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Human Factors in Patient Safety

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https://www.readbyqxmd.com/read/28428030/complement-inhibition-with-eculizumab-for-thrombotic-microangiopathy-rescues-a-living-donor-kidney-transplant-in-a-patient-with-antiphospholipid-antibody-syndrome
#1
Praveen Ramakrishnan Geethakumari, Patrick Mille, Rakesh Gulati, Srikanth Nagalla
Antiphospholipid antibody syndrome (APS) is an enigmatic heterogeneous disorder despite several revelations in its pathobiology. Renal transplantation in patients with APS has been notoriously difficult due to the high risk of development of thrombotic microangiopathy (TMA), which is often refractory to conventional treatment modalities such as aggressive anticoagulation and plasmapheresis. We describe a case of a 58-year-old male with secondary APS undergoing living unrelated renal transplantation for end-stage renal disease from lupus nephritis...
March 10, 2017: Transfusion and Apheresis Science
https://www.readbyqxmd.com/read/28418889/efficacy-and-safety-of-everolimus-in-chinese-metastatic-hr-positive-her2-negative-breast-cancer-patients-a-real-world-retrospective-study
#2
Chengcheng Gong, Yannan Zhao, Biyun Wang, Xichun Hu, Zhonghua Wang, Jian Zhang, Sheng Zhang
BACKGROUND: Everolimus combined with endocrine therapy has been proved to be effective among postmenopausal women with hormone receptor-positive human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic breast cancer (MBC). We aimed to evaluate the efficacy and safety of everolimus plus endocrine therapy in Chinese real-world practice for the first time, and investigate factors associated with efficacy. METHODS: Seventy-five HR+/HER2- MBC patients were included in this retrospective study who received everolimus plus endocrine therapy after progression on prior endocrine therapy in Fudan University Shanghai Cancer Center (FUSCC) between June 2013 and February 2016...
March 17, 2017: Oncotarget
https://www.readbyqxmd.com/read/28418101/effect-of-an-electronic-medication-administration-record-application-on-patient-safety
#3
Noelia Vicente Oliveros, Teresa Gramage Caro, Covadonga Pérez Menendez-Conde, Ana María Álvarez-Díaz, Sagrario Martín-Aragón Álvarez, Teresa Bermejo Vicedo, Eva Delgado Silveira
RATIONALE, AIMS, AND OBJECTIVES: To evaluate the effect of an electronic medication administration record (eMAR) application on the rate of medication errors in medication administration recording (ME-MAR). METHODS: A before-and-after, quasiexperimental study was conducted in a university hospital that implemented the eMAR application in March 2014. Data collection was conducted in April 2012 (pre-) and June 2014 (post-) by two pharmacists. The ME-MARs were analysed by the staff involved to identify their cause...
April 18, 2017: Journal of Evaluation in Clinical Practice
https://www.readbyqxmd.com/read/28417303/paediatric-in-patient-prescribing-errors-in-malaysia-a-cross-sectional-multicentre-study
#4
Teik Beng Khoo, Jing Wen Tan, Hoong Phak Ng, Chong Ming Choo, Intan Nor Chahaya Bt Abdul Shukor, Siao Hean Teh
Background There is a lack of large comprehensive studies in developing countries on paediatric in-patient prescribing errors in different settings. Objectives To determine the characteristics of in-patient prescribing errors among paediatric patients. Setting General paediatric wards, neonatal intensive care units and paediatric intensive care units in government hospitals in Malaysia. Methods This is a cross-sectional multicentre study involving 17 participating hospitals. Drug charts were reviewed in each ward to identify the prescribing errors...
April 17, 2017: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/28416172/epidemiology-of-ebolavirus-disease-evd-and-occupational-evd-in-health-care-workers-in-sub-saharan-africa-need-for-strengthened-public-health-preparedness
#5
REVIEW
Nlandu Roger Ngatu, Ntumba Jean-Marie Kayembe, Elayne Kornblatt Phillips, Joa Okech-Ojony, Masika Patou-Musumari, Mukunda Gaspard-Kibukusa, Ndona Madone-Mandina, Mabasi Godefroid-Mayala, Lubogo Mutaawe, Casimir Manzengo, Dimosi Roger-Wumba, Sayumi Nojima
Ebolavirus disease (EVD) is a severe contagious disease in humans, and health care workers (HCW) are at risk of infection when caring for EVD patients. This paper highlights the epidemiologic profile of EVD and its impact on the health care workforce in Africa. A documentary study was conducted which consisted of a review of available literature regarding the epidemiology of EVD, occupational EVD (OEVD), and work safety issues in Sub-Saharan Africa; the literature findings are enriched by field experiences from the authors...
