Implementation of a clinical decision support system improves compliance with restrictive transfusion policies in hematology patients.

BACKGROUND: There is increasing evidence for restrictive red blood cell (RBC) transfusion but compliance with recommended transfusion triggers is variable. A clinical decision support system (CDSS) has been found to reduce unnecessary transfusion in some clinical settings when physicians are advised they are noncompliant with the current guidelines. The objective was to assess the impact of a CDSS for blood product ordering in patients with hematologic disease. STUDY DESIGN AND METHODS: All platelet (PLT) and RBC transfusions were identified in hematology patients in three periods: before (baseline), immediately after (CDSS1), and 7 months after implementation of CDSS for blood ordering (CDSS2). Compliance with the recommended transfusion triggers was monitored for all orders made by CDSS or non-CDSS methods during each period. RESULTS: Ninety-seven patients with a variety of hematologic diagnoses received 502 RBC and 572 PLT transfusions during the three periods with no significant difference in 1) the mean number of transfusions per patient, 2) the proportion of patients transfused, 3) posttransfusion hemoglobin (Hb), and 4) pre- and posttransfusion PLT count, although mean pretransfusion Hb decreased. The proportion of noncompliant RBC and PLT transfusion requests improved from baseline to CDSS2 (69.0% to 43.4% p ≤ 0.005 for RBCs; and 41.9% to 31.2%, p = 0.16 for PLT) when all orders were compared, although this improvement was not significant at the 5% level for PLTs. CONCLUSIONS: The introduction of CDSS for blood product ordering supported by education and physician feedback in the hematology setting had an immediate impact on improving compliance with guidelines for restrictive transfusion practice.

Effect of pamidronate on bone loss after kidney transplantation: a randomized trial.

BACKGROUND: Kidney transplantation is associated with an increased risk of bone fracture and rapid loss of bone mineral density after kidney transplantation. STUDY DESIGN: Randomized controlled trial. SETTING & PARTICIPANTS: Patients were randomly assigned to treatment (n = 46) or control (no treatment; n = 47) groups. Patients were stratified according to parathyroid hormone level and sex. Those with parathyroid hormone level less than 150 pg/mL were excluded. INTERVENTION: The treatment and control groups received pamidronate, 1 mg/kg, perioperatively and then at 1, 4, 8, and 12 months or no treatment, respectively. All received calcium (500 mg) and vitamin D (400 units) daily. Immunosuppression was cyclosporine and prednisolone, with no difference in dosing between the 2 groups. OUTCOMES & MEASUREMENTS: Bone mineral density was evaluated by means of dual-energy x-ray absorptiometry of the lumbar spine and hip at baseline and 3, 6, 12, and 24 months, with the primary end point at 1 year of percentage of change in bone mineral density from baseline. Clinical fractures were recorded and also evaluated by means of spinal radiographs at baseline and 1 and 2 years. RESULTS: Pamidronate protected bone mineral density at the lumbar spine; bone mineral density increased by 2.1% in the treatment group and decreased by 5.7% in the control group at 12 months (P = 0.001). Protection was also seen in Ward's area of the hip (P = 0.002) and the total hip (P = 0.004). There was no difference in femoral neck bone mineral density loss between the 2 groups. Fracture rates in the treatment and control groups were 3.3% and 6.4% per annum, respectively. LIMITATIONS: This study was not powered to detect differences in fracture rates. CONCLUSION: Pamidronate protects against posttransplantation bone loss at the lumbar spine and Ward's area of the hip.

The second United Kingdom Heart and Renal Protection (UK-HARP-II) Study: a randomized controlled study of the biochemical safety and efficacy of adding ezetimibe to simvastatin as initial therapy among patients with CKD.

BACKGROUND: Evaluating the effects of decreasing low-density lipoprotein (LDL) cholesterol levels requires large randomized trials. In preparation for such a trial, we assessed the biochemical efficacy, safety, and tolerability of adding ezetimibe, 10 mg/d, to simvastatin, 20 mg/d, as initial therapy for such patients. METHODS: Two hundred three patients (152 predialysis patients with creatinine levels > or = 1.7 mg/dL [> or = 150 micromol/L], 18 patients on peritoneal dialysis therapy, and 33 patients on hemodialysis therapy) were randomly assigned to the administration of simvastatin, 20 mg/d, plus ezetimibe, 10 mg/d; or simvastatin, 20 mg, plus placebo ezetimibe daily. RESULTS: After 6 months, allocation to simvastatin monotherapy was associated with a 31-mg/dL (0.8-mmol/L) decrease in nonfasting LDL cholesterol levels compared with baseline. Allocation to simvastatin plus ezetimibe produced an additional 18-mg/dL (0.47-mmol/L) decrease in LDL cholesterol level, representing an incremental 21% reduction over that achieved with simvastatin monotherapy (P < 0.0001). There were no statistically significant effects of the addition of ezetimibe to simvastatin on triglyceride or high-density lipoprotein cholesterol levels. Ezetimibe was not associated with an excess risk of abnormal liver function test results or of elevated creatine kinase levels and did not impair absorption of fat-soluble vitamins. There were no serious adverse events caused by study treatment. CONCLUSION: This 6-month study shows that the addition of ezetimibe to simvastatin, 20 mg/d, as initial therapy for patients with chronic kidney disease was well tolerated and produced an additional 21% decrease in LDL cholesterol levels. The clinical efficacy and safety of combination therapy in this population are now being assessed in a large randomized trial.

