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Research by Methodological Approach: Economic evaluations alongside clinical trials


Better Outcomes for Older people with Spinal Trouble

The BOOST trial is studying the physiotherapy treatment of back and leg pain or symptoms due to lumbar spinal stenosis (also called neurogenic claudication). This is a condition that affects older people and limits their ability to walk and stand which impacts on their ability to remain independent. Please find out more about this study here.

HE: Stavros Petrou, Benjamin Parker Funder: NIHR PGfAR


Patients with acute respiratory failure often require invasive ventilation to unload the respiratory muscles and support gas exchange until the cause of the respiratory failure improves. Invasive ventilation used over a prolonged period of time might lead to ventilator associated pneumonia. This, in turn, is associated with increased morbidity and trends towards increased mortality. For these reasons, clinicians caring for patients who need invasive ventilation strive to reduce the duration of invasive ventilation while optimising the chance for successful extubation. A meta-analysis suggested that use of non-invasive ventilation to wean critically ill adults off invasive ventilation was associated with decreased mortality and other clinical benefits (Burns et al. BMJ, 2009, 338:b1574). The net clinical and cost effectiveness of non-invasive ventilation based weaning compared to other weaning strategies is uncertain. The Breathe study is a pragmatic, multi-centre randomised controlled trial designed to evaluate the clinical benefits and cost effectiveness of non-invasive weaning. Please find the study's webpages here.

HE: Stavros Petrou, Mandy Maredza

CAPACITY - Studying Chronic Constipationcapacity

Development of a UK evidence based pathway for the management of chronic constipation in adults.

CapaCiTY involves an NIHR-funded programme of research providing trial-based evidence for patients with chronic symptoms who fail to respond to more basic care. A suite of multicentre trials will assess types of investigation, specialist nurse-led bowel retraining, anal irrigation and surgery. A common outcome framework will assess changes in symptoms, patient acceptability, quality-of-life and cost. Findings will be synthesised to develop national guidance and a treatment pathway for appropriate care.

The study is being managed by the Pragmatic Clinical Trials Unit at Barts Health NHS Trust and Queen Mary University of London, with further details on the Trial website.


Emmett C, Close H, Mason J, Taheri S, Stevens N, Eldridge S, Norton C, Knowles C, Yiannakou Y. Low-volume versus high-volume initiated trans-anal irrigation therapy in adults with chronic constipation: study protocol for a randomised controlled trial. Trials 2017;18:151

Norton C, Emmanuel A, Stevens N, Scott SM, Grossi U, Bannister S, Eldridge S, Mason JM, Knowles CH. Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: study protocol for a randomised controlled trial. Trials 2017;18:139

HE: James Mason PI: Charles Knowles Funder: NIHR PGfAR


Chronic Headache Education and Self-management Study

Chronic headache, that is headache occurring on 15 or more days per month for more than three months, is a common problem, affecting around one in 30 of the population. There are three main types of chronic headache; migraine, tension type and medication overuse. There is very little information on the use of non-drug treatments or how to support people to manage their chronic headaches better (supported self-management). We want to develop and test a self-management support programme for people living with chronic headache comprising of individually tailored and generic components (the CHESS intervention). The programme will draw on the experience of people with chronic headaches to identify both what sort of interventions would be acceptable and what would be a meaningful benefit from the intervention. For more information on this trial, please visit these pages.

HE: Stavros Petrou, Felix Achana PI: Martin Underwood


Dementia And Physical Activity

DAPA is a randomised controlled trial funded by the National Institute for Health Research Health Technology Assessment programme to estimate the effect of a 4-month, moderate- to hard-intensity exercise training programme and subsequent advice to remain active, on cognition (primary outcome) at 12 months in people with mild to moderate dementia. Community-dwelling participants (with their carers where possible), who are able to walk 3 metres without human assistance, able to undertake an exercise programme and do not have any unstable or terminal illness are recruited. Participants are then randomised by an independent statistician using a computerised random number generator to usual care or exercise at a 2:1 ratio in favour of exercise. The exercise intervention comprises 29, 1-hour-long exercise classes, run twice weekly at suitable venues such as leisure centres, which include aerobic exercise (on static bikes) and resistance exercise (using weights). Goals for independent exercise are set while the classes are still running, and supported thereafter with phone calls.

