The safety and tolerability of ferric citrate as a phosphate binder in dialysis patients.

Background: A phase II open-label study was conducted in hemodialysis patients evaluating the short-term safety, tolerability, and iron absorption with ferric citrate when used as a phosphate binder.

Methods: Enrollment occurred in two periods. Period 1 recruited patients taking 6-15 pills/day of binder with phosphorus of ≥2.

New paradigm for patient-reported outcomes assessment in foot & ankle research: computerized adaptive testing.

Background: Accurately measuring, reporting and comparing outcomes is essential for improving health care delivery. Current challenges with available health status scales include patient fatigue, floor/ceiling effects and validity/reliability.

Methods: This study compared Patient Reported Outcomes Measurement Information System (PROMIS)-based Lower Extremity Physical Function Computerized Adaptive Test (LE CAT) and two legacy scales -the Foot and Function Index (FFI) and the sport module from the Foot and Ankle Ability Measure (spFAAM) -for 287 patients scheduled for elective foot and ankle surgery.

Relationship between ambulatory BP and clinical outcomes in patients with hypertensive CKD.

Background And Objectives: Abnormal ambulatory BP (ABP) profiles are commonplace in CKD, yet the prognostic value of ABP for renal and cardiovascular outcomes is uncertain. This study assessed the relationship of baseline ABP profiles with CKD progression and subsequent cardiovascular outcomes to determine the prognostic value of ABP beyond that of clinic BP measurements.

Design, Setting, Participants, & Measurements: Between 2002 and 2003, 617 African Americans with hypertensive CKD treated to a clinic BP goal of <130/80 mmHg were enrolled in this prospective, observational study.

The Joint Commission Children's Asthma Care quality measures and asthma readmissions.

Background And Objectives: The Joint Commission introduced 3 Children's Asthma Care (CAC 1-3) measures to improve the quality of pediatric inpatient asthma care. Validity of the commission's measures has not yet been demonstrated. The objectives of this quality improvement study were to examine changes in provider compliance with CAC 1-3 and associated asthma hospitalization outcomes after full implementation of an asthma care process model (CPM).

Implementation of a publication strategy in the context of reporting biases. A case study based on new documents from Neurontin litigation.

Background: Previous studies have documented strategies to promote off-label use of drugs using journal publications and other means. Few studies have presented internal company communications that discussed financial reasons for manipulating the scholarly record related to off-label indications. The objective of this study was to build on previous studies to illustrate implementation of a publication strategy by the drug manufacturer for four off-label uses of gabapentin (Neurontin, Pfizer, Inc.

Transposon insertion in a cinnamyl alcohol dehydrogenase gene is responsible for a brown midrib1 mutation in maize.

Maize brown midrib1 (bm1) mutant plants have reduced lignin content and offer significant advantages when used in silage and biofuel applications. Cinnamyl alcohol dehydrogenase (CAD) catalyzes the conversion of hydroxycinnamyl aldehydes to monolignols, a key step in lignin biosynthesis. Maize CAD2 has been implicated as the underlying gene for bm1 phenotypes since bm1 plants have reduced CAD activity and lower CAD2 transcript level.

25-hydroxyvitamin D deficiency is associated with an increased risk of metabolic syndrome in patients with non-diabetic chronic kidney disease.

Background: Patients with chronic kidney disease (CKD) not requiring dialysis have a high prevalence of 25-hydroxyvitamin D (25(OH)D) deficiency but the relationship between 25(OH)D levels and metabolic syndrome is unknown in this population.

Methods: This study analyzed stored plasma samples from 495 non-diabetic subjects with severe kidney disease, not yet on dialysis, who participated in the homocysteine in kidney and end stage renal disease study. Metabolic syndrome was defined as the presence of all three of the following: (1) Serum triglycerides ≥ 150 mg/dl or drug treatment for hypertriglyceridemia; (2) serum high density lipoprotein-cholesterol (HDL-C) < 50 mg/dl for women or < 40 mg/dl for men or drug treatment for dyslipidemia; and (3) blood pressure ≥ 130/85 mmHg or drug treatment for hypertension.

Estimating glomerular filtration rate from serum creatinine and cystatin C.

Background: Estimates of glomerular filtration rate (GFR) that are based on serum creatinine are routinely used; however, they are imprecise, potentially leading to the overdiagnosis of chronic kidney disease. Cystatin C is an alternative filtration marker for estimating GFR.

