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Human Factors in Patient Safety

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https://www.readbyqxmd.com/read/28335630/the-design-prototyping-and-formative-evaluation-of-an-assistive-robotic-table-art-for-stroke-patients
#1
Anthony L Threatt, Jessica Merino, Johnell O Brooks, Stan Healy, Constance Truesdail, Joseph Manganelli, Ian Walker, Keith Evan Green
OBJECTIVE: This article presents the results of an exploratory study in which 14 healthcare subject matter experts (H-SMEs) in addition to four research and design subject matter experts (RD-SMEs) at a regional rehabilitation hospital engaged in a series of complementary, participatory activities in order to design an assistive robotic table (ART). BACKGROUND: As designers, human factor experts, and healthcare professionals continue to work to integrate assistive human-robot technologies in healthcare, it is imperative to understand how the technology affects patient care from clinicians' perspectives...
April 2017: HERD
https://www.readbyqxmd.com/read/28328728/crew-resource-management-in-the-trauma-room-a-prospective-3-year-cohort-study
#2
Marck H T M Haerkens, Matthijs Kox, Pieter M Noe, Johannes G Van Der Hoeven, Peter Pickkers
OBJECTIVE: Human factors account for the majority of adverse events. Human factors awareness training entitled Crew Resource Management (CRM) is associated with improved safety and reduced complications and mortality in critically ill patients. We determined the effects of CRM implementation in the trauma room of an Emergency Department (ED). PATIENTS AND METHODS: A prospective 3-year cohort study was carried out in a level 1 ED, admitting more than 12 000 patients annually (>1500 trauma related)...
March 21, 2017: European Journal of Emergency Medicine: Official Journal of the European Society for Emergency Medicine
https://www.readbyqxmd.com/read/28315060/results-of-a-phase-ib-trial-of-combination-immunotherapy-with-a-cd8-%C3%A2-t-cell-eliciting-vaccine-and-trastuzumab-in-breast-cancer-patients
#3
G Travis Clifton, Jennifer K Litton, Karen Arrington, Sathibalan Ponniah, Nuhad K Ibrahim, Victor Gall, Gheath Alatrash, George E Peoples, Elizabeth A Mittendorf
BACKGROUND: CD8+ T cell-eliciting vaccines are being investigated in breast cancer patients. Preclinical data showed that trastuzumab increases the susceptibility of tumor cells to lysis by vaccine-generated CD8+ T cells, suggesting potential benefit of a combination immunotherapy strategy. The current trial was undertaken to demonstrate the safety of this approach. METHODS: This study was designed as a dose-escalation trial enrolling clinically disease-free, human leukocyte antigen A2+ or A3+ , human epidermal growth factor receptor 2 (HER2)-positive breast cancer patients...
March 17, 2017: Annals of Surgical Oncology
https://www.readbyqxmd.com/read/28314310/first-line-bevacizumab-and-paclitaxel-for-her2-negative-metastatic-breast-cancer-a-french-retrospective-observational-study
#4
Veronique Dieras, Simona Pop, Frederique Berger, Marie-Eglantine Dujaric, Philippe Beuzeboc, Laurence Escalup, François Clement Bidard, Paul Henri Cottu, Christophe LE Tourneau, Sophie Piperno-Neumann, Valerie Laurence, Mathieu Robain, Bernard Asselain, Jean-Yves Pierga
AIM: To assess outcomes in patients treated with first-line bevacizumab-containing therapy for human epidermal growth factor receptor (HER)2-negative metastatic breast cancer (mBC) at a single centre with a homogenous standard-of-care. PATIENTS AND METHODS: Information on patient and disease characteristics, efficacy, and safety was extracted from computer-based records of all patients receiving first-line bevacizumab-paclitaxel at the Curie Institute, Paris, France, between 2008 and 2011...
March 2017: Anticancer Research
https://www.readbyqxmd.com/read/28306384/the-dichotomy-of-the-application-of-a-systems-approach-in-uk-healthcare-the-challenges-and-priorities-for-implementation
#5
Laura Pickup, Alexandra Lang, Sarah Atkinson, Sarah Sharples
There is increasing demand for a systems approach within national healthcare guidelines to provide a systematic and sustainable framework for improvements in patient safety. Supported by this is the growing body of evidence within Human Factors/Ergonomics (HFE) healthcare literature for the inclusion of this approach in health service design, provision and evaluation. This paper considers the current interpretation of this within UK healthcare systems and the dichotomy which exists in the challenge to implement a systems approach...
