DOPPS Research Slides, 2000-2008

DOPPS - Dialysis Outcomes and Practice Patterns Study

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Port FK, Pisoni RL, Bommer J, Locatelli F, Jadoul M, Eknoyan G, Kurokawa K, Canaud BJ, Finley MP, Young EW. Improving Outcomes for Dialysis Patients in the International Dialysis Outcomes and Practice Patterns Study. Clin J Am Soc Nephrol 2006; 1(2): 246-255

The international Dialysis Outcomes and Practice Patterns Study (DOPPS) is well suited to evaluate levels of deviation from emerging and established guidelines to clinical practice of hemodialysis, over time and by country. The DOPPS can also evaluate whether the target levels that are chosen in the guidelines are in agreement with outcomes such as elevated risk for mortality, hospitalization, and vascular access failure. At a special DOPPS symposium during the 2004 congress of the American Society of Nephrology, the authors presented such findings; key points from that symposium are presented in this article, focusing on vascular access, mineral metabolism, dialysis dose, and anemia management. Although an observational study cannot prove causality, DOPPS suggests large opportunities to improve care and outcomes of dialysis patients. The international perspective of DOPPS assists in the new efforts for international guidelines. Some encouraging trends in recent years are documented in these areas.

Kimata N, Akiba T, Pisoni RL, Albert JM, Satayathum S, Cruz JM, Akizawa T, Andreucci VE, Young EW, Port FK. Mineral metabolism and haemoglobin concentration among haemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant 2005; 20(5): 927-935

BACKGROUND: Bone and mineral metabolism is abnormal in most chronic haemodialysis patients and is associated with a high mortality risk. Because of possible pathogenic links between anaemia and intact parathyroid hormone (iPTH), the present study evaluated associations of mineral metabolism indicators with haemoglobin (Hb). METHODS: Data were collected from 317 facilities (12 089 haemodialysis patients) in Australia, Belgium, Canada, France, Germany, Italy, Japan, New Zealand, Spain, Sweden, the United Kingdom and the United States by the Dialysis Outcomes and Practice Patterns Study (DOPPS). The major outcome studied was probability of haemodialysis patients having a target Hb, per guidelines, of >/=11 g/dl at baseline. Major predictor variables were patient characteristics and laboratory markers of mineral metabolism: albumin-corrected serum calcium (calcium(Alb)), serum phosphorus (PO(4)) and iPTH. Analyses were adjusted for demographics, 15 comorbidity classes, baseline laboratory values, body mass index, years on dialysis, erythropoietin dose, vitamin D and catheter use, cause of end-stage renal disease and country. RESULTS: The adjusted odds ratio (AOR) of having Hb >/=11 g/dl was significantly higher (P<0.0001) in patients with higher calcium(Alb) (AOR = 1.32 per 1 mg/dl), higher PO(4) (AOR = 1.08 per 1 mg/dl) and lower iPTH (AOR = 0.96 per 100 pg/ml). Furthermore, 4 month intrapatient changes in Hb concentration were significantly (P<0.0001) related to 4 month changes in calcium(Alb) (0.17 g/dl Hb rise per 1 mg/dl higher calcium(Alb)) and PO(4) (0.11 g/dl Hb rise per 1 mg/dl higher PO(4)). Mean weekly recombinant human erythropoietin (rHuEpo) doses were higher for patients with high PO(4) or iPTH levels, but lower for patients with calcium(Alb) >9.5 mg/dl, after patient mix and Hb concentration adjustments. CONCLUSIONS: The results of this study indicate that higher serum calcium(Alb) and PO(4) levels are each independently associated with better anaemia control. This relationship is independent of vitamin D use, PTH levels and prescribed rHuEpo dose. Despite this benefit of better anaemia control at higher serum calcium(Alb) and PO(4) concentrations, lower calcium and PO(4) levels, as recommended by the K/DOQI guidelines, should still serve as the long-term goal for HD patients in order to minimize tissue calcification and mortality risk.

Locatelli F, Pisoni RL, Akizawa T, Cruz JM, DeOreo P, Lameire N, Held PJ. Anemia Management for Hemodialysis Patients: K/DOQI Guidelines and DOPPS Findings. Am J Kidney Dis 2004; 44 (Suppl 2):S27-S33

BACKGROUND: After recombinant human erythropoietin was introduced into routine nephrologic practice, specific clinical guidelines were developed to optimize the quality of anemia management for patients with chronic kidney disease. METHODS: The Dialysis Outcomes and Practice Patterns Study (DOPPS), an international investigation providing patient- and facility-level data on hemodialysis practice, was developed to provide information on various aspects of current practices in hemodialysis management, including treatment of renal anemia. RESULTS: Hemoglobin concentration is strongly associated with both morbidity and mortality in hemodialysis patients. Although some improvements can be documented in anemia management practices in the years after the publication of international guidelines, wide variations in anemia management are still observed among countries. CONCLUSION: Many efforts are still needed to allow a greater proportion of patients to reach the recommended hemoglobin concentrations. Significantly improved outcomes may therefore be expected by a more widespread reaching of the recommended hemoglobin levels. The results of the DOPPS point to the difficulties in implementing clinical guidelines in the everyday management of individual patients. In specific circumstances, a well-designed observational study may offer credible information and serve as a basic instrument for monitoring the implementation of clinical guidelines in typical clinical practice.

Pisoni RL, Bragg-Gresham JL, Young EW, Akizawa T, Asano Y, Locatelli F, Bommer J, Cruz JM, Kerr PG, Mendelssohn DC, Held PJ, Port FK. Anemia management outcomes from 12 countries in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis 2004; 44(1):94-111

BACKGROUND: Anemia is common in hemodialysis (HD) patients. METHODS: Data collected from nationally representative samples of HD patients (n = 11,041) in 2002 to 2003 were used to describe current anemia management for long-term HD patients at 309 dialysis units in 12 countries. Analyses of associations and outcomes were adjusted for demographics, 15 comorbid classes, laboratory values, country, and facility clustering. RESULTS: For patients on dialysis therapy for longer than 180 days, 23% to 77% had a hemoglobin (Hgb) concentration less than 11 g/dL (<110 g/L), depending on country; 83% to 94% were administered erythropoietin (EPO). Mean Hgb levels were 12 g/dL (120 g/L) in Sweden; 11.6 to 11.7 g/dL (116 to 117 g/L) in the United States, Spain, Belgium, and Canada; 11.1 to 11.5 g/dL (111 to 115 g/L) in Australia/New Zealand, Germany, Italy, the United Kingdom, and France; and 10.1 g/dL (101 g/L) in Japan. Hgb levels were substantially lower for new patients with end-stage renal disease, and EPO use before ESRD ranged from 27% (United States) to 65% (Sweden). By patient, EPO use significantly declined with greater Hgb concentration (adjusted odds ratio, 0.61 per 1-g/dL [10-g/L] greater Hgb level; P < 0.0001), as did EPO dosage. Case-mix-adjusted mortality and hospitalization risk declined by 5% and 6% per 1-g/dL greater patient baseline Hgb level (P < or = 0.003 each), respectively. Furthermore, patient mortality and hospitalization risks were 10% to 12% lower for every 1-g/dL greater facility mean Hgb level. Patients were significantly more likely to have Hgb levels of 11 g/dL or greater (> or =110 g/L) if they were older; were men; had polycystic kidney disease; had greater albumin, transferrin saturation, or calcium levels; were not dialyzing with a catheter; or had lower ferritin levels. Facilities with greater intravenous iron use showed significantly greater facility mean Hgb concentrations. Mean EPO dose varied from 5,297 (Japan) to 17,360 U/wk (United States). Greater country mean EPO doses were significantly associated with greater country mean Hgb concentrations. Several patient characteristics were associated with greater EPO doses. Even in some countries with high intravenous iron use, 35% to 40% of patients had a transferrin saturation less than 20% (below guidelines). CONCLUSION: These findings indicate large international variations in anemia management, with significant improvements during the last 5 years, although many patients remain below current anemia guidelines, suggesting large and specific opportunities for improvement.

Locatelli F, Pisoni RL, Combe C, Bommer J, Andreucci VE, Piera L, Greenwood R, Feldman HI, Port FK, Held PJ. Anaemia in haemodialysis patients of five European countries: association with morbidity and mortality in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Department of Nephrology and Dialysis, A. Manzoni Hospital, Lecco, Italy. Nephrol Dial Transplant. 2004 Nov;19(11):2928

BACKGROUND: The Dialysis Outcomes and Practice Patterns Study (DOPPS) is a prospective, observational study based on data collected from nationally representative samples of haemodialysis facilities. The burden of anaemia in haemodialysis patients is substantial, leading to considerable morbidity, mortality and reduced quality of life. This study examines anaemia management and outcomes based on data from five European countries participating in the DOPPS: France, Germany, Italy, Spain and the UK. METHODS: Baseline data on demographics, co-morbidities and anaemia management in 4591 haemodialysis patients from 101 nephrology facilities were collected in 1998-2000. Using multivariate Cox survival analyses to adjust for patient characteristics, relationships between haemoglobin concentration at study entry and rates of mortality and hospitalization were evaluated. RESULTS: For a year 2000 sample of prevalent patients on haemodialysis >180 days, mean haemoglobin concentration was 11.0 g/dl; 53% had a haemoglobin concentration > or = 11 g/dl [1998-1999 = 44% (P < 0.05)]. In 2000, 84% of prevalent patients were prescribed recombinant human erythropoietin (rHuEpo). Higher haemoglobin concentrations were associated with decreased relative risk (RR) for mortality (RR = 0.95 for every 1 g/dl higher haemoglobin, P = 0.03) and hospitalization (RR = 0.96, P = 0.02). Patients with haemoglobin <10 g/dl were 29% more likely to be hospitalized than patients with haemoglobin 11-12 g/dl (P < 0.001). CONCLUSION: Even after adjustment, lower haemoglobin concentrations were associated with higher morbidity and mortality in European haemodialysis patients. A trend to increased haemoglobin concentrations was observed following publication of the European Best Practice Guidelines (EBPG) on anaemia management for chronic kidney disease patients, but efforts must continue to achieve EBPG goals.

Port FK, Pisoni RL, Bragg-Gresham JL, Satayathum SS, Young EW, Wolfe RA, Held PJ. DOPPS estimates of patient life years attributable to modifiable hemodialysis practices in the United States. Blood Purif. 2004; 22(1):175-80

Data from the Dialysis Outcomes and Practice Patterns Study (DOPPS) allow estimation of the percentage of patients outside published hemodialysis guidelines and their associated mortality risk. We estimated the number of life years that could be gained from adherence to four of these guidelines and two other modifiable practices, i.e. dialysis dose, phosphate control, improved anemia, partial correction of serum albumin, reduced interdialytic weight gain and less use of catheters for vascular access. We extrapolated DOPPS data on these practices and guidelines to the US hemodialysis population for a 5-year projected period. Of the practices we examined, the highest relative risk of mortality was associated with having albumin <3.5 g/dl (relative risk=1.38, p<0.0001); 20.5% of the patients in the study fell outside the target range. The adjusted sum of the patient years attributable to all six practice patterns was 143,617; a more conservative estimate, modeling life years potentially gained by bringing half of all patients outside targets within them, is 69,367. The magnitude of potential savings in life years should encourage greater adherence to guidelines and practices that are significantly associated with better survival.

Pisoni RL. Erythropoetin therapy in Europe: Results from the DOPPS. Contrib Nephrol. 2002; 137: 396-402

Funk-Schrag W. Diabetes: Dialysis Outcomes and Practice Patterns Study Results and Innovative Patient Care Programs. Journal of Nephrology Social Work 2007; 26: 41-44

Diabetes is now the leading cause of chronic kidney disease (CKD) in the United States and is also growing in numbers worldwide. The cost of caring for people with diabetes and CKD is escalating and is especially highest from the month prior to starting dialysis to 6 months after beginning dialysis. According to the Dialysis Outcomes Practice Patterns Study (DOPPS), a person with kidney failure who also has diabetes is at higher risk for hospitalization, mortality, retinopathy, blindness and lower limb amputation. The dialysis health care team is challenged to develop new methods of caring for people with diabetes and CKD. Innovative programs reviewed in this article show improved clinical outcomes and an increase in patients' ability to self-manage their disease.

Hayashino Y, Fukuhara S, Akiba T, Akizawa T, Asano Y, Saito A, Bragg-Gresham JL, Ramirez SPB, Port FK, Kurokawa K. Diabetes, glycemic control and mortality risk in patients on hemodialysis: the Japan Dialysis Outcomes and Practice Patterns Study. Diabetologia 2007; 50(6):1170-1177

AIMS/HYPOTHESIS: There are few data on the target level of glycaemic control among patients with diabetes on haemodialysis. We investigated the impact of glycaemic control on mortality risk among diabetic patients on haemodialysis. SUBJECTS AND METHODS: Data were analysed from the Dialysis Outcomes Practice Pattern Study (DOPPS) for randomly selected patients on haemodialysis in Japan. The diagnosis of diabetes at baseline and information on clinical events during follow-up were abstracted from the medical records. A Cox proportional hazards model was used to evaluate the association between presence or absence of diabetes, glycaemic control (HbA(1c) quintiles) and mortality risk. RESULTS: Data from 1,569 patients with and 3,342 patients without diabetes on haemodialysis were analysed. Among patients on haemodialysis, those with diabetes had a higher mortality risk than those without (multivariable hazard ratio 1.37, 95% CI 1.08-1.74). Compared with those in the bottom quintile of HbA(1c) level, the multivariable-adjusted hazard ratio for mortality was not increased in the bottom second to fourth quintiles of HbA(1c) (HbA(1c) 5.0-5.5% to 6.2-7.2%), but was significantly increased to 2.36 (95% CI 1.02-5.47) in the fifth quintile (HbA(1c) > or = 7.3%). The effect of poor glycaemic control did not statistically correlate with baseline mortality risk (p = 0.27). CONCLUSIONS/INTERPRETATION: Among dialysis patients, poorer glycaemic control in those with diabetes was associated with higher mortality risk. This suggests a strong effect of poor glycaemic control above an HbA(1c) level of about 7.3% on mortality risk, and that this effect does not appear to be influenced by baseline comorbidity status.

Locatelli F, Pisoni RL, Combe C, Bommer J, Andreucci VE, Piera L, Greenwood R, Feldman HI, Port FK, Held PJ. Anaemia in haemodialysis patients of five European countries: association with morbidity and mortality in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Department of Nephrology and Dialysis, A. Manzoni Hospital, Lecco, Italy. Nephrol Dial Transplant. 2004 Nov;19(11):2928

BACKGROUND: The Dialysis Outcomes and Practice Patterns Study (DOPPS) is a prospective, observational study based on data collected from nationally representative samples of haemodialysis facilities. The burden of anaemia in haemodialysis patients is substantial, leading to considerable morbidity, mortality and reduced quality of life. This study examines anaemia management and outcomes based on data from five European countries participating in the DOPPS: France, Germany, Italy, Spain and the UK. METHODS: Baseline data on demographics, co-morbidities and anaemia management in 4591 haemodialysis patients from 101 nephrology facilities were collected in 1998-2000. Using multivariate Cox survival analyses to adjust for patient characteristics, relationships between haemoglobin concentration at study entry and rates of mortality and hospitalization were evaluated. RESULTS: For a year 2000 sample of prevalent patients on haemodialysis >180 days, mean haemoglobin concentration was 11.0 g/dl; 53% had a haemoglobin concentration > or = 11 g/dl [1998-1999 = 44% (P < 0.05)]. In 2000, 84% of prevalent patients were prescribed recombinant human erythropoietin (rHuEpo). Higher haemoglobin concentrations were associated with decreased relative risk (RR) for mortality (RR = 0.95 for every 1 g/dl higher haemoglobin, P = 0.03) and hospitalization (RR = 0.96, P = 0.02). Patients with haemoglobin <10 g/dl were 29% more likely to be hospitalized than patients with haemoglobin 11-12 g/dl (P < 0.001). CONCLUSION: Even after adjustment, lower haemoglobin concentrations were associated with higher morbidity and mortality in European haemodialysis patients. A trend to increased haemoglobin concentrations was observed following publication of the European Best Practice Guidelines (EBPG) on anaemia management for chronic kidney disease patients, but efforts must continue to achieve EBPG goals.

Fissell RB, Bragg-Gresham JL, Woods JD, Jadoul M, Gillespie B, Hedderwick SA, Rayner HC, Greenwood RN, Akiba T, Young EW. Patterns of hepatitis C prevalence and seroconversion in hemodialysis units from three continents: The DOPPS. Kidney Int 2004; 65:2335-2342

BACKGROUND: Hepatitis C virus (HCV) remains a problem within hemodialysis units. This study measures HCV prevalence and seroconversion rates across seven countries and investigates associations with facility-level practice patterns. METHODS: The study sample was from the Dialysis Outcomes and Practice Patterns Study (DOPPS), a prospective, observational study of adult hemodialysis patients randomly selected from 308 representative dialysis facilities in France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States. Logistic regression was used to model odds of HCV prevalence, and Cox regression was used to model time from study entry to HCV seroconversion. RESULTS: Mean HCV facility prevalence was 13.5% and varied among countries from 2.6% to 22.9%. Increased HCV prevalence was associated with longer time on dialysis, male gender, black race, diabetes, hepatitis B (HBV) infection, prior renal transplant, and alcohol or substance abuse in the previous 12 months. Approximately half of the facilities (55.6%) had no seroconversions during the study period. HCV seroconversion was associated with longer time on dialysis, human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), HBV infection, and recurrent cellulitis or gangrene. An increase in highly trained staff was associated with lower HCV prevalence (OR = 0.93 per 10% increase, P= 0.003) and risk of seroconversion (RR = 0.92, P= 0.07). Seroconversion was associated with an increase in facility HCV prevalence (RR = 1.36, P < 0.0001), but not with isolation of HCV-infected patients (RR = 1.01, P= 0.99). CONCLUSION: There are differences in HCV prevalence and rate of seroconversion at the country and the hemodialysis facility level. The observed variation suggests opportunities for improved HCV outcomes.

Goodkin DA, Bragg-Gresham JL, Koenig KG, Wolfe RA, Akiba T, Andreucci VE, Saito A, Rayner HC, Kurokawa K, Port FK, Held PJ, Young EW. Association of comorbid conditions and mortality in hemodialysis patients in Europe, Japan, and the United States in the Dialysis Outcomes and Practice Patterns Study (DOPPS). J Am Soc Nephrol 2003; 14(12): 3270-3277

Mortality rates among hemodialysis patients vary greatly across regions. Representative databases containing extensive profiles of patient characteristics and outcomes are lacking. The Dialysis Outcomes and Practice Patterns Study (DOPPS) is a prospective, observational study of representative samples of hemodialysis patients in France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States (US) that captures extensive data relating to patient characteristics, prescriptions, laboratory values, practice patterns, and outcomes. This report describes the case-mix features and mortality among 16,720 patients followed up to 5 yr. The crude 1-yr mortality rates were 6.6% in Japan, 15.6% in Europe, and 21.7% in the US. After adjusting for age, gender, race, and 25 comorbid conditions, the relative risk (RR) of mortality was 2.84 (P < 0.0001) for Europe compared with Japan (reference group) and was 3.78 (P < 0.0001) for the US compared with Japan. The adjusted RR of mortality for the US versus Europe was 1.33 (P < 0.0001). For most comorbid diseases, prevalence was highest in the US, where the mean age (60.5 +/- 15.5 yr) was also highest. Older age and comorbidities were associated with increased risk of death (except for hypertension, which carried a multivariate RR of mortality of 0.74 [P < 0.0001]). Variability in demographic and comorbid conditions (as identified by dialysis facilities) explains only part of the differences in mortality between dialysis centers, both for comparisons made across continents and within the US. Adjustments for the observed variability will allow study of association between practice patterns and outcomes.

Burdick RA, Bragg-Gresham JL, Woods JD, Hedderwick SA, Kurokawa K, Combe C, Saito A, LaBrecque J, Port FK, Young EW. Patterns of hepatitis B prevalence and seroconversion in hemodialysis units from three continents: The DOPPS. Kidney Int 2003; 63: 2222-2229

BACKGROUND: Hepatitis B (HBV) historically has been a public health issue within hemodialysis units. This study estimates HBV prevalence and seroconversion rates across seven countries and investigates associations with facility level practice patterns. METHODS: The study sample was from the Dialysis Outcomes and Practice Patterns Study (DOPPS), a cross-sectional, prospective, observational study of adult hemodialysis patients randomly selected from 308 dialysis facilities in France, Germany, Italy, Spain, the United Kingdom, Japan, and the United States. Logistic regression was used to model the odds ratio (OR) of HBV prevalence, and Cox regression was used to model time from entry into the study to HBV seroconversion. RESULTS: In this sample, mean HBV facility prevalence was 3.0% with a median of 1.9%. The percentage of facilities with an HBV prevalence 0% to 5% was 78.5%. Adjusted HBV prevalence was higher in France, Germany, and Italy and lower in Japan and the United Kingdom. The majority of facilities (78.1%) had a seroconversion rate of 0 conversions per 100 patient-years. Presence of a protocol for HBV-infected patients was significantly associated with HBV seroconversion in the separate practice pattern model [risk ratio (RR) = 0.52, P = 0.03] and in the combined practice pattern model (RR = 0.44, P = 0.01). CONCLUSION: There are differences in HBV prevalence and rate of seroconversion both at the country and the hemodialysis facility level. Presence of a protocol for HBV-infected patients was strongly and significantly associated with decreased risk for seroconversion. The observed variation suggests opportunities for improved HBV outcomes with further definition of optimal practice patterns at the facility level.

