Improving informed consent to clinical trials: A Decision Aid for women invited to participate in a breast cancer prevention trial (IBIS-II)

Current informed consent to clinical trial is often inadequate. Clinicians often report difficulty in explaining trials, and audio-tape audits have shown that in many consent interviews critical information is omitted or poorly presented. It is important to develop ways of improving this process and ensuring that patients understand and feel empowered to reach decisions concordant with their values and needs. The decision targeted in this IBIS-II Decision Aid (DA), whether or not to participate in the IBIS-II trial, is a particularly hard one, involving uncertain benefits and possibly large costs in a group of women who are completely well at the time of recruitment. The use for the DA will be much wider than patients with elevated risk of breast cancer, and may be applied to those with many diseases in which the natural history and evidence about treatment effectiveness is still emerging and who are considering entering a clinical trial. If effective, the DA study has the potential to transform the process of gaining informed consent in large, multi-centre trials. The IBIS-II DA was piloted in 2005 and a randomised controlled trial of the DA will start in 2006.

Investigators: Phyllis Butow, Ilona Juraskova, John Forbes, Alan Coates, Fran Boyle & Nicole McCarthy.

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