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Human Factors in Patient Safety

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https://www.readbyqxmd.com/read/28107664/safety-and-efficacy-of-cardiopoietic-stem-cells-in-the-treatment-of-post-infarction-left-ventricular-dysfunction-from-cardioprotection-to-functional-repair-in-a-translational-pig-infarction-model
#1
Maximilian Y Emmert, Petra Wolint, Andras Jakab, Sean P Sheehy, Francesco S Pasqualini, Thi Dan Linh Nguyen, Monika Hilbe, Burkhardt Seifert, Benedikt Weber, Chad E Brokopp, Dominika Macejovska, Etem Caliskan, Arnold von Eckardstein, Ruth Schwartlander, Viola Vogel, Volkmar Falk, Kevin Kit Parker, Mariann Gyöngyösi, Simon P Hoerstrup
To date, clinical success of cardiac cell-therapies remains limited. To enhance the cardioreparative properties of stem cells, the concept of lineage-specification through cardiopoietic-guidance has been recently suggested. However, so far, only results from murine studies and from a clinical pilot-trial in chronic heart-failure (CHF) are available, while systematic evidence of its therapeutic-efficacy is still lacking. Importantly, also no data from large animals or for other indications are available. Therefore, we here investigate the therapeutic-efficacy of human cardiopoietic stem cells in the treatment of post-infarction LV-dysfunction using a translational pig-model...
November 23, 2016: Biomaterials
https://www.readbyqxmd.com/read/28106226/applied-taguchi-method-for-fatigue-testing-of-customized-hip-implant
#2
Mangesh R Dharme, Abhaykumar M Kuthe, Tushar R Deshmukh
PURPOSE: Human activities generate stresses, which vary with time and may result in fatigue failure of the customized hip implant. This study aims to investigate fatigue testing of customized hip implants using the minimum number of experiments by the Taguchi method, for 147 patients. This study was also useful to determine the influential geometrical parameters on the fatigue safety factor of customized hip implants. METHODS: Horizontal offset (HO), vertical offset (VO) and neck shaft angle (NSA) of the hip joint of 147 patients were measured on computed tomography (CT) scanned images...
January 20, 2017: International Journal of Artificial Organs
https://www.readbyqxmd.com/read/28103925/protocol-for-a-realist-review-of-workplace-learning-in-postgraduate-medical-education-and-training
#3
Anel Wiese, Caroline Kilty, Colm Bergin, Patrick Flood, Na Fu, Mary Horgan, Agnes Higgins, Bridget Maher, Grainne O'Kane, Lucia Prihodova, Dubhfeasa Slattery, Deirdre Bennett
BACKGROUND: Postgraduate medical education and training (PGMET) is a complex social process which happens predominantly during the delivery of patient care. The clinical learning environment (CLE), the context for PGMET, shapes the development of the doctors who learn and work within it, ultimately impacting the quality and safety of patient care. Clinical workplaces are complex, dynamic systems in which learning emerges from non-linear interactions within a network of related factors and activities...
January 19, 2017: Systematic Reviews
https://www.readbyqxmd.com/read/28103444/efficacy-and-safety-of-a-recombinant-factor-viii-produced-from-a-human-cell-line-simoctocog-alfa
#4
Massimo Franchini, Pier Mannuccio Mannucci
The development of inhibitors against infused factor VIII (FVIII) has a detrimental impact on health and quality of life of patients with hemophilia A. Several observational studies and a recently published randomized trial indicate that the inhibitor risk in previously untreated patients (PUPs) is higher following the use of recombinant FVIII (rFVIII) products compared with plasma-derived FVIII concentrates. There is currently a great interest towards newer rFVIII products that adopt various technological solutions to reduce the inhibitor risk...
January 19, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28092200/the-challenges-surrounding-preclinical-testing-in-transcatheter-device-development-and-the-implications-on-the-clinic
#5
Ralf Holzer, Jake Goble, Ziyad Hijazi
Transcatheter devices have contributed significantly to the advances achieved in treating many cardiovascular conditions over the last few decades. Sophisticated and detailed preclinical testing is not only a regulatory requirement to support an investigational device exemption (IDE) application, but more crucially its success and accuracy is needed to safeguard patients during the subsequent clinical testing stages. Areas Covered: This article covers the regulatory background as well as specific considerations related to pre-clinical testing of transcatheter devices...
