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Safety surveillance

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https://www.readbyqxmd.com/read/28526929/analytical-management-of-patients-undergoing-oral-anticoagulant-therapy-could-have-a-strong-impact-on-clinical-outcomes-a-follow-up-study
#1
Vincenzo De Iuliis, Sebastiano Ursi, Gianfranco Vitullo, Irma Griffo, Antonio Marino, Marika Caruso, Francesco Cipollone, Sabrina Capodifoglio, Veronica Breda, Elena Toniato, Alfonso Pennelli, Pio Conti, Stefano Martinotti
INTRODUCTION: Oral anticoagulant therapy, such as vitamin K antagonists (VKAs), is prominent for the prevention of cerebral ischemic stroke or systemic embolism and all-cause mortality in patients with atrial fibrillation, venous thromboembolism, and mechanical or biological valve. VKA treatment requires monitoring of the international normalized ratio (INR) in order to maintain it in a therapeutic range, avoiding side effects, the main and most significant of which is bleeding. The aim of the present study was to evaluate the event rates of several clinical composite outcomes, such as bleeding, thromboembolic events, and all-cause death...
May 19, 2017: Cardiology and Therapy
https://www.readbyqxmd.com/read/28520482/foodborne-disease-outbreaks-in-correctional-institutions-united-states-1998-2014
#2
Mariel A Marlow, Ruth E Luna-Gierke, Patricia M Griffin, Antonio R Vieira
OBJECTIVES: To present the first update on the epidemiology of US foodborne correctional institution outbreaks in 20 years. METHODS: We analyzed data from the Centers for Disease Control and Prevention's Foodborne Disease Outbreak Surveillance System to describe correctional institution outbreaks from 1998 to 2014 and compare them with other foodborne outbreaks. RESULTS: Two hundred foodborne outbreaks in correctional institutions were reported, resulting in 20 625 illnesses, 204 hospitalizations, and 5 deaths...
May 18, 2017: American Journal of Public Health
https://www.readbyqxmd.com/read/28515198/post-authorisation-passive-enhanced-safety-surveillance-of-seasonal-influenza-vaccines-protocol-of-a-pilot-study-in-england
#3
Simon de Lusignan, Gaël Dos Santos, Ana Correa, François Haguinet, Ivelina Yonova, Florence Lair, Rachel Byford, Filipa Ferreira, Karen Stuttard, Tom Chan
AIM: To pilot enhanced safety surveillance of seasonal influenza vaccine meeting the European Medicines Agency (EMA) requirement to rapidly detect a significant increase in the frequency or severity of adverse events of interest (AEIs), which may indicate risk from the new season's vaccine. STUDY DESIGN: A prospective passive enhanced safety surveillance combining data collection from adverse drug reaction (ADR) cards with automated collection of pseudonymised routinely collected electronic health record (EHR) data...
May 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28514621/registry-based-surveillance-of-medical-device-safety
#4
LETTER
Frederic S Resnic, Arjun Majithia
No abstract text is available yet for this article.
May 18, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28514620/registry-based-surveillance-of-medical-device-safety
#5
LETTER
Albeir Y Mousa, Mike Broce, B Daniel Lucas
New England Journal of Medicine, Volume 376, Issue 20, Page 1994-1995, May 2017.
May 18, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28512731/active-surveillance-for-prostate-cancer-how-to-do-it-right
#6
REVIEW
Juan D Garisto, Laurence Klotz
Prostate cancer is the most common malignancy affecting men. There has been a nearly 70% increase in new prostate cancer cases, mostly classified as low risk, that have been diagnosed in early stages as a consequence of prostate-specific antigen (PSA) screening. Data regarding the natural history of this disease confirm the clinical insignificance of low-grade prostate cancer, which is associated with scant or no metastatic dissemination. Active surveillance is a conservative management approach, conducted for those patients with "low-risk" or "favorable-risk" disease, which avoids long-term adverse effects on the patient's quality of life...
