Volume 16 Supplement 2

3rd International Clinical Trials Methodology Conference

Open Access

The treatment preferences of adolescents and their parents, what has the smile RCT shown us? Smile: specialist medical intervention and lightning evaluation

  • Lucy Beasant1,
  • Nicola Mills1 and
  • Esther Crawley1
Trials201516(Suppl 2):P71

https://doi.org/10.1186/1745-6215-16-S2-P71

Published: 16 November 2015

Background

Recruitment and retention in adult RCTs is affected by patient treatment preference. Identifying preference, providing evidence-based information, and emphasising the equivalence of treatments has facilitated recruitment to adult RCTs. There is no evidence on how to identify preference in paediatric RCTs.

Methods

Recruitment consultations were recorded and content analysis was used to analyse the strength of preferences prior to randomisation. In-depth interviews were undertaken with participants (13 mothers and 12 adolescents) in a paediatric RCT (the SMILE RCT). Interview transcripts were analysed thematically.

Results

Content analysis revealed that most parents and adolescents did not express strong treatment preferences in recruitment consultations prior to randomisation. However, interviews suggested preferences were held but not expressed. We identified the following themes:

1. CONFLICTING PARENT-CHILD PREFERENCE: Most mothers had a stronger and more polarised preference. Adolescents expressed a preference more often if interviewed alone.

2. REASONS FOR PREFERENCE: Mothers wanted: extra treatment and “keeping options open”. Some discussed: “nothing to lose”; financial hardship and education. Adolescents preference was based on; feeling tired; anxiety; meeting new people; treatment was already helping.

3. UNDERSTANDING RANDOMISATION. Most demonstrated a good understanding of randomisation although many used terms such as ‘lucky’ and ‘chosen’.

4. ALLOCATION DISAPPOINTMENT. Parental disappointment led to changes in communication during recruitment consultations.

Conclusions

Adolescents and parent preferences differ, and adolescents are less likely to express preference if their parent is present. Post randomisation interviews suggest that the majority of mothers were not in equipoise, but their child was still randomised to the RCT.

Authors’ Affiliations

(1)
University of Bristol

Copyright

© Beasant et al. 2015

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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