Meeting
HTA Funding Committee (Clinical Evaluation and Trials)
Day 1 - Tuesday 6th July 2021
Venue
Virtual Meeting held via Microsoft Teams
Present members
Professor Lucy Chappell (Chair)
Professor Charlotte Coles (Acting Deputy Chair)
Professor Andrew Farmer (HTA Programme Director)
Dr Jennifer Bostock (Public Committee member)
Dr Kate Brown
Dr Elizabeth Camacho
Mr Paul Charlton (Public Committee member)
Professor Alun Davies
Professor Richard Emsley
Dr Katie Gillies
Dr Chloe Grimmett (Trainee Committee member)
Professor Daniel Hind
Professor Sally Hopewell
Associate Professor Rebecca Kearney
Mrs Deborah Keatley (Public Committee member)
Professor Alan Montgomery
Professor Gavin Perkins
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 Jason Horsley (Consultant Advisor)
Steph Garfield-Birkbeck (Head of the HTA Programme Secretariat)
Ms Helen Payne (Senior Research Manager)
Dr Brogan Ashley (Research Manager)
Miss Hebe Sims (Assistant Research Manager)
Mrs Debbie Carter (Administrator)
Apologies
Mrs Deborah Keatley – morning only
Professor Daniel Hind – from 1pm
Professor Olivia Wu
Ms Jo Haviland
Observers
Professor Rupert Pearse – Deputy Chair of the HTA General Committee
Ms Emma Small – DA representative for Health and Care Research Wales
Quoracy Information
Voting members: 27 Quorum = 18
Voting members present on Day 1: 25 (92%)
Stage 2 Commissioned proposal shortlisted at January 2021 Commissioned Committee
20/18 Minimally invasive operative interventions for bladder outlet obstruction due to benign prostatic hyperplasia
Chair: Professor Lucy Chappell
Conflicts: Professor Daniel Hind, Professor James Wason
NIHR131984: Prostate Resection versus Minimally Invasive Surgery Evaluation Trial- PREMISE trial.
(Dr Tobias Page, The Newcastle Upon Tyne Hospitals NHS Foundation Trust)
Decision: Programme Oversight Committee to consider fund with changes
20/90 Researcher-led Primary Research Stage 2 Proposals, shortlisted at March Funding Committee
NIHR133464: Trial of IGe tests for Eczema Relief (TIGER): randomised controlled trial of test-guided dietary advice for children with eczema, with internal pilot and nested economic and process evaluations
(Dr Matthew Ridd, University of Bristol)
Chair: Professor Lucy Chappell
Conflicts: Dr Elizabeth Camacho, Dr Kathryn Radford, Ms Jennifer Bostock, Professor Alan Montgomery, Professor Andrew Farmer
Decision: Programme Oversight Committee to consider fund with changes
NIHR133518: ThOracic Umbrella RadIotherapy STudy in stage IV NSCLC - TOURIST
(Dr David Woolf, The Christie NHS Foundation Trust)
Chair: Professor Lucy Chappell
Conflicts: Dr Chloe Grimmett, Dr Elizabeth Camacho, Professor Kapil Sayal, Professor Thomas Pinkney
Decision: Programme Oversight Committee to consider fund with changes
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 Charlotte Coles
Conflicts: Ms Jennifer Bostock, Professor Andrew Farmer, Professor Lucy Chappell
Decision: Stage 2 Resubmission
NIHR133599: The Utility Of Frequency-Modulated Electromagnetic Neural Stimulation (FREMS) As A Third Line Treatment In Patients With Painful Diabetes-Related Peripheral Neuropathy: A Randomised Controlled Trial (FREMS-PDPN)
(Dr Abd Tahrani, University of Birmingham)
Chair: Professor Charlotte Coles
Conflicts: Professor Lucy Chappell, Professor Thomas Pinkney
Decision: Programme Oversight Committee to consider fund with changes
