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Human Factors in Patient Safety

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https://www.readbyqxmd.com/read/27907972/-tenofovir-alafenamide-fumarate-a-new-generation-of-tenofovir
#1
Svatava Snopková, Kateřina Havlíčková, Petr Husa
Antiretroviral therapy as a life-long treatment has to meet the criteria of maximum efficiency while maintaining the highest possible level of safety and tolerance. Tenofovir disoproxil fumarate (TDF) is an antiretroviral drug with an excellent effect of virological suppression. However, some patients can over time develop clinically significant nephrotoxicity or bone loss. Tenofovir alafenamide fumarate (TAF) is a novel prodrug of tenofovir (TFV) that is more stable in human plasma and more efficiently penetrates into target cells than TFV...
September 2016: Klinická Mikrobiologie a Infekc̆ní Lékar̆ství
https://www.readbyqxmd.com/read/27907031/in-vitro-pre-clinical-validation-of-suicide-gene-modified-anti-cd33-redirected-chimeric-antigen-receptor-t-cells-for-acute-myeloid-leukemia
#2
Kentaro Minagawa, Muhammad O Jamil, Mustafa Al-Obaidi, Larisa Pereboeva, Donna Salzman, Harry P Erba, Lawrence S Lamb, Ravi Bhatia, Shin Mineishi, Antonio Di Stasi
BACKGROUND: Approximately fifty percent of patients with acute myeloid leukemia can be cured with current therapeutic strategies which include, standard dose chemotherapy for patients at standard risk of relapse as assessed by cytogenetic and molecular analysis, or high-dose chemotherapy with allogeneic hematopoietic stem cell transplant for high-risk patients. Despite allogeneic hematopoietic stem cell transplant about 25% of patients still succumb to disease relapse, therefore, novel strategies are needed to improve the outcome of patients with acute myeloid leukemia...
2016: PloS One
https://www.readbyqxmd.com/read/27906760/improving-the-quality-of-ward-based-surgical-care-with-a-human-factors-intervention-bundle
#3
Maximilian J Johnston, Sonal Arora, Dominic King, Ara Darzi
OBJECTIVE: This study aimed to explore the impact of a human factors intervention bundle on the quality of ward-based surgical care in a UK hospital. SUMMARY OF BACKGROUND DATA: Improving the culture of a surgical team is a difficult task. Engagement with stakeholders before intervention is key. Studies have shown that appropriate supervision can enhance surgical ward safety. METHODS: A pre-post intervention study was conducted. The intervention bundle consisted of twice-daily attending ward rounds, a "chief resident of the week" available at all times on the ward, an escalation of care protocol and team contact cards...
November 30, 2016: Annals of Surgery
https://www.readbyqxmd.com/read/27906723/safety-and-outcome-measures-of-first-in-human-intraperitoneal-%C3%AE-radioimmunotherapy-with-212pb-tcmc-trastuzumab
#4
Ruby F Meredith, Julien J Torgue, Tania A Rozgaja, Eileen P Banaga, Patty W Bunch, Ronald D Alvarez, J Michael Straughn, Michael C Dobelbower, Andrew M Lowy
PURPOSE: One-year monitoring of patients receiving intraperitoneal (IP) Pb-TCMC-trastuzumab to provide long-term safety and outcome data. A secondary objective was to study 7 tumor markers for correlation with outcome. METHODS: Eighteen patients with relapsed intra-abdominal human epidermal growth factor receptor-2 expressing peritoneal metastases were treated with a single IP infusion of Pb-TCMC-trastuzumab, delivered <4 h after 4 mg/kg IV trastuzumab. Seven tumor markers were studied for correlation with outcome...
