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NIHR HTA Funding Committee Public Minutes 10-11 March 2020

Contents

Published: 05 June 2020

Version: V1 Jun20

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Date

Tuesday 10th March 2020 (Day 1)

Place 

Danubius Hotel, Regent’s Park, London

Present members

Professor Lucy Chappell
Professor Julia Brown
Professor Hywel Williams
Ms Gail Thornton
Mrs Deborah Keatley
Professor William Hollingworth
Professor Daniel Lasserson
Associate Professor Rebecca Kearney 
Dr Susan Jowett
Dr David Ekers
Dr Kate Brown
Professor Richard Emsley
Professor Daniel Prieto-Alhambra
Dr Kathryn Radford
Professor Alan Montgomery
Professor Steph Taylor
Professor Thomas Pinkney
Professor Charlotte Coles
Professor Sally Hopewell
Professor Kapil Sayal
Dr Daniel Hind
Professor Alun Davies
Professor Jonathan Rees
Professor David Weller
Professor James Wason

NETSCC, HTA Secretariat

Dr Jason Horsley (Consultant Advisor, NETSCC)
Steph Garfield-Birkbeck (Head of the HTA Programme Secretariat)
Mrs Karen Williams (Senior Research Manager)
Dr Cristina Lujan Barroso (Research Manager)
Miss Constance Temple-Brown (Assistant Research Manager)

Observers

Dr Shannon Amoils from BHF, Professor Bryan Williams from BHF, Professor Morris Brown from BHF. All three observers left after item 5.1 NIHR129917 – Professor Nikola Sprigg.

Apologies

Dr Jennifer Logue
Professor Sharon Simpson
Dr Natalie Blencowe
Dr Elena Pizzo
Ms Jo Haviland

 

Day 1

Researcher-Led Stage 2 and Tobacco Call shortlisted at November 2019 Committee

19/59: HTA Researcher-led call Primary Research

Chair: Professor Lucy Chappell

Declared a conflict and left the room: Dr Kathryn Radford, Dr Susan Jowett, Professor Alan Montgomery, Professor Hywel Williams, Professor Kapil Sayal

Arrived: Professor Morris Brown, Professor Bryan Williams, Dr Shannon Amoils 

NIHR129917: Tranexamic acid for hyper acute spontaneous intracerebral haemorrhage TICH-3 (Professor Nikola Sprigg, The University of Nottingham)

Funding Committee recommendation: Programme Oversight Committee to consider fund with changes

19/60: HTA Tobacco Cessation, Control and Harm Reduction Interventions

Chair: Professor Julia Brown

Declared a conflict and left the room: Dr Susan Jowett, Professor Alan Montgomery, Professor Daniel Lasserson, Professor Lucy Chappell, Professor Richard Emsley

Left meeting: Professor Morris Brown, Professor Bryan Williams, Dr Shannon Amoils 

NIHR129735: Health effects of mid-term and long-term use of e-cigarettes (HEC study) (Professor Peter Hajek, Queen Mary University of London)

Funding Committee recommendation: Decline

19/59: HTA Researcher-led call Primary Research

Chair: Professor Julia Brown

Declared a conflict and left the room: Dr Katherine Brown, Professor David Ekers, Professor Lucy Chappell

Left meeting: Daniel Prieto-Alhambra 

NIHR130092: Randomised Controlled Trial on Effectiveness of Medication to Manage Sexual Preoccupation in Adult Male Prisoners Convicted of Sexual Offences (TEMMPASO) (Dr Artemis Igoumenou, University College London)

Funding Committee recommendation: Decline

19/59: HTA Researcher-led call Primary Research

Chair: Professor Lucy Chappell

Declared a conflict and left the room: Dr Susan Jowett, Professor Daniel Lasserson, Professor Thomas Pinkney 

NIHR130487: A randomised controlled trial of a facilitated home-based rehabilitation intervention in patients with heart failure with preserved ejection fraction and their caregivers: the REACH-HFpEF Study (Professor Rod Taylor, University of Glasgow)

