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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/28447101/development-and-use-of-a-clinical-decision-support-tool-for-behavioral-health-screening-in-primary-care-clinics
#2
Timothy E Burdick, Rodger S Kessler
OBJECTIVE: Screening, brief intervention, and referral for treatment (SBIRT) for behavioral health (BH) is a key clinical process. SBIRT tools in electronic health records (EHR) are infrequent and rarely studied. Our goals were 1) to design and implement SBIRT using clinical decision support (CDS) in a commercial EHR; and 2) to conduct a pragmatic evaluation of the impact of the tools on clinical outcomes. METHODS: A multidisciplinary team designed SBIRT workflows and CDS tools...
April 26, 2017: Applied Clinical Informatics
https://www.readbyqxmd.com/read/28447016/deriving-meaningful-insights-from-clinical-trial-and-postmarketing-safety-data-perspectives-from-india
#3
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/28441001/-mexican-asthma-guidelines-guima-2017
#4
Désirée Larenas-Linnemann, Jorge Salas-Hernández, Juan Carlos Vázquez-García, Ignacio Ortiz-Aldana, Margarita Fernández-Vega, Blanca Estela Del Río-Navarro, María Del Carmen Cano-Salas, Jorge Agustín Luna-Pech, José Antonio Ortega-Martell, Jade Romero-Lombard, Erika Del Carmen López-Estrada, Jimena Villaverde-Rosas, José Luis Mayorga-Butrón, Mario Humberto Vargas-Becerra, Martín Bedolla-Barajas, Noel Rodríguez-Pérez, Ambrocio Aguilar-Aranda, Carlos Adrián Jiménez-González, Carlos García-Bolaños, Claudia Garrido-Galindo, David Alejandro Mendoza-Hernández, Enrique Mendoza-López, Gerardo López-Pérez, Guillermo Hideo Wakida-Kuzonoki, Héctor Hernán Ruiz-Gutiérrez, Héctor León-Molina, Héctor Martínez-De la Lanza, Héctor Stone-Aguilar, Javier Gómez-Vera, Jorge Olvera-Salinas, José Joel Oyoqui-Flores, José Luis Gálvez-Romero, José Santos Lozano-Sáenz, Juan Ignacio Salgado-Gama, Marcos Alejandro Jiménez-Chobillon, Martha Angélica García-Avilés, Martha Patricia Guinto-Balanzar, Miguel Alejandro Medina-Ávalos, Robert Camargo-Angeles, Rogelio García-Torrentera, Saraí Toral-Freyre, Gabriel Montes-Narváez, Héctor Solorio-Gómez, Juan Rosas-Peña, Sergio Jesús Romero-Tapia, Adela Reyes-Herrera, Francisco Cuevas-Schacht, Joaquín Esquer-Flores, José Antonio Sacre-Hazouri, Lorenzo Compean-Martínez, Pablo Julián Medina-Sánchez, Sergio Garza-Salinas, Carlos Báez-Loyola, Iraís Romero-Alvarado, José Luis Miguel-Reyes, Laura Elizabeth Huerta-Espinosa, Manuel Ángel Correa-Flores, Ricardo Castro-Martínez
BACKGROUND: The need for a national guideline, with a broad basis among specialists and primary care physicians was felt in Mexico, to try unifying asthma management. As several high-quality asthma guidelines exist worldwide, it was decided to select the best three for transculturation. METHODS: Following the internationally recommended methodology for guideline transculturation, ADAPTE, a literature search for asthma guidelines, published 1-1-2007 through 31-12-2015 was conducted...
2017: Revista Alergia Mexico: Organo Oficial de la Sociedad Mexicana de Alergia e Inmunología, A.C
https://www.readbyqxmd.com/read/28440774/diagnostic-and-therapeutic-update-on-diabetic-foot-osteomyelitis
#5
José Luis Lázaro-Martínez, Aroa Tardáguila-García, José Luis García-Klepzig
Diabetic foot osteomyelitis (DFO) is the most common infection associated to diabetic foot ulcers (DFU). This review is designed to provide an update on the diagnosis and treatment of DFO based on an analysis of MEDLINE through PubMed using as search criterion "Diabetic Foot Osteomyelitis". Authors have included in this review the most relevant manuscripts regarding diagnosis and treatment of DFO. After review and critical analysis of publications, it may be concluded that diagnosis of DFO is not simple because of its heterogeneous presentation...
