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Clinical trial simulation

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https://www.readbyqxmd.com/read/28107090/cost-effectiveness-analysis-in-the-spanish-setting-of-the-peak-trial-of-panitumumab-plus-mfolfox6-compared-with-bevacizumab-plus-mfolfox6-for-first-line-treatment-of-patients-with-wild-type-ras-metastatic-colorectal-cancer
#1
Fernando Rivera, Manuel Valladares, Salvador Gea, Noemí López-Martínez
OBJECTIVE: To assess the cost-effectiveness of panitumumab in combination with mFOLFOX6 (oxaliplatin, 5-fluorouracil and leucovorin) versus bevacizumab in combination with mFOLFOX6 as first-line treatment of patients with wild-type RAS metastatic colorectal cancer (mCRC) in Spain. METHODS: A semi-Markov model was developed including the following health states: Progression free; Progressive disease: Treat with best supportive care; Progressive disease: Treat with subsequent active therapy; Attempted resection of metastases; Disease free after metastases resection; Progressive disease: after resection and relapse; Death...
January 20, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/28099993/conditional-estimation-in-two-stage-adaptive-designs
#2
Per Broberg, Frank Miller
We consider conditional estimation in two-stage sample size adjustable designs and the consequent bias. More specifically, we consider a design which permits raising the sample size when interim results look rather promising, and which retains the originally planned sample size when results look very promising. The estimation procedures reported comprise the unconditional maximum likelihood, the conditionally unbiased Rao-Blackwell estimator, the conditional median unbiased estimator, and the conditional maximum likelihood with and without bias correction...
January 18, 2017: Biometrics
https://www.readbyqxmd.com/read/28098411/an-efficient-basket-trial-design
#3
Kristen M Cunanan, Alexia Iasonos, Ronglai Shen, Colin B Begg, Mithat Gönen
The landscape for early phase cancer clinical trials is changing dramatically because of the advent of targeted therapy. Increasingly, new drugs are designed to work against a target such as the presence of a specific tumor mutation. Because typically only a small proportion of cancer patients will possess the mutational target, but the mutation is present in many different cancers, a new class of basket trials is emerging, whereby the drug is tested simultaneously in different baskets, that is, subgroups of different tumor types...
January 18, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28095918/anti-staphylococcal-activity-resulting-from-epithelial-lining-fluid-elf-concentrations-of-amikacin-inhale-administered-via-the-pulmonary-drug-delivery-system
#4
Islam M Ghazi, Mordechai Grupper, David P Nicolau
BACKGROUND: Amikacin inhale (BAY41-6551), a unique drug-device combination of a specially formulated drug solution and a pulmonary drug delivery system device (AMK-I) is currently under phase III study as an adjunctive therapy to IV antibiotics for the treatment of Gram-negative pneumonia in mechanically ventilated patients. While the epidemiology of nosocomial pneumonia is predominated by Gram-negative pathogens such as Pseudomonas aeruginosa and the Enterobacteriaceae, Staphylococcus aureus is increasingly recognized as a pathogen of concern for these pulmonary based infections...
January 17, 2017: Annals of Clinical Microbiology and Antimicrobials
https://www.readbyqxmd.com/read/28095849/simulated-case-management-of-home-telemonitoring-to-assess-the-impact-of-different-alert-algorithms-on-work-load-and-clinical-decisions
#5
Illapha Cuba Gyllensten, Amanda Crundall-Goode, Ronald M Aarts, Kevin M Goode
BACKGROUND: Home telemonitoring (HTM) of chronic heart failure (HF) promises to improve care by timely indications when a patient's condition is worsening. Simple rules of sudden weight change have been demonstrated to generate many alerts with poor sensitivity. Trend alert algorithms and bio-impedance (a more sensitive marker of fluid change), should produce fewer false alerts and reduce workload. However, comparisons between such approaches on the decisions made and the time spent reviewing alerts has not been studied...
