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Safety surveillance

Antoine Haddad, Tarek Bou Assi, Olivier Garraud
Unlike their Western counterparts, some of the Eastern/Southern Mediterranean countries lack centralized coordinated blood transfusion services leading to an unequal blood safety level. This was recently highlighted by a recent World Health Organization (WHO) regional committee report in which WHO urges these countries to establish and implement a national blood system with well-coordinated blood transfusion activities and to make attempts to reach 100% voluntary non-remunerated blood donation. The objective is thus to meet the same levels or standards as Western countries in term of self-sufficiency and blood safety...
2018: Frontiers in Medicine
Barbara Albiger, Joana Revez, Katrin Claire Leitmeyer, Marc J Struelens
In an era of global health threats caused by epidemics of infectious diseases and rising multidrug resistance, microbiology laboratories provide essential scientific evidence for risk assessment, prevention, and control. Microbiology has been at the core of European infectious disease surveillance networks for decades. Since 2010, these networks have been coordinated by the European Centre for Disease Prevention and Control (ECDC). Activities delivered in these networks include harmonization of laboratory diagnostic, antimicrobial susceptibility and molecular typing methods, multicentre method validation, technical capacity mapping, training of laboratory staff, and continuing quality assessment of laboratory testing...
2018: Frontiers in Public Health
Roshan P Shah, Leanna MacLean, Wayne G Paprosky, Scott Sporer
BACKGROUND: Radiostereometric analysis (RSA) accurately assesses arthroplasty implant performance and is routinely used for research purposes. Because of its efficacy in detecting implant failure in research subjects, we deployed the use of RSA beads for routine surveillance in all elective total hip and total knee arthroplasty patients. METHODS: We retrospectively compared 143 patients who received RSA beads intraoperatively with 343 patients who did not receive RSA beads...
March 12, 2018: Journal of the American Academy of Orthopaedic Surgeons
Veena Hoffman, Remon Abu-Elyazeed, Cheryl Enger, Daina B Esposito, Michael C Doherty, Scott C Quinlan, Kathleen Skerry, Crystal N Holick, Peter Basile, Leonard R Friedland, Nicolas Praet, Stéphanie Wéry, Corinne Willame, David D Dore, Dominique Rosillon
As part of a regulatory commitment for post-licensure safety monitoring of live, oral human rotavirus vaccine (RV1), this study compared the incidence rates (IR) of intussusception, acute lower respiratory tract infection (LRTI) hospitalization, Kawasaki disease, convulsion, and mortality in RV1 recipients versus inactivated poliovirus vaccine (IPV) recipients in concurrent (cIPV) and recent historical (hIPV) comparison cohorts. Vaccine recipients were identified in 2 claims databases from August 2008 - June 2013 (RV1 and cIPV) and January 2004 - July 2008 (hIPV)...
March 13, 2018: Human Vaccines & Immunotherapeutics
Emily Kay-Rivest, Marco A Mascarella, Pramod Puligandla, Sherif Emil, Christine Saint-Martin, Lily H P Nguyen, Sam J Daniel, Robert Baird
BACKGROUND/PURPOSE: Intrathyroidal thymic tissue may be misinterpreted as a thyroid lesion in children, leading to invasive tests or resection. We sought to describe the characteristic imaging features of these lesions and to evaluate the safety of non-operative management. METHODS: A retrospective review of all patients less than 18years old with intrathyroidal thymic tissue from 2000 to 2016 was performed. Data collection included patient demographics, imaging results, interventions, and outcomes...
February 8, 2018: Journal of Pediatric Surgery
Stefan Wietek
AIM: To present data from three studies of a Post-Authorization Safety Surveillance (PASS) program for the subset of patients receiving octagam® 5% or 10% for chronic inflammatory demyelinating polyneuropathy (CIDP). METHODS: Data on patients with CIDP treated with octagam were analyzed to assess its safety and tolerability. RESULTS: Of 2314 patients included in the studies, 58 patients (mean age: 64.6 years) received octagam for CIDP, mean dose of which was 0...
March 8, 2018: Neurodegenerative Disease Management
Malaz Boustani, Catherine A Alder, Craig A Solid
OBJECTIVES: To describe the essential components of an Agile Implementation (AI) process, which rapidly and effectively implements evidence-based healthcare solutions, and present a case study demonstrating its utility. DESIGN: Case demonstration study. SETTING: Integrated, safety net healthcare delivery system in Indianapolis. PARTICIPANTS: Interdisciplinary team of clinicians and administrators. MEASUREMENTS: Reduction in dementia symptoms and caregiver burden; inpatient and outpatient care expenditures...