November 30, 2016: American Journal of Clinical Oncology
https://www.readbyqxmd.com/read/27906683/long-term-tolerance-and-cardiac-function-in-breast-cancer-patients-receiving-trastuzumab-therapy
#5
Ping Huang, Shujun Dai, Zhimin Ye, Yajuan Liu, Zhanhong Chen, Yabing Zheng, Xiying Shao, Lei Lei, Xiaojia Wang
We examined the long-term clinical tolerance and cardiac safety of trastuzumab treatment in ninety-four female patients diagnosed with breast cancer with human epidermal growth factor receptor 2 (HER-2) overexpression. Electrocardiography (ECG) was monitored throughout trastuzumab treatment, and left ventricular ejection fractions (LVEFs) were estimated using echocardiography prior to treatment with trastuzumab and every 3 months after its first application. The duration of trastuzumab treatments ranged from 3 to 60 months...
November 30, 2016: Oncotarget
https://www.readbyqxmd.com/read/27906070/subretinal-adipose-tissue-derived-mesenchymal-stem-cell-implantation-in-advanced-stage-retinitis-pigmentosa-a-phase-i-clinical-safety-study
#6
Ayse Oner, Z Burcin Gonen, Neslihan Sinim, Mustafa Cetin, Yusuf Ozkul
BACKGROUND: This prospective clinical case series aimed to investigate the safety of subretinal adipose tissue-derived mesenchymal stem cell (ADMSC) implantation in advanced stage retinitis pigmentosa (RP). METHODS: This study included 11 patients with end-stage RP who received subretinal implantation of ADMSCs. All patients had a total visual field defect and five of them only had light perception. The best corrected visual acuity (BCVA) in the study was 20/2000...
December 1, 2016: Stem Cell Research & Therapy
https://www.readbyqxmd.com/read/27904592/factors-affecting-the-quality-of-hospital-hotel-services-from-the-patients-and-their-companions-point-of-view-a-national-study-in-iran
#7
Seyed Majid Shirzadi, Pouran Raeissi, Amir Ashkan Nasiripour, Seyed Jamaleddin Tabibi
BACKGROUND: The hospitality design of a hospital is a complex process that depends on careful planning, systematic thinking, and consideration of various factors. This study aimed to determine the viewpoints of patients and their relatives on factors affecting hospital hotel services in Iran in 2015. The results of this study can be used to design a suitable model for the assessment and improvement of hospitality service quality. MATERIALS AND METHODS: In this cross-sectional descriptive study, 10 hospitals of Iran were included...
2016: Journal of Research in Medical Sciences: the Official Journal of Isfahan University of Medical Sciences
https://www.readbyqxmd.com/read/27898092/transposon-mediated-generation-of-cellular-and-mouse-models-of-splicing-mutations-to-assess-the-efficacy-of-snrna-based-therapeutics
#8
Elena Barbon, Mattia Ferrarese, Laetitia van Wittenberghe, Peggy Sanatine, Giuseppe Ronzitti, Fanny Collaud, Pasqualina Colella, Mirko Pinotti, Federico Mingozzi
Disease-causing splicing mutations can be rescued by variants of the U1 small nuclear RNA (U1snRNAs). However, the evaluation of the efficacy and safety of modified U1snRNAs as therapeutic tools is limited by the availability of cellular and animal models specific for a given mutation. Hence, we exploited the hyperactive Sleeping Beauty transposon system (SB100X) to integrate human factor IX (hFIX) minigenes into genomic DNA in vitro and in vivo. We generated stable HEK293 cell lines and C57BL/6 mice harboring splicing-competent hFIX minigenes either wild type (SChFIX-wt) or mutated (SChFIXex5-2C)...
November 29, 2016: Molecular Therapy. Nucleic Acids
https://www.readbyqxmd.com/read/27898033/towards-clinical-application-of-neurotrophic-factors-to-the-auditory-nerve-assessment-of-safety-and-efficacy-by-a-systematic-review-of-neurotrophic-treatments-in-humans
#9
REVIEW
Aren Bezdjian, Véronique J C Kraaijenga, Dyan Ramekers, Huib Versnel, Hans G X M Thomeer, Sjaak F L Klis, Wilko Grolman
Animal studies have evidenced protection of the auditory nerve by exogenous neurotrophic factors. In order to assess clinical applicability of neurotrophic treatment of the auditory nerve, the safety and efficacy of neurotrophic therapies in various human disorders were systematically reviewed. Outcomes of our literature search included disorder, neurotrophic factor, administration route, therapeutic outcome, and adverse event. From 2103 articles retrieved, 20 randomized controlled trials including 3974 patients were selected...