January 17, 2017: BMC Medical Informatics and Decision Making
https://www.readbyqxmd.com/read/28095838/communication-with-families-regarding-organ-and-tissue-donation-after-death-in-intensive-care-comfort-protocol-for-an-intervention-study
#6
Julie E Potter, Robert G Herkes, Lin Perry, Rosalind M Elliott, Anders Aneman, Jorge L Brieva, Elena Cavazzoni, Andrew T H Cheng, Michael J O'Leary, Ian M Seppelt, Val Gebski
BACKGROUND: Discussing deceased organ donation can be difficult not only for families but for health professionals who initiate and manage the conversations. It is well recognised that the methods of communication and communication skills of health professionals are key influences on decisions made by families regarding organ donation. METHODS: This multicentre study is being performed in nine intensive care units with follow-up conducted by the Organ and Tissue Donation Service in New South Wales (NSW) Australia...
January 17, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/28089763/comparison-of-multi-arm-multi-stage-design-and-adaptive-randomization-in-platform-clinical-trials
#7
REVIEW
Jianchang Lin, Veronica Bunn
Platforms trials are clinical trials that allow for concurrent evaluations of multiple treatments, thus allowing for more efficient and ethical studies compared to traditional two-arm trials. Conventional group-sequential multi-arm multi-stage (MAMS) designs use pre-specified stopping boundaries and treatment selection rules to determine if experimental treatments should be dropped. Flexible MAMS designs allow for interim modifications to the design plan without compromising error rates. Bayesian response adaptive randomization (BRAR) designs increase patient allocation to treatment arms that are performing well during the course of the trial...
January 12, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28089562/sequential-multiple-assignment-randomized-trials-an-opportunity-for-improved-design-of-stroke-reperfusion-trials
#8
William J Meurer, Nicholas J Seewald, Kelley Kidwell
BACKGROUND: Modern clinical trials in stroke reperfusion fall into 2 categories: alternative systemic pharmacological regimens to alteplase and "rescue" endovascular approaches using targeted thrombectomy devices and/or medications delivered directly for persistently occluded vessels. Clinical trials in stroke have not evaluated how initial pharmacological thrombolytic management might influence subsequent rescue strategy. A sequential multiple assignment randomized trial (SMART) is a novel trial design that can test these dynamic treatment regimens and lead to treatment guidelines that more closely mimic practice...
January 12, 2017: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
https://www.readbyqxmd.com/read/28087265/myocardial-relaxation-is-accelerated-by-fast-stretch-not-reduced-afterload
#9
Charles S Chung, Charles W Hoopes, Kenneth S Campbell
Fast relaxation of cross-bridge generated force in the myocardium facilitates efficient diastolic function. Recently published research studying mechanisms that modulate the relaxation rate has focused on molecular factors. Mechanical factors have received less attention since the 1980s when seminal work established the theory that reducing afterload accelerates the relaxation rate. Clinical trials using afterload reducing drugs, partially based on this theory, have thus far failed to improve outcomes for patients with diastolic dysfunction...
January 11, 2017: Journal of Molecular and Cellular Cardiology
https://www.readbyqxmd.com/read/28079584/the-development-and-implementation-of-cognitive-aids-for-critical-events-in-pediatric-anesthesia-the-society-for-pediatric-anesthesia-critical-events-checklists
#10
Anna Clebone, Barbara K Burian, Scott C Watkins, Jorge A Gálvez, Justin L Lockman, Eugenie S Heitmiller
Cognitive aids such as checklists are commonly used in modern operating rooms for routine processes, and the use of such aids may be even more important during critical events. The Quality and Safety Committee of the Society for Pediatric Anesthesia (SPA) has developed a set of critical-event checklists and cognitive aids designed for 3 purposes: (1) as a repository of the latest evidence-based and expert opinion-based information to guide response and management of critical events, (2) as a source of just-in-time information during critical events, and (3) as a method to facilitate a shared understanding of required actions among team members during a critical event...
