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https://www.readbyqxmd.com/read/28453694/clinical-benefit-price-and-approval-characteristics-of-fda-approved-new-drugs-for-treating-advanced-solid-cancer-2000-2015
#1
A Vivot, J Jacot, J-D Zeitoun, P Ravaud, P Crequit, R Porcher
Background: Prices of anti-cancer drugs are skyrocking. We aimed to assess the clinical benefit of new drugs for treating advanced solid tumors at the time of their approval by the US Food and Drug Administration (FDA) and to search for a relation between price and clinical benefit of drugs. Materials and methods: We included all new molecular entities and new biologics for treating advanced solid cancer that were approved by the FDA between 2000 and 2015. The clinical benefit of drugs was graded based on FDA medical review of pivotal clinical trials using the 2016-updated of the American Society of Clinical Oncology Value Framework (ASCO-VF) and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS)...
May 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28453675/circosvcf-circos-visualization-of-whole-genome-sequence-variations-stored-in-vcf-files
#2
E Drori, D Levy, P Smirin-Yosef, O Rahimi, M Salmon-Divon
Summary: Visualization of whole-genomic variations in a meaningful manner assists researchers in gaining new insights into the underlying data, especially when it comes in the context of whole genome comparisons. CircosVCF is a web based visualization tool for genome-wide variant data described in VCF files, using circos plots. The user friendly interface of CircosVCF supports an interactive design of the circles in the plot, and the integration of additional information such as experimental data or annotations...
May 1, 2017: Bioinformatics
https://www.readbyqxmd.com/read/28453615/do-patient-access-schemes-for-high-cost-cancer-drugs-deliver-value-to-society-lessons-from-the-nhs-cancer-drugs-fund
#3
A Aggarwal, T Fojo, C Chamberlain, C Davis, R Sullivan
Background: The NHS Cancer Drugs Fund (CDF) was established in 2010 to reduce delays and improve access to cancer drugs, including those that had been previously appraised but not approved by NICE (National Institute for Health and Care Excellence). After 1.3 billion GBP expenditure, a UK parliamentary review in 2016 rationalized the CDF back into NICE. Methods: This paper analyses the potential value delivered by the CDF according to six value criteria. This includes validated clinical benefits scales, cost-effectiveness criteria as defined by NICE and an assessment of real-world data...
April 27, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28449368/a-randomized-placebo-and-sitagliptin-controlled-trial-of-the-safety-and-efficacy-of-omarigliptin-a-once-weekly-dpp-4-inhibitor-in-japanese-patients-with-type-2-diabetes
#4
Ira Gantz, Taro Okamoto, Yuka Ito, Kotoba Okuyama, Edward A O'Neill, Keith D Kaufman, Samuel S Engel, Eseng Lai
AIMS: To assess the safety and efficacy of omarigliptin in Japanese patients with type 2 diabetes (T2D). MATERIALS AND METHODS: In a 24-week double-blind trial, 414 patients with T2D were randomized to omarigliptin 25 mg once-weekly (q.w.), sitagliptin 50 mg once daily (q.d.) or placebo. The double-blind period was followed by a 28-week open-label extension during which all patients received omarigliptin 25 mg q.w. Efficacy endpoints were HbA1c, 2-hour post-meal glucose (PMG) and fasting plasma glucose (FPG)...
April 27, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28449330/exploring-the-experience-of-nurse-practitioners-who-have-committed-medical-errors-a-phenomenological-approach
#5
Romuald Delacroix
BACKGROUND AND PURPOSE: To explore the experience of committing medical error from the perspective of nurse practitioners (NPs). Overall, the purpose of the study is to discern NPs' behaviors, perceptions, and coping mechanisms in response to having made a medical error. METHODS: Qualitative research based on two face-to-face audio-recorded semistructured interviews with 10 NPs who had made medical errors in practice. The analysis was guided by concepts in phenomenology...