November 26, 2016: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/27893502/implementing-a-4c-approach-to-quality-improvement
#10
Michelle McGonigal
Designing a quality improvement activity can be labor intensive and intimidating to facilitators who have not been specially trained in process improvement methodologies. To simplify the process, a team was formed with the specific task of developing a basic model that addresses key concepts in change theory. The 2010 Institute of Medicine report stresses the importance of health care professionals working together, collaboratively, to use data to improve patient outcomes and improve care nationally. In addition, as noted in Quality and Safety Education for Nurses (2013), competencies have been developed to promote frontline problem solving including using data for quality improvement, providing safe care, functioning in collaborative teams, respecting and addressing patient and family concerns, applying evidence-based practice, and using informatics to make decisions...
January 2017: Critical Care Nursing Quarterly
https://www.readbyqxmd.com/read/27882700/effects-of-lapatinib-or-trastuzumab-alone-and-in-combination-in-human-epidermal-growth-factor-receptor-2-positive-breast-cancer-a-meta-analysis-of-randomized-controlled-trials
#11
Yong Xin, Wen Wen Guo, Qian Huang, Pei Zhang, Long-Zhen Zhang, Guan Jiang, Ye Tian
This meta-analysis compared the efficiency and safety of lapatinib and trastuzumab, alone or in combination, administered with neoadjuvant chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer. For dichotomous variables, the relative risk ratio (RR) and 95% confidence interval (CI) were used to investigate outcome measures: pathological complete response (pCR), neutropenia, diarrhea, dermatologic toxicity, and congestive heart failure (CHF). Eight randomized controlled trials of 2350 participants (837 receiving lapatinib, 913 trastuzumab, and 555 combination therapy) were selected to compare the efficiency and safety of lapatinib to trastuzumab...
November 23, 2016: Cancer Medicine
https://www.readbyqxmd.com/read/27873029/induction-of-pluripotency-in-long-term-cryopreserved-human-neonatal-fibroblasts-in-feeder-free-condition
#12
Maria Csobonyeiova, Lubica Krajciova, Andreas Nicodemou, Stefan Polak, Lubos Danisovic
A novel approach for stem cell generation is the attempt to induce conversion of the adult somatic cells into pluripotent stem cells so called induced pluripotent stem cells (iPSCs) by introducing specific transcription factors. iPSCs have two essential cell characteristics, they are pluripotent and posses long term cell-renewal capacity. Additionally, iPSCs can be derived from patient-specific somatic cells, thus bypassing ethical and immunological issues. The aim of our study was to reprogram long-term cryopreserved human neonatal fibroblasts by new method using lipid nano-particle technology (Lipofectamine 3000 reagent transfection system) in combination with Epi 5 reprogramming vectors...
November 21, 2016: Cell and Tissue Banking
https://www.readbyqxmd.com/read/27871759/rabbit-atg-or-basiliximab-induction-for-rapid-steroid-withdrawal-after-renal-transplantation-harmony-an-open-label-multicentre-randomised-controlled-trial
#13
Oliver Thomusch, Michael Wiesener, Mirian Opgenoorth, Andreas Pascher, Rainer Peter Woitas, Oliver Witzke, Bernd Jaenigen, Markus Rentsch, Heiner Wolters, Thomas Rath, Tülay Cingöz, Urs Benck, Bernhard Banas, Christian Hugo
BACKGROUND: Standard practice for immunosuppressive therapy after renal transplantation is quadruple therapy using antibody induction, low-dose tacrolimus, mycophenolate mofetil, and corticosteroids. Long-term steroid intake significantly increases cardiovascular risk factors with negative effects on the outcome, especially post-transplantation diabetes associated with morbidity and mortality. In this trial, we examined the efficacy and safety parameters of rapid steroid withdrawal after induction therapy with either rabbit antithymocyte globulin (rabbit ATG) or basiliximab in immunologically low-risk patients during the first year after kidney transplantation...
