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Human Factors in Patient Safety

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https://www.readbyqxmd.com/read/28643113/-safety-culture-in-orthopedics-and-trauma-surgery-course-concept-interpersonal-competence-by-the-german-society-for-orthopaedics-and-trauma-dgou-and-lufthansa-aviation-training
#1
REVIEW
A-K Doepfer, R Seemann, D Merschin, R Stange, M Egerth, M Münzberg, M Mutschler, B Bouillon, R Hoffmann
Patient safety has become a central and measurable key factor in the routine daily medical practice. The human factor plays a decisive role in safety culture and has moved into focus regarding the reduction of treatment errors and undesired critical incidents. Nonetheless, the systematic training in communication and interpersonal competences has so far only played a minor role. The German Society of Orthopaedics and Trauma (DGOU) in cooperation with the Lufthansa Aviation Training initiated a course system for interpersonal competence...
June 22, 2017: Der Ophthalmologe: Zeitschrift der Deutschen Ophthalmologischen Gesellschaft
https://www.readbyqxmd.com/read/28641055/long-term-safety-evaluation-of-natalizumab-for-the-treatment-of-multiple-sclerosis
#2
Marinella Clerico, Carlo Alberto Artusi, Alessandra Di Liberto, Simona Rolla, Valentina Bardina, Pierangelo Barbero, Stefania Federica De Mercanti, Luca Durelli
Introduction Natalizumab is a humanized monoclonal antibody highly effective in relapsing-remitting multiple sclerosis (MS). Important concerns about its safety have been pointed out because of the risk of progressive multifocal leukoencephalopathy (PML), caused by the opportunistic John-Cunningham virus (JCV). Areas covered This review analyzes all the safety aspects related to the use of natalizumab in MS patients. Fatigue and allergic reactions are not-severe adverse events (AEs) occurring more frequently than placebo and no differences in serious AEs (SAE) have been observed comparing to interferon-β1a during clinical trials...
June 22, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28640389/efficacy-and-safety-of-recombinant-human-lymphotoxin-%C3%AE-derivative-with-cisplatin-and-fluorouracil-in-patients-with-metastatic-esophageal-squamous-cell-carcinoma-a-randomized-multicenter-open-label-controlled-phase-2b-trial
#3
Feng-Hua Wang, Yun Wang, Guo-Ping Sun, Jian-Hua Chen, Ying-Cheng Lin, Wei Liu, Rong-Sheng Zheng, Jia Chen, He-Long Zhang, Hai-Tao Lan, Jun Qi, Yang-Qing Liu, Yan-Ming Deng, Heng Zhao, Jian-Ping Xiong, Qing Xu, Wen-Qi Jiang, Yu-Hong Li
BACKGROUND: Recombinant human lymphotoxin-α derivative (rhLTα-Da) is a lymphotoxin-α derivative that is missing 27 N-terminal amino acid residues. Previous studies indicated a benefit from the addition of rhLTα-Da to cisplatin-based treatment in patients with metastatic esophageal squamous cell carcinoma. The current study was conducted to evaluate the efficacy and safety of rhLTα-Da plus cisplatin and fluorouracil (PF) in patients with mESCC. METHODS: Patients from 15 centers in China were randomly assigned (1:1:1) to 3 arms (arm A, PF plus 10 μg/m(2) daily rhLTα-Da; arm B, PF plus 20 μg/m(2) daily rhLTα-Da; arm C, PF alone)...
June 22, 2017: Cancer
https://www.readbyqxmd.com/read/28637800/pharmacokinetics-biodistribution-and-radiation-dosimetry-for-89-zr-trastuzumab-in-patients-with-esophagogastric-cancer
#4
Joseph A O'Donoghue, Jason S Lewis, Neeta Pandit-Taskar, Stephen E Fleming, Heiko Schoder, Steven M Larson, Volkan Beylergil, Shutian Ruan, Serge Lyashchenko, Pat B Zanzonico, Wolfgang Andreas Weber, Jorge A Carrasquillo, Yelena Y Janjigian
Trastuzumab with chemotherapy improves clinical outcomes in patients with human epidermal growth factor receptor 2 (HER2)-positive esophagogastric adenocarcinoma (EGA). Despite the therapeutic benefit, responses are rarely complete and the majority of patients develop progression. This is the first report evaluating (89)Zr-trastuzumab in HER2-positive EGA in which we evaluate the safety, pharmacokinetics, biodistribution, and dosimetry. Methods: Trastuzumab was conjugated with deferoxamine and radiolabeled with (89)Zr...
