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https://www.readbyqxmd.com/read/28819983/an-evaluation-of-the-effectiveness-of-a-risk-based-monitoring-approach-implemented-with-clinical-trials-involving-implantable-cardiac-medical-devices
#1
Christopher A Diani, Angie Rock, Phil Moll
Background Risk-based monitoring is a concept endorsed by the Food and Drug Administration to improve clinical trial data quality by focusing monitoring efforts on critical data elements and higher risk investigator sites. BIOTRONIK approached this by implementing a comprehensive strategy that assesses risk and data quality through a combination of operational controls and data surveillance. This publication demonstrates the effectiveness of a data-driven risk assessment methodology when used in conjunction with a tailored monitoring plan...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28818419/a-school-based-brand-marketing-program-s-adherence-to-federal-nutrition-criteria
#2
Alyssa J Moran, Eric B Rimm, Elsie M Taveras
INTRODUCTION: The Healthy, Hunger-Free Kids Act of 2010 gave the U.S. Department of Agriculture authority to regulate school wellness policies, which include nutritional standards for foods advertised in schools. Brand marketing programs, which encourage students to purchase a company's products in exchange for money or rewards, were not explicitly prohibited. This study assesses the nutritional quality of products participating in "Box Tops for Education" ("Box Tops"), one of the largest national brand marketing programs in schools...
August 14, 2017: American Journal of Preventive Medicine
https://www.readbyqxmd.com/read/28818225/patient-centered-outcomes-of-a-dual-action-pneumatic-compression-device-in-comparison-to-compression-stockings-for-patients-with-chronic-venous-disease
#3
Fedor Lurie, Marc Schwartz
OBJECTIVE: The ACTitouch (AT) device (Tactile Medical, Minneapolis, Minn) represents a new generation of pneumatic compression devices by combining sustained compression with intermittent pneumatic compression. The sustained compression mode provides automatic pressure adjustment every 30 minutes, ensuring pressure consistency regardless of leg volume changes and environmental influences. Designed for mobile patients, this device has not been studied in comparison to standard compression stockings (CS)...
September 2017: Journal of Vascular Surgery. Venous and Lymphatic Disorders
https://www.readbyqxmd.com/read/28817738/compliance-with-supportive-periodontal-treatment-in-patients-with-dental-implants
#4
Kai-Fang Hu, Ying-Chu Lin, Kun-Yen Ho, Yu-Hsiang Chou
PURPOSE: The need for dental implants is increasing, and supportive periodontal treatment can achieve long-term success and prevent peri-implantitis. Contributing factors to noncompliance with long-term scheduled supportive periodontal treatment remain unclear. To investigate whether demographic and clinical characteristics are associated with noncompliance, the authors analyzed data for patients who had received dental implants. MATERIALS AND METHODS: The authors recruited patients participating in a supportive periodontal treatment program after receiving permanent prostheses on implants placed from 2005 to 2013...
August 17, 2017: International Journal of Oral & Maxillofacial Implants
https://www.readbyqxmd.com/read/28817390/hypoalbuminemia-is-a-predictive-factor-for-fistula-formation-in-recurrent-cervical-cancer
#5
Lavanya H Palavalli Parsons, Brandon Roane, Dustin B Manders, Debra L Richardson, Siobhan M Kehoe, Matthew Carlson, David S Miller, Jayanthi S Lea
OBJECTIVE: Antivascular endothelial growth factor monoclonal antibodies inhibit tumor angiogenesis, consequently impeding the recruitment of new vasculature to existing and new tumor lesions. We sought to evaluate toxicities in women with recurrent cervical cancer after receiving bevacizumab combination chemotherapy. METHODS: A review was conducted of women with recurrent and metastatic cervical cancer who were treated with salvage chemotherapy with or without bevacizumab between 2005 and 2015...
