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Date<br />

Place<br />

Present Members<br />

NETSCC Secretariat<br />

Observers<br />

Apologies<br />

<strong>NIHR</strong> <strong>HTA</strong> <strong>PROGRAMME</strong><br />

<strong>HTA</strong> Surgery Themed Call Board<br />

Minutes of Full Proposal Meeting<br />

Tuesday 12 and Wednesday 13 March 2013<br />

Danubius Hotel Regents Park, London<br />

Professor Steve Goodacre (Chair)<br />

Professor Hywel Williams (Deputy Chair)<br />

Professor Amanda Farrin<br />

Professor Gordon Murray<br />

Professor Simon Dixon<br />

Professor Jane Blazeby<br />

Professor Matthew Costa<br />

Professor Paula Ghaneh<br />

Professor Hisham Mehanna<br />

Professor Thanos Athanasiou<br />

Professor Rod Taylor<br />

Professor Freddie Hamdy<br />

Professor James Mason<br />

Professor Dion Morton<br />

Professor Ceri Phillips<br />

Professor Andrew Bradbury<br />

Professor Sam Eljamel<br />

Ms Lynda Wyld<br />

Professor Ken Stein<br />

Professor John Scholefield<br />

Professor Tom Walley (Director, <strong>HTA</strong> Programme)<br />

Dr Peter Davidson (Director, NETSCC <strong>HTA</strong>)<br />

Dr Nick Hicks (Consultant Advisor)<br />

Dr Sarah Puddicombe (Assistant Director)<br />

Mrs Fay Habens (Programme Manager)<br />

Mrs Andrea Ingram (Assistant Programme Manager)<br />

N/A<br />

Professor John Scholefield (Day 2 Only)<br />

Professor Simon Dixon (Day 2 Only)<br />

Professor Jane Blazeby (Day 2 Only)<br />

<strong>HTA</strong> Surgery Themed Call<br />

1


Discussion of Surgery Full Proposals<br />

<strong>HTA</strong> Surgery Themed Call<br />

Hutchinson (12/35/57): Randomised Evaluation of Surgery with Craniectomy for<br />

patients Undergoing Evacuation of Acute Subdural Haematoma (RESCUE-ASDH)<br />

Professor Goodacre chaired. Professor Morton and Professor Murray left the room.<br />

The board discussed the proposal and wished to see a resubmission.<br />

Goldberg (12/35/27): Total Ankle Replacement Versus Ankle Arthrodesis (TARVA)<br />

trial: A pragmatic, randomised controlled trial to assess clinical and cost<br />

effectiveness, with an internal feasibility phase.<br />

Professor Goodacre chaired.<br />

The board discussed the proposal and recommended it for funding, subject to certain<br />

conditions.<br />

Theologis (12/35/36): A Pragmatic Randomised Controlled Multi-Centre Trial of<br />

Minimally-Invasive versus Conventional Multi-level Surgery in Children with Cerebral<br />

Palsy<br />

Professor Goodacre chaired. Professor Hamdy left the room<br />

The board discussed the proposal and declined it.<br />

Young (12/35/01): Scaldcare: Does surgical management using biosynthetic skin<br />

substitutes for small scalds in young children decrease the rate of skin grafting<br />

compared to traditional non-surgical treatment and is it cost effective?<br />

Dr Davidson chaired. Professor Goodacre, Professor Williams, Professor Scholefield,<br />

Professor Blazeby, Professor Morton, Professor Mehanna and Ms Wyld left the room.<br />

The board discussed the proposal and declined it.<br />

Goyal (12/35/17): POSNOC - POsitive Sentinel NOde: adjuvant therapy alone versus<br />

adjuvant therapy plus Clearance or axillary radiotherapy: A randomised controlled<br />

trial of axillary treatment in women with early stage breast cancer who have<br />

metastases in one or two sentinel nodes.<br />

Dr Davidson chaired. Professor Williams, Professor Scholefield and Ms Wyld left the room.<br />

The board discussed the proposal and recommended it for funding, subject to certain<br />

conditions.<br />

Hamdy (12/35/54): A randomised controlled trial of Partial prostate Ablation versus<br />

Radical prosTatectomy (PART) in intermediate risk unilateral clinically localised<br />

prostate cancer.<br />

Professor Williams chaired. Professor Blazeby, Professor Hamdy and Ms Wyld left the<br />

room.<br />

The board discussed the proposal and wished to see a resubmission.<br />

Bradbury (12/35/45): Multicentre randomised controlled trial to compare the clinical<br />

and cost-effectiveness of a ‘vein bypass first’ with an ‘best endovascular first’<br />

revascularisation strategy for severe limb ischaemia due to infrageniculate arterial<br />

disease (Bypass v Angioplasty in Severe Ischaemia of the Leg,BASIL-2)<br />

Professor Williams chaired. Professor Bradbury, Professor Morton and Professor Mehanna<br />

2


left the room.<br />

<strong>HTA</strong> Surgery Themed Call<br />

The board discussed the proposal and recommended it for funding, subject to certain<br />

conditions.<br />

Tucker (12/35/44): Transabdominal versus Conventional Transthoracic Pleural Drain<br />

