Day 1 - 22 January 2019
Venue:
Holiday Inn Regent's Park, London
Present members:
Professor Joy Adamson, Professor Steven Brown, Mr Paul Charlton (Public Contributor), Professor Saul Faust, Professor Simon Gilbody (Deputy Chair), Professor Steve Goodacre (Chair), Professor Richard Grieve, Professor Angela Hassiotis, Dr Gail Hayward, Mr Rakesh Heer, Professor Catherine Hewitt, Professor Pat Hoddinott, Professor Pip Logan, Professor Nick Maskell, Professor Jane Nixon, Associate Professor Daniel Perry, Dr Greta Rait, Professor Chris Rogers, Professor Jonathan Ross, Professor Tracey Sach, Professor Andrew Shennan (Attended afternoon only), Professor Sobha Sivaprasad, Mr David Symes (Public Contributor), Professor Catrin Tudur-Smith, Dr KatrinaTurner, Professor Hywel Williams (Programme Director), Professor Nefyn Williams
NETSCC, HTA Secretariat:
Dr Nick Hicks (Consultant Adviser), Dr Jemma Kwint (Scientific Adviser), Karen Williams (Senior Research Manager), Kathy Tier (Research Manager), Alessandra Wilkinson-Smith (Assistant Research Manager), Louisa Saunders (Assistant Research Manager), Jane Mooney (Administrator)
Apologies:
Professor Gary Collins, Professor Rebecca Reynolds
Observers:
Philip Pallmann (Cardiff University), Dr Kay Pattison (Department of Health and Social Care)
Quoracy Information:
Voting members: 27 Quorum = 18
Voting members present on Day 1: 25 (93%)
Commissioning Stage 2 Proposals, shortlisted at May/September’s Committee Meeting
17/121: Gastrointestinal side effects in cancer immune checkpoint therapy
Chair: Steve Goodacre Declared a conflict and left the room: Mr Rakesh Heer, Professor Hywel Williams, Professor Saul Faust
17/121/03: 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)
Committee recommendation: Decline Return to POC
17/133: Scanning confocal ophthalmoscopy for diabetic eye screening
Chair: Steve Goodacre Declared a conflict and left the room: Professor Catrin Tudur Smith, Professor Chris Rogers, Professor Jane Nixon, Professor Sobha Sivaprasad
17/133/01: Scanning Confocal Ophthalmoscopy for Diabetic Eye Screening (SCODES) (Professor Peter Scanlon, Gloucestershire Hospitals NHS Foundation Trust)
Committee recommendation: Decline Return to POC
18/25: Microstructural scaffold insertion following microfracture for chondral knee defects
Chair: Steve Goodacre Declared a conflict and left the room: Dr Katrina Turner, Professor Chris Rogers
NIHR127849: A Randomised Controlled Trial of Scaffold InSertion and MIcrofracture Compared to Microfracture Alone for the Treatment of Chondral or Osteochondral Defects of the Knee: The SISMIC Study (Dr Michael Whitehouse, University of Bristol)
Committee recommendation: Programme Oversight Committee to consider fund with changes
18/26: Surgical management of pressure ulcers
Chair: Simon Gilbody Declared a conflict and left the room: Associate Professor Daniel Perry, Dr Katrina Turner, Mr Rakesh Heer, Professor Catherine Hewitt, Professor Chris Rogers, Professor Hywel Williams, Professor Jane Nixon, Professor Steve Goodacre
NIHR127850: Surgical interventions to treat severe pressure sores (SIPS) (Professor Barnaby Reeves, University of Bristol)
Committee recommendation: Programme Oversight Committee to consider fund with changes
NIHR127401: Pressure Ulcer Collaborative Surgical Evaluation (PRECISE) (Professor Jane Nixon, University of Leeds)
Committee recommendation: Decline
18/27: Alternative bisphosphonate regimens for the prevention of osteoporotic fracture in adults
Chair: Simon Gilbody Declared a conflict and left the room: Associate Professor Daniel Perry, Associate Professor Gail Hayward, Dr Katrina Turner, Professor Catherine Hewitt, Professor Chris Rogers, Professor Hywel Williams, Professor Jonathan Ross, Professor Joy Adamson, Professor Saul Faust, Professor Steve Goodacre, Professor Tracey Sach
NIHR127597: Alternative bisphosphonate regimens for the PRevention of OsteOporotic Fracture; the PROOF study (Professor Andrew Judge, University of Bristol)
Committee recommendation: Decline
NIHR127550: The BLAST OFF (Bisphosphonate aLternAtive regimenS for the prevenTion of Osteoporotic Fragility Fractures) Study (Professor Opinder Sahota, Nottingham University Hospitals NHS Trust)