Port FK, Pisoni RL, Bommer J, Locatelli F, Jadoul M, Eknoyan G, Kurokawa K, Canaud BJ, Finley MP, Young EW. Improving Outcomes for Dialysis Patients in the International Dialysis Outcomes and Practice Patterns Study. Clin J Am Soc Nephrol 2006; 1(2): 246-255

The international Dialysis Outcomes and Practice Patterns Study (DOPPS) is well suited to evaluate levels of deviation from emerging and established guidelines to clinical practice of hemodialysis, over time and by country. The DOPPS can also evaluate whether the target levels that are chosen in the guidelines are in agreement with outcomes such as elevated risk for mortality, hospitalization, and vascular access failure. At a special DOPPS symposium during the 2004 congress of the American Society of Nephrology, the authors presented such findings; key points from that symposium are presented in this article, focusing on vascular access, mineral metabolism, dialysis dose, and anemia management. Although an observational study cannot prove causality, DOPPS suggests large opportunities to improve care and outcomes of dialysis patients. The international perspective of DOPPS assists in the new efforts for international guidelines. Some encouraging trends in recent years are documented in these areas.

Port FK, Wolfe RA, Hulbert-Shearon TE, Ashby VB, McCullough KP, Held PJ. High dialysis dose is associated with lower mortality among women but not among men. Am J Kidney Dis 2004; 43(6):1014-1023

BACKGROUND: Several observational studies reported lower mortality risk among hemodialysis patients treated with doses greater than the standard dose. The present study evaluates, with observational data, the secondary randomized Hemodialysis (HEMO) Study finding that greater dialysis dose may benefit women, but not men. METHODS: Data from 74,120 US hemodialysis patients starting end-stage renal disease therapy were analyzed. Patients were classified into 1 of 5 categories of hemodialysis dose according to their average urea reduction ratio (URR), and their relative risk (RR) for mortality was evaluated by using Cox proportional hazards models. Similar analyses using equilibrated Kt/V were completed for 10,816 hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS) in 7 countries. RESULTS: For both men and women, RR was substantially lower in the URR 70%-to-75% category compared with the URR 65%-to-70% category. Among women, RR in the URR greater-than-75% category was significantly lower compared with the URR 70%-to-75% group (P < 0.0001); however, no further association with mortality risk was observed for the greater-than-75% category among men (P = 0.22). RR associated with doses greater than the Kidney Disease Outcomes Quality Initiative guidelines (URR > or = 65%) was significantly different for men compared with women (P < 0.01). Similar differences by sex were observed in DOPPS analyses. CONCLUSION: The agreement of these observational studies with the HEMO Study supports the existence of a survival benefit from greater dialysis doses for women, but not for men. Responses to greater dialysis dose by sex deserve additional study to explain these differences.

Saran R, Canaud B, Depner T, Keen M, McCullough KP, Marshall MR, Port FK. Dose of Dialysis: Key Lessons from Major Observational Studies and Clinical Trials. Am J Kidney Dis 2004; 44 (Suppl 2):S47-S53

Analyses based on the National Cooperative Dialysis Study (NCDS) provided the impetus for routine quantification of delivered dialysis dose in hemodialysis practice throughout the world, by suggesting minimum targets for small solute (urea) clearance. Morbidity and mortality in dialysis populations remain high despite many technological advances in dialysis delivery. A number of observational studies reported association between higher dose of dialysis as measured by Kt/V urea or urea reduction ratio with lower mortality risk. During the 1990s, a steady increase in dialysis dose and a modest reduction in mortality on dialysis were observed. However, observational studies only reveal associations and are limited by selection bias and confounding. The Kidney Disease Outcomes Quality Initiative guidelines on dialysis adequacy are based on results of observational studies and expert opinion. Since the NCDS, the HEMO Study was the first major randomized clinical trial designed to study the effect of dose of dialysis and dialyzer flux on patient outcomes. Despite adequate separation of dose and flux, however, results of the trial did not prove a beneficial effect of higher dose. The Dialysis Outcomes and Practice Patterns Study (DOPPS), in a major international effort designed to examine the effect of practice patterns on outcomes, has made significant contributions to the topic of dialysis dose. The following review critically examines data from observational studies, including the DOPPS, and from the HEMO Study, emphasizing important lessons from both, and discusses future paradigms for achieving dialysis adequacy to improve patient outcomes.

Hirth RA, Greer SL, Albert JM, Young EW, Piette JD. Out-of-pocket spending and medication adherence among dialysis patients in twelve countries. Health Affairs 2008; 27(1):89-102

Few studies have examined drug costs and adherence in similar patient cohorts across countries. Using representative samples of hemodialysis patients from twelve countries, we examined out-of-pocket medication spending and cost-related nonadherence. Mean monthly spending ranged from $8 in the United Kingdom to $114 in the United States. The proportion of patients reporting nonadherence because of cost ranged from 3 percent in Japan to 29 percent in the United States. Out-of-pocket spending was related to national pharmaceutical financing policies and predicted national nonadherence rates. However, inconsistencies in the relationship between patient costs and nonadherence suggested that other social or policy factors also matter.

Dor A, Pauly MV, Eichleay MA, Held PJ. End-stage renal disease and economic incentives: The International Study of Health Care Organization and Financing (ISHCOF). Int J Health Care Finance Econ 2007; 7(2-3): 73-111

End-stage renal disease (ESRD) is a debilitating, costly, and increasingly common condition. Little is known about how different financing approaches affect ESRD outcomes and delivery of care. This paper presents results from a comparative review of 12 countries with alternative models of incentives and benefits, collected under the International Study of Health Care Organization and Financing, a substudy within the Dialysis Outcomes and Practice Patterns Study. Variation in spending per ESRD patient is relatively small, but correlated with overall per capita health care spending. Remaining differences in costs and outcomes do not seem strongly linked to differences in incentives.

Hospitalization

Funk-Schrag W. Diabetes: Dialysis Outcomes and Practice Patterns Study Results and Innovative Patient Care Programs. Journal of Nephrology Social Work 2007; 26: 41-44

Diabetes is now the leading cause of chronic kidney disease (CKD) in the United States and is also growing in numbers worldwide. The cost of caring for people with diabetes and CKD is escalating and is especially highest from the month prior to starting dialysis to 6 months after beginning dialysis. According to the Dialysis Outcomes Practice Patterns Study (DOPPS), a person with kidney failure who also has diabetes is at higher risk for hospitalization, mortality, retinopathy, blindness and lower limb amputation. The dialysis health care team is challenged to develop new methods of caring for people with diabetes and CKD. Innovative programs reviewed in this article show improved clinical outcomes and an increase in patients' ability to self-manage their disease.

Rayner HC, Pisoni RL, Bommer J, Canaud B, Hecking E, Locatelli F, Piera L, Bragg-Gresham JL, Feldman H, Goodkin DA, Wolfe RA, Held PJ, Port FK. Mortality and hospitalisation in haemodialysis patients in five European countries: Results from the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant 2004; 19(1): 108-120

BACKGROUND: Mortality and hospitalization rates are reported for nationally representative random samples of haemodialysis patients treated at randomly selected dialysis facilities in five European countries participating in the Dialysis Outcomes and Practice Pattern Study (DOPPS) (France, Germany, Italy, Spain and the UK). RESULTS: In the UK, 28.1% of haemodialysis patients received prior peritoneal dialysis treatment compared with 4.2-8.3% in other countries. Kidney transplantation rates ranged from 3.3 (per 100 patient years) in Italy to 11.6 in Spain. The relative risk (RR) of mortality, adjusted for age, sex and diabetes status was significantly higher in the UK (RR = 1.39, P = 0.02) compared with Italy (reference) and increased in association with age (RR = 1.60 for every 10 years older, P <0.001), diabetes as cause of end-stage renal disease (ESRD) (RR = 1.55, P < 0.001), male patients <65 years (RR = 1.29, P = 0.02) and peritoneal dialysis in the 12 months prior to starting haemodialysis (RR = 1.72, P = 0.06). Hospitalization for cardiovascular disease was highest in France and Germany (0.40 and 0.43 hospitalizations per patient year, respectively) and lowest in the UK (0.19), although cardiovascular comorbidity was similar in the UK and France. Hospitalization rates for vascular access-related infection ranged from 0.01 hospitalizations per patient year in Italy to 0.08 in the UK, consistent with the higher dialysis catheter use in the UK (25%) vs Italy (5%). Hospitalization risk was significantly higher in France than in other Euro-DOPPS countries and was significantly (P < 0.05) associated with prior peritoneal dialysis therapy, peripheral vascular disease, gastrointestinal bleeding in the prior 12 months, diabetes, cancer, cardiac disease, psychiatric disease and recent onset of ESRD (within 30 days of study entry). CONCLUSIONS: The large differences in haemodialysis practice and outcomes in the Euro-DOPPS countries suggest opportunities for improvement in patient care.

Lopes AA, Leavey SF, McCullough K, Gillespie B, Bommer J, Canaud BJ, Saito A, Fukuhara S, Held PJ, Port FK, Young EW. Early readmission and length of hospitalization practices in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Hemodialysis International 2004; 8:287-294

Background: Rising hospital care costs have created pressure to shorten hospital stays and emphasize outpatient care. This study tests the hypothesis that shorter median length of stay (LOS) as a dialysis facility practice is associated with higher rates of early readmission. Methods: Readmission within 30 days of each hospitalization was evaluated for participants in the Dialysis Outcomes and Practice Patterns Study, an observational study of randomly selected hemodialysis patients in the United States (142 facilities, 5095 patients with hospitalizations), five European countries (101 facilities, 2281 patients with hospitalizations), and Japan (58 facilities, 883 patients with hospitalizations). Associations between median facility LOS (estimated from all hospitalizations at the facility and interpreted as a dialysis facility practice pattern) and odds of readmission were assessed using logistic regression, adjusted for patient characteristics and the LOS of each index hospitalization. Results: Risk of readmission was directly and significantly associated with LOS of the index hospitalization (adjusted odds ratio [AOR] 1.005 per day in median facility LOS, p = 0.007) and inversely associated with median facility LOS (AOR = 0.974 per day, p = 0.016). This latter association was strongest for US hemodialysis centers (AOR = 0.954 per day, p = 0.015). Conclusions: Dialysis facilities with shorter median hospital LOS for their patients have higher odds of readmission, particularly in the United States, where there is greater pressure to shorten LOS. The determinants and consequences of practices related to hospital LOS for hemodialysis patients should be further studied.

Locatelli F, Pisoni RL, Akizawa T, Cruz JM, DeOreo P, Lameire N, Held PJ. Anemia Management for Hemodialysis Patients: K/DOQI Guidelines and DOPPS Findings. Am J Kidney Dis 2004; 44 (Suppl 2):S27-S33

BACKGROUND: After recombinant human erythropoietin was introduced into routine nephrologic practice, specific clinical guidelines were developed to optimize the quality of anemia management for patients with chronic kidney disease. METHODS: The Dialysis Outcomes and Practice Patterns Study (DOPPS), an international investigation providing patient- and facility-level data on hemodialysis practice, was developed to provide information on various aspects of current practices in hemodialysis management, including treatment of renal anemia. RESULTS: Hemoglobin concentration is strongly associated with both morbidity and mortality in hemodialysis patients. Although some improvements can be documented in anemia management practices in the years after the publication of international guidelines, wide variations in anemia management are still observed among countries. CONCLUSION: Many efforts are still needed to allow a greater proportion of patients to reach the recommended hemoglobin concentrations. Significantly improved outcomes may therefore be expected by a more widespread reaching of the recommended hemoglobin levels. The results of the DOPPS point to the difficulties in implementing clinical guidelines in the everyday management of individual patients. In specific circumstances, a well-designed observational study may offer credible information and serve as a basic instrument for monitoring the implementation of clinical guidelines in typical clinical practice.

Mapes DL, Bragg-Gresham JL, Bommer J, Fukuhara S, McKevitt P, Wikstrom B, Lopes AA. Health-Related Quality of Life in the DOPPS. Am J Kidney Dis 2004; 44 (Suppl 2):S54-S60

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.

Saran R, Bragg-Gresham JL, Rayner HC, Goodkin DA, Keen ML, van Dijk PC, Kurokawa K, Piera L, Saito A, Fukuhara S, Young EW, Held PJ, Port FK. Nonadherence in hemodialysis: Associations with mortality, hospitalization, and practice patterns in the DOPPS. Kidney Int 2003; 64: 254-262

BACKGROUND: Nonadherence among hemodialysis patients compromises dialysis delivery, which could influence patient morbidity and mortality. The Dialysis Outcomes and Practice Patterns Study (DOPPS) provides a unique opportunity to review this problem and its determinants on a global level. METHODS: Nonadherence was studied using data from the DOPPS, an international, observational, prospective hemodialysis study. Patients were considered nonadherent if they skipped one or more sessions per month, shortened one or more sessions by more than 10 minutes per month, had a serum potassium level openface>6.0 mEq/L, a serum phosphate level openface>7.5 mg/dL (>2.4 mmol/L), or interdialytic weight gain (IDWG)>5.7% of body weight. Predictors of nonadherence were identified using logistic regression. Survival analysis used the Cox proportional hazards model adjusting for case-mix. RESULTS: Skipping treatment was associated with increased mortality [relative risk (RR) = 1.30, P = 0.01], as were excessive IDWG (RR = 1.12, P = 0.047) and high phosphate levels (RR = 1.17, P = 0.001). Skipping also was associated with increased hospitalization (RR = 1.13, P = 0.04), as were high phosphate levels (RR = 1.07, P = 0.05). Larger facility size (per 10 patients) was associated with higher odds ratios (OR) of skipping (OR = 1.03, P = 0.06), shortening (OR = 1.03, P = 0.05), and IDWG (OR = 1.02, P = 0.07). An increased percentage of highly trained staff hours was associated with lower OR of skipping (OR = 0.84 per 10%, P = 0.02); presence of a dietitian was associated with lower OR of excessive IDWG (OR = 0.75, P = 0.08). CONCLUSION: Nonadherence was associated with increased mortality risk (skipping treatment, excessive IDWG, and high phosphate) and with hospitalization risk (skipping, high phosphate). Certain patient/facility characteristics also were associated with nonadherence.

Port FK, Pisoni RL, Bommer J, Locatelli F, Jadoul M, Eknoyan G, Kurokawa K, Canaud BJ, Finley MP, Young EW. Improving Outcomes for Dialysis Patients in the International Dialysis Outcomes and Practice Patterns Study. Clin J Am Soc Nephrol 2006; 1(2): 246-255

The international Dialysis Outcomes and Practice Patterns Study (DOPPS) is well suited to evaluate levels of deviation from emerging and established guidelines to clinical practice of hemodialysis, over time and by country. The DOPPS can also evaluate whether the target levels that are chosen in the guidelines are in agreement with outcomes such as elevated risk for mortality, hospitalization, and vascular access failure. At a special DOPPS symposium during the 2004 congress of the American Society of Nephrology, the authors presented such findings; key points from that symposium are presented in this article, focusing on vascular access, mineral metabolism, dialysis dose, and anemia management. Although an observational study cannot prove causality, DOPPS suggests large opportunities to improve care and outcomes of dialysis patients. The international perspective of DOPPS assists in the new efforts for international guidelines. Some encouraging trends in recent years are documented in these areas.

Port FK, Eknoyan G. The Dialysis Outcomes and Practice Patterns Study and the Kidney Disease Outcomes Quality Initiative: A Cooperative Initiative to Improve Outcomes for Hemodialysis Patients Worldwide. Am J Kidney Dis 2004; 44 (Suppl 2):S1-S6

Two initiatives were launched in the closing years of the past century with the goal of improving the treatment outcomes of patients with kidney failure: the Kidney Disease Outcomes Quality Initiative, which formed expert panels to develop evidence-based clinical practice guidelines, and the Dialysis Outcomes and Practice Patterns Study (DOPPS), which now gathers data on practice patterns in dialysis facilities in 12 countries, including the United States. Recently, the Kidney Disease: Improving Global Outcomes (KDIGO) program was established to promote worldwide coordination and integration of initiatives to develop and implement clinical practice guidelines and provides new opportunities of cooperation with the international scope of the DOPPS. Collaboration between the DOPPS and KDIGO will lead to broader dissemination of relevant information to nephrologists, health care providers, and patients. Linking the DOPPS scope of work with the KDIGO goals will help develop continuous quality improvement programs and the provision of direct feedback to participating dialysis centers throughout the world. This will establish an essential component in the translation to clinical practice of evidence-based guidelines worldwide.

Locatelli F, Pisoni RL, Akizawa T, Cruz JM, DeOreo P, Lameire N, Held PJ. Anemia Management for Hemodialysis Patients: K/DOQI Guidelines and DOPPS Findings. Am J Kidney Dis 2004; 44 (Suppl 2):S27-S33

BACKGROUND: After recombinant human erythropoietin was introduced into routine nephrologic practice, specific clinical guidelines were developed to optimize the quality of anemia management for patients with chronic kidney disease. METHODS: The Dialysis Outcomes and Practice Patterns Study (DOPPS), an international investigation providing patient- and facility-level data on hemodialysis practice, was developed to provide information on various aspects of current practices in hemodialysis management, including treatment of renal anemia. RESULTS: Hemoglobin concentration is strongly associated with both morbidity and mortality in hemodialysis patients. Although some improvements can be documented in anemia management practices in the years after the publication of international guidelines, wide variations in anemia management are still observed among countries. CONCLUSION: Many efforts are still needed to allow a greater proportion of patients to reach the recommended hemoglobin concentrations. Significantly improved outcomes may therefore be expected by a more widespread reaching of the recommended hemoglobin levels. The results of the DOPPS point to the difficulties in implementing clinical guidelines in the everyday management of individual patients. In specific circumstances, a well-designed observational study may offer credible information and serve as a basic instrument for monitoring the implementation of clinical guidelines in typical clinical practice.

Combe C, McCullough KP, Asano Y, Ginsberg N, Maroni B, Pifer T. K/DOQI and the DOPPS: Nutrition Guidelines, Indicators, and Practices. Am J Kidney Dis 2004; 44 (Suppl 2):S39-S46

BACKGROUND: Nutritional markers are important predictors of morbidity and mortality in dialysis patients. The Clinical Practice Guidelines for Nutrition in Chronic Renal Failure provides guidelines for assessing nutritional status that were evaluated using data from the Dialysis Outcomes and Practice Patterns Study (DOPPS). METHODS: The level of various nutritional markers (serum albumin, modified subjective global assessment, serum creatinine, normalized protein catabolic rate [nPCR], and body mass index) were described for representative samples of patients and facilities from 7 countries (France, Germany, Italy, Spain, Japan, United Kingdom, and United States) participating in the DOPPS. RESULTS: A strong inverse association was observed between mortality and serum albumin, with a mortality risk 1.38 times higher for patients with serum albumin concentration less than 3.5 g/dL (35 g/L). There were significant differences by country in the proportion of moderately and severely malnourished patients as determined by the modified subjective global assessment score. In the US sample, severely and moderately malnourished patients had a higher mortality risk compared with those not malnourished, 33% and 5% higher, respectively. An inverse relationship exists between serum creatinine concentration and mortality, with a mortality risk 60% to 70% higher in the lowest quartile group compared with the highest quartile group in Europe and the United States. Levels of nPCR varied significantly between European countries, and there was no association between mortality and nPCR in US data. After adjustment for demographic and comorbidity factors, the mortality risk decreased as body mass index increased in both US and European samples. CONCLUSION: DOPPS data highlight the importance of routine assessment of nutritional status, using multiple parameters, in clinical practice to improve patient care.

Hirth RA, Greer SL, Albert JM, Young EW, Piette JD. Out-of-pocket spending and medication adherence among dialysis patients in twelve countries. Health Affairs 2008; 27(1):89-102

Few studies have examined drug costs and adherence in similar patient cohorts across countries. Using representative samples of hemodialysis patients from twelve countries, we examined out-of-pocket medication spending and cost-related nonadherence. Mean monthly spending ranged from $8 in the United Kingdom to $114 in the United States. The proportion of patients reporting nonadherence because of cost ranged from 3 percent in Japan to 29 percent in the United States. Out-of-pocket spending was related to national pharmaceutical financing policies and predicted national nonadherence rates. However, inconsistencies in the relationship between patient costs and nonadherence suggested that other social or policy factors also matter.

Bailie GR, Elder SJ, Mason NA, Asano Y, Cruz J-M, Fukuhara S, Lopes AA, Mapes DL, Mendelssohn DC, Bommer J, Young EW. Sexual dysfunction in hemodialysis (HD) patients treated with antihypertensive or antidepressant medications: the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant 2007; 22: 1163 - 1170

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 alpha-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 alpha-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 alpha-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.

