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NIHR HTA Funding Committee Public Minutes 19-20 January 2021

Contents

Date     

Tuesday 19 January 2021 (Day 1)

Place    

Microsoft Teams

Present members

Professor Marian Knight (Chair)

Professor Andrew Farmer (Programme Director)

Professor Catherine Hewitt (Deputy Chair)

Dr Ben Ainsworth

Mr Roshan Bootun

Professor Monica Busse

Mr Paul Charlton (Public Member)

Dr Emilio Fernandez-Egea

Dr Pollyanna Hardy

Professor Angela Hassiotis

Mr Rakesh Heer

Ms Debby Lennard (Public Member)

Professor Nick Maskell

Professor Jane Nixon

Professor Daniel Perry

Professor Rebecca Reynolds

Professor Chris Rogers

Professor Jonathan Ross

Professor Andrew Shennan

Professor Sobha Sivaprasad

Dr Beth Stuart

Dr Chris Sutton

Associate Professor Lyvonne Tume

Professor Nefyn Williams

 

NETSCC, HTA Secretariat

Dr Jason Horsley (Consultant Advisor)

Steph Garfield-Birkbeck (Head of the HTA Programme)

Karen Williams (Senior Research Manager)

Kathy Tier (Research Manager)

Connie Temple-Brown (Assistant Research Manager)

Louisa Saunders (Assistant Research Manager)

Apologies           

Professor Joy Adamson

Professor Saul Faust

Professor Richard Grieve

Professor Pip Logan

Associate Professor Antonieta Medina-Lara

Dr Greta Rait

Observers          

Jeremy Taylor (Director, CED l Jane Luff AD, Infrastructure and Faculty) 10-12pm

Quoracy Information     

Voting members: 28 Quorum = 19

Voting members present on Day 1: 22 (79%)

 

Commissioned Stage 2 applications shortlisted at September 2020 Committee meeting

20/18 Minimally invasive operative interventions for bladder outlet obstruction due to benign prostatic hyperplasia

Chair: Professor Marian Knight

Declared a conflict and left the meeting: Professor Chris Rogers, Professor Rakesh Heer

Arrived at the Meeting: Jeremy Taylor (observer)

Left Meeting: Steph Garfield-Birkbeck

NIHR131984: Prostate Resection versus Minimally Invasive Surgery Evaluation Trial- PREMISE trial.

(Dr Tobias Page, The Newcastle Upon Tyne Hospitals NHS Foundation Trust)

Funding Committee recommendation: Decline Return to POC

20/19 Nasal decolonisation of MRSA

Chair: Professor Marian Knight

Declared a conflict and left the meeting: Dr Christopher Sutton, Professor Catherine Hewitt, Professor Jonathan Ross

NIHR132718: A multi-centre randomised controlled non-inferiority and cost effectiveness trial comparing Polyhexanide and Chlorhexidine with Neomycin to Mupiricon for nasal meticillin-resistant Staphylococcus aureus (MRSA) decolonisation amongst adult hospital in-patients

(Professor Mike Reed, Northumbria Healthcare NHS Foundation Trust)

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

19/124 Effectiveness of meniscal allograft transplantation

Chair: Professor Catherine Hewitt

Declared a conflict and left the meeting: Dr Christopher Sutton, Professor Andrew Farmer, Professor Daniel Perry, Professor Marian Knight

NIHR131629: The Meniscal Transplant surgery or Optimised Rehabilitation full randomised trial (MeTeOR2)

(Mr Andrew Metcalfe, University of Warwick)

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

19/120 Relapsing polymyalgia rheumatica

Chair: Professor Catherine Hewitt

Declared a conflict and left the meeting: Professor Andrew Farmer, Professor Jane Nixon, Professor Marian Knight, Professor Rakesh Heer

Left meeting: Chris Sutton

NIHR131475: Steroid-Reducing Options for ReLapsING PMR (STERLING-PMR): a pragmatic, randomised trial to compare the clinical and cost-effectiveness of adding immunosuppression to steroid-tapering treatment for patients with relapsing PMR, versus steroid-tapering alone.

