Purpose Quantitative analytic methods are being increasingly used in postmarketing surveillance. However, currently existing methods are limited to spontaneous reporting data and are inapplicable to hospital electronic medical record (EMR) data. The principal objectives of this study were to propose a novel algorithm for detecting the signals of adverse drug reactions using EMR data focused on laboratory abnormalities after treatment with medication, and to evaluate the potential use of this method as a signal detection tool. Methods We developed an algorithm referred to as the Comparison on Extreme Laboratory Test results, which takes an extreme representative value pair according to the types of laboratory abnormalities on the basis of each patient's medication point. We used 10 years' EMR data from a tertiary teaching hospital, containing 32 033 710 prescriptions and 115 241 147 laboratory tests for 530 829 individual patients. Ten drugs were selected randomly for analysis, and 51 laboratory values were matched. The sensitivity, specificity, positive predictive value, and negative predictive value of the algorithm were calculated. Results The mean number of detected laboratory abnormality signals for each drug was 27 (±7.5). The sensitivity, specificity, positive predictive value, and negative predictive value of the algorithm were 64 -100%, 22 -76%, 22 -75%, and 54 -100%, respectively. Conclusions The results of this study demonstrated that the Comparison on Extreme Laboratory Test results algorithm described herein was extremely effective in detecting the signals characteristic of adverse drug reactions. This algorithm can be regarded as a useful signal detection tool, which can be routinely applied to EMR data.

BackgroundFor phosphate control, patient education is essential due to the limited clearance of phosphate by dialysis. However, well-designed randomized controlled trials about dietary and phosphate binder education have been scarce.MethodsWe enrolled maintenance hemodialysis patients and randomized them into an education group (n = 48) or a control group (n = 22). We assessed the patients’ drug compliance and their knowledge about the phosphate binder using a questionnaire.ResultsThe primary goal was to increase the number of patients who reached a calcium-phosphorus product of lower than 55. In the education group, 36 (75.0%) patients achieved the primary goal, as compared with 16 (72.7%) in the control group (P = 0.430). The education increased the proportion of patients who properly took the phosphate binder (22.9% vs. 3.5%, P = 0.087), but not to statistical significance. Education did not affect the amount of dietary phosphate intake per body weight (education vs. control: −1.18 ± 3.54 vs. −0.88 ± 2.04 mg/kg, P = 0.851). However, the dietary phosphate-to-protein ratio tended to be lower in the education group (−0.64 ± 2.04 vs. 0.65 ± 3.55, P = 0.193). The education on phosphate restriction affected neither the Patient-Generated Subjective Global Assessment score (0.17 ± 4.58 vs. −0.86 ± 3.86, P = 0.363) nor the level of dietary protein intake (−0.03 ± 0.33 vs. −0.09 ± 0.18, P = 0.569).ConclusionEducation did not affect the calcium-phosphate product. Education on the proper timing of phosphate binder intake and the dietary phosphate-to-protein ratio showed marginal efficacy.

The risk of hyperkalemic events in hospitalized patients treated with different ARBs was defined. Telmisartan showed a relatively lower hyperkalemic risk profile in hospitalized patients compared with other ARBs.

