Postdialysis outcomes associated with consistent anemia treatment in predialysis patients with chronic kidney disease.

AIMS: Anemia and cardiovascular (CV) events are major complications of chronic kidney disease (CKD) during dialysis. We conducted a retrospective observational study in CKD patients with anemia to evaluate the association between predialysis use of erythropoiesis-stimulating agents (ESAs) and postdialysis CV outcomes. METHODS: The study analyzed claims data on incident hemodialysis patients aged > or = 18 years (identified between January 2000 and November 2005). Patients were identified as anemic and ESA-treated prior to dialysis. ESA treatment was categorized into 4 consistency groups (from least to most consistent ESA use). RESULTS: Of 5,848 hemodialysis patients, 52% were identified as anemic prior to onset of dialysis. Predialysis ESA treatment was received by 62% of anemic patients, with only 23% receiving the most consistent treatment. The risk of a CV event was significantly lower for the ESA-treated compared with ESA-untreated patients (relative risk (RR) 0.70, 95% (95% confidence intervals (CI) 0.61 - 0.82)). Compared with ESA-untreated, those who received ESAs had significantly lower risk of acute myocardial infarction (RR 0.65 (95% CI 0.44 - 0.95)) or inpatient mortality (RR 0.52 (95% CI 0.40 - 0.68)). ESA-treated patients in each of the 4 consistency groups had significantly lower risk of CV events compared with ESA-untreated patients, with the greatest benefit seen in patients who received most consistent ESA (RR 0.61 (95% CI 0.48 - 0.76)). CONCLUSIONS: This analysis suggests consistent ESA use to treat anemia of CKD in the predialysis period is associated with improved cardiovascular outcomes in postdialysis patients.

Hospital-acquired renal insufficiency: a prospective study.

Twenty-two hundred sixty-two consecutive medical and surgical admissions were evaluated prospectively to determine the contribution of iatrogenic factors to the development of renal insufficiency in hospital. Of 2,216 patients at risk, some degree of renal insufficiency developed in 4.9 percent. Decreased renal perfusion, postoperative renal insufficiency, radiographic contrast media, and aminoglycosides accounted for 79 percent of the episodes. Iatrogenic factors, broadly defined, accounted for 55 percent of all episodes. Poor prognostic indicators included oliguria, urine sediment abnormalities and, most importantly, severity of renal insufficiency; with an increase in serum creatinine of 3 mg/dl or greater, the mortality rate was 64 percent. Age, admission serum creatinine levels, and the number of episodes of renal insufficiency did not significantly affect outcome. We conclude that there is a substantial risk of the development of renal failure in hospital and that the mortality rate due to hospital-acquired renal insufficiency remains high.

Subcutaneous erythropoietin results in lower dose and equivalent hematocrit levels among adult hemodialysis patients: Results from the 1998 End-Stage Renal Disease Core Indicators Project.

The National Kidney Foundation's Dialysis Outcome Quality Initiative (NKF-DOQI) guidelines recommend that epoetin alfa should be administered by the subcutaneous route in hemodialysis patients. We determined whether hematocrit levels in hemodialysis patients differed by route of epoetin alfa administration after controlling for demographic factors and iron status. Data were available for 7,092 of the 7,658 patients randomly chosen for inclusion in the 1997 Health Care Financing Administration Core Indicators sample. Epoetin alfa was administered to 96% of the study cohort and was administered subcutaneously in 10% of patients. After controlling for hematocrit, patient characteristics, adequacy of dialysis, iron status, serum albumin, postdialysis weight, and duration of dialysis, the epoetin alfa dose by the intravenous route was 193.6 units/kg/wk (95% confidence interval, 189.5 to 197.8 units/kg/wk) compared with 167.4 units/kg/wk (95% confidence interval, 153.9 to 180.8 units/kg/wk) for the subcutaneous route (P < 0.001). The mean hematocrit for the subcutaneous route was 32.7% +/- 3.4% and for the intravenous route was 33.0% +/- 3.2% (P < 0.05). Factors independently associated with increased hematocrit included male gender, white race, older patient age, greater number of years on dialysis, higher serum albumin concentration, higher urea reduction ratio, and percent transferrin saturation (all P < 0.001). After controlling for patient factors and weekly epoetin alfa dose, there was no association between route of epoetin alfa administration and hematocrit level (P = 0.144). Patients receiving epoetin alfa by the subcutaneous route had comparable hematocrit values using a lower epoetin alfa dose than patients receiving epoetin alfa intravenously. These data support the NKF-DOQI recommendation that epoetin alfa be administered subcutaneously in long-term hemodialysis patients.

