Improving informed consent: pilot of a decision aid for women invited to participate in a breast cancer prevention trial (IBIS-II DCIS)

Health Expect. 2008 Sep;11(3):252-62. doi: 10.1111/j.1369-7625.2008.00498.x.


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.

Aims: This study piloted a DA booklet for a high priority breast cancer prevention trial, IBIS-II DCIS, which compares the efficacy of an aromatase inhibitor (anastrozole) with tamoxifen in women who have had surgery for ductal carcinoma in situ (DCIS).

Method: Thirty-one Australian women participating in the IBIS-I breast cancer prevention trial and who are currently in follow-up agreed to read the IBIS-II DCIS participant information sheet and the DCIS DA booklet, complete a set of standardized questionnaires, and provide feedback on the DA via a semi-structured phone interview.

Results: Women found the DA helpful in deciding about trial participation, reporting that it aided their understanding over and above the approved IBIS-II DCIS participant information sheet and was not anxiety provoking. Women's understanding of the rationale and methods of clinical trials and the IBIS-II DCIS trial was very good; with more than 80% of items answered correctly. The only areas that were not understood well were the concepts of randomization and blinding.

Conclusions: This study suggests that the DA will be acceptable to and valued by potential participants in the IBIS-II DCIS study. The revised DA is currently being evaluated prospectively in a randomized controlled trial. If successful, such DAs could transform the consent process to large clinical trials and may also reduce dropout rates.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anastrozole
  • Antineoplastic Combined Chemotherapy Protocols*
  • Aromatase Inhibitors / administration & dosage
  • Australia
  • Breast Neoplasms / prevention & control*
  • Breast Neoplasms / secondary
  • Carcinoma, Intraductal, Noninfiltrating / pathology
  • Carcinoma, Intraductal, Noninfiltrating / surgery
  • Decision Support Techniques*
  • Feedback
  • Female
  • Health Knowledge, Attitudes, Practice*
  • Humans
  • Informed Consent*
  • Middle Aged
  • Nitriles / administration & dosage
  • Patient Education as Topic / methods*
  • Patient Selection*
  • Pilot Projects
  • Risk Assessment
  • Selective Estrogen Receptor Modulators / administration & dosage
  • Tamoxifen / administration & dosage
  • Teaching Materials*
  • Triazoles / administration & dosage


  • Aromatase Inhibitors
  • Nitriles
  • Selective Estrogen Receptor Modulators
  • Triazoles
  • Tamoxifen
  • Anastrozole