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https://www.readbyqxmd.com/read/28544622/an-investigation-into-the-two-stage-meta-analytic-copula-modelling-approach-for-evaluating-time-to-event-surrogate-endpoints-which-comprise-of-one-or-more-events-of-interest
#1
Natalie Dimier, Susan Todd
Clinical trials of experimental treatments must be designed with primary endpoints that directly measure clinical benefit for patients. In many disease areas, the recognised gold standard primary endpoint can take many years to mature, leading to challenges in the conduct and quality of clinical studies. There is increasing interest in using shorter-term surrogate endpoints as substitutes for costly long-term clinical trial endpoints; such surrogates need to be selected according to biological plausibility, as well as the ability to reliably predict the unobserved treatment effect on the long-term endpoint...
May 19, 2017: Pharmaceutical Statistics
https://www.readbyqxmd.com/read/28543946/predicting-dose-sparing-benefit-and-bleeding-risk-of-pharmacokinetic-based-personalized-prophylactic-dosing-of-factor-viii-products
#2
M A Tegenge, H Yang, R A Forshee
BACKGROUND: Previously published factor VIII (FVIII) pharmacokinetic (PK)-based dosing approaches employ fixed infusion interval with a wide dose range that may lead to increased risk of bleeding, excessive doses or decreased health-related quality of life. AIM: The objectives of the study includes (i) personalizing infusion interval in lieu of fixed infusion, (ii) constraining dose within the range of 10-50 IU/kg and (iii) characterizing bleeding risk of PK-based dosing in comparison with empiric standard doses...
May 24, 2017: Haemophilia: the Official Journal of the World Federation of Hemophilia
https://www.readbyqxmd.com/read/28542103/predictive-accuracy-of-surgimaptm-surgical-planning-for-sagittal-imbalance-a-cohort-study
#3
Francesco Langella, Jorge Hugo Villafañe, Marco Damilano, Riccardo Cecchinato, Matteo Pejrona, Maryem Ismael, Pedro Berjano
STUDY DESIGN: A cohort study. OBJECTIVE: To evaluate the predictive value of surgical planning using Surgimap™ regarding postoperative sagittal alignment. SUMMARY OF BACKGROUND DATA: Surgical planning in sagittal imbalance is recognized as a key step of treatment to ensure results. METHODS: The study involved 40 non-consecutive patients who underwent surgery for sagittal misalignment. Postoperative alignment measured by sagittal vertical axis (SVA) and pelvic tilt (PT) was considered the gold standard...
May 25, 2017: Spine
https://www.readbyqxmd.com/read/28541890/event-triggered-model-predictive-control-for-embedded-artificial-pancreas-systems
#4
Ankush Chakrabarty, Stamatina Zavitsanou, Francis Doyle Iii, Eyal Dassau
OBJECTIVE: The development of artificial pancreas (AP) technology for deployment in low-energy, embedded devices is contingent upon selecting an efficient control algorithm for regulating glucose in people with type 1 diabetes mellitus (T1DM). In this paper, we aim to lower the energy consumption of the AP by reducing controller updates, that is, the number of times the decision-making algorithm is invoked to compute an appropriate insulin dose. METHODS: Physiological insights into glucose management are leveraged to design an event-triggered model predictive controller (MPC) that operates efficiently, without compromising patient safety...
May 23, 2017: IEEE Transactions on Bio-medical Engineering
https://www.readbyqxmd.com/read/28541721/a-joint-bayesian-model-for-integrating-microarray-and-rna-sequencing-transcriptomic-data
#5
Tianzhou Ma, Faming Liang, Steffi Oesterreich, George C Tseng
As the sequencing cost continued to drop in the past decade, RNA sequencing (RNA-seq) has replaced microarray to become the standard high-throughput experimental tool to analyze transcriptomic profile. As more and more datasets are generated and accumulated in the public domain, meta-analysis to combine multiple transcriptomic studies to increase statistical power has received increasing popularity. In this article, we propose a Bayesian hierarchical model to jointly integrate microarray and RNA-seq studies...
