NIHR HTA Commissioning Board. Minutes of the May 2018 Meeting

Transcription

1 NIHR HTA Commissioning Board Minutes of the May 2018 Meeting Date Tuesday 22nd May 2018 (Day 1) Place Present members Danubius Hotel, London Members: Professor Deborah Ashby Professor Simon Gilbody Professor Hywel Williams Professor Ibrahim Abubakar Professor Steven Brown Mr Paul Charlton Professor Saul Faust Professor Richard Grieve Professor Paul Griffiths Dr Gail Hayward Mr Rakesh Heer Professor Catherine Hewitt Professor Pat Hoddinott Professor Robert Howard Professor Pip Logan Professor William McGuire Mr Daniel Perry Dr Greta Rait Professor Chris Rogers Professor Jonathan Ross Professor Tracey Sach Professor Andrew Shennan Mr David Symes Professor Catrin Tudur-Smith Dr Katrina Turner Chair Deputy Chair Programme Director NETSCC HTA Secretariat Apologies Observers Ms Stephanie Garfield-Birkbeck Dr Nick Hicks (Consultant Advisor) Mrs Karen Williams (Senior Research Manager) Ms Kathy Tier (Research Manager) Miss Alessandra Wilkinson-Smith (Assistant Research Manager) Professor Joy Adamson Professor Gary Collins Professor Sobha Sivaprasad Natalie Owen, Department of Health and Social Care

2 Day 1 1. Chair s introduction 2. Secretariat update 3. Board update 4. Minutes of the January 2018 meeting and any updates from previous meetings /72: Treatment of steroid resistant ulcerative colitis Panel: Interventional Procedures Declared a conflict and left the room: Professor Jonathan Ross, Professor Pat Hoddinott, Professor Paul Griffiths, Professor Steven Brown /72/02: PoPSTER: Patient preferences and current Practice for adults with STERoid resistant ulcerative colitis (Professor Alan Lobo, Sheffield Teaching Hospitals NHS Foundation Trust) Board recommendation: Prioritisation Group to consider straight fund /72/03: A mixed-methods study exploring current clinical practice and views on treatment options for steroid resistant ulcerative colitis. (Dr Jonathan Mathers, University of Birmingham) /14: Zoledronic acid to reduce fractures in patients with alcoholic liver disease Panel: Emergency & hospital Care Declared a conflict and left the room: Professor Chris Rogers,Professor Saul Faust /14/02: Reducing Fractures In LivEr Disease (REFILED) (Dr Andrew Cook, University of Southampton) Return to PG /83: Biological response modifier drugs for rare autoimmune diseases

3 Declared a conflict and left the room: Professor Catrin Tudur Smith, Professor Deborah Ashby, Professor Hywel Williams /83/01: Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory vasculitis in adults and children. (Professor David Jayne, University of Cambridge) Board recommendation: Prioritisation Group to consider fund with changes /79: Trauma-focused cognitive behavioural therapy for post-traumatic stress disorder in schizophrenia Panel: Mental Health Declared a conflict and left the room: Professor Catrin Tudur Smith /79/08: Multisite Randomised Controlled Trial of Trauma-Focused Cognitive Behaviour Therapy for psychosis (TF-CBTp) to reduce posttraumatic stress disorder (PTSD) symptoms in patients with co-morbid PTSD and psychosis, compared to CBTp without the PTSD-focus: the TRUST (TRaUma and psychosis Therapy) trial (Dr Emmanuelle Peters, King's College London) Return to PG /83: Biological response modifier drugs for rare autoimmune diseases Declared a conflict and left the room: Mr Daniel Perry, Professor Deborah Ashby, Professor Tracey Sach, Katrin Tudur Smith /83/04: A Randomised Controlled Trial of Adalimumab versus Pamidronate in Chronic Recurrent Multifocal Osteomyelitis (CRMO) using a Bayesian Design (Professor Athimalaipet Ramanan, University Hospitals Bristol NHS Foundation Trust)

