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Patient Safety and Quality

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https://www.readbyqxmd.com/read/27914633/what-can-big-data-offer-the-pharmacovigilance-of-orphan-drugs
#1
John Price
The pharmacovigilance of drugs for orphan diseases presents problems related to the small patient population. Obtaining high-quality information on individual reports of suspected adverse reactions is of particular importance for the pharmacovigilance of orphan drugs. The possibility of mining "big data" to detect suspected adverse reactions is being explored in pharmacovigilance generally but may have limited application to orphan drugs. Sources of big data such as social media may be infrequently used as communication channels by patients with rare disease or their caregivers or by health care providers; any adverse reactions identified are likely to reflect what is already known about the safety of the drug from the network of support that grows up around these patients...
November 30, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27914503/rationale-and-design-of-the-transcatheter-aortic-valve-replacement-to-unload-the-left-ventricle-in-patients-with-advanced-heart-failure-tavr-unload-trial
#2
Ernest Spitzer, Nicolas M Van Mieghem, Philippe Pibarot, Rebecca T Hahn, Susheel Kodali, Mathew S Maurer, Tamim M Nazif, Josep Rodés-Cabau, Jean-Michel Paradis, Arie-Pieter Kappetein, Ori Ben-Yehuda, Gerrit-Anne van Es, Faouzi Kallel, William N Anderson, Jan Tijssen, Martin B Leon
BACKGROUND: Coexistence of moderate aortic stenosis (AS) in patients with heart failure (HF) with reduced ejection fraction is not uncommon. Moderate AS increases afterload, whereas pharmacologic reduction of afterload is a pillar of contemporary HF management. HYPOTHESIS: Unloading the left ventricle by reducing the transaortic gradient with transfemoral transcatheter aortic valve replacement (TAVR) may improve clinical outcomes in patients with moderate AS and HF with reduced ejection fraction...
December 2016: American Heart Journal
https://www.readbyqxmd.com/read/27914499/exercise-training-improves-exercise-capacity-and-quality-of-life-after-transcatheter-aortic-valve-implantation-a-randomized-pilot-trial
#3
Axel Pressler, Jeffrey W Christle, Benjamin Lechner, Viola Grabs, Bernhard Haller, Ina Hettich, David Jochheim, Julinda Mehilli, Rüdiger Lange, Sabine Bleiziffer, Martin Halle
BACKGROUND: Transcatheter aortic valve implantation (TAVI) is increasingly applied for aortic stenosis in elderly patients with impaired mobility and reduced quality of life. These patients may particularly benefit from postinterventional exercise programs, but no randomized study has evaluated the safety and efficacy of exercise in this population. METHODS: In a prospective pilot study, 30 patients after TAVI (mean age, 81±6 years, 44% female, 83±34 days postintervention) were randomly allocated 1:1 to a training group (TG) performing 8 weeks of supervised combined endurance and resistance exercise or to usual care...
December 2016: American Heart Journal
https://www.readbyqxmd.com/read/27913517/treatment-of-low-risk-myelodysplastic-syndromes
#4
Valeria Santini
The majority of myelodysplastic syndrome (MDS) patients belong to the International Prognostic Scoring System (IPSS) and IPSS-revised (IPSS-R) lower-risk categories. Their precise diagnostics and prognostic stratification is often a challenge, but may ensure the optimization of therapy. The availability of diverse treatment options has significantly improved the quality of life and survival of this group of patients. Anemia is the most relevant cytopenia in terms of frequency and symptoms in lower-risk MDS, and may be treated successfully with erythropoietic stimulating agents, provided a careful selection is performed on the basis of IPSS-R, endogenous erythropoietin levels, and transfusion independence...
December 2, 2016: Hematology—the Education Program of the American Society of Hematology
https://www.readbyqxmd.com/read/27913269/the-structure-organisation-and-perioperative-management-of-ambulatory-surgery-and-anaesthesia-in-france-methodology-of-the-sfar-opera-study
#5
Pierre Albaladejo, Frédéric Aubrun, Charles-Marc Samama, Laurent Jouffroy, Marc Beaussier, Dan Benhamou, Pauline Romegoux, Kristina Skaare, Jean Luc Bosson, Claude Ecoffey
The organization of health care establishments and perioperative care are essential for ensuring the quality of care and safety of patients undergoing outpatient surgery. In order to correctly inventory these organizations and practices, in 2013-2014, the French Society of Anaesthesia and Intensive Care organized an extensive practical survey in French ambulatory surgery units entitled the "OPERA" study (Organisation PERiopératoire de l'anesthésie en chirurgie Ambulatoire). From among all of the ambulatory surgery centres listed by the Agences Régionales de Santé [Regional Health Agencies, France], 206 public and private centres were randomly selected...
