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Human Factors in Patient Safety

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https://www.readbyqxmd.com/read/29457921/ribociclib-for-the-treatment-of-hormone-receptor-positive-human-epidermal-growth-factor-receptor-2-negative-advanced-breast-cancer
#1
Howard A Burris
The emergence of cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors marked a significant advancement in the treatment of advanced breast cancer. Ribociclib is an orally bioavailable, highly selective inhibitor of CDK4/6. In combination with various endocrine therapies, ribociclib has demonstrated clinical activity as a first-line therapy for patients with HR+, HER2- advanced breast cancer, without compromising the favorable toxicity profile associated with endocrine therapy. Thus, ribociclib is now considered a new standard of care for HR+, HER2- advanced breast cancer...
March 2018: Expert Review of Anticancer Therapy
https://www.readbyqxmd.com/read/29456473/adverse-events-of-trastuzumab-emtansine-t-dm1-in-the-treatment-of-her2-positive-breast-cancer-patients
#2
REVIEW
Lidia Kowalczyk, Rupert Bartsch, Christian F Singer, Alex Farr
The human epidermal growth factor receptor 2 (HER2) is commonly associated with poor prognosis and is overexpressed in approximately 15-20% of all breast cancers. The introduction of HER2-targeted therapies led to significant improvement in the prognosis of patients with HER2-positive breast cancer, for both early and advanced disease. These targeted therapies include the antibodies trastzumab and pertuzumab, the tyrosine kinase inhibitor lapatinib, and the antibody-drug conjugate trastuzumab emtansine (T-DM1)...
December 2017: Breast Care
https://www.readbyqxmd.com/read/29453628/safety-tolerability-and-preliminary-activity-of-imgn529-a-cd37-targeted-antibody-drug-conjugate-in-patients-with-relapsed-or-refractory-b-cell-non-hodgkin-lymphoma-a-dose-escalation-phase-i-study
#3
Anastasios Stathis, Ian W Flinn, Sumit Madan, Kami Maddocks, Arnold Freedman, Steven Weitman, Emanuele Zucca, Mihaela C Munteanu, M Lia Palomba
Background CD37 is expressed on B-cell lymphoid malignancies, thus making it an attractive candidate for targeted therapy in non-Hodgkin lymphoma (NHL). IMGN529 is an antibody-drug conjugate comprising a CD37-binding antibody linked to the maytansinoid DM1, a potent anti-mitotic agent. Methods This first-in-human, phase 1 trial recruited adult patients with relapsed or refractory B-cell NHL. The primary objective was to determine the maximum tolerated dose (MTD) and recommended phase 2 dose. Secondary objectives were to evaluate safety, pharmacokinetics, and preliminary clinical activity...
February 17, 2018: Investigational New Drugs
https://www.readbyqxmd.com/read/29449785/a-systematic-review-of-burnout-among-doctors-in-china-a-cultural-perspective
#4
REVIEW
Dana Lo, Florence Wu, Mark Chan, Rodney Chu, Donald Li
Background: Numerous studies around the world has already suggested that burnout among doctors is a global phenomenon. However, studies for burnout in doctors are relatively limited in Chinese communities when compared to the West. As risk factors, barriers to intervention and strategies combatting burnout in different parts of the world can vary a lot due to different social culture and healthcare system, study with a focus at doctors in China from a cultural perspective is a worthful endeavor...
2018: Asia Pacific Family Medicine
https://www.readbyqxmd.com/read/29448072/a-phase-iii-study-comparing-sb3-a-proposed-trastuzumab-biosimilar-and-trastuzumab-reference-product-in-her2-positive-early-breast-cancer-treated-with-neoadjuvant-adjuvant-treatment-final-safety-immunogenicity-and-survival-results
#5
X Pivot, I Bondarenko, Z Nowecki, M Dvorkin, E Trishkina, J-H Ahn, S-A Im, T Sarosiek, S Chatterjee, M Z Wojtukiewicz, Y Shparyk, V Moiseyenko, M Bello, V Semiglazov, Y Lee, J Lim
BACKGROUND: The equivalent efficacy between SB3, a proposed trastuzumab biosimilar, and the trastuzumab reference product (TRZ) in terms of the breast pathologic complete response rate after neoadjuvant therapy in patients with early or locally advanced human epidermal growth factor receptor 2-positive breast cancer was demonstrated in the previous report. Here, we report the final safety, immunogenicity and survival results after neoadjuvant-adjuvant treatment. PATIENTS AND METHODS: Patients were randomised 1:1 to receive neoadjuvant SB3 or TRZ for 8 cycles concurrently with chemotherapy (4 cycles of docetaxel followed by 4 cycles of 5-fluorouracil/epirubicin/cyclophosphamide)...
