Day 1 - 12 September 2023
Venue
Virtual via Microsoft Teams
Present Members
- Rupert Pearse (Chair)
- Nefyn Williams (Deputy Chair)
- Andrew Farmer (Programme Director)
- Monica Busse
- Rui Duarte
- Emilio Fernandez-Egea
- David Gillespie
- Pollyanna Hardy
- Angela Hassiotis
- Trevor Jones (Public Committee member)
- Antonieta Medina-Lara
- Ben Ollivere
- Greta Rait
- Rebecca Reynolds
- Beth Stuart
- Christopher Sutton
- Lyvonne Tume
- Mike Bradburn
- Amanda Adler
- Saul Faust
- Pedro Saramago Goncalves
- Andrew Clegg
- Reuben Ogollah
- Sian Lloyd-Jones (Public Committee member)
- Liz Hunter (Public Committee member)
- Miriam Brazzelli
- Amy Grove
Secretariat
- Jason Horsley
- Karen Williams
- Kathy Tier
- Brogan Ashley
- Louisa Saunders
Apologies
- Jane Nixon
- Najib Rahman
Observers
- Julie Simpson
- Julie McCarroll
- Maria Hassard
- Cheyenne Mascall
Quoracy Information
- Voting members: 28
- Quorum = 17 = 66%
- Emergency Quorum = 14 = 50%
- Voting members present on Day 1: 26
Stage 2 Applications
22/89 Janus kinase inhibitors for the treatment of juvenile idiopathic arthritis
NIHR154877 - A multi-centre, open-label, randomised, non-inferiority trial of tofacitinib versus adalimumab in children and young people with active polyarticular-course juvenile idiopathic arthritis or juvenile psoriatic arthritis who have had inadequate response or intolerance to methotrexate
Chair: Rupert Pearse
Conflicts: David Gillespie, Saul Faust
Decision: Decline
22/133 Point of care Doppler ultrasound prior to emergency scrotal exploration Resubmission
NIHR156285 - Rapid Evaluation of the SCrotum with Ultrasound prior to Exploration (RESCUE). Point of Care Ultrasound in suspected testicular torsion: a diagnostic test accuracy study
Chair: Rupert Pearse
Conflicts: Rui Duarte, Pollyanna Hardy, Amy Grove, Greta Rait, Miriam Brazzelli, Rupert Pearse, Saul Faust
Decision: Decline
23/80 ROSSINI 2 Extension
NIHR160509 - ROSSINI 2 EXTENSION - A Phase 3, multi-arm, multi-stage (MAMS), pragmatic, blinded multicentre RCT to evaluate the use of in-theatre interventions, alone or in combination, to reduce SSI rates in patients undergoing abdominal surgery.
Chair: Nefyn Williams
Conflicts: Rui Duarte, Amanda Adler, Rupert Pearse, Pollyanna Hardy, Amy Grove, Greta Rait
Decision: Programme Oversight Committee to consider fund with changes
22/148 Surgical treatment of proximal ACL ruptures with ACL repair or ACL reconstruction
Chair: Nefyn Williams
Conflicts: Christopher Sutton, Amanda Adler, Miriam Brazzelli, Amy Grove, Andrew Farmer, Ben Ollivere
NIHR157938 – ACL STARR – Anterior Cruciate Ligament Stratified Accelerated Repair or Reconstruction Single blind randomised control trial for patients with proximal ACL injuries treatment with ACL repair v ACL reconstruction.
Decision: Programme Oversight Committee to consider fund with changes
NIHR158440 – AURORA Study – Anterior Cruciate Ligament Reconstruction or Repair
Decision: Decline
22/149 Surgery for pectus excavatum
NIHR158749 – A randomised controlled trial of surgery versus no treatment to RESTORE cardiopulmonary function in severe pectus excavatum – The RESTORE Trial.
Chair: Rupert Pearse
Conflicts: David Gillespie, Pollyanna Hardy
Decision: Programme Oversight Committee to consider fund with changes
22/150 Intravesical treatments for recurrent urinary tract infection (rUTI) in women.
