Cost functions for dialysis facilities and the quality of dialysis.
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Cost Control↗
Biomedical subjects
H I Feldman
Publications and source records attributed to H I Feldman.
The effect of antilymphocyte induction therapy on renal allograft survival. A meta-analysis of individual patient-level data. Anti-Lymphocyte Antibody Induction Therapy Study Group.
PURPOSE: Randomized, controlled trials have not shown that the perioperative use of antilymphocyte antibodies (induction therapy) improves survival of cadaveric kidney allografts. This study combined individual patient-level data from published trials to examine the effect of induction therapy on allograft survival. DATA SOURCES: Randomized, controlled trials identified from MEDLINE. STUDY SELECTION: Published trials that compared adult recipients of cadaveric renal allografts who did and did not receive antilymphocyte antibodies in the perioperative period were selected if individual patient-level data were available. DATA EXTRACTION AND ANALYSIS: Individual patient-level data were collected for each of 628 study patients. Multivariable Cox proportional hazards regression was used to estimate the effect of induction therapy on allograft survival. RESULTS: The adjusted rate ratio for allograft failure with induction therapy compared with conventional therapy was 0.62 (95% CI, 0.43 to 0.90) (P = 0.012) over 2 years and 0.82 (CI, 0.62 to 1.09) (P = 0.17) over 5 years. The effect of induction therapy on allograft survival diminished over time; no benefit overall was seen after 2 years after transplantation (rate ratio, 1.13 [CI, 0.72 to 1.78]) (P > 0.2). Greater HLA-DR mismatch, delayed allograft function, diabetes mellitus in the recipient, African-American ethnicity of the recipient, and presensitization (panel-reactive antibody levels > or = 20%) were significantly associated with allograft failure at 5 years. Among high-risk patients, only those who were presensitized benefited from induction therapy at 2 years (rate ratio, 0.12 [CI, 0.03 to 0.44]) (P = 0.001). Results were similar at 5 years. CONCLUSIONS: Using individual-level data, this study showed a benefit of induction therapy at 2 years, particularly among presensitized patients. Although the benefit of this therapy subsequently waned, presensitized patients continued to have benefit at 5 years.
Adolescent↗
Comparison of Doppler US and CT angiography for evaluation of renal artery stenosis.
RATIONALE AND OBJECTIVES: The authors compared Doppler ultrasound (US) with computed tomographic (CT) angiography in the evaluation of stenosis of the main renal artery. MATERIALS AND METHODS: Fifty-six patients who had undergone conventional angiography of the renal arteries participated in a prospective comparison of Doppler US (45 patients) and CT angiography (52 patients). US evaluation included both the main renal artery and segmental renal arteries. RESULTS: There were 27 main renal arteries with at least 50% stenosis in 20 patients. In 36 patients, there was no significant stenosis. All cases of main renal artery stenosis detected with Doppler US of the segmental arteries were also identified with Doppler US of the main renal artery. The by-artery sensitivity (63%) of US of the main renal artery was greater than that (33%) of US of the segmental arteries. CT angiography was more sensitive (96%) than Doppler US (63%) in the detection of stenosis, but the specificity of CT (88%) was similar to that of US (89%). The difference in the area under the receiver operating characteristic curve (AUC) between CT (AUC = 0.94) and US (AUC = 0.82) was statistically significant (P = .038). CONCLUSION: Doppler US of the main renal artery is more sensitive than Doppler US of segmental arteries in the detection of stenosis. CT angiography is more accurate than Doppler US in the evaluation of renal artery stenosis.
Adult↗
Race and delayed kidney allograft function.