Committee recommendation: Programme Oversight Committee to consider fund with changes
18/31: Discontinuation of growth hormone treatment in pubertal children
Chair: Steve Goodacre Declared a conflict and left the room: Professor Jonathan Ross
Andrew Shennan joined the meeting
NIHR127468: The GHD reversal study (Professor Mehul Dattani, UCL Institute of Child Health)
Committee recommendation: Programme Oversight Committee to consider fund with changes
18/32: Management of orthostatic hypotension
Chair: Steve Goodacre Declared a conflict and left the room: Associate Professor Gail Hayward, Mr Rakesh Heer, Professor Catherine Hewitt
NIHR127385: A comparison of fludrocortisone, midodrine or usual care to treat orthostatic hypotension – a multi-arm multi-stage randomised controlled trial (Dr James Frith, University of Newcastle upon Tyne)
Committee recommendation: Programme Oversight Committee to consider fund with changes
18/33: Valuing the benefits and harms of antenatal and newborn screening programmes in the UK
Chair: Simon Gilbody Declared a conflict and left the room: Associate Professor Daniel Perry, Associate Professor Gail Hayward
NIHR127489: Valuing the benefits and harms of antenatal and newborn screening programmes in health economic assessments (Associate Professor Oliver Rivero-Arias, University of Oxford)
Committee recommendation: Programme Oversight Committee to consider fund with changes
18/28: Paediatric wrist fractures - operate or not?
Chair: Simon Gilbody Declared a conflict and left the room: Associate Professor Daniel Perry, Associate Professor Gail Hayward, Professor Catherine Hewitt, Professor Catrin Tudur Smith
NIHR127674: CRAFFT – Children’s Radius Acute Fracture Fixation Trial. A multi-centre prospective randomized non-inferiority trial of surgical reduction versus non-surgical casting for displaced distal radius fractures in children. (Associate Professor Daniel Perry, University of Oxford)
Committee recommendation: Programme Oversight Committee to consider fund with changes
18/34: Routinely used interventions for improving attachment in infants and young children
Chair: Steve Goodacre Declared a conflict and left the room: Professor Catherine Hewitt, Professor Joy Adamson, Professor Simon Gilbody
Louisa Saunders left the meeting
NIHR127810: Routinely used interventions for improving attachment in infants and young children: an updated systematic review and comprehensive UK survey (Professor Barry Wright, University of York)
Committee recommendation: Programme Oversight Committee to consider fund with changes
NIHR127724: Manualised Attachment Programmes (MAPs) for the Early Years in the UK and Australia: A Review of Current Practice and Evidence (Dr Karen Whittaker, University of Central Lancashire)
Committee recommendation: Decline
18/35: Behavioural intervention to treat anxiety in adults with autism and moderate to severe learning disabilities
Chair: Simon Gilbody Declared a conflict and left the room: Dr Katrina Turner
NIHR127412: Behavioural interventions to treat anxiety in adults with autism and moderate to severe intellectual disabilities (BEAMS-ID) (Professor Peter Langdon, University of Kent)
Committee recommendation: Decline Return to POC
18/36: Anticonvulsant augmentation of antipsychotic medication in the management of psychosis
Chair: Steve Goodacre Declared a conflict and left the room: Professor Andrew Shennan, Professor Catrin Tudur Smith, Professor Jonathan Ross
Kay Pattison joined the meeting
NIHR127755: ATLANTIS: AnTiconvuLsant AugmeNtation Trial In Schizophrenia (Professor Oliver Howes, Institute of Psychiatry, Psychology & Neuroscience, King's College London)
Committee recommendation: Programme Oversight Committee to consider fund with changes
Day 2 - 23 January 2019
Venue:
Holiday Inn Regent’s Park, London
Present members:
