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Research Design Service North East – Success Maker Service

Case Studies of researchers who have worked with Research Design Service North East

Resources for Living Pilot – awarded NIHR RfPB funding

For patients who survive head and neck cancer, side effects of treatment may limit the ability to eat and swallow, to consume certain foods, to work, travel and socialise around food. This study will include food workshops with a research chef and research team to explore the potential of ‘progressive cuisine’ to improve head and neck cancer survivors’ eating and experience of food. Advice focused on how to design and integrate the quantitative and qualitative elements of the project, and on maximising benefit for both current participants (as part of the research process) and for future patients.

DEVLOP UK – awarded NIHR HTA funding

Currently, only 1 in 5 donor lungs available in the UK are used in lung transplants. One of the reasons for this is that damage may occur, and poor function develop, around the time of death. Unfortunately, many patients who would benefit from a lung transplant die before suitable donor lungs become available. EVLP is a technique that allows previously unusable donor lungs to be used. Initial results suggested good patient outcomes but a large, well conducted study was needed before routine use. Support focussed on identifying experts in clinical trial design, statistics and health economics who helped build the research team and on refining the proposal. The official study launch generated substantial media interest. The findings of this study have been published in the Health Technology Assessment Journal.

FFA-UK – awarded NIHR RfPB funding

The NICE Bipolar Disorder guidelines recommend psychotherapy in addition to the treatment mainstay of medication and note the importance of family involvement in the management of young people with EOBD. There are however no UK studies of a family-based approach to psychotherapy for adolescents with bipolar disorder delivered in an NHS context. The research aimed to establish the feasibility and acceptability of using a family focused treatment (FFT-A UK version) as an adjunct to pharmacotherapy in the management of EOBD; and to assess the attitudes of young people and their families towards the requirements of research participation. Advisers were involved from the inception of this research; supporting the applicant to prepare an application for funding for pre-pilot work and then the RfPB application. The findings of this study have been published in the Pilot & Feasibility Studies Journal.

MAVRIC – awarded  NIHR RfPB funding

Aortic valve replacement (AVR) is one of the most common cardiac surgical procedures performed worldwide. Over one third of patients undergoing the conventional procedure develop clinically significant bleeding and require a transfusion, which can have adverse effects. Small scale retrospective studies have shown that blood loss and transfusion requirement is significantly less with a minimally invasive procedure; a robust trial of this is imperative. The MAVRIC trial will determine if manubrium-limited ministernotomy should be adopted as best practice for patients requiring AVR surgery. Advisers were instrumental in refining the research question, study design and statistical analyses. Trials of cardiac surgical procedures present unique challenges and expert input was crucial.

UK Mini Mitral – awarded NIHR HTA funding

Heart surgery to repair one of the valves in the heart (the mitral valve) is commonly performed in the NHS. To repair the valve, the operation usually involves cutting the breastbone completely (from the collar bone to the bottom of the breastbone); this is called a sternotomy. An operation has been developed which means that the valve can be repaired using a much smaller cut on the side of the chest.  This operation is called a mini-thoracotomy. It is currently not known which operation is better for patients and for the NHS because there is no good research to show what effects the two different types of surgery to access the heart and repair the valve have on patients. This is a multi-centre, randomised controlled trial, comparing mitral valve repair (MVr) via minimally invasive thoracoscopically-guided right minithoracotomy (intervention under study) and mitral valve repair via conventional median sternotomy (usual care) to determine return to usual return to usual activity based on change in the SF36v2 physical functioning scale at 12 weeks following surgery. 400 patients across 8 centres will be randomised in a 1:1 ratio between the intervention and usual care arms, stratified by baseline SF36v2 physical functioning scale and presence or absence of Atrial Fibrillation.

SORTED – awarded NIHR RfPB funding

Hypothyroidism (underactive thyroid) affects up to 16% of individuals. Currently, all individuals with hypothyroidism are treated as a uniform group irrespective of age. There are several compelling reasons as to why this may not be appropriate, one of which is the normal range of blood Thyroid Stimulating Hormone (TSH) level.  The TSH level is a marker of thyroid hormone replacement, is derived from healthy younger people and may not be appropriate across all age ranges.  Based on the findings of this feasibility study it was determined that a future definitive randomised controlled trial is possible.  To recruit to time and target it would require buy-in from a large number of general practices and the provision of patient study visits at home rather than hospital out-patients. The feasibility study also provided information on withdrawal rate and that to achieve the target TSH levels, several dose adjustments may be required.

Family based support to build capability and resilience in family carers of adults with learning disabilities and challenging behaviours: collaborative research – awarded NIHR RfPB funding

The aim of this research is to conduct a formative evaluation, using participatory approaches, of a new Family Based Support Programme for family carers of adults with learning disabilities and challenging behaviours. The intervention will incorporate aspects of Positive Behaviour Support and Acceptance and Commitment Therapy with a focus on mindfulness. The inclusion of the Positive Behaviour Support element was a direct outcome of the strong public involvement in the development of the funding application – parent carers advised that family members would be less likely to engage with an intervention that they saw as primarily “for them”. The research will provide qualitative insights regarding the elements of the programme that are most effective in supporting carers and building their resilience, and will also gather information regarding the criteria for success from the carers perspective.