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ELAIN trial

Raymond Oppong, Sue Jowett, Martyn Lewis, Kris Clarkson, Zoe Paskins, Peter Croft, John J Edwards, Emma Healey, Kelvin P Jordan, Andrew Morden, Bie Nio Ong, Mark Porcheret, Andrew Finney, Elaine Hay, Krysia Dziedzic
Objectives: The aim of this study was to estimate the cost-effectiveness of a model OA consultation for OA to support self-management compared with usual care. Methods: An incremental cost-utility analysis using patient responses to the three-level EuroQoL-5D (EQ-5D) questionnaire was undertaken from a UK National Health Service perspective alongside a two-arm cluster-randomized controlled trial. Uncertainty was explored through the use of cost-effectiveness acceptability curves...
March 14, 2018: Rheumatology
Diana M Sobieraj, Erin R Weeda, Elaine Nguyen, Craig I Coleman, C Michael White, Stephen C Lazarus, Kathryn V Blake, Jason E Lang, William L Baker
Importance: Combined use of inhaled corticosteroids and long-acting β-agonists (LABAs) as the controller and the quick relief therapy termed single maintenance and reliever therapy (SMART) is a potential therapeutic regimen for the management of persistent asthma. Objective: To conduct a systematic review and meta-analysis of the effects of SMART in patients with persistent asthma. Data Sources and Study Selection: The databases of MEDLINE via OVID, EMBASE, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews were searched from database inception through August 2016 and updated through November 28, 2017...
March 19, 2018: JAMA: the Journal of the American Medical Association
Diana M Sobieraj, William L Baker, Elaine Nguyen, Erin R Weeda, Craig I Coleman, C Michael White, Stephen C Lazarus, Kathryn V Blake, Jason E Lang
Importance: Long-acting muscarinic antagonists (LAMAs) are a potential adjunct therapy to inhaled corticosteroids in the management of persistent asthma. Objective: To conduct a systematic review and meta-analysis of the effects associated with LAMA vs placebo or vs other controllers as an add-on therapy to inhaled corticosteroids and the use of a LAMA as add-on therapy to inhaled corticosteroids and long-acting β-agonists (LABAs; hereafter referred to as triple therapy) vs inhaled corticosteroids and LABA in patients with uncontrolled, persistent asthma...
March 19, 2018: JAMA: the Journal of the American Medical Association
Respati W Ranakusuma, Yupitri Pitoyo, Eka D Safitri, Sarah Thorning, Elaine M Beller, Sudigdo Sastroasmoro, Chris B Del Mar
BACKGROUND: Acute otitis media (AOM) is a common acute infection in children. Pain is its most prominent and distressing symptom. Antibiotics are commonly prescribed for AOM, although they have only a modest effect in reducing pain at two to three days. There is insufficient evidence for benefits of other treatment options, including systemic corticosteroids. However, systemic corticosteroids are potent anti-inflammatory drugs, and so theoretically could be effective, either alone or as an addition to antibiotics...
March 15, 2018: Cochrane Database of Systematic Reviews
Laura M Scorr, Michael R Silver, John Hanfelt, Elaine Sperin, Alan Freeman, H A Jinnah, Stewart A Factor
Oromandibular dystonia (OMD) causes involuntary movements of masticatory and lingual muscles impairing eating, speaking, and swallowing. Treatment options are limited. The objective of this study was to determine the safety and efficacy of abobotulinumtoxinA (aboBoNTA) in OMD. A dose-finding study (phase 1) followed by a single session, prospective, single-blind trial (phase 2) was carried out. OMD subjects were evaluated at baseline, 6 and 12 weeks. Muscles injected were tailored to individual symptoms using EMG guidance, but the aboBoNTA dose for each muscle was pre-specified based on phase 1 results...
March 14, 2018: Neurotherapeutics: the Journal of the American Society for Experimental NeuroTherapeutics
Monica Taylor, Elizabeth F Nagle, Fredric L Goss, Elaine N Rubinstein, Andrew Simonson
Monitoring an athlete's energy intake and energy expenditure (EE) is an important consideration of nutritional planning for sport conditioning and peak performance. In order to provide appropriate recommendations regarding nutritional requirements and caloric needs, an accurate determination of energy requirements is necessary. By knowing an individual's EE, a coach, athletic performance staff or trainer can effectively determine training loads and volumes necessary for periodization and seasonal planning for a particular sport...
2018: International Journal of Exercise Science
Suzanne Phelan, Rena R Wing, Anna Brannen, Angelica McHugh, Todd A Hagobian, Andrew Schaffner, Elissa Jelalian, Chantelle N Hart, Theresa O Scholl, Karen Munoz-Christian, Elaine Yin, Maureen G Phipps, Sarah Keadle, Barbara Abrams
Background: Behavioral lifestyle interventions during pregnancy can prevent excessive gestational weight gain (GWG) in women with normal weight; however, effective interventions to reduce GWG in ethnically diverse women with obesity are lacking. Objective: A randomized controlled trial was conducted to test whether a behavioral lifestyle intervention with partial meal replacement reduces GWG rate in Hispanic and non-Hispanic women with overweight or obesity relative to enhanced usual care...