Funding Committee recommendation: Programme Oversight Committee to consider fund with changes

19/60: HTA Tobacco Cessation, Control and Harm Reduction Interventions

Chair: Professor Lucy Chappell

Declared a conflict and left the room: Professor David Ekers, Professor David Weller 

NIHR129438: Cessation of Smoking Trial in the Emergency Department (CoSTED) (Dr Ian Pope, Norfolk and Norwich University Hospitals NHS Foundation Trust)

Funding Committee recommendation:  Programme Oversight Committee to consider fund with changes

19/60: HTA Tobacco Cessation, Control and Harm Reduction Interventions  

Chair: Professor Lucy Chappell

Declared a conflict and left the room: Professor Daniel Prieto-Alhambra, Professor David Ekers, Professor David Weller, Professor James Wason

NIHR129780: The ENHANCE-D Study – ENHANCing smoking cEssation interventions in Dentistry (Dr Richard Holliday, Northumbria Healthcare NHS Foundation Trust)

Funding Committee recommendation: Programme Oversight Committee to consider fund with changes

19/11: HTA Researcher-led call Primary Research

Chair: Professor Lucy Chappell

Declared a conflict and left the room: Mrs Debbie Keatley 

NIHR129748: Surgeons Trial Of Prophylaxis for Epilepsy in seizure naïve patients with Meningioma: a randomised controlled trial (STOP’EM) (Professor Michael Jenkinson, University of Liverpool)

Funding Committee recommendation: Programme Oversight Committee to consider straight to fund

Commissioned Stage 2 Applications shortlisted from November 2019 Committee


19/26: Maternal intrapartum glycaemic control

Chair: Professor Julia Brown

Declared a conflict and left the room: Dr Katherine Brown, Professor Alan Montgomery, Professor David Weller, Professor Hywel Williams, Professor Lucy Chappell 

NIHR130403: MAternal iNtrapartum Glycaemic cOntrol: MANGO study (Professor Fiona Denison, The University of Edinburgh)

Funding Committee recommendation: Decline 

NIHR130175: Glycaemic control in labour with Diabetes (GILD) (Dr Nia Jones, The University of Nottingham)

Funding Committee recommendation: Programme Oversight Committee to consider fund with changes

19/25: Anaesthesia for arteriovenous fistula formation                             

Chair: Professor Charlotte Coles

Declared a conflict and left the room: Dr Kathryn Radford, Ms Gail Thornton, Professor Alan Montgomery, Professor Hywel Williams, Professor James Wason, Professor Julia Brown, Professor Thomas Pinkney, Professor William Hollingworth, Dr Jason Horsley

NIHR130567: Anaesthesia Choice for Creation of ArtEriovenous FiStulae (ACCESs study) A randomised controlled trial comparing clinical (one-year functional patency rate) and cost-effectiveness of regional versus local anaesthesia for primary arteriovenous fistula formation (Ms Emma Aitken, NHS Greater Glasgow & Clyde)

Funding Committee recommendation: Programme Oversight Committee to consider fund with changes

NIHR130600: Local Anaesthesia versus Regional Anaesthesia for primary arteriovenous fistula (AVF) formation surgery: the LARA study (Dr Ronelle Mouton, North Bristol NHS Trust)

Funding Committee recommendation: Decline

19/27: Peritoneal endometriosis: To treat or not?

Chair: Professor Lucy Chappell                                             

Declared a conflict and left the room: Dr Kathryn Radford, Dr Susan Jowett, Professor Alan Montgomery, Professor Daniel Lasserson, Professor David Weller, Professor Hywel Williams, Professor Thomas Pinkney

Arrived: Daniel Prieto-Alhambra 

NIHR129801: ESPriT2: A multi-centre randomised controlled trial to determine the effectiveness of laparoscopic treatment of isolated superficial peritoneal endometriosis for the management of chronic pelvic pain in women (Professor Andrew Horne, The University of Edinburgh)

