Theme 3

Specific interests include attempts to understand the recruitment process from the perspective of the patient, clinician and observer, and how to resolve the tension between improving recruitment and maintaining patient voluntariness.

Current studies

RECRUIT
There is a need for well-tested medicines for children but there are potential difficulties in recruiting children into randomised controlled trials. RECRUIT is a pioneering study which uses qualitative methods to examine recruitment to clinical trials in children in neonatology, asthma, rheumatoid arthritis and neurological disorders. A triangulation of observation of trial recruitment encounters, family interviews and recruiter interviews gives valuable insight into the recruitment processes from different view points. Data will be analysed to create recommendations about recruitment to trials involving medicines for children.

The features of a late phase trial with high recruitment in paediatric oncology
Recruitment to trials in childhood leukaemia is usually very high. Data collected as part of the CRUK funded RAPPORT study (a longitudinal qualitative study of the parent-practitioner relationship in the care of children with acute lymphoblastic leukaemia - ALL) are being analysed to investigate what lessons can be learnt to optimise recruitment in other fields. Audio-recorded consultations between parents and consultants in which randomisation to the UK ALL 2003 trial was discussed will be triangulated against qualitative interviews with parents after these consultations to examine the conduct of communication about the trial in the light of how it was experienced by parents.

Comparing recruitment of children and adults to randomised controlled trials (PhD Studentship)
Insight into potential differences between adult and child recruitment is important to improve experiences of trial recruitment for both children and adults as well as to optimise enrolment procedures. This study will focus on trials which recruit both children and adults. The protocol is under development but data collection is likely to comprise observations of trial discussions between patients/families, interviews with patients and families approached to participate in a trial and interviews with practitioners involved in enrolling trial participants. Observations of trial management and steering group meetings and trial recruitment training events may also be analysed, together with documentary analysis of trial management and recruitment training literature.

The group is also interested in developing methods for maximising retention of patients through longer-term trials and in considering the implications of loss to follow-up for patient reported outcomes.

Current studies

Quality of Life and the SANAD trial.
The SANAD trial compared standard and new treatments for people with established epilepsy. Part of this trial involved measuring quality of life over 4 years. These data are being analysed for any predictors (clinical, demographic and patient reported outcomes) of withdrawal and retention. Predictors of withdrawal and retention will help in developing guidelines for maximising retention of patients through longer term trials.

The group is developing research around the degree of consensus and divergence between patients and clinicians about priorities for trial outcome measures, including meaningfulness and relevance to these groups of commonly employed outcomes.

Current studies

Examining different models of user involvement in the design and conduct of clinical trials (PhD Studentship)
User involvement in health research is now a central tenet of Department of Health policy. There is a developing evidence base around how to include users but less evidence around how cost-effective user involvement can be achieved.

This study will examine different models of user involvement across different trials to explore the perspectives of stakeholders about the process and outcome of involvement. An ethnographic approach will be adopted using a range of methods including interviews with patients, clinicians and trialists, observation of trial decision-making processes and a large survey of ongoing UK trials to explore widely employed models of user involvement.