April 13, 2017: Journal of Epidemiology
https://www.readbyqxmd.com/read/28415567/efficacy-and-safety-of-t-dm1-in-the-common-practice-of-her2-advanced-breast-cancer-setting-a-multicenter-study
#6
Alessandra Fabi, Michelino De Laurentiis, Michele Caruso, Enrichetta Valle, Luca Moscetti, Daniele Santini, Katia Cannita, Luisa Carbognin, Mariangela Ciccarese, Rosalba Rossello, Grazia Arpino, Vita Leonardi, Filippo Montemurro, Nicla La Verde, Daniele Generali, Alberto Zambelli, Giuseppa Scandurra, Michelangelo Russillo, Ida Paris, Anna Maria D'Ottavio, Gianfranco Filippelli, Marianna Giampaglia, Simonetta Stani, Agnese Fabbri, Daniele Alesini, Daniela Cianniello, Diana Giannarelli, Francesco Cognetti
Ado-trastuzumab emtansine (T-DM1) is an antibody-drug conjugate approved for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive, metastatic breast cancer (mBC). The aim of this 'field-practice' study was to investigate the efficacy and safety of T-DM1, focusing on treatment line, previous lapatinib treatment and patterns of metastasis. Three hundred and three patients with HER2-positive mBC who received T-DM1 were identified by reviewing the medical records of 24 Italian Institutions...
March 18, 2017: Oncotarget
https://www.readbyqxmd.com/read/28413662/phase-i-study-of-nanoparticle-albumin-bound-paclitaxel-carboplatin-and-trastuzumab-in-women-with-human-epidermal-growth-factor-receptor-2-overexpressing-breast-cancer
#7
Kenji Tezuka, Tsutomu Takashima, Shinichiro Kashiwagi, Hidemi Kawajiri, Shinya Tokunaga, Seika Tei, Shigehiko Nishimura, Shigehito Yamagata, Satoru Noda, Takeo Nishimori, Yoko Mizuyama, Takeshi Sunami, Katsumi Ikeda, Yoshinari Ogawa, Naoyoshi Onoda, Tetsuro Ishikawa, Shinzoh Kudoh, Minoru Takada, Kosei Hirakawa
Although the concurrent use of anthracycline-containing chemotherapy and taxane with trastuzumab are considered the treatment of choice for the primary systemic therapy of human epidermal growth factor receptor 2 (HER2)-overexpressing early breast cancer, non-anthracycline regimens, such as concurrent administration of docetaxel and carboplatin with trastuzumab, exhibited similar efficacies in a previous study. In addition, tri-weekly treatment with nanoparticle albumin-bound paclitaxel (nab-paclitaxel) resulted in significantly higher response rates and a favorable safety profile compared with standard paclitaxel for metastatic breast cancer patients in another phase III study...
April 2017: Molecular and Clinical Oncology
https://www.readbyqxmd.com/read/28410711/failure-modes-and-effects-analysis-of-bilateral-same-day-cataract-surgery
#8
Neal H Shorstein, Carol Lucido, James Carolan, Liyan Liu, Geraldine Slean, Lisa J Herrinton
PURPOSE: To systematically analyze potential process failures related to bilateral same-day cataract surgery toward the goal of improving patient safety. SETTING: Twenty-one Kaiser Permanente surgery centers, Northern California, USA. DESIGN: Retrospective cohort study. METHODS: Quality experts performed a Failure Modes and Effects Analysis (FMEA) that included an evaluation of sterile processing, pharmaceuticals, perioperative clinic and surgical center visits, and biometry...
March 2017: Journal of Cataract and Refractive Surgery
https://www.readbyqxmd.com/read/28405006/the-adjuvant-value-of-andrographis-paniculata-in-metastatic-esophageal-cancer-treatment-from-preclinical-perspectives
#9
Lin Li, Grace Gar-Lee Yue, Julia Kin-Ming Lee, Eric Chun-Wai Wong, Kwok-Pui Fung, Jun Yu, Clara Bik-San Lau, Philip Wai-Yan Chiu
Esophageal cancer (EC) is the fourth and sixth leading cause of cancer-related deaths in China and United States, respectively. The dismal prognosis of EC is mainly attributed to distant metastases, which may not be overcome by chemotherapy alone. Hence, the use of alternative adjuvant treatments, such as herbal medicines, for metastatic EC remains a great desire of patients. Our previous study demonstrated the in vivo anti-tumor and in vitro anti-invasion activities of Andrographis paniculata (AP) in esophageal cancer...