Funding Committee recommendation: Programme Oversight Committee to consider fund with changes

19/53: Rivastigmine for psychotic symptoms associated with Parkinson’s disease

Chair: Professor Julia Brown

Declared a conflict and left the room: Professor Hywel Williams, Professor Lucy Chappell, Professor Richard Emsley, William Hollinsworth 

NIHR130606: What is the clinical and cost-effectiveness of rivastigmine compared with antipsychotic drug treatment for treating psychotic symptoms associated with Parkinson's disease? (Dr Dominic ffytche, Institute of Psychiatry, Psychology & Neuroscience, King's College London)

Funding Committee recommendation: Decline return to POC

19/59: HTA Researcher-led call Primary Research

Chair: Professor Julia Brown

Declared a conflict and left the room: Professor Hywel Williams, Professor Lucy Chappell

NIHR129617: Evaluating the clinical and cost-effectiveness of Sodium Bicarbonate administration for critically ill patients with Acute Kidney Injury (MOSAICC – Multicentre evaluation Of Sodium bicarbonate in Acute kidney Injury in Critical Care)  (Professor Lui Forni, University of Surrey)

Funding Committee recommendation: Stage 2 Resubmission once the results of the STARRT-AKI trial are available

Commissioning Stage 1 Applications received from January 2020 Call Close

19/71: OCT-angiography for the detection of neovascular age-related macular degeneration

Chair: Professor Lucy Chappell

Declared a conflict and left the room: Dr Susan Jowett, Professor Daniel Lasserson, Professor James Wason, Professor Alun Davies, Professor Thomas Pinkney

NIHR131432: OpticAl Coherence TomograpHy Angiography for the dEtection of Neovascular Age-related Macular Degeneration: a Comprehensive Diagnostic Accuracy Study - the ATHENA study (Dr Konstantinos Balaskas, Moorfields Eye Hospital NHS Foundation Trust)

Funding Committee recommendation: Shortlist

NIHR131398: The Diagnostic ability of Optical Coherence Tomography Angiography in Wet Age-Related Macular degeneration (DOCTA WARM) (Professor M Francesca Cordeiro, Imperial College London)

Funding Committee recommendation: Decline (a show of hands vote took place to assess the support for the proposal: 0 supported, 18 did not)

19/70: Cervical spine immobilisation following blunt trauma

Chair: Professor Julia Brown

Declared a conflict and left the room: Associate Professor Rebecca Kearney, Professor Daniel Hind, Professor Daniel Lasserson, Professor Alun Davies    

Left the meeting: David Weller, Hywel Williams

NIHR131430: Cervical Spine Immobilisation Following Blunt Trauma (HTA 19/70), Spinal Immobilisation Study (SIS) (Professor Mark Wilson, Imperial College Healthcare NHS Trust)

Funding Committee recommendation: Shortlist (a show of hands vote took place to assess the support for the proposal: 16 supported, 2 did not)

19/69: Clinical and cost effectiveness of alternative catheter design at preventing catheter-associated urinary tract infection

Chair: Professor Julia Brown

Declared a conflict and left the room: None

NIHR131172: Multicentre trial of the clinical and cost effectiveness of a novel urinary catheter design in preventing catheter-associated urinary tract infection compared with the traditional Foley design for adults requiring long-term catheterisation (CADET). (Dr Catherine Murphy, University of Southampton)

Funding Committee recommendation: Shortlist

Day 2

Present members

Professor Lucy Chappell
Professor Julia Brown
Professor Hywel Williams
Ms Gail Thornton
Mrs Deborah Keatley
Professor William Hollingworth
Professor Daniel Lasserson
Associate Professor Rebecca Kearney 
Dr Susan Jowett
Dr David Ekers
Dr Kate Brown
Professor Richard Emsley
Professor Daniel Prieto-Alhambra
Dr Kathryn Radford
Professor Alan Montgomery
Professor Steph Taylor
Professor Thomas Pinkney
Dr Charlotte Coles
Professor Sally Hopewell
Professor Kapil Sayal
Dr Daniel Hind
Professor Alun Davis
Professor Jonathan Rees
Professor James Wason

