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Real world evidence

Matthew D Rocklage, Derek D Rucker, Loran F Nordgren
Persuasion is a foundational topic within psychology, in which researchers have long investigated effective versus ineffective means to change other people's minds. Yet little is known about how individuals' communications are shaped by the intent to persuade others. This research examined the possibility that people possess a learned association between emotion and persuasion that spontaneously shifts their language toward more emotional appeals, even when such appeals may be suboptimal. We used a novel quantitative linguistic approach in conjunction with controlled laboratory experiments and real-world data...
March 1, 2018: Psychological Science
Ahilan Sivaganesan, Brandon Hirsch, Frank M Phillips, Matthew J McGirt
Here, we systematically review clinical studies that report morbidity and outcomes data for cervical and lumbar surgeries performed in ambulatory surgery centers (ASCs). We focus on anterior cervical discectomy and fusion (ACDF), posterior cervical foraminotomy, cervical arthroplasty, lumbar microdiscectomy, lumbar laminectomy, and minimally invasive transforaminal interbody fusion (TLIF) and lateral lumbar interbody fusion, as these are prevalent and surgical spine procedures that are becoming more commonly performed in ASC settings...
March 12, 2018: Neurosurgery
Midori Kjellin, Terése Wesslén, Erik Löfblad, Johan Lennerstrand, Anders Lannergård
BACKGROUND: The clinical experience with protease-inhibitor (PI) triple regimen appears disappointing regarding effect, side effects, high work load, and costs. This real-world study evaluates baseline and emerging resistance-associated substitutions (RASs) and their significance for treatment outcome. METHOD: Thirty-six genotype 1a/b patients treated according to Swedish recommendations during 2011-2013 with triple therapy including pegylated interferon and ribavirin in combination with a protease-inhibitor, either boceprevir (BOC) or telaprevir (TVR), were retrospectively evaluated...
March 14, 2018: Upsala Journal of Medical Sciences
James E Frampton, Stephen Silberstein
An intramuscular formulation of onabotulinumtoxinA (onabotA; Botox® ) is currently the only therapy specifically approved for the prevention of headaches in adults with chronic migraine (CM) in the EU and North America. This article provides a narrative review of relevant data on the drug in this indication from an EU perspective. OnabotA was originally approved on the basis of pooled data from two phase III studies (PREEMPT 1 and 2). In these pivotal studies, injection of up to five cycles of onabotA (155-195 U/cycle) at 12-week intervals was generally well tolerated and effective in producing statistically significant and clinically meaningful improvements in headache symptoms, acute headache pain medication usage, headache impact and health-related quality of life in adults with CM, of whom approximately two-thirds were acute medication overusers and approximately one-third had failed to respond to ≥ 3 prior oral prophylactic therapies...
March 12, 2018: Drugs
Christos Ellinas
Spreading broadly refers to the notion of an entity propagating throughout a networked system via its interacting components. Evidence of its ubiquity and severity can be seen in a range of phenomena, from disease epidemics to financial systemic risk. In order to understand the dynamics of these critical phenomena, computational models map the probability of propagation as a function of direct exposure, typically in the form of pairwise interactions between components. By doing so, the important role of indirect interactions remains unexplored...
March 12, 2018: Scientific Reports
L A Kirby, D Moraczewski, K Warnell, K Velnoskey, E Redcay
The ability to perceive others' actions and goals from human motion (i.e., biological motion perception) is a critical component of social perception and may be linked to the development of real-world social relationships. Adult research demonstrates two key nodes of the brain's biological motion perception system-amygdala and posterior superior temporal sulcus (pSTS)-are linked to variability in social network properties. The relation between social perception and social network properties, however, has not yet been investigated in middle childhood-a time when individual differences in social experiences and social perception are growing...
March 6, 2018: Developmental Cognitive Neuroscience
Gail M Rosenbaum, Vinod Venkatraman, Laurence Steinberg, Jason M Chein
Adolescents are known to take more risks than adults, which can be harmful to their health and well-being. However, despite age differences in real-world risk taking, laboratory risk-taking paradigms often do not evince these developmental patterns. Recent findings in the literature suggest that this inconsistency may be due in part to differences between how adolescents process information about risk when it is described (e.g., in a description-based classroom intervention) versus when it is experienced (e...
March 2018: Developmental Review: DR
S Mathoulin-Pélissier, K Pritchard-Jones
Rare cancers are not so rare, their incidence is increasing and, as a group, they have worse survival than the common cancers. These factors emphasise the societal need to ensure sufficient focus on research into their biological basis, aetiological factors, new more effective therapies and organisation of healthcare to improve access to best practice and innovation. Accuracy of diagnosis is one of the first hurdles to be overcome, with around one third of tumours being reclassified - by type or risk group - when subject to a centralised pathology review process...
