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Human Factors in Patient Safety

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https://www.readbyqxmd.com/read/29244528/phase-iii-randomized-study-of-dual-human-epidermal-growth-factor-receptor-2-her2-blockade-with-lapatinib-plus-trastuzumab-in-combination-with-an-aromatase-inhibitor-in-postmenopausal-women-with-her2-positive-hormone-receptor-positive-metastatic-breast-cancer
#1
Stephen R D Johnston, Roberto Hegg, Seock-Ah Im, In Hae Park, Olga Burdaeva, Galina Kurteva, Michael F Press, Sergei Tjulandin, Hiroji Iwata, Sergio D Simon, Sarah Kenny, Severine Sarp, Miguel A Izquierdo, Lisa S Williams, William J Gradishar
Purpose Human epidermal growth factor receptor 2 (HER2) targeting plus endocrine therapy (ET) improved clinical benefit in HER2-positive, hormone receptor (HR)-positive metastatic breast cancer (MBC) versus ET alone. Dual HER2 blockade enhances clinical benefit versus single HER2 blockade. The ALTERNATIVE study evaluated the efficacy and safety of dual HER2 blockade plus aromatase inhibitor (AI) in postmenopausal women with HER2-positive/HR-positive MBC who received prior ET and prior neo(adjuvant)/first-line trastuzumab (TRAS) plus chemotherapy...
December 15, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29237905/a-clinical-study-of-polyethylene-glycol-recombinant-human-granulocyte-colony-stimulating-factor-prevention-neutropenia-syndrome-in-patients-with-esophageal-carcinoma-and-lung-cancer-after-concurrent-chemoradiotherapy
#2
Fang Liu, Yu Du, Boning Cai, Maohui Yan, Wei Yang, Qianqian Wang
OBJECTIVE: To compare the efficacy and safety of PEG-rhG-CSF and recombinant human G-CSF (rhG-CSF) for the prevention and delayed application in febrile neutropenia, hospitalization rate in concurrent chemoradiotherapy of tumors. METHODS: A total of 163 patients, who received concurrent chemoradiotherapy for solid tumors. There were 75 patients in the PEG-rhG-CSF group (PEG group), who received 146 cycles of concurrent chemoradiotherapy, of which 132 cycles (90...
2017: Journal of Cancer Research and Therapeutics
https://www.readbyqxmd.com/read/29224506/aav5-factor-viii-gene-transfer-in-severe-hemophilia-a
#3
Savita Rangarajan, Liron Walsh, Will Lester, David Perry, Bella Madan, Michael Laffan, Hua Yu, Christian Vettermann, Glenn F Pierce, Wing Y Wong, K John Pasi
Background Patients with hemophilia A rely on exogenous factor VIII to prevent bleeding in joints, soft tissue, and the central nervous system. Although successful gene transfer has been reported in patients with hemophilia B, the large size of the factor VIII coding region has precluded improved outcomes with gene therapy in patients with hemophilia A. Methods We infused a single intravenous dose of a codon-optimized adeno-associated virus serotype 5 (AAV5) vector encoding a B-domain-deleted human factor VIII (AAV5-hFVIII-SQ) in nine men with severe hemophilia A...
December 9, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29223619/differential-effects-of-hepatic-cirrhosis-on-the-intrinsic-clearances-of-sorafenib-and-imatinib-by-cyps-in-human-liver
#4
Michael Murray, Tina B Gillani, Sussan Ghassabian, Robert J Edwards, Tristan Rawling
The tyrosine kinase inhibitors sorafenib and imatinib are important in the treatment of a range of cancers but adverse effects in some patients necessitate dosage modifications. CYP3A4 has a major role in the oxidation of sorafenib to its N-oxide and N-hydroxymethyl metabolites and also acts in concert with CYP2C8 to mediate imatinib N-demethylation. CYP3A4 expression and function are impaired in patients with advanced liver disease, whereas the functions of CYP2C enzymes are relatively preserved. We evaluated the biotransformation of sorafenib and imatinib in well-characterized microsomal fractions from 17 control subjects and 19 individuals with hepatic cirrhosis of varying severity...
December 6, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29218462/a-single-institution-experience-with-palbociclib-toxicity-requiring-dose-modifications
#5
Jun Gong, May Cho, Kim Wai Yu, James Waisman, Yuan Yuan, Joanne Mortimer
PURPOSE: Since the widespread implementation of adding palbociclib to endocrine therapy in clinical practice, myelosuppression is becoming increasingly recognized as a toxicity that may lead to dose modification. We aimed to characterize toxicities observed with palbociclib resulting in dose modifications and prescriber preferences in modifying palbociclib dosage in response to treatment-related toxicities outside the context of a clinical trial. METHODS: We conducted a single institution, retrospective study of treatment-related adverse events (AEs) resulting in modifications in dose and schedule and the methods by which dose modifications occurred in patients with advanced hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer receiving palbociclib and endocrine therapy...
