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https://www.readbyqxmd.com/read/27926652/hysteroscopic-sterilization-with-essure-summary-of-the-u-s-food-and-drug-administration-actions-and-policy-implications-for-postmarketing-surveillance
#1
Jessica R Walter, Comeron W Ghobadi, Emily Hayman, Shuai Xu
In September 2015, the U.S. Food and Drug Administration (FDA) convened a meeting of the Obstetrics and Gynecology Advisory Board Committee to address the sudden increase of patient-reported adverse events surrounding Essure, a Class III device offering a less invasive method for permanent female sterilization. After a review of the premarketing and postmarketing data and existing scientific literature, the FDA concluded there was insufficient evidence to remove the device from the market. However, the FDA did release a new guidance document requiring a black box warning for the device and ordered a new postmarketing study comparing Essure's safety and efficacy with laparoscopic tubal sterilization...
December 2, 2016: Obstetrics and Gynecology
https://www.readbyqxmd.com/read/27926563/truth-in-reporting-how-data-capture-methods-obfuscate-actual-surgical-site-infection-rates-within-a-health-care-network-system
#2
Liliana Bordeianou, Christy E Cauley, Donna Antonelli, Sarah Bird, David Rattner, Matthew Hutter, Sadiqa Mahmood, Deborah Schnipper, Marc Rubin, Ronald Bleday, Pardon Kenney, David Berger
BACKGROUND: Two systems measure surgical site infection rates following colorectal surgeries: the American College of Surgeons National Surgical Quality Improvement Program and the Centers for Disease Control and Prevention National Healthcare Safety Network. The Centers for Medicare & Medicaid Services pay-for-performance initiatives use National Healthcare Safety Network data for hospital comparisons. OBJECTIVE: This study aimed to compare database concordance...
January 2017: Diseases of the Colon and Rectum
https://www.readbyqxmd.com/read/27922839/safety-of-perioperative-glucocorticoids-in-elective-noncardiac-surgery-a-systematic-review-and-meta-analysis
#3
Andrew J Toner, Vyhunthan Ganeshanathan, Matthew T Chan, Kwok M Ho, Tomas B Corcoran
BACKGROUND: Glucocorticoids are increasingly used perioperatively, principally to prevent nausea and vomiting. Safety concerns focus on the potential for hyperglycemia and increased infection. The authors hypothesized that glucocorticoids predispose to such adverse outcomes in a dose-dependent fashion after elective noncardiac surgery. METHODS: The authors conducted a systematic literature search of the major medical databases from their inception to April 2016...
December 6, 2016: Anesthesiology
https://www.readbyqxmd.com/read/27919207/safety-and-effectiveness-of-24-week-treatment-with-iguratimod-a-new-oral-disease-modifying-antirheumatic-drug-for-patients-with-rheumatoid-arthritis-interim-analysis-of-a-postmarketing-surveillance-study-of-2679-patients-in-japan
#4
Tsuneyo Mimori, Masayoshi Harigai, Tatsuya Atsumi, Takao Fujii, Masataka Kuwana, Hiroaki Matsuno, Shigeki Momohara, Syuji Takei, Naoto Tamura, Yoshinari Takasaki, Satoshi Ikeuchi, Satoru Kushimoto, Takao Koike
OBJECTIVE: To determine the real-world safety and effectiveness of iguratimod (IGU) for rheumatoid arthritis (RA), a 52-week, Japanese, postmarketing surveillance study was conducted. An interim analysis at week 24 was performed. METHODS: This study included all RA patients who received IGU following its introduction to the market. All adverse events (AEs) and adverse drug reactions (ADRs) were collected. Effectiveness was evaluated by the change in Disease Activity Score 28-C-reactive protein (DAS28-CRP) from baseline to week 24...
December 6, 2016: Modern Rheumatology
https://www.readbyqxmd.com/read/27913724/novel-application-of-steroid-eluting-stents-in-choanal-atresia-repair-a-case-series
#5
John N Bangiyev, Nandini Govil, Anthony Sheyn, Michael Haupert, Prasad John Thottam
PURPOSE: To describe the application of mometasone furoate eluting sinus stent technology in the treatment of choanal atresia (CA) in the hopes of preventing postsurgical stenosis. METHODS: We analyzed 3 consecutive patients aged 4 days to 16 years undergoing repair of CA at a tertiary pediatric hospital. Mometasone furoate eluting sinus stents were placed intraoperatively. Postoperative need for revision surgery as well as routine surveillance endoscopy were used to determine success of surgery...
