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HTA Funding Committee Public Minutes 17-18 January 2023

Contents

Published: 30 March 2023

Version: 2

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Day 1 – Tuesday 17 January 2023

Venue  

  • Virtual via Microsoft Teams

Present Members         

  • Rupert Pearse (Chair)
  • Nefyn Williams (Deputy Chair)
  • Andrew Farmer (Programme Director)
  • Amanda Adler
  • Mike Bradburn
  • Monica Busse
  • Andrew Clegg
  • Laurentiu Craciunas (Committee Member Development Scheme Participant)
  • Nathan Davies
  • Rui Duarte
  • Saul Faust
  • Emilio Fernandez-Egea
  • David Gillespie
  • Pollyanna Hardy
  • Angela Hassiotis
  • Liz Hunter (Public Committee Member)
  • Trevor Jones (Public Committee Member)
  • Easter Joury (Committee Member Development Scheme Participant)
  • Sian Lloyd-Jones (Public Committee Member)
  • Nick Maskell
  • Antonieta Medina-Lara
  • Jane Nixon
  • Reuben Ogollah
  • Ben Ollivere
  • Najib Rahman
  • Greta Rait
  • Rebecca Reynolds
  • Pedro Saramago Goncalves
  • Andrew Shennan
  • Beth Stuart
  • Christopher Sutton
  • Lyvonne Tume

Secretariat       

  • James Morris (Consultant Advisor)
  • Karen Williams (Senior Research Manager)
  • Kathy Tier (Research Manager)
  • Daniel Housego (Research Manager)
  • Louisa Saunders (Assistant Research Manager)
  • Maria Oosterwijk (Administrator)

Apologies        

  • Galina Velikova
  • Andrew Shennan until lunch

Observers        

  • None

Quoracy information     

  • Voting members: 31 (Emergency Quoracy = 16 = 50%)
  • Voting members present on Day 1: (min) 29 (96%)

Stage 2 applications     

21/535 Follow-up strategy after radical treatment for prostate cancer       

NIHR150376 - The FOLLOW UP study - a natural experiment comparing the clinical and cost-effectiveness of follow-up strategies after radical treatment for prostate cancer. (Rakesh Heer)        
Chair: Rupert Pearse
Conflicts: David Gillespie, Nick Maskell, Beth Stuart, Mike Bradburn, Nefyn Williams
Left the meeting: Rebecca Reynolds     
Decision: Programme Oversight Committee to consider fund with changes          

22/33 Botulinum toxin in the management of chronic masticatory myofascial pain

NIHR153888 - Managing chronic Myalgia Temporomandibular Disorder (M-TMD): a pragmatic randomised controlled trial of Botulinum toxin type A, Lidocaine, and Amitriptyline/Gabapentin, with internal pilot and cost-effectiveness analysis (MiTiGate trial) (Justin Durham)            
Chair: Rupert Pearse
Conflicts: David Gillespie, Easter Joury, Andrew Clegg, Rui Duarte, Pollyanna Hardy
Arrived at the meeting: Rebecca Reynolds         
Decision: Programme Oversight Committee to consider fund with changes          

21/585 Early endovascular repair in type b uncomplicated sub-acute aortic dissection     

NIHR151696 - Early Aortic Repair in patients Needing Endovascular/open Surgery for Type B Aortic Dissection (EARNEST): A randomised trial to assess the clinical and cost-effectiveness of thoracic endovascular aortic repair in the subacute phase after uncomplicated type B aortic dissection. (Colin Bicknell)      
Chair: Nefyn Williams
Conflicts: Rupert Pearse           
Decision: Programme Oversight Committee to consider fund with changes           

22/27 Antipsychotics for the treatment of borderline personality disorder 

NIHR152880 - Full Title - The clinical and cost effectiveness of quetiapine for people with borderline personality disorder: A pragmatic, double-blind, placebo-controlled, randomised trial. Short Title - Quetiapine Effectiveness Study in Borderline Personality Disorder (QUEST). (Inti Qurashi) 
Chair: Rupert Pearse
Conflicts: Rui Duarte, David Gillespie, Pollyanna Hardy, Christopher Sutton, Nefyn Williams, Emilio Fernandez-Egea, Angela Hassiotis         
Decision: Programme Oversight Committee to consider fund with changes           

