Background:Decision aids may improve informed consent in clinical trial recruitment, but have not been evaluated in this context. This study investigated whether decision aids (DAs) can reduce decisional difficulties among women considering participation in the International Breast Cancer Intervention Study-II (IBIS-II) trial.Methods:The IBIS-II trial investigated breast cancer prevention with anastrazole in two cohorts: women with increased risk (Prevention), and women treated for ductal carcinoma in situ (DCIS). Australia, New Zealand and United Kingdom participants were randomised to receive a DA (DA group) or standard trial consent materials (control group). Questionnaires were completed after deciding about participation in IBIS-II (post decision) and 3 months later (follow-up).Results:Data from 112 Prevention and 34 DCIS participants were analysed post decision (73 DA; 73 control); 95 Prevention and 24 DCIS participants were analysed at follow-up (58 DA; 61 control). There was no effect on the primary outcome of decisional conflict. The DCIS–DA group had higher knowledge post decision, and the Prevention-DA group had lower decisional regret at follow-up.Conclusions:This was the first study to evaluate a DA in the clinical trial setting. The results suggest DAs can potentially increase knowledge and reduce decisional regret about clinical trial participation.
Background Patients and clinicians report difficulties with the process of informed consent to clinical trials and audiotape audits show that critical information is often omitted or poorly presented. Decision aids (DAs) may assist in improving consent.
Background Informed consent is required for both standard cancer treatments and experimental cancer treatments in a clinical trial. Effective and sensitive physician-patient communication about informed consent is difficult to achieve. Our aim was to train doctors in clear, collaborative and ethical communication about informed consent and evaluate the impact of training on doctor behaviour, stress and satisfaction.
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