November 29, 2016: Anaesthesia, Critical Care & Pain Medicine
https://www.readbyqxmd.com/read/27913152/development-and-validation-of-an-objective-scoring-tool-for-robot-assisted-radical-prostatectomy-prostatectomy-assessment-and-competency-evaluation-pace
#6
Ahmed A Hussein, Khurshid R Ghani, James Peabody, Richard Sarle, Ronney Abaza, Daniel Eun, Jim Hu, Michael Fumo, Brian Lane, Jeffrey Montgomery, Nobuyuki Hinata, Deborah Rooney, Bryan Comstock, Hei Kit Chan, Sridhar S Mane, James L Mohler, Gregory Wilding, David Miller, Khurshid A Guru
INTRODUCTION: and Background: Comprehensive training and skill acquisition by urologic surgeons are vital to optimize surgical outcomes and patient safety. We sought to develop and validate an objective and procedure specific tool to assess the quality of robot-assisted radical prostatectomy (RARP)-Prostatectomy Assessment and Competence Evaluation (PACE) METHODS: Development and content validation of PACE was performed by deconstruction of RARP into seven key domains utilizing the Delphi methodology...
November 29, 2016: Journal of Urology
https://www.readbyqxmd.com/read/27913032/intervention-studies-of-inhaled-corticosteroids-combined-with-long-acting-theophylline-or-long-acting-%C3%AE-2-agonists-in-patients-with-moderate-to-severe-asthma-a-randomized-controlled-study
#7
Yan Wang, Ping Chen, Anna Dai, Shengyun Shang, Lingfei Kong
PURPOSE: To evaluate and contrast the therapeutic effect and safety of fluticasone aerosol combined with theophylline tablets in patients with moderate to severe asthma, compared with salmeterol/fluticasone propionate aerosol. METHODS: After a screening period, patients meeting the inclusion criteria were randomly assigned to the experiment group (fluticasone aerosol combined with theophylline tablets) or the control group (salmeterol/fluticasone aerosol combined with placebo tablets) for 12 weeks of treatment...
November 29, 2016: Clinical Therapeutics
https://www.readbyqxmd.com/read/27912976/implications-of-a-negative-abdominal-ct-in-the-management-of-pediatric-blunt-abdominal-trauma
#8
Sarah Braungart, Thomas Beattie, Paula Midgley, Mark Powis
BACKGROUND: No consensus exists on management of children with a negative trauma CT following blunt abdominal trauma (BAT). Asymptomatic children are frequently "admitted for observation" following negative CT owing to concerns about missing an intraabdominal injury (IAI) without evidence for this practice. We aimed to investigate the feasibility of discharge following a negative CT scan in children sustaining blunt abdominal trauma. METHODS: Retrospective audit at a UK paediatric major trauma center and review of the literature...
November 14, 2016: Journal of Pediatric Surgery
https://www.readbyqxmd.com/read/27912964/a-systematic-review-and-meta-analysis-of-the-herbal-formula-buzhong-yiqi-tang-for-stable-chronic-obstructive-pulmonary-disease
#9
REVIEW
Yuanbin Chen, Johannah Linda Shergis, Lei Wu, Xuhua Yu, Qigang Zeng, Yinji Xu, Xinfeng Guo, Anthony Lin Zhang, Charlie Changli Xue, Lin Lin
OBJECTIVE: To systematically evaluate the efficacy and safety of Buzhong Yiqi Tang (BZYQT) for stable chronic obstructive pulmonary disease (COPD). METHODS: Three electronic English databases (PubMed, EMBASE and CENTRAL) and four Chinese databases (CBM, CNKI, CQVIP and WFMO) were searched from their inceptions until 30th June 2016. Participants were diagnosed with COPD according to the Chinese Medical Association's COPD diagnosis and treatment guidelines or Global Initiative for Chronic Obstructive Lung Disease (GOLD), and were in stable stage...
December 2016: Complementary Therapies in Medicine
https://www.readbyqxmd.com/read/27912961/the-effect-of-chinese-herbal-medicine-on-hemorrhagic-shock-a-systematic-review-and-meta-analysis
#10
REVIEW
Da-Long Wang, Xiao-Guang Lu, Wen-Xiu Guo, Tuo Chen, Yi Song, Zhi-Wei Fan
BACKGROUND: Chinese herbal medicine (CHM) has been widely used in the treatment of hemorrhagic shock (HS) in China. Many controlled trials have been undertaken to investigate its efficacy. OBJECTIVE: To evaluate the effectiveness and safety of CHM for Hemorrhagic Shock patients. METHODS: We screening the Web of ScienceDirect database, PubMed, the Cochrane Library, EMBASE, China Biomedical Database web (CBM), China National Knowledge Infrastructure (CNKI) and WanFang database (WF), from inception to January 2015...