22/34 Surgical and non-surgical management of basal thumb osteoarthritis         

Chair: Rupert Pearse
Conflicts: Beth Stuart, Christopher Sutton, Mike Bradburn, Trevor Jones, Saul Faust, Pedro Saramago Goncalves, Andrew Clegg, Reuben Ogollah, Ben Ollivere     

NIHR153210
- Short Title Base of thumb arthritis: Therapies, Excision or Replacement? (BETTER) (Sumedh Talwalkar)            
Decision: Decline         

NIHR154694 - Surgery versus Conservative OsteOarthritis of Thumb Trial (SCOOTT)An RCT to determine clinical and cost effectiveness of treating arthritis of the base of the thumb, with or without surgery, and to determine the clinical and cost effectiveness of trapeziectomy versus base of thumb joint replacement. (Emma Reay)          
Decision: Programme Oversight Committee to consider fund with changes          

22/32 Biologic disease-modifying anti-rheumatic drugs in pregnancy       

Chair: Nefyn Williams
Conflicts: Rebecca Reynolds, Christopher Sutton, Lyvonne Tume, Mike Bradburn, Amanda Adler, Saul Faust, Rupert Pearse, Pollyanna Hardy, Andrew Farmer, Nathan Davies, Angela Hassiotis, Greta Rait, Laurentiu Craciunas

NIHR153577
- The Monoclonal Antibody Medications in inflammatory Arthritis: stopping or continuing in pregnancy (MAMA) trial (Marian Knight)     
Decision: Programme Oversight Committee to consider fund with changes          

NIHR154385 - Investigating the benefits and harms of continuing biologic disease-modifying anti-rheumatic drugs (bDMARDs) compared with withdrawing bDMARDs in pregnant women with rheumatoid & other inflammatory arthritis? (Ian Giles)        
Decision: Decline         

22/35 Thromboprophylaxis in lower limb immobilisation  

NIHR154716 - Thromboprophylaxis in Lower Limb Immobilisation (TiLLI): a study comprising two linked randomised controlled trials evaluating the effectiveness and cost effectiveness of different methods of pharmacological prophylaxis for patients with temporary lower limb immobilisation (Daniel Horner)      
Chair: Nefyn Williams
Conflicts: Nathan Davies, Greta Rait, Beth Stuart, Andrew Farmer, Rupert Pearse, Amanda Adler, Andrew Clegg, Mike Bradburn, Easter Joury
Arrived at the meeting: Andrew Shennan            
Decision: Programme Oversight Committee to consider fund with changes          

22/30 Post-operative pain in patients undergoing spinal surgery  

Chair: Nefyn Williams
Conflicts: Andrew Farmer, David Gillespie, Beth Stuart, Mike Bradburn, Saul Faust, Reuben Ogollah, Rupert Pearse, Rui Duarte, Ben Ollivere, Easter Joury 

NIHR152886 - Erector Spinae Plane blockade or INtrathecAL opioids for analgesia following spinal surgery (SPINAL). (David Hewson)            
Decision: Decline         

NIHR153170 - Pain Relief After Instrumented Spinal surgEry trial (PRAISE Trial) (Matthew Wilson)          
Decision: Programme Oversight Committee to consider fund with changes          

22/31 Glucagon-like peptide-1 receptor agonist therapy for people with severe mental illness living with overweight or obesity

Chair: Rupert Pearse
Conflicts: Greta Rait, Mike Bradburn, Nathan Davies, Angela Hassiotis, Andrew Farmer, Emilio Fernandez-Egea, Rui Duarte, Beth Stuart, Christopher Sutton, Nefyn Williams, Saul Faust, Pedro Saramago Goncalves, Laurentiu Craciunas           

NIHR153463 - SEmaglutide for the management of weight In Severe Mental Illness Conditions: SEISMIC randomised controlled trial (Artemis Igoumenou)      
Decision: Decline Return to POC           

NIHR154249 - The effectiveness and cost-effectiveness of Semaglutide in people with severe Mental ILlnEss living with overweight or obesity (SMILE) (Fiona Gaughran)
Decision: Decline Return to POC           

Stage 1 applications     

22/90 Self-care of children and young people with neurodisability

Chair: Rupert Pearse
Conflicts: David Gillespie, Angela Hassiotis, Christopher Sutton,Pollyanna Hardy, Beth Stuart      

NIHR155930 - ACHIEVE (AdolesCents Home based InterVEntion Study) - Improving self-care for adolescents with learning disabilities (Jill Bradshaw)        
Decision: Decline         