November 18, 2016: Lancet
https://www.readbyqxmd.com/read/27871200/denosumab-targeting-the-rankl-pathway-to-treat-rheumatoid-arthritis
#14
Yahui Grace Chiu, Christopher T Ritchlin
Rheumatoid arthritis (RA) is a chronic inflammatory disorder characterized by focal pathologic bone resorption due to excessive activity of osteoclasts (OC). Receptor activator of nuclear factor kappa B ligand (RANKL) is essential for the proliferation, differentiation, and survival of OC. Denosumab (DMab) is a humanized monoclonal antibody that binds to RANKL with high affinity and blocks its subsequent association with its receptor RANK on the surface of OC precursors. Area covered: The authors review the molecular and cellular mechanisms underlying therapeutic applications of DMab, provide recent highlights on pharmacology, efficacy and safety of DMab, and discuss the potential of DMab as a novel therapeutic option for the treatment of rheumatoid arthritis...
November 30, 2016: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/27870574/evaluation-of-bgj398-a-fibroblast-growth-factor-receptor-1-3-kinase-inhibitor-in-patients-with-advanced-solid-tumors-harboring-genetic-alterations-in-fibroblast-growth-factor-receptors-results-of-a-global-phase-i-dose-escalation-and-dose-expansion-study
#15
Lucia Nogova, Lecia V Sequist, Jose Manuel Perez Garcia, Fabrice Andre, Jean-Pierre Delord, Manuel Hidalgo, Jan H M Schellens, Philippe A Cassier, D Ross Camidge, Martin Schuler, Ulka Vaishampayan, Howard Burris, G Gary Tian, Mario Campone, Zev A Wainberg, Wan-Teck Lim, Patricia LoRusso, Geoffrey I Shapiro, Katie Parker, Xueying Chen, Somesh Choudhury, Francois Ringeisen, Diana Graus-Porta, Dale Porter, Randi Isaacs, Reinhard Buettner, Jürgen Wolf
Purpose This two-part, first-in-human study was initiated in patients with advanced solid tumors harboring genetic alterations in fibroblast growth factor receptors (FGFRs) to determine the maximum tolerated dose (MTD), the recommended phase II dose (RP2D), and the schedule, safety, pharmacokinetics, pharmacodynamics, and antitumor activity of oral BGJ398, a selective FGFR1-3 tyrosine kinase inhibitor. Patients and Methods Adult patients were treated with escalating dosages of BGJ398 5 to 150 mg once daily or 50 mg twice daily continuously in 28-day cycles...
November 21, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/27863620/paediatric-airway-foreign-body-the-human-factors-influencing-patient-safety-in-our-hospitals
#16
O C Okonkwo, A Simons, J Nichani
Foreign bodies in the pediatric airway are an uncommon emergency with a high morbidity and mortality rate. Morbidity ranges from 10 to 20% worldwide and this pathology accounts for up to 7% of accidental deaths in children under 4. Dealing with this emergency safely and effectively is complex, requiring a tight coupling of procedures and processes and optimal anesthetic and operating conditions to prevent errors. These factors are recognized by the World Health Organization as 'Human Factors'. We perform a multi-center assessment of human factors pertinent to this emergency...