April 12, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28400641/secukinumab-first-in-class-interleukin-17a-inhibitor-for-the-treatment-of-psoriasis
#10
Kiran Godse
Psoriasis is a complex inflammatory disease that occurs in genetically susceptible individuals and presents with the development of erythematous scaly plaques on the skin. Interleukins (ILs) in the Th17 pathway play a pivotal role in the pathogenesis of psoriasis and have thus become targets for recent biologic drug development. Secukinumab is a human monoclonal IgG1k antibody that has been developed to target and block the actions of IL-17A. Secukinumab recently approved for use as first-line systemic therapy in a patient with moderate to severe psoriasis has been studied first in psoriasis before other diseases...
March 2017: Indian Journal of Dermatology
https://www.readbyqxmd.com/read/28399902/efficacy-and-safety-of-everolimus-in-combination-with-trastuzumab-and-paclitaxel-in-asian-patients-with-her2-advanced-breast-cancer-in-bolero-1
#11
Masakazu Toi, Zhimin Shao, Sara Hurvitz, Ling-Ming Tseng, Qingyuan Zhang, Kunwei Shen, Donggeng Liu, Jifeng Feng, Binghe Xu, Xiaojia Wang, Keun Seok Lee, Ting Ying Ng, Antonia Ridolfi, Florence Noel-Baron, Francois Ringeisen, Zefei Jiang
BACKGROUND: The current exploratory analysis was performed to evaluate the efficacy and safety of everolimus for treatment of human epidermal growth factor receptor 2-positive (HER2+) advanced breast cancer in the Asian subset of patients in the BOLERO-1 trial. METHODS: Postmenopausal women with HER2+ advanced breast cancer, who had not received systemic therapy for advanced disease, were randomized 2:1 to receive everolimus or placebo, plus trastuzumab and paclitaxel...
April 11, 2017: Breast Cancer Research: BCR
https://www.readbyqxmd.com/read/28398242/drug-induced-liver-injury-can-biomarkers-assist-rucam-in-causality-assessment
#12
REVIEW
Rolf Teschke, Johannes Schulze, Axel Eickhoff, Gaby Danan
Drug induced liver injury (DILI) is a potentially serious adverse reaction in a few susceptible individuals under therapy by various drugs. Health care professionals facing DILI are confronted with a wealth of drug-unrelated liver diseases with high incidence and prevalence rates, which can confound the DILI diagnosis. Searching for alternative causes is a key element of RUCAM (Roussel Uclaf Causality Assessment Method) to assess rigorously causality in suspected DILI cases. Diagnostic biomarkers as blood tests would be a great help to clinicians, regulators, and pharmaceutical industry would be more comfortable if, in addition to RUCAM, causality of DILI can be confirmed...
April 11, 2017: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28394204/medication-adherence-staying-within-the-boundaries-of-safety
#13
Robin Sue Mickelson, Richard J Holden
An important domain of patient safety is the management of medications in home and community settings by patients and their caregiving network. This study applied human factors/ergonomics theories and methods to data about medication adherence collected from 61 patients with heart failure accompanied by 31 informal caregivers living in the US. Seventy non-adherence events were identified, described, and analysed for performance shaping factors. Half were classified as errors and half as violations. Performance shaping factors included elements of the person or team (e...
April 10, 2017: Ergonomics
https://www.readbyqxmd.com/read/28391576/phase-i-trial-and-pharmacokinetic-study-of-tanibirumab-a-fully-human-monoclonal-antibody-to-vascular-endothelial-growth-factor-receptor-2-in-patients-with-refractory-solid-tumors
#14
Su Jin Lee, Seon Young Lee, Weon Sup Lee, Jin San Yoo, Jong-Mu Sun, Jeeyun Lee, Se Hoon Park, Joon Oh Park, Myung-Ju Ahn, Ho Yeong Lim, Won Ki Kang, Young Suk Park
Background Tanibirumab is a fully human monoclonal antibody to vascular endothelial growth factor receptor 2 (VEGFR-2). We conducted a first-in-human phase I study of tanibirumab in patients with solid tumors refractory to standard chemotherapy. Primary endpoints were evaluating safety, pharmacokinetics (PKs), estimating maximum-tolerated dose (MTD) and recommended phase II dose (RP2D). Methods We designed our study to escalate tanibirumab at 9 different dose levels with a 3 + 3 method and tanibirumab (1-28 mg/kg) was administered intravenously on D1, 8, 15 in 28-day courses...
April 8, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28391340/targeting-the-tyrosine-kinase-signalling-pathways-for-treatment-of-immune-mediated-glomerulonephritis-from-bench-to-bedside-and-beyond
#15
Terry King-Wing Ma, Stephen P McAdoo, Frederick Wai Keung Tam
Glomerulonephritis (GN) affects patients of all ages and is an important cause of morbidity and mortality. Non-selective immunosuppressive drugs have been used in immune-mediated GN but often result in systemic side effects and occasionally fatal infective complications. There is increasing evidence from both preclinical and clinical studies that abnormal activation of receptor and non-receptor tyrosine kinase signalling pathways are implicated in the pathogenesis of immune-mediated GN. Activation of spleen tyrosine kinase (SYK), Bruton's tyrosine kinase (BTK), platelet-derived growth factor receptor (PDGFR), epidermal growth factor receptor (EGFR) and discoidin domain receptor 1 (DDR1) have been demonstrated in anti-GBM disease...
