POSTER PRESENTATION Open Access

The development of a DVD to aid patients’understanding of surgical breast reconstructionclinical trials: QUEST Trials A & BJudith Mills1, Maria Emson1, Judith M Bliss1, Zoe E Winters2*

From Clinical Trials Methodology Conference 2011Bristol, UK. 4-5 October 2011

IntroductionThere is a pressing need for further clinical evidenceto better inform both patients and clinicians whenrecommending the optimal type and timing of breastreconstruction. The QUEST trials are unique; the firstsurgical trials comparing different types (A) and timing(B) of Latissimus dorsi (LD) reconstruction with a pri-mary outcome of quality of life (QoL). Surgical trialsare challenging, therefore necessitating a feasibilitystudy to assess the acceptability of randomisation fromboth the perspectives of the patients and healthcareprofessionals. It was decided to develop a DVD tocompliment the patient information sheet, in order tohelp patients understand the concepts of the clinicaltrials, surgical techniques, randomisation and clinicalequipoise.

MethodsAll the women filmed in the DVD had a prior breastreconstruction and were invited to participate in a Q&Asession with the Chief Investigator (CI) of the QUESTtrials. The CI and 2 breast care nurses were also inter-viewed about the surgical techniques, complications andside-effects and the time taken to return to normaleveryday activities after a breast reconstruction. Allwomen will be given a short questionnaire to complete,assessing their level of understanding of randomisationand clinical equivalence irrespective of their entry intothe QUEST trial.

ResultsFilming took place over 1 day in Bristol and editing overa further 2 months. Drawings were produced to picto-rially explain clinical equivalence, randomisation and thedifferent types of LD reconstruction. The DVDs and thepatient information sheets will be given to all womenwho are eligible and interested in the QUEST trials. Wewill be evaluating the impact of this DVD on patientrecruitment by both quantitative (questionnaires) andqualitative (interviews) methodology.

ConclusionsIt proved feasible to develop a patient targeted DVDbased on the experience of patients and healthcare pro-fessionals to enable potential QUEST participants tomake fully informed decisions.

Author details1Clinical Trials & Statistic Unit (CTSU-ICR), The Institute of Cancer Research,Sutton, Surrey, UK. 2University of Bristol, Department of Clinical ScienceSouth Bristol, Bristol, UK.

Published: 13 December 2011

doi:10.1186/1745-6215-12-S1-A85Cite this article as: Mills et al.: The development of a DVD to aidpatients’ understanding of surgical breast reconstruction clinical trials:QUEST Trials A & B. Trials 2011 12(Suppl 1):A85.

2University of Bristol, Department of Clinical Science South Bristol, Bristol, UKFull list of author information is available at the end of the article

Mills et al. Trials 2011, 12(Suppl 1):A85http://www.trialsjournal.com/content/12/S1/A85 TRIALS

© 2011 Mills et al; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative CommonsAttribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction inany medium, provided the original work is properly cited.