based on the framework developed here. Definition of chronic kidney disease. Why "Kidney"? The word "kidney" is of Middle English origin and is immediately understood by patients, their families, providers, health care professionals, and the lay public of native English speakers. On the other hand, "renal" and "nephrology," derived from Latin and Greek roots, respectively, commonly require interpretation and explanation. The Work Group and the NKF are committed to communicating in language that can be widely understood, hence the preferential use of "kidney" throughout these guidelines. The term "End-Stage Renal Disease" (ESRD) has been retained because of its administrative usage in the United States referring to patients treated by dialysis or transplantation, irrespective of their level of kidney function. Why Develop a New Classification? Currently, there is no uniform classification of the stages of chronic kidney disease. A review of textbooks and journal articles clearly demonstrates ambiguity and overlap in the meaning of current terms. The Work Group concluded that uniform definitions of terms and stages would improve communication between patients and providers, enhance public education, and promote dissemination of research results. In addition, it was believed that uniform definitions would enhance conduct of clinical research. Why Base a New Classification System on Severity of Disease? Adverse outcomes of kidney disease are based on the level of kidney function and risk of loss of function in the future. Chronic kidney disease tends to worsen over time. Therefore, the risk of adverse outcomes increases over time with disease severity. Many disciplines in medicine, including related specialties of hypertension, cardiovascular disease, diabetes, and transplantation, have adopted classification systems based on severity to guide clinical interventions, research, and professional and public education. Such a model is essential for any public health approach to disease. Why Classify Severity as the Level of GFR? The level of glomerular filtration rate (GFR) is widely accepted as the best overall measure of kidney function in health and disease. Providers and patients are familiar with the concept that "the kidney is like a filter." GFR is the best measure of the kidneys' ability to filter blood. In addition, expressing the level of kidney function on a continuous scale allows development of patient and public education programs that encourage individuals to "Know your number!" The term "GFR" is not intuitively evident to anyone. Rather, it is a learned term, which allows the ultimate expression of the complex functions of the kidney in one single numerical expression. Conversely, numbers are an intuitive concept and easily understandable by everyone.