Chair: Rupert Pearse
Conflicts: Andrew Farmer, Beth Stuart, Monica Busse, David Gillespie, Greta Rait, Saul Faust, Ben Ollivere, Miriam Brazzelli
NIHR158130 – IntraVESical Preparations for Recurrent Urinary TrAct Infection Prevention (The VESPA Study): a multi-arm, multi-site open label randomised superiority trial.
Decision: Programme Oversight Committee to consider fund with changes
NIHR158512 – Bladder Instillation for recurrent UTI ( BIN-UTI)
Decision: Decline
22/155 Oral versus intramuscular glucocorticoids in rheumatoid arthritis
Chair: Rupert Pearse
Conflicts: Andrew Farmer, Rui Duarte, Pollyanna Hardy, Amy Grove, Christopher Sutton, Ben Ollivere, Reuben Ogollah, Nefyn Williams
Left the meeting: Julie McCarroll
NIHR158151 – Injection Versus Steroid Tablets in Rheumatoid Arthritis (InVeST-RA)
Decision: Decline
NIHR158471 – The clinical and cost effectiveness of heu vErsus heumatoidar glucocorticoiDs in heumatoid aRthritis: LEADER A Randomised Controlled Trial
Decision: Programme Oversight Committee to consider fund with changes
22/156 Children and young people's mental health
NIHR158299 – Safety Nets: A randomised controlled trial to test the clinical and cost-effectiveness of a social prescribing intervention to support young people accessing child and adolescent mental health services (CAMHS)
Chair: Rupert Pearse
Conflicts: Pedro Saramago Goncalves
Decision: Decline
22/156 Children and young people's mental health
Chair: Nefyn Williams
Conflicts: Emilio Fernandez-Egea, Pollyanna Hardy, Rebecca Reynolds, Christopher Sutton, Greta Rait, Andrew Farmer, Mike Bradburn
NIHR157687 - ASTAR2: A randomized controlled trial of Predictive Parenting to reduce mental health and behaviour problems in young autistic children
Decision: Decline
NIHR157696 – Clinical and cost-effectiveness of adapted online parent-led treatment compared to treatment as usual for autistic children with anxiety problems in Child and Adolescent Mental Health Services: A randomised controlled trial Decision: Programme Oversight Committee to consider fund with changes
22/166 Rehabilitation and care following stroke
NIHR158951 - Walking in the home and community after stroke: a pragmatic multi-centre randomised controlled trial to evaluate auditory rhythmical cueing training compared to walking training alone and usual NHS care (ACTIVATE2).
Chair: Rupert Pearse
Conflicts: Nefyn Williams, Monica Busse, Amy Grove
Decision: Decline
22/166 Rehabilitation and care following stroke
NIHR157510 - Remote STrOke Rehabilitation (ReSTORe): a UK-wide randomised controlled trial with embedded process evaluation and economic analysis.
Chair: Rupert Pearse
Conflicts: Rui Duarte, Amy Grove, David Gillespie, Mike Bradburn
Decision: Programme Oversight Committee to consider fund with changes
22/166 Rehabilitation and care following stroke
NIHR158240 - A randomised controlled trial to evaluate the clinical and cost effectiveness of the Action Falls rehabilitation programme compared to usual care alone to reduce falls in stroke survivors.
Chair: Rupert Pearse
Conflicts: Pollyanna Hardy, Beth Stuart, Christopher Sutton, Nefyn Williams, Andrew Farmer, Pedro Saramago Goncalves, Reuben Ogollah, Trevor Jones, Ben Ollivere, Andrew Clegg
Decision: Programme Oversight Committee to consider fund with changes
22/168 The diagnostic accuracy of colon capsule endoscopy
Chair: Rupert Pearse
Conflicts: Christopher Sutton, Mike Bradburn, Monica Busse, David Gillespie, Miriam Brazzelli, Beth Stuart, Rebecca Reynolds
NIHR158034 - ColoCap: determining the diagnostic accuracy of colon capsule endoscopy compared to standard colonoscopy in patients at risk of colorectal disease.