NIHR133642: PROMIS: Prostaglandin Pessary vs Oral Misoprostol for Induction of Labour at Term
(Dr Andrew Sharp, University of Liverpool)
Chair: Professor Charlotte Coles
Conflicts: Ms Jennifer Bostock, Professor Alan Montgomery, Professor Gavin Perkins, Professor Katherine Brown, Professor Lucy Chappell, Professor Rebecca Kearney, Professor Thomas Pinkney, Dr Elizabeth Camacho
Decision: Decline
NIHR133708: Stepped Care for comorbid mental and physical health disorders in children and young people (StepChange)
(Professor Roz Shafran, University College London)
Chair: Professor Lucy Chappell
Conflicts: Dr Elena Pizzo, Professor Andrew Farmer, Professor Charlotte Coles, Professor Kapil Sayal
Decision: Decline
NIHR133580: Adjunctive Local Drug Treatment at the Time Of Endoscopic Surgery for Recurrent Bulbar Urethral Stricture in Men (ReBUS)
(Mr Nadir Osman, Sheffield Teaching Hospitals NHS Foundation Trust)
Chair: Professor Lucy Chappell
Conflicts: Professor Alan Montgomery, Professor James Wason
Arrived at the meeting: Mrs Deborah Keatley
Decision: Decline
NIHR133056: Sugammadex for preventIoN oF pOst-operative pulmoNary complIcAtions (SINFONIA)
(Dr Jon Silversides, Belfast Health and Social Care Trust)
Chair: Professor Lucy Chappell
Conflicts: Dr Elena Pizzo, Professor Gavin Perkins, Professor Jonathan Rees, Professor Rebecca Kearney, Professor Thomas Pinkney, Professor Rupert Pearse
Left meeting: Mr Paul Charlton
Decision: Programme Oversight Committee to consider fund with changes
NIHR133787: Randomised trial of Suction for Primary Pneumothorax Early Resolution
(Dr Rob Hallifax, University of Oxford)
Chair: Professor Charlotte Coles
Conflicts: Associate Professor Sally Hopewell, Professor Andrew Farmer, Professor Daniel Prieto-Alhambra, Professor Lucy Chappell
Decision: Programme Oversight Committee to consider fund with changes
HTA Researcher-Led Stage 1
NIHR134839: PRESSURE 3: Pressure ulcer prevention - early heel specific adjunct devices for heel pressure ulcer prevention in people with a fractured hip
(Professor Jane Nixon, University of Leeds)
Chair: Professor Lucy Chappell
Conflicts: Associate Professor Sally Hopewell, Professor Alan Montgomery, Professor Andrew Farmer, Professor Daniel Prieto-Alhambra, Professor Gavin Perkins, Professor Jonathan Rees, Professor Rebecca Kearney, Professor Thomas Pinkney
Decision: Shortlist
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 Charlotte Coles
Conflicts: Dr Elizabeth Warburton, Ms Jennifer Bostock, Professor Andrew Farmer, Professor Daniel Prieto-Alhambra, Professor Gavin Perkins, Professor Jonathan Rees, Professor Lucy Chappell, Professor Rebecca Kearney
Decision: Shortlist
NIHR134901: DRESING trial (Dressing to Reduce EVD Sepsis in NeurosurGery)
(Mr Hiren Patel, Salford Royal NHS Foundation Trust)
Chair: Professor Lucy Chappell
Conflicts: Professor Alan Montgomery, Professor Charlotte Coles
Decision: Decline
NIHR134052: RandomiseD ContRol Trial to test the Null Hypothesis that discontinuation of bEta blockade 12 months after Acute Myocardial infarction with preserved Left Ventricular function will cause no harm. DREAM LV
(Professor Christopher Gale, University of Leeds)
Chair: Professor Lucy Chappell
Conflicts: Professor Gavin Perkins
Decision: Decline
NIHR134863: MultiModal intervention (Exercise, Anti-inflammatory & Dietary counselling) for renal cachexia (MMEAD): Cluster Randomised Controlled Trial with Internal Pilot, Process Evaluation and Economic Appraisal.