BACKGROUND: Allograft survival among black recipients is poorer than among whites. Delayed allograft function is associated with a significant reduction in renal allograft survival. The relationship between delayed allograft function and black race is incompletely specified and was the focus of this investigation. METHODS: A non-concurrent study of 325 recipients of cadaveric allografts followed for the occurrence of delayed allograft function defined as dialysis during the first week following transplantation for the principal analysis. A secondary definition of delayed allograft function was formulated based on the serum creatinine 2 weeks after transplantation. Unadjusted and adjusted logistic regression analysis were used to examine the unconfounded relationship between race and delayed allograft function. RESULTS: Fifty-seven of 91 (62.6%) black recipients experienced delayed allograft function compared to 113 of 234 (48.3%) whites. The odds ratio for black race as a predictor of delayed allograft function was 1.80, P=0.02, (95% CI, 1.09, 2.95). This finding was stable despite adjustment for other predictors of delayed allograft function in a multivariate model, but the precision of this estimate was less (P=0.10) because of missing data. Additionally, adjusted models with imputed values for missing covariates, models using a secondary definition of delayed allograft function, and models excluding patients whose cyclosporin therapy was delayed, all consistently demonstrated a similar association between black race and delayed allograft function. CONCLUSIONS: This study demonstrated an increased risk of delayed allograft function among black recipients. This relationship may play a role in the poorer allograft outcomes experienced by black recipients. Given the negative effect of delayed allograft function on allograft survival, efforts to identify its modifiable risk factors should be a high priority.
Adult↗
Centralization of histocompatibility laboratories: impact on organ allocation efficiency and outcomes of cadaveric renal transplantation.
This project was undertaken to determine whether centralization of histocompatibility laboratory services for renal transplants performed within eastern Pennsylvania could improve the efficiency of allograft allocation and short-term allograft function. A nonconcurrent cohort study was performed comparing renal allografts transplanted between September 15, 1993, and September 14, 1994, to those transplanted between September 15, 1994, and September 14, 1995. All allografts were procured and allocated by the Delaware Valley Transplant Program, the organ procurement agency in eastern Pennsylvania. Cold preservation time and delayed allograft function were used to measure efficiency of allograft allocation and short term allograft function, respectively. The mean cold preservation time was reduced from 25.08 hours to 20.68 hours (P < 0.001). The percentage of delayed allograft function was 19.9 and 17.4 for the pre- and postcentralization groups, respectively (P = 0.5). Therefore, centralization of histocompatibility tissue typing was a regionally effective process intervention for reducing cold preservation time without adversely impacting short-term graft function. The magnitude of this reduction varied between individual centers. Further investigation is required to determine the effect on long-term allograft function and system wide costs.
Adult↗
Evaluation of low density spine software for the assessment of bone mineral density in children.
Pediatric dual-energy X-ray absorptiometry spine scans often cannot be analyzed with standard software due to a failure to identify the bone edges of low density vertebrae. Low density spine (LDS) software improves bone detection compared with standard software. The objective of this study was to compare bone mineral density (BMD) measurements obtained with the standard and LDS software in 27 healthy nonobese, 32 obese, and 41 chronically ill children, ages 2-18 years. Lumbar spine (L1-L4) BMD, measured by standard analysis, ranged from 0.531-1.244 gm/cm2. Reanalysis with the LDS software resulted in a systematic increase (mean +/- SD) in estimated bone area of 17.0+/-5.0%, an increase in bone mineral content of 6.1+/-6.3%, and a mean decrease in BMD of 8.7+/-1.7% (all p < 0.001). This resulted in a mean decrease in BMD Z score of 0.7+/-0.2. Linear regression models, predicting standard BMD from LDS BMD, were fit for the three subject groups (R2 = 0.993-0.995). Small differences in slopes were detected across groups (p = 0.07); LDS BMD predicted higher standard BMD in obese subjects. In conclusion, LDS analysis resulted in a clinically significant decrease in measured BMD. The association between analysis methods was exceptionally high (R2 > 0.99), indicating that LDS BMD accurately predicts standard BMD. Although LDS BMD in obese subjects predicts higher standard BMD results than in nonobese subjects, the small difference is of questionable clinical significance. LDS software is a useful tool for the assessment of BMD in children.
Absorptiometry, Photon↗
Lack of hepatotoxic effects of parenteral ketorolac in the hospital setting.
