Meeting
HTA Funding Committee (Clinical Evaluation and Trials)
Day 1 – Tuesday 2nd November 2021
Venue
Virtual Meeting via Microsoft Teams
Present members
- Professor Olivia Wu (Chair)
- Professor Andrew Farmer (HTA Programme Director)
- Dr Jennifer Bostock (Public Committee member)
- Dr Kate Brown
- Professor Charlotte Coles
- Professor Alun Davies
- Professor Richard Emsley
- Dr Katie Gillies
- Dr Chloe Grimmett (Trainee Committee member)
- Ms Jo Haviland
- Professor Daniel Hind
- Associate Professor Rebecca Kearney
- Mrs Deborah Keatley (Public Committee member)
- Professor Alan Montgomery
- Professor Thomas Pinkney
- Dr Elena Pizzo
- Professor Daniel Prieto-Alhambra
- Dr Kathryn Radford
- Professor Jonathan Rees
- Professor Kapil Sayal
- Dr Elizabeth Warburton
- Professor James Wason
- Professor David Weller
- Ms Beth Woods
NETSCC, HTA Secretariat
- Dr Nick Hicks (Consultant Advisor)
- Steph Garfield-Birkbeck (Head of the HTA Programme)
- Ms Karen Williams (Senior Research Manager)
- Dr Brogan Ashley (Research Manager)
- Ms Kathy Tier (Research Manager)
- Miss Hebe Sims (Assistant Research Manager)
Apologies
- Mrs Deborah Keatley – morning only
- Professor Gavin Perkins
- Dr Elizabeth Camacho
- Associate Professor Sally Hopewell
Observers
- Mrs Hannah de Merode (Public Committee member)
- Associate Professor Paul French
- Dr Pamela Jacobsen
- Dr Nigel Rees
- Dr Julie Simpson – DA representative from Scotland
- Dr Kathy Rowan – (HS&DR)
- Louise Lambert – (CRN)
Quoracy Information
- Voting members: 27 Quorum = 18
- Voting members present on Day 1: 24 (88%)
Stage 2 Applications
21/01 Researcher-Led call Primary Research
NIHR133774: Optimising Prescription of Treatment In older patients with Mild hypertension at Increased risk of Serious adverse Events (OPTIMISE2): a non-inferiority trial
(Professor Richard McManus, University of Oxford)
Chair: Professor Olivia Wu
Conflicts: Dr Katie Gillies, Ms Jennifer Bostock, Professor Andrew Farmer, Professor Daniel Prieto-Alhambra, Professor Gavin Perkins, Professor Jonathan Rees, Associate Professor Rebecca Kearney
Decision: Programme Oversight Committee to consider fund with changes
21/01 Researcher-Led call Primary Research
NIHR134839: WHITE-PRESSURE3: World Hip Trauma Evaluation - Pressure ulcer prevention 3; A randomised clinical trial assessing early heel specific adjunct devices for heel pressure ulcer prevention in people with a fractured hip.
(Professor Jane Nixon, University of Leeds)
Chair: Professor Olivia Wu
Conflicts: Dr Katie Gillies, Dr Nigel Rees, Professor Alan Montgomery, Professor Andrew Farmer, Professor Daniel Prieto-Alhambra, Professor Gavin Perkins, Professor Jonathan Rees, Associate Professor Rebecca Kearney, Professor Thomas Pinkney
Decision: Programme Oversight Committee to consider fund with changes
21/01 Researcher-Led call Primary Research
NIHR133027: The clinical effectiveness and cost-effectiveness of Structured Psychological Support for people with personality disorder: Randomised controlled trial.
(Professor Mike Crawford, Imperial College London)
Chair: Professor Olivia Wu
Conflicts: Associate Professor Paul French, Professor Alan Montgomery, Professor Andrew Farmer
Decision: Programme Oversight Committee to consider fund with changes
21/46 HTA Prehabilitation: Living with and beyond cancer
NIHR134257: Evaluation of PeRsOnalised PrEhabilitation in acute myeloid Leukaemia (PROPEL).
(Professor Janet Dunn, University of Warwick)
Chair: Professor Olivia Wu
Conflicts: Dr Chloe Grimmett, Dr Nigel Rees, Professor Andrew Farmer, Professor Gavin Perkins, Professor Katherine Brown, Associate Professor Rebecca Kearney
Decision: Programme Oversight Committee to consider fund with changes
21/46 HTA Prehabilitation: Living with and beyond cancer
NIHR134214: Fit4Surgery 2: A randomised controlled trial to investigate an App-based, motivation-theory grounded, personalised, comprehensive, prehabilitation programme versus usual care to enhance recovery of physical function and reduce complications after lung cancer surgery.