Decision: Programme Oversight Committee to consider fund with changes
NIHR158780 - The diagnostic accuracy of colon capsule endoscopy- FIT for purpose?
Decision: Decline
Day 2 - 13th September 2023
Venue
Virtual via Microsoft Teams
Present Members
- Rupert Pearse (Chair)
- Nefyn Williams (Deputy Chair)
- Andrew Farmer (Programme Director)
- Monica Busse
- Rui Duarte
- Emilio Fernandez-Egea
- David Gillespie
- Pollyanna Hardy
- Angela Hassiotis
- Trevor Jones (Public Committee member)
- Antonieta Medina-Lara
- Ben Ollivere
- Greta Rait
- Rebecca Reynolds
- Beth Stuart
- Christopher Sutton
- Lyvonne Tume
- Mike Bradburn
- Amanda Adler
- Saul Faust
- Andrew Clegg
- Reuben Ogollah
- Najib Rahman
- Sian Lloyd-Jones (Public Committee member)
- Liz Hunter (Public Committee member)
- Miriam Brazzelli
- Amy Grove
Secretariat
- Jason Horsley
- Karen Williams
- Kathy Tier
- Brogan Ashley
- Louisa Saunders
Apologies
- Jane Nixon
- Pedro Saramago Goncalves
- Monica Busse (between 9:45 - 13:45)
Observers
- Julie Simpson
- Julie McCarroll
- Janet Diffin
- Becky Barnett-Neve
Quoracy Information
- Voting members: 28
- Quorum = 17 = 66%
- Emergency Quorum = 14 = 50%
- Voting members present on Day 2: 25
22/152 Through-knee versus above-knee major limb amputation
NIHR157343 - Through knee Amputations impact on Quality of Life compared to Above Knee Amputations - The HAMLET Trial
Chair: Rupert Pearse
Conflicts: Christopher Sutton, Saul Faust
Decision: Programme Oversight Committee to consider fund with changes
22/167 Imaging pathways for investigation following heart failure diagnosis
NIHR159132 - CROSS sectional versus invasive imaging in patients with Heart Failure (CROSS-HF)
Chair: Nefyn Williams
Conflicts: Reuben Ogollah
Left the meeting: Ben Ollivere
Decision: Programme Oversight Committee to consider fund with changes
22/146 Maintenance treatment for bipolar disorder
NIHR158667 - The effectiveness of Lithium plus Quetiapine COMBination versus LithIum versus QuetiapiNe monothErapy in the maintenance treatment of bipolaR disorder: the COMBINER trial.
Chair: Nefyn Williams
Conflicts: Rui Duarte, Christopher Sutton, Pollyanna Hardy, Trevor Jones, Angela Hassiotis, Ben Ollivere
Arrived at the meeting: Julie McCarroll
Left the meeting: Saul Faust
Decision: Programme Oversight Committee to consider fund with changes
Stage 1 Applications
22/158 Inhibition of the renin-angiotensin system in takotsubo cardiomyopathy Resubmission
NIHR157523 – A Randomised Controlled Trial of Renin-Angiotensin Inhibition for Cardiovascular Events Reduction after Takotsubo Cardiomyopathy (EVEREST).
Chair: Rupert Pearse
Conflicts: Rebecca Reynolds, Miriam Brazzelli, Andrew Clegg
Arrived at the meeting: Saul Faust
Decision: Shortlist
23/30 Repetitive Transcranial Magnetic Stimulation for depression in adolescents
NIHR161272 – Determining the feasibility of testing the effectiveness of repetitive Transcranial Magnetic Stimulation in treatment-resistent depression in adolescents.
Chair: Rupert Pearse
Conflicts: None
Left the meeting: Amanda Adler, David Gillespie
Decision: Decline
23/33 The clinical and cost-effectiveness of colesevelam for the treatment of bile acid diarrhoea
Chair: Nefyn Williams
Conflicts: Rui Duarte, Ben Ollivere, Mike Bradburn, Reuben Ogollah, Amy Grove, Pollyanna Hardy
Arrived at the meeting: Amanda Adler, David Gillespie, Monica Busse
NIHR160696 - Comparing the clinical and cost-effectiveness of COlesevelam for Bile Acid diarrhoea with colestyramine or Loperamide, including long Term follow-up (COBALT).