March 17, 2017: Ergonomics
https://www.readbyqxmd.com/read/28303724/non-alcoholic-fatty-liver-disease-nafld-pathogenesis-classification-and-effect-on-drug-metabolizing-enzymes-and-transporters
#6
Enoch Cobbina, Fatemeh Akhlaghi
Non-alcoholic fatty liver disease (NAFLD) is a spectrum of liver disorders. It is defined by the presence of steatosis in more than 5% of hepatocytes with little or no alcohol consumption. Insulin resistance, the metabolic syndrome or type 2 diabetes and genetic variants of PNPLA3 or TM6SF2 seem to play a role in the pathogenesis of NAFLD. The pathological progression of NAFLD follows tentatively a "three-hit" process namely steatosis, lipotoxicity and inflammation. The presence of steatosis, oxidative stress and inflammatory mediators like TNF-α and IL-6 has been implicated in the alterations of nuclear factors such as CAR, PXR, PPAR-α in NAFLD...
March 17, 2017: Drug Metabolism Reviews
https://www.readbyqxmd.com/read/28296464/classifying-alarms-seeking-durability-credibility-consistency-and-simplicity
#7
Judy Reed Edworthy, Joseph J Schlesinger, Richard R McNeer, Michael Sonne Kristensen, Christopher L Bennett
Alongside the development and testing of new audible alarms intended to support International Electrotechnical Commission 60601-1-8, a global standard concerned with alarm safety, the categories of risk that the standard denotes require further thought and possible updating. In this article, we revisit the origins of the categories covered by the standard. These categories were based on the ways that tissue damage can be caused. We consider these categories from the varied professional perspectives of the authors: human factors, semiotics, clinical practice, and the patient or family (layperson)...
February 2017: Biomedical Instrumentation & Technology
https://www.readbyqxmd.com/read/28279187/pulp-regeneration-by-transplantation-of-dental-pulp-stem-cells-in-pulpitis-a-pilot-clinical-study
#8
Misako Nakashima, Koichiro Iohara, Masashi Murakami, Hiroshi Nakamura, Yayoi Sato, Yoshiko Ariji, Kenji Matsushita
BACKGROUND: Experiments have previously demonstrated the therapeutic potential of mobilized dental pulp stem cells (MDPSCs) for complete pulp regeneration. The aim of the present pilot clinical study is to assess the safety, potential efficacy, and feasibility of autologous transplantation of MDPSCs in pulpectomized teeth. METHODS: Five patients with irreversible pulpitis were enrolled and monitored for up to 24 weeks following MDPSC transplantation. The MDPSCs were isolated from discarded teeth and expanded based on good manufacturing practice (GMP)...
March 9, 2017: Stem Cell Research & Therapy
https://www.readbyqxmd.com/read/28277160/production-of-recombinant-coagulation-factors-are-humans-the-best-host-cells
#9
Kamilla Swiech, Virgínia Picanço-Castro, Dimas Tadeu Covas
The main treatment option for Hemophilia A/B patients involves the administration of recombinant coagulation factors on-demand or in a prophylactic approach. Despite the safety and efficacy of this replacement therapy, the development of antibodies against the coagulation factor infused, which neutralize the procoagulant activity, is a severe complication. The production of recombinant coagulation factors in human cell lines is an efficient approach to avoid such complication. Human cell lines can produce recombinant proteins with post translation modifications more similar to their natural counterpart, reducing potential immunogenic reactions...
February 23, 2017: Bioengineered
https://www.readbyqxmd.com/read/28276855/the-safety-of-vedolizumab-for-the-treatment-of-ulcerative-colitis
#10
Gregor Novak, Pieter Hindryckx, Reena Khanna, Vipul Jairath, Brian G Feagan
Vedolizumab is a humanized monoclonal antibody to the α4β7-integrin that blocks lymphocyte trafficking to the gut and is approved for treatment of patients with moderate-to-severe ulcerative colitis (UC). The gut-selective mechanism of action has the potential to improve vedolizumab's safety profile compared to other approved biologic drugs. Areas covered: We review the mechanism of action, efficacy and safety of vedolizumab treatment for UC. The positioning of vedolizumab in management algorithms is also discussed...