First United Kingdom Heart and Renal Protection (UK-HARP-I) study: biochemical efficacy and safety of simvastatin and safety of low-dose aspirin in chronic kidney disease.

BACKGROUND: Patients with chronic kidney disease are at increased risk for cardiovascular disease, but the efficacy and safety of simvastatin and aspirin are unknown in this patient group. METHODS: Patients were randomly assigned in a 2 x 2 factorial design to the administration of: (1) 20 mg of simvastatin daily versus matching placebo, and (2) 100 mg of modified-release aspirin daily versus matching placebo. RESULTS: Overall, 448 patients with chronic kidney disease were randomly assigned (242 predialysis patients with a creatinine level > or = 1.7 mg/dL [> or =150 micromol/L], 73 patients on dialysis therapy, and 133 patients with a functioning transplant). Compliance with study treatments was 80% at 12 months. Allocation to treatment with 100 mg of aspirin daily was not associated with an excess of major bleeds (aspirin, 4 of 225 patients [2%] versus placebo, 6 of 223 patients [3%]; P = not significant [NS]), although there was a 3-fold excess of minor bleeds (34 of 225 [15%] versus 12 of 223 patients [5%]; P = 0.001). Among those with predialysis renal failure or a functioning transplant at baseline, aspirin did not increase the number of patients who progressed to dialysis therapy (7 of 187 [4%] versus 6 of 188 patients [3%]; P = NS) or experienced a greater than 20% increase in creatinine level (63 of 187 patients [34%] versus 56 of 188 patients [30%]; P = NS). After 12 months of follow-up, allocation to 20 mg of simvastatin daily reduced nonfasting total cholesterol levels by 18% (simvastatin, 163 mg/dL [4.22 mmol/L] versus placebo, 196 mg/dL [5.08 mmol/L]; P < 0.0001), directly measured low-density lipoprotein cholesterol levels by 24% (89 mg/dL [2.31 mmol/L] versus 114 mg/dL [2.96 mmol/L]; P < 0.0001), and triglyceride levels by 13% (166 mg/dL [1.87 mmol/L] versus 186 mg/dL [2.10 mmol/L]; P < 0.01), but there was no significant effect on high-density lipoprotein cholesterol levels (2% increase; P = NS). Allocation to simvastatin therapy was not associated with excess risk for abnormal liver function test results or elevated creatine kinase levels. CONCLUSION: During a 1-year treatment period, simvastatin, 20 mg/d, produced a sustained reduction of approximately one quarter in low-density lipoprotein cholesterol levels, with no evidence of toxicity, and aspirin, 100 mg/d, did not substantially increase the risk for a major bleeding episode. Much larger trials are now needed to assess whether these treatments can prevent vascular events.

A user-centred home monitoring and self-management system for patients with heart failure: a multicentre cohort study.

AIMS: Previous generations of home monitoring systems have had limited usability. We aimed to develop and evaluate a user-centred and adaptive system for health monitoring and self-management support in patients with heart failure. METHODS AND RESULTS: Patients with heart failure were recruited from three UK centres and provided with Internet-enabled tablet computers that were wirelessly linked with sensor devices for blood pressure, heart rate, and weight monitoring. Patient observations, interviews, and concurrent analyses of the automatically collected data from their monitoring devices were used to increase the usability of the system. Of the 52 participants (median age 77 years, median follow-up 6 months [interquartile range, IQR, 3.6-9.2]), 24 (46%) had no, or very limited prior, experience with digital technologies. It took participants about 1.5 min to complete the daily monitoring tasks, and the rate of failed attempts in completing tasks was <5%. After 45 weeks of observation, participants still used the system on 4.5 days per week (confidence interval 3.2-5.7 days). Of the 46 patients who could complete the final survey, 93% considered the monitoring system as easy to use and 38% asked to keep the system for self-management support after the study was completed. CONCLUSION: We developed a user-centred home monitoring system that enabled a wide range of heart failure patients, with differing degrees of IT literacy, to monitor their health status regularly. Despite no active medical intervention, patients felt that they benefited from the reassurance and sense of connectivity that the monitoring system provided.

Sevelamer.

Hyperphosphataemia in patients with chronic renal failure has traditionally been treated with calcium- and aluminium-containing phosphate binders. This article briefly discusses the rationale and complications of these treatments and reviews sevelamer that is a novel non-calcium-, non-aluminium-containing phosphate binder and the evidence to support its use in clinical practice.