January 10, 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28079566/retesting-the-hypothesis-of-a-clinical-randomized-controlled-trial-in-a-simulation-environment-to-validate-anesthesia-simulation-in-error-research-the-vaser-study
#11
Alan F Merry, Jacqueline A Hannam, Craig S Webster, Kylie-Ellen Edwards, Jane Torrie, Chris Frampton, Daniel W Wheeler, Arun K Gupta, Ravi P Mahajan, Rachel Evley, Jennifer M Weller
BACKGROUND: Simulation has been used to investigate clinical questions in anesthesia, surgery, and related disciplines, but there are few data demonstrating that results apply to clinical settings. We asked "would results of a simulation-based study justify the same principal conclusions as those of a larger clinical study?" METHODS: We compared results from a randomized controlled trial in a simulated environment involving 80 cases at three centers with those from a randomized controlled trial in a clinical environment involving 1,075 cases...
January 12, 2017: Anesthesiology
https://www.readbyqxmd.com/read/28079203/complexation-of-short-ds-rna-dna-oligonucleotides-with-gemini-micelles-a-time-resolved-saxs-and-computational-study
#12
Sara Falsini, Emanuela Di Cola, Martin In, Maria Giordani, Stefano Borocci, Sandra Ristori
Gene therapy is based on nucleic acid delivery to pathogenic cells in order to modulate their gene expression. The most used non viral vectors are lipid-based nanoaggregates, which are safer than viral carriers and have been shown to assemble easily with both DNA and RNA. However, the transfection efficiency of non viral carriers still needs to be improved before intensive practise in clinical trials can be implemented. For this purpose, the in depth characterization of the complexes formed by nucleic acids and their transporters is of great relevance...
January 12, 2017: Physical Chemistry Chemical Physics: PCCP
https://www.readbyqxmd.com/read/28078530/evaluation-of-the-population-pharmacokinetic-properties-of-lidocaine-and-its-metabolites-after-long-term-multiple-applications-of-a-lidocaine-plaster-in-post-herpetic-neuralgia-patients
#13
Roberta Bursi, Chiara Piana, Joachim Grevel, Dymphy Huntjens, Irmgard Boesl
BACKGROUND AND OBJECTIVES: Lidocaine 5% medicated plaster is the first lidocaine containing product for chronic use. As no previous investigations have been conducted to evaluate the population pharmacokinetics of long-term exposure to lidocaine 5% medicated plasters, further insights into the evaluation of the pharmacokinetic properties of lidocaine and its metabolites were needed for the assessment of its safety. METHODS: The population pharmacokinetic properties of lidocaine and its metabolites were evaluated after multiple applications of lidocaine 5% medicated plasters based on data collected for up to 14...
January 12, 2017: European Journal of Drug Metabolism and Pharmacokinetics
https://www.readbyqxmd.com/read/28078075/a-design-method-for-fes-bone-health-therapy-in-sci
#14
Brian Andrews, James Shippen, Monica Armengol, Robin Gibbons, William Holderbaum, William Harwin
FES assisted activities such as standing, walking, cycling and rowing induce forces within the leg bones and have been proposed to reduce osteoporosis in spinal cord injury (SCI). However, details of the applied mechanical stimulus for osteogenesis is often not reported. Typically, comparisons of bone density results are made after costly and time consuming clinical trials. These studies have produced inconsistent results and are subject to sample size variations. Here we propose a design process that may be used to predict the clinical outcome based on biomechanical simulation and mechano-biology...
September 15, 2016: European Journal of Translational Myology
https://www.readbyqxmd.com/read/28074265/pharmacokinetic-and-exposure-response-analyses-of-pertuzumab-in-combination-with-trastuzumab-and-docetaxel-during-neoadjuvant-treatment-of-her2-%C3%A2-early-breast-cancer
#15
Angelica L Quartino, Hanbin Li, Jin Y Jin, D Russell Wada, Mark C Benyunes, Virginia McNally, Lucia Viganò, Ihsan Nijem, Bert L Lum, Amit Garg
PURPOSE: The NeoSphere trial evaluated pertuzumab in the neoadjuvant setting [early breast cancer (EBC)] with pathological complete response (pCR) as the primary efficacy end point. This analysis of pertuzumab aimed to (1) compare its pharmacokinetics (PK) in patients with EBC versus advanced cancers, (2) to further evaluate PK drug-drug interactions (DDIs) when given in combination with trastuzumab, and (3) to assess the relationship between exposure and efficacy to assess the clinical dosing regimen in the EBC patients...