February 2017: Endocrinol Diabetes Nutr
https://www.readbyqxmd.com/read/28439923/immunosuppressive-drugs-in-whole-blood-validation-of-a-commercially-available-lc-ms-ms-kit-and-comparison-with-immunochemical-assays
#6
Elisa Polledri, Rosa Mercadante, Chiara Ferris Fusarin, Rita Maiavacca, Silvia Fustinoni
RATIONALE: In the determination of immunosuppressive drugs cyclosporine A (CSA), tacrolimus (TARO), sirolimus (SIRO), and everolimus (EVE) in whole blood there is an open debate about which is the best assay between immunochemistry and liquid chromatography-tandem mass spectrometry (LC-MS/MS). This work is aimed to explore this topic, focusing on the use of updated assays and the analysis of a large number of samples. METHOD: A certified in vitro diagnostic kit coupled with a medical device LC-MS/MS was validated and applied to the analysis of 1192 blood samples of patients treated with immunosuppressive drugs...
April 24, 2017: Rapid Communications in Mass Spectrometry: RCM
https://www.readbyqxmd.com/read/28439218/pediatric-reference-intervals-for-biochemical-markers-gaps-and-challenges-recent-national-initiatives-and-future-perspectives
#7
Houman Tahmasebi, Victoria Higgins, Angela W S Fung, Dorothy Truong, Nicole M A White-Al Habeeb, Khosrow Adeli
Reference intervals provide valuable information to medical practitioners in their interpretation of quantitative laboratory test results, and are critical in the assessment of patient health and in clinical decision-making. The reference interval serves as a health-associated benchmark with which to compare an individual test result. While the concept of reference intervals and their utility appear straightforward, the process of establishing accurate and reliable reference intervals is considerably complex and involved...
March 2017: EJIFCC
https://www.readbyqxmd.com/read/28438784/professional-and-conscience-based-refusals-the-case-of-the-psychiatrist-s-harmful-prescription
#8
Morten Magelssen
By way of a case story, two common presuppositions in the academic debate on conscientious objection in healthcare are challenged. First, the debate typically presupposes a sharp division between conscience-based refusals based on personal core moral beliefs and refusals based on professional (eg, medical) reasons. Only the former might involve the moral gravity to warrant accommodation. The case story challenges this division, and it is argued that just as much might sometimes be at stake morally in refusals based on professional reasons...
April 24, 2017: Journal of Medical Ethics
https://www.readbyqxmd.com/read/28437836/nurses-attitudes-toward-the-single-checking-of-medications
#9
Rachel Cross, Paul N Bennett, Cherene Ockerby, Wei Chun Wang, Judy Currey
BACKGROUND AND AIM: The policy of single over double checking of medications has been adopted by many health services; however, nurses' attitudes toward single-checking medications remains unclear. The aim of this study was to explore the attitudes of nurses who single check and administer medications in a setting where single checking has been in place for over a decade. METHODS: A cross-sectional survey design using the validated Single Checking Administration Medication Scale-II to registered nurses (n = 299) working in one metropolitan teaching hospital in Victoria, Australia...