May 15, 2017: Oncology (Williston Park, NY)
https://www.readbyqxmd.com/read/28512233/identification-assessment-and-management-of-new-and-re-emerging-animal-related-risks-uk-perspective
#7
R Kosmider, J Gibbens, R Avigad
Veterinary surveillance programmes aim to reduce the burden to the public, livestock and wider society posed by animal-related 'risks' (referred to as 'threats' later in the paper in line with a definition used by the European Food Safety Authority) including the re-emergence of diseases believed absent or eradicated. To achieve this, it is important to have a systematic approach to identifying and dealing with such threats rapidly and effectively. This paper describes the transparent, systematic and auditable process used for identifying, assessing, escalating and prioritising new and re-emerging animal-related threats in the UK...
May 16, 2017: Veterinary Record
https://www.readbyqxmd.com/read/28511812/acute-management-of-symptomatic-subependymal-giant-cell-astrocytoma-with-everolimus
#8
Monica S Arroyo, Darcy A Krueger, Eileen Broomall, Charles B Stevenson, David N Franz
BACKGROUND: Subependymal giant cell astrocytomas (SEGA) are slow-growing tumors, which can cause obstructive hydrocephalus in patients with tuberous sclerosis complex (TSC). These tumors require routine surveillance with magnetic resonance imaging. Current consensus guidelines recommend treatment of asymptomatic SEGAs with an mechanistic target of rapamycin (mTOR) inhibitor because these medications have demonstrated efficacy and safety in multiple prospective clinical trials. For symptomatic SEGAs, standard therapy typically involves surgical resection of the tumor to relieve mass effect and resolve hydrocephalus...
April 18, 2017: Pediatric Neurology
https://www.readbyqxmd.com/read/28510606/safety-and-efficacy-of-cell-free-and-concentrated-ascites-reinfusion-therapy-cart-in-refractory-ascites-post-marketing-surveillance-results
#9
Norio Hanafusa, Ayako Isoai, Tomoaki Ishihara, Tetsuya Inoue, Ken Ishitani, Taiju Utsugisawa, Toshihiko Yamaka, Tetsuya Ito, Hiroshi Sugiyama, Atsushi Arakawa, Yosuke Yamada, Yasuo Itano, Hirokazu Onodera, Ryosuke Kobayashi, Naoko Torii, Toyoko Numata, Taihei Kashiwabara, Yoshihiro Matsuno, Michio Kato
We performed post-marketing surveillance to evaluate the safety and efficacy of cell-free and concentrated ascites reinfusion therapy (CART). In total, 356 CART sessions in 147 patients at 22 centers were performed. The most common primary disease was cancer (128 cases, 300 sessions). Mean amount of ascites collected was 3.7 L, and mean concentration ratio was 9.2. Mean amount of reinfused protein was 67.8 g (recovery rate, 72.0%). Performance status, dietary intake, urine volume, body weight and abdominal circumference were significantly improved after CART...
2017: PloS One
https://www.readbyqxmd.com/read/28507610/improving-patient-safety-in-hospitals-through-usage-of-cloud-supported-video-surveillance
#10
Predrag Dašić, Jovan Dašić, Bojan Crvenković
BACKGROUND: Patient safety in hospitals is of equal importance as providing treatments and urgent healthcare. With the development of Cloud technologies and Big Data analytics, it is possible to employ VSaaS technology virtually anywhere, for any given security purpose. AIM: For the listed benefits, in this paper, we give an overview of the existing cloud surveillance technologies which can be implemented for improving patient safety. MATERIAL AND METHODS: Modern VSaaS systems provide higher elasticity and project scalability in dealing with real-time information processing...
April 15, 2017: Open Access Macedonian Journal of Medical Sciences
https://www.readbyqxmd.com/read/28506182/elemental-properties-of-copper-slag-and-measured-airborne-exposures-at-a-copper-slag-processing-facility
#11
Christopher Mugford, Jenna L Gibbs, Randy Boylstein
In 1974, the National Institute for Occupational Safety and Health recommended a ban on the use of abrasives containing >1% silica, giving rise to abrasive substitutes like copper slag. We present results from a National Institute for Occupational Safety and Health industrial hygiene survey at a copper slag processing facility that consisted of the collection of bulk samples for metals and silica; and full-shift area and personal air samples for dust, metals, and respirable silica. Carcinogens, suspect carcinogens, and other toxic elements were detected in all bulk samples, and area and personal air samples...