January 16, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28088688/randomized-phase-iii-study-to-assess-efficacy-and-safety-of-adjuvant-capox-with-or-without-bevacizumab-in-patients-after-resection-of-colorectal-liver-metastases-hepatica-study
#6
Nikol Snoeren, Richard van Hillegersberg, Sander B Schouten, Andre M Bergman, Erikv van Werkhoven, Otilia Dalesio, Rob A E M Tollenaar, Henk M Verheul, Joost van der Sijp, Inne H M Borel Rinkes, E E Voest
Bevacizumab is a humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF). Recurrence after resection of colorectal liver metastases (CRLMs), presumably caused by VEGF-mediated outgrowth of micrometastases, might decrease when VEGF is inhibited. This study examines the efficacy and safety of adding bevacizumab to an adjuvant regimen of CAPOX in patients undergoing radical resection for their CRLMs. Patients with resected CRLMs were randomized after surgery to receive CAPOX and bevacizumab (arm A) or CAPOX alone (arm B) as adjuvant treatment...
January 12, 2017: Neoplasia: An International Journal for Oncology Research
https://www.readbyqxmd.com/read/28079584/the-development-and-implementation-of-cognitive-aids-for-critical-events-in-pediatric-anesthesia-the-society-for-pediatric-anesthesia-critical-events-checklists
#7
Anna Clebone, Barbara K Burian, Scott C Watkins, Jorge A Gálvez, Justin L Lockman, Eugenie S Heitmiller
Cognitive aids such as checklists are commonly used in modern operating rooms for routine processes, and the use of such aids may be even more important during critical events. The Quality and Safety Committee of the Society for Pediatric Anesthesia (SPA) has developed a set of critical-event checklists and cognitive aids designed for 3 purposes: (1) as a repository of the latest evidence-based and expert opinion-based information to guide response and management of critical events, (2) as a source of just-in-time information during critical events, and (3) as a method to facilitate a shared understanding of required actions among team members during a critical event...
January 10, 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28077675/post-hoc-assessment-of-the-immunogenicity-of-bioengineered-factor-viia-demonstrates-the-use-of-preclinical-tools
#8
Kasper Lamberth, Stine Louise Reedtz-Runge, Jonathan Simon, Ksenia Klementyeva, Gouri Shankar Pandey, Søren Berg Padkjær, Véronique Pascal, Ileana R León, Charlotte Nini Gudme, Søren Buus, Zuben E Sauna
Immunogenicity is an important consideration in the licensure of a therapeutic protein because the development of neutralizing anti-drug antibodies (ADAs) can affect both safety and efficacy. Neoantigens introduced by bioengineering of a protein drug are a particular cause for concern. The development of a bioengineered recombinant factor VIIa (rFVIIa) analog was discontinued after phase 3 trials because of the development of ADAs. The unmodified parent molecule (rFVIIa), on the other hand, has been successfully used as a drug for more than two decades with no reports of immunogenicity in congenital hemophilia patients with inhibitors...
January 11, 2017: Science Translational Medicine
https://www.readbyqxmd.com/read/28076342/knowledge-beliefs-and-attitudes-report-on-patient-care-and-safety-in-undergraduate-students-validating-the-modified-apsq-iii-questionnaire
#9
Ezequiel García Elorrio, Dolores Macchiavello, Viviana Rodriguez, Yael Catalano, Giuliana Corna, Josefina Dahinten, Marina Ontivero
INTRODUCTION: Patient safety aims to achieve healthcare free of damage. The World Health Organization indicates that this objective is achieved through communication, analysis, and prevention of adverse events in patients. Organizational culture has been identified as one of the main factors for interventions aimed to reduce medical errors; and an essential component of safety culture is the attitude of health professionals towards medical error. Attitudes can be improved through appropriate education in biomedical careers but its inclusion in Argentina is scarce...
December 20, 2016: Medwave
https://www.readbyqxmd.com/read/28073086/human-neural-progenitors-derived-from-integration-free-ipscs-for-sci-therapy
#10
Ying Liu, Yiyan Zheng, Shenglan Li, Haipeng Xue, Karl Schmitt, Georgene W Hergenroeder, Jiaqian Wu, Yuanyuan Zhang, Dong H Kim, Qilin Cao
As a potentially unlimited autologous cell source, patient induced pluripotent stem cells (iPSCs) provide great capability for tissue regeneration, particularly in spinal cord injury (SCI). However, despite significant progress made in translation of iPSC-derived neural progenitor cells (NPCs) to clinical settings, a few hurdles remain. Among them, non-invasive approach to obtain source cells in a timely manner, safer integration-free delivery of reprogramming factors, and purification of NPCs before transplantation are top priorities to overcome...