NETSCC, HTA Secretariat

Dr Jason Horsley (Consultant Advisor, NETSCC)
Steph Garfield-Birkbeck (Head of the HTA Programme Secretariat)
Mrs Karen Williams (Senior Research Manager)
Dr Cristina Lujan Barroso (Research Manager)
Miss Constance Temple-Brown (Assistant Research Manager)

Observers

Suzannah Kinsella, JLA

Apologies

Dr Jennifer Logue
Dr Sharon Simpson
Dr Natalie Blencowe
Dr David Weller
Dr Elena Pizzo
Ms Jo Haviland

 

Day 2

Researcher-Led Stage 1s Close introduction received from January 2020 Call 

19/102: HTA Researcher-led call Primary Research 

Chair: Professor Lucy Chappell

Declared a conflict and left the room: Professor Daniel Hind

Arrived: Suzannah Kinsella

NIHR131231: Evaluation of the Ampcare ESP (Effective Swallowing Protocol) for swallowing difficulties post stroke: a multi-centred, randomised, controlled trial. (Professor Susan Pownall, Sheffield Teaching Hospitals NHS Foundation Trust)

Committee recommendation: Decline

19/102: HTA Researcher-led call Primary Research

Chair: Professor Lucy Chappell

Declared a conflict and left the room: Associate Professor Rebecca Kearney, Associate Professor Sally Hopewell, Ms Gail Thornton, Professor Alan Montgomery, Professor Daniel Prieto-Alhambra, Professor Jonathan Rees, Professor Thomas Pinkney, Professor William Hollingworth 

NIHR131187: The clinical and cost-effectiveness of aspirin compared with other anticoagulants for preventing venous thromboembolism following total hip replacement. A multicentre non-inferiority randomised controlled trial (Professor Ashley Blom, University of Bristol)

Committee recommendation: Decline

19/102: HTA Researcher-led call Primary Research

Chair: Professor Julia Brown

Declared a conflict and left the room: none

NIHR130863: STudy of Antibiotic Treatment In Children with Protracted Bacterial Bronchitis (STATIC PBB) (Dr Francis Gilchrist, Keele University)

Committee recommendation: Decline

19/102: HTA Researcher-led call Primary Research

Chair: Professor Julia Brown

Declared a conflict and left the room: Professor Lucy Chappell, Professor Alun Davies 

NIHR131107: A randomised trial of standard versus reduced frequency of pembrolizumab for first-line patients with advanced non-small cell lung Cancer (NSCLC) utilising a novel multi-arm frequency-response optimisation design – CONVOLUTE (Professor Michael Seckl, Imperial College London)

Committee recommendation: Shortlist

19/102: HTA Researcher-led call Primary Research 

Chair: Professor Lucy Chappell

Declared a conflict and left the room: Professor Julia Brown, Professor Thomas Pinkney, Associate Professor Rebecca Kearney 

NIHR131090: A randomised controlled trial of up to 12 months antibiotic prophylaxis for patients with immune systems severely impaired by blood cancer and its therapy; assessment for risk of carriage of antibiotic resistant bacteria and benefit from reduced deaths and infections requiring antibiotics (Professor Mark Drayson, University of Birmingham)

Committee recommendation: Decline

19/102: HTA Researcher-led call Primary Research

Chair: Professor Lucy Chappell

Declared a conflict and left the room: None 

NIHR131370: A randomised controlled trial assessing the clinical and cost effectiveness of the modified ketogenic diet for adults with treatment refractory epilepsy (KESTREL) (Professor Anthony Marson, University of Liverpool)

Committee recommendation: Decline

19/102: HTA Researcher-led call Primary Research

Chair: Professor Lucy Chappell

Declared a conflict and left the room: Associate Professor Rebecca Kearney, Professor Daniel Hind, Professor Daniel Lasserson, Professor Thomas Pinkney