4 7.1 17/86: The clinical and cost effectiveness of screening for Group B Streptococcus (GBS) in pregnancy Declared a conflict and left the room: Mr Rakesh Heer, Professor Deborah Ashby, Professor Hywel Williams, Professor Jonathan Ross, Professor Philippa Logan, Professor William McGuire, Professor Andrew Shennan Professor Williams was conflicted but stayed in the room in his role as Programme Director in order to provide information about the background to the call and to hear the initial comments from designated board members. He then left when a full discussion took place, followed by voting /86/01: Group B Streptococcus - the Antenatal Universal Screening and TReatment trial (GB-ASTRAL) (Dr Fiona Denison, The University of Edinburgh) /86/06: The clinical and cost-effectiveness of testing for Group B Streptococcus: a cluster randomised trial with economic and acceptability evaluations (GBS3) (Professor Jane Daniels, The University of Nottingham) Board recommendation: Prioritisation Group to consider fund with changes /80: Psychosocial intervention to address the mental health needs of parents/carers of children newly diagnosed with autism Panel: Mental Health Declared a conflict and left the room: Paul Griffiths /80/09: EMPOWER-ASD Trial: An Evaluation of the Manchester Postdiagnostic Workshops for Education, Empowerment and Stress Reduction in parents/carers of children newly diagnosed with ASD (Professor Jonathan Green, The University of Manchester) Board recommendation: Prioritisation Group to consider fund with changes

5 /80/10: Development and Evaluation of a Post-Diagnostic Support Group for Parents who have a Child on the Autism Spectrum (E-PoDS) (Dr Nick Gore, University of Kent) /83: Biological response modifier drugs for rare autoimmune diseases Declared a conflict and left the room: Professor Chris Rogers, Professor Deborah Ashby, Professor Tracey Sach /83/06: The Use of Rituximab In the treatment of Nephrotic Glomerulonephritis (TURING) (Dr Lisa Willcocks, Cambridge University Hospital NHS Trust) Board recommendation: Prioritisation Group to consider fund with changes /82: Treatment to target in gout Panel: Primary Care Declared a conflict and left the room: Dr Gail Hayward, Professor Hywel Williams, Professor Tracey Sach /82/02: What is the clinical and cost-effectiveness of using a goaldirected allopurinol-based treat-to-target protocol in people with recurrent gout attacks? (Dr A Abhishek, University of Nottingham) Board recommendation: Prioritisation Group to consider fund with changes /76: Home-blended food for children with gastrostomy tubes Panel: Women & Children's Health Declared a conflict and left the room: Professor Simon Gilbody, Professor Paul Griffiths, Professor William McGuire Natalie Owen left the meeting

6 /76/05: The Feed Me How Study: Establishing the benefits, risks and resource implications of home-blended food in children and young people (6 months-18 years) with long-term enteral feeding needs via a gastrostomy tube. (Professor Jane Coad, Coventry University) /76/06: Home-Blended food for children with gastrostomy tubes (Dr Lorna Fraser, University of York) Board recommendation: Prioritisation Group to consider fund with changes /81: Intra-articular corticosteroid injections in osteoarthritis Panel: Primary Care Declared a conflict and left the room: Dr Katrina Turner, Mr Daniel Perry, Professor Chris Rogers /81/03: RecUrrent Intra-articular Corticosteroid injections in Osteoarthritis; the RUbICOn study (Dr Michael Whitehouse, University of Bristol) return to PG /84: Whole slide imaging in pathology Declared a conflict and left the room: Professor Hywel Williams /84/02: Whole slide imaging for primary diagnosis in pathology (Dr Darren Treanor, Leeds Teaching Hospitals NHS Trust) /84/07: Multi-centred validation of digital whole slide imaging for routine diagnosis (Professor David Snead, University Hospitals Coventry & Warwickshire NHS Trust) Board recommendation: Prioritisation Group to consider fund with changes.