BACKGROUND: No large controlled studies to date have examined the hepatic safety of parenteral ketorolac, which is used to treat acutely ill hospitalized patients who may be at greatest risk of liver injury. OBJECTIVE: To measure the association between the use of parenteral ketorolac and subsequent liver injury. METHODS: A nonexperimental cohort study conducted in 35 hospitals in the greater Philadelphia, Pa, region examined 10,272 courses of parenteral ketorolac (the exposed group) and 10,247 courses of parenteral opioid (the comparison group). Liver injury was defined by a modified international consensus definition that relied exclusively on liver function tests. Proportional hazards regression was used to calculate the rate ratio and 95% confidence interval for the association between ketorolac exposure and the occurrence of liver injury, controlling for potentially confounding factors, and to explore the possible effects of duration and dose. RESULTS: The incidence of liver injury was 1.0% in the ketorolac group and 1.2% in the opioid group, yielding an unadjusted rate ratio of 0.77 (95% confidence interval, 0.59 1.01). Simultaneously adjusting for multiple potentially confounding factors did not change this result. There was no evidence for a duration-response relationship (P = .96) or a dose-response relationship (P = .23). We were unable to identify any subgroups that were susceptible to possible hepatotoxic effects of parenteral ketorolac. CONCLUSIONS: This study failed to find evidence of a hepatotoxic effect of parenteral ketorolac use in the hospital setting and provides strong evidence against the existence of a clinically meaningful association between exposure to parenteral ketorolac in the hospital setting and liver injury.
Analgesics, Non-Narcotic↗
National kidney allograft sharing: a decision analysis.
BACKGROUND: Expansion of the current program of national sharing of cadaveric kidney allografts is of uncertain benefit, and the logistical barriers to expanding organ sharing are large. This study estimated the improvement in allograft survival from expanding organ sharing in the United States. METHODS: A decision analysis based on allograft survival data from cadaveric allograft recipients throughout the United States compared the mean allograft survival resulting from four allograft-sharing strategies: no national sharing, national sharing of allografts matched at 6 histocompatibility alleles, national sharing of allografts matched at 4 or more alleles, and national sharing of allografts matched at 2 or more alleles. RESULTS: Sharing allografts matched at 4 or more alleles was optimal (mean allograft survival=6.35 years). This survival was little better than the mean survival of the other three strategies (no national sharing, 6.21 years; national sharing of allografts matched at 6 alleles, 6.31 years; and sharing of allografts matched at 2 or more alleles, 6.33 years). The increment in the proportion of allografts surviving 4 years or more under the optimal strategy compared with no national sharing was <2%. A similar decision model comparing kidney transplant outcomes before and after the introduction of cyclosporine showed that this drug has had a much greater impact on mean allograft survival than would be expected to occur with national allograft sharing: 6.07 years with cyclosporine versus 3.79 years without cyclosporine. CONCLUSIONS: Expanding national allograft sharing would achieve little improvement in mean allograft survival. The limited benefit and logistical barriers to expansion of allograft sharing should be considered before following recommendations to expand the current U.S. allograft-sharing program.
Alleles↗
Parenteral ketorolac: the risk for acute renal failure.
BACKGROUND: Acute renal failure has been associated with parenteral ketorolac tromethamine, but the risk that is associated with this therapy has not been quantified. OBJECTIVE: To compare the risk for acute renal failure associated with ketorolac with that associated with opioids. DESIGN: Retrospective cohort study. SETTING: 35 hospitals in or near Philadelphia. PATIENTS: Patients receiving 10,219 courses of parenteral ketorolac and patients receiving 10,145 courses of parenteral opioids. MEASUREMENTS: Acute renal failure was defined by 1) an increase in the serum creatinine concentration of 50% or more and 2) either an absolute increase of 44.2 mumol/L or more for concentrations that were less than 132.6 mumol/L at baseline or an absolute increase of 88.4 mumol/L or more for concentrations that were 132.6 mumol/L or more at baseline. In addition, a secondary definition required a diagnosis by a physician. RESULTS: The overall incidence of acute renal failure was 1.1% after therapy with either ketorolac or opioids. Multivariate-adjusted rate ratios comparing ketorolac with opioids for acute renal failure were 1.09 (95% CI, 0.83 to 1.42) overall, 1.00 (CI, 0.76 to 1.33) for less than 5 days of therapy, and 2.08 (CI, 1.08 to 4.00; P = 0.03) for more than 5 days of therapy. Similar results were obtained when the secondary definition of acute renal failure was used. CONCLUSIONS: Overall, acute renal failure was uncommon in this hospitalized population. Compared with opioids, ketorolac administered for 5 days or less did not increase the rate of renal failure. However, among patients who were treated with analgesics for more than 5 days, ketorolac may be associated with an elevated rate of acute renal failure.