Bragg-Gresham JL, Fissell RB, Mason NA, Bailie GR, Gillespie BW, Wizemann V, Cruz JM, Akiba T, Kurokawa K, Ramirez S, Young EW. Diuretic use, residual renal function, and mortality among hemodialysis patients in the Dialysis Outcomes and Practice Pattern Study (DOPPS). Am J Kidney Dis 2007; 49(3): 426-31

BACKGROUND: Information about residual renal function (RRF) and outcomes associated with practices of diuretic use in patients with end-stage renal disease is not available worldwide. METHODS: Diuretic use was investigated in 16,420 hemodialysis patients from the Dialysis Outcomes and Practice Patterns Study, a prospective observational study of hemodialysis patients selected from nationally representative facilities on 3 continents. Logistic regressions were used to investigate associations between diuretic use and patient characteristics. Outcomes of interdialytic weight gain, increased serum potassium and phosphorus levels, and odds of retaining RRF after 1 year were investigated. Cox regression was used to analyze the association between mortality and diuretic use. RESULTS: Facility diuretic use varied substantially from 0% to 83.9% of patients. Diuretic use decreased sharply after the start of dialysis therapy. Loop diuretic use ranged from 9.2% in the United States to 21.3% in Europe, whereas use within 90 days of starting dialysis therapy ranged from 25.0% in the United States to 47.6% in Japan. Diuretic use was associated with lower interdialytic weight gain and lower odds of hyperkalemia (potassium > 6.0 mmol/L). Patients with RRF on diuretic therapy had almost twice the odds of retaining RRF after 1 year in the study versus patients not on diuretic therapy. Patients administered diuretics had a 7% lower all-cause mortality risk (P = 0.12) and 14% lower cardiac-specific mortality risk (P = 0.03) versus patients not administered diuretics. CONCLUSION: Variation exists in facility practices of diuretic use. In patients with RRF, there may be benefit associated with continuing diuretic use rather than automatically discontinuing diuretic therapy at dialysis initiation.

Bailie GR, Mason NA, Elder SJ, Andreucci VE, Greenwood RN, Akiba T, Saito A, Bragg-Gresham JL, Gillespie BW, Young EW. Large variations in prescriptions of gastrointestinal medications in hemodialysis patients on three continents: the Dialysis Outcomes and Practice Patterns Study (DOPPS).Hemodial Int. 2006 Apr;10(2):180-8

Little is known about proton pump inhibitor (PPI) or H(2) receptor antagonist (HA) prescription patterns or regarding use of predictors in hemodialysis patients. Proton pump inhibitor and HA prescribing patterns were investigated in 8628 hemodialysis patients from seven countries enrolled in the prospective, observational Dialysis Outcomes and Practice Patterns Study. Logistic regression examined predictors associated with PPI and HA use, adjusting for age, sex, country, time with end-stage renal disease, medications, 14 comorbid conditions, and the association between the number of comorbid conditions and the prescription of gastrointestinal (GI) medications. In a cross-section from February 1, 2000, 3.4% to 36.9% of patients received an HA and 0.8% to 26.9% took a PPI, depending upon the country. From 1996 to 2001, the prescription of HAs declined while PPI use increased. Facility use of HAs and PPIs ranged from 0% to 94% of patients. H2 receptor antagonist or PPI use was significantly and independently associated with age, narcotic use, corticosteroids, acetaminophen, nonsteroidal anti-inflammatory drugs, tricyclic antidepressants, selective serotonin reuptake inhibitors, coronary artery disease history, cardiovascular diseases other than hypertension or congestive heart failure, peripheral vascular disease, pulmonary disease, and GI bleed. Proton pump inhibitors or HAs were more likely to be prescribed in Italy, Spain, and the United Kingdom than in the United States. The odds of PPI prescription increased if serum phosphorus <5.5 mEq/L or serum albumin <3.5 g/dL. Prescription of GI medications was associated with many comorbidities and use of several medications. Extreme variability of prescription patterns suggests that there is no standard approach in treatment practices.

Mason NA, Bailie GR, Satayathum S, Bragg-Gresham JL, Akiba T, Akizawa T, Combe C, Rayner HC, Saito A, Gillespie BW, Young EW. HMG-coenzyme A reductase inhibitor use is associated with mortality reduction in hemodialysis patients. Am J Kidney Dis 2005; 45(1): 119-26

BACKGROUND: Cardiovascular disease is the most common cause of mortality in patients with end-stage renal disease. Cardiovascular benefits of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) have been clearly established in the general population, but not in dialysis patients. This study examined statin prescription patterns and assessed the relationship between statin prescription and clinical outcomes in hemodialysis (HD) patients. METHODS: Data were analyzed from the Dialysis Outcomes and Practice Patterns Study, a prospective observational study of HD patients randomly selected from representative dialysis facilities in France, Germany, Italy, Spain, the United Kingdom, Japan, and the United States. Predictors of statin prescription were investigated by means of logistic regression. Cox regression models tested the association between statin prescription and risk for mortality and cardiac events, with adjustments for common demographic factors and comorbid conditions. RESULTS: Statins were prescribed for 11.8% of HD patients overall. Most facilities (81.2%) prescribed statins to less than 20% of their patients. Patients prescribed statins had a 31% lower relative risk for death compared with those not prescribed statins (P < 0.0001). Statins were associated with a 23% lower cardiac mortality risk (P = 0.03) and a 44% lower noncardiac mortality risk (P < 0.0001). At a facility level, prescribing statins was associated with lower overall mortality rate, with a 5% lower risk for every 10% increase in number of patients prescribed statins within the facility (P = 0.02). CONCLUSION: Statin prescription is associated with reduced mortality in HD patients, providing additional support for the value of statin therapy in this patient group.

Hecking E, Bragg-Gresham JL, Rayner HC, Pisoni RL, Andreucci VE, Combe C, Greenwood R, McCullough K, Feldman HI, Young EW, Held PJ, Port FK. Haemodialysis prescription, adherence, and nutritional indicators in five European countries: Results from the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant 2004; 19(1): 100-107

BACKGROUND: The Dialysis Outcomes and Practice Patterns Study (DOPPS) is a prospective, observational study designed to evaluate practice patterns in random samples of haemodialysis facilities and patients across three continents. Participating countries include France, Germany, Italy, Spain and the UK (Euro-DOPPS), Japan and the USA. DOPPS data collection has used the same questionnaires and protocols across all participating countries to assess components of dialysis therapy and outcomes. This study focuses on dialysis prescription, adherence and nutrition among the Euro-DOPPS countries. METHODS: In each Euro-DOPPS country, patients were selected randomly from 20-21 representative facilities. Simple means and frequencies were calculated to compare relevant data elements to gain insights into differences in therapeutic aspects among nationally representative patients. Participants entering the study within 90 days of beginning dialysis therapy were excluded from these analyses. RESULTS: Among the five countries, mean delivered dose as measured by normalized urea clearance (Kt/V) varied from 1.28 to 1.50 and was accompanied by differences in dialysis prescription components, including blood flow rates, treatment times, and dialyser membrane and flux characteristics. By country, a nearly 2-fold difference was observed in indicators of patient adherence and management (skipping and shortening dialysis, hyperkalaemia, hyperphosphataemia and high interdialytic weight gain). Indicators of malnutrition varied substantially. CONCLUSIONS: This study demonstrates differences in the management of haemodialysis patients across Euro-DOPPS and offers opportunities for improving dialysis dose, adherence and nutrition. Correlation of differences in practice patterns at the dialysis unit level with patient outcomes will offer new insights into improving dialysis therapy.

Bailie GR, Mason NA, Bragg-Gresham JL, Gillespie B, Young EW. Analgesic prescription patterns among hemodialysis patients in the DOPPS: Potential for under-prescription. Kidney Int 2004; 65:2419-2425

BACKGROUND: Dialysis patients require special consideration regarding analgesics, given their altered pharmacokinetic and pharmacodynamic profiles and increased potential for adverse reactions. METHODS: Analgesic prescription patterns were investigated using data from the Dialysis Outcomes and Practice Patterns Study (DOPPS), with 3749 patients in 142 United States facilities studied between May 1996 and September 2001. RESULTS: The proportion of patients prescribed any analgesic decreased from 30.2% to 24.3%; narcotic prescriptions decreased from 18.0% to 14.9%. The most commonly prescribed narcotics were propoxyphene/acetaminophen combinations (47.2%). Combinations containing acetaminophen were prescribed concurrently for 84.1% of patients on narcotics. About one half of prescriptions for narcotics, acetaminophen, and cyclooxygenase-2 (COX-2) agents were for 12 months or more; one half of prescriptions for nonsteroidal anti-inflammatory drugs (NSAIDs) were for 8 months or more. The proportion of patients prescribed analgesics varied by facility (mean +/- SD = 27.9%+/- 18.9% for all analgesics, range 0% to 89.3%). Analgesic prescription was more likely among the elderly, women, and patients with cardiovascular disease (other than coronary artery disease or congestive heart failure), lung and psychiatric disease, cancer (other than skin), and recurrent cellulitis. Patients prescribed laxatives were almost twice as likely to be on a narcotic (odds ratio = 1.95, P < 0.0001). Analgesic prescription did not correlate with loss of residual renal function or hospitalization for a gastrointestinal disorder. Three-quarters of patients reporting moderate to very severe pain were not prescribed analgesics. Furthermore, 74% of patients with pain that interfered with work had no analgesic prescription. CONCLUSION: Dialysis patients and providers may benefit from both refinement of existing guidelines and a renewed understanding regarding appropriate prescription of analgesics.

Andreucci VE, Fissell RB, Bragg-Gresham JL, Ethier J, Greenwood R, Pauly M, Wizemann V, Port FK. DOPPS Data on Medications in Hemodialysis Patients. Am J Kidney Dis 2004; 44 (Suppl 2):S61-S67

BACKGROUND: Medications affect many measures of hemodialysis patients' well-being. METHODS: The Dialysis Outcomes and Practice Patterns Study (DOPPS) has evaluated the use of hydroxymethyl glutaryl coenzyme A reductase inhibitors (statins), analgesics, antidepressants, and multivitamins. Additionally, DOPPS has reported on the associations between vascular access outcomes and related medications. RESULTS: Prescription of statins varied widely across countries, with the highest use in the United States. Patients prescribed statins had lower risk of cardiac and noncardiac causes of mortality than those who were not prescribed statins. DOPPS data also show that statins are underprescribed relative to recent Kidney Disease Outcomes Quality Initiative guidelines. No guidelines have been established for analgesic use, but high pain levels self-reported by hemodialysis patients suggest opportunities for improved pain management strategies. Guidelines for analgesic use in dialysis patients may help balance improved quality of life against potential side effects of analgesics. Medical and patient questionnaires show that depression in hemodialysis patients is common, frequently underdiagnosed, usually untreated, and associated with increased rates of mortality and hospitalization. Calcium channel blockers were associated with improved primary graft patency, aspirin with improved secondary graft patency, and angiotensin-converting enzyme inhibitors with improved secondary fistula patency. All 3 medications were associated with significantly decreased relative risk for access failure. There is large country variation in multivitamin use, with significantly higher use in the United States compared with Europe and Japan. Patients taking multivitamins had lower mortality risk than patients not taking multivitamins. CONCLUSION: DOPPS findings on medications indicate that prospective trials are needed before guidelines can be developed for appropriate medication use in these different therapeutic categories.

Fissell RB, Bragg-Gresham JL, Gillespie BW, Goodkin DA, Bommer J, Saito A, Akiba T, Port FK, Young EW. International variation in vitamin prescription and association with mortality in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis 2004; 44(2):293-299

BACKGROUND: The prevalence of water-soluble vitamin use among hemodialysis (HD) patients and whether mortality and hospitalization are associated with water-soluble vitamin use by HD patients have not previously been reported. The present study investigates patterns of water-soluble vitamin use among HD patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS) I and evaluates outcomes associated with vitamin use. METHODS: The study sample came from the DOPPS I, a prospective observational study of adult HD patients (N = 16,345) randomly selected from 308 representative dialysis facilities in France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States. Time-dependent Cox regression models were used to assess relative risk (RR) for mortality and hospitalization for patients administered water-soluble vitamins versus those not administered water-soluble vitamins. RESULTS: There was large variation by region in the percentage of patients administered water-soluble vitamins: Europe ranged from a low of 3.7% in the United Kingdom to a high of 37.9% in Spain; 5.6% in Japan; and 71.9% in the United States. Patient use of water-soluble vitamins was associated with a substantially and significantly lower risk for mortality (RR, 0.84; P = 0.001). Lower RR for facility-level mortality also was associated with greater water-soluble vitamin use (RR, 0.98; P = 0.05 per 10% more patients administered water-soluble vitamins at the facility). CONCLUSION: Although only a randomized trial could prove that water-soluble vitamins improve outcomes, use of water-soluble vitamins is a minimal-risk practice pattern associated with improved outcomes in this prospective observational study.

Pisoni RL. Erythropoetin therapy in Europe: Results from the DOPPS. Contrib Nephrol. 2002; 137: 396-402

Saran R, Dykstra DM, Wolfe RA, Gillespie BM, Held PJ, Young EW. Association between vascular access failure and the use of specific drugs: The Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis 2002; 40(6): 1255-1263

BACKGROUND: Several drugs have been proposed to improve vascular access patency based on favorable anticoagulant, antiplatelet, or vascular-remodeling properties. However, there is little evidence to guide drug strategies. METHODS: The association between vascular access patency and the use of specific drugs was studied in a large sample of US hemodialysis patients enrolled in the Dialysis Outcomes and Practice Patterns Study, an international, prospective, observational study. In general, it was assumed that the drugs were prescribed for indications unrelated to vascular access preservation. Primary (unassisted survival) and secondary vascular access patency (assisted survival) were modeled using Cox regression (time to failure) adjusted for age, sex, race, body mass index, incidence to end-stage renal disease, diabetes mellitus, hypertension, valvular disease, chronic obstructive pulmonary disease, aortic aneurysm, deep-vein thrombosis, number of previous permanent accesses, and facility-clustering effects. Fistulae (n = 900) and grafts (n = 1,944) were evaluated separately. Technical failures within the first 30 days of surgical placement were excluded from the analysis. RESULTS: Treatment with calcium channel blockers was associated with improved primary graft patency (relative risk [RR] for failure, 0.86; P = 0.034). Aspirin therapy was associated with better secondary graft patency (RR, 0.70; P < 0.001). Treatment with angiotensin-converting enzyme inhibitors was associated with significantly better secondary fistula patency (RR, 0.56; P = 0.010). Patients administered warfarin showed worse primary graft patency (RR, 1.33; P = 0.037). CONCLUSION: These findings should help guide clinical trial priorities toward vascular access preservation using one or more of the agents that show significant risk reduction for access failure in this study. Copyright 2002 by the National Kidney Foundation, Inc.

Johnstone S. Depression Management for Hemodialysis Patients: Using DOPPS Data to Further Guide Nephrology Social Work Intervention. Journal of Nephrology Social Work 2007; 26: 18-31

The future of disease management for the chronic kidney disease population will need to focus beyond the physiological markers of dialysis adequacy, albumin, and blood pressure and include psychosocial and behavioral health variables that also mediate treatment outcomes. A growing body of literature, including the Dialysis Outcomes and Practice Patterns Study (DOPPS), has linked depression to survival and health care utilization in people on hemodialysis. DOPPS identified the need for improved identification and management of depression. It also provides further guidance for nephrology social workers, who will continue to serve as the lead mental health providers to this at-risk population. This article reviews this literature and proposes practice guidelines for nephrology social workers to help manage depression in the dialysis clinic setting.

Tanaka M, Yamazaki S, Hayashino Y, Fukuhara S, Akiba T, Saito A, Asano Y, Port FK, Kurokawa K, Akizawa T. Hypercalcaemia is associated with poor mental health in haemodialysis patients: results from Japan DOPPS. Nephrol Dial Transplant. 2007; 22(6): 1658-64

BACKGROUND: The Dialysis Outcomes and Practice Patterns Study (DOPPS) reported high incidence of depression in haemodialysis patients. Hypercalcaemia and high parathyroid hormone (PTH) levels are aetiological factors of psychological disorders. We examined the association between mineral metabolism abnormalities and mental health in Japanese-DOPPS patients. METHODS: We used baseline data of Japan-DOPPS, Phase 1 (2755 patients, 1999-2001) and Phase 2 (2286 patients, 2002-03). The outcome variable was mental health using the mental health domain of SF-36. We examined the association between serum corrected calcium, phosphorus, calcium x phosphorus product and intact PTH concentrations, and mental health using analysis of covariance and also the associations between corrected calcium levels and current use of vitamin D and calcium-containing phosphate binder. RESULTS: There was a significant association between mental health and corrected calcium levels. A significantly lower mental health score was noted in patients with corrected calcium > or = 11 mg/dl than in <8.4 (P = 0.04), > or =8.4 to <10.2 (P = 0.009) and > or =10.2 to <11 mg/dl (P = 0.003). The association was significant even after adjustment for age, sex and other confounders. However, there was no relationship between intact PTH and mental health. High-corrected calcium levels were significantly associated with the use of intravenous active vitamin D and calcium-containing phosphate binder. CONCLUSIONS: Hypercalcaemia, but not high intact PTH, is associated with poor mental health in dialysis patients. While a cause-effect relationship between hypercalcaemia and deterioration of mental health needs further confirmation by longitudinal and prospective studies, our observational findings suggest the importance of control of serum calcium concentration in dialysis patients.

Bailie GR, Elder SJ, Mason NA, Asano Y, Cruz J-M, Fukuhara S, Lopes AA, Mapes DL, Mendelssohn DC, Bommer J, Young EW. Sexual dysfunction in hemodialysis (HD) patients treated with antihypertensive or antidepressant medications: the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant 2007; 22: 1163 - 1170

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 alpha-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 alpha-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 alpha-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.

Lambie M, Rayner HC, Bragg-Gresham JL, Pisoni RL, Andreucci VE, Canaud B, Port FK, Young EW. Starting and withdrawing haemodialysis — associations between nephrologists’ opinions, patient characteristics, and practice patterns (data from the Dialysis Outcomes and Practice Patterns Study). Nephrol Dial Transplant 2006; 21: 2814-2820

BACKGROUND: The incidence and prevalence of haemodialysis vary widely across countries. The variation may be attributable to differences in the incidence of end-stage renal disease and/or in the availability of haemodialysis. Previous studies have identified differences in nephrologists' opinions about the availability of haemodialysis and its appropriateness for patients with comorbidities. We studied the associations between nephrologists' opinions, availability of haemodialysis, patient characteristics and comorbidities, and facilities' withdrawal rates. METHODS: Most of our analyses used data from 242 haemodialysis units in six countries (France, Germany, Italy, Spain, UK and the USA) in the first phase of the Dialysis Outcomes and Practice Patterns Study (DOPPS I). Opinions about access to and practice patterns in dialysis facilities, measured by the level of agreement with standardized statements, were collected from medical directors and nurse managers. A sub-analysis considered data from corresponding facilities in DOPPS II. RESULTS: We found wide variations in the prevalence of waiting lists for new dialysis patients (UK 60%; USA 25%; Germany 0%; P < 0.05), in agreement with starting haemodialysis for patients with advanced age, dementia and comorbidities (UK, France < USA < other countries; P < 0.05), and in agreement with withdrawing dialysis (other countries < UK/USA; P < 0.05). The estimated glomerular filtration rate at the start of dialysis was not significantly different in units with waiting lists. Significant associations were found between nephrologists' opinions and the odds of patients being > or =80 years old, and between opinions and the rate and relative risk of withdrawal of haemodialysis. No significant associations were found between opinions and patients' comorbidities or dependency. CONCLUSION: Differences within and across countries in nephrologists' opinions regarding starting and withdrawing haemodialysis reflect differences in access to haemodialysis and the practice of withdrawal of haemodialysis in their facilities.

Kurella M, Mapes DL, Port FK, Chertow GM. Correlates and Outcomes of Dementia Among Dialysis Patients: The Dialysis Outcomes and Practice Patterns Study. Nephrol Dial Transplant 2006; 21(9):2543-8

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.

Lopes AA, Albert JM, Young EW, Satayathum S, Pisoni RL, Andreucci VE, Mapes DL, Mason NA, Fukuhara S, Wikström B, Saito A, Port FK. Screening for depression in hemodialysis patients: Associations with diagnosis, treatment, and outcomes in the DOPPS. Kidney Int 2004; 66:2047-2053

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 > or =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 > or =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 > or =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 > or =10, respectively. In Cox models adjusted for several comorbidities, CES-D scores > or =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.

Lopes AA, Bragg J, Young E, Goodkin D, Mapes D, Combe C, Piera L, Held P, Gillespie B, Port FK, for the Dialysis Outcomes and Practice Patterns Study (DOPPS). Depression as a predictor of mortality and hospitalization among hemodialysis patients in the United States and Europe. Kidney Int 2002; 62: 199-207

BACKGROUND: Depression is not uncommon among patients with end-stage renal disease (ESRD) being treated by hemodialysis. We investigated whether risk of mortality and rate of hospitalization may be predicted from physician-diagnosed depression and patients' self-reports of depressive symptoms. METHODS: Data were analyzed from the Dialysis Outcomes and Practice Patterns Study (DOPPS) for randomly selected ESRD patients being treated by hemodialysis in the United States (142 facilities, 2855 patients) and five European countries (101 facilities, 2401 patients). The diagnosis of depression during the past year was abstracted from the medical records. In addition, the patients were asked to indicate how much of their time over the previous four weeks they had felt (1) "so down in the dumps that nothing could cheer you up" and (2) "downhearted and blue." A response of "a good bit,""most," or "all" of the time were classified as depressed. RESULTS: The prevalence of depression was nearly 20%. The relative risks of mortality and hospitalization among depressed (vs. non-depressed), adjusted for time on dialysis, age, race, socioeconomic status, comorbid indicators and country were, respectively: 1.23 and 1.11 for physician-diagnosed depression, 1.48 and 1.15 for the "so down in the dumps" question, and 1.35 and 1.11 for the "downhearted and blue" question (P < 0.05 for all six relative risks). These associations were not significantly different between US and European patients. CONCLUSIONS: Self-reported depression by two simple questions was associated with increased risks of mortality and hospitalization for hemodialysis patients. Future research needs to assess whether early identification and treatment of depression may help to improve quality of life and survival in hemodialysis patients.

