Marcus Jepson

Improving Recruitment to Randomised Control Trials: Practical Lessons from the QuinteT Research Group

Marcus Jepson, Catherine R. Holt

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Development and application of quality assurance methods for interventions in randomised controlled trials of surgical oncology: the ROMIO study (a comparison of minimally invasive and open oesophagectomy)

Natalie Blencowe, Anni King, Beverly A. Shirkey, Chris Metcalfe et autres

INTRODUCTION: Results of RCTs are criticised because the quality assurance (QA) of surgical interventions is not considered. This is particularly true in cancer trials, because higher standards of surgery may confer more favourable outcomes. Although methods for surgical QA exist, it is …

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Assessing the clinical and cost-effectiveness of endovascular vs open revascularisation in severe occlusive aorto-iliac disease (EVOCC trial): study protocol for a randomised controlled trial

Athanasios Saratzis, Alun H. Davies, Αθανάσιος Διαμαντόπουλος, Robert Davies et autres

INTRODUCTION: Severe aorto-iliac steno-occlusive atherosclerotic disease is a major cause of morbidity and amputation in patients with peripheral arterial disease. While both open surgical and endovascular revascularisation are standard treatments in this patient group, there is no high-quality randomised evidence to determine …

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Laryngeal Reinnervation vs Type I Thyroplasty in Unilateral Vocal Fold Paralysis ( VOCALIST ): A Randomized Feasibility Study

Martin Birchall, Eleftheria Iliadou, Helen Blackshaw, Marcus Jepson et autres

OBJECTIVES: We wished to determine the feasibility of performing a multi-centre phase III randomized controlled trial that compares laryngeal reinnervation to type I thyroplasty for adults with unilateral vocal fold paralysis (UVFP) in the UK. METHODS: A feasibility study was designed; 27 …

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The role of healthcare professionals’ communication in trial participation decisions: a qualitative investigation of recruitment consultations and patient interviews across three RCTs

Nicola Farrar, Daisy Elliott, Marcus Jepson, Bridget Young et autres

BACKGROUND: Although the challenges of recruiting to randomised controlled trials (RCTs) are well documented, few studies have focused on the impact that the communication between recruiters and patients has on patients' participation decisions. Recruiters are thought to influence patient decision-making, but the …

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PREHABILITATION FOR FRAIL PATIENTS UNDERGOING HIP AND KNEE ARTHROPLASTY: JOINT PREP FEASIBILITY STUDY FOR A RANDOMIZED CONTROLLED TRIAL

Tanzeela Khalid, Yaniv Shlomo, Wendy Bertram, Lucy Culliford et autres

Introduction Approximately 20-25% of patients having joint replacement in the UK have moderate-severe frailty. Frailty is associated with poorer outcomes after joint replacement. Targeting frailty pre-operatively with exercise and protein supplementation could improve post-operative outcomes. Prior to conducting a randomised controlled trial …

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A07 - EDI&S Outputs of appointing a Trainee Executive Group in delivering a multi-centre randomized controlled surgical trial: Lessons learnt from The Sunflower Study

Hannah Byrne, G Fowler, Lucy Huppler, Cho Ee Ng et autres

Abstract Background Randomised controlled trials (RCTs) are widely accepted as the ‘gold standard’ for evaluating the effectiveness of health interventions. Trial recruitment is notoriously difficult, with approximately 57% of publicly funded RCTs not meeting recruitment target sample sizes. Trainee involvement can be …

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Prehabilitation for frail patients undergoing hip and knee replacement in the UK: Joint PREP feasibility study for a randomised controlled trial

Tanzeela Khalid, Yoav Ben‐Shlomo, Wendy Bertram, Lucy Culliford et autres

OBJECTIVE: To determine the feasibility of conducting a randomised controlled trial (RCT) to evaluate a prehabilitation programme for frail patients undergoing total hip replacement (THR) or total knee replacement (TKR). DESIGN: Randomised feasibility study with embedded qualitative work. SETTING: Three National Health …

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Correction: PET-CT-guided, symptom-based, patient-initiated surveillance versus clinical follow-up in head neck cancer patients (PETNECK2): study protocol for a multicentre feasibility study and non-inferiority, randomised, phase III trial

Paul Nankivell, Piers Gaunt, Claire Gaunt, J W Sissons et autres

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PET-CT-guided, symptom-based, patient-initiated surveillance versus clinical follow-up in head neck cancer patients (PETNECK2): study protocol for a multicentre feasibility study and non-inferiority, randomised, phase III trial

Paul Nankivell, Piers Gaunt, Claire Gaunt, J W Sissons et autres

BACKGROUND: Approximately 40% of treated head and neck cancer (HNC) patients develop recurrence. The risk of recurrence declines with time from treatment. Current guidelines recommend clinical follow-up every two months for the first two years after treatment, with reducing intensity over the …

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Laparoscopic or open abdominal surgery with thoracotomy for patients with oesophageal cancer: ROMIO randomized clinical trial

Khurshid Akhtar, Bilal Alkhaffaf, Arun Ariyarathenam, Kerry Avery et autres

OBJECTIVE: This study investigated if hybrid oesophagectomy with minimally invasive gastric mobilization and thoracotomy enabled faster recovery than open surgery. METHODS: In eight UK centres, this pragmatic RCT recruited patients for oesophagectomy to treat localized cancer. Participants were randomly allocated to hybrid …

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Study protocol for a randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain: 2 (TOPIC 2)

Ben Shelley, Andreas Göebel, Stephen Grant, Louise Jackson et autres

BACKGROUND: Thoracotomy is considered one of the most painful surgical procedures and can cause debilitating chronic post-surgical pain lasting months or years postoperatively. Aggressive management of acute pain resulting from thoracotomy may reduce the likelihood of developing chronic pain. This trial compares …

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