Publications by authors named "Norma J Ofsthun"

The end-stage kidney disease (ESKD) Data Standards Project was launched by the Kidney Health Initiative (KHI) with the goal of standardizing dialysis-related measurements for research use. KHI is a public-private partnership between the American Society of Nephrology, US Food and Drug Administration, and organizations with an interest in kidney disease. KHI promotes safe and effective patient-centered therapies for people with kidney disease.

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Background: Sickle cell disease (SCD) is the most common inherited hematological disorder and a well-described risk factor for end-stage kidney disease (ESKD). Mortality and hospitalizations among patients with SCD who develop ESKD remain understudied. Furthermore, prior studies focused only on SCD patients where ESKD was caused by SCD.

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Background And Objectives: In the United States, intravenous vitamin D analogs are the first-line therapy for management of secondary hyperparathyroidism in hemodialysis patients. Outside the United States, oral calcitriol (1,25-dihydroxyvitamin D) is routinely used. We examined standard laboratory parameters of patients on in-center hemodialysis receiving intravenous vitamin D who switched to oral calcitriol.

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Objective: The high pill burden of many phosphate binders (PBs) may contribute to increased prevalence of hyperphosphatemia and poor nutritional status observed among patients undergoing maintenance hemodialysis therapy. We examined the real-world effectiveness of sucroferric oxyhydroxide (SO), a PB with low pill burden, in managing serum phosphorus in patients with prevalent hemodialysis over a 1-year period.

Design: Historical cohort analyses of de-identified electronic medical records.

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Rationale & Objective: The relationship between tobacco smoking and comorbid condition outcomes in hemodialysis (HD) patients is not well understood. This study examined the association of tobacco smoking status with hospitalization and mortality in HD patients.

Study Design: Retrospective cohort study.

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Background: A database analysis was conducted to assess the effectiveness of sucroferric oxyhydroxide (SO) on lowering serum phosphorus and phosphate binder (PB) pill burden among adult peritoneal dialysis (PD) patients prescribed SO as part of routine care.

Methods: Adult PD patients (n = 258) prescribed SO through a renal pharmacy service were analyzed. Baseline was 3 months before SO prescription.

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Aims: Hyperphosphatemia has been associated with an increased risk of mortality in patients with end-stage renal disease. We sought to assess the real-world effectiveness of sucroferric oxyhydroxide (SO), an iron-based phosphate binder (PB), in control of serum phosphorus levels, and to determine the associated pill burden in hemodialysis patients.

Materials And Methods: Adult, in-center hemodialysis patients first prescribed SO through a renal pharmacy service as part of routine clinical care between April 1, 2014 and March 31, 2015 were included in the analysis.

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Anemia treatment in hemodialysis-dependent (HDD) CKD patients involves adequate supply of iron and an erythropoiesis-stimulating agent (ESA). Despite widespread usage of these agents, there is no generally accepted "standard dosing algorithm" for treating anemia in HDD-CKD patients. The new anemia Quality Incentive Program (QIP) introduced by the Centers for Medicare & Medicaid Services represents a motivation to standardize and harmonize iron and ESA regimens with interactive electronic algorithms and novel modes of deliveries for IV iron and ESA doses.

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Patients with CKD face many consequences of renal failure, including disorders of bone and mineral metabolism. The current approach to management of these mineral metabolism issues lacks comprehensive quantitative assessment, so a kinetic modeling program has been designed to quantify intake and removal of phosphorus and calcium, as well as provide recommendations for treatment and prescriptions based on total mass balance and serum concentrations. This program is known as phosphorus kinetic modeling or PKM.

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The International Quotidian Dialysis Registry (IQDR) is a global initiative designed to study practices and outcomes associated with the use of hemodialysis (HD) regimens of increased frequency and/or duration. The IQDR grew out of the initiative that lead to the randomized prospective studies of nocturnal HD and short hours daily dialysis vs. conventional thrice weekly HD that are conducted by the Frequent Hemodialysis Network sponsored by the National Institutes of Health.

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The International Quotidian Dialysis Registry (IQDR) is a global initiative designed to study practices and outcomes associated with the use of hemodialysis regimens of increased frequency and/or duration. Several small studies suggest that compared with conventional hemodialysis (HD), short-daily, nocturnal, and long conventional HD regimens may improve surrogate endpoints and quality of life. However, methodologically robust comparisons on hard outcomes are sorely lacking.

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We retrospectively evaluated 29 patients dialyzed for 6 months in-center on Fresenius 2008H or 2008K dialysis machines followed by 6 months at home using the Fresenius 2008K@home to determine the safety and efficacy of home hemodialysis (HHD) using the 2008K@home. Patients who initiated HHD were identified from order records and qualified for inclusion if they had available records and a minimum of three pre- and postdialysis blood urea nitrogen measurements during each period. Dialysis adequacy (mean standard weekly Kt/V) remained stable during the in-center (IC; 2.

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Alternative hemodialysis (HD) schedules, including short-daily and nocturnal HD, continue to proliferate, with the hope of offering improved patient outcomes. Three nights per week and every other night, nocturnal HD are now being provided to more patients worldwide, both at home and in-center. However, alternative HD schedules are still experimental in most centers, and studies establishing the efficacy of these therapies with respect to major clinical outcomes are needed.

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On April 1, 2006, new Centers for Medicare and Medicaid Services (CMS) rules for billing erythropoietin (EPO) for dialysis patients went into effect. Two key provisions of the rules were to cap the dose for a single patient at 500,000 IU/month and to mandate a 25% reduction in dose for patients whose latest hemoglobin (HGB) or hematocrit (HCT) in the prior month exceeded 13 g/dl or 39%, respectively. The purpose of this article is to document the effect of the rules change on HGB outcomes in a single large dialysis provider whose computer system was modified to enforce the rules.

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Background: This study compares the associations of predialysis systolic blood pressure (SBP) with mortality risk in both incident and prevalent hemodialysis (HD) cohorts by using both conventional and time-varying Cox analyses, thus addressing limitations of prior studies.

Methods: A total of 56,338 incident patients starting HD therapy during 1997 to 2001 and 69,590 prevalent HD patients on January 1, 2002, were grouped into the following categories: (1) SBP less than 120 mm Hg, (2) 120 < or = SBP < 140 mm Hg, (3) 140 < or = SBP < 160 mm Hg, (4) 160 < or = SBP < 180 mm Hg, (5) 180 < or = SBP < 200 mm Hg, and (6) SBP of 200 mm Hg or greater. Conventional and time-varying models evaluated 1-year and 3-year (incident patients only) survival.

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Background: It is unknown to what degree physicians adjust erythropoietin doses to achieve hemoglobin levels (11.0 to 12.0 g/dL [110 to 120 g/L]) recommended by the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI) for patients with end-stage renal disease receiving hemodialysis.

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