<p>Title: Challenges in maximising recruitment to an RCT through working with a service user group</p><p>Authors: Alys Young, Gill Pearl and Audrey Bowen on behalf of the ACT NoW Study</p><p>Institutional affiliation: University of Manchester</p><p>Email: [email protected]</p><p>Telephone: 0161 275 8230</p><p>Abstract</p><p>Background Low levels of recruitment into randomised controlled trials is a recurring difficulty and one that potentially threatens the validity of any RCT (Donovan et al, 2002a; 2002b). In cognate fields, research has been carried out with trial participants and other service users to understand the likely difficulties associated with recruitment from user perspectives and to modify recruitment materials and methods to maximise participation (Edwards et al, 1998; Featherstone and Donovan, 1999). However, the vast majority of this work has taken place with service users who would not experience communication challenges in participating in the research in the first place. By contrast, this paper concerns a study in which service users with aphasia and/or dysarthria worked alongside researchers, within a participatory action research framework, to design the recruitment materials that would be used in a large RCT (the ACTNoW trial).</p><p>Method Eight service users (with aphasia and/or dysarthria) and two carers were recruited to participate in monthly meetings facilitated by a qualified speech and language therapist and an experienced qualitative researcher. The aims of involvement were to design information and consent materials that would be used in the recruitment of patients with aphasia and/or dysarthria to a randomised controlled trial. These designs had to be such as to: (i) meet the required content of MREC approved studies; (ii) be adaptable and flexible to meet the full range of likely communication impairments and challenges faced by potential recruits; (iii) be likely to maximise recruitment to the RCT. From a methodological point of view the key challenges were to: (i) to ensure maximal understanding and participation from group members who themselves displayed a range of communication impairments; (ii) to adapt traditional focus group techniques to meet the range of communication needs in the group; (iii) to deliver a product that was both ‘aphasia – friendly’ and ‘MREC – friendly’.</p><p>1 Results Three kinds of results will be presented. (i) an analysis of the range of group work techniques and adaptations made in order to ensure understanding of task and group functioning as research partners; (ii) an analysis of barriers to understanding key concepts such as ‘trial’; ‘randomisation’; ‘informed consent’; ‘interview’; ‘research’; and associated timescales and how these were overcome. (iii) samples of the range and kinds of materials that were developed with evaluation of underpinning rationale.</p><p>Discussion The range of multi media techniques for information, consent materials that were developed was commended by MREC and has been used already in the completed feasibility study associated with the trial. High feasibility study recruitment was positively affected by the materials and no major changes are required going into the main trial</p><p>Conclusion The successful work of the research user group (RUG) is continuing into the main 4 year trial where they will play a central role within training, monitoring, support and dissemination of the study. [word count: 468]</p><p>References Donovan J., Mills N., Smith M., Brindle L., Peters T., Frankel S., Neal D., Hamdy F. (2002a) Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT study. BMJ 325; 766-770.</p><p>Donovan J., Brindle L., Mills N. (2002b) Capturing users’ experiences of participating in cancer trials. European Journal of Cancer Care 11: 210-214.</p><p>Edwards S.J.L., Lilford R.J., Hewison J. (1998) The ethics of randomised controlled trials for the perspectives of patients, the public, and healthcare professionals. BMJ 317: 1209-1212.</p><p>Featherstone K., Donovan J.L (1999) Random allocation of allocation at random? Patient’s perspective of participation in a randomised controlled trial. BMJ 317: 1177-1180.</p><p>2</p>