January 2017: Annals of Otology, Rhinology, and Laryngology
https://www.readbyqxmd.com/read/27907128/fasa-registry-on-acute-myocardial-infarction-farmi-feasibility-study-and-pilot-phase-results
#6
Ehsan Bahramali, Alireza Askari, Habib Zakeri, Mojtaba Farjam, Azizallah Dehghan, Kazem Zendehdel
BACKGROUND: Myocardial infarction (MI) is the leading cause of death in Iran. Every attempt to improve treatment patterns and patient outcomes needs a surveillance system to both consider the efficacy and safety measures. Fasa Registry on Myocardial Infarction (FaRMI) is the first population-based registry for acute MI in Iran targeted to provide meticulous description of patients' characteristics, to explore the management patterns of these patients, to discover the degree of adherence to the practice guidelines, and to investigate the determinants of poor in-hospital and later outcomes...
2016: PloS One
https://www.readbyqxmd.com/read/27902662/surveillance-a-nursing-intervention-for-improving-patient-safety-in-critical-care-environment
#7
Dale M Pfrimmer, Maren R Johnson, Martha L Guthmiller, Joanna L Lehman, Vickie K Ernste, Lori M Rhudy
BACKGROUND: Nursing surveillance has been identified as a key intervention in early recognition and prevention of errors/adverse events. Nursing Intervention Classification (NIC) defines surveillance as "the purposeful and ongoing acquisition, interpretation, and synthesis of patient data for clinical decision making." Because nurses are the main staffing constant in the critical care environment, the importance of surveillance as an intervention is fundamental. OBJECTIVE: The aim of this study was to explore how surveillance is expressed by critical care nurses...
January 2017: Dimensions of Critical Care Nursing: DCCN
https://www.readbyqxmd.com/read/27900937/post-authorization-changes-in-the-safety-and-efficacy-assessment-recommended-indications-and-drug-quality-profile-of-adalimumab-a-chronological-overview
#8
Gergely Iványi, Romána Zelkó
OBJECTIVE: The intention of the present study was to demonstrate the postauthorization changes of adalimumab (European trade name: Humira), evaluating the variations in its safety, efficacy, and quality profile. METHODS: Type-II, major variations of the Summary of Product Characteristics (SmPC) from September 8, 2003 to November 19, 2015, were analyzed, which, according to Commission Regulation (EC) No. 1234/2008, have to reflect changes that may have a significant impact on the safety, efficacy, or quality profile of a medicinal product...
November 30, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27900605/to-establish-a-body-of-evidence-on-safety-for-postmarketing-chinese-medicine-a-new-research-paradigm
#9
Xing Liao, Yan-Ming Xie, Nicola Robinson, Yong-Yan Wang
The issue of safety evaluation on postmarketing Chinese medicines has become a hot topic in mainland China recently. Researchers and decision-makers can obtain a variety of evidence resources about safety in order to evaluate the safety profile for postmarketing Chinese medicines. A registry study on ten Chinese medicine injections for postmarketing surveillance has come to the end. From such a study observing more than 300,000 patients for more than 4 years, a theoretical research question emerges, that is, how to identify and evaluate safety evidence systematically...
November 29, 2016: Chinese Journal of Integrative Medicine
https://www.readbyqxmd.com/read/27896144/clinical-decision-support-for-drug-related-events-moving-towards-better-prevention
#10
REVIEW
Sandra L Kane-Gill, Archita Achanta, John A Kellum, Steven M Handler
Clinical decision support (CDS) systems with automated alerts integrated into electronic medical records demonstrate efficacy for detecting medication errors (ME) and adverse drug events (ADEs). Critically ill patients are at increased risk for ME, ADEs and serious negative outcomes related to these events. Capitalizing on CDS to detect ME and prevent adverse drug related events has the potential to improve patient outcomes. The key to an effective medication safety surveillance system incorporating CDS is advancing the signals for alerts by using trajectory analyses to predict clinical events, instead of waiting for these events to occur...