May 16, 2017: Journal of Occupational and Environmental Hygiene
https://www.readbyqxmd.com/read/28505280/mining-e-cigarette-adverse-events-in-social-media-using-bi-lstm-recurrent-neural-network-with-word-embedding-representation
#12
Jiaheng Xie, Xiao Liu, Daniel Dajun Zeng
Objective: Recent years have seen increased worldwide popularity of e-cigarette use. However, the risks of e-cigarettes are underexamined. Most e-cigarette adverse event studies have achieved low detection rates due to limited subject sample sizes in the experiments and surveys. Social media provides a large data repository of consumers' e-cigarette feedback and experiences, which are useful for e-cigarette safety surveillance. However, it is difficult to automatically interpret the informal and nontechnical consumer vocabulary about e-cigarettes in social media...
May 13, 2017: Journal of the American Medical Informatics Association: JAMIA
https://www.readbyqxmd.com/read/28505041/the-potential-return-on-public-investment-in-detecting-adverse-drug-effects
#13
Krista F Huybrechts, Rishi J Desai, Moa Park, Joshua J Gagne, Mehdi Najafzadeh, Jerry Avorn
BACKGROUND: Many countries lack fully functional pharmacovigilance programs, and public budgets allocated to pharmacovigilance in industrialized countries remain low due to resource constraints and competing priorities. OBJECTIVE: Using 3 case examples, we sought to estimate the public health and economic benefits resulting from public investment in active pharmacovigilance programs to detect adverse drug effects. RESEARCH DESIGN: We assessed 3 examples in which early signals of safety hazards were not adequately recognized, resulting in continued exposure of a large number of patients to these drugs when safer and effective alternative treatments were available...
June 2017: Medical Care
https://www.readbyqxmd.com/read/28500861/overview-of-high-risk-medical-device-recalls-in%C3%A2-obstetrics%C3%A2-and-gynecology-from-2002-through-2016-%C3%A2-implications-for-device-safety
#14
Timothy M Janetos, Comeron W Ghobadi, Shuai Xu, Jessica R Walter
The field of women's health has endured numerous recent controversies involving medical devices such as pelvic meshes, laparoscopic morcellators, and a hysteroscopic sterilization device. With the recent passage of the 21st Century Cures Act, new legislation will change how the Food and Drug Administration regulates medical devices. Given these controversies and new changes, we investigated high-risk, class I recalls in women's health from 2002 through 2016. Class I recalls for medical devices are defined by the Food and Drug Administration as the most serious recall events and are designated for situations when there is a reasonable probability of serious adverse health consequences or death...
April 29, 2017: American Journal of Obstetrics and Gynecology
https://www.readbyqxmd.com/read/28495223/feasibility-of-text-message-influenza-vaccine-safety-monitoring-during-pregnancy
#15
Melissa S Stockwell, Maria Cano, Kathleen Jakob, Karen R Broder, Cynthia Gyamfi-Bannerman, Paula M Castaño, Paige Lewis, Angela Barrett, Oidda I Museru, Ormarys Castellanos, Philip S LaRussa
INTRODUCTION: The feasibility and accuracy of text messaging to monitor events after influenza vaccination throughout pregnancy and the neonatal period has not been studied, but may be important for seasonal and pandemic influenza vaccines and future maternal vaccines. METHODS: This prospective observational study was conducted during 2013-2014 and analyzed in 2015-2016. Enrolled pregnant women receiving inactivated influenza vaccination at a gestational age <20 weeks were sent text messages intermittently through participant-reported pregnancy end to request fever, health events, and neonatal outcomes...
May 2, 2017: American Journal of Preventive Medicine
https://www.readbyqxmd.com/read/28494909/remifentanil-as-an-alternative-to-epidural-analgesia-for-vaginal-delivery-a-meta-analysis-of-randomized-trials
#16
Myeongjong Lee, Fang Zhu, Jessica Moodie, Zhe Zhang, Davy Cheng, Janet Martin
OBJECTIVES: Although epidural analgesia is considered the gold standard for labor pain management, its use may be restricted in some conditions due to clinical contraindications or availability, and suitable alternatives may be required. The objective of this meta-analysis was to determine whether evidence from randomized trials suggests remifentanil PCA (R-PCA) results in significant differences in maternal satisfaction, analgesic efficacy, and safety compared with conventional epidural analgesia (EA)...