June 21, 2017: Journal of Nuclear Medicine: Official Publication, Society of Nuclear Medicine
https://www.readbyqxmd.com/read/28634748/exposure-response-relationship-of-ramucirumab-in-east-asian-patients-from-rainbow-a-randomized-clinical-trial-in-second-line-treatment-of-gastric-cancer
#5
Tae You Kim, Chia-Jui Yen, Salah-Eddin Al-Batran, David Ferry, Ling Gao, Yanzhi Hsu, Rebecca Cheng, Mauro Orlando, Atsushi Ohtsu
BACKGROUND: Ramucirumab is a recombinant human IgG1 neutralizing monoclonal antibody specific for vascular endothelial growth factor receptor-2. Second-line ramucirumab, in conjunction with paclitaxel (ramucirumab 8 mg/kg or placebo in combination with 80 mg/m(2) paclitaxel), has been shown to be effective and safe in patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma in RAINBOW, a global phase III randomized clinical trial. We conducted an exploratory exposure-response analysis of efficacy and safety of ramucirumab in East Asian patients from the RAINBOW trial...
June 20, 2017: Gastric Cancer
https://www.readbyqxmd.com/read/28628602/procoagulant-activity-of-human-mesenchymal-stem-cells
#6
Barbara A Christy, Maryanne C Herzig, Robbie K Montgomery, Christopher Delavan, James A Bynum, Kristin M Reddoch, Andrew P Cap
BACKGROUND: Allogeneic mesenchymal stem cells (MSCs) show great potential for the treatment of military and civilian trauma based on their reduced immunogenicity and ability to modulate inflammation and immune function in the recipient. Although generally considered to be safe, MSCs express tissue factor (TF), a potent activator of coagulation. In the current study, we evaluated multiple MSC populations for tissue factor expression and procoagulant activity to characterize safety considerations for systemic use of MSCs in trauma patients who may have altered coagulation homeostasis...
July 2017: Journal of Trauma and Acute Care Surgery
https://www.readbyqxmd.com/read/28625777/safety-and-tolerability-of-subcutaneous-trastuzumab-for-the-adjuvant-treatment-of-human-epidermal-growth-factor-receptor-2-positive-early-breast-cancer-safeher-phase-iii-study-s-primary-analysis-of-2573-patients
#7
J Gligorov, B Ataseven, M Verrill, M De Laurentiis, K H Jung, H A Azim, N Al-Sakaff, S Lauer, M Shing, X Pivot
AIM: To assess the safety and tolerability of adjuvant subcutaneous trastuzumab (Herceptin(®) SC, H SC), delivered from an H SC Vial via hand-held syringe (Cohort A) or single-use injection device (Cohort B), with or without chemotherapy, for human epidermal growth factor receptor 2 (HER2)-positive stage I to IIIC early breast cancer (EBC) in the phase III SafeHer study (NCT01566721). METHODS: Patients received 600 mg fixed-dose H SC every 3 weeks for 18 cycles...
