TARGIT-B International RCT to compare targeted intra-operative radiotherapy boost for breast cancer
TARGIT-B International RCT to compare targeted intra-operative radiotherapy boost with conventional external beam radiation boost after lumpectomy for breast cancer in women with high risk of local recurrence
VELRAD Videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in penile cancer
VELRAD Videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in patients with penile cancer: a feasibility randomised controlled trial
Evaluating the effectiveness of the alcohol reduction smartphone app, Drink Less, for excessive drinkers in the UK: a randomised controlled trial
Digital interventions are effective for reducing alcohol consumption but evidence is limited regarding smartphone apps. Drink Less is a theory- and evidence-informed app to help people reduce their alcohol consumption that has been refined in terms of its content and design for usability across the socio-demographic spectrum. We aim to evaluate the effectiveness and cost-effectiveness of recommending Drink Less at reducing alcohol consumption compared with usual digital care.
Identifying facilitators and barriers to implementation of tumor biopsy pathway for small renal masses (IFIT-B)
Kidney tumours are increasingly detected in patients having investigations for unrelated symptoms. Currently, it is not possible to tell whether a tumour is benign or cancer by a scan, blood or urine test. Most patients diagnosed with a kidney tumour are offered surgery, but this carries serious risks. Most side effects of biopsies (discomfort, bruising and blood in the urine) resolve without treatment. Nearly 6 in 10 kidney tumours are benign or are low grade (59%), meaning that they are unlikely to cause harm. This means that over half of patients can potentially avoid surgery if they have a biopsy. Currently, access to biopsies is not equal across the UK. We want to find out what the barriers are and what action is required to offer a tumour biopsy service to all patients to help guide treatment decision and improve outcomes.
NeuroSAFE- A single-blinded, multi-centre RCT comparing NeuroSAFE Robot prostatectomy (RALP) to standard RALP
Robot-assisted laparoscopic prostatectomy (RALP) offers potential cure for localised prostate cancer but is associated with considerable toxicity. Potency and urinary continence are improved when the neurovascular bundles (NVBs) are spared during a nerve spare (NS) RALP. There is reluctance, however, to perform NS RALP when there are concerns that the cancer extends beyond the capsule of the prostate into the NVB, as NS RALP in this instance increases the risk of a positive surgical margin (PSM). The NeuroSAFE technique involves intraoperative fresh-frozen section analysis of the posterolateral aspect of the prostate margin to assess whether cancer extends beyond the capsule. There is evidence from large observational studies that functional outcomes can be improved and PSM rates reduced when the NeuroSAFE technique is used during RALP. To date, however, there has been no randomised controlled trial (RCT) to substantiate this finding. The NeuroSAFE PROOF feasibility study is designed to assess whether it is feasible to randomise men to NeuroSAFE RALP versus a control arm of ‘standard of practice’ RALP.
Cytoreductive surgery with hyperthermic intraoperative peritoneal chemotherapy (HIPEC) versus standard of care in people with peritoneal metastases
There is uncertainty about whether cytoreductive surgery (CRS)+hyperthermic intraoperative peritoneal chemotherapy (HIPEC) improves survival and/or quality of life compared with standard of care (SoC) in people with peritoneal metastases who can withstand major surgery.
To compare the relative benefits and harms of CRS+HIPEC versus SoC in people with peritoneal metastases from colorectal, ovarian or gastric cancers eligible to undergo CRS+HIPEC by a systematic review and individual participant data (IPD) meta-analysis. To compare the cost-effectiveness of CRS+HIPEC versus SoC from a National Health Service (NHS) and personal social services perspective using a model-based cost–utility analysis.
A feasibility study of a cohort embedded RCT comparing NEphron Sparing Treatment (NEST) for small renal masses
Small renal masses (SRMs; ≤4 cm) account for two-thirds of new diagnoses of kidney cancer, the majority of which are incidental findings. The natural history of the SRM seems largely indolent. There is an increasing concern regarding surgical overtreatment and the associated health burden in terms of morbidity and economy. Observational data support the safety and efficacy of percutaneous cryoablation but there is an unmet need for high-quality evidence on non-surgical management options and a head-to-head comparison with standard of care is lacking. Historical interventional trial recruitment difficulties demand novel study conduct approaches. We aim to assess if a novel trial design, the cohort embedded randomised controlled trial (RCT), will enable carrying out such a comparison.
Treatment of Unresectable Locally Advanced Pancreas Cancer with Percutaneous Irreversible Electroporation Following Initial Systemic Chemotherapy: A Feasibility RCT (LAP-PIE)
Surgery (pancreatic resection) is the only treatment with the potential to cure pancreatic cancer. However only 10 to 20% of people are eligible for surgery. One of the major reasons is that the cancer has spread into the surrounding structures, often the superior mesenteric vein and/or artery. This circumstance affecting about 30% of all patients is termed locally advanced pancreatic cancer (LAPC). Currently, the recommended treatment for LAPC is chemotherapy. Those with a response to chemotherapy would again be considered for resection. Overall 65% of patients post chemotherapy remain with localised but unresectable disease (UK SCALOP trial induction protocol data). Irreversible electroporation (IRE) is a new method of treating localised cancers which are not suitable for surgery. The IRE treatment destroys cancer cells using electricity. Under general anaesthetic the IRE electrodes are inserted into the borders of the pancreas cancer prior to an electrical charge being passed through the cancer. Early studies of IRE in pancreas cancer show that IRE treatment may increase how long people with LAPC live (median survival 25months) but these studies were not controlled or randomised. The improved outcome could therefore be related to patient selection. The aim of this study is to assess the feasibility of performing IRE therapy in patients with locally advanced pancreas cancer (LAPC) whose disease remains locally unresectable following initial chemotherapy.
