169,997 research outputs found

    Use of prior manufacturer specifications with Bayesian logic eludes preliminary phase issues in quality control: An example in a hemostasis laboratory

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    The present study seeks to demonstrate the feasibility of avoiding the preliminary phase, which is mandatory in all conventional approaches for internal quality control (IQC) management. Apart from savings on the resources consumed by the preliminary phase, the alternative approach described here is able to detect any analytic problems during the startup and provide a foundation for subsequent conventional assessment. A new dynamically updated predictive control chart (PCC) is used. Being Bayesian in concept, it utilizes available prior information. The manufacturer's prior quality control target value, the manufacturer's maximum acceptable interassay coefficient of variation value and the interassay standard deviation value defined during method validation in each laboratory, allow online IQC management. An Excel template, downloadable from journal website, allows easy implementation of this alternative approach in any laboratory. In the practical case of prothrombin percentage measurement, PCC gave no false alarms with respect to the 1(ks) rule (with same 5% false-alarm probability on a single control sample) during an overlap phase between two IQC batches. Moreover, PCCs were as effective as the 1(ks) rule in detecting increases in both random and systematic error after the minimal preliminary phase required by medical biology guidelines. PCCs can improve efficiency in medical biology laboratories

    A comparison of the 12s rule and Bayesian approach for quality control: Application to one-stage clotting factor VIII assay

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    An ideal medical biology internal quality control (IQC) plan should both monitor the laboratory methods efficiently and implement the relevant clinical-biological specifications. However, many laboratories continue to use the 1(2s) quality control rule without considering the high risk of false rejection and without considering the relationship of analytical performance to quality requirements. Alternatively, one can move to the Bayesian arena, enabling probabilistic quantification of the information coming in, on a daily basis from the laboratory's IQC tests, and taking into account the laboratory's medical and economic contexts. Using the example of one-stage clotting factor VIII assay, the present study compares frequentist (1(2s) quality control rule) and Bayesian IQC management with respect to prescriber requirements, process start-up phase issues, and abnormal scenarios in IQC results. To achieve comparable confidence, the traditional 1(2s) quality control rule requires more data than the Bayesian approach in order to detect an increase in the random or systematic error of the method. Moreover, the Bayesian IQC management approach explicitly implements respect of prescriber requirements in terms of calculating the probability that the variable in question lies in a given predefined interval: for example, the factor VIII concentration required after knee surgery in a hemophilia patient. (C) 2014 Wolters Kluwer Health I Lippincott Williams & Wilkins

    Bayesian logic in statistical test control: Application to coagulation factor VIII assay

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    Coagulation factor VIII was assayed around the critical concentration of 80 U/dl, which is optimal for postoperative haemostasis in haemophiliac patients, in order to assess the use of Bayesian logic in interpreting internal quality control results during a change of reagent or control batch. A mathematical model based on Bayesian inference, requiring no preliminary control-plan phase, was compared with a classical approach, which necessarily involves performing a preliminary phase. Tsiamyrtzis and Hawkins' Bayesian model proved applicable to rapid statistical control of factor VIII assay, detecting shift at least as efficiently as classical approaches, which depend on running the kind of costly and controversial preliminary control phase recommended by Shewhart. Blood Coagul Fibrinolysis 21:289-295 (C) 2010 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins

    VWF/FVIII concentrates in high-risk immunotolerance : the resist studies

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    Background: Inhibitor eradication with immune tolerance induction (ITI) is the best long-term therapeutic strategy in Haemophilia A (HA) patients with inhibitors. Several parameters are known to be related to the ITI success. One that has more recently been proposed is the type of FVIII concentrate. Recent clinical findings indicate that plasma-derived FVIII products containing von Willebrand factor (VWF/FVIII) could have an impact on ITI success rate, even in poor prognosis patients. Study design: Two key prospective clinical studies have been designed to confirm the previous results supporting the use of VWF/FVIII in ITI: RESIST experienced (RESISTexp) and RESIST naïve (RESIST-naïve). RESIST: Exp is a prospective, nonrandomized study designed to assess rescue treatment with VWF/FVIII at high dosage (200 IU/kg daily) in patients who failed a previous ITI attempt with any dose of a VWF-free FVIII concentrate (plasma-derived or recombinant). RESISTnaïve is a prospective, controlled, randomized, open-label study comparing two types of FVIII concentrates (VWF-free FVIII and VWF/FVIII) in their ability to induce tolerance in high responding HA patients, with no previous ITI attempt and with poor prognosis for success. Both types of concentrates will be administered at high dosage (200 IU/kg daily). Enrolment criteria are: severe haemophilia A (FVIII 5 BU), any inhibitor level at study enrolment, and at least one of the following risk factors for ITI failure: (a) peak inhibitor titer > 200 BU, (b) titer at ITI start > 10 BU, (c) age > 7 years, (d) time between inhibitor occurrence and ITI > 2 years. Patient undergoing concomitant immunosuppressive treatment are not eligible for either study. Primary end point is success in achieving ITI defined as: complete or partial. Secondary endpoints are: ITI maintenance, time to success, safety/compliance to treatment and cost of care. Conclusions: The results of RESIST studies will be crucial in understanding the role of VWF/FVIII in ITI outcome and will contribute to providing effective treatment for the devastating complication of FVIII antibody development in HA patient

    Going Beyond Counting First Authors in Author Co-citation Analysis

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    The present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed

    Mitomycin C in highly myopic eyes - Author reply

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    Ophthalmology. 2005 Feb;112(2):208-18; discussion 219. Mitomycin C modulation of corneal wound healing after photorefractive keratectomy in highly myopic eyes. Gambato C, Ghirlando A, Moretto E, Busato F, Midena E. SourceRefractive Surgery Service and Antimetabolite Therapy Research Unit, Department of Ophthalmology, University of Padova, Padova, Italy. Abstract PURPOSE: To evaluate the role of topical mitomycin C in corneal wound healing (CWH) after photorefractive keratectomy (PRK) in highly myopic eyes. DESIGN: Prospective, double-masked, randomized clinical trial. PARTICIPANTS: Seventy-two eyes of 36 patients affected by high (>7 diopters) myopia. METHODS: In each patient, one eye was randomly assigned to PRK with intraoperative topical 0.02% mitomycin C application, and the fellow eye was treated with a placebo. Postoperatively, mitomycin C-treated eyes received artificial tears (3 times daily, tapered in 3 months), whereas the fellow eye was treated with fluorometholone sodium 2% and artificial tears (3 times daily, tapered in 3 months). MAIN OUTCOME MEASURES: Uncorrected visual acuity (UCVA) and best-corrected visual acuity (BCVA), contrast sensitivity, manifest refraction, and biomicroscopy. Contrast sensitivity was determined using the Pelli-Robson chart. Corneal confocal microscopy documented CWH. RESULTS: Mean follow-up was 18 months (range, 12-36). No side effects or toxic effects were documented. At 12-month follow-up examination, UCVAs (logarithm of the minimum angle of resolution) were 0.4+/-0.48 and 0.5+/-0.53 (P = .03) in mitomycin C-treated eyes and corticosteroid-treated eyes, respectively. At 1 year, corneal haze developed in 20% of corticosteroid-treated eyes, versus 0% of mitomycin C-treated eyes. At 12, 24, and 36 months, corneal confocal microscopy showed activated keratocytes and extracellular matrix significantly more evident in untreated eyes (Ps = 0.004, 0.024, and 0.046, respectively). CONCLUSION: Topical intraoperative application of 0.02% mitomycin C can reduce haze formation in highly myopic eyes undergoing PRK. Comment in Ophthalmology. 2006 Feb;113(2):357; author reply 357-8

    Dispelling the Myths Behind First-author Citation Counts

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    We conducted a full-scale evaluative citation analysis study of scholars in the XML research field to explore just how different from each other author rankings resulting from different citation counting methods actually are, and to demonstrate the capability of emerging data and tools on the Web in supporting more realistic citation counting methods. Our results contest some common arguments for the continued use of first-author citation counts in the evaluation of scholars, such as high correlations between author rankings by first-author citation counts and other citation counting methods, and high costs of using more realistic citation counting methods that are not well-supported by the ISI databases. It is argued that increasingly available digital full text research papers make it possible for citation analysis studies to go beyond what the ISI databases have directly supported and to employ more sophisticated methods

