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Health Technology Assessment: HTA

David Inwald, Ruth R Canter, Kerry Woolfall, Caitlin B O'Hara, Paul R Mouncey, Zohra Zenasni, Nicholas Hudson, Steven Saunders, Anjali Carter, Nicola Jones, Mark D Lyttle, Simon Nadel, Mark J Peters, David A Harrison, Kathryn M Rowan
BACKGROUND: There has been no randomised controlled trial (RCT) of fluid bolus therapy in paediatric sepsis in the developed world despite evidence that excess fluid may be associated with harm. OBJECTIVES: To determine the feasibility of the Fluids in Shock (FiSh) trial - a RCT comparing restricted fluid bolus (10 ml/kg) with current practice (20 ml/kg) in children with septic shock in the UK. DESIGN: (1) Qualitative feasibility study exploring parents' views about the pilot RCT...
September 2018: Health Technology Assessment: HTA
Jane Goodwin, Jan Lecouturier, Anna Basu, Allan Colver, Sarah Crombie, Johanna Smith, Denise Howel, Elaine McColl, Jeremy R Parr, Niina Kolehmainen, Andrew Roberts, Keith Miller, Jill Cadwgan
BACKGROUND: Standing frames are recommended as part of postural management for young people with cerebral palsy (CP) Gross Motor Function Classification System (GMFCS) level IV or V. They may have a variety of benefits, including improving bone mineral density, gastrointestinal function and social participation. The NHS needs to know if these benefits are real, given the cost implications of use and the reported negative effects (e.g. pain). The lack of evidence for the clinical effectiveness of standing frames demonstrates the need for evaluative research...
September 2018: Health Technology Assessment: HTA
Ruben Mujica-Mota, Jo Varley-Campbell, Irina Tikhonova, Chris Cooper, Ed Griffin, Marcela Haasova, Jaime Peters, Stefano Lucherini, Juan Talens-Bou, Linda Long, David Sherriff, Mark Napier, John Ramage, Martin Hoyle
BACKGROUND: Neuroendocrine tumours (NETs) are a group of heterogeneous cancers that develop in cells in the diffuse neuroendocrine system. OBJECTIVES: To estimate the clinical effectiveness of three interventions [everolimus (Afinitor® ; Novartis International AG, Basel, Switzerland), lutetium-177 DOTATATE (177Lu-DOTATATE) (Lutathera® ; Imaging Equipment Ltd, Radstock, UK) and sunitinib (Sutent® ; Pfizer Inc., New York, NY, USA)] for treating unresectable or metastatic NETs with disease progression and establish the cost-effectiveness of these interventions...
September 2018: Health Technology Assessment: HTA
Philip M Bath, Lisa J Woodhouse, Jason P Appleton, Maia Beridze, Hanne Christensen, Robert A Dineen, Katie Flaherty, Lelia Duley, Timothy J England, Diane Havard, Stan Heptinstall, Marilyn James, Chibeka Kasonde, Kailash Krishnan, Hugh S Markus, Alan A Montgomery, Stuart Pocock, Marc Randall, Annamarei Ranta, Thompson G Robinson, Polly Scutt, Graham S Venables, Nikola Sprigg
BACKGROUND: Two antiplatelet agents are better than one for preventing recurrent stroke after acute ischaemic stroke or transient ischaemic attack (TIA). Therefore, intensive treatment with three agents might be better still, providing it does not cause undue bleeding. OBJECTIVE: To compare the safety and efficacy of intensive therapy with guideline antiplatelet therapy for acute ischaemic stroke and TIA. DESIGN: International prospective randomised open-label blinded end-point parallel-group superiority clinical trial...
August 2018: Health Technology Assessment: HTA
Steve Goodacre, Kimberley Horspool, Neil Shephard, Daniel Pollard, Beverley J Hunt, Gordon Fuller, Catherine Nelson-Piercy, Marian Knight, Steven Thomas, Fiona Lecky, Judith Cohen
BACKGROUND: Pulmonary embolism (PE) is a leading cause of death in pregnancy and post partum, but the symptoms of PE are common in normal pregnancy. Simple diagnostic tests are needed to select women for diagnostic imaging. OBJECTIVE: To estimate the accuracy, effectiveness and cost-effectiveness of clinical features, decision rules and biomarkers for selecting pregnant or postpartum women with a suspected PE for imaging. DESIGN: An expert consensus study to develop new clinical decision rules, a case-control study of women with a diagnosed PE or a suspected PE, a biomarker study of women with a suspected PE or diagnosed deep-vein thrombosis (DVT) and decision-analysis modelling...