March 2, 2018: European Journal of Surgical Oncology
Marco Orsini Federici, Janette McQuillan, Giovanni Biricolti, Serena Losi, Jeremie Lebrec, Catrina Richards, Cristiana Miglio, Kirsi Norrbacka
INTRODUCTION: Real-world evidence on glucagon-like peptide-1 receptor agonist (GLP-1 RAs) usage is emerging in different European countries but is lacking in Italy. This retrospective cohort study aimed to describe the real-world drug utilization patterns in patients initiating GLP-1 RAs for treating T2DM in Italy. METHODS: Adults aged ≥ 20 years and with ≥ 1 oral antidiabetic drug (alone or in combination with insulin) other than GLP-1 RAs in the 6 months prior to initiating exenatide twice daily (exBID), exenatide once weekly (exQW), dulaglutide once weekly (DULA), liraglutide once daily (LIRA) or lixisenatide once daily (LIXI) between March and July 2016 were retrospectively identified in the Italian IMS LifeLink™ longitudinal prescriptions database (retail pharmacy data)...
March 10, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Juan Sanchis, Albert Ariza-Solé, Emad Abu-Assi, Oriol Alegre, Fernando Alfonso, José Antonio Barrabés, José Antonio Baz, Antonio Carol, Pablo Díez Villanueva, Bruno García Del Blanco, Jaime Elízaga, Eduard Fernandez, Abel García Del Egido, Joan García Picard, Iván Gómez Blázquez, Joan Antoni Gómez Hospital, Rosana Hernández-Antolín, Cinta Llibre, Francisco Marín, David Martí Sánchez, Roberto Martín, Manuel Martínez Sellés, Gema Miñana, María José Morales Gallardo, Julio Núñez, Armando Pérez de Prado, Eduardo Pinar, Marcelo Sanmartín, Alessandro Sionis, Adolfo Villa, Jaume Marrugat, Héctor Bueno
INTRODUCTION AND OBJECTIVES: Although clinical guidelines recommend invasive management in non-ST-segment elevation myocardial infarction (NSTEMI), this strategy is underused in frail elderly patients in the real world. Furthermore, these patients are underrepresented in clinical trials and therefore the evidence is scarce. Our hypothesis is that an invasive strategy will improve prognosis in elderly frail patients with NSTEMI. METHODS: This will be a prospective, multicenter, randomized trial, in which the conservative and invasive strategies will be compared in patients meeting all of the following inclusion criteria: NSTEMI diagnosis, age ≥ 70 years, and frailty defined by a category ≥ 4 in the Clinical Frailty Scale...
March 7, 2018: Revista Española de Cardiología
C E M Griffiths, M Augustin, L Naldi, R Romiti, E Guevara-Sangines, T Howe, G Pietri, I Gilloteau, C Richardson, H Tian, S J Jo
BACKGROUND: Psoriasis is a chronic immune-mediated inflammatory disease, which often requires lifelong treatment. A strong partnership between the patient and healthcare practitioners should help to achieve effective treatment outcomes. OBJECTIVE: To assess concordance of views between psoriasis patients and their treating dermatologists relative to psoriasis severity, presence of symptoms and satisfaction with disease control achieved. METHODS: We used data from the Growth from Knowledge (GfK) Disease Atlas real-world evidence programme, a syndicated, retrospective, cross-sectional survey among dermatologists and their systemic therapy eligible psoriasis patients, conducted across 9 countries...
March 10, 2018: Journal of the European Academy of Dermatology and Venereology: JEADV
Salvatore Caponnetto, Arianna Draghi, Troels Holz Borch, Marianna Nuti, Enrico Cortesi, Inge Marie Svane, Marco Donia
The exclusion of "real-world" patients from registration clinical trials of cancer immunotherapy represents a significant emerging issue. For instance, a large fraction of cancer patients develops brain metastases during the course of the disease, but results from large prospective clinical trials investigating this considerable proportion of the cancer patient population are currently lacking. To provide a useful tool for the clinician in a "real-world" setting, we have reviewed the available literature regarding the safety and efficacy of immune check-point inhibitors in patients with cancer metastatic to the brain...
March 8, 2018: Cancer Immunology, Immunotherapy: CII
X J Ji, K Sun, Z Y Hu, Y Zhang, Y P Ma, Z Sun, K P Li, J Zhu, J L Zhang, F Huang
Objective: The aim of this study was to set up a large, longitudinal and prospective database to compare the clinical manifestations in human leucocyte antigen (HLA)-B(27) positive and negative patients with ankylosing spondylitis(AS) based on real-world evidence in Chinese population. Methods: A total of 897 outpatients with confirmed AS were recruited consecutively by smart management system for spondyloarthritis (SMSP) from April 13, 2016 to June 6, 2017 in Chinese PLA General Hospital from 30 provinces and autonomous regions...