November 4, 2016: World Journal of Critical Care Medicine
https://www.readbyqxmd.com/read/27895472/safety-and-effectiveness-of-daily-teriparatide-for-osteoporosis-in-patients-with-severe-stages-of-chronic-kidney-disease-post-hoc-analysis-of-a-postmarketing-observational-study
#11
Atsushi Nishikawa, Fumito Yoshiki, Masanori Taketsuna, Kenta Kajimoto, Hiroyuki Enomoto
Teriparatide (recombinant 1-34 N-terminal sequence of human parathyroid hormone) for the treatment of osteoporosis should be prescribed with caution in patients with severe stages of chronic kidney disease (CKD). However, in clinical settings, physicians and surgeons who treat such patients have few available options. We sought to further explore the safety and effectiveness of teriparatide for the treatment of osteoporosis in Japanese patients with severe stages of CKD. This was a post hoc analysis of a postmarketing surveillance study that included patients with osteoporosis at high risk of fracture and stage 4 or 5 CKD...
2016: Clinical Interventions in Aging
https://www.readbyqxmd.com/read/27894929/ultra-thin-disposable-gastroscope-for-screening-and-surveillance-of-gastroesophageal-varices-in-patients-with-liver-cirrhosis-a-prospective-comparative-study
#12
Dep K Huynh, Leanne Toscano, Vinh-An Phan, Tsai-Wing Ow, Mark Schoeman, Nam Q Nguyen
BACKGROUND AND AIMS: The study aims to evaluate the role of an unsedated, ultra-thin disposable gastroscopy (TDG) against conventional gastroscopy (CG) in screening and surveillance of gastroesophageal varices (GOVs) in patients with liver cirrhosis. METHOD: 48 patients (56.4±1.3 years; 38M:10F) with liver cirrhosis referred for screening (n=12) or surveillance (n=36) of GOVs were prospectively enrolled. Unsedated gastroscopy was initially performed with TDG (E...
November 25, 2016: Gastrointestinal Endoscopy
https://www.readbyqxmd.com/read/27894687/reprint-of-biomonitoring-of-genotoxic-effects-for-human-exposure-to-nanomaterials-the-challenge-ahead
#13
REVIEW
Laetitia Gonzalez, Micheline Kirsch-Volders
Exposures to nanomaterials (NMs), with their specific physico-chemical characteristics, are likely to increase over the next years, as their production for industrial, consumer and medical applications is steadily rising. Therefore, there is an urgent need for the implementation of human biomonitoring studies of genotoxic effects after NM exposures in order to monitor and assure safety for workers and the general population. In this review, most commonly used biomarkers of early genetic effects were analyzed for their adequacy after NM exposures...
October 2016: Mutation Research
https://www.readbyqxmd.com/read/27893129/us-emergency-department-visits-for-outpatient-adverse-drug-events-2013-2014
#14
Nadine Shehab, Maribeth C Lovegrove, Andrew I Geller, Kathleen O Rose, Nina J Weidle, Daniel S Budnitz
Importance: The Patient Protection and Affordable Care Act of 2010 brought attention to adverse drug events in national patient safety efforts. Updated, detailed, nationally representative data describing adverse drug events can help focus these efforts. Objective: To describe the characteristics of emergency department (ED) visits for adverse drug events in the United States in 2013-2014 and describe changes in ED visits for adverse drug events since 2005-2006...
November 22, 2016: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/27888959/bearing-witness-the-lived-experience-of-sitting-with-patients
#15
Rebecca Schroeder
There is abundant literature focused on the practice of using hospital sitters as part of standard patient safety care. However, minimal attention has been paid to understanding the actual experiences of hospital workers as they sit with distressed and often agitated patients. With the overwhelming number of hospitalized patients who require sitters, attention must be paid to the healthcare workers' perspective. In this study a phenomenological approach was used to elicit the perceptions of these hospital sitters...
December 2016: Archives of Psychiatric Nursing
https://www.readbyqxmd.com/read/27886039/use-of-personal-digital-assistants-to-detect-healthcare-associated-infections-in-a-neonatal-intensive-care-unit-in-egypt
#16
Elham Am El-Feky, Doa'a A Saleh, Jehan El-Kholy, Ahmed Mahmoud Sayed, Yasmeen Mansi, Mohamed Hashem
INTRODUCTION: Personal digital assistants (PDAs) used in electronic laboratory-based surveillance are a promising alternative to conventional surveillance to detect healthcare-associated infections (HAIs). The aim of the study was to monitor, detect, and analyze HAIs using PDAs in a neonatal intensive care unit (NICU). METHODOLOGY: In this descriptive study, 1,053 neonates admitted to the NICU in the obstetrics and gynecology ward at the Cairo University hospital were included and evaluated for HAIs by collecting data using PDAs programmed by Naval Medical Research Unit 3, Cairo, with the definitions for HAIs provided by the National Healthcare Safety Network of the Centers for Disease Control and Prevention...