August 2018: Health Technology Assessment: HTA
Mark Corbett, David Marshall, Melissa Harden, Sam Oddie, Robert Phillips, William McGuire
BACKGROUND: Extravasation injuries are caused by unintended leakages of fluids or medicines from intravenous lines, but there is no consensus on the best treatment approaches. OBJECTIVES: To identify which treatments may be best for treating extravasation injuries in infants and young children. DESIGN: Scoping review and survey of practice. POPULATION: Children aged < 18 years with extravasation injuries and NHS staff who treat children with extravasation injuries...
August 2018: Health Technology Assessment: HTA
Peter Jd Andrews, H Louise Sinclair, Aryelly Rodríguez, Bridget Harris, Jonathan Rhodes, Hannah Watson, Gordon Murray
BACKGROUND: Traumatic brain injury (TBI) is a major cause of disability and death in young adults worldwide. It results in around 1 million hospital admissions annually in the European Union (EU), causes a majority of the 50,000 deaths from road traffic accidents and leaves a further ≈10,000 people severely disabled. OBJECTIVE: The Eurotherm3235 Trial was a pragmatic trial examining the effectiveness of hypothermia (32-35 °C) to reduce raised intracranial pressure (ICP) following severe TBI and reduce morbidity and mortality 6 months after TBI...
August 2018: Health Technology Assessment: HTA
Marie Westwood, Bram Ramaekers, Shona Lang, Sabine Grimm, Sohan Deshpande, Shelley de Kock, Nigel Armstrong, Manuela Joore, Jos Kleijnen
BACKGROUND: Ovarian cancer is the sixth most common cancer in UK women and can be difficult to diagnose, particularly in the early stages. Risk-scoring can help to guide referral to specialist centres. OBJECTIVES: To assess the clinical and cost-effectiveness of risk scores to guide referral decisions for women with suspected ovarian cancer in secondary care. METHODS: Twenty-one databases, including MEDLINE and EMBASE, were searched from inception to November 2016...
August 2018: Health Technology Assessment: HTA
Simon G Thompson, Matthew J Bown, Matthew J Glover, Edmund Jones, Katya L Masconi, Jonathan A Michaels, Janet T Powell, Pinar Ulug, Michael J Sweeting
BACKGROUND: Abdominal aortic aneurysm (AAA) screening programmes have been established for men in the UK to reduce deaths from AAA rupture. Whether or not screening should be extended to women is uncertain. OBJECTIVE: To evaluate the cost-effectiveness of population screening for AAAs in women and compare a range of screening options. DESIGN: A discrete event simulation (DES) model was developed to provide a clinically realistic model of screening, surveillance, and elective and emergency AAA repair operations...
August 2018: Health Technology Assessment: HTA
Joanne Blair, Andrew McKay, Colin Ridyard, Keith Thornborough, Emma Bedson, Matthew Peak, Mohammed Didi, Francesca Annan, John W Gregory, Dyfrig Hughes, Carrol Gamble
BACKGROUND: The risk of developing long-term complications of type 1 diabetes (T1D) is related to glycaemic control and is reduced by the use of intensive insulin treatment regimens: multiple daily injections (MDI) (≥ 4) and continuous subcutaneous insulin infusion (CSII). Despite a lack of evidence that the more expensive treatment with CSII is superior to MDI, both treatments are used widely within the NHS. OBJECTIVES: (1) To compare glycaemic control during treatment with CSII and MDI and (2) to determine safety and cost-effectiveness of the treatment, and quality of life (QoL) of the patients...
August 2018: Health Technology Assessment: HTA
Paul Aveyard, Nicola Lindson, Sarah Tearne, Rachel Adams, Khaled Ahmed, Rhona Alekna, Miriam Banting, Mike Healy, Shahnaz Khan, Gurmail Rai, Carmen Wood, Emma C Anderson, Alia Ataya-Williams, Angela Attwood, Kayleigh Easey, Megan Fluharty, Therese Freuler, Megan Hurse, Jasmine Khouja, Lindsey Lacey, Marcus Munafò, Deborah Lycett, Andy McEwen, Tim Coleman, Anne Dickinson, Sarah Lewis, Sophie Orton, Johanna Perdue, Clare Randall, Rebecca Anderson, Natalie Bisal, Peter Hajek, Celine Homsey, Hayden J McRobbie, Katherine Myers-Smith, Anna Phillips, Dunja Przulj, Jinshuo Li, Doug Coyle, Katherine Coyle, Subhash Pokhrel
BACKGROUND: Nicotine preloading means using nicotine replacement therapy prior to a quit date while smoking normally. The aim is to reduce the drive to smoke, thereby reducing cravings for smoking after quit day, which are the main cause of early relapse. A prior systematic review showed inconclusive and heterogeneous evidence that preloading was effective and little evidence of the mechanism of action, with no cost-effectiveness data. OBJECTIVES: To assess (1) the effectiveness, safety and tolerability of nicotine preloading in a routine NHS setting relative to usual care, (2) the mechanisms of the action of preloading and (3) the cost-effectiveness of preloading...