March 1, 2018: Zhonghua Nei Ke za Zhi [Chinese Journal of Internal Medicine]
Stewart Forsyth, Philip C Calder, Francis Zotor, Paul Amuna, Barbara Meyer, Bruce Holub
BACKGROUND: A wealth of information on the functional roles of docosahexaenoic acid (DHA) and arachidonic acid (ARA) from cellular, animal, and human studies is available. Yet, there remains a lack of cohesion in policymaking for recommended dietary intakes of DHA and ARA in early life. This is predominantly driven by inconsistent findings from a relatively small number of randomised clinical trials (RCTs), which vary in design, methodology, and outcome measures, all of which were conducted in high-income countries...
March 8, 2018: Annals of Nutrition & Metabolism
Michelle O'Reilly, Nikki Kiyimba, Jessica N Lester
The field of couple and family therapy has benefitted from evidence generated from qualitative approaches. Evidence developed from approaches relying on language and social interaction using naturally occurring recordings of real-world practice has the benefit of facilitating practice-based recommendations and informing practice. The aim of this article is to provide an overview of one approach to discourse analysis, Discursive Psychology (DP), demonstrating how a social constructionist framework and focus on discourse can provide an important contribution to the field of therapy...
March 8, 2018: Journal of Marital and Family Therapy
Gian Paolo Fadini, Giancarlo Zatti, Ileana Baldi, Daniele Bottigliengo, Agostino Consoli, Andrea Giaccari, Giorgio Sesti, Angelo Avogaro
In randomized controlled trials (RCTs), SGLT-2 inhibitors (SGLT2i) showed glycaemic and extra-glycaemic benefits. The DARWIN-T2D (DApagliflozin Real World evIdeNce in Type 2 Diabetes) was a multicenter retrospective study designed to evaluate baseline characteristics of patients receiving dapagliflozin versus selected comparators (DPP-4 inhibitors, gliclazide, or GLP-1 receptor agonists), and drug effectiveness in routine clinical practice. From a population of 281,217 patients, the analysis included 17,285 initiating dapagliflozin or comparator glucose lowering medications (GLM), 6751 of whom had a follow-up examination...
March 8, 2018: Diabetes, Obesity & Metabolism
A W Singer, K R Reddy, L E Telep, A O Osinusi, D M Brainard, M Buti, A P Chokkalingam
BACKGROUND: Eradication of hepatitis C virus (HCV) infection via interferon-based treatment lowers hepatocellular carcinoma risk; some research suggests this effect extends to interferon-free treatment. AIMS: The objective of this retrospective cohort study was to examine the association of direct-acting antiviral (DAA) exposure with risk of incident liver cancer in real-world data. METHODS: From United States administrative claims data through March 31, 2017, we identified 30 183 adult HCV patients exposed to DAAs...
March 7, 2018: Alimentary Pharmacology & Therapeutics
Stephen P McKenna, Jeanette Wilburn
The assessment of 'patient value' is fundamental to clinical trials, real world evidence studies and outcomes-based reimbursement schemes. Measures of health-related quality of life (HRQL) are widely used in health research. Such measures are effective in determining the presence or absence of symptoms and functional ability. However, HRQL measures were not intended, nor designed, to determine the value to patients of alternative health states. Functions have no intrinsic value - they are a means to fulfil human needs...
March 7, 2018: Journal of Medical Economics
Rubén Queiro, Anahy Brandy, Mª Carmen Rosado, Andrés Lorenzo, Pablo Coto, Carmen Carriles, Mercedes Alperi, Javier Ballina
BACKGROUND/AIMS: Ustekinumab (UST) is a fully human immunoglobulin G1 monoclonal antibody approved for treating moderate to severe psoriasis and, more recently, psoriatic arthritis (PsA) as well. However, information regarding its clinical usefulness in a real-world setting is scarce. We aimed to evaluate the effectiveness and safety of UST in a real-world clinical setting. METHODS: This single-center observational study included PsA outpatients (n = 50) treated with UST from March 2015 to March 2017...
March 6, 2018: Journal of Clinical Rheumatology: Practical Reports on Rheumatic & Musculoskeletal Diseases
H Yang, J F Heidendael, J R de Groot, T C Konings, G Veen, A P J van Dijk, F J Meijboom, G Tj Sieswerda, M C Post, M M Winter, B J M Mulder, B J Bouma
BACKGROUND: Current guidelines on oral anticoagulation (OAC) in adults with congenital heart disease (ACHD) and atrial arrhythmias (AA) consist of heterogeneous and divergent recommendations with limited level of evidence, possibly leading to diverse OAC management and different outcomes. Therefore, we aimed to evaluate real-world implementation and outcome of three guidelines on OAC management in ACHD patients with AA. METHODS: The ESC GUCH 2010, PACES/HRS 2014 and ESC atrial fibrillation (AF) 2016 guidelines were assessed for implementation...
April 15, 2018: International Journal of Cardiology
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