April 24, 2017: Worldviews on Evidence-based Nursing
https://www.readbyqxmd.com/read/28437620/american-association-of-clinical-endocrinologists-and-american-college-of-endocrinology-guidelines-for-management-of-dyslipidemia-and-prevention-of-cardiovascular-disease
#10
Paul S Jellinger, Yehuda Handelsman, Paul D Rosenblit, Zachary T Bloomgarden, Vivian A Fonseca, Alan J Garber, George Grunberger, Chris K Guerin, David S H Bell, Jeffrey I Mechanick, Rachel Pessah-Pollack, Kathleen Wyne, Donald Smith, Eliot A Brinton, Sergio Fazio, Michael Davidson
OBJECTIVE: The development of these guidelines is mandated by the American Association of Clinical Endocrinologists (AACE) Board of Directors and American College of Endocrinology (ACE) Board of Trustees and adheres with published AACE protocols for the standardized production of clinical practice guidelines (CPGs). METHODS: Recommendations are based on diligent reviews of the clinical evidence with transparent incorporation of subjective factors, according to established AACE/ACE guidelines for guidelines protocols...
April 2017: Endocrine Practice
https://www.readbyqxmd.com/read/28437162/adjuvant-systemic-therapy-and-adjuvant-radiation-therapy-for-stage-i-to-iiia-completely-resected-non-small-cell-lung-cancers-american-society-of-clinical-oncology-cancer-care-ontario-clinical-practice-guideline-update
#11
Mark G Kris, Laurie E Gaspar, Jamie E Chaft, Erin B Kennedy, Christopher G Azzoli, Peter M Ellis, Steven H Lin, Harvey I Pass, Rahul Seth, Frances A Shepherd, David R Spigel, John R Strawn, Yee C Ung, Michael Weyant
Purpose The panel updated the American Society of Clinical Oncology (ASCO) adjuvant therapy guideline for resected non-small-cell lung cancers. Methods ASCO convened an update panel and conducted a systematic review of the literature, investigating adjuvant therapy in resected non-small-cell lung cancers. Results The updated evidence base covered questions related to adjuvant systemic therapy and included a systematic review conducted by Cancer Care Ontario current to January 2016. A recent American Society for Radiation Oncology guideline and systematic review, previously endorsed by ASCO, was used as the basis for recommendations for adjuvant radiation therapy...
April 24, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28436376/carpal-tunnel-syndrome-symptoms-causes-and-treatment-options-literature-reviev
#12
Radoslav Zamborsky, Milan Kokavec, Lukas Simko, Martin Bohac
Carpal Tunnel Syndrome (CTS) is the most common form of entrapment neuropathy. Several authors have investigated the anatomical and pathophysiological features of CTS and have identified several parameters that, in combination, play a significant role in its pathophysiology. Advancement in biological research on CTS has enabled the advent of efficient diagnostic techniques such as provocative tests and nerve conduction studies. Sophisticated technologies, such as magnetic resonance imaging (MRI) and ultrasonography (US), have facilitated the diagnosis of CTS...
January 26, 2017: Ortopedia, Traumatologia, Rehabilitacja
https://www.readbyqxmd.com/read/28436043/european-society-of-endodontology-position-statement-the-use-of-antibiotics-in-endodontics
#13
REVIEW
J J Segura-Egea, K Gould, B Hakan Şen, P Jonasson, E Cotti, A Mazzoni, H Sunay, L Tjäderhane, P M H Dummer
This Position Statement represents a consensus of an expert committee convened by the European Society of Endodontology (ESE) on Antibiotics in Endodontics. The statement is based on current scientific evidence as well as the expertise of the committee. The goal is to provide dentists and other healthcare workers with evidence-based criteria for when to use antibiotics in the treatment of endodontic infections, traumatic injuries of the teeth, revascularisation procedures in immature teeth with pulp necrosis, and in prophylaxis for medically compromised patients...