December 2016: Complementary Therapies in Medicine
https://www.readbyqxmd.com/read/27912934/effect-of-sequential-treatment-with-tcm-syndrome-differentiation-on-acute-exacerbation-of-chronic-obstructive-pulmonary-disease-and-aecopd-risk-window
#11
Li Jiansheng, Wang Haifeng, Li Suyun, Zhang Hailong, Yu Xueqing, Zhang Xiaoyun, Li Fengsen, Zhou Xianmei, Sun Zikai, Mao Yimin, Ma Lijun, Zhang Yijie, Zhang Guojun, Tang Bingxiang
OBJECTIVE: To evaluate the efficacy and safety of the comprehensive interventions based on three Traditional Chinese medicine (TCM) patterns therapy in acute exacerbations of chronic obstructive pulmonary disease (AECOPD) and AECOPD risk window. METHODS: A prospective, multi-center, single-blinded, double-dummy and randomized controlled clinical trial is being conducted to test the therapeutic effects of a sequential two stage treatment. A total of 364 patients were enrolled into this study with 182 in each treatment group (TCM and conventional)...
December 2016: Complementary Therapies in Medicine
https://www.readbyqxmd.com/read/27911456/mid-term-results-of-recap-magnum-taperloc-metal-on-metal-total-hip-arthroplasty-with-mean-follow-up-of-7-1-years
#12
Antonios A Koutalos, Aristotelis Kourtis, Ian C Clarke, Evert J Smith
INTRODUCTION: Despite enthusiasm for metal-on-metal bearings, disappointing short- to mid-term outcomes has all but halted the use of this bearing articulation. This review presents mid-term results for the ReCap Magnum total hip replacement. PATIENTS AND METHODS: This prospective study evaluated 79 ReCap/Magnum/Taperloc total hip replacements with mean follow-up of 7.1 (range 3.7-9.2) years. 43 were female and 36 male. Metal ions were measured and radiographic measurement included a 'margin of safety' angle to quantify risk of edge loading...
December 2, 2016: Hip International: the Journal of Clinical and Experimental Research on Hip Pathology and Therapy
https://www.readbyqxmd.com/read/27911406/ultrasound-guided-botulinum-toxin-a-injections-a-method-of-treating-sialorrhea
#13
Pierangelo Barbero, Marco Busso, Carlo Alberto Artusi, Stefania De Mercanti, Marco Tinivella, Andrea Veltri, Luca Durelli, Marinella Clerico
Neurological diseases can be complicated by sialorrhea, an excessive flow of saliva. Patients suffering from moderate to severe sialorrhea have an impaired quality of life, often worsened by correlated complications such as aspiration pneumonia, oral infections, dental caries, and maceration of the skin. Diverse therapeutic approaches have been proposed for the treatment of sialorrhea, including surgery and the use of anticholinergic agents, with limited results and the possible occurrence of serious adverse events...
November 9, 2016: Journal of Visualized Experiments: JoVE
https://www.readbyqxmd.com/read/27910796/reinforcement-of-emergency-department-reduces-acute-admissions-to-medical-department
#14
Mansoor Ahmed Dawood, Gideon Ertner, Jacob Hansen-Schwartz
INTRODUCTION: The medical decision capacity of emergency departments (ED) may rest within the department itself or depend on external consultation. The stepwise development of the ED at Zealand University Hospital, Køge, was used to analyse the influence of medical organisation in the ED on the hospital admission pattern. METHODS: Data were recorded for the month of September of 2009, 2012 and 2014. These periods corresponded to the establishment of the department in 2009 and the 2012-period before organisational change was initiated in 2013, with a substantial increase in the number of senior physicians directly in charge of clinical decisions and the establishment of a limited bedding capacity...
December 2016: Danish Medical Journal
https://www.readbyqxmd.com/read/27909139/safety-and-efficacy-of-sbi-087-a-subcutaneous-agent-for-b-cell-depletion-in-patients-with-active-rheumatoid-arthritis-results-from-a-phase-ii-randomized-double-blind-placebo-controlled-study
#15
Nemanja Damjanov, Malgorzata Tlustochowicz, Jacob Aelion, Maria Greenwald, Annette Diehl, Indranil Bhattacharya, Elena Peeva, Sandeep Menon, Ian Gourley
OBJECTIVE: To evaluate subcutaneous SBI-087 to treat rheumatoid arthritis (RA). METHODS: A total of 210 adult patients with active RA were randomized to receive either 200 mg SBI-087 or placebo (Pbo), according to one of these patterns: SBI/Pbo/Pbo (SBI on Day 1), SBI/SBI/Pbo (SBI days 1 and 15), SBI/Pbo/SBI (SBI days 1 and 84), SBI/SBI/SBI (SBI days 1, 15, and 84), or Pbo/Pbo/Pbo (Pbo all 3 days). All patients were seropositive and taking background methotrexate...