November 24, 2016: Journal of Infection in Developing Countries
https://www.readbyqxmd.com/read/27882801/rapid-assessment-of-the-reactogenicity-of-a-2016-2017-seasonal-influenza-vaccine-results-from-a-feasibility-study
#17
Anke L Stuurman, Thomas Verstraeten, Antoon De Schryver
BACKGROUND: ​​The European Medicines Agency (EMA) calls for a strategy for enhanced safety surveillance of seasonal influenza vaccines. OBJECTIVE: We assessed the feasibility of collecting reactogenicity data within one month of the start of the vaccination campaign in Belgium. METHODS: One hundred subjects aged 18 to 65 years who had received inactivated seasonal influenza vaccine in occupational setting were enrolled. For 7 days after vaccination, subjects received a daily SMS with a link to a web-based questionnaire where reactogenicity events and their severity were solicited...
December 1, 2016: Expert Review of Vaccines
https://www.readbyqxmd.com/read/27881530/menstrual-cups-and-sanitary-pads-to-reduce-school-attrition-and-sexually-transmitted-and-reproductive-tract-infections-a-cluster-randomised-controlled-feasibility-study-in-rural-western-kenya
#18
Penelope A Phillips-Howard, Elizabeth Nyothach, Feiko O Ter Kuile, Jackton Omoto, Duolao Wang, Clement Zeh, Clayton Onyango, Linda Mason, Kelly T Alexander, Frank O Odhiambo, Alie Eleveld, Aisha Mohammed, Anna M van Eijk, Rhiannon Tudor Edwards, John Vulule, Brian Faragher, Kayla F Laserson
OBJECTIVES: Conduct a feasibility study on the effect of menstrual hygiene on schoolgirls' school and health (reproductive/sexual) outcomes. DESIGN: 3-arm single-site open cluster randomised controlled pilot study. SETTING: 30 primary schools in rural western Kenya, within a Health and Demographic Surveillance System. PARTICIPANTS: Primary schoolgirls 14-16 years, experienced 3 menses, no precluding disability, and resident in the study area...
November 23, 2016: BMJ Open
https://www.readbyqxmd.com/read/27881517/overview-of-phase-iv-clinical-trials-for-postmarket-drug-safety-surveillance-a-status-report-from-the-clinicaltrials-gov-registry
#19
Xinji Zhang, Yuan Zhang, Xiaofei Ye, Xiaojing Guo, Tianyi Zhang, Jia He
OBJECTIVE: Phase IV trials are often used to investigate drug safety after approval. However, little is known about the characteristics of contemporary phase IV clinical trials and whether these studies are of sufficient quality to advance medical knowledge in pharmacovigilance. We aimed to determine the fundamental characteristics of phase IV clinical trials that evaluated drug safety using the ClinicalTrials.gov registry data. METHODS: A data set of 19 359 phase IV clinical studies registered in ClinicalTrials...
November 23, 2016: BMJ Open
https://www.readbyqxmd.com/read/27878626/reducing-fluoroscopic-radiation-exposure-during-endomyocardial-biopsy-in-pediatric-transplant-recipients
#20
Jeffrey G Gossett, Christina L Sammet, Anya Agrawal, Karen Rychlik, David F Wax
Endomyocardial biopsy (EMB) with fluoroscopy is used for rejection surveillance in pediatric heart transplantation. Lowering frame rate may reduce radiation, but decreases temporal resolution and image quality. We undertook a quality initiative reducing frame rate from 10 frames per second (FPS) to 5 FPS. To assess whether lowering frame rate can reduce radiation exposure without compromising safety, data on EMBs from 9/2009 to 4/2013 without angiography or intervention were reviewed. Effective dose was calculated from dose area product (DAP) and fluoroscopy time...
November 23, 2016: Pediatric Cardiology
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