7 8.4 17/85: Follow up of quiescent neovascular age-related macular degeneration Declared a conflict and left the room: Mr Rakesh Heer, Professor Catherine Hewitt, Professor Chris Rogers, Professor Simon Gilbody /85/05: Quality-Assured Follow up of quiescent Neovascular age-related macular degeneration by non-medical practitioners: a randomised controlled trial The FENETRE study (Dr Konstantinos Balaskas, Moorfields Eye Hospital NHS Foundation Trust) Board recommendation: Prioritisation Group to consider fund with changes /71: Treatment of new onset atrial fibrillation in the ICU Panel: Emergency & Hospital Care Declared a conflict and left the room: Professor Richard Grieve, Professor Simon Gilbody, Professor William McGuire /71/02: ICU:BEATS Better Endotyping of AF Treatment Subgroups - Understanding and optimising treatments of new onset atrial fibrillation in the ICU - (Professor Benjamin O'Brien, Barts Health NHS Trust) /71/04: Critical care Atrial Fibrillation Evaluation (CAFE) (Professor Peter Watkinson, University of Oxford) Board recommendation: Prioritisation Group to consider fund with changes

8 Date Tuesday 23 rd May 2018 (Day 2) Place Present members Danubius Hotel, London Members: Professor Deborah Ashby Professor Simon Gilbody Professor Hywel Williams Professor Ibrahim Abubakar Professor Steven Brown Mr Paul Charlton Professor Gary Collins Professor Saul Faust Professor Richard Grieve Professor Paul Griffiths Dr Gail Hayward Mr Rakesh Heer Professor Catherine Hewitt Professor Pat Hoddinott Professor Robert Howard Professor Pip Logan Professor William McGuire Mr Daniel Perry Dr Greta Rait Professor Chris Rogers Professor Jonathan Ross Professor Tracey Sach Mr David Symes Dr Katrina Turner Chair Deputy Chair Programme Director NETSCC, HTA Secretariat Apologies Observers Dr Nick Hicks (Consultant Advisor) Mrs Karen Williams (Senior Research Manager) Ms Kathy Tier (Research Manager) Miss Alessandra Wilkinson-Smith (Assistant Research Manager) Professor Joy Adamson Professor Andrew Shennan Professor Sobha Sivaprasad Professor Catrin Tudur-Smith None

9 Day /126: Selective serotonin reuptake inhibitor to prevent depression following traumatic brain injury Panel: Mental Health Declared a conflict and left the room: Dr Greta Rait, Professor Catrin Tudur Smith, Professor Deborah Ashby, Professor Jonathan Ross, Professor Richard Grieve, Dr Gail Hayward /126/02: An investigation into the use of Selective Serotonin Reuptake Inhibitors In the management of Traumatic brain injury (ASSIST TBI) (Professor Antonio Belli, University of Birmingham) Return to PG /126/04: STOP-D: A Randomised Controlled Trial of the Effectiveness of SerTaline versus placebo for Prevention of Depression following Traumatic Brain Injury (Dr Vanessa Raymont, University of Oxford) Return to PG /121: Gastrointestinal side effects in cancer immune checkpoint therapy Panel: Emergency & Hospital Care Declared a conflict and left the room: Professor Hywel Williams, Professor Jonathan Ross, Professor Saul Faust /121/03: ARTISTIX A randomised trial of intravenous steroid therapy +/- infliximab for gastrointestinal side effects in cancer immune checkpoint therapy (Dr Matthew Wheater, University Hospital Southampton NHS Foundation Trust) /121/04: A Trial of Gastrointestinal Immune-Related Side Effects in Patients with Cancer (The Giraffe Trial) (Dr Neil Steven, University of Birmingham)

10 9.3 17/122: Joint distraction for knee osteoarthritis without alignment correction Panel: Interventional Procedures Declared a conflict and left the room: Professor Catherine Hewitt /122/06: Knee Arthroplasty versus Joint Distraction Study (KARDS) for Osteoarthritis (Professor Hemant Pandit, University of Leeds) /123: Intensive day patient versus inpatient treatment for anorexia nervosa in adult specialised eating disorder services Panel: Mental Health Declared a conflict and left the room: Professor Deborah Ashby, Professor Hywel Williams /123/02: Inpatient vs Day Patient Cognitive Behavioural Therapy for Anorexia Nervosa (I CAN) trial (Dr Agnes Ayton, Oxford Health NHS Foundation Trust) /123/03: A Randomised Controlled Multi-Centre Open-Label Parallel Group Non-Inferiority Trial of the Clinical Effectiveness, Acceptability and Cost-Effectiveness of a Stepping into Day Treatment Approach versus Inpatient Treatment as Usual for Anorexia Nervosa in Adult Specialist Eating Disorder Services (Professor Ulrike Schmidt, King's College London) /124: Psychosocial intervention for internalised stigma to improve outcomes for people with schizophrenia Panel: Mental Health Declared a conflict and left the room: Mr Rakesh Heer, Professor Catherine Hewitt, Professor Catrin Tudur Smith, Professor Jonathan Ross, Professor Pat Hoddinott, Professor Paul Griffiths, Professor Simon Gilbody

