Please find below details of research studies which the Health Board is currently engaged in:
|BCUHB start date
|Proposed end date
|Link to Privacy Notice
|ISARIC/WHO Clinical Characterisation Protocol for Severe Emerging Infection
|The aims of the study include gaining important information about infections which are of public health interest, and finding better ways to manage and treat these infections in the future.
|BPSU study - Multisystem inflammatory syndrome, Kawasaki disease and toxic shock syndrome
|During April 2020, a number of children became very unwell with symptoms and signs of hyperinflammation and were admitted to the paediatric intensive care units. At present, we do not understand the relationship between SARS-CoV-2 and this new condition, or even if there is one. We will ask paediatricians to report all cases which have features of this multisystem inflammation.
|Neonatal Complications of Coronavirus Disease (COVID-19) Study
|This is a national study collecting information about newborn babies who have coronavirus and need medical care or who are born to mothers who have coronavirus. Paediatricians and neonatologists in the UK are asked to report any babies that meet the surveillance case definition to the BPSU every week.
|Postoperative vasopressor usage: a prospective international observational study. Relation to Perioperative Atrial Fibrillation.
|Please see information for patients on the below link: https://www.esaic.org/research/clinical-trial-network/squeeze/squeeze-uk/information-for-patients/
|SQUEEZE Study | ESAIC
|The SuPPORT Project - Supporting Parents and Professionals through NeOnatal Resuscitation in Theatre
|Study specific privacy information: FAQs | The SuPPORT Project
|Evaluating the clinical and cost-effectiveness of a conservative approach to oxygen therapy for invasively ventilated adults in intensive care: UK-ROX
|UK-ROX is a national research study comparing different targets for oxygen treatment for patients in intensive care units. The study is coordinated by the Intensive Care National Audit & Research Centre (ICNARC) and will involve 16,500 patients from around 100 NHS intensive care units. All information will be used to help improve the care of future patients.
|Study Website: https://www.icnarc.org/Our-Research/Studies/Uk-Rox
|Talking in Primary Care: A cluster-randomized controlled trial in primary care to test the effectiveness and cost-effectiveness of communication skills elearning for practitioners on patients’ musculoskeletal pain and enablement (TIP)
|Musculoskeletal (MSK) pain is a common problem for patients and it is often related to conditions such as osteoarthritis. MSK pain can be difficult to treat and can affect peoples’ social life, wellbeing and employment. It can be tricky for Primary Care Practitioners (GPs, nurses, and primary care physiotherapists) to know how best to help. Research shows that changing GP communication can help reduce pain and improve patients’ quality of life, satisfaction with their care, and also increase patients’ confidence to self-manage their health conditions. These could reduce the need for further treatments and appointment. This trial involves a communication e-learning training package that we developed and tested in a small feasibility trial. It aims to help increase expressions of empathy and realistic positive communication within remote and in-person primary care consultations. We will compare outcomes in GP practices that have been trained in the enhanced communication, with practices that have not had the training. We will measure the effects on patients’ pain, confidence in managing their symptoms, other symptoms, and quality of life with online questionnaires and interviews. We will also measure the economic costs of the training compared to any patient benefits. This enhanced communication might benefit all patients(not just those with MSK pain) so our project we will also include patients who present with other symptoms.
|The university's data protection policy governing the use of personal data by the university can be found on its' website: https://www.southampton.ac.uk/legalservices/what-we-do/data-protection-and-foi.page
|The privacy notice for research participants provides more information on how the University of Southampton collects and uses your personal data when you take part in one of our research projects and can be found at:
|Privacy Notice for Research Participants.pdf (southampton.ac.uk)
|World Hip Trauma Evaluation (WHiTE) Platform – a framework for clinical trials for fragility hip fracture in those aged 60 and over
|The WHiTE platform is a framework designed to efficiently deliver multiple randomised comparisons of interventions for patients aged 60 years and over with a hip fracture. It is based upon experience derived from the planning and delivery of a related group of randomised trials of interventions for hip fracture. The purpose of the platform is to simplify the patient pathway through research in this field and capture efficiencies in the reduction of documents and clinical reporting forms duplication. As new research questions arise, randomised comparisons will be added to the platform.
