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Safety surveillance

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https://www.readbyqxmd.com/read/28748367/commercial-online-social-network-data-and-statin-side-effect-surveillance-a-pilot-observational-study-of-aggregate-mentions-on-facebook
#1
Marco D Huesch
INTRODUCTION: Surveillance of the safety of prescribed drugs after marketing approval has been secured remains fraught with complications. Formal ascertainment by providers and reporting to adverse-event registries, formal surveys by manufacturers, and mining of electronic medical records are all well-known approaches with varying degrees of difficulty, cost, and success. Novel approaches may be a useful adjunct, especially approaches that mine or sample internet-based methods such as online social networks...
July 26, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28747607/safety-and-effectiveness-of-certolizumab-pegol-in-patients-with-rheumatoid-arthritis-interim-analysis-of-post-marketing-surveillance
#2
Hideto Kameda, Keiichiro Nishida, Toshihiro Nannki, Akira Watanabe, Yukiya Oshima, Shigaki Momohara
  Objective: To evaluate the safety and effectiveness of certolizumab pegol (CZP) in a real-world setting among Japanese patients with rheumatoid arthritis. METHODS: Post-marketing surveillance data from 2,579 patients treated with CZP were analyzed. Adverse events (AEs) observed during the 24-week CZP treatment period were recorded. Disease activity was evaluated using DAS28-ESR and DAS28-CRP at baseline, Week 12, Week 24, or at withdrawal. RESULTS: The total period of exposure to CZP was 1313...
2017: Nihon Rinshō Men'eki Gakkai Kaishi, Japanese Journal of Clinical Immunology
https://www.readbyqxmd.com/read/28747134/reporting-medical-device-safety-incidents-to-regulatory-authorities-an-analysis-and-classification-of-technology-induced-errors
#3
Sari Palojoki, Kaija Saranto, Lasse Lehtonen
The European Union Medical Device Directive 2007/47/EC1 defines software with a medical purpose as a medical device. The implementation of health information technology suffers from patient safety problems that require effective post-market surveillance. The purpose of this study was to review, classify and discuss the incident data submitted to a nationwide database of the Finnish National Competent Authority with other forms of data. We analysed incident reports submitted to the authority database by users of electronic health records from 2010 to 2015...
July 1, 2017: Health Informatics Journal
https://www.readbyqxmd.com/read/28741382/sodium-glucose-co-transporter-2-inhibitor-luseogliflozin-in-the-management-of-type-2-diabetes-a-drug-safety-evaluation
#4
Daisuke Yabe, Yoshiyuki Hamamoto, Yusuke Seino, Hitoshi Kuwata, Takeshi Kurose, Yutaka Seino
Sodium glucose co-transporter-2 (SGLT2) inhibitors have been developed recently as a new class of anti-diabetic drug, and are becoming widely used in the management of type 2 diabetes (T2D). As these agents have a considerably different glucose-lowering mechanism from those of other anti-diabetic drugs, safe use of this drug class needs to be discussed based on data available from preapproval clinical trials as well as real-world studies. The SGLT2 inhibitor luseogliflozin was developed by Taisho Pharmaceutical Co...
July 25, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28741377/renal-cell-carcinoma-alternative-nephron-sparing-treatment-options-for-small-renal-masses-a-systematic-review
#5
Fieke M Prins, Linda G W Kerkmeijer, Anne A Pronk, Evert-Jan P A Vonken, Richard P Meijer, Axel Bex, Maurits M Barendrecht
<i>Background</i> The standard treatment of T1 renal cell carcinoma is (partial-) nephrectomy. For patients where surgery is not the treatment of choice, for example in the elderly, in case of severe comorbidity, inoperability or refusal of surgery, alternative treatment options are available. These treatment options include active surveillance, radiofrequency ablation, cryoablation, microwave ablation or stereotactic body radiotherapy. In the present overview, the efficacy, safety and outcome of these different options are summarized, particularly focusing on recent developments...