Management of anemia in chronic kidney disease (predialysis) patients: nephrology nursing implications.

Anemia is a frequent problem in patients with chronic kidney disease (CKD) who are not yet receiving dialysis and can lead to major health complications is left untreated. The successful management of these patients entails repletion of iron stores, often through use of intravenous iron, particularly in patients receiving erythropoietin therapy. To encourage patient compliance with anemia management protocols, the nephrology nurse can play a key role in patient education in reducing barriers to proper management and in raising the awareness of the benefits of treating this condition.

The forum of ESRD networks: past, present and future.

The increasing visibility and credibility of the Forum of ESRD Networks in the national ESRD landscape is due, in large part, to the Forum's longstanding and unwavering advocacy for improved ESRD patient outcomes through the application of continuous quality improvement methodologies and the development of a data infrastructure which encompasses a universal patient sample. This advocacy is untainted by the agenda of any single professional constituency, and its success is limited only by the commitment that all stakeholders (payers, providers, and patients) have to the process. The data infrastructure, SIMS-VISION, is almost a reality, and has the potential to significantly improve the quality of care through the provision of provider-specific profiles to drive quality improvement. The application of quality improvement principles themselves will take longer, and requires the commitment of facility medical directors, whom the Forum hopes to reach through its collaborative education project with the RPA. Through its clearinghouse activities, the Forum hopes to foster evidence-based medicine, increasing provider awareness of clinical practice guidelines and other literature which may improve the quality of patient care. The Forum's strategic plans for achieving its goals closely parallel the recommendations of the President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry, and emphasize not only the information infrastructure, quality measuring/reporting, and evidence-based medicine, but also enhancing patient participation, building partnerships, and facilitating education and research. The Forum's strategic plan, as reconfigured according to the President's Advisory Commission domains, has been endorsed by the Renal Coalition as the national renal quality agenda, and the Coalition's constituent organizations are exploring projects and funding sources to achieve some of these goals as well.

Quality and accountability in the ESRD program.

The quality of care received by patients with end-stage renal disease (ESRD) in the United States has received considerable public attention during the past several years because of a number of social, economic, and political factors. There has been a lingering impression that the poorer survival of dialysis patients in the United States, compared with their counterparts in other industrialized countries, is because of process factors for which there are opportunities for improvement, rather than just an adverse case mix. Recent reports by the Office of the Inspector General and the General Accounting Office have recommended that the Health Care Financing Administration (HCFA) improve its oversight of dialysis providers and hold the providers more accountable for their patient care outcomes. This requires the development of validated clinical performance measures that, in turn, should be derived from evidence-based clinical practice guidelines. The dual oversight model, with the state survey agencies agencies performing a quality assurance function to require facilities to meet minimal standards of operation (Medicare's conditions of participation) to prevent patient harm, and with the ESRD Networks performing a quality improvement function to bring processes and outcomes for all patients to a higher level, appears to be sound. HCFA's move toward increased provider accountability has included the development of facility-specific profiles for processes of care (dialysis adequacy) and outcomes (hemoglobin level and standardized mortality ratio), which may trigger state surveyor activities and that will be available for public scrutiny on a HCFA-sponsored web site. The adoption and application of continuous quality improvement methodologies at the dialysis provider level will be an important strategy for favorably positioning the facility in a competitive and demanding health care marketplace.

