Meeting
NIHR HTA Funding Committee Commissioning September 2022
Day 1 – Tuesday 13th September 2022
Venue
- Virtual via Microsoft Teams
Present Members
- Rupert Pearse (Chair)
- Catherine Hewitt (Deputy Chair)
- Andrew Farmer (Programme Director)
- Amanda Adler
- Mike Bradburn
- Monica Busse
- Paul Charlton (Public Committee Member)
- Laurentiu Craciunas (Committee Member Development Scheme Participant)
- Rui Duarte
- Saul Faust
- Emilio Fernandez-Egea
- David Gillespie
- Pollyanna Hardy
- Angela Hassiotis
- Trevor Jones (Public Committee Member)
- Easter Joury (Committee Member Development Scheme Participant)
- Antonieta Medina-Lara
- Jane Nixon
- Ben Ollivere
- Rebecca Reynolds
- Pedro Saramago Goncalves
- Beth Stuart
- Christopher Sutton
- Lyvonne Tume
- Galina Velikova
- Nefyn Williams
Secretariat
- Jason Horsley (Consultant Advisor)
- Steph Garfield-Beck (Head of the HTA Programme
- Karen Williams (Senior Research Manager)
- Kathy Tier (Research Manager)
- Hebe Sims (Assistant Research Manager)
- Maria Oosterwijk (Administrator)
Apologies
- Nathan Davies
- Andrew Shennan
- Nick Maskell until 1pm
- Greta Rait until 10am
Observers
- Sian Lloyd-Jones
- Liz Hunter
- Emma Small
- Mike Batley - afternoon
- Mark Peters Deputy
Quoracy Information
- Voting members: 28 (Quoracy = 18)
- Voting members present on Day 1: 24 (86 %)
Stage 2 Applications
21/589 Coenzyme Q10 in chronic heart failure
Chair: Rupert Pearse
Conflicts: Beth Stuart, Antonieta Medina-Lara, Nick Maskell, Rui Duarte, Pollyanna Hardy
Arrived: Steph Garfield-Birkbeck
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: Programme Oversight Committee to consider fund with changes
NIHR152716 - Does Ubiquinone Alleviate Heart Failure? The DUAL-HF Study (Richard Steeds)
Decision: Decline
21/578 Antidepressants for post-stroke emotionalism
Chair: Andrew Farmer
Conflicts: Christopher Sutton, Mike Bradburn, Rebecca Reynolds, Nathan Davies, Angela Hassiotis, Antonieta Medina-Lara, Galina Velikova, Greta Rait, 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: Programme Oversight Committee to consider fund with changes
21/580 Maintenance treatment for bipolar disorder
Chair: Andrew Farmer
Conflicts: Christopher Sutton, Pollyanna Hardy, Trevor Jones
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: Decline Return to POC
21/584 Point of care Doppler ultrasound prior to emergency scrotal exploration
Chair: Andrew Farmer
Conflicts: Rupert Pearse, Nathan Davies, Rui Duarte, Pollyanna Hardy, Beth Stuart, Saul Faust, Greta Rait
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: Invite resubmission.
21/582 Point of care ultrasound for breech presentation at term
Chair: Catherine Hewitt
Conflicts: Pollyanna Hardy, Rebecca Reynolds, Monica Busse, David Gillespie, Lyvonne Tume, Andrew Farmer, Mike Bradburn, Greta Rait
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 longitudinal and economic analyses and an implementation evaluation (Kate Walker)
Decision: Decline
NIHR152029 - Diagnostic accuracy of handheld ultrasound at 36 weeks of gestation to determine fetal presentation (Christoph Lees)
Decision: Programme Oversight Committee to consider fund with changes
21/583 Patient reported outcome measures (PROMs) for pelvic floor disorders
Chair: Catherine Hewitt
Conflicts: Andrew Farmer, Galina Velikova, Mike Bradburn, Antonieta Medina-Lara, Christopher Sutton
Left the meeting: Steph Garfield-Birkbeck and Amanda Adler left the meeting
NIHR152187 - A Patient-reported outcome measure for PRolApse, Incontinence and meSh complication surgEry: The APPRAISE study (Georgina Jones)
Decision: Programme Oversight Committee to consider fund with changes
NIHR152285 - Co-creation and validation of a women-centred Patient Reported Outcome Measure and preference-based index specific to surgery for prolapse and incontinence (INStrument for Prolapse and Incontinence outcomes impoRtant to womEn: INSPIRE) (Suzanne Hagen)
Decision: Decline
21/586 Management of Perthes’ disease in children
Chair: Catherine Hewitt
Conflicts: Galina Velikova, Andrew Farmer, Jane Nixon, Saul Faust, Nick Maskell, Nefyn Williams
Arrived: Amanda Adler re-joined the meeting.
