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HTA Funding Committee Public Minutes 18-19 May 2022

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Published: 21 July 2022

Version: 1

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Meeting

NIHR HTA Funding Committee Commissioning May 2022

Day 1 – Tuesday 17th May 2022

Venue

Danubius Hotel, Regents Park, London

Present Members

  • Catherine Hewitt (Deputy Chair)
  • Andrew Farmer (HTA Programme Director and Chair)
  • Amanda Adler
  • Monica Busse
  • Mike Bradburn
  • Paul Charlton (Public Committee Member)
  • Laurentiu Craciunas (Committee Member Development Scheme Participant)
  • Nathan Davies
  • Saul Faust
  • Emilio Fernandez-Egea
  • David Gillespie
  • Pollyanna Hardy
  • Angela Hassiotis
  • Trevor Jones (Public Committee Member)
  • Easter Joury (Committee Member Development Scheme Participant)
  • Ben Ollivere
  • Rebecca Reynolds
  • Andrew Shennan
  • Beth Stuart
  • Christopher Sutton
  • Lyvonne Tume
  • Galina Velikova
  • Nefyn Williams

Secretariat

  • Jason Horsley (Consultant Advisor)
  • Karen Williams (Senior Research Manager)
  • Kathy Tier (Research Manager)
  • Louisa Saunders (Assistant Research Manager)

Apologies

  • Rui Duarte
  • Debby Lennard
  • Nick Maskell
  • Antonieta Medina-Lara
  • Jane Nixon
  • Greta Rait

Quoracy Information

Voting members: 25 (Quoracy 66% = 17)
Voting members present on Day 1: 20 (80 %)

Stage 2 Applications

21/542 Medication to manage sexual preoccupation in sex offenders

Chair: Andrew Farmer
Conflicts: Catherine Hewitt, Monica Busse, Laurentiu Craciunas, Nathan Davies, Angela Hassiotis, Nefyn Williams

NIHR150371 - Randomised Controlled Trial on Effectiveness of Medication to Manage Sexual Preoccupation in Adult Prisoners Convicted of Sexual Offences (TEMMPASO)(Artemis Igoumenou)
Decision: Decline

NIHR151549 - Randomised Control Trial of fluoxetine for the treatment of problematic sexual arousal in adult males serving a custodial sentence for a sexual offence. (Belinda Winder)
Decision: Programme Oversight Committee to consider fund with changes

21/536 Sodium bicarbonate in neonatal care

Chair: Catherine Hewitt
Conflicts: Andrew Farmer, Pollyanna Hardy, Andrew Shennan, Lyvonne Tume, Mike Bradburn, David Gillespie, Saul Faust

NIHR151000 - NEOMAC – NEOnatal Metabolic ACidosis trial: The clinical effectiveness and safety of intravenous sodium bicarbonate in critically ill babies with metabolic acidosis: a pragmatic randomised controlled multicentre trial. (Mark Johnson)
Decision: Decline

NIHR151086 - Bicarbonate for AcidosiS in very pretErm babies: a randomised clinical trial: The BASE Trial (Sabita Uthaya)
Decision: Programme Oversight Committee to consider fund with changes

21/538 Benefits and harms of reduced dose oral isotretinoin in the management of acne vulgaris

Chair: Catherine Hewitt
Conflicts: Andrew Farmer, Trevor Jones, Ben Ollivere, Beth Stuart
Arrived at the meeting: Rebecca Reynolds

NIHR151318 - Investigating the benefits and harms of reduced daily dose oral isotretinoin in the treatment of acne: A parallel group, assessor blind, non-inferiority, multicentre randomised controlled trial, with an internal pilot (Acne-ID) (Esther Burden-Teh)
Decision: Programme Oversight Committee to consider fund with changes

21/537 Neuroendoscopic lavage for preterm babies with post-haemorrhagic ventricular dilatation

Chair: Catherine Hewitt
Conflicts: Pollyanna Hardy, Nathan Davies, Lyvonne Tume
Left the meeting: Nefyn Williams

