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Quality and safety

Sally Cudmore, Andrea Doolan, Seán Lacey, Fergus Shanahan
The study objective was to evaluate the safety and effects of Lepicol® (pysllium fibre, inulin and 5 probiotic strains) in adults with chronic, functional constipation during a 4 week intervention. 69 subjects with functional constipation according to Rome III criteria were randomised to receive Lepicol (n = 35) or placebo (n = 34) daily. Both groups had improved frequency of bowel movements, with an increase of 1.082 bowel movements in the Lepicol group over placebo after one week, and 1.079 more than placebo after week 2, but with no significant difference at week 4...
October 24, 2016: International Journal of Food Sciences and Nutrition
J Stevanović, L A de Jong, B S Kappelhoff, E P Dvortsin, M Voorhaar, M J Postma
BACKGROUND: Dabigatran was proven to have similar effect on the prevention of recurrence of venous thromboembolism (VTE) and a lower risk of bleeding compared to vitamin K antagonists (VKA). The aim of this study is to assess the cost-effectiveness (CE) of dabigatran for the treatment and secondary prevention in patients with VTE compared to VKAs in the Dutch setting. METHODS: Previously published Markov model was modified and updated to assess the CE of dabigatran and VKAs for the treatment and secondary prevention in patients with VTE from a societal perspective in the base-case analysis...
2016: PloS One
R M Paredes Esteban, J I Garrido Pérez, A Ruiz Palomino, G Guerrero Peña, F Vázquez Rueda, M J Berenguer García, R Miñarro Del Moral, M Tejedor Fernández
OBJECTIVES: In 2014 our department starts to apply the PatientSafety Strategic in Pediatric Surgery. Our aim is to describe the results obtained. METHODS: For the measurement of adverse events (AE) we used a modification of the Global Trigger Tool of the Institute for Healthcare Improvement. Population analysed: patients undergoing surgery with hospitalization. On a monthly basis, audits of the medical records of 12 patients discharged in the prior week of the assessment were performed...
April 20, 2016: Cirugía Pediátrica: Organo Oficial de la Sociedad Española de Cirugía Pediátrica
J Gómez-Chacón Villalba, L Rodríguez Caraballo, A Marco Macián, V Segarra Llido, J J Vila Carbó
AIMS: To describe our experience using Minimally Invasive Surgery (MIS) techniques in tertiary center with specific oncological pediatric surgery unit. METHODS: Retrospective review of patients undergoing MIS techniques in pediatric oncology surgery unit between January 2011 and December 2014. MIS procedures were considered made by both techniques such as laparoscopy and thoracoscopy with both diagnostic and therapeutic intent. RESULTS: 4 procedures were diagnostic and the rest were therapeutic: During the study, 56 procedures were performed by MIS...
April 20, 2016: Cirugía Pediátrica: Organo Oficial de la Sociedad Española de Cirugía Pediátrica
Cüneyt Toprak, Gökhan Kahveci, Alev Kılıçgedik, Cevat Kırma, Selçuk Pala, Mustafa Bulut, Cihangir Kaymaz, Nihal Özdemir, İbrahim Akın İzgi, Mehmet İnanır, Anıl Avcı, Ali Metin Esen
OBJECTIVE: Mitral valve regurgitation (MR) is the second most common heart valve disease in Europe. Without intervention, prognosis of severe symptomatic MR is poor. Percutaneous edge-to-edge mitral valve repair with MitraClip is a promising mitral regurgitation treatment technique in select, high-surgical-risk patients. The present objective was to describe the experience of a single center with MitraClip use in a high-risk series in Turkey. METHODS: Between May 2013 and September 2014, 28 high-surgical-risk patients with MR of at least grade 3+ and mean EuroSCORE of 26% underwent MitraClip implantation at our institution...
October 2016: Türk Kardiyoloji Derneği Arşivi: Türk Kardiyoloji Derneğinin Yayın Organıdır
Paul R Harmatz, Eugen Mengel, Tarekegn Geberhiwot, Nicole Muschol, Christian J Hendriksz, Barbara K Burton, Elisabeth Jameson, Kenneth I Berger, Andrea Jester, Marsha Treadwell, Zlatko Sisic, Celeste Decker
Efficacy and safety of elosulfase alfa enzyme replacement therapy (ERT) were assessed in an open-label, phase 2, multi-national study in Morquio A patients aged ≥5 years unable to walk ≥30 meters in the 6-min walk test. Patients received elosulfase alfa 2.0 mg/kg/week intravenously for 48 weeks. Efficacy measures were functional dexterity, pinch/grip strength, mobility in a modified timed 25-foot walk, pain, quality of life, respiratory function, and urine keratan sulfate (KS). Safety/tolerability was also assessed...