May 25, 2017: Journal of Computational Biology: a Journal of Computational Molecular Cell Biology
https://www.readbyqxmd.com/read/28541602/three-dimensional-printing-in-cardiology-current-applications-and-future-challenges
#6
Hongxing Luo, Jarosław Meyer-Szary, Zhongmin Wang, Robert Sabiniewicz, Yuhao Liu
Three-dimensional (3D) printing has attracted a huge interest in recent years. Broadly speaking, it refers to the technology which converts a predesigned virtual model to a touchable object. In clinical medicine, it usually converts a series of two-dimensional medical images acquired through computed tomography, magnetic resonance imaging or 3D echocardiography into a physical model. Medical 3D printing consists of three main steps: image acquisition, virtual reconstruction and 3D manufacturing. It is a promising tool for preoperative evaluation, medical device design, hemodynamic simulation and medical education, it is also likely to reduce operative risk and increase operative success...
May 25, 2017: Cardiology Journal
https://www.readbyqxmd.com/read/28541510/optimization-of-linezolid-therapy-in-the-critically-ill-the-effect-of-adjusted-infusion-regimens
#7
Max Taubert, Johannes Zander, Sebastian Frechen, Christina Scharf, Lorenz Frey, Michael Vogeser, Uwe Fuhr, Michael Zoller
Objectives: Insufficient linezolid levels, which are associated with a poorer outcome, are often observed in ICU patients who receive standard dosing. Although strategies to overcome these insufficient levels have been discussed, appropriate alternative dosing regimens remain to be identified. Methods: Various infusion regimens (1200-3600 mg/day; q6h, q8h, q12h and continuous) were simulated in 67 000 ICU patients. The probability of attaining pharmacodynamic targets ( T >MIC ≥85%, AUC/MIC ≥100, cumulative fraction of response for Staphylococcus aureus and Enterococcus spp...
May 24, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/28540639/exploiting-pharmacokinetic-models-of-tamoxifen-and-endoxifen-to-identify-factors-causing-subtherapeutic-concentrations-in-breast-cancer-patients
#8
Lena Klopp-Schulze, Markus Joerger, Sebastian G Wicha, Rob Ter Heine, Chantal Csajka, Zinnia P Parra-Guillen, Charlotte Kloft
BACKGROUND AND OBJECTIVES: A better understanding of the highly variable pharmacokinetics (PK) of tamoxifen and its active metabolite endoxifen in breast cancer patients is crucial to support individualised treatment. This study used a modelling and simulation approach to quantitatively assess the influence of cytochrome P450 (CYP) 2D6 activity and other relevant factors on tamoxifen and endoxifen PK to identify subgroups at risk for subtherapeutic endoxifen concentrations. METHODS: Simulations were performed using two previously published PK models jointly describing tamoxifen and endoxifen with CYP2D6 and CYP3A4/5 enzyme activities implemented as covariates...
May 24, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28538983/assocation-of-a-surgical-task-during-training-with-team-skill-acquisition-among-surgical-residents-the-missing-piece-in-multidisciplinary-team-training
#9
Jessica L Sparks, Dustin L Crouch, Kathryn Sobba, Douglas Evans, Jing Zhang, James E Johnson, Ian Saunders, John Thomas, Sarah Bodin, Ashley Tonidandel, Jeff Carter, Carl Westcott, R Shayn Martin, Amy Hildreth
Importance: The human patient simulators that are currently used in multidisciplinary operating room team training scenarios cannot simulate surgical tasks because they lack a realistic surgical anatomy. Thus, they eliminate the surgeon's primary task in the operating room. The surgical trainee is presented with a significant barrier when he or she attempts to suspend disbelief and engage in the scenario. Objective: To develop and test a simulation-based operating room team training strategy that challenges the communication abilities and teamwork competencies of surgeons while they are engaged in realistic operative maneuvers...
