NIHR HTA Clinical Evaluation and Trials Board. Minutes of the Meeting

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1 NIHR HTA Clinical Evaluation and Trials Board Minutes of the Meeting Date Tuesday 11 and Wednesday 12 July 2017 Place Danubius Hotel Regents Park, London Present members Professor Hywel Williams Professor Steve Goodacre Professor Julia Brown Mrs Catherine White Ms Gail Thornton Professor Lucy Chappell Professor Tim Coleman Professor Lorraine De Souza Professor Sandra Eldridge Professor Amanda Farrin Professor Paul Ewings Professor David (Ted) Garway-Heath Professor Peter Langhorne Professor Edwin Van Teijlingen Professor Stephen Walters Professor Scott Weich Professor William Hollingworth Professor Daniel Lasserson Professor Peter Langhorne Professor Stephanie Taylor Professor Hisham Mehanna Professor Luke Vale Dr Susan Jowett Dr Jennifer Logue Dr Sharon Simpson HTA Programme Director Chair Deputy Chair PPI representative PPI representative NETSCC, HTA Secretariat Dr Martin Ashton-Key (Consultant Advisor, NETSCC) Mrs Vicky Taylor (Senior Research Manager) Dr Cristina Lujan (Research Manager) Mr Alan Newman (Assistant Research Manager) Mrs Debbie Carter (Administrator) (Day 1) Apologies Professor Douglas Tincello (Day 1 and 2) Professor Scott Weich (Day 1) Arrived after start of meeting on day 2 Professor Peter Langhorne Arrived after start of meeting on day 1 Professor Hisham Mehanna (Day 2) Arrived after start of meeting on day 1 Professor Sandra Eldridge (Day 2) Professor Hywel Williams (Day 2 afternoon) Observers Day 1 Diane Yip, Department of Health Day 2 Charlotte Coles, Cambridge University Hospitals. New board member, observing July Board.

2 Day 1 Researcher-Led Full Proposals 16/31/25: VINDICATE 2: VItamiN D treating Chronic heart failure (the effect of vitamin D supplementation on hospitalisation and mortality in patients with heart failure): multicentre, phase III, randomised placebo-controlled trial (Witte, University of Leeds) DBMs: 1. Edwin van Teijlingen 2. Sandra Eldridge 3. Gail Thornton Declared a conflict and left the room: Jennifer Logue, Amanda Farrin, Julia Brown, Luke Vale, Sharon Simpson 15/188/21: CONVOLUTE: A Randomised Open-Label Phase III non-inferiority Trial of Continuous vs Non-Continuous Pembrolizumab for patients with relapsed Non-Small Cell Lung Cancer (NSCLC) (Seckl, Imperial College London) DBMs: 1. Paul Ewings 2. Hisham Mehanna 3. Luke Vale Declared a conflict and left the room: None Board recommendation: Resubmit full proposal 16/111/42: Combined diet, exercise, physical activity and pain management intervention to promote weight loss and enhance physical function in older people with obesity - a feasibility and acceptability study (Witham, University of Dundee) DBMs: 1. Amanda Farrin 2. Daniel Lasserson 3. Lorraine De Souza Declared a conflict and left the room: Jennifer Logue, Sharon Simpson 16/111/78: 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) (Geraghty, University of Southampton) DBMs: 1. Lorraine De Souza 2. Edwin van Teijlingen 3. Stephen Walters Declared a conflict and left the room: Daniel Lasserson, Susan Jowett, Hywel Williams, Lucy Chappell, Stephanie Taylor Page 2 of 11

3 16/111/69: Saline Nasal Irrigation For Rhinosinusitis II (SNIFSII): A randomized controlled trial in acute rhinosinusitis (Little, University of Southampton) DBMs: 1. Jennifer Logue 2. Sandra Eldridge 3. Gail Thornton Declared a conflict and left the room: Daniel Lasserson, Susan Jowett, Hywel Williams, Lucy Chappell, Stephanie Taylor, William Hollingworth 16/111/136: Renal Replacement Anticoagulant Management (RRAM) (Watkinson, Intensive Care National Audit & Research Centre) DBMs: 1. Jennifer Logue 2. Sandra Eldridge 3. David Garway-Heath Declared a conflict and left the room: Daniel Lasserson, Steve Goodacre, William Hollingworth 16/111/95: Managing Repetitive Behaviours: Clinical and cost effectiveness trial of a parent group intervention to manage restricted and repetitive behaviours in young children with ASD. (Grahame, Northumberland, Tyne and Wear NHS Foundation Trust) DBMs: 1. Lucy Chappell 2. Sharon Simpson 3. Paul Ewings Declared a conflict and left the room: Luke Vale 16/111/64: Low Perioperative Urine Output (LoPU) Trial: A single blinded multi-centre randomised controlled trial and economic evaluation of low vs standard urine output targets in major bowel surgery (Soop, Salford Royal NHS Foundation Trust) DBMs: 1. Tim Coleman 2. Stephen Walters 3. Mrs Catherine White Declared a conflict and left the room: William Hollingworth Arrived to the meeting: Peter Langhorne Julia Brown was absent for this discussion 16/111/61: Getting Recovery Right After Neck Dissection (GRRAND) (Winter, University of Oxford) Page 3 of 11