(Dr Sarah Mackie, University of Leeds)

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

20/26 Antifungal Stewardship in Haemato-oncology

Chair: Professor Marian Knight

Declared a conflict and left the meeting: Dr Christopher Sutton, Professor Catherine Hewitt

Arrived at meeting: Steph Garfield-Birkbeck

NIHR132329: Improving Antifungal Stewardship in Haemato-oncology using a Biomarker-guided algorithm Versus Empirical treatment (I-SAVE)

(Dr Samir Agrawal, Barts & The London School of Medicine & Dentistry)

Funding Committee recommendation: Decline

NIHR132674: Biomarker Driven Antifungal Stewardship in AML: The BioDriveAFS Trial

(Dr Gavin Barlow, Hull York Medical School)

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

20/24: Psychological intervention for complex post-traumatic stress disorder

Chair: Professor Catherine Hewitt

Declared a conflict and left the meeting: Dr Ben Ainsworth, Ms Debby Lennard, Professor Andrew Farmer, Professor Jonathan Ross, Professor Marian Knight, Professor Monica Busse, Professor Nefyn Williams, Professor Rebecca Reynolds

Returned to meeting: Chris Sutton

Left meeting: Jeremy Taylor (Observer)

NIHR132705: Does a Phased Approach Enhance Outcomes for Trauma-Focused Cognitive Therapy for Complex Posttraumatic Stress Disorder?

(Professor Anke Ehlers, University of Oxford)

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

NIHR131977: Randomised controlled trial of enhanced skills training in affective and interpersonal regulation coupled with exposure work (ESTAIR) versus trauma focused cognitive behavioural therapy (TFCBT) for complex post-traumatic stress disorder (CPTSD).

(Professor Jonathan Bisson, Cardiff University)

Funding Committee recommendation: Decline

20/23 Diagnostic tools to establish the presence and severity of peripheral arterial disease in people with diabetes

Chair: Professor Marian Knight

Declared a conflict and left the meeting: Mr Roshan Bootun, Professor Chris Rogers, Professor Jane Nixon, Professor Jonathan Ross, Professor Nick Maskell, Professor Rakesh Heer, Professor Rebecca Reynolds

NIHR131855: Diagnostic tools to establish the presence and severity of peripheral arterial disease in people with diabetes

(Mr Usman Jaffer, Imperial College Healthcare NHS Trust)

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

NIHR132140: Peripheral Arterial Disease in Diabetes Mellitus: Diagnosis and Assessment of Severity. The PAD DIAGNOSE study.

(Mr Patrick Coughlin, Cambridge University Hospital Trusts)

Funding Committee recommendation: Decline

20/25: Guided self-help for depression in adults with autism spectrum disorders

Chair: Professor Marian Knight

Declared a conflict and left the meeting: Dr Ben Ainsworth, Professor Angela Hassiotis, Professor Chris Rogers, Professor Nick Maskell

Arrived at meeting: Andrew Shennan

NIHR132343: A randomised controlled trial of guided self-help for depression for autistic adults

(Dr Ailsa Russell, University of Bath)

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

20/27 Management of ankle fractures in children

Chair: Professor Chris Rogers

Declared a conflict and left the meeting: Professor Andrew Farmer, Professor Catherine Hewitt, Professor Daniel Perry, Professor Marian Knight, Professor Nefyn Williams

NIHR132675: Outcomes of Displaced Distal tibial fractures - Surgery Or Casts in KidS (ODD SOCKS). A multi-centre prospective randomized superiority trial of conservative versus surgical treatment for displaced distal tibial fractures in children.

(Mr Nicholas Peterson, Alder Hey Children's NHS Foundation Trust)

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

19/128 Administration routes of steroids in the first-line treatment of idiopathic sensorineural hearing loss

Chair: Professor Marian Knight

Declared a conflict and left the meeting: Dr Christopher Sutton, Ms Pollyanna Hardy, Professor Greta Rait, Professor Jonathan Ross, Professor Rakesh Heer

Left meeting: Monica Busse-Morris

NIHR131528: Administration routes of steroids in the first-line treatment of idiopathic sudden sensorineural hearing loss

(Mr James Tysome, Cambridge University Hospitals NHS Foundation Trust)

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

NIHR131660: Steroids as a first-line treatment for idiopathic Sudden Sensorineural HEaring Loss – a randomised controlled double-blinded trial comparing routes of administration: the SeaSHeL trial

(Professor Anne Schilder, UCL Ear Institute)

Funding Committee recommendation: Decline

20/98 SIMS Trial Follow up call

Chair: Professor Catherine Hewitt

Declared a conflict and left the meeting: Professor Jonathan Ross, Professor Marian Knight, Professor Rebecca Reynolds

left meeting: Stephanie Garfield-Birbeck

NIHR133092: Long-Term Outcomes Of Synthetic Mid-Urethral Slings (Mesh Tapes) In Surgical Treatment Of Stress Urinary Incontinence In Women – A Long-term Follow-Up Of The SIMS RCT.

