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https://www.readbyqxmd.com/read/28214913/assessment-of-efficacy-and-safety-of-the-herbal-medicinal-product-bno-1016-in-chronic-rhinosinusitis
#1
J Palm, I Steiner, D Abramov-Sommariva, A Ammendola, S Mitzenheim, H Steindl, M Wonnemann, C Bachert
BACKGROUND: The objective of this clinical trial (CRS-02) was to assess the efficacy, safety and tolerability of two dosages of the herbal medicinal product BNO 1016 (Sinupret extract) in patients with chronic rhinosinusitis (CRS). METHODOLOGY: 929 patients suffering from CRS were enrolled in this randomised placebo-controlled trial with a treatment period of 12 weeks. The primary endpoint was the mean Major Symptom Score (MSS) in week 8 and week 12 compared to placebo...
February 19, 2017: Rhinology
https://www.readbyqxmd.com/read/28214229/-iso%C3%A2-9001%C3%A2-certification-of-innovation-and-clinical-research-departments-extending-the-scope-of-health-assessment
#2
C Sambou, S Guillemaut, M Morelle, A Achache, A-G Le Corroller, D Perol, L Perrier
BACKGROUND: The International organization for standardization (ISO) is the world leader in providing industrial and commercial standards and certifications. Beyond medical devices, four French clinical research and innovation departments have received an ISO 9001 certification (the standard for quality management). Simultaneously, medico-economic studies have become increasingly important in the public decision process. Using the clinical research and innovation department from the Léon-Bérard Cancer Center as an example, the purpose of this article is to show how the scope of the ISO 9001 certification has been extended to cover medico-economic studies...
February 14, 2017: Revue D'épidémiologie et de Santé Publique
https://www.readbyqxmd.com/read/28213088/personalized-medicine-genetic-risk-prediction-of-drug-response
#3
REVIEW
Ge Zhang, Daniel W Nebert
Pharmacogenomics (PGx), a substantial component of "personalized medicine", seeks to understand each individual's genetic composition to optimize drug therapy -- maximizing beneficial drug response, while minimizing adverse drug reactions (ADRs). Drug responses are highly variable because innumerable factors contribute to ultimate phenotypic outcomes. Recent genome-wide PGx studies have provided some insight into genetic basis of variability in drug response. These can be grouped into three categories. [a] Monogenic (Mendelian) traits include early examples mostly of inherited disorders, and some severe (idiosyncratic) ADRs typically influenced by single rare coding variants...
February 14, 2017: Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28204995/dalteparin-or-vitamin-k-antagonists-to-prevent-recurrent-venous-thromboembolism-in-cancer-patients-a-patient-level-economic-analysis-for-france-and-austria
#4
George Dranitsaris, Lesley G Shane, Jean-Philippe Galanaud, Gunar Stemer, Philippe Debourdeau, Seth Woodruff
BACKGROUND: International guidelines recommend extended duration secondary prophylaxis in cancer patients who develop primary venous thromboembolism (VTE). Agent selection is guided in part by one large randomized trial (i.e., CLOT; Lee et al., N Engl J Med 349:146-53, 2003) which demonstrated that dalteparin reduced the relative risk of recurrence by 52% compared with oral vitamin K antagonists (VKA; HR = 0.48, 95% CI, 0.30 to 0.77). In a subgroup analysis from that same trial, patients with renal impairment also derived benefit with dalteparin (VTE rates = 3% vs...
February 15, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28183482/use-of-biological-agents-in-asthma-pharmacoeconomic-lessons-learned-from-omalizumab
#5
EDITORIAL
Steven Draikiwicz, John Oppenheimer
No abstract text is available yet for this article.
February 2017: Chest
https://www.readbyqxmd.com/read/28183342/rheumatology-around-the-world-perspectives-from-australia-and-new-zealand
#6
EDITORIAL
Fiona M F McQueen
Rheumatology continues to be an exciting and vibrant specialty for specialists practising in New Zealand and Australia. Clinicians follow treat-to-target regimens to manage peripheral and axial inflammatory arthritides using conventional and biological agents, which have revolutionised management of rheumatic disease over the past two decades. However, optimal clinical practice has significant pharmacoeconomic implications which impact on health funding at a national level, and the advent of biosimilars is keenly awaited...
February 10, 2017: Arthritis Research & Therapy
https://www.readbyqxmd.com/read/28179749/danish-translation-and-linguistic-validation-of-the-body-q-a-description-of-the-process
#7
Lotte Poulsen, Michael Rose, Anne Klassen, Kirsten K Roessler, Jens Ahm Sørensen
BACKGROUND: Patient-reported outcome (PRO) instruments are increasingly being included in research and clinical practice to assess the patient point of view. Bariatric and body contouring surgery has the potential to improve or restore a patient's body image and health-related quality of life (HR-QOL). A new PRO instrument, called the BODY-Q, has recently been developed specifically for this patient group. The aim of the current study was to translate and perform a linguistic validation of the BODY-Q for use in Danish bariatric and body contouring patients...