Insertion at Oesophagectomy for Resectable Oesophageal and Gastrooesophageal<br />

Junctional Cancer (TATT)<br />

Professor Goodacre chaired. Professor Morton, Professor Bradbury, Professor Blazeby<br />

and Professor Mehanna left the room. Professor Walley joined the meeting.<br />

The board discussed the proposal and declined it.<br />

Philpott (12/35/49): A systematic review, economic evaluation and value of<br />

information analysis of medical and surgical treatments for chronic rhinosinusitis<br />

Professor Goodacre chaired. Professor Scholefield left the meeting.<br />

The board discussed the proposal and declined it.<br />

<strong>HTA</strong> Surgery Themed Call Board<br />

Day 2<br />

Discussion of Surgery Full Proposals<br />

King (12/35/38): Treatment of Advanced Glaucoma Study (TAGS): A multicentre<br />

randomised controlled trial comparing primary medical treatment with primary<br />

trabeculectomy for people with newly diagnosed advanced glaucoma<br />

Professor Goodacre chaired. Professor Williams left the room.<br />

The board discussed the proposal and recommended it for funding, subject to certain<br />

conditions.<br />

Charteris (12/35/64): A randomised controlled trial of adjunctive intraocular and<br />

periocular steroid (triamcinolone acetonide) versus standard treatment in eyes<br />

undergoing vitreoretinal surgery for open globe trauma<br />

Professor Goodacre chaired.<br />

The board discussed the proposal and recommended it for funding, subject to certain<br />

conditions.<br />

Francis (12/35/58): No Surgery Trial: Can early breast cancer patients safely avoid<br />

surgery following a pCR (pathological Complete Response) resulting from neoadjuvant<br />

anti-HER2 therapy with chemotherapy, confirmed by multiple ultrasound<br />

directed biopsies?<br />

Professor Williams chaired. Professor Morton, Ms Wyld, Professor Bradbury, Professor<br />

Murray and Professor Mehanna left the room.<br />

The board discussed the proposal and declined it.<br />

Powell (12/35/22): STAT: Small Thoracic Aneurysm Trial<br />

3


Professor Williams chaired. Professor Athanasiou left the room.<br />

The board discussed the proposal and declined it.<br />

<strong>HTA</strong> Surgery Themed Call<br />

Jayne (12/35/07): A randomised comparison of the Fenix® magnetic anal sphincter<br />

versus sacral nerve stimulation for adult faecal incontinence.<br />

Professor Williams chaired. Professor Farrin and Ms Wyld left the room.<br />

The board discussed the proposal and recommended it for funding, subject to certain<br />

conditions.<br />

Hashim (12/35/15): A randomised controlled trial to determine the clinical and cost<br />

effectiveness of thulium laser transurethral vaporesection of the prostate (ThuVARP)<br />

versus transurethral resection of the prostate (TURP) in the National <strong>Health</strong> Service<br />

(NHS).<br />

Professor Williams chaired.<br />

The board discussed the proposal and recommended it for funding, subject to certain<br />

conditions.<br />

Bundred (12/35/50): A randomised controlled trial testing the effect of primary<br />

endocrine therapy on re-excision and reoperation rates amongst women treated for<br />

postmenopausal hormone receptor positive ductal carcinoma in situ (DCIS)<br />

Professor Williams chaired. Professor Murray and Professor Walley left the room.<br />

The board discussed the proposal and declined it.<br />

Bhattacharya (12/35/23): A multicentre randomised controlled trial comparing<br />

laparoscopic supra-cervical hysterectomy with second generation endometrial<br />

ablation for the treatment of heavy menstrual bleeding (HEAT)<br />

Professor Goodacre chaired.<br />

The board discussed the proposal and recommended it for funding, subject to certain<br />

conditions.<br />

Luyt (12/35/61): Surgical drainage, irrigation, and fibrinolytic therapy (DRIFT) in<br />

premature infants with post-haemorrhagic ventricular dilatation: Brain function and<br />

structure at school age<br />

Professor Goodacre chaired.<br />

The board discussed the proposal and declined it.<br />

Post meeting note: Following a post board review a resubmission was invited.<br />

Torkington (12/35/29): Hughes Abdominal Repair Trial - abdominal wall closure<br />

technique to reduce incidence of incisional hernias: multi-centre pragmatic<br />

randomised trial<br />

Professor Goodacre chaired. Professor Phillips left the room.<br />

The board discussed the proposal and recommended it for funding, subject to certain<br />

conditions.<br />

Paleri (12/35/32): A feasibility randomised controlled trial of pre-treatment<br />

gastrostomy tube versus oral feeding plus as-needed nasogastric tube feeding in<br />

4


<strong>HTA</strong> Surgery Themed Call<br />

patients undergoing chemoradiation for head and neck cancer (TUBE trial)<br />

Professor Goodacre chaired.<br />

The board discussed the proposal and recommended it for funding, subject to certain<br />

conditions.<br />

McDaid (12/35/02): Primary shoulder replacement surgery for people with arthritis: a<br />

systematic review and decision model<br />

Professor Goodacre chaired. Professor Mason left the room.<br />

The board discussed the proposal and declined it.<br />

Close of meeting.<br />

5

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