Data management to understand outcomes and trends in ESRD.

Although a number of databases currently exist for the end-stage renal disease (ESRD) program in the United States, these databases are difficult to use to drive continuous quality improvement (CQI) activities at the ESRD provider level. The largest databases, such as the United States Renal Data System (USRDS) and the Medicare billing system, can generate facility-specific profiles for a limited set of parameters, but these parameters are not appropriately derived and validated clinical performance measures (CPMs) and the data on which they are based are 1 to 2 years old. The ESRD Core Indicators Project uses a sampling methodology to generate annual "snapshots" of the ESRD program but cannot generate facility-specific profiles to drive CQI. The ESRD Networks have the capability of collecting provider-specific data to drive CQI activities by generating profiles based on validated CPMs, but the Networks have been hampered in doing so by an aging data management infrastructure. The Standardized Information Management System (SIMS) and the Vital Information System for Outcomes Improvement in Nephrology (VISION) projects will provide the electronic highway for transmission of data from the Networks to the Health Care Financing Administration and from ESRD providers to the Networks, respectively. This will allow for paperless real time collection, validation, analysis, and management of quality of care data to drive CQI activities at the provider level. The Data Management and Analysis Proposal (DMAP) of the Forum of ESRD Networks recommends the establishment of a virtual service bureau to integrate all of the above ESRD databases to facilitate national and focused quality improvement projects, provide user-friendly database access for scholarly activities, and link financial and clinical data sets to generate cost-effectiveness analyses.

Role of external oversight in quality activities: accreditation, credentialing, licensure, and deemed status.

There currently exist a number of organizations which provide quality oversight to the ESRD program in the United States. The state surveyors confirm that dialysis facilities comply with Medicare's conditions of coverage, but surveyor activities have traditionally followed a quality assurance rather than a continuous quality improvement (CQI) model. State surveyors focus primarily on nursing homes, so their content knowledge of ESRD quality issues may be limited. The ESRD Networks have CQI expertise on their staffs, and their quality agenda is driven by their medical review boards, whose members bring scientific and technical expertise from the provider community. The success of the Networks in achieving quality goals has been hampered by personnel and resource limitations and by inconsistent direction by the Health Care Financing Administration (HCFA). Texas has developed a dialysis facility licensure program that partners its ESRD Network and its Medicare state surveyors in quality oversight activities. This collaboration has led to improved patient outcomes and may prove to be a model for other states. Non-Medicare payers may contract with dialysis providers based on performance specifications that exceed those of Medicare's conditions of coverage. A private credentialing mechanism for dialysis facilities that satisfies the performance specifications of all payers has been proposed but, in the absence of deemed status for Medicare survey and certification activities, is unlikely to achieve widespread acceptance.

Implementing the Health Care Quality Improvement Program in the Medicare ESRD Program: a new era of quality improvement in ESRD.

Improving the quality of health care is a central challenge for America's health care system. The mission of the End-Stage Renal Disease (ESRD) program is to promote the quality, effectiveness, and efficiency of ESRD patient care and program administration. The program provides an ideal opportunity to demonstrate the use of information to help clinicians analyze and improve the care they deliver to patients in an ambulatory setting. This is possible because the program has established regional surveillance systems, called ESRD Networks, that gather information on the occurrence and outcomes of treatment of Medicare beneficiaries with ESRD. The Health Care Financing Administration, which is responsible for the administration of the program, and the renal community have worked together since 1990 to identify ways of incorporating new methods of quality improvement into the program. These methods include statistical evaluation of the processes and outcomes of care in dialysis populations; communicating recommended practices with clinical guidelines and algorithms; regional peer review and feedback (ie, technical assistance and/or collaborations for quality improvement); interventions that focus on the provision of assistance for quality improvement efforts; continuing collection and active feedback of data to providers; and a commitment to continue to evaluate and revise quality improvement activities to reflect lessons learned and newly identified needs. These ideas have been included in the 1994-1997 scope of work for the ESRD Networks and is called the ESRD Health Care Quality Improvement Program (HCQIP). This article describes the background for the ESRD HCQIP and the program's elements.