4 DBMs: 1. Lorraine De Souza 2. Paul Ewings 3. Jennifer Logue Declared a conflict and left the room: Daniel Lasserson, Hisham Mehanna, Luke Vale, William Hollingworth 16/111/111: 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) (Gao, University of Birmingham) DBMs: 1. Stephanie Taylor 2. Tim Coleman 3. Sandra Eldridge Declared a conflict and left the room: Daniel Lasserson, Lucy Chappell, Steve Goodacre, William Hollingworth Board recommendation: Prioritisation Group to consider straight fund 16/31/13: A phase 3 trial of Rivastigmine to prevent falls in Parkinson's Disease (Henderson, Royal United Hospital Bath NHS Trust) DBMs: 1. Hisham Mehanna 2. Amanda Farrin 3. Daniel Lasserson Declared a conflict and left the room: Gail Thornton, Paul Ewings, William Hollingworth 16/31/63: A randomised controlled trial of specialist physiotherapy for Functional Motor Disorder (Physio4FMD) (Nielsen, St George's, University of London) DBMs: 1. Edwin van Teijlingen 2. Sandra Eldridge 3. William Hollingworth Declared a conflict and left the room: Gail Thornton, David Garway-Heath, Lorraine De Souza, Lucy Chappell, Sharon Simpson, Stephanie Taylor, Stephen Walters, Steve Goodacre 16/111/07: Prevention of lower leg skin tears in frail older people living in the community. Randomised controlled trial with blinded outcome assessment, embedded cohort study, and cost-effectiveness analysis of protective socks against usual care: STOPCUTS. (Campbell, Royal Devon and Exeter NHS Foundation Trust) DBMs: 1. Daniel Lasserson 2. Lorraine De Souza 3. Tim Coleman Declared a conflict and left the room: Susan Jowett, Amanda Farrin, Hywel Williams, Julia Brown, Paul Ewings, Sharon Simpson, William Hollingworth Page 4 of 11

5 Contract variation: 11/01/04: HALT-IT trial (Haemorrhage Alleviation with Tranexamic acid Intestinal System), a large randomised placebo controlled trial among patients with acute gastrointestinal haemorrhage of the effects of tranexamic acid on death and transfusion requirement (Roberts, London School of Hygiene & Tropical Medicine) Chair: Hywel Williams DBMs: 1. William Hollingworth 2. Sandra Eldridge 3. Tim Coleman Declared a conflict and left the room: Steve Goodacre Board recommendation: Resubmission Introduction to Commissioning FulI Process 16/78 Timing of defibulation surgery for women who have undergone female genital mutilation (3 applications) DBMs: 1. Stephanie Taylor 2. Stephen Walters 3. Hisham Mehanna 4. Edwin van Teijlingen Declared a conflict and left the room: Jennifer Logue, Susan Jowett, Hywel Williams 16/78/04: Female Genital Mutilation: a qualitative study exploring survivors and healthcare professionals views on the timing of deinfibulation surgery (FGM Sister Study) (Jones, University of Birmingham) Board recommendation: Prioritisation Group to consider straight fund 16/78/05: Timing of deinfibulation surgery for women who have undergone type III female genital mutilation: a qualitative study of the perspectives and experiences of women and health professionals. (Evans, The University of Nottingham) 16/78/11: Timing of defibulation surgery for women who have undergone female genital mutilation (Shawe, University of Surrey) 16/91 Take home naloxone for opiate overdose (2 applications) DBMs: 1. Sharon Simpson 2. Susan Jowett 3. Paul Ewings Declared a conflict and left the room: Hywel Williams, Stephen Walters, Steve Goodacre Page 5 of 11