(Dr Babu Naidu, University of Birmingham)
Chair: Professor Andrew Farmer
Conflicts: Professor Gavin Perkins, Professor Thomas Pinkney
Decision: Programme Oversight Committee to consider fund with changes
21/46 HTA Prehabilitation: Living with and beyond cancer
NIHR133872: Pre-opFit: Complex Needs-Based Multimodal Prehabilitation Interventions in Patients Prior to Major Elective Cancer Surgery - A Randomised Controlled Trial Assessing Clinical and Cost-Effectiveness.
(Professor Sandy Jack, University of Southampton)
Chair: Professor Olivia Wu
Conflicts: Dr Chloe Grimmett, Ms Bethan Woods, Ms Jennifer Bostock, Professor Alan Montgomery, Professor Andrew Farmer, Professor Daniel Hind
Joined the meeting: Mrs Debbie Keatley
Decision: Decline
21/01 Researcher-Led call Primary Research
NIHR133874: Clinical and cost-effectiveness of early patient-directed rehabilitation versus standard rehabilitation after surgical repair of the rotator cuff of the shoulder: a multi-centre, randomised controlled trial with integrated Quintet Recruitment Intervention (RaCeR 2)
(Professor Chris Littlewood, Manchester Metropolitan University)
Chair: Professor Olivia Wu
Conflicts: Ms Bethan Woods, Professor Andrew Farmer, Professor Daniel Prieto-Alhambra, Professor Jonathan Rees, Associate Professor Rebecca Kearney, Associate Professor Paul French
Decision: Programme Oversight Committee to consider fund with changes
21/01 Researcher-Led call Primary Research
NIHR134681: DRAFT-CASP: Distal Radius Acute Fracture Trial – Cast versus Splint; a randomised non-inferiority trial comparing clinical and cost-effectiveness of a standard care cast versus removable splint for adults with a distal radius fracture that does not require manipulation.
(Professor Matthew Costa, University of Oxford)
Chair: Professor Olivia Wu
Conflicts: Dr Katie Gillies, Dr Nigel Rees, Professor Alan Montgomery, Professor Andrew Farmer, Professor Daniel Prieto-Alhambra, Professor Gavin Perkins, Professor Jonathan Rees, Associate Professor Rebecca Kearney, Professor Thomas Pinkney
Decision: Programme Oversight Committee to consider fund with changes
21/01 Researcher-Led call Primary Research
NIHR134412: Optimal timing of parenteral nutrition for very preterm babies. The OPTIMAL trial
(Dr Sabita Uthaya, Imperial College London)
Chair: Professor Olivia Wu
Conflicts: Professor Alan Montgomery, Professor Andrew Farmer, Professor Daniel Prieto-Alhambra, Associate Professor Katherine Brown
Decision: Decline
21/01 Researcher-Led call Primary Research
NIHR134074: Pregabalin for treatment resistant generalized anxiety disorder
(Professor Glyn Lewis, University College London)
Chair: Professor Andrew Farmer
Conflicts: Associate Professor Paul French, Dr Elena Pizzo, Dr Elizabeth Camacho, Ms Jennifer Bostock, Professor Alan Montgomery
Decision: Programme Oversight Committee to consider fund with changes
21/01 Researcher-Led call Primary Research
NIHR134593: Study of technologies for the diagnosis of angle closure glaucoma (ACE)
(Professor Augusto Azuara-Blanco, Queen's University Belfast)
Chair: Professor Andrew Farmer
Conflicts: Dr Katie Gillies
Decision: Programme Oversight Committee to consider fund with changes
21/01 Researcher-Led call Primary Research
NIHR134344: Surveillance After Resection of Oesophageal aNd Gastric cancer (SARONG) trial
(Dr Sheraz Markar, University of Oxford, Nuffield Department of Surgical Sciences)
Chair: Professor Olivia Wu
Conflicts: Professor Andrew Farmer, Professor Daniel Prieto-Alhambra, Professor Jonathan Rees, Associate Professor Rebecca Kearney
Decision: Programme Oversight Committee to consider fund with changes
Day 2 – Wednesday 3rd November 2021
Venue
Virtual Meeting via Microsoft Teams
Present members
- Professor Olivia Wu (Chair)
- Professor Andrew Farmer (HTA Programme Director)
- Dr Jennifer Bostock (Public Committee member)
- Dr Kate Brown
- Dr Elizabeth Camacho
- Professor Charlotte Coles
- Professor Alun Davies
- Professor Richard Emsley
- Dr Katie Gillies
- Dr Chloe Grimmett (Trainee Committee member)
- Ms Jo Haviland
- Professor Daniel Hind
- Professor Sally Hopewell
- Associate Professor Rebecca Kearney
- Mrs Deborah Keatley (Public Committee member)
- Professor Alan Montgomery
- Professor Thomas Pinkney
- Dr Elena Pizzo
- Professor Daniel Prieto-Alhambra
- Dr Kathryn Radford
- Professor Jonathan Rees
- Professor Kapil Sayal
- Dr Elizabeth Warburton
- Professor James Wason