June 2017: Journal of Clinical Anesthesia
https://www.readbyqxmd.com/read/28494844/west-nile-virus-surveillance-in-europe-moving-towards-an-integrated-animal-human-vector-approach
#17
Céline M Gossner, Laurence Marrama, Marianne Carson, Franz Allerberger, Paolo Calistri, Dimitrios Dilaveris, Sylvie Lecollinet, Dilys Morgan, Norbert Nowotny, Marie-Claire Paty, Danai Pervanidou, Caterina Rizzo, Helen Roberts, Friedrich Schmoll, Wim Van Bortel, Andrea Gervelmeyer
This article uses the experience of five European countries to review the integrated approaches (human, animal and vector) for surveillance and monitoring of West Nile virus (WNV) at national and European levels. The epidemiological situation of West Nile fever in Europe is heterogeneous. No model of surveillance and monitoring fits all, hence this article merely encourages countries to implement the integrated approach that meets their needs. Integration of surveillance and monitoring activities conducted by the public health authorities, the animal health authorities and the authorities in charge of vector surveillance and control should improve efficiency and save resources by implementing targeted measures...
May 4, 2017: Euro Surveillance: Bulletin Européen sur les Maladies Transmissibles, European Communicable Disease Bulletin
https://www.readbyqxmd.com/read/28494843/passive-enhanced-safety-surveillance-for-vaxigrip-and-intanza-15-%C3%A2%C2%B5g-in-the-united-kingdom-and-finland-during-the-northern-hemisphere-influenza-season-2015-16
#18
Hélène Bricout, Anne Laure Chabanon, Audrey Souverain, Christine Sadorge, Timo Vesikari, Timothy David Caroe
Enhanced safety surveillance (ESS) was conducted in the United Kingdom and Finland for Vaxigrip and Intanza 15 µg to comply with the European Medicines Agency interim guidance aimed to detect any potential increase in reactogenicity in near real time following the annual update of the influenza vaccine strain composition. This pilot passive ESS was established to strengthen safety monitoring by facilitating spontaneous vaccinee reports and estimating near real-time vaccinee exposure. The primary objective was to estimate the reporting rates of suspected adverse reactions (ARs) occurring within 7 days post vaccination during the northern hemisphere 2015/16 influenza season...
May 4, 2017: Euro Surveillance: Bulletin Européen sur les Maladies Transmissibles, European Communicable Disease Bulletin
https://www.readbyqxmd.com/read/28493162/single-setting-endoscopic-retrograde-cholangiopancreatography-ercp-and-cholecystectomy-improve-the-rate-of-surgical-site-infection
#19
Michele M Loor, Jean Dominique Morancy, James K Glover, Gregory J Beilman, Catherine L Statz
INTRODUCTION: Cholecystectomy is a common surgical procedure. The presence of common bile duct stones complicates treatment, often requiring a second procedure for stone retrieval. For such patients, endoscopic retrograde cholangiopancreatography (ERCP) provides adequate therapy, and can be performed before, after, or at the same time as cholecystectomy. In 2013, duodenoscopes were implicated by the Centers for Disease Control and Prevention in transmission of carbapenem-resistant Enterobacteriaceae...
May 10, 2017: Surgical Endoscopy
https://www.readbyqxmd.com/read/28490974/the-introduction-of-biosimilars-of-low-molecular-weight-heparins-in-europe-a-critical-review-and-reappraisal-endorsed-by-the-italian-society-for-haemostasis-and-thrombosis-siset-and-the-italian-society-for-angiology-and-vascular-medicine-siapav
#20
REVIEW
Davide Imberti, Marco Marietta, Hernan Polo Friz, Claudio Cimminiello
Recently, the European Medicines Agency (EMA) authorized the introduction and marketing of Thorinane® and Inhixa®, biosimilars of the Low Molecular Weight Heparin (LMWH) enoxaparin. The authorization path is considerably different from the guidelines published by the EMA in 2009, as well as from the recommendations from the International Society on Thrombosis and Haemostasis published in 2013. Indeed, both of them recommended that LMWHs biosimilars therapeutic equivalence should be demonstrated in at least one adequately designed clinical trial...
2017: Thrombosis Journal
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