Please visit these pages for more information about the study.

HE: Stavros Petrou, Ifthekar Khan


Facet-joint injections for people with with persistent non-specific low back pain (FIS)

The Facet Injection Study (FIS) is a mixed-methods, randomised, multicentre feasibility study to assess the clinical and cost-effectiveness of facet joint injections compared to best usual non-invasive care in patients with persistent non-specific low back pain. Please find more information about the study here.

HE: Stavros Petrou


Full Randomised Controlled Trial of Arthroscopic Surgery for Hip Impingement versus best coNventional care

The FASHIoN study is a multicentre randomised controlled trial comparing the clinical and cost effectiveness of arthroscopy surgery versus best conservative care for patients with femoroacetabular impingement syndrome. Please find the study's website here.

HE: Stavros Petrou, Felix Achana


FIRST STEPS: a trial of the effectiveness of the Group Family Nurse Partnership (gFNP) programme compared to routine care in improving outcomes for high risk mothers and preventing abuse

Child abuse and neglect is a major public health problem and infants are a high-risk group accounting for up to 13% of child protection registrations in the UK, and a significant number of deaths. The provision of sensitive caregiving during the first few years is important because brain development is rapid at this time, but also very vulnerable to negative influences. A nurse home visiting programme, Family Nurse Partnership (FNP) which starts early in pregnancy and extends until infants are 24 months old has been identified as one with strong evidence that it reduces the later risk of child abuse. It is now offered widely in England but is only available to first-time mothers under 20.

Group Family Nurse Partnership (gFNP), a newly developed programme, based on the FNP curriculum and strength-based approach, is delivered in a group context to 8-12 women with similar expected delivery dates, starting in pregnancy and lasting until infants are 12 months old. Partners are also encouraged to attend the group sessions. Following the success of group-based antenatal care such as the US Centering Pregnancy Model, preferred by many to traditional care and leading to improved prenatal outcomes among high-risk women, the gFNP programme combines the provision of the FNP curriculum with midwifery care in pregnancy and infant health checks in infancy. Women are encouraged to monitor their own health. The aim of this study is to examine if provision of the gFNP programme, compared to routine antenatal and postnatal services, can reduce risk factors for maltreatment.

Please find the ISRCTN registry of the study here.

HE: Stavros Petrou


UK Fixation of Distal Tibia Fractures Trial is a randomised controlled trial comparing intramedullary nail fixation with locking plate fixation for patients with a distal tibia fracture.

The treatment of fractures of the lower third of the tibia remains controversial. These injuries are difficult to manage because the blood supply to the skin over the bone is poor and because the proximity of the fracture to the ankle joint. Infections and problems of bone healing are well recognised complications. Most of these injuries require surgery. The most common methods of fixation are: intramedullary nail fixation and locking plate fixation. At present, there is limited evidence as to which technique is better with regards to healing of the bone, ankle function and quality of life. This is a multi-centre randomised controlled trial where participants will be randomised on a 1:1 basis, stratified by trial centre and participant age. The target recruitment is 320 patients and patients will be followed up at 6 weeks, 3 months, 6 months and 12 months post operatively.

Please find more information about the study here.

HE: Stavros Petrou, Mandy Maredza PI: Matt Costa Funder: NIHR HTA


Managing the Link and Strengthening Transition from Child (CAMHS) to Adult Mental Health Care Services (AMHS)

There is international concern about young people who get ‘lost’ during their move from CAMHS to AMHS. Disruption of care during transition may adversely affect the health, wellbeing and potential of this vulnerable group. The main aim of the MILESTONE project is to understand and improve transition of care from CAMHS to AMHS across different healthcare systems in Europe.

Findings from the study will help transform mental health care in the EU for young people, enhance patient outcomes, quality of life, and service satisfaction, and improve mental health status at individual and population levels.

For more information about the study, please visit these pages.

HE: Jason Madan, Alastair Canaway PI: Swaran Singh Funder: EU FP7

OHCA / Paramedic 2ohca

Should adrenaline be used when someone's heart stops?