NIHR131105: Pre-hospitAl Randomised triAl of MEDICation route in out-of-hosital cardiac arrest (PARAMEDIC3) (Professor Gavin Perkins, University of Warwick)

Committee recommendation: Shortlist

19/102: HTA Researcher-led call Primary Research

Chair: Professor Lucy Chappell

Declared a conflict and left the room: Dr Katherine Brown, Professor Julia Brown

Left meeting: Professor Hywel Williams 

NIHR131341: Cluster Randomised Controlled Trial of a Service to Support the Mental Health and Coping of Parents with Excessively Crying Infants (Professor Jayne Brown, De Montfort University)

Committee recommendation: Shortlist

19/102: HTA Researcher-led call Primary Research

Chair: Professor Lucy Chappell

Declared a conflict and left the room: Professor Daniel Hind 

NIHR130848: CiproPAL (Ciprofloxacin Prophylaxis in Acute Leukaemia): A randomised trial to assess the use of ciprofloxacin prophylaxis to prevent bacterial infection in children treated on the induction phase of the ALLTogether-1 treatment protocol (Dr Robert Phillips, The University of York)

Committee recommendation: Shortlist (a show of hands vote took place to assess the support for the proposal: 15 supported, 6 did not)

19/102: HTA Researcher-led call Primary Research

Chair: Professor Julia Brown

Declared a conflict and left the room: Associate Professor Sally Hopewell, Professor Daniel Lasserson, Professor Daniel Prieto-Alhambra, Professor Jonathan Rees

NIHR131233: A randomised controlled trial of TRANSrectal biopsy versus Local Anaesthetic Transperineal biopsy Evaluation (TRANSLATE) of potential clinically significant prostate cancer. (Associate Professor Richard Bryant, University of Oxford)

Committee recommendation: Shortlist

19/102: HTA Researcher-led call Primary Research

Chair: Professor Julia Brown

Declared a conflict and left the room: Professor Lucy Chappell, Professor Richard Emsley

NIHR131350: Clinical and cost effectiveness of triple chronotherapy (wake therapy) v sleep therapy for the rapid treatment of depression: a parallel randomised controlled trial (Professor David Veale, South London and Maudsley NHS Foundation Trust)

Committee recommendation: Decline

19/102: HTA Researcher-led call Primary Research

Chair: Professor Julia Brown

Declared a conflict and left the room: Professor Alan Montgomery, Professor William Hollingworth

NIHR131306: Multi-modality local consolidative treatment versus conventional care of advanced lung cancer after first line systemic anti-cancer treatment: a multi-centre randomised controlled trial with an internal pilot. RAdical Management Of Advanced Non-small cell lung cancer (RAMON) (Professor Eric Lim, Royal Brompton & Harefield NHS Foundation Trust)

Committee recommendation: Shortlist (a show of hands vote took place to assess the support for the proposal: 17 supported, 1 abstained)

19/102: HTA Researcher-led call Primary Research

Chair: Professor Lucy Chappell

Declared a conflict and left the room: Associate Professor Sally Hopewell, Professor Daniel Prieto-Alhambra, Mrs Debbie Keatley, Professor Jonathan Ross

NIHR130886: Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma (MelMarT-II) ClinicalTrials.gov Identifier: NCT03860883 (Professor Marc Moncrieff, Norfolk and Norwich University Hospitals NHS Foundation Trust)

Committee recommendation: Shortlist

19/102: HTA Researcher-led call Primary Research

Chair: Professor Lucy Chappell

Declared a conflict and left the room: Professor James Wason, Professor Alun Davies, Mrs Debbie Keatley

NIHR130993: Evaluating the clinical and cost-effectiveness of biparametric MRI compared to multi-parametric MRI in detecting and ruling-out important prostate cancer (Professor Hashim Ahmed, Imperial College London)

Committee recommendation: Shortlist

19/102: HTA Researcher-led call Primary Research

Chair: Professor Lucy Chappell

Declared a conflict and left the room: Professor James Wason, Professor Julia Brown