January 1, 2017: Nephrology, Dialysis, Transplantation
https://www.readbyqxmd.com/read/28390867/efficacy-and-safety-of-medi2070-an-antibody-against-interleukin-23-patients-with-moderate-to-severe-crohn-s-disease-a-phase-2a-study
#16
Bruce E Sands, Jingjing Chen, Brian G Feagan, Mark Penney, William A Rees, Silvio Danese, Peter D R Higgins, Paul Newbold, Raffaella Faggioni, Kaushik Patra, Jing Li, Paul Klekotka, Chris Morehouse, Erik Pulkstenis, Jörn Drappa, René van der Merwe, Robert A Gasser
BACKGROUND & AIMS: MEDI2070 is a human monoclonal antibody that selectively inhibits interleukin 23 (IL23), a cytokine implicated in the pathogenesis of Crohn's disease (CD). We analyzed its safety and efficacy in treatment of CD in a phase 2a study. METHODS: We conducted a double-blind, placebo-controlled, study of 119 adults with moderate to severe CD failed by treatment with tumor necrosis factor (TNF) antagonists. Patients were randomly assigned (1:1) to groups given MEDI2070 (700 mg) or placebo intravenously at weeks 0 and 4...
April 5, 2017: Gastroenterology
https://www.readbyqxmd.com/read/28389776/senotherapy-growing-old-and-staying-young
#17
REVIEW
Roland Schmitt
Cellular senescence, which has been linked to age-related diseases, occurs during normal aging or as a result of pathological cell stress. Due to their incapacity to proliferate, senescent cells cannot contribute to normal tissue maintenance and tissue repair. Instead, senescent cells disturb the microenvironment by secreting a plethora of bioactive factors that may lead to inflammation, regenerative dysfunction and tumor progression. Recent understanding of stimuli and pathways that induce and maintain cellular senescence offers the possibility to selectively eliminate senescent cells...
April 7, 2017: Pflügers Archiv: European Journal of Physiology
https://www.readbyqxmd.com/read/28389174/a-biotin-drug-extraction-and-acid-dissociation-bead-procedure-to-eliminate-matrix-and-drug-interference-in-a-protein-complex-anti-drug-antibody-ada-isotype-specific-assay
#18
Hongmei Niu, Thomas Klem, Jinsong Yang, Yongchang Qiu, Luying Pan
Monitoring anti-drug antibody (ADA) responses in patients receiving protein therapeutics treatment is an important safety assessment for regulatory agencies, drug manufacturers, clinicians and patients. Recombinant human IGF-1/IGFBP-3 (rhIGF-1/rhIGFBP-3) is a 1:1 formulation of naturally occurring protein complex. The individual IGF-1 and IGFBP-3 proteins have multiple binding partners in serum matrix with high binding affinity to each other, which presents challenges in ADA assay development. We have developed a biotin-drug extraction with acid dissociation (BEAD) procedure followed by an electrochemiluminescence (ECL) direct assay to overcome matrix and drug interference...
April 4, 2017: Journal of Immunological Methods
https://www.readbyqxmd.com/read/28386567/mechanistic-insight-and-management-of-diabetic-nephropathy-recent-progress-and-future-perspective
#19
REVIEW
Rui Xue, Dingkun Gui, Liyang Zheng, Ruonan Zhai, Feng Wang, Niansong Wang
Diabetic nephropathy (DN) is the most serious microvascular complication of diabetes and the largest single cause of end-stage renal disease (ESRD) in many developed countries. DN is also associated with an increased cardiovascular mortality. It occurs as a result of interaction between both genetic and environmental factors. Hyperglycemia, hypertension, and genetic predisposition are the major risk factors. However, the exact mechanisms of DN are unclear. Despite the benefits derived from strict control of glucose and blood pressure, as well as inhibition of renin-angiotensin-aldosterone system, many patients continue to enter into ESRD...
2017: Journal of Diabetes Research
https://www.readbyqxmd.com/read/28383473/pro-coagulant-activity-of-human-mesenchymal-stem-cells
#20
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 pro-coagulant activity in order to characterize safety considerations for systemic use of MSCs in trauma patients who may have altered coagulation homeostasis...
April 5, 2017: Journal of Trauma and Acute Care Surgery
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