NIHRDataInsights/HRCSData huggingface dataset:
Title: Comparison of close contact cast (CCC) technique to open surgical reduction and internal fixation (ORIF) in the treatment of unstable ankle fractures in patients over 60 years
Funder: Department of Health (England)

Abstract: Ankle fractures account for 9% of all fractures with a quarter of these occurring in adults over 60. The short term disability and long-term consequences on restoring independence are considerable in this older age group where multiple co-morbidities are common; and a threefold increase is predicted by 2030. The current treatment options for the older patient are open reduction and internal fixation (ORIF) and traditional moulded plaster of Paris but both are associated with complications including malunion and soft tissue healing. We will compare ORIF with a modification of the traditional casting treatment - close contact casting (CCC) which provides better fracture stabilisation potential and lower skin damage risk. It is a technique developed from the total contact casting used extensively and successfully for more than 20 years in treating leg ulcers in diabetics who have the frailest of skin. Participants will be randomised to receive ORIF or CCC after emergency admission for surgery for displaced unstable ankle fractures in the Trauma and Orthopaedic Surgery Departments of a minimum of 20 NHS acute hospitals throughout the UK. Ankle fracture healing takes 6-8 weeks and recovery is achieved to a steady state by 6 months; this defines the study duration and time points for data collection in this trial. The 6 month review will be undertaken to monitor changes in mobility function health related quality of life complication rates and resource use associated with each of the interventions. That review will be conducted face to face by an assessor blinded to the intervention. The parallel economic evaluation will consider both an NHS perspective and a broader societal perspective including the individual and their family.


Research activity codes: 6.3 MEDICAL DEVICES;6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS
Title: Diagnostic accuracy of the Thessaly Test standardised clinical history and other clinical examination tests for meniscal tears
Funder: Chief Scientist Office (Scotland)

Abstract: The study aims to determine if the Thessaly test can be used by primary care clinicians as an effective screening tool for meniscal tears. An accurate diagnostic test could obviate the need for referral to hospital based clinicians or further investigation by MRI or arthroscopy thus reducing NHS costs and freeing up NHS resources.There is evidence that the Thessaly test a dynamic reproduction of joint loading in the knee has high sensitivity specificity and accuracy for detecting both medial and lateral meniscal tears. However in the presence of other knee pathologies such as ACL injury the sensitivity and specificity are significantly reduced. More recently a combination of the Thessaly test with either joint line tenderness or McMurrays has been reported to have better diagnostic accuracy but no normal knees were included in the study. Our study aims to recruit 300 knee patients and 50 control normal knees to examine if any test or combination of tests has high diagnostic accuracy when performed by knee specialists and non-specialists. We will also include a range of other knee pathologies to see if they influence the accuracy of the Thessaly or other tests.The study will be run in the Orthopaedic Unit at Glasgow Royal Infirmary where patients with knee pathology will be examined by both a knee specialist and a primary healthcare clinician. Each clinician will take a clinical history and use 4 physical tests to diagnose meniscal tear (Thessaly Test McMurray’s Test Apley’s Test and Joint Line Tenderness Test) in a randomised order. All patients will then have an MRI scan to determine the true presence of meniscal tear. We do not plan to make any direct interventions in patient care.


Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: INJURIES AND ACCIDENTS
Title: Randomised trial of a multifaceted podiatry intervention for fall prevention
Funder: Department of Health (England)

Abstract: BackgroundFalls and fall related fractures are a serious cause of morbidity and cost to society a burden which will increase with an ageing population. There is some evidence to suggest that foot problems and inappropriate footwear may increase the risk of falls whilst some treatments provided by podiatrists such as lesion debridement and foot orthoses may improve balance. Apart from one recently completed trial in Australia there has not been a large pragmatic trial evaluating the role of podiatric care combined with footwear advice and orthotic inserts for falls prevention or any assessment of whether it would be economically viable within a UK setting. This trial aims to address these issues. AimThe aim of this study is to compare the clinical and cost effectiveness of a multifaceted podiatry intervention for falls prevention in the over 70s and assess the podiatrist’s and participant’s views and experiences of the intervention and the trial process.Intervention A multifaceted podiatry intervention consisting of: footwear assessment and shoe provision; foot orthosis; foot and ankle exercise programme falls prevention leaflet.ControlUsual care and a falls prevention leafletParticipantsCommunity dwelling men and women aged 70 years and over who have had one fall in the past 12 months or one fall in the past 24 months requiring hospital attention will be eligible for the study. OutcomesThe primary outcome is the rate of falls (i.e: falls/person/time) over a 12 month period.Secondary outcomes include: Proportion of fallers proportion of multiple fallers patient reported time to first fall during follow-up EQ-5D short falls efficacy scale fear of falling activity of daily living fracture rate health service utilisation and geriatric depressions scale.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;6.7 PHYSICAL
Health categories: INJURIES AND ACCIDENTS
Title: A randomised controlled trial of standard-of-care wound management versus negative pressure wound therapy in the treatment of adult patients with an open fracture of the lower limb
Funder: Department of Health (England)