December 7, 2017: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/29204064/vaccinations-in-immunosuppressive-dependent-pediatric-inflammatory-bowel-disease
#6
Huyen-Tran Nguyen, Phillip Minar, Kimberly Jackson, Patricia C Fulkerson
AIM: To determine the vaccination rates in pediatric immunosuppression-dependent inflammatory bowel disease (IBD) and review the safety and efficacy of vaccinations in this population. METHODS: The electronic medical records from October 2009 to December 2015 of patients diagnosed with IBD at 10 years of age or younger and prescribed anti-tumor necrosis factor alpha (anti-TNF-α) therapy were reviewed for clinical history, medication history, vaccination history, and hepatitis B and varicella titers...
November 14, 2017: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/29202857/medication-adherence-and-its-associated-factors-among-diabetic-patients-at-zewditu-memorial-hospital-addis-ababa-ethiopia
#7
Muhammed Ali, Tigestu Alemu, Oumer Sada
OBJECTIVE: Diabetes is a global problem with devastating human, social and economic impact. Anti-diabetic medications play a major role in the glycemic control of patients with diabetes. However, inadequate adherence compromises safety and treatment effectiveness, leading to increased mortality and morbidity. The aim of this study was to assess adherence to anti-diabetic medications and associated factors among patient with diabetes mellitus receiving care at Zewditu Memorial Hospital...
December 4, 2017: BMC Research Notes
https://www.readbyqxmd.com/read/29198055/phase-ii-study-of-buparlisib-bkm120-and-trastuzumab-in-patients-with-her2-%C3%A2-locally-advanced-or-metastatic-breast-cancer-resistant-to-trastuzumab-based-therapy
#8
B Pistilli, T Pluard, A Urruticoechea, D Farci, A Kong, T Bachelot, S Chan, H S Han, G Jerusalem, P Urban, D Robinson, S L Mouhaër, E D Tomaso, C Massacesi, C Saura
PURPOSE: A Phase Ib study in patients with trastuzumab-resistant, human epidermal growth factor receptor-2- (HER2)-positive advanced breast cancer defined the recommended Phase II dose of buparlisib as 100 mg/day in combination with 2 mg/kg weekly trastuzumab, and reported preliminary signs of clinical activity. Here we present results from the Phase II portion. METHODS: Patients with trastuzumab-resistant, HER2-positive advanced breast cancer received buparlisib plus trastuzumab...
December 2, 2017: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/29194338/nurses-use-of-positive-deviance-when-encountering-electronic-health-records-related-unintended-consequences
#9
Alycia A Bristol, Christine W Nibbelink, Sheila M Gephart, Jane M Carrington
As organizations adopt electronic health records (EHRs), nurses frequently encounter system barriers and difficulty performing role expectations. This article describes nurses' experiences with unintended consequences emerging from the use of an EHR. In some situations, nurses were positively deviant when encountering unintended consequences relating to EHRs to accomplish patient care or protect patient safety. Nurses engaged in work-arounds to provide patient care when the EHR did not meet their needs, sometimes in positively deviant ways...
January 2018: Nursing Administration Quarterly
https://www.readbyqxmd.com/read/29191585/treatment-outcomes-by-histology-in-revel-a-randomized-phase-iii-trial-of-ramucirumab-plus-docetaxel-for-advanced-non-small-cell-lung-cancer
#10
Luis G Paz-Ares, Maurice Pérol, Tudor-Eliade Ciuleanu, Ruben Dario Kowalyszyn, Martin Reck, Conrad R Lewanski, Konstantinos Syrigos, Oscar Arrieta, Kumar Prabhash, Keunchil Park, Joanna Pikiel, Tuncay Göksel, Pablo Lee, Anna Zimmermann, Gebra Cuyun Carter, Ekaterine Alexandris, Edward B Garon
OBJECTIVES: Ramucirumab, a recombinant human immunoglobulin G1 monoclonal antibody inhibiting vascular endothelial growth factor receptor-2, increased overall survival (OS) combined with docetaxel versus docetaxel alone in non-small cell lung cancer (NSCLC) in the REVEL trial. Pre-specified exploratory analysis examined efficacy and safety by histology. MATERIALS AND METHODS: 1253 patients with NSCLC were randomized to receive ramucirumab (10mg/kg; n=628) plus docetaxel (75mg/m2) or placebo plus docetaxel (n=625) after disease progression on or after platinum-based therapy, with or without bevacizumab or maintenance therapy...