Acute Kidney Injury↗
Effect of anti-lymphocyte induction therapy on renal allograft survival: a meta-analysis.
Induction immunosuppression with antilymphocyte antibodies has not been shown to improve cadaveric kidney allograft survival in randomized, controlled trials despite widespread use. This meta-analysis of randomized, controlled trials assessed the effectiveness of induction therapy in prolonging allograft survival. Studies of induction therapy were identified in Medline (1986 through 1996), using the terms "monoclonal antibodies" or "antilymphocyte serum," and "kidney transplantation," "human," and "clinical trial." Bibliographies, pharmaceutical manufacturers, the United Network for Organ Sharing, National Institutes of Health, and study authors were also consulted. Seven of 247 identified studies met the following inclusion criteria: (1) an adult study population; (2) assessment of antilymphocyte antibodies in the immediate posttransplant period; (3) a control arm of cyclosporine, azathioprine, and prednisone in the immediate posttransplant period; and (4) presentation of survival data. Two readers independently extracted protocol and survival data from each study. Summary odds ratios (fixed and random effects) and a rate ratio from proportional hazards regression at 2 yr were estimated to examine the effect of induction therapy on allograft survival. The summary odds ratios were both 0.66 (confidence interval [CI], 0.45 to 0.96; P = 0.03), and the rate ratio was 0.69 (CI, 0.49 to 0.97; P = 0.03), indicating a beneficial effect of induction therapy on allograft survival. Allograft survival was 85.6% (CI, 82.1 to 89.1%) in the induction therapy group and 79.6% (CI, 75.6 to 83.6%) in the conventional therapy group. These results were stable in a sensitivity analysis based on study quality. Allograft survival was prolonged with induction therapy compared with conventional immunosuppression. These data indicate a potential role for the routine use of induction therapy in renal transplantation to optimize the survival of cadaveric allografts.
Adult↗
Problems with interpreting results of PSA.
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Humans↗
Effect of dialyzer reuse on survival of patients treated with hemodialysis.
OBJECTIVE: To evaluate the impact of dialyzer reuse on the survival of US hemodialysis patients. STUDY DESIGN AND PARTICIPANTS: Nonconcurrent cohort study of 27938 patients beginning hemodialysis in the United States in 1986 and 1987. MAIN OUTCOME MEASURE: Patient survival. RESULTS: Dialysis in freestanding facilities reprocessing dialyzers with the combination of peracetic and acetic acids was associated with greater mortality than treatment in facilities not reprocessing dialyzers (rate ratio [RR],1.10, 95% confidence interval [CI], 1.02-1.18; P=.02) In contrast, there was no significant difference between survival in freestanding facilities reprocessing dialyzers with either formaldehyde (RR,1.03, 95% CI, 0.96-1.10; P=.45) or glutaraldehyde (RR, 1.13, 95% CI, 0.95-1.35, P=.18) and survival in freestanding facilities not reprocessing dialyzers. Among freestanding facilities reprocessing dialyzers, use of peracetic/acetic acid was associated with a higher rate of death than use of formaldehyde (RR = 1.08, 95% CI, 1.01-1.14; P=.02). There was no statistical difference between survival in hospital-based facilities reprocessing dialyzers with either peracetic/acetic acid (RR=0.95, 95% CI, 0.85-1.06; P=.40), formaldehyde (RR=1.06, 95% CI, 0.98-1.15; P=.12), or glutaraldehyde (RR=1.09, 95% CI, 0.71-1.67; P=.70) and survival in hospital-based facilities not reprocessing dialyzers. In addition, choice of sterilant was not associated with a statistically significant difference in survival among hospital-based facilities reprocessing dialyzers. CONCLUSIONS: Dialysis in freestanding facilities reprocessing dialyzers with peracetic/acetic acid may be associated with worse survival than dialysis in free-standing facilities not reprocessing dialyzers or in those reprocessing with formaldehyde. We were unable to determine whether these relationships arose from greater comorbidity among patients treated in facilities using peracetic/acetic acid, poor quality of dialysis procedures in these facilities, or direct toxicity of peracetic/acetic acid. These findings raise important concerns about potentially avoidable mortality among US hemodialysis patients treated in dialysis facilities reprocessing hemodialyzers.