March 7, 2018: Journal of the American Geriatrics Society
N I Bi-Xian, S Ming-Xue, X U Xiang-Zhen, W Xiao-Ting, D Yang, J Xiao-Lin
Objective To know the contamination status of Giardia lamblia and Cryptosporidium in drinking water of Jiangsu Province, so as to provide the evidence for producing hygiene and safety drinking water. Methods A total of 28 water plants of 13 cities in Jiangsu Province were selected, and the source water (10 L), chlorinated water (100 L) and tap water (100 L) were collected separately in each site. The water samples were then treated by filtration, washing, centrifuging concentration, immune magnetic separation, and immunofluorescent assay, to detect the numbers of Giardia cysts and Cryptosporidium oocysts...
May 17, 2017: Zhongguo Xue Xi Chong Bing Fang Zhi za Zhi, Chinese Journal of Schistosomiasis Control
David Martin, Joshua J Gagne, Susan Gruber, Rima Izem, Jennifer C Nelson, Michael D Nguyen, Rita Ouellet-Hellstrom, Sebastian Schneeweiss, Sengwee Toh, Alexander M Walker
No abstract text is available yet for this article.
March 5, 2018: Pharmacoepidemiology and Drug Safety
Catherine G Corey, Joanne T Chang, Brian L Rostron
BACKGROUND: Currently, an estimated 7.9 million US adults use electronic nicotine delivery systems (ENDS). Although published reports have identified fires and explosions related to use of ENDS since 2009, these reports do not provide national estimates of burn injuries associated with ENDS batteries in the US. FINDINGS: We analyzed nationally representative data provided in the National Electronic Injury Surveillance System (NEISS) to estimate the number of US emergency department (ED) visits for burn injuries associated with ENDS batteries...
March 5, 2018: Injury Epidemiology
Masateru Okazaki, Hisanori Kobayashi, Hirohito Shimizu, Yutaka Ishii, Tsutomu Yajima, Masayoshi Kanbori
INTRODUCTION: Golimumab has been proven as an effective treatment for rheumatoid arthritis in clinical trials. However, there is a scarcity of data regarding its use in elderly patients in a real-world setting. This study aims to evaluate the safety, effectiveness, and treatment persistence of golimumab in elderly Japanese patients (≥ 75 years) with rheumatoid arthritis. METHODS: This study was a post hoc analysis of post-marketing surveillance data on 5137 Japanese patients with active rheumatoid arthritis who received golimumab for 24 weeks...
March 2, 2018: Rheumatology and Therapy
Ming-Yan Cai, Bo-Qun Zhu, Mei-Dong Xu, Wen-Zheng Qin, Yi-Qun Zhang, Wei-Feng Chen, Marie Ooi, Quan-Lin Li, Li-Qing Yao, Ping-Hong Zhou
BACKGROUND AND AIM: The management of subepithelial tumors with a predominant extraluminal growth pattern or extra-gastrointestinal (GI) tumors can be challenging and traditionally requires a surgical resection that is not only invasive but may carry a significant risk of morbidity and mortality. We aim to assess the feasibility, safety and efficacy of a novel endoscopic technique termed as submucosal tunnel endoscopic resection for Extraluminal Tumors (STER-ET). METHODS: We prospectively enrolled patients who underwent STER-ET for gastrointestinal subepithelial tumors with a predominant extraluminal growth pattern or extra-GI tumors located at the level of cardia or the proximal part of the lesser curvature of the stomach seen on cross-sectional imaging between January 2016 and March 2017...
February 27, 2018: Gastrointestinal Endoscopy
Galina Beketova, Oleksandr Grynevych, Lyudmila Solomakha, Natalia Golovnia
Scientific literature data on the experience of use of Proteflazid® (drops) and Immunoflazid® (syrup) for the treatment of viral diseases in children of the first six years of life are analysed in the article. A systematic review was conducted on the basis of postmarketing comparative clinical trials and long-term follow-up (during the period of 2002 to 2016) that involved about 1500 children (the intent-to-treat population comprised more than 800 of them). The safety and efficacy of the Proteflazid® (drops) and Immunoflazid® (syrup) usage in children for the treatment of viral infections have been proven...