Cardiac arrest is the term used to describe sudden cessation of heart function.

paramedic 2

After cardiac arrest occurs, blood stops being circulated to the vital organs and consciousness is lost within seconds. Unless resuscitation is started promptly death will occur within a few minutes.

Each year about 30,000 people receive resuscitation for an Out-of-Hospital Cardiac Arrest (OHCA) in the United Kingdom (UK). Only one in every twenty people that have a cardiac arrest survive to go home from hospital. Information collected by the Department of Health has shown large differences in the number of people that survive an OHCA depending on where they live. In simple terms people in some parts of the country are twice or three times more likely to survive than in other areas.

This project is working with UK Ambulance Services to try and find out the reasons behind such big differences in survival. It has develop a standard way of collecting information about OHCA and for finding out if a resuscitation attempt was successful. The study uses existing information collected by ambulance services during the course of their routine duties. The information will be used to obtain a better understanding of why survival rates vary so widely. It will work out which are the most effective treatments and help ambulance services improve the quality of care for victims of OHCA. For more information about the study, please visit this page.

The PARAMEDIC2 trial is looking at whether adrenaline is helpful or harmful in the treatment of a cardiac arrest that occurs outside a hospital. Answering this question will help to improve the treatment of people who have a cardiac arrest. Please visit these pages for more information on the study.

HE: Stavros Petrou, Felix Achana PI: Gavin Perkins

Parents Under Pressure Parents Under Pressure

The Parents Under Pressure™ (PuP) programme is a twenty week home-visiting service for parents who are drug and/or alcohol dependent and have a child under two and a half years of age. It is designed for families in which there are many difficult life circumstances that impact on parenting capacity and family functioning. Please find more information about the study on these pages.

HE: Stavros Petrou, Sungwook Kim

PROSPER prosper

Exercise to prevent shoulder conditions in patients undergoing breast cancer treatment: The Prevention Of Shoulder Problems Study

The PROSPER trial aims to prevent shoulder problems in women treated for breast cancer. The trial will investigate the clinical and cost-effectiveness of early supervised exercise compared to usual care, on outcomes of shoulder/arm function, health-related quality of life, chronic pain and other postoperative complications, following treatment for breast cancer. Please find more information about the study here.

HE Stavros Petrou, Alastair Canaway PI: Julie Bruce Funder: NIHR HTA

REACT (Glucose Monitoring)react

Real Time Coninuous Glucose Monitoriug in Neonatal Intensive Care

Both high and low blood sugar levels are common in preterm babies and this has been linked with poor outcome. One of the difficulties of managing sugar levels in preterm babies is that it involves a sample of blood being taken and as clinical teams try to avoid disturbing babies there is often a long time between measurements. There is now a device ‘real time continuous glucose monitoring’ (rCGM) that is used by some children and adults with diabetes which can provide data on glucose (sugar) levels continuously. This involves a small sensor being placed under the skin but it can be left there for up to a week and allows the medical team to respond quickly and treat changes in sugar levels to keep the sugar level within a normal range.

By preventing both high and low sugar levels this intervention could improve the way we care for these preterm babies who have a unique physiology. As well as helping with the short term care of these babies targeting sugar levels may improve growth and long term health and neurodevelopment.

Please find more information about the study here.

HE: Stavros Petrou, Benjamin Parker PI: Kathryn Beardsall Funder: MRC / NIHR EME


Duration of anticoagulation therapy in SELECTeD patients with advanced cancer at risk of recurrence of venous thromboembolism

SELECT-D is an integrated, primary and secondary health care sector-led, Phase III, prospective, randomised, open-label, multi-centre pilot study comparing Dalteparin versus Rivaroxaban with a second placebo-controlled randomisation comparing the duration of anticoagulation therapy (six months versus indefinite treatment) in residual vein thrombosis [RVT] positive (+ve) patients. This is a UK-wide trial, directed by Warwick Medical School, University Hospitals Coventry and Warwickshire, West Midlands South Comprehensive Local Research Network, Thames Valley and West Midlands South Primary Care Research Network.

For more information about the study, please visit this page.