January 5, 2017: Stem Cell Research
https://www.readbyqxmd.com/read/28070607/-human-factors-in-medicine
#11
M Lazarovici, H Trentzsch, S Prückner
The concept of human factors is commonly used in the context of patient safety and medical errors, all too often ambiguously. In actual fact, the term comprises a wide range of meanings from human-machine interfaces through human performance and limitations up to the point of working process design; however, human factors prevail as a substantial cause of error in complex systems. This article presents the full range of the term human factors from the (emergency) medical perspective. Based on the so-called Swiss cheese model by Reason, we explain the different types of error, what promotes their emergence and on which level of the model error prevention can be initiated...
January 9, 2017: Der Anaesthesist
https://www.readbyqxmd.com/read/28069561/cancer-survivors-experience-with-telehealth-a-systematic-review-and-thematic-synthesis
#12
REVIEW
Anna Cox, Grace Lucas, Afrodita Marcu, Marianne Piano, Wendy Grosvenor, Freda Mold, Roma Maguire, Emma Ream
BACKGROUND: Net survival rates of cancer are increasing worldwide, placing a strain on health service provision. There is a drive to transfer the care of cancer survivors-individuals living with and beyond cancer-to the community and encourage them to play an active role in their own care. Telehealth, the use of technology in remote exchange of data and communication between patients and health care professionals (HCPs), is an important contributor to this evolving model of care. Telehealth interventions are "complex," and understanding patient experiences of them is important in evaluating their impact...
January 9, 2017: Journal of Medical Internet Research
https://www.readbyqxmd.com/read/28067682/utilizing-a-human-factors-nursing-worksystem-improvement-framework-to-increase-nurses-time-at-the-bedside-and-enhance-safety
#13
C Adam Probst, Megan Carter, Caton Cadigan, Cortney Dalcour, Cindy Cassity, Penny Quinn, Tiana Williams, Donna Cook Montgomery, Claudia Wilder, Yan Xiao
OBJECTIVE: The aim of this study is to increase nurses' time for direct patient care and improve safety via a novel human factors framework for nursing worksystem improvement. BACKGROUND: Time available for direct patient care influences outcomes, yet worksystem barriers prevent nurses adequate time at the bedside. METHODS: A novel human factors framework was developed for worksystem improvement in 3 units at 2 facilities. Objectives included improving nurse efficiency as measured by time-and-motion studies, reducing missing medications and subsequent trips to medication rooms and improving medication safety...
January 7, 2017: Journal of Nursing Administration
https://www.readbyqxmd.com/read/28060539/bococizumab-for-the-treatment-of-hypercholesterolaemia
#14
Nicola Ferri, Alberto Corsini, Cesare R Sirtori, Massimiliano Ruscica
Low-density lipoprotein cholesterol (LDL-C) remains a well-established risk factor for cardiovascular disease (CVD). LDL-C levels are considered primary targets of therapy. A new series of systemic biomolecules, the monoclonal antibodies (mAbs) of proprotein convertase subtilisin/kexin type 9 (PCSK9), have a higher activity in reducing LDL-C. Areas covered: The authors critically review the current evidence on the efficacy and safety of bococizumab, a humanized mAb against PCSK9, which was surprisingly discontinued in November 2016...
February 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28058456/-human-factors-in-medicine
#15
M Lazarovici, H Trentzsch, S Prückner
The concept of human factors is commonly used in the context of patient safety and medical errors, all too often ambiguously. In actual fact, the term comprises a wide range of meanings from human-machine interfaces through human performance and limitations up to the point of working process design; however, human factors prevail as a substantial cause of error in complex systems. This article presents the full range of the term human factors from the (emergency) medical perspective. Based on the so-called Swiss cheese model by Reason, we explain the different types of error, what promotes their emergence and on which level of the model error prevention can be initiated...
January 2017: Der Urologe. Ausg. A
https://www.readbyqxmd.com/read/28058010/protocol-for-laparoscopic-cholecystectomy-is-it-rocket-science
#16
REVIEW
Tomohide Hori, Fumitaka Oike, Hiroaki Furuyama, Takafumi Machimoto, Yoshio Kadokawa, Toshiyuki Hata, Shigeru Kato, Daiki Yasukawa, Yuki Aisu, Maho Sasaki, Yusuke Kimura, Yuichiro Takamatsu, Masato Naito, Masaya Nakauchi, Takahiro Tanaka, Daigo Gunji, Kiyokuni Nakamura, Kiyoko Sato, Masahiro Mizuno, Taku Iida, Shintaro Yagi, Shinji Uemoto, Tsunehiro Yoshimura
Laparoscopic cholecystectomy (LC) does not require advanced techniques, and its performance has therefore rapidly spread worldwide. However, the rate of biliary injuries has not decreased. The concept of the critical view of safety (CVS) was first documented two decades ago. Unexpected injuries are principally due to misidentification of human factors. The surgeon's assumption is a major cause of misidentification, and a high level of experience alone is not sufficient for successful LC. We herein describe tips and pitfalls of LC in detail and discuss various technical considerations...