May 24, 2017: JAMA Surgery
https://www.readbyqxmd.com/read/28538445/a-national-survey-on-the-use-of-immersive-simulation-for-interprofessional-education-in-physical-therapist-education-programs
#10
Brad Stockert, Patricia J Ohtake
INTRODUCTION: There is growing recognition that collaborative practice among healthcare professionals is associated with improved patient outcomes and enhanced team functioning, but development of collaborative practitioners requires interprofessional education (IPE). Immersive simulation, a clinically relevant experience that deeply engages the learner in realistic clinical environments, is used increasingly for IPE. The purpose of this study was to assess the use of immersive simulation as a strategy for IPE in physical therapist (PT) education programs...
May 20, 2017: Simulation in Healthcare: Journal of the Society for Simulation in Healthcare
https://www.readbyqxmd.com/read/28538110/the-effect-of-individual-movements-and-interventions-on-the-spread-of-influenza-in-long-term-care-facilities
#11
Mehdi Najafi, Marek Laskowski, Pieter T de Boer, Evelyn Williams, Ayman Chit, Seyed M Moghadas
BACKGROUND: Nosocomial influenza poses a serious risk among residents of long-term care facilities (LTCFs). OBJECTIVE: We sought to evaluate the effect of resident and staff movements and contact patterns on the outcomes of various intervention strategies for influenza control in an LTCF. METHODS: We collected contact frequency data in Canada's largest veterans' LTCF by enroling residents and staff into a study that tracked their movements through wireless tags and signal receivers...
May 1, 2017: Medical Decision Making: An International Journal of the Society for Medical Decision Making
https://www.readbyqxmd.com/read/28536776/development-of-improved-dosing-regimens-for-mycophenolate-mofetil-based-on-population-pharmacokinetic-analyses-in-adults-with-lupus-nephritis
#12
Azrin N Abd Rahman, Susan E Tett, Halim A Abdul Gafor, Brett C McWhinney, Christine E Staatz
BACKGROUND AND OBJECTIVE: Mycophenolic acid (MPA) provides effective treatment for lupus nephritis patients. Owing to its large pharmacokinetic variability, it is questionable whether standard fixed dose therapy can achieve optimal MPA exposure. The aim of this study was to develop a population pharmacokinetic model of MPA and its metabolite, 7-O-MPA-β-glucuronide (MPAG), to identify important covariate influences and better predict patient dosing requirements. METHODS: MPA and MPAG concentration-time profiles were collected from 25 patients receiving mycophenolate mofetil (MMF) with or without cyclosporine (CsA) co-therapy...
May 23, 2017: European Journal of Drug Metabolism and Pharmacokinetics
https://www.readbyqxmd.com/read/28535715/two-part-models-with-stochastic-processes-for-modelling-longitudinal-semicontinuous-data-computationally-efficient-inference-and-modelling-the-overall-marginal-mean
#13
Sean Yiu, Brian Dm Tom
Several researchers have described two-part models with patient-specific stochastic processes for analysing longitudinal semicontinuous data. In theory, such models can offer greater flexibility than the standard two-part model with patient-specific random effects. However, in practice, the high dimensional integrations involved in the marginal likelihood (i.e. integrated over the stochastic processes) significantly complicates model fitting. Thus, non-standard computationally intensive procedures based on simulating the marginal likelihood have so far only been proposed...
January 1, 2017: Statistical Methods in Medical Research
https://www.readbyqxmd.com/read/28532631/competency-based-medical-education-and-assessment-of-training-review-of-selected-national-obstetrics-and-gynaecology-curricula
#14
Milena Garofalo, Rajesh Aggarwal
There are global variations in obstetrics and gynaecology (OBGYN) training curricula, both in length and in their structure and content. The ultimate goal for all residency programs is to ensure a skilled, competent physician, capable of independent practice by the end of his or her training. An online search was used for nationally recognized OBGYN training curricula. The curricula of Australia, Canada, the Netherlands, the United Kingdom, and the United States were individually reviewed and evaluated for their use of competency-based medical education and methods of assessment, including simulation...