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: Programme Oversight Committee to consider fund with changes
21/588 Timing of pharmacological thromboprophylaxis in traumatic brain injury
Chair: Catherine Hewitt
Conflicts: Mike Bradburn, Andrew Farmer, Pollyanna Hardy, Galina Velikova
NIHR152722 - Timing Of venous thromboembolism Prophylaxis for adult patients with Traumatic Brain Injury (TOP-TBl): a pragmatic, randomised trial (Angelos Kolias)
Decision: Programme Oversight Committee to consider fund with changes
21/581 Colpocleisis for the treatment of pelvic organ prolapse in women
Chair: Andrew Farmer
Conflicts: Pollyanna Hardy
NIHR151938 - Exploring the feasibility and acceptability of conducting a study comparing the effectiveness of colpocleisis with sacrospinous fixation in women with pelvic organ prolapse (the C-POP study) (Laura Jones)
Decision: Programme Oversight Committee to consider fund with changes
NIHR152485 - COlpocleisis versus saCrospinous fixAtion for suRgical treatment of prolapsE in women – a mixed methods feasibility study (The CO-CARE Study) (Sara Maclennan)
Decision: Decline
21/590 Thromboprophylaxis following endovenous treatment for people with varicose veins
Chair: Andrew Farmer
Conflicts: Mike Bradburn, Rebecca Reynolds
NIHR152877 - THRomboprophylaxis in Individuals undergoing superficial endoVEnous treatment (THRIVE) – a multi-centre assessor-blind randomised-controlled trial (Alun Davies)
Decision: Shortlist Programme Oversight Committee to consider fund with changes
21/591 Surgical treatment of proximal ACL ruptures with ACL repair or ACL reconstruction
Chair: Catherine Hewitt
Conflicts: Ben Ollivere, Christopher Sutton, Andrew Farmer, Pollyanna Hardy, Rebecca Reynolds, Greta Rait, Amanda Adler
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: Decline Return to POC
NIHR152855 - Anterior Cruciate Ligament Reconstruction Or Repair (AURORA) (Mark Blyth)
Decision: Decline Return to POC
21/587 Should we prescribe postoperative antibiotics to patients with facial fracture?
Chair: Rupert Pearse
Conflicts: Christopher Sutton, Catherine Hewitt, Andrew Farmer, Antonieta Medina-Lara, Nefyn Williams
Left the meeting: Ben Ollivere left the meeting
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: Programme Oversight Committee to consider fund with changes
Day 2 – Wednesday 14th September 2022
Venue
- Virtual via Microsoft Teams
Present Members
- Rupert Pearse (Chair)
- Catherine Hewitt (Deputy Chair)
- Andrew Farmer (Programme Director)
- Amanda Adler
- Mike Bradburn
- Monica Busse
- Paul Charlton (Public Committee Member)
- Laurentiu Craciunas (Committee Member Development Scheme Participant)
- Rui Duarte
- Saul Faust
- Emilio Fernandez-Egea
- David Gillespie
- Pollyanna Hardy
- Angela Hassiotis
- Trevor Jones (Public Committee Member)
- Easter Joury (Committee Member Development Scheme Participant)
- Antonieta Medina-Lara
- Ben Ollivere
- Rebecca Reynolds
- Pedro Saramago Goncalves
- Beth Stuart
- Christopher Sutton
- Lyvonne Tume
- Galina Velikova
- Nefyn Williams
Secretariat
- Jason Horsley (Consultant Advisor)
- Steph Garfield-Bikbeck (Head of the HTA Programme
- Karen Williams (Senior Research Manager)
- Kathy Tier (Research Manager)
- Hebe Sims (Assistant Research Manager)
- Maria Oosterwijk (Administrator)
Apologies
- Nathan Davies
- Andrew Shennan
- Jane Nixon
Observers
- Sian Lloyd-Jones
- Liz Hunter
- Emma Small
Quoracy Information
- Voting members: 28 (Quoracy = 18)
- Voting members present on Day 2: 23 (82 %)
Straight to Stage 2 Applications
22/40 NIHR HTA Application development award – Towards evaluation of digital and technology-enabled healthcare
Chair: Rupert Pearse
Conflicts: Christopher Sutton, Antonieta Medina-Lara, Nefyn Williams
NIHR153944 - Acceptability and feasibility of using the Virtual Engagement Rehabilitation Assistant (VERA) for community-based neurological rehabilitation (Kathryn Jarvis)
Decision: Programme Oversight Committee to consider fund with changes
22/40 NIHR HTA Application development award – Towards evaluation of digital and technology-enabled healthcare
Chair: Rupert Pearse
Conflicts: Monica Busse