Pisoni RL, Gillespie BW, Dickinson DM, Chen K, Kutner M, Wolfe RA. The Dialysis Outcomes and Practice Patterns Study: Design, Data Elements, and Methodology. Am J Kidney Dis 2004; 44 (Suppl 2):S7-S15

The Dialysis Outcomes and Practice Patterns Study (DOPPS) is a prospective, observational study designed to elucidate aspects of hemodialysis practice that are associated with the best outcomes for hemodialysis patients. In DOPPS I, 308 hemodialysis units from 7 countries participated, including 145 facilities from the United States (1996-2001), 62 facilities from Japan (1999-2001), and 101 facilities from France, Germany, Italy, Spain, and the United Kingdom (all 1998-2000). DOPPS II (2002-2004) has included 320 hemodialysis units and more than 12,400 hemodialysis patients from the 7 DOPPS I countries as well as Australia, Belgium, Canada, New Zealand, and Sweden. Dialysis units are chosen via a stratified random selection procedure to provide proportional sampling by region and type of facility within each country. In DOPPS I and II, longitudinal data have been collected from both a prevalent (cross-sectional) patient sample and an incident patient sample. Data have also been collected on numerous facility practice patterns. Most DOPPS analyses incorporate both facility- and patient-level data in regression-based analyses to investigate predictors of survival, hospitalization, quality of life, vascular access type, and other outcomes. DOPPS longitudinal data also help identify trends in subject characteristics, practice indicators, medication use, and outcomes. The DOPPS remains a unique source of data on hemodialysis patients and facilities. It continues to refine its methods of data collection and analysis with the goal of improving hemodialysis practice and end-stage renal disease patient lives worldwide.

Port FK, Wolfe RA, Held PJ, Young EW. Random sample (DOPPS) versus census-based registry approaches to kidney disease research. Blood Purif 2003; 21: 85-88

This review describes advantages and limitations of registries that base their analyses on the census of all patients. Registries may utilize the random sample approach to enrich their data for more detailed and informative research. The Dialysis Outcomes and Practice Pattern Study (DOPPS) and its random sample approach is discussed here in detail, with examples on the value of this method. The DOPPS is currently being expanded to allow for even more valuable studies. This methodology can also be applied to large countries that do not have an existing registry, as it is an effective way of collecting detailed information at a relatively low cost that is representative of the country or population as a whole.

Young EW, Goodkin DA, Mapes DL, Port FK, Keen ML, Chen K, Maroni BL, Wolfe RA, Held PJ. The Dialysis Outcomes and Practice Patterns Study (DOPPS): An international hemodialysis study. Kidney Int 2000; 57 (suppl 74): S-74-S-81

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.

Mineral Metabolism

Blayney M, Pisoni RL, Bragg-Gresham JL, Bommer J, Piera L, Saito A, Akiba T, Keen ML, Young EW, Port FK. High alkaline phosphatase levels in hemodialysis patients is associated with higher risk of hospitalization and death. Kidney Int. 2008; 74(5): 655-63

We evaluated risks associated with elevated alkaline phosphatase in hemodialysis patients using longitudinal data from the Dialysis Outcomes and Practice Patterns Study, a prospective observational study of hemodialysis patients in 12 countries. Alkaline phosphatase levels were normalized by the upper limit of the laboratory-reported reference range. Cause-specific hospitalization and mortality risks were evaluated using Cox proportional hazards models, stratified by region and adjusted for phosphorus, calcium, albumin, parathyroid hormone, case mix, and numerous comorbidities. The odds of high normalized alkaline phosphatase were increased twofold in the United States in comparison to Japan. Elevations of normalized alkaline phosphatase were significantly associated with several comorbid conditions, increased fractures, parathyroidectomy, risk of hospitalization due to major adverse cardiac events, higher all-cause cardiovascular, and infection-related mortality risk. Our results also show that elevated serum normalized alkaline phosphatase was associated with higher risks of hospitalization and death in hemodialysis patients, independent of calcium, phosphorus, and parathyroid hormone levels.

Tenori F, Blayney MJ, Albert JM, Gillespie BW, Kerr PG, Bommer J, Young EW, Akizawa T, Akiba T, Pisoni RL, Robinson BM, Port FK. Mortality risk for dialysis patients with different levels of serum calcium, phosphorus, and PTH: the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis, 2008; 52(3): 519-530

BACKGROUND: Abnormalities in serum calcium, phosphorus, and parathyroid hormone (PTH) concentrations are common in patients with chronic kidney disease and have been associated with increased morbidity and mortality. No clinical trials have been conducted to clearly identify categories of calcium, phosphorus, and PTH levels associated with the lowest mortality risk. Current clinical practice guidelines are based largely on expert opinions, and clinically relevant differences exist among guidelines across countries. We sought to describe international trends in calcium, phosphorus, and PTH levels during 10 years and identify mortality risk categories in the Dialysis Outcomes and Practice Patterns Study (DOPPS), an international study of hemodialysis practices and associated outcomes. STUDY DESIGN: Prospective cohort study. PARTICIPANTS: 25,588 patients with end-stage renal disease on hemodialysis therapy for longer than 180 days at 925 facilities in DOPPS I (1996-2001), DOPPS II (2002-2004), or DOPPS III (2005-2007). PREDICTORS: Serum calcium, albumin-corrected calcium (Ca(Alb)), phosphorus, and PTH levels. OUTCOMES: Adjusted hazard ratios for all-cause and cardiovascular mortality calculated using Cox models. RESULTS: Distributions of mineral metabolism markers differed across DOPPS countries and phases, with lower calcium and phosphorus levels observed in the most recent phase of DOPPS. Survival models identified categories with the lowest mortality risk for calcium (8.6 to 10.0 mg/dL), Ca(Alb) (7.6 to 9.5 mg/dL), phosphorus (3.6 to 5.0 mg/dL), and PTH (101 to 300 pg/mL). The greatest risk of mortality was found for calcium or Ca(Alb) levels greater than 10.0 mg/dL, phosphorus levels greater than 7.0 mg/dL, and PTH levels greater than 600 pg/mL and in patients with combinations of high-risk categories of calcium, phosphorus, and PTH. LIMITATIONS: Because of the observational nature of DOPPS, this study can only indicate an association between mineral metabolism categories and mortality. CONCLUSIONS: Our results provide important information about mineral metabolism trends in hemodialysis patients in 12 countries during a decade. The risk categories identified in the DOPPS cohort may be relevant to efforts at international harmonization of existing clinical guidelines for mineral metabolism.

Kimata N, JM Albert, T Akiba, S Yamazaki, T Kawaguchi, S Fukuhara, T Akizawa, A Saito, Y Asano, K Kurokawa, RL Pisoni, and FK Port. Association of Mineral Metabolism factors with All-Cause and Cardiovascular Mortality in Hemodialysis Patients: the Japan Dialysis Outcomes and Practice Patterns Study (J-DOPPS). Hemodial Int. 2007; 11(3): 340-8

Abnormalities in mineral metabolism have been linked to mortality in hemodialysis (HD) patients. We postulated that these abnormalities would have a particularly large deleterious impact on deaths due to cardiovascular causes in Japan. This study describes the recent status of abnormal mineral metabolism, significant predictors, and potential consequences in the Dialysis Outcomes and Practice Patterns Study (DOPPS), Phases 1 and 2, in Japan. Major predictor variables were patient demographics, comorbidities, and laboratory markers of mineral metabolism such as albumin-adjusted serum calcium (calciumAlb), phosphorus, and intact PTH (iPTH). In a cross section of 3973 Japanese HD patients in DOPPS I and II, a large faction had laboratory values outside of the recommended Kidney Disease Outcomes Quality Initiative (K/DOQI) guideline range for serum concentrations of phosphorus (51% of patients above upper target range), calciumAlb (43.7% above), calcium-phosphorus (Ca x P) product (41.1% above), and iPTH (18.6% above). All-cause mortality was significantly and independently associated with calciumAlb (relative risk [RR]=1.22 per 1 mg/dL, p=0.0005) and iPTH (RR=1.04 per 100 pg/mL, p=0.04). Cardiovascular mortality was significantly associated with calciumAlb (RR=1.28, p=0.02), phosphorus (RR=1.13 per 1 mg/dL, p=0.008), Ca x P product (RR=1.07 per 2 mg(2)/dL(2), p=0.002), and PTH (RR=1.08, p=0.0001). This study expands our understanding of the relationship between altered mineral metabolism and mortality outcomes, showing slightly stronger associations with cardiovascular causes than observed for all-cause mortality. These findings have important therapeutic implications for Japanese HD patients.

Port FK, Pisoni RL, Bommer J, Locatelli F, Jadoul M, Eknoyan G, Kurokawa K, Canaud BJ, Finley MP, Young EW. Improving Outcomes for Dialysis Patients in the International Dialysis Outcomes and Practice Patterns Study. Clin J Am Soc Nephrol 2006; 1(2): 246-255

The international Dialysis Outcomes and Practice Patterns Study (DOPPS) is well suited to evaluate levels of deviation from emerging and established guidelines to clinical practice of hemodialysis, over time and by country. The DOPPS can also evaluate whether the target levels that are chosen in the guidelines are in agreement with outcomes such as elevated risk for mortality, hospitalization, and vascular access failure. At a special DOPPS symposium during the 2004 congress of the American Society of Nephrology, the authors presented such findings; key points from that symposium are presented in this article, focusing on vascular access, mineral metabolism, dialysis dose, and anemia management. Although an observational study cannot prove causality, DOPPS suggests large opportunities to improve care and outcomes of dialysis patients. The international perspective of DOPPS assists in the new efforts for international guidelines. Some encouraging trends in recent years are documented in these areas.

Kimata N, Akiba T, Pisoni RL, Albert JM, Satayathum S, Cruz JM, Akizawa T, Andreucci VE, Young EW, Port FK. Mineral metabolism and haemoglobin concentration among haemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant 2005; 20(5): 927-935

BACKGROUND: Bone and mineral metabolism is abnormal in most chronic haemodialysis patients and is associated with a high mortality risk. Because of possible pathogenic links between anaemia and intact parathyroid hormone (iPTH), the present study evaluated associations of mineral metabolism indicators with haemoglobin (Hb). METHODS: Data were collected from 317 facilities (12 089 haemodialysis patients) in Australia, Belgium, Canada, France, Germany, Italy, Japan, New Zealand, Spain, Sweden, the United Kingdom and the United States by the Dialysis Outcomes and Practice Patterns Study (DOPPS). The major outcome studied was probability of haemodialysis patients having a target Hb, per guidelines, of >/=11 g/dl at baseline. Major predictor variables were patient characteristics and laboratory markers of mineral metabolism: albumin-corrected serum calcium (calcium(Alb)), serum phosphorus (PO(4)) and iPTH. Analyses were adjusted for demographics, 15 comorbidity classes, baseline laboratory values, body mass index, years on dialysis, erythropoietin dose, vitamin D and catheter use, cause of end-stage renal disease and country. RESULTS: The adjusted odds ratio (AOR) of having Hb >/=11 g/dl was significantly higher (P<0.0001) in patients with higher calcium(Alb) (AOR = 1.32 per 1 mg/dl), higher PO(4) (AOR = 1.08 per 1 mg/dl) and lower iPTH (AOR = 0.96 per 100 pg/ml). Furthermore, 4 month intrapatient changes in Hb concentration were significantly (P<0.0001) related to 4 month changes in calcium(Alb) (0.17 g/dl Hb rise per 1 mg/dl higher calcium(Alb)) and PO(4) (0.11 g/dl Hb rise per 1 mg/dl higher PO(4)). Mean weekly recombinant human erythropoietin (rHuEpo) doses were higher for patients with high PO(4) or iPTH levels, but lower for patients with calcium(Alb) >9.5 mg/dl, after patient mix and Hb concentration adjustments. CONCLUSIONS: The results of this study indicate that higher serum calcium(Alb) and PO(4) levels are each independently associated with better anaemia control. This relationship is independent of vitamin D use, PTH levels and prescribed rHuEpo dose. Despite this benefit of better anaemia control at higher serum calcium(Alb) and PO(4) concentrations, lower calcium and PO(4) levels, as recommended by the K/DOQI guidelines, should still serve as the long-term goal for HD patients in order to minimize tissue calcification and mortality risk.

Young EW, Albert JM, Satayathum S, Goodkin DA, Pisoni RL, Akiba T, Akizawa T, Kurokawa K, Bommer J, Piera L, Port FK. Predictors and consequences of altered mineral metabolism: The Dialysis Outcomes and Practice Patterns Study. Kidney Int 2005; 67:1179-1187

BACKGROUND: Altered mineral metabolism contributes to bone disease, cardiovascular disease, and other clinical problems in patients with end-stage renal disease. METHODS: This study describes the recent status, significant predictors, and potential consequences of abnormal mineral metabolism in representative groups of hemodialysis facilities (N= 307) and patients (N= 17,236) participating in the Dialysis Outcomes and Practice Patterns Study (DOPPS) in the United States, Europe, and Japan from 1996 to 2001. RESULTS: Many patients fell out of the recommended guideline range for serum concentrations of phosphorus (8% of patients below lower target range, 52% of patients above upper target range), albumin-corrected calcium (9% below, 50% above), calcium-phosphorus product (44% above), and intact PTH (51% below, 27% above). All-cause mortality was significantly and independently associated with serum concentrations of phosphorus (RR 1.04 per 1 mg/dL, P= 0.0003), calcium (RR 1.10 per 1 mg/dL, P < 0.0001), calcium-phosphorus product (RR 1.02 per 5 mg(2)/dL(2), P= 0.0001), PTH (1.01 per 100 pg/dL, P= 0.04), and dialysate calcium (RR 1.13 per 1 mEq/L, P= 0.01). Cardiovascular mortality was significantly associated with the serum concentrations of phosphorus (RR 1.09, P < 0.0001), calcium (RR 1.14, P < 0.0001), calcium-phosphorus product (RR 1.05, P < 0.0001), and PTH (RR 1.02, P= 0.03). The adjusted rate of parathyroidectomy varied 4-fold across the DOPPS countries, and was significantly associated with baseline concentrations of phosphorus (RR 1.17, P < 0.0001), calcium (RR 1.58, P < 0.0001), calcium-phosphorus product (RR 1.11, P < 0.0001), PTH (RR 1.07, P < 0.0001), and dialysate calcium concentration (RR 0.57, P= 0.03). Overall, 52% of patients received some form of vitamin D therapy, with parenteral forms almost exclusively restricted to the United States. Vitamin D was potentially underused in up to 34% of patients with high PTH, and overused in up to 46% of patients with low PTH. Phosphorus binders (mostly calcium salts during the study period) were used by 81% of patients, with potential overuse in up to 77% patients with low serum phosphorus concentration, and potential underuse in up to 18% of patients with a high serum phosphorus concentration. CONCLUSION: This study expands our understanding of the relationship between altered mineral metabolism and outcomes and identifies several potential opportunities for improved practice in this area.

Young EW, Akiba T, MD, Albert JM, McCarthy JT, Kerr PG, Mendelssohn DC, Jadoul M. Magnitude and Impact of Abnormal Mineral Metabolism in Hemodialysis Patients in the Dialysis Outcomes and Practice Patterns Study. Am J Kidney Dis 2004; 44 (Suppl 2):S34-S38

BACKGROUND: Mineral metabolism has emerged as an important predictor of morbidity and mortality in dialysis patients, independent of bone and muscle concerns. Several expert panels have issued management guidelines for mineral metabolism. METHODS: The state of mineral metabolism (serum parathyroid hormone [PTH], phosphorus, calcium, and calcium-phosphorus product) was described for representative samples of patients and facilities from 7 countries (France, Germany, Italy, Japan, Spain, United Kingdom, and United States) participating in the Dialysis Outcomes and Practice Patterns Study (DOPPS I, 1996-2001; DOPPS II, 2002-2004). RESULTS: A relatively modest percentage of patients fell within the guideline range for PTH (21.4% in DOPPS I, 26.2% in DOPPS II), serum phosphorus (40.8%, 44.4%), albumin-corrected serum calcium (40.5%, 42.5%), and calcium-phosphorus product (56.6%, 61.4%). Results were not dramatically different across countries. The majority of patients not within guideline ranges had high serum levels of phosphorus (51.6% in DOPPS I, 46.7% in DOPPS II), calcium (50.1%, 48.6%), and calcium-phosphorus product (43.4%, 38.6%) and low (<150 pg/mL) concentrations of PTH (52.9%, 47.5%). It was rare for patients to fall within recommended ranges for all indicators of mineral metabolism; 23% to 28% fell within guideline for at least 3 measures and only 4.6% to 5.5% of patients were within range for all 4. The risks of all-cause and cardiovascular mortality were directly and independently associated with each of the 4 indicators. CONCLUSION: The DOPPS provides a useful comparison benchmark for the state of mineral metabolism management of patients with kidney disease; it also affirms the association between mineral metabolism and important patient outcomes.

Port FK, Pisoni RL, Bragg-Gresham JL, Satayathum SS, Young EW, Wolfe RA, Held PJ. DOPPS estimates of patient life years attributable to modifiable hemodialysis practices in the United States. Blood Purif. 2004; 22(1):175-80

Data from the Dialysis Outcomes and Practice Patterns Study (DOPPS) allow estimation of the percentage of patients outside published hemodialysis guidelines and their associated mortality risk. We estimated the number of life years that could be gained from adherence to four of these guidelines and two other modifiable practices, i.e. dialysis dose, phosphate control, improved anemia, partial correction of serum albumin, reduced interdialytic weight gain and less use of catheters for vascular access. We extrapolated DOPPS data on these practices and guidelines to the US hemodialysis population for a 5-year projected period. Of the practices we examined, the highest relative risk of mortality was associated with having albumin <3.5 g/dl (relative risk=1.38, p<0.0001); 20.5% of the patients in the study fell outside the target range. The adjusted sum of the patient years attributable to all six practice patterns was 143,617; a more conservative estimate, modeling life years potentially gained by bringing half of all patients outside targets within them, is 69,367. The magnitude of potential savings in life years should encourage greater adherence to guidelines and practices that are significantly associated with better survival.

Moist LM, Bragg-Gresham JL, Pisoni RL, Saran R, Akiba T, Jacobson SH, Fukuhara S, Mapes DL, Rayner HC, Saito A, Port FK. Travel time to dialysis as a predictor of health-related quality of life, adherence, and mortality: The Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis 2008; 51(4): 641-650

BACKGROUND: Longer travel time to the dialysis unit creates a substantial burden for many patients. This study evaluated the effect of self-reported 1-way travel time to hemodialysis on mortality, health-related quality of life (HR-QOL), adherence, withdrawal from dialysis therapy, hospitalization, and transplantation. STUDY DESIGN: Prospective observational cohort. SETTING & PARTICIPANTS: Patients enrolled in the Dialysis Outcomes and Practices Patterns Study who completed a patient questionnaire (n = 20,994). PREDICTOR: One-way travel time to hemodialysis treatment, categorized as 15 or less, 16 to 30, 31 to 60, and longer than 60 minutes. Covariates included demographics, comorbid conditions, serum albumin level, time on dialysis therapy, and country. OUTCOME & MEASUREMENT: HR-QOL was examined by using a linear mixed model. Cox proportional hazards regression was used to examine associations with mortality, withdrawal from dialysis therapy, hospitalization, and transplantation. RESULTS: Longer travel time was associated with greater adjusted relative risk (RR) of death (P = 0.05 for overall trend). Adjusted HR-QOL subscales were significantly lower for those with longer travel times compared with those traveling 15 minutes or less. There were no associations of travel time with withdrawal from dialysis therapy (P = 0.6), hospitalization (P = 0.4), or transplantation (P = 0.7). LIMITATIONS: The questionnaire nonresponse rate was substantial, and nonresponders were older, with more comorbid conditions. Travel time was assessed by using a single nonvalidated question. CONCLUSIONS: Longer travel time is associated significantly with greater mortality risk and decreased HR-QOL. Exploring opportunities to decrease travel time should be incorporated into the dialysis clinical routine.

Elder SJ, Pisoni RL, Akizawa T, Fissell R, Andreucci VE, Fukuhara S, Kurokawa K, Rayner HC, Furniss AL, Port FK, Saran R. Sleep Quality in Hemodialysis Patients: Results from the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant 2008; 23: 998-1004

BACKGROUND: Poor sleep quality (SQ) affects many haemodialysis (HD) patients and could potentially predict their morbidity, mortality, quality of life (QOL) and patterns of medication use. METHODS: Data on SQ were collected from 11,351 patients in 308 dialysis units in seven countries in the Dialysis Outcomes and Practice Patterns Study (DOPPS) between 1996 and 2001 through a patient self-reported SQ scale, ranging from 0 (worst) to 10 (best). A score of <6 reflected poor SQ. Sleep disturbance was also assessed by self-reported daytime sleepiness, feeling drained and nocturnal awakening. Logistic and multiple linear regression were used to assess predictors of SQ and associations with QOL. Cox regression examined associations with mortality. Analyses accounted for case-mix, facility clustering and country. RESULTS: Nearly half (49%) of patients experienced poor SQ. Mean SQ scores varied by country, ranging from 4.9 in Germany to 6.5 in Japan. Patients with poor SQ were more likely to be prescribed antihistamines, antidepressants, anti-inflammatories, narcotics, gastrointestinal (GI) medications, anti-asthmatics or hypnotics. Physical exercise at least once a week (vs < once a week) was associated with lower odds of poor SQ (AOR = 0.55-0.85, P < 0.05). Poorer SQ was associated with significantly lower mental and physical component summary (MCS/PCS) scores (MCS scores 1.9-13.2 points lower and PCS scores 1.5-7.7 points lower when SQ scores were <10 vs 10). The RR of mortality was 16% higher for HD patients with poor SQ. CONCLUSIONS: Poor SQ is common among HD patients in DOPPS countries and is independently associated with several QOL indices, medication use patterns and mortality. Assessment and management of SQ should be an important component of care.