Methods: Using cross-sectional analyses, we developed estimating equations based on cystatin C alone and in combination with creatinine in diverse populations totaling 5352 participants from 13 studies.

A shrunken-2 transgene increases maize yield by acting in maternal tissues to increase the frequency of seed development.

The maize (Zea mays) shrunken-2 (Sh2) gene encodes the large subunit of the rate-limiting starch biosynthetic enzyme, ADP-glucose pyrophosphorylase. Expression of a transgenic form of the enzyme with enhanced heat stability and reduced phosphate inhibition increased maize yield up to 64%. The extent of the yield increase is dependent on temperatures during the first 4 d post pollination, and yield is increased if average daily high temperatures exceed 33 °C.

A lower extremity physical function computerized adaptive testing instrument for orthopaedic patients.

Background: The aim of this study was to develop a lower extremity (LE) physical function computerized adaptive testing (CAT) instrument based on Patient Reported Outcomes Measurement Information System (PROMIS) physical function items.

Methods: The PROMIS physical function item bank was administered to adult outpatient orthopaedic patients. Three hundred eighty-two patients presenting with LE disorders were analyzed using item response theory modeling.

Estimating GFR among participants in the Chronic Renal Insufficiency Cohort (CRIC) Study.

Background: Glomerular filtration rate (GFR) is considered the best measure of kidney function, but repeated assessment is not feasible in most research studies.

Study Design: Cross-sectional study of 1,433 participants in the Chronic Renal Insufficiency Cohort (CRIC) Study (ie, the GFR subcohort) to derive an internal GFR estimating equation using a split-sample approach.

Setting & Participants: Adults from 7 US metropolitan areas with mild to moderate chronic kidney disease; 48% had diabetes and 37% were black.

SU-E-I-102: Independent Implementation of AAPM TG-150 Draft Image Receptor Test Recommendations.

Purpose: To determine whether a proposed suite of generic tests for digital radiography (DR) detectors could be reduced to practice.

Methods: MATLAB software was developed to analyze images according to descriptions in a document drafted by the TG150 Detector Subgroup. Forprocessing images were acquired directly from the acquisition stations of three DR and one Computed Radiography system.

Molecular characterisation of beak and feather disease virus (BFDV) in New Zealand and its implications for managing an infectious disease.

Beak and feather disease virus (BFDV) infections are often fatal to both captive and wild parrot populations. Its recent discovery in a wild population of native red-fronted parakeets has raised concerns for the conservation of native parrots, all of which are threatened or endangered. The question of a recent introduction versus a native genotype of the virus poses different conservation-management challenges, and thus, a clear understanding of the molecular phylogeny of BDFV is a crucial step towards integrated management planning.

Associations of plasma 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D concentrations with death and progression to maintenance dialysis in patients with advanced kidney disease.

Background: Low vitamin D concentrations are prevalent in patients with chronic kidney disease (CKD). We investigated the relationship between plasma 25-hydroxyvitamin D (25[OH]D) or 1,25-dihydroxyvitamin D (1,25[OH](2)D) concentrations with death, cardiovascular events, and dialysis therapy initiation in patients with advanced CKD.

Study Design: The HOST (Homocysteinemia in Kidney and End Stage Renal Disease) Study was a randomized double-blind trial evaluating the effects of high doses of folic acid on death and long-term dialysis therapy initiation in patients with advanced CKD (stages 4 and 5 not yet on dialysis therapy).

Factors associated with intern noncompliance with the 2003 Accreditation Council for Graduate Medical Education's 30-hour duty period requirement.

Background: In 2003 the Accreditation Council for Graduate Medical Education mandated work hour restrictions. Violations can results in a residency program being cited or placed on probation. Recurrent violations could results in loss of accreditation.

Improved equation for estimating single-pool Kt/V at higher dialysis frequencies.

Rationale: To measure adequacy in patients dialyzed other than three times per week, guidelines recommend the use of 'standard' Kt/V, which commonly is estimated from treatment Kt/V, time and frequency; however, the accuracy of equations that predict treatment Kt/V in patients being dialyzed other than three times per week has not been evaluated.

Methods: In patients enrolled in the Frequent Hemodialysis Network (FHN) Daily and Nocturnal Trials who were being dialyzed three, four or six times per week, we tested the accuracy of the following Kt/V prediction equation: Kt/V = -ln(R - GFAC × T_hours) + (4-3.5 × R) × 0.

Agreement in classifying bloodstream infections among multiple reviewers conducting surveillance.