NIHR154034 - A Phase II pilot feasibility trial of transcutaneous auricular vagus nerve stimulation for people with Myalgic Encephalomyelitis. (Nicola Clague-Baker)
Decision: Decline
22/40 NIHR HTA Application development award – Towards evaluation of digital and technology-enabled healthcare
Chair: Rupert Pearse
Conflicts: None Advised
Arrived: Emma Small joined the meeting
NIHR154056 - Virtual Evaluations of personalised joint health using wearable Sensors in Persons with haemophiliA (VESPA) (David Stephensen)
Decision: Decline
22/40 NIHR HTA Application development award – Towards evaluation of digital and technology-enabled healthcare
Chair: Rupert Pearse
Conflicts: Galina Velikova
NIHR154215 - Transforming management of advanced prostate cancer through digital health: increasing representation of ethnic minorities and developing a collaboration for research scale-up. (Adrian Brown)
Decision: Programme Oversight Committee to consider fund with changes
22/40 NIHR HTA Application development award – Towards evaluation of digital and technology-enabled healthcare
Chair: Rupert Pearse
Conflicts: None Advised
NIHR154303 - Development of a randomised controlled trial with parallel process evaluation of a digital prehabilitation solution in patients undergoing treatment for oesophago-gastric cancer (Krishna Moorthy)
Decision: Decline
22/40 NIHR HTA Application development award – Towards evaluation of digital and technology-enabled healthcare
Chair: Rupert Pearse
Conflicts: None Advised
NIHR154413 - Optimising website resources to improve food-related quality of life in inflammatory bowel disease (Kevin Whelan)
Decision: Decline
22/40 NIHR HTA Application development award – Towards evaluation of digital and technology-enabled healthcare
Chair: Rupert Pearse
Conflicts: Galina Velikova, Beth Stuart
NIHR154473 - Development of a complex intervention to support community-based patients approaching end of life to monitor and manage their symptoms: The Weldmar Connect study (Richard Wagland)
Decision: Decline
Stage 1 Applications
21/535 Follow-up strategy after radical treatment for prostate cancer
Chair: Rupert Pearse
Conflicts: Nathan Davies, Jane Nixon, Beth Stuart, Galina Velikova
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: Shortlist
21/585 Early endovascular repair in type b uncomplicated sub-acute aortic dissection
Chair: Christopher Sutton
Conflicts: Catherine Hewitt, Nick Maskell, Jane Nixon, Galina Velikova, Easter Joury, Rupert Pearse, Amanda Adler, Andrew Farmer, Rui Duarte, Pollyanna Hardy, Paul Charlton, Pedro Saramago Goncalves
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: Shortlist
NIHR152246 - Dissection of the Aorta Medical thErapy or Stent-graft (DAMES Trial) (Robert Hinchliffe)
Decision: Decline
NIHR152396 - Management of uncomplicated Type B Aortic Dissection (MONACO on SUNDAY Trial) (Maciej Juszczak)
Decision: Decline
22/32 Biologic disease-modifying anti-rheumatic drugs in pregnancy
Chair: Catherine Hewitt
Conflicts: Laurentiu Craciunas, Rebecca Reynolds, Andrew Farmer, Christopher Sutton, Amanda Adler, Rupert Pearse, Pollyanna Hardy, Angela Hassiotis, Andrew Shennan, Galina Velikova, Greta Rait
Left the meeting: Lyvonne Tume and Monica Busse left the meeting
NIHR153577 - The Monoclonal Antibody Medications in inflammatory Arthritis: stopping or continuing in pregnancy (MAMA) trial (Marian Knight)
Decision: Shortlist
NIHR154385 - Investigating the benefits and harms of continuing biologic disease-modifying anti-rheumatic drugs (bDMARDs) compared with withdrawing bDMARDs in pregnant women with rheumatoid & other inflammatory arthritis? (Ian Giles)
Decision: Shortlist
22/30 Post-operative pain in patients undergoing spinal surgery
Chair: Catherine Hewitt
Conflicts: Mike Bradburn, Rupert Pearse, Nick Maskell, Beth Stuart, Easter Joury, Ben Ollivere, Saul Faust, Pollyanna Hardy, Rui Duarte, Antonieta Medina-Lara, Rebecca Reynolds, Christopher Sutton
Arrived: Lyvonne Tume has re-joined the meeting
NIHR152886 - Erector Spinae Plane blockade or INtrathecAL opioids for analgesia following spinal surgery (SPINAL). (David Hewson)
Decision: Shortlist
NIHR153170 - Pain Relief After Instrumented Spinal surgEry trial (PRAISE Trial) (Matthew Wilson)
Decision: Shortlist
