Email updates

Keep up to date with the latest news and content from BMC Medical Research Methodology and BioMed Central.

Open Access Research article

Balancing high accrual and ethical recruitment in paediatric oncology: a qualitative study of the 'look and feel' of clinical trial discussions

Lucie MT Byrne-Davis1*, Peter Salmon2, Katja Gravenhorst2, Tim OB Eden3 and Bridget Young2

Author Affiliations

1 University of Manchester, Education & Research Centre, University Hospital of South Manchester, Southmoor Road, Manchester, M23 9LT UK

2 Institute of Psychology, Health and Society, University of Liverpool, Whelan Building, Brownlow Hill, Liverpool, UK

3 Academic Unit of Paediatric and Adolescent Oncology, School of Cancer Studies and Enabling Sciences, University of Manchester, c/o Christie Hospital, Manchester, UK

For all author emails, please log on.

BMC Medical Research Methodology 2010, 10:101  doi:10.1186/1471-2288-10-101

Published: 22 October 2010

Abstract

Background

High accrual to clinical trials enables new treatment strategies to be tested rapidly, accurately and with generalisability. Ethical standards also must be high so that participation is voluntary and informed. However, this can be difficult to achieve in trials with complex designs and in those which are closely embedded in clinical practice. Optimal recruitment requires a balance of both ethical and accrual considerations. In the context of a trial of stratified treatments for children with acute lymphoblastic leukaemia (UKALL2003) we examined how recruitment looked to an observer and how it felt to the parents, to identify how doctors' communication could promote or inhibit optimal recruitment.

Methods

We audio-recorded, transcribed and analysed routine doctor-patient consultations (n = 20) and interviews between researchers and parents (n = 30 parents) across six UK treatment centres. Analysis was informed by the constant comparative method. For consultation transcripts, analysis focussed on how doctors presented the trial. We compared this with analysis of the interview transcripts which focussed on parents' perceptions and understanding of the trial.

Results

Parents and doctors discussed the trial in most consultations, even those that did not involve a decision about randomisation. Doctors used language allying them both with the trial and with the parent, indicating that they were both an 'investigator' and a 'clinician'. They presented the trial both as an empirical study with a scientific imperative and also as offering personalisation of treatment for the child. Parents appeared to understand that trial involvement was voluntary, that it was different from routine care and that they could withdraw from the trial at any time. Some were confused about the significance of the MRD test and the personalisation of treatment.

Conclusions

Doctors communicated in ways that generally promoted optimal recruitment, indicating that trials can be embedded into clinical practice. However, parents were unclear about some details of the trial's rationale, suggesting that recruitment to trials with complicated designs, such as those involving stratified treatments, might need enhanced explanation.