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Medication safety

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https://www.readbyqxmd.com/read/28934785/1-year-results-of-a-randomized-controlled-trial-of-conservative-management-vs-minimally-invasive-surgical-treatment-for-sacroiliac-joint-pain
#1
Julius Dengler Dengler, Djaya Kools, Robert Pflugmacher, Alessandro Gasbarrini, Domenico Prestamburgo, Paolo Gaetani, Eddie van Eeckhoven, Daniel Cher, Bengt Sturesson
BACKGROUND: Low back pain (LBP) emanating from the sacroiliac joint (SIJ) is a common finding. Devices to fuse the SIJ are now commercially available, but high-quality evidence supporting their effectiveness is limited. OBJECTIVES: To compare the safety and effectiveness of conservative management (CM) to minimally invasive sacroiliac joint fusion (SIJF) in patients with chronic LBP originating from the SIJ. STUDY DESIGN: Prospective, multicenter randomized controlled trial...
September 2017: Pain Physician
https://www.readbyqxmd.com/read/28934584/principles-and-benefits-of-explicitly-designed-medical-device-safety-architecture
#2
Brian R Larson, Paul Jones, Yi Zhang, John Hatcliff
The complexity of medical devices and the processes by which they are developed pose considerable challenges to producing safe designs and regulatory submissions that are amenable to effective reviews. Designing an appropriate and clearly documented architecture can be an important step in addressing this complexity. Best practices in medical device design embrace the notion of a safety architecture organized around distinct operation and safety requirements. By explicitly separating many safety-related monitoring and mitigation functions from operational functionality, the aspects of a device most critical to safety can be localized into a smaller and simpler safety subsystem, thereby enabling easier verification and more effective reviews of claims that causes of hazardous situations are detected and handled properly...
2017: Biomedical Instrumentation & Technology
https://www.readbyqxmd.com/read/28934557/a-safety-evaluation-of-empagliflozin-plus-linagliptin-for-treating-type-2-diabetes
#3
Baptist Gallwitz
Dipeptidyl-peptidase-IV inhibitors (DPP-4i) and sodium-glucose-transporter-2 inhibitors (SGLT-2i) are oral antidiabetic drugs that improve glycemic parameters and possess a very low intrinsic hypoglycemia risk and favorable cardiovascular data. Areas covered: An overview on the clinical studies investigating the combination therapy with the DPP-4i linagliptin and the SGLT-2i empagliflozin is given. The clinical evidence for the efficacy and safety of free combinations as well as for their fixed dose combinations is presented...
September 21, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28934402/a-world-health-organization-field-trial-assessing-a-proposed-icd-11-framework-for-classifying-patient-safety-events
#4
Alan J Forster, Burnand Bernard, Saskia E Drösler, Yana Gurevich, James Harrison, Jean-Marie Januel, Patrick S Romano, Danielle A Southern, Vijaya Sundararajan, Hude Quan, Saskia E Vanderloo, Harold A Pincus, William A Ghali
Objective: To assess the utility of the proposed World Health Organization (WHO)'s International Classification of Disease (ICD) framework for classifying patient safety events. Setting: Independent classification of 45 clinical vignettes using a web-based platform. Study participants: The WHO's multi-disciplinary Quality and Safety Topic Advisory Group. Main outcome measure(s): The framework consists of three concepts: harm, cause and mode...
August 1, 2017: International Journal for Quality in Health Care
https://www.readbyqxmd.com/read/28934265/comparative-effectiveness-of-different-transarterial-embolization-therapies-alone-or-in-combination-with-local-ablative-or-adjuvant-systemic-treatments-for-unresectable-hepatocellular-carcinoma-a-network-meta-analysis-of-randomized-controlled-trials
#5
Konstantinos Katsanos, Panagiotis Kitrou, Stavros Spiliopoulos, Ioannis Maroulis, Theodore Petsas, Dimitris Karnabatidis
BACKGROUND: The optimal transcatheter embolization strategy for patients with unresectable hepatocellular carcinoma (HCC) remains elusive. We conducted a systematic review and network meta-analysis (NMA) of different embolization options for unresectable HCC. METHODS: Medical databases were searched for randomized controlled trials evaluating bland transarterial embolization (TAE), conventional TACE, drug-eluting bead chemoembolization (DEB-TACE), or transarterial radioembolization (TARE), either alone or combined with adjuvant chemotherapy, or local liver ablation, or external radiotherapy for unresectable HCC up to June 2017...