Adult↗
Recipient body size and cadaveric renal allograft survival.
Transplantation of renal allografts inadequate to meet recipient metabolic demands has been hypothesized to be one cause of chronic allograft failure. This cohort study examined the relationship of each of three measures of recipient body size and one measure of recipient metabolic rate to the rate of allograft failure among 239 recipients of cadaveric renal allografts between 1985 and 1990. All subjects were followed until allograft failure, death, or December 31, 1992, whichever occurred first. Using multivariate Cox proportional hazards analysis, all measures of recipient size and metabolic rate were found to be strong and statistically significant predictors of allograft survival adjusted for other predictors of allograft survival including allograft rejection, delayed allograft function, recipient race, prior renal transplantation, and donor age. The adjusted relative risk (RR) of allograft failure for a 15-kg increase in recipient body weight was 1.47, P < 0.0001 (95% confidence interval (CI), 1.21-1.78); adjusted RR for a 10-U increase in recipient body mass index was 2.34, P < 0.0001 (95% CI, 1.53-3.58); adjusted RR for a 0.5 m2 increase in recipient body surface area was 2.34, P < 0.001 (95% CI, 1.40-3.91); and adjusted RR for a 250 Kcal increase in metabolic rate was 1.49, P < 0.01 (95% CI, 1.17-1.89). These results are consistent with prior research indicating that a renal tissue supply-demand mismatch may accelerate failure of renal allografts. Alternative explanations of this relationship between recipient body size and allograft survival include inadequate immunosuppressive medication administration among recipients with a larger body size. Additional research is warranted to examine more fully the relationship between recipient body size and allograft survival.
Adolescent↗
Hemodialysis vascular access morbidity.
Complications associated with hemodialysis vascular access represent one of the most important sources of morbidity among ESRD patients in the United States today. In this study, new data on the magnitude and growth of vascular access-related hospitalization in the United States is presented, demonstrating that the costs of this morbidity will soon exceed $1 billion per yr. This study also reviews published literature on the morbidity associated specifically with native arteriovenous fistulae, polytetrafluoroethylene bridge grafts, and permanent central venous catheters. Next, new information on the changing patterns of vascular access type in the United States is presented, demonstrating the continuing evolution of medical practice away from the use of arteriovenous fistulae in favor of more reliance on synthetic bridge grafts. Based on these data, a discussion is provided of the tradeoffs among the most commonly available modalities of vascular access today. Although radial arteriovenous fistulae continue to represent the optimal access modality, the appropriate roles for brachial arteriovenous fistulae, synthetic bridge grafts, and central venous catheters are less certain because of inadequate data on the long-term function of the first and the high rates of complications associated with the latter two. To reduce vascular access-related morbidity, strategies must be developed not only to prevent and detect appropriately early synthetic vascular access dysfunction, but to better identify the patients in a whom radial arteriovenous fistula is a viable clinical option.
Age Factors↗
Delayed function reduces renal allograft survival independent of acute rejection.
BACKGROUND: Mechanisms by which delayed allograft function reduces renal allograft survival are poorly understood. This study evaluated the relationship of delayed allograft function to acute rejection and long-term survival of cadaveric allografts. METHODS: 338 recipients of cadaveric allografts were followed until death, resumption of dialysis, retransplantation, loss to follow-up, or the study's end, which ever came first. Delayed allograft function was defined by dialysis during the first week following transplantation. Multivariate Cox proportional hazards survival analysis was used to assess the relationship of delayed allograft function to rejection and allograft survival. RESULTS: Delayed allograft function, recipient age, preformed reactive antibody levels, prior kidney transplantation, recipient race, rejection during the first 30 days and rejection subsequent to 30 days following transplantation were predictive of allograft survival in multivariate survival models. Delayed allograft function was associated with shorter allograft survival after adjustment for acute rejection and other covariates (relative rate of failure [RR]+1.72 [95% CI, 1.07, 2.76]). The adjusted RR of allograft failure associated with any rejection during the first 30 days was 1.99 (1.23, 3.21), and for rejection subsequent to the first 30 days was 3.53 (2.9 08, 6.00). The impact of delayed allograft function did not change substantially (RR=1.84 [1.15, 2.95]) in models not controlling for acute rejection. These results were stable among several subgroups of patients and using alternative definitions of allograft survival and delayed allograft function. CONCLUSIONS: This study demonstrates that delayed allograft function and acute allograft rejection have important independent and deleterious effects on cadaveric allograft survival. These results suggest that the effect of delayed allograft function is mediated, in part, through mechanisms not involving acute clinical rejection.
