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Human Factors in Patient Safety

N A Nixon, M B Hannouf, S Verma
Cancer therapy has evolved significantly with increased adoption of biologic agents ("biologics"). That evolution is especially true for her2 (human epidermal growth factor receptor-2)-positive breast cancer with the introduction of trastuzumab, a monoclonal antibody against the her2 receptor, which, in combination with chemotherapy, significantly improves survival in both metastatic and early disease. Although the efficacy of biologics is undeniable, their expense is a significant contributor to the increasing cost of cancer care...
June 2018: Current Oncology
Julie Polisena, Rossana Castaldo, Oriana Ciani, Carlo Federici, Simone Borsci, Matteo Ritrovato, Daniel Clark, Leandro Pecchia
OBJECTIVES: Current health technology assessment (HTA) methods guidelines for medical devices may benefit from contributions by biomedical and clinical engineers. Our study aims to: (i) review and identify gaps in the current HTA guidelines on medical devices, (ii) propose recommendations to optimize the impact of HTA for medical devices, and (iii) reach a consensus among biomedical engineers on these recommendations. METHODS: A gray literature search of HTA agency Web sites for assessment methods guidelines on devices was conducted...
June 18, 2018: International Journal of Technology Assessment in Health Care
Matthew Cardinal, Constantino Kantaridis, Tong Zhu, Pengling Sun, Debra D Pittman, John E Murphy, Steven Arkin
BACKGROUND: Tissue factor pathway inhibitor (TFPI) is a protease inhibitor of tissue factor-activated coagulation factor VII (TF-FVIIa) complex and activated factor X (FXa). PF-06741086 is a monoclonal antibody that targets TFPI to increase clotting activity. OBJECTIVES: This study was a randomized, double-blind, sponsor-open, placebo-controlled, single intravenous (IV) or subcutaneous (SC) dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-06741086...
June 16, 2018: Journal of Thrombosis and Haemostasis: JTH
Kwang Hwan Park, Seung Hwan Han, Joon Pio Hong, Seung-Kyu Han, Doo-Hyung Lee, Bom Soo Kim, Jae Hoon Ahn, Jin Woo Lee
AIMS: This study was conducted to evaluate the efficacy and safety of a novel spray-applied growth factor therapy containing recombinant human epidermal growth factor (rhEGF) for the treatment of chronic diabetic foot ulcers (DFU). METHODS: This study was a phase III double-blind, randomized, placebo-controlled trial. 167 adult patients at six medical centers were randomized to receive routine wound care plus either topical spray treatment with 0.005% rhEGF (n = 82) or an equivalent volume of saline spray (n = 85) twice a day until ulcer healing or for up to 12 weeks...
June 11, 2018: Diabetes Research and Clinical Practice
Eric Yanke, Helene Moriarty, Pascale Carayon, Nasia Safdar
OBJECTIVES: Using a novel human factors engineering approach, the Systems Engineering Initiative for Patient Safety model, we evaluated environmental service workers' (ESWs) perceptions of barriers and facilitators influencing adherence to the nationally mandated Department of Veterans Affairs Clostridium difficile infection (CDI) prevention bundle. METHODS: A focus group of ESWs was conducted. Qualitative analysis was performed employing a visual matrix display to identify barrier/facilitator themes related to Department of Veterans Affairs CDI bundle adherence using the Systems Engineering Initiative for Patient Safety work system as a framework...
June 11, 2018: Journal of Patient Safety
Atul Deodhar, Alice B Gottlieb, Wolf-Henning Boehncke, Bin Dong, Yuhua Wang, Yanli Zhuang, William Barchuk, Xie L Xu, Elizabeth C Hsia
BACKGROUND: Guselkumab, a human monoclonal antibody that binds to the p19 subunit of interleukin 23, has been approved for the treatment of moderate-to-severe psoriasis. Psoriatic arthritis is a common comorbidity of psoriasis with an umet need for novel treatments. We assessed the efficacy and safety of guselkumab in patients with active psoriatic arthritis. METHODS: We did a randomised, double-blind, placebo-controlled, phase 2a trial at 34 rheumatology and dermatology practices in Canada, Germany, Poland, Romania, Russia, Spain, and the USA...
June 2, 2018: Lancet
Hiroshi Kyono, Kayo Haraguchi, Shota Kojima, Takumi Ota, Chulho Jung, Sung Mo Yang, Sangwoo Park, Jineon So, Sunyoung Kim, Jooncheol Kwon, Suyeon Ko, Minae Yun
Etanercept is a dimeric genetic recombinant glycoprotein consisting of Fc domain of human Immunoglobulin G1 and the extracellular domain of human tumor necrosis factor (TNF) receptor type II. Etanercept exerts therapeutic effects on inflammatory diseases such as rheumatoid arthritis and juvenile idiopathic arthritis by neutralizing biological activities of TNFα/Lymphotoxin (LT) α. Mochida Pharmaceutical and LG Chem have developed syringe, pen, and vial products of Etanercept BS (biosimilar) as the first biosimilar of Enbrel in Japan...