2017: PloS One
https://www.readbyqxmd.com/read/28934249/variability-in-objective-and-subjective-measures-affects-baseline-values-in-studies-of-patients-with-copd
#6
Wayne H Anderson, Jae Wook Ha, David J Couper, Wanda K O'Neal, R Graham Barr, Eugene R Bleecker, Elizabeth E Carretta, Christopher B Cooper, Claire M Doerschuk, M Bradley Drummond, MeiLan K Han, Nadia N Hansel, Victor Kim, Eric C Kleerup, Fernando J Martinez, Stephen I Rennard, Donald Tashkin, Prescott G Woodruff, Robert Paine, Jeffrey L Curtis, Richard E Kanner
RATIONALE: Understanding the reliability and repeatability of clinical measurements used in the diagnosis, treatment and monitoring of disease progression is of critical importance across all disciplines of clinical practice and in clinical trials to assess therapeutic efficacy and safety. OBJECTIVES: Our goal is to understand normal variability for assessing true changes in health status and to more accurately utilize this data to differentiate disease characteristics and outcomes...
2017: PloS One
https://www.readbyqxmd.com/read/28934186/opioid-overdose-outbreak-west-virginia-august-2016
#7
Joel Massey, Michael Kilkenny, Samantha Batdorf, Sarah K Sanders, Debra Ellison, John Halpin, R Matthew Gladden, Danae Bixler, Loretta Haddy, Rahul Gupta
On August 15, 2016, the Mayor's Office of Drug Control Policy in Huntington, West Virginia, notified the Cabell-Huntington Health Department (CHHD) of multiple calls regarding opioid overdose received by the emergency medical system (EMS) during 3 p.m.-8 p.m. that day. A public health investigation and response conducted by the West Virginia Bureau for Public Health (BPH) and CHHD identified 20 opioid overdose cases within a 53-hour period in Cabell County; all cases included emergency department (ED) encounters...
September 22, 2017: MMWR. Morbidity and Mortality Weekly Report
https://www.readbyqxmd.com/read/28934019/cochlear-implantation-under-conscious-sedation-with-local-anesthesia-safety-efficacy-costs-and-satisfaction
#8
Samion Shabashev, Yasser Fouad, T Kate Huncke, J Thomas Roland
OBJECTIVE: To evaluate the safety, efficiency, cost effectiveness, and satisfaction of patients undergoing cochlear implantation under conscious sedation versus general anesthesia. STUDY DESIGN: Retrospective case review of 20 patients who underwent cochlear implantation under conscious sedation which was compared to 20 age-matched patients where surgery was performed under general anesthesia. METHODS: Perioperative times, length of stay, anesthesia drug costs, postoperative complications, and patient satisfaction were compared between the two groups...
September 21, 2017: Cochlear Implants International
https://www.readbyqxmd.com/read/28933918/pharmacokinetics-of-a-new-amphetamine-extended-release-oral-suspension-in-children-with-attention-deficit-hyperactivity-disorder
#9
Carolyn R Sikes, Russ L McMahen, Jeffrey G Stark, Dorothy Engelking
OBJECTIVE: An extended-release amphetamine (AMP) oral suspension has been developed to facilitate medication ingestion and dose titration. This study sought to determine the pharmacokinetic (PK) profile of this new formulation in children with attention-deficit/hyperactivity disorder (ADHD). METHODS: This was an open-label, single-period, PK study in 29 pediatric participants with ADHD. Participants were stratified into age groups 1 (6-7 years), 2 (8-9 years), and 3 (10-12 years), and dosed with 15 mL extended-release AMP liquid suspension (equivalent to 30 mg mixed AMP salts) after an overnight fast...
September 21, 2017: Journal of Child and Adolescent Psychopharmacology
https://www.readbyqxmd.com/read/28933701/a-cross-sectional-descriptive-study-of-medication-use-among-persons-with-a-gastrointestinal-stoma
#10
Bianca Augusta Pereira de Paula, Geisa Cristina da Silva Alves, Álvaro PercÍnio, Mariana Linhares Pereira, Juliano Teixeira Moraes, Cristina Sanches
Research on the use of medications in people with intestinal stomas is lacking, creating gaps in knowledge of pharmacoepidemiology in these patients. A cross-sectional, descriptive study was conducted over a period of 4 months in Divinópolis, Brazil to describe the profile of medication use among people enrolled in the Health Support Service for People with Stoma - Level II (SSPS II) of a municipality in the state of Minas Gerais, Brazil. All patients from SSPS II with a colostomy or ileostomy were invited by phone to participate; those with incomplete registration data and/or who were <18 years old, hospitalized for any reason, or had their stoma reversed were excluded from participation...