Professor Joy Adamson, Professor Steven Brown, Mr Paul Charlton (Public Contributor), Professor Saul Faust, Professor Simon Gilbody (Deputy Chair), Professor Steve Goodacre (Chair), Professor Richard Grieve, Professor Angela Hassiotis, Dr Gail Hayward, Mr Rakesh Heer, Professor Catherine Hewitt, Professor Pat Hoddinott, Professor Pip Logan, Professor Nick Maskell, Professor Jane Nixon, Associate Professor Daniel Perry, Dr Greta Rait, Professor Chris Rogers, Professor Jonathan Ross, Professor Tracey Sach, Professor Andrew Shennan, Professor Sobha Sivaprasad, Mr David Symes (Public Contributor), Professor Catrin Tudur-Smith, Dr KatrinaTurner, Professor Hywel Williams (Programme Director), Professor Nefyn Williams
NETSCC, HTA Secretariat:
Steph Garfield-Birkbeck (Head of the HTA Programme) PM only, Dr Nick Hicks (Consultant Adviser), Dr Jemma Kwint (Scientific Adviser), Karen Williams (Senior Research Manager) AM only, Kathy Tier (Research Manager), Alessandra Wilkinson-Smith (Assistant Research Manager)
Apologies:
Professor Gary Collins, Professor Rebecca Reynolds
Observers:
Claire O'Neill (Swansea University)
Quoracy Information:
Voting members: 27 Quorum = 18
Voting members present on Day 2: 25 (93%)
Commissioning Stage 1 proposals
18/80: Precision Medicine
Chair: Steve Goodacre Declared a conflict and left the room: Mr Paul Charlton, Professor Catrin Tudur Smith, Professor Richard Grieve
NIHR128490: PERsonalised Medicine for Intensification of Treatment (PERMIT): the case of type 2 Diabetes Mellitus (Professor Richard Grieve, London School of Hygiene & Tropical Medicine)
Committee recommendation: Shortlist
18/106:Treating specific phobias in children with moderate to severe learning disabilities
Chair: Steve Goodacre Declared a conflict and left the room: Professor Catherine Hewitt, Professor Jane Nixon, Professor Joy Adamson, Professor Simon Gilbody
NIHR128689: Treating specific phobias in children with moderate to severe learning disabilities (Professor Barry Wright, University of York)
Committee recommendation: Decline Return to POC
18/107: Intervention or expectant management for early onset fetal growth restriction in twin pregnancy
Chair: Simon Gilbody Declared a conflict and left the room: Associate Professor Daniel Perry, Professor Andrew Shennan, Professor Catrin Tudur Smith, Professor Jonathan Ross, Professor Nefyn Williams, Professor Saul Faust, Professor Steve Goodacre
NIHR128263: 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)
Committee recommendation: Shortlist
NIHR128596: FERN: Intervention or Expectant Management for Early Onset Selective Fetal Growth Restriction in Monochorionic Twin Pregnancy (Professor Asma Khalil, St George's, University of London)
Committee recommendation: Shortlist
18/109: Management of partial-thickness rotator cuff tears
Chair: Steve Goodacre Declared a conflict and left the room: Associate Professor Daniel Perry, Dr Katrina Turner, Professor Catherine Hewitt, Professor Chris Rogers, Professor Joy Adamson
NIHR128043: Partial Rotator Cuff Tear Repair Trial (PRO CURE Trial) (Professor Jonathan Rees, University of Oxford)
Committee recommendation: Shortlist
NIHR128604: Partial ROTator Cuff Tears Management (PROTeCT-M): A Randomised Controlled Trial (Dr David Ellard, University of Warwick)
Committee recommendation: Shortlist
18/110: Management of undisplaced intracapsular hip fracture
Chair: Simon Gilbody Declared a conflict and left the room: Associate Professor Daniel Perry, Associate Professor Gail Hayward, Dr Katrina Turner, Professor Catherine Hewitt, Professor Catrin Tudur Smith, Professor Chris Rogers, , Professor Saul Faust, Professor Steve Goodacre
Jane Mooney left the meeting
NIHR128399: World Hip Trauma Evaluation - FRUITI: Fix or Replace Undisplaced Intracapsular fractures Trial of Interventions (Associate Professor Xavier Griffin, University of Oxford)
Committee recommendation: Shortlist
NIHR128553: Fix Or REplace Surgery In General Hip Trauma (FORESIGHT) Trial (Mr Gorav Datta, University Hospital Southampton NHS Foundation Trust)
Committee recommendation: Shortlist
18/111: Improving communication for adults with profound and multiple learning disabilities
Chair: Simon Gilbody Declared a conflict and left the room: Professor Jane Nixon, Professor Joy Adamson
NIHR128310: A randomised feasibility trial of Intensive Interaction plus usual care versus usual care for communication in adults with profound and multiple learning disabilities (INROAD)(Professor Juliet Goldbart, Manchester Metropolitan University)