NIHR151288 - Developmental Optimisation using Lavage in Preterm intraventricular Haemorrhage in Neonates (DOLPHIN-UK). (Kristian Aquilina)
Decision: Programme Oversight Committee to consider fund with changes

21/535 Follow-up strategy after radical treatment for prostate cancer

Chair: Andrew Farmer
Conflicts: Beth Stuart, Galina Velikova, Mike Bradburn, Saul Faust
Re-joined the meeting: Nefyn Williams

NIHR150376 - The FOLLOW UP study - a natural experiment comparing the clinical and cost-effectiveness of follow-up strategies after radical treatment for prostate cancer. (Rakesh Heer)
Decision: Resubmission at Stage 1

21/532 Intensive Interaction for children and young people with profound and multiple learning disabilities

Chair: Andrew Shennan
Conflicts: Andrew Farmer, Catherine Hewitt, Monica Busse, David Gillespie, Angela Hassiotis, Ben Ollivere, Beth Stuart, Christopher Sutton, Pollyanna Hardy

NIHR151154 - A cluster Randomised Controlled Trial of Intensive Interaction plus standard practice vs standard practice alone for children with PMLD: Communication Skills Intensive Interaction trial (CoSii) (Rachel McNamara)
Decision: Decline

NIHR151428 - Intensive Interaction for children and young people with profound and multiple learning disabilities: INTERACT trial (Jill Bradshaw)
Decision: Programme Oversight Committee to consider fund with changes

21/540 Pharmacological treatments for low back pain or sciatica

Chair: Catherine Hewitt
Conflict: Pollyanna Hardy

NIHR151008 - The Medal Trial - MEDications in Acute Low back pain (Adrian Gardner)
Decision: Programme Oversight Committee to consider fund with changes

Stage 1 applications

21/578 Antidepressants for post-stroke emotionalism

Chair: Andrew Farmer
Conflicts: Nathan Davies, Rebecca Reynolds, Christopher Sutton, Galina Velikova, Nefyn Williams

NIHR152423 - EASE: Evaluating Antidepressants for emotionaliSm after strokE: A multi-centre, randomised, double-blind, placebo-controlled trial to establish the effect(s) of administration of sertraline (50 mg once daily for Six Months) in people with a recent stroke and post-stroke emotionalism (Niall Broomfield)
Decision: Shortlist

21/580 Maintenance treatment for bipolar disorder

Chair: Andrew Farmer
Conflicts: Pollyanna Hardy, Trevor Jones, Christopher Sutton

NIHR151990 - The effectiveness of Lithium plus Quetiapine COMBination versus LithIum versus QuetiapiNe monothErapy in the maintenance treatment of bipolaR disorder: the COMBINER trial. (Steven Marwaha)
Decision: Shortlist

21/584 Point of care Doppler ultrasound prior to emergency scrotal exploration

Chair: Andrew Farmer
Conflicts: Nathan Davies, Pollyanna Hardy, Beth Stuart, Lyvonne Tume, Saul Faust

NIHR151917 - Rapid Evaluation with SCrotal Ultrasound prior to Exploration (RESCUE). Point of Care Ultrasound in suspected testicular torsion: a diagnostic test accuracy study. (Veeru Kasivisvanathan)
Decision: Shortlist

21/581 Colpocleisis for the treatment of pelvic organ prolapse in women

Chair: Andrew Farmer
Conflicts: Pollyanna Hardy

NIHR151921 - Colpoclesis or Sacrospinous Fixation for management of Pelvic Organ Prolapse (Manjula Annappa)
Decision: Decline

NIHR151938 - Exploring the feasibility and acceptability of conducting a study comparing the effectiveness of colpocleisis with sacrospinous fixation in women over 65 with pelvic organ prolapse (the C-POP study) (Laura Jones)
Decision: Shortlist

NIHR152485 - COlpocleisis versus saCrospinous fixAtion for suRgical treatment of prolapsE in women – a mixed methods feasibility study (The CO-CARE Study) (Sara Maclennan)
Decision: Shortlist