(Professor Joanne Reid, The Queen's University of Belfast)
Chair: Professor Lucy Chappell
Conflicts: Professor James Wason
Decision: Decline
Day 2 - Wednesday 7th July 2021
Venue
Virtual Meeting held via Microsoft Teams
Present members
Professor Lucy Chappell (Chair)
Professor Charlotte Coles (Acting Deputy Chair)
Professor Andrew Farmer (HTA Programme Director)
Dr Jennifer Bostock (Public Committee member)
Dr Kate Brown
Dr Elizabeth Camacho
Mr Paul Charlton (Public Committee member)
Professor Alun Davies
Professor Richard Emsley
Dr Katie Gillies
Dr Chloe Grimmett (Trainee Committee member)
Professor Daniel Hind
Professor Sally Hopewell
Associate Professor Rebecca Kearney
Mrs Deborah Keatley (Public Committee member)
Professor Alan Montgomery
Professor Gavin Perkins
Professor Thomas Pinkney
Dr Elena Pizzo
Professor Daniel Prieto-Alhambra
Dr Kathryn Radford
Professor Jonathan Rees
Professor Kapil Sayal
Professor James Wason
Ms Beth Woods
NETSCC, HTA Secretariat
Dr Jason Horsley (Consultant Advisor)
Steph Garfield-Birkbeck (Head of the HTA Programme Secretariat)
Ms Helen Payne (Senior Research Manager)
Dr Brogan Ashley (Research Manager)
Miss Hebe Sims (Assistant Research Manager)
Mrs Debbie Carter (Administrator)
Apologies
Mrs Deborah Keatley – morning only
Professor David Weller
Professor Olivia Wu
Ms Jo Haviland
Dr Elizabeth Warburton
Observers
Professor Catherine Hewitt – Deputy Chair of HTA Commissioning Committee
Ms Emma Small – DA representative for Health and Care Research Wales
Quoracy Information
Voting members: 27 Quorum = 18
Voting members present on Day 2: 24 (88%)
Cross-NETS Commissioning Stage 1 proposals
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 Lucy Chappell
Conflicts: Professor Andrew Farmer, Professor Gavin Perkins, Professor Rebecca Kearney, Professor Thomas Pinkney, Dr Chloe Grimmett
Arrived at meeting: Dr Kate Brown arrived
Decision: Shortlist
21/01: HTA Researcher-led call Primary Research
NIHR134676: Improving Sleep for Care Home Residents through Sleep Scheduling: IMPRESS Trial
(Professor Robert Howard, University College London)
Chair: Professor Lucy Chappell
Conflicts: Dr Kathryn Radford, Professor Alan Montgomery, Professor Daniel Prieto-Alhambra
Decision: Decline
NIHR134628: DOes early gdM diagnosis Improve pregNancy Outcomes (DOMINO)?
(Professor Rebecca Reynolds, The University of Edinburgh)
Chair: Professor Andrew Farmer
Conflicts: Professor Charlotte Coles, Professor Lucy Chappell, Professor Thomas Pinkney
Left meeting: Professor Alun Davies left
Decision: Shortlist
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 Lucy Chappell
Conflicts: Professor Gavin Perkins, Professor Thomas Pinkney
Decision: Shortlist
21/01: HTA Researcher-led call Primary Research
NIHR133797: A randomised trial to compare the effectiveness of Gardasil-9 HPV vaccine versus no additional therapy in PREVENTing recurrence in patients with eradicated high-grade anogenital intraepithelial neoplasia (the PREVENT trial)
(Dr Sadie Jones, Cardiff University)
Chair: Professor Lucy Chappell
Conflicts: None
Decision: Decline
NIHR134344: Surveillance After Resection of Oesophageal aNd Gastric cancer (SARONG) trial
(Associate Professor Sheraz Markar, University of Oxford, Nuffield Department of Surgical Sciences)
Chair: Professor Lucy Chappell
Conflicts: Associate Professor Sally Hopewell, Professor Andrew Farmer, Professor Daniel Prieto-Alhambra, Professor Jonathan Rees
Left meeting: Dr Chloe Grimmett, Dr Elizabeth Camacho
Decision: Shortlist
21/46: HTA Prehabilitation: Living with and beyond cancer
NIHR134537: Comprehensive Geriatric Assessment with or without Remote Symptom Monitoring for People Living with Frailty and Metastatic Colorectal Cancer: the CAREFOR study
(Dr Paul Ross, Guy's and St Thomas' NHS Foundation Trust)
Chair: Professor Charlotte Coles
Conflicts: Dr Chloe Grimmett, Professor Alan Montgomery, Professor Lucy Chappell
Decision: Decline
21/01: HTA Researcher-led call Primary Research
NIHR134290: Tackling hospital acquired malnutrition in critically ill patients: A randomised trial of intermittent versus continuous feeding
(Dr Zudin Puthucheary, Queen Mary University of London)
Chair: Professor Charlotte Coles
Conflicts: Professor Lucy Chappell
Decision: Decline
21/46: HTA Prehabilitation: Living with and beyond cancer
NIHR134386: Could it be Magic?
A 2-component prehabilitation programme to optimise outcomes in older adults undergoing elective intra-abdominal cancer surgery.