- Professor David Weller
- Ms Beth Woods
NETSCC, HTA Secretariat
- Dr Nick Hicks (Consultant Advisor)
- Ms Karen Williams (Senior Research Manager)
- Dr Brogan Ashley (Research Manager)
- Ms Kathy Tier (Research Manager)
- Miss Hebe Sims (Assistant Research Manager)
Apologies
- Mrs Deborah Keatley – morning only
- Professor Gavin Perkins
- Professor Thomas Pinkney – morning only
- Steph Garfield-Birkbeck (Head of the HTA Programme Secretariat)
Observers
- Dr Julie Simpson – DA representative from Scotland
- Dr Kathy Rowan – (HS&DR)
Quoracy Information
- Voting members: 27 Quorum = 18
- Voting members present on Day 2: 25 (92%)
Stage 1 Applications
21/503 Peer-led harm reduction for problem substance use among people who are homeless
Chair: Professor Andrew Farmer
Conflicts: Professor Richard Emsley, Professor Olivia Wu, Dr Katie Gillies
NIHR150358: Effectiveness and cost-effectiveness of a peer-delivered, relational, harm reduction intervention to improve mental health, quality of life, and related outcomes, for people experiencing homelessness and substance use problems: The ‘SHARPS’ cluster randomised controlled trial.
(Professor Tessa Parkes, University of Stirling)
Decision: Shortlist
NIHR150423: randomised controlled trial to test the efficacy and cost-effectiveness of the Peer2Peer Transition. Project for people with a history of drug use who are at risk of drug-related harm and homelessness on release from prison
(Professor Gail Gilchrist, King's College London)
Decision: Decline
21/504 Amiodarone vs beta blockade for new onset atrial fibrillation in adult intensive care
Chair: Professor Olivia Wu
Conflicts: Dr Kate Brown, Professor Daniel Hind, Associate Professor Rebecca Kearney, Professor Jonathan Rees, Professor Daniel Prieto-Alhambra, Professor Thomas Pinkney, Dr Nigel Rees, Professor Andrew Farmer
NIHR150027: Amiodarone vs Beta Blockade for new onset atrial fibRillation in icU - a Pragmatic sTudy (ABBRUPT)
(Honorary Professor Tony Whitehouse, University Hospitals Birmingham NHS Foundation Trust)
Decision: Shortlist
NIHR150481: Atrial fibrillation management with Beta Blockade versus Amiodarone (ABBA): a randomised controlled trial
(Professor Peter Watkinson, University of Oxford)
Decision: Shortlist
21/511 HTA Researcher-led call Primary Research
NIHR150576: A randomised controlled trial to evaluate the effectiveness and cost effectiveness of Systemic Autism-related Family Enabling (SAFE), an intervention for families of autistic children
(Associate Professor Rebecca Stancer, University of Plymouth)
Chair: Professor Olivia Wu
Conflicts: Professor Richard Emsley
Decision: Decline
21/511 HTA Researcher-led call Primary Research
NIHR150598: Haemodynamic Optimisation in Femoral Fracture- The HOFF Trial
(Dr Simon Davies, York Teaching Hospital NHS Foundation Trust)
Chair: Professor Olivia Wu
Conflict: Professor Jonathan Rees, Ms Bethan Woods
Decision: Decline
21/511 HTA Researcher-led call Primary Research
NIHR150364: Prehospital Recognition and Antibiotics for emergency patients with Sepsis: evaluation of safety, costs and effectiveness (PhRASe 2)
(Dr Jenna Jones, Swansea University)
Chair: Professor Olivia Wu
Conflicts: Professor Daniel Hind, Professor Thomas Pinkney, Dr Nigel Rees
Left the meeting: Dr Katie Gillies
Decision: Shortlist
21/511 HTA Researcher-led call Primary Research
NIHR150588: A randomised controlled trial comparing videolaryngoscopy to standard laryngoscopy for neonatal intubation. The VIBE study (VIdeo for Baby Endotracheal intubation)
(Dr Joyce O'Shea, University of Oxford)
Chair: Professor Olivia Wu
Conflicts: Professor Thomas Pinkney, Professor Andrew Farmer
Decision: Decline
21/511 HTA Researcher-led call Primary Research
NIHR150563: INduCtion of Labour in women with Uncomplicated pregnancies and risk factors for aDverse perinatal outcomEs (INCLUDE): A randomised trial with qualitative and economic evaluation, and individual participant data meta-analysis
(Professor Shakila Thangaratinam, University of Birmingham)
Chair: Professor Andrew Farmer
Conflicts: Professor Alan Montgomery, Professor Thomas Pinkney, Dr Elena Pizzo, Professor Olivia Wu
Arrived at meeting: Mrs Debbie Keatley
Decision: Decline
21/511 HTA Researcher-led call Primary Research
NIHR150122: Comparison of haemorrhoid artery ligation (HAL) versus superior rectal artery embolisation (SRAE) for the treatment of Grade 2 or 3 haemorrhoids. Short title: The HAL-EMBO trial.
