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Biomedical subjects

James P Ebben

Publications and source records attributed to James P Ebben.

9 recordsLinked to original sources

EPO adjustments in patients with elevated hemoglobin levels: provider practice patterns compared with recommended practice guidelines.

BACKGROUND: This study investigates provider practices regarding recombinant human erythropoietin (rHuEPO) dose when patient hemoglobin levels exceeded National Kidney Foundation-Dialysis Outcomes Quality Initiative target levels and reached 13 g/dL or greater (>or=130 g/L). METHODS: The study population (N = 167,796) was hemodialysis patients prevalent on January 1, 2003, who were on renal replacement therapy at least 90 days with Medicare as primary payer and rHuEPO claims in 2 or more consecutive months. Patient characteristics were obtained from the Centers for Medicare & Medicaid Services (CMS) Medical Evidence Report, and comorbid conditions were determined from Medicare claims. Providers and rHuEPO claims were linked by using CMS-assigned provider numbers and the CMS Annual End-Stage Renal Disease Facility Survey. Between-provider differences in patient characteristics were examined by using chi-square test, and provider effect on appropriate response, by using logistic regression. RESULTS: DaVita's percentage of monthly claims for patients with hemoglobin levels of 13 g/dL or greater (>or=130 g/L; 16.7%) and mean monthly rHuEPO dose (54,299 units) were highest. Dialysis Clinic Inc's percentage of such claims (2.0%) and mean monthly dose (38,687 units) were lowest. Dialysis Clinic Inc, Fresenius, and Renal Care Group had the highest percentage of recommended dose adjustments (mean, 70% of units); hospital-based units had the lowest (59%). By adjusted odds ratio, adjustments were 20% more likely for Dialysis Clinic Inc, Fresenius, and Renal Care Group compared with DaVita, National Nephrology Associates, hospital-based units, and independents (17% to 28% less likely). CONCLUSION: rHuEPO dose reduction practices are dependent on specific dialysis providers and whether units are hospital based or independent.

Adolescent↗

Projecting the number of patients with end-stage renal disease in the United States to the year 2015.

The size of the prevalent ESRD population in the United States increased dramatically during the 1990s, from 196,000 in 1991 to 382,000 in 2000. Incidence also increased considerably during the same period, from 53,000 to 93,000 per year. If previous trends in ESRD incidence and prevalence continue, then current levels of health care resources that are devoted to the care of these patients will eventually be unable to meet the demand. This study discusses a Markov model developed to predict ESRD incidence, prevalence, and mortality to the year 2015 and incorporating expected changes in age/race distributions, diabetes prevalence, ESRD incidence, and probability of death. The model predicted that by 2015 there will be 136,166 incident ESRD patients per year (lower/upper limits 110,989 to 164,550), 712,290 prevalent patients (595,046 to 842,761), and 107,760 ESRD deaths annually (96,068 to 118,220). Incidence and prevalence counts are expected to increase by 44 and 85%, respectively, from 2000 to 2015 and incidence and prevalence rates per million population by 32 and 70%, respectively. The financial and human resources that will be needed to care for these patients in 2015 will be considerably greater than in 2005.

Age Distribution↗

Reuse-associated mortality in incident hemodialysis patients in the United States, 2000 to 2001.

BACKGROUND: The impact of dialyzer reuse on the mortality of hemodialysis patients is debated. This study assesses reuse-associated mortality across US dialysis provider systems (for-profit, not-for-profit; hospital-based, and freestanding units) in incident patients. METHODS: Incident Medicare hemodialysis patients who initiated dialysis therapy from January 1, 2000, to December 31, 2001, were included and followed up to December 31, 2002. A 3-month entry period was used to determine comorbidity and disease severity. Applying various analytic approaches, mortality rates for patients treated with reused (or reprocessed) or single-use dialyzers were compared. Because of differences among dialysis units, facility clustering was addressed. RESULTS: Of 75,831 patients, 61,391 patients (81.0%) were classified as on reuse, and 14,440 patients (19.0%), as on single use, as of the start of follow-up. The overall mortality rate was 25.0/100 patient-years. No difference in mortality risk was found between patients treated with reuse compared with single use in an intent-to-treat approach (hazard ratio, 0.98; 95% confidence interval, 0.94 to 1.02; P = 0.266) after adjusting for chain affiliation, for-profit status, year of dialysis inception, age, sex, race, renal diagnosis, comorbidity, and hospitalization days. Findings were similar in an as-treated approach (hazard ratio, 0.97; 95% confidence interval, 0.93 to 1.01; P = 0.136). No survival advantage associated with single use was found for subgroups. CONCLUSION: No overall survival advantage or disadvantage is associated with dialyzer reuse compared with single use in incident hemodialysis patients in the United States; however, continued monitoring is advised.

Adult↗

Dialyser reuse-associated mortality and hospitalization risk in incident Medicare haemodialysis patients, 1998-1999.