August 2018: Health Technology Assessment: HTA
Khalid S Khan, Konstantinos Tryposkiadis, Seema A Tirlapur, Lee J Middleton, Andrew J Sutton, Lee Priest, Elizabeth Ball, Moji Balogun, Anju Sahdev, Tracy Roberts, Judy Birch, Jane P Daniels, Jonathan J Deeks
BACKGROUND: Chronic pelvic pain (CPP) symptoms in women are variable and non-specific; establishing a differential diagnosis can be hard. A diagnostic laparoscopy is often performed, although a prior magnetic resonance imaging (MRI) scan may beneficial. OBJECTIVES: To estimate the accuracy and added value of MRI in making diagnoses of (1) idiopathic CPP and (2) the main gynaecological causes of CPP. To quantify the impact MRI can have on decision-making with respect to triaging for therapeutic laparoscopy and to conduct an economic evaluation...
July 2018: Health Technology Assessment: HTA
Louise Clare Brown, Hashim U Ahmed, Rita Faria, Ahmed El-Shater Bosaily, Rhian Gabe, Richard S Kaplan, Mahesh Parmar, Yolanda Collaco-Moraes, Katie Ward, Richard Graham Hindley, Alex Freeman, Alexander Kirkham, Robert Oldroyd, Chris Parker, Simon Bott, Nick Burns-Cox, Tim Dudderidge, Maneesh Ghei, Alastair Henderson, Rajendra Persad, Derek J Rosario, Iqbal Shergill, Mathias Winkler, Marta Soares, Eldon Spackman, Mark Sculpher, Mark Emberton
BACKGROUND: Men with suspected prostate cancer usually undergo transrectal ultrasound (TRUS)-guided prostate biopsy. TRUS-guided biopsy can cause side effects and has relatively poor diagnostic accuracy. Multiparametric magnetic resonance imaging (mpMRI) used as a triage test might allow men to avoid unnecessary TRUS-guided biopsy and improve diagnostic accuracy. OBJECTIVES: To (1) assess the ability of mpMRI to identify men who can safely avoid unnecessary biopsy, (2) assess the ability of the mpMRI-based pathway to improve the rate of detection of clinically significant (CS) cancer compared with TRUS-guided biopsy and (3) estimate the cost-effectiveness of a mpMRI-based diagnostic pathway...
July 2018: Health Technology Assessment: HTA
Craig R Ramsay, Jan E Clarkson, Anne Duncan, Thomas J Lamont, Peter A Heasman, Dwayne Boyers, Beatriz Goulão, Debbie Bonetti, Rebecca Bruce, Jill Gouick, Lynne Heasman, Laura A Lovelock-Hempleman, Lorna E Macpherson, Giles I McCracken, Alison M McDonald, Fiona McLaren-Neil, Fiona E Mitchell, John Dt Norrie, Marjon van der Pol, Kirsty Sim, James G Steele, Alex Sharp, Graeme Watt, Helen V Worthington, Linda Young
BACKGROUND: Periodontal disease is preventable but remains the most common oral disease worldwide, with major health and economic implications. Stakeholders lack reliable evidence of the relative clinical effectiveness and cost-effectiveness of different types of oral hygiene advice (OHA) and the optimal frequency of periodontal instrumentation (PI). OBJECTIVES: To test clinical effectiveness and assess the economic value of the following strategies: personalised OHA versus routine OHA, 12-monthly PI (scale and polish) compared with 6-monthly PI, and no PI compared with 6-monthly PI...
July 2018: Health Technology Assessment: HTA
Tess Harris, Sally Kerry, Christina Victor, Steve Iliffe, Michael Ussher, Julia Fox-Rushby, Peter Whincup, Ulf Ekelund, Cheryl Furness, Elizabeth Limb, Nana Anokye, Judith Ibison, Stephen DeWilde, Lee David, Emma Howard, Rebecca Dale, Jaime Smith, Rebecca Normansell, Carole Beighton, Katy Morgan, Charlotte Wahlich, Sabina Sanghera, Derek Cook
BACKGROUND: Guidelines recommend walking to increase moderate to vigorous physical activity (MVPA) for health benefits. OBJECTIVES: To assess the effectiveness, cost-effectiveness and acceptability of a pedometer-based walking intervention in inactive adults, delivered postally or through dedicated practice nurse physical activity (PA) consultations. DESIGN: Parallel three-arm trial, cluster randomised by household. SETTING: Seven London-based general practices...