Cost-effectiveness analysis of a non-invasive screening strategy in diagnosis of varices for patients with liver cirrhosis
Current guidelines in the UK recommend that all cirrhotic patients should be screen at diagnosis for varices, with follow up every 2-3 years for patients without varices and 1-2 yearly for patients with small varices, to assess for enlargement and need of prophylactic treatment. We investigate the cost-effectiveness of a non-invasive screening compared to endoscopy (EGD) in diagnosis of varices for patients with liver cirrhosis.
Evaluating an early social communication intervention for children with Down Syndrome
Down syndrome (DS) is a relatively common genetic condition which affects approximately 1 in every 700 babies. There are approxinmately 38,000 people with DS living in England and Wales. DS is the most common cause of learning disability. Children with DS have particular difficulties with speech and language. This makes it difficult for them to participate fully in life, access health care services and educational opportunities. As DS is detected before or at birth, we can provide support from early on. There are currently no standard interventions for improving the language skills of children with DS under the age of 24 months. Existing research suggests that the earlier an intervention is carried out, the better the outcomes. Evidence also suggests that early parent-based interventions may be effective in improving language outcomes. Improving the language skills of young children with DS is vital for their future social and emotional well-being and behaviour, and consequently contribution to society. Our aim is to carry out a feasibility study which will inform a future pilot/full trial to test whether the intervention is effective in improving language skills before children with DS start school.
Mediterranean diet to prevent type 2 diabetes in women with gestational diabetes: a feasibility study - MERIT
Our aim is to evaluate the effects of a Mediterranean diet, in preventing the development of type 2 diabetes after giving birth, in women with gestational diabetes (GDM). Gestational diabetes is high blood sugar that develops during pregnancy. Before we run a large-scale trial to answer this question, we plan to test the feasibility of running the Mediterranean diet intervention in an NHS setting. Additionally, we will look at the acceptability of the study and interventions, particularly in the postnatal period, to women and healthcare professionals.
Effectiveness and acceptability of metformin in preventing onset of type 2 diabetes after gestational diabetes in postnatal women - OMAHA
Up to half of all women diagnosed with gestational diabetes mellitus develop type 2 diabetes within 5 years after delivery. Metformin is effective in preventing type 2 diabetes in high-risk non-pregnant individuals, but its effect when commenced in the postnatal period is not known. We plan to assess the feasibility of evaluating metformin versus placebo in minimising the risk of dysglycaemia including type 2 diabetes after delivery in postnatal women with a history of gestational diabetes through a randomised trial.
Mixed methods evaluation of the Getting it Right First Time programme: improvements to NHS orthopaedic care in England
Orthopaedic procedures, such as total hip replacement and total knee replacement, are among the commonest surgical procedures in England. The Getting it Right First Time project (GIRFT) aims to deliver improvements in quality and reductions in the cost of NHS orthopaedic care across the country. We will examine whether the planned changes have delivered improvements in the quality of care and patient outcomes. We will also study the processes involved in developing and implementing changes to care, and professional and organisational factors influencing these processes. In doing so, we will identify lessons to guide future improvement work in other services.
Provision of the NHS 111/Urgent Care Patient Relationship Manager Evaluation
Improving the delivery of urgent and emergency care (UEC) services in London is a main priority of NHS England London. To this aim, NHS England London has implemented the Patient Relationship Manager (PRM) system, a Cloud-based clinical record system, designed to improve patient care by information sharing. It works by assisting in directing NHS 111 calls to the most appropriate health care professional depending on the nature of the call. The economic analysis of the PRM aims to estimate the incremental cost of the service and the potential benefit in economic terms. The expected benefits of the PRM from an economic perspective are the operational efficiencies for both integrated Urgent Care Services, and the wider urgent and emergency care networks. These may translate in changes in the use of Urgent Care Services and the potential saving for the NHS.
Endovascular Thrombectomy in Patients with Large Core Ischemic Strokes: a Cost-Utility Analysis from the SELECT Study
Every year, 15 million people worldwide suffer a stroke. Nearly 6 million die and another 5 million are left permanently disabled. For acute ischemic stroke, intravenous recombinant plasminogen activator (IV-tPA) has demonstrated efficacy and cost-effectiveness when administer to eligible patients. However, the prognosis for patients remains disappointing in part because IV-tPA alone is often unable to achieve recanalization, especially when there is a major vessel occlusion. In this case, there is increasing evidence that mechanical thrombectomy has the potential to improve recanalization rates and outcomes for patients with ischemic stroke. We use a Markov model to model the lifetime cost-utility of mechanical thrombectomy compared to IV-tPA alone in the USA.