April 27, 2017: Journal of the American Association of Nurse Practitioners
https://www.readbyqxmd.com/read/28449320/a-randomised-double-blind-trial-of-the-safety-and-efficacy-of-omarigliptin-a-once-weekly-dpp-4-inhibitor-in-subjects-with-type-2-diabetes-and-renal-impairment
#6
Antonio Chacra, Ira Gantz, Geraldine Mendizabal, Lucila Durlach, Edward A O'Neill, Zachary Zimmer, Shailaja Suryawanshi, Samuel S Engel, Eseng Lai
AIMS: To assess the safety and efficacy of omarigliptin in subjects with type 2 diabetes mellitus (T2DM) and chronic renal impairment (RI). METHODS: Patients with T2DM with moderate RI (estimated glomerular filtration rate [eGFR] ≥30 to <60 mL/min/1.73 m(2) ) (N=114), severe RI (eGFR <30 mL/min/1.73 m(2) ) (N=55) or end-stage renal disease on dialysis (N=44), who were either not on an antihyperglycaemic agent therapy for at least 12 weeks at screening, washed-off of oral antihyperglycaemic agent monotherapy or low-dose dual combination therapy, or on insulin monotherapy, with baseline glycated haemoglobin (HbA1c) of 6...
April 27, 2017: International Journal of Clinical Practice
https://www.readbyqxmd.com/read/28449247/informant-discrepancy-defines-discrete-clinically-useful-autism-spectrum-disorder-subgroups
#7
Matthew D Lerner, Andres De Los Reyes, Deborah A G Drabick, Alan H Gerber, Kenneth D Gadow
BACKGROUND: Discrepancy between informants (parents and teachers) in severity ratings of core symptoms commonly arise when assessing autism spectrum disorder (ASD). Whether such discrepancy yields unique information about the ASD phenotype and its clinical correlates has not been examined. We examined whether degree of discrepancy between parent and teacher ASD symptom ratings defines discrete, clinically meaningful subgroups of youth with ASD using an efficient, cost-effective procedure...
April 27, 2017: Journal of Child Psychology and Psychiatry, and Allied Disciplines
https://www.readbyqxmd.com/read/28449036/resting-connectivity-between-salience-nodes-predicts-recognition-memory
#8
Joseph M Andreano, Alexandra Touroutoglou, Bradford C Dickerson, Lisa Feldman Barrett
The resting connectivity of the brain's salience network, particularly the ventral subsystem of the salience network, has been previously associated with various measures of affective reactivity. Numerous studies have demonstrated that increased affective arousalleads to enhanced consolidation of memory. This suggests that individuals with greater ventral salience network connectivity will exhibit greater responses to affective experience, leading to a greater enhancement of memory by affect. To test this hypothesis, resting ventral salience connectivity was measured in 41 young adults, who were then exposed to neutral and negative affect inductions during a paired associate memory test...
April 25, 2017: Social Cognitive and Affective Neuroscience
https://www.readbyqxmd.com/read/28448887/macro-raman-spectroscopy-for-bulk-composition-and-homogeneity-analysis-of-multi-component-pharmaceutical-powders
#9
Hui Wang, David Barona, Sulayman Oladepo, Lisa Williams, Susan Hoe, David Lechuga-Ballesteros, Reinhard Vehring
A new macro-Raman system equipped with a motorized translational sample stage and low-frequency shift capabilities was developed for bulk composition and homogeneity analysis of multi-component pharmaceutical powders. Different sampling methods including single spot and scanning measurement were compared. It was found that increasing sample volumes significantly improved the precision of quantitative composition analysis, especially for poorly mixed powders. The multi-pass cavity of the macro-Raman system increased effective sample volumes by 20 times from the sample volume defined by the collection optics, i...
April 23, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28448781/assessment-of-clinical-pharmacy-interventions-to-reduce-outpatient-use-of-high-risk-medications-in-the-elderly
#10
Sarah C Weddle, A Shaun Rowe, Julie W Jeter, Rachel C Renwick, Shaunta' M Chamberlin, Andrea S Franks
BACKGROUND: Use of high-risk medications in the elderly (HRME) and drug-disease (Rx-DIS) interactions in the elderly, as defined by the Healthcare Effectiveness Data and Information Set (HEDIS) Measures, are significantly associated with mortality, hospital admission, and need for emergency care. No published studies to date evaluate interventions to reduce the use of HEDIS-defined HRME, although many studies have postulated a beneficial effect of such interventions. OBJECTIVE: To evaluate the effect of pharmacist interventions on use of HRME and Rx-DIS interactions in the outpatient elderly population...