June 15, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28614922/-recombinant-human-tumor-necrosis-factor-receptor-type-%C3%A2-igg-fc-fusion-protein-for-treatment-of-occupational-medicamentosa-like-dermatitis-induced-by-trichloroethylene
#8
L L Lv, Z H Yan, X Shi, R Q Liu, X Ling, S P Ji, J Zhang, P Li, Y L Cai, L L Chen, X J Chen, L X Xie, D D Lu, L Ding, Q Q Xu, Y Zhang, X W Yang, J Jing, L Ying, C P Yu, J J Chen, X D Sun
Objective: To investigate the efficacy and safety of the recombinant human tumor necrosis factor receptor Ⅱ-IgG Fc fusion protein (rhTNFR: Fc, etanercept) for the treatment of occupational medicamentosa-like dermatitis induced by trichloroethylene (OMLDT) . Methods: In September 2011 to February 2016, 12 patients with OMLDT were treated with etanercept 25 mg, subcutaneous injection, twice per week, doubling of first dose. The course of treatment was 6 weeks. The drug eruption area and severity index (DASI) score, the proportion of patients achieving a 50%, 75% and 90% reduction in DASI (DASI50, DASI75, DASI90) and the serum level of TNF-α were used to assess the efficacy at different times...
April 20, 2017: Chinese Journal of Industrial Hygiene and Occupational Diseases
https://www.readbyqxmd.com/read/28611661/discovery-and-development-of-calcium-channel-blockers
#9
REVIEW
Théophile Godfraind
In the mid 1960s, experimental work on molecules under screening as coronary dilators allowed the discovery of the mechanism of calcium entry blockade by drugs later named calcium channel blockers. This paper summarizes scientific research on these small molecules interacting directly with L-type voltage-operated calcium channels. It also reports on experimental approaches translated into understanding of their therapeutic actions. The importance of calcium in muscle contraction was discovered by Sidney Ringer who reported this fact in 1883...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28594533/implementation-of-teamstepps-in-orthopaedic-surgery
#10
Harpal S Khanuja, Zan A Naseer, Lynne C Jones, James R Ficke, Dwight W Burney Iii
An Institute of Medicine report published in 2000 brought attention to the devastating consequences of medical errors. The report estimated that 98,000 deaths occurred in US hospitals each year as a result of medical errors and spawned investigations into factors that are associated with medical errors as well as strategies to avoid them. Taking cues from high-reliability organizations, such as the airline industry, evidence-based tools were developed to minimize human risk factors and foster teamwork, communication, and other skills that are essential to patient safety and quality...
February 15, 2017: Instructional Course Lectures
https://www.readbyqxmd.com/read/28592615/a-phase-ib-dose-escalation-study-of-the-safety-tolerability-and-pharmacokinetics-of-cobimetinib-and-duligotuzumab-in-patients-with-previously-treated-locally-advanced-or-metastatic-cancers-with-mutant-kras
#11
Christopher H Lieu, Manuel Hidalgo, Jordan D Berlin, Andrew H Ko, Andres Cervantes, Patricia LoRusso, David E Gerber, J Paul Eder, S Gail Eckhardt, Amy V Kapp, Amy Tsuhako, Bruce McCall, Andrea Pirzkall, Anne Uyei, Josep Tabernero
LESSONS LEARNED: Cobimetinib and duligotuzumab were well tolerated as single agents and in combination with other agents.The cobimetinib and duligotuzumab combination was associated with increased toxicity, most notably gastrointestinal, and limited efficacy in the patient population tested. BACKGROUND: KRAS-mutant tumors possess abnormal mitogen-activated protein kinases (MAPK) pathway signaling, leading to dysregulated cell proliferation. Cobimetinib blocks MAPK signaling...
June 7, 2017: Oncologist
https://www.readbyqxmd.com/read/28588899/mechanistic-insights-into-adxs11-001-human-papillomavirus-associated-cancer-immunotherapy
#12
REVIEW
Brett A Miles, Bradley J Monk, Howard P Safran
Immune responses to the facultative intracellular bacterium Listeria monocytogenes (Lm) are robust and well characterized. Utilized for decades as a model of host-disease immunology, Lm is well suited for use as an immunotherapeutic bacterial vector for the delivery of foreign antigen. Genetic modification of Lm has been undertaken to create an attenuated organism that is deficient in its master transcriptional regulator, protein-related factor A, and incorporates a truncated, nonhemolytic version of the listeriolysin O (LLO) molecule to ensure its adjuvant properties while also preventing escape of the live organism from the phagolysosome...