NIHR156487 - Investigating the clinical and cost-effectiveness of CHildren’s Early Self-care Support in children with neurodisability: the CHESS cluster randomised controlled trial (Niina Kolehmainen)      Decision: Shortlist        

22/91 Rescue packs in chronic obstructive pulmonary disease    

Chair: Rupert Pearse
Conflicts: Pollyanna Hardy, Nick Maskell, Lyvonne Tume, Andrew Clegg, Saul Faust, David Gillespie, Najib Rahman, Andrew Farmer, Monica Busse, Beth Stuart, Christopher Sutton, Nefyn Williams         

NIHR156698 - Rescue packs post-discharge in chronic obstructive pulmonary disease (The RAPID study) (Mona Bafadhel)         
Decision: Shortlist        

NIHR156744 - Data-Enabled Trial of Rescue packs to prevent hOspITal readmission after an acute exacerbation of COPD (DETROIT) (David Gillespie)      
Decision: Shortlist        

22/92 Withdrawing long term macrolides in bronchiectasis          

NIHR156597 - Bronchiectasis: Optimising Azithromycin prevention Treatment to reduce exacerbations (BOAT): A double blind pragmatic randomised controlled trial (Anthony De-Soyza)   
Chair: Nefyn Williams
Conflicts: Najib Rahman
Left the meeting: Andrew Shennan        
Decision: Shortlist        

22/94 Optimal management of perianal Crohn’s disease 

NIHR157164 - Randomised evaluation of surgical techniques for anal fistula repair in patients with Crohn’s disease using a trials within cohort design - 'Repair pCD' (Phil Tozer)      
Chair: Nefyn Williams
Conflicts: David Gillespie, Beth Stuart, Saul Faust, Andrew Farmer, Rupert Pearse, Greta Rait, Reuben Ogollah  
Decision: Decline return to POC

22/93 The clinical and cost-effectiveness of colesevelam for the treatment of bile acid diarrhoea   

NIHR156493 - COlesevelam for Bile Acid diarrhoea: clinical and cost effectiveness with Long Term follow-up. (COBALT) (Ramesh Arasaradnam)       
Chair: Rupert Pearse
Conflicts: Rui Duarte, Pollyanna Hardy
Decision: Decline Return to POC            

Day 2 - Wednesday 18 January 2023

Venue 

  • Virtual via Microsoft Teams

Present Members        

  • Rupert Pearse (Chair)
  • Nefyn Williams (Deputy Chair)
  • Andrew Farmer (Programme Director)
  • Amanda Adler
  • Mike Bradburn
  • Monica Busse
  • Andrew Clegg
  • Laurentiu Craciunas (Committee Member Development Scheme Participant)
  • Nathan Davies
  • Rui Duarte
  • Saul Faust
  • Emilio Fernandez-Egea
  • David Gillespie
  • Pollyanna Hardy
  • Angela Hassiotis
  • Liz Hunter (Public Committee Member)
  • Trevor Jones (Public Committee Member)
  • Easter Joury (Committee Member Development Scheme Participant)
  • Sian Lloyd-Jones (Public Committee Member)
  • Nick Maskell
  • Antonieta Medina-Lara
  • Jane Nixon
  • Reuben Ogollah
  • Ben Ollivere
  • Najib Rahman
  • Greta Rait
  • Rebecca Reynolds
  • Beth Stuart
  • Christopher Sutton
  • Lyvonne Tume

Secretariat      

  • James Morris (Consultant Advisor)
  • Karen Williams (Senior Research Manager)
  • Kathy Tier (Research Manager)
  • Daniel Housego (Research Manager)
  • Louisa Saunders (Assistant Research Manager)
  • Maria Oosterwijk (Administrator)

Apologies       

  • Galina Velikova
  • Andrew Shennan
  • Lyvonne Tume until 11am
  • Pedro Saramago Goncalves

Observers       

  • None

Quoracy information 

  • Voting members: 31 (Emergency Quoracy = 16 = 50%)
  • Voting members present on Day 2: (min) 27 (87 %)

Stage 2 applications

22/104 HTA Application Acceleration Award – platform studies in areas considered strategic priorities

NIHR155476 - Development of a Platform Trial in Paediatric Intensive Care (Paul Mouncey)
Chair: Rupert Pearse
Conflicts: Pollyanna Hardy, Nefyn Williams, Rui Duarte
Decision: Programme Oversight Committee to consider fund with changes