August 16, 2017: American Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28816756/characterizing-the-posttransfer-period-among-patients-with-pediatric-onset-ibd-the-impact-of-academic-versus-community-adult-care-on-emergent-health-resource-utilization
#6
Natasha Bollegala, Eric I Benchimol, Anne M Griffiths, Adrienne Kovacs, Allan H Steinhart, Xinbei Zhao, Geoffrey C Nguyen
BACKGROUND: Patients diagnosed with inflammatory bowel disease (IBD) during childhood require transfer to an adult gastroenterologist, in Ontario usually just before their 18th birthday. Pediatric onset IBD is a complex phenotype with demonstrated noncompliance risk that may require targeted measures to optimize health care outcomes in the adult care setting. PURPOSE: The purpose of this study was to determine the impact of posttransfer health care setting (academic versus community gastroenterologist) on emergent health resource utilization...
September 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28816746/characterizing-the-posttransfer-period-among-patients-with-pediatric-onset-ibd-the-impact-of-academic-versus-community-adult-care-on-emergent-health-resource-utilization
#7
Natasha Bollegala, Eric I Benchimol, Anne M Griffiths, Adrienne Kovacs, Allan H Steinhart, Xinbei Zhao, Geoffrey C Nguyen
BACKGROUND: Patients diagnosed with inflammatory bowel disease (IBD) during childhood require transfer to an adult gastroenterologist, in Ontario usually just before their 18th birthday. Pediatric onset IBD is a complex phenotype with demonstrated noncompliance risk that may require targeted measures to optimize health care outcomes in the adult care setting. PURPOSE: The purpose of this study was to determine the impact of posttransfer health care setting (academic versus community gastroenterologist) on emergent health resource utilization...
August 14, 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28816610/tobacco-control-law-implementation-in-a-middle-income-country-transnational-tobacco-control-network-overcoming-tobacco-industry-opposition-in-colombia
#8
Randy Uang, Eric Crosbie, Stanton A Glantz
The objective of this paper is to examine the implementation of Colombia's tobacco control law. Methods involved are triangulated government legislation, news sources, and interviews with policy-makers and health advocates in Colombia. Colombia, a middle-income country, passed a tobacco control law in 2009 that included a prohibition on tobacco advertising, promotion, and sponsorship; and required pictorial health warning labels, ingredients disclosure, and a prohibition on individual cigarette sales. Tobacco companies challenged the implementation through litigation, tested government enforcement of advertising provisions and regulations on ingredients disclosure, and lobbied local governments to deprioritise policy responses to single cigarette sales...
August 17, 2017: Global Public Health
https://www.readbyqxmd.com/read/28811941/seizure-associated-takotsubo-syndrome-a-rare-combination
#9
Htay Htay Kyi, Nour Aljariri Alhesan, Sunil Upadhaya, Samer Al Hadidi
Takotsubo cardiomyopathy (TC) is increasingly recognized in neurocritical care population especially in postmenopausal females. We are presenting a 61-year-old African American female with past medical history of epilepsy, bipolar disorder, and hypertension who presented with multiple episodes of seizures due to noncompliance with antiepileptic medications. She was on telemetry which showed ST alarm. Electrocardiogram (ECG) was ordered and showed ST elevation in anterolateral leads and troponins were positive...
2017: Case Reports in Cardiology
https://www.readbyqxmd.com/read/28807192/does-compliance-with-antibiotic-prophylaxis-in-pediatric-simple-appendicitis-matter
#10
Krislynn M Mueck, Luke R Putnam, Kathryn T Anderson, Kevin P Lally, KuoJen Tsao, Lillian S Kao
BACKGROUND: Institutional protocols for preincisional antibiotic prophylaxis can standardize care and improve outcomes. However, challenges remain in compliance with such protocols for urgent or emergent operations. We hypothesized that compliance with an institutional protocol for antibiotic prophylaxis for appendectomy for appendicitis in pediatric patients results in reduced surgical site infections (SSIs) after simple appendectomy. METHODS: This retrospective study assessed all pediatric patients (≤18 y) who underwent appendectomy for confirmed simple appendicitis at a tertiary children's hospital between 2012 and 2015...