(Professor Mohamed Abdel-Fattah, University of Aberdeen)

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

   

Date     

Wednesday 20 January 2021 (Day 2)

Place    

Microsoft Teams

Present members

Professor Marian Knight (Chair)

Professor Andrew Farmer (Programme Director)

Professor Catherine Hewitt (Deputy Chair)

Dr Ben Ainsworth

Mr Roshan Bootun

Professor Monica Busse

Mr Paul Charlton (Public Member)

Dr Emilio Fernandez-Egea

Professor Richard Grieve

Dr Pollyanna Hardy

Professor Angela Hassiotis

Mr Rakesh Heer

Ms Debby Lennard (Public Member)

Professor Nick Maskell

Professor Jane Nixon

Professor Daniel Perry

Professor Rebecca Reynolds

Professor Chris Rogers

Professor Jonathan Ross

Professor Andrew Shennan

Professor Sobha Sivaprasad

Dr Beth Stuart

Dr Chris Sutton

Associate Professor Lyvonne Tume

Professor Nefyn Williams

 

NETSCC, HTA Secretariat

Dr Jason Horsley (Consultant Advisor)

Steph Garfield-Birkbeck (Head of the HTA Programme)

Karen Williams (Senior Research Manager)

Kathy Tier (Research Manager)

Connie Temple-Brown (Assistant Research Manager)

Louisa Saunders (Assistant Research Manager)

Apologies           

Professor Joy Adamson

Professor Saul Faust

Professor Pip Logan

Associate Professor Antonieta Medina-Lara

Dr Greta Rait

Observers          

Professor Rupert Pearse (Deputy Chair, General Funding Committee) morning only

Quoracy Information     

Voting members: 28 Quorum = 19

Voting members present on Day 2: 23 (82%)

 

Commissioned Stage 2 applications shortlisted at September 2020 Committee meeting continued

20/21 Subcutaneous vs oral methotrexate for rheumatoid arthritis

Chair: Professor Catherine Hewitt

Declared a conflict and left the meeting: Dr Christopher Sutton, Professor Jonathan Ross

Arrived at meeting: Rupert Pearse (observer)

Left Meeting: Dan Perry, Steph Garfield-Birkbeck

NIHR132711: Multi-centre randomised open-label assessor-blinded two arm parallel group trial of subcutaneous versus oral methotrexate for rheumatoid arthritis (RA), with feasibility assessment, economic evaluation and qualitative study.

Short-title: Methotrexate Oral Or SubcutanEous for RA [The MOOSE study].

(Professor Abhishek Abhishek, University of Nottingham)

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

NIHR132072: COmparison of Subcutaneous Methotrexate compared with oral methotrexate treatment strategy In patients with early rheumatoid arthritis, aiming for remission: an open label Clinical trial. The COSMIC trial.

(Dr Suzanne Verstappen, The University of Manchester)

Funding Committee recommendation: Decline

Commissioning Stage 1 applications – received from November call close

20/96 Partial vs radical nephrectomy for clinically localised renal cell carcinoma

Chair: Professor Marian Knight

Declared a conflict and left the meeting: Professor Nick Maskell, Professor Rakesh Heer

Arrived at meeting: Dan Perry,

NIHR133322: A multi-centre, open-label, pragmatic cohort embedded randomized controlled, parallel-group, non-inferiority phase III trial to compare the efficacy of PaRtial versus tOtal nePhrectomy for clinically localisEd moderately complex renal cancer, incorporating a 1 year internal pilot (PROPER) trial

(Associate Professor Maxine Tran, University College London)

Funding Committee recommendation: Shortlist

NIHR133561: The PARTIAL study – a randomised trial of clinical and cost effectiveness of PARTIAL vs total nephrectomy for clinically localised renal cell carcinoma

(Professor Naeem Soomro, The Newcastle Upon Tyne Hospitals NHS Foundation Trust)

Funding Committee recommendation: Shortlist

20/73 Surgery for endometrioma in women undergoing IVF

Chair: Professor Catherine Hewitt

Declared a conflict and left the meeting: Dr Christopher Sutton, Ms Pollyanna Hardy, Professor Greta Rait, Professor Jonathan Ross, Professor Rakesh Heer, Professor Rebecca Reynolds

Arrived at meeting: Steph Garfield-Birkbeck

NIHR133621: Surgery for endometrioma in women undergoing IVF

(Professor Abha Maheshwari, NHS Grampian)

Funding Committee recommendation: Shortlist

20/22 Rectus Sheath Blockade in Emergency Laparotomy

Chair: Professor Marian Knight

Declared a conflict and left the meeting: Dr Christopher Sutton, Ms Debby Lennard, Ms Pollyanna Hardy, Professor Andrew Farmer, Professor Chris Rogers, Professor Daniel Perry, Professor Jane Nixon, Professor Jonathan Ross, Professor Nefyn Williams, Professor Nick Maskell, Professor Rebecca Reynolds