June 2018: Health Technology Assessment: HTA
Naiem Moiemen, Jonathan Mathers, Laura Jones, Jonathan Bishop, Philip Kinghorn, Mark Monahan, Melanie Calvert, Gemma Slinn, Fay Gardiner, Amy Bamford, Susan Wright, Ian Litchfield, Nicole Andrews, Karen Turner, Margaret Grant, Jonathan Deeks
BACKGROUND: Eleven million people suffer a fire-related injury worldwide every year, and 71% have significant scarring. Pressure garment therapy (PGT) is a standard part of burn scar management, but there is little evidence of its clinical effectiveness or cost-effectiveness. OBJECTIVE: To identify the barriers to, and the facilitators of, conducting a randomised controlled trial (RCT) of burn scar management with and without PGT and test whether or not such a trial is feasible...
June 2018: Health Technology Assessment: HTA
Jane E Norman, Neil Marlow, Claudia-Martina Messow, Andrew Shennan, Philip R Bennett, Steven Thornton, Stephen C Robson, Alex McConnachie, Stavros Petrou, Neil J Sebire, Tina Lavender, Sonia Whyte, John Norrie
BACKGROUND: Progesterone prophylaxis is widely used to prevent preterm birth but is not licensed and there is little information on long-term outcome. OBJECTIVE: To determine the effect of progesterone prophylaxis in women at high risk of preterm birth on obstetric, neonatal and childhood outcomes. DESIGN: Double-blind, randomised placebo-controlled trial. SETTING: Obstetric units in the UK and Europe between February 2009 and April 2013...
June 2018: Health Technology Assessment: HTA
Sarah Brown, Colin C Everett, Kamran Naraghi, Claire Davies, Bryony Dawkins, Claire Hulme, Christopher McCabe, Sue Pavitt, Paul Emery, Linda Sharples, Maya H Buch
BACKGROUND: Rheumatoid arthritis (RA), the most common autoimmune disease in the UK, is a chronic systemic inflammatory arthritis that affects 0.8% of the UK population. OBJECTIVES: To determine whether or not an alternative class of biologic disease-modifying antirheumatic drugs (bDMARDs) are comparable to rituximab in terms of efficacy and safety outcomes in patients with RA in whom initial tumour necrosis factor inhibitor (TNFi) bDMARD and methotrexate (MTX) therapy failed because of inefficacy...
June 2018: Health Technology Assessment: HTA
Kate Radford, Chris Sutton, Tracey Sach, Jain Holmes, Caroline Watkins, Denise Forshaw, Trevor Jones, Karen Hoffman, Rory O'Connor, Ruth Tyerman, Jose Antonio Merchán-Baeza, Richard Morris, Emma McManus, Avril Drummond, Marion Walker, Lelia Duley, David Shakespeare, Alison Hammond, Julie Phillips
BACKGROUND: Up to 160,000 people incur traumatic brain injury (TBI) each year in the UK. TBI can have profound effects on many areas of human functioning, including participation in work. There is limited evidence of the clinical effectiveness and cost-effectiveness of vocational rehabilitation (VR) after injury to promote early return to work (RTW) following TBI. OBJECTIVE: To assess the feasibility of a definitive, multicentre, randomised controlled trial (RCT) of the clinical effectiveness and cost-effectiveness of early, specialist VR plus usual care (UC) compared with UC alone on work retention 12 months post TBI...
May 2018: Health Technology Assessment: HTA
Peter S Hall, Elizabeth D Mitchell, Alison F Smith, David A Cairns, Michael Messenger, Michelle Hutchinson, Judy Wright, Karen Vinall-Collier, Claire Corps, Patrick Hamilton, David Meads, Andrew Lewington
BACKGROUND: Acute kidney injury (AKI) is highly prevalent in hospital inpatient populations, leading to significant mortality and morbidity, reduced quality of life and high short- and long-term health-care costs for the NHS. New diagnostic tests may offer an earlier diagnosis or improved care, but evidence of benefit to patients and of value to the NHS is required before national adoption. OBJECTIVES: To evaluate the potential for AKI in vitro diagnostic tests to enhance the NHS care of patients admitted to the intensive care unit (ICU) and identify an efficient supporting research strategy...
May 2018: Health Technology Assessment: HTA
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