NIHR153768 - Post-operative pain in patients undergoing spinal surgery (STOP trial) (Vikki Wylde)
Decision: Decline
NIHR154720 - POPSS TRIAL: Post Operative Pain after Spinal Surgery A Pragmatic Randomised Control Three-arm trial evaluating the clinical and cost-effectiveness of Erector spinae block(ESP) and intrathecal diamorphine compared to Usual Care in patients after major spinal surgery. (Tonny Veenith)
Decision: Decline
22/31 Glucagon-like peptide-1 receptor agonist therapy for people with severe mental illness living with overweight or obesity
Chair: Rupert Pearse
Conflicts: Andrew Farmer, Nathan Davies, Laurentiu Craciunas, Emilio Fernandez-Egea, Mike Bradburn, Angela Hassiotis, Greta Rait, Catherine Hewitt, Rui Duarte, Rebecca Reynolds, Beth Stuart, Christopher Sutton, Nefyn Williams, Saul Faust, Pedro Saramago Goncalves
NIHR153463 - SEmaglutide for the management of weight In Severe Mental Illness Conditions: SEISMIC randomised controlled trial (Artemis Igoumenou)
Decision: Shortlist
NIHR154249 - The effectiveness and cost-effectiveness of Semaglutide in people with severe Mental ILlnEss living with overweight or obesity (SMILE) (Fiona Gaughran)
Decision: Shortlist
NIHR154500 - A Feasibility Study of the Role of Semaglutide in Over-weight People with Schizophrenia: The Road Back to Better Physical Health (Adrian Heald)
Decision: Decline
NIHR154629 - Offering Pragmatic and Effective Novel weight management – Semaglutide Evaluation in Severe Antipsychotic treated MEntal illness (OPEN SESAME): A double-bind, randomised placebo-controlled trial evaluating a pragmatic semaglutide-based treatment pathway in severe mental illness (David Webb)
Decision: Decline
22/33 Botulinum toxin in the management of chronic masticatory myofascial pain
Chair: Rupert Pearse
Conflicts: Rui Duarte, Nefyn Williams, Andrew Farmer, David Gillespie, Pollyanna Hardy, Catherine Hewitt, Jane Nixon, Galina Velikova
NIHR153871 - Should we use Botulinum toxin-A for the management of chronic masticatory myofascial pain? The BoMP Trial (Botulinum toxin for Myofascial Pain Trial) (Aomesh Bhatt)
Decision: Decline
NIHR153888 - Managing persistent Myalgia Temporomandibular Disorder (M-TMD): a pragmatic randomised controlled trial of Botulinum toxin, Lignocaine, and Amitriptyline/Gabapentin, with internal pilot and cost-effectiveness analysis (MiTiGate trial) (Justin Durham)
Decision: Shortlist
22/34 Surgical and non-surgical management of basal thumb osteoarthritis
Chair: David Gillespie
Conflicts: Catherine Hewitt, Beth Stuart, Christopher Sutton, Mike Bradburn, Amanda Adler, Andrew Farmer, Rupert Pearse, Ben Ollivere, Galina Velikova, Pedro Saramago Goncalves
NIHR153210 - Short Title Base of thumb arthritis: Therapies, Excision or Replacement? (BETTER) (Sumedh Talwalkar)
Decision: Shortlist
NIHR154178 - The TOTEM Study: a comparison of the clinical and cost effectiveness of two management strategies (surgery versus rehabilitation) for the management of thumb base osteoarthritis (Matthew Gardiner)
Decision: Decline
NIHR154694 - Surgery versus Conservative OsteOarthritis of Thumb Trial (SCOOTT) (Emma Reay)
Decision: Shortlist
22/35 Thromboprophylaxis in lower limb immobilisation
Chair: Catherine Hewitt
Conflicts: Rupert Pearse, Beth Stuart, Mike Bradburn, Andrew Farmer, Easter Joury, Saul Faust, Greta Rait
NIHR154716 - Thromboprophylaxis in Lower Limb Immobilisation (TiLLI): a study comprising two linked randomised controlled trials evaluating the effectiveness and cost effectiveness of different methods of pharmacological prophylaxis for patients with temporary lower limb immobilisation (Daniel Horner)
Decision: Shortlist
22/27 Antipsychotics for the treatment of borderline personality disorder
Chair: Rupert Pearse
Conflicts: Rui Duarte, Nefyn Williams, Pollyanna Hardy, Angela Hassiotis
Left the meeting: Antonieta Medina-Lara left the meeting
NIHR152880 - Full Title - The clinical and cost effectiveness of quetiapine for people with borderline personality disorder: A pragmatic, double-blind, placebo-controlled, randomised trial with an open label follow-up. Short Title - Quetiapine Effectiveness Study in Borderline Personality Disorder (QUEST). (Inti Qurashi)
Decision: Shortlist