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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
Pinar Ulug, Robert J Hinchliffe, Michael J Sweeting, Manuel Gomes, Matthew T Thompson, Simon G Thompson, Richard J Grieve, Raymond Ashleigh, Roger M Greenhalgh, Janet T Powell
BACKGROUND: Ruptured abdominal aortic aneurysm (AAA) is a common vascular emergency. The mortality from emergency endovascular repair may be much lower than the 40-50% reported for open surgery. OBJECTIVE: To assess whether or not a strategy of endovascular repair compared with open repair reduces 30-day and mid-term mortality (including costs and cost-effectiveness) among patients with a suspected ruptured AAA. DESIGN: Randomised controlled trial, with computer-generated telephone randomisation of participants in a 1 : 1 ratio, using variable block size, stratified by centre and without blinding...
May 2018: Health Technology Assessment: HTA
Suzanne H Richards, John L Campbell, Christopher Dickens, Rob Anderson, Manish Gandhi, Andy Gibson, David Kessler, Luke Knight, Willem Kuyken, David A Richards, Rod S Taylor, Katrina Turner, Obioha C Ukoumunne, Antoinette Davey, Fiona C Warren, Rachel E Winder, Christine A Wright
BACKGROUND: Around 19% of people screened by UK cardiac rehabilitation programmes report having moderate or severe symptoms of depression. These individuals are at an increased risk of cardiac mortality and morbidity, reduced quality of life and increased use of health resources compared with their non-depressed counterparts. Maximising psychological health is a goal of cardiac rehabilitation, but psychological care is patchy. OBJECTIVE(S): To examine the feasibility and acceptability of embedding enhanced psychological care (EPC) within cardiac rehabilitation, we tested the feasibility of developing/implementing EPC and documented the key uncertainties associated with undertaking a definitive evaluation...
May 2018: Health Technology Assessment: HTA
John G Lawrenson, Ella Graham-Rowe, Fabiana Lorencatto, Stephen Rice, Catey Bunce, Jill J Francis, Jennifer M Burr, Patricia Aluko, Luke Vale, Tunde Peto, Justin Presseau, Noah M Ivers, Jeremy M Grimshaw
BACKGROUND: Diabetic retinopathy screening (DRS) is effective but uptake is suboptimal. OBJECTIVES: To determine the effectiveness of quality improvement (QI) interventions for DRS attendance; describe the interventions in terms of QI components and behaviour change techniques (BCTs); identify theoretical determinants of attendance; investigate coherence between BCTs identified in interventions and determinants of attendance; and determine the cost-effectiveness of QI components and BCTs for improving DRS...
May 2018: Health Technology Assessment: HTA
Sarah E Lamb, Dipesh Mistry, Sharisse Alleyne, Nicky Atherton, Deborah Brown, Bethan Copsey, Sukhdeep Dosanjh, Susanne Finnegan, Beth Fordham, Frances Griffiths, Susie Hennings, Iftekhar Khan, Kamran Khan, Ranjit Lall, Samantha Lyle, Vivien Nichols, Stavros Petrou, Peter Zeh, Bart Sheehan
BACKGROUND: Approximately 670,000 people in the UK have dementia. Previous literature suggests that physical exercise could slow dementia symptom progression. OBJECTIVES: To estimate the clinical effectiveness and cost-effectiveness of a bespoke exercise programme, in addition to usual care, on the cognitive impairment (primary outcome), function and health-related quality of life (HRQoL) of people with mild to moderate dementia (MMD) and carer burden and HRQoL...
May 2018: Health Technology Assessment: HTA
Norman Waugh, Emma Loveman, Jill Colquitt, Pamela Royle, Jian Lee Yeong, Geraldine Hoad, Noemi Lois
BACKGROUND: Age-related macular degeneration (AMD) is the leading cause of visual loss in older people. Advanced AMD takes two forms, neovascular (wet) and atrophic (dry). Stargardt disease (STGD) is the commonest form of inherited macular dystrophy. OBJECTIVE: To carry out a systematic review of treatments for dry AMD and STGD, and to identify emerging treatments where future NIHR research might be commissioned. DESIGN: Systematic review...
May 2018: Health Technology Assessment: HTA
Allan House, Louise Bryant, Amy M Russell, Alexandra Wright-Hughes, Liz Graham, Rebecca Walwyn, Judy M Wright, Claire Hulme, John L O'Dwyer, Gary Latchford, Shaista Meer, Jacqueline C Birtwistle, Alison Stansfield, Ramzi Ajjan, Amanda Farrin
BACKGROUND: Obesity and type 2 diabetes are common in adults with a learning disability. It is not known if the principles of self-management can be applied in this population. OBJECTIVES: To develop and evaluate a case-finding method and undertake an observational study of adults with a learning disability and type 2 diabetes, to develop a standardised supported self-management (SSM) intervention and measure of adherence and to undertake a feasibility randomised controlled trial (RCT) of SSM versus treatment as usual (TAU)...
May 2018: Health Technology Assessment: HTA
Matthew L Costa, Juul Achten, Susie Hennings, Nafisa Boota, James Griffin, Stavros Petrou, Mandy Maredza, Melina Dritsaki, Thomas Wood, James Masters, Ian Pallister, Sarah E Lamb, Nick R Parsons
BACKGROUND: The best treatment for fractures of the distal tibia remains controversial. Most of these fractures require surgical fixation, but the outcomes are unpredictable and complications are common. OBJECTIVES: To assess disability, quality of life, complications and resource use in patients treated with intramedullary (IM) nail fixation versus locking plate fixation in the 12 months following a fracture of the distal tibia. DESIGN: This was a multicentre randomised trial...