(Professor Susan Moug, NHS Greater Glasgow & Clyde)
Chair: Professor Andrew Farmer
Conflicts: Dr Katie Gillies, Ms Jennifer Bostock, Professor Charlotte Coles, Professor Lucy Chappell, Dr Chloe Grimmett
Decision: Decline
21/01: HTA Researcher-led call Primary Research
NIHR134532: Implementation of Metformin theraPy to Ease Decline of kidney function in Polycystic Kidney Disease (IMPEDE-PKD) Randomised Placebo-Controlled Trial
(Dr Ragada El-Damanawi, Sheffield Kidney Institute)
Chair: Professor Lucy Chappell
Conflicts: Ms Bethan Woods, Professor Andrew Farmer, Professor Charlotte Coles, Professor Daniel Hind, Professor James Wason
Decision: Decline
NIHR134774: Safety and effectiveness of Acute heart Failure carE as Out-patient: a multi-centre randomised controlled trial (SAFE)
(Dr Kenneth Wong, Blackpool Teaching Hospitals NHS Foundation Trust)
Chair: Professor Lucy Chappell
Conflicts: Professor Alan Montgomery, Professor Andrew Farmer
Arrived at the meeting: Professor Charlotte Coles
Left meeting: Mr Paul Charlton
Decision: Decline
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 Lucy Chappell
Conflicts: Associate Professor Sally Hopewell, Ms Bethan Woods, Professor Andrew Farmer, Professor Daniel Prieto-Alhambra, Professor Jonathan Rees, Professor Rebecca Kearney
Arrived at the meeting: Mrs Deborah Keatley
Decision: Shortlist
21/46: HTA Prehabilitation: Living with and beyond cancer
NIHR133932: PREhabilitation - a combined Exercise and Nutrition programme for Head and Neck Cancer patients treated with (chemo)radiotherapy (PRE-ENHANCE)
(Professor Joanne Patterson, University of Liverpool)
Chair: Professor Lucy Chappell
Conflicts: Professor Daniel Hind
Decision: Decline
21/01: HTA Researcher-led call Primary Research
NIHR134681: Distal Radius Acute Fracture Trial - CASP: Cast versus Splint
(Professor Matthew Costa, University of Oxford)
Chair: Professor Lucy Chappell
Conflicts: Associate Professor Sally Hopewell, Professor Alan Montgomery, Professor Andrew Farmer, Professor Daniel Prieto-Alhambra, Professor Gavin Perkins, Professor Jonathan Rees, Professor Rebecca Kearney, Professor Thomas Pinkney
Decision: Shortlist
NIHR134412: Optimal timing of parenteral nutrition for very preterm babies. The OPTIMAL trial
(Dr Sabita Uthaya, Imperial College London)
Chair: Professor Charlotte Coles
Conflicts: Professor Alan Montgomery, Professor Andrew Farmer, Professor Daniel Prieto-Alhambra, Professor Katherine Brown, Professor Lucy Chappell
Decision: Shortlist
NIHR134074: Pregabalin for treatment resistant generalized anxiety disorder
(Professor Glyn Lewis, University College London)
Chair: Professor Charlotte Coles
Conflicts: Dr Elena Pizzo, Ms Jennifer Bostock, Professor Lucy Chappell
Arrived at the meeting: Dr Elizabeth Camacho
Decision: Shortlist
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 Hospital Southampton NHS Foundation Trust)
Chair: Professor Lucy Chappell
Conflicts: Dr Chloe Grimmett, Ms Bethan Woods, Ms Jennifer Bostock, Professor Alan Montgomery, Professor Andrew Farmer, Professor Thomas Pinkney
Decision: Shortlist
21/01: HTA Researcher-led call Primary Research
NIHR134574: PREDNOS3: What is the optimal steroid treatment dose to treat relapses of childhood nephrotic syndrome?
(Dr Martin Christian, Nottingham University Hospitals NHS Trust)
Chair: Professor Lucy Chappell
Conflicts: Professor Thomas Pinkney
Decision: Decline
NIHR134890: A randomised controlled trial of remote Cognitive Behavioural Therapy with a Trauma Focus versus Usual Care for women with Post-traumatic Stress Disorder following miscarriage
(Professor Thomas Bourne, Imperial College London)
Chair: Professor Charlotte Coles
Conflicts: Professor Lucy Chappell, Professor Thomas Pinkney
Decision: Decline
NIHR134593: Study of technologies for the diagnosis of angle closure glaucoma (ACE)
(Professor Augusto Azuara-Blanco, Queen's University Belfast)
Chair: Professor Lucy Chappell
Conflicts: Dr Katie Gillies
Decision: Shortlist