Summary

We design and deliver studies that explore participants' and researchers' experiences of many aspects of RCTs across a range of clinical areas and using a range of different methodologies.  Some of these studies have been primary qualitative studies (using interviews, focus groups and non-participant observations) that have explored the following:

  • patients experiences of the recruitment process;
  • patients experiences of retention in trials;
  • stakeholders (patients, trialists, research nurses, trial managers, ethics committee members) perceptions of how best to support informed decisions about trial participation and what outcomes matter for evaluation;
  • development of measures of decision quality for RCT informed consent;
  • trial site staff’s (consultants and research nurses) experiences of recruiting to RCTs;
  • surgeons and methodologists perceptions and beliefs about expertise based RCTs;
  • stakeholders’ beliefs and perceptions of placebo controlled surgery.

In addition to primary studies, we have also delivered a number of syntheses of qualitative studies exploring participant reported reasons for trial participation or drop-out.

Work in this area is actively ongoing across the portfolio of RCTs.

Contact

Katie Gillies; k.gillies@abdn.ac.uk

Louise Locock; louise.locock@abdn.ac.uk

Status

Ongoing

Publications

Boylan, A-M, Locock, L. & Machin, L. (in press). 'From waste product to blood, brains and narratives: developing a pluralist sociology of contributions to health research'. Sociology of Health & Illness

Skea, ZC, Treweek, S. & Gillies, K. (2017). 'It’s trying to manage the work”: A qualitative evaluation of recruitment processes within a UK multi-centre trial'. BMJ Open, vol 7, no. 8, pp. 1-8.

Locock, L. & Boylan, A-M (2016). 'Biosamples as gifts? How participants in biobanking projects talk about donation'. Health Expectations, vol 19, no. 4, pp. 805-816.

Gillies K, Entwistle V, Treweek SP, Fraser C, Williamson PR, Campbell MK. Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. Trials. 2015 Oct 27;16:484.

Luchtenberg, M., Maeckelberghe, E., Locock, L., Powell, L. & Verhagen, AAE. (2015). 'Young People's Experiences of Participation in Clinical Trials: Reasons for Taking Part'. American Journal of Bioethics, vol 15, no. 11, pp. 3-13.

Gillies, K., Skea, ZC. & Campbell, MK. (2014). 'Decision aids for randomised controlled trials: a qualitative exploration of stakeholders' views'. BMJ Open, vol 4, no. 8, e005734

Gillies, K., Elwyn, G. & Cook, J. (2014). 'Making a decision about trial participation: the feasibility of measuring deliberation during the informed consent process for clinical trials'. Trials, vol 15, no. 1, pp. 307

McCann S, Campbell M, Entwistle V. Recruitment to clinical trials: a meta-ethnographic synthesis of studies of reasons for participation. J Health Serv Res Policy. 2013 Oct;18(4):233-41