Abstract: Feasibility summaryThe feasibility phase will take place in 5 centres over a period of 6 months. The trial will run as described below with the addition of a qualitative sub-study assessing patients’ experience of giving consent for the trial and the acceptability of the trial procedures to patients and staff. Screening logs will be kept at each site to determine the number of patients assessed for eligibility and reasons for any exclusion. In addition the number of eligible and recruited patients and the number of patients who withdraw will be recorded. Main RCT summary All adult patients presenting at the trial centres within 72 hours of sustaining an open fracture of the lower limb are potentially eligible to take part in the trial. Inclusion within the trial depends on the severity the wound associated with the fracture; Gustilo and Anderson Grade 2 and 3 injuries will be included.A randomisation sequence stratified by trial centre patient age (as a surrogate for bone density) and Gustilo and Anderson grade will be administered via a secure web-based service. The allocation will be to either standard wound management or negative pressure wound therapy applied at the end of the initial surgical debridement of the wound.The patients will have clinical follow-up in the local fracture clinic up to a minimum of 12 months as per standard NHS practice after this injury. Functional and quality of life outcome data will be collected using the DRI SF36 and EQ-5D questionnaires at 3 months 6 months 9 months and 12 months post-operatively. These postal questionnaires will be administered centrally by a data administrator. In addition information will be requested with regards to resource use and any late complications or surgical interventions related to their injury with specific note of continuing treatment for deep infection.


Research activity codes: 6.3 MEDICAL DEVICES;6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS
Title: European study of therapeutic hypothermia (32-35°C) for intracranial pressure reduction after traumatic brain injury (Eurotherm3235)
Funder: Chief Scientist Office (Scotland)

Abstract: Design (PR): Prospective randomised controlled trial. Setting: Intensive care units providing care for patients after TBI.Strategy for literature review: 9 systematic reviews (2011) on hypothermia and traumatic brain injury were published 2002-09 (2 Cochrane reviews). Assessment of the relevance to this trial intervention was made.Target Population: Adult patients following TBI who have ICP > 20mmHg abnormal brain CT scan core temperature > 36°C not pregnant.Health technologies assessed: This trial is not an assessment of a particular cooling device but an assessment of the effectiveness of therapeutic hypothermia using the usual cooling method available at each centre. Measurement of costs and outcomes: Assessment of functional outcome is using the extended Glasgow Outcome Score. This will be administered by postal questionnaire in the first instance however if this is not returned patients will receive a telephone call from the trial team to go through it.An economic evaluation will be performed. The costs and benefits of therapeutic hypothermia will be measured and compared against the current treatment for TBI.Project timetables: An internal pilot has been completed and has developed the largest non-commercial neuro-critical care collaborative network to date. In the UK we have 20 specialist centres that will on average admit 40-50 TBI patients per year (range 40-135 patients/year RAIN database). Recruitment Plan. This describes centre & patient recruitment to achieve approximately 0.3 patients/centre/month and is based on feasibility assessment during the internal pilot.Timetable: No of sites/centres Patients recruited CumulativeCumulativeInternal pilot 27 50Year 1 to July 2013 71 205Year 2 to July 2014 80 325Year 3 to July 2015 80 461Year 4 to July 2016 80 600Year 5 Close out analysis write up & publishExpertise in team: The multi-disciplinary team includes international experts in trial design & management clinical specialists from surgery and medicine statistical expertise (world leading) health economic analysis (from an NHS department increasing relevance to service) and author of a relevant systematic review.


Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: INJURIES AND ACCIDENTS
Title: For patients with a displaced fracture of the distal tibia is there a clinical and cost-effectiveness difference between ‘locking’ plate fixation and intramedullary nail fixation? (FixDT)
Funder: Department of Health (England)