February 12, 2018: European Journal of Cancer
https://www.readbyqxmd.com/read/29445293/clinical-utility-of-ustekinumab-in-crohn-s-disease
#6
REVIEW
Paulo Gustavo Kotze, Christopher Ma, Abdulelah Almutairdi, Remo Panaccione
The introduction of anti-tumor necrosis factor (TNF) therapy marked an important milestone in the management of moderate-to-severe Crohn's disease (CD). However, there remains a pressing demand for alternative therapeutic options for patients with primary nonresponse, secondary loss of response, or intolerable side effects to conventional treatment and TNF antagonists. Ustekinumab (UST) is a fully human IgG1κ monoclonal antibody that inhibits the p40 subunit shared by the proinflammatory cytokines, the interleukin (IL)-12 and -23...
2018: Journal of Inflammation Research
https://www.readbyqxmd.com/read/29443720/retained-guidewires-in-the-veterans-health-administration-getting-to-the-root-of-the-problem
#7
Leila Cherara, Gary L Sculli, Douglas E Paull, Lisa Mazzia, Julia Neily, Peter D Mills
OBJECTIVES: The aims of this study were to investigate the demographics, causes, and contributing factors of retained guidewires (GWs) and to make specific recommendations for their prevention. METHODS: The Veterans Administration patient safety reporting system database for 2000-2016 was queried for cases of retained GWs (RGWs). Data extracted for each case included procedure location, provider experience, insertion site, urgency, time to discovery, root causes, and corrective actions taken...
February 13, 2018: Journal of Patient Safety
https://www.readbyqxmd.com/read/29436084/clinical-trials-and-registries-in-haemophilia-opponents-or-collaborators-comparison-of-pup-data-derived-from-different-data-sources
#8
C Keipert, C J Jonker, H M van den Berg, A Hilger
INTRODUCTION: The "Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products" (ClinGL) provides the requirements for the performing of clinical trials (CTs) for marketing authorization in Europe. The number of eligible previously untreated patients (PUPs) for CTs might be difficult to meet because of the concurrent development of FVIII concentrates, and additional data sources must be explored. AIM: The extent to which CTs and the PedNet registry met relevant parameters, identified in the ClinGL, as well as inhibitor incidences were investigated in patients from both sources...
February 13, 2018: Haemophilia: the Official Journal of the World Federation of Hemophilia
https://www.readbyqxmd.com/read/29423221/a-phase-i-clinical-trial-of-dtcapfs-a-derivative-of-a-novel-human-hormone-peptide-for-the-treatment-of-advanced-metastatic-solid-tumors
#9
Salomon M Stemmer, Ofer Benjaminov, Michael H Silverman, Uziel Sandler, Ofer Purim, Naomi Sender, Chen Meir, Pnina Oren-Apoteker, Joel Ohana, Yoram Devary
The aim of the present phase I first-in-human study was to investigate the safety/efficacy of dTCApFs (a novel hormone peptide that enters cells through the T1/ST2 receptor), in advanced/metastatic solid tumors. The primary objective of this open-label dose-escalation study was to determine the safety profile of dTCApFs. The study enrolled patients (aged ≥18 years) with pathologically confirmed locally advanced/metastatic solid malignancies, who experienced treatment failure or were unable to tolerate previous standard therapy...
January 2018: Molecular and Clinical Oncology
https://www.readbyqxmd.com/read/29404658/-miscommunication-as-a-risk-focus-in-patient-safety-work-process-analysis-in-prehospital-emergency-care
#10
S Wilk, L Siegl, K Siegl, C Hohenstein
BACKGROUND: In an analysis of a critical incident reporting system (CIRS) in out-of-hospital emergency medicine, it was demonstrated that in 30% of cases deficient communication led to a threat to patients; however, the analysis did not show what exactly the most dangerous work processes are. Current research shows the impact of poor communication on patient safety. OBJECTIVES: An out-of-hospital workflow analysis collects data about key work processes and risk areas...
