Meeting
HTA Funding Committee (Clinical Evaluations and Trials)
Day 1 - 1 November 2022
Venue
- virtual via Microsoft Teams
Present members
- Olivia Wu (Chair)
- Rakesh Heer (Deputy Chair)
- Andrew Farmer (HTA Programme Director)
- Elizabeth Camacho
- Jennifer Bostock (Public Committee Member)
- Hannah de Merode (Public Committee Member)
- Jon Dorling
- Francesca Fiorentino
- Paul French
- Katie Gillies
- Joanne Haviland
- Daniel Hind
- Sally Hopewell
- Pamela Jacobsen (Committee Member Development Scheme Participant)
- Rebecca Kearney
- Gavin Perkins
- Thomas Pinkney
- Jonathan Rees
- Nigel Rees
- Gurdeep Sagoo
- Elizabeth Warburton
- James Wason
- Sam Creavin
- Claudia Cooper
- Munyaradzi Dimairo
- Edward Wilson
Secretariat
- Nick Hicks (Consultant Advisor)
- Steph Garfield-Birkbeck (Head of the HTA Programme Secretariat)
- Helen Payne (Senior Research Manager)
- Brogan Ashley (Research Manager)
- Hebe Sims (Assistant Research Manager)
- Debbie Carter (Administrator)
Apologies
- David Weller
- Kapil Sayal
- Alun Davies
- Elena Pizzo
Observers
- Emma Small
- Sheona St Hilaire
- Janet Diffin
- Julie Simpson
- Julie McCarroll
Quoracy information
- voting members: 30 (Emergency Quoracy = 15 = 50%)
- voting members present on Day 1: 25 (83 %)
Stage 2 Applications
22/1 Researcher-Led Primary Research
NIHR152252 - SHorter vs Longer CoUrse AnTibiotics – an AdaptivE BaYEsian Design Study (SHUTEYE) (Tony Whitehouse)
Chair: Rakesh Heer
Conflicts: Gavin Perkins, Thomas Pinkney
Decision: Decline
NIHR153131 - Antidepressants to prevent relapse in depression in older people (ANTLER 75+ Trial) (Robert Howard)
Chair: Olivia Wu
Conflicts: Elizabeth Camacho, Claudia Cooper, Andrew Farmer, Jennifer Bostock, Paul French, Sam Creavin, Rakesh Heer, Gurdeep Sagoo
Decision: Programme Oversight Committee to consider fund with changes
NIHR152686 - The ELIPSE Study - a randomised controlled trial comparing the clinical and cost-effectiveness of lymph node removal in patients undergoing curative surgery for localised high-risk prostate cancer. (Krishna Narahari)
Chair: Olivia Wu
Conflicts: Francesca Fiorentino, Gurdeep Sagoo, Rakesh Heer, Katie Gillies, James Wason
Decision: Resubmission
NIHR150364 - Prehospital Recognition and Antibiotics for emergency patients with Sepsis: evaluation of safety, costs and effectiveness (PhRASe 2) (Jenna Jones)
Chair: Rakesh Heer
Conflicts: Jennifer Bostock, Gavin Perkins, Nigel Rees, Daniel Hind, Munyaradzi Dimairo
Decision: Decline
NIHR151099 - ACORN: A multi-site randomised COntrolled trial to evaluate the impact of a group tReatment for aNtenatal anxiety (Heather O'Mahen)
Chair: Olivia Wu
Conflicts: Elizabeth Camacho, James Wason, Pamela Jacobsen, Rakesh Heer, Gavin Perkins
Decision: Programme Oversight Committee to consider fund with changes
NIHR152506 - Restart tICrH: A Randomised Trial of Timing to Restart Direct Oral Anticoagulants after Traumatic Intracranial Haemorrhage (Catherine McMahon)
Chair: Rakesh Heer
Conflicts: Andrew Farmer, Gavin Perkins, Elizabeth Warburton, Jennifer Bostock, Gurdeep Sagoo
Decision: Programme Oversight Committee to consider fund with changes
NIHR152733 - Empirical oral AntibioticS for possible UTI in well appearing Young febrile infants (EASY). (Thomas Waterfield)
Chair: Rakesh Heer
Conflicts: Jon Dorling, Gavin Perkins