October 24, 2016: American Journal of Medical Genetics. Part A
Lane F Donnelly, Shirley S Cherian, Kimberly B Chua, Sam Thankachan, Laura A Millecker, Alex G Koroll, George S Bisset
BACKGROUND: Because of the increasing complexities of providing imaging for pediatric health care services, a more reliable process to manage the daily delivery of care is necessary. Objective We describe our Daily Readiness Huddle and the effects of the process on problem identification and improvement. MATERIALS AND METHODS: Our Daily Readiness Huddle has four elements: metrics review, clinical volume review, daily readiness assessment, and problem accountability...
October 22, 2016: Pediatric Radiology
Thai H Ho, Rafael Nunez-Nateras, Yue-Xian Hou, Alan H Bryce, Donald W Northfelt, Amylou C Dueck, Bryan Wong, Melissa L Stanton, Richard W Joseph, Erik P Castle
BACKGROUND: Prostate tissue expresses 2 estrogen receptor (ER) isoforms, ER-α and ER-β, and estrogen-based therapies have shown activity in preclinical studies. Raloxifene, a selective ER modulator, has inhibited the growth of prostate cancer xenograft models and was tested in a phase II trial of castration-resistant prostate cancer (CRPC), with some patients achieving stable disease. However, no studies have examined the safety of the combination of bicalutamide plus raloxifene for CRPC...
September 8, 2016: Clinical Genitourinary Cancer
Arno Olthoff, Per-Ole Carstens, Shuo Zhang, Eva von Fintel, Tim Friede, Joachim Lotz, Jens Frahm, Jens Schmidt
OBJECTIVE: To assess safety and feasibility of real-time (RT) MRI for evaluation of dysphagia and to compare this technique to standard assessment by flexible endoscopic evaluation of swallowing (FEES) and videofluoroscopy (VF) in a cohort of patients with inclusion body myositis (IBM). METHODS: Using RT-MRI, FEES, and VF, an unselected cohort of 20 patients with IBM was studied as index disease with a uniform dysphagia. Symptoms of IBM and dysphagia were explored by standardized tools including Swallowing-Related Quality of Life Questionnaire (SWAL-QoL), IBM Functional Rating Scale, Patient-Reported Functional Assessment, and Medical Research Council Scale...
October 21, 2016: Neurology
Henry A Pitt, Amy J Goldberg, Abhijit S Pathak, Jonathan A Shinefeld, Sally M Hinkle, Selwyn O Rogers, Verdi J DiSesa, Larry R Kaiser
BACKGROUND: Survival of surgical inpatients is a key quality metric. Patient, surgeon, and system factors all contribute to inpatient mortality, and sophisticated risk adjustment is required to assess outcomes. When the mortality of general surgery patients was determined to be high at a safety-net hospital, a comprehensive approach was undertaken to improve patient survival. METHODS: General surgical service line mortality was measured in the database of the University HealthSystem Consortium from January 2013 through June 2015...
October 18, 2016: Surgery
Panagiotis Tsakanikas, Dimitris Pavlidis, Efstathios Panagou, George-John Nychas
Recently, imaging and machine vision are gaining attention to food stakeholders since these are considered to be the emerging tools for food safety and quality assessment throughout the whole food chain. Herein, multispectral imaging, a surface chemistry sensor type, has been evaluated in terms of monitoring aerobically packaged beef filet spoilage at different storage temperatures (2, 8, and 15°C) and storage time. Spectral data acquired from the surface of meat samples (with/without background flora; +BF/-BF respectively) along with microbiological analysis...
December 1, 2016: Talanta
Ying Zhang, Jin Sun, Yun-Jiao Zhang, Qian-Yun Chai, Kang Zhang, Hong-Li Ma, Xiao-Ke Wu, Jian-Ping Liu
BACKGROUND: Although Traditional Chinese Medicine (TCM) has been widely used in clinical settings, a major challenge that remains in TCM is to evaluate its efficacy scientifically. This randomized controlled trial aims to evaluate the efficacy and safety of berberine in the treatment of patients with polycystic ovary syndrome. In order to improve the transparency and research quality of this clinical trial, we prepared this statistical analysis plan (SAP). METHODS: The trial design, primary and secondary outcomes, and safety outcomes were declared to reduce selection biases in data analysis and result reporting...
October 21, 2016: Trials
Marit Hegg Reime, Tone Johnsgaard, Fred Ivan Kvam, Morten Aarflot, Marit Breivik, Janecke Merethe Engeberg, Guttorm Brattebø
Poor teamwork is an important factor in the occurrence of critical incidents because of a lack of non-technical skills. Team training can be a key to prevent these incidents. The purpose of this study was to explore the experience of nursing and medical students after a simulation-based interprofessional team training (SBITT) course and its impact on professional and patient safety practices, using a concurrent mixed-method design. The participants (n = 262) were organized into 44 interprofessional teams...