February 5, 2018: Der Anaesthesist
https://www.readbyqxmd.com/read/29401002/phosphatidylinositol-3-kinase-%C3%AE-selective-inhibition-with-alpelisib-byl719-in-pik3ca-altered-solid-tumors-results-from-the-first-in-human-study
#11
Dejan Juric, Jordi Rodon, Josep Tabernero, Filip Janku, Howard A Burris, Jan H M Schellens, Mark R Middleton, Jordan Berlin, Martin Schuler, Marta Gil-Martin, Hope S Rugo, Ruth Seggewiss-Bernhardt, Alan Huang, Douglas Bootle, David Demanse, Lars Blumenstein, Christina Coughlin, Cornelia Quadt, José Baselga
Purpose We report the first-in-human phase Ia study to our knowledge ( ClinicalTrials.gov identifier: NCT01219699) identifying the maximum tolerated dose and assessing safety and preliminary efficacy of single-agent alpelisib (BYL719), an oral phosphatidylinositol 3-kinase α (PI3Kα)-selective inhibitor. Patients and Methods In the dose-escalation phase, patients with PIK3CA-altered advanced solid tumors received once-daily or twice-daily oral alpelisib on a continuous schedule. In the dose-expansion phase, patients with PIK3CA-altered solid tumors and PIK3CA-wild-type, estrogen receptor-positive/human epidermal growth factor receptor 2-negative breast cancer received alpelisib 400 mg once daily...
February 5, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29397126/universal-videolaryngoscopy-a-structured-approach-to-conversion-to-videolaryngoscopy-for-all-intubations-in-an-anaesthetic-and-intensive-care-department
#12
T M Cook, N J Boniface, C Seller, J Hughes, C Damen, L MacDonald, F E Kelly
BACKGROUND: Videolaryngoscopy (VL) is increasingly used, but not yet routine practice, for tracheal intubation. Few departments formally trial equipment before adopting it into practice. We describe the decision-making and implementation processes that our department used when introducing universal VL, with the C-MAC © (Karl Storz, Germany), throughout our anaesthesia and intensive care departments. METHODS: We used a structured process to assess the feasibility of a change to universal VL...
January 2018: British Journal of Anaesthesia
https://www.readbyqxmd.com/read/29394872/design-for-patient-safety-a-systems-based-risk-identification-framework
#13
M C Emre Simsekler, James R Ward, P John Clarkson
Current risk identification practices applied to patient safety in healthcare are insufficient. The situation can be improved, however, by studying systems approaches broadly and successfully utilised in other safety-critical industries, such as aviation and chemical industries. To illustrate this, this paper first investigates current risk identification practices in the healthcare field, and then examines the potential of systems approaches. A systems-based approach, called the Risk Identification Framework (RID Framework), is then developed to enhance improvement in risk identification...
February 2, 2018: Ergonomics
https://www.readbyqxmd.com/read/29392319/nanosecond-laser-treatment-for-age-related-macular-degeneration-does-not-induce-focal-vision-loss-or-new-vessel-growth-in-the-retina
#14
Kirstan A Vessey, Tracy Ho, Andrew I Jobling, Samuel A Mills, Mai X Tran, Alice Brandli, Jackson Lam, Robyn H Guymer, Erica L Fletcher
Purpose: Subthreshold, nanosecond pulsed laser treatment shows promise as a treatment for age-related macular degeneration (AMD); however, the safety profile needs to be robustly examined. The aim of this study was to investigate the effects of laser treatment in humans and mice. Methods: Patients with AMD were treated with nanosecond pulsed laser at subthreshold (no visible retinal effect) energy doses (0.15-0.45 mJ) and retinal sensitivity was assessed with microperimetry...
February 1, 2018: Investigative Ophthalmology & Visual Science
https://www.readbyqxmd.com/read/29383815/viral-safety-of-coagulation-factor-concentrates-memoirs-from-an-insider
#15
Pier Mannuccio Mannucci
The purpose of this essay is to recall the actions taken globally to improve the viral safety of coagulation factor concentrates, mainly in the years from 1985 to 1990, at a time of confusing and often contradictory information on bloodborne viral infections in multitransfused patients with hemophilia (PWH). I shall first recall the problem of the transmission and control of the hepatitis viruses and then that of the human immunodeficiency virus (HIV): not only for temporal reasons but also because understanding the progress of knowledge on hepatitis and the poor success of the early measures taken to tackle this problem in PWH is essential to understand how the problem of HIV transmission was ultimately dealt with success...
January 31, 2018: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/29381780/x-linked-hypophosphatemia-and-fgf23-related-hypophosphatemic-diseases-prospect-for-new-treatment
#16
Yuka Kinoshita, Seiji Fukumoto
Phosphate plays essential roles in many biological processes, and the serum phosphate level is tightly controlled. Chronic hypophosphatemia causes impaired mineralization of the bone matrix and results in rickets and osteomalacia. Fibroblast growth factor 23 (FGF23) is a bone-derived hormone that regulates phosphate metabolism. FGF23 excess induces hypophosphatemia via impaired phosphate reabsorption in the renal proximal tubules and decreased phosphate absorption in the intestines. There are several types of genetic and acquired form of FGF23-related hypophosphatemic diseases...