NIHR155477 - Venous leg ulcErs: management and eradication, the VEIN Platform Study (Alun Davies)
Chair: Rupert Pearse
Conflicts: Rui Duarte, Antonieta Medina-Lara, Jane Nixon, Greta Rait, Pollyanna Hardy, Christopher Sutton
Decision: Programme Oversight Committee to consider fund with changes

NIHR156219 - Creating a national platform trial for Acute Kidney Injury (Nicholas Selby)
Chair: Nick Maskell
Conflicts: Beth Stuart, Christopher Sutton, Lyvonne Tume, Monica, Busse, David Gillespie, Pollyanna Hardy, Rupert Pearse, Andrew Farmer, Nefyn Williams, Najib Rahman
Decision: Decline

NIHR156228 - COMBINING WEIGHT LOSS, PHYSICAL ACTIVITY AND SLEEP INTERVENTIONS IN THE MANAGEMENT OF TYPE 2 DIABETES: A MULTI-ARM, MULTI-STAGE TRIAL (Thomas Yates)
Chair: Nefyn Williams
Conflicts: Amanda Adler, Mike Bradburn
Decision: Decline

NIHR156397 - Diabetic Foot Ulcer REsearch PlatFORM – DFU-REFORM (Jane Nixon)
Chair: Rupert Pearse
Conflicts: Nick Maskell, Jane Nixon, Andrew Clegg
Decision: Programme Oversight Committee to consider fund with changes 
NIHR156509 - Personalised and novel therapies for recurrent head or neck cancer through adaptive platform trials (PANTHEoN) (Ben O'Leary)

Chair: Rupert Pearse
Conflicts: Nefyn Williams
Decision: Decline

22/104 HTA Application Acceleration Award – platform studies in areas considered strategic priorities

Chair: Rupert Pearse
Conflicts: Nathan Davies, Antonieta Medina-Lara, Christopher Sutton, Nefyn Williams, Reuben Ogollah, Rebecca Reynolds, Trevor Jones, Jane Nixon, Andrew Clegg
Arrived at the meeting: Lyvonne Tume

NIHR155217 - UK Stroke Trials Effectiveness Platform (UK STEP) (Philip Bath)
Decision: Decline
NIHR156616 - Developing a national platform for delivering efficient trials for people living with stroke: Life After Stroke Platform (LEAP) (Amanda Farrin)
Decision: Programme Oversight Committee to consider fund with changes

NIHR156550 - Prehospital Point of Care Testing to Enable Decision-making (PrePoCTED) (Jonathan Benger)
Chair: Rupert Pearse
Conflicts: Nick Maskell, Pollyanna Hardy, Christopher Sutton, Saul Faust
Decision: Programme Oversight Committee to consider fund with changes

22/104 HTA Application Acceleration Award – platform studies in areas considered strategic priorities

Chair: Rupert Pearse
Conflicts: David Gillespie, Nick Maskell, Jane Nixon, Greta Rait, Beth Stuart, Christopher Sutton, Amanda Adler, Saul Faust, Andrew Clegg, Najib Rahman, Andrew Farmer, Rui Duarte, Pollyanna Hardy, Nefyn Williams, Monica Busse, Antonieta Medina-Lara
Left the meeting: Lyvonne Tume

NIHR156089 - Digitally Enabled platForm EvaluatioN of Diagnostics for AntiMicrobial Prescribing (DEFEND AMP) (Martin Llewelyn)
Decision: Decline

NIHR156664 - Platform Randomised evaluation of clinical Outcomes using novel TEChnologies to optimise antimicrobial Therapy (PROTECT) (Philip Pallmann)
Decision: Programme Oversight Committee to consider fund with changes

NIHR156512 - Optimising recovery from brain injury following cardiac arrest: development of a trial platform (Keith Couper)
Chair: Rupert Pearse
Conflicts: Lyvonne Tume
Decision: Decline

NIHR156028 - PRACTISE - AF: Platform tRiAl to improve outComes afTer cardIac SurgEry – Atrial Fibrillation (Accelerator Award) (Ben Gibbison)
Chair: Nefyn Williams
Conflicts: Nick Maskell, Andrew Clegg, Rupert Pearse
Left the meeting: Laurentiu Craciunas
Decision: Programme Oversight Committee to consider fund with changes