Background In the general population, the trabecular bone score (TBS) represents the bone microarchitecture and predicts fracture risk independent of bone mineral density (BMD). A few studies reported that TBS is significantly reduced in dialysis patients. Chronic kidney disease-mineral and bone disorder (CKD-MBD) are accompanied by increased fracture risk, cardiovascular morbidity, and mortality. We investigated whether TBS is associated with comorbidity related to CKD-MBD or frailty in hemodialysis patients. Methods In this prospective observational study, TBS was obtained using the TBS iNsight software program (Med-Imaps) with BMD dual energy x-ray absorptiometry (DXA) images (L1–L4) from prevalent hemodialysis patients. A Tilburg frailty indicator was used to evaluate frailty, and hand grip strength and bio-impedance (InBody) were measured. A patient-generated subjective global assessment (PG-SGA) was used for nutritional assessment. The history of cardiovascular events (CVE) and demographic, clinical, laboratory, and biomarker data were collated. We then followed up patients for the occurrence of CKD-MBD related complications. Results We enrolled 57 patients in total. The mean age was 56.8 ± 15.9 years (50.9% female). Prevalence of Diabetes mellitus (DM) was 40.4% and CVE was 36.8%. Mean TBS was 1.44 ± 0.10. TBS significantly reduced in the CVE group (1.38 ± 0.08 vs. 1.48 ± 0.10, p <  0.001). Multivariable regression analysis was conducted adjusting for age, sex, dialysis vintage, DM, CVE, albumin, intact parathyroid hormone, fibroblast growth factor 23, handgrip strength, and phosphate binder dose. Age ( ß = − 0.030; p = 0.001) and CVE ( ß = − 0.055; p = 0.024) were significant predictors of TBS. During the follow up period after TBS measurements (about 20 months), four deaths, seven incident fractures, and six new onset CVE were recorded. Lower TBS was associated with mortality ( p = 0.049) or new onset fracture ( p = 0.007, by log-rank test). Conclusion Lower TBS was independently associated with increased age and CVE prevalence in hemodialysis patients. Mortality and fracture incidence were significantly higher in patients with lower TBS values. These findings suggest that TBS may indicate a phenotype of frailty and also a CKD-MBD phenotype reciprocal to CVE.

Either CI or GNRI was a valid tool for longitudinal observation of nutritional status of patients on chronic HD and facilitated the screening of cases with malnutrition. Compared with GNRI, CI ranked higher in performance for the assessment and monitoring of nutritional status in HD patients.

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Purpose-The prevalence of chronic kidney disease (CKD) is increasing rapidly in many countries and has become a major public health concern. Although intakes of long-chain omega-3 polyunsaturated fatty acids (LCω3PUFA) and its food source -fish -may have renal protective effects, little is known about the longitudinal association between these dietary factors and CKD incidence.Methods-A total of 4133 healthy individuals of black and white race aged 18 to 30 at baseline (1985-86) from the Coronary Artery Risk Development in Young Adults study were enrolled and followed up over 25 years. LCω3PUFA and fish intake were assessed by an interview-based dietary history questionnaire at baseline, year 7 (1992-93), and 20 (2005-06).Results-Four hundred eighty-nine incident cases of CKD were identified. After adjustment for potential confounders, LCω3PUFA intake was inversely associated with CKD incidence [HR = 0.73 (95% CI: 0.60 to 0.89), P = 0.002, with one standard division (0.19 g/day) increment in LCω3PUFA], This inverse association was persisted among females [0.64 (95% CI: 0.48, 0.84; P

Introduction: Continuous venovenous hemodiafiltration (CVVHDF) may alter teicoplanin pharmacokinetics and increase the risk of incorrect dosing. The objective of this prospective observational study was to assess the effect of CVVHDF on the pharmacokinetics of teicoplanin as maintenance therapy. Methods: Blood, urine, and dialysate samples were collected to measure teicoplanin levels. CVVHDF clearance (CLCVVHDF), total clearance (CLTOTAL), and volume of distribution (Vd) were calculated by simplex‐linear modeling. The influence of CVVHDF dose on teicoplanin pharmacokinetics was assessed. Findings: Ten samples from eight patients were studied. Creatinine clearance was 3.4 ± 5.1 ml/min/1.73 m2. Three patients were anuria. The dose for CVVHDF was 32.1 ± 7.0 mL/kg/h. Vd was 1.6 ± 0.7 L/kg. T1/2 was 100.1 ± 42.7 hours. CLTOTAL of teicoplanin was 11.9 ± 5.4 mL/min and CLCVVHDF was 5.8 ± 4.2 mL/min. Contribution of CLCVVHDF to CLTOTAL was 51.2% ± 23.6%. CLCVVHDF of individual teicoplanin varied widely. Large intra‐occasion differences were also observed. Dose of CLCVVHDF did not influence overall CLTOTAL, Vd, or half‐life. The proportion of CLTOTAL due to CLCVVHDF varied widely. It was high in some cases. Discussion: In patients receiving CVVHDF, there is great variability in teicoplanin pharmacokinetics which complicates empiric approach to dosing, suggesting the need for therapeutic drug monitoring.