Abstract: Design: The proposed project is a multi-centre randomised clinical trial comparing two techniques for the operative fixation of fractures of the distal tibiaSetting: Patients will be recruited from Major Trauma Centres and Trauma Units accross the UKTarget population: Adult patients with an extra-articular fracture of the distal tibia.Health technologies being assessed: Intramedullary nailing versus locking plate fixationMeasurements of cost and outcomes: The primary outcome measure for this study is the Disability Rating Index. The DRI score is a validated questionnaire which is self-reported. It consists of 12 items specifically related to function of the lower limb. The secondary outcome measures in this trial are: Olerud and Molander (OMAS) is a self-administered patient questionnaire. It is a good outcome tool for assessing symptoms after an ankle fracture. The score is based on nine different items: pain stiffness swelling stair climbing running jumping squatting supports and work/activities of daily living. The scoring system correlates well with parameters considered to summarise the results after this type of injury and is therefore recommended for use in scientific investigations. EQ-5D; a validated generalised quality of life questionnaire consisting of 5 domains related to daily activities with a 3-level answer possibility. The combination of answers leads to the QoL score. Complications; all complications will be recorded.Radiographic evaluation; Standard anterior-posterior and lateral radiographs of the tibia and fibula will be taken at baseline 6-weeks and 12 months after the injury. Resource use will be monitored for the economic analysis. NHS costs associated with each arm of the trial will be estimated using data from the finance departments of the hospitals and services concerned and national sources. The cost consequences following discharge including NHS costs and patients out-of-pocket expenses will be recorded via a short questionnaire which will be administered at 3 6 and 12 months post surgery. Patient self-reported information on service use has been shown to be accurate in terms of the intensity of use of different services.


Research activity codes: 6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS
Title: Refining, Reducing and Replacing in vivo WHO-standard preclinical assays of snake venom pathology and antivenom efficacy.
Funder: National Centre for the Replacement, Refinement and Reduction of Animals in Research

Abstract: The Alistair Reid Venom Research Unit (ARVRU) of the Liverpool School of Tropical Medicine (LSTM) and MicroPharm Ltd have a long association in the production and delivery of life-saving snake antivenoms for West Africa, which suffers the continent’s highest snakebite mortality burden. Antivenom is the mainstay of snakebite treatment and is immunoglobulin purified from the sera of venom-immunised horses and sheep. There is a legal/regulatory requirement to conduct in vivo preclinical efficacy testing of new and existing antivenoms prior to human treatment. These assays carry a 'substantial' severity grading by the UK HOme Office. The objective of this PhD Studentship is to assess whether a cell-based system can be used to replace in vivo preclinical testing, and to determine the extent to which various 3R-modifications can be incorporated into these assays to reduce the numbers of animals and the associated pain, suffering and distress whilst retaining the scientific/regulatory validity of the assays.


Research activity codes: 5.1 PHARMACEUTICALS;5.9 RESOURCES AND INFRASTRUCTURE (TREATMENT DEVELOPMENT)
Health categories: INJURIES AND ACCIDENTS
Title: Development of non-radioactive labels for a receptor binding assay for paralytic shellfish poisoning (PSP) toxin testing
Funder: National Centre for the Replacement, Refinement and Reduction of Animals in Research

Abstract: There is an important need to perform detection of toxins in shellfish to safeguard the public. If consumed, illnesses ranging from severe food poisoning to paralysis and death can result. Due to factors such as climate change and increasing pollution the number of toxic episodes is markedly increasing each year. For many years the major tool for biotoxin monitoring in shellfish has been the mouse bioassay (MBA). While this has served to protect the public it has resulted in the painful deaths of over a million mice annually. Enormous efforts are being placed into finding alternatives to the MBA and Queen’s University have had a major role in this by developing fast, reliable and low cost rapid screening tests. The current project is aimed at advancing a receptor based test developed by another research group into a method which will gain global acceptance as a replacement to the MBA. While the receptor test developed by an American research group has been shown to be very effective in detecting a wide range of toxins it has one very major disadvantage, i.e. it currently needs a radioactive component to work. In many parts of the world it is either not permitted to use radioisotopes or dealing with them is a very difficult and expensive procedure. The research effort will be to replace this radioactive element with a safe and easy to use label which will remove a huge hindrance to the global uptake of the receptor test. The new procedure developed will be rigorously tested to make sure it provides a high level of assurance that shellfish are safe to eat. Stakeholders from regulatory agencies and shellfish producers will be invited to a workshop to have a demonstration of the method and receive training in its use. The method will also be subject to a collaborative study.


Research activity codes: 3.5 RESOURCES AND INFRASTRUCTURE (PREVENTION)
Health categories: INJURIES AND ACCIDENTS
Title: Improving the principles of the 3Rs through new integrative metabolomic and gene expression resources for signalling studies in burn injuries
Funder: National Centre for the Replacement, Refinement and Reduction of Animals in Research

Abstract: Burn injury-associated pain is an excruciating type of pain that is often compounded by a lack of successful pain control. In order to develop better pain control in burn injuries, a more detailed understanding of the molecular basis of burn injury-associated pain is required. Mechanistically, such pain is believed to be mediated by poorly characterised biologically active substances that accumulate in burn-injured tissues during tissue damage which, in-turn, cause inflammatory processes that activate and/or sensitise nociceptive sensory nerve fibres in and around the injured area through cell receptors. Here, we aim to create a comprehensive new integrative biological resource defining the metabalome of burn injured tissues, and of gene expression profiles of primary sensory neurons (PSN), all of which will be made available to the research community to promote further studies of the molecular basis of burn injury-associated pain. Using state-of-the-art high resolution technologies, this study will provide more relevant, reliable and detailed information using significantly reduced numbers of animals than conventional hypothesis-driven studies. Further, this study will represent a significant improvement in refinement, as animal subjects will not experience pain, suffering or distress. Finally, this study will also define a significant improvement in replacing studies on live animals, as gene expression studies will use cultured PSN. We believe that the databases we will generate will be valuable resources that will significantly contribute to improving the 3Rs across pain and burns research.