October 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/29190672/first-in-human-phase-i-study-of-isth0036-an-antisense-oligonucleotide-selectively-targeting-transforming-growth-factor-beta-2-tgf-%C3%AE-2-in-subjects-with-open-angle-glaucoma-undergoing-glaucoma-filtration-surgery
#11
Norbert Pfeiffer, Bogomil Voykov, Giulia Renieri, Katharina Bell, Paul Richter, Melanie Weigel, Hagen Thieme, Barbara Wilhelm, Katrin Lorenz, Martin Feindor, Katja Wosikowski, Michel Janicot, Daniela Päckert, Regina Römmich, Carola Mala, Petra Fettes, Eugen Leo
PURPOSE: To evaluate the safety and tolerability of intravitreal ISTH0036, an antisense oligonucleotide selectively targeting transforming growth factor beta 2 (TGF-β2), in patients with primary open angle glaucoma (POAG) undergoing trabeculectomy (TE; glaucoma filtration surgery). METHODS: In this prospective phase I trial glaucoma patients scheduled for TE with mitomycin C (MMC) received a single intravitreal injection of ISTH0036 at the end of surgery in escalating total doses of 6...
2017: PloS One
https://www.readbyqxmd.com/read/29187430/the-yin-and-yang-of-platelet-rich-plasma-in-breast-reconstruction-after-mastectomy-or-lumpectomy-for-breast-cancer
#12
REVIEW
Eleftherios Spartalis, Diamantis I Tsilimigras, Petros Charalampoudis, Georgia-Sofia Karachaliou, Demetrios Moris, Antonios Athanasiou, Michael Spartalis, Vasileios Bolkas, Dimitrios Dimitroulis, Nikolaos Nikiteas
Surgery remains the mainstay of treatment for breast cancer, including complete or partial mastectomy and lumpectomy. Breast reconstruction has gained popularity mainly due to its tremendous impact on the psychological status of the patients. Autologous fat grafting is a well-established method used in cosmetic surgery; however, fat re-absoprtion, fat necrosis, calcifications and oil-cyst formation are some usually encountered complications limiting the efficacy of this approach. Platelet-rich plasma (PRP) has recently been postulated as a promising method for tissue regeneration since it contains high levels of diverse human growth factors...
December 2017: Anticancer Research
https://www.readbyqxmd.com/read/29184849/giving-drugs-a-second-chance-overcoming-regulatory-and-financial-hurdles-in-repurposing-approved-drugs-as-cancer-therapeutics
#13
REVIEW
J Javier Hernandez, Michael Pryszlak, Lindsay Smith, Connor Yanchus, Naheed Kurji, Vijay M Shahani, Steven V Molinski
The repositioning or "repurposing" of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these "new" medicines in oncology...
2017: Frontiers in Oncology
https://www.readbyqxmd.com/read/29180886/next-generation-of-biologics-for-the-treatment-of-crohn-s-disease-an-evidence-based-review-on-ustekinumab
#14
REVIEW
Aranzazu Jauregui-Amezaga, Michael Somers, Heiko De Schepper, Elisabeth Macken
The limited efficacy of the currently available medical therapies in a proportion of patients with Crohn's disease has led to the research and development of molecules that can block new inflammatory pathways. Ustekinumab is a fully human IgG1 monoclonal antibody which targets the common p40 subunit of the cytokines interleukin-12 as well as interleukin-23. Consequently, the Th1 and Th17 inflammatory responses are inhibited. Ustekinumab has been recently approved for its use in patients with Crohn's disease...
2017: Clinical and Experimental Gastroenterology
https://www.readbyqxmd.com/read/29180848/safety-and-efficacy-of-the-addition-of-pertuzumab-to-t-dm1-%C3%A2-taxane-in-patients-with-her2-positive-locally-advanced-or-metastatic-breast-cancer-a-pooled-analysis
#15
REVIEW
Jing Zhang, Jinying Li, Chenjing Zhu, Yanlin Song, Fan Xia, Xuelei Ma
Background: The aim of this review was to systematically evaluate the safety and efficacy of the addition of pertuzumab to trastuzumab emtansine (T-DM1) ± taxane in patients with human epidermal growth factor receptor 2 (HER2)-positive, locally advanced breast cancer (LABC) or metastatic breast cancer (MBC). Materials and methods: Several databases were searched for relevant clinical trials. The study characteristics, details of adverse events (AEs) and details of treatment efficacy were extracted for analysis...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/29176419/the-role-of-checklists-and-human-factors-for-improved-patient-safety-in-plastic-surgery
#16
Claude Oppikofer, David Schwappach
LEARNING OBJECTIVES: After studying the article, participants should be able to: 1. Describe the role of human factors and nontechnical skills for patient safety and recognize the need for customization of surgical checklists. 2. Apply encouragement to speaking up and understand the importance of patient involvement for patient safety. 3. Recognize the potential for improvement regarding patient safety in their own environment and take a leading role in the patient safety process. 4. Assess their own safety status and develop measures to avoid unnecessary distraction in the operating room...