August 2017: Journal of Surgical Research
https://www.readbyqxmd.com/read/28800838/noncompliance-with-surgical-antimicrobial-prophylaxis-guidelines-a-jordanian-experience-in-cesarean-deliveries
#11
Mariam Hantash Abdel Jalil, Khawla Abu Hammour, Mervat Alsous, Rand Hadadden, Wedad Awad, Faris Bakri, Kamil Fram
BACKGROUND: Surgical site infections are common, especially in developing countries. Nevertheless, up to 60% of surgical site infections can be prevented with appropriate perioperative care, which includes among other measures using suitable surgical antimicrobial prophylaxis (SAP). METHODS: After a short interview with patients and retrospective review of medical charts, compliance with 6 SAP parameters was assessed for appropriateness; those parameters are indication, choice, dose, time of administration, intraoperative redosing interval, and duration of prophylaxis in 1,173 operations...
August 8, 2017: American Journal of Infection Control
https://www.readbyqxmd.com/read/28800444/do-parental-adhd-symptoms-reduce-the-efficacy-of-parent-training-for-preschool-adhd-a-secondary-analysis-of-a-randomized-controlled-trial
#12
Rex Forehand, Justin Parent, Virginia D Peisch, Edmund Sonuga-Barke, Nicholas Long, Nicole Lafko Breslend, Howard B Abikoff
Previous studies have suggested that children with Attention-Deficit/Hyperactivity Disorder (ADHD) may benefit less from behavioral parent training (BPT) if their parents have high levels of ADHD symptoms. We conducted a secondary analysis of data from a randomized controlled trial to test the hypothesis that parental ADHD symptoms reduce the efficacy of two BPT programs in a sample of preschoolers with ADHD. One intervention was specifically designed for children with ADHD (NFPP: New Forest Parenting Programme) and one was designed for children with Oppositional Defiant Disorder (ODD) (HNC: Helping the Noncompliant Child)...
August 4, 2017: Behaviour Research and Therapy
https://www.readbyqxmd.com/read/28799521/transcatheter-mitral-valve-replacement-long-term-outcomes-of-first-in-man-experience-with-an-apically-tethered-device-a-case-series-from-a-single-centre
#13
Alison Duncan, Anan Daqa, James Yeh, Simon Davies, Anselm Uebing, Cesare Quarto, Neil Moat
AIMS: Transcatheter mitral valve replacement (TMVR) is a novel technique for treating mitral regurgitation. We report 18-month/2-year outcomes of the 5 first-in-man patients undergoing chronic TMVR with the Tendyne device. METHODS AND RESULTS: Five patients (STS score 14%-23%) underwent TMVR using a Tendyne system under compassionate use at a single centre. 1 patient (who was noncompliant with anti-coagulation) died 9 months after TMVR following a cerebrovascular accident...
August 13, 2017: EuroIntervention
https://www.readbyqxmd.com/read/28796022/a-pilot-study-of-the-usefulness-of-a-single-olanzapine-plasma-concentration-as-an-indicator-of-early-drug-effect-in-a-small-sample-of-first-episode-psychosis-patients
#14
Arantzazu Zabala, Mariana Bustillo, Imanol Querejeta, Marta Alonso, Oiane Mentxaka, Ana González-Pinto, Amaia Ugarte, J Javier Meana, Miguel Gutiérrez, Rafael Segarra
PURPOSE/BACKGROUND: Studies analyzing concentration-effect relationships in second-generation antipsychotics have reported contradictory results in chronic schizophrenia. No data are available for the early stages of the disease. The present study aims to evaluate the association between a single olanzapine plasma concentration, clinical response, and severity of adverse effects in first-episode psychosis (FEP); to test the utility of various plasma breakpoints as markers of early response to treatment; and to identify variables affecting olanzapine concentrations...
August 8, 2017: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28792291/executive-function-in-cancer-patients-with-posttraumatic-stress-disorder
#15
Juan Yang, Juncheng Guo, Xiangling Jiang
Background Cancer patients with posttraumatic stress disorder can lead to their noncompliant behaviors. However, less is known about the neurocognitive functioning of posttraumatic stress disorder in general cancer types or patient populations. The current study attempted to examine the prevalence of posttraumatic stress disorder and their relationships with executive function in individuals with cancer. Methods A total of 285 cancer patients with posttraumatic stress disorder and 150 healthy individuals were recruited for the present study...