Decision: Programme Oversight Committee to consider fund with changes
22/77 Fast Track Stage 2 Applications
NIHR154434 - HEALTH: a randomised comparison of laparoscopic supracervical hysterectomy with endometrial ablation for women with heavy menstrual bleeding - medium-term follow-up at a minimum of five years (Kevin Cooper)
Chair: Olivia Wu
Conflicts: Katie Gillies, Rakesh Heer
Decision: Programme Oversight Committee to consider fund with changes
21/598 Health and social care outcomes and cost-effectiveness of assistive technologies Stage 2 Application
NIHR152941 - Mapping and evidence synthesis for assistive technologies to support adults living at home with long-term continence or toilet-use problems (Catherine Murphy)
Chair: Rakesh Heer
Conflicts: None Advised
Decision: Programme Oversight Committee to consider Fund with changes
Stage 1 Applications
22/36 Microsuction compared with irrigation to remove earwax
NIHR155082 - A randomised trial of micro-suction and electronic water irrigation to remove earwax in adults seen in primary care (MI-WAX) (Irwin Nazareth)
Chair: Olivia Wu
Conflicts: Elizabeth Camacho, Claudia Cooper, Edward Wilson
Decision: Decline
22/61 Researcher-Led Primary Research
NIHR152151 - Prothrombin complex concentrates versus fresh frozen plasma in adult patients who are undergoing heart surgery (PROPHESY-2 trial). (Laura Green)
Chair: Thomas Pinkney
Conflicts: Andrew Farmer, Olivia Wu, Gavin Perkins, Joanne Haviland, Elizabeth Warburton, Rakesh Heer, James Wason, Claudia Cooper
Left the meeting: Steph Garfield-Beck has left the meeting
Decision: Shortlist
NIHR153216 - DEXACELL: Dexamethasone as an adjunctive therapy for the management of cellulitis - a randomised controlled trial in urgent secondary care (Edward Carlton)
Chair: Olivia Wu
Conflicts: Andrew Farmer, Jennifer Bostock, Rebecca Kearney, Gavin Perkins
Arrived: Steph Garfield-Beck re-joined the meeting
Decision: Shortlist
NIHR152208 - STEPFORWARD: A randomised controlled trial of the clinical and cost-effectiveness of a hydraulic self-aligning ankle-foot for patients with a below-knee amputation categorised as having "limited community mobility" (Natalie Vanicek)
Chair: Rakesh Heer
Conflicts: Elizabeth Warburton
Left the meeting: Sam Creavin has left the meeting
Decision: Shortlist
NIHR153742 - EXamining antibiotics for ulCerated skIn cancer Surgical Excision (EXCISE): a pragmatic, multi-arm 'durations' design randomised controlled trial. (Rachel Abbott)
Chair: Olivia Wu
Conflicts: Katie Gillies, Andrew Farmer, Jennifer Bostock
Left the meeting: Dan Hind left the meeting
Decision: Shortlist
NIHR153760 - Quitting Using E-cigarettes before Surgery Trial (QUEST) (Ian Pope)
Chair: Olivia Wu
Conflicts: Pamela Jacobsen, Edward Wilson, Andrew Farmer, Thomas Pinkney, Jennifer Bostock
Decision: Shortlist
Day 2 - 2 November 2022
Venue
- virtual via Microsoft Teams
Present members
- Olivia Wu (Chair)
- Rakesh Heer (Deputy Chair)
- Andrew Farmer (HTA Programme Director)
- Elizabeth Camacho
- Jennifer Bostock (Public Committee Member)
- Hannah de Merode (Public Committee Member)
- Jon Dorling
- Francesca Fiorentino
- Paul French
- Katie Gillies
- Joanne Haviland
- Daniel Hind
- Sally Hopewell
- Pamela Jacobsen (Committee Member Development Scheme Participant)
- Rebecca Kearney
- Gavin Perkins