October 13, 2016: Nurse Education in Practice
Hardeep Singh, Mark L Graber, Timothy P Hofer
Timely and accurate diagnosis is foundational to good clinical practice and an essential first step to achieving optimal patient outcomes. However, a recent Institute of Medicine report concluded that most of us will experience at least one diagnostic error in our lifetime. The report argues for efforts to improve the reliability of the diagnostic process through better measurement of diagnostic performance. The diagnostic process is a dynamic team-based activity that involves uncertainty, plays out over time, and requires effective communication and collaboration among multiple clinicians, diagnostic services, and the patient...
October 20, 2016: Journal of Patient Safety
David C Classen, William Munier, Nancy Verzier, Noel Eldridge, David Hunt, Mark Metersky, Chesley Richards, Yun Wang, P Jeffrey Brady, Amy Helwig, James Battles
The explicit declaration in the landmark 1999 Institute of Medicine report "To Err Is Human" that, in the United States, 44,000 to 98,000 patients die each year as a consequence of "medical errors" gave widespread validation to the magnitude of the patient safety problem and catalyzed a number of U.S. federal government programs to measure and improve the safety of the national healthcare system. After more than 10 years, one of those federal programs, the Medicare Patient Safety Monitoring System (MPSMS), has reached a level of maturity and stability that has made it useful for the consistent measurement of the safety of inpatient care...
October 20, 2016: Journal of Patient Safety
Adrienne M Laury, Sarah N Bowe, Joshua Lospinoso
Importance: To date, an otolaryngology-specific morbidity and mortality (M&M) conference has never been reported or evaluated. Objective: To propose a novel otolaryngology-specific M&M format and to assess its success using a validated assessment tool. Design, Setting, and Participants: Preintervention and postintervention cohort study spanning 14 months (September 2014 to November 2015), with 32 faculty, residents, and medical students attending the department of otolaryngology M&M conference, conducted at the the San Antonio Uniformed Services Health Education Consortium...
October 20, 2016: JAMA Otolaryngology—Head & Neck Surgery
Russell Byrum, Lauren Keith, Christopher Bartos, Marisa St Claire, Matthew G Lackemeyer, Michael R Holbrook, Krisztina Janosko, Jason Barr, Daniela Pusl, Laura Bollinger, Jiro Wada, Linda Coe, Lisa E Hensley, Peter B Jahrling, Jens H Kuhn, Margaret R Lentz
Medical imaging using animal models for human diseases has been utilized for decades; however, until recently, medical imaging of diseases induced by high-consequence pathogens has not been possible. In 2014, the National Institutes of Health, National Institute of Allergy and Infectious Diseases, Integrated Research Facility at Fort Detrick opened an Animal Biosafety Level 4 (ABSL-4) facility to assess the clinical course and pathology of infectious diseases in experimentally infected animals. Multiple imaging modalities including computed tomography (CT), magnetic resonance imaging, positron emission tomography, and single photon emission computed tomography are available to researchers for these evaluations...
October 3, 2016: Journal of Visualized Experiments: JoVE
Janine Naß, Mita Banerjee, Thomas Efferth, Anita Wohlmann
Illness is a disruptive experience that requires high-quality care. The best evidence-based medical treatment risks losing some of its efficacy, however, when patients feel misunderstood when faced with the complexity of their experiences. They might stop treatment, refuse to disclose relevant information or seek unsound alternatives. A narrative-based approach to health care understands the patient's case history as a narrative that can be read or analyzed like a story. In other words, this approach honors individual illness experiences through the stories that patients tell...
October 20, 2016: International Journal of Clinical Pharmacy
Arathi Kizhedath, Simon Wilkinson, Jarka Glassey
Biopharmaceuticals, monoclonal antibody (mAb)-based therapeutics in particular, have positively impacted millions of lives. MAbs and related therapeutics are highly desirable from a biopharmaceutical perspective as they are highly target specific and well tolerated within the human system. Nevertheless, several mAbs have been discontinued or withdrawn based either on their inability to demonstrate efficacy and/or due to adverse effects. Approved monoclonal antibodies and derived therapeutics have been associated with adverse effects such as immunogenicity, cytokine release syndrome, progressive multifocal leukoencephalopathy, intravascular haemolysis, cardiac arrhythmias, abnormal liver function, gastrointestinal perforation, bronchospasm, intraocular inflammation, urticaria, nephritis, neuropathy, birth defects, fever and cough to name a few...
October 20, 2016: Archives of Toxicology
Mahboob Nemati, Aliasghar Hamidi, Solmaz Maleki Dizaj, Vahid Javaherzadeh, Farzaneh Lotfipour
Traditional microbiological methods tend to be labor-intensive and time-consuming. Rapid and novel methods in microbiological tests provide more sensitive, precise and reproducible results compared with conventional methods. In microbiology, the most rapid testing methods belong to the field of biotechnology such as PCR, ELISA, ATP bioluminescence and etc. Nevertheless impedance microbiology, biosensors and analytical procedures to determine microbial constituents are of significance. The present review article was conducted using internet databases and related scientific literatures and articles that provide information on developments in the rapid methods in microbiology...
September 2016: Advanced Pharmaceutical Bulletin
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