December 21, 2016: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/28056917/fulranumab-in-patients-with-interstitial-cystitis-bladder-pain-syndrome-observations-from-a-randomized-double-blind-placebo-controlled-study
#17
Hao Wang, Lucille J Russell, Kathleen M Kelly, Steven Wang, John Thipphawong
BACKGROUND: This study was designed to evaluate the efficacy and safety of fulranumab, a fully human monoclonal antibody directed against nerve growth factor (NGF), for pain relief in patients with interstitial cystitis/bladder pain syndrome (IC/BPS). METHODS: In this multicenter, double-blind study, adults with IC/BPS (i.e., interstitial cystitis symptom index [ICSI] total score ≥8) accompanied by chronic, moderate-to-severe pain were randomized to fulranumab 9 mg or matching placebo, administered subcutaneously at weeks 1, 5, and 9...
January 5, 2017: BMC Urology
https://www.readbyqxmd.com/read/28056400/efficacy-and-safety-of-eribulin-as-first-to-third-line-treatment-in-patients-with-advanced-or-metastatic-breast-cancer-previously-treated-with-anthracyclines-and-taxanes
#18
Shigeto Maeda, Michiyo Saimura, Shigeki Minami, Kaname Kurashita, Reiki Nishimura, Yuichiro Kai, Hiroshi Yano, Kohjiro Mashino, Shoshu Mitsuyama, Mototsugu Shimokawa, Kazuo Tamura
OBJECTIVES: Despite the survival benefit and acceptable tolerability of eribulin for advanced/metastatic breast cancer (MBC) patients pretreated with anthracyclines and taxanes, there is limited evidence of the clinical benefit of early eribulin use. We investigated the efficacy and safety of first- to third-line eribulin use in patients with MBC. MATERIALS AND METHODS: In this phase II, open-label, single-arm study conducted at 14 sites in Kyushu, Japan, women with histologically confirmed human epidermal growth factor receptor 2-negative MBC were enrolled between December 1, 2011 and November 30, 2013 (Data cut-off: November 30, 2014)...
January 2, 2017: Breast: Official Journal of the European Society of Mastology
https://www.readbyqxmd.com/read/28056202/trastuzumab-emtansine-with-or-without-pertuzumab-versus-trastuzumab-plus-taxane-for-human-epidermal-growth-factor-receptor-2-positive-advanced-breast-cancer-primary-results-from-the-phase-iii-marianne-study
#19
Edith A Perez, Carlos Barrios, Wolfgang Eiermann, Masakazu Toi, Young-Hyuck Im, Pierfranco Conte, Miguel Martin, Tadeusz Pienkowski, Xavier Pivot, Howard Burris, Jennifer A Petersen, Sven Stanzel, Alexander Strasak, Monika Patre, Paul Ellis
Purpose Trastuzumab and pertuzumab are human epidermal growth factor receptor 2 (HER2) -targeted monoclonal antibodies, and trastuzumab emtansine (T-DM1) is an antibody-drug conjugate that combines the properties of trastuzumab with the cytotoxic activity of DM1. T-DM1 demonstrated encouraging efficacy and safety in a phase II study of patients with previously untreated HER2-positive metastatic breast cancer. Combination T-DM1 and pertuzumab showed synergistic activity in cell culture models and had an acceptable safety profile in a phase Ib and II study...
January 10, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28055955/chimeric-antigen-receptor-modified-t-cells-inhibit-the-growth-and-metastases-of-established-tissue-factor-positive-tumors-in-nog-mice
#20
Qing Zhang, Haiyu Wang, Huizhong Li, Jinjing Xu, Kang Tian, Jie Yang, Zheng Lu, Junnian Zheng
Chimeric antigen receptor (CAR)-modified T cell (CAR T) is a promising therapeutic option for patients with cancer. Such an approach requires the identification of tumor-specific antigen targets that are expressed in solid tumors. We developed a new third-generation CAR directed against tissue factor (TF), a surface molecule overexpressed in some types of lung cancer, melanoma and other cancers. First, we demonstrated by immunohistochemistry that TF was overexpressed in squamous cell carcinoma and adenocarcinoma of non-small cell lung cancer (NSCLC) and melanoma using a human tissue microarray...
December 30, 2016: Oncotarget
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