NIHR156043 - Accelerating the development of a perinatal platform trial to efficiently evaluate the effectiveness of multiple interventions in maternity and neonatal care (Ed Juszczak)
Chair: Nefyn Williams
Conflicts: Beth Stuart, Lyvonne Tume, Mike Bradburn, Saul Faust, Rupert Pearse, Pollyanna Hardy, Trevor Jones, Reuben Ogollah, Andrew Farmer, Najib Rahman, Ben Ollivere
Left the meeting: Angela Hassiotis
Decision: Programme Oversight Committee to consider fund with changes

NIHR156728 - ROSSINI-Platform - Reduction Of Surgical Site Infection with a platform trial utilising a 'Basket-MAMS' design - Application Accelerator Award (Thomas Pinkney)
Chair: Andrew Farmer
Conflicts: Rui Duarte, Jane Nixon, Amanda Adler, Rupert Pearse, Pedro Saramago Goncalves, Pollyanna Hardy, Greta Rait, Nefyn Williams
Arrived at the meeting: Lyvonne Tume
Decision: Programme Oversight Committee to consider fund with changes

NIHR156925 - MONITOR-PsA 2 – Multicentre Observational Network in Treatment Outcomes Research in PsA-2 (Laura Coates)
Chair: Rupert Pearse
Conflicts: David Gillespie, Andrew Clegg, Andrew Farmer, Najib Rahman
Decision: Decline

NIHR155342 - Designing a platform trial to assess the effectiveness of interventions for peripheral arterial disease: The PAEDIS trial development project. (Athanasios Saratzis)
Chair: Nefyn Williams
Conflicts: Rui Duarte, Antonieta Medina-Lara, Jane Nixon, Rebecca Reynolds, Pollyanna Hardy
Decision: Programme Oversight Committee to consider fund with changes

Stage 1 Applications

22/85 Positive airway pressure therapy in chronic obstructive pulmonary disease-obstructive sleep apnoea overlap syndrome

NIHR154890 - Exacerbation Prevention in COPD-OSA overlap syndrome (EPiC-OSA) (Patrick Murphy)
Chair: Rupert Pearse
Conflicts: Saul Faust, Najib Rahman, Andrew Farmer
Decision: Shortlist

22/86 Surgical management of successfully reduced incarcerated inguinal hernia in children

Chair: Rupert Pearse
Conflicts: Rui Duarte, Pollyanna Hardy, Lyvonne Tume, Saul Faust

NIHR156482 - Emergency vs elective repair of successfully reduced incarcerated inguinal hernia in children (Nigel Hall) 
Decision: Decline Return to POC

NIHR157263 - INdex admission Compared to Arranged repair of successfully Reduced inCarcerated inguinal hERniA in children- a randomised controlled Trial - INCARCERAT (Bashar Aldeiri)
Decision: Decline

22/88 Repetitive Transcranial Magnetic Stimulation for depression in adolescents

NIHR156157 - The clinical and cost-effectiveness of intermittent THeta-burst REpetitive transcranial magnetic stimulation for the treatment of Adolescent Depression: iTHREAD (Jack Rogers)
Chair: Nefyn Williams
Conflicts: Rui Duarte, Trevor Jones, Greta Rait, Beth Stuart, Christopher Sutton, Nathan Davies, Pollyanna Hardy, Angela Hassiotis
Left the meeting: Ben Ollivere
Decision: Decline Return to POC

22/123 Comprehensive geriatric assessment for frail older heart failure patients with preserved ejection fraction

Chair: Greta Rait
Conflicts: Jane Nixon, Antonieta Medina-Lara, Nefyn Williams, Andrew Clegg, Andrew Farmer, Pollyanna Hardy ,Amanda Adler, Rupert Pearse

NIHR155936 - Comprehensive geriatric assessment to sustain independence for older people living with heart failure with preserved ejection fraction and frailty (Andrew Clegg) 
Decision: Shortlist

NIHR157102 - The PRESERVE-CGA randomised trial: Proactive patient-centred, geriatrician-led Comprehensive Geriatric Assessment for frail older adults with heart failure PRESERVEd ejection fraction. (Rebekah Schiff)
Decision: Shortlist

22/89 Janus kinase inhibitors for the treatment of juvenile idiopathic arthritis

NIHR154877 - A multi-centre, open-label, randomised controlled trial of tofacitinib versus adalimumab in children and young people with active polyarticular-course juvenile idiopathic arthritis who have had inadequate response or intolerance to methotrexate (Ethan Sen)
Chair: Rupert Pearse
Conflicts: David Gillespie, Saul Faust, Andrew Clegg
Decision: Shortlist