Background: Mandatory reporting of healthcare-associated infections (HAIs) is increasing. Evidence for agreement among different reviewers applying HAI surveillance criteria is limited. We aim to characterize agreement among infection preventionists (IPs) conducting surveillance for central line-associated bloodstream infection (CLABSI) with each other and as compared with simplified laboratory-based definitions.

Nonparametric multistate representations of survival and longitudinal data with measurement error.

This paper proposes a nonparametric procedure to describe the progression of longitudinal cohorts over time from a population averaged perspective, leading to multistate probability curves with the states defined jointly by survival and longitudinal outcomes measured with error. To account for the challenges of informative dropout and nonlinear shapes of the longitudinal trajectories, we apply a bias corrected penalized spline regression to estimate the unobserved longitudinal trajectory for each subject. We then estimate the multistate probability curves on the basis of the survival data and the estimated longitudinal trajectories.

The effect of frequent hemodialysis on nutrition and body composition: frequent Hemodialysis Network Trial.

We investigated the effects of frequency of hemodialysis on nutritional status by analyzing the data in the Frequent Hemodialysis Network Trial. We compared changes in albumin, body weight, and composition among 245 patients randomized to six or three times per week in-center hemodialysis (Daily Trial) and 87 patients randomized to six times per week nocturnal or three times per week conventional hemodialysis, performed largely at home (Nocturnal Trial). In the Daily Trial, there were no significant differences between groups in changes in serum albumin or the equilibrated protein catabolic rate by 12 months.

Design of clinical trials in acute kidney injury: a report from an NIDDK workshop--prevention trials.

AKI is an important clinical problem that has become increasingly more common. Mortality rates associated with AKI remain high despite advances in supportive care. Patients surviving AKI have increased long-term mortality and appear to be at increased risk of developing CKD and progressing to ESRD.

Design of clinical trials in AKI: a report from an NIDDK workshop. Trials of patients with sepsis and in selected hospital settings.

AKI remains an important clinical problem, with a high mortality rate, increasing incidence, and no Food and Drug Administration-approved therapeutics. Advances in addressing this clinical need require approaches for rapid diagnosis and stratification of injury, development of therapeutic agents based on precise understanding of key pathophysiological events, and implementation of well designed clinical trials. In the near future, AKI biomarkers may facilitate trial design.

Design of clinical trials in acute kidney injury: report from an NIDDK workshop on trial methodology.

Acute kidney injury (AKI) remains a complex clinical problem associated with significant short-term morbidity and mortality and lacking effective pharmacologic interventions. Patients with AKI experience longer-term risks for progressive chronic ESRD, which diminish patients' health-related quality of life and create a larger burden on the healthcare system. Although experimental models have yielded numerous promising agents, translation into clinical practice has been unsuccessful, possibly because of issues in clinical trial design, such as delayed drug administration, masking of therapeutic benefit by adverse events, and inadequate sample size.

Kidney function can improve in patients with hypertensive CKD.

The typical assumption is that patients with CKD will have progressive nephropathy. Methodological issues, such as measurement error and regression to the mean, have made it difficult to document whether kidney function might improve in some patients. Here, we used data from 12 years of follow-up in the African American Study of Kidney Disease and Hypertension to determine whether some patients with CKD can experience a sustained improvement in GFR.

Racial differences in markers of mineral metabolism in advanced chronic kidney disease.

Background And Objectives: This study examined differences in the concentration of markers of mineral metabolism across race in patients with advanced CKD not requiring dialysis and ESRD.

Design, Setting, Participants, & Measurements: Concentrations of 25-hydroxyvitamin D (25(OH)D), 1,25-dihydroxyvitamin D (1,25(OH)(2)D), intact parathyroid hormone (iPTH), and fibroblast growth factor 23 (FGF-23) were measured in stored plasma samples of 1497 patients with advanced CKD not yet on dialysis and ESRD who participated in the Homocysteine in Kidney and End Stage Renal Disease study. Linear regression models were used to examine the relationship between race and 25(OH)D, 1,25(OH)(2)D, iPTH, and FGF-23 concentrations.

Effects of frequent hemodialysis on measures of CKD mineral and bone disorder.

More frequent hemodialysis sessions and longer session lengths may offer improved phosphorus control. We analyzed data from the Frequent Hemodialysis Network Daily and Nocturnal Trials to examine the effects of treatment assignment on predialysis serum phosphorus and on prescribed dose of phosphorus binder, expressed relative to calcium carbonate on a weight basis. In the Daily Trial, with prescribed session lengths of 1.