6 Left the meeting: Lucy Chapell 16/91/04: TIME: Take home naloxone Intervention Multi centre Emergency setting feasibility trial (Snooks, Swansea University) 16/91/14: Take-Home Naloxone for Prevention of Opiate Overdose Deaths: feasibility of substantive trials (N4POD Feasibility Naloxone for Prevention of Overdose Deaths) (Strang, South London and Maudsley NHS Foundation Trust) 16/92 The role of prophylactic antibiotics for botulinum toxin A injections for overactive bladder 16/92/02: AntiBiotics to prevent post-procedure urinary tract infection for patients undergoing treatment with intravesical onabotulinum toxin A The ABBA trial. (Harding, The Newcastle Upon Tyne Hospitals NHS Foundation Trust) DBMs: 1. Susan Jowett 2. Jennifer Logue 3. Sandra Eldridge Declared a conflict and left the room: Luke Vale Return to PG Summing up and close of day 1 Day 2 Welcome and introduction to the day with recap from day 1 Scott Weich arrived later in the morning 16/105/12: The effectiveness of Walk150 walking programme to improve physical performance for people with mild/moderate long term musculoskeletal conditions: a randomised controlled trial with health economic analyses. (Minns Lowe, Oxford University Hospitals NHS Foundation Trust) DBMs: 1. Tim Coleman 2. Susan Jowett 3. Peter Langhorne Declared a conflict and left the room: David Garway-Heath, Stephanie Taylor 16/31/136: SPRING - Seizure Prophylaxis IN Glioma (Grant, Common Services Agency) DBMs: 1. Hisham Mehanna (w/c) 2. Peter Langhorne 3. Amanda Farrin Declared a conflict and left the room: David Garway-Heath, Luke Vale, William Hollingworth Page 6 of 11

7 16/111/106: 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 (Kotecha, Cardiff University) DBMs: 1. Lucy Chappell 2. Stephanie Taylor 3. Scott Weich Declared a conflict and left the room: None Left the meeting: Charlotte Coles Introduction to CET EoI Process 16/31/147: Mechanical/Tissue valve or Ross operation for aortic valve replacement (AVR) in adults: a multicentre pragmatic randomised controlled trial (MeTRo) (Stoica, University Hospitals Bristol NHS Foundation Trust) DBMs: 1. David Garway-Heath 2. Gail Thornton 3. Tim Coleman Declared a conflict and left the room: Stephen Walters, Steve Goodacre, William Hollingworth 16/167/130: Evaluation of a carer intervention (E-CITE) to improve patient and carer outcomes during cancer chemotherapy: a two-arm randomised controlled trial (Ream, University of Surrey) DBMs: 1. Hisham Mehanna (w/c) 2. Sharon Simpson 3. Luke Vale Declared a conflict and left the room: None Scott Weich arrived at the meeting 16/167/120: A UK multicentre randomised controlled trial to determine the efficacy of treatments for acute antibody mediated rejection in renal transplantation (Willicombe, Imperial College London) DBMs: 1. Edwin van Teijlingen 2. William Hollingworth 3. Amanda Farrin Declared a conflict and left the room: Susan Jowett, Luke Vale Left the meeting: Hywel Williams Page 7 of 11

8 16/111/91: 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 (Wright, Leeds and York Partnership NHS Foundation Trust) DBMs: 1. Amanda Farrin 2. Lucy Chappell 3. Sharon Simpson Declared a conflict and left the room: Scott Weich 16/167/91: Resection or Medical therapy for Terminal Ileal Crohn's Disease (ROManTIC) (Brown, Sheffield Teaching Hospitals NHS Foundation Trust) DBMs: 1. Stephanie Taylor 2. David Garway-Heath 3. Mrs Catherine White Declared a conflict and left the room: Alan Montgomery, Hywel Williams, Scott Weich, Stephen Walters, Steve Goodacre 16/167/42: STudy of Antibiotic Treatment In Children with chronic cough (STATIC) (Gilchrist, University Hospitals of North Midlands NHS Trust) DBMs: 1. Lucy Chappell 2. Stephen Walters 3. David Garway-Heath Declared a conflict and left the room: William Hollingworth 16/167/107: 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) (Cresswell, Institute of Cancer Research) DBMs: 1. Susan Jowett 2. Scott Weich 3. Daniel Lasserson Declared a conflict and left the room: Jennifer Logue, David Garway-Heath, Luke Vale, William Hollingworth 16/167/58: Work and Vocational AdvicE (WAVE) Trial (Foster, North Staffordshire Clinical Commissioning Group) DBMs: 1. William Hollingworth 2. Mrs Catherine White 3. Lorraine De Souza Declared a conflict and left the room: Susan Jowett, Gail Thornton, Hywel Williams, Scott Weich Page 8 of 11