Hayashino Y, Fukuhara S, Akiba T, Akizawa T, Asano Y, Saito A, Bragg-Gresham JL, Ramirez SPB, Port FK, Kurokawa K. Diabetes, glycemic control and mortality risk in patients on hemodialysis: the Japan Dialysis Outcomes and Practice Patterns Study. Diabetologia 2007; 50(6):1170-1177

AIMS/HYPOTHESIS: There are few data on the target level of glycaemic control among patients with diabetes on haemodialysis. We investigated the impact of glycaemic control on mortality risk among diabetic patients on haemodialysis. SUBJECTS AND METHODS: Data were analysed from the Dialysis Outcomes Practice Pattern Study (DOPPS) for randomly selected patients on haemodialysis in Japan. The diagnosis of diabetes at baseline and information on clinical events during follow-up were abstracted from the medical records. A Cox proportional hazards model was used to evaluate the association between presence or absence of diabetes, glycaemic control (HbA(1c) quintiles) and mortality risk. RESULTS: Data from 1,569 patients with and 3,342 patients without diabetes on haemodialysis were analysed. Among patients on haemodialysis, those with diabetes had a higher mortality risk than those without (multivariable hazard ratio 1.37, 95% CI 1.08-1.74). Compared with those in the bottom quintile of HbA(1c) level, the multivariable-adjusted hazard ratio for mortality was not increased in the bottom second to fourth quintiles of HbA(1c) (HbA(1c) 5.0-5.5% to 6.2-7.2%), but was significantly increased to 2.36 (95% CI 1.02-5.47) in the fifth quintile (HbA(1c) > or = 7.3%). The effect of poor glycaemic control did not statistically correlate with baseline mortality risk (p = 0.27). CONCLUSIONS/INTERPRETATION: Among dialysis patients, poorer glycaemic control in those with diabetes was associated with higher mortality risk. This suggests a strong effect of poor glycaemic control above an HbA(1c) level of about 7.3% on mortality risk, and that this effect does not appear to be influenced by baseline comorbidity status.

Lopes AA, Elder SJ, Ginsberg N, Andreucci VE, Cruz JM, Fukuhara S, Mapes DL, Saito A, Pisoni RL, Saran R, Port FK. Lack of appetite in haemodialysis patients: Associations with patient characteristics, indicators of nutritional status, and outcomes in the international DOPPS. Nephrol Dial Transplant 2007; 22(12): 3538-3546

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) = 2.23; 95% confidence interval (CI) = 1.90-2.62] and the risk of hospitalization 33% higher (RR = 1.33; 95% CI = 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.

Kimata N, JM Albert, T Akiba, S Yamazaki, T Kawaguchi, S Fukuhara, T Akizawa, A Saito, Y Asano, K Kurokawa, RL Pisoni, and FK Port. Association of Mineral Metabolism factors with All-Cause and Cardiovascular Mortality in Hemodialysis Patients: the Japan Dialysis Outcomes and Practice Patterns Study (J-DOPPS). Hemodial Int. 2007; 11(3): 340-8

Abnormalities in mineral metabolism have been linked to mortality in hemodialysis (HD) patients. We postulated that these abnormalities would have a particularly large deleterious impact on deaths due to cardiovascular causes in Japan. This study describes the recent status of abnormal mineral metabolism, significant predictors, and potential consequences in the Dialysis Outcomes and Practice Patterns Study (DOPPS), Phases 1 and 2, in Japan. Major predictor variables were patient demographics, comorbidities, and laboratory markers of mineral metabolism such as albumin-adjusted serum calcium (calciumAlb), phosphorus, and intact PTH (iPTH). In a cross section of 3973 Japanese HD patients in DOPPS I and II, a large faction had laboratory values outside of the recommended Kidney Disease Outcomes Quality Initiative (K/DOQI) guideline range for serum concentrations of phosphorus (51% of patients above upper target range), calciumAlb (43.7% above), calcium-phosphorus (Ca x P) product (41.1% above), and iPTH (18.6% above). All-cause mortality was significantly and independently associated with calciumAlb (relative risk [RR]=1.22 per 1 mg/dL, p=0.0005) and iPTH (RR=1.04 per 100 pg/mL, p=0.04). Cardiovascular mortality was significantly associated with calciumAlb (RR=1.28, p=0.02), phosphorus (RR=1.13 per 1 mg/dL, p=0.008), Ca x P product (RR=1.07 per 2 mg(2)/dL(2), p=0.002), and PTH (RR=1.08, p=0.0001). This study expands our understanding of the relationship between altered mineral metabolism and mortality outcomes, showing slightly stronger associations with cardiovascular causes than observed for all-cause mortality. These findings have important therapeutic implications for Japanese HD patients.

Bragg-Gresham JL, Fissell RB, Mason NA, Bailie GR, Gillespie BW, Wizemann V, Cruz JM, Akiba T, Kurokawa K, Ramirez S, Young EW. Diuretic use, residual renal function, and mortality among hemodialysis patients in the Dialysis Outcomes and Practice Pattern Study (DOPPS). Am J Kidney Dis 2007; 49(3): 426-31

BACKGROUND: Information about residual renal function (RRF) and outcomes associated with practices of diuretic use in patients with end-stage renal disease is not available worldwide. METHODS: Diuretic use was investigated in 16,420 hemodialysis patients from the Dialysis Outcomes and Practice Patterns Study, a prospective observational study of hemodialysis patients selected from nationally representative facilities on 3 continents. Logistic regressions were used to investigate associations between diuretic use and patient characteristics. Outcomes of interdialytic weight gain, increased serum potassium and phosphorus levels, and odds of retaining RRF after 1 year were investigated. Cox regression was used to analyze the association between mortality and diuretic use. RESULTS: Facility diuretic use varied substantially from 0% to 83.9% of patients. Diuretic use decreased sharply after the start of dialysis therapy. Loop diuretic use ranged from 9.2% in the United States to 21.3% in Europe, whereas use within 90 days of starting dialysis therapy ranged from 25.0% in the United States to 47.6% in Japan. Diuretic use was associated with lower interdialytic weight gain and lower odds of hyperkalemia (potassium > 6.0 mmol/L). Patients with RRF on diuretic therapy had almost twice the odds of retaining RRF after 1 year in the study versus patients not on diuretic therapy. Patients administered diuretics had a 7% lower all-cause mortality risk (P = 0.12) and 14% lower cardiac-specific mortality risk (P = 0.03) versus patients not administered diuretics. CONCLUSION: Variation exists in facility practices of diuretic use. In patients with RRF, there may be benefit associated with continuing diuretic use rather than automatically discontinuing diuretic therapy at dialysis initiation.

Canaud B, Bragg-Gresham JL, Marshall MR, Desmeules S, Gillespie BW, Depner T, Klassen P, Port FK. Mortality risk for patients receiving hemodiafiltration versus hemodialysis: European results from the DOPPS. Kidney Int 2006; 69:2087-2093

Hemodiafiltration (HDF) is used sporadically for renal replacement therapy in Europe but not in the US. Characteristics and outcomes were compared for patients receiving HDF versus hemodialysis (HD) in five European countries in the Dialysis Outcomes and Practice Patterns Study. The study followed 2165 patients from 1998 to 2001, stratified into four groups: low- and high-flux HD, and low- and high-efficiency HDF. Patient characteristics including age, sex, 14 comorbid conditions, and time on dialysis were compared between each group using multivariate logistic regression. Cox proportional hazards regression assessed adjusted differences in mortality risk. Prevalence of HDF ranged from 1.8% in Spain to 20.1% in Italy. Compared to low-flux HD, patients receiving low-efficiency HDF had significantly longer average duration of end-stage renal disease (7.0 versus 4.7 years), more history of cancer (15.4 versus 8.7%), and lower phosphorus (5.3 versus 5.6 mg/dl); patients receiving high-efficiency HDF had significantly more lung disease (15.5 versus 10.2%) and received a higher single-pool Kt/V (1.44 versus 1.35). High-efficiency HDF patients had lower crude mortality rates than low-flux HD patients. After adjustment, high-efficiency HDF patients had a significant 35% lower mortality risk than those receiving low-flux HD (relative risk=0.65, P=0.01). These observational results suggest that HDF may improve patient survival independently of its higher dialysis dose. Owing to possible selection bias, the potential benefits of HDF must be tested by controlled clinical trials before recommendations can be made for clinical practice.

Fissell RB, Bragg-Gresham JL, Lopes AA, Cruz JM, Fukuhara S, Asano Y, Brown WW, Keen ML, Port FK, Young EW. Factors associated with “Do not resuscitate” orders and rates of withdrawal from hemodialysis in the international DOPPS. Kidney Int 2005; 68(3):1282-1288

BACKGROUND: Worldwide statistics on practice patterns regarding "do not resuscitate" (DNR) orders and patient withdrawal from hemodialysis have not been uniformly collected or analyzed. METHODS: Using data concerning adult hemodialysis patients randomly selected from 308 representative dialysis facilities in France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States participating in the Dialysis Outcomes and Practice Patterns Study, DNR orders were tabulated at study entry from a prevalent cross-section of patients (N = 8615), using multivariate logistic regression to investigate characteristics associated with DNR status, Cox models to identify risk factors for withdrawal from hemodialysis, and scores from the mental component summary (MCS) and physical component summary (PCS) of the SF-36 to assess health-related quality of life. RESULTS: The United States had the highest prevalence of DNR orders (7.5%) and rate of withdrawal from hemodialysis (3.5 per 100 patient-years). Significant and independent associations with higher odds ratio (OR) of DNR were observed for older age (OR 1.16 per 10 years higher, P = 0.03) and nursing home residence (OR 2.34, P = 0.003), and with higher relative risk (RR) of withdrawal from dialysis (RR 2.38, P < 0.001). Patients who withdrew from hemodialysis died within a mean of 7.8 days and a median of 6.0 days. CONCLUSION: The higher prevalence of DNR and rate of withdrawal from hemodialysis in the United States are consistent with its greater legal and cultural emphasis on patient autonomy. By showing characteristics associated with these outcomes, this study contributes to our understanding of why hemodialysis patients request DNR or withdraw from treatment.

Young EW, Albert JM, Satayathum S, Goodkin DA, Pisoni RL, Akiba T, Akizawa T, Kurokawa K, Bommer J, Piera L, Port FK. Predictors and consequences of altered mineral metabolism: The Dialysis Outcomes and Practice Patterns Study. Kidney Int 2005; 67:1179-1187

BACKGROUND: Altered mineral metabolism contributes to bone disease, cardiovascular disease, and other clinical problems in patients with end-stage renal disease. METHODS: This study describes the recent status, significant predictors, and potential consequences of abnormal mineral metabolism in representative groups of hemodialysis facilities (N= 307) and patients (N= 17,236) participating in the Dialysis Outcomes and Practice Patterns Study (DOPPS) in the United States, Europe, and Japan from 1996 to 2001. RESULTS: Many patients fell out of the recommended guideline range for serum concentrations of phosphorus (8% of patients below lower target range, 52% of patients above upper target range), albumin-corrected calcium (9% below, 50% above), calcium-phosphorus product (44% above), and intact PTH (51% below, 27% above). All-cause mortality was significantly and independently associated with serum concentrations of phosphorus (RR 1.04 per 1 mg/dL, P= 0.0003), calcium (RR 1.10 per 1 mg/dL, P < 0.0001), calcium-phosphorus product (RR 1.02 per 5 mg(2)/dL(2), P= 0.0001), PTH (1.01 per 100 pg/dL, P= 0.04), and dialysate calcium (RR 1.13 per 1 mEq/L, P= 0.01). Cardiovascular mortality was significantly associated with the serum concentrations of phosphorus (RR 1.09, P < 0.0001), calcium (RR 1.14, P < 0.0001), calcium-phosphorus product (RR 1.05, P < 0.0001), and PTH (RR 1.02, P= 0.03). The adjusted rate of parathyroidectomy varied 4-fold across the DOPPS countries, and was significantly associated with baseline concentrations of phosphorus (RR 1.17, P < 0.0001), calcium (RR 1.58, P < 0.0001), calcium-phosphorus product (RR 1.11, P < 0.0001), PTH (RR 1.07, P < 0.0001), and dialysate calcium concentration (RR 0.57, P= 0.03). Overall, 52% of patients received some form of vitamin D therapy, with parenteral forms almost exclusively restricted to the United States. Vitamin D was potentially underused in up to 34% of patients with high PTH, and overused in up to 46% of patients with low PTH. Phosphorus binders (mostly calcium salts during the study period) were used by 81% of patients, with potential overuse in up to 77% patients with low serum phosphorus concentration, and potential underuse in up to 18% of patients with a high serum phosphorus concentration. CONCLUSION: This study expands our understanding of the relationship between altered mineral metabolism and outcomes and identifies several potential opportunities for improved practice in this area.

Mason NA, Bailie GR, Satayathum S, Bragg-Gresham JL, Akiba T, Akizawa T, Combe C, Rayner HC, Saito A, Gillespie BW, Young EW. HMG-coenzyme A reductase inhibitor use is associated with mortality reduction in hemodialysis patients. Am J Kidney Dis 2005; 45(1): 119-26

BACKGROUND: Cardiovascular disease is the most common cause of mortality in patients with end-stage renal disease. Cardiovascular benefits of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) have been clearly established in the general population, but not in dialysis patients. This study examined statin prescription patterns and assessed the relationship between statin prescription and clinical outcomes in hemodialysis (HD) patients. METHODS: Data were analyzed from the Dialysis Outcomes and Practice Patterns Study, a prospective observational study of HD patients randomly selected from representative dialysis facilities in France, Germany, Italy, Spain, the United Kingdom, Japan, and the United States. Predictors of statin prescription were investigated by means of logistic regression. Cox regression models tested the association between statin prescription and risk for mortality and cardiac events, with adjustments for common demographic factors and comorbid conditions. RESULTS: Statins were prescribed for 11.8% of HD patients overall. Most facilities (81.2%) prescribed statins to less than 20% of their patients. Patients prescribed statins had a 31% lower relative risk for death compared with those not prescribed statins (P < 0.0001). Statins were associated with a 23% lower cardiac mortality risk (P = 0.03) and a 44% lower noncardiac mortality risk (P < 0.0001). At a facility level, prescribing statins was associated with lower overall mortality rate, with a 5% lower risk for every 10% increase in number of patients prescribed statins within the facility (P = 0.02). CONCLUSION: Statin prescription is associated with reduced mortality in HD patients, providing additional support for the value of statin therapy in this patient group.

Bommer J, Locatelli F, Satayathum S, Keen ML, Goodkin DA, Saito A, Akiba T, Port FK, Young EW. Association of predialysis serum bicarbonate levels with risk of mortality and hospitalization in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis 2004; 44(4):661-671

BACKGROUND: Experimental and some clinical data suggest that metabolic acidosis contributes to poor nutritional status, a strong predictor for mortality in hemodialysis patients. However, recent cross-sectional studies indicate that severe predialysis metabolic acidosis is associated with a greater normalized protein catabolic rate (nPCR) and greater serum albumin levels. Given this controversy, we analyzed data from the Dialysis Outcomes and Practice Pattern Study (DOPPS) for associations between predialysis serum bicarbonate and albumin concentrations, nPCR, and patient risk for mortality and hospitalization. METHODS: Data from more than 7,000 representative and randomly selected hemodialysis DOPPS patients from France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States were analyzed. Serum bicarbonate (total CO2 ) levels predialysis were corrected to the midweek interdialytic interval. RESULTS: The midweek predialysis serum bicarbonate level averaged 21.9 mEq/L (mmol/L) and correlated inversely with nPCR, serum albumin, and serum phosphorus values. Before and after adjusting for 15 comorbidities, nutrition, and equilibrated Kt/V, a U-curve best represented the association between predialysis serum bicarbonate level and risk for mortality or hospitalization. Patients with midweek predialysis serum bicarbonate levels of 20.1 to 21.0 mEq/L (mmol/L) faced the lowest risk for mortality, whereas those with bicarbonate levels of 21.1 to 22.0 mEq/L faced the lowest risk for hospitalization. Both high (>27 mEq/L) and low (< or =17 mEq/L) serum bicarbonate levels were associated with increased risk for mortality and hospitalization. CONCLUSION: Moderate predialysis acidosis seems to be associated with better nutritional status and lower relative risk for mortality or hospitalization than is observed in patients with normal ranges of midweek predialysis serum bicarbonate concentration (approximately 24 mEq/L) or severe acidosis (<16 mEq/L).

Locatelli F, Pisoni RL, Akizawa T, Cruz JM, DeOreo P, Lameire N, Held PJ. Anemia Management for Hemodialysis Patients: K/DOQI Guidelines and DOPPS Findings. Am J Kidney Dis 2004; 44 (Suppl 2):S27-S33

BACKGROUND: After recombinant human erythropoietin was introduced into routine nephrologic practice, specific clinical guidelines were developed to optimize the quality of anemia management for patients with chronic kidney disease. METHODS: The Dialysis Outcomes and Practice Patterns Study (DOPPS), an international investigation providing patient- and facility-level data on hemodialysis practice, was developed to provide information on various aspects of current practices in hemodialysis management, including treatment of renal anemia. RESULTS: Hemoglobin concentration is strongly associated with both morbidity and mortality in hemodialysis patients. Although some improvements can be documented in anemia management practices in the years after the publication of international guidelines, wide variations in anemia management are still observed among countries. CONCLUSION: Many efforts are still needed to allow a greater proportion of patients to reach the recommended hemoglobin concentrations. Significantly improved outcomes may therefore be expected by a more widespread reaching of the recommended hemoglobin levels. The results of the DOPPS point to the difficulties in implementing clinical guidelines in the everyday management of individual patients. In specific circumstances, a well-designed observational study may offer credible information and serve as a basic instrument for monitoring the implementation of clinical guidelines in typical clinical practice.

Young EW, Akiba T, MD, Albert JM, McCarthy JT, Kerr PG, Mendelssohn DC, Jadoul M. Magnitude and Impact of Abnormal Mineral Metabolism in Hemodialysis Patients in the Dialysis Outcomes and Practice Patterns Study. Am J Kidney Dis 2004; 44 (Suppl 2):S34-S38

BACKGROUND: Mineral metabolism has emerged as an important predictor of morbidity and mortality in dialysis patients, independent of bone and muscle concerns. Several expert panels have issued management guidelines for mineral metabolism. METHODS: The state of mineral metabolism (serum parathyroid hormone [PTH], phosphorus, calcium, and calcium-phosphorus product) was described for representative samples of patients and facilities from 7 countries (France, Germany, Italy, Japan, Spain, United Kingdom, and United States) participating in the Dialysis Outcomes and Practice Patterns Study (DOPPS I, 1996-2001; DOPPS II, 2002-2004). RESULTS: A relatively modest percentage of patients fell within the guideline range for PTH (21.4% in DOPPS I, 26.2% in DOPPS II), serum phosphorus (40.8%, 44.4%), albumin-corrected serum calcium (40.5%, 42.5%), and calcium-phosphorus product (56.6%, 61.4%). Results were not dramatically different across countries. The majority of patients not within guideline ranges had high serum levels of phosphorus (51.6% in DOPPS I, 46.7% in DOPPS II), calcium (50.1%, 48.6%), and calcium-phosphorus product (43.4%, 38.6%) and low (<150 pg/mL) concentrations of PTH (52.9%, 47.5%). It was rare for patients to fall within recommended ranges for all indicators of mineral metabolism; 23% to 28% fell within guideline for at least 3 measures and only 4.6% to 5.5% of patients were within range for all 4. The risks of all-cause and cardiovascular mortality were directly and independently associated with each of the 4 indicators. CONCLUSION: The DOPPS provides a useful comparison benchmark for the state of mineral metabolism management of patients with kidney disease; it also affirms the association between mineral metabolism and important patient outcomes.

Saran R, Canaud B, Depner T, Keen M, McCullough KP, Marshall MR, Port FK. Dose of Dialysis: Key Lessons from Major Observational Studies and Clinical Trials. Am J Kidney Dis 2004; 44 (Suppl 2):S47-S53

Analyses based on the National Cooperative Dialysis Study (NCDS) provided the impetus for routine quantification of delivered dialysis dose in hemodialysis practice throughout the world, by suggesting minimum targets for small solute (urea) clearance. Morbidity and mortality in dialysis populations remain high despite many technological advances in dialysis delivery. A number of observational studies reported association between higher dose of dialysis as measured by Kt/V urea or urea reduction ratio with lower mortality risk. During the 1990s, a steady increase in dialysis dose and a modest reduction in mortality on dialysis were observed. However, observational studies only reveal associations and are limited by selection bias and confounding. The Kidney Disease Outcomes Quality Initiative guidelines on dialysis adequacy are based on results of observational studies and expert opinion. Since the NCDS, the HEMO Study was the first major randomized clinical trial designed to study the effect of dose of dialysis and dialyzer flux on patient outcomes. Despite adequate separation of dose and flux, however, results of the trial did not prove a beneficial effect of higher dose. The Dialysis Outcomes and Practice Patterns Study (DOPPS), in a major international effort designed to examine the effect of practice patterns on outcomes, has made significant contributions to the topic of dialysis dose. The following review critically examines data from observational studies, including the DOPPS, and from the HEMO Study, emphasizing important lessons from both, and discusses future paradigms for achieving dialysis adequacy to improve patient outcomes.