2018: Nihon Yakurigaku Zasshi. Folia Pharmacologica Japonica
Aneurin Canham, Gyuchan Thomas Jun, Patrick Waterson, Suzanne Khalid
There is growing awareness of the limitations of current practice regarding the investigation of patient safety incidents, including a reliance on Root Cause Analysis (RCA) and a lack of safety expertise. Human Factors and Ergonomics (HFE) can offer safety expertise and systemic approaches to incident analysis. However, HFE is underutilised in healthcare. This study aims to explore the integration of HFE systemic accident analysis into current practice. The study compares the processes and outputs of a current practice RCA-based incident analysis and a Systems Theoretic Accident Modelling and Processes (STAMP) analysis on the same medication error incident...
October 2018: Applied Ergonomics
Elena Tomaselli Muensterman, James E Tisdale
Prolongation of the heart rate-corrected QT (QTc) interval increases the risk for torsades de pointes (TdP), a potentially fatal arrhythmia. The likelihood of TdP is higher in patients with risk factors, which include female sex, older age, heart failure with reduced ejection fraction, hypokalemia, hypomagnesemia, concomitant administration of ≥ 2 QTc interval-prolonging medications, among others. Assessment and quantification of risk factors may facilitate prediction of patients at highest risk for developing QTc interval prolongation and TdP...
June 8, 2018: Pharmacotherapy
Man-Chiu Poon, Roseline d'Oiron
Glanzmann's thrombasthenia (GT) and Bernard-Soulier's syndrome (BSS) are well-understood congenital bleeding disorders, showing defect/deficiency of platelet glycoprotein (GP) IIb/IIIa (integrin αIIbβ3) and GPIb-IX-V complexes respectively, with relevant clinical, laboratory, biochemical, and genetic features. Following platelet transfusion, affected patients may develop antiplatelet antibodies (to human leukocyte antigen [HLA], and/or αIIbβ3 in GT or GPIb-IX in BSS), which may render future platelet transfusion ineffective...
June 7, 2018: Seminars in Thrombosis and Hemostasis
Naoko Matsuda, Xiaoping Wang, Bora Lim, Savitri Krishnamurthy, Ricardo H Alvarez, Jie S Willey, Charla A Parker, Juhee Song, Yu Shen, Jianhua Hu, Wenhui Wu, Nan Li, Gildy V Babiera, James L Murray, Banu K Arun, Abenaa M Brewster, James M Reuben, Michael C Stauder, Chad M Barnett, Wendy A Woodward, H T Carisa Le-Petross, Anthony Lucci, Sarah M DeSnyder, Debu Tripathy, Vicente Valero, Naoto T Ueno
Importance: Combining conventional chemotherapy with targeted therapy has been proposed to improve the pathologic complete response (pCR) rate in patients with inflammatory breast cancer (IBC). Epidermal growth factor receptor (EGFR) expression is an independent predictor of low overall survival in patients with IBC. Objective: To evaluate the safety and efficacy of the anti-EGFR antibody panitumumab plus neoadjuvant chemotherapy in patients with primary human epidermal growth factor receptor 2 (HER2)-negative IBC...
June 7, 2018: JAMA Oncology
Michal Izrael, Shalom Guy Slutsky, Tamar Admoni, Louisa Cohen, Avital Granit, Arik Hasson, Joseph Itskovitz-Eldor, Lena Krush Paker, Graciela Kuperstein, Neta Lavon, Shiran Yehezkel Ionescu, Leonardo Javier Solmesky, Rachel Zaguri, Alina Zhuravlev, Ella Volman, Judith Chebath, Michel Revel
BACKGROUND: Amyotrophic lateral sclerosis (ALS) is a motor neuron (MN) disease characterized by the loss of MNs in the central nervous system. As MNs die, patients progressively lose their ability to control voluntary movements, become paralyzed and eventually die from respiratory/deglutition failure. Despite the selective MN death in ALS, there is growing evidence that malfunctional astrocytes play a crucial role in disease progression. Thus, transplantation of healthy astrocytes may compensate for the diseased astrocytes...
June 6, 2018: Stem Cell Research & Therapy
S Raso, C Hermans
The development of recombinant factor VIII (rFVIII) was initially driven by the necessity to treat hemophilia A (HA) patients with FVIII concentrates without the risk of transmitting infectious agents. Over the last three decades the safety of rFVIII has been further improved by completely removing animal or human proteins from the manufacturing process, so that patients would not be exposed to known or emerging pathogens. Recent efforts have concentrated on improving the expression of rFVIII, reducing its immunogenicity and enhancing its pharmacokinetic (PK) behavior...
April 2018: Drugs of Today
Klaus Kucher, Donald Johns, Doris Maier, Rainer Abel, Andreas Badke, Hagen Baron, Roland Thietje, Steven Casha, Renate Meindl, Baltazar Gomez-Mancilla, Christian Pfister, Rüdiger Rupp, Norbert Weidner, Anis Mir, Martin E Schwab, Armin Curt
BACKGROUND: Neutralization of central nervous system neurite growth inhibitory factors, for example, Nogo-A, is a promising approach to improving recovery following spinal cord injury (SCI). In animal SCI models, intrathecal delivery of anti-Nogo-A antibodies promoted regenerative neurite growth and functional recovery. OBJECTIVE: This first-in-man study assessed the feasibility, safety, tolerability, pharmacokinetics, and preliminary efficacy of the human anti-Nogo-A antibody ATI355 following intrathecal administration in patients with acute, complete traumatic paraplegia and tetraplegia...