Research activity codes: 2.6 RESOURCES AND INFRASTRUCTURE (AETIOLOGY);2.1 BIOLOGICAL AND ENDOGENOUS FACTORS
Health categories: INJURIES AND ACCIDENTS
Title: Self-Harm wEb Portal Cymru (SHeP-Cymru)
Funder: Division for Social Care and Health Research (Wales)

Abstract: Self-harm is an important public health and social care problem covering a spectrum of behaviours and intents. Assessing and reducing the risks and needs of people who self-harm is potentially one of the most important objectives for suicide prevention strategies. Currently there is no monitoring of self-harm beyond emergency department attendance for planning of wider service provision. Most people who self-harm are managed in general practice or seek no help at all and are not represented by current research or practice. The support needed by individuals who self-harm goes beyond that provided by health services including support with housing, employment and support for families. This aim of this study is to develop an innovative web-based platform for self-harm research. Such a platform will allow participants both known and unknown to services to contribute to research in a safe and ethical manner. Consent will be sought from Welsh residents to link information gained via the web-portal with routinely collected data in the Secure Anonymised Information Linkage (SAIL) databank. This innovative design will allow service provision to be informed by both routinely collected data that can go beyond emergency department attendance (incorporating contact with general practitioners and hospital admissions) and, by individuals themselves, including those who remain unknown to services. In addition individuals will be asked to contribute sources of information and advice that they have consulted in any form (e.g. books, websites etc) to a secure database, allowing the quality of these resources to be assessed. A methodology will be developed for assessing the impact of quality and quantity of media exposure on behaviour at both a group and individual level. Such a design will provide a unique platform for future research and recruitment with the potential for creating the most comprehensive picture to date of individuals who self-harm.


Research activity codes: 5.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: INJURIES AND ACCIDENTS
Title: A community trial to determine whether 'Safe Storage' reduces pesticide self-poisoning in rural Asia.
Funder: Wellcome Trust

Abstract: We will set up a large community-based, cluster randomised controlled trial of162 villages (mean adult population 900) in rural Sri Lanka to determine the effectiveness and cost of the provision of safe storage containers to prevent pesticide poisoning. The study will be based in Anuradhapura District where wehave carried out public health studies of pesticide poisoning since 2002. 81 intervention and 81 control villages will be recruited. Randomisation will be clustered, with villages rather than households randomised. A census will be performed at baseline and after 3 years to establish the population demographics and number of person-years exposed. The primary outcome will be the incidence of pesticide self-poisoning; secondary outcomes will be the incidence of all self-poisoning, all self-harm, fatal self-harm, pesticide poisioning and unintentional paediatric pesticide poisoning. We will use Poisson regression models, taking account of clusteringand stratification, for the analysis. The study will provide definitive evidence concerning the cost-effectiveness of this approach that will determine whether it should be promoted across Asia


Research activity codes: 3.2 INTERVENTIONS TO ALTER PHYSICAL AND BIOLOGICAL ENVIRONMENTAL RISKS
Health categories: INJURIES AND ACCIDENTS
Title: Development of a synthetic bioactivated membrane dressing
Funder: Wellcome Trust

Abstract: Scarring impacts many patients, for example by reducing movement of the limbs or even making people blind. Scars are also often unsightly sometimes causing psychological problems When wounds such as burns are treated, the main priority is to stop dehydration and infection; no dressings are designed to actively prevent scar formation. We have invented membrane technologies that can incorporate a molecule that is one of the body's natural protections against scar formation, this molecule is called Decorin. We have shown that this molecule, delivered from a membrane wound dressing, can stop formation of scars in the lab. In this project, we will demonstrate that the new dressing is successful in both animals and humans. Importantly, we will make sure that the technology can be produced in large quantities that behave in a predictable way, so that it could be turned into a medical product and used in the clinic. The resulting medical product will help to improve the quality of life of many patients who have been injured in a way that would normally result in scarring. If this new dressing is successful in treating burns it could also be used in many other applications where scarring is a problem.


Research activity codes: 6.3 MEDICAL DEVICES;5.3 MEDICAL DEVICES
Health categories: INJURIES AND ACCIDENTS