Abstract
BackgroundHealth services research is expected to involve service users as active partners in the research process, but few examples report how this has been achieved in practice in trials. We implemented a model to involve service users in a multi-centre randomised controlled trial in pre-hospital emergency care. We used the generic Standard Operating Procedure (SOP) from our Clinical Trials Unit (CTU) as the basis for creating a model to fit the context and population of the SAFER 2 trial.MethodsIn our model, we planned to involve service users at all stages in the trial through decision-making forums at 3 levels: 1) strategic; 2) site (e.g. Wales; London; East Midlands); 3) local. We linked with charities and community groups to recruit people with experience of our study population. We collected notes of meetings alongside other documentary evidence such as attendance records and study documentation to track how we implemented our model.ResultsWe involved service users at strategic, site and local level. We also added additional strategic level forums (Task and Finish Groups and Writing Days) where we included service users. Service user involvement varied in frequency and type across meetings, research stages and locations but stabilised and increased as the trial progressed.ConclusionInvolving service users in the SAFER 2 trial showed how it is feasible and achievable for patients, carers and potential patients sharing the demographic characteristics of our study population to collaborate in a multi-centre trial at the level which suited their health, location, skills and expertise. A standard model of involvement can be tailored by adopting a flexible approach to take account of the context and complexities of a multi-site trial.Trial registrationCurrent Controlled Trials ISRCTN60481756. Registered: 13 March 2009
Highlights
Health services research is expected to involve service users as active partners in the research process, but few examples report how this has been achieved in practice in trials
UK government policy requires involvement by service users in all research undertaken through the National Health Service (NHS) [4,5,6,7,8] and most national and international research funding programmes expect service users to be involved in the development and conduct of studies which are submitted to them [9,10,11]
Proposed structures of involvement We developed a model for involvement that took into account the multiple layers of a multi-site trial and allowed active involvement in overall or specific aspects of the trial
Summary
Health services research is expected to involve service users as active partners in the research process, but few examples report how this has been achieved in practice in trials. We implemented a model to involve service users in a multi-centre randomised controlled trial in pre-hospital emergency care. There is increased expectation that people who use health and care services should be involved in research including trials, but little evidence that this is happening in practice. Though service user involvement in health services research is growing, the majority of studies in which service users are involved are qualitative, rather than trials [1,2,3]. The network of UK Clinical Trials Units encourages service users to work with researchers in designing and undertaking trials (see http://www.ukcrc-ctu.org.uk/?page=Patients). Involving service users in research is encouraged to improve relevance, quality and accountability of research [12,13,14,15,16]
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