NIHR132347: Rectus Sheath Catheters as post-operative analgesia in patients undergoing emergency laparotomy (RESECT trial)

(Miss Kiran Altaf, Liverpool University Hospitals Foundation Trust)

Funding Committee recommendation: Decline

NIHR133554: CAMELOT - Continuous rectus sheath Analgesia in eMErgency LaparOTomy Multi-centre, randomised sham-controlled trial of rectus sheath catheter-delivered local anaesthetic infusion compared with usual care in patients undergoing emergency bowel surgery

(Dr Mark Edwards, University Hospital Southampton NHS Foundation Trust)

Funding Committee recommendation: Shortlist

NIHR133625: RELAY Trial (Rectus sheath catheters in Emergency LAparotomY).

A multicentre, open label, pragmatic, two arm, parallel group, randomised controlled trial with an internal pilot and economic evaluation.

(Dr Ciro Morgese, University Hospitals Birmingham NHS Foundation Trust)

Funding Committee recommendation: Shortlist

NIHR133637: A randomised trial of rectus sheath blockade in emergency midline laparotomy

(Mr Hugh Paterson, The University of Edinburgh)

Funding Committee recommendation: Decline

NIHR133646: A prospective, multicentre, double blind, randomised controlled trial in emergency LAparotomy looking at Patient Reported Outcome measures following Rectus sheath BLOCKade (LAPROBLOCK)

(Dr Shiva Tripathi, Lancashire Teaching Hospitals NHS Foundation Trust)

Funding Committee recommendation: Decline

20/75 Conservative management of primary spontaneous pneumothorax

Chair: Professor Catherine Hewitt

Declared a conflict and left the meeting: Professor Andrew Farmer, Professor Chris Rogers, Professor Marian Knight, Professor Nick Maskell

NIHR133653: “CONservative versus Standard carE for primary spontaneous PneumoThorax” (CONSEPT)

(Professor Nick Maskell, University of Bristol)

Funding Committee recommendation: Shortlist

20/72 Oxybutynin for the treatment of vasomotor symptoms associated with menopause

Chair: Professor Catherine Hewitt

Declared a conflict and left the meeting: Dr Christopher Sutton, Ms Pollyanna Hardy, Professor Jonathan Ross, Professor Marian Knight

NIHR133638: Can Oxybutynin or alternative drugs lessen menOpausal hot fLushes: the COOL trial

(Professor T Justin Clark, Birmingham Women's NHS Foundation Trust)

Funding Committee recommendation: Decline

NIHR133461: Oxybutynin or antidepressants for hot flushes in women who cannot or choose not to use hormone replacement therapy: randomised trial and economic evaluation (the BLUSH trial)

(Dr Melanie Davies, University College London Hospitals NHS Foundation Trust)

Funding Committee recommendation: Shortlist

20/74 Antidepressants for post-stroke emotionalism

Chair: Professor Catherine Hewitt

Declared a conflict and left the meeting: Dr Christopher Sutton, Ms Debby Lennard, Professor Jane Nixon, Professor Rebecca Reynolds

Left meeting: Angela Hassiotis

NIHR133015: A multi-centre, international, randomised, double-blind, placebo-controlled trial to establish the effect(s) of administration of sertraline (50 mg once daily) in people with a recent stroke and post-stroke emotionalism

(Professor Niall Broomfield, Norwich Medical School, University of East Anglia)

Funding Committee recommendation: Shortlist

20/76 Reverse vs conventional shoulder replacement for adults with osteoarthritis

Chair: Professor Marian Knight

Declared a conflict and left the meeting: Dr Christopher Sutton, Professor Andrew Farmer, Professor Catherine Hewitt, Professor Daniel Perry, Professor Jonathan Ross

NIHR133337: Conventional versus reverse total shoulder arthroplasty trial (ConVeRTS)

(Associate Professor David Ellard, University of Warwick)

Funding Committee recommendation: Shortlist

NIHR133418: Reverse or Anatomical (replacement) for Painful Shoulder Osteoarthritis: Differences between Interventions. Acronym; RAPSODI

(Professor Ian Trail, Wrightington, Wigan & Leigh NHS Foundation Trust)

Funding Committee recommendation: Shortlist

NIHR133608: The ROTATOR Trial - Reverse Or Total AnaTomic for Osteoarthritis with intact Rotator cuff

(Mr Christopher Smith, Royal Devon and Exeter NHS Foundation Trust)

Funding Committee recommendation: Decline