- Thomas Pinkney
- Elena Pizzo
- Jonathan Rees
- Nigel Rees
- Gurdeep Sagoo
- Elizabeth Warburton
- James Wason
- Claudia Cooper
- Munyaradzi Dimairo
- Edward Wilson
Secretariat
- Nick Hicks (Consultant Advisor)
- Steph Garfield-Birkbeck (Head of the HTA Programme Secretariat)
- Helen Payne (Senior Research Manager)
- Brogan Ashley (Research Manager)
- Hebe Sims (Assistant Research Manager)
- Debbie Carter (Administrator)
Apologies
- David Weller
- Kapil Sayal
- Alun Davies
- Sam Creavin
Observers
- Sheona St Hilaire
- Janet Diffin
- Julie Simpson
- Julie McCarroll
Quoracy information
- voting members: 30 (Emergency Quoracy = 15 = 50%)
- voting members present on Day 2: 24 (80 %)
Stage 1 Applications
22/61 Researcher-Led Primary Research
NIHR153808 - A Phase III randomised control clinical trial of radiotherapy with radiosensitisation versus intravesicular Bacillus Calmette-Guerin therapy for high-risk non-muscle invasive bladder cancer - TRAIN (Ananya Choudhury)
Chair: Olivia Wu
Conflicts: Joanne Haviland, Rakesh Heer, Elizabeth Warburton, Andrew Farmer, Gurdeep Sagoo
Decision: Shortlist
NIHR154131 - Adjunctive Local Drug Treatment at the Time Of Endoscopic Surgery for Primary and Recurrent Bulbar Urethral Stricture in Men (PReBUS) (Nadir Osman)
Chair: Olivia Wu
Conflicts: Daniel Hind, Thomas Pinkney, Rakesh Heer, Paul French, Munyaradzi Dimairo
Decision: Shortlist
NIHR154157 - Tackling hospital acquired malnutrition in critically ill patients to improve physical function and quality of life: A randomised trial of intermittent versus continuous feeding (Zudin Puthucheary)
Chair: Rakesh Heer
Conflicts: Jennifer Bostock, Thomas Pinkney, Edward Wilson, Joanne Haviland, Claudia Cooper, Elizabeth Warburton
Decision: Decline
NIHR154755 - Atrial Fibrillation Treatment with Catheter Ablation or Left Bundle Pacing with Atrioventricular Node Junction Ablation In Older Adults, a Randomised Clinical Trial (Tom Wong)
Chair: Andrew Farmer
Conflicts: Rakesh Heer, Edward Wilson, Olivia Wu
Decision: Decline
NIHR154837 - A randomised controlled trial of acting on elevated troponin at the time of hospital admission for an exacerbation of chronic obstructive pulmonary disease to reduce the risk of a major cardiovascular event (Jennifer Quint)
Chair: Olivia Wu
Conflicts: Elizabeth Camacho, Francesca Fiorentino, Thomas Pinkney, Rebecca Kearney, Rakesh Heer
Arrived at the meeting: Steph Garfield-Beck has joined the meeting
Decision: Decline
NIHR154853 - Treatment of >400µ centre-involving Diabetic macular oedema with fAricimab monotherapy versus combined faricimab and subthreshold Micropulse lasEr (SML) applied when central retinal thickness is reduced below 400µ (DAME): A pragmatic randomised equivalence trial (Noemi Lois)
Chair: Olivia Wu
Conflicts: Rakesh Heer, Katie Gillies
Decision: Decline
NIHR154915 - Fix Or Replace Enhancing distal humeruS fracTure outcomes (FOREST) (Ben Ollivere)
Chair: Olivia Wu
Conflicts: Elizabeth Camacho, Jon Dorling, Thomas Pinkney, Jonathan Rees, Rebecca Kearney
Decision: Shortlist
NIHR155054 - A Randomised Multiple Centre Trial of Conservative versus Liberal Fluid Administration for Children Receiving a Kidney Transplant (LIMITS) (Wesley Hayes)
Chair: Olivia Wu
Conflicts: Daniel Hind, Andrew Farmer, Munyaradzi Dimairo
Decision: Shortlist