December 2016: Journal of Rheumatology
https://www.readbyqxmd.com/read/27909037/safety-and-efficacy-of-stereotactic-body-radiation-therapy-combined-with-s-1-simultaneously-followed-by-sequential-s-1-as-an-initial-treatment-for-locally-advanced-pancreatic-cancer-silapanc-trial-study-design-and-rationale-of-a-phase-ii-clinical-trial
#16
Xiaofei Zhu, Xiaoping Ju, Fei Cao, Fang Fang, Shuiwang Qing, Yuxin Shen, Zhen Jia, Yangsen Cao, Huojun Zhang
INTRODUCTION: Upfront surgeries are not beneficial to most patients with pancreatic cancer. Therefore, more emphasis has been placed chemoradiotherapy in locally advanced pancreatic cancer recently. Gemcitabine-based regimens or FOLFIRINOX (a chemotherapy regimen including leucovorin, 5-FU, irinotecan, oxaliplatin) has been proven as a standard chemotherapy in pancreatic cancer. However, severe toxicities may prevent the completion of chemotherapy. S-1 has showed better objective response rates, similar overall survival rates and progression-free survival rates compared with gemcitabine, revealing that S-1 may be a potential candidate in treating pancreatic cancer, especially for patients refractory to gemcitabine...
December 1, 2016: BMJ Open
https://www.readbyqxmd.com/read/27908946/strategies-for-acute-and-critical-care-nurses-implementing-complementary-therapies-requested-by-patients-and-their-families
#17
Debra Kramlich
As consumer use of complementary and alternative medicine or modalities continues to increase in the United States, requests for these therapies in the acute and critical care setting will probably continue to expand in scope and frequency. Incorporation of complementary therapies in the plan of care is consistent with principles of patient- and family-centered care and collaborative decision-making and may provide a measure of relief for the distress of admission to an acute or critical care setting. An earlier article provided an overview of complementary and alternative therapies that nurses may encounter in their practices, with specific attention to implications for acute and critical care nurses...
December 2016: Critical Care Nurse
https://www.readbyqxmd.com/read/27908918/alpha-blockers-for-treatment-of-ureteric-stones-systematic-review-and-meta-analysis
#18
John M Hollingsworth, Benjamin K Canales, Mary A M Rogers, Shyam Sukumar, Phyllis Yan, Gretchen M Kuntz, Philipp Dahm
OBJECTIVE:  To investigate the efficacy and safety of alpha blockers in the treatment of patients with ureteric stones. DESIGN:  Systematic review and meta-analysis. DATA SOURCES:  Cochrane Central Register of Controlled Trials, Web of Science, Embase, LILACS, and Medline databases and scientific meeting abstracts to July 2016. REVIEW METHODS:  Randomized controlled trials of alpha blockers compared with placebo or control for treatment of ureteric stones were eligible...
December 1, 2016: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/27908450/the-learning-curve-effect-on-embolization-of-cerebral-dural-arteriovenous-fistula-single-center-experience-in-48%C3%A2-consecutive-patients
#19
D Le Foll, H Raoult, J C Ferré, F Naudet, D Trystram, J Y Gauvrit
BACKGROUND: Cerebral dural arteriovenous fistulas (DAVFs) are rare intracranial vascular lesions but can cause significant morbidity and mortality. OBJECTIVES: To analyze the effect of the center's experience on DAVF embolization efficacy and safety. METHODS: From May 2008 to October 2014, 57 embolization procedures were attempted on 48 patients (37 men and 11 women; median age: 63.9 years) for DAVF in a single center. DAVF presented with cortical venous reflux in 44/48 cases (91...
November 28, 2016: Journal of Neuroradiology. Journal de Neuroradiologie
https://www.readbyqxmd.com/read/27908277/comparison-of-unilateral-and-bilateral-percutaneous-vertebroplasty-for-osteoporotic-vertebral-compression-fractures-a-systematic-review-and-meta-analysis
#20
Haolin Sun, Chunde Li
BACKGROUND: The aim of this meta-analysis is to examine the safety and effectiveness of unilateral percutaneous vertebroplasty (PVP) for treatment of osteoporotic vertebral compression fractures (OVCFs) compared with that of bilateral treatment. METHODS: The multiple databases including PubMed, Springer, EMBASE, OVID, and China Journal Full-text Database were adopted to search for relevant studies in English or Chinese, and full-text articles involving comparison of unilateral and bilateral PVP surgery were reviewed...
December 1, 2016: Journal of Orthopaedic Surgery and Research
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