NIHR131339: The COSI study: a multi-site RCT to explore the clinical and cost effectiveness of the Circle of Security Intervention for mothers in perinatal mental health services (Professor Peter Fonagy, Anna Freud Centre)

Committee recommendation: Shortlist

19/102: HTA Researcher-led call Primary Research

Chair: Professor Julia Brown

Declared a conflict and left the room: Professor Lucy Chappell, Professor William Hollingworth, Associate Professor Rebecca Kearney

NIHR131352: A Randomised Placebo-Controlled Trial of Antenatal Corticosteroids for Planned Birth in Twins: STOPPIT-3 (Dr Sarah Stock, The University of Edinburgh)

Committee recommendation: Shortlist

19/102: HTA Researcher-led call Primary Research

Chair: Professor Julia Brown

Declared a conflict and left the room: Associate Professor Sally Hopewell, Professor Alan Montgomery, Professor Daniel Prieto-Alhambra, Professor Lucy Chappell

NIHR131200: Prophylactic antenatal corticosteroids for the prevention of short- and long-term morbidity associated with induction of labour at 34 – 37 weeks of gestation: a multi-centre randomised controlled trial (Dr Paul Ayuk, The Newcastle Upon Tyne Hospitals NHS Foundation Trust)

Committee recommendation: Decline

19/102: HTA Researcher-led call Primary Research

Chair: Professor Lucy Chappell

Declared a conflict and left the room: Professor Daniel Hind

NIHR131313: Impact of a new risk tool (STUMBL Score) on the management of blunt chest wall trauma: a stepped wedge, cluster randomised controlled trial (STUMBL2 trial). (Associate Professor Ceri Battle, Swansea Bay University Health Board)

Committee recommendation: Decline

19/102: HTA Researcher-led call Primary Research

Chair: Professor Lucy Chappell

Declared a conflict and left the room: Dr Kathryn Radford, Professor Daniel Lasserson, Professor William Hollingworth

NIHR130906: MULTI-CENTRE TRIAL OF HOME ENTERAL NUTRITION VERSUS USUAL CARE AFTER OESOPHAGECTOMY FOR CANCER (MONACO 1) (Professor David Bowrey, University Hospitals of Leicester NHS Trust)

Committee recommendation: Shortlist

19/102: HTA Researcher-led call Primary Research

Chair: Professor Lucy Chappell

Declared a conflict and left the room: Dr Kathryn Radford, Dr Susan Jowett, Professor Alan Montgomery, Professor Daniel Lasserson, Professor Kapil Sayal, Professor Thomas Pinkney

Left meeting: Gail Thorton

NIHR130689: The Metoclopramide for Avoiding Pneumonia after Stroke (MAPS-2) Trial: a double-blind, randomised controlled trial of metoclopramide for the prevention of pneumonia in patients with dysphagia after an acute stroke (Professor Christine Roffe, University Hospitals of North Midlands NHS Trust)

Committee recommendation: Shortlist

19/102: HTA Researcher-led call Primary Research

Chair: Professor Lucy Chappell

Declared a conflict and left the room: Professor Thomas Pinkney

Arrived meeting: Gail Thorton

Left meeting: Debbie Keatley

NIHR131346: CONservative TReatment of Appendicitis in Children – a randomised controlled Trial – CONTRACT 2 (Associate Professor Nigel Hall, University of Southampton)

Committee recommendation: Shortlist

19/102: HTA Researcher-led call Primary Research

Chair: Professor Lucy Chappell

Declared a conflict and left the room: Dr Kathryn Radford, Professor Alan Montgomery, Professor Daniel Lasserson, Professor James Wason

NIHR131344: The clinical and cost effectiveness of a holistic online self-management platform for people with diabetes compared to routine care: A mixed-methods stepped-wedge cluster randomised controlled trial. (Dr Iskandar Idris, University of Nottingham)

Committee recommendation: Decline (a show of hands vote took place to assess the support for the proposal: 2 supported, 13 did not)