May 19, 2017: Journal of Obstetrics and Gynaecology Canada: JOGC, Journal D'obstétrique et Gynécologie du Canada: JOGC
https://www.readbyqxmd.com/read/28532387/robust-estimation-of-the-expected-survival-probabilities-from-high-dimensional-cox-models-with-biomarker-by-treatment-interactions-in-randomized-clinical-trials
#15
Nils Ternès, Federico Rotolo, Stefan Michiels
BACKGROUND: Thanks to the advances in genomics and targeted treatments, more and more prediction models based on biomarkers are being developed to predict potential benefit from treatments in a randomized clinical trial. Despite the methodological framework for the development and validation of prediction models in a high-dimensional setting is getting more and more established, no clear guidance exists yet on how to estimate expected survival probabilities in a penalized model with biomarker-by-treatment interactions...
May 22, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28530853/designing-clinical-trials-that-accept-new-arms-an-example-in-metastatic-breast-cancer
#16
Steffen Ventz, Brian M Alexander, Giovanni Parmigiani, Richard D Gelber, Lorenzo Trippa
Purpose The majority of randomized oncology trials are two-arm studies that test the efficacy of new therapies against a standard of care, thereby assigning a large proportion of patients to nonexperimental therapies. In contrast, multiarm studies efficiently share a common control arm while evaluating multiple experimental therapies. A major bottleneck for traditional multiarm trials is the requirement that all therapies-often drugs from different companies-have to be available at the same time when the trial starts...
May 22, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28528578/a-cluster-randomized-trial-to-reduce-caesarean-delivery-rates-in-quebec-cost-effectiveness-analysis
#17
Mira Johri, Edmond S W Ng, Clara Bermudez-Tamayo, Jeffrey S Hoch, Thierry Ducruet, Nils Chaillet
BACKGROUND: Widespread increases in caesarean section (CS) rates have sparked concerns about risks to mothers and infants and rising healthcare costs. A multicentre, two-arm, cluster-randomized trial in Quebec, Canada assessed whether an audit and feedback intervention targeting health professionals would reduce CS rates for pregnant women compared to usual care, and concluded that it reduced CS rates without adverse effects on maternal or neonatal health. The effect was statistically significant but clinically small...
May 22, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28526893/do-we-need-3d-tube-current-modulation-information-for-accurate-organ-dosimetry-in-chest-ct-protocols-dose-comparisons
#18
Xochitl Lopez-Rendon, Guozhi Zhang, Walter Coudyzer, Wim Develter, Hilde Bosmans, Federica Zanca
OBJECTIVES: To compare the lung and breast dose associated with three chest protocols: standard, organ-based tube current modulation (OBTCM) and fast-speed scanning; and to estimate the error associated with organ dose when modelling the longitudinal (z-) TCM versus the 3D-TCM in Monte Carlo simulations (MC) for these three protocols. METHOD: Five adult and three paediatric cadavers with different BMI were scanned. The CTDIvol of the OBTCM and the fast-speed protocols were matched to the patient-specific CTDIvol of the standard protocol...
May 19, 2017: European Radiology
https://www.readbyqxmd.com/read/28525290/brief-commentary-on-the-article-a-novel-clinical-simulated-suture-education-for-basic-surgical-skill-suture-on-the-biological-tissue-fixed-on-standardized-patient-evaluated-with-objective-structured-assessment-of-technical-skill-osats-tools
#19
Meer M Chisthi
No abstract text is available yet for this article.
May 19, 2017: Journal of Investigative Surgery: the Official Journal of the Academy of Surgical Research
https://www.readbyqxmd.com/read/28524798/revisiting-the-rules-for-freehand-ventriculostomy-a-virtual-reality-analysis
#20
Clemens Raabe, Jens Fichtner, Jürgen Beck, Jan Gralla, Andreas Raabe
OBJECTIVE Frontal ventriculostomy is one of the most frequent and standardized procedures in neurosurgery. However, many first and subsequent punctures miss the target, and suboptimal placement or misplacement of the catheter is common. The authors therefore reexamined the landmarks and rules to determine the entry point and trajectory with the best hit rate (HtR). METHODS The authors randomly selected CT scans from their institution's DICOM pool that had been obtained in 50 patients with normal ventricular and skull anatomy and without ventricular puncture...
May 19, 2017: Journal of Neurosurgery
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