May 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28448209/solution-focused-brief-therapy-for-chilean-primary-care-patients-exploring-a-linguistic-adaptation
#11
Karla González Suitt, Cynthia Franklin, Rayen Cornejo, Yessenia Castro, Sara Smock Jordan
Solution-focused brief therapy (SFBT) is a resource-based, future-oriented therapeutic approach that focuses on finding exceptions to problems and identifying coping strategies to build solutions. SFBT has been efficacious with individuals with alcohol use disorders. Chile experiences high levels of alcohol consumption and alcohol-related health consequences. Despite the international dissemination of SFBT, this is the first study to attempt a linguistic adaptation of SFBT in a Latin American country. We conducted 9 cognitive interviews to examine 13 translated main SFBT tools and 3 focus groups to gather information on cultural aspects of alcohol use in primary care...
April 27, 2017: Journal of Ethnicity in Substance Abuse
https://www.readbyqxmd.com/read/28448117/eliminating-the-animal-species-constraints-in-antibody-selection-for-multicolor-immunoassays
#12
Yao Sun, Xiaohu Gao
Molecular profiling on the single-cell level helps unveil the mystery of gene expression patterns in individual cells at subcellular resolution, enabling discovery of small but meaningful variations that are often overlooked at the population level. Similar to other immunoassays, the most common and economical protocols are developed by combining primary antibodies (1'Abs) and fluorophore-labeled secondary antibodies (2'Abs). The selection of 1' and 2' Abs, however, has been limited by the availability of animal species, consequently resulting in low multiplexing capability...
April 27, 2017: Bioconjugate Chemistry
https://www.readbyqxmd.com/read/28448087/effect-of-a-mediterranean-type-diet-on-inflammatory-and-cartilage-degradation-biomarkers-in-patients-with-osteoarthritis
#13
J Dyer, G Davison, S M Marcora, A R Mauger
OBJECTIVES: To investigate the effects of a Mediterranean type diet on patients with osteoarthritis (OA). PARTICIPANTS: Ninety-nine volunteers with OA (aged 31 - 90 years) completed the study (83% female). SETTING: Southeast of England, UK. DESIGN: Participants were randomly allocated to the dietary intervention (DIET, n = 50) or control (CON, n = 49). The DIET group were asked to follow a Mediterranean type diet for 16 weeks whereas the CON group were asked to follow their normal diet...
2017: Journal of Nutrition, Health & Aging
https://www.readbyqxmd.com/read/28447959/using-measurable-dosimetric-quantities-to-characterize-the-inter-structural-tradeoff-in-inverse-planning
#14
Hongcheng Liu, Peng Dong, Lei Xing
Traditional inverse planning relies on the use of weighting factors to balance the conflicting requirements of different structures. The manual trial-and-error determination of the weighting factors has long been recognized as a time-consuming part of treatment planning. The purpose of this work is to develop an inverse planning framework that parameterizes the dosimetric tradeoff among the structures with physically meaningful quantities to simplify the search for clinically sensible plans. In this formalism, instead of using the weighting factors, permissible variation range of the prescription dose or dose volume histogram (DVH) of the involved structures are used to characterize the "importance" of the structures...
April 27, 2017: Physics in Medicine and Biology
https://www.readbyqxmd.com/read/28447539/feasibility-of-preference-driven-radiotherapy-dose-treatment-planning-to-support-shared-decision-making-in-anal-cancer
#15
Heidi S Rønde, Leonard Wee, John Pløen, Ane L Appelt
PURPOSE/OBJECTIVE: Chemo-radiotherapy is an established primary curative treatment for anal cancer, but clinically equal rationale for different target doses exists. If joint preferences (physician and patient) are used to determine acceptable tradeoffs in radiotherapy treatment planning, multiple dose plans must be simultaneously explored. We quantified the degree to which different toxicity priorities might be incorporated into treatment plan selection, to elucidate the feasible decision space for shared decision making in anal cancer radiotherapy...