April 24, 2017: International Endodontic Journal
https://www.readbyqxmd.com/read/28434948/international-and-multidisciplinary-expert-recommendations-for-the-use-of-biologics-in-systemic-lupus-erythematosus
#14
REVIEW
Jean-François Kleinmann, Florence Tubach, Véronique Le Guern, Alexis Mathian, Christophe Richez, David Saadoun, Karim Sacre, Jérémie Sellam, Raphaèle Seror, Zahir Amoura, Emmanuel Andres, Sylvain Audia, Brigitte Bader-Meunier, Gilles Blaison, Bernard Bonnotte, Patrice Cacoub, Sophie Caillard, Laurent Chiche, Olivier Chosidow, Nathalie Costedoat-Chalumeau, Claire Daien, Eric Daugas, Nairouz Derdèche, Andrea Doria, Olivier Fain, Fadi Fakhouri, Dominique Farge, Cem Gabay, Sylvie Guillo, Eric Hachulla, Najia Hajjaj-Hassouni, Mohamed Hamidou, Frédéric A Houssiau, Noémie Jourde-Chiche, Isabelle Koné-Paut, Aïcha Ladjouz-Rezig, Olivier Lambotte, Dan Lipsker, Xavier Mariette, Nicolas Martin-Silva, Thierry Martin, François Maurier, Roderich Meckenstock, Arsène Mékinian, Olivier Meyer, Shirine Mohamed, Jacques Morel, Bruno Moulin, Denis Mulleman, Thomas Papo, Vincent Poindron, Xavier Puéchal, Leonardo Punzi, Pierre Quartier, Laurent Sailler, Amar Smail, Martin Soubrier, Agnès Sparsa, Zoubida Tazi-Mezalek, Leith Zakraoui, Stéphane Zuily, Jean Sibilia, Jacques-Eric Gottenberg
BACKGROUND/PURPOSE: Despite conventional immunosuppressants, active and steroid-dependent systemic lupus erythematosus (SLE) represents a therapeutic challenge. Only one biologic, belimumab, has been approved, but other biologics are sometimes used off-label. Given the lack of evidence-based data in some clinical situations encountered in real life, we developed expert recommendations for the use of biologics for SLE. METHODS: The recommendations were developed by a formal consensus method...
April 18, 2017: Autoimmunity Reviews
https://www.readbyqxmd.com/read/28434919/a-review-of-dtca-techniques-appraising-their-success-and-potential-impact-on-medication-users
#15
REVIEW
Zaheer-Ud-Din Babar, Ashna Medina Siraj, Louise Curley
BACKGROUND: Direct-to-consumer advertising (DTCA) has been present in some countries for nearly two decades. Its success and ramifications have been examined but not yet cataloged recently in a comprehensive manner. OBJECTIVE: To review existing literature studies on the topic of DTCA techniques to provide an analysis of the current methods considered by drug marketers to enhance the effect of pharmaceutical product promotion and its success, as well as examine ramifications on the drug use process...
April 12, 2017: Research in Social & Administrative Pharmacy: RSAP
https://www.readbyqxmd.com/read/28434104/mullerian-dysgenesis-a-critical-review-of-the-literature
#16
REVIEW
Souzana Choussein, Dimitrios Nasioudis, Dimitrios Schizas, Konstantinos P Economopoulos
PURPOSE: To present an update of the genetic, clinical, diagnostic, and therapeutic aspects of Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome. METHODS: Studies were considered eligible if they have evaluated patients with MRKH syndrome. Eligible articles were identified by a search of MEDLINE bibliographical database from 1950 to August 2016. A purely descriptive approach was adopted concerning all outcomes examined by the individual studies. RESULTS: MRKH syndrome is defined as congenital aplasia of the upper vagina and impairment of uterine development in normal 46XX females...