Mapes DL, Bragg-Gresham JL, Bommer J, Fukuhara S, McKevitt P, Wikstrom B, Lopes AA. Health-Related Quality of Life in the DOPPS. Am J Kidney Dis 2004; 44 (Suppl 2):S54-S60

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.

Fissell RB, Bragg-Gresham JL, Gillespie BW, Goodkin DA, Bommer J, Saito A, Akiba T, Port FK, Young EW. International variation in vitamin prescription and association with mortality in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis 2004; 44(2):293-299

BACKGROUND: The prevalence of water-soluble vitamin use among hemodialysis (HD) patients and whether mortality and hospitalization are associated with water-soluble vitamin use by HD patients have not previously been reported. The present study investigates patterns of water-soluble vitamin use among HD patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS) I and evaluates outcomes associated with vitamin use. METHODS: The study sample came from the DOPPS I, a prospective observational study of adult HD patients (N = 16,345) randomly selected from 308 representative dialysis facilities in France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States. Time-dependent Cox regression models were used to assess relative risk (RR) for mortality and hospitalization for patients administered water-soluble vitamins versus those not administered water-soluble vitamins. RESULTS: There was large variation by region in the percentage of patients administered water-soluble vitamins: Europe ranged from a low of 3.7% in the United Kingdom to a high of 37.9% in Spain; 5.6% in Japan; and 71.9% in the United States. Patient use of water-soluble vitamins was associated with a substantially and significantly lower risk for mortality (RR, 0.84; P = 0.001). Lower RR for facility-level mortality also was associated with greater water-soluble vitamin use (RR, 0.98; P = 0.05 per 10% more patients administered water-soluble vitamins at the facility). CONCLUSION: Although only a randomized trial could prove that water-soluble vitamins improve outcomes, use of water-soluble vitamins is a minimal-risk practice pattern associated with improved outcomes in this prospective observational study.

Locatelli F, Pisoni RL, Combe C, Bommer J, Andreucci VE, Piera L, Greenwood R, Feldman HI, Port FK, Held PJ. Anaemia in haemodialysis patients of five European countries: association with morbidity and mortality in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Department of Nephrology and Dialysis, A. Manzoni Hospital, Lecco, Italy. Nephrol Dial Transplant. 2004 Nov;19(11):2928

BACKGROUND: The Dialysis Outcomes and Practice Patterns Study (DOPPS) is a prospective, observational study based on data collected from nationally representative samples of haemodialysis facilities. The burden of anaemia in haemodialysis patients is substantial, leading to considerable morbidity, mortality and reduced quality of life. This study examines anaemia management and outcomes based on data from five European countries participating in the DOPPS: France, Germany, Italy, Spain and the UK. METHODS: Baseline data on demographics, co-morbidities and anaemia management in 4591 haemodialysis patients from 101 nephrology facilities were collected in 1998-2000. Using multivariate Cox survival analyses to adjust for patient characteristics, relationships between haemoglobin concentration at study entry and rates of mortality and hospitalization were evaluated. RESULTS: For a year 2000 sample of prevalent patients on haemodialysis >180 days, mean haemoglobin concentration was 11.0 g/dl; 53% had a haemoglobin concentration > or = 11 g/dl [1998-1999 = 44% (P < 0.05)]. In 2000, 84% of prevalent patients were prescribed recombinant human erythropoietin (rHuEpo). Higher haemoglobin concentrations were associated with decreased relative risk (RR) for mortality (RR = 0.95 for every 1 g/dl higher haemoglobin, P = 0.03) and hospitalization (RR = 0.96, P = 0.02). Patients with haemoglobin <10 g/dl were 29% more likely to be hospitalized than patients with haemoglobin 11-12 g/dl (P < 0.001). CONCLUSION: Even after adjustment, lower haemoglobin concentrations were associated with higher morbidity and mortality in European haemodialysis patients. A trend to increased haemoglobin concentrations was observed following publication of the European Best Practice Guidelines (EBPG) on anaemia management for chronic kidney disease patients, but efforts must continue to achieve EBPG goals.

Rayner HC, Pisoni RL, Bommer J, Canaud B, Hecking E, Locatelli F, Piera L, Bragg-Gresham JL, Feldman H, Goodkin DA, Wolfe RA, Held PJ, Port FK. Mortality and hospitalisation in haemodialysis patients in five European countries: Results from the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant 2004; 19(1): 108-120

BACKGROUND: Mortality and hospitalization rates are reported for nationally representative random samples of haemodialysis patients treated at randomly selected dialysis facilities in five European countries participating in the Dialysis Outcomes and Practice Pattern Study (DOPPS) (France, Germany, Italy, Spain and the UK). RESULTS: In the UK, 28.1% of haemodialysis patients received prior peritoneal dialysis treatment compared with 4.2-8.3% in other countries. Kidney transplantation rates ranged from 3.3 (per 100 patient years) in Italy to 11.6 in Spain. The relative risk (RR) of mortality, adjusted for age, sex and diabetes status was significantly higher in the UK (RR = 1.39, P = 0.02) compared with Italy (reference) and increased in association with age (RR = 1.60 for every 10 years older, P <0.001), diabetes as cause of end-stage renal disease (ESRD) (RR = 1.55, P < 0.001), male patients <65 years (RR = 1.29, P = 0.02) and peritoneal dialysis in the 12 months prior to starting haemodialysis (RR = 1.72, P = 0.06). Hospitalization for cardiovascular disease was highest in France and Germany (0.40 and 0.43 hospitalizations per patient year, respectively) and lowest in the UK (0.19), although cardiovascular comorbidity was similar in the UK and France. Hospitalization rates for vascular access-related infection ranged from 0.01 hospitalizations per patient year in Italy to 0.08 in the UK, consistent with the higher dialysis catheter use in the UK (25%) vs Italy (5%). Hospitalization risk was significantly higher in France than in other Euro-DOPPS countries and was significantly (P < 0.05) associated with prior peritoneal dialysis therapy, peripheral vascular disease, gastrointestinal bleeding in the prior 12 months, diabetes, cancer, cardiac disease, psychiatric disease and recent onset of ESRD (within 30 days of study entry). CONCLUSIONS: The large differences in haemodialysis practice and outcomes in the Euro-DOPPS countries suggest opportunities for improvement in patient care.

Port FK, Pisoni RL, Bragg-Gresham JL, Satayathum SS, Young EW, Wolfe RA, Held PJ. DOPPS estimates of patient life years attributable to modifiable hemodialysis practices in the United States. Blood Purif. 2004; 22(1):175-80

Data from the Dialysis Outcomes and Practice Patterns Study (DOPPS) allow estimation of the percentage of patients outside published hemodialysis guidelines and their associated mortality risk. We estimated the number of life years that could be gained from adherence to four of these guidelines and two other modifiable practices, i.e. dialysis dose, phosphate control, improved anemia, partial correction of serum albumin, reduced interdialytic weight gain and less use of catheters for vascular access. We extrapolated DOPPS data on these practices and guidelines to the US hemodialysis population for a 5-year projected period. Of the practices we examined, the highest relative risk of mortality was associated with having albumin <3.5 g/dl (relative risk=1.38, p<0.0001); 20.5% of the patients in the study fell outside the target range. The adjusted sum of the patient years attributable to all six practice patterns was 143,617; a more conservative estimate, modeling life years potentially gained by bringing half of all patients outside targets within them, is 69,367. The magnitude of potential savings in life years should encourage greater adherence to guidelines and practices that are significantly associated with better survival.

Fissell RB, Bragg-Gresham JL, Woods JD, Jadoul M, Gillespie B, Hedderwick SA, Rayner HC, Greenwood RN, Akiba T, Young EW. Patterns of hepatitis C prevalence and seroconversion in hemodialysis units from three continents: The DOPPS. Kidney Int 2004; 65:2335-2342

BACKGROUND: Hepatitis C virus (HCV) remains a problem within hemodialysis units. This study measures HCV prevalence and seroconversion rates across seven countries and investigates associations with facility-level practice patterns. METHODS: The study sample was from the Dialysis Outcomes and Practice Patterns Study (DOPPS), a prospective, observational study of adult hemodialysis patients randomly selected from 308 representative dialysis facilities in France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States. Logistic regression was used to model odds of HCV prevalence, and Cox regression was used to model time from study entry to HCV seroconversion. RESULTS: Mean HCV facility prevalence was 13.5% and varied among countries from 2.6% to 22.9%. Increased HCV prevalence was associated with longer time on dialysis, male gender, black race, diabetes, hepatitis B (HBV) infection, prior renal transplant, and alcohol or substance abuse in the previous 12 months. Approximately half of the facilities (55.6%) had no seroconversions during the study period. HCV seroconversion was associated with longer time on dialysis, human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), HBV infection, and recurrent cellulitis or gangrene. An increase in highly trained staff was associated with lower HCV prevalence (OR = 0.93 per 10% increase, P= 0.003) and risk of seroconversion (RR = 0.92, P= 0.07). Seroconversion was associated with an increase in facility HCV prevalence (RR = 1.36, P < 0.0001), but not with isolation of HCV-infected patients (RR = 1.01, P= 0.99). CONCLUSION: There are differences in HCV prevalence and rate of seroconversion at the country and the hemodialysis facility level. The observed variation suggests opportunities for improved HCV outcomes.

Port FK, Wolfe RA, Hulbert-Shearon TE, Ashby VB, McCullough KP, Held PJ. High dialysis dose is associated with lower mortality among women but not among men. Am J Kidney Dis 2004; 43(6):1014-1023

BACKGROUND: Several observational studies reported lower mortality risk among hemodialysis patients treated with doses greater than the standard dose. The present study evaluates, with observational data, the secondary randomized Hemodialysis (HEMO) Study finding that greater dialysis dose may benefit women, but not men. METHODS: Data from 74,120 US hemodialysis patients starting end-stage renal disease therapy were analyzed. Patients were classified into 1 of 5 categories of hemodialysis dose according to their average urea reduction ratio (URR), and their relative risk (RR) for mortality was evaluated by using Cox proportional hazards models. Similar analyses using equilibrated Kt/V were completed for 10,816 hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS) in 7 countries. RESULTS: For both men and women, RR was substantially lower in the URR 70%-to-75% category compared with the URR 65%-to-70% category. Among women, RR in the URR greater-than-75% category was significantly lower compared with the URR 70%-to-75% group (P < 0.0001); however, no further association with mortality risk was observed for the greater-than-75% category among men (P = 0.22). RR associated with doses greater than the Kidney Disease Outcomes Quality Initiative guidelines (URR > or = 65%) was significantly different for men compared with women (P < 0.01). Similar differences by sex were observed in DOPPS analyses. CONCLUSION: The agreement of these observational studies with the HEMO Study supports the existence of a survival benefit from greater dialysis doses for women, but not for men. Responses to greater dialysis dose by sex deserve additional study to explain these differences.

Goodkin DA, Bragg-Gresham JL, Koenig KG, Wolfe RA, Akiba T, Andreucci VE, Saito A, Rayner HC, Kurokawa K, Port FK, Held PJ, Young EW. Association of comorbid conditions and mortality in hemodialysis patients in Europe, Japan, and the United States in the Dialysis Outcomes and Practice Patterns Study (DOPPS). J Am Soc Nephrol 2003; 14(12): 3270-3277

Mortality rates among hemodialysis patients vary greatly across regions. Representative databases containing extensive profiles of patient characteristics and outcomes are lacking. The Dialysis Outcomes and Practice Patterns Study (DOPPS) is a prospective, observational study of representative samples of hemodialysis patients in France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States (US) that captures extensive data relating to patient characteristics, prescriptions, laboratory values, practice patterns, and outcomes. This report describes the case-mix features and mortality among 16,720 patients followed up to 5 yr. The crude 1-yr mortality rates were 6.6% in Japan, 15.6% in Europe, and 21.7% in the US. After adjusting for age, gender, race, and 25 comorbid conditions, the relative risk (RR) of mortality was 2.84 (P < 0.0001) for Europe compared with Japan (reference group) and was 3.78 (P < 0.0001) for the US compared with Japan. The adjusted RR of mortality for the US versus Europe was 1.33 (P < 0.0001). For most comorbid diseases, prevalence was highest in the US, where the mean age (60.5 +/- 15.5 yr) was also highest. Older age and comorbidities were associated with increased risk of death (except for hypertension, which carried a multivariate RR of mortality of 0.74 [P < 0.0001]). Variability in demographic and comorbid conditions (as identified by dialysis facilities) explains only part of the differences in mortality between dialysis centers, both for comparisons made across continents and within the US. Adjustments for the observed variability will allow study of association between practice patterns and outcomes.

Saran R, Bragg-Gresham JL, Rayner HC, Goodkin DA, Keen ML, van Dijk PC, Kurokawa K, Piera L, Saito A, Fukuhara S, Young EW, Held PJ, Port FK. Nonadherence in hemodialysis: Associations with mortality, hospitalization, and practice patterns in the DOPPS. Kidney Int 2003; 64: 254-262

BACKGROUND: Nonadherence among hemodialysis patients compromises dialysis delivery, which could influence patient morbidity and mortality. The Dialysis Outcomes and Practice Patterns Study (DOPPS) provides a unique opportunity to review this problem and its determinants on a global level. METHODS: Nonadherence was studied using data from the DOPPS, an international, observational, prospective hemodialysis study. Patients were considered nonadherent if they skipped one or more sessions per month, shortened one or more sessions by more than 10 minutes per month, had a serum potassium level openface>6.0 mEq/L, a serum phosphate level openface>7.5 mg/dL (>2.4 mmol/L), or interdialytic weight gain (IDWG)>5.7% of body weight. Predictors of nonadherence were identified using logistic regression. Survival analysis used the Cox proportional hazards model adjusting for case-mix. RESULTS: Skipping treatment was associated with increased mortality [relative risk (RR) = 1.30, P = 0.01], as were excessive IDWG (RR = 1.12, P = 0.047) and high phosphate levels (RR = 1.17, P = 0.001). Skipping also was associated with increased hospitalization (RR = 1.13, P = 0.04), as were high phosphate levels (RR = 1.07, P = 0.05). Larger facility size (per 10 patients) was associated with higher odds ratios (OR) of skipping (OR = 1.03, P = 0.06), shortening (OR = 1.03, P = 0.05), and IDWG (OR = 1.02, P = 0.07). An increased percentage of highly trained staff hours was associated with lower OR of skipping (OR = 0.84 per 10%, P = 0.02); presence of a dietitian was associated with lower OR of excessive IDWG (OR = 0.75, P = 0.08). CONCLUSION: Nonadherence was associated with increased mortality risk (skipping treatment, excessive IDWG, and high phosphate) and with hospitalization risk (skipping, high phosphate). Certain patient/facility characteristics also were associated with nonadherence.

Burdick RA, Bragg-Gresham JL, Woods JD, Hedderwick SA, Kurokawa K, Combe C, Saito A, LaBrecque J, Port FK, Young EW. Patterns of hepatitis B prevalence and seroconversion in hemodialysis units from three continents: The DOPPS. Kidney Int 2003; 63: 2222-2229

BACKGROUND: Hepatitis B (HBV) historically has been a public health issue within hemodialysis units. This study estimates HBV prevalence and seroconversion rates across seven countries and investigates associations with facility level practice patterns. METHODS: The study sample was from the Dialysis Outcomes and Practice Patterns Study (DOPPS), a cross-sectional, prospective, observational study of adult hemodialysis patients randomly selected from 308 dialysis facilities in France, Germany, Italy, Spain, the United Kingdom, Japan, and the United States. Logistic regression was used to model the odds ratio (OR) of HBV prevalence, and Cox regression was used to model time from entry into the study to HBV seroconversion. RESULTS: In this sample, mean HBV facility prevalence was 3.0% with a median of 1.9%. The percentage of facilities with an HBV prevalence 0% to 5% was 78.5%. Adjusted HBV prevalence was higher in France, Germany, and Italy and lower in Japan and the United Kingdom. The majority of facilities (78.1%) had a seroconversion rate of 0 conversions per 100 patient-years. Presence of a protocol for HBV-infected patients was significantly associated with HBV seroconversion in the separate practice pattern model [risk ratio (RR) = 0.52, P = 0.03] and in the combined practice pattern model (RR = 0.44, P = 0.01). CONCLUSION: There are differences in HBV prevalence and rate of seroconversion both at the country and the hemodialysis facility level. Presence of a protocol for HBV-infected patients was strongly and significantly associated with decreased risk for seroconversion. The observed variation suggests opportunities for improved HBV outcomes with further definition of optimal practice patterns at the facility level.

Lopes AA, Bragg J, Young E, Goodkin D, Mapes D, Combe C, Piera L, Held P, Gillespie B, Port FK, for the Dialysis Outcomes and Practice Patterns Study (DOPPS). Depression as a predictor of mortality and hospitalization among hemodialysis patients in the United States and Europe. Kidney Int 2002; 62: 199-207

BACKGROUND: Depression is not uncommon among patients with end-stage renal disease (ESRD) being treated by hemodialysis. We investigated whether risk of mortality and rate of hospitalization may be predicted from physician-diagnosed depression and patients' self-reports of depressive symptoms. METHODS: Data were analyzed from the Dialysis Outcomes and Practice Patterns Study (DOPPS) for randomly selected ESRD patients being treated by hemodialysis in the United States (142 facilities, 2855 patients) and five European countries (101 facilities, 2401 patients). The diagnosis of depression during the past year was abstracted from the medical records. In addition, the patients were asked to indicate how much of their time over the previous four weeks they had felt (1) "so down in the dumps that nothing could cheer you up" and (2) "downhearted and blue." A response of "a good bit,""most," or "all" of the time were classified as depressed. RESULTS: The prevalence of depression was nearly 20%. The relative risks of mortality and hospitalization among depressed (vs. non-depressed), adjusted for time on dialysis, age, race, socioeconomic status, comorbid indicators and country were, respectively: 1.23 and 1.11 for physician-diagnosed depression, 1.48 and 1.15 for the "so down in the dumps" question, and 1.35 and 1.11 for the "downhearted and blue" question (P < 0.05 for all six relative risks). These associations were not significantly different between US and European patients. CONCLUSIONS: Self-reported depression by two simple questions was associated with increased risks of mortality and hospitalization for hemodialysis patients. Future research needs to assess whether early identification and treatment of depression may help to improve quality of life and survival in hemodialysis patients.

Pifer TB, McCullough KP, Port FK, Goodkin DA, Maroni BJ, Held PJ, Young EW. Mortality risk in hemodialysis patients and changes in nutritional indicators: DOPPS. Kidney Int 2002; 62(6): 2238-2245

BACKGROUND: Nutritional status is strongly associated with outcomes among hemodialysis patients. We analyzed the independent predictive value of several readily measured nutritional indicators, including a modified subjective global assessment (mSGA), body mass index (BMI), serum albumin, serum creatinine, normalized protein catabolic rate (nPCR), serum bicarbonate, lymphocyte count, and neutrophil count, using baseline and six-month follow-up measurements. METHODS: The study sample consisted of 7719 U.S. adult hemodialysis patients enrolled in the international Dialysis Outcomes and Practice Patterns Study (DOPPS), a prospective observational study that includes a random sample of hemodialysis patients from 145 dialysis facilities in the United States. Cox regression was used to estimate the relative risk of mortality associated with differences in measurements at baseline and six months later. Each analysis was adjusted for age, race, sex, and 15 summary comorbid conditions. RESULTS: Lower baseline measurements of mSGA, BMI, serum albumin, serum creatinine, and lymphocyte count were independently associated with significantly higher risk of mortality. During six-month follow-up, decreases in BMI, serum albumin, and serum creatinine were also associated with significantly higher mortality risk. The risk of mortality increased with higher baseline and six-month increases in neutrophil count. CONCLUSIONS: This study confirms that several readily-measured nutritional indicators predict mortality among hemodialysis patients and that changes in indicator values over six months provide additional important prognostic information. Interventions that modify these indicators of nutritional status may have an important impact on the survival of hemodialysis patients.