July 25, 2017: Journal of Endourology
https://www.readbyqxmd.com/read/28739492/efficacy-and-safety-of-citalopram-compared-to-atypical-antipsychotics-on-agitation-in-nursing-home-residents-with-alzheimer-dementia
#6
Giovanni Viscogliosi, Iulia Maria Chiriac, Evaristo Ettorre
OBJECTIVE: To assess efficacy and safety of citalopram compared to quetiapine and olanzapine for the treatment of agitation in patients with Alzheimer disease (AD). DESIGN: Longitudinal, 6-month study. SETTING: Nursing home (NH). PARTICIPANTS: 75 NH residents with AD and agitation, randomized to citalopram (n = 25), quetiapine (n = 25), or olanzapine (n = 25). MEASUREMENTS: Changes in Neuropsychiatric Inventory (NPI) agitation subscale score and the modified Alzheimer Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC) were used to assess treatment efficacy...
July 21, 2017: Journal of the American Medical Directors Association
https://www.readbyqxmd.com/read/28738046/safety-culture-establishing-processes-to-support-trust-and-accountability-for-risk-reduction-%C3%A2
#7
Tracy Wyant
Oncology nurses are tasked with developing skills that enable vigilant risk surveillance through situational awareness. However, care distractions, task interruptions, increased workloads, and time constraints are common challenges that compete with the ability to provide optimal safe care. A commitment to safety is a professional and organizational expectation, and being empowered to overcome safety-related challenges necessitates multilevel and interprofessional accountability.
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August 1, 2017: Clinical Journal of Oncology Nursing
https://www.readbyqxmd.com/read/28736649/neoadjuvant-transarterial-radiation-lobectomy-for-colorectal-hepatic-metastases-a-small-cohort-analysis-on-safety-efficacy-and-radiopathologic-correlation
#8
Jehan L Shah, Ivan R Zendejas-Ruiz, Linday M Thornton, Brian S Geller, Joseph R Grajo, Amy Collinsworth, Thomas J George, Beau Toskich
Colorectal cancer patients have a high incidence of liver metastasis (ml-CRC). Surgical resection is the gold standard for treatment of hepatic metastasis but only a small percent of patients are traditional candidates based on disease extent and adequate size of the future liver remnant (FLR). Interventions such as portal vein embolization (PVE) and associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) are performed to increase FLR for operative conversion. Limitations to PVE include intrahepatic disease progression, portal vascular invasion, and utilization with concurrent chemotherapy...
June 2017: Journal of Gastrointestinal Oncology
https://www.readbyqxmd.com/read/28736032/central-line-associated-bloodstream-infection-rate-elevation-attributable-to-national-healthcare-safety-network-surveillance-definition-changes-ongoing-opportunities-for-infection-prevention-or-both
#9
Andrew Corley, Maggie Cantara, Julia Gardner, Polly Trexler, Clare Rock, Lisa L Maragakis
Calendar year 2015 intensive care unit (ICU) central line-associated bloodstream infections (CLABSIs) from 1 hospital were reviewed using 2014 CLABSI surveillance definitions to assess the relative impact of definition changes and infection control practices on CLABSI rates. Increased ICU primary CLABSI rates were found to be a result of both surveillance definition changes and infection control practices.
July 20, 2017: American Journal of Infection Control
https://www.readbyqxmd.com/read/28735777/heroin-and-fentanyl-overdoses-in-kentucky-epidemiology-and-surveillance
#10
Svetla Slavova, Julia F Costich, Terry L Bunn, Huong Luu, Michael Singleton, Sarah L Hargrove, Jeremy S Triplett, Dana Quesinberry, William Ralston, Van Ingram
BACKGROUND: The study aims to describe recent changes in Kentucky's drug overdose trends related to increased heroin and fentanyl involvement, and to discuss future directions for improved drug overdose surveillance. METHODS: The study used multiple data sources (death certificates, postmortem toxicology results, emergency department [ED] records, law enforcement drug submissions, and prescription drug monitoring records) to describe temporal, geographic, and demographic changes in drug overdoses in Kentucky...
June 27, 2017: International Journal on Drug Policy
https://www.readbyqxmd.com/read/28734773/epico-4-0-total-quality-in-the-management-of-invasive-candidiasis-in-critically-ill-patients-by-analysing-the-integrated-process
#11
Rafael Zaragoza, Ricard Ferrer, Pedro Llinares, Emilio Maseda, Alejandro Rodríguez, Santiago Grau, Guillermo Quindós
BACKGROUND: A high quality integrated process in the clinical setting of non-neutropenic critically ill patients at risk for invasive candidiasis is a necessary tool to improve the management of these patients. AIMS: To identify the key points on invasive candidiasis in order to develop a set of recommendations with a high level of consensus required for the creation of a total quality integrated process for the management of non-neutropenic critically ill patients at risk of invasive candidiasis...
July 19, 2017: Revista Iberoamericana de Micología
https://www.readbyqxmd.com/read/28731889/stent-thrombosis-with-bioabsorbable-polymer-drug-eluting-stents-insights-from-the-food-and-drug-administration-database
#12
Abdur R Khan, Avnish Tripathi, Talha A Farid, Bilal Abaid, Deepak L Bhatt, Jon R Resar, Michael P Flaherty
BACKGROUND: SYNERGY, a bioabsorbable polymer-based, everolimus-eluting stent (BP-DES), recently received regulatory approval in the USA for use in percutaneous coronary interventions. Yet, information on the safety of BP-DES in routine clinical practice is limited. Our aim was to compare the safety of the recently approved BP-DES with current durable polymer drug-eluting stents (DP-DES) by analyzing adverse events, namely, stent thrombosis (ST), reported to the Manufacturer and User Facility Device Experience (MAUDE) database...
July 20, 2017: Coronary Artery Disease
https://www.readbyqxmd.com/read/28730722/metagenome-based-surveillance-and-diagnostic-approaches-to-studying-the-microbial-ecology-of-food-production-and-processing-environments
#13
Conor J Doyle, Paul W O'Toole, Paul D Cotter
Metagenomic-based analyses have the potential to revolutionise our understanding of the microbiology of food production and processing environments. By adopting such approaches it will be possible to more accurately determine sources of microbial contamination, identify critical control points for such contaminants, and select practices that optimise quality and safety. This mini-review will discuss the merits of adopting metagenostic-based approaches, highlight novel insights that they have provided to date and consider how they could be further implemented...
July 20, 2017: Environmental Microbiology
https://www.readbyqxmd.com/read/28726115/the-impact-of-coronary-calcification-on-angiographic-and-3-year-clinical-outcomes-of-everolimus-eluting-stents-results-of-a-xience-v-promus-post-marketing-surveillance-study
#14
Nobuo Shiode, Ken Kozuma, Jiro Aoki, Masaki Awata, Mamoru Nanasato, Kengo Tanabe, Junichi Yamaguchi, Hajime Kusano, Hong Nie, Takeshi Kimura
Coronary calcification (CCA) is one of the independent predictors for major adverse cardiac events (MACEs) in coronary intervention. Post-marketing surveillance study Japan is a prospective registry designed to evaluate the safety and efficacy of the everolimus-eluting stent (EES, XIENCE V/PROMUS Stent) in routine clinical practice at 47 centers. In this study, 1848 lesions (1546 patients) were assessed using quantitative coronary angiography. In these 1546 patients, renal function data were unknown in 26 patients...
July 19, 2017: Cardiovascular Intervention and Therapeutics
https://www.readbyqxmd.com/read/28725217/metagenomics-the-next-culture-independent-game-changer
#15
REVIEW
Jessica D Forbes, Natalie C Knox, Jennifer Ronholm, Franco Pagotto, Aleisha Reimer
A trend towards the abandonment of obtaining pure culture isolates in frontline laboratories is at a crossroads with the ability of public health agencies to perform their basic mandate of foodborne disease surveillance and response. The implementation of culture-independent diagnostic tests (CIDTs) including nucleic acid and antigen-based assays for acute gastroenteritis is leaving public health agencies without laboratory evidence to link clinical cases to each other and to food or environmental substances...