May 1, 2018: Neurorehabilitation and Neural Repair
Guy Jerusalem, Richard H de Boer, Sara Hurvitz, Denise A Yardley, Elena Kovalenko, Bent Ejlertsen, Sibel Blau, Mustafa Özgüroglu, László Landherr, Marianne Ewertz, Tetiana Taran, Jenna Fan, Florence Noel-Baron, Anne-Laure Louveau, Howard Burris
Importance: Everolimus plus exemestane and capecitabine are approved second-line therapies for advanced breast cancer. Objective: A postapproval commitment to health authorities to estimate the clinical benefit of everolimus plus exemestane vs everolimus or capecitabine monotherapy for estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. Design: Open-label, randomized, phase 2 trial of treatment effects in postmenopausal women with advanced breast cancer that had progressed during treatment with nonsteroidal aromatase inhibitors...
June 3, 2018: JAMA Oncology
Dennis J Slamon, Patrick Neven, Stephen Chia, Peter A Fasching, Michelino De Laurentiis, Seock-Ah Im, Katarina Petrakova, Giulia Val Bianchi, Francisco J Esteva, Miguel Martín, Arnd Nusch, Gabe S Sonke, Luis De la Cruz-Merino, J Thaddeus Beck, Xavier Pivot, Gena Vidam, Yingbo Wang, Karen Rodriguez Lorenc, Michelle Miller, Tetiana Taran, Guy Jerusalem
Purpose This phase III study evaluated ribociclib plus fulvestrant in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer who were treatment naïve or had received up to one line of prior endocrine therapy in the advanced setting. Patients and Methods Patients were randomly assigned at a two-to-one ratio to ribociclib plus fulvestrant or placebo plus fulvestrant. The primary end point was locally assessed progression-free survival. Secondary end points included overall survival, overall response rate, and safety...
June 3, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Heikki Joensuu, Judith Fraser, Hans Wildiers, Riikka Huovinen, Päivi Auvinen, Meri Utriainen, Paul Nyandoto, Kenneth K Villman, Päivi Halonen, Helena Granstam-Björneklett, Lotta Lundgren, Liisa Sailas, Taina Turpeenniemi-Hujanen, Minna Tanner, Jeffrey Yachnin, Diana Ritchie, Oskar Johansson, Teppo Huttunen, Patrick Neven, Peter Canney, Vernon J Harvey, Pirkko-Liisa Kellokumpu-Lehtinen, Henrik Lindman
Importance: Trastuzumab plus chemotherapy is the standard adjuvant treatment for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. While the standard duration of trastuzumab treatment is 12 months, the benefits and harms of trastuzumab continued beyond the chemotherapy are unclear. Objective: To evaluate the efficacy and safety of adjuvant trastuzumab continued beyond chemotherapy in women treated with up-front chemotherapy containing a taxane and trastuzumab...
May 31, 2018: JAMA Oncology
Fatemeh Faraji, Zahra Karjoo, Maryam Vakili Moghaddam, Sahel Heidari, Reza Zolfaghari Emameh, Reza Falak
Immune response elicited by therapeutic proteins is an important safety and efficacy issue for regulatory agencies, drug manufacturers, clinicians, and patients. Administration of therapeutic proteins can potentially induce the production of anti-drug antibodies or cell-mediated immune responses. At first, it was speculated that the immunogenicity is related to the non-human origin of these proteins. Later on, it was confirmed that the human proteins may also show immunogenicity. In this review article, we will focus on a number of factors, which play crucial roles in the human protein immunogenicity...
May 31, 2018: International Reviews of Immunology
Wolfgang Jelkmann
PURPOSE OF REVIEW: Sotatercept and luspatercept are recombinant soluble activin type-II receptor-IgG-Fc fusion proteins that are tested in clinical trials for the treatment of various types of anemias, including renal anemia. The mechanism of the action of the novel drugs is incompletely understood, but it seems to be based on the inactivation of soluble proteins of the transforming growth factor-ß (TGFß) family. This review considers pros and cons of the clinical use of the drugs in reference to the current therapy with recombinant erythropoiesis-stimulating agents (ESAs)...
May 29, 2018: Current Opinion in Nephrology and Hypertension
Tadashi Kamio, Ken Masamune
BACKGROUND: Although the ICU is the most appropriate place to care for mechanically ventilated patients, a considerable number are ventilated in general medical care wards all over the world. However, adverse events focusing on mechanically ventilated patients in general care have not been explored. METHODS: Data from the Japan Council for Quality Health Care database were analyzed. Patient safety incidents from January 2010 to November 2017 regarding mechanical ventilation were collected, and comparisons of patient safety incidents between ICUs/high care units (HCUs) and general care wards were made...
May 29, 2018: Respiratory Care
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