11 /124/01: Clinical and Cost-effectiveness of workshops to promote Responses to Experienced and Anticipated Discrimination and Internalised STigma: READIEST trial. (Dr Claire Henderson, King's College London) /124/02: Peer support for internalised stigma to improve outcomes for people with schizophrenia (Professor Anthony Morrison, Greater Manchester West Mental Health NHS Foundation Trust) /125: Eye movement desensitisation and reprocessing for symptoms of post-traumatic stress disorder in adults with learning disabilities Panel: Mental Health Declared a conflict and left the room: Dr Greta Rait, Professor Robert Howard /125/01: A randomised controlled trial of Eye Movement Desensitisation and Reprocessing (EMDR) plus Standard Care (SC) vs. SC alone for DSM-5 Posttraumatic Stress Disorder (PTSD) in adults with intellectual disabilities (Professor Michael Brown, The Queen's University of Belfast) /125/04: Eye movement desensitisation and reprocessing for symptoms of post-traumatic stress disorder in adults with intellectual disabilities (Professor Paul Willner, Swansea University) /120: Hyperosmolar therapy in traumatic brain injury Panel: Emergency & Hospital Care Declared a conflict and left the room: Professor Catrin Tudur Smith, Professor Deborah Ashby, Professor Jonathan Ross Paul Griffith left the meeting /120/01: Sugar or Salt (SOS) trial: Hyperosmolar therapy in traumatic brain injury (Professor Gavin Perkins, University of Warwick)

12 /120/02: Hyper-Osmolar Therapy in Traumatic Brain Injury (HOT TBI) (Dr Chris Uff, Barts Health NHS Trust) /127: Partial removal of dentinal caries in permanent teeth Panel: Primary Care Declared a conflict and left the room: Mr Rakesh Heer, Professor Catherine Hewitt, Professor Pat Hoddinott, Professor Simon Gilbody, Professor Tracey Sach, Professor William McGuire /127/03: CREDENCE- Complete or partial removal DENtinal Caries in permanent teeth in a primary care setting The clinical and cost effectiveness of partial dentinal caries removal versus complete/near complete removal in vital permanent teeth of both children from areas of social deprivation and adults. (Professor Sue Pavitt, University of Leeds) /127/04: Partial Versus Complete Deep Caries Removal in Permanent Teeth TriAL (ViTAL) (Dr Ikhlas El karim, The Queen's University of Belfast) /127/05: The clinical and cost-effectiveness of partial vs complete removal of dentinal caries in permanent teeth: a London and Leeds study (Dr S Sidhu, Queen Mary University London) /127/07: Selective Caries Removal in Permanent Teeth (SCRIPT) (Professor Janet Clarkson, University of Dundee) /127/08: PRagmatic trial testing partial carries RemoVal in general dental practice (PRESERVE) (Professor Morgana Vianna, Cardiff University)

13 /128: Sputum colour charts to guide antibiotic self-treatment of acute exacerbation of COPD Panel: Primary Care Declared a conflict and left the room: Dr Gail Hayward, Dr Katrina Turner, Mr Rakesh Heer, Professor Hywel Williams, Professor Jonathan Ross, Professor Pat Hoddinott, Professor Tracey Sach, Professor Saul Faust /128/01: COPD COLOUR CHART TRIAL- CCC TRIAL (Honorary Professor Adam Hill, Lothian Health Board) /128/04: Sputum colour charts to guide antibiotic self-treatment of acute exacerbation of COPD (Colour-COPD) (Dr Alice Turner (nee Wood), University of Birmingham) /128/05: Optimising antibiotic self-treatment in COPD flares: (The OASIS Study) (Dr Nick Francis, Cardiff University) /129: Exercise therapy for people with pulmonary hypertension Panel: Primary Care Declared a conflict and left the room: Dr Greta Rait, Mr Daniel Perry, Professor Deborah Ashby, Professor Paul Griffiths /129/02: Supervised Pulmonary Hypertension Exercise Rehabilitation (SPHERe) trial (Dr Gordon McGregor, University Hospitals Coventry & Warwickshire NHS Trust) /129/06: What is the clinical and cost-effectiveness of supervised exercise therapy for people with pulmonary hypertension? (Dr Martin Johnson, Golden Jubilee National Hospital)