2017: Gynecologic Oncology Research and Practice
https://www.readbyqxmd.com/read/28588689/safety-of-neural-stem-cell-transplantation-in-patients-with-severe-traumatic-brain-injury
#13
Zhigang Wang, Yong Luo, Lvan Chen, Wu Liang
Neural stem cell (NSC) therapy is a promising treatment for traumatic brain injury (TBI). In addition, mesenchymal stem cells (MSCs) have been investigated for the treatment of TBI due to their functions in neural regeneration and their neurotrophic effect. In the present study, the safety, feasibility and biological effects of autologous MSC-derived NSC-like cell transplantation were investigated in 10 patients with severe TBI. All patients received intravenous or intrathecal injections of human NSC-like cells and were evaluated with physical and neurological examinations, routine laboratory tests and neuroradiological findings...
June 2017: Experimental and Therapeutic Medicine
https://www.readbyqxmd.com/read/28580882/monarch-2-abemaciclib-in-combination-with-fulvestrant-in-women-with-hr-her2-advanced-breast-cancer-who-had-progressed-while-receiving-endocrine-therapy
#14
George W Sledge, Masakazu Toi, Patrick Neven, Joohyuk Sohn, Kenichi Inoue, Xavier Pivot, Olga Burdaeva, Meena Okera, Norikazu Masuda, Peter A Kaufman, Han Koh, Eva-Maria Grischke, Martin Frenzel, Yong Lin, Susana Barriga, Ian C Smith, Nawel Bourayou, Antonio Llombart-Cussac
Purpose MONARCH 2 ( ClinicalTrials.gov identifier: NCT02107703) compared the efficacy and safety of abemaciclib, a selective cyclin-dependent kinase 4 and 6 inhibitor, plus fulvestrant with fulvestrant alone in patients with advanced breast cancer (ABC). Patients and Methods MONARCH 2 was a global, double-blind, phase III study of women with hormone receptor-positive and human epidermal growth factor receptor 2-negative ABC who had progressed while receiving neoadjuvant or adjuvant endocrine therapy (ET), ≤ 12 months from the end of adjuvant ET, or while receiving first-line ET for metastatic disease...
June 3, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28579757/profile-of-sarilumab-and-its-potential-in-the-treatment-of-rheumatoid-arthritis
#15
REVIEW
Maria Gabriella Raimondo, Martina Biggioggero, Chiara Crotti, Andrea Becciolini, Ennio Giulio Favalli
In recent years the use of biotechnological agents has drastically revolutionized the therapeutic approach and the progression of rheumatoid arthritis (RA). In particular, interleukin-6 (IL-6) has been demonstrated as a pivotal cytokine in the pathogenesis of the disease by contributing to both the innate and the adaptive immune system perturbation, and to the production of acute-phase proteins involved in the systemic expression of the disorder. The first marketed IL-6 blocker was tocilizumab, a humanized anti-IL-6 receptor (anti-IL-6R) monoclonal antibody...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28576675/buparlisib-plus-fulvestrant-versus-placebo-plus-fulvestrant-in-postmenopausal-hormone-receptor-positive-her2-negative-advanced-breast-cancer-belle-2-a-randomised-double-blind-placebo-controlled-phase-3-trial
#16
José Baselga, Seock-Ah Im, Hiroji Iwata, Javier Cortés, Michele De Laurentiis, Zefei Jiang, Carlos L Arteaga, Walter Jonat, Mark Clemons, Yoshinori Ito, Ahmad Awada, Stephen Chia, Agnieszka Jagiełło-Gruszfeld, Barbara Pistilli, Ling-Ming Tseng, Sara Hurvitz, Norikazu Masuda, Masato Takahashi, Peter Vuylsteke, Soulef Hachemi, Bharani Dharan, Emmanuelle Di Tomaso, Patrick Urban, Cristian Massacesi, Mario Campone
BACKGROUND: Phosphatidylinositol 3-kinase (PI3K) pathway activation is a hallmark of endocrine therapy-resistant, hormone receptor-positive breast cancer. This phase 3 study assessed the efficacy of the pan-PI3K inhibitor buparlisib plus fulvestrant in patients with advanced breast cancer, including an evaluation of the PI3K pathway activation status as a biomarker for clinical benefit. METHODS: The BELLE-2 trial was a randomised, double-blind, placebo-controlled, multicentre study...