December 2017: Plastic and Reconstructive Surgery
https://www.readbyqxmd.com/read/29166733/-comparative-study-on-the-efficacy-and-safety-between-pegfilgrastim-peg-rhg-csf-and-recombinant-human-granulocyte-colony-stimulating-factor-in-promoting-hematopoietic-recovery-after-allogeneic-hematopoietic-stem-cell-transplantation-after-hematological-malignancy
#17
F Yang, X D Sun, L Yuan, J C Zhang, J W Hu, N Liu, X Lou, Y F Su, Z Y Yu, J L Chen, Y H Li, L D Hu, H Chen, M Jiang
Objective: To observe the efficacy and safety between Pegfilgrastim (PEG-rhG-CSF) and Recombinant human granulocyte colony stimulating factor (rhG-CSF) in hematological malignancy after allogeneic hematopoietic stem cell transplantation (allo-HSCT) . Methods: 157 patients after allo-HSCT were enrolled in this study from June 2015 to November 2016. Two agents of G-CSF were used to stimulate hematopoietic recovery after transplantation. There were 65 cases in PEG-rhG-CSF and 92 cases in rhG-CSF groups. Patients in PEG-rhG-CSF group were given a single subcutaneous dose of 6 mg on the first day and +8 d, while cases in rhG-CSF group were given in dose of 5 μg·kg(-1)·d(-1) by subcutaneous injection from +1 d continuing to neutrophils more than 1...
October 14, 2017: Zhonghua Xue Ye Xue za Zhi, Zhonghua Xueyexue Zazhi
https://www.readbyqxmd.com/read/29166732/-application-of-pegylated-recombinant-human-granulocyte-colony-stimulating-factor-to-prevent-chemotherapy-induced-neutropenia-in-patients-with-lymphoma-a-prospective-multicenter-open-label-clinical-trial
#18
H Q Huang, B Bai, Y H Gao, D H Zou, S H Zou, H Tan, Y P Song, Z Y Li, J Jin, W Li, H Su, Y P Gong, M Z Zhong, Y R Shuang, J Zhu, J Q Zhang, Z Cai, Q L Teng, W J Sun, Y Yang, Z J Xia, H L Chen, L M Hua, Y Y Bao, N Wu
Objective: To evaluate the efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) in prophylaxis neutropenia after chemotherapy in patients with lymphoma. Methods: This was a multicenter, single arm, open, phase Ⅳ clinical trial. Included 410 patients with lymphoma received multiple cycles of chemotherapy and PEG-rhG-CSF was administrated as prophylactic. The primary endpoint was the incidence of Ⅲ/Ⅳ grade neutropenia and febrile neutropenia (FN) after each chemotherapy cycle...
October 14, 2017: Zhonghua Xue Ye Xue za Zhi, Zhonghua Xueyexue Zazhi
https://www.readbyqxmd.com/read/29165125/nurses-willingness-to-care-for-patients-infected-with-hiv-or-hepatitis-b-c-in-vietnam
#19
Tomohiro Ishimaru, Koji Wada, Huong Thi Xuan Hoang, Anh Thi My Bui, Hung Dinh Nguyen, Hung Le, Derek R Smith
OBJECTIVES: This study examined the factors associated with nurses' willingness to care for patients infected with human immunodeficiency virus (HIV) or hepatitis B or C virus (HBV/HCV) in Vietnam. METHODS: A cross-section of 400 Vietnamese nurses from two hospitals were selected using stratified random sampling, to whom a self-administered questionnaire was administered which included demographic items, previous experience with patients infected with HIV or HBV/HCV, and their attitudes toward these patients...
March 16, 2017: Environmental Health and Preventive Medicine
https://www.readbyqxmd.com/read/29161386/to-err-is-human-use-of-simulation-to-enhance-training-and-patient-safety-in-anaesthesia
#20
H Higham, B Baxendale
Human beings who work in complex, dynamic, and stressful situations make mistakes. This is as true for anaesthetists as for any other health-care professional, but we face unique challenges in the many roles and responsibilities we have in diverse clinical contexts. As a profession, we are well versed in the development and utilization of improvement techniques and technologies that prioritize high-quality, safe care for patients. This article focuses on one particular domain of patient safety in which anaesthetists have been pre-eminent, the use of simulation in training to improve both professional capabilities and patient safety in anaesthetic practice...
December 1, 2017: British Journal of Anaesthesia
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