February 23, 2018: Polski Merkuriusz Lekarski: Organ Polskiego Towarzystwa Lekarskiego
Bernardino C Branco, Miguel F Montero-Baker, Eduardo Espinoza, Maria Gamero, Rodrigo Zea-Vera, Nicos Labropoulos, Luis R Leon
Objective Inferior vena cava occlusion is a potentially life-threatening complication related to caval filters. We present our experience with filter-induced inferior vena cava occlusion in order to assess the feasibility, safety, and effectiveness of endovascular management. Methods A retrospective review of all patients undergoing inferior vena cava filter placement over a 60-month study period was performed. From this cohort, a total of 10 cases of inferior vena cava occlusion after filter placement were identified...
January 1, 2018: Vascular
Kunj Bhatt, Ali Pourmand, Neal Sikka
INTRODUCTION: Advances in technology have revolutionized the medical field and changed the way healthcare is delivered. Unmanned aerial vehicles (UAVs) are the next wave of technological advancements that have the potential to make a huge splash in clinical medicine. UAVs, originally developed for military use, are making their way into the public and private sector. Because they can be flown autonomously and can reach almost any geographical location, the significance of UAVs are becoming increasingly apparent in the medical field...
February 28, 2018: Telemedicine Journal and E-health: the Official Journal of the American Telemedicine Association
Corinne M Hohl, Serena S Small, David Peddie, Katherin Badke, Chantelle Bailey, Ellen Balka
BACKGROUND: Adverse drug events are unintended and harmful events related to medications. Adverse drug events are important for patient care, quality improvement, drug safety research, and postmarketing surveillance, but they are vastly underreported. OBJECTIVE: Our objectives were to identify barriers to adverse drug event documentation and factors contributing to underreporting. METHODS: This qualitative study was conducted in 1 ambulatory center, and the emergency departments and inpatient wards of 3 acute care hospitals in British Columbia between March 2014 and December 2016...
February 27, 2018: JMIR Public Health and Surveillance
Jiro Aoki, Ken Kozuma, Masaki Awata, Mamoru Nanasato, Nobuo Shiode, Kengo Tanabe, Junichi Yamaguchi, Hajime Kusano, Hong Nie, Takeshi Kimura
The Cobalt Chromium Everolimus-Eluting Stent (CoCr-EES) Post Marketing Surveillance (PMS) Japan study is a prospective multicenter registry designed to evaluate the safety and efficacy of XIENCE V/PROMUS everolimus-eluting stents in routine clinical practice at 47 centers representative of the clinical environment in Japan. We enrolled 2010 consecutive patients (2649 lesions) who underwent percutaneous coronary intervention using CoCr-EES. Clinical outcomes were evaluated through 5 years. Mean age was 68.8 years, 41...
February 26, 2018: Cardiovascular Intervention and Therapeutics
Leslie K Ballas, Ryan Kraus, Lingyun Ji, Susan Groshen, Mariana C Stern, Inderbir Gill, David I Quinn, Eugene Chung, Andre Abreu, Ann S Hamilton
INTRODUCTION: Active surveillance (AS) is one recommended option for low-risk prostate cancer and involves close follow-up and monitoring. Our objective was to determine whether non-clinical trial patients adhere to AS protocols and how many are lost to follow-up (LTFU). PATIENTS AND METHODS: Retrospective chart review was performed for patients with nonmetastatic prostate cancer who initiated AS at Los Angeles County Hospital (LAC) and University of Southern California Norris Comprehensive Cancer Center (Norris) between January 1, 2008, and January 1, 2015...
February 6, 2018: Clinical Genitourinary Cancer
Andreas H Taenzer, Brian C Spence
The prevention of adverse events continues to be the focus of patient safety work. Although rapid response systems have improved the efferent limb of the patient's rescue, the detection of the patient's deterioration (the afferent limb) has not been solved. This article provides an overview of the complex issues surrounding patient surveillance by addressing the principal considerations of continuous monitoring as they relate to implementation, choice of sensors and physiologic variables, notification, and alarm balancing, as well as future research opportunities...
April 2018: Critical Care Clinics
Cheng-Ho Chang, Ping-Tao Tseng, Nai-Yu Chen, Pei-Chin Lin, Pao-Yen Lin, Jane Pei-Chen Chang, Feng-Yu Kuo, Jenshinn Lin, Ming-Chang Wu, Kuan-Pin Su
BACKGROUND: Omega-3 fatty acids [eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)] are widely recommended for health promotion. Over the last decade, prescription omega-3 fatty acid products (RxOME3FAs) have been approved for medical indications. Nonetheless, there is no comprehensive analysis of safety and tolerability of RxOME3FAs so far. METHODS: A systematic review of randomized controlled trials (RCTs) was carried out based on searches in six electronic databases...
February 2018: Prostaglandins, Leukotrienes, and Essential Fatty Acids
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