Committee recommendation: Decline Return to POC
18/53: Clozapine for children and young people with treatment resistant schizophrenia
Chair: Steve Goodacre Declared a conflict and left the room: Professor Andrew Shennan, Professor Catrin Tudur Smith, Professor Greta Rait, Professor Jonathan Ross
NIHR128597: A Multi-centre Rater-blinded Randomized Trial of Clozapine vs Amisulpride in Treatment-Resistant Early Onset Schizophrenia (Professor Paramala Santosh, South London and Maudsley NHS Foundation Trust)
Committee recommendation: Decline Return to POC
18/112:A psychological programme for adults with intellectual disability and harmful sexual behaviours
Chair: Steve Goodacre Declared a conflict and left the room: Professor Tracey Sach
NIHR128550: RCT of group CBT for men with intellectual and/or developmental disabilities and harmful sexual behaviour: the HaSB-IDD trial (Professor Glynis Murphy, University of Kent)
Committee recommendation: Shortlist
18/121: Improving engagement and health and care outcomes for people with co-existing mental health and substance misuse conditions
Chair: Steve Goodacre Declared a conflict and left the room: Professor Andrew Shennan, Professor Catherine Hewitt, Professor Greta Rait, Professor Nefyn Williams, Professor Simon Gilbody
NIHR128128: The RECO study: Realist Evaluation of service models and systems for CO- existing mental health and substance use conditions.(Professor Elizabeth Hughes, University of Leeds)
Committee recommendation: Shortlist
NIHR128586: A realist evaluation of engaging people with coexisting mental health and substance use conditions with support and treatment. What works for whom and in which circumstances? (Dr Seren Roberts, Bangor University)
Committee recommendation: Decline
18/114: Selective serotonin reuptake inhibitor to prevent depression following traumatic brain injury
Chair: Steve Goodacre Declared a conflict and left the room: Associate Professor Daniel Perry, Professor Andrew Shennan, Professor Catrin Tudur Smith
NIHR128643: The Thames Valley Head injury Antidepressant Medication Effectiveness Study (THAMES)(Dr Vanessa Raymont, University of Oxford)
Committee recommendation: Decline Return to POC
18/115: Medication for ADHD in adults with a history of psychosis or bipolar disorder
Chair: Simon Gilbody Declared a conflict and left the room: Professor Greta Rait
NIHR128547: The clinical and cost-effectiveness of Stimulant compared with Non-stimulant medication for adults with Attention-deficit / hyperactivity disorder and a history of Psychosis or biPolar disordER: SNAPPER (Professor Steven Marwaha, University of Birmingham)
Committee recommendation: Decline Return to POC
18/116: Medication for ADHD in children and young people with a co-existing tic disorder
Chair: Simon Gilbody Declared a conflict and left the room: Professor Andrew Shennan, Professor Greta Rait, Professor Hywel Williams, Professor Jonathan Ross, Professor Tracey Sach
NIHR128472: Stimulant Medication for ADHD and Tics - Understanding Response versus Non-stimulants (SATURN study): a randomised trial of the clinical and cost-effectiveness of methylphenidate versus guanfacine for ADHD in children and young people with a co-existing tic disorder
(Professor Chris Hollis, The University of Nottingham)
Committee recommendation: shortlist
18/122: Pain management strategies in chronic pancreatitis
Chair: Steve Goodacre Declared a conflict and left the room: Professor Greta Rait
NIHR128632: Evidence-based pain management pathway for people with chronic pancreatitis (Professor Kurinchi Gurusamy, University College London)
Committee recommendation: Decline return to POC
18/120: Identification of older patients likely to require enhanced care on discharge from hospital
Chair: Simon Gilbody Declared a conflict and left the room: Associate Professor Gail Hayward, Professor Jane Nixon, Professor Jonathan Ross, Professor Joy Adamson, Steve Goodacre, Professor Tracey Sach
Karen Williams & Hywel Williams left the meeting over lunch, Steph Garfield-Birkbeck arrived and supported minute taking.