March 2017: International Journal of Psychiatry in Medicine
https://www.readbyqxmd.com/read/28791693/atypical-antipsychotics-for-disruptive-behaviour-disorders-in-children-and-youths
#16
REVIEW
Jik H Loy, Sally N Merry, Sarah E Hetrick, Karolina Stasiak
BACKGROUND: This is an update of the original Cochrane Review, last published in 2012 (Loy 2012). Children and youths with disruptive behaviour disorders may present to health services, where they may be treated with atypical antipsychotics. There is increasing usage of atypical antipsychotics in the treatment of disruptive behaviour disorders. OBJECTIVES: To evaluate the effect and safety of atypical antipsychotics, compared to placebo, for treating disruptive behaviour disorders in children and youths...
August 9, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28791494/adherence-with-perindopril-therapy-a-pilot-study-using-therapeutic-drug-monitoring-of-perindoprilat-and-an-evaluation-of-the-clearance-estimation
#17
Martin Šíma, Martin Vodička, Věra Marešová, Tomáš Šálek, Radomír Čabala, Ondřej Slanař
Background Although measurement of drug serum levels is an objective direct method for testing compliance, it can be distorted by "white-coat compliance" or by variations in drug elimination. Objective The aim of this prospective study was to evaluate the prevalence of noncompliance with perindopril therapy in adult out-patients using pharmacokinetic simulations. The additional aim was to compare the predictive performance of two glomerular filtration rate markers-creatinine and cystatin C. Setting Department of Cardiology, Tomas Bata Regional Hospital in Zlín, Czech Republic...
August 8, 2017: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/28790833/collaboration-in-pharmacovigilance-lamotrigine-and-fatal-severe-cutaneous-adverse-reactions-a-review-of-spontaneous-reports
#18
Neil Brickel, Haris Shaikh, Andrew Kirkham, Greg Davies, Michelle Chalker, Pascal Yoshida
Pharmacovigilance presents many challenges, particularly when managing unpredictable, rare conditions, eg, severe cutaneous adverse reactions (SCARs). Such rare events are often only detected from spontaneous reports, which present their own limitations, particularly during a prolonged global launch schedule. GlaxoSmithKline's routine pharmacovigilance includes regular reviews of global adverse event (AE) reports and aggregate data from a central safety database. Lamotrigine is one of the several antiepileptic drugs associated with SCARs...
2017: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/28774653/evaluation-of-a-train-the-trainer-program-for-stable-coronary-artery-disease-management-in-community-settings-a-pilot-study
#19
Zhiyun Shen, Changying Jiang, Liqun Chen
OBJECTIVE: To evaluate the feasibility and effectiveness of conducting a train-the-trainer (TTT) program for stable coronary artery disease (SCAD) management in community settings. METHODS: The study involved two steps: (1) tutors trained community nurses as trainers and (2) the community nurses trained patients. 51 community nurses attended a 2-day TTT program and completed questionnaires assessing knowledge, self-efficacy, and satisfaction. By a feasibility and non-randomized control study, 120 SCAD patients were assigned either to intervention group (which received interventions from trained nurses) or control group (which received routine management)...
July 24, 2017: Patient Education and Counseling
https://www.readbyqxmd.com/read/28770517/changes-in-healthcare-utilization-after-etanercept-initiation-in-patients-with-rheumatoid-arthritis-a-retrospective-claims-analysis
#20
Neil A Accortt, Jennifer Schenfeld, Eunice Chang, Elya Papoyan, Michael S Broder
INTRODUCTION: Effective treatment for rheumatoid arthritis (RA) may lead to lower overall and RA-related healthcare utilization. We evaluated healthcare utilization before and after initiation of the tumor necrosis factor inhibitor etanercept in patients with moderate to severe RA. METHODS: This retrospective cohort study used data from the MarketScan(®) claims database. Data from adult patients with RA newly exposed to etanercept between January 1, 2010 and December 31, 2013 were analyzed...
August 2, 2017: Advances in Therapy
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