Decision: Shortlist
NIHR160898 - The clinical and cost-effectiveness of colesevelam for the treatment of bile acid diarrhoea
Decision: Shortlist
23/38 Nebulised therapy in patients with chronic obstructive pulmonary disease and disabling breathlessness
Chair: Rupert Pearse
Conflicts: Pollyanna Hardy, Rebecca Reynolds, Amy Grove, Saul Faust, Miriam Brazzelli
Arrived at the meeting: Ben Ollivere
Left the meeting: Andrew Farmer
NIHR159413 - Nebulised salbutamol in patients with Chronic Obstructive Pulmonary Disease and disabling breathlessness (NEB-COPD)
Decision: Decline
NIHR160716 - Nebulised therapy in patients with chronic obstructive pulmonary disease (COPD) and disabling breathlessness: a crossover randomised controlled trial
Decision: Decline
NIHR160920 - Using nebulised therapy to improve breathlessness in COPD (UNIB-COPD)
Decision: Shortlist
23/31 Prophylactic nebulised antibiotics for patients with a permanent tracheostomy or who have undergone a laryngectomy
NIHR160121 - TRUST-Neb trial - Tracheostomy and Upper airway Surgery (laryngectomy) Treatment Nebulised Antibiotic Trials in adults and children
Chair: Rupert Pearse
Conflicts: David Gillespie, Saul Faust, Andrew Farmer, Amanda Adler, Najib Rahman
Left the meeting: Julie McCarroll
Decision: Decline
23/32 Optimal management of perianal Crohn’s disease
NIHR160906 - Randomised evaluation of surgical techniques for anal fistula repair in patients with Crohn’s disease using a trials within cohort design - 'Repair pCD'
Chair: Nefyn Williams
Conflicts: Beth Stuart, Andrew Farmer, Rupert Pearse
Left the meeting: Rebecca Reynolds
Decision: Shortlist
23/35 Extended duration tocilizumab for giant cell arteritis
NIHR161069 - TOCCATA: tocilizumab continuation for giant cell arteritis: a multi-centre, parallel-group, randomised, placebo-controlled phase 3 trial to determine the clinical and cost-effectiveness of continuing versus discontinuing tocilizumab after one year in patients with giant cell arteritis.
Chair: Rupert Pearse
Conflicts: Rui Duarte, Mike Bradburn, Andrew Farmer, Antonieta Medina-Lara, Andrew Clegg
Arrived at the meeting: Rebecca Reynolds
Decision: Shortlist
23/36 Oral corticosteroids, NSAIDs or colchicine for gout flares
NIHR160813 - A pragmatic randomised trial comparing Oral Corticosteroids and Colchicine for the treatment of goUt flaRes in people with relative contraindications to non-steroidal anti-inflammatory drugs (the OCCUR trial)
Chair: Nefyn Williams
Conflicts: Andrew Farmer, Trevor Jones, Beth Stuart, Christopher Sutton, Saul Faust, Amy Grove, Reuben Ogollah, Sian Lloyd-Jones, Ben Ollivere, Greta Rait
Decision: Shortlist
23/34 Screening for COPD during the targeted lung health check
Chair: Rupert Pearse
Conflicts: Andrew Farmer, Rui Duarte, David Gillespie, Pollyanna Hardy, Ben Ollivere, Beth Stuart, Nefyn Williams, Amy Grove, Saul Faust, Najib Rahman
NIHR159400 - SPOT-COPD: SPirOmetry during Targeted lung health checks for COPD case-finding
Decision: Decline
NIHR160435 - SPIRACLE: Spirometry for early COPD at Targeted Lung Health Check
Decision: Shortlist
NIHR161197 - Is screening and initiation of treatment for COPD integrated into the NHS targeted lung health checks (TLHC) more effective and cost-effective than usual care
Decision: Decline