Leavey SF, McCullough K, Hecking E, Goodkin D, Port FK, Young EW. Body mass index and mortality in 'healthier' as compared with 'sicker' haemodialysis patients: results from the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant. 2001; 16(12): 2386-2394

BACKGROUND: Haemodialysis (HD) patients with lower body mass index (BMI) have a higher relative mortality risk (RR), irrespective of race. However, only Asian Americans treated with HD have been found to have an elevated RR with higher BMI. Asian Americans on HD are 'healthier' than other race groups (i.e. have better overall survival). We hypothesized that an increased mortality risk might be associated with high BMI in a variety of other 'healthier' subgroups of HD patients. METHODS: The prospective Dialysis Outcomes and Practice Patterns Study (DOPPS) provided baseline demographic, comorbidity and BMI data on 9714 HD patients in the US and Europe (France, Germany, Italy, Spain, and the UK) from 1996-2000. Using multivariate survival analyses, we evaluated BMI-mortality relationships in HD subpopulations defined by continent, race (black and white), gender, tertiles of severity of illness (based on a score derived from comorbid conditions and serum albumin concentration), age (<45, 45-64, >or=65), smoking, and diabetic status. RESULTS: Relative mortality risk decreased with increasing BMI. This was statistically significant (P<0.007) except for the smallest subgroup of patients who were <45 years old and were also in the healthiest tertile of comorbidity. All else equal, BMI <20 was consistently associated with the highest relative mortality risk. Overall a lower relative mortality risk (RR) as compared with BMI 23-24.9, was found for overweight (BMI 25-29.9; RR 0.84, P=0.008), for mild obesity (BMI 30-34.9; RR 0.73, P=0.0003), and for moderate obesity (BMI 35-39.9; RR 0.76, P=0.02). CONCLUSION: In a wide variety of HD patient subgroups, differing with respect to their baseline health status, increasing body size correlates with a decreased mortality risk. This contrasts with the association between BMI and mortality in the general population, and deserves further study.

Lopes AA, Elder SJ, Ginsberg N, Andreucci VE, Cruz JM, Fukuhara S, Mapes DL, Saito A, Pisoni RL, Saran R, Port FK. Lack of appetite in haemodialysis patients: Associations with patient characteristics, indicators of nutritional status, and outcomes in the international DOPPS. Nephrol Dial Transplant 2007; 22(12): 3538-3546

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) = 2.23; 95% confidence interval (CI) = 1.90-2.62] and the risk of hospitalization 33% higher (RR = 1.33; 95% CI = 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.

Combe C, McCullough KP, Asano Y, Ginsberg N, Maroni B, Pifer T. K/DOQI and the DOPPS: Nutrition Guidelines, Indicators, and Practices. Am J Kidney Dis 2004; 44 (Suppl 2):S39-S46

BACKGROUND: Nutritional markers are important predictors of morbidity and mortality in dialysis patients. The Clinical Practice Guidelines for Nutrition in Chronic Renal Failure provides guidelines for assessing nutritional status that were evaluated using data from the Dialysis Outcomes and Practice Patterns Study (DOPPS). METHODS: The level of various nutritional markers (serum albumin, modified subjective global assessment, serum creatinine, normalized protein catabolic rate [nPCR], and body mass index) were described for representative samples of patients and facilities from 7 countries (France, Germany, Italy, Spain, Japan, United Kingdom, and United States) participating in the DOPPS. RESULTS: A strong inverse association was observed between mortality and serum albumin, with a mortality risk 1.38 times higher for patients with serum albumin concentration less than 3.5 g/dL (35 g/L). There were significant differences by country in the proportion of moderately and severely malnourished patients as determined by the modified subjective global assessment score. In the US sample, severely and moderately malnourished patients had a higher mortality risk compared with those not malnourished, 33% and 5% higher, respectively. An inverse relationship exists between serum creatinine concentration and mortality, with a mortality risk 60% to 70% higher in the lowest quartile group compared with the highest quartile group in Europe and the United States. Levels of nPCR varied significantly between European countries, and there was no association between mortality and nPCR in US data. After adjustment for demographic and comorbidity factors, the mortality risk decreased as body mass index increased in both US and European samples. CONCLUSION: DOPPS data highlight the importance of routine assessment of nutritional status, using multiple parameters, in clinical practice to improve patient care.

Hecking E, Bragg-Gresham JL, Rayner HC, Pisoni RL, Andreucci VE, Combe C, Greenwood R, McCullough K, Feldman HI, Young EW, Held PJ, Port FK. Haemodialysis prescription, adherence, and nutritional indicators in five European countries: Results from the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant 2004; 19(1): 100-107

BACKGROUND: The Dialysis Outcomes and Practice Patterns Study (DOPPS) is a prospective, observational study designed to evaluate practice patterns in random samples of haemodialysis facilities and patients across three continents. Participating countries include France, Germany, Italy, Spain and the UK (Euro-DOPPS), Japan and the USA. DOPPS data collection has used the same questionnaires and protocols across all participating countries to assess components of dialysis therapy and outcomes. This study focuses on dialysis prescription, adherence and nutrition among the Euro-DOPPS countries. METHODS: In each Euro-DOPPS country, patients were selected randomly from 20-21 representative facilities. Simple means and frequencies were calculated to compare relevant data elements to gain insights into differences in therapeutic aspects among nationally representative patients. Participants entering the study within 90 days of beginning dialysis therapy were excluded from these analyses. RESULTS: Among the five countries, mean delivered dose as measured by normalized urea clearance (Kt/V) varied from 1.28 to 1.50 and was accompanied by differences in dialysis prescription components, including blood flow rates, treatment times, and dialyser membrane and flux characteristics. By country, a nearly 2-fold difference was observed in indicators of patient adherence and management (skipping and shortening dialysis, hyperkalaemia, hyperphosphataemia and high interdialytic weight gain). Indicators of malnutrition varied substantially. CONCLUSIONS: This study demonstrates differences in the management of haemodialysis patients across Euro-DOPPS and offers opportunities for improving dialysis dose, adherence and nutrition. Correlation of differences in practice patterns at the dialysis unit level with patient outcomes will offer new insights into improving dialysis therapy.

Port FK, Pisoni RL, Bragg-Gresham JL, Satayathum SS, Young EW, Wolfe RA, Held PJ. DOPPS estimates of patient life years attributable to modifiable hemodialysis practices in the United States. Blood Purif. 2004; 22(1):175-80

Data from the Dialysis Outcomes and Practice Patterns Study (DOPPS) allow estimation of the percentage of patients outside published hemodialysis guidelines and their associated mortality risk. We estimated the number of life years that could be gained from adherence to four of these guidelines and two other modifiable practices, i.e. dialysis dose, phosphate control, improved anemia, partial correction of serum albumin, reduced interdialytic weight gain and less use of catheters for vascular access. We extrapolated DOPPS data on these practices and guidelines to the US hemodialysis population for a 5-year projected period. Of the practices we examined, the highest relative risk of mortality was associated with having albumin <3.5 g/dl (relative risk=1.38, p<0.0001); 20.5% of the patients in the study fell outside the target range. The adjusted sum of the patient years attributable to all six practice patterns was 143,617; a more conservative estimate, modeling life years potentially gained by bringing half of all patients outside targets within them, is 69,367. The magnitude of potential savings in life years should encourage greater adherence to guidelines and practices that are significantly associated with better survival.

Pifer TB, McCullough KP, Port FK, Goodkin DA, Maroni BJ, Held PJ, Young EW. Mortality risk in hemodialysis patients and changes in nutritional indicators: DOPPS. Kidney Int 2002; 62(6): 2238-2245

BACKGROUND: Nutritional status is strongly associated with outcomes among hemodialysis patients. We analyzed the independent predictive value of several readily measured nutritional indicators, including a modified subjective global assessment (mSGA), body mass index (BMI), serum albumin, serum creatinine, normalized protein catabolic rate (nPCR), serum bicarbonate, lymphocyte count, and neutrophil count, using baseline and six-month follow-up measurements. METHODS: The study sample consisted of 7719 U.S. adult hemodialysis patients enrolled in the international Dialysis Outcomes and Practice Patterns Study (DOPPS), a prospective observational study that includes a random sample of hemodialysis patients from 145 dialysis facilities in the United States. Cox regression was used to estimate the relative risk of mortality associated with differences in measurements at baseline and six months later. Each analysis was adjusted for age, race, sex, and 15 summary comorbid conditions. RESULTS: Lower baseline measurements of mSGA, BMI, serum albumin, serum creatinine, and lymphocyte count were independently associated with significantly higher risk of mortality. During six-month follow-up, decreases in BMI, serum albumin, and serum creatinine were also associated with significantly higher mortality risk. The risk of mortality increased with higher baseline and six-month increases in neutrophil count. CONCLUSIONS: This study confirms that several readily-measured nutritional indicators predict mortality among hemodialysis patients and that changes in indicator values over six months provide additional important prognostic information. Interventions that modify these indicators of nutritional status may have an important impact on the survival of hemodialysis patients.

Leavey SF, McCullough K, Hecking E, Goodkin D, Port FK, Young EW. Body mass index and mortality in 'healthier' as compared with 'sicker' haemodialysis patients: results from the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant. 2001; 16(12): 2386-2394

BACKGROUND: Haemodialysis (HD) patients with lower body mass index (BMI) have a higher relative mortality risk (RR), irrespective of race. However, only Asian Americans treated with HD have been found to have an elevated RR with higher BMI. Asian Americans on HD are 'healthier' than other race groups (i.e. have better overall survival). We hypothesized that an increased mortality risk might be associated with high BMI in a variety of other 'healthier' subgroups of HD patients. METHODS: The prospective Dialysis Outcomes and Practice Patterns Study (DOPPS) provided baseline demographic, comorbidity and BMI data on 9714 HD patients in the US and Europe (France, Germany, Italy, Spain, and the UK) from 1996-2000. Using multivariate survival analyses, we evaluated BMI-mortality relationships in HD subpopulations defined by continent, race (black and white), gender, tertiles of severity of illness (based on a score derived from comorbid conditions and serum albumin concentration), age (<45, 45-64, >or=65), smoking, and diabetic status. RESULTS: Relative mortality risk decreased with increasing BMI. This was statistically significant (P<0.007) except for the smallest subgroup of patients who were <45 years old and were also in the healthiest tertile of comorbidity. All else equal, BMI <20 was consistently associated with the highest relative mortality risk. Overall a lower relative mortality risk (RR) as compared with BMI 23-24.9, was found for overweight (BMI 25-29.9; RR 0.84, P=0.008), for mild obesity (BMI 30-34.9; RR 0.73, P=0.0003), and for moderate obesity (BMI 35-39.9; RR 0.76, P=0.02). CONCLUSION: In a wide variety of HD patient subgroups, differing with respect to their baseline health status, increasing body size correlates with a decreased mortality risk. This contrasts with the association between BMI and mortality in the general population, and deserves further study.

Quality of Life

Elder SJ, Pisoni RL, Akizawa T, Fissell R, Andreucci VE, Fukuhara S, Kurokawa K, Rayner HC, Furniss AL, Port FK, Saran R. Sleep Quality in Hemodialysis Patients: Results from the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant 2008; 23: 998-1004

BACKGROUND: Poor sleep quality (SQ) affects many haemodialysis (HD) patients and could potentially predict their morbidity, mortality, quality of life (QOL) and patterns of medication use. METHODS: Data on SQ were collected from 11,351 patients in 308 dialysis units in seven countries in the Dialysis Outcomes and Practice Patterns Study (DOPPS) between 1996 and 2001 through a patient self-reported SQ scale, ranging from 0 (worst) to 10 (best). A score of <6 reflected poor SQ. Sleep disturbance was also assessed by self-reported daytime sleepiness, feeling drained and nocturnal awakening. Logistic and multiple linear regression were used to assess predictors of SQ and associations with QOL. Cox regression examined associations with mortality. Analyses accounted for case-mix, facility clustering and country. RESULTS: Nearly half (49%) of patients experienced poor SQ. Mean SQ scores varied by country, ranging from 4.9 in Germany to 6.5 in Japan. Patients with poor SQ were more likely to be prescribed antihistamines, antidepressants, anti-inflammatories, narcotics, gastrointestinal (GI) medications, anti-asthmatics or hypnotics. Physical exercise at least once a week (vs < once a week) was associated with lower odds of poor SQ (AOR = 0.55-0.85, P < 0.05). Poorer SQ was associated with significantly lower mental and physical component summary (MCS/PCS) scores (MCS scores 1.9-13.2 points lower and PCS scores 1.5-7.7 points lower when SQ scores were <10 vs 10). The RR of mortality was 16% higher for HD patients with poor SQ. CONCLUSIONS: Poor SQ is common among HD patients in DOPPS countries and is independently associated with several QOL indices, medication use patterns and mortality. Assessment and management of SQ should be an important component of care.

Moist LM, Bragg-Gresham JL, Pisoni RL, Saran R, Akiba T, Jacobson SH, Fukuhara S, Mapes DL, Rayner HC, Saito A, Port FK. Travel time to dialysis as a predictor of health-related quality of life, adherence, and mortality: The Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis 2008; 51(4): 641-650

BACKGROUND: Longer travel time to the dialysis unit creates a substantial burden for many patients. This study evaluated the effect of self-reported 1-way travel time to hemodialysis on mortality, health-related quality of life (HR-QOL), adherence, withdrawal from dialysis therapy, hospitalization, and transplantation. STUDY DESIGN: Prospective observational cohort. SETTING & PARTICIPANTS: Patients enrolled in the Dialysis Outcomes and Practices Patterns Study who completed a patient questionnaire (n = 20,994). PREDICTOR: One-way travel time to hemodialysis treatment, categorized as 15 or less, 16 to 30, 31 to 60, and longer than 60 minutes. Covariates included demographics, comorbid conditions, serum albumin level, time on dialysis therapy, and country. OUTCOME & MEASUREMENT: HR-QOL was examined by using a linear mixed model. Cox proportional hazards regression was used to examine associations with mortality, withdrawal from dialysis therapy, hospitalization, and transplantation. RESULTS: Longer travel time was associated with greater adjusted relative risk (RR) of death (P = 0.05 for overall trend). Adjusted HR-QOL subscales were significantly lower for those with longer travel times compared with those traveling 15 minutes or less. There were no associations of travel time with withdrawal from dialysis therapy (P = 0.6), hospitalization (P = 0.4), or transplantation (P = 0.7). LIMITATIONS: The questionnaire nonresponse rate was substantial, and nonresponders were older, with more comorbid conditions. Travel time was assessed by using a single nonvalidated question. CONCLUSIONS: Longer travel time is associated significantly with greater mortality risk and decreased HR-QOL. Exploring opportunities to decrease travel time should be incorporated into the dialysis clinical routine.

Lopes AA, Elder SJ, Ginsberg N, Andreucci VE, Cruz JM, Fukuhara S, Mapes DL, Saito A, Pisoni RL, Saran R, Port FK. Lack of appetite in haemodialysis patients: Associations with patient characteristics, indicators of nutritional status, and outcomes in the international DOPPS. Nephrol Dial Transplant 2007; 22(12): 3538-3546

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) = 2.23; 95% confidence interval (CI) = 1.90-2.62] and the risk of hospitalization 33% higher (RR = 1.33; 95% CI = 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.

Witten B. DOPPS: Making the Case for Using Functioning and Well-Being Surveys to Assess Risk and Improve Outcomes. Journal of Nephrology Social Work 2007; 26: 32-40

Multiple studies of people with chronic kidney disease and kidney failure included measurement of functioning and well-being using the SF-36 or the Kidney Disease Quality of Life™ survey. Those on dialysis have scored consistently lower than norms. The Dialysis Outcomes and Practice Patterns Study found that in patients on hemodialysis low physical component summary and mental component summary scores were significantly associated with higher risks of hospitalization, death, and dialysis withdrawal. Higher scores on the "down in the dumps" and "downhearted and blue" questions were significantly associated with higher risk of hospitalization, death, and dialysis withdrawal. Preliminary research has found that rehabilitation interventions can improve functioning and well-being and that scores can help direct team care planning. More research is needed to determine which clinical social work interventions are associated with improved scores and outcomes. Answering this question could greatly improve the lives of those with kidney disease, save taxpayers' money, and help dialysis centers stay financially viable.

Lambie M, Rayner HC, Bragg-Gresham JL, Pisoni RL, Andreucci VE, Canaud B, Port FK, Young EW. Starting and withdrawing haemodialysis — associations between nephrologists’ opinions, patient characteristics, and practice patterns (data from the Dialysis Outcomes and Practice Patterns Study). Nephrol Dial Transplant 2006; 21: 2814-2820

BACKGROUND: The incidence and prevalence of haemodialysis vary widely across countries. The variation may be attributable to differences in the incidence of end-stage renal disease and/or in the availability of haemodialysis. Previous studies have identified differences in nephrologists' opinions about the availability of haemodialysis and its appropriateness for patients with comorbidities. We studied the associations between nephrologists' opinions, availability of haemodialysis, patient characteristics and comorbidities, and facilities' withdrawal rates. METHODS: Most of our analyses used data from 242 haemodialysis units in six countries (France, Germany, Italy, Spain, UK and the USA) in the first phase of the Dialysis Outcomes and Practice Patterns Study (DOPPS I). Opinions about access to and practice patterns in dialysis facilities, measured by the level of agreement with standardized statements, were collected from medical directors and nurse managers. A sub-analysis considered data from corresponding facilities in DOPPS II. RESULTS: We found wide variations in the prevalence of waiting lists for new dialysis patients (UK 60%; USA 25%; Germany 0%; P < 0.05), in agreement with starting haemodialysis for patients with advanced age, dementia and comorbidities (UK, France < USA < other countries; P < 0.05), and in agreement with withdrawing dialysis (other countries < UK/USA; P < 0.05). The estimated glomerular filtration rate at the start of dialysis was not significantly different in units with waiting lists. Significant associations were found between nephrologists' opinions and the odds of patients being > or =80 years old, and between opinions and the rate and relative risk of withdrawal of haemodialysis. No significant associations were found between opinions and patients' comorbidities or dependency. CONCLUSION: Differences within and across countries in nephrologists' opinions regarding starting and withdrawing haemodialysis reflect differences in access to haemodialysis and the practice of withdrawal of haemodialysis in their facilities.

Mapes DL, Bragg-Gresham JL, Bommer J, Fukuhara S, McKevitt P, Wikstrom B, Lopes AA. Health-Related Quality of Life in the DOPPS. Am J Kidney Dis 2004; 44 (Suppl 2):S54-S60

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.

Lopes AA, Albert JM, Young EW, Satayathum S, Pisoni RL, Andreucci VE, Mapes DL, Mason NA, Fukuhara S, Wikström B, Saito A, Port FK. Screening for depression in hemodialysis patients: Associations with diagnosis, treatment, and outcomes in the DOPPS. Kidney Int 2004; 66:2047-2053

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 > or =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 > or =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 > or =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 > or =10, respectively. In Cox models adjusted for several comorbidities, CES-D scores > or =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.

Lopes AA, Bragg-Gresham JL, Satayathum S, McCullough K, Pifer T, Goodkin DA, Mapes D, Young E, Wolfe R, Held P, Port FK for the Worldwide DOPPS Committee. Health-related quality of life and associated outcomes among hemodialysis patients of different ethnicities in the United States: The Dialysis Outcomes and Practice Patterns Study. Am J Kidney Dis 2003; 41(3): 605-615

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. Copyright 2003 by the National Kidney Foundation, Inc.

Fukuhara S, Lopes AA, Bragg-Gresham JL, Kurokawa K, Mapes DL, Akizawa T, Bommer J, Canaud BJ, Port FK, Held PJ; Worldwide Dialysis Outcomes and Practice Patterns Study. Health-related quality of life among dialysis patients on three continents: the Dialysis Outcomes and Practice Patterns Study. Kidney Int. 2003 Nov; 64(5):1903-10

BACKGROUND: Assessing health-related quality of life (HRQOL) can provide information on the types and degrees of burdens that afflict patients with chronic medical conditions, including end-stage renal disease (ESRD). Several studies have shown important international differences among ESRD patients treated with hemodialysis, but no studies have compared these patients' HRQOL. Our goal was to document international differences in HRQOL among dialysis patients and to identify possible explanations of those differences. METHODS: We examined data from the Dialysis Outcomes and Practice Patterns Study (DOPPS), a prospective, observational, international study of hemodialysis patients. We performed a cross-sectional analysis of DOPPS data from the United States, five countries in Europe (France, Germany, Italy, Spain, and the United Kingdom), and Japan. Linear mixed models were used to analyze differences in HRQOL, using the KDQOL-SFTM. Norm-based scores were used to minimize cultural response bias. Linear regression analysis was used to adjust for confounding factors. Other variables included demographic variables, comorbidities, primary cause of ESRD, complications of ESRD and treatment, and socioeconomic status. RESULTS: In all generic HRQOL subscales, patients on all three continents had much lower scores than their respective population norm values. Patients in the United States had the highest scores on the mental health subscale and the highest mental component summary scores. Japanese patients reported better physical functioning than did patients in the United States or Europe, but they also reported the greatest burden of kidney disease. Overall, these differences remained even after adjusting for possible confounders. CONCLUSION: On all three continents, ESRD and hemodialysis profoundly affect HRQOL. In the United States, the effects on mental health are smaller than in other countries. Japanese hemodialysis patients perceived that their kidney disease imposes a greater burden, but their physical functioning was significantly higher. Different distributions of socioeconomic factors and major comorbid conditions could explain little of this difference in physical functioning. Other possible factors, such as quality of dialysis and related health care, deserve careful study.

Callahan MB. Designing Nephrology Social Work Interventions to Improve Self-Management and Adherence Based on the Dialysis Outcomes and Practice Patterns Study. Journal of Nephrology Social Work 2007; 26: 11-17

Along with other studies, the Dialysis Outcomes and Practice Patterns Study demonstrates that adherence to treatment has been shown to impact morbidity and mortality for people with chronic kidney disease. Dialysis treatment teams continue to seek ways to help patients understand the short- and long-term effects of nonadherence to medical recommendations. This article highlights nephrology social work interventions designed to improve patient self-management skills through cognitive behavioral techniques.

