NIHR HTA Clinical Evaluation and Trials Board 11 th and 12 th July 2017

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1 Full Proposals The following full proposals have been supported by the HTA Prioritisation Group, subject to certain conditions: Project ref. Applicant Institution Project Title 16/111/78 Dr Adam Geraghty Southampton Supporting self-management of low back pain with an internet intervention in primary care: A randomised controlled trial of clinical and cost-effectiveness (SupportBack 2) 16/111/136 Dr Peter Watkinson Intensive Care National Audit & Research Centre Renal Replacement Anticoagulant Management (RRAM) 16/111/95 Dr Victoria Grahame Northumberland, Tyne and Wear NHS Foundation Managing Repetitive Behaviours: Clinical and cost effectiveness trial of a parent group intervention to manage restricted and repetitive behaviours in young children with ASD. 16/111/111 16/31/13 Professor Fang Gao Smith Dr Emily Henderson Birmingham Royal United Hospital Bath NHS A Randomised Controlled Trial to investigate the clinical and costeffectiveness of Paravertebral Blockade compared with Thoracic Epidural Blockade in reducing Chronic Post-Thoracotomy Pain (TOPIC 2) A phase 3 trial of Rivastigmine to prevent falls in Parkinson's Disease 16/31/63 Mr Glenn Nielsen St George's, A randomised controlled trial of specialist physiotherapy for Functional Motor Disorder (Physio4FMD) Page 1 of 5

2 16/78/04 Dr Laura Jones Birmingham Female Genital Mutilation: a qualitative study exploring survivors and healthcare professionals views on the timing of deinfibulation surgery (FGM Sister Study) 16/91/04 Professor Helen Snooks Swansea University TIME: Take home naloxone Intervention Multi centre Emergency setting feasibility trial 16/31/136 Dr Robin Grant Common Services Agency SPRING - Seizure Prophylaxis IN Glioma 16/111/106 Professor Sailesh Kotecha Cardiff University AZithromycin ThErapy for Chronic lung disease (AZTEC): A randomised, placebo controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants Further information on the above projects will be provided on the HTA website, once the project has started. Page 2 of 5

3 Expression of Interest Applications The following expressions of interest have been shortlisted to submit a full proposal for consideration by the NIHR HTA Clinical Evaluation and Trials Board at its next meeting. Project ref. Applicant Institution Project Title 16/31/147 Mr Serban Stoica Bristol NHS Foundation Mechanical/Tissue valve or Ross operation for aortic valve replacement (AVR) in adults: a multicentre pragmatic randomised controlled trial (MeTRo) 16/167/130 Professor Emma Ream Surrey Evaluation of a carer intervention (E-CITE) to improve patient and carer outcomes during cancer chemotherapy: a two-arm randomised controlled trial 16/167/120 Dr Michelle Willicombe 16/111/91 Professor Barry Wright 16/167/91 Professor Steven Brown Imperial College Leeds and York Partnership NHS Foundation Sheffield Teaching Hospitals NHS Foundation A UK multicentre randomised controlled trial to determine the efficacy of treatments for acute antibody mediated rejection in renal transplantation Autism Spectrum Social Stories In Schools Trial 2 (ASSSIST2): A randomised controlled trial and economic evaluation of a Social Stories intervention to address the social and emotional health of children with ASD in mainstream primary schools Resection or Medical therapy for Terminal Ileal Crohn's Disease (ROManTIC) 16/167/42 Dr Francis Gilchrist of North Midlands NHS STudy of Antibiotic Treatment In Children with chronic cough (STATIC) Page 3 of 5

4 16/167/107 Ms Jo Cresswell Institute of Cancer Research HIVEC III: A randomised controlled trial comparing adjuvant recirculated hyperthermic intravesical chemotherapy (HIVEC ) with mitomycin C (MMC) vs Bacillus Calmette Guérin (BCG) in high risk non muscle invasive bladder cancer (HRNMIBC) 16/167/123 Professor Laura Magee St George's, WILL (When to Induce Labour to Limit risk in pregnancy hypertension) - a multicentre, randomised controlled trial 16/167/56 Dr Rebecca Kearney 16/167/124 Dr David Landau 16/167/121 Dr Nawaz Walji 17/29/01 Dr Catherine Carr Coventry & Warwickshire NHS University College Coventry & Warwickshire NHS East NHS Foundation Acute Rehabilitation following Traumatic anterior shoulder dislocation (ARTISAN)- A Multi Centre RCT IDEAL2: A randomised trial of isotoxic dose escalated chemoradiation versus standard dose for patients with stage III non-small cell lung cancer (NSCLC). The TARDIS trial: Test Directed Adjuvant Radiotherapy for Ductal Carcinoma-in-Situ Effectiveness of group arts therapy for diagnostically heterogeneous patients: Randomised controlled trial in mental health services (ERA). 17/29/07 Professor Scott Weich The Sheffield Effectiveness of group arts therapies for diagnostically heterogeneous patients in mental health services 16/163/04 Professor Elizabeth Nelson Leeds Swabbing OR Tissue sampling in Diabetic Foot Ulcers (SORT_DFU) Trial Page 4 of 5

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