February 1, 2018: American Journal of Clinical Nutrition
Richard D Carvajal, Sophie Piperno-Neumann, Ellen Kapiteijn, Paul B Chapman, Stephen Frank, Anthony M Joshua, Josep M Piulats, Pascal Wolter, Veronique Cocquyt, Bartosz Chmielowski, T R Jeffry Evans, Lauris Gastaud, Gerald Linette, Carola Berking, Jacob Schachter, Manuel J Rodrigues, Alexander N Shoushtari, Delyth Clemett, Dana Ghiorghiu, Gabriella Mariani, Shirley Spratt, Susan Lovick, Peter Barker, Elaine Kilgour, Zhongwu Lai, Gary K Schwartz, Paul Nathan
Purpose Uveal melanoma is the most common primary intraocular malignancy in adults with no effective systemic treatment option in the metastatic setting. Selumetinib (AZD6244, ARRY-142886) is an oral, potent, and selective MEK1/2 inhibitor with a short half-life, which demonstrated single-agent activity in patients with metastatic uveal melanoma in a randomized phase II trial. Methods The Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Metastatic Uveal Melanoma (SUMIT) study was a phase III, double-blind trial ( ClinicalTrial...
March 12, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Samantha L Irwin, William Qubty, I Elaine Allen, Irene Patniyot, Peter J Goadsby, Amy A Gelfand
OBJECTIVE: To assess the feasibility, tolerability, and patient acceptability of single-pulse transcranial magnetic stimulation (sTMS) for migraine prevention in adolescents in an open-label pilot study. BACKGROUND: Migraine is common in adolescents and can be disabling. Well tolerated preventative therapies that are safe and effective are needed. METHODS: This was an open-label prospective pilot feasibility study of sTMS for migraine prevention in adolescents aged 12-17 years...
March 12, 2018: Headache
Sanuji Gajamange, David Raffelt, Thijs Dhollander, Elaine Lui, Anneke van der Walt, Trevor Kilpatrick, Joanne Fielding, Alan Connelly, Scott Kolbe
Long term irreversible disability in multiple sclerosis (MS) is thought to be primarily driven by axonal degeneration. Axonal degeneration leads to degenerative atrophy, therefore early markers of axonal degeneration are required to predict clinical disability and treatment efficacy. Given that additional pathologies such as inflammation, demyelination and oedema are also present in MS, it is essential to develop axonal markers that are not confounded by these processes. The present study investigated a novel method for measuring axonal degeneration in MS based on high angular resolution diffusion magnetic resonance imaging...
2018: NeuroImage: Clinical
Adam W A Geraghty, Rosie Stanford, Beth Stuart, Paul Little, Lisa C Roberts, Nadine E Foster, Jonathan C Hill, Elaine M Hay, David Turner, Wansida Malakan, Linda Leigh, Lucy Yardley
OBJECTIVE: To determine the feasibility of a randomised controlled trial of an internet intervention for low back pain (LBP) using three arms: (1) usual care, (2) usual care plus an internet intervention or (3) usual care plus an internet intervention with additional physiotherapist telephone support. DESIGN AND SETTING: A three-armed randomised controlled feasibility trial conducted in 12 general practices in England. PARTICIPANTS: Primary care patients aged over 18 years, with current LBP, access to the internet and without indicators of serious spinal pathology or systemic illness...
March 9, 2018: BMJ Open
Elaine C Thompson, Jennifer Krizman, Travis White-Schwoch, Trent Nicol, Cynthia R LaBella, Nina Kraus
OBJECTIVE: Concussions can result in auditory processing deficits even in the absence of hearing loss. In children and adolescents, the extent to which these impairments have functional consequences for everyday listening, such as the ability to understand speech in noisy environments, is unknown. RESEARCH DESIGN: Case-control study. SUBJECTS AND METHODS: Forty youth comprised the participants: 20 had sustained a concussion and were recovering from their injury, and 20 controls had sustained non-concussive orthopaedic (e...
March 8, 2018: Brain Injury: [BI]
Jonathan T Caranfa, Elaine Nguyen, Rafay Ali, Iregi Francis, Albert Zichichi, Elliott Bosco, Craig I Coleman, William L Baker, Christine G Kohn
BACKGROUND: Randomized controlled trials (RCTs) have compared mechanical endovascular therapy (MET) in addition to intravenous tissue plasminogen activator (IVtPA) to IVtPA alone for the management of acute ischemic stroke (AIS). Direct comparative studies between individual METs are not available. In lieu of head-to-head randomized control trials, we performed an adjusted indirect treatment comparison (ITC) meta-analysis to assess the comparative efficacy and safety of different METs, Solitaire+IVtPA and Penumbra+IVtPA in AIS patients...