NIHR155123 - A multicentre randomised trial of surgical versus percutaneous treatment of ischaemic heart failure in the United Kingdom, with embedded internal pilot and health economic analysis (BCIS4) (Gavin Murphy)
Chair: Rakesh Heer
Conflicts: James Wason, Olivia Wu
Left the meeting: Steph Garfield-Beck, Elena Pizzo and Jo Haviland left the meeting
Decision: Shortlist
NIHR155133 - Dexamethasone and postoperative bleeding following tonsillectomy in children (Blueberry study) - Double-blind, randomized, placebo controlled, multi-centre, international, pragmatic, non-inferiority trial. (Gil Gavel)
Chair: Olivia Wu
Conflicts: Katie Gillies, Rakesh Heer
Arrived at the meeting: Elena Pizzo re-joined the meeting
Decision: Decline
NIHR155373 - A Randomised, phase III clinical trial assessing the optimal management (Medical vs Computed Tomography Coronary Angiography (CTCA) guided vs Invasive) for Patients With Prior Coronary Artery Bypass Surgery presenting with a Non-ST Segment Elevation Acute Coronary Syndrome (BYPASS-ACS Study) (Daniel Jones)
Chair: Andrew Farmer
Conflicts: Joanne Haviland, Olivia Wu, Rakesh Heer, Munyaradzi Dimairo, Dan Hind
Arrived at the meeting: Steph Garfield-Beck has re-joined the meeting
Decision: Decline
22/44 Innovative ventilation technologies for treatment of patients in ICU (HTA)
NIHR153743 - Weaning ventilated children in the paediatric intensive care unit (PICU) with Neurally Adjusted Ventilatory Assist (NAVA) versus standard care: a pragmatic randomised controlled trial with a cost consequences evaluation (Reinout Mildner)
Chair: Rakesh Heer
Conflicts: Thomas Pinkney
Arrived/Left the meeting: Gavin Perkins has left the meeting. Jo Haviland has re-joined the meeting.
Decision: Shortlist
NIHR154796 - Awake prone positioning in patients with acute hypoxaemic respiratory failure not due to COVID-19: a multi-centre, pragmatic, allocation concealed, individual patient randomised, parallel group, open-label clinical trial (AWAKE-PRONE) (Keith Couper)
Chair: Olivia Wu
Conflicts: Nigel Rees, James Wason, Gurdeep Sagoo, Thomas Pinkney, Rakesh Heer, Rebecca Kearney
Decision: Shortlist
NIHR154501 - Airway Pressure Release Ventilation (APRV) vs conventional ventilation for patients with moderate to severe acute hypoxemic respiratory failure (RELEASE) (Luigi Camporota)
Chair: Olivia Wu
Conflicts: Thomas Pinkney, Nigel Rees, Francesca Fiorentino, Rebecca Kearney, Katie Gillies
Decision: Shortlist
NIHR154892 - Airway Pressure Release Ventilation (APRV) versus Prone Positioning in Severe Acute Respiratory Distress Syndrome (ARDS) (Callum Kaye)
Chair: Olivia Wu
Conflicts: Jennifer Bostock, Katie Gillies, Jonathan Rees, Rakesh Heer, Thomas Pinkney, Elizabeth Warburton
Decision: Shortlist
NIHR155119 - Neurally adjusted ventilatory assist in the adult critical care unit: A randomized, parallel group, allocation concealed, controlled, open, phase 3 pragmatic clinical and cost effectiveness trial with internal pilot (Daniel Hadfield)
Chair: Rakesh Heer
Conflicts: Francesca Fiorentino, Nigel Rees, Rebecca Kearney
Decision: Shortlist
NIHR154798 - Innovative ventilation technologies in adults and children: an evidence synthesis to inform clinical practice and future research priorities (Keith Couper)
Chair: Olivia Wu
Conflicts: Thomas Pinkney, Nigel Rees, Rebecca Kearney
Decision: Shortlist