BACKGROUND: The reuse of haemodialysers has been practiced in the United States for >20 years. We investigated mortality and hospitalization risk according to various reuse practices, testing the hypothesis that outcomes are improved in patients treated with dialysers cleaned with bleach and sterilized with formaldehyde. METHODS: We studied 1998 and 1999 incident Medicare haemodialysis patients, with follow-up through December 31, 2000 (49 273 patients). Clinical conditions and dialysis therapy were characterized from Medicare claims data. Included were patients who could be linked to a dialysis provider. Demographic characteristics were obtained from the Centers for Medicare and Medicaid Services (CMS) Medical Evidence Report. Mortality information was obtained from the CMS ESRD Death Notification; hospitalization information, from Medicare in-patient claims files. Data on reuse practices were obtained from the annual survey of haemodialysis units conducted by the Centers for Disease Control and Prevention. RESULTS: Cox regression analyses found no significant differences in mortality or first-hospitalization risk for patients in dialysis units not using bleach as a cleaning agent. Outcomes for patients treated in units using glutaraldehyde did not vary according to use of bleach. In the analysis of first-hospitalization risk, there was no difference according to various germicide/bleach combinations. Overall, there was no significant difference in relative risk of death or in hospitalization risk among the reuse groups (including the no-reuse group). CONCLUSIONS: For the 1998-1999 period, reuse practices were not associated with a survival advantage or disadvantage. Our findings may reflect the National Kidney Foundation's 1997 introduction of clinical practice guidelines, the intent of which was to bring about increased consistency of care within the dialysis community in the United States.

Equipment Reuse↗

Chronic kidney disease: the distribution of health care dollars.

BACKGROUND: The cost of care for end-stage renal disease (ESRD) is known to be high. The factors responsible for higher ESRD cost develop during chronic kidney disease (CKD), where the data on distribution of cost are limited. METHODS: This retrospective cohort study of 1995 through 1998 incident dialysis patients was performed to study the distribution of costs during the 24 months prior to initiation of dialysis. Patient data were obtained from the Centers for Medicare and Medicaid Services (CMS). Patients who were Medicare eligible for at least 2 years prior to initiation of dialysis were included in the study. Financial data were obtained from Medicare Part A and Part B claims and inflationary adjustments were made. The study period was divided into four segments based on overall distribution of cost. RESULTS: The mean age was 75 years, 51% were males, 73% were white, and 22% were black. Overall, patient comorbidity increased significantly during the study years. Cost showed a sharp increase in the last 6 months prior to initiation of dialysis. Hospitalization was the major component of cost throughout study period. Patients who initiated hemodialysis incurred a higher cost compared to patients who initiated other modes of kidney replacement therapy. Patients with diabetes or cardiovascular disease incurred higher cost compared to those who had no diabetes or cardiovascular disease, respectively. CONCLUSION: These data showed that hospitalization was the major component of the sharp increase in cost around the initiation of dialysis. Increased comorbidity was associated with higher cost. A focus on timely management of CKD may prevent future morbidity and costs.

Aged↗

The association of initial hemodialysis access type with mortality outcomes in elderly Medicare ESRD patients.

BACKGROUND: Dialysis access is critical for therapy delivery. Few studies have linked type of dialysis access to patient survival in the elderly population. METHODS: We included 1995 to 1997 incidence Medicare hemodialysis patients (N = 66,595) who were 67 years and older at dialysis therapy initiation. Medicare Physician/Supplier claims were used to determine initial access type: simple fistula, autologous vein graft, synthetic graft, and hemodialysis catheter. We used International Classification of Diseases, Ninth Revision, Clinical Modification, codes to determine vascular access placement for renal failure. A Cox regression analysis assessed risk for death within 1 year, with explanatory variables of incidence year, age, sex, race, diabetes, initial access type, body mass index, days from first access placement date to initial dialysis date, and serum albumin, creatinine, and blood urea nitrogen levels. RESULTS: One-year crude death rates were 24.9%, 27.2%, 28.1%, and 41.5% for patients with simple fistulae, autologous vein grafts, synthetic grafts, and hemodialysis catheters, respectively. Patients with simple fistulae (the reference) had the lowest (P < 0.0001) likelihood of death compared with those with synthetic grafts (hazard ratio [HR], 1.160; 95% confidence interval [CI], 1.084 to 1.241) or catheters (HR, 1.696; 95% CI, 1.593 to 1.806). No difference (P > 0.09) in mortality risk was detected between simple fistulae and autologous vein grafts or between autologous vein grafts and synthetic grafts. CONCLUSION: In the US Medicare dialysis population, type of initial hemodialysis access was associated with 1-year mortality. Mortality risks were (in ascending order) fistulae, grafts, and catheters.

Aged↗

Peritoneal and hemodialysis: I. Differences in patient characteristics at initiation.

