March 2014 Study Highlight - ROSE (13911) - Cardiovascular and Non Malignant Haematology Specialty Groups
ROSE (Rivaroxaban Observational Safety Evaluation) is a national, non-commercial observational study that celebrates recruiting nearly 500 patients in the first four months of the three year study that aims to recruit 3400 patients overall.
To date nearly half the trusts in England and Wales have agreed to participate. The “first patient in” was recruited by Dudley Hospital four days after the study opened in September2013. Active sites are generally achieving their local FPI targets despite the study specific requirement to only follow what happens to patients in routine clinical practice.
The following PI and their teams have to date surpassed their original patient participation estimate and continue to recruit.
- Non-malignant haematology - Dudley Hospital, Newcastle upon Tyne NHS Trust (RVI).
- Stroke -University Hospital Leicester, Weston Area Health NHS Trust and University Hospitals Bristol.
- Cardiology - North Cumbria University Hospitals. With North West London Hospitals NHS Trust, Hillingdon and West Middlesex very near to target.
The study has been well supported across the networks and Specialty Groups.For example the Non-Malignant Haematology Specialty Group have helped raise awareness about the study, sending a study mailshot to their members and the study team have attended one of their national meetings.
Portsmouth Hospitals NHS Trust identified that patients without capacity were under represented in the target patient population leading to submission of a substantial amendment to include them in the study. The sponsor also shares the number of patients recruited into the study who experience Atrial Fibrillation with the Stroke Research Network.
For further information, please contact Pat Brown (ROSE study facilitator).
UK Recruitment to the ROSE study
February 2014 Study Highlight - PASTIES (10515)
The PASTIES study comprises two parallel randomised trials comparing patient controlled analgesia (PCA) to routine care in patients with non-traumatic abdominal pain and musculoskeletal injury.
Patients are recruited in the emergency department but the study follows patients for the first 12 hours after admission to hospital. Recruitment commenced in July 2011, but fell behind target over the first few months of the study period. Despite running well, the main challenges were recruiting patients into the study due to a lack of actively recruiting sites and set up across the existing sites.
The Injuries and Emergencies Specialty Group became involved in early 2012 once recruitment started to fall behind. They worked with the trial team and encouraged them to continue with the additional centre that they had already planned in Bristol.
The group also helped to find set up 2 additional centres Royal London and Leicester, which started recruiting in January 2013. The study is due to close at the end of January 2014, and has exceeded the recruitment targets.
If you would like further information on this study – please contact Catherine Lawrence, the Group’s Administrator.
LUMINOUS is one of the world’s largest observational studies in ophthalmology, following patients treated with Lucentis® (ranibizumab) in its licensed indications (wet age related macular degeneration, vision loss associated with diabetic macular oedema, macular oedema associated with retinal vein occlusion, myopic choroidal neovascularization) in a clinical practice setting.
There has been a strong clinical development program for Lucentis; in addition to this, real world data on its use in a clinical setting in patients more diverse than those included within the pivotal trials will help inform clinical practice.
Launched in March 2011, with an overall recruitment target of 30,000, the study will run for 5 years in over 40 countries. The UK has 44 participating sites and is currently the top recruiting country, contributing over 8000 patients of the current global recruitment of over 18,000 patients.
The success of the LUMINOUS study in the UK is in no small part attributable to the NIHR Clinical Research Network adopting this study to portfolio status. This results in access to the NHS infrastructure where there is a local network of dedicated skilled research support staff including research nurses and other allied health professionals, who can help identify eligible patients, arrange consent to participate in the study, monitor patients as they progress through the study and contribute to high quality data collection and input.
A recent investigator meeting held in the UK was well attended by both Principal Investigators and research staff.The levels of interactivity and enthusiasm were high, indicating the strong degree of ownership and motivation for the study.
This hard work is now translating into results, with data from the first interim analyses, of which the UK contributed over 40% of the patients, being recently presented to an audience of over 1000 of the world’s key ophthalmologists at the American Academy of Ophthalmology (AAO) in New Orleans 2013.Further data will be released at congresses over the coming years.
For further details please contact Mr Christopher Brand, UK Chief Investigator
Led by DeNDRoN and supported by the Age and Ageing Specialty Group
The study’s primary aim is to validate informant tools to identify patients with unrecognised dementia and delirium in the high risk setting of medical inpatients. Dementia affects up to 40% of older patients in general hospitals, but is often not recognised. The identification of dementia allows for the best care to be given during the inpatient stay as well as benefitting patients and carers on discharge. A diagnosis allows access to appropriate care planning and medication. The study is also examining clinical and novel inflammatory markers to see if these can be used to predict the poor outcomes associated with delirium.
This study exemplifies the practical and ethical difficulties involved in identifying, consenting and recruiting older patients who are acutely unwell and lacking capacity – all within the first 48 hours of admission to hospital. The main anticipated barrier to recruitment was the high number of consultee declarations needed as the majority of potential participants would lack capacity to consent at the time of enrolment. However, because of careful groundwork and awareness raising about the dearth of research in older adults and in those lacking capacity, consultees (usually family members) are very largely positive towards the study. Recruitment started in March 2013 is due to end in February 2015, and is currently well ahead of target.
The study is funded jointly through a Clinical Research Fellowship awarded to Dr Thomas Jackson from the Research into Ageing Fund at Age UK and the British Geriatrics Society (BGS). Age UK and BGS are key stakeholders of the Age and Ageing group and work closely with it to raise awareness and increase engagement in age-related research. The funding letter for this grant award contained the Age and Ageing specialty group leaflet, the name of the local Lead, and a clear expectation about this being an Age and Ageing portfolio study. The collaboration between Age and Ageing and the joint funders has enabled direct support of the clinical research fellow, through both study management and training, including Dr Jackson contributing to a national specialty group meeting.
For more information contact Dr Thomas Jackson email@example.com
The Acne Genetics Study (funded by the British Skin Foundation) is a multi-centre study aiming to identify genotypes associated with acne. Research indicates that there is a strong genetic basis to the development of acne. Family and twin studies showing that first degree relatives of acne sufferers have a 3-4 fold increased risk of acne but so far, few acne candidate genes have been proposed. Understanding the genetic basis of acne could potentially identify new therapeutic options, identify those genetically susceptible to severe scarring forms of the disease and help determine the relative contribution of environmental factors influencing disease phenotype and severity.The study was identified as being in need of support when it was realised that the initial sample size estimate for the study was too low and needed to be increased dramatically from 2000 to 5000 patients. The closing date of the study was not an issue and so the solution proposed was to identify more recruiting centres to help boost recruitment.
The Dermatology Specialty Group (DSG) identified this as a study to which they could make a difference. Over ten additional recruiting centers were opened by local leads, who then raised the profile of the study on a local basis. In addition the study was discussed as a standing item at DSG National Meetings with the CI Catherine Smith who is the local lead for dermatology for London South. CLRNs have helped by providing nursing support for the study on an on-going basis.
Before DSG involvement the study recruited 2,662 patients in the 3 year period March 2008-June 2011. Following DSG involvement recruitment almost doubled over the next 12 months increasing to 4,705 by June 2012 and then up to 7,254 by end of July 2013.
For further details you can contact Robert Pleass, who is the Dermatology Research Manager at Guy's and St. Thomas' NHS Foundation Trust, and the study co-ordinator for the "Genetics in Acne" project.