22. European Stroke Conference 961 Recent news in stroke research Assessing the Experience of Stroke Patients participating in Research Studies C.L. Kelly1, J.M. Ford2, J. Hardicre3 Salford Royal NHS Foundation Trust, Manchester, UNITED KINGDOM1, Salford Royal NHS Foundation Trust, Manchester, UNITED KINGDOM2, Salford Royal NHS Foundation Trust, Man-chester, UNITED KINGDOM3 Background The North West Stroke Research Network (NW SRN) supports a portfolio of research studies at hospitals across the North West of England. We conducted a survey of research participants in 2011 to assess the performance of our staff in relation to patient experience of being in a trial. The results indicated some areas where improvements could be made. We conducted staff training during the first quarter of 2012 and carried out a second survey to assess the impact of this on participant expe-rience. 854 © 2013 S. Karger AG, Basel Scientific Programme Method A 6 months retrospective survey was conducted in 2011 using a questionnaire developed in conjunc-tion with stroke survivors and carers. This included Likert scales and free text. The survey was re-peated in 2012 to assess whether staff training had resulted in improved participant experience Results On each occasion ~450 questionnaires were sent out; the response rate was ~30%; ~10% were com-pleted by a carer and ~90% by patients with ~50% male respondents. Overall there was an improvement in reported participant experience between 2011 and 2012 with average scores from the question “Based on your experience, would you take part in future research trials” showing an increase from 7.8 to 8.7 out of 10. The one negative change was an increase in the percentage of participants who could not remember which trial there were in or were unaware of having participated in a trial raising from 26% to 38%. There was also less regional variation in 2012 compared with 2011. Conclusion There is evidence that training provided to NW SRN staff in 2012 has improved participant experi-ence. The reduction in the variation in between regions suggests that good practice has been shared. The decrease of awareness in participants of being a trial may be caused by difference in trials e.g. no follow-ups, hyper-acute studies, more control groups. It could suggest poorer information giving, but this contradicted by reported improved satisfaction with information given. 962 Recent news in stroke research Successful Delivery of Stroke Rehabilitation Trials of Complex Interventions: The Examples of the Training Caregivers after Stroke (TRACS) and Longer Term Stroke Care (LoTS care) Trials. J. Dickerson1, A. Forster2, K. Chapman3, K. Mellish4, J. Young5, A. Patel6, L. Kalra7, J. Nixon8, D. Smithard9, M. Knapp10, I. Holloway11, S. Anwar12, A. Farrin13 University of Leeds and Bradford Teaching Hospitals NHS Trust, Bradford, UNITED KING-DOM1, University of Leeds and Bradford Teaching Hospitals NHS Trust, Bradford, UNITED KINGDOM2, Bradford Teaching Hospitals NHS Trust, Bradford, UNITED KINGDOM3, Bradford Teaching Hospitals NHS Trust, Bradford, UNITED KINGDOM4, University of Leeds and Bradford Teaching Hospitals NHS Trust, Bradford, UNITED KINGDOM5, King’s College London, London, UNITED KINGDOM6, King’s College London, London, UNITED KINGDOM7, Univeristy of Leeds, Leeds, UNITED KINGDOM8, King’s College London, London, UNITED KINGDOM9,Lon-don School of Economics and Political Science, London, UNITED KINGDOM10, University of Leeds, Leeds, UNITED KINGDOM11, University of Leeds, Leeds, UNITED KINGDOM12, Univer-sity of Leeds, Leeds, UNITED KINGDOM13 Background: Research trials looking at complex interventions in healthcare settings pose numer-ous challenges in both trial design and project management. This paper describes in detail the study methods and management used to achieve successful delivery of two pioneering cluster randomised controlled trials (RCTs) of complex interventions in stroke rehabilitation - the TRACS and LoTS care trials. Methods: When a complex intervention is to be embedded in the usual care of a health service and delivered by the care team, a cluster RCT design is the method of choice. This minimises the risk of between-group treatment contamination, but does expose the research to a number of other risks of bias. Challenges in cluster trial design include: identifying and completing setup for all clusters prior to block randomisation; ensuring the use of independent researchers, the blinding of all participants, and continual monitoring to avoid any selection bias. Challenges related to the complex intervention include: engaging all clinical staff at an early stage; training of staff in the intervention; giving suffi-cient time for the intervention to be embedded before recruitment commences; and monitoring usual care in the control arm. Results: The TRACS and LoTS care trials are the first ever successfully completed large scale mul-ticentre cluster RCTs of complex interventions in stroke rehabilitation. They are also the two largest stroke rehabilitation RCTs in the world completed to date, recruiting 928 patient and caregiver dy-ads, and 800 patients and 208 carers respectively. Conclusions: It is possible to successfully deliver cluster RCTs of complex interventions in stroke rehabilitation. We describe aspects of trial design, planning and management that are crucial to effective delivery. Future large scale cluster RCTs of complex interventions should adhere to the methods and management used in TRACS and LoTS care.
Karger_ESC London_2013
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