|White 11 FRUITI 02/02/2023
White 12 DUALITY 29/09/2023
|The Data Protection Act registration number is Z575783X for University of Oxford.
|World Hip Trauma Evaluation 11 Fix or Replace Undisplaced Intracapsular fractures Trial of Interventions (FRUITI)
|White 11 FRUITI We will examine whether either fixing the broken bone or replacing the hip joint gives a better result for people 60 years and over with hip fractures from at least 40 hospitals across the UK. We want to look at how well people feel and how active they are following their fracture. We will also work out the cost of the two treatments – for the individual, for the health service and in terms of social support in the year following the fracture
|The policy document can be accessed through the link below:
|World Hip Trauma Evaluation 12 Dual mobility versus standard articulation total hip replacement in the treatment of older adults with a hip fracture (DUALITY)
|White 12 DUALITY We will investigate two treatments for one specific type of hip fracture. Currently, surgeons use one of two types of total hip replacement, which is an operation to replace both the ball and socket of the hip joint. One type uses a small ball within the socket, in the other the ball is enclosed within a larger plastic ball; we do not know which is the better treatment. We will investigate which of these treatments gives a better result for people aged 65 years and over with a hip fracture from 30 hospitals across the UK. We want to look at whether people have had any complications after their surgery, particularly dislocation, where the ball comes out of the socket. We will ask people how they feel and how active they are a year after their fracture. We will also work out the cost of the two treatments – for the individual, for the health service and in terms of social support in the following year.
|Data protection policy | Compliance (ox.ac.uk)
Home | Compliance (ox.ac.uk)
The NDORMS data privacy and security notices can be found at:
|Randomized, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP)
|REMAP-CAP is a trial designed by clinicians who cared for patients and conducted research during the 2009 H1N1 pandemic. Planning began in 2011. REMAP-CAP builds on the combined input of the world’s leading ICU trial networks. These networks have enrolled tens of thousands of patients into trials. They have extensive experience designing, conducting, and reporting clinical trials that enrol patients who are severely ill.
|GBS3 THE CLINICAL AND COST-EFFECTIVENESS OF TESTING FOR GROUP B STREPTOCOCCUS IN PREGNANCY: A CLUSTER RANDOMISED TRIAL WITH ECONOMIC AND ACCEPTABILITY EVALUATIONS
|Group B Streptococcus is also known as GBS, Strep B or group B Strep. It is a common bacteria that normally causes no harm. In the UK, 1 in 4 pregnant women carry group B Strep in their vagina and rectum. You’re unlikely to know you carry it.
|Privacy Notice: Clinical, Medical and Human Physiology Research Participant Privacy Notice - The University of Nottingham
|If you carry group B Strep, your baby may be exposed to it around labour and birth. While most babies won’t be affected, there is a very small chance of your baby becoming seriously ill or even dying. In extremely rare cases group B Strep infection can cause miscarriage, early labour or stillbirth.
|This GBS3 trial is looking at whether testing pregnant women for Group B Streptococcus reduces the risk of infection in newborn babies compared to the current strategy in place in the UK. The current strategy in the UK is to offer antibiotics during labour to women who are considered at raised risk of their baby developing a group B Strep infection.
|There are two different tests, which we are comparing against the current strategy.
|Lab Based Test at 3-5 weeks before anticipated delivery date (Enriched Culture Medium Testing)
|Bedside Test at start of labour (Intrapartum Rapid Testing) – this is the test being offered at BCUHB.
|AIRWAYS-3: Randomised trial of a supraglottic airway device versus tracheal intubation during in-hospital cardiac arrest
|This is a multi-centre, open-label, pragmatic, individually randomised, parallel group, superiority trial and economic evaluation to determine the clinical and cost effectiveness of SGA (supraglottic airway device) versus TI (tracheal intubation) during in hospital cardiac arrest. The trial will be conducted in the acute setting in NHS hospitals throughout the UK
|Privacy Notice see Patient Information Sheet: Site File Trial Documentation (warwick.ac.uk)
The HRA/HCRW protect and promote the interests of patients and the public in health and social care research: Privacy notice - Health Research Authority (hra.nhs.uk). They give approval where the data collection is by the direct healthcare team, and the data is anonymised at the point of research.To find out more about patient information, and health and care research, please click on the link below: