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Human Factors in Patient Safety

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https://www.readbyqxmd.com/read/28720463/incidence-rates-of-guillain-barr%C3%A3-gbs-chronic-fatigue-systemic-exertion-intolerance-disease-cfs-seid-and-postural-orthostatic-tachycardia-syndrome-pots-prior-to-introduction-of-human-papilloma-virus-hpv-vaccination-among-adolescent-girls-in-finland-2002-2012
#1
J Skufca, J Ollgren, E Ruokokoski, O Lyytikäinen, H Nohynek
BACKGROUND: In Finland a vaccination programme against human papillomavirus (HPV) was introduced in November 2013 for girls aged 11-12 years with a catchup for girls 13-15 years. Allegations that HPV vaccine is causing Guillain Barré syndrome (GBS) and non-specific diagnostic entities, such as chronic fatigue syndrome/systemic exertion intolerance disease (CFS/SEID) and postural orthostatic tachycardia syndrome (POTS), continue to surface. We examined population register-based incidence rates of CFS/SEID, GBS and POTS to provide baseline data for future HPV vaccine safety evaluations...
June 2017: Papillomavirus Research
https://www.readbyqxmd.com/read/28720147/safety-and-immunogenicity-of-the-quadrivalent-human-papillomavirus-qhpv-vaccine-in-hiv-positive-spanish-men-who-have-sex-with-men-msm
#2
Carmen Hidalgo-Tenorio, Jessica Ramírez-Taboada, Concepción Gil-Anguita, Javier Esquivias, Mohamed Omar-Mohamed-Balgahata, Antonio SamPedro, Miguel Lopez-Ruz, Juan Pasquau
BACKGROUND: Safety and immunogenicity of the quadrivalent human papillomavirus (qHPV) vaccine were evaluated in HIV-positive Spanish MSM. The prevalence of High Squamous Intraepithelial Lesions (HSIL) and genotypes of high-risk human papillomavirus (HR-HPV) were also determined, as well as risk factors associated with the presence of HR-HPV in anal mucosa. METHODS: This is a randomised, double blind, placebo-controlled trial of the quadrivalent HPV (qHPV) vaccine...
July 18, 2017: AIDS Research and Therapy
https://www.readbyqxmd.com/read/28719152/a-first-in-human-phase-i-multicenter-open-label-dose-escalation-study-of-the-oral-raf-vegfr-2-inhibitor-raf265-in-locally-advanced-or-metastatic-melanoma-independent-from-braf-mutation-status
#3
Benjamin Izar, William Sharfman, F Stephen Hodi, Donald Lawrence, Keith T Flaherty, Ravi Amaravadi, Kevin B Kim, Igor Puzanov, Jeffrey Sosman, Reinhard Dummer, Simone M Goldinger, Lyhping Lam, Shefali Kakar, Zhongwen Tang, Oliver Krieter, David F McDermott, Michael B Atkins
To establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLT), safety profile, and anti-tumor efficacy of RAF265. We conducted a multicenter, open-label, phase-I, dose-escalation trial of RAF265, an orally available RAF kinase/VEGFR-2 inhibitor, in patients with advanced or metastatic melanoma. Pharmacokinetic (PK) analysis, pharmacodynamics (PD) and tumor response assessment were conducted. We evaluated metabolic tumor response by 18[F]-fluorodeoxyglucose-positron-emission tomography (FDG-PET), tissue biomarkers using immunohistochemistry (IHC), and modulators of angiogenesis...
July 18, 2017: Cancer Medicine
https://www.readbyqxmd.com/read/28713035/intracerebral-gene-therapy-in-children-with-mucopolysaccharidosis-type-iiib-syndrome-an-uncontrolled-phase-1-2-clinical-trial
#4
Marc Tardieu, Michel Zérah, Marie-Lise Gougeon, Jérome Ausseil, Stéphanie de Bournonville, Béatrice Husson, Dimitrios Zafeiriou, Giancarlo Parenti, Philippe Bourget, Béatrice Poirier, Valérie Furlan, Cécile Artaud, Thomas Baugnon, Thomas Roujeau, Ronald G Crystal, Christian Meyer, Kumaran Deiva, Jean-Michel Heard
BACKGROUND: Mucopolysaccharidosis type IIIB syndrome (also known as Sanfilippo type B syndrome) is a lysosomal storage disease resulting in progressive deterioration of cognitive acquisition after age 2-4 years. No treatment is available for the neurological manifestations of the disease. We sought to assess the safety and efficacy of a novel intracerebral gene therapy. METHODS: Local regulatory authorities in France allowed inclusion of up to four children in this phase 1/2 study...
July 13, 2017: Lancet Neurology
https://www.readbyqxmd.com/read/28711793/efficacy-and-safety-of-everolimus-and-exemestane-in-hormone-receptor-positive-hr-human-epidermal-growth-factor-negative-her2-advanced-breast-cancer-patients-new-insights-beyond-clinical-trials-the-eva-study
#5
M E Cazzaniga, M Airoldi, V Arcangeli, S Artale, F Atzori, A Ballerio, G V Bianchi, L Blasi, S Campidoglio, M Ciccarese, M C Cursano, M Piezzo, A Fabi, L Ferrari, A Ferzi, C Ficorella, A Frassoldati, A Fumagalli, O Garrone, V Gebbia, D Generali, N La Verde, M Maur, A Michelotti, G Moretti, A Musolino, R Palumbo, M Pistelli, M Porpiglia, D Sartori, C Scavelli, A Schirone, A Turletti, M R Valerio, P Vici, A Zambelli, L Clivio, V Torri
BACKGROUND: The BOLERO-2 trial reported efficacy and safety of Everolimus (EVE) and Exemestane (EXE) combination in HR+ advanced breast cancer (ABC) patients. The BALLET trial further evaluated the safety of EVE-EXE in HR+ ABC patients, without reporting efficacy data. Aim of the EVA real-life study was to collect data of efficacy and safety of EVE-EXE combination in the clinical setting, as well as exploring efficacy according to EVE Dose-Intensity (DI) and to previous treatment with Fulvestrant...
July 13, 2017: Breast: Official Journal of the European Society of Mastology
https://www.readbyqxmd.com/read/28711306/can-the-aviation-industry-be-useful-in-teaching-oncology-about-safety
#6
J M Davies, G Delaney
Healthcare practitioners have long considered aviation as a domain from which much can be learned about safety. Over the past 30 years, attempts have been made to apply aviation safety-related concepts to healthcare. Although some applications have been successful, a few decades later, many healthcare safety experts have learned that the appeal of the aviation-healthcare analogy is an illusion. Both domains are so basically dissimilar that simple adoption of aviation concepts will not be successful. However, what has succeeded is healthcare's adaptation of specific aviation safety concepts...
July 12, 2017: Clinical Oncology: a Journal of the Royal College of Radiologists
https://www.readbyqxmd.com/read/28710808/the-application-of-physiologically-based-pharmacokinetic-modelling-to-assess-the-impact-of-antiretroviral-mediated-drug-drug-interactions-on-piperaquine-antimalarial-therapy-during-pregnancy
#7
Olusola Olafuyi, Michael Coleman, Raj K S Badhan
Antimalarial therapy during pregnancy poses important safety concerns due to potential teratogenicity and maternal physiological and biochemical changes during gestation. Piperaquine (PQ) has gained interest for use in pregnancy in response to increasing resistance towards sulfadoxine-pyrimethamine in sub-Saharan Africa. Co-infection with HIV is common in many developing countries, however, little is known about the impact of anti-retroviral (ARV) mediated drug-drug interaction (DDI) on PQ pharmacokinetics during pregnancy...
July 14, 2017: Biopharmaceutics & Drug Disposition
https://www.readbyqxmd.com/read/28710747/phase-i-study-of-chimeric-antigen-receptor-modified-t-cells-in-treating-her2-positive-advanced-biliary-tract-cancers-and-pancreatic-cancers
#8
Kaichao Feng, Yang Liu, Yelei Guo, Jingdan Qiu, Zhiqiang Wu, Hanren Dai, Qingming Yang, Yao Wang, Weidong Han
This phase I clinical trial (NCT01935843) is to evaluate the safety, feasibility, and activity of chimeric antigen receptor-engineered T cell (CART) immunotherapy targeting human epidermal growth factor receptor 2 (HER2) in patients with advanced biliary tract cancers (BTCs) and pancreatic cancers (PCs). Eligible patients with HER2-positive (>50%) BTCs and PCs were enrolled in the trial. Well cultured CART-HER2 cells were infused following the conditioning treatment composed of nab-paclitaxel (100-200 mg/m(2)) and cyclophosphamide (15-35 mg/kg)...
July 14, 2017: Protein & Cell
https://www.readbyqxmd.com/read/28704187/striving-for-better-medical-education-the-simulation-approach
#9
REVIEW
Boris E Sakakushev, Blagoi I Marinov, Penka P Stefanova, Stefan St Kostianev, Evangelos K Georgiou
Medical simulation is a rapidly expanding area within medical education due to advances in technology, significant reduction in training hours and increased procedural complexity. Simulation training aims to enhance patient safety through improved technical competency and eliminating human factors in a risk free environment. It is particularly applicable to a practical, procedure-orientated specialties. Simulation can be useful for novice trainees, experienced clinicians (e.g. for revalidation) and team building...
June 1, 2017: Folia Medica
https://www.readbyqxmd.com/read/28691756/surgical-specimen-handover-from-the-operating-theatre-to-laboratory-can-we-improve-patient-safety-by-learning-from-aviation-and-other-high-risk-organisations
#10
Peter A Brennan, Marieke T Brands, Lucy Caldwell, Felipe Paiva Fonseca, Nic Turley, Susie Foley, Siavash Rahimi
Essential communication between healthcare staff is considered one of the key requirements for both safety and quality care when patients are handed over from one clinical area to other. This is particularly important in environments such as the operating theatre and intensive care where mistakes can be devastating. Healthcare has learned from other high-risk organisations (HRO) such aviation where the use of checklists and human factors awareness has virtually eliminated human error and mistakes. To our knowledge, little has been published around ways to improve pathology specimen handover following surgery, with pathology request forms often conveying the bare minimum of information to assist the laboratory staff...
July 10, 2017: Journal of Oral Pathology & Medicine
https://www.readbyqxmd.com/read/28691218/safety-of-a-pasteurized-plasma-derived-factor-viii-and-von-willebrand-factor-concentrate-analysis-of-33-years-of-pharmacovigilance-data
#11
Peter Kouides, Kathrin Wawra-Hehenberger, Anna Sajan, Henry Mead, Toby Simon
BACKGROUND: Haemate-P/Humate-P (Humate-P) is a pasteurized human plasma-derived concentrate containing both Factor VIII and von Willebrand factor for treatment of hemophilia A and von Willebrand disease (VWD). STUDY DESIGN AND METHODS: We analyzed the safety of Humate-P based on more than 33 years of postmarketing pharmacovigilance data, representing an estimated exposure of approximately 25,000 patient-years. The analysis comprises reports of potential adverse drug reactions (ADRs) from all sources, reported as part of routine pharmacovigilance at CSL Behring...
July 10, 2017: Transfusion
https://www.readbyqxmd.com/read/28682681/de-escalation-strategies-in-human-epidermal-growth-factor-receptor-2-her2-positive-early-breast-cancer-bc-final-analysis-of-the-west-german-study-group-adjuvant-dynamic-marker-adjusted-personalized-therapy-trial-optimizing-risk-assessment-and-therapy-response
#12
Nadia Harbeck, Oleg Gluz, Matthias Christgen, Ronald Ernest Kates, Michael Braun, Sherko Küemmel, Claudia Schumacher, Jochem Potenberg, Stefan Kraemer, Anke Kleine-Tebbe, Doris Augustin, Bahriye Aktas, Helmut Forstbauer, Joke Tio, Raquel von Schumann, Cornelia Liedtke, Eva-Maria Grischke, Johannes Schumacher, Rachel Wuerstlein, Hans Heinrich Kreipe, Ulrike Anneliese Nitz
Purpose Human epidermal growth factor receptor 2 (HER2)-positive/hormone receptor (HR)-positive breast cancer is a distinct subgroup associated with lower chemotherapy sensitivity and slightly better outcome than HER2-positive/HR-negative disease. Little is known about the efficacy of the combination of endocrine therapy (ET) with trastuzumab or with the potent antibody-cytotoxic, anti-HER2 compound trastuzumab emtansine (T-DM1) with or without ET for this subgroup. The West German Study Group trial, ADAPT (Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer) compares pathologic complete response (pCR) rates of T-DM1 versus trastuzumab with ET in early HER2-positive/HR-positive breast cancer...
July 6, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28681650/safety-pharmacokinetics-and-efficacy-of-e6011-an-antifractalkine-monoclonal-antibody-in-a-first-in-patient-phase-1-2-study-on-rheumatoid-arthritis
#13
Yoshiya Tanaka, Tsutomu Takeuchi, Hisanori Umehara, Toshihiro Nanki, Nobuyuki Yasuda, Fumitoshi Tago, Makoto Kawakubo, Yasumi Kitahara, Seiichiro Hojo, Tetsu Kawano, Toshio Imai
OBJECTIVE: Fractalkine (CX3CL1/FKN) is a chemokine that regulates chemotaxis and adhesion of CX3C chemokine receptor 1 (CX3CR1)-expressing inflammatory cells. We conducted the first phase 1/2, open-label, multiple ascending dose study of E6011, a humanized anti-FKN monoclonal antibody, in Japanese rheumatoid arthritis (RA) patients (clinicaltrial.gov identifier: NCT02196558). METHODS: Active RA patients with an inadequate response or intolerance to methotrexate or tumor necrosis factor (TNF) inhibitor received E6011 at week 0, 1, 2, and thereafter every 2 weeks for 12 weeks...
July 6, 2017: Modern Rheumatology
https://www.readbyqxmd.com/read/28678068/anesthesia-adverse-events-voluntarily-reported-in-the-veterans-health-administration-and-lessons-learned
#14
Julia Neily, Elda S Silla, Sam John T Sum-Ping, Roberta Reedy, Douglas E Paull, Lisa Mazzia, Peter D Mills, Robin R Hemphill
BACKGROUND: Anesthesia providers have long been pioneers in patient safety. Despite remarkable efforts, anesthesia errors still occur, resulting in complications, injuries, and even death. The Veterans Health Administration (VHA) National Center of Patient Safety uses root cause analysis (RCA) to examine why system-related adverse events occur and how to prevent future similar events. This study describes the types of anesthesia adverse events reported in VHA hospitals and their root causes and preventative actions...
July 1, 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28675553/a-combined-intervention-to-reduce-interruptions-during-medication-preparation-and-double-checking-a-pilot-study-evaluating-the-impact-of-staff-training-and-safety-vests
#15
Saskia Huckels-Baumgart, Milena Niederberger, Tanja Manser, Christoph R Meier, Carla Meyer-Massetti
AIM: The aim was to evaluate the impact of staff training and wearing safety vests as a combined intervention on interruptions during medication preparation and double-checking. BACKGROUND: Interruptions and errors during the medication process are common and an important issue for patient safety in the hospital setting. METHODS: We performed a pre- and post-intervention pilot-study using direct structured observation of 26 nurses preparing and double-checking 431 medication doses (225 pre-intervention and 206 post-intervention) for 36 patients (21 pre-intervention and 15 post-intervention)...
July 3, 2017: Journal of Nursing Management
https://www.readbyqxmd.com/read/28675291/efficacy-of-carboxymethyl-beta-glucan-in-cervical-intraepithelial-neoplasia-a-retrospective-case-control-study
#16
Patrizia Stentella, Alberto Biamonti, Carlo Carraro, Paolo Inghirami, Pasquale Mancino, Daniela Pietrangeli, Sergio Votano, Paola Lazzari, Caterina DE Medici
BACKGROUND: Persistent human papillomavirus (HPV) infection constitutes the principal risk factor for the development of cervical intraepithelial neoplasia (CIN) and cervical cancer. For this reason, new drugs have been studied to support the host immune system against the HPV infection. The aim of this retrospective, case-control study was to detect the efficacy and safety of carboxymethyl β-glucan (Colpofix®) gel as adjuvant therapy in HPV infection. METHODS: The medical records of patients attending the Colposcopy Service of four hospitals in Rome from 2011 to 2013 were collected...
October 2017: Minerva Ginecologica
https://www.readbyqxmd.com/read/28671914/assessment-of-automating-safety-surveillance-from-electronic-health-records-analysis-for-the-quality-and-safety-review-system
#17
Allan Fong, Katharine Adams, Anita Samarth, Laura McQueen, Manan Trivedi, Tahleah Chappel, Erin Grace, Susan Terrillion, Raj M Ratwani
BACKGROUND AND OBJECTIVES: In an effort to improve and standardize the collection of adverse event data, the Agency for Healthcare Research and Quality is developing and testing a patient safety surveillance system called the Quality and Safety Review System (QSRS). Its current abstraction from medical records is through manual human coders, taking an average of 75 minutes to complete the review and abstraction tasks for one patient record. With many healthcare systems across the country adopting electronic health record (EHR) technology, there is tremendous potential for more efficient abstraction by automatically populating QSRS...
June 30, 2017: Journal of Patient Safety
https://www.readbyqxmd.com/read/28671897/proactive-safety-management-in-trauma-care-applying-the-human-factors-analysis-and-classification-system
#18
Tara N Cohen, Jennifer S Cabrera, Tracy L Litzinger, Kevin A Captain, Michael A Fabian, Steven G Miles, Scott T Reeves, Scott A Shappell, Albert J Boquet
INTRODUCTION: This article examines the reliability of the Human Factors Analysis and Classification System (HFACS) for classifying observational human factors data collected prospectively in a trauma resuscitation center. METHODS: Three trained human factors analysts individually categorized 1,137 workflow disruptions identified in a previously collected data set involving 65 observed trauma care cases using the HFACS framework. RESULTS: Results revealed that the framework was substantially reliable overall (κ = 0...
June 30, 2017: Journal for Healthcare Quality: Official Publication of the National Association for Healthcare Quality
https://www.readbyqxmd.com/read/28670201/-teamwork-in-hospitals-a-quasi-experimental-study-protocol-applying-a-human-factors-approach
#19
Randi Ballangrud, Sissel Eikeland Husebø, Karina Aase, Oddveig Reiersdal Aaberg, Anne Vifladt, Geir Vegard Berg, Marie Louise Hall-Lord
BACKGROUND: Effective teamwork and sufficient communication are critical components essential to patient safety in today's specialized and complex healthcare services. Team training is important for an improved efficiency in inter-professional teamwork within hospitals, however the scientific rigor of studies must be strengthen and more research is required to compare studies across samples, settings and countries. The aims of the study are to translate and validate teamwork questionnaires and investigate healthcare personnel's perception of teamwork in hospitals (Part 1)...
2017: BMC Nursing
https://www.readbyqxmd.com/read/28668911/recognizing-the-ordinary-as-extraordinary-insight-into-the-way-we-work-to-improve-patient-safety-outcomes
#20
Elizabeth A Henneman
The Institute of Medicine (now National Academy of Medicine) reports "To Err is Human" and "Crossing the Chasm" made explicit 3 previously unappreciated realities: (1) Medical errors are common and result in serious, preventable adverse events; (2) The majority of medical errors are the result of system versus human failures; and (3) It would be impossible for any system to prevent all errors. With these realities, the role of the nurse in the "near miss" process and as the final safety net for the patient is of paramount importance...
July 2017: American Journal of Critical Care: An Official Publication, American Association of Critical-Care Nurses
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