April 22, 2017: Archives of Gynecology and Obstetrics
https://www.readbyqxmd.com/read/28430547/enhancing-insights-into-pulmonary-vascular-disease-pvd-through-a-precision-medicine-approach-a-joint-nhlbi-cmref-workshop-report
#17
John H Newman, Stuart Rich, Steven H Abman, John H Alexander, John Barnard, Gerald J Beck, Raymond L Benza, Todd M Bull, Stephen Y Chan, Hyung J Chun, Declan Doogan, Jocelyn Dupuis, Serpil C Erzurum, Robert P Frantz, Mark Geraci, Hunter Gillies, Mark Gladwin, Michael P Gray, Anna R Hemnes, Roy S Herbst, Adrian F Hernandez, Nicholas S Hill, Evelyn M Horn, Kendall Hunter, Zhi-Cheng Jing, Roger Johns, Sanjay Kaul, Steven M Kawut, Tim Lahm, Jane A Leopold, Greg D Lewis, Stephen C Mathai, Vallerie V McLaughlin, Evangelos D Michelakis, Steven D Nathan, William Nichols, Grier Page, Marlene Rabinovitch, Jonathan Rich, Franz Rischard, Sharon Rounds, Sanjiv J Shah, Victor F Tapson, Naomi Lowy, Norman Stockbridge, Gail Weinmann, Lei Xiao
The Division of Lung Diseases of the National Heart, Lung and Blood Institute, (NHLBI) and the Cardiovascular Medical Education and Research Fund (CMREF), held a workshop to discuss to leverage of the anticipated scientific output from the recently launched "Redefining Pulmonary Hypertension (PH) through Pulmonary Vascular Disease Phenomics" (PVDOMICS) program. PVDOMICS is a protocol driven network to analyze PH patient populations to define novel pulmonary vascular disease (PVD) phenotypes. Basic, translational and clinical investigators, patient advocacy organizations, regulatory agencies, and pharmaceutical industry experts discussed the application of precision medicine to PVD clinical trials...
April 21, 2017: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/28428947/update-on-programmed-death-1-and-programmed-death-ligand-1-inhibition-in-the-treatment-of-advanced-or-metastatic-non-small-cell-lung-cancer
#18
REVIEW
Marco A J Iafolla, Rosalyn A Juergens
PURPOSE: Non-small-cell lung cancer (NSCLC) has a large worldwide prevalence with a high mortality rate. Chemotherapy has offered modest improvements in survival over the past two decades. Immune checkpoint modulation with programmed death-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibition has shown the promise of changing the future landscape of cancer therapy. This update reviews recent advances in the treatment of NSCLC with immune checkpoint modulation. METHODS: Publications and proceedings were identified from searching PubMed and proceedings from the annual meetings of the American Society of Clinical Oncology, European Society for Medical Oncology, and European Lung Cancer Conference...
2017: Frontiers in Oncology
https://www.readbyqxmd.com/read/28428169/assessing-the-medication-adherence-app-marketplace-from-the-health-professional-and-consumer-vantage-points
#19
Lindsey E Dayer, Rebecca Shilling, Madalyn Van Valkenburg, Bradley C Martin, Paul O Gubbins, Kristie Hadden, Seth Heldenbrand
BACKGROUND: Nonadherence produces considerable health consequences and economic burden to patients and payers. One approach to improve medication nonadherence that has gained interest in recent years is the use of smartphone adherence apps. The development of smartphone adherence apps has increased rapidly since 2012; however, literature evaluating the clinical app and effectiveness of smartphone adherence apps to improve medication adherence is generally lacking. OBJECTIVE: The aims of this study were to (1) provide an updated evaluation and comparison of medication adherence apps in the marketplace by assessing the features, functionality, and health literacy (HL) of the highest-ranking adherence apps and (2) indirectly measure the validity of our rating methodology by determining the relationship between our app evaluations and Web-based consumer ratings...
April 19, 2017: JMIR MHealth and UHealth
https://www.readbyqxmd.com/read/28426852/an-outbreak-of-endogenous-fungal-endophthalmitis-among-intravenous-drug-abusers-in-new-england
#20
Aubrey R Tirpack, Jay S Duker, Caroline R Baumal
Importance: Intravenous drug abuse (IVDA) is a known risk factor for endogenous fungal endophthalmitis (EFE), a severe intraocular infection caused by hematogenous seeding of mycotic organisms to the eye. Reporting significant increases in heroin-related deaths since 2014, the New England region is in the midst of an opioid crisis that has led to a substantial increase in patients at risk for this vision-threatening disease. Objective: To present an update on characteristics, management, and visual outcomes in patients with EFE...
April 20, 2017: JAMA Ophthalmology
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