December 2016: International Journal of Pediatric Otorhinolaryngology
https://www.readbyqxmd.com/read/27856208/randomized-comparison-of-allogeneic-vs-autologous-mesenchymal-stem-cells-for-non-lschemic-dilated-cardiomyopathy-poseidon-dcm-trial
#17
Joshua M Hare, Darcy L DiFede, Angela M Castellanos, Victoria Florea, Ana M Landin, Jill El-Khorazaty, Aisha Khan, Muzammil Mushtaq, Maureen H Lowery, John J Byrnes, Robert C Hendel, Mauricio G Cohen, Carlos E Alfonso, Krystalenia Valasaki, Marietsy V Pujol, Samuel Golpanian, Eduard Ghersin, Joel E Fishman, Pradip Pattany, Samirah A Gomes, Cindy Delgado, Roberto Miki, Fouad Abuzeid, Mayra Vidro-Casiano, Courtney Premer, Audrey Medina, Valeria Porras, Konstantinos E Hatzistergos, Erica Anderson, Adam Mendizabal, Raul Mitrani, Alan W Heldman
BACKGROUND: While human mesenchymal stem cells (hMSCs) have been tested in ischemic cardiomyopathy, few studies exist in chronic non-ischemic dilated cardiomyopathy (NIDCM). OBJECTIVES: The POSEIDON-DCM trial is a randomized comparison of safety and efficacy of autologous (auto) vs. allogeneic (allo) bone marrow-derived hMSCs in NIDCM. METHODS: Thirty-seven patients were randomized to either allo- or auto-hMSCs in a 1:1 ratio. Patients were recruited between December 2011 and July 2015 at the University of Miami Hospital...
November 14, 2016: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/27853683/medical-ethics-in-plastic-surgery-a-mini-review
#18
REVIEW
Nasrin Nejadsarvari, Ali Ebrahimi, Azin Ebrahimi, Haleh Hashem-Zade
Currently, cosmetic surgery is spread around the world. Several factors are involved in this rapidly evolving field such as socio-economic development, changes in cultural norms, globalization and the effects of Western culture, advertising, media, and mental disorders. Nowadays the cosmetic surgery is becoming a profitable business, which deals exclusively with human appearance and less from the perspective of beauty based on physical protests and considering factors such as sex, age, and race. The morality of plastic surgery subspecialty has undergone many moral dilemmas in the past few years...
September 2016: World Journal of Plastic Surgery
https://www.readbyqxmd.com/read/27852935/safety-pharmacokinetics-and-pharmacodynamics-of-rslv-132-an-rnase-fc-fusion-protein-in-systemic-lupus-erythematosus-a-randomized-double-blind-placebo-controlled-study
#19
D J Burge, J Eisenman, K Byrnes-Blake, P Smolak, K Lau, S B Cohen, A J Kivitz, R Levin, R W Martin, Y Sherrer, J A Posada
Blood-borne RNA circulating in association with autoantibodies is a potent stimulator of interferon production and immune system activation. RSLV-132 is a novel fully human biologic Fc fusion protein that is comprised of human RNase fused to the Fc domain of human IgG1. The drug is designed to remain in circulation and digest extracellular RNA with the aim of preventing activation of the immune system via Toll-like receptors and the interferon pathway. The present study describes the first clinical study of nuclease therapy in 32 subjects with systemic lupus erythematosus...
November 16, 2016: Lupus
https://www.readbyqxmd.com/read/27843368/an-evidence-based-review-of-certolizumab-pegol-in-the-treatment-of-active-psoriatic-arthritis-place-in-therapy
#20
REVIEW
María Laura Acosta-Felquer, Javier Rosa, Enrique R Soriano
Certolizumab pegol (CZP) is a pegylated humanized tumor necrosis factor-α inhibitor (TNFi) approved for the treatment of psoriatic arthritis (PsA) in Europe, the USA, and Latin American countries. CZP neutralizes TNF-α at its soluble and membrane portions. Due to the lack of Fc region, it does not induce complement or antibody-dependent cytotoxicity in vitro, unlike other TNFi. RAPID-PsA study, the only randomized clinical trial performed in PsA, is a Phase III clinical trial conducted in 409 PsA patients during 24 weeks...
2016: Open Access Rheumatology: Research and Reviews
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