9 Julia Brown was absent from this discussion and waive 12 month resubmission rule. 16/167/123: WILL (When to Induce Labour to Limit risk in pregnancy hypertension) - a multicentre, randomised controlled trial (Magee, St George's, University of London) DBMs: 1. Scott Weich 2. Mrs Catherine White 3. Peter Langhorne Declared a conflict and left the room: Susan Jowett, Alan Montgomery, Hywel Williams, Lucy Chappell Julia Brown was absent from this discussion 16/167/99: One-stage or two-stage revision surgery for prosthetic knee joint infection: the INFORM-Knee randomised controlled trial (Blom, North Bristol NHS Trust) DBMs: 1. Luke Vale 2. Tim Coleman 3. Scott Weich Declared a conflict and left the room: Hywel Williams, William Hollingworth Julia Brown was absent for this discussion 16/167/56: Acute Rehabilitation following Traumatic anterior shoulder dislocation (ARTISAN)- A Multi Centre RCT (Kearney, University Hospitals Coventry & Warwickshire NHS Trust) DBMs: 1. William Hollingworth 2. Lorraine De Souza 3. Peter Langhorne Declared a conflict and left the room: Scott Weich, Stephanie Taylor 16/167/68: Neurodevelopmental outcomes of a Randomised Double Blind Controlled trial of Preterm Parenteral Nutrition: the NEON follow- up study (Uthaya, Imperial College London) DBMs: 1. Lucy Chappell 2. Susan Jowett 3. Stephen Walters Declared a conflict and left the room: None 16/167/124: IDEAL2: A randomised trial of isotoxic dose escalated chemoradiation versus standard dose for patients with stage III non-small cell lung cancer (NSCLC). (Landau, University College London) Page 9 of 11

10 DBMs: 1. Luke Vale 2. Daniel Lasserson 3. Paul Ewings Declared a conflict and left the room: Steve Goodacre 16/167/105: European Study Group for Pancreatic Cancer (ESPAC) trial 6. Multi-centre, open label, randomised controlled trial of neoadjuvant chemotherapy versus immediate surgery in patients with resectable pancreatic cancer. (Ghaneh, University of Liverpool) DBMs: 1. Luke Vale 2. Scott Weich 3. Daniel Lasserson Declared a conflict and left the room: None 16/167/121: The TARDIS trial: Test Directed Adjuvant Radiotherapy for Ductal Carcinoma-in-Situ (Walji, University Hospitals Coventry & Warwickshire NHS Trust) DBMs: 1. William Hollingworth 2. Peter Langhorne 3. David Garway-Heath Declared a conflict and left the room: Julia Brown, Amanda Farrin Introduction to Commissioning EoI Process 16/86 Interventions to Treat Visuo-perceptual Disorders Following Stroke (1 application) DBMs: 1. Peter Langhorne 2. David Garway-Heath 3. Lorraine De Souza Declared a conflict and left the room: Steve Goodacre 16/86/05: Non-Pharmacological Interventions to treat visuoperceptual disorders following stroke (Barker, Sheffield Hallam University) Return to PG 17/29 Effectiveness of group arts therapy for diagnostically heterogeneous patients in mental health services (2 applications) DBMs: 1. Edwin van Teijlingen 2. Sharon Simpson 3. Gail Thornton Declared a conflict and left the room: David Garway-Heath, Scott Weich, Stephanie Taylor, Steve Goodacre Page 10 of 11

11 17/29/01: Effectiveness of group arts therapy for diagnostically heterogeneous patients: Randomised controlled trial in mental health services (ERA). (Carr, East London NHS Foundation Trust) 17/29/07: Effectiveness of group arts therapies for diagnostically heterogeneous patients in mental health services (Weich, The University of Sheffield) 16/163 Microbiological sampling and treatment for infection complicating diabetic foot ulceration (1 application) DBMs: 1. Luke Vale 2. Lucy Chappell 3. Stephen Walters Declared a conflict and left the room: Amanda Farrin, Julia Brown 16/163/04: Swabbing OR Tissue sampling in Diabetic Foot Ulcers (SORT_DFU) Trial (Nelson, University of Leeds) Summing up and close of meeting Page 11 of 11

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

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