Failure of increased sodium avidity to facilitate renal acid excretion in dogs fed sulfuric acid.

Previous studies have suggested that the increment in renal acid excretion caused by sulfuric acid feeding is mediated solely by an interplay between the sulfate-induced increase in distal sodium delivery and the gradual augmentation of distal sodium reabsorption that occurs as sodium losses accumulate. This hypothesis predicts that if distal sodium reabsorption were stimulated sufficiently prior to the administration of sulfuric acid, excretion of the hydrogen ion load would occur promptly, thus obviating the fall in plasma bicarbonate or loss of cation that normally occurs. To test this prediction, we fed sulfuric acid (7 mEq of H+/kg/day) to dogs in which distal sodium avidity had been enhanced prior to acid feeding either by diuretic-induced sodium depletion (N = 6) or by deoxycorticosterone acetate 7.5 mg, twice a day and a low-sodium diet (N = 8). Contrary to expectation, over the first 3 days of acid feeding there was a significant fall in plasma bicarbonate (7.1 and 7.5 mEq/liter) and an increase in urinary sodium excretion (48 mEq in both groups). Moreover, changes in both plasma bicarbonate and urinary sodium excretion were similar to those observed previously (5.9 mEq/liter and 46 mEq, respectively) in normal dogs fed the same dose of sulfuric acid.

Anemia management of adult hemodialysis patients in the US results: from the 1997 ESRD Core Indicators Project.

BACKGROUND: The Health Care Financing Administration's End-Stage Renal Disease (ESRD) Core Indicators Project collects clinical information on prevalent adult patients receiving in-center hemodialysis (HD) care in the United States to assess the quality of care delivered. Although hematocrit values, transferrin saturations, and iron prescription practices have improved over the last five years, we sought to determine whether continued opportunities for improvement of this domain of care exist. METHODS: A random sample of 7292 adult in-center HD patients was selected. Dialysis facility staff provided clinical information for the period of October through December 1996 for 6858 (94%) patients; complete laboratory information was available from 4991 (73%) returned forms. Hematocrit values, transferrin saturations, serum ferritin concentrations, epoetin alfa dosing, and iron prescriptions were abstracted from patient medical records to assess anemia management practices. RESULTS: The mean hematocrit for this cohort was 32.6 +/- 3.5%. Seventy-two percent of patients had hematocrit values> 30%. Forty-two percent had hematocrit values of 33 to 36%, and 10% were severely anemic (hematocrit <28%). Ninety-four percent of the patients received epoetin alfa intravenously (i.v.) and 6% subcutaneously. The mean weekly dose was 202.4 +/- 137.2 units/kg. The mean transferrin saturation was 27.4 +/- 12.6%; 73% of patients had a mean transferrin saturation > or = 20%. The mean serum ferritin concentration was 386 +/- 422 ng/mL; 79 and 12% of patients had a serum ferritin concentration of> 100 and> 800 ng/mL, respectively. Nine percent of the sample (N = 434) had a transferrin saturation <20% and serum ferritin concentration <100 ng/mL. Regardless of the patient's transferrin saturation, approximately three fourths of the patients received either oral or i.v. iron, and only approximately one half of the patients received i.v. iron. Of the subset of patients with transferrin saturation <20% and serum ferritin concentration <800 ng/mL, only 53% were prescribed intravenous iron. Multivariate linear regression analysis revealed that serum albumin, urea reduction ratio, age, and transferrin saturation were significantly positively associated with hematocrit. Epoetin alfa dose and serum ferritin concentration were significantly and negatively associated with the hematocrit (P < 0.001). CONCLUSION: Although substantial improvements have been made in anemia management for adult in-center HD patients over the past five years, significant opportunities persist to improve iron prescription practices.