May 30, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28575464/phase-ii-trial-of-dacomitinib-a-pan-her-human-epidermal-growth-factor-receptor-tyrosine-kinase-inhibitor-in-recurrent-glioblastoma-patients-with-egfr-amplification
#17
Juan Manuel Sepúlveda-Sánchez, María Ángeles Vaz, Carmen Balañá, Miguel Gil-Gil, Gaspar Reynés, Óscar Gallego, María Martínez-García, Elena Vicente, María Quindós, Raquel Luque, Ana Ramos, Yolanda Ruano, Pedro Pérez-Segura, Manuel Benavides, Pilar Sánchez-Gómez, Aurelio Hernández-Laín
Background.: We conducted a multicenter, 2-stage, open-label, phase II trial to assess the efficacy and safety of dacomitinib in adult patients with recurrent glioblastoma (GB) and epidermal growth factor receptor (EGFR) gene amplification with or without EGFRvIII deletion. Methods.: Patients with first recurrence were enrolled in two cohorts: Cohort A) patients with EGFR gene amplification without EGFRvIII mutation; Cohort B) patients with EGFR gene amplification and EGFRvIII mutation...
June 1, 2017: Neuro-oncology
https://www.readbyqxmd.com/read/28575413/comprehensive-protocol-of-traceability-during-ivf-the-result-of-a-multicentre-failure-mode-and-effect-analysis
#18
L Rienzi, F Bariani, M Dalla Zorza, E Albani, F Benini, S Chamayou, M G Minasi, L Parmegiani, L Restelli, G Vizziello, A Nanni Costa
STUDY QUESTION: Can traceability of gametes and embryos be ensured during IVF? SUMMARY ANSWER: The use of a simple and comprehensive traceability system that includes the most susceptible phases during the IVF process minimizes the risk of mismatches. WHAT IS KNOWN ALREADY: Mismatches in IVF are very rare but unfortunately possible with dramatic consequences for both patients and health care professionals. Traceability is thus a fundamental aspect of the treatment...
May 31, 2017: Human Reproduction
https://www.readbyqxmd.com/read/28575273/positioning-ustekinumab-in-crohn-s-disease-from-clinical-evidence-to-clinical-practice
#19
Silvio Danese, Stefanos Bonovas, Laurent Peyrin-Biroulet
Biological medicines have revolutionized the treatment of Crohn's disease (CD). Yet, the management of patients not responding to tumor necrosis factor (TNF) antagonists remains a clinical challenge. Ustekinumab is a human monoclonal antibody blocking the biological activity of interleukins 12 and 23, which regulate the immune system and immune-mediated inflammatory disorders. It has recently been approved for the treatment of adult patients with moderately to severely active CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF antagonist, or have medical contraindications to such therapies...
June 2, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28574957/-attention-everyone-time-out-safety-attitudes-and-checklist-practices-in-anesthesiology-in-germany-a-cross-sectional-study
#20
Christopher Neuhaus, Aline Spies, Henryk Wilk, Markus A Weigand, Christoph Lichtenstern
BACKGROUND: The use of perioperative checklists has generated a growing body of evidence pointing toward reduction of mortality and morbidity, improved compliance with guidelines, reduction of adverse events, and improvements in human factor-related areas. Usual quality management metrics generally fall short in assessing compliance with their perioperative application. Our study assessed application attitudes and compliance with safety measures centered around the World Health Organization (WHO) "Safe Surgery Saves Lives" campaign as perceived by anesthesia professionals in Germany...
June 1, 2017: Journal of Patient Safety
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