Acute Disease↗
Risk of foot complications in long-term diabetic patients with and without ESRD: a preliminary study.
OBJECTIVE: The purpose of this preliminary study was to generate hypotheses for future research about the relationship between ESRD and foot complications in patients with long-term diabetes. DESIGN: A cross-sectional prevalence study was conducted comparing a sample of long-term diabetic patients with ESRD to a sample of long-term diabetic patients without ESRD. SAMPLE/SETTING: A convenience sample of 132 patients with long-term diabetes (> 15 years), with (N = 60) and without (N = 72) ESRD, was selected from ambulatory care settings and dialysis units. METHODS: Data were collected by chart audit, structured interview, and physical examination. RESULTS: Foot complications were greater in individuals with diabetes and ESRD (25%) than in diabetic individuals without ESRD (10%) (p = 0.02). Neither neuropathy, past or current smoking, race, gender, nor age were significantly associated with current foot complications (either current infection, ulcer, gangrene, or amputation). CONCLUSIONS: Research is needed to better understand foot complications in persons with long-term diabetes and ESRD so that the effectiveness of nursing and medical interventions to stabilize or prevent foot complications can be evaluated.
Adult↗
Renal failure among male Hispanics in the United States.
This study examined epidemiologic patterns and time trends among male patients with Hispanic surnames in the Medicare End-Stage Renal Disease Program and compared US Hispanics with non-Hispanic Blacks and Whites. Male Hispanics had substantially higher proportions of end-stage renal disease attributed to diabetes than did Blacks and Whites. There were notable regional differences among Hispanics. Between 1980 and 1990, the incidence of treated renal failure among Hispanics increased more than that among Blacks or Whites. The increasing number of Hispanics in the United States with end-stage renal disease emphasizes the importance of explicit health evaluations and prevention strategies for Hispanic populations.
Adolescent↗
Projections of hypertension-related renal disease in middle-aged residents of the United States.
OBJECTIVE: To establish nationwide projections for hypertension-related renal disease among middle-aged residents of the United States and compare disease burden in demographic subgroups. DESIGN: Integrated analysis of data from the US Census, the National Health and Nutrition Examination Survey of 1976 through 1980 (NHANES II), the 1971 through 1975 NHANES I Epidemiologic Follow-up Study, the Hypertension Detection and Follow-up Program trial, and the US Renal Data System. POPULATION: African-American and white residents of the United States, aged 30 to 69 years. MAIN OUTCOME MEASURES: Incidence rates and counts of hypertension, hypertension-related hypercreatinemia, and hypertension-related end-stage renal disease (ESRD). RESULTS: Each year, approximately 1.8 million middle-aged Americans develop hypertension, 140,000 develop hypertension-related hypercreatinemia, and 5300 develop hypertension-related ESRD. African Americans are at increased risk for hypertension (relative risk [RR], 1.6; population-attributable risk [PAR], 5%), hypercreatinemia if hypertensive (RR, 2.4; PAR, 18%), ESRD if hypertensive with hypercreatinemia (RR, 2.7; PAR, 32%), and hypertension-related ESRD overall (RR, 8.0; PAR, 44%). Compared with women, men are at increased risk for hypertension (RR, 1.3; PAR, 13%) and hypertension-related ESRD (RR, 1.6; PAR, 23%). Most cases of hypercreatinemia in hypertensives (73%) occur among those with mild hypertension. CONCLUSIONS: Progression to ESRD is rare in persons with hypertension-related renal disease, and factors other than blood pressure probably play an important role. A large proportion of hypertension-related renal disease cases occur among population subgroups considered to be at low risk. Interventions that favorably influence factors associated with the progression of hypertension-related renal disease in African Americans, in men, and in persons with mild hypertension, hold the greatest potential for reducing the population burden of hypertension-related ESRD.
Adult↗