HE: Stavros Petrou, Mandy Maredza PI: Annie Young, Andrea Marshall Funder: Bayer plc


UKSTAR: UK Study of Tendo Achilles Rehabilitation

The UK Study of tendo Achilles Rehabilitation is a multicentre randomised clinical trial sponsored by the University of Oxford. The trial is comparing the plaster cast versus walking boot treatment for non-operatively managed Achilles tendon ruptures and is funded by Health Technology Assessment - National Institute of Health Research. Please visit this page for more information about the study.

HE: Stavros Petrou PI: Matt Costa Funder: NIHR HTA

STOP GAPstopgap

Pyoderma Gangrenosum Study

Pyoderma gangrenosum is a rare inflammatory disorder that causes painful, rapidly spreading ulcers on the skin. We compared the effectiveness of the two most commonly used treatments in tablet form and measured how well people respond to treatments applied to the skin. Please visit this page for more information about the study.

HE: James Mason PI: Hywel Williams Funder: NIHR


Shortened Treatment Regimens for MDR-TB

Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing. Despite the availability and effectiveness of affordable six-month treatments for tuberculosis (TB), the worldwide control of this disease is currently being impacted by the emergence of multidrug resistant TB (MDR-TB). MDR-TB refers to TB that is resistant to at least isoniazid and rifampicin. These are the two most powerful first-line drugs used to treat pulmonary TB. MDR-TB usually develops while a person is taking TB treatment due to either inappropriate treatment or failure of patients to complete their treatment. This strain of drug-resistant bacteria can also be spread to other people through the air. MDR-TB is much more difficult to treat than TB strains that are sensitive to the commonly used drugs. Currently the standard treatments for MDR-TB can last as long as 24 months with a success rate of no more than 50%. With an approximately 500,000 new cases every year there is an urgent need to develop shorter and more effective treatments. A newly-developed 9-month treatment is being tested in this study based on a high dose flouroquinolone and clofazimine. The aim of this investigation is to show that this shorter treatment, which has had good results in a cohort of over 500 patients in Bangladesh but has not been evaluated in a randomised trial, is at least as effective as the lengthier treatments recommended by the World Health Organisation. A second stage of the STREAM trial started in early 2016.

Fore more information about the study, please visit these pages.

HE: Jason Madan PI: Andrew Nunn (MRC CTU) Funder: USAID


Wound healing in Surgery for Trauma

Wound Healing In Surgery for Trauma is a Randomised Controlled Trial of standard wound management versus negative pressure wound therapy in the treatment of adult patients having surgical incisions for major trauma to the lower limb. Please see this page for more information on the study.

HE: Jason Madan PI: Matt Costa Funder: NIHR


Wound Management of Open Lower Limb Fractures

A randomised controlled trial of standard care wound management versus negative pressure wound therapy in the treatment of adult patients with an open fracture of the lower limb. Please find more information on the study on this page.

HE: Stavros Petrou, Benjamin Parker Funder: NIHR HTA


Warwick Pain and Insomnia Study

Chronic pain patients often also have severe problems sleeping, which can amplify their pain and increase their distress and disability. These patients do request treatment for their insomnia, but such treatment is never a main focus in pain management programmes. In primary care drugs remain first-line treatments for pain-related insomnia despite limited evidence of their long-term effectiveness and safety. Hybrid cognitive-behavioural therapy (Hybrid CBT) is a new approach to tackling pain-related insomnia. It addresses pain and sleep simultaneously, exploiting factors underpinning the persistence of both problems. Delivered as a brief but intensive treatment in secondary care, Hybrid CBT was effective in not only improving sleep and reducing pain interference, but also counteracting fatigue and depression. The improvements were also clinically meaningful, however, it is not yet known if the patient benefits could be translated to primary care. This study therefore aims to test the feasibility of delivering this promising intervention in a primary-care setting. The results of the study will inform the planning and implementation of a definitive randomised controlled trial (RCT) evaluating the clinical- and cost-effectiveness of the Hybrid CBT in primary care. Please find more information on the study on this page.

HE: Jason Madan, Benjamin Parker Funder: NIHR RfPB