April 27, 2017: Acta Oncologica
https://www.readbyqxmd.com/read/28447475/olaratumab-for-advanced-soft-tissue-sarcoma
#16
Alexander Tobias, Michael P O'Brien, Mark Agulnik
Olaratumab is a humanized IgG1 monoclonal antibody that blocks the platelet-derived growth factor receptor alpha (PDGFRα). Its antagonistic behavior inhibits the receptor's tyrosine kinase activity, thereby, turning off the downstream signaling cascades responsible for soft tissue sarcoma tumorigenesis. In October 2016, olaratumab received Food and Drug Administration (FDA) approval for its use in combination with doxorubicin for treatment of advanced soft tissue sarcoma. Areas covered: This drug profile takes a comprehensive look at the clinical studies leading to FDA approval of olaratumab as well as its safety and efficacy as a front-line treatment option for sarcoma patients...
April 27, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28447364/the-ja-and-aba-signaling-pathways-crosstalk-during-one-but-not-repeated-dehydration-stresses-a-non-specific-panicky-or-a-meaningful-response
#17
Zoya Avramova
Experiencing diverse and recurring biotic and abiotic stresses throughout life, plants have evolved mechanisms to respond, survive and, eventually, adapt to changing habitats. The initial response to drought involves a large number of genes that are involved also in response to other stresses. According to current models, this initial response is non-specific, becoming stress-specific only at later time points. The question, then, is whether non-specific activation of various stress-signaling systems leading to the expression of numerous stresses-regulated genes is a false-alarm ('panicky') response or whether it has biologically relevant consequences for the plant...
April 26, 2017: Plant, Cell & Environment
https://www.readbyqxmd.com/read/28447029/cornell-alliance-for-science-evaluation-of-consensus-on-genetically-modified-food-safety-weaknesses-in-study-design
#18
Michael N Antoniou, Claire J Robinson
Cornell Alliance for Science has launched an initiative in which "citizen scientists" are called upon to evaluate studies on health risks of genetically modified (GM) crops and foods. The purpose is to establish whether the consensus on GM food safety claimed by the American Association for the Advancement of Science (AAAS) is supported by a review of the scientific literature. The Alliance's citizen scientists are examining more than 12,000 publication abstracts to quantify how far the scientific literature supports the AAAS's statement...
2017: Frontiers in Public Health
https://www.readbyqxmd.com/read/28447016/deriving-meaningful-insights-from-clinical-trial-and-postmarketing-safety-data-perspectives-from-india
#19
REVIEW
Anand Harugeri, Vineet Shastri, Chanakya Patel
Today, drug safety data collection in India is both manual and electronic with reporting of potential overlapping and duplicate data, which is likely incomplete for further review and analysis. Furthermore, standardized data collection and timelines are not aligned with international standards. Complete coverage of safety data from all sources throughout the life of the drug cannot be ensured. There is no requirement to submit periodic safety data in clinical trials to regulatory authority. There is clearly a lack of emphasis on deriving meaningful safety data insights for ensuring patient safety...
April 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28445826/exposure-to-fine-particulate-matter-causes-oxidative-and-methylated-dna-damage-in-young-adults-a-longitudinal-study
#20
Ching-Huang Lai, Han-Bin Huang, Yue-Cune Chang, Ting-Yao Su, Ying-Chuan Wang, Gia-Chi Wang, Jia-En Chen, Chin-Sheng Tang, Trong-Neng Wu, Saou-Hsing Liou
An increased understanding is needed of the physiological effects and plausible biological mechanisms that link PM2.5 (particulate matter with an aerodynamic diameter below 2.5μm) exposure to mortality and morbidities such as atherosclerosis and respiratory disease. PM2.5 causes carcinogenic health effects. Biomonitoring in humans has suggested that 8-oxo-7, 8-dihydro-2-deoxyguanosine (8-oxodG) and N7-methylguanine (N7-MeG) are correlated with oxidative and methylated DNA damage. Thus, it is meaningful to explore the mechanisms of mutagenesis and carcinogenesis associated with oxidative and methylated DNA damage by simultaneously measuring these two markers...
April 23, 2017: Science of the Total Environment
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