BACKGROUND: Comparisons of mortality outcomes between peritoneal dialysis (PD) and hemodialysis (HD) patients have shown varying results, which may be caused by the unequally distributed clinical conditions of patients at initiation. To address this issue, we evaluated the clinical characteristics of 105,954 patients at the initiation of PD and HD, using the U.S. national incidence data on treated end-stage renal disease from the Medical Evidence Form, 1995 to 1997. METHODS: A general linear model was used to analyze differences of age, albumin, creatinine, blood urea nitrogen (BUN), and hematocrit; categorical data analysis to evaluate body mass index (BMI), grouped into four categories: < 19, 19-25 (< 25), 25-30 (< 30), and 30+; and logistic regression to assess the likelihood of initiating PD versus HD. Diabetics (DM) were analyzed separately from non-diabetics (NDM). Explanatory variables in the logistic regression included incidence year, race, gender, age, BMI, albumin, creatinine, BUN, and hematocrit. Race included white and black. Age was categorized into four groups: 20-44, 45-64, 65-74, and 75+. RESULTS: At the initiation of dialysis PD patients were approximately 6 years younger (P < 0.0001) than HD patients. PD patients also had higher (P < 0.0001) albumin (+0.35 g/dL for DM and +0.23 g/dL for NDM) and hematocrit (+1.64% for DM and +1.71% for NDM) levels, and lower (P < 0.04) BUN (-8.75 mg/dL for DM and -5.24 mg/dL for NDM) and creatinine (-0.51 mg/dL for DM and -0.23 mg/dL for NDM) levels than HD patients. Whites had a higher (P < 0.0001) likelihood of starting PD than blacks, and patients with BMI <19 had a lower (P < 0.0001) chance of beginning on PD. CONCLUSION: PD patients had favorable clinical conditions at the initiation of dialysis, which should be taken into consideration when comparing dialysis outcomes between the two modalities.

Adult↗

Peritoneal and hemodialysis: II. Mortality risk associated with initial patient characteristics.

BACKGROUND: Patients initiating with peritoneal dialysis (PD) have favorable clinical conditions compared with hemodialysis (HD) patients, which may contribute to the varying results found in studies of mortality across the two therapies. METHODS: National incidence data of end-stage renal disease patients from 1995 to 1997 were used, excluding the first 90 days of treatment and including all patients who were on either PD or HD on day 91. Patients were then followed for a one-year period. A Cox proportional hazards regression analysis was used, separating diabetics and non-diabetics, and two statistical models were applied. Model 1 included race, gender, age, initial modality, and incidence year as explanatory variables. Model 2 added body mass index (BMI), initial levels of serum albumin, creatinine, and blood urea nitrogen. RESULTS: Age was most highly associated with mortality, followed by biochemical variables, BMI, gender, and dialysis modality. In diabetics, the hazard ratio (HR) from Model 1 indicated no difference [1.046, 95% confidence limits (CL) 0.989-1.105; P> 0.1, HD was the reference] in mortality between PD and HD, while Model 2 demonstrated that PD patients had a 13.4% (1.134, CL 1.072-1.100, P < 0.0001) higher chance of death. In non-diabetics, hazard ratios (HRs) from Models 1 and 2 indicated that PD patients had a 23.5% (0.765, 0.722-0.812, P < 0.0001) and 11.9% (0.881, 0.30-0.935, P < 0.0001), respectively, lower likelihood of death than HD patients. CONCLUSION: Our study indicates that the results changed depending on the analytical methods used. We recommend that, due to the unequally distributed clinical conditions of patients at initiation, comparisons of mortality outcomes between dialysis modalities should be made with caution.

Age Distribution↗

Anemia treatment in the pre-ESRD period and associated mortality in elderly patients.

BACKGROUND: Anemia is a common complication of advancing chronic kidney disease, yet little is known about the consistency of anemia treatment before end-stage renal disease (ESRD) and mortality on dialysis therapy. METHODS: We studied 89,193 incident Medicare patients with ESRD in 1995 to 1997 aged 67 plus years with claims 2 years before their dialysis therapy initiation. Patients were classified as follows: no epoetin, 25% or less (least consistent), greater than 25% to 50%, greater than 50% to 75%, and greater than 75% (most consistent) epoetin treatment in the available months from the first pre-ESRD epoetin dose to the first ESRD service date. Cox regression modeled the risk for 1-year death in the post-ESRD period, adjusting for age, sex, race, diabetic status, albumin level, and incidence year. RESULTS: Sixty percent of patients had hematocrits less than 30% at ESRD initiation, yet only 15.6% (N = 13,877) had epoetin claims before ESRD. The most consistent epoetin treatment group had hematocrits increase from 27.5% to 30.8% (P < 0.0001) by month 4 of treatment. Patients with the most consistent epoetin treatment had a greater mean hematocrit (29.2% +/- 0.11%; P < 0.0001) and albumin level (3.31 +/- 0.01 g/dL [33.1 g/L]) at initiation than those with the least consistent treatment (28.1% +/- 0.10% and 3.21 +/- 0.01 g/dL [32.1 g/L], respectively). The relative risk for death in patients with the least consistent versus the most consistent (the reference) epoetin treatment was 1.460 (95% CI, 1.245 to 1.713; P < 0.0001) 1 year after the first ESRD service date. CONCLUSION: Elderly patients with consistent pre-ESRD epoetin treatment had lower risks for death in the first year of dialysis therapy after ESRD initiation.

Aged↗