2017: Frontiers in Microbiology
https://www.readbyqxmd.com/read/28722500/post-marketing-surveillance-study-of-the-long-term-use-of-mizoribine-for-the-treatment-of-lupus-nephritis-2-year-results
#16
Tsutomu Takeuchi, Kenya Okada, Hisao Yoshida, Nobuyuki Yagi
OBJECTIVES: To understand the status of mizoribine use in patients with lupus nephritis (LN) and to collect safety- and efficacy-related data on 2-year treatment with mizoribine. METHODS: A continuous survey was conducted between March 2010 and July 2015. RESULTS: The analysis set included 559 patients (mean age 39.5 years, females 82.6%, mean duration of systemic lupus erythematosus (SLE) 8.4 years, mean duration of LN 5.9 years). Renal function was satisfactory for 6 months, but worsened from 12 months, with significant worsening at 24 months...
July 19, 2017: Modern Rheumatology
https://www.readbyqxmd.com/read/28720612/translating-staff-experience-into-organisational-improvement-the-heads-up-stepped-wedge-cluster-controlled-non-randomised-trial
#17
Samuel Pannick, Thanos Athanasiou, Susannah J Long, Iain Beveridge, Nick Sevdalis
OBJECTIVES: Frontline insights into care delivery correlate with patients' clinical outcomes. These outcomes might be improved through near-real time identification and mitigation of staff concerns. We evaluated the effects of a prospective frontline surveillance system on patient and team outcomes. DESIGN: Prospective, stepped wedge, non-randomised, cluster controlled trial; prespecified per protocol analysis for high-fidelity intervention delivery. PARTICIPANTS: Seven interdisciplinary medical ward teams from two hospitals in the UK...
July 18, 2017: BMJ Open
https://www.readbyqxmd.com/read/28707992/transitional-care-services-a-quality-and-safety-process-improvement-program-in-neurosurgery
#18
Faith C Robertson, Jessica L Logsdon, Hormuzdiyar H Dasenbrock, Sandra C Yan, Siobhan M Raftery, Timothy R Smith, William B Gormley
OBJECTIVE Readmissions increasingly serve as a metric of hospital performance, inviting quality improvement initiatives in both medicine and surgery. However, few readmission reduction programs have targeted surgical patient populations. The objective of this study was to establish a transitional care program (TCP) with the goal of decreasing length of stay (LOS), improving discharge efficiency, and reducing readmissions of neurosurgical patients by optimizing patient education and postdischarge surveillance...
July 14, 2017: Journal of Neurosurgery
https://www.readbyqxmd.com/read/28704818/active-surveillance-cultures-and-targeted-decolonization-are-associated-with-reduced-methicillin-susceptible-staphylococcus-aureus-infections-in-vlbw-infants
#19
Lukas Wisgrill, Johanna Zizka, Lukas Unterasinger, Judith Rittenschober-Böhm, Thomas Waldhör, Athanasios Makristathis, Angelika Berger
BACKGROUND: Methicillin-susceptible Staphylococcus aureus (MSSA) is a major contributor to infectious episodes of very low birth weight infants (VLBWI), resulting in significant morbidity and mortality. OBJECTIVE: To examine the efficacy and safety of surveillance cultures and the decolonization of MSSA-colonized VLBWI. METHODS: VLBWI admitted to our neonatal wards in 2011-2016 were retrospectively analyzed. Rates of MSSA-attributable infections were compared before and after the implementation of active surveillance cultures and the decolonization of MSSA-colonized patients...
July 14, 2017: Neonatology
https://www.readbyqxmd.com/read/28704346/mortality-from-amyotrophic-lateral-sclerosis-and-parkinson-s-disease-among-different-occupation-groups-united-states-1985-2011
#20
John D Beard, Andrea L Steege, Jun Ju, John Lu, Sara E Luckhaupt, Mary K Schubauer-Berigan
Amyotrophic lateral sclerosis (ALS) and Parkinson's disease, both progressive neurodegenerative diseases, affect >1 million Americans (1,2). Consistently reported risk factors for ALS include increasing age, male sex, and cigarette smoking (1); risk factors for Parkinson's disease include increasing age, male sex, and pesticide exposure, whereas cigarette smoking and caffeine consumption are inversely associated (2). Relative to cancer or respiratory diseases, the role of occupation in neurologic diseases is much less studied and less well understood (3)...
July 14, 2017: MMWR. Morbidity and Mortality Weekly Report
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