NIHR128109: Identification of older patients likely to require enhanced care on discharge from hospital (Professor Simon Conroy, University of Leicester)
Committee recommendation: Shortlist
NIHR128436: The Hospital Electronic Record Frailty Index (HerFI): An Enhanced Care Alert Score to identify older patients likely to require enhanced care on discharge from hospital (Dr Thomas Jackson, University of Birmingham)
Committee recommendation: Decline
NIHR128650: Quality of life after cardiac surgery (Mr Samer Nashef, Papworth Hospital NHS Foundation Trust)
Committee recommendation: Decline
NIHR128563: Using mixed methods to develop and validate tools for predicting new care-home admission after hospitalisation (Dr Terence Quinn, University of Glasgow)
Committee recommendation: Decline
NIHR128657: Predictive risk score to identify older patients likely to require enhanced care on discharge from hospital (Associate Professor Sarah Pendlebury, University of Oxford, Nuffield Department of Clinical Neurosciences)
Committee recommendation: Decline
18/117: Adjustable hook-and-loop-fastened compression systems for the treatment of venous leg ulcers
Chair: Steve Goodacre Declared a conflict and left the room: Professor Andrew Shennan, Professor Catherine Hewitt, Professor Hywel Williams, Professor Jane Nixon, Professor Joy Adamson, Professor Simon Gilbody, Professor Steven Brown
NIHR128625: Adjustable hook-and-loop-fastened compression systems for the treatment of venous leg ulcers (Dr Jo Dumville, The University of Manchester)
Committee recommendation: Shortlist
NIHR128462: Velcro wRAp DevIces versus standard Compression bandaging for venous Leg ulcEration: the RADICLE trial. (Dr Prakash Saha, King's College London)
Committee recommendation: Shortlist
18/118: Timing of stoma closure in neonates
Chair: Simon Gilbody Declared a conflict and left the room: Associate Professor Daniel Perry, Professor Steve Goodacre
NIHR128617: Timing of Stoma Closure in Neonates (ToSCiN) Study (Mr Nick Lansdale, Royal Manchester Children's Hospital)
Committee recommendation: Shortlist
18/119: Nutrient enriched diet for babies with a brain injury
Chair: Steve Goodacre Declared a conflict and left the room: last minute conflict from Joy
Pat Hodinott left
NIHR128322: Investigating the clinical and cost effectiveness of a nutrient enriched diet for babies with a brain insult: The Dolphin Randomised controlled trial (Professor Jeremy Parr, University of Newcastle upon Tyne)
Committee recommendation: Decline Return to POC
18/113: Trauma-focused cognitive behavioural therapy for post-traumatic stress disorder in schizophrenia
Chair: Steve Goodacre Declared a conflict and left the room: Professor Andrew Shennan, Professor Catrin Tudur Smith, Professor Saul Faust, Professor Tracey Sach
Professor Nefyn Williams left the meeting
NIHR128570: Trauma-focused COgnitive behavioural therapy for PTSD in people with a diagnosis of schizophrEnia: the COPE study. (Dr Dawn-Marie Walker, University of Southampton)
Committee recommendation: Decline
NIHR128623: Multisite Randomised Controlled Trial of Trauma-Focused Cognitive Behaviour Therapy for psychosis (TF-CBTp) to reduce post-traumatic stress disorder (PTSD) symptoms in patients with co-morbid PTSD and psychosis, compared to usual treatment: the TRUST (TRaUma and pSychosis Therapy) trial
(Dr Emmanuelle Peters, King's College London)
Committee recommendation: Shortlist
Review and close
In summary, the HTA Commissioning Committee recommended 10 Stage 2 proposals for consideration by the Programme Oversight Committee for funding subject to changes and 7 were declined.
In addition, 15 Stage 1 applications were shortlisted to submit a Stage 2 proposal and 13 were declined. The shortlisted Stage 1 applications will be considered as Stage 2 applications by The Funding Committee in May 2019.