(Dr Clare Louise Bent, University Hospitals Dorset NHS Foundation Trust)
Chair: Professor Olivia Wu
Conflicts: Dr Chloe Grimmett, Professor Alan Montgomery, Professor Daniel Hind, Ms Bethan Woods, Professor Andrew Farmer, Dr Jennifer Bostock
Decision: Decline
21/511 HTA Researcher-led call Primary Research
NIHR150026: ALGORITHM DRIVEN PROTAMINE FOR REVERSAL OF HEPARIN IN CAROTID ENDARTERECTOMY (PRoCEA)
(Dr Florian Falter, Papworth Hospital NHS Foundation Trust)
Chair: Professor Olivia Wu
Conflicts: Dr Elizabeth Warburton, Professor James Wason, Professor Andrew Farmer, Dr Jennifer Bostock
Decision: Decline
21/511 HTA Researcher-led call Primary Research
NIHR150142: Clarifying the patient benefit of different rhythm control strategies for patients with atrial fibrillation in the United Kingdom
(Dr Rui Providencia, University College London)
Chair: Professor Andrew Farmer
Conflicts: None
Decision: Decline
21/511 HTA Researcher-led call Primary Research
NIHR150600: The United Kingdom arm of the Transfusion Requirements in Cardiac Surgery IV (TRICS IV) trial
(Professor Gavin Murphy, University of Leicester)
Chair: Professor Andrew Farmer
Conflicts: Professor Thomas Pinkney
Decision: Shortlist
21/511 HTA Researcher-led call Primary Research
NIHR150343: Optimum therapy for thromboembolic complications after mitral valve repair-The PROTECT MVR Trial
(Mr Enoch Akowuah, South Tees Hospitals NHS Foundation Trust)
Chair: Professor Olivia Wu
Conflicts: Professor James Wason
Decision: Decline
21/511 HTA Researcher-led call Primary Research
NIHR150610: Tube versus Trabeculectomy in Uveitic Glaucoma (TTUG) study
(Mr Velota Sung, Sandwell and West Birmingham Hospitals NHS Trust)
Chair: Professor Andrew Farmer
Conflicts: Professor Thomas Pinkney, Professor Olivia Wu
Decision: Decline
21/511 HTA Researcher-led call Primary Research
NIHR150195: Surgery compared with sling immobilisation in the management of adults with a displaced unstable fracture of the distal clavicle: a multi-centre, non-inferiority, randomised controlled trial (DIDACT – DIsplaced DistAl Clavicle Trial)
(Associate Professor Harvinder Singh, University Hospitals of Leicester NHS Trust)
Chair: Professor Andrew Farmer
Conflicts: Associate Professor Rebecca Kearney, Professor Jonathan Rees, Ms Bethan Woods
Decision: Shortlist
21/511 HTA Researcher-led call Primary Research
NIHR150510: Supporting women With postnatal weight mAnagemeNt: A multi-centre randomised controlled trial of clinical and cost-effectiveness of a commercial weight management programme for postnatal weight management support. SWAN II study.
(Professor Debra Bick, University of Warwick)
Chair: Professor Olivia Wu
Conflicts: Associate Professor Rebecca Kearney
Decision: Decline
21/511 HTA Researcher-led call Primary Research
NIHR150628: An Open-Label, Multicentre, Randomised Controlled Phase III Trial Assessing the Benefits of Upfront Surgery versus Active Surveillance in Stage IV Grade I/II Small Intestinal Neuroendocrine Tumours
(Mr Samuel Ford, University Hospitals Birmingham NHS Foundation Trust)
Chair: Professor Olivia Wu
Conflicts: Professor Thomas Pinkney
Decision: Decline
21/511 HTA Researcher-led call Primary Research
NIHR150660: A multicentre randomised controlled trial comparing a locking plastic clip to other methods of cystic duct closure in laparoscopic cholecystectomy (removal of the gallbladder by keyhole surgery) to reduce the risk of postoperative bile leak.The LapLock Study.
(Mr Bhaskar Kumar, Norfolk and Norwich University Hospitals NHS Foundation Trust)
Chair: Professor Olivia Wu
Conflicts: None
Left the meeting: Associate Professor Sally Hopewell
Decision: Decline