2017: European Journal of Plastic Surgery
https://www.readbyqxmd.com/read/28172881/p582-the-pharmacoeconomic-impact-of-biosimilar-infliximab-ct-p13-in-europe-from-january-2015-to-june-2016
#8
S Han, S Kim, J Kim, D-H Kwon, J-S Choi, S-R Yoon, S-H Yun, D-S Kim, J-H Bae, H-J Choi, H-Y Sung, S-W Yoon
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28159174/antimicrobial-therapy-for-legionnaire-s-disease-antibiotic-stewardship-implications
#9
REVIEW
Cheston B Cunha, Burke A Cunha
Legionnaire's disease is a common cause of community-acquired pneumonia (CAP). Although no single clinical feature is diagnostic, if characteristic extrapulmonary findings are present a presumptive clinical syndromic diagnosis is possible. Depending on geographic location, season, and physician awareness, Legionnaire's disease may be included in the differential diagnosis of CAP. Some antibiotics effective against Legionella sp are also effective in treating the typical bacterial causes of CAP. From an antimicrobial stewardship program (ASP) perspective, monotherapy is preferred to double-drug therapy...
March 2017: Infectious Disease Clinics of North America
https://www.readbyqxmd.com/read/28148262/demographic-factors-associated-with-dietary-supplement-prescriptions-filled-by-united-states-military-service-members-2005-2013
#10
Joseph J Knapik, Rosenie T Jean, Krista G Austin, Ryan A Steelman, Emily K Farina, Harris R Lieberman
BACKGROUND: Dietary supplements (DSs) can be purchased over-the-counter but may also be prescribed by medical personnel for specific therapeutic reasons. Few studies have examined this latter source of DSs despite the fact that 79% of physicians and 82% of nurses have recommended DSs to their patients. This investigation examined demographic factors associated with temporal trends in oral DS prescriptions filled by all United States (US) service members (SMs) from 2005 to 2013 (n = 1,427,080 ± 22,139, mean ± standard deviation per year)...
January 31, 2017: BMC Complementary and Alternative Medicine
https://www.readbyqxmd.com/read/28145941/lessons-learned-in-applying-the-international-society-for-pharmacoeconomics-and-outcomes-research-methodology-to-translating-canadian-emergency-department-information-system-presenting-complaints-list-into-german
#11
Dominik Brammen, Felix Greiner, Harald Dormann, Carsten Mach, Christian Wrede, Anne Ballaschk, Declan Stewart, Steven Walker, Christine Oesterling, Martin Kulla
OBJECTIVES: The patient's presenting complaint guides diagnosis and treatment in the emergency department, but there is no classification system available in German. The Canadian Emergency Department Information System (CEDIS) Presenting Complaint List (PCL) is available only in English and French. As translation risks the altering of meaning, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) has set guidelines to ensure translational accuracy. The aim of this paper is to describe our experiences of using the ISPOR guidelines to translate the CEDIS PCL into German...
January 31, 2017: European Journal of Emergency Medicine: Official Journal of the European Society for Emergency Medicine
https://www.readbyqxmd.com/read/28138260/dalteparin-versus-vitamin-k-antagonists-for-the-prevention-of-recurrent-venous-thromboembolism-in-patients-with-cancer-and-renal-impairment-a-canadian-pharmacoeconomic-analysis
#12
George Dranitsaris, Lesley G Shane, Mark Crowther, Guillaume Feugere, Seth Woodruff
BACKGROUND: Patients with cancer are at increased risk of venous thromboembolism (VTE) and the risk is further elevated after a primary VTE. To reduce the risk of recurrent events, extended prophylaxis with vitamin K antagonists (VKA) is available for use. However, in a large randomized trial (Comparison of Low-Molecular-Weight Heparin versus Oral Anticoagulant Therapy for the Prevention of Recurrent Venous Thromboembolism in Patients with Cancer [CLOT]; Lee et al), extended duration dalteparin reduced the relative risk of recurrent VTE by 52% compared to VKA (p=0...
2017: ClinicoEconomics and Outcomes Research: CEOR
https://www.readbyqxmd.com/read/28129821/-main-variables-in-the-economic-cost-of-treating-an-infection
#13
Santiago Grau
The economic cost of treating an infection can be influenced by multiple factors related to patient characteristics, the type of infection, the isolated microorganism and some mechanisms of bacterial resistance. Of these, the factor generating the largest number of studies is bacterial resistance but many of these studies show major limitations. Antimicrobial stewardship has been proposed as a means to reduce the economic cost of treating infections. However, the strategies included in antibiotic stewardship should be assessed to identify both their clinical impact and their cost-effectiveness...
January 2017: Enfermedades Infecciosas y Microbiología Clínica
https://www.readbyqxmd.com/read/28125918/assessment-of-the-quality-of-pharmacoeconomic-evaluation-literature-in-china
#14
Fang Zhang, Xu He, Wei Xiang, Shu Chuen Li
OBJECTIVE: To evaluate the quality of Chinese pharmacoeconomic-evaluation literature published between 2012-2014 retrieved from the Chinese National Knowledge Infrastructure (CNKI) in order to assess their adherence to recommendations of the Chinese Pharmacoeconomic Guidelines. METHODS: Identified literature was screened according to pre-specified criteria to access legibility for inclusion. Each included piece of literature was systematically compared against the recommendations proposed by the relevant Chinese guidelines...