March 5, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28272293/barriers-and-facilitators-of-adverse-event-reporting-by-adolescent-patients-and-their-families
#11
Payal Naresh Sawhney, Linda Sue Davis, Nancy M Daraiseh, Lisa Belle, Kathleen E Walsh
OBJECTIVES: The objectives were (1) to describe barriers and facilitators of adverse event reporting by adolescent patients and parents in a pediatric hospital and (2) to identify characteristics the participants wished to have in a formal reporting system of adverse events. METHODS: We used a qualitative design in which 6 focus groups, 3 with parents and 3 with adolescents, were conducted. The transcripts of audio recordings, notes of team debriefings, and written field notes of group behaviors were analyzed using NVivo software for qualitative data analysis...
March 7, 2017: Journal of Patient Safety
https://www.readbyqxmd.com/read/28265716/don-t-stress-about-crf-assessing-the-translational-failures-of-crf1antagonists
#12
REVIEW
Samantha R Spierling, Eric P Zorrilla
BACKGROUND: Dr. Athina Markou sought treatments for a common neural substrate shared by depression and drug dependence. Antagonists of corticotropin-releasing factor (CRF) receptors, a target of interest to her, have not reached the clinic despite strong preclinical rationale and sustained translational efforts. METHODS: We explore potential causes for the failure of CRF1 antagonists and review recent findings concerning CRF-CRF1 systems in psychopathology. RESULTS: Potential causes for negative outcomes include (1) poor safety and efficacy of initial drug candidates due to bad pharmacokinetic and physicochemical properties, (2) specificity problems with preclinical screens, (3) the acute nature of screens vs...
March 7, 2017: Psychopharmacology
https://www.readbyqxmd.com/read/28257340/first-in-human-ultrasound-molecular-imaging-with-a-vegfr2-specific-ultrasound-molecular-contrast-agent-br55-in-prostate-cancer-a-safety-and-feasibility-pilot-study
#13
Martijn Smeenge, François Tranquart, Christophe K Mannaerts, Theo M de Reijke, Marc J van de Vijver, M Pilar Laguna, Sibylle Pochon, Jean J M C H de la Rosette, Hessel Wijkstra
OBJECTIVE: BR55, a vascular endothelial growth factor receptor 2 (VEGFR2)-specific ultrasound molecular contrast agent (MCA), has shown promising results in multiple preclinical models regarding cancer imaging. In this first-in-human, phase 0, exploratory study, we investigated the feasibility and safety of the MCA for the detection of prostate cancer (PCa) in men using clinical standard technology. MATERIALS AND METHODS: Imaging with the MCA was performed in 24 patients with biopsy-proven PCa scheduled for radical prostatectomy using a clinical ultrasound scanner at low acoustic power...
March 2, 2017: Investigative Radiology
https://www.readbyqxmd.com/read/28257288/root-cause-analyses-of-reported-adverse-events-occurring-during-gastrointestinal-scope-and-tube-placement-procedures-in-the-veterans-health-association
#14
Christina Soncrant, Peter D Mills, Julia Neily, Douglas E Paull, Robin R Hemphill
OBJECTIVE: This study describes reported adverse events related to gastrointestinal (GI) scope and tube placement procedures (between January 2010 and June 2012), in the Veterans Health Administration. Adverse events, including those related to GI procedures resulting in preventable harm, continue to occur. METHODS: This is a descriptive review of root cause analysis reports of GI scope and tube placement procedures from the National Center for Patient Safety database...
March 3, 2017: Journal of Patient Safety
https://www.readbyqxmd.com/read/28256066/a-randomized-phase-ii-study-of-nab-paclitaxel-as-first-line-chemotherapy-in-patients-with-her2-negative-metastatic-breast-cancer
#15
Kenji Tamura, Kenichi Inoue, Norikazu Masuda, Shintaro Takao, Masahiro Kashiwaba, Yutaka Tokuda, Hiroji Iwata, Naohito Yamamoto, Kenjiro Aogi, Toshiaki Saeki, Takahiro Nakayama, Nobuaki Sato, Tatsuya Toyama, Takanori Ishida, Hitoshi Arioka, Mitsue Saito, Shinji Ohno, Hideko Yamauchi, Kimito Yamada, Junichiro Watanabe, Hiroshi Ishiguro, Yasuhiro Fujiwara
Weekly administration of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) has been shown to be a safe and effective treatment for metastatic breast cancer (MBC) in clinical studies. We conducted a multicenter, randomized, open-label phase II study to compare the efficacy and safety of weekly nab-paclitaxel and docetaxel in Japanese patients with human epidermal growth factor receptor 2-negative MBC. The primary endpoint was progression-free survival (PFS). Patients were randomized to receive nab-paclitaxel (150 mg/m(2) nab-paclitaxel once per week for 3 of 4 weeks; n = 100) or docetaxel (75 mg/m(2) docetaxel every 3 weeks; n = 100)...