May 2018: Health Technology Assessment: HTA
Robert Pickard, Thomas Chadwick, Yemi Oluboyede, Catherine Brennand, Alexander von Wilamowitz-Moellendorff, Doreen McClurg, Jennifer Wilkinson, Laura Ternent, Holly Fisher, Katherine Walton, Elaine McColl, Luke Vale, Ruth Wood, Mohamed Abdel-Fattah, Paul Hilton, Mandy Fader, Simon Harrison, James Larcombe, Paul Little, Anthony Timoney, James N'Dow, Heather Armstrong, Nicola Morris, Kerry Walker, Nikesh Thiruchelvam
BACKGROUND: People carrying out clean intermittent self-catheterisation (CISC) to empty their bladder often suffer repeated urinary tract infections (UTIs). Continuous once-daily, low-dose antibiotic treatment (antibiotic prophylaxis) is commonly advised but knowledge of its effectiveness is lacking. OBJECTIVE: To assess the benefit, harms and cost-effectiveness of antibiotic prophylaxis to prevent UTIs in people who perform CISC. DESIGN: Parallel-group, open-label, patient-randomised 12-month trial of allocated intervention with 3-monthly follow-up...
May 2018: Health Technology Assessment: HTA
Shakila Thangaratinam, Nadine Marlin, Sian Newton, Annalise Weckesser, Manny Bagary, Lynette Greenhill, Rachel Rikunenko, Maria D'Amico, Ewelina Rogozińska, Andrew Kelso, Kelly Hard, Jamie Coleman, Ngawai Moss, Tracy Roberts, Lee Middleton, Julie Dodds, Angela Pullen, Sandra Eldridge, Alexander Pirie, Elaine Denny, Doug McCorry, Khalid S Khan
BACKGROUND: Pregnant women with epilepsy on antiepileptic drugs (AEDs) may experience a reduction in serum AED levels. This has the potential to worsen seizure control. OBJECTIVE: To determine if, in pregnant women with epilepsy on AEDs, additional therapeutic drug monitoring reduces seizure deterioration compared with clinical features monitoring after a reduction in serum AED levels. DESIGN: A double-blind, randomised trial nested within a cohort study was conducted and a qualitative study of acceptability of the two strategies was undertaken...
May 2018: Health Technology Assessment: HTA
Maureen Seguin, Catherine Dodds, Esther Mugweni, Lisa McDaid, Paul Flowers, Sonali Wayal, Ella Zomer, Peter Weatherburn, Ibidun Fakoya, Thomas Hartney, Lorraine McDonagh, Rachael Hunter, Ingrid Young, Shabana Khan, Nick Freemantle, Jabulani Chwaula, Memory Sachikonye, Jane Anderson, Surinder Singh, Eleni Nastouli, Greta Rait, Fiona Burns
BACKGROUND: Timely diagnosis of human immunodeficiency virus (HIV) enables access to antiretroviral treatment, which reduces mortality, morbidity and further transmission in people living with HIV. In the UK, late diagnosis among black African people persists. Novel methods to enhance HIV testing in this population are needed. OBJECTIVES: To develop a self-sampling kit (SSK) intervention to increase HIV testing among black Africans, using existing community and health-care settings (stage 1) and to assess the feasibility for a Phase III evaluation (stage 2)...
April 2018: Health Technology Assessment: HTA
Leone Ridsdale, Alison McKinlay, Gabriella Wojewodka, Emily J Robinson, Iris Mosweu, Sarah J Feehan, Adam J Noble, Myfanwy Morgan, Stephanie Jc Taylor, Paul McCrone, Sabine Landau, Mark Richardson, Gus Baker, Laura H Goldstein
BACKGROUND: Epilepsy is a common neurological condition resulting in recurrent seizures. Research evidence in long-term conditions suggests that patients benefit from self-management education and that this may improve quality of life (QoL). Epilepsy self-management education has yet to be tested in a UK setting. OBJECTIVES: To determine the effectiveness and cost-effectiveness of Self-Management education for people with poorly controlled epILEpsy [SMILE (UK)]...
April 2018: Health Technology Assessment: HTA
Emma Simpson, Emma Hock, Matt Stevenson, Ruth Wong, Naila Dracup, Allan Wailoo, Philip Conaghan, Cristina Estrach, Christopher Edwards, Richard Wakefield
BACKGROUND: Synovitis (inflamed joint synovial lining) in rheumatoid arthritis (RA) can be assessed by clinical examination (CE) or ultrasound (US). OBJECTIVE: To investigate the added value of US, compared with CE alone, in RA synovitis in terms of clinical effectiveness and cost-effectiveness. DATA SOURCES: Electronic databases including MEDLINE, EMBASE and the Cochrane databases were searched from inception to October 2015. REVIEW METHODS: A systematic review sought RA studies that compared additional US with CE...
April 2018: Health Technology Assessment: HTA
Linda Sharples, Colin Everett, Jeshika Singh, Christine Mills, Tom Spyt, Yasir Abu-Omar, Simon Fynn, Benjamin Thorpe, Victoria Stoneman, Hester Goddard, Julia Fox-Rushby, Samer Nashef
BACKGROUND: Atrial fibrillation (AF) can be treated using a maze procedure during planned cardiac surgery, but the effect on clinical patient outcomes, and the cost-effectiveness compared with surgery alone, are uncertain. OBJECTIVES: To determine whether or not the maze procedure is safe, improves clinical and patient outcomes and is cost-effective for the NHS in patients with AF. DESIGN: Multicentre, Phase III, pragmatic, double-blind, parallel-arm randomised controlled trial...
April 2018: Health Technology Assessment: HTA
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