Johnstone S. Depression Management for Hemodialysis Patients: Using DOPPS Data to Further Guide Nephrology Social Work Intervention. Journal of Nephrology Social Work 2007; 26: 18-31

The future of disease management for the chronic kidney disease population will need to focus beyond the physiological markers of dialysis adequacy, albumin, and blood pressure and include psychosocial and behavioral health variables that also mediate treatment outcomes. A growing body of literature, including the Dialysis Outcomes and Practice Patterns Study (DOPPS), has linked depression to survival and health care utilization in people on hemodialysis. DOPPS identified the need for improved identification and management of depression. It also provides further guidance for nephrology social workers, who will continue to serve as the lead mental health providers to this at-risk population. This article reviews this literature and proposes practice guidelines for nephrology social workers to help manage depression in the dialysis clinic setting.

Witten B. DOPPS: Making the Case for Using Functioning and Well-Being Surveys to Assess Risk and Improve Outcomes. Journal of Nephrology Social Work 2007; 26: 32-40

Multiple studies of people with chronic kidney disease and kidney failure included measurement of functioning and well-being using the SF-36 or the Kidney Disease Quality of Life™ survey. Those on dialysis have scored consistently lower than norms. The Dialysis Outcomes and Practice Patterns Study found that in patients on hemodialysis low physical component summary and mental component summary scores were significantly associated with higher risks of hospitalization, death, and dialysis withdrawal. Higher scores on the "down in the dumps" and "downhearted and blue" questions were significantly associated with higher risk of hospitalization, death, and dialysis withdrawal. Preliminary research has found that rehabilitation interventions can improve functioning and well-being and that scores can help direct team care planning. More research is needed to determine which clinical social work interventions are associated with improved scores and outcomes. Answering this question could greatly improve the lives of those with kidney disease, save taxpayers' money, and help dialysis centers stay financially viable.

Funk-Schrag W. Diabetes: Dialysis Outcomes and Practice Patterns Study Results and Innovative Patient Care Programs. Journal of Nephrology Social Work 2007; 26: 41-44

Diabetes is now the leading cause of chronic kidney disease (CKD) in the United States and is also growing in numbers worldwide. The cost of caring for people with diabetes and CKD is escalating and is especially highest from the month prior to starting dialysis to 6 months after beginning dialysis. According to the Dialysis Outcomes Practice Patterns Study (DOPPS), a person with kidney failure who also has diabetes is at higher risk for hospitalization, mortality, retinopathy, blindness and lower limb amputation. The dialysis health care team is challenged to develop new methods of caring for people with diabetes and CKD. Innovative programs reviewed in this article show improved clinical outcomes and an increase in patients' ability to self-manage their disease.

King K. Withdrawal from Dialysis: The Literature, DOPPS, and Implications for Practice. Journal of Nephrology Social Work 2007; 26: 45-53

Summary: Withdrawal from dialysis is a common occurrence in the United States, although withdrawal rates vary throughout the world. DOPPS data focusing on withdrawal and the similarities and differences among various countries are reported. Literature related to withdrawal is explored and includes the decision-making process, the reasons underlying the decision, patient characteristics, and the dying experience. Finally, practice suggestions to enhance the delivery of care during the decision-making process and at end of life are offered.

McKevitt PM, Bommer J, Bragg-Gresham JL, Pisoni RL, Keen ML, Lopes AA, Andreucci VE, Marumo F, Akiba T, Akizawa T, Port FK. DOPPS and the Elderly: Implications for Nephrology Social Work Practice. Journal of Nephrology Social Work 2007; 26: 55-65

Over the past three and a half decades, since Medicare funding became available for people with end-stage renal disease in the United States, the numbers of elderly on dialysis have increased dramatically and now represent well over half of the dialysis population. Beginning in the late 1970s, psychosocial issues and challenges faced by elderly people on dialysis emerged in the literature. Among other findings, these studies identified increased comorbidities and depressive symptomatology, decreased physical and mental functioning, and improved compliance. These studies were limited in size and represented either single facilities or multiple regional facilities. The Dialysis Outcomes and Practice Patterns Study (DOPPS) is an observational, longitudinal study providing a wide range of data on a sample of people on hemodialysis randomly selected from nationally representative samples of dialysis facilities in 12 countries. In the current investigation, DOPPS findings indicate that the mean age of people on hemodialysis in nearly all study countries is at least 60 years, that cardiac disease is one of the most common comorbidities, that elderly patients are at significantly greater risk for malnutrition, and that compliance with treatment schedules is significantly better in elderly people. Health-Related Quality of Life scores demonstrate that physical functioning is markedly decreased, though mental component summary scores did not decrease with age. Finally, risk of death and withdrawal from dialysis are significantly higher for the elderly. Psychosocial evaluation of the elderly and social work intervention to maximize social, psychological, mental, and physical functioning are addressed, as well as end-of-life issues.

Satayathum S, Pisoni RL, McCullough KP, Merion RM, Wikström B, Levin N, Chen K, Wolfe RA, Goodkin DA, Piera L, Asano Y, Kurokawa K, Fukuhara S, Held PJ, Port FK. Kidney transplantation and wait-listing rates from the international Dialysis Outcomes and Practice Patterns Study (DOPPS). Kidney Int. 2005; 68(1):330-7

BACKGROUND: The international Dialysis Outcomes and Practice Patterns Study (DOPPS I and II) allows description of variations in kidney transplantation and wait-listing from nationally representative samples of 18- to 65-year-old hemodialysis patients. The present study examines the health status and socioeconomic characteristics of United States patients, the role of for-profit versus not-for-profit status of dialysis facilities, and the likelihood of transplant wait-listing and transplantation rates. METHODS: Analyses of transplantation rates were based on 5267 randomly selected DOPPS I patients in dialysis units in the United States, Europe, and Japan who received chronic hemodialysis therapy for at least 90 days in 2000. Left-truncated Cox regression was used to assess time to kidney transplantation. Logistic regression determined the odds of being transplant wait-listed for a cross-section of 1323 hemodialysis patients in the United States in 2000. Furthermore, kidney transplant wait-listing was determined in 12 countries from cross-sectional samples of DOPPS II hemodialysis patients in 2002 to 2003 (N= 4274). RESULTS: Transplantation rates varied widely, from very low in Japan to 25-fold higher in the United States and 75-fold higher in Spain (both P values <0.0001). Factors associated with higher rates of transplantation included younger age, nonblack race, less comorbidity, fewer years on dialysis, higher income, and higher education levels. The likelihood of being wait-listed showed wide variation internationally and by United States region but not by for-profit dialysis unit status within the United States. CONCLUSION: DOPPS I and II confirmed large variations in kidney transplantation rates by country, even after adjusting for differences in case mix. Facility size and, in the United States, profit status, were not associated with varying transplantation rates. International results consistently showed higher transplantation rates for younger, healthier, better-educated, and higher income patients.

Vascular Access

Saran R, Elder SJ, Goodkin DA, Akiba T, Ethier J, Rayner HC, Saito A, Young EW, Gillespie BW, Merion RM, Pisoni RL. Enhanced Training in Vascular Access Creation Predicts Arteriovenous Fistula Placement and Patency in Hemodialysis Patients: Results From the Dialysis Outcomes and Practice Patterns Study. Ann Surg 2008; 247(5): 885-891

OBJECTIVE: To investigate whether intensity of surgical training influences type of vascular access placed and fistula survival. SUMMARY BACKGROUND DATA: Wide variations in fistula placement and survival occur internationally. Underlying explanations are not well understood. METHODS: Prospective data from 12 countries in the Dialysis Outcomes and Practice Patterns Study were analyzed; outcomes of interest were type of vascular access in use (fistula vs. graft) in hemodialysis patients at study entry and time from placement until primary and secondary access failures, as predicted by surgical training. Logistic and Cox regression models were adjusted for patient characteristics and time on hemodialysis. RESULTS: During training, US surgeons created fewer fistulae (US mean = 16 vs. 39-426 in other countries) and noted less emphasis on vascular access placement compared with surgeons elsewhere. Significant predictors of fistula versus graft placement in hemodialysis patients included number of fistulae placed during training (adjusted odds ratio [AOR] = 2.2 for fistula placement, per 2 times greater number of fistulae placed during training, P < 0.0001) and degree of emphasis on vascular access creation during training (AOR = 2.4 for fistula placement, for much-to-extreme emphasis vs. no emphasis, P = 0.0008). Risk of primary fistula failure was 34% lower (relative risk = 0.66, P = 0.002) when placed by surgeons who created >/=25 (vs. <25) fistulae during training. CONCLUSIONS: Surgical training is key to both fistula placement and survival, yet US surgical programs seem to place less emphasis on fistula creation than those in other countries. Enhancing surgical training in fistula creation would help meet targets of the Fistula First Initiative.

Hasegawa T, Elder SJ, Bragg-Gresham JL, Pisoni RL, Yamazaki S, Akizawa T, Jadoul M, Rayner HC, Port FK, Fukuhara S. Consistent aspirin use associated with improved arteriovenous fistula survival among incident hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study. Clin J Am Soc Nephrol 2008;3: 1373-1378

BACKGROUND AND OBJECTIVES: The relationship between aspirin use and arteriovenous fistula (AVF) survival has been lacking. The aim of this study was to evaluate the association between AVF survival and aspirin use. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Data on 2815 incident hemodialysis patients (on dialysis < or= 30 d) using an AVF at enrollment into the Dialysis Outcomes and Practice Patterns Study between 1996 and 2004 were analyzed. Cox regression was used to examine the association between aspirin use and the risk of final AVF failure, first AVF failure, and a gastrointestinal bleeding event. Aspirin use was determined at baseline and one year later. Patients using aspirin at baseline and one year later were considered consistent aspirin users. All models accounted for facility clustering effects and were adjusted for age, race, gender, body mass index, prior permanent access failure, prior placement of a catheter, 10 comorbid conditions, laboratory data, and other medications, and stratified by regions. RESULTS: Consistent aspirin use was significantly related to a lower risk of final AVF failure. Facility-level analysis, which may reduce confounding by indication, also showed a nearly significant trend of reduced risk of final AVF failure with greater prevalence of consistent aspirin use within dialysis facilities (P for trend = 0.07). The occurrence of a new gastrointestinal bleeding event during the study period was not associated with aspirin use. CONCLUSIONS: These results suggest that consistent aspirin use may be beneficial for AVF survival among incident hemodialysis patients.

Port FK, Pisoni RL, Bommer J, Locatelli F, Jadoul M, Eknoyan G, Kurokawa K, Canaud BJ, Finley MP, Young EW. Improving Outcomes for Dialysis Patients in the International Dialysis Outcomes and Practice Patterns Study. Clin J Am Soc Nephrol 2006; 1(2): 246-255

The international Dialysis Outcomes and Practice Patterns Study (DOPPS) is well suited to evaluate levels of deviation from emerging and established guidelines to clinical practice of hemodialysis, over time and by country. The DOPPS can also evaluate whether the target levels that are chosen in the guidelines are in agreement with outcomes such as elevated risk for mortality, hospitalization, and vascular access failure. At a special DOPPS symposium during the 2004 congress of the American Society of Nephrology, the authors presented such findings; key points from that symposium are presented in this article, focusing on vascular access, mineral metabolism, dialysis dose, and anemia management. Although an observational study cannot prove causality, DOPPS suggests large opportunities to improve care and outcomes of dialysis patients. The international perspective of DOPPS assists in the new efforts for international guidelines. Some encouraging trends in recent years are documented in these areas.

Saran R, Dykstra DM, Pisoni RL, Akiba T, Akizawa T, Canaud B, Chen K, Piera L, Saito A, Young EW. Timing of first cannulation and vascular access failure in haemodialysis: An analysis of practice patterns at dialysis facilities in the DOPPS. Nephrol Dial Transplant 2004; 19(9):2334-2340

BACKGROUND: Optimal waiting time before first use of vascular access is not known. METHODS: Two practices-first cannulation time for fistulae and grafts, and blood flow rate-were examined as potential predictors of vascular access failure in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Access failure (defined as time to first failure or first salvage intervention) was modelled using Cox regression. RESULTS: Among 309 haemodialysis facilities, 2730 grafts and 2154 fistulae were studied. For grafts, first cannulation typically occurred within 2-4 weeks at 62% of US, 61% of European and 42% of Japanese facilities. For fistulae, first cannulation occurred <2 months after placement in 36% of US, 79% of European and 98% of Japanese facilities. Overall, the relative risk (RR) of graft failure in Europe was lower compared with the USA (RR = 0.69, P = 0.04). The RR of graft failure (reference group = first cannulation at 2-3 weeks) was 0.84 with first cannulation at <2 weeks (P = 0.11), 0.94 with first cannulation at 3-4 weeks (P = 0.48) and 0.93 with first cannulation at >4 weeks (P = 0.48). The RR of fistula failure was 0.72 with first cannulation at <4 weeks (P = 0.08), 0.91 at 2-3 months (P = 0.43) and 0.87 at >3 months (P = 0.31) (reference group = first cannulation at 1-2 months). Facility median blood flow rate was not a significant predictor of access failure. CONCLUSIONS: Earlier cannulation of a newly placed vascular access at the haemodialysis facility level was not associated with increased risk of vascular access failure. Potential for confounding due to selection bias cannot be excluded, implying the importance of clinical judgement in determining time to first use of vascular access.

Port FK, Pisoni RL, Bragg-Gresham JL, Satayathum SS, Young EW, Wolfe RA, Held PJ. DOPPS estimates of patient life years attributable to modifiable hemodialysis practices in the United States. Blood Purif. 2004; 22(1):175-80

Data from the Dialysis Outcomes and Practice Patterns Study (DOPPS) allow estimation of the percentage of patients outside published hemodialysis guidelines and their associated mortality risk. We estimated the number of life years that could be gained from adherence to four of these guidelines and two other modifiable practices, i.e. dialysis dose, phosphate control, improved anemia, partial correction of serum albumin, reduced interdialytic weight gain and less use of catheters for vascular access. We extrapolated DOPPS data on these practices and guidelines to the US hemodialysis population for a 5-year projected period. Of the practices we examined, the highest relative risk of mortality was associated with having albumin <3.5 g/dl (relative risk=1.38, p<0.0001); 20.5% of the patients in the study fell outside the target range. The adjusted sum of the patient years attributable to all six practice patterns was 143,617; a more conservative estimate, modeling life years potentially gained by bringing half of all patients outside targets within them, is 69,367. The magnitude of potential savings in life years should encourage greater adherence to guidelines and practices that are significantly associated with better survival.

Rayner HC, Pisoni RL, Gillespie BW, Goodkin DA, Akiba T, Akizawa T, Saito A, Young EW, Port FK. Creation, cannulation and survival of arteriovenous fistulae: data from the Dialysis Outcomes and Practice Patterns Study. Kidney Int. 2003; 63(1):323-30

BACKGROUND: An arteriovenous (A-V) fistula is the optimal vascular access for hemodialysis. The National Kidney Foundation Dialysis Outcomes Quality Initiative (DOQI) recommends that fistulae should mature for at least one month before cannulation, but this recommendation is not evidence-based. If fistulae are created prior to ESRD and cannulation is possible earlier without compromising fistula survival, the need for temporary catheters would be reduced. METHODS: Prospective observational data were analyzed for a random sample (N = 3674) of incident patients at the time of initiating hemodialysis, hemofiltration or hemodiafiltration in 309 facilities in France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States, taking part in the Dialysis Outcomes and Practice Patterns Study (DOPPS). RESULTS: Although the proportion of patients who had pre-dialysis care by a nephrologist differed little between countries, there were large variations in the proportion of patients who commenced hemodialysis via an A-V fistula, A-V graft or central venous catheter. The usual time interval between referral and creation of A-V fistulae also differed greatly between countries. For new hemodialysis (HD) patients initiating HD with an A-V fistula (N = 894) the following results were observed: (1). median time to first cannulation varied greatly between countries: Japan and Italy (25 and 27 days), Germany (42 days), Spain and France (80 and 86 days), UK and US (96 and 98 days). (2). No association was found between cannulation 28 days for patient characteristics of age, gender, and fifteen different classes of patient co-morbid factors. (3). Risk of A-V fistula failure was increased for incident patients who had a prior temporary access [relative risk (RR) = 1.81, P = 0.01] or who were female (RR = 1.52, P = 0.02). (4). Cannulation 14 days. (5) No significant difference in A-V fistula failure was seen for fistulae cannulated in 15 to 28 days compared with 43 to 84 days. CONCLUSION: Significant differences in clinical practice currently exist between countries regarding the creation of A-V fistulae prior to starting hemodialysis and the timing of initial cannulation. Cannulation within 14 days of creation is associated with reduced long-term fistula survival. Fistulae ideally should be left to mature for at least 14 days before first cannulation.

Young EW, Dykstra DM, Goodkin DA, Mapes DL, Wolfe RA, Held PJ. Hemodialysis vascular access preferences and outcomes in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Kidney Int 2002; 61: 2266-2271

BACKGROUND: Synthetic 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. METHODS: The 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. RESULTS: Grafts 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. CONCLUSIONS: No 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.

Pisoni RL, Young EW, Dykstra DM, Greenwood RN, Hecking E, Gillespie B, Wolfe RA, Goodkin DA, Held PJ. Vascular access use in Europe and the United States: Results from the DOPPS. Kidney Int 2002; 61: 305-316

Background A direct broad-based comparison of vascular access use and survival in Europe (EUR) and the United States (US) has not been performed previously. Case series reports suggest that vascular access practices differ substantially in the US and EUR. We report on a representative study (DOPPS) which has used the same data collection protocol for> 6400 hemodialysis (HD) patients to compare vascular access use at 145 US dialysis units and 101 units in five EUR countries (France, Germany, Italy, Spain, and the United Kingdom). Methods Logistic analysis evaluated factors associated with native arteriovenous fistula (AVF) versus graft use or permanent access versus catheter use for prevalent and incident HD patients. Times to failure for AVF and graft were analyzed using Cox proportional hazards regression. Results AVF was used by 80% of EUR and 24% of US prevalent patients, and was significantly associated with younger age, male gender, lower body mass index, non-diabetic status, lack of peripheral vascular disease, and no angina. After adjusting for these factors, AVF versus graft use was still much higher in EUR than US (AOR = 21, P < 0.0001). AVF use within facilities varied from 0 to 87% (median 21%) in the US, and 39 to 100% (median 83%) in EUR. For patients who were new to HD, access use was: 66% AVF in EUR versus 15% in US (AOR = 39, P < 0.0001), 31% catheters in EUR vs. 60% in US, and 2% grafts in EUR vs. 24% in US. In addition, 25% of EUR and 46% of US incident patients did not have a permanent access placed prior to starting HD. In EUR, 84% of new HD patients had seen a nephrologist for> 30 days prior to ESRD compared with 74% in the US (P < 0.0001); pre-ESRD care was associated with increased odds of AVF versus graft use (AOR = 1.9, P = 0.01). New HD patients had a 1.8-fold greater odds (P = 0.002) of starting HD with a permanent access if a facility's typical time from referral to access placement was 2 weeks. AVF use when compared to grafts was substantially lower (AOR = 0.61, P = 0.04) when surgery trainees assisted or performed access placements. When used as a patient's first access, AVF survival was superior to grafts regarding time to first failure (RR = 0.53, P = 0.0002), and AVF survival was longer in EUR compared with the US (RR = 0.49, P = 0.0005). AVF and grafts each displayed better survival if used when initiating HD compared with being used after patients began dialysis with a catheter. Conclusion Large differences in vascular access use exist between EUR and the US, even after adjustment for patient characteristics. The results strongly suggest that a facility's preferences and approaches to vascular access practice are major determinants of vascular access use.

Saran R, Dykstra DM, Wolfe RA, Gillespie BM, Held PJ, Young EW. Association between vascular access failure and the use of specific drugs: The Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis 2002; 40(6): 1255-1263

BACKGROUND: Several drugs have been proposed to improve vascular access patency based on favorable anticoagulant, antiplatelet, or vascular-remodeling properties. However, there is little evidence to guide drug strategies. METHODS: The association between vascular access patency and the use of specific drugs was studied in a large sample of US hemodialysis patients enrolled in the Dialysis Outcomes and Practice Patterns Study, an international, prospective, observational study. In general, it was assumed that the drugs were prescribed for indications unrelated to vascular access preservation. Primary (unassisted survival) and secondary vascular access patency (assisted survival) were modeled using Cox regression (time to failure) adjusted for age, sex, race, body mass index, incidence to end-stage renal disease, diabetes mellitus, hypertension, valvular disease, chronic obstructive pulmonary disease, aortic aneurysm, deep-vein thrombosis, number of previous permanent accesses, and facility-clustering effects. Fistulae (n = 900) and grafts (n = 1,944) were evaluated separately. Technical failures within the first 30 days of surgical placement were excluded from the analysis. RESULTS: Treatment with calcium channel blockers was associated with improved primary graft patency (relative risk [RR] for failure, 0.86; P = 0.034). Aspirin therapy was associated with better secondary graft patency (RR, 0.70; P < 0.001). Treatment with angiotensin-converting enzyme inhibitors was associated with significantly better secondary fistula patency (RR, 0.56; P = 0.010). Patients administered warfarin showed worse primary graft patency (RR, 1.33; P = 0.037). CONCLUSION: These findings should help guide clinical trial priorities toward vascular access preservation using one or more of the agents that show significant risk reduction for access failure in this study. Copyright 2002 by the National Kidney Foundation, Inc.

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