January 27, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/28125370/a-systematic-review-of-the-effect-of-cancer-treatment-on-work-productivity-of-patients-and-caregivers
#15
Khalid M Kamal, Jordan R Covvey, Ankur Dashputre, Somraj Ghosh, Surbhi Shah, Monali Bhosle, Christopher Zacker
BACKGROUND: Cancer is a leading cause of death with substantial financial costs. While significant data exist on the economic burden of care, less is known about the indirect costs of treatment and, specifically, the effect on work productivity of patients and their caregivers. To examine the full effect of cancer and the potential value of new therapies, all aspects of care, including indirect costs and patient-reported outcomes, should be evaluated. OBJECTIVE: To perform a systematic review of the literature examining the effect of cancer treatment on work productivity in patients and their caregivers...
February 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28125365/cost-effectiveness-of-pembrolizumab-versus-ipilimumab-in-ipilimumab-na%C3%A3-ve-patients-with-advanced-melanoma-in-the-united-states
#16
Jingshu Wang, Bartosz Chmielowski, James Pellissier, Ruifeng Xu, Kendall Stevinson, Frank Xiaoqing Liu
BACKGROUND: Recent clinical trials have shown that pembrolizumab significantly prolonged progression-free survival and overall survival compared with ipilimumab in ipilimumab-naïve patients with unresectable or metastatic melanoma. However, there has been no published evidence on the cost-effectiveness of pembrolizumab for this indication. OBJECTIVE: To assess the long-term cost-effectiveness of pembrolizumab versus ipilimumab in ipilimumab-naïve patients with unresectable or meta-static melanoma from a U...
February 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28121576/amcp-seeks-an-end-to-20-years-of-confusion-over-fdama-section-114
#17
Michael D Dalzell
The FDA never issued regulations to clarify the boundaries of promotion of pharmacoeconomic data, something it's been dragging its feet on for nearly 20 years. In turn, pharma companies, fearful of being penalized for off-lable promotion, have erred on the side of caution, hesitating to take advantage of Section 114.
September 2016: Managed Care
https://www.readbyqxmd.com/read/28112800/comparison-of-the-paper-based-and-electronic-versions-of-the-dermatology-life-quality-index-dlqi-evidence-of-equivalence
#18
F M Ali, N Johns, A Finlay, M S Salek, V Piguet
BACKGROUND: The use of patient-reported outcome measures in electronic format has been increasing. However, these formats are usually not validated or compared to the original paper-based formats, so there is no evidence that they are completed in the same way. OBJECTIVES: The aim of this study was to compare the conventional paper version and a web-based application version (iPad(®) ) of the DLQI to assess equivalence of scores. METHODS: The study employed a randomized cross-over design using a within-subjects comparison of the two formats of the questionnaire...
January 23, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/28109551/-economic-impact-of-optimising-antiretroviral-treatment-in-human-immunodeficiency-virus-infected-adults-with-suppressed-viral-load-in-spain-by-implementing-the-grade-a-1-evidence-recommendations-of-the-2015-gesida-national-aids-plan
#19
Esteban Ribera, José Manuel Martínez-Sesmero, Javier Sánchez-Rubio, Rafael Rubio, Juan Pasquau, José Luis Poveda, Alejandro Pérez-Mitru, Celia Roldán, Beatriz Hernández-Novoa
INTRODUCTION: The objective of this study is to estimate the economic impact associated with the optimisation of triple antiretroviral treatment (ART) in patients with undetectable viral load according to the recommendations from the GeSIDA/PNS (2015) Consensus and their applicability in the Spanish clinical practice. METHODS: A pharmacoeconomic model was developed based on data from a National Hospital Prescription Survey on ART (2014) and the A-I evidence recommendations for the optimisation of ART from the GeSIDA/PNS (2015) consensus...
January 18, 2017: Enfermedades Infecciosas y Microbiología Clínica
https://www.readbyqxmd.com/read/28102877/feasibility-acceptability-and-construct-validity-of-eq-5d-in-systemic-sclerosis
#20
Roberta Gualtierotti, Francesca Ingegnoli, Luciana Scalone, Paolo Cortesi, Eleonora Bruschi, Maria Gerosa, Pier Luigi Meroni
BACKGROUND: Systemic sclerosis is a chronic disabling disease that is often associated with severe physical and psychological impairment. Nonetheless, health-related quality of life (HRQoL) in patients with systemic sclerosis is often left behind in clinical practice and research. One of the reasons for this lack of evaluation is the current use of tools, such as the short form-36 (SF-36) questionnaire, that are complete but complicated to use in everyday routine. Other self-reported outcome measures such as the health assessment questionnaire (HAQ) are simple, but specifically designed for physical disability...
January 19, 2017: Swiss Medical Weekly
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