January 26, 2018: Endocrine Reviews
https://www.readbyqxmd.com/read/29373274/efficacy-and-safety-of-ramucirumab-with-docetaxel-versus-placebo-with-docetaxel-as-second-line-treatment-of-advanced-non-small-cell-lung-cancer-a-subgroup-analysis-according-to-patient-age-in-the-revel-trial
#17
Suresh S Ramalingam, Maurice Pérol, Martin Reck, Ruben Dario Kowalyszyn, Oliver Gautschi, Martin Kimmich, Eun Kyung Cho, Grzegorz Czyzewicz, Alexandru Grigorescu, Nina Karaseva, Shaker Dakhil, Pablo Lee, Annamaria Zimmerman, Andreas Sashegyi, Ekaterine Alexandris, Gebra Cuyun Carter, Katherine B Winfree, Edward B Garon
INTRODUCTION: Ramucirumab, a recombinant human immunoglobulin G1 monoclonal antibody receptor antagonist designed to block the ligand-binding site of vascular endothelial growth factor receptor-2 (VEGFR-2), was evaluated as second-line treatment in combination with docetaxel in patients with non-small-cell lung cancer in the REVEL trial (NCT01168973). Ramucirumab significantly improved overall survival (OS) and progression-free survival (PFS). We report age subgroup analysis results primarily on the basis of a 65-year cutoff...
December 21, 2017: Clinical Lung Cancer
https://www.readbyqxmd.com/read/29373094/phase-iii-randomized-double-blind-study-comparing-the-efficacy-safety-and-immunogenicity-of-sb3-trastuzumab-biosimilar-and-reference-trastuzumab-in-patients-treated-with-neoadjuvant-therapy-for-human-epidermal-growth-factor-receptor-2-positive-early-breast
#18
Xavier Pivot, Igor Bondarenko, Zbigniew Nowecki, Mikhail Dvorkin, Ekaterina Trishkina, Jin-Hee Ahn, Yuriy Vinnyk, Seock-Ah Im, Tomasz Sarosiek, Sanjoy Chatterjee, Marek Z Wojtukiewicz, Vladimir Moiseyenko, Yaroslav Shparyk, Maximino Bello, Vladimir Semiglazov, Sujeong Song, Jaeyun Lim
Purpose This phase III study compared SB3, a trastuzumab (TRZ) biosimilar, with reference TRZ in patients with human epidermal growth factor receptor 2-positive early breast cancer in the neoadjuvant setting ( ClinicalTrials.gov identifier: NCT02149524). Patients and Methods Patients were randomly assigned to receive neoadjuvant SB3 or TRZ for eight cycles concurrently with chemotherapy (four cycles of docetaxel followed by four cycles of fluorouracil, epirubicin, and cyclophosphamide) followed by surgery, and then 10 cycles of adjuvant SB3 or TRZ...
January 26, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29369195/the-effectiveness-of-korean-medicine-treatment-in-male-patients-with-infertility-a-study-protocol-for-a-prospective-observational-pilot-study
#19
Kwan-Ii Kim, Junyoung Jo
Male factor subfertility has increasingly been considered the cause of infertility in couples. Many men with male infertility have sperm problems such as oligozoospermia, asthenozoospermia, or teratozoospermia. Because abnormal semen parameters are idiopathic to some extent, no standard therapy has been established to date. Herbal medicine has been reported to have beneficial properties in the treatment of subfertility, especially in improving semen quality both in vivo and in human studies. Therefore, we intend to investigate the effectiveness and safety of treatment using Korean medicine (KM) for infertile male patients with poor semen quality...
January 2018: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29364966/novel-anti-cancer-drug-coti-2-synergizes-with-therapeutic-agents-and-does-not-induce-resistance-or-exhibit-cross-resistance-in-human-cancer-cell-lines
#20
Saman Maleki Vareki, Kowthar Y Salim, Wayne R Danter, James Koropatnick
Emerging drug-resistance and drug-associated toxicities are two major factors limiting successful cancer therapy. Combinations of chemotherapeutic drugs have been used in the clinic to improve patient outcome. However, cancer cells can acquire resistance to drugs, alone or in combination. Resistant tumors can also exhibit cross-resistance to other chemotherapeutic agents, resulting in sub-optimal treatment and/or treatment failure. Therefore, developing novel oncology drugs that induce no or little acquired resistance and with a favorable safety profile is essential...
2018: PloS One
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