Day 2 – Wednesday 18th May 2022

Venue

Danubius Hotel, Regents Park, London

Present Members

  • Catherine Hewitt (Deputy Chair)
  • Andrew Farmer (HTA Programme Director)
  • Amanda Adler
  • Monica Busse
  • Mike Bradburn
  • Paul Charlton (Public Committee Member)
  • Laurentiu Craciunas (Committee Member Development Scheme Participant)
  • Nathan Davies
  • Saul Faust
  • Emilio Fernandez-Egea
  • David Gillespie
  • Pollyanna Hardy
  • Angela Hassiotis
  • Trevor Jones (Public Committee Member)
  • Easter Joury (Committee Member Development Scheme Participant)
  • Ben Ollivere
  • Rebecca Reynolds
  • Andrew Shennan
  • Beth Stuart
  • Christopher Sutton
  • Lyvonne Tume
  • Galina Velikova
  • Nefyn Williams

Secretariat

  • Jason Horsley (Consultant Advisor)
  • Karen Williams (Senior Research Manager)
  • Kathy Tier (Research Manager)
  • Louisa Saunders (Assistant Research Manager)

Apologies

  • Rui Duarte
  • Debby Lennard
  • Nick Maskell
  • Antonieta Medina-Lara
  • Jane Nixon
  • Greta Rait

Quoracy Information

Voting members: 25 (Quoracy 66% = 17)
Voting members present on Day 2: 20 (80 %)

21/582 Point of care ultrasound for breech presentation at term

Chair: Catherine Hewitt
Conflicts: Monica Busse, Nathan Davies, Andrew Farmer, David Gillespie, Pollyanna Hardy, Rebecca Reynolds, Andrew Shennan, Mike Bradburn, Saul Faust

NIHR151733 - Breech ultrasound detection study (BUDS): A multicentre diagnostic test accuracy study of point of care ultrasound to detect breech presentation at term with alongside qualitative and economic studies (Kate Walker)
Decision: Shortlist

NIHR152029 - Diagnostic accuracy of handheld ultrasound at 36 weeks of gestation to determine fetal presentation (Christoph Lees)
Decision: Shortlist

NIHR152272 - Point of care ultrasound: Can it be used by midwives to accurately predict breech babies during pregnancy? (Natasha Singh)
Decision: Decline

NIHR152671 - DEcreasing TErm Non Cephalic Presentation through Training in handheld point of care UltraSound (POC-US): A cluster randomised clinical trial with embedded diagnostic accuracy study (DETECT-US) (Sara Hillman)
Decision: Decline

21/583 Patient reported outcome measures (PROMs) for pelvic floor disorders

Chair: Catherine Hewitt
Conflicts: Laurentiu Craciunas, Andrew Farmer, David Gillespie, Rebecca Reynolds, Christopher Sutton, Galina Velikova, Mike Bradburn

NIHR152187 - A Patient-reported outcome measure for PRolApse, Incontinence and meSh complication surgEry: The APPRAISE study (Georgina Jones)
Decision: Shortlist

NIHR152285 - Co-creation and validation of a women-centred Patient Reported Outcome Measure specific to surgery for prolapse and incontinence ( INStrument for Prolapse and Incontinence outcomes impoRtant to womEn: INSPIRE) (Suzanne Hagen)
Decision: Shortlist

NIHR152816 - Patient reported outcome measures (PROMs) for pelvic floor disorders : Development of the International Consultation on Incontinence Questionnaire (ICIQ) Pelvic Floor Screener (Christopher Harding)
Decision: Decline

21/585 Early endovascular repair in type b uncomplicated sub-acute aortic dissection

Chair: Christopher Sutton
Conflicts: Andrew Farmer, Catherine Hewitt, Pollyanna Hardy, Galina Velikova, Paul Charlton, Amanda Adler

NIHR151696 - Early Aortic Repair in patients Needing Endovascular/open Surgery for Type B Aortic Dissection (EARNEST): A randomised trial to assess the clinical and cost-effectiveness of thoracic endovascular aortic repair in the subacute phase after uncomplicated type B aortic dissection. (Colin Bicknell)
Decision: Resubmission