2018: PloS One
Ruey Leng Loo, Xin Zou, Lawrence J Appel, Jeremy K Nicholson, Elaine Holmes
Background: Interindividual variation in the response to diet is common, but the underlying mechanism for such variation is unclear. Objective: The objective of this study was to use a metabolic profiling approach to identify a panel of urinary metabolites representing individuals demonstrating typical (homogeneous) metabolic responses to healthy diets, and subsequently to define the association of these metabolites with improvement of risk factors for cardiovascular diseases (CVDs)...
March 1, 2018: American Journal of Clinical Nutrition
Hildegard Kolb, Austyn Snowden, Elaine Stevens
AIM: To identify effective treatments and risk factors associated with death rattle in adults at the end of life. BACKGROUND: The presence of noisy, pooled respiratory tract secretions is among the most common symptoms in dying patients around the world. It is unknown if 'death rattle' distresses patients, but it can distress relatives and clinicians. Treatments appear unsatisfactory, so prophylaxis would be ideal if possible. DESIGN: Quantitative systematic review and narrative summary following Cochrane Collaboration guidelines...
March 1, 2018: Journal of Advanced Nursing
Bolette S Rafn, Stanley Hung, Alison M Hoens, Margaret L McNeely, Chiara A Singh, Winkle Kwan, Carol Dingee, Elaine C McKevitt, Urve Kuusk, Jinsi Pao, Nancy Van Laeken, Charlie H Goldsmith, Kristin L Campbell
OBJECTIVE: To evaluate prospective surveillance and targeted physiotherapy (PSTP) compared to education (EDU) on the prevalence of arm morbidity and describe the associated program cost. DESIGN: Pilot randomized single-blinded controlled trial. SETTING: Urban with assessments and treatment delivered in hospitals. PARTICIPANTS: Women scheduled for breast cancer surgery. INTERVENTIONS: Participants were randomly assigned (1:1) to PSTP ( n = 21) or EDU ( n = 20) and assessed presurgery and 12 months postsurgery...
February 1, 2018: Clinical Rehabilitation
Douglas Chesher, Michael Oddy, Ulpee Darbar, Parag Sayal, Adrian Casey, Aidan Ryan, Annalisa Sechi, Charlotte Simister, Aoife Waters, Yehani Wedatilake, Robin H Lachmann, Elaine Murphy
X-linked hypophosphatemia (XLH) is the most common monogenic disorder causing hypophosphatemia. This case-note review documents the clinical features and the complications of treatment in 59 adults (19 male, 40 female) with XLH. XLH is associated with a large number of private mutations; 37 different mutations in the PHEX gene were identified in this cohort, 14 of which have not been previously reported. Orthopaedic involvement requiring surgical intervention (osteotomy) was frequent. Joint replacement and decompressive laminectomy were observed in those older than 40 years...
February 19, 2018: Journal of Inherited Metabolic Disease
Nicola Heslehurst, Judith Rankin, Catherine McParlin, Falko F Sniehotta, Denise Howel, Stephen Rice, Elaine McColl
Background: Weight management in pregnancy guidelines exist, although dissemination alone is an ineffective means of implementation. Midwives identify the need for support to overcome complex barriers to practice. An evaluation of an intervention to support midwives' guideline implementation would require a large-scale cluster randomised controlled trial. A pilot study is necessary to explore the feasibility of delivery and evaluation prior to a definitive trial. The GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING) trial aims to test whether it is feasible and acceptable to deliver a behaviour change intervention to support midwives' implementation of weight management guidelines...
2018: Pilot and Feasibility Studies
Vincent Deary, Elaine McColl, Paul Carding, Tracy Miller, Janet Wilson
Background: Medically unexplained loss or alteration of voice-functional dysphonia-is the commonest presentation to speech and language therapists (SLTs). Besides the impact on personal and work life, functional dysphonia is also associated with increased levels of anxiety and depression and poor general health. Voice therapy delivered by SLTs improves voice but not these associated symptoms. The aims of this research were the systematic development of a complex intervention to improve the treatment of functional dysphonia, and the trialling of this intervention for feasibility and acceptability to SLTs and patients in a randomised pilot study...
2018: Pilot and Feasibility Studies
Jon Kobashigawa, Monica Colvin, Luciano Potena, Duska Dragun, Maria G Crespo-Leiro, Juan F Delgado, Michael Olymbios, Jayan Parameshwar, Jignesh Patel, Elaine Reed, Nancy Reinsmoen, E Rene Rodriguez, Heather Ross, Randall C Starling, Dolly Tyan, Simon Urschel, Andreas Zuckermann
Despite the successes from refined peri-operative management techniques and immunosuppressive therapies, antibodies remain a serious cause of morbidity and mortality for patients both before and after heart transplantation. Patients awaiting transplant who possess antibodies against human leukocyte antigen are disadvantaged by having to wait longer to receive an organ from a suitably matched donor. The number of pre-sensitized patients has been increasing, a trend that is likely due to the increased use of mechanical circulatory support devices...
January 31, 2018: Journal of Heart and Lung Transplantation
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