March 3, 2017: Cancer Science
https://www.readbyqxmd.com/read/28252041/protective-effects-of-nebivolol-from-oxidative-stress-to-prevent-hypertension-related-target-organ-damage
#16
REVIEW
A Coats, S Jain
Hypertension is one of the leading risk factors for morbidity and mortality in patients with cardiovascular and cerebrovascular diseases and renal impairment. It also leads to target organ damage (TOD), which worsens organ function and the patient's clinical status. Reactive oxygen species (ROS)-mediated oxidative stress may contribute significantly to TOD in patients with hypertension. NO (nitric oxide) is a paracrine factor derived from endothelial cells that has been shown to alleviate ROS-mediated oxidative damage...
March 2, 2017: Journal of Human Hypertension
https://www.readbyqxmd.com/read/28248749/medication-safety-in-two-intensive-care-units-of-a-community-teaching-hospital-after-electronic-health-record-implementation-sociotechnical-and-human-factors-engineering-considerations
#17
Pascale Carayon, Tosha B Wetterneck, Randi Cartmill, Mary Ann Blosky, Roger Brown, Peter Hoonakker, Robert Kim, Sandeep Kukreja, Mark Johnson, Bonnie L Paris, Kenneth E Wood, James M Walker
OBJECTIVE: The aim of the study was to assess the impact of Electronic Health Record (EHR) implementation on medication safety in two intensive care units (ICUs). METHODS: Using a prospective pre-post design, we assessed 1254 consecutive admissions to two ICUs before and after an EHR implementation. Each medication event was evaluated with regard to medication error (error type, medication-management stage) and impact on patient (severity of potential or actual harm)...
February 28, 2017: Journal of Patient Safety
https://www.readbyqxmd.com/read/28241880/development-of-the-major-trauma-case-review-tool
#18
Kate Curtis, Rebecca Mitchell, Amy McCarthy, Kellie Wilson, Connie Van, Belinda Kennedy, Gary Tall, Andrew Holland, Kim Foster, Stuart Dickinson, Henry T Stelfox
BACKGROUND: As many as half of all patients with major traumatic injuries do not receive the recommended care, with variance in preventable mortality reported across the globe. This variance highlights the need for a comprehensive process for monitoring and reviewing patient care, central to which is a consistent peer-review process that includes trauma system safety and human factors. There is no published, evidence-informed standardised tool that considers these factors for use in adult or paediatric trauma case peer-review...
February 28, 2017: Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine
https://www.readbyqxmd.com/read/28241824/treatment-of-chronic-non-healing-ulcers-using-autologous-platelet-rich-plasma-a-case-series
#19
Manish Suthar, Saniya Gupta, Suhail Bukhari, Venkatesh Ponemone
BACKGROUND: Non-healing ulcers are a major health problem worldwide and have great impact at personal, professional and social levels, with high cost in terms of human and material resources. Recalcitrant non-healing ulcers are inevitable and detrimental to the lower limb and are a major cause of non-traumatic lower limb amputations. Application of autologous Platelet Rich Plasma (PRP) has been a major breakthrough for the treatment of non-healing and diabetic foot ulcers, as it is an easy and cost-effective method, and provides the necessary growth factors that enhance tissue healing...
February 27, 2017: Journal of Biomedical Science
https://www.readbyqxmd.com/read/28236776/evolving-landscape-of-human-epidermal-growth-factor-receptor-2-positive-breast-cancer-treatment-and-the-future-of-biosimilars
#20
REVIEW
Christian Jackisch, Philip Lammers, Ira Jacobs
Human epidermal growth factor receptor 2-positive (HER2+) breast cancer comprises approximately 15%-20% of all breast cancers and is associated with a poor prognosis. The introduction of anti-HER2 therapy has significantly improved clinical outcomes for patients with HER2+ breast cancer, and multiple HER2-directed agents (ie, trastuzumab, pertuzumab, lapatinib, and ado-trastuzumab emtansine [T-DM1]) are approved for clinical use in various settings. The treatment landscape for patients with HER2+ breast cancer is continuing to evolve...
April 2017: Breast: Official Journal of the European Society of Mastology
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