January 10, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28072732/comparison-of-the-i-gel-and-other-supraglottic-airways-in-adult-manikin-studies-systematic-review-and-meta-analysis
#16
Jiwon An, Sang Beom Nam, Jong Seok Lee, Jinae Lee, Hanna Yoo, Hye Mi Lee, Min-Soo Kim
BACKGROUND: The i-gel has a gel-like cuff composed of thermoplastic elastomer that does not require cuff inflation. As the elimination of cuff inflation may shorten insertion time, the i-gel might be a useful tool in emergency situations requiring prompt airway care. This systematic review and meta-analysis of previous adult manikin studies for inexperienced personnel was performed to compare the i-gel with other supraglottic airways. METHODS: We searched PubMed, the Cochrane Library, and EMBASE for eligible randomized controlled trials (RCTs) published before June 2015, including with a crossover design, using the following search terms: "i-gel," "igel," "simulation," "manikin," "manikins," "mannequin," and "mannequins...
January 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28070895/influence-analysis-for-skew-normal-semiparametric-joint-models-of-multivariate-longitudinal-and-multivariate-survival-data
#17
An-Min Tang, Nian-Sheng Tang, Hongtu Zhu
The normality assumption of measurement error is a widely used distribution in joint models of longitudinal and survival data, but it may lead to unreasonable or even misleading results when longitudinal data reveal skewness feature. This paper proposes a new joint model for multivariate longitudinal and multivariate survival data by incorporating a nonparametric function into the trajectory function and hazard function and assuming that measurement errors in longitudinal measurement models follow a skew-normal distribution...
January 9, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28068165/physiological-and-perceived-effects-of-forearm-or-head-cooling-during-simulated-firefighting-activity-and-rehabilitation
#18
Susan Yeargin, Amy L McKenzie, Lindsey E Eberman, J Derek Kingsley, David J Dziedzicki, Patrick Yoder
CONTEXT:  Cooling devices aim to protect firefighters by attenuating a rise in body temperature. Devices for head cooling (HC) while firefighting and forearm cooling (FC) during rehabilitation (RHB) intervals are commonly marketed, but research regarding their efficacy is limited. OBJECTIVE:  To investigate the physiological and perceived effects of HC and FC during firefighting drills and RHB. DESIGN:  Randomized controlled clinical trial...
November 2016: Journal of Athletic Training
https://www.readbyqxmd.com/read/28066526/comparative-effectiveness-of-an-adjustable-transfemoral-prosthetic-interface-accommodating-volume-fluctuation-case-study
#19
Jason T Kahle, Tyler D Klenow, M Jason Highsmith
The socket-limb interface is vital for functionality and provides stability and mobility for the amputee. Volume fluctuation can lead to compromised fit and function. Current socket technology does not accommodate for volume fluctuation. An adjustable interface may improve function and comfort by filling this technology gap. The purpose of this study was to compare the effectiveness of the standard of care (SOC) ischial ramus containment to an adjustable transfemoral prosthetic interface socket in the accommodation of volume fluctuation...
September 2016: Technology and Innovation
https://www.readbyqxmd.com/read/28063865/evaluation-of-a-mastery-learning-intervention-on-hospitalists-code-status-discussion-skills
#20
Rashmi K Sharma, Eytan Szmuilowicz, Adeboye Ogunseitan, Sasha F Jones, Jessica A Montalvo, Kevin J O'Leary, Diane B Wayne
CONTEXT: Although code status discussions (CSD) occur frequently in the hospital setting, discussions often lack content necessary for informed decision making. Simulation-based mastery learning (SBML) has been used to improve clinical skills among resident physicians and may provide a novel way to improve hospitalists' CSD skills. OBJECTIVES: The objective of this pilot randomized controlled trial was to develop and evaluate a CSD SBML intervention for hospitalists...
January 4, 2017: Journal of Pain and Symptom Management
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