    SAFETY AND EFFECTIVENESS OF ACTIVATED PROTHROMBIN COMPLEX CONCENTRATE (APCC) MONOTHERAPY IN PATIENTS WITH HEMOPHILIA AND INHIBITORS (PWHI) UNDERGOING SURGERY: A SYSTEMATIC REVIEW AND META-ANALYSIS

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    Introduction: Control of hemostasis during and after surgical procedures in PwHI is challenging. aPCC (Feiba®, Baxalta Inc, a Takeda company, Lexington, MA, USA), a bypassing agent, is indicated for patients with congenital hemophilia A or B with inhibitors for on-demand, prophylaxis and perioperative management, and for acquired hemophilia patients. We present a systematic literature review of studies reporting aPCC safety and a meta-analysis of the hemostatic effectiveness of aPCC monotherapy during major and minor surgical procedures in PwHI. Methods: This systematic review and meta-analysis was carried out in MedLine through Pubmed from January 1, 1980 (aPCC inception) to June 30, 2018. Prospective, retrospective, randomized and non-randomized studies that reported the safety and hemostatic effectiveness of aPCC monotherapy in PwHI during surgery were eligible. Studies investigating concomitant/sequential infusion of aPCC with rFVIIa, tranexamic acid or emicizumab were excluded. Safety outcomes included serious adverse events (SAEs), including thromboembolic event (TEE), thrombotic microangiopathy (TMA), and other AEs associated with aPCC monotherapy. The hemostatic effectiveness was assessed intraoperatively by the surgeon and late postoperatively by the hematologist and rated as “excellent, good, fair or poor”. Results: Of 645 publications describing aPCC as monotherapy in PwHI, 14 publications (including 158 patients) reported aPCC monotherapy in a surgical setting (100 major and 162 minor surgeries). TEE occurrence was reported in 4 major surgeries in 4 patients. One SAE of a clot in an arteriovenous fistula (possibly-related to aPCC) was reported. No reports of TMAs were identified in publications of studies that used aPCC as monotherapy. The proportion (95% confidence interval, CI) of major procedures in which hemostatic effectiveness was rated as excellent/good was 0.91 [(0.83-0.99); p=0.04 for heterogeneity] and for minor procedures this was 0.98 [(0.95-1.00); p=0.86 for heterogeneity]. Discussion/Conclusion: In this analysis of published studies involving patients treated with aPCC monotherapy in a surgical setting, a low rate of TEE occurrence and no TMAs were reported, while the hemostatic effectiveness of aPCC monotherapy was rated as excellent/good in >90% of both minor and major surgical procedures

    A Multi-Language Comparison of Influences on Author Verification using Character N-Grams

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    We create a new multi-language corpus for author verification based on Wikipedia talkpages, and evaluate the influence that differences in topic and time have on character n-gram author profiles. Topic alignment between two texts is found to increase author verification precision, and an authors writing style is found to change over time, but not more significantly after 3 years than after 1 year.Information ArchitectureWISElectrical Engineering, Mathematics and Computer Scienc

    A 0.12mm<sup>2</sup> Wien-Bridge Temperature Sensor with 0.1°C (3σ) Inaccuracy from -40°C to 180°C

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    Resistor-based temperature sensors can achieve much higher resolution and energy efficiency than conventional BJT-based sensors [1], but they typically occupy more area (&gt; 0.25 mm 2 ) and have lower operating temperatures (le 125 {circ} {C}) [2]-[4]. This work describes a 0.12mm 2 resistor-based sensor that uses a Wien-bridge (WB) filter to achieve 0.1 {circ} {C} (3 sigma) inaccuracy from - 40 {circ} {C} to 180 {circ} {C}. Compared to a state-of-the-art WB sensor [4], it occupies 6 × less area and achieves comparable relative accuracy over a 76% wider operating range. Session 10.3 Green Open Access added to TU Delft Institutional Repository ‘You share, we take care!’ – Taverne project https://www.openaccess.nl/en/you-share-we-take-care Otherwise as indicated in the copyright section: the publisher is the copyright holder of this work and the author uses the Dutch legislation to make this work public.Electronic InstrumentationMicroelectronic
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