September 2017: Ostomy/wound Management
https://www.readbyqxmd.com/read/28933560/unintentional-nontraffic-injury-and-fatal-events-threats-to-children-in-and-around-vehicles
#11
Mark R Zonfrillo, Mackenzie L Ramsay, Janette E Fennell, Amber Rollins
Objective There have been substantial reductions in motor vehicle crash-related child fatalities due to advances in legislation, public safety campaigns, and engineering. Less is known about nontraffic injuries and fatalities to children in and around motor vehicles. The objective of this study was to describe the frequency of various nontraffic incidents, injuries, and fatalities to children using a unique surveillance system and database. Methods Instances of nontraffic injuries and fatalities in the United States to children 0-14 years were tracked from January 1990 - December 2014 using a compilation of sources including media reports, individual accounts from families of affected children, medical examiner reports, police reports, child death review teams, coroner reports, medical professionals, legal professionals, and other various modes of publication...
September 21, 2017: Traffic Injury Prevention
https://www.readbyqxmd.com/read/28933343/the-european-medical-corps-first-public-health-team-mission-and-future-perspectives
#12
Joana M Haussig, Ettore Severi, Jonathan Hj Baum, Veerle Vanlerberghe, Amparo Laiseca, Laurent Defrance, Cristina Brailescu, Denis Coulombier, Josep Jansa
The 2013-2016 Ebola epidemic in West Africa challenged traditional international mechanisms for public health team mobilisation to control outbreaks. Consequently, in February 2016, the European Union (EU) launched the European Medical Corps (EMC), a mechanism developed in collaboration with the World Health Organization (WHO) to rapidly deploy teams and equipment in response to public health emergencies inside and outside the EU. Public Health Teams (PHTs), a component of the EMC, consist of experts in communicable disease prevention and control from participating countries and the European Centre for Disease Prevention and Control (ECDC), to support affected countries and WHO in risk assessment and outbreak response...
September 14, 2017: Euro Surveillance: Bulletin Européen sur les Maladies Transmissibles, European Communicable Disease Bulletin
https://www.readbyqxmd.com/read/28933125/-analysis-of-diemailing-kudiezi-injection-use-in-real-world-in-7-189-patients-with-cerebral-infarction
#13
Xing Liao, Yin Zhang, Yan-Ming Xie, Yan Liu, Dan-Hui Yi, Yi-Li Zhang, Feng Chen
This is a study based on hospital intensive monitoring to explore medication use of Diemailing Kudiezi injection(one Chinese herbal medicine injection) in real word in the patients with cerebral infarction. The active monitoring model was adopted and hospital intensive monitoring on safety of 7 189 cases of patients with cerebral infarction was conducted to obtain the drug use information of Diemailing injection. The results were analyzed by using statistical description and association rule method. The statistical description and association rule analysis were conducted based on patients' basic demographic characteristics, use of Diemailing injection and combined use of drugs...
December 2016: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/28933045/a-prospective-single-arm-trial-of-modified-long-biliopancreatic-and-short-alimentary-limbs-roux-en-y-gastric-bypass-in-type-2-diabetes-patients-with-mild-obesity
#14
Abdon José Murad, Ricardo Vitor Cohen, Eudes Paiva de Godoy, Christian Lamar Scheibe, Giuliano Peixoto Campelo, Almino Cardoso Ramos, Roclides Castro de Lima, Luís Eduardo Veras Pinto, Daniel Coelho, Hamilton Belo França Costa, Ígor Marreiros Pereira Pinto, Tiago Pereira, Francisco Raúl Santos Teófilo, José Aparecido Valadão
BACKGROUND: Type-2 diabetes (T2D) patients with body mass index (BMI) below 35 kg/m(2) carry lower remission rates than severely obese T2D individuals submitted to "standard limb lengths" Roux-en-Y gastric bypass (RYGB). Mild-obese patients appear to have more severe forms of T2D, where the mechanisms of glycemic control after a standard-RYGB may be insufficient. The elongation of the biliopancreatic limb may lead to greater stimulation of the distal intestine, alterations in bile acids and intestinal microbiota, among other mechanisms, leading to better metabolic outcomes...