14 /130: Pre-pregnancy weight loss in obese women on LARC Panel: Women & Children's Health Declared a conflict and left the room: Dr Greta Rait, Mr Rakesh Heer, Professor Andrew Shennan, Professor Hywel Williams, Professor Jonathan Ross, Professor Saul Faust Gail Hayward left the meeting /130/01: Pre-pregnancy feasibility and acceptability trial of a structured programme promoting weight loss and positive lifestyle in a diverse population of women planning the removal of long acting reversible contraception (LARC) in family planning or general practice setting. (Dr Eugene Oteng-Ntim, Guy's and St Thomas' NHS Foundation Trust) /130/05: The feasibility and acceptability of a planned pre-pregnancy weight loss intervention: The Plan-it study (Dr Susan Channon, Cardiff University) /130/06: LOsing WEight BEfore Conception (LOWBEC) (Dr Paul Hardiman, University College London) /130/08: Optimising Pre-pregnancy weight After Long acting reversible contraceptive device removal- A Feasibility Study (OPAL-F) (Dr Nerys Astbury, University of Oxford) /130/09: Pre pregnancy weight loss and LARC (Professor Sharon Cameron, The University of Edinburgh) /132: Intervention or expectant management for early onset fetal growth restriction in twin pregnancy Panel: Women & Children's Health

15 Declared a conflict and left the room: Mr Daniel Perry, Professor Catrin Tudur Smith, Professor Deborah Ashby, Professor Jonathan Ross, Professor William McGuire /132/05: SLIGHT: SeLectIve fetal GrowtH restriction in monochorionic Twins: is a randomised controlled trial of active intervention versus expectant management feasible? (Professor Mark Kilby, University of Birmingham) Return to PG /132/06: Intervention or Expectant Management for Early Onset Selective Fetal Growth Restriction in Monochorionic Twin Pregnancy (FERN) (Professor Asma Khalil, St George's, University of London) Return to PG /135: Cytoreductive surgery with hyperthermic intraoperative peritoneal chemotherapy Declared a conflict and left the room: Dr Greta Rait, Professor Ibrahim Abubakar, Professor Jonathan Ross /135/01: The effectiveness of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy compared with standard treatments for peritoneal metastasis from colorectal, gastric or ovarian cancer? A systematic review, economic evaluation and future research priority setting exercise. (Mr Haney Youssef, Heart of England NHS Foundation Trust) /135/02: Cytoreductive surgery with hyperthermic intraoperative peritoneal chemotherapy versus standard of care in people with peritoneal metastases from colorectal, ovarian or gastric origin: systematic review, individual participant data meta-analyses, and cost-effectiveness (Mr Kurinchi Gurusamy, University College London)

16 /134: Identification of older patients likely to require enhanced care on discharge from hospital Declared a conflict and left the room: Professor Chris Rogers, Professor Gary Collins, Professor Richard Grieve, Professor Tracey Sach /134/02: Can a prediction tool be developed to identify frail older inpatients at high risk of institutionalisation, or with a need for intensive support at home? (Professor Simon Conroy, University of Leicester) Return to PG /134/06: Quality-of-life after cardiac surgery (Mr Samer Nashef, Papworth Hospital NHS Foundation Trust) Return to PG /133: Scanning confocal ophthalmoscopy for diabetic eye screening Declared a conflict and left the room: Professor Chris Rogers, Professor Saul Faust /133/01: Scanning confocal ophthalmoscopy for diabetic eye screening (Professor Peter Scanlon, Gloucestershire Hospitals NHS Foundation Trust) /140: Optimising the use of statin therapy in cardiovascular disease prevention Panel: Primary Care Declared a conflict and left the room: Professor Steven Brown /140/02: Cost-effectiveness of statin therapies evaluated using individual participant data from large randomised clinical trials (Professor Borislava Mihaylova, Queen Mary University of London)