NIHR152246 - Dissection of the Aorta Medical thErapy or Stent-graft (DAMES Trial) (Robert Hinchliffe)
Decision: Resubmission

NIHR152396 - Management of uncomplicated Type B Aortic Dissection (MONACO on SUNDAY Trial) (Maciej Juszczak) 
Decision: Resubmission

21/586 Management of Perthes’ disease in children

Chair: Catherine Hewitt
Conflicts: Andrew Farmer, Ben Ollivere, Nefyn Williams, Galina Velikova

NIHR152309 - Op or Non-STOP Study (Operative or Non-Surgical Treatment of Perthes' Disease) - A multi-centre prospective randomised superiority trial of containment surgery compared to best conservative treatment for Perthes’ disease of the hip in children. (Daniel Perry)
Decision: Shortlist

21/587 Should we prescribe postoperative antibiotics to patients with facial fracture?

Chair: Andrew Shennan
Conflicts: Catherine Hewitt, Nathan Davies, Andrew Farmer, Beth Stuart, Christopher Sutton, Nefyn Williams

NIHR152682 - Should we use post-operative antibiotics following surgery for patients with mandible fractures? The MANTRA trial (MANdibular TRauma and Antibiotic use) (Panayiotis Kyzas)
Decision: Shortlist

NIHR152870 - A nationwide prospective randomised study evaluating whether a five day course of antibiotics after surgery to repair mandibular fractures reduces the risk of post-operative infection Short Title Should we prescribe postoperative antibiotics to patients with mandibular fractures? (SAM)(Simon Holmes)
Decision: Decline

21/588 Timing of pharmacological thromboprophylaxis in traumatic brain injury

Chair: Catherine Hewitt
Conflicts: Andrew Farmer, Pollyanna Hardy, Lyvonne Tume

NIHR152722 - Timing Of venous thromboembolism Prophylaxis for adult patients with Traumatic Brain Injury (TOP-TBl): a pragmatic, randomised trial (Angelos Kolias)
Decision: Shortlist

21/589 Coenzyme Q10 in chronic heart failure

Chair: Nefyn Williams
Conflicts: Andrew Farmer, Catherine Hewitt, Pollyanna Hardy, Rebecca Reynolds, Beth Stuart, Galina Velikova, Amanda Adler

NIHR152160 - Co-enzyme Q10 for people with heart failure and a reduced left ventricular ejection fraction (Pierpaolo Pellicori) 
Decision: Decline

NIHR152257 - The effectiveness and cost effectiveness of coenzyme Q10 in heart failure with reduced ejection fraction: a pragmatic, patient-centred, data-enabled trial in primary care (Maria Pufulete)
Decision: Shortlist

NIHR152716 - Does Ubiquinone Alleviate Heart Failure? The DUAL-HF Study (Richard Steeds)
Decision: Shortlist

21/590 Thromboprophylaxis following endovenous treatment for people with varicose veins

Chair: Andrew Farmer
Conflicts: Catherine Hewitt, Rebecca Reynolds

NIHR152877 - THRomboprophylaxis in Individuals undergoing superficial endoVEnous treatment (THRIVE) – a multi-centre assessor-blind randomised-controlled trial (Alun Davies)
Decision: Shortlist

21/591 Surgical treatment of proximal ACL ruptures with ACL repair or ACL reconstruction

Chair: Catherine Hewitt
Conflicts: Andrew Farmer, Pollyanna Hardy, Ben Ollivere, Christopher Sutton, Amanda Adler
Left the meeting: Andrew Shennan

NIHR152103 - 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. (Stephen McDonnell)
Decision: Shortlist

NIHR152846 - STability following ACL Repair compared to Reconstruction (STARR) Trial: A multicentre, randomised controlled trial comparing primary repair augmented with lateral extra-articular tenodesis versus autologous graft reconstruction for acute proximal tears of the anterior cruciate ligament. (Tarek Boutefnouchet)
Decision: Decline

NIHR152855 - Anterior Cruciate Ligament Reconstruction Or Repair (AURORA) (Mark Blyth)
Decision: Shortlist