September 20, 2017: Obesity Surgery
https://www.readbyqxmd.com/read/28932571/management-of-pulmonary-hypertension-from-left-heart-disease-in-candidates-for-orthotopic-heart-transplantation
#15
REVIEW
Anna Koulova, Alan L Gass, Saikrishna Patibandla, Chhaya Aggarwal Gupta, Wilbert S Aronow, Gregg M Lanier
Pulmonary hypertension in left heart disease (PH-LHD) commonly complicates prolonged heart failure (HF). When advanced, the PH becomes fixed or out of proportion and is associated with increased morbidity and mortality in patients undergoing orthotopic heart transplant (OHT). To date, the only recommended treatment of out of proportion PH is the treatment of the underlying HF by reducing the pulmonary capillary wedge pressure (PCWP) with medications and often along with use of mechanical circulatory support...
August 2017: Journal of Thoracic Disease
https://www.readbyqxmd.com/read/28932291/neurological-safety-of-fingolimod-an-updated-review
#16
REVIEW
Fumihito Yoshii, Yusuke Moriya, Tomohide Ohnuki, Masafuchi Ryo, Wakoh Takahashi
Fingolimod (FTY) is the first oral medication approved for treatment of relapsing-remitting multiple sclerosis (RRMS). Its effectiveness and safety were confirmed in several phase III clinical trials, but proper evaluation of safety in the real patient population requires long-term post-marketing monitoring. Since the approval of FTY for RRMS in Japan in 2011, it has been administered to approximately 5000 MS patients, and there have been side-effect reports from 1750 patients. Major events included infectious diseases, hepatobiliary disorders, nervous system disorders and cardiac disorders...
August 2017: Clinical & Experimental Neuroimmunology
https://www.readbyqxmd.com/read/28932272/the-place-of-eluxadoline-in-the-management-of-irritable-bowel-syndrome-with-diarrhea
#17
REVIEW
Sherry Levio, Brooks D Cash
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder characterized by abdominal pain associated with defecation with altered stool frequency or stool form. The global prevalence of IBS ranges from 10% to 15% and total healthcare cost attributable to IBS is significant. Among individuals with IBS, the condition has dramatic effects on health-related quality of life, work and school productivity, and activities of daily living. It may be diagnosed with confidence, based on symptom-based diagnostic criteria, exclusion of alarm features and directed diagnostic testing...
September 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/28932089/efficacy-and-safety-of-sofosbuvir-and-daclatasvir-in-treatment-of-kidney-transplantation-recipients-with-hepatitis-c-virus-infection
#18
Yan Xue, Li-Xin Zhang, Lei Wang, Tao Li, Yun-Dong Qu, Feng Liu
AIM: To assess the efficacy and safety of sofosbuvir and daclatasvir regimens for kidney transplantation (KT) patients with hepatitis C virus (HCV) infection. METHODS: This study enrolled a prospective cohort of consecutive Chinese KT patients with HCV infection. They were given sofosbuvir combined with daclatasvir, with or without ribavirin. They were monitored regularly during and after the treatment. RESULTS: Six patients were recruited in our prospective study cohort...
August 28, 2017: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/28931497/use-of-simulation-based-on-an-electronic-health-records-environment-to-evaluate-the-structure-and-accuracy-of-notes-generated-by-medical-scribes-proof-of-concept-study
#19
Robert Pranaat, Vishnu Mohan, Megan O'Reilly, Maxwell Hirsh, Karess McGrath, Gretchen Scholl, Deborah Woodcock, Jeffrey A Gold
BACKGROUND: The increasing adoption of electronic health records (EHRs) has been associated with a number of unintended negative consequences with provider efficiency and job satisfaction. To address this, there has been a dramatic increase in the use of medical scribes to perform many of the required EHR functions. Despite this rapid growth, little has been published on the training or assessment tools to appraise the safety and efficacy of scribe-related EHR activities. Given the number of reports documenting that other professional groups suffer from a number of performance errors in EHR interface and data gathering, scribes likely face similar challenges...
September 20, 2017: JMIR Medical Informatics
https://www.readbyqxmd.com/read/28930950/increased-mortality-in-trauma-patients-who-develop-postintubation-hypotension
#20
Robert S Green, Michael B Butler, Mete Erdogan
BACKGROUND: Postintubation hypotension (PIH) is common and associated with poor outcomes in critically ill patient populations requiring emergency endotracheal intubation (ETI). The importance of PIH in the trauma population remains unclear. The objective of this study was to determine the prevalence of PIH in trauma patients and assess the association of PIH with patient outcomes. METHODS: Retrospective case series of adult (≥16 years) patients who were intubated on arrival at a tertiary trauma center in